Methods for performing gastroplasty Number:7,520,884 from the United States Patent and Trademark Office (PTO) owispatent

Title: Methods for performing gastroplasty

Abstract: 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.

Patent Number: 7,520,884 Issued on 04/21/2009 to Swanstrom,   et al.

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Inventors:	Swanstrom; Lee L. (Portland, OR), Ewers; Richard C. (Fullerton, CA), Maahs; Tracy D. (Rancho Santa Margarita, CA), Chen; Eugene G. (Carlsbad, CA), Saadat; Vahid (Atherton, CA)
Assignee:	USGI Medical Inc. (San Clemente, CA)
Appl. No.:	10/841,233
Filed:	May 7, 2004

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Current U.S. Class:	606/153
Current International Class:	A61B 17/08 (20060101)
Field of Search:	623/23.65 600/29,30,37,104,106 128/898 606/153

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Primary Examiner: Matthews; William H
Attorney, Agent or Firm: Levine Bagade Han LLP Fowler; Charles C.

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Claims

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What is claimed is:

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; securing the approximated tissue folds with the securing element; and reinforcing the approximated and secured tissue folds.

2. The method of claim 1, wherein approximating the tissue folds further comprises approximating the tissue folds with instruments advanced down the patient's throat.

3. The method of claim 1, wherein forming tissue folds further comprises forming serosal-to-serosal tissue folds.

4. The method of claim 1, wherein securing the approximated tissue folds comprises securing the tissue folds with at least one securing element, and wherein approximating the tissue folds further comprises approximating the tissue folds via a ratcheting or tensioning mechanism of the securing element.

5. A method for performing gastroplasty, the method comprising: endoluminally forming a plurality of tissue folds secured by tissue anchors on opposing walls of a patient's stomach with instruments advanced down the throat of the patient: endoluminally approximating the opposing walls with instruments advanced down the throat of the patient; and reinforcing the approximated opposing walls using a plurality of tissue anchors.

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Description

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CROSS-REFERENCES TO RELATED APPLICATIONS

NOT APPLICABLE

STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

NOT APPLICABLE

REFERENCE TO A "SEQUENCE LISTING," A TABLE, OR A COMPUTER PROGRAM LISTING APPENDIX SUBMITTED ON A COMPACT DISK

NOT APPLICABLE

BACKGROUND OF THE INVENTION

Field of the Invention

The 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 post-operative 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.RTM. 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 INVENTION

Improved 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 ("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 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.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1D are schematic views of illustrative securing elements for use in performing gastroplasty;

FIGS. 2A-2C are schematic cross-sectional views illustrating a method of approximating opposing walls of a patient's gastric lumen;

FIG. 3 is a schematic side-sectional view illustrating formation and securing of a serosal-to-serosal fold;

FIGS. 4A-4D are schematic cross-sectional views illustrating a method of forming, securing and approximating opposing serosal-to-serosal folds, as well as optionally reinforcing the individual folds;

FIG. 5 is a schematic cross-sectional view illustrating an alternative method of forming, securing and approximating opposing serosal-to-serosal folds;

FIGS. 6A and 6B are schematic cross-sectional views illustrating another alternative method of forming, securing and approximating the folds, as well as optionally reinforcing the approximated folds;

FIG. 7 is a schematic cross-sectional view illustrating yet another alternative method of forming, securing and approximating the folds;

FIG. 8 is a schematic cross-sectional view illustrating still another method of forming, securing and approximating the folds;

FIGS. 9A and 9B are schematic side-sectional views illustrating a method of forming, securing and approximating opposing ridges of serosal-to-serosal gastric tissue folds;

FIGS. 10A and 10B are side and side-sectional views illustrating a method of approximating anterior and posterior segments or ridges of a patient's stomach to form a sleeve, Magenstrasse and Mill, VBG pouch, etc.;

FIGS. 11A and 11B are side and side-sectional views illustrating a method of approximating opposing sides of the gastric lumen at substantially random locations;

FIGS. 12A and 12B are side and side-sectional views illustrating a method of forming both a sleeve and random approximations within the gastric lumen; and

FIGS. 13A and 13B are side and side-sectional views illustrating a method of approximating opposing walls of the stomach over significant lengths.

DETAILED DESCRIPTION OF THE INVENTION

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 FIG. 1, exemplary securing elements for use in performing gastroplasty are described. In FIG. 1A, securing element 10 comprises suture 20 having at least one knot 22. Knots 22 may be pre-tied, or may be tied by the medical practitioner as needed.

In FIG. 1B, securing element 10 comprises anchor assembly 30 having proximal basket 32 and distal basket 34 that are connected by suture 33. The length of suture disposed between the proximal and distal baskets may be fixed or adjustable. Additional exemplary anchor assemblies are described in Applicant's co-pending U.S. patent application Ser. No. 10/612,170, filed Jul. 1, 2003, which is incorporated herein by reference in its entirety.

In FIG. 1C, securing element 10 comprises bar- or t-anchor assembly 40. Assembly 40 comprises proximal t-anchor 42 and distal t-anchor 44 that are connected by suture 43. As with anchor assembly 30, the length of suture disposed between the proximal and distal t-anchors may be fixed or adjustable. Exemplary apparatus and methods for delivering, deploying and adjusting anchor assembly 40 are described in Applicant's co-pending U.S. patent application Ser. No. 10/735,030, filed Dec. 12, 2003, which is incorporated herein by reference in its entirety.

In FIG. 1D, securing element 10 comprises multi-barbed device 50. Device 50 comprises substrate 52 having a plurality of barbs 54 that project therefrom. Barbs 54 illustratively project from both sides of substrate 52 in FIG. 1D, but it should be understood that the barbs alternatively may project from only one side of the substrate. Barbs 54 optionally may comprise hooks and/or loops, and a plurality of complementary hook/loop multi-barbed devices 50 may be used in conjunction to adhere such complementary devices together. Additional exemplary multi-barbed devices are described in Applicant's co-pending U.S. patent application Ser. No. 09/746,579, filed Dec. 20, 2000, which is incorporated herein by reference in its entirety. Additional variations of securing element 10 will be apparent to those of skill in the art.

Referring now to FIG. 2, a method of approximating opposing walls of a patient's gastric lumen is described. In FIG. 2A, wall W of stomach S is secured at a first location with securing element 10a. In FIG. 2B, wall W is secured at an opposing second location with securing element 10b. Elements 10a and 10b are connected by suture 11. In FIG. 2C, the length of suture disposed between elements 10a and 10b is reduced, thereby approximating the opposing locations of the stomach wall.

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 FIG. 2, securing elements 10 extend from the interior of stomach S to the exterior of the stomach. This may be undesirable for some high-risk patients or procedures, as a possibility exists of puncturing or otherwise damaging surrounding anatomy when placing securing elements across gastric wall W to the exterior of the gastric lumen.

With reference to FIG. 3, a method for endoluminally securing the wall at specified locations without exiting the gastric lumen is described. Gastric wall W of stomach S comprises multiple tissue layers, including mucosa M, muscularis Mu and serosa S. In FIG. 3, wall W has been plicated to form serosal-to-serosal tissue fold F. Exemplary methods and apparatus for plicating tissue wall W to form fold F 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 in its entirety. Tissue fold F has been secured with securing element 10 illustratively having a first portion disposed on a first side of fold F, a suture that extends through the fold, and a second portion disposed on the opposite side of fold F. The length of suture disposed between the first and second portions of securing element 10 preferably is adjustable to provide specified tensioning across fold F.

Referring now to FIG. 4, a method of forming, securing and approximating opposing serosal-to-serosal folds is described. In FIG. 4A, a first serosal-to-serosal fold F.sub.1 is formed and is secured at a first location within stomach S via first securing element 10a. Likewise, a second serosal-to-serosal fold F.sub.2 is formed and secured at a second opposing location within stomach S via second securing element 10b. A first portion of securing element 10c then is passed through first fold F.sub.1, while a second portion of the securing element is passed through second fold F.sub.2, as in FIG. 4B. In FIG. 4C, the length of suture disposed between the first and second portions of securing element 10c is reduced, thereby approximating opposing tissue folds F.sub.1 and F.sub.2. As will apparent to those of skill in the art, such approximation may be used to achieve endoluminal gastroplasty.

The serosal-to-serosal tissue folds optionally may be reinforced to enhance long-term durability. In FIG. 4D, an additional securing element has been placed through each serosal-to-serosal fold. Securing element 10d has been placed through fold F.sub.1, while securing element 10e has been placed through fold F.sub.2. Although folds F.sub.1 and F.sub.2 illustratively have been reinforced after they have been approximated, it will be apparent to those of skill in the art that the folds alternatively may be reinforced prior to, or during, approximation.

With reference to FIG. 5, an alternative method of forming, securing and approximating opposing serosal-to-serosal folds is described. In FIG. 5, first securing element 10a, which secures tissue fold F.sub.1, and second securing element 10b, which secures tissue fold F.sub.2, are connected to one another by suture 11. Tissue folds F.sub.1 and F.sub.2 are approximated by reducing the length of suture 11 disposed between securing elements 10a and 10b (in FIG. 5, the folds illustratively are shown in a partially approximated configuration).

Referring now to FIG. 6, another alternative method of forming, securing and approximating opposing tissue folds is described. In FIG. 6A, a single securing element 10 is used to form and secure both first tissue fold F.sub.1 and second tissue fold F.sub.2, as well as to approximate the two tissue folds. Securing element 10 preferably also is configured to maintain such approximation of the tissue folds.

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.

As seen in FIG. 6B, the approximated serosal-to-serosal tissue folds may be reinforced to ensure that the folds remain closely approximated. In FIG. 6B, securing element 10' has been placed across folds F.sub.1 and F.sub.2 after the folds have been approximated. Element 10' alternatively may be placed prior to approximation, e.g., t