Closed loop gastric restriction devices and methods

• US 7,775,967 B2
• Filed: 07/09/2007
• Issued: 08/17/2010
• Est. Priority Date: 03/23/2004
• Status: Expired due to Fees

• Current Assignee: Michael E. Gertner
• Original Assignee: Michael E. Gertner
• Inventors: Gertner, Michael
• Primary Examiner(s): Lacyk; John P
• Application Number:
  US11/774,613
• Publication Number:
  US 20070276293A1
• Time in Patent Office: 1,135 Days
• Field of Search: 128897-899, 600 29- 32, 600/37, 600/593, 604 27- 28, 604/909, 606139-141, 606/157, 606201-203, 606/213, 606/228, 606/151, 607/41
• US Class Current: 600/37
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0456 Surface features on the anchor, e.g. ribs increasing friction between the suture and the anchor
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0462 One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0488 : Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/06052 : Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61B 2017/1135 : End-to-side connections, e.g. T- or Y-connections
• CPC Class Codes: A61F 2002/044 : Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 5/0083 : Reducing the size of the stomach, e.g. gastroplasty surgical interventions A61B17/00
• CPC Class Codes: A61N 1/36007 : of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

In some embodiments, methods to sense parameters associated with restriction procedures and/or devices are disclosed. In some embodiments, the parameters are sensed directly from the region of the procedure and/or device and in other embodiments, associated neural pathways are sensed. Methods for further optimization of the obesity treatment regimens are also disclosed.

Claims

1. A system to treat an obese patient comprising:

a) an adjustable implantable restriction device comprising a volume of fluid;

b) an implantable pressure sensor adapted to measure changes in fluid pressure within the restriction device, the fluid pressure changes related to patient ingestion of food which passes through the lumen of the stomach of the patient;

c) memory adapted to store information related to ingestion of food by the patient; and

d) a gain control which modifies the relationship between an input signal from the pressure sensor and an output signal, based on the information related to ingestion of food by the patient, wherein the input signal is related to food passing through the restriction device.

2. The system of claim 1 further comprising an automated system which fills or empties the restriction device based on measurements from the pressure sensor.

3. The system of claim 1 further comprising a subcutaneous access port and wherein said pressure sensor is located within said port.

4. The system of claim 1, wherein the sensor is adapted to detect and the memory is adapted to record the eating patterns of a patient.

5. The system of claim 1 wherein the system is adapted to detect and record in said memory one of the following eating patterns:

meal frequency, meal volume, and meal consistency.

6. The system of claim 1 further comprising telemetry hardware which enables communication through the skin of a patient.

7. The system of claim 1 further comprising an inductive circuit configured to receive power through the skin of the patient.

8. The system of claim 1 further comprising an electrical stimulator adapted to provide stimulation to the gastrointestinal system of a patient.

9. The system of claim 8 wherein said electrical stimulator is activated when a food bolus passes through the lumen of the stomach.

10. The system of claim 1 wherein said restriction device is a band adapted to encircle the stomach.

11. The system of claim 9 wherein said restriction device is a band adapted to encircle the stomach.

12. The system of claim 3 wherein said subcutaneous access port is configured to allow for calibration of the pressure sensor or charging of a power supply.

13. A method of monitoring an adjustable restriction device in a patient comprising:

a) detecting pressure changes in the restriction device as a bolus of food passes through the stomach;

b) recording at least one of;

the degree of pressure change with time of the food bolus, consistency of the food bolus, frequency of meals, and meal volume; and

c) automatically changing the volume within the adjustable restriction device in a predetermined manner based on the recording.

14. A method of monitoring an adjustable restriction device in a patient comprising:

a) detecting pressure changes in the restriction device as a bolus of food passes through the stomach;

b) recording at least one of;

the degree of pressure change with time of the food bolus, consistency of the food bolus, frequency of meals, and meal volume;

c) activating an electrical stimulator based on the recording wherein the electrical stimulator output is related to the pre-set relationship between the electrical stimulator and the recording, wherein the pre-set relationship is based on previously recorded data from step (b); and

d) changing from outside the patient the pre-set relationship between the electrical stimulator and the pressure recording.