MXPA06008894A - Single pass gastric restriction with a corkscrew style wall anchor - Google Patents

Abstract

A gastric reduction apparatus endoscopically draws stomach walls into apposition. The apparatus includes an applicator body having a proximal end and a distal end. The applicator body also includes a suction slot shaped and dimensioned for housing a corkscrew anchor. A firing mechanism is associated with the corkscrew anchor for rotation of the corkscrew anchor in a manner causing the corkscrew anchor to penetrate and engage tissue brought adjacent the suction slot. A method for gastric reduction is achieved by introducing a gastric reduction apparatus as disclosed above within the stomach of an individual, applying the corkscrew anchor to a stomach wall and drawing stomach walls together to create a cavity within the stomach.

Description

GASTRIC RESTRICTION OF A SINGLE STEP WITH A WALL ANCHOR SACACORCHOS STYLE FIELD OF THE INVENTION The present invention relates to gastric reduction surgery. More particularly, the invention relates to a method and apparatus for carrying out gastric reduction surgery endoscopically through the implementation of a corkscrew or helical style wall anchor.

BACKGROUND OF THE INVENTION Pathological obesity is a serious medical condition. In fact, pathological obesity has become highly pervasive in the United States, as well as other countries, and the trend seems to be orienting in a negative direction. Complications associated with pathological obesity include hypertension, diabetes, coronary artery disease, stroke, congestive heart failure, multiple orthopedic problems and pulmonary insufficiency, with markedly decreased life expectancy. With this in mind, and as those skilled in the art will certainly appreciate, the monetary and physical costs associated with pathological obesity are substantial. In fact, it is estimated that the costs related to obesity exceed 100 billion dollars in the United States alone. A variety of surgical procedures have been developed to treat obesity. One of the most commonly performed procedures is Roux-en-Y gastric bypass (RYGB). This procedure is highly complex, and is used to treat people who exhibit pathological obesity. Even though this is a complex operation, more than 100,000 procedures are performed annually in the United States alone. Other forms of bariatric surgery include Fobi bag, biliopancreatic diversion, and gastroplastic stapling or "stomach stapling". In addition, implantable devices are known that limit the passage of food through the stomach and affect satiety. RYGB involves the movement of the jejunum to a high position, using a Roux-en-Y loop. The stomach is completely divided into two unequal portions (a smaller upper portion and a larger lower gastric pouch), using an automatic stapling device. The upper pouch typically measures less than about 20 cm 3, while the larger lower pouch generally remains intact, and continues to secrete stomach juices that flow through the bowel path. A segment of the small intestine is then taken from the lower abdomen and joined with the upper pouch to form an anastomosis created through an opening of 1.27 cm, also called the stoma. This segment of the small intestine is called the "Roux's 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 bound duodenum segment, are then reconnected to form another anastomotic connection with the Roux handle at a site approximately 50 to 150 cm from the stoma, typically using a stapling instrument. It is in this connection that the digestive juices of the stomach, pancreas and liver of the bypass enter the jejunum and ileum to aid in the digestion of the food. Due to the small size of the upper pouch, patients are forced to eat at a slower pace, and are satiated much more quickly. 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 quite long and painful. In view of the highly invasive nature of the common RYGB procedure, other less invasive procedures have been developed. The most common form of gastric reduction surgery includes the application of vertical staples along the stomach to create an adequate pouch. This procedure is commonly performed laparoscopically and, as such, requires substantial preoperative, operative and post-operative resources. With the foregoing in mind, procedures are needed that allow the performance of gastric reduction surgery in a time-efficient and patient-friendly manner. The present invention provides said method and an associated apparatus.BRIEF DESCRIPTION OF THE INVENTION It is, therefore, an object of the present invention to provide a gastric reduction apparatus for endoscopically placing stomach walls. The apparatus includes the body of an applicator that includes a proximal end and a distal end. The body of the applicator also includes a suction groove configured and sized to receive a corkscrew anchor. A trigger mechanism is associated with the corkscrew anchor for rotation of the corkscrew anchor in a manner that causes the corkscrew anchor to penetrate and mesh tissue positioned adjacent to the suction slot. It is also an object of the present invention to provide a method for gastric reduction. The method is achieved by introducing a gastric reduction device as described above into an individual's stomach, applying the corkscrew anchor to a stomach wall, and joining the stomach walls to create a cavity within the stomach. Other objects and advantages of the present invention will become apparent from the following detailed description when viewed in conjunction with the accompanying drawings, which set forth certain embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a perspective view of the corkscrew anchors of the present invention used in gastric reduction surgery. Figure 2 is a perspective view of a corkscrew anchor in accordance with the present invention. Figure 3 is a side view of the present gastric reduction apparatus. Figures 4 and 5 are detailed views of the applicator body of the gastric reduction apparatus with and without the corkscrew anchor positioned therein, respectively. Figures 6, 7, 8 and 9 are cross-sectional views showing the operation of the gastric reduction apparatus. Figure 10 is a detailed inside view of the gastric reduction apparatus.

DETAILED DESCRIPTION OF THE PREFERRED MODALITY The detailed embodiment of the present invention is described herein. However, it should be understood that the described mode is only an example of the invention, which can be described in various ways. Therefore, the details described herein should not be construed as limiting, but only as the basis for the claims and as a basis for teaching one skilled in the art how to make and / or use the invention. With regard to the various figures, an endoscopic gastric reduction apparatus 10 is described for efficiently performing gastric reduction surgery. The gastric reduction apparatus 10 functions by applying respective corkscrew anchors 12 to the anterior and posterior gastric walls 14, 16 for the creation of a closure generated by pulling the anterior and posterior walls 14, 16. In general, the gastric reduction apparatus 10 uses suction to put, respectively, the anterior and posterior stomach walls 14, 16 in contact with the gastric reduction apparatus 10. Then, retainer bars 18, 20 are advanced through the access openings of the gastric reduction apparatus 10. , and through the tissue maintained therein to firmly hold the anterior and posterior stomach walls 14, 16 adjacent to the apparatus 10. The stomach tissue is maintained in a configuration in which the spaces in the gastric reduction apparatus 10 are spaced apart. to the same extent as the corkscrew anchors 12, and the spaces will allow a full thickness penetration of the fabric. In particular, the corkscrew anchors pass alternately through mucosa, muscle and serous layer, and then again through the stomach wall in a reverse rotational direction. This results in full thickness penetration of the stomach wall. The tight retention of the suction on the tissue ensures that the corkscrew anchors 12 never touch adjacent organs. The vacuum is then replaced with light insufflation to remove the walls of the anterior and posterior stomach 14, 16 of the gastric reduction apparatus 10. Once the corkscrew anchors 12 are installed, the gastric reduction apparatus 10 is removed to allow the cinching of a pre-woven suture 22 that passes through the corkscrew anchors 12, to form the gastric pouch In particular, this results in the application of two opposing corkscrew anchors 12 which are subsequently attracted through the use of a pre-woven mattress stitch 22 cinched down on the two corkscrew anchors 12. Although a mattress stitch is described in accordance with a preferred embodiment of the present invention, those skilled in the art will appreciate that other stitch designs may be used without departing from the spirit of the present invention. Referring to Figures 3 to 10, the gastric reduction apparatus 10 includes a longitudinally extending body 24 of the applicator having a distal end 26 and a proximal end 28. The body 24 of the applicator has anterior and posterior suction grooves 30. , 32 configured and sized for the housing of respective corkscrew anchors 12. The suture 22 is pretreated to access the suction grooves 30, 32 and the corkscrew anchors 12 held respectively therein. The suture 22 is held in place within the suction grooves 30, 32 by the retaining member 23 around which the suture 22 is threaded in a predetermined manner by alternately joining the anterior and posterior sides that allow attachment to the corkscrew anchors 12 and the release of the body 24 from the applicator once the anchor members 12 are secured to the stomach wall. Since the anterior and posterior sides of the body 24 of the applicator are substantially identical, only the anterior suction side will be described in detail. The anterior suction slot 30 includes a series of suction holes 34 formed within the central wall 36 of the body 24 of the applicator. The central wall 36 divides the anterior suction slot 30 from the rear suction slot 32, and is substantially hollow for the creation of a vacuum in accordance with the present invention. The anterior suction slot 30 is configured and sized to receive tissue therein. The anterior suction groove 30 extends along the body 24 of the applicator defining a cavity 36 in which the anterior stomach tissue can be attracted respectively during the installation of the corkscrew anchor 12. The body 24 of the applicator also includes a storage section 40 adjacent to the anterior suction slot 30, in which the corkscrew anchor 12 is stored prior to installation in accordance with the present invention. The storage section 40 is partially covered and positioned directly adjacent to the anterior suction slot 30. In this way, and as will be discussed below in greater detail, the corkscrew anchor 12 will move distally within the body 24 of the applicator according to the corkscrew anchor 12 is rotated and threaded on the tissue of the stomach wall 14, 16. With respect to the corkscrew anchor 12, it is formed in the shape of a spiral, and includes a first pointed end configured and sized for penetration through stomach tissue in the manner discussed below. The corkscrew anchor is preferably manufactured from nitinol, titanium, stainless steel, plastics or absorbable PDS or PGA (polyglycolic acid). As for the diameter of the anchor, it must be configured and sized with a sufficient diameter to pass through the tissue to which it is secured without adversely affecting the fabric. According to a preferred embodiment, the proximal end of the body 24 of the applicator includes a fixation member 44 provided with tines, configured and dimensioned for attachment to the distal end of a shaft 46 that couples the body 24 of the applicator to the handle 48 of the apparatus gastric reduction 10 located at the proximal end of the apparatus 10. The fixation member 44 places the body 24 of the applicator in communication with the suction line of the shaft 46 for creation of a vacuum within the anterior and posterior suction grooves., 32. As discussed above, the anterior and posterior suction grooves 30, 32 are configured and dimensioned to allow stomach tissue to be sucked therein, so that the tissue comes into intimate contact with the body 24 of the applicator for penetration of the corkscrew anchor 12 according to the corkscrew anchor 12 is rotated. Tissue retention bars 18, 20 are also provided for tracking the corkscrew anchor 12. It is also contemplated that the retention rods 18, 20 can be used to firmly hold the tissue within the anterior and posterior suction grooves 30, 32 during the application of the corkscrew anchors 12. In particular, the first and second fabric retaining bars 18, 20 are positioned on opposite sides of each of the respective anterior and posterior suction grooves 30, 32. The retainer bars 18, 20 move longitudinally within the suction grooves 30, 32 to allow engagement with tissue sucked into the suction grooves 30, 32. The tissue retainer bars 18, 20 are controlled by means of cables (not shown) extending between the body 24 of the applicator and the handle 48 at the proximal end of the gastric reduction apparatus 10. As mentioned briefly above, the gastric reduction apparatus 10 further includes a handle 48 on its proximal end. The handle 48 is generally opposite the body 24 of the applicator positioned at the distal end of the apparatus 10. The two ends are connected by the shaft 46, through which runs a meshing shaft 50 for firing the corkscrew anchor 12, a suction line 51 for creating a vacuum with the suction slots 30, 32, and cables for the control of the first and second retainer bars 18, 20. The engagement shaft 50 of the trigger mechanism is coupled to the body 24 of the applicator for rotating the corkscrew anchors 12 in a form which will be discussed in more detail below. With this in mind, the meshing shaft 50 includes a proximal end connected to a knob 52 on the handle 48 for manual rotation of the meshing shaft 50. The meshing shaft 50 also includes a distal end connected to triggering gears 54 (for means of a central gear 56) housed within the body 24 of the applicator for controlled rotation of the corkscrew anchor 12 during installation. According to a preferred embodiment of the present invention, the central gear 56 drives the series of firing (or planetary) gears 54. In practice, the gastric reduction apparatus 10 is introduced orally until the distal end of the apparatus 10, that is, the body 24 of the applicator, reaches the stomach. The gastric reduction apparatus 10 is positioned at the desired location within the stomach for application of the corkscrew anchors 12 in the posterior or anterior walls 14, 16. Once the body 24 of the applicator of the gastric reduction apparatus 10 is properly positioned within the stomach (see Figure 6), suction is drawn into the anterior and posterior suction grooves 30, 32, and on the anterior and posterior walls 14, 16 of the stomach, until the stomach tissue is placed in the grooves of suction 30, 32 (see Figure 7). The corkscrew anchors 12 are then rotated and advanced longitudinally into the anterior and posterior suction grooves 30, 32. The first and second retainer bars 18, 20 prevent the corkscrew anchors 12 from coming out of the suction grooves. 30, 32 (see Figure 8). The firing of the corkscrew anchors 12 is achieved by rotation of the corkscrew firing gears 54 which are releasably engaged to the corkscrew anchors 12. The corkscrew firing gears 54 are caused to rotate by rotation of the central gear 56 which is driven by the gear shaft 50. The gear shaft 50 is finally connected to the knob 52 on the handle 48, so that the general practitioner performing the procedure can control the rotation of the corkscrew anchors 12, and finally the installation of the corkscrew anchors 12. After the corkscrew anchors 12 are triggered, the first and second cork bars retention 18, 20 are retracted, and light insufflation is applied. The corkscrew anchors 12 at this point have been spirally moved through the pre-woven suture 22 held in place by retention members 23, and the suture 22 can then be used to cinch the corkscrew anchors 12 together to form the restriction. gastric (see Figure 9). The suture is attached with slots or releasable tape. The tips of the respective corkscrew anchors 12, spiraling forward, advance through segments of the suture path, so that the suture 22 and the corkscrew anchors 12 on each side of the device 10 are operatively coupled during the extraction of the suture. device (see figures 1, 4, 6, 7, 8 and 9). The suture 22 is then cinched, placing the anterior and posterior walls 14, 16 of the stomach in apposition. A suture clasp is placed over a proximal end of the suture to retain the apposition of the anterior and posterior walls. Alternatively, the suture can be tied to retain apposition. In addition, tissue adhesive can be used in conjunction with the anchor, to improve the seal resulting therefrom. Fibrin-based vegetable gums, such as those available from Ethicon, could be used to adhere tissue. Although the preferred embodiments have been shown and described, it will be understood that there is no attempt to limit the invention using such a description, but rather it is intended to encompass all modifications and alternate constructions that are within the spirit and scope of the invention.

Claims (16)

NOVELTY OF THE INVENTION CLAIMS

1. - A gastric reduction apparatus for endoscopically apposing stomach walls, comprising: the body of an applicator including a proximal end and a distal end, the body of the applicator also including a suction slot configured and sized for housing a corkscrew anchor; and a trigger mechanism associated with the corkscrew anchor for rotation of the corkscrew anchor in a manner that causes the corkscrew anchor to penetrate and mesh tissue positioned adjacent the suction slot.

2. The gastric reduction apparatus according to claim 1, further characterized in that the body of the applicator includes an anterior suction slot and a posterior suction slot.

3. The gastric reduction apparatus according to claim 2, further characterized in that a corkscrew anchor is housed within each of the anterior suction slot and the posterior suction slot.

4. The gastric reduction apparatus according to claim 1, further characterized in that the suction slot includes at least one retainer bar to assist in guiding the corkscrew anchor into the suction slot.

5. - The gastric reduction apparatus according to claim 1, further characterized in that the firing mechanism is a gear assembly.

6. The gastric reduction apparatus according to claim 5, further characterized in that the gear assembly includes a gear shaft and trigger gears.

7. The gastric reduction apparatus according to claim 1, further characterized in that it includes a pre-woven suture attached to the corkscrew anchor.

8. A method for gastric reduction, comprising the following steps: introduction of a gastric reduction device into the stomach of an individual, the gastric reduction apparatus including the body of an applicator including a proximal end and a distal end, the body of the applicator also including a suction groove configured and dimensioned for housing a corkscrew anchor; a trigger mechanism associated with the corkscrew anchor for rotation of the corkscrew anchor in a manner that causes the corkscrew anchor to penetrate and mesh tissue positioned adjacent the suction slot; application of the corkscrew anchor to a wall of the stomach; and union of the stomach walls to create a cavity inside the stomach.

9. The gastric reduction apparatus according to claim 8, further characterized in that the application step includes the application of a corkscrew anchor to a wall of the anterior stomach, and application of a corkscrew anchor to a posterior stomach wall .

10. The method according to claim 9, further characterized in that it includes the step of stringing the corkscrew anchors with a suture.

11. The method according to claim 10, further characterized in that the threading step is performed before the application step of the corkscrew anchors.

12. The method according to claim 10, further characterized in that the suture is used to join the wall of the stomach to create a cavity.

13. The method according to claim 8, further characterized in that it includes the step of stringing the corkscrew anchor with a suture.

14. The method according to claim 13, further characterized in that the threading step is performed before the application step of the corkscrew anchor.

15. The method according to claim 13, further characterized in that the suture is used to join the stomach wall to create a cavity.

16. The method according to claim 13, further characterized in that the introduction step includes transorally introducing the gastric reduction device.