Drawings
The present invention will be more readily understood from the following detailed description in conjunction with the accompanying drawings, in which:
figures 1 through 4 illustrate a method of endoluminal fundoplication according to one embodiment of the present invention;
FIG. 1 is a cross-sectional view of the distal end of the esophagus and the upper stomach wall with the endoscope inserted through the esophagus and into the stomach cavity, with the tissue grasper attached in place at the gastroesophageal junction;
FIG. 2 is a cross-sectional view similar to FIG. 1, further showing the tissue displacement device and the displaced gastric fundus, thereby forming an intussusception of the esophagus into the gastric cavity;
FIG. 3 is a cross-sectional view similar to FIG. 2, further showing the tissue fastener device and fasteners placed through intussusception;
FIG. 4 is a cross-sectional view of the distal end of the esophagus and the upper stomach wall with an endoscope inserted through the esophagus and into the stomach cavity, two fasteners placed within the intussusception, and a syringe inserted within the intussusception;
figure 5 is a cross-sectional view of an intussusception of the esophagus into the gastric cavity with a lower overtube inserted through the esophageal and gastric walls;
FIG. 6 is a cross-sectional view similar to FIG. 5 with the distal end of the T-fastener deployed;
FIG. 7 is a cross-sectional view similar to FIG. 5 with the hypotube retracted into the body tissue and the T-fastener deployed at both the proximal and distal ends;
FIG. 8 is a perspective view of a T-mount with a T-brace at each end;
FIG. 9 is a perspective view of a fastener having four bifurcated supports at each end;
FIG. 10 is a perspective view of a fastener having three bifurcated supports at each end;
FIG. 11 is a perspective view of a fastener having six bifurcated supports at each end, wherein the prongs are curved;
figure 12 is a perspective view of a fastener having an expandable support at each end;
FIG. 13a is a longitudinal view of a fastener having a deformable portion near each end, the fastener being in an undeformed position;
FIG. 13b is a longitudinal view of the fastener of FIG. 13a with the deformable portions adjacent each end in a deformed position;
FIG. 14 is an isometric view of a fastener including a portion having a barbed tack and another portion having a mating washer according to another embodiment of the present invention;
FIGS. 15a and 15b are cross-sectional views of two embodiments of endoscopes having one and two overtubes, respectively;
FIGS. 16a, 16b, 16c and 16d are side views of a fastener deployer for use with another embodiment of the invention; and
figures 17a to 17e are schematic views of the operation steps of different embodiments of the present invention including a fundoplication folder.
Detailed Description
The method of the present invention may be practiced using a flexible endoscope 16 preferably equipped with a tissue grasping device 18 (see fig. 1), a tissue displacement device 22 (see fig. 2), a fastener mover 24 (see fig. 3), and a syringe 28 (see fig. 4). The endoscope preferably has one or more sheaths through which various instruments can be passed. For example, the endoscope may be equipped with a tissue displacement device that passes through the lumen of the upper sheath and can be extended to the distal end of the endoscope under the control of the endoscope. In addition, the endoscope preferably has a secondary upper sheath through which the fastener delivery device passes, and a syringe operating at its distal end. The endoscopist is able to manipulate the endoscope, including the tissue grasper, tissue displacer, fastener delivery device, and syringe, from the proximal end of the endoscope.
Different types of endoscopes can be used in the procedure. If necessary, an overtube having one or more tubes may be slid over the endoscope to the fundoplication position for insertion of additional instruments. For example, fig. 15a shows an endoscope 16 having several channels 15, the channels 15 providing irrigation, aspiration, illumination, and video feedback. The endoscope 16 of this embodiment includes a working channel a. To facilitate insertion of additional instruments, an overtube 20 may be used, which forms a sheath (sheath) defining additional working channels E and F extending to the distal end of endoscope 16. Similarly, fig. 15B shows an endoscope 16' with two working channels a and B. In this case, the upper tube 20' only has to provide access for one additional working channel F. Here, an "endoscope device" is generally used for indication and diagnosis, and, when necessary, an overtube forms an additional working channel.
In one embodiment, the patient's stomach is insufflated to perform surgery. In this method, the patient is also sedated using intravenous anesthetic injection.
Using the method of the present invention, the flexible endoscope 16 is first inserted into the patient's mouth, through the esophagus 10 and into the stomach, as shown in FIG. 1. The inserted endoscope 16 is then typically positioned at the attachment site 14 at the gastroesophageal junction. An endoscopist or other practitioner practicing the method can locate the target site by viewing the GEJ through an endoscope. Methods for locating target sites via endoscopes are well known and widely used.
The tissue grasper 18 can be positioned and coupled to the positioning attachment site 14 to grasp the tissue, as shown in fig. 1. The tissue grasper 18 passes through the lumen of the endoscope 16 and is operable by the practitioner from the proximal end of the endoscope 16. Preferably, the practitioner is able to control the engagement/disengagement of the grasper 18, as well as the tension applied by the grasper 18 on the engaged tissue. The tension is controlled by extending the grasper 18 or retracting the grasper 18 toward the distal end of the endoscope 16. The portion of tissue grabber 18 that engages or grabs tissue may include hooks, clips, grabbers, combinations thereof, or the like as is known in the art.
After the tissue at the GEJ has been grasped, the tissue displacement device 22 is used to displace the gastric fundus 12, effectively forming an intussusception 30 of the esophagus 10 in the stomach 32, as shown in figure 2. The tissue displacement device 22 passes through a lumen surrounding the overtube 20 of the endoscope 16 and can be pushed or rotated to a position away from the distal end of the endoscope 16. The displacement device 22 preferably includes a bulbous end at the end of a stiff cable or nitinol strip. The practitioner may operate the tissue displacement device 22 by moving it to a position against the fundus of the stomach, for example by pushing or rotating it.
The tissue displacement device 22, once in position against the gastric fundus 12, is further pushed and rotated to press against and reposition the gastric fundus 12. At the same time, the tissue grabber 18 grabs the tissue at the attachment site 14, applying a force opposite to the force applied by the tissue displacement device 22. The resultant effect of these reactive forces is to bring the fundus 12 closer to the esophagus, forming a smaller acute angle of His, indicated by reference numeral 34. The displacement of the fundus 12 creates a tissue flap 30, effectively intussuscepting the esophagus 10 within the stomach 32. In one embodiment, the tissue flap may have a height of about 1 to 3 cm.
In a preferred embodiment, the steps of pulling tissue with the tissue grasper 18 and displacing the fundus with the tissue displacer 22 are repeated at several locations around the intussusception. For example, the procedure may be performed at four to twelve equally spaced locations around the circumference of the esophagus.
The reduction of the angle of His 34 and the formation of the intussusception reduce the extent of reflux of gastric contents into the esophagus 10. A valve is generally formed between the stomach and esophagus. When gas is generated within gastric cavity 32, or particularly within fundus 12, pressure is applied to the surrounding portion of esophagus 10, isolating it from the stomach. In addition, stomach contents move back and forth within the gastric cavity 12 due to contraction of the stomach muscles and movement of the body. Intussusception 30 alleviates GER by forming a barrier-like valve through which gastric contents must pass in order to reach esophagus 10.
The intussuscepted esophagus 30 is then secured to the wall of the fundus 12 to secure the placement. The fastener delivery device 24 is used to insert fasteners 26 into the intussusception 30 to secure the gastric and esophageal tissue. Since multiple nerves and blood vessels typically pass through the tissue being fixed, the practitioner should position the nerves and blood vessels prior to inserting the fixation member 26 so as not to injure or sever them. In particular, the practitioner should locate the vagus nerve, the aorta and various gastric vessels extending along the sides of the esophagus. A variety of methods are known in the art for locating such anatomical features, including ultrasound, fluoroscopy, and x-ray.
Once the above features are positioned, the practitioner loads the fastener 26 into the fastener delivery device 24 and inserts the fastener delivery device 24 through the second sheath 25 until the operating end of the delivery device 24 is at the desired fastener insertion site. The delivery device 24 is then used to place the fastener at the desired location, as shown in FIG. 3. The fastener 26 is preferably inserted through an intussusception of 1cm and 2.5cm above the tip 14 of the newly formed tissue flap 30, with the tip 14 extending into the gastric cavity 32. The fastener 26 may also be inserted at other locations along the length of the tissue flap, preferably having a length of about 1 to 3 cm.
The fastener delivery device 24 can be rotated within the esophagus and stomach lumen to insert the fasteners around the entire circumference of the esophagus. Preferably, the fasteners are inserted at approximately 30 ° intervals. For example, the delivery device 24 may be rotated in one direction from the initial insertion site to insert fasteners at 30, 60, 120, and 180 from the initial site. The delivery device 24 is then returned to the original insertion site and rotated in the opposite direction, again inserting fasteners at 30 intervals until the entire circumference of the intussusception is secured.
Preferably, the intussusception should extend a full 360 degrees, i.e. the entire circumference of the esophagus. The valve formed by the intussusception is similar to the "gerd standard" open or laparoscopic procedure, a Nissen fundoplication. However, it is not possible to achieve the full 360 degrees with the lumen approach. In that case, a Toupet fundoplication extending 270 degrees around the esophagus may be performed. The lumenal approach is generally not performed over an arc of approximately 60 degrees of the posterior side of the esophagus. Fasteners may be placed at 30 intervals around the remainder of the esophagus.
Figure 5 shows a hypotube (hypotube)40 having a beveled edge, the hypotube 40 having been inserted through the fastener delivery device 24 and moved further forward to pierce the esophageal wall 44 and the gastric wall 46, respectively. Hypotube 40 may be a hypodermic needle cannula or other type of thin tube, preferably stainless steel.
A T-fastener 42, as is known in the art, can be inserted through the hypotube 40 until the end of the fastener 42 deploys on the intussuscepted side of the stomach. The hypotube 40 is then retracted toward the sheath 24 such that the deployed end of the T-fastener engages the stomach wall 46 when the hypotube 40 is retracted, as shown in FIG. 6. As shown in FIG. 7, the hypotube 40 is further retracted into the sheath 24 until the proximal end of the T-fastener is pulled out of the hypotube 40 by the pulling force exerted by the distal end of the T-fastener 42. The proximal end of the T-fastener 42 is then seated against the inner wall of the esophagus, thereby holding the stomach wall and esophagus together. The length of the longitudinal center portion of the T-fastener determines the maximum distance between the inner wall of the esophagus and the inner wall of the stomach.
Figures 9-11 illustrate various T-fastener configurations that may be used to secure esophageal and gastric walls. Conventional T-mounts 48 have a simple T-bar at each end. With this fastener, the forces holding the stomach and esophagus tissues in the post-deformation position are taken up by the T-bar at each end of the fastener, these forces acting on the small area it has. This type of T-bar may be pulled through the stomach or esophagus wall. Thus, it may be desirable to employ a T-fastener of the present invention that has a large area for the force distribution of the secured tissue. Figure 9 shows a T-mount with two T-bar supports at each end. In addition, the area of force distribution for the fixation tissue is increased by using a T-fastener with three prongs, four prongs, or six prongs (see fig. 10, 9, and 11, respectively).
FIG. 12 shows another fastener 56 of the present invention that may be used to fasten gastric and esophageal tissue. The fixture 56 has a longitudinal central portion of an inflatable ball 58 at each end. The fastener 56 may be inserted through the stomach and esophagus tissue in the same manner as the insertion of the T-fastener described above. Once the fastener 56 is secured, air, water, or other substance may be introduced into the expandable end 58, thereby expanding the expandable end 58 and securing the stomach and esophageal tissue. The expandable end may be spherical or disc-shaped.
In one embodiment, a ball may be formed at the end of the fastener 42, as shown in FIG. 12, and may be stored within the downtube 40 upon insertion through the walls 44, 46. When downtube 40 is retracted, the ball may be inflated by a liquid flowing through an inflation tube formed within downtube 40. A similar procedure may be performed to inflate the balloon at the proximal end of the fixation member 42 before detachment from the hypotube 40. Seals of known design may be employed to ensure that both balls are inflated.
Fig. 13-14 also illustrate alternative fasteners 60 of the present invention for securing gastric and esophageal tissue. The fastener 60 is an elongated member having deformable portions 62, 64 at the distal and proximal ends, preferably made of polypropylene or other non-repellant, durable material.
The deformable portions 62, 62 preferably have a net-like structure that is deflected by pressing the ends of the fastener 60 toward each other to expand radially. As shown in fig. 5-7, the fastener 60 is inserted into the stomach and esophagus tissue in the same manner as described above with respect to the insertion of the T-fastener. The ends are opened when the proximal and distal ends are in the desired positions in the esophagus and stomach, respectively.
In one embodiment, the fastener 60 is formed so that it is normally biased toward the deformed position, as shown in FIG. 13 b. This type of fastener 60 is capable of maintaining a small diameter configuration when installed into the downtube 40, and upon release, will expand due to natural deflection. The deformable portions 62 and 64 are compressed to insert the fastener through the delivery device 24 and through the stomach and esophageal tissue. The fastener 60 is then moved forward through the hypotube 40 until the distal deformable portion 64 extends beyond the distal end 40 of the hypotube, returning to its normal radially expanded position. Hypotube 40 can then be retracted, expanding proximal deformable portion 62 to its normal radially expanded position. The deformations 62, 64 then act as a support to hold the stomach and esophagus tissues in place.
Further, the fastener 60 may be formed with the deformable portion 60 so that it is normally in a non-deformed position, as shown in FIG. 13 a. A generally non-deforming fastener is inserted through the stomach and esophagus tissue in the same manner as the normally deformed embodiment described above. The normal non-deforming fastener must then be manipulated to assume the deformed position shown in figure 13b after being placed in the desired position for deployment of esophageal and gastric tissue. Such an operation may be accomplished using a crimper inserted through the lumen of the endoscope. This device acts like a known mechanism for inserting rivets. As will be appreciated by those skilled in the art, any device that is inserted through the endoscope lumen and is capable of compressing the ends of the fastener 60 to buckle the deformable portion can be used as the crimper.
The end of the fixture 60 may also have a needle point to facilitate insertion. Such a tip allows the fastener 60 to be inserted directly into and through the stomach and esophageal tissue without the need for the hypotube 40.
As shown in FIG. 16, the hypotube 40 described above with reference to FIGS. 5-7 can be replaced with an inserter 100 that deploys a fastener 102. When the inserter 100 is in position through the esophageal and gastric walls 44, 46, as shown in fig. 16a, the action wire 104 extending the length of the endoscope 16 is pulled causing the distal stent 106 to expand, as shown in fig. 16 b. When the inserter 100 is retracted, as shown in fig. 16c, the action wire 104 is pulled again, so that the proximal stents 108 are deployed and the walls 44, 46 are sandwiched between the stents 106, 108, as shown in fig. 16 d.
In various embodiments of the invention, a two-piece fastener may be used, including a barbed nail 70 and a mating washer 74, as shown in FIG. 14. The spike 70 includes a disk portion 71 having a barbed connector 72. The barbed connector 72 is inserted through the mating washer 74 such that the connector 72 is engaged by the washer 74. The two members 70 and 74 are preferably made of an elastomeric polymer material.
In an alternative embodiment of the device of the present invention, the piercing spike 70 and mating washer 74 may be inserted using a fundoplicator 120, as shown in FIGS. 17a to 17 e. FIG. 17a shows the fundoplicator 120 at the end of a flexible tube 121 inserted through the esophagus 10 into the patient's stomach 32. An endoscope 16 may also be incorporated to visually monitor the procedure. Once in place, the fundoplicator 120 deploys the pivotable tissue displacement portion 124, as shown in FIG. 17b, to move into position against the fundus 12.
The clamping portion 128 of the fundoplicator 120 is used to clamp the attachment site 14, as shown in FIG. 17c, such that downward movement of the fundoplicator 120 pulls a region of the esophagus 10 into the stomach 32. Spikes 130 may also be used to facilitate this process. Once the esophagus is opened in place, tissue displacement portion 124 is pivoted toward anvil portion 126 of fundoplicator 120 to push fundus 12 toward the esophagus to create an intussusception.
When tissue displacement portion 124 reaches anvil portion 126, as shown in FIG. 17d, the fastener piercing staple 70 mounted on tissue displacement portion 124 pierces the stomach wall 46 and esophageal wall 44 and is secured to mating washer 74 mounted on anvil portion 126. This process forms a tissue flap 132. As described above for other embodiments of the invention, the process may be repeated at different circumferential locations around the esophagus to form a valve having the desired shape for separating the stomach 32 from the esophagus 10, as shown in FIG. 17 e.
Finally, an adhesive may be injected into the intussuscepted tissue, as shown in figure 4, to cause a fibrotic response that secures the fundoplicated stomach and esophageal tissue. Sodium morrhuate (sodium morrhuate), for example, is a known agent that can be injected into the tissue fold formed between the stomach and esophageal tissues to produce a fibrotic reaction that permanently bonds the fundus to the esophagus.
Several compounds can be used as binders. Among the gluing compounds, for example, cyanoacrylate adhesives, muscle cement proteins, the transforming growth factor Beta, prolamine gels, the gel-resorcinol-formaldehyde glue and the Hystoacryl may be used. Among the sclerosant compounds, sodium morrhuate, sodium tetradecyl sulfate, ethanolamine oleate, aerosol-tale and sterile bleomycin sulfate may be used.
When such an adhesive is used, the fastener need only secure the tissue until the reaction caused by the adhesive is sufficient to secure the tissue in place. The fixture used may be made of a material that is biodegradable or absorbable by the organism, or it may be removable.