Implantable medical device and patch system and method of use

• US 20050182389A1
• Filed: 04/30/2002
• Published: 08/18/2005
• Est. Priority Date: 04/30/2001
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: LaPorte, Steve, Riff, Kenneth Mark, Olsen, James M., Heruth, Kenneth T., Lent, Mark S., Haller, Markus, Hooper, William J.
• Application Number:
  US10/137,516
• Publication Number:
  US 20050182389A1
• Time in Patent Office: Days
• US Class Current: 604/890.100
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/08 Arrangements or circuits for monitoring, protecting, controlling or indicating for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A system, method and apparatus relating to a therapeutic substance delivery patch for attachment to a patient such that the patch is in contact with the patient'"'"'s skin, wherein the patch coordinates its delivery of the therapeutic substance to the patient based on information received relating to the operation of the implanted device. The information received by the patch may be received through telemetry from the implanted device, or alternatively from the patch sensing the action of the implanted device, or alternatively from the patch sensing the patient'"'"'s physiologic reaction to the action taken by the implanted device.

Claims

1. A method of administering a therapeutic substance to a patient having an implanted medical device, wherein the implanted medical device generates a signal, the method comprising:

attaching a patch containing the therapeutic substance to the patient so that the patch is in contact with the skin of the patient;

generating a signal from the implanted medical device; and

administering the therapeutic substance from the patch to the patient in response to the signal generated by the medical device.

2. The method according to claim 1 wherein the medical device further comprises a sensor, the method further comprising:

sensing a physiologic characteristic of the patient by the medical device wherein the signal generated by the medical device represents the physiologic characteristic.

3. The method according to claim 2 wherein the physiologic characteristic is selected from the group consisting of temperature, blood oxygen saturation, activity level, lung wetness, glucose level, thoracic impedance, EKG, heart rate, respiration rate, EMG, EEG, blood pressure, intra cerebral ventricular (ICV) pressure, and position of the patient.

4. The method according to claim 1 wherein the signal generated by the medical device represents operational information of the medical device.

5. The method according to claim 1 wherein the attaching a patch containing the therapeutic substance to the skin of the patient comprises adhering the patch to the skin.

6. The method according to claim 1 wherein the patch is a transdermal drug delivery patch.

7. The method according to claim 6 wherein the transdermal drug delivery patch comprises an iontophoretic transdermal drug delivery patch.

8. The method according to claim 6 wherein the transdermal drug delivery patch comprises a sonophoretic transdermal drug delivery patch.

9. The method according to claim 6 wherein the transdermal drug delivery patch utilizes a laser to assist in transmission of the drug through the skin of the patient.

10. The method according to claim 1 wherein the administering the therapeutic substance to the patient in response to the signal generated by the medical device comprises administering the therapeutic substance through a needle attached to the patch.

11. The method according to claim 1 wherein administering the therapeutic substance to the patient in response to the signal generated by the implanted medical device comprises directing the therapeutic substance into an implanted catheter access port wherein the catheter access port delivers the drug to a selected location in the body.

12. The method according to claim 11 wherein the selected location comprises the brain.

13. The method according to claim 11 wherein the selected location comprises the spinal cord.

14. The method according to claim 11 wherein the selected location comprises the vascular system.

15. The method according to claim 11 wherein the selected location comprises the heart.

16. The method according to claim 1 wherein the step of administering the therapeutic substance to the patient in response to the signal generated by the medical device comprises administering a drug to the patient.

17. The method according to claim 1 wherein the step of administering the therapeutic substance to the patient in response to the signal generated by the medical device comprises administering a biologic agent to the patient.

18. The method according to claim 1 wherein the step of administering the therapeutic substance to the patient in response to the signal generated by the medical device includes delivery of a therapeutic substance selected from the group consisting of anti-arrhythmic drugs, diuretic drugs, vasodilators, muscle relaxants, pain relieving drugs, analgesics, anti-clotting drugs, blood thinners, anti-seizure drugs, gene therapeutic substances, naturitic peptides, insulin, or any other therapeutic substance whose administration would be improved if the delivery could be optimally timed to the receipt of information from an implantable medical device.

19. The method according to claim 1 wherein the medical device is selected from the group consisting of a nerve stimulator, brain stimulator, muscle stimulator, infusion pump, drug delivery device, monitoring device, cochlear implant, oxygen sensing device, pacemaker, defibrillator, cardioverter, pacemaker/cardioverter/defibrillator (PCD), left ventricular assist device and total artificial heart device.

20. A method of administering a therapeutic substance to a patient having an implanted medical device that is adapted to take an action on the patient, the method comprising:

attaching a patch containing the therapeutic substance to the patient so that the patch is in contact with the skin of the patient and a sensor for sensing a physiologic reaction to the action taken by the medical device;

sensing with the sensor the physiologic reaction to the action taken by the implanted medical device; and

administering the therapeutic substance to the patient in response to the reaction sensed by the sensor.

21. The method according to claim 20 wherein the medical device has an active mode and an inactive mode relating to at least one activity of the medical device, wherein the step of sensing with the sensor the patient'"'"'s physiologic reaction to the action taken by the medical device comprises determining whether the medical device is in the active or inactive mode.

22. A method of administering an therapeutic substance to a patient having an implanted medical device that is adapted to take an action on the patient, the method comprising:

attaching a patch containing the therapeutic substance to the patient so that the patch is in contact with the skin of the patient and a sensor for sensing the action taken by the medical device;

sensing with the sensor the action taken by the implanted medical device; and

administering the therapeutic substance to the patient in response to the action sensed by the sensor.

23. The method according to claim 22 wherein the medical device has an active mode and an inactive mode relating to at least one activity of the medical device, wherein the step of sensing with the sensor the action taken by the medical device comprises determining whether the medical device is in the active or inactive mode.

24. A method of administering an therapeutic substance to a patient having an implanted medical device that is adapted to take an action on the patient, the method comprising:

attaching a patch containing the therapeutic substance to the patient so that the patch is in contact with the skin of the patient and a sensor for determining if the medical device has taken an action on the patient;

determining with the sensor whether the medical device has taken an action on the patient; and

administering the therapeutic substance to the patient in response to the determination carried out in the determining step.

25. The method according to claim 24 wherein the determining step comprises sensing a parameter relevant to whether the medical device has taken an action on the patient or a physiologic reaction of the patient expected in response to the action, and inferring whether the medical device has taken the action.

26. A method of administering a therapeutic substance to a patient having an implanted blood pressure monitor, wherein the implanted blood pressure monitor generates a signal, the method comprising:

attaching a patch containing the therapeutic substance to the patient so that the patch is in contact with the skin of the patient;

generating a signal from the implanted blood pressure monitor representing the blood pressure of the patient; and

administering the therapeutic substance from the patch to the patient in response to the signal generated by the medical device.

27. The method according to claim 26 wherein the therapeutic substance is selected from the group consisting of diuretic drugs, beta blockers, and vasodilators.

28. A method of administering a therapeutic substance to a patient having an epileptic seizure or in anticipation or prediction of an epileptic seizure, the patient having an implanted neurostimulator including deep brain stimulation leads, wherein the implanted neurostimulator generates a signal, the method comprising:

attaching a patch containing the therapeutic substance to the patient so that the patch is in contact with the skin of the patient;

generating a signal from the implanted neurostimulator representing the electric potentials in the brain of the patient; and

administering the therapeutic substance from the patch to the patient in response to the signal generated by the implanted neurostimulator.

29. The method according to claim 28 wherein the therapeutic substance is selected from the group consisting of Phenytoin and Conantonkin-G.

30. A method of administering a therapeutic substance to a patient having diabetes, the patient having an implanted glucose monitor, wherein the implanted glucose monitor generates a signal, the method comprising:

attaching a patch containing the therapeutic substance to the patient so that the patch is in contact with the skin of the patient;

generating a signal from the implanted glucose monitor representing glucose level; and

administering the therapeutic substance from the patch to the patient in response to the signal generated by the implanted glucose monitor.

31. The method according to claim 30 wherein the therapeutic substance is selected from the group consisting of insulin and glucagons.

32. A method of administering a narcotic antagonist to a patient receiving opioids, the patient having an implanted medical device capable of sensing respiration rate, wherein the implanted medical device generates a signal, the method comprising:

attaching a patch containing the narcotic antagonist to the patient so that the patch is in contact with the skin of the patient;

generating a signal from the implanted medical device representing respiration rate; and

administering the narcotic antagonist from the patch to the patient in response to the signal generated by the implanted medical device.

33. The method according to claim 32 wherein the opioid comprises morphine and the narcotic antagonist comprises naloxone.

34. The method according to claim 32 wherein the opioid comprises fentanyl and the narcotic antagonist comprises naloxone.

35. The method according to claim 32 wherein the opioid comprises sufentanil and the narcotic antagonist comprises naloxone.

36. The method according to claim 32 wherein the opioid comprises hydromorphone and the narcotic antagonist comprises naloxone.

37. A method of administering an antiarrythmic drug to a patient, the patient having an implanted medical device capable of sensing heart rate, wherein the implanted medical device generates a signal, the method comprising:

attaching a patch containing the antiarrythmic drug to the patient so that the patch is in contact with the skin of the patient;

generating a signal from the implanted medical device representing heart rate; and

administering the antiarrythmic drug from the patch to the patient in response to the signal generated by the implanted medical device.

38. A drug delivery patch capable of administering a therapeutic substance to a patient based on information received from an implanted medical device, the patch comprising:

a housing configured for attachment to the patient so that the housing contacts the patient'"'"'s skin;

a therapeutic substance reservoir coupled to the housing, the therapeutic substance reservoir having a reservoir outlet;

a power source carried in the housing;

electronics carried in the housing and coupled to the power source, the electronics comprising a telemetric receiver capable of receiving a signal generated from the implanted medical device; and

a pump coupled to the electronics and coupled to the reservoir outlet, the pump configured for pumping a therapeutic substance from the therapeutic substance reservoir through an infusion outlet at a programmed rate based on the signal received from the implanted medical device.

39. A therapeutic substance delivery patch capable of administering a therapeutic substance to a patient based on information received from an implanted medical device, the patch comprising:

a housing including reservoir means for containing the therapeutic substance;

attachment means for attaching the patch to the patient so that the patch is in contact with the patient'"'"'s skin;

communication means for receiving a signal from the implanted medical device representing a physiologic condition of the patient;

control means for controlling the functions of the patch through a control signal wherein the control signal is based at least in part on the signal from the implanted medical device; and

delivery means for delivering a metered amount of the therapeutic substance to the patient in response to the control signal.

40. The therapeutic substance delivery patch according to claim 39 wherein the therapeutic substance is selected from the group consisting of antiarrythmic drugs;

diuretic drugs;

beta blockers;

vasodilators;

muscle relaxants;

pain relieving drugs;

analgesics;

anti-clotting drugs;

blood thinners;

anti-seizure drugs;

naturitic peptides; and

narcotic antagonists.

41. The therapeutic substance delivery patch according to claim 39 wherein the therapeutic substance is selected from the group consisting of amiodarone;

bumentanide;

conantonkin-G;

flecainide;

ibutilide;

isosorbide;

furosemide;

metaprolol;

naloxone;

nitroglycerine;

phenytoin;

procainamide;

propranolol;

insulin;

glucagons; and

sotalol.

42. The therapeutic substance delivery patch according to claim 39 wherein the attachment means comprises an adhesive applied to the housing.

43. A therapeutic substance delivery patch capable of administering a therapeutic substance to a patient based on information sensed from an implanted medical device, the patch comprising:

a housing including reservoir means for containing the therapeutic substance;

attachment means for attaching the patch to the patient so that the patch is in contact with the patient'"'"'s skin;

sensing means for sensing an action taken by the implanted medical device;

control means for controlling the functions of the patch through a control signal wherein the control signal is based at least in part on the sensed action; and

delivery means for delivering a metered amount of the therapeutic substance to the patient in response to the control signal.

44. A therapeutic substance delivery patch capable of administering a therapeutic substance to a patient based on sensed physiologic information, the patch comprising:

a housing including reservoir means for containing the therapeutic substance;

attachment means for attaching the patch to the patient so that the patch is in contact with the patient'"'"'s skin;

sensing means for sensing a physiologic reaction to an action taken by the implanted medical device;

control means for controlling the functions of the patch through a control signal wherein the control signal is based at least in part on the sensed reaction; and

delivery means for delivering a metered amount of the therapeutic substance to the patient in response to the control signal.

45. The therapeutic substance delivery patch according to claim 44 wherein the sensing means comprises a sensor capable of sensing conditions selected from the group consisting of galvanic skin resistance, temperature, oxygen saturation, blood pressure, activity level of patient, lung wetness, glucose level, thoracic impedance, EKG, heart rate, respiration rate, EMG, EEG, ICV pressure, and position of patient.

46. A therapeutic substance therapy system for delivery of a therapeutic substance into a human body comprising:

(a) an implanted medical device capable of generating a telemetric signal;

(b) a therapeutic substance delivery patch attached to the patient so that the patch is in contact with the skin of a patient, the therapeutic substance delivery patch comprising;

(i) a telemetric receiving antenna for receiving the telemetric signal from the implanted medical device;

(ii) a reservoir capable of holding the therapeutic substance; and

(iii) means for delivering the agent into the body.

47. A therapeutic substance therapy system for delivery of a therapeutic substance into a human body comprising:

(a) an implanted medical device capable of generating an electric therapy signal, the electric therapy signal provided to the patient for therapeutic reasons;

(b) a therapeutic substance delivery patch attached to the patient so that the patch is in contact with the skin of a patient, the therapeutic substance delivery patch comprising;

(i) a sensor for sensing the electric therapy signal;

(ii) a reservoir capable of holding the therapeutic substance; and

(iii) means for delivering the agent into the body based at least in part on the sensed electric therapy signal.

48. A therapeutic substance therapy system for delivery of a therapeutic substance into a human body comprising:

(a) an implanted medical device capable of generating an electric therapy signal, the electric therapy signal provided to the patient for therapeutic reasons wherein the electric therapy signal results in a physiologic reaction;

(b) a therapeutic substance delivery patch attached to the patient so that the patch is in contact with the skin of a patient, the therapeutic substance delivery patch comprising;

(i) a sensor for sensing the physiologic reaction to the electric therapy signal;

(ii) a reservoir capable of holding the therapeutic substance; and

(iii) means for delivering the agent into the body based at least in part on the sensed physiologic reaction to the electric therapy signal.