Methods and apparatus for delivering a drug influencing appetite for treatment of eating disorders

• US 20030204181A1
• Filed: 04/26/2002
• Published: 10/30/2003
• Est. Priority Date: 04/26/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Starkebaum, Warren L.
• Granted Patent: US 7,043,295 B2
• Time in Patent Office: Days
• US Class Current: 604/891.1
• CPC Class Codes: A61F 5/0026 Anti-eating devices using electrical stimulation
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 2210/1003 Spinal column
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• 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

Methods and systems for treating patients suffering from eating disorders, e.g. obesity, through the dispensation of a drug by an implantable infusion pump (IIP) delivering drug into the cerebral spinal fluid (CSF) at a site of the intrathecal space in amounts and at times effective to suppress the patient'"'"'s appetite through interaction of the drug transported through the CSF with receptors in the brain. Delivery of a programmed drug dosage is preferably by one of time-out of programmed time(s) of day, a command received from the patient, or a trigger signal developed from a sensed GI tract signal accompanying peristalsis.

Claims

1. A method of delivering drug from an implantable infusion pump to receptors of the brain to therapeutically treat an eating disorder of a patient by suppressing or enhancing appetite, the method comprising the steps of:

surgically implanting an intrathecal drug infusion catheter so that a distal drug delivery portion lies in a predetermined intrathecal space site of the spinal column in cerebral spinal fluid (CSF) communication with receptors in the brain;

coupling the proximal end of the drug infusion catheter to an drug infusion pump;

implanting the drug infusion pump in the patient'"'"'s body; and

operating the pump to discharge a predetermined dosage of drug into the CSF sufficient to suppress or enhance appetite through interaction of drug transported through the CSF with receptors in the brain.

2. The method of claim 1, wherein the operating step further comprises:

providing the patient with an external medical device for communicating with the pump; and

utilizing the external medical device to communicate a command to the pump to discharge the predetermined dosage of drug into the CSF sufficient to suppress or enhance appetite through interaction with receptors in the brain.

3. The method of claim 2, wherein the operating step further comprises:

timing out a delay time from each discharge; and

inhibiting the pump from responding to the command if the delay time has not timed out.

4. The method of claim 1, wherein the drug is insulin acting to suppress appetite when detected by the receptors in the brain, and the operating step further comprises:

providing the patient with an external medical device for communicating with the pump; and

utilizing the external medical device to communicate a command to the pump to discharge a dosage of insulin in the range of 1×

10<sup>−

5</sup>-15×

10<sup>−

2</sup> Units/Kg/day into the CSF sufficient to suppress appetite through interaction with receptors in the brain.

5. The method of claim 1, wherein the drug is insulin acting to suppress appetite when detected by the receptors in the brain, and the operating step further comprises:

providing the patient with an external medical device for communicating with the pump; and

utilizing the external medical device to communicate a command to the pump to discharge the predetermined dosage of insulin into the CSF sufficient to suppress or enhance appetite through interaction with receptors in the brain.

6. The method of claim 1, wherein the operating step further comprises:

timing out the time of day; and

operating the drug infusion pump at one or more predetermined time of day to discharge the predetermined dosage of drug into the CSF sufficient to suppress or enhance appetite through interaction with receptors in the brain.

7. The method of claim 1, wherein the drug is insulin acting to suppress appetite when detected by the receptors in the brain, and the operating step further comprises:

timing out the time of day; and

operating the pump at one or more predetermined time of day to discharge a dosage of insulin into the CSF sufficient to suppress appetite through interaction with receptors in the brain.

8. The method of claim 1, wherein the drug is insulin acting to suppress appetite when detected by the receptors in the brain, and the operating step further comprises:

timing out the time of day; and

operating the pump at one or more predetermined time of day to discharge a dosage of insulin in the range of 1×

10<sup>−

5</sup>-15×

10<sup>−

2</sup> Units/Kg/day into the CSF sufficient to suppress appetite through interaction with receptors in the brain.

9. The method of claim 1, wherein the operating step further comprises the steps of:

detecting an electrical signal of the GI tract characteristic of peristalsis; and

triggering the operation of the drug infusion pump to discharge the predetermined dosage of drug into the CSF in timed relation to the detection of the electrical signal to suppress or enhance appetite through interaction with receptors in the brain.

10. The method of claim 9, wherein the operating step further comprises:

timing out a delay time from each discharge; and

inhibiting the pump from responding to the detection of the electrical signal of the GI tract if the delay time has not timed out.

11. The method of claim 9, wherein the detecting step further comprises the steps of:

implanting GI tract sense electrodes at predetermined sites of the GI tract traversed by electrical signals in the GI tract wall characteristic of peristalsis;

coupling the GI tract sense electrodes to GI tract sensing circuitry for detecting the electrical signals of the GI tract characteristic of peristalsis; and

triggering the operation of the drug infusion pump to discharge the predetermined dosage of drug into the CSF in timed relation to the detection of the electrical signals to suppress or enhance appetite through interaction with receptors in the brain.

12. The method of claim 11, wherein the GI tract sensing circuitry is located in the drug infusion pump.

13. The method of claim 9, wherein the detecting step further comprises the steps of:

implanting GI tract sense electrodes at predetermined sites of the GI tract traversed by electrical signals in the GI tract wall characteristic of peristalsis;

coupling the GI tract sense electrodes to GI tract sensing circuitry of a GI tract monitor for detecting the signals of the GI tract characteristic of peristalsis;

implanting the GI tract monitor in the patient'"'"'s body;

operating the GI tract monitor to develop a GI tract signal upon detection of the signals of the GI tract characteristic of peristalsis;

transmitting the detected electrical signals of the GI tract to the drug infusion pump; and

triggering the operation of the drug infusion pump to discharge the predetermined dosage of drug into the CSF in timed relation to the detection of the electrical signals of the GI tract to suppress or enhance appetite through interaction with receptors in the brain.

14. The method of claim 13, wherein the drug is insulin acting to suppress appetite when detected by the receptors in the brain, and the operating step further comprises the steps of:

detecting an electrical signal of the GI tract characteristic of peristalsis; and

triggering the operation of the drug infusion pump to discharge a predetermined dosage of insulin into the CSF in timed relation to the detection of the electrical signal to suppress appetite through interaction with receptors in the brain.

15. The method of claim 9, wherein the drug is insulin acting to suppress appetite when detected by the receptors in the brain, and the operating step further comprises the steps of:

detecting an electrical signal of the GI tract characteristic of peristalsis; and

triggering the operation of the drug infusion pump to discharge a predetermined dosage of insulin into the CSF in timed relation to the detection of the electrical signal to suppress appetite through interaction with receptors in the brain.

16. The method of claim 9, wherein the drug is insulin acting to suppress appetite when detected by the receptors in the brain, and the operating step further comprises the steps of:

detecting an electrical signal of the GI tract characteristic of peristalsis; and

triggering the operation of the drug infusion pump to discharge a dosage of insulin in the range of 1×

10<sup>−

5</sup>-15×

10<sup>−

2</sup> Units/Kg/day into the CSF in timed relation to the detection of the electrical signal to suppress appetite through interaction with receptors in the brain.

17. A method of delivering drug from an implantable infusion pump to receptors of the brain to therapeutically treat an eating disorder of a patient by suppressing or enhancing appetite, the method comprising the steps of:

surgically implanting an intrathecal drug infusion catheter so that a distal drug delivery portion lies in cerebral spinal fluid (CSF) in communication with receptors in the brain;

coupling the proximal end of the drug infusion catheter to an drug infusion pump;

implanting the drug infusion pump in the patient'"'"'s body;

detecting an electrical signal of the GI tract characteristic of peristalsis; and

triggering the operation of the drug infusion pump to discharge the predetermined dosage of drug into the CSF in timed relation to the detection of the electrical signal to suppress or enhance appetite through interaction with receptors in the brain.

18. The method of claim 17, wherein the operating step further comprises:

timing out a delay time from each discharge; and

inhibiting the pump from responding to the detection of the electrical signal of the GI tract if the delay time has not timed out.

19. The method of claim 17, wherein the detecting step further comprises the steps of:

implanting GI tract sense electrodes at predetermined sites of the GI tract traversed by electrical signals in the GI tract wall characteristic of peristalsis;

coupling the GI tract sense electrodes to GI tract sensing circuitry for detecting the electrical signals of the GI tract characteristic of peristalsis; and

triggering the operation of the drug infusion pump to discharge the predetermined dosage of drug into the CSF in timed relation to the detection of the electrical signals to suppress or enhance appetite through interaction with receptors in the brain.

20. The method of claim 19, wherein the GI tract sensing circuitry is located in the drug infusion pump.

21. The method of claim 17, wherein the detecting step further comprises the steps of:

implanting GI tract sense electrodes at predetermined sites of the GI tract traversed by electrical signals in the GI tract wall characteristic of peristalsis;

coupling the GI tract sense electrodes to GI tract sensing circuitry of a GI tract monitor for detecting the signals of the GI tract characteristic of peristalsis;

implanting the GI tract monitor in the patient'"'"'s body;

operating the GI tract monitor to develop a GI tract signal upon detection of the signals of the GI tract characteristic of peristalsis;

transmitting the detected electrical signals of the GI tract to the drug infusion pump; and

triggering the operation of the drug infusion pump to discharge the predetermined dosage of drug into the CSF in timed relation to the detection of the electrical signals of the GI tract to suppress or enhance appetite through interaction with receptors in the brain.

22. The method of claim 17, wherein the drug is insulin acting to suppress appetite when detected by the receptors in the brain, and the triggering step further comprises triggering the operation of the drug infusion pump to discharge a predetermined dosage of insulin into the CSF in timed relation to the detection of the electrical signal to suppress appetite through interaction with receptors in the brain.

23. The method of claim 17, wherein the drug is insulin acting to suppress appetite when detected by the receptors in the brain, and the triggering step further comprises triggering the operation of the drug infusion pump to discharge a predetermined dosage of insulin in the range of 1×

10<sup>−

5</sup>-15×

10<sup>−

2</sup> Units/Kg/day into the CSF in timed relation to the detection of the electrical signal to suppress appetite through interaction with receptors in the brain.

24. A system comprising an implantable infusion pump for delivering drug to receptors of the brain to therapeutically treat an eating disorder of a patient by suppressing or enhancing the patient'"'"'s appetite, the system comprising:

an intrathecal drug infusion catheter having catheter lumen extending from a catheter proximal end and a distal drug infusion portion adapted to be implanted so that the distal drug delivery portion lies in a predetermined intrathecal space site of the spinal column in cerebral spinal fluid (CSF) in communication with receptors in the brain;

a drug infusion pump comprising an drug reservoir, a roller pump and infusion discharge control circuitry adapted to be implanted in the patient and coupled to a proximal end of the drug infusion catheter, the infusion discharge control circuitry providing an infusion discharge control signal; and

means responsive to an infusion discharge control signal of the infusion discharge control circuitry for initiating operation of the roller pump to discharge a predetermined dosage of drug into the cerebral spinal fluid (CSF) sufficient to suppress or enhance appetite through interaction of drug transported through the CSF with receptors in the brain.

25. The system of claim 24, further comprising an external medical device operable by the patient or a medical care provider to generate an drug discharge command, and the drug infusion discharge control circuitry comprises:

means for receiving and responding to the drug discharge command from the external medical device to develop the infusion discharge control signal; and

means for timing out a delay time from each discharge; and

means for inhibiting the pump from responding to the command if the delay time has not timed out.

26. The system of claim 24, further comprising an external medical device operable by the patient or a medical care provider to generate an drug discharge command, and the drug infusion discharge control circuitry comprises means for receiving and responding to the drug discharge command from the external medical device to develop the infusion discharge control signal.

27. The system of claim 26, wherein the drug is insulin acting to suppress appetite when detected by the receptors in the brain, and the triggering step further comprises triggering the operation of the drug infusion pump to discharge a predetermined dosage of insulin into the CSF in timed relation to the detection of the electrical signal to suppress appetite through interaction with receptors in the brain.

28. The system of claim 26, wherein the drug is insulin acting to suppress appetite when detected by the receptors in the brain, and the triggering step further comprises triggering the operation of the drug infusion pump to discharge a predetermined dosage of insulin in the range of 1×

10<sup>−

5</sup>-15×

10<sup>−

2</sup> Units/Kg/day into the CSF in timed relation to the detection of the electrical signal to suppress appetite through interaction with receptors in the brain.

29. The system of claim 24, wherein the drug infusion discharge control circuitry comprises:

means for timing out the time of day; and

means for operating the drug infusion pump at one or more predetermined time of day to discharge the predetermined dosage of drug into the CSF sufficient to suppress or enhance appetite through interaction with receptors in the brain.

30. The system of claim 29, wherein the drug is insulin acting to suppress appetite when detected by the receptors in the brain, and the triggering step further comprises triggering the operation of the drug infusion pump to discharge a predetermined dosage of insulin into the CSF in timed relation to the detection of the electrical signal to suppress appetite through interaction with receptors in the brain.

31. The system of claim 29, wherein the drug is insulin acting to suppress appetite when detected by the receptors in the brain, and the triggering step further comprises triggering the operation of the drug infusion pump to discharge a predetermined dosage of insulin in the range of 1×

10<sup>−

5</sup>-15×

10<sup>−

2</sup> Units/Kg/day into the CSF in timed relation to the detection of the electrical signal to suppress appetite through interaction with receptors in the brain.

32. The system of claim 24, wherein the drug infusion discharge control circuitry comprises:

means for detecting an electrical signal of the GI tract characteristic of peristalsis; and

means for triggering the operation of the drug infusion pump to discharge the predetermined dosage of drug into the CSF in timed relation to the detection of the electrical signal to suppress or enhance appetite through interaction with receptors in the brain.

33. The system of claim 32, wherein the drug infusion discharge control circuitry comprises:

means for timing out a delay time from each discharge; and

means for inhibiting the pump from responding to the detection of the electrical signal of the GI tract if the delay time has not timed out.

34. The system of claim 24, further comprising:

GI tract sense electrodes adapted to be implanted at predetermined sites of the GI tract traversed by electrical signals in the GI tract wall characteristic of peristalsis; and

GI tract sensing circuitry coupled with the GI tract sense electrodes for detecting the electrical signals of the GI tract characteristic of peristalsis; and

wherein the drug infusion discharge control circuitry comprises means for triggering the operation of the drug infusion pump to discharge the predetermined dosage of drug into the CSF in timed relation to the detection of the electrical signals to suppress or enhance appetite through interaction with receptors in the brain.

35. The system of claim 34, wherein the GI tract sensing circuitry is located in the drug infusion pump.

36. The system of claim 24, further comprising:

GI tract leads bearing a sense electrodes adapted to be implanted at predetermined sites of the GI tract traversed by electrical signals in the GI tract wall characteristic of peristalsis; and

a GI tract monitor adapted to be implanted in the patient'"'"'s body and coupled to the GI tract leads sense electrodes and further comprising;

sense means for detecting the signals of the GI tract characteristic of peristalsis;

means for developing a GI tract signal upon detection of the signals of the GI tract characteristic of peristalsis; and

means for transmitting the detected electrical signals of the GI tract to the drug infusion pump; and

wherein;

the drug infusion discharge control circuitry comprises means for receiving the transmitted electrical signals of the GI tract and for triggering the operation of the drug infusion pump to discharge the predetermined dosage of drug into the CSF in timed relation to the detection of the electrical signals of the GI tract to suppress or enhance appetite through interaction with receptors in the brain.

37. The system of claim 24, wherein the drug is insulin acting to suppress appetite when detected by the receptors in the brain, and the operating step further comprises:

means for detecting an electrical signal of the GI tract characteristic of peristalsis; and

means for triggering the operation of the drug infusion pump to discharge a predetermined dosage of insulin into the CSF in timed relation to the detection of the electrical signal to suppress appetite through interaction with receptors in the brain.

38. The system of claim 24, wherein the drug is insulin acting to suppress appetite when detected by the receptors in the brain, and the operating step further comprises:

means for detecting an electrical signal of the GI tract characteristic of peristalsis; and

means for triggering the operation of the drug infusion pump to discharge a dosage of insulin in the range of 1×

10<sup>−

5</sup>-15×

10<sup>−

2</sup> Units/Kg/day into the CSF in timed relation to the detection of the electrical signal to suppress appetite through interaction with receptors in the brain.

39. A system delivering drug from an implantable infusion pump to receptors of the brain to therapeutically treat an eating disorder of a patient by suppressing or enhancing appetite comprising:

a drug infusion catheter having catheter lumen extending from a catheter proximal end and a distal drug infusion portion adapted to be implanted so that the distal drug delivery portion lies in cerebral spinal fluid (CSF) in communication with receptors in the brain;

a drug infusion pump comprising an drug reservoir, a roller pump, and infusion discharge control circuitry adapted to be implanted in the patient and coupled to a proximal end of the drug infusion catheter;

means for detecting an electrical signal of the GI tract characteristic of peristalsis; and

means for triggering the operation of the drug infusion pump to discharge the predetermined dosage of drug into the CSF in timed relation to the detection of the electrical signal to suppress or enhance appetite through interaction with receptors in the brain.

40. The system of claim 39, further comprising:

means for timing out a delay time from each discharge; and

means for inhibiting the pump from responding to the detection of the electrical signal of the GI tract if the delay time has not timed out.

41. The system of claim 39, wherein the detecting means further comprises:

GI tract sensing circuitry for detecting the electrical signals of the GI tract characteristic of peristalsis

GI tract sense electrodes adapted to be implanted at predetermined sites of the GI tract traversed by electrical signals in the GI tract wall characteristic of peristalsis; and

GI tract leads coupling the GI tract sense electrodes to the GI tract sensing circuitry.

42. The system of claim 41, wherein the GI tract sensing circuitry is located in the drug infusion pump.

43. The system of claim 39, wherein the detecting means further comprises:

GI tract leads having GI tract sense electrodes adapted to be implanted at predetermined sites of the GI tract traversed by electrical signals in the GI tract wall characteristic of peristalsis; and

a GI tract monitor adapted to be implanted in the patient'"'"'s body comprising;

GI tract sensing circuitry coup[led to the GI tract leads for detecting the electrical signals of the GI tract characteristic of peristalsis; and

means for transmitting the detected electrical signals of the GI tract to the drug infusion pump.

44. The system of claim 39, wherein the drug is insulin acting to suppress appetite when detected by the receptors in the brain, and the triggering means further comprises means for triggering the operation of the drug infusion pump to discharge a predetermined dosage of insulin into the CSF in timed relation to the detection of the electrical signal to suppress appetite through interaction with receptors in the brain.

45. The system of claim 39, wherein the drug is insulin acting to suppress appetite when detected by the receptors in the brain, and the triggering means further comprises means for triggering the operation of the drug infusion pump to discharge a predetermined dosage of insulin in the range of 1×

10<sup>−

5</sup>-15×

10<sup>−

2</sup> Units/Kg/day into the CSF in timed relation to the detection of the electrical signal to suppress appetite through interaction with receptors in the brain.