GI-ENDOCRINE DRUG DELIVERY DEVICE AND METHOD OF USE

• US 20170007434A1
• Filed: 07/11/2016
• Published: 01/12/2017
• Est. Priority Date: 07/10/2015
• Status: Abandoned Application

• Current Assignee: Hamilton Scientific, Ltd.
• Original Assignee: Hamilton Scientific, Ltd.
• Inventors: Rothkopf, Michael
• Application Number:
  US15/206,886
• Publication Number:
  US 20170007434A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2005/002 for sensing mechanical parameters
• CPC Class Codes: A61F 2005/0023 for sensing chemical parameters
• CPC Class Codes: A61F 5/0059 with wireless means
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

Shown are a device, system and method that improve the diabetes care of a patient that has undergone gastric surgery. The device provides continuously or intermediate monitoring at various intervals before and after meals of several sensors to perceive, among other things, the blood glucose level, EKG/heart rate and volume of meals a patient has consumed. Readings are sent to a control unit that receives input from at least one of: a meal sensor, glucose monitor, and EKG sensor to control a drug delivery unit that doses a prescribed agent at a specific quantity and time based on the readings to provide proper diabetes care for the patient. Components of the system such as the meal sensor glucose monitor, EKG sensor, control unit and drug delivery device may be implanted subcutaneously in the patient or outside the patient and may communicate with each other either wirelessly or may be directly wired together.

Claims

1. A gastric drug delivery device for improving diabetes patient care, comprising:

a meal sensor apparatus having a base;

the base defining a chamber;

a pressure transducer disposed within the meal sensor apparatus, and the pressure transducer in fluid communication with the chamber;

a gastric band bladder in fluid communication with the chamber, and wherein deflection of the band bladder causes a pressure differential in the chamber that is readable by the transducer.

2. The gastric drug delivery device of claim 1, further including a control unit that receives information from the transducer and determines a volume food consumed based on corresponding waveforms of the pressure differential read by the pressure transducer.

3. The gastric drug delivery device of claim 2 wherein the control unit further includes a memory to record at least one of a frequency of meals, and a volume of meals.

4. The gastric drug delivery device of claim 2 wherein information from the transducer to the control unit is sent either by wireless connection or wire connection.

5. The gastric drug delivery device of claim 1, where the pressure differential is caused by a patient swallowing food or drinking a liquid.

6. The gastric drug delivery device of claim 2 further including a drug delivery system, the drug delivery system including a drug delivery pump that is activated by the information provided by the meal sensor apparatus.

7. The gastric drug delivery device of claim 6 further including a glucose monitor in communication with the control unit.

8. The gastric drug delivery device of claim 7 wherein the glucose monitor monitors glucose blood levels of the patient and wherein the monitoring is activated by the pressure differential.

9. The gastric drug delivery device of claim 2 further including an EKG monitor in communication with the control unit.

10. The gastric drug delivery device of claim 1 further including a CPU system integrator/controller connected to the meal sensing apparatus for controlling a drug delivery system.

11. The gastric drug delivery device of claim 10 wherein the CPU system determines the volume of food and frequency of meals a patient consumes.

12. The gastric drug delivery device of claim 11 wherein the CPU system further includes a non-transitory computer readable medium that records at least one of data of the volume of food and data of the frequency of meals a patient consumes.

13. The gastric drug delivery device of claim 12 wherein the data is wireless or hard wired transmitted to a computer storage facility apart from the patient.

14. The gastric drug delivery device of claim 12 wherein the data is stored in an implantable storage unit.

15. An implantable gastric drug delivery device for improving diabetes patient care, comprising:

an implantable meal sensor apparatus having a base;

the base defining a chamber;

a pressure transducer disposed within the meal sensor apparatus, and the pressure transducer in fluid communication with the chamber;

a gastric band bladder in fluid communication with the chamber, and wherein movement of the band bladder causes a pressure differential in the chamber that is readable by the transducer;

an implantable EKG monitor;

an implantable glucose monitor;

an implantable CPU system integrator/controller configured to receive information from the meal sensor apparatus, EKG monitor and glucose monitor and to determine the volume of food consumed; and

a drug delivery pump in communication with the implantable CPU system, the drug delivery pump for pumping an active agent at the command of the CPU system integrator/controller based on the data received by the CPU system in response to at least one of;

an initiation of eating, size of the meal, number of swallowed food boluses, interval between meals, change in glucose levels during digestion, heart rate response during digestion and any combination thereof.

16. A process of treating of diabetes through a gastric drug delivery device, comprising:

reading a pressure differential by a meal sensing apparatus having a transducer disposed in a subcutaneous port, wherein the pressure differential is between a gastric band bladder connected to a catheter, and a chamber in the subcutaneous port, and wherein movement of the band bladder causes the pressure differential through the catheter and chamber that is readable by the transducer; and

initiating a drug delivery pump to deliver an active agent.

17. The process in claim 16 further including:

monitoring blood glucose levels, the monitoring being initiated when the transducer senses the pressure differential from the patient eating a meal.

18. The process in claim 17 further including monitoring the heart rate of a patient by an EKG monitor.

19. The process in claim 18, wherein the meal sensor apparatus, glucose monitor and EKG monitor are all implantable devices connected together.

20. The process in claim 16, further including recording in a non-transitory readable medium located in a control unit an act of swallowing food as a patient initiates a meal to determine at least one of:

the frequency of the patient eating and a volume of meals.