MXPA06008893A - Apparatus for single pass gastric restriction - Google Patents

Abstract

A gastric reduction apparatus that facilitates the creation of a transoral linear passageway through the stomach includes an elongated body including a proximal end and a distal end. The elongated body is generally sinusoidal shaped with at least one tissue engaging surface oriented such that a needle will pass therethrough. The elongated body also includes at least one needle passing channel respectively formed adjacent the at least one tissue engaging surface. The at least one needle passing channel generally passes through the center of the sinusoidal waveforms defined by the at least one tissue engaging surface such that a needle will pass entirely through stomach tissue contacting the tissue engaging surface of the elongated body. The elongated body further includes a suture passing channel.

Description

APPARATUS FOR RESTRAINING AN INDIVIDUAL GASTRIC PASS FIELD OF THE INVENTION The present invention relates to gastric reduction surgery. More particularly, the invention relates to the method and apparatus for performing gastric reduction surgery by means of endoscopy.

BACKGROUND OF THE INVENTION Morbid obesity is a serious medical condition. In fact, morbid obesity has become highly dominant in the United States, as well as in other countries, and the trend seems to be heading in a negative direction. The complications associated with morbid obesity include hypertension, diabetes, coronary artery disease, embolism, obstructed heart disease, multiple orthopedic problems and pulmonary insufficiency with a marked decrease in life expectancy. With this in mind, and as experts in the art certainly appreciate, the monetary and physical costs associated with morbid obesity are considerable. In fact, the costs related to obesity are estimated to be over 100 trillion dollars in the United States alone. A variety of surgical procedures have been developed to treat obesity. The most commonly performed procedure is the Roux-en-Y gastric bypass (RYGB). This procedure is highly complex and is commonly used to treat people who exhibit morbid obesity. However, with this in mind, more than 100,000 procedures are performed annually in the United States alone. Other forms of bariatric surgery include Fobi bag, bilio-pancreatic divert, and gastroplasty or "stomach staple." In addition, it is known that implantable devices limit the passage of food to the stomach and affect satiety. RYGB involves the displacement of the jejunum to a superior position using a Roux-en-Y loop. The stomach is completely divided into two unequal portions (a small upper portion and a longer lower gastric pouch) using an automatic stapling device. The upper pouch typically measures less than 20 cubic centimeters, while the longer lower pouch remains intact and continues to secrete stomach juices that flow through the intestinal tract. A segment of the small intestine is then brought from the lower abdomen and joined with the upper pouch to form an anastomosis created through an opening of 1.27 centimeters, also called the stoma. This segment of the small intestine is called the "Roux loop" and carries the food from the upper pouch to the rest of the intestines, where the food is digested. The remaining lower pouch, and the attached duodenum segment, are then reconnected to form another anastomotic connection in the Roux loop at a site approximately 50 to 150 centimeters from the stoma, typically using a stapling device. It is in this connection that the digestive juices of the stomach, pancreas and liver bypass enter the jejunum and ileum to aid in the digestion of food. Given the small size of the upper bag, patients are forced to eat more slowly and to be satisfied much faster. This results in a reduction in caloric intake. The conventional RYGB procedure requires a large amount of operating time. Due to the degree of invasiveness, the post-operative recovery time can be very long and painful. In view of the highly invasive nature associated with the RYGB procedure, other less invasive procedures have been developed. For example, laparoscopy and other procedures to reduce the size of the stomach have been developed. These surgical gastric reduction procedures are conventionally performed to restrict a patient's food intake by reducing the size of the stomach to a reservoir having a volume in the range of about 15 to about 200 ml. The most common form of gastric bypass surgery involves the application of vertical staples along the stomach to create an adequate pouch. This procedure is commonly performed laparoscopically and as such requires considerable preoperative, operative and postoperative resources. Alternatively, vertical sheath gastrectomy involves the complete removal of the discarded portion of the stomach.

With this precedent in mind, procedures are necessary to perform gastric reduction surgery efficiently and in a patient-friendly manner. The present invention provides such a method and an associated apparatus.

BRIEF DESCRIPTION OF THE INVENTION This is, therefore, a purpose of the present invention to provide an apparatus that facilitates the creation of a transoral runner into the stomach. The apparatus includes an elongate body including a proximal end and a distal end. The elongated body is generally sinusoidal during implantation with at least one tissue connecting surface directed such that a needle passes therethrough. The elongated body also includes at least one needle passage channel respectively formed adjacent to at least one tissue connection surface. The at least one needle passageway generally passes through the center of the sinusoidal undulating formation delimited by at least one tissue connecting surface such that the needle passes completely through the stomach tissue connecting the tissue connecting surface. of the elongated body. The elongate body further includes a suture passage channel. It is also a purpose of the present invention to provide a method for performing gastric reduction surgery. The method was achieved by possessing a gastric reduction apparatus as described above in the stomach, creating a vacuum control tissue of the stomach wall together with the at least one tissue connecting surface of the gastric reduction apparatus, passing through the minus one needle along with the shaft of the gastric reduction apparatus through the needle passage channel located adjacent to the tissue connecting surface, folding the needle and leaving behind a cord suture, releasing a pre-woven suture from the gastric reduction and pulling towards the pre-woven suture causing a pre-woven suture to attract by joining the stomach walls. Other purposes and advantages of the present invention will be apparent from the following detailed description when viewed in conjunction with the accompanying drawings, which establish certain embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a perspective view of gastric reduction apparatus of the present one in use. Figure 2 is a cross-sectional view showing the suture according to the present invention. Figure 3 is a perspective view of the gastric reduction apparatus. Figure 4 is a cross-sectional view of the gastric reduction apparatus. Figure 5 is a cross-sectional view of the gastric reduction apparatus with tissue attracted in contact with the tissue connection surface. Figures 6a and 6b show the release of the anchor during the application of the cord suture. Figure 7 is a cross-sectional view of an alternative embodiment of a gastric reduction apparatus in accordance with the present invention. Figure 8 is a cross-sectional view of the gastric reduction apparatus shown in Figure 7 with tissue attracted in contact with the tissue connection surface. Figure 9 is a cross-sectional view showing the suture according to the embodiment described with reference to figures 7 and 8. Figure 10 is a cross-sectional view showing the suture according to still another embodiment.

DESCRIPTION OF THE PREFERRED MODALITIES.

The detailed embodiments of the present invention are described herein. It should be understood, however, that the described embodiments are merely illustrative of the invention, which may exemplify in various ways. Accordingly, the details described herein should not be construed as limiting, but merely as the basis of the claims and as the basis for teaching to a person skilled in the art how to make and / or use the invention. With reference to figures 1, 2, 3, 4, 5, 6a and 6b, a first embodiment of an apparatus 10 and the surgical method of gastric reduction are described. In accordance with this invention, a gastric reduction apparatus 10 is provided which facilitates the secure connection of cord sutures 12a, 12b and a mattress stitch 14 to the gastric wall 16 allowing the creation of a transoral runner to the stomach 18 Although the present apparatus is described at this point to be used in the performance of gastric reduction surgery, those skilled in the art will appreciate the apparatus and the underlying concepts that can be applied in various soft tissue apposition procedures where the tissue is group either permanently or temporarily. In summary, the posterior and anterior gastric walls 20, 22 are joined transorally. The walls 20, 22 are secured to approximately 3 to 5 cm parallel to the lower curvature beginning considerably close to the Hiss angle and ending at a distance of approximately 10 to 12 cm. The present technique has proven to be an effective mechanism for weight reduction without the need to implement more elaborate surgical techniques. The gastric reduction apparatus 10 is formed and dimensioned to selectively attach it to the distal end 24 of a traditional endoscopic flexible gastroscope 26. The gastric reduction apparatus 10 is manipulated within the stomach 18 using traditional endoscopic manipulation techniques to position the gastric reduction apparatus 10 in the desired direction within the stomach 18. The gastric reduction apparatus 10 includes a proximal end and a distal end 30. The proximal end 28 is formed and dimensioned for secure attachment to the distal end 24 of the gastroscope 26 while the distal end 30 of a gastric reduction apparatus 10 is free to be cloned into the stomach 18. Although a preferred embodiment employs an apparatus secured to the distal end of a gastroscope, those skilled in the art will certainly appreciate that the apparatus can be formed with its own axis. The gastric reduction apparatus 10 includes an elongated body 32. The body 32 is generally sinusoidal with opposite anterior and posterior tissue connective surfaces 34, located along the upper and lower part of the sinusoidal body 32. As will be explained in more detail below, the tissue connecting surface 34, 36 is oriented such that a needle 38, 40 can substantially traverse both anterior or posterior walls completely 20, 22 in a single step. Regarding the amplitude of the sinusoidal body, the amplitude of the waves varies for its optimal use in each patient. The range of the sinusoidal waves is sufficient to attract the opposite anterior and posterior walls 20, 22 of the stomach 18 within a superimposed configuration such that a needle 38, 40 can pass respectively through the posterior or anterior wall 20, 22 for the purpose of placing cord sutures 12a, 12b in a manner that is explained below in great detail. While a specific sine wave is described according to a preferred embodiment of the present invention, those skilled in the art will undoubtedly appreciate that the scope of the sine wave and the exact shape of the wave can be varied without departing from the essence of the wave. present invention. According to a first embodiment, a double cord joint is used. Strictly speaking, the gastric reduction apparatus 10 only needs to offer a sufficient sinusoidal shape to position the respective anterior and posterior walls 20, 22 in an overlapping configuration such that the first needle 38 is passed through the anterior gastric wall 20 for placement of a first cord suture 12a and subsequently of a second cord suture 12b. Although the use of two needles in accordance with the preferred embodiment of the present invention is contemplated, those skilled in the art will undoubtedly appreciate that a single needle can be employed in both placements of the first and second cord sutures. The gastric reduction apparatus 10 is composed of an elongated body 32 having a suction inlet 42. The additional apparatus 10 includes a series of suction holes 44 along the anterior and posterior tissue connection surfaces respectively 34, 36.

The suction holes 44 are in fluid communication with the suction inlet 42 and are formed and sized to attract tissue therein contained in the application of a vacuum within the gastric reduction apparatus 10. The suction holes 44 on opposite sides of the body 32 are oriented to simultaneously or sequentially attract the anterior wall of the stomach 20 and the posterior wall of the stomach 22 toward intimate contact with the anterior and posterior tissue connecting surfaces 34., 36 for the insertion of needles 38, 40 and the placement of sutures 12a, 12b in the manner explained below in great detail. Although an apparatus offering suction on opposite sides thereof is disclosed in accordance with a preferred embodiment of the present invention, those skilled in the art would appreciate that the apparatus be constructed with a simple suction side where it is desirable to apply sutures. cord in a multi-step procedure. The gastric reduction apparatus 10 also includes first and second needle passage channels 46, 48 respectively adjacent the anterior and posterior tissue connecting surfaces 34, 36. More specifically, the respective first and second needle passage channels 46. , 48 generally pass through the center of the sinusoidal waves defined by the anterior and posterior tissue connecting surfaces 34, 36 such that the needle 38, 40 passes entirely through the stomach tissue wall 16 in a manner described later in great detail. The gastric reduction apparatus 10 includes additional suture passage channels 50 respectively aligned and associated with the first and second needle passage channels 46, 48. The suture passage channels 50 are formed and sized to allow the passage of sutures of the suture. cord 12a, 12b through them during the use of the present apparatus 10. In practice, and in accordance with the first embodiment, the gastric reduction apparatus 10 uses suction, via inlet suction 42 to attract the anterior and posterior gastric walls 20, 22 within the suction holes 44 and toward a more intimate contact with the anterior and posterior tissue connecting surfaces 34, 36. The tissue is held in a corrugated configuration, wherein the corrugations are larger in depth than the thickness of the fabric. In this way, the first and second long needles 38, 40 are respectively passed through the first and second needle passage channels 46, 48 and the corrugated tissue in a manner that they pass completely through the anterior and posterior gastric walls. 22. It is contemplated that a set of temporary tabs will be used to advance at an angle to the axis of the apparatus to add a measure of tissue grip during the present procedure. Once the gastric reduction device 10 is positioned within the stomach 18 and the vacuum is created to support the tissue of the anterior and posterior stomach walls 20, 22 within the corrugations of the posterior and anterior tissue connecting surfaces 34 , 26 of the gastrical reduction apparatus O, the first and second long needles 38, 40 are passed respectively along the axis of the apparatus 10 through the needle passage channels 46, 48 located adjacent to the opposite suction holes 44. and to the anterior and posterior tissue connecting surfaces 34, 36. Referring to Figures 6a and 6b, at the head of each of the needles 38, 40 the suture 12a, 12b is quickly placed through the use of an anchor 51 secured to the distal end thereof. As those skilled in the art will appreciate, the anchor 51 is supported within a distal recess 53 formed in the needle 38, 40 while a distal end of the needle 38, 40 reaches its desired location in which the anchor 51 traps tissue after the withdrawal of the needle 38, 40 and the anchor 51 is released from the distal hollow 53 to secure the suture at the desired location. As those skilled in the art will appreciate, although Figures 6a and 6b only show the first needle 38, the description also applies to the second needle 40. According to each of the needles 38, 40 pass through the passage channels of the needle 38. needle 46, 48 of the gastric reduction apparatus 10, conventional needles 38, 40 pierce the undulations in the stomach wall 16, passing alternately through the mucosa, muscle layer, and serosa, and back through the stomach wall 16 in a reverse direction resulting in full thickness penetration. Total control of the suction of the anterior and posterior stomach walls 20, 22 ensures that the respective first and second needles 38, 40 never touch the adjacent organs. Once the suture 12a and 12b is completely drawn through the tissue, the anchor 51 is released from within the distal recess 53 of the needle 38, 40 and the needle 38, 40 is retracted. With the needle 38, 40 removed, the anchor 51 and the cord suture 12a and 12b are left behind as shown in Figures 2, 6a and 6b. The result of the cord suture 12a and 12b is placed in both the posterior and anterior walls 20, 22 of the stomach in the manner described below. Once the cord suture 12a and 12b is appropriately positioned within both the posterior and anterior walls 20, 22 of the stomach 18, a zigzag mattress stitch 14 preassembled in the gastric reduction apparatus 10 is released from the gastric reduction apparatus 10. The zigzag mattress stitch suture 14 is secured to the cord sutures 12a and 12b in such a way that attracting on the mattress stitch suture 14 causes the anterior and posterior gastric walls 20, 22 to be attracted together in a manner creating a transoral cavity through the stomach (see figure 2). As shown in Figure 3, the mattress stitch suture 14 is woven around the apparatus in such a way that it alternately moves up and down the cord suture line along both anterior surface connecting surface walls. and subsequent 34, 36. Although the use of a mattress stitch is disclosed in accordance with the preferred embodiment of the present invention, those skilled in the art will undoubtedly appreciate that another stitch pattern is used without deviating from the essence of the stitch. the present invention. With reference to Figures 7, 8 and 9, an alternate embodiment is disclosed wherein only a single needle passage is necessary for the application of the cord suture 112 through the posterior and anterior walls 120, 122 of the stomach. . More particularly, the body 132 of the gastric reduction apparatus 110 includes sinusoidal undulations that are very extreme such that the anterior and posterior walls 120, 122 of the stomach can be simultaneously attracted within the gastric reduction apparatus 110 in an overlapping configuration. While a specific sine wave is shown in accordance with a preferred embodiment of the present invention, those skilled in the art will undoubtedly appreciate that the surface of the sine wave and the exact shape of the wave may vary without departing from the essence of the present invention. . Therefore, a conventional needle 138 is pushed through the needle passage channel 146 of the gastric reduction apparatus 110 such that it pierces the posterior and anterior walls 120, 122 in alternating sequence. When the apparatus 1100 is removed, the cord suture 112 remains and is secured to both the posterior and anterior walls 120, 122 of the stomach 118. The zigzagging mattress stitch 114 is maintained in the same way and zigzags over the gastric reduction apparatus 110. similar to when the cord suture 112 is fitted with a simple suture near the anterior and posterior walls 120, 122 of the stomach 118. A suture fastener 152 at the proximal end of the suture 112 will be sufficient to maintain the suture 112 in the suture 112. tight position maintaining the anterior and posterior walls 120, 122 in a joint relationship forming the transoral cavity. According to an additional embodiment even, and referring to Figure 10, it is considered that the needles 238, 240 passing through the corrugations of the previously disclosed apparatus 10 can remain in place as opposed to the application of the suture of of cord to the anterior and posterior walls. According to this modality, the ends of the needles 238, 240 will be terminated by adding balls that do not cause damage to the fabric 254a, 254b, 256a, 256b at both ends. The mattress stitch suture 214 will then be detachably connected to the apparatus 10. As with the previously described embodiment, the needle 238, 240 is passed through the apparatus 10, passes in and out of the pre-woven suture 214 as it passes through. of the tissue. In that way, the pre-woven suture 214 is crimped with the normal needles 238, 240 on both sides of the apparatus 10. After removal of the gastric reduction apparatus 10 from the body, the pre-woven mattress stitch 214 serves to bring the the two needles 238, 240 together. Regardless of the mode employed according to the present invention, several advantages are offered. In particular, the present invention offers a one-shot mechanism without instrument change. In addition, the gastric pouch created in accordance with the present invention is highly standardized to be repeatable. The suction that attracts the stomach within the mechanism also establishes the cord without compromising the organs around the stomach and achieves it in a relatively fast procedure. In addition, the present procedure requires only local anesthesia, minimal changes in the body, is reversible and revisable and can be performed in stages. Inspection of the procedure should be performed using a distally mounted camera (CCD or CMOS) that is connected inside the instrument to ensure that the gastric wall is bent in the correct orientation. The camera should be mounted on an articulated or retroflexible arm to visualize backwards with respect to the instrument. Alternatively, a two-chamber unit should be used to show the two views on one side of the stomach. In addition, various knot techniques can be employed in accordance with the present invention. For example, girdling the fabric should be accomplished by pulling a sliding knot, tied off the body, under the mouth and esophagus. Reinforcement materials may be used to improve the fixation, for example, mesh and fastening may be employed within the essence of the present invention. Since the preferred embodiments have been shown and described, it will be understood that there is no intention to limit the invention with said description, rather, it is intended to cover all modifications and construction alternatives that fall within the essence and scope of the invention.

Claims (14)

NOVELTY OF THE INVENTION CLAIMS

1. - A gastric reduction device that facilitates the creation of a transoral linear runner through the stomach, comprising an elongate body including a proximal end and a distal end, the elongated body is generally sinusoidal with at least one connection surface of fabric oriented in such a way that the ne will pass through it; the elongated body also includes at least one ne passage channel formed respectively adjacent to the at least one tissue connection surface, the at least one ne passage generally passing through the center of the wave forms sinusoids defined by at least one tissue connecting surface such that a ne will pass entirely through the stomach tissue by contacting the tissue connecting surface of the elongated body; The elongate body also includes a suture passage channel.

2. The gastric reduction apparatus according to claim 1, further characterized in that the elongated body is formed and sized for the selective adhesion of a distal end of a flexible endoscopic gastroscope.

3. The gastric reduction apparatus according to claim 1, further characterized in that the elongated body includes connecting surfaces of anterior and posterior anterior tissue along the upper and lower part of the elongate body.

4. The gastric reduction apparatus according to claim 3, further characterized in that the elongate body includes first and second ne passage channels respectively formed adjacent the anterior and posterior tissue connecting surfaces.

5. The gastric reduction apparatus according to claim 4, further characterized in that the first and second ne passage channels pass through the center of the sinusoidal waveforms defined by the anterior and posterior tissue connecting surfaces of such that the ne passed entirely through the stomach tissue by contacting the anterior and posterior tissue connecting surfaces of the stomach wall.

6. The gastric reduction apparatus according to claim 3, further characterized in that the elongate body includes a suction inlet and at least one suction hole along the respective anterior and posterior tissue connection surfaces.

7. The gastric reduction apparatus according to claim 3, further characterized in that the scope of the sine wave defining the anterior and posterior tissue connecting surfaces is to attract the anterior and posterior anterior walls of the stomach in an overlying configuration of such that a ne passes respectively through the posterior or anterior walls to place cord sutures.

8. - The gastric reduction apparatus according to claim, further characterized in that the elongated body is formed and sized by the creation of a cord suture.

9. The gastric reduction apparatus according to claim 8, further characterized in that the elongated body is formed and sized by the creation of a double cord suture.

10. The gastric reduction apparatus according to claim 1, further characterized in that the elongated body includes a suction inlet and a series of suction holes along at least one tissue connecting surface.

11. The gastric reduction apparatus according to claim 1, further characterized in that the elongated body includes sinusoidal corrugations in such a manner that the anterior and posterior walls of the stomach are simultaneously attracted within the gastric reduction apparatus in an overlapping configuration which allows a single ne to simultaneously pierce both the anterior and posterior walls of the stomach.

12. The gastric reduction apparatus according to claim 11, further characterized in that the elongated body includes a single needle passage channel.

13. The gastric reduction apparatus according to claim 1, further characterized in that the needle includes means for reducing trauma positioned at both ends thereof.

14. The gastric reduction apparatus according to claim 1, further characterized in that it further includes a pre-woven suture positioned around the elongate body.