HK1089344A - Tissue retractor and method for using the retractor - Google Patents

Description

Tissue retractor and method of use

Technical Field

The present invention relates to a tissue retractor, and more particularly to a retractable tissue retractor that can be used as an endoscopic device and that can be passed through the working lumen of a flexible endoscope. Tissue retractors find application in endoscopic and open-cavity procedures, including telescopic endoscopy, laparoscopy, and general surgery. The length and diameter of such tissue retractors may be fixed or may vary to suit the particular requirements of the surgical procedure. Retractable endoscopic tissue retractors may be used to secure gastrointestinal tissue, retracting it and operating it in some manner. The tissue retractor is capable of grasping a particular structural layer on the wall of the intestine and stomach by adjusting the shape and/or length of the needle and its extended position at the tip of the device. For example, by adjusting the tissue retractor, it can be passed through the mucosal layer and into the muscle layer for grasping, thereby forming a more secure connection with the tissue and allowing manipulation through the entire tissue thickness. On the other hand, by adjustment, such instruments are able to grasp the mucosal layer, so that it is possible to operate only on the mucosal layer.

Background

In the prior art, there are many conventional instruments used to manipulate organ tissue during the course of endoscopic procedures for gastroesophageal reflux disease (GERD).

For example, the instrument of U.S. patent No. 6,494,888B1 to Laufer et al (hereinafter collectively referred to as "Laufer"), is an instrument used to readjust the structure of the stomach tissue. A tissue manipulator 700 includes an elongated cable assembly 716 and a distal end effector 718 manipulated by the cable assembly 716 to perform the various steps of the tissue reconstruction process. See Laufer in fig. 9A to 9F. End effector 718 has 2 jaw elements 720 and 722 for engaging tissue, particularly the gastroesophageal junction (GEJ). During implantation of the two-element anchors 732 and 734 (see Laufer, fig. 8), a screw 740 is threaded into and tightened sufficiently against the gastroesophageal junction tissue, and the gastroesophageal junction tissue is then pulled by the screw within the opening formed by the jaw elements 720 and 722 in the open position as shown in fig. 9D and 9E. Such helical tissue retractors 740, 741 and 742 are detailed in fig. 3D. However, these retractors all have certain drawbacks. For example, the screw 740 may penetrate too deeply, which may lead to negative results if the stomach is broken entirely (i.e., through the mucosal, muscle and serosal layers). Because the aorta, liver, diaphragm and some other vital organs are closely distributed at the bottom of the stomach. If the spiral 740 penetrates the serosal layer, these vital organs are likely to be damaged. Also, the helical shape of screw 740 itself may make it less likely to be pulled out of the organ when it is withdrawn, and therefore the physician must pull the entire assembly 718 out with force, which can easily damage the tissue. Depending on the angle of entry of the instrument, the auger 740 may only enter the mucosal layer. If this happens, it is highly likely that the anchors 732, 734 will only be implanted in the mucosa, thereby failing the entire implantation procedure, since the mucosa is a relatively thin and loosely adherent layer. Also, since the anchor is threaded into the tissue, rotation of the screw as it is threaded into the tissue may distort the tissue, thereby causing undesirable stress on the tissue, which may damage the tissue and cause its function to deteriorate. At the same time, the screw must be rotated in order to enter the screw into the tissue. In practice, it is much more difficult to transmit torque through an elongated flexible device than it is to transmit axial loads. Thus, the method of pushing the needle into the tissue is more reliable than the method of screwing the screw into the tissue. At the same time, all of the force applied to the tissue at the instrument's engagement point must be provided through the instrument's shaft, since the force applied to the tissue at its other engagement point is not accompanied by a reaction force at its other engagement point.

Currently, the most widely used for gastrointestinal tissue surgery is the universal telescopic tissue grasper for endoscopic surgery (e.g., an instrument known as olympus grasper (catalog number FG49L-1) manufactured by olympus). One major drawback of this olympus grasper is that it does not pass through the mucosal layer to securely grasp the muscle layer. Another disadvantage is that it requires pressure to be maintained on the handle while grasping the tissue, which can take up the user's hand and also can result in inadvertent release of the tissue.

None of these prior art devices provide for simple, safe, accurate, and selective grasping of tissue during surgery.

Disclosure of Invention

It is known that the tissue of the digestive tract is mainly composed of 3 layers, i.e., a mucosal layer, a muscle layer and a serosal layer, from the inside to the outside. The mucosal layer is a relatively thin layer of tissue that is loosely attached to the muscle layer. When the fixator is inserted during the treatment of gastroesophageal reflux disease (GERD), merely retracting the mucosal layer does not provide sufficient plication. It is desirable to be able to retract the entire thickness of the stomach wall because such retraction can provide a beneficial plication that can be inserted into a plication holder for the treatment of gastroesophageal reflux disease (GERD). It is generally undesirable to perforate the serosal layer. One of the most significant reasons is that an unsealed perforation in the serosal layer, if large enough, can allow the contents of the stomach to enter the peritoneal cavity or the chest cavity, resulting in a potentially fatal infection.

It is therefore a primary object of the present invention to provide a tissue retractor and method of use that overcomes the above-mentioned disadvantages of instruments and of the conventional instrument type, and that provides effective grasping of the tissue of the alimentary tract during surgery, avoiding trauma to the serosa, and providing better grasping of the tissue without compressing and/or tearing the tissue.

The treatment of specific structural layers of the stomach wall is required for various endoscopic procedures. For example, in a mucosal resection, the mucosal layer is peeled off from the muscle layer and removed. The current procedure for this procedure is to inject a liquid under the mucosal layer, so that the mucosal layer bulges up from the muscle layer, and the mucosal tissue is excised using electrocautery. The tissue retractor of the present invention can be used to selectively grasp the mucosal layer and lift it from the muscle layer, thus making the mucosectomy very simple. When a thick fold is formed in the stomach, the muscle layer of the stomach wall must be grasped more forcefully to ensure that the stomach wall will contract to a sufficient thickness when the fold is formed. By adjusting the needle and the manner in which the needle extends from the retractor tip, the retractor can be made to selectively grasp different tissue layers of the stomach wall. The ability to grasp particular structural layers on the gastrointestinal wall is an advantage of such retractors, depending on the particular procedure being performed.

The tissue retractors of the present invention may also be used in laparoscopic and general surgical procedures. It can be used to retract organs that are in the field of surgery or to pull tissues together and hold them in place while suturing. One advantage of an organ retractor or tissue apposition device made according to the present invention is that it is capable of both holding tissue and not having to clamp onto tissue. Such tissue retractors can hold tissue atraumatically by passing a fine needle through the tissue. To further reduce tissue damage, the tips of these needles are conical rather than multi-faceted. This is particularly important when retracting sensitive organs, such as the pancreas. The tissue graspers currently in use are more of an aggressive, dentate, jointed end effector that requires the application of a clamping force in order to hold the tissue, thereby creating potential trauma during the procedure.

One common procedure for a common telescopic endoscopy procedure is to swap endoscopes. If the examination site of the first scope is at a location within the alimentary tract that is not readily accessible, it is preferred that the second scope (interchangeable scope) be at the same location, and that a tissue retractor be used to guide the second scope into the location of the first scope. The telescopic endoscope of the retractor according to the invention can provide a movable handle. Thus, when the scope needs to be exchanged, the tissue retractor can be passed over the first scope and placed at a desired location within the tissue. The handle of the tissue retractor can then be removed. Thereafter, when the first scope is slid over the tissue retractor shaft and removed, the shaft of the tissue retractor remains in place. The second scope can then be advanced over the shaft of the tissue retractor into the original position of the first scope, with the shaft tube acting as a guide wire. The shaft of the tissue retractor can then be removed and taken off as needed.

Also, the retractor can be configured such that the distal end of the retractor is disposed in tissue and spaced apart from the main shaft. In such embodiments, the distal end of the instrument is removably attached to the spindle and the steering wire is removably attached to the needle. The needle is disposed within the target tissue and the shaft of the instrument is pulled proximally, thereby allowing the steering wires to slide independently of the needle and the distal end of the instrument to slide independently of the shaft. The released tip adheres firmly to the tissue and can be used as a marker, as a suture attachment point for sutures such as purse string sutures, tissue apposition sutures, and as a fixation point for devices such as pH coupons, microcapsular cameras, and feeding tubes.

In the instrument and method of use of the present invention, the needle is allowed to be deployed deep through the mucosal layer and into the muscle layer, allowing it to more securely attach to tissue, thereby significantly reducing the likelihood of perforating the serosa and also reducing the likelihood of merely grabbing the mucosal layer because the insertion is too shallow. The present invention is capable of engaging tissue at two opposing points, whereby the tissue engaging force of each point opposes the force of the other point, resulting in a small force being transmitted to the telescopic shaft of the instrument. The use of such a device does not require the shaft to provide significant torque and axial load. The present invention can provide better visibility during placement of the retractor because it does not require clamps which obscure the image of the retracted position. Because of the thin diameter of the needle and the absence of a blade tip, this instrument is also less traumatic to tissue than conventional graspers. After the needle is placed, the user can release the control handle and also grip the tissue well, which allows the user to release the handle for other surgical tasks after or while the tissue is being treated. This tissue retractor is separate from the endoscope, but is sized to fit within the working lumen of the endoscope.

Other features of the invention are set forth with particularity in the appended claims.

Although such a retractable tissue retractor and method of use thereof have been illustrated and described in detail herein, the present invention is not limited to just that which has been described, as many variations and structural modifications may be made without departing from the spirit and scope of the invention and within the scope of the appended claims.

The construction and method of use of the invention, together with additional objects and advantages thereof, will be best understood from the following description of specific devices when read in connection with the accompanying drawings.

Drawings

FIG. 1 is a partial perspective view of the distal end of a retractable tissue retractor made in accordance with the present invention, with the needles shown in an extended position;

FIG. 2 is a partial perspective side view of the distal end of the retractor depicted in FIG. 1 with a left portion of the outer sheath cut away to reveal the internal construction of the retractor;

FIG. 3 is a partial perspective side view of the distal portion of the retractor depicted in FIG. 1 with a right portion of the outer sheath cut away to reveal the internal construction of the retractor;

FIG. 4 is a partial perspective side view of the distal portion of the retractor depicted in FIG. 3 with the needle in a slightly retracted position and with a greater portion of the right side of the outer sheath cut away;

FIG. 5 is a partial perspective side view of the distal portion of the retractor depicted in FIG. 4 with the needle in a substantially retracted position;

FIG. 6 is a partial side elevational view of the needle and drive wire of FIGS. 2-5;

FIG. 7 is a partially exploded view of most of the components of the retractor shown in FIG. 1;

fig. 8 is a partial perspective and exploded view of the distal portion of the retractor shown in fig. 1-5 and 7;

FIG. 9 is a partial perspective view of the distal end of the retractable tissue retractor of the present invention with the needle in the extended position;

FIG. 10 is a perspective view of the handle of the proximal end of the retractor of the invention in its retracted position;

FIG. 11 is a partial cross-sectional view of certain components of the handle shown in FIG. 10 in a retracted position;

FIG. 12 is an exploded view of certain components of the handle shown in FIG. 10;

FIG. 13 is a partial cross-sectional view of certain components of the handle of FIG. 6 in a retracted position;

FIG. 14 is a partial cross-sectional view of an enlarged portion of the distal handle assembly of FIG. 13;

FIG. 15 is a cross-sectional view (along section line 15-15) of a button assembly of the handle of FIG. 10;

figures 16 to 23 are partial cross-sectional partial views and partial plan views of a method of using the retractor of the invention in retracting tissue at different retraction angles;

FIG. 24 is a partial cross-sectional partial view and a partial plan view of the method of using the retractor of the invention with the needle extending out of the window closer to the tip than in FIGS. 16 to 23;

FIG. 25 is a partial side view of the plication device with an endoscope attached, as the instrument is inserted into the stomach;

FIG. 26 is a partial side view of the plication device and endoscope when they are not attached and the jaw device is in an open position;

FIG. 27 is a fragmentary perspective view very similar to FIG. 26, with the addition of a view of the retractor of the present invention being endoscopically accessed and engaging target tissue where a fold is to be formed;

FIG. 28 is a partial perspective view of the jaws of the plication device creating a plication on the target tissue with the plication holder in a locked state;

FIG. 29 is a partial perspective view of the jaws of the plication device being opened around the target tissue and the fastener causing the target tissue to form a plication;

figure 30 is a partial side perspective view of the crimping device with the jaws in an open position and the retainer disposed therein;

fig. 31 to 41 are partial cross-sectional and partial elevational views in section of a surgical procedure with a retractor of the invention, the retractor having been advanced through a working lumen of an endoscope into the stomach and operated under endoscopic visualization.

Detailed Description

The invention will be better understood from a reading of the following description, with reference to the figures, which are previously given reference numerals.

Before the present invention is disclosed and described, it is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and that the invention is not intended to be limited to the specific terminology used herein. It must be noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the" encompass plural forms thereof unless the context clearly dictates otherwise.

Turning now to the drawing reference numbers in detail, and particularly to fig. 1, there is shown in fig. 1 a perspective view of the distal portion of an embodiment of the retractable tissue retractor 1 of the present invention, with the needle 4 in the use or extended position.

The distal tip 5 is mounted at the distal end of the outer sheath 8. The distal tip 5 is preferably secured to the distal end of the outer sheath 8. For example, the distal tip 5 may have a mushroom-shaped head 52 with a cylindrical body smaller than its head 52 in the radial direction. The cylindrical body may be smoothly inserted into the hollow distal end of the outer sheath 8 and secured thereto using some fixation method. For example, the body may be welded, heat shrunk, welded or glued to the outer sheath 8, or the body may have external threads screwed into internal threads distributed on the inner surface of the distal end of the outer sheath 8. The distal end 5 may be formed, for example, as a single piece, or may be formed from two halves (not shown) secured together. If the distal end 5 is formed of two half constructions, the two halves must be self-locking. Thus, two holes and two pins can be made in each of the two halves of the head, for example, the pins and holes of the two halves respectively correspond to each other in order to fix the two halves together. The two end halves do not have to form mirror symmetry. The holes and pins on the halving device may be identical in shape. Of course, any similar securing means or combination may be used, such as screws, rivets, pins and slots and/or posts and sockets to lock the two halves to each other.

The tip may be formed from a thin walled, round-headed deep drawn member to maximize the inner diameter of the tip, thereby allowing curved needles of greater chordal height (shorter, smaller radius) to be installed. In deep distraction procedures, the extraction window of the needle 4 can be made through the wall of the tip, or the needle 4 can be machined by using a procedure comprising at least one of the following methods: wire cutting (wire EDM), laser, conventional milling, etc.

The distal tip 5 and the outer sheath 8 together form an exit window 6 on either side of the distal tip through which the needle 4 passes. In another case, the distal tip 5 is independently formed with exit windows 6 on both sides thereof through which the needles 4 pass, respectively. The needle 4 is preferably made of steel so that a substantially rigid pre-formed arc can be formed. The needle 4 may also be made of a ceramic, such as alumina or zirconia, or a polymer, such as ULTEM * or a liquid crystal polymer.

Fig. 2-5 are side views of the outer jacket with various portions cut away, showing the internal components of the outer jacket 8.

In fig. 2 and 3, the needle 4 is fully extended. The cross-sectional view of fig. 2 shows the best connection of the first side of the needle 4 projecting to the right with a cylindrical drive rod 3 (as shown in fig. 2). The sectional view of fig. 3 shows the best connection of the first side of the needle 4 projecting to the left with a cylindrical drive rod 3 (as shown in fig. 3).

In fig. 4, the needle 4 is partially retracted into the distal tip 5/outer sheath 8. The cross-sectional view of fig. 4 shows the best connection between the needle 4 and the drive rod 3, showing the connection of a first side of the needle 4 projecting to the right with a second side of the needle 4 projecting to the left (as shown in fig. 4).

In fig. 5, the needle 4 is fully retracted into the distal tip 5/outer sheath 8. As shown in fig. 2 to 5 and 6 (in which the distal head 5 and the outer sheath 8 are not clearly shown), the needle 4 is movably connected to the drive rod 3, preferably pivotally connected thereto. The needle 4 may be crimped, bent or otherwise fixed to the drive rod 3, or the needle 4 may form an integral part of the drive rod 3, as long as the needle 4 is movable relative to the rod. The preferred embodiment of the retractor 1 has two needles 4. However, the number of needles 4 may be reduced or increased according to specific needs.

Fig. 1 to 5 show different views of the needle 4 between a retracted and an extended position. This movement in its entirety is referred to as selective movement because the user can selectively place the needle anywhere between fully retracted and fully extended.

Since the needle 4 is preferably of a rigid construction, the needle 4 will maintain its arcuate shape and will not deform during repeated retraction and extension throughout the life of the retractor 1. Thus, when the phrases "insubstantial deformation" or "substantially non-deformable" or "substantially rigid" are used herein to describe the needle 4, it is intended that the needle 4 be flexed within the elastic range of the material from which it is made, and in some cases, beyond which it may be. These definitions do not include pseudoelastic materials. When the needle 4 is made of steel, it can bend within the typical elastic range of stainless steel, such as cold drawn steel 304 and 17-7C H900 steel, and the pressure on the needle should not exceed the yield point of each material during normal use. The exit window 6 is shaped and positioned very closely together so that the needle 4 can be freely extended or retracted to the distal tip 5/outer sheath 8 without substantial deformation. The needle 4 is curved so as to ensure its protrusion from the respective protrusion window 6. It should be noted that the needle 4 may also be made of a material having a plastic deformation instead of an elastic deformation. In this case, the needle 4 may be broken due to low cycle fatigue, and thus cannot be reused many times. If fully annealed Monel wire (Monel wire) is used, the needle may be broken after repeated use, despite plastic deformation of the needle.

Thus, in the preferred embodiment, when needle 4 is fully retracted into outer sheath 8 (as shown in FIG. 5), needle 4 is first bent away from shaft 3 such that the surface of needle 4 makes light contact with the inner surface of distal tip 5/outer sheath 8 at point 54, point 54 being located on longitudinal line 1 (parallel to axis 13) of distal tip 5/outer sheath 8, and needle 4 is radially furthest from axis 13 of distal tip 5. Farther from point 54, needle 4 bends toward shaft 13, preferably passing through shaft 13 in a direction opposite (180 degrees) from longitudinal line 1. Needle 4 may be bent back to point 42 of needle 4 to contact the inner surface of distal tip 5/outer sheath 8 at approximately a point on the 2 nd longitudinal line (parallel to axis 13), which is opposite (180 degrees) from the 1 st longitudinal line. Alternatively, the point 42 on the needle may be configured as a kink-proof point, whereby the needle may be extended to a position in contact with the inner surface of the distal tip 5/outer sheath 8.

The needle 4 preferably has a tapered needle end 44. Thus, as shown in the uppermost portion of fig. 5, this taper may form a cam follower 46 for a cam surface 56 located inside/below head 52 of distal tip 5.

The retractor 1 is arranged to selectively grasp the appropriate number of layers of the stomach depending on the curvature of the needle 4 and the size and/or orientation of the window 6. Particularly with respect to stomach tissue, the retractor 1 can be used to selectively grasp the mucosal layer 202 (see fig. 16-23), lift it from the muscle layer 204, and then perform a mucosal resection, which simplifies the procedure. If a fold is formed along the entire thickness of the stomach, the muscle layer of the stomach wall must be grasped with greater force to ensure that the entire thickness of the stomach wall is retracted when the fold is formed (see FIGS. 28, 29, and 39-41). By adjusting the needle 4 and the way the needle 4 extends from the tip 5 of the retractor 1, the retractor 1 can be made to selectively grip different layers in the stomach wall. Depending on the particular requirements of the operation being performed, it may be an advantage of the instrument to grasp only a particular layer of the gastrointestinal wall.

The exploded view of figure 7 shows a larger portion of the retractor 1 in which the outer sheath 8 is wrapped around the coil winding 7. As shown, there is also an outer sheath 9 (preferably made of polyethylene or TEFLON *), a screw connector 10 and strain relief 11, each of which is further described below.

Fig. 8 shows the connection between the drive wire 2 and the shaft 3, which is a partial cross-sectional view of the distal end of the retractor 1. The rod 3 is preferably formed integrally with the drive wire 2. However, the rod body 3 can also be connected to the drive line 2 by welding, gluing or gluing. Alternatively, the shaft 3 may have a hollow bend at the proximal end, not shown, into which the distal end of the drive wire 2 may be slid and then the drive wire 2 and shaft 3 fixedly attached by mechanical stress compression. Alternatively, the proximal bend may be formed as a thermal contact sleeve, which may be secured to the drive wire 2 by heat welding, molding or otherwise shaping the sleeve.

In another alternative embodiment, it is preferred to selectively remove the stick 3 from the drive wire 2. In such an embodiment, the distal tip 5 of the retractor 1 can be detached from the main shaft (including the drive wire 2, coil windings 7, outer sheath 8 and outer sheath 9) after it has been deployed into tissue. To form this selective detachment, the distal tip 5 is loosely connected to at least one of the coil windings 7 and the outer sheath 8, and the drive wire is removably connected to the shaft 3. For example, the drive wire 2 may have an externally threaded end that threads into an internally threaded bore in the shaft 3, and after the needle 4 is deployed into the tissue, the drive wire 2 is loosened, thereby releasing the shaft 3 and the needle 4 and tip 5 from the retractor. Alternative release means may be used, such as a non-permanent press on the shaft 3 to the drive wire 2, which can be released with a proximally directed force. When the loose tips (3, 4 and 5) are tightly secured to the tissue, they can act as suture attachment points for markers, purse string closure threads, and tissue apposition sutures, such as fixation points for various devices such as pH probes, microcapsular cameras, and feeding tubes.

The partial section of fig. 8 shows the drive wire 2, the shaft 3 and the needle 4 placed in a coil winding 7, the coil winding 7 being mounted axially in the outer sheath 8. A proximal stop 12 is located at a proximal position of the distal portion for limiting the retraction range of the needle 4.

The coil windings 7 are preferably formed of wound oval or circular wire, forming a taut spring shape, capable of developing longitudinal strength upon slight longitudinal expansion, and are radially flexible or pliable. Since the coil is wound in this manner, an internal thread 71 is naturally formed in the coil winding 7.

The shield 12 is hollow to enable the drive wire 2 to pass smoothly therethrough (in the preferred embodiment, the sheath 9 must not pass through the shield 12). Therefore, the inner diameter of the baffle 12 must be slightly larger than the outer diameter of the drive wire 2. Therefore, an external thread 121 is provided on the outer surface of the baffle plate 12. A recess 122 is required at the end of the shield 12 and is shaped to accommodate the operation of a flat-head screwdriver.

To install the assembly of fig. 6 into the outer sheath 8 and the distal end of the coil winding 7, the baffle 12 is inserted into the coil winding 7 at a specific position (by rotating a screwdriver placed in the groove 122, the baffle 12 is screwed in). The proximal end of the drive wire 2 is threaded through the distal end of the coil winding 7 and the hollow interior of the shield 12. Thus, as the drive wire 2 moves proximally, the proximal face 31 of the shaft 3 will contact the distal face 123 of the stop 12, preventing the drive wire 2 from continuing to move proximally and blocking retraction of the needle 4.

The drive wire 2 is used to deploy and retract the needle 4. As shown in fig. 1-5, needle 4 extends from distal tip 5 through opening 6 in distal tip 5. Fig. 4 and 6 are intended to illustrate the movement of needle 4 through distal tip 5. When the retractor 1 is in the desired retracted position, the user moves the drive wire 2 distally (as described in more detail below). As the needle 4 starts to move distally (in particular in a linear direction with respect to the longitudinal movement of the drive wire 2), the tapered portion of each needle tail 44 of the needle 4 contacts the inner/lower part of the distal tip 5. Because the tapered section is at an acute angle to the inside/lower portion of distal tip 5 (and because needle tip 42 is not in contact with the inside/lower portion of distal tip 5), the inside/lower portion of distal tip 5 acts as a cam surface 56 for the tapered section, which forms a cam follower 46 due to its shape. In this configuration, it is ensured that the needles 4 each time they move distally protrude from their respective windows. As the drive wire 2 moves proximally, the needle 4 retracts into the distal tip 5, the edge openings of the window 6 all act as cam surfaces, and the respective edges of the needle 4 support the cam surfaces and act as cam followers. As described above, cam surface 56 can be varied to extend needle 4 deeper, shallower, farther, nearer and/or slightly closer depending on the procedure in which retractor 1 is being used.

As shown in fig. 9, a hollow body or bowl 54 may be formed on distal face 53 of distal tip 5 to facilitate the drawing of tissue therein when distal tip 5 is pressed against the tissue. A retention pin 62 may also be formed on the distal surface 53 of the distal tip 5, preferably centrally located within the hollow body 54. The retention pins function to hold the tip 5 in place, preventing it from being wiped from the tissue surface (e.g., human tissue, especially stomach wall) when the tip 5 of the tissue retractor is initially pushed against the tissue. It will be noted that the hollow body 54 allows the tissue surface to be pressed therein and around the retention pins 62 in order to fix the retractor 1 in the gripping position of the tissue surface, preventing radial displacement thereof with respect to the pins 62.

In the preferred embodiment, the retractable tissue retractor 1 is an endoscopic device that operates through the working lumen of a retractable endoscope 4000. The method of using such an endoscopic retractor 1 will be described in detail below. During such a procedure, the tissue retractor 1 is used to hold the esophagus or any other alimentary tract tissue 4100, 9100 so that it can be moved or manipulated in some manner. When the tissue retractor 1 is passed through one of the working lumens 4080 of the endoscope 4000 (see fig. 26), the needle 4 is in a fully retracted state in the tip 5. Once the tip 5 reaches the predetermined position, it is held tightly against the tissue 4100, 9100. The tip 5 preferably has a retention pin 62 to assist in locating the desired location on the tissue and to place the tip 5 in the desired location. Needle 4 is then activated so that it extends beyond tip 5 and is inserted into tissue 4100, 9100. When the needle is inserted into and rolled up the tissue 4100, 9100, the needle is firmly secured. See fig. 37 and 38. In this case, the tissues 4100 and 9100 can be manipulated as needed. To release the tissues 4100, 9100, the needle 4 is simply withdrawn into the tip 5. Because the needle 4 is preformed in a substantially rigid arc, the needle can retain its original shape during repeated retraction/extension.

In fig. 10, a handle 100 of the retractable tissue retractor is shown, which is used to control the extension and retraction of the needle 4. The handle 100 includes a protrusion assembly 200, a handle assembly 300, a push rod assembly 400, and a latch assembly 500.

As can be seen in FIG. 11, the prodger assembly 200 has a projection 220 that defines a distal opening 210 and two coaxial cylindrical cavities that communicate with each other, as well as a hollow cylindrical cavity 212 and a proximal cavity 214. The projection 220 has an annular external set screw slot 221 and it also has a hollow cylindrical cavity 222 (communicating with the proximal cavity 214) for receiving the overtravel spring 230 at that location (the exterior of the spring 230 is substantially cylindrical, corresponding to the cylindrical shape of the cavity 222). The lumen 222 has a distal face 226 formed proximally from the proximal face 224 of the projection 220. Adjacent proximal face 224, lumen 222 defines a recess 228. This groove preferably traverses the entire circumference of the cavity 222. The groove 228 is used to receive a retaining ring 240 that is used to secure the connector 10 within the cylindrical cavity 222, thereby holding the overtravel spring 230 in place within the cavity 222 of the projection 220.

The handle assembly 300 includes a handle body 310 having a handle body cavity 320 formed therein that extends along an axis 301 of the handle body 310. A retraction spring 330 is disposed within the handle body cavity 320. The handle 310 defines a push rod aperture 350 and a button aperture 360 adjacent the proximal end 340. The projection 220 is removably attached to the shank body 310 by two set screws 321 passing through the shank body 310 and extending into the shank body cavity 320 and screw slot 221 (see fig. 12). The proximal face 224 of the projection 220 supports a distal end of the retraction spring 330.

The push rod assembly 400 is comprised of a push rod 410, piston 420, cross pin 430, cross pin tube 432 (also referred to herein as an accessory tube), and button 440. The piston 420 defines a piston bore 422 (see fig. 12) that preferably has a shape that substantially corresponds to the shape of the cross pin 430. The piston 420 also has a longitudinal groove or slot 424 extending from the piston bore 422 to the distal-most end of the piston 420. The slot 424 is shaped to receive the cross pin tube 432. The cross pin 430 has an axial bore for receiving a cross pin tube 432. This axial bore extends along the shaft 301 of the shank body 310. The cross pin 430 also defines an internal thread 434 that extends at least half the radial length of the cross pin (defined by a line perpendicular to the axis 301 when the cross pin 430 is inserted into the piston bore 422). The threads 432 extend the entire length of the tube, thereby enabling the cross pin 430 to be inserted into the piston bore 422 from either direction. The cross pin set screw 436 is threaded into the attachment tube internal threads 432 and tightened against the attachment tube 432 and the drive wire 2 (with the attachment tube 432 and the drive wire 2 threaded into the axial bore of the cross pin 430) to securely fasten the two parts together with the cross pin 430.

A button 510 for locking the push rod 410 is mounted in a button aperture 360 located near the proximal end of the handle body 310. The button 510 has an aperture 516 that is arcuate, as shown in fig. 15. The button 510 is placed on a button spring 520, and this button spring is also placed in the button hole 360. The button 510 has a transverse hole 512 into which the locking pin 530 is inserted. In the installed position, the locking pin 530 and the inner surface of the aperture 516 form an interior space 514 within the button 510 that encloses the push rod 410, thereby retaining the button 510 within the handle body 310.

To install the nib assembly 200, handle assembly 300, push rod assembly 400, and locking assembly 500, the drive wire 2 is passed through the sheath 9, and the drive wire 2 extends approximately 7 to 10 centimeters (3 to 4 inches) from the proximal end of the sheath; the coil winding 7 passes through the outer sheath 9; the coil winding 7 passes through the outer protective layer 8; the overflow riser 11 penetrates through the outer protective layer 8; the protruding portion 220 passes through the strain relief 11; the inner diameter of distal bore 212 is larger than the outer diameter of the strain relief. Therefore, there is a gap between the protruding portion 220 and the strain relief 11. Overtravel spring 230 may now pass through strain relief 11 and may move freely into hollow interior 222 of nose 220. The drive wire 2, coil winding 7 and accessory tube 432 are preferably all made of stainless steel. In this way, the sheath can be used to avoid friction between the steel drive wire 2 and the steel coil winding 7.

Next, the screw connector 10 is fixed to an attachment assembly comprising the strain relief 11, the outer sheath 8, the coil winding 7, the outer sheath 9 and the drive wire 2. Preferably by crimping 101 at the distal end of the screw connector 10. Fig. 14 shows a cross-sectional view of the area around the screw connector 10. Such a crimp does not impart any radial force to the drive wire 2. The drive wire 2 is thus easily slid into the sheath 9 and relative to a fixed accessory assembly comprising the strain relief 11, the outer sheath 8, the coil winding 7 and the sheath 9.

The outer sheath 8 is preferably made of heat shrink tubing and is tightly shrunk onto the coil windings 7. This configuration provides a smooth outer surface for the retractor device while providing longitudinal stiffness to the shaft. Longitudinal rigidity is important because the needle 4 is arranged by pushing the drive wire 2 through the instrument shaft, so that the shaft is effectively under pressure. If the outer sheath 8 is not tightly shrunk onto the coil windings 7, the coil windings 7 will be stretched out and the retractor will not be activated. For this reason, the screw connector 10 must be tightly press-fitted to the outer sheath 8 above the coil winding 7 to prevent the coil winding 7 from protruding outward during starting.

Thus, when fully assembled, the distal and proximal bores 212, 214 will accommodate a portion of the strain relief 11, outer sheath 8, coil winding 7, outer sheath 9 and drive wire 2. Strain relief 11 is sized to extend distally about 10 to 15 centimeters (4 to 6 inches) beyond opening 210 to prevent undesirable bending of lumens 7, 8 near opening 210. In addition, when button 440 is pressed into position within handle 310 with needle 4 fully inserted therethrough, a proximal bore 214 is formed to receive the distal end of screw connector 10, the diameter of proximal bore 214 being wider than the diameter of distal bore 212. This extended position is referred to herein as "overtravel" and will be discussed in further detail below.

To install the luer connector 10 in the projection 220, the proximal surface of the luer connector 10 is advanced to compress the overtravel spring 230 so that the proximal surface extends into the bore interior 222 of the projection 220, which passes distally through the groove 228. When securing the screw connector 10 in this position, the snap ring 240 (shaped like the letter C with an eyelet at each end of the letter C for receiving the ends of the clamp, e.g., in the shape of a needle nose) is squeezed and then inserted into the recess 228. Because the retaining ring 240 has a radial expansion sufficient to insert inwardly past the innermost edge of the groove 228, it acts as a proximal stop to prevent the screw connector 10 from passing the retaining ring 240 as it moves proximally.

In the mounted position of the screw connector 10, the drive wire 2 protrudes proximally from the proximal end face 224 of the protruding part 220. The accessory tube 432 passes through this raised portion until the two proximal ends are aligned with each other. The two aligned ends then pass through the axial bore of cross pin 430 at least to internal thread 434, preferably completely into and through the other side of the internal thread. Because there is a distance between the proximal end of cross pin 430 and the distal end of installed push rod 410, the two aligned proximal ends will protrude slightly toward the proximal end of the axial bore. To fixedly attach the drive wire 2 and the accessory tube 432 to the cross pin 430, the cross pin set screw 436 is rotated inward until sufficient force is exerted on the accessory tube 432 to prevent the accessory tube 432 and the drive wire 2 from disengaging from the cross pin 430.

Before or after the cross pin 430 is fixed on the attachment tube 432, the drive wire 2 can be passed through the retraction spring 330, since the inner diameter of the retraction spring 330 is comparable to or slightly larger than the length of the diameter of the cross pin 430 (the length of the cross pin 430 along the diameter perpendicular to the drive wire 2 and the shaft 301). Subsequently, the retraction spring 330 is compressed sufficiently to allow the cross pin 430 to be inserted into the piston bore 422, thereby sliding the accessory tube 432 into the longitudinal slot 424 of the piston 420. In this position, the overtravel spring 230 and the retraction spring 330 are already preloaded. The pre-compression of the retraction spring is provided such that the pre-compression force is sufficient to retract the needle during use of the retractor. The precompression of the overtravel spring 230 is set so that the force to advance the needle 4 does not exceed the precompression force. That is, the needle 4 will move forward until the overtravel spring 230 begins to compress due to the overtravel. In this configuration, the retraction spring 330 is disposed between the proximal face 224 of the nose 220 and the distal face 429 of the piston 420, biasing the piston 420 toward the button 440.

The externally threaded distal end 412 of the push rod 410 is threaded into the internal threads 428 of the proximal end of the piston 420. Thus, the plunger 420 is engaged with the push rod 410 in a form-locking connection (form-locking). A form-locking connection is to be understood as meaning a connection of two elements together according to their own shape, as opposed to a tension-locking connection, which is to lock two elements together by an external force acting on them. Then, the axial movement of the drive wire 2 is linearly accompanied by the axial movement of the piston 420.

The stem body 310 passes from the distal end through the proximal end of the push rod 410, the piston 420 and the retention spring 330, and finally, just through the proximal end 223 of the projection 220, and is secured thereto by at least one set screw 321 (see fig. 12). However, before the proximal end of push rod 410 enters button aperture 360, button spring 520 is inserted into button aperture 360, and pre-installed button 510 (shown in FIG. 15 with pin 530 inserted into transverse aperture 512) presses against button spring 520, compressing the spring to an extent such that its contained space 514 (the distance between pin 530 and inner surface 516 of button 510) is approximately aligned with axis 301, and thus further aligned with the axis of push rod 410. In this position, the proximal end of the push rod 410 will pass through the contained space 514 without any friction and then extend from the proximal end of the handle body 310. Notably, to facilitate threading of the proximal end of the push rod 410 into the proximal end of the handle 310, the proximal end face 322 of the handle bore 320 must taper gradually in the direction of the push rod bore 350.

An annular pin slot 414 is formed at the proximal end of push rod 410 for receiving a button securing pin 442 that securely attaches button 440 to push rod 410. In an alternative embodiment, not shown, the proximal end of the push rod 410 is formed with an external thread that corresponds to an internal thread in the push button 440, such that the push button 440 may be screwed onto the push rod 410. Push rod 410 also defines an annular latch recess 416, and when push rod 410 is pushed from the proximal position shown in fig. 5, 10 and 13 to the distal position shown in fig. 1, 2, 3 and 11, recess 416 is adapted to receive pin 530. In the proximal position, needle 4 is retracted within tip 5, and in the distal position, needle 4 extends beyond tip 5. With pin 530 in recess 416, needle 4 is in a distal position and button 440 is only able to move slightly due to the clearance created by recess 416 along the longitudinal extension of plunger 410. The user can selectively operate the button 510 so that the pin 530 locks the pushrod 410, or by pressing the button 510, the pin 530 is moved aside so that the recess 416 is no longer engaged with the pin, thus allowing the pushrod 410 to move freely in the longitudinal direction. Thus, it can be said that the lock function of the button 510 can selectively hold the needle 4 at a specified position. Of course, a plurality of spaced apart recesses 416 may be formed to create different holding positions as shown in FIG. 11.

It is noted that the distal end of the accessory tube 432 is held in close proximity to the distal end of the luer connector 10 when the plunger 420 is in the proximal-most position, and that the distal end of the accessory tube 432 is held in a remote distance from the distal opening 210 of the projection 220 when the button 440 is pressed to the distal position (as shown in fig. 11) corresponding to the position in which the needle 4 is fully extended from the tip 5 (as shown in fig. 1) so that the pin 530 engages the pin recess 416. However, this distal position, as shown in FIG. 11, is not the most distal position of the button 440. This feature of the retractor is also intended since it is an instrument that is inserted into the patient for certain purposes, especially through an endoscope, and because of the nature of the patient and the nature of the endoscope, the retractor is made in a curved shape.

The geometry of the coaxially positioned drive wire 2, outer sheath 9, coil winding 7 and outer sheath 8 determines that the length of drive wire 2 required to traverse the curved lumens 7, 8 increases when the outer sheath 8 and/or coil winding 7 is in a curved state (e.g., as it traverses an endoscope). The drive wire 2 is therefore provided so as to be sufficiently long so that when the lumens 7, 8 are bent in use, no over-extension occurs. However, when the coil windings 7 and the outer sheath 8 straighten, operation of the pushrod 410 can cause over-extension because the drive wire 2 is longer than the lumens 7, 8 surrounding the drive wire 2. In this case, there is the risk of excessive protrusion of the needle, which can injure the tissue to be retracted and cause damage to the needle itself. To compensate for this over-extension, the projection device 200 is provided with an overtravel spring 230 which is mounted within the bore 222 of the projection 220. The overtravel spring 230 is supported at its distal end by the distal face 226 of the bore interior 222 while its proximal end is supported by the distal face 104 of one of the heads 102 of the screw connector 10 (see fig. 14). This arrangement enables the lumens 7, 8, 9 (and 11) and the drive wire 2 to be decoupled from one another very effectively. In order for the needle to be fully deployed in position with over-travel, the button 440 must be depressed more if the lumens 7, 8 are in flexion. Overtravel spring 230 therefore has a K factor that is adjusted to allow the needle to fully deploy so that it can be depressed to move further and compensate for overtravel. Because of the adjustment that can be made to the overtravel spring 230, the passage of the coil winding 7 through the coil connector 10 will compress the overtravel spring 230 and move the entire subassembly of the lumens 7, 8 and 9 distally and thus prevent over-extension of the push rod 410. In this manner, the overtravel spring 230 acts as a buffer, eliminating over-extension of the push rod 410 and completely preventing negative effects during use. More specifically, the overtravel spring 230 prevents over-extension of the needle 4 and prevents the coil windings 7 from being over-extended. The coil winding 7 and the outer sheath 8 are in a bent state during most of the operation. The configuration of the coil windings 7 and the retraction spring 330 serves to provide a suitable degree of extension of the needle 4 in this case.

When the button 440 is pushed, the retraction spring 330 will compress and the drive wire 2 will extend the needle 4 out of the tip 5. After needle 4 has been extended to a certain distance, pin 530 will drop into pin recess 416 formed on pushrod 410, thereby preventing further movement of pushrod 410 while locking needle 4 in the deployed position (assuming button 510 is not depressed). With the needle 4 fixed in the deployed position, the user is then free to release the handle without fear of retraction of the needle 4, and they can free their hand for other surgical procedures until the needle 4 needs to be retracted. By depressing button 510, pin 530 is forced out of pin recess 416 because retraction spring 330 provides a proximally tilting force to plunger 420, thereby releasing plunger 410 and automatically retracting needle 4.

The optimal dimensions of the exemplary handle 100 are given below for the example provided only. The overall longitudinal length of the handle 100 is preferably about 17 centimeters (6.74 inches). The preferred longitudinal length of the shank 310 is between 13 and 14 centimeters (5.29 inches). The optimal distance between the distal face of the button 440 and the proximal face of the handle body 310 is about 2.5 to 3 centimeters (1.05 inches).

The operation of the retractable tissue retractor of the present invention will be described below with reference to figures 16-23.

When the retractor 1 is passed through the endoscope, the needle 4 is fully received in the tip 5 of the retractor 1. The tip 5 is positioned at a desired location, particularly a selected location on the stomach wall, using the camera of the endoscope. Once tip 5 is advanced into contact with the innermost layer of the stomach, mucosal layer 202, a pin 62 is used to secure tip 5 in place.

For the treatment of gastroesophageal reflux disease, the most desirable method is to grasp the muscle layer 204 of the stomach, the middle layer next to the mucosal layer 202. For this reason, grasping the serosal layer 206 of the stomach (the outermost layer of the stomach) is not desirable. Thus, the shape memory curvature of the needle 4 is set so that the depth of penetration does not exceed the muscle layer 204. Structures that can ensure this function are shown in fig. 16-23.

When tip 5 is in position in the stomach, tip 5 is squeezed against mucosal layer 202, while needle 4 is extended beyond tip 5 to penetrate the stomach tissue and eventually reach muscle layer 204. The depth of insertion of needle 4 depends on the extent to which tip 5 is pressed against the mucosal layer.

If the tip 5 presses against the mucosal layer 202 such that the mucosal layer 202 forms an angle of 160 degrees with the distal face of the tip 5, as shown in fig. 16, the needle 4 can penetrate the mucosal layer 202 just or not at all.

If tip 5 presses against mucosal layer 202 such that mucosal layer 202 forms a 120 degree angle with the distal face of tip 5, as shown in fig. 17, needle 4 will penetrate into mucosal layer 202, but will penetrate just into muscle layer 204 or not at all into muscle layer 204.

If tip 5 is pressed against mucosal layer 202 so that mucosal layer 202 is at a 90 degree angle to the distal face of tip 5, as shown in fig. 18, needle 4 will penetrate muscle layer 204 to a depth sufficient to perform the appropriate retraction procedure.

If tip 5 squeezes the mucosal layer 202 such that the mucosal layer 202 is at a 75 degree angle to the distal face of tip 5, as shown in FIG. 19, needle 4 will penetrate into the muscle layer 204 to a depth well beyond the proper retracted thickness.

If tip 5 squeezes the mucosal layer 202 such that the mucosal layer 202 is at a 60 degree angle to the distal face of tip 5, as shown in fig. 20, needle 4 will penetrate into the muscle layer 204 to a depth well beyond the proper retracted thickness.

If tip 5 presses against mucosal layer 202 so that mucosal layer 202 is at a 45 degree angle to the distal face of tip 5, as shown in fig. 21, needle 4 penetrates muscle layer 204 to a thickness far in excess of the appropriate retracted thickness, but not far enough to reach serosal layer 206.

If tip 5 presses against mucosal layer 202 so that mucosal layer 202 is at a 30 degree angle to the distal face of tip 5, as shown in fig. 25, needle 4 penetrates muscle layer 204 to a thickness far beyond the proper retracted thickness, but not far enough to reach serosal layer 206.

If tip 5 squeezes the mucosal layer 202 such that the mucosal layer 202 assumes a 5 degree angle with the distal face of tip 5, as shown in fig. 23, the penetration of needle 4 into the muscle layer 204 will be much more than the proper retracted thickness, just prior to reaching the serosal layer 206.

Of course, the actual degree of penetration will depend on the thickness of the mucosal layer 202 and the thickness of the various layers of the patient's stomach, i.e., 202, 204, and 206, at the particular retracted position. However, for non-abnormal patients, the amount of curvature of the needle should be determined as described above.

When the tissue is properly retracted, the tissue can be manipulated and moved as desired. The tissue can be released simply by pushing button 510 to withdraw needle 4 into tip 5.

The needle 4 is sized and shaped so that it cannot enter the serosal layer 206. As shown in Figs. 16-23, regardless of the amount of force with which tip 5 is pressed against the stomach tissue, needle 4 will remain safely in serosal layer 206 and will only penetrate mucosal layer 202 and muscular layer 204, thereby ensuring the optimal placement of the gastroesophageal reflux disease (GERD) fixation clamp into the patient.

By varying the position of the needle outlet and/or by adjusting the angle at which the outlet is located at the tip of the retractor 1, the needle 4 can extend close to the plane located at the tip of the retractor 1, and be perpendicular to the longitudinal axis of the tip 5 or distal to this plane. Furthermore, the depth of penetration of the needle inside the tissue can be limited or increased by varying the length and the radius of curvature of the needle 4. If the outlet of the needle 4 is close to this end plane, the penetration depth of the needle 4 will be limited. This is illustrated in fig. 24. Conversely, if the needles 4 extend beyond said plane, their penetration depth will increase. If the needles 4 increase in length and the radius of curvature increases, the penetration depth will increase, whereas conversely if they decrease in length and the radius of curvature decreases, the penetration depth will be limited. By varying the set of parameters and their size, the retractor 1 can be made to penetrate into tissue in different ways in order to grasp a particular tissue layer to suit the needs of the procedure.

In the endoscopic treatment of gastroesophageal reflux disease, clinical experience has shown that: the user can determine whether it is appropriate to retract the stomach wall, in other words, whether it is reasonable to retract the mucosal layer 202 and the muscle layer 204. When retracting the mucosal layer 202 and the muscle layer 204, the retracted stomach tissue exhibits a substantially different shape than when retracting the mucosal layer 202 alone. The mucosal layer 202 is similar to the pouch in a pouch in that the mucosal layer 202 does not adhere completely to the muscle layer 204, and thus, when only the mucosal layer 202 is retracted, the retracted mucosal layer 202 forms a clearly visible steeply-sloping peak. In contrast, when both the mucosal layer 202 and the muscle layer 204 are retracted, a clearly visible smooth sloping mound is formed. The size and shape of the needle 4 also ensures that the likelihood of penetration of the serosal layer 206 is reduced by making visual confirmation that at least the muscle layer 204 is grasped. Unlike the mucosal layer 202, which is actually attached to the muscle layer 204, the serosal layer 206 is a very thin layer of tissue that moves with the muscle layer.

For the treatment of gastroesophageal reflux disease, the retractor 1 can be operated in the following manner according to the method of the invention. Please refer to fig. 25. Sleeve 3200 of end effector 2020 is slidably coupled to the distal end of endoscope 4000, and end effector 2020 is slid proximally over endoscope 4000. The distal end of endoscope 4000 is then inserted into the tracheopharyngeal tract and through esophagus 4140 into stomach 4160, and end-effector 2020 of the crimper is preferably mounted approximately 20 centimeters behind the distal end of endoscope 4000. While the trigger handle and/or control shaft 2060 is operated to slide the end-effector 2020 past the distal end of the endoscope 4000 and into the stomach 4160, the endoscope 4000 acts as a guide wire for the sleeve 3200. Alternatively, the endoscope may be retroflexed to the LES4020 of the esophagus 4140 to observe the advanced state of the end effector.

If the endoscope is dorsiflexed during insertion of the end effector 2020, the end effector 2020 can be seen entering the stomach 4160 under the view of the endoscope 4000. Once the end effector 2020 is positioned in the stomach 4160, if the endoscope 4000 is in a retroflexed state, it is preferably straightened and the end effector 2020 is moved distally, away from the endoscope 4000 to completely separate the endoscope 4000 from the grasping implant. Referring to fig. 26, endoscope 4000 is then again bent back while the trigger handle is operated to open jaws 2260 and 2280 of end effector 2020.

Referring to fig. 27, the retractor 1 of the invention is then preferably inserted into one of the working lumens 4080 of the endoscope 4000, aligned with the target tissue 4100 adjacent the LES4020 at a distance of 3 cm into the stomach 41601, with the center of the fold at the LES 4020. Retractor 1 begins to manipulate tissue 4100, pulling it back between jaws 2260 and 2280 of the grasping implant end effector 2020. The retractor 1 operates on the deep muscles of the stomach wall and then retracts a fold of the entire stomach wall thickness between the two jaws. In addition, the grasping implant's actuating handle and/or control shaft 2060 is simultaneously retracted (i.e., in the direction of instrument withdrawal) to bring jaws 2260 and 2280 into proximity with tissue 4100 in a direction substantially parallel to esophagus 4140. This is a very desirable approach angle, which cannot be achieved by the conventional endoscopic gastroesophageal reflux disease diagnosis and treatment instrument. That is, any instrument that reverses to retroflexion must extend through an arc of very small radius. When dorsiflexion is performed through this radius, the distal end of the instrument will thus be displaced so that the end effector will be further from the GEL than it is from an instrument that does not require dorsiflexion. Thus, it would not be possible for a retroflexion instrument to be displaced at least a few centimeters both parallel to the access passage and from the access passage.

The proximal trigger grip clips 2260 and 2280 are then manipulated to close, as shown in fig. 28. When the jaws 2260 and 2280 are moved and the retractor 1 holds the center point of the tissue 4100 in a fixed position between the two jaws, the jaws 2260 and 2280 form a tissue fold 4120 between the two parts of the holder when the male 1200 and female 1400 pieces of the holder 1000 are pulled together. When the two jaws 2260 and 2280 are closed around the tissue fold 4120, the rods 3200 and 3400 of the male member 1200 of the fastener 100 preferably penetrate through the serosal layer of the fold into the tissue 4100, forming serosal-serosal contact on the interior surface of the fold. When the two jaws are closed, the piercing rod 2560 of the female jaw 2280 preferably pierces the deep muscle of the tissue 4100 to adequately grip the tissue 4100. The experimental flow shows that: such contact can result in tissue adhesion after healing, i.e., permanent changes in the structure of tissue 4100 even if holder 1000 is subsequently removed. In this way, a region of reduced compliance is created in the vicinity of LES 4020.

The location and size of the folds 4120 and the relative position of the anchor members 1200, 1400 can be observed through the endoscope 4000. In addition, by manipulating an adjacent trigger lever, more or less clamping force can be applied to the pleated tissue until the male penetrating rod is fully penetrated.

Referring to fig. 29, if the pleats 4120 are in a satisfactory condition, the adjacent trigger handles may be manipulated to lock the male and female members 1200 and 1400 of the holder 1000 and release the coupled holder 1000 from between the jaws 2260 and 2280. If the shape of the pleats or retainers is not satisfactory, the jaws 2260, 2280 can be opened and repositioned, if necessary, to form another pleat 4120 before being locked or unlocked.

After use of holder 1000, jaws 2260 and 2280 are then closed, endoscope 4000 is in a straightened state and distal effector 2020 is repositioned over the distal end of endoscope 4000. The clip implant is withdrawn with endoscope 4000 through esophagus 4140 and removed from the patient. Alternatively, endoscope 4000 may be removed and the clamping implant withdrawn, preferably in a mirror image of the endoscope.

Although it is preferred to separate the clip implant from endoscope 4000 during this procedure, the clip implant can be attached to the endoscope for operation. That is, referring to fig. 30, by opening clips 2260, 2280, along endoscope 4000, only end effector 2020 is retracted until contacting 4100 tissue surrounding LES4020, which provides access to the target tissue. The jaws 2260, 2280 are then closed and the holder 1000 is used as described. To utilize this procedure, clamping implanter sleeve 3200 must be adjusted relative to jaws 2260 and 2280 so that jaws 2260 and 2280 can clean 4000 when opened and closed.

Although the clip implant is adapted to connect to the endoscope, it is also recognized that by retrofitting the clip implant, it can be used completely separate from endoscope 4000.

Referring now to fig. 34-41, shown therein is a second alternative embodiment of end effector 7020 of grasping implant 200. A tapered nosepiece 8200 is mounted on the housing 7900 of the end effector 7020 to define a longitudinal channel 8220 sized to receive a wire 8240. The diameter of the wire 8240 is less than one millimeter. The nosepiece 8200 is preferably made of a highly flexible material such as silicone.

According to one suitable method of use, referring to FIG. 31, endoscope 4000 is first inserted, preferably through the endoscope's finger tube 4140, and then into the stomach 4160 according to known procedures. Next, referring to FIG. 32, a lead 8240 is advanced through the endoscope and into the stomach 4160. Referring to fig. 33, endoscope 4000 is then preferably withdrawn over guide wire 8240. Referring to the illustration 34, the end effector 7020 is then passed over the lead 8240 and introduced into the stomach 4160 without viewing the scope. The tapered nosepiece 8200 and the relatively small frontal cross-sectional area of the system facilitate the introduction process. Referring to fig. 35, after the end effector 7020 is positioned in the stomach 4160, the lead 8240 is preferably withdrawn from the stomach 4160. Referring now to fig. 36 and 37, the endoscope 4000 is then reintroduced along the control shaft 2060 of the grasping implant, into the stomach 4160, and then allowed to invert to view the end effector 7020. The jaws 7260 and 7280 of the end effector 7020 are opened and extended adjacent to the tissue to be creased. Referring to fig. 38, retractor 1 is deployed through one working lumen 4080 of endoscope 4000 and then tissue 9100 is manipulated at the desired location of the fold 4120. As described above, the needle 4 of the retractor 1 extends through the mucosal layer 202 and the muscle layer 204 (deep muscle), securing these layers of tissue together, preventing them from delaminating. Referring to fig. 39, the jaws of the distal effector 7020 close, forming a fold 4120 around the engaged tissue 4100, the fold 4120 being substantially parallel to the esophagus 4140. The location of pleats 4120 extends from the location of retractor 1 to the end of jaws 7260 and 7280 of the grasping implant. Referring to fig. 40, the holder 1000 is arranged to open the jaws 7260, 7280 of the end effector 7020. Referring to fig. 41, the jaws 7260, 7280 of the end effector 7020 are closed and the end effector 7020 is withdrawn from the esophagus 4140 under the mirror image of the endoscope 4000. That is, the jaws of the closed end effector 7020 are preferably positioned directly at the distal end of the endoscope 4000 to minimize the cross-sectional area of the endoscope/clip implanter system and to enable continuous visualization of the end effector during retraction through the esophagus 4140.

One common procedure in the telescopic endoscopy procedure is: the endoscope is exchanged during the examination. If the first endoscope 4000 is in a position in the alimentary tract that is difficult to reach, and the second (swap) endoscope is preferably in the same position, the tissue retractor 1 may be used to guide the second endoscope into the position in which the first endoscope is located. A retractor 1 usable for endoscopy constructed according to the present invention may be equipped with a removable handle 100. Thus, when it is desired to exchange the endoscope, the tissue retractor 1 can be passed through a first endoscope and then placed in the desired position in the tissue, as shown for example in fig. 27, 38 and 39. The handle 100 may then be removed. Thereafter, the first endoscope 4000 is slid over the tissue retractor shaft 8 and removed, leaving the retractor shaft 8 in place. A second endoscope is then mounted onto the tissue retractor shaft 8, much like the lead 8240 used in fig. 32, 33 and 34, and then advanced to the original position. Thereafter, the shaft 8 is released and removed as needed.

Other embodiments of the invention may be devised readily by those skilled in the art and having skill in the art upon consideration of the specification and practice of the invention contained herein. The specifications and examples in the present invention are used as examples only.

While the preferred embodiments of the invention have been illustrated and described, it will be clear that the embodiments of the invention are not so limited. Numerous modifications, changes and variations of the present invention, as well as alternative and equivalent arrangements of parts, may be devised by those skilled in the art without departing from the spirit and scope of the present invention as defined by the appended claims of this patent.

Several embodiments of retractors and methods of use thereof in endoluminal treatment of gastroesophageal reflux disease (GERD) have been described and illustrated herein. Although specific embodiments of the present invention have been described, the embodiments of the present invention are not limited thereto because the scope of the present invention includes the entire allowable development space of the technology thereof and the allowable range of the specification. For example, while providing the optimal size of the retractor, the system and its components may have different relative sizes. For example, if a pediatric endoscope (4-6 mm) is used, the cross-sectional area may be further reduced. Also while a "look-behind" clip implanter is disclosed for a fixator specifically designed for the treatment of gastroesophageal reflux disease, for the treatment of other conditions, such as obesity, ulcers, stomach cancer, measurement or monitoring of PH instrumentation, insertion tubes, etc., a "look-ahead" straight-type instrument with a similar clip assembly may be used for the fixator. Furthermore, the straight instrument can be smaller in diameter and can be operated through the working lumen of an endoscope. Accordingly, other modifications may occur to those skilled in the art without departing from the spirit and scope of the invention as defined by the appended claims.

Claims (69)

1. A retractor for operating on a target, the retractor comprising:

a body having a distal end and a proximal end;

a retraction device, said retraction device having:

a head connected to said distal end of said body;

an adjuster movably disposed within said head; and

a plurality of substantially rigid and arcuate needles movably connected to the regulator;

and

an actuator connected to said proximal end of said body, said actuator being operatively connected to said actuator through said body, said actuator moving said actuator when activated to selectively extend or retract said needle from or into said head.

2. The retractor of claim 1, wherein:

said body having a longitudinal extension, said longitudinal extension having a longitudinal direction; and

the needle projects out of the head substantially in a direction perpendicular to the longitudinal direction.

3. The retractor of claim 1, wherein: the head is removably connected to the distal end of the body.

4. The retractor of claim 1, wherein: the head is integrally formed with the body.

5. The retractor of claim 1, wherein: an aperture is provided in the head for each of the needles.

6. The retractor of claim 5, wherein: the aperture is configured to allow the needle to pass therethrough without substantial deformation of the needle.

7. The retractor of claim 5, wherein: the aperture is configured to allow the needle to pass therethrough substantially without friction.

8. The retractor of claim 5, wherein: the apertures are located on opposite sides of the head, and the needles are disposed on opposite sides of the regulator in substantial alignment with the apertures.

9. The retractor of claim 8, wherein: at least one surface of the aperture guides the needle in a direction substantially perpendicular to a direction of movement of the adjuster.

10. The retractor of claim 1, wherein: the actuation means is removably connected to the proximal end of the body.

11. The retractor of claim 1, wherein: the adjuster is movably disposed in the body.

12. The retractor of claim 1, wherein: the arc of the needle does not exceed one circle.

13. The retractor of claim 1, wherein: the arc of the needle is not greater than a semicircle.

14. The retractor of claim 1, wherein: the needles are two needles.

15. The retractor of claim 1, wherein: the material of the needle is at least one of the following materials: steel, non-pseudoelastic metals, ceramics and polymers.

16. The retractor of claim 1, wherein: the needle is pivotally connected to the adjuster.

17. The retractor of claim 1, wherein:

the main body is provided with a coil winding and an outer protective layer wrapped outside the coil winding; and

the regulator is movably mounted within the coil winding and the head.

18. The retractor of claim 1, wherein: the retraction device grips the object when the needle is extended from the head and releases the object when the needle is retracted into the head.

19. The retractor of claim 1, wherein:

the touch device is provided with a rod body; and

the rod body penetrates through the main body and is connected with the regulator together for moving the regulator.

20. The retractor of claim 19, wherein: the rod body is integrally formed with the adjuster.

21. The retractor of claim 19, wherein: the rod body is detachably connected with the regulator.

22. The retractor of claim 1, wherein: also included is a proximal stop disposed within the body for limiting the retraction range of the needle.

23. The retractor of claim 1, wherein: the trigger has a lock that selectively holds the needle in a certain position.

24. The retractor of claim 23, wherein: the lock selectively holds the needle in the extended position.

25. The retractor of claim 1, wherein: the actuation means is provided with an overtravel preventer for limiting the extent of the needle beyond the head.

26. The retractor of claim 1, wherein: the touch device is a one-hand touch device.

27. The retractor of claim 5, wherein: the head has a cam surface for guiding the needle through the aperture.

28. The retractor of claim 1, wherein: the head has a retention pin for retaining the head in a user selected rest position.

29. A tissue retractor for manipulating tissue within a patient when used with a retractable endoscope having at least one working lumen, the retractor comprising:

a body having a proximal end and a distal end;

a retraction device, the retraction device comprising:

a head connected to said distal end of said body;

a regulator movably disposed within the body; and

a substantially rigid arcuate needle movably connected to the regulator; and

an actuator connected to said proximal end of said body, said actuator being operatively connected to said actuator through said body, said actuator moving said actuator to selectively extend and retract said needle out of and into said head upon actuation;

wherein the body and the retraction device are configured to fit within a working lumen of an endoscope.

30. The retractor of claim 29, wherein: the needle is sized to selectively grasp tissue of the alimentary tract.

31. The retractor of claim 29, wherein: the needle is made to extend into the mucosal layer without extending into the muscle layer.

32. The retractor of claim 29, wherein: the needle is made to extend through the mucosal layer and into the muscle layer.

33. The retractor of claim 29, wherein: the needle is made to extend into the mucosal and muscle layers without extending into the serosal layers.

34. The retractor of claim 29, wherein: the needles are made to extend selectively through different layers of the stomach wall.

35. The retractor of claim 29, wherein:

two openings are arranged on two opposite sides of the head part;

the needles are disposed on opposite sides of the regulator in substantial alignment with the aperture; and

at least one face of the aperture guides the needle in a direction substantially perpendicular to the direction of movement of the adjuster.

36. The retractor of claim 29, wherein:

said body having a longitudinal extension, said longitudinal extension having a longitudinal direction; and

the needle projects substantially out of the head in a direction substantially perpendicular to the longitudinal direction.

37. The retractor of claim 29, wherein: the head is removably connected to the distal end of the body.

38. The retractor of claim 29, wherein: the head is integrally formed with the body.

39. The retractor of claim 35, wherein: the aperture is configured to allow the needle to move therein without substantial deformation.

40. The retractor of claim 35, wherein: the aperture is configured to allow the needle to move therein substantially frictionless.

41. The retractor of claim 29, wherein: the actuation means is removably connected to the proximal end of the body.

42. The retractor of claim 29, wherein: the needles are two needles.

43. The retractor of claim 29, wherein: the material of the needle is at least one of the following group of materials: steel, non-pseudoelastic metals, ceramics and polymers.

44. The retractor of claim 29, wherein: the needle is pivotally connected to the adjuster.

45. The retractor of claim 29, wherein: also included is a proximal stop disposed within the body for limiting the retraction range of the needle.

46. The retractor of claim 29, wherein: the trigger device also has a lock that selectively secures the needle in a certain position.

47. The retractor of claim 46, wherein: the locking device may selectively retain the needle in the extended position.

48. The retractor of claim 29, wherein: the actuation means has an overtravel preventer for limiting the extent of the needle beyond the head.

49. A tissue retractor, said retractor comprising:

a body having a proximal end and a distal end;

a retraction device, said retraction device having:

a head connected to said distal end of said body and having two opposed openings;

an adjuster movably disposed within said head; and

two substantially rigid needles, each pivotally connected to said adjuster to facilitate passage of said needle through said respective aperture, said needles being arcuate; and

a single-handed trigger coupled to said proximal end of said body and operatively coupled between said body and said actuator, said trigger moving said actuator to selectively extend or retract said needle out of or into said head upon actuation of said trigger.

50. A method for retracting tissue, the method comprising:

placing a retractable endoscope having at least one working lumen in proximity to tissue to be retracted;

passing the tissue retractor of claim 1 through the working lumen of the endoscope;

placing the head of the retractor at a desired retracted position on the tissue;

activating the actuation device in the desired retracted position to extend the needle into the tissue; and

retracting the tissue with a retractor.

51. The method of claim 50, wherein the method further comprises: triggering the trigger to release the needle from the tissue and into the head.

52. A method for retracting tissue, the method comprising:

placing the endoscope of claim 29 adjacent the tissue to be retracted;

passing the tissue retractor through the working lumen of the endoscope;

placing the head of the retractor in a desired retracted position in the tissue;

activating the actuation device in the desired retracted position to extend the needle into the tissue; and

retracting the tissue with the retractor.

53. The method of claim 52, wherein the method further comprises: triggering the trigger to cause the needle to release the tissue and retract into the head.

54. A method for retracting tissue during treatment of gastroesophageal reflux disease, the method comprising:

placing a telescopic endoscope having at least one working lumen at a desired retracted position of the stomach wall;

passing the tissue retractor of claim 1 through the working lumen of the endoscope;

placing the head of the retractor in the desired retracted position of the stomach wall;

activating the actuation device at the desired retracted position to extend the needle into the stomach wall; and

retracting the stomach wall with the retractor.

55. The method of claim 54, wherein the method further comprises: the needle is formed into an arc to limit the depth of penetration of the needle in the stomach wall to no more than the muscle layer.

56. The method of claim 54, wherein the method further comprises:

providing a grasping implant and plication device with a proximal actuating handle and a distal effector with jaws that include a male and female member of a plication holder;

placing the distal effector in a position adjacent to the retracted stomach wall;

operating the proximal trigger handle to open the jaws of the distal effector;

pulling the retracted stomach wall into the open jaws of the distal effector;

operating said trigger handle to close said jaws about the retracted stomach wall while fully maintaining the center point of the stomach wall intermediate said retractor jaws and closing said jaws as said male and female members of said fastener to form a tissue fold when said fold is clamped therein;

when the jaws are closed around the pleat, causing the fastener to pierce the pleat, the projection of the fastener passing through the serosal layer of the pleat, forming a serosal-serosal contact at the inner surface of the pleat;

determining a satisfactory position and size of the fold and relative position of the anchor member to the endoscope, and:

if satisfactory implantation is made, operating a proximal trigger handle to lock the male and female members of the fastener and release the locked fastener from the jaws; and

if a satisfactory implant is not formed, reopening the jaws to reorient them to form another plication until a satisfactory plication is determined, and then manipulating the proximal actuating handle to lock the male and female elements of the fastener and release the locked fastener from the jaws;

opening the jaws; and

removing the clip implantation and pleating device and the endoscope from the patient through the esophagus.

57. The method of claim 56, wherein the method further comprises:

approximating the jaws to the stomach wall to be retracted in a direction substantially parallel to the esophagus; and

forming a fold substantially parallel to the esophagus.

58. A method for retracting tissue in the treatment of gastroesophageal reflux disease, the method comprising:

placing the endoscope of claim 29 on the stomach wall of the stomach at a location proximate to the desired retraction;

passing the tissue retractor through the working lumen of the endoscope;

placing the head of the retractor in the desired retracted position of the stomach wall;

activating the actuation device to extend the needle to the desired retracted position of the stomach wall; and

retracting the stomach wall with the retractor.

59. The method of claim 58, wherein the method further comprises: the needle is formed into an arc to limit the depth of penetration of the needle into the stomach wall to no more than the muscle layer.

60. The method of claim 58, wherein the method further comprises:

providing a grasper implant and plication device with a proximal trigger handle and a distal effector with jaws comprising male and female elements of a plication holder;

placing the distal effector at a location adjacent to a retracted stomach wall;

operating the proximal trigger handle to open the jaws of the distal effector;

pulling the retracted stomach wall into the open jaws of the distal effector;

operating said trigger handle to close said jaws about said retracted stomach wall while substantially maintaining a center point of said stomach wall intermediate said retractor jaws, and forming a tissue fold when said jaws are closed as said male and female members of said fastener to sandwich said formed fold therein;

causing the fastener to pierce the plication as the jaws close around the plication, the protrusion of the fastener passing through the serosal layer of the plication, creating serosal-serosal contact at the interior surface of the plication;

determining a satisfactory position and size of the fold and relative position of the holder component to the endoscope, and:

operating said proximal trigger handle to lock said male and female members of said fastener and release said locked fastener from said jaws if a satisfactory implant is made; and

if a satisfactory implant is not formed, reopening the jaws to reorient them to form another plication until a satisfactory plication is formed, and then manipulating the proximal actuating handle to lock the male and female elements of the fastener and release the locked fastener from the jaws;

opening the jaws; and

removing the clip from the patient through the esophagus with the implantation and plication device and the endoscope.

61. The method of claim 60, wherein the method further comprises:

approximating the jaws to the stomach wall to be retracted in a direction substantially parallel to the esophagus; and

forming a fold substantially parallel to the esophagus.

62. The method of claim 50, wherein the method further comprises:

providing a retractor having a removable handle; and

after the needle is extended into the tissue, the handle is removed.

63. The method of claim 62, wherein the method further comprises: directing a second endoscope at a location above the retractor body toward the head of the retractor.

64. The method of claim 52, wherein the method further comprises:

providing a retractor having a removable handle;

removing the handle after the needle has been extended into the tissue; and

directing a second endoscope at a location above said retractor body toward said head of said retractor;

65. a method of grasping an object, the method comprising:

positioning said head of said retractor of claim 1 at a desired location on said target;

activating the actuation means to extend the needle into the desired position in the target to grasp the target with the retractor.

66. The retractor of claim 1, wherein: the body is composed of one of an elastic body and a rigid body.

67. The retractor of claim 29, wherein: the main body is a group consisting of an elastic main body and a rigid main body.

68. The retractor of claim 1, wherein: upon activation of the actuation means, the actuation means moves the actuator to selectively extend the needle out of the head and into the tissue of the patient and to withdraw the needle from the tissue and back into the head.

69. The retractor of claim 1, wherein: the needle is made to control the depth of penetration in the tissue.