MULTI-METHOD AND MULTI-APPARATUS FOR TREATING OBESITY

Abstract

A multi-method and multi-apparatus for treating obesity. The multi-method includes a method for estimating a volume of an intragastric balloon appropriate for an individual patient, a method for using an enterocutaneous fistula to inspect an intragastric balloon without sedation and endoscopic complications associated with an upper endoscopy, and a method for decreasing ability of the stomach of an individual patient to distend or expand after a meal increasing satiety and helping the individual patient to comply with a weight loss diet. The multi-apparatus includes an intragastric balloon for inflating without installation of a pressurized gas or liquid, an intragastric balloon for minimizing trauma of the intragastric balloon on the gastric mucosa, and an intragastric balloon for administering therapeutic medications.

Description

BACKGROUND

1. Field of the Invention

The embodiments of the present invention relate to a treatment for obesity, and more particularly, the embodiments of the present invention relate to a multi-method and multi-apparatus for treating obesity.

2. Description of the Related Art

In the published medical literature, there are a significant number of patients who experience adverse gastrointestinal complaints in the period immediately after the deployment of an intragastric balloon. In this experience, all patients are treated with one specific model and size of balloon.

Thus, there exists a need for an intragastric balloon wherein both the geometry or shape of the balloon, as well as the volume of the balloon, are components that can be manipulated to enhance the therapeutic effect and to minimize complications.

In the published medical literature, intragastric balloons are placed in a deflated form and than inflated once in the stomach. The only material holding the balloons in their active shape is either air, liquid, or both. It is possible for these substances to leak out of the balloon causing the balloon to deflate and fail.

Thus, there exists a need for an intragastric balloons including a skeleton of metal struts that strengthen the balloon structure and prevent premature balloon failure, which could lead to a loss of therapeutic effect in obesity and can also lead to small bowel obstruction or gastric outlet obstruction.

In the published medical literature, intragastric balloons have been associated with the complication of irritation of the lining of the stomach (gastritis) and gastric ulceration. Considering the example of the intragastric balloon already patented by the instant inventors as U.S. Pat. No. 4,694,827, this complication was contemplated and a solution offered by using an intragastric balloon having protrusions and channels.

Non-compliance with therapeutic medications is a well known clinical problem interfering with good patient outcomes. Many different solutions have been attempted to deal with this problem, and to date, none have been completely satisfactory.

In the medical literature, damage to the lining of the stomach has been a major complication of intragastric balloon therapy. In many cases, severe damage, such as ulceration, may require removal of the balloon. Alternatively, there are many cases of patients with symptoms that might be related to the intragastric balloon, but might also be related to intercurrent viral illnesses, food poisoning, or milder complications of balloon therapy, not necessitating balloon extraction. In current practice, patients would undergo an upper endoscopy to assess the situation.

There are a multitude of methods purported to treat obesity in humans. Among the most effective of these methods are surgical techniques that alter the volume of the stomach available to receive food from the mouth and esophagus. The most popular of these surgical techniques is often referred to as a (Roux en Y) gastric bypass procedure. The gastric bypass is thought to work by limiting the amount of food that can be ingested at one time, although it may also alter gastrointestinal hormones and decrease the appetite.

Numerous innovations for inflatable medical devices have been provided in the prior art, which will be described below in chronological order to show advancement in the art, and which is incorporated herein by reference thereto. Even though these innovations may be suitable for the specific individual purposes to which they address, however, they differ from the present invention in that they do not teach a multi-method and multi-apparatus for treating obesity.

• (1) U.S. Pat. No. 766,336 to Farrington.

U.S. Pat. No. 766,336 issued to Farrington on Aug. 2, 1904 teaches a device including a fluid-supply tube having a plurality of parallel slots and springs arranged within the tube and adapted to be partly projected through the slots. The springs have their inner ends secured to the tube. An adjustable member is secured to the outer ends of the springs. Elastic covers extend around that portion of the springs projecting through the slots.

• (2) U.S. Pat. No. 797,676 to Flowers.

U.S. Pat. No. 797,676 issued to Flowers on Aug. 22, 1905 teaches a syringe including a nozzle having outlets and an expandable sack enveloping the nozzle, having outlets, and formed with longitudinal ribs stiffening and reinforcing the sack in the direction of its length and admitting of its diametrical expansion.

• (3) U.S. Pat. No. 4,416,267 to Garren et al.

U.S. Pat. No. 4,416,267 issued to Garren et al. on Nov. 22, 1983 in class 128 and subclass 1 R teaches a stomach insert for treating obesity in humans by reducing the stomach volume, which includes a flexible torus-shaped inflatable balloon having a central opening extending therethrough. At least a portion of the balloon has a self-sealing substance to facilitate puncture thereof with a needle for inflating the balloon and sealing of the puncture upon removal of the needle. The method includes positioning the balloon inside the stomach of the person being treated for obesity so as to reduce the stomach volume.

• (4) U.S. Pat. No. 4,694,827 to Weiner et al.

U.S. Pat. No. 4,694,827 issued to Weiner et al. on Sep. 22, 1987 in class 128 and subclass 303 R teaches generally, a balloon insertable and inflatable in the stomach to deter ingestion of food and having, when inflated, a plurality of smooth-surfaced convex protrusions disposed to permit engagement of the stomach wall by the balloon only at spaced localities for minimizing mechanical trauma of the stomach wall by the balloon.

Specifically, as shown in FIG. 1, which is a diagrammatic side elevational view in partial section of a prior art balloon fully expanded within a stomach, a balloon 10 being flexible-walled, imperforate, air-inflatable, and insertable and inflatable within the stomach 12 of a human 14 or animal 16 to deter ingestion of food 18 by occupying a substantial portion 20 of the volume 22 of the stomach 12 is taught. The balloon 10 has a plurality of wall portions 24 forming protrusions 26 that are smooth-surfaced, convex, and outward when inflated. The protrusions 26 are distributed around the balloon 10 and cooperatively define a plurality of channels 28 that are outwardly open for passage of fluent material 30 between the outer surface 32 of the balloon 10 and the wall 34 of the stomach 12, and are shaped and disposed to permit engagement of the wall 34 of the stomach 12 by the balloon 10 only at spaced localities 36 so as to maintain a substantial portion 38 of the wall 34 of the stomach 12 away from contact with the balloon 10 for minimizing complications due to mechanical trauma of the balloon 10 against the wall 34 of the stomach 12.

The protrusions 26 and the channels 28 minimize physical contact with the wall 34 of the stomach 12 and stimulate cytoprotection. Cytoprotection is an innate mechanism of preservation of the stomach 12 from adverse effects of a harsh environment of a gastric lumen.

It is apparent that numerous innovations for inflatable medical devices have been provided in the prior art that are adapted to be used. Furthermore, even though these innovations may be suitable for the specific individual purposes to which they address, however, they would not be suitable for the purposes of the embodiments of the present invention as heretofore described, namely, a multi-method and multi-apparatus for treating obesity.

SUMMARY

Thus, an object of the embodiments of the present invention is to provide a multi-method and multi-apparatus for treating obesity, which avoids the disadvantages of the prior art.

Briefly stated, another object of the embodiments of the present invention is to provide a multi-method and multi-apparatus for treating obesity. The multi-method includes a method for estimating a volume of an intragastric balloon appropriate for an individual patient, a method for using an enterocutaneous fistula to inspect an intragastric balloon without sedation and endoscopic complications associated with an upper endoscopy, and a method for decreasing ability of the stomach of an individual patient to distend or expand after a meal to increase satiety and help the individual patient to comply with a weight less diet. The multi-apparatus includes an intragastric balloon for inflating without installation of a pressurized gas or liquid, an intragastric balloon for minimizing trauma of the intragastric balloon on the gastric mucosa, and an intragastric balloon for administering therapeutic medications.

The novel features considered characteristic of the embodiments of the present invention are set forth in the appended claims. The embodiments of the present invention themselves, however, both as to their construction and their method of operation together with additional objects and advantages thereof will be best understood from the following description of the specific embodiments when read and understood in connection with the accompanying drawing.

BRIEF DESCRIPTION OF THE DRAWINGS

So the manner in which the above recited features of the present disclosure can be understood in detail, a more particular description of embodiments of the present disclosure, briefly summarized above, may be had by reference to embodiments, which are illustrated in the appended drawings. It is to be noted, however, the appended drawings illustrate only typical embodiments of embodiments encompassed within the scope of the present disclosure, and, therefore, are not to be considered limiting, for the present disclosure may admit to other equally effective embodiments, wherein:

FIG. 1 is a diagrammatic side elevational view in partial section of a prior art balloon fully expanded within a stomach;

FIGS. 2A-2C are a flowchart of the method of an embodiment of the present invention for estimating volume of an intragastric balloon appropriate for an individual patient;

FIG. 3 is a diagrammatic side elevational view in partial section of a balloon of an embodiment of the present invention fully expanded within a stomach;

FIG. 4 is a diagrammatic side elevational view in partial section of a balloon of another embodiment of the present invention fully expanded within a stomach;

FIG. 5 is a diagrammatic side elevational view in partial section of a balloon of another embodiment of the present invention fully expanded within a stomach;

FIG. 6 is a diagrammatic side elevational view in partial section of a balloon of another embodiment of the present invention fully expanded within a stomach;

FIG. 7 is a diagrammatic side elevational view in partial section of a balloon of another embodiment of the present invention fully expanded within a stomach;

FIG. 8 is a diagrammatic side elevational view in partial section of a balloon of another embodiment of the present invention fully expanded within a stomach;

FIG. 9 is a diagrammatic side elevational view in partial section of a balloon of another embodiment of the present invention fully expanded within a stomach;

FIG. 10A-10B are a flowchart of the method of another embodiment of the present invention for using an enterocutaneous fistula to inspect an intragastric balloon without sedation and endoscopic complications associated with an upper endoscopy; and

FIGS. 11A-11E are a flowchart of the method of another embodiment of the present invention for decreasing ability of the stomach of an individual patient to distend or expand after a meal increasing satiety and helping the individual patient to comply with a weight loss diet.

The headings used herein are for organizational purposes only and are not meant to be used to limit the scope of the description or the claims. As used throughout this application, the word “may” is used in a permissive sense (i.e., meaning having the potential to), rather than the mandatory sense (i.e., meaning must). Similarly, the words “include”, “including”, and “includes” mean including but not limited to. To facilitate understanding, like reference numerals have been used, where possible, to designate like elements common to the figures.

LIST OF REFERENCE NUMERALS UTILIZED IN THE DRAWING

A. Prior Art

10 balloon

12 stomach of human 14 or animal 16

14 human

16 animal

18 food

20 substantial portion of volume 22 of stomach 12

22 volume of stomach 12

24 plurality of wall portions

26 protrusions

28 plurality of channels

30 fluent material

32 outer surface of balloon 10

34 wall of stomach 12

36 spaced localities

38 substantial portion of wall 34 of stomach 12

B. Method of Embodiment of Present Invention for Estimating Volume of Intragastric Balloon Appropriate for Individual Patient

40 method of embodiment of present invention for estimating volume 42 of intragastric balloon 44 appropriate for individual patient 46

42 volume of intragastric balloon 44 appropriate for individual patient 46

44 intragastric balloon appropriate for individual patient 46

46 individual patient

48 water of material 62 ingested

50 physician administering method 40

52 person administering method 40

54 specialized equipment

56 electrogastrograph of specialized equipment 54

58 upper endoscope of specialized equipment 54

60 barostat balloon of specialized equipment 54

62 material ingested

64 water solution suspension of material 62 ingested

66 non-aqueous based material of material 62 ingested

68 temperature

70 room temperature of temperature 68

72 other temperature of temperature 68

74 10 minutes time

76 other interval of time

C. Intragastric Balloon for Inflating without Installation of Pressurized Gas or Liquid

78 intragastric balloon

80 plurality of struts

82 skeleton of intragastric balloon 78

84 protrusions of intragastric balloon 78

86 channels of intragastric balloon 78

90 shape

92 volume of intragastric balloon 78

100 valve of intragastric balloon 78

102 opening of intragastric balloon 78

106 gastric environment

108 holes of plurality of struts 80

110 fastening points of plurality of struts 80

112 internal wires

114 central longitudinal strut of plurality of struts 80

118 one end of central longitudinal strut 114 of plurality of struts 80

120 portion of central longitudinal strut 114 of plurality of struts 80

122 endoscopic device

124 endoscopic forceps

126 stomach

132 grasping point

134 two parallel layers of metals of plurality of struts 80

136 esophagus

138 spring

D. Intragastric Balloon for Minimizing Trauma of Intragastric Balloon on Gastric

Mucosa

140 plurality of protrusions

142 balloon

144 one of plurality of protrusions 140

145 opposite side of balloon 142

146 another one of plurality of protrusions 140

148 antral wall of stomach 152

150 proximal portion of stomach 152

152 stomach

154 distal antrum of stomach 152

156 one tether

158 long axis of central longitudinal strut 160 of plurality of struts 162

160 central longitudinal strut 160 of plurality of struts 162

162 plurality of struts

164 ball and socket assembly

168 electrical device

169 electrical signals of electrical device 168

170 antrum of stomach 152

172 counterweight

174 fixed counterweight of counterweight 172

176 plurality of struts of balloon 142

E. Intragastric Balloon for Administering Therapeutic Medications

178 therapeutic medication

180 matrix of therapeutic medication 178

182 balloon

184 one of struts 186 of balloon 182

186 struts of balloon 182

190 pocket

192 attachment in wall 194 of balloon 188

196 holes of balloon 182

198 gastric contents

F. Method for Using Enterocutaneous Fistula to Inspect Intragastric Balloon without Sedation and Endoscopic Complications Associated with Upper Endoscopy

200 method of embodiment of present invention for using enterocutaneous fistula 202 to inspect intragastric balloon 204 without sedation and endoscopic complications associated with upper endoscopy

202 enterocutaneous fistula

204 intragastric balloon

206 percutaneous gastrostomy

208 tract

210 upper endoscope

212 stomach

214 gastric mucosa

G. Method for Restricting Expansion of Stomach for Individual Patient

218 method of embodiment of present invention for decreasing ability of stomach 220 of individual patient 222 to distend or expand after meal 224 increasing satiety and helping individual patient 222 to comply with weight loss diet 226

220 stomach of individual patient 222

222 individual patient

224 meal

226 weight less diet

228 balloon

230 other space occupying device

232 pillow

234 band

236 width of band 234

238 weight of individual patient 222

240 anatomy of individual patient 222

242 portion of band 234

244 pressure pack

246 balloon

248 adhesive

250 skin of individual patient 222

252 standard tee shirt

254 other shirt

256 separate tube

258 roentgenography

260 fluoroscopy

262 xiphoid process of sternum 264 of individual patient 222

264 sternum of individual patient 222

266 lower edge of rib cage 268 of individual patient 222

268 rib cage of individual patient 222

270 circumference of portion 272 of stomach 220 of individual patient 222

272 portion of stomach 220 of individual patient 222

274 greatest diameter

276 buttons

278 hook and loop fasteners

280 pulley device

282 one end of band 234

284 left upper quadrant portion of stomach 220 of individual patient 222

286 pulse oximetry

288 blood gas measurement

290 capnography

292 tension of band 234

DETAILED DESCRIPTION

A. A Method for Estimating Volume of an Intragastric Balloon Appropriate for an Individual Patient

Referring now to the figures, in which like numerals indicate like parts, and particularly to FIGS. 2A-2C, which are a flowchart of the method of an embodiment of the present invention for estimating volume of an intragastric balloon appropriate for an individual patient, the method of an embodiment of the present invention is shown generally at 40 for estimating volume 42 of an intragastric balloon 44 appropriate for an individual patient 46, and comprises the steps of:

STEP 1: Drinking by the individual patient 46 who is a candidate for the intragastric balloon 44 as much water 48 as possible over a 10 minute period of time.

STEP 2: Monitoring volume of the water 48 ingested.

STEP 3: Advising by the individual patient 46 to a physician 50 or person 52 administering the method 40 when the individual patient 46 feels uncomfortably bloated or alternatively, if the individual patient 46 vomits, the volume of the water 48 ingested will be determined.

STEP 4: Selecting for the individual patient 46 the intragastric balloon 44 that is a fraction of the volume leading to uncomfortable symptoms, with the volume of the intragastric balloon 44 being 75% of the ingested volume of water 48.

STEP 5: Monitoring the individual patient 46 with specialized equipment 54 during ingestion, as with, but not limited to, an electrogastrograph 56, an upper endoscope 58, or a barostat balloon 60.

STEP 6: Challenging over time, the individual patient 46 with the intragastric balloon 44 with another load of water 48 as in STEP 1 above to see if the individual patient 46 can tolerate a larger intragastric balloon 44 because it is anticipated that a larger intragastric balloon 44 might be expected to have a greater therapeutic effect in the management of obesity and satiety symptoms.

In the above embodiment, the water 48 is specified as material 62 ingested. The water 48 is only mentioned as a preferred example. The material 62 ingested may be a water solution suspension 64, or other non-aqueous based material 66. Temperature 68 is implied as room temperature 70, but may be some other temperature 72. Time 74 is specified as 10 minutes, but may be some other interval of time 76.

B. An Intragastric Balloon for Inflating without Installation of a Pressurized Gas or Liquid

As shown in FIG. 3, which is a diagrammatic side elevational view in partial section of a balloon of an embodiment of the present invention fully expanded within a stomach, an intragastric balloon 78 comprises a plurality of struts 80. The plurality of struts 80 form a skeleton 82 of the intragastric balloon 78, run longitudinally, are parallel to protrusions 84 and channels 86 of the intragastric balloon 78, are fabricated out of a metal or a composite with a memory for its shape 90, such as nitinol, and are shaped so that when released, they expand to fill out volume 92 of the intragastric balloon 78, with this shape being the shape that would otherwise be created if the intragastric balloon 78 was inflated with air, water, or both.

The intragastric balloon 78 further comprises a valve 100 or opening 102 to allow air and gastric fluid into the intragastric balloon 78 as the intragastric balloon 78 is expanded in the gastric environment 106.

In one embodiment, the plurality of struts 80 have holes 108 or other fastening points 110 midway. These fastening points 110 are connected by internal wires 112 to a central longitudinal strut 114 of the plurality of struts 80 running straight and longitudinally through the length of the balloon 78. One end 118 or portion 120 of this central longitudinal strut 114 of the plurality of struts 80 is accessible by an endoscopic device 122.

In another embodiment, with the balloon 78 held steadily in position with an endoscopic forceps 124 or an Ewald tube, an instrument can grasp the end 118 of the central longitudinal strut 114 of the plurality of struts 80 and pull it. This would collapse the balloon 78, allowing it to be removed from the stomach 126 in its collapsed state.

In another embodiment, there is a shelf or ledge that allows the balloon 78 to be stabilized against a standard 36 French Ewald tube to facilitate traction on the central longitudinal strut 114 of the plurality of struts 80.

In another embodiment, there would be a grasping point 132 for the endoscopic forceps 124 to grasp and stabilize the balloon 78 for removal from the stomach 126.

In another embodiment, the plurality of struts 80 obtain their curved shapes by being configured of two parallel layers of metals 134 with different coefficients of thermal expansion. In this embodiment, the balloon 78 is chilled with ice before its deployment though the esophagus 136 into the stomach 126. At body temperature, the plurality of struts 80 expand to their designed shapes. On removal, the stomach 126 is lavaged with ice water to allow the plurality of struts 80 of the balloon 78 to shrink.

In another embodiment, the central longitudinal strut 114 of the plurality of struts 80 is a spring 138. The spring 138 is stretched when the balloon 78 is collapsed and ready to deploy in the stomach 126. When released in the stomach 126, the spring 138 retracts to its non-stretched length, expanding the balloon 78. The spring 138 gives the balloon 78 more resilience, almost like a shock absorber, in the gastric environment 106.

C. An Intragastric Balloon for Minimizing Trauma of the Intragastric Balloon on the Gastric Mucosa

As shown in FIG. 4, which is a diagrammatic side elevational view in partial section of a balloon of another embodiment of the present invention fully expanded within a stomach, the plurality of protrusions 140 of the balloon 142 run diagonally rather than longitudinally.

As shown in FIG. 5, which is a diagrammatic side elevational view in partial section of a balloon of another embodiment of the present invention fully expanded within a stomach, in another embodiment, one 144 of the plurality of protrusions 140 is made more prominent. On an opposite side 145 of the balloon 142, another one 146 of the plurality of protrusions 140 is made less prominent. When a gastric peristaltic wave passes over the balloon 142, more pressure is placed on the one 144 of the plurality of protrusions 140 that is more prominent and less on the one 146 of the plurality of protrusions 140 that is less prominent. As the balloon 142 impacts the antral wall 148 distally, there is a tendency for the balloon 142 to rotate along its long axis, which is repeated with every peristaltic wave, so that different points are presented to the gastric mucosa.

As shown in FIG. 6, which is a diagrammatic side elevational view in partial section of a balloon of another embodiment of the present invention fully expanded within a stomach, in another embodiment, the balloon 142 is tethered by at least one tether 156 to a proximal portion 150 of the stomach 152 to prevent forward migration of the balloon 142 to impact in the distal antrum 154. With the one tether 156 attached to long axis 158 of the central longitudinal strut 160 of the plurality of struts 162, the balloon 142 is able to rotate freely with a ball and socket assembly 164. With the at least one tether 156 attached to the balloon 142, the balloon 142 twists on the at least one tether 156 and then is forced to turn backwards due to tension on the at least one tether 156. The at least one tether 156 is attached to the balloon 142 and the proximal portion 150 of the stomach 152 to maximize stimulation of this area to maximize effects of ghrelin or other digestive hormones associated with the stomach 152.

As shown in FIG. 7, which is a diagrammatic side elevational view in partial section of a balloon of another embodiment of the present invention fully expanded within a stomach, in another embodiment, an electrical device 168 is incorporated into the balloon 142 to provide electrical signals 169 to the antrum 170 of the stomach 152 to maximize stimulating effects of ghrelin and other digestive hormones.

As shown in FIG. 8, which is a diagrammatic side elevational view in partial section of a balloon of another embodiment of the present invention fully expanded within a stomach, in another embodiment, a counterweight 172 is built into the balloon 142 to accentuate eccentricity of the balloon 142 and allow it to spin. This can be a fixed counterweight 174 or attached to the plurality of struts 176 of the balloon 142.

D. An Intragastric Balloon for Administering Therapeutic Medications

As shown in FIG. 9, which is a diagrammatic side elevational view in partial section of a balloon of another embodiment of the present invention fully expanded within a stomach, a therapeutic medication 178 is placed in a matrix 180 that is slowly dissolving and inert. This matrix 180 is deployed loosely in the balloon 182 or fabricated to attach to one 184 of the struts 186 of the balloon 182 or inside a pocket 190 or attachment 192 in the wall 194 of the balloon 182.

The balloon 182 is fabricated with holes 196 to freely allow the gastric contents 198 to enter the balloon 182. The matrix 180 slowly dissolves, thereby releasing the therapeutic medication 178.

E. A Method for Using an Enterocutaneous Fistula to Inspect an Intragastric Balloon without Sedation and Endoscopic Complications Associated with Upper Endoscopy

As shown in FIGS. 10A-10B, which are a flowchart of the method of another embodiment of the present invention for using an enterocutaneous fistula to inspect an intragastric balloon without sedation and endoscopic complications associated with an upper endoscopy, the method of the embodiment of the present invention is shown generally at 200 for using an enterocutaneous fistula 202 to inspect an intragastric balloon 204 without sedation and endoscopic complications associated with an upper endoscopy, and comprises the steps of:

STEP 1: Placing a percutaneous gastrostomy 206 in a usual manner.

STEP 2: Allowing the percutaneous gastrostomy 206 to heal.

STEP 3: Dilating the tract 208 to allow passage of an upper endoscope 210 directly into the stomach 212.

STEP 4: Evaluating the balloon 204 and the gastric mucosa 214.

F. A Method for Restricting Expansion of the Stomach for an Individual Patient

As shown in FIGS. 11A-11E, which are a flowchart of the method of another embodiments of the present invention for restricting expansion of the stomach for an individual patient, the method of the embodiment of the present invention is shown generally at 218 for decreasing ability of the stomach 220 of an individual patient 222 to distend or expand after a meal 224 increasing satiety and helping the individual patient 222 to comply with a weight loss diet 226, and comprises the steps of:

STEP 1: Attaching a balloon 228 or other space occupying device 230 or pillow 232 to a band 234 that is of cloth, is 3 inches wide, is one of resistant to stretching and elastic, has a width 236 that is dependent upon the weight 238 of the individual patient 222 and anatomy 240 of the individual patient 222, and has a portion 242 thereof widened compared to the rest of the band 234 to accommodate one of a pressure pack 244 and a balloon 246.

STEP 2: Utilizing an adhesive 248 on at least one of the skin 250 of the individual patient 222 and the band 234 to prevent the band 234 from migrating while being worn by the individual patient 222.

STEP 3: Utilizing one of a standard tee shirt 252 and other shirt 254 having a separate tube 256 within or outside of it allowing the band 234 and/or the space-occupying device 230 to be enclosed so that it will be covered or disguised by the separate tube 256.

STEP 4: Utilizing roentgenography 258 or fluoroscopy 260 to locate the stomach 220 of the individual patient 222 to facilitate proper placement of the band 234 and the space-occupying device 230.

STEP 5: Wrapping the band 234 around the stomach 220 of the individual patient 222 in one of an area caudal to the xiphoid process 262 of the sternum 264 and cranial to the lower edge 266 of the rib cage 268 of the individual patient 222 and along the circumference 270 of the portion 272 of the stomach 220 of the individual patient 222 with the greatest diameter 274 and in a repeating FIG. 8 so that different areas of the skin 250 of the individual patient 222 are touched by the band 234 allowing adjacent areas to recover from tension of the band 234.

STEP 6: Closing/attaching the band 234 with one of buttons 276 and hook and loop fasteners (VELCRO®) 278.

STEP 7: Attaching a pulley device 280 to one end 282 of the band 234 for use in tightening the band 234.

STEP 8: Applying pressure to the left upper quadrant portion 284 of the stomach 220 of the individual patient 222 by use of one of the balloon 228, the other space-occupying device 230, and the pillow 232.

STEP 9: Utilizing one of pulse oximetry 286, blood gas measurement 288, and capnography 290 to determine if the band 234 significantly decreases respiratory status of the individual patient 222.

STEP 10: Measuring tension 292 of the band 234 and tension applied to the skin 250 of the individual patient 222 to ascertain likelihood of causing damage or ulceration to the skin 250 of the individual patient 222.

In another embodiment, outside appearance of the shirt 254 appears normal to an observer, with the band 234 held in place by the cloth tube 256. The cloth tube 256 is of such a volume that when the band 234 is activated, there would be sufficient space to allow the shirt 254 to hang freely.

In another embodiment, the band 234 is incorporated into the tee shirt 252 in such a way that it is obvious to a casual observer creating an obvious constriction.

In another embodiment, a device with the appearance of standard suspenders is attached to an adjustable belt around the waist of the individual patient 222 to hold the band 234 in a proper position as with one of hook and loop fasteners (Velcro), buttons, and snap devices.

G. The Conclusions

It will be understood that each of the elements described above or two or more together may also find a useful application in other types of constructions differing from the types described above.

While the embodiments of the present invention have been illustrated and described as embodied in a multi-method and multi-apparatus for treating obesity, however, they are not limited to the details shown, since it will be understood that various omissions, modifications, substitutions, and changes in the forms and details of the embodiments of the present invention illustrated and their operation can be made by those skilled in the art without departing in any way from the spirit of the embodiments of the present invention.

Without further analysis the foregoing will so fully reveal the gist of the embodiments of the present invention that others can by applying current knowledge readily adapt them for various applications without omitting features that from the standpoint of prior art fairly constitute characteristics of the generic or specific aspects of the embodiments of the present invention.

It should be emphasized that the above-described embodiments of the present disclosure are merely possible examples of implementations, merely set forth for a clear understanding of the principles of the disclosure. Many variations and modifications may be made to the above-described embodiment(s) of the disclosure without departing substantially from the spirit and principles of the disclosure. All such modifications and variations are intended to be included herein within the scope of this disclosure and the present disclosure and protected by the following claims.

While the foregoing is directed to embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof. For example, although numerous embodiments having various features have been described herein, combinations of such various features in other combinations not discussed herein are contemplated within the scope of embodiments of the present invention.

Claims

1. A method for estimating volume of an intragastric balloon appropriate for an individual patient, the method comprising: drinking by the individual patient, who is a candidate for the intragastric balloon, as much of a fluid as possible over a given period of time;monitoring volume of the fluid ingested;advising, by the individual patient, to a physician or person administering the method when the individual patient feels uncomfortably bloated or if the individual patient vomits so that the volume of the fluid ingested is determined;selecting for the individual patient the intragastric balloon that is a fraction of the volume leading to uncomfortable symptoms; andmonitoring the individual patient with specialized equipment during ingestion.

2. The method of claim 1, wherein the drinking step includes drinking by the individual patient, who is a candidate for the intragastric balloon, as much fluid as possible over a 10 minute period of time.

3. The method of claim 1, wherein the selecting step includes selecting for the individual patient the intragastric balloon that is 75% of the ingested volume of fluid.

4. The method of claim 1, wherein the monitoring step includes monitoring the individual patient with one of an electrogastrograph, an upper endoscope, and a barostat balloon.

5. The method of claim 1, further comprising the step of challenging over time the individual patient with the intragastric balloon with another load of the fluid to see if the individual patient can tolerate a larger intragastric balloon because a larger intragastric balloon has greater therapeutic effect in management of obesity and satiety symptoms.

6. The method of claim 1, wherein the drinking step includes drinking by the individual patient, who is a candidate for the intragastric balloon, as much of a fluid that is selected from the group consisting of water, a water solution suspension and a non-aqueous based material as possible over a given period of time.

7. The method of claim 1, wherein the selecting step includes selecting for the individual patient the intragastric balloon that will be a fraction of the volume leading to uncomfortable symptoms at room temperature.

8. A method for using an enterocutaneous fistula to inspect an intragastric balloon without sedation and endoscopic complications associated with an upper endoscopy, comprising: placing a percutaneous gastrostomy in a usual manner;allowing the percutaneous gastrostomy to heal;dilating the tract to allow passage of an upper endoscope directly into the stomach; andevaluating the balloon and the gastric mucosa.

9. A method for decreasing ability of the stomach of an individual patient to distend or expand after a meal to increase satiety and help the individual patient to comply with a weight loss diet, comprising: locating the stomach of the individual patient to facilitate proper placement of a band;wrapping the band around the stomach of the individual patient; andclosing/attaching the band to apply pressure to the stomach of the individual patient, thereby decreasing the ability of the stomach of the individual patient to distend or expand after the meal, thereby increasing the satiety and helping the individual patient to comply with the weight loss diet.

10. The method of claim 9, wherein the locating step includes locating the stomach of the individual patient to facilitate proper placement of a band by utilizing one of roentgenography and fluoroscopy.

11. The method of claim 9, wherein the wrapping step includes wrapping the band around the stomach of the individual patient in one of an area caudal to the xiphoid process of the sternum and cranial to the lower edge of the rib cage of the individual patient and along the circumference of the portion of the stomach of the individual patient.

12. The method of claim 9, wherein the closing/attaching step includes closing/attaching the band with one of buttons and hook and loop fasteners.

13. The method of claim 9, further comprising the step of attaching a pulley device to one end of the band to tighten the band.

14. The method of claim 9, wherein the closing/attaching step includes closing/attaching the band to apply pressure to the stomach of the individual patient at the left upper quadrant portion of the stomach of the individual patient by use of one of the balloon, other space-occupying device, and the pillow.

15. The method of claim 9, further comprising the step of utilizing one of pulse oximetry, blood gas measurement, and capnography to determine if the band significantly decreases respiratory status of the individual patient.

16. The method of claim 9, further comprising the step of measuring tension of the band and tension applied to skin of the individual patient to ascertain likelihood of causing damage or ulceration to the skin of the individual patient.

17. The method of claim 9, further comprising the step of attaching one of a balloon, another space occupying device, and a pillow to the band.

18. The method of claim 17, wherein the locating step includes locating the stomach of the individual patient to facilitate proper placement of a band that is of cloth, is 3 inches wide, is one of resistant to stretching and elastic, has a width that is dependent upon weight of the individual patient and anatomy of the individual patient, and has a portion thereof widened compared to the rest of the band to accommodate one of the balloon, the another space occupying device, and the pillow.

19. The method of claim 9, further comprising the step of utilizing an adhesive on at least one of the skin of the individual patient and the band to prevent the band from migrating while being worn by the individual patient.

20. The method of claim 9, further comprising the step of attaching a device with an appearance of standard suspenders to an adjustable belt around the waist of the individual patient to hold the band in a proper position by one of hook and loop fasteners, buttons, and snap devices.