METHODS FOR PERFORMING GASTROPLASTY
Methods for performing gastroplasty include reducing the effective volume or cross-sectional area of the stomach via approximation of gastric tissue. Such reduction preferably is achieved endoluminally, either with or without laparoscopic ports. In one variation, a sleeve, pouch, Magenstrasse and Mill, Vertical Banded Gastroplasty (“VBG”), etc., is formed within the stomach by approximating opposing anterior and posterior segments or ridges of the stomach wall at locations inferior to the gastroesophageal junction. In another variation, opposing walls of the stomach are approximated at a plurality of substantially random locations to reduce an effective volume of the stomach. In yet another variation, both a sleeve and random approximations are formed, the random approximations preferably disposed in a portion of the stomach excluded by the sleeve. In still another variation, opposing walls of the stomach are approximated over significant lengths at random or specified locations.
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This application is a divisional of U.S. application Ser. No. 10/841,233 filed May 7, 2004, which is incorporated by reference in its entirety.
STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED RESEARCH OR DEVELOPMENTNOT APPLICABLE
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BACKGROUND OF THE INVENTION Field of the InventionThe present invention relates to methods for reducing the effective cross-sectional area of a gastro-intestinal (“GI”) lumen.
Extreme or morbid obesity is a serious medical condition pervasive in the United States and other countries. Its complications include hypertension, diabetes, coronary artery disease, stroke, congestive heart failure, multiple orthopedic problems and pulmonary insufficiency with markedly decreased life expectancy.
Several surgical techniques have been developed to treat morbid obesity, including bypassing an absorptive surface of the small intestine, bypassing a portion of the stomach, and reducing the stomach size, e.g., via Vertical Banded Gastroplasty (“VBG”) or Magenstrasse and Mill. These procedures may be difficult to perform in morbidly obese patients and/or may present numerous potentially life-threatening postoperative complications. Thus, less invasive techniques have been pursued.
U.S. Pat. Nos. 4,416,267 and 4,485,805 to Garren et al. and Foster, Jr., respectively, propose disposal of an inflated bag within a patient's stomach to decrease the effective volume of the stomach that is available to store food. Accordingly, the patient is satiated without having to consume a large amount of food. A common problem with these inflated bags is that, since the bags float freely within the patient's stomach, the bags may migrate to, and block, a patient's pyloric opening, the portal leading from the stomach to the duodenum, thereby restricting passage of food to the remainder of the gastro-intestinal tract.
Apparatus and methods also are known in which an adjustable elongated gastric band is disposed around the outside of a patient's stomach near the esophagus to form a collar that, when tightened, squeezes the stomach into an hourglass shape, thereby providing a stoma that limits the amount of food that a patient may consume comfortably. An example of an adjustable gastric band is the LAP-BAND® made by INAMED HEALTH of Santa Barbara, Calif.
Numerous disadvantages are associated with using the adjustable gastric band. First, the band may be dislodged if the patient grossly overeats, thereby requiring additional invasive surgery to either reposition or remove the band. Similarly, overeating may cause the band to injure the stomach wall if the stomach over-expands. The laparoscopic disposal of the gastric band around the stomach requires a complex procedure, requires considerable skill on the part of the clinician, and is not free of dangerous complications.
In view of the drawbacks associated with prior art techniques for treating morbid obesity, it would be desirable to provide improved methods for performing gastroplasty.
SUMMARY OF THE INVENTIONImproved methods for performing gastroplasty are achieved by reducing the effective volume or cross-sectional area of the stomach via approximation of gastric tissue. Such reduction preferably is achieved endoluminally, either with or without laparoscopic ports. The methods generally comprise delivering securing elements, such as anchors and/or suture, on opposing sides of the gastric lumen, and then approximating the opposing walls of the lumen via the securing elements. Preferably, serosal-to-serosal folds of gastric tissue are formed on opposing sides of the gastric lumen, and are then approximated. A variety of methods for forming, securing and approximating the opposing serosal-to-serosal folds are described. In one variation, the opposing folds are individually formed and secured, and are then approximated and secured to one another. The individual folds may be reinforced after initial securing. In an alternative variation, the folds are not individually secured, but rather are only secured to one another after approximation. The approximated folds also may be reinforced after initial securing.
In addition to approximation of individual opposing folds of gastric tissue, opposing ridges of serosal-to-serosal folds may be formed and approximated. In this manner, a sleeve or an approximation of significant length may be formed. A variety of methods for forming, securing and approximating the opposing ridges are described.
In one variation, a sleeve, pouch, Magenstrasse, Vertical Banded Gastroplasty (“VDG”), etc. is formed within the stomach by approximating opposing anterior and posterior segments or ridges of the stomach wall at locations inferior to the gastroesophageal junction. In another variation, opposing walls of the stomach are approximated at a plurality of substantially random locations to reduce an effective volume of the stomach. In yet another variation, both a sleeve and random approximations are formed, the random approximations preferably disposed in the larger portion of the stomach excluded by the sleeve. In still another variation, opposing walls of the stomach are approximated over significant lengths at random or specified locations.
Improved methods for reducing the effective volume or cross-sectional area of a gastro-intestinal (“GI”) lumen via approximation of gastric tissue are described. The methods generally comprise delivering securing elements, such as anchors and/or suture, e.g. knotted suture, on opposing sides of the gastric lumen, and then approximating the opposing walls of the lumen via the securing elements. With reference to
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Prior art gastroplasty techniques typically achieve gastroplasty by manipulating or operating on the exterior of a patient's stomach. However, in order to minimize invasiveness, it is desirable to endoluminally perform gastroplasty, for example, via instruments inserted down a patient's throat or via instruments inserted laparoscopically and transgastrically within the gastric lumen. Although tissue approximation may be achieved endoluminally utilizing the method of
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The serosal-to-serosal tissue folds optionally may be reinforced to enhance long-term durability. In
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Securing element 10 illustratively comprises first and second suture loops 12a and 12b that may be grasped to adjust the length of suture disposed between the first and second tissue folds to approximate the folds. For example, one or both of suture loops 12a and 12b may be pulled away from the tissue folds while one or both of anchoring elements 13a and 13b of securing element 10 are held stationary or advanced toward the folds. Alternatively, the suture loop(s) may be held stationary while the anchoring element(s) are advanced. The anchoring elements preferably comprise a ratcheting mechanism that adjusts, e.g. reduces, and maintains the length of suture 11 disposed between the anchoring elements (thereby approximating the tissue folds) upon such force application. Illustrative ratcheting mechanisms for securing element 10 are described, for example, in Applicant's co-pending U.S. patent application Ser. No. 10/735,030, filed Dec. 12, 2003, which previously has been incorporated herein by reference.
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As will apparent to those of skill in the art, endoluminal pouch or Magenstrasse gastroplasty optionally may be achieved without forming tissue fold ridges R) and R2. For example, the opposing walls of stomach S may be approximated to form Magenstrasse Ma in a manner similar to that described hereinabove with respect to
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The side-sectional view of
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Pouch P and the approximations at random locations L may be formed concurrently or successively in any order. Random locations L preferably are confined to the region of stomach S disposed outside of sleeve or pouch P to ensure safe passage of food through the pouch. Providing pouch P in conjunction with approximations at random locations L may more fully restrict the stomach, thereby enhancing a sensation of satiety, prolonging the resident time of food within the stomach, and/or reducing a quantity of food that may be comfortably consumed.
Referring now to
Although various illustrative embodiments are described above, it will be evident to one skilled in the art that various changes and modifications are within the scope of the invention. It is intended in the appended claims to cover all such changes and modifications that fall within the true spirit and scope of the invention.
Claims
1. A method for performing gastroplasty, the method comprising:
- inserting a securing element down the throat of a patient to a position within the stomach of the patient;
- forming tissue folds on opposing walls of a patient's stomach;
- approximating the tissue folds to thereby form a sleeve or pouch within the patient's stomach; and
- securing the approximated tissue folds forming a sleeve or pouch with the securing element.
2. The method of claim 1, further comprising reinforcing the approximated and secured tissue folds.
3. The method of claim 1, further comprising endoluminally approximating tissue folds at substantially random locations confined to regions of the stomach disposed outside of the sleeve or pouch.
4. The method of claim 3, further comprising securing the approximated tissue folds at substantially random locations.
5. The method of claim 4, further comprising reinforcing the approximated and secured tissue folds at substantially random locations.
6. The method of claim 1, wherein approximating the tissue folds to thereby form a sleeve or pouch further comprises endoluminally forming a sleeve or pouch that extends from a location just inferior to the patient's gastroesophageal junction to a location opening to the patient's antral mill.
7. The method of claim 6, further comprising reinforcing the approximated and secured tissue folds.
8. The method of claim 1, wherein approximating the tissue folds further comprises approximating the tissue folds over a significant length greater than or equal to about 1 cm.
9. The method of claim 8, further comprising reinforcing the approximated and secured tissue folds.
10. A method for performing gastroplasty, the method comprising:
- advancing instruments down the throat of a patient to a position within a the patient's stomach;
- forming a plurality of tissue folds secured by tissue anchors on opposing walls of the patient's stomach; and
- endoluminally forming a pouch or sleeve within the stomach by approximating the tissue folds on the opposing walls of the stomach with the instruments, wherein the pouch or sleeve extends from a location just inferior to the patient's gastroesophageal junction to a location opening to the patient's antral mill, and wherein the pouch or sleeve is partially defined by a portion of the lesser curvature of the patient's stomach.
11. The method of claim 10, further comprising securing the approximated tissue folds forming a sleeve or pouch with a first plurality of tissue anchors.
12. The method of claim 11, further comprising reinforcing the approximated and secured tissue folds.
13. The method of claim 1 further comprising reinforcing the approximated and secured tissue folds with a second plurality of tissue anchors.
Type: Application
Filed: Apr 20, 2009
Publication Date: Aug 20, 2009
Applicant: USGI MEDICAL, INC. (San Clemente, CA)
Inventors: Lee L. SWANSTROM (Portland, OR), Richard C. EWERS (Fullerton, CA), Tracy D. MAAHS (Rancho Santa Margarita, CA), Eugene G. CHEN (Carlsbad, CA), Vahid SAADAT (Atherton, CA)
Application Number: 12/426,894
International Classification: A61B 17/08 (20060101);