Device and method of causing weight loss using removable variable volume intragastric bladder

• US 5,259,399 A
• Filed: 03/02/1992
• Issued: 11/09/1993
• Est. Priority Date: 03/02/1992
• Status: Expired due to Fees

• Current Assignee: Alan Brown
• Original Assignee: Alan Brown
• Inventors: Brown, Alan
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): LACYK, JOHN P
• Application Number:
  US07/844,135
• Time in Patent Office: 617 Days
• Field of Search: 128/897-899, 128/8, 606/191, 606/192, 606/196, 606/198, 604/96-103, 604/54
• US Class Current: 128/897
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/004 remotely adjustable

Abstract

A method and apparatus for causing weight loss in obese humans by occupying a segment of the stomach volume using a variable volume bladder filled with fluid. The bladder is inserted into the upper part of the stomach including the fundus through a percutaneous endoscopic gastrostony tube, which was non-surgically placed to create a permanent channel to the stomach. The inserted bladder is filled and emptied using a filling system for pumping fluid in and out of the bladder according to a predetermined scheme. The filling system comprises a reversible pump, a two-way valve connected to the filling tube, an electronic control means for automatically controlling the action of the filling system, and a battery. The electronic control means is connected to a plurality of sensors placed on the human body to detect digestion cycle and hemodynamic parameters. The electronic control means collects information detected by the sensors, governs the filling system according to the obtained information and predetermined operation scheme, and records times and volumes of the fluid transferred through the two-way valve.

Claims

1. A method of causing weight loss in obese humans by occupying a segment of the stomach volume using an inflated bladder, said method comprising the steps of:

(a) measuring the volume and location of the stomach including the fundus by radiological techniques,

(b) selecting a bladder contoured in size and shape to substantially occupy the fundus or the body of the stomach measurement,

(c) introducing by percutaneous endscopic techniques a percutaneous endoscopic gastrostomy (P.E.G.) tube to establish access from the outside to the body of the stomach through the abdominal wall,

(d) inserting said bladder through said percutaneous endoscopic gastrostomy tube into the stomach so the size and shape of said bladder, cooperating with the position of placement of said gastrostomy tube, maintains said bladder in the upper part of the stomach including the fundus, and

(e) filling and emptying said bladder with fluid repeatedly over time through a filling tube that extends through said gastrostomy tube, in the manner that said bladder when filled occupies a large portion of said stomach to cause a feeling of satiety, thereby to achieve decreased consumption of food by a patient, and said emptying of said bladder provides periods of reduced trauma to the stomach to promote the patient'"'"'s health and feeling of well being, said bladder capable of being withdrawn from said stomach through said P.E. G. tube to enable inspection and replacement and to enable ready access to the lumen of the stomach through the abdominal wall.

2. The method of claim 1 wherein said measurement of the volume and location of said stomach is conducted by employing an air contrast upper GI series, including the making of frontal and lateral projection radiographs.

3. The method of claim 1 wherein said measurement of the volume and location of said stomach is conducted by employing computerized tomography.

4. The method of claim 1 wherein said introduction of said P.E.G. tube in said obese person comprises the steps of:

(a) inspecting said stomach of said obese person using both an endoscope and a fluoroscope, said endoscope introduced into the stomach through the mouth down through the esophagus,

(b) establishing a location for said gastrostomy tube placed to maintain said bladder in the desired position,

(c) when a needle, forming a puncture in the abdomen at said location, the needle passing through the thick layer of abdominal fat of said obese person, and via said puncture inserting a guidewire from outside through the abdominal wall into said fundus of said stomach, grasping the distal portion of said guidewire using said introduced endoscope and by pulling said endoscope out of the mouth extracting the distal end of said guidewire out of the mouth while the proximal end of said guidewire is held outside of the puncture formed in the abdomen,

(d) placing said gastrostomy tube through the abdominal wall by attaching said gastrostomy tube to the distal portion of said guidewire while said portion extends out of the patient'"'"'s mouth and pulling on the proximal end of said guidewire until said percutaneous endoscopic gastrostomy tube passes through the esophagus, stomach, and abdominal wall to the outside, and

(e) securing said sealing said placed gastrostomy tube on the stomach wall and on the abdominal wall and cutting said gastrostomy tube to the appropriate length.

5. The method of claim 1 further comprising the steps of:

(a) removing said bladder from the stomach through said gastrostomy tube,

(b) inserting an endoscope into the stomach through said gastrostomy tube in order to examine the gastric wall for trauma and ulceration, and

(c) re-inserting said bladder through said gastrostomy tube into the stomach so the size and shape of said bladder, cooperating with the position of placement of said gastrostomy tube, again maintains said bladder in the fundus or the body of the stomach.

6. The method of claim 1 wherein said repeated filling or emptying said bladder is automatically controlled by a filling system.

7. The method of claim 1 further including the steps of:

(a) detecting condition of said obese patient with sensors measuring indicators of digestion and hemodynamic parameters,

(b) transmitting information from said sensors to an electronic control means linked to a filling system used for filling and emptying said bladder, and

(c) controlling filling and emptying of said bladder by said filling system using said electronic control means.

8. The method of claim 6 wherein said filling and emptying of said bladder being performed by a reversible air pump forcing air into said bladder or releasing air from said bladder as governed by said electronics control means receiving input from said sensors and operating according a predetermined procedure.

9. The method of claim 6 further including manually inducing said filling or emptying of said bladder by overriding said electronics control means connected to said filling system.

10. A medical device for treatment of obese humans by occupying a segment of the stomach volume comprising

a bladder sized and shaped to substantially occupy the fundus or the body of the stomach,

a filling tube connectable to said bladder for repeated filling and emptying of said bladder located in the stomach of said obese humans, and

said filling tube and said bladder collapsed in condition to pass through a percutaneous endoscopic gastrostomy (P.E.G.) tube into the stomach, said filling tube having sufficient lengths to extend proximally through said gastrostomy tube to enable said filling and emptying of said bladder.

11. The device of claim 10 including a stylet extending into the bladder to enable thrusting of the collapsed bladder through said P.E.G. tube into the stomach.

12. A system for automatically filling and emptying a bladder positioned in the stomach to enable weight loss in obese humans, said system being connected to a bladder through a filling tube, said system comprising

(a) a valve adapted to control amount of fluid introduced or released from said bladder through said filling tube,

(b) a reservoir of fluid for introduction into said bladder through said valve, and

(c) an electronics control means for controlling filling and emptying said bladder with said fluid according to a predetermined set of criteria.

14. The system of claim 12 or 13 further comprising a plurality of sensors connected to provide information to said electronic control means,

said sensors being placed in the human body to monitor indicators of digestion or hemodynamic parameters and said electronic control means adapted to control said filling and emptying of said bladder in accordance with digestive cycles corresponding to said indicators.

15. A system of claim 12 or 13 wherein said electronic control means is adapted to keep an electronic record of inflation and deflation times and volumes of fluid passed through said valve.

13. A system for automatically filling and emptying a bladder positioned in the stomach in order to cause weight loss in obese humans, said system being connected to said bladder through a filling tube, said system comprising

(a) a valve for controlling amount of fluid introduced or released from said bladder through said filling tube,

(b) a pump for introducing air into said bladder through said valve, and

(c) an electronics control means for controlling filling and emptying said bladder with said fluid according to a predetermined set of criteria.