Technique for using heat flow management to treat brain disorders

• US 6,248,126 B1
• Filed: 01/12/1999
• Issued: 06/19/2001
• Est. Priority Date: 01/12/1998
• Status: Expired due to Term

• Current Assignee: Johns Hopkins University
• Original Assignee: Johns Hopkins University
• Inventors: Webber, W. Robert S., Lesser, Ronald P.
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): RAM, JOCELYN D
• Application Number:
  US09/228,414
• Time in Patent Office: 889 Days
• Field of Search: 607/113, 607/98, 607/99, 607/96, 606/21, 606/20, 606/27
• US Class Current: 607/113
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61F 2007/0008 Scalp
• CPC Class Codes: A61F 2007/0075 using a Peltier element, e.g. near the spot to be heated or cooled
• CPC Class Codes: A61F 2007/0078 with a battery
• CPC Class Codes: A61F 2007/0095 with a temperature indicator
• CPC Class Codes: A61F 2007/0295 for heating or cooling or use at more than one temperature
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/00 Heating or cooling appliances for medical or therapeutic treatment of the human body heating or cooling means in connection with bedsteads or mattresses A47C21/00 ; massage, therapeutic baths A61H; hyperthermia using electric or magnetic fields or ultrasound A61N; electric heating elements H05B
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36075 Headache or migraine
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36135 using physiological parameters

Abstract

A method of treating a brain disorder by heat transfer from brain tissue comprising the steps of surgically cutting a heat transfer aperture into a patient'"'"'s skull, thereby exposing a predetermined portion of patient'"'"'s brain; surgically implanting into said heat transfer aperture a heat pump having one or more electrical sensor elements and one or more temperature sensor elements; surgically implanting a heat transfer management unit in a body cavity of said patient such that a micro controller of the heat transfer management unit is connected to one or more activity sensor elements and one or more temperature sensor elements contacting brain tissue and connecting the heat transfer management unit to said heat pump via a lead bundle. Optionally, the heat transfer unit may be located external to the patient'"'"'s body. Responsive to signals from one or more activity or temperature sensor elements, mathematical algorithms of the heat transfer management unit determine abnormal brain activity, causing the heat pump to remove heat from the brain tissue into a heat sink, thereby cooling the predetermined portion of the patient'"'"'s brain. This technique utilizes acute hypothermia by means of a Peltier cooler or similar device to cool the brain temperature to reduce or prevent seizure initiation and/or propagation. The method may be used in association with brain stimulation and/or drug application to acutely avoid the occurrence of a seizure episode.

Claims

1. A method of treating a brain disorder by heat transfer from brain tissue comprising the steps of:

surgically cutting a heat transfer aperture into a patient'"'"'s skull, thereby exposing a predetermined portion of patient'"'"'s brain;

surgically implanting into said heat transfer aperture a heat pump having one or more activity sensor elements and one or more temperature sensor elements;

surgically implanting a heat transfer management unit in a body cavity of said patient such that a micro controller of the heat transfer management unit is connected to one or more activity sensor elements and one or more temperature sensor elements contact brain tissue; and

connecting the heat transfer management unit to said heat pump via a lead bundle;

whereby responsive to signals from one or more activity sensor elements, mathematical algorithms of the heat transfer management unit determine abnormal brain activity, causing the heat pump to remove heat from the brain tissue into a heat sink, thereby cooling the predetermined portion of the patient'"'"'s brain.

2. A method according to claim 1, wherein heat transfer is controlled by brain temperature as detected by one or more temperature sensor elements, thereby preventing excessive heat transfer either into or out of the brain.

3. A method according to claim 2, wherein brain temperature is detected by sensors located at the brain surface or implanted within the brain.

4. A method according to claim 2, wherein control of heat transfer may be initiated by external agents via an induction loop which sends signals to the heat transfer management unit.

5. A method according to claim 1, wherein said heat pump uses Peltier junctions to achieve heat transfer.

6. A method according to claim 1, wherein said heat transfer management unit is implanted in a body cavity selected from the group consisting of abdomen, a subcutaneous pocket and a subclavicular pocket.

7. A method according to claim 1, wherein said heat sink comprises silicon oxide paste contained in a thin sac of biologically inert material.

8. A method according to claim 1, whereby power to operate the heat pump may be provided by at least one member selected from the group consisting of internal batteries, internal rechargeable cells, a subcutaneous coil, a subcutaneous induction loop, an external power source having an induction loop and a combination of internal and an external power sources.

9. A method according to claim 1, wherein said brain disorder comprises a member selected from the group consisting of epilepsy, intractable pain, psychiatric disorders and movement disorders.

10. A method according to claim 1, wherein activity sensors on ceramic plates implanted in or on the brain detect or predict seizure occurrence by analyzing brain activity via analysis with an algorithm, wherein such detection promotes heat pump-mediated brain cooling to reduce or prevent seizure initiation and/or propagation.

11. A method of reducing or preventing the occurrence of a seizure comprising cooling brain tissue according to claim 1, and electrically stimulating the brain at or near a seizure focus or a structure that modulates seizures.

12. A method of reducing or preventing the occurrence of a seizure comprising cooling brain tissue according to claim 1, and infusing a therapeutic agent into the brain at or near a seizure focus or a structure that modulates seizures.

13. A method of reducing or preventing the occurrence of a seizure comprising cooling brain tissue according to claim 1, electrically stimulating the brain at or near a seizure focus or a structure that modulates seizures, and infusing a therapeutic agent into the brain at or near a seizure focus or a structure that modulates seizures.

14. A method according to any one of claims 11-13, wherein said electrical stimulation or said infusion of therapeutic agent is directed to a brain area comprising a member selected from the group consisting of neocortex, hippocampus, amygdala thalamus, hypothalamus, caudate or other nuclei of the basal ganglia, cerebellum and brain stem.

15. A method according to claim 12 or claim 13, wherein said therapeutic agent comprises a member selected from the group consisting of hydantoins, deoxybarbiturates, benzodiazepines, glutamate receptor agonists, glutamate receptor antagonists, γ

-aminobutyric acid receptor agonists, γ

-aminobutyric acid receptor antagonists, dopamine receptor agonists, dopamine receptor antagonists and anesthetics.

16. A method of controllably warming a hypothermic brain by heat transfer to brain tissue comprising the steps of:

surgically cutting a heat transfer aperture into a patient'"'"'s skull, thereby exposing a predetermined portion of patient'"'"'s brain;

surgically implanting into said heat transfer aperture a heat pump having one or more activity sensor elements and one or more temperature sensor elements;

attaching a heat transfer management unit such that a micro controller of the heat transfer management unit is connected to one or more activity sensor elements and one or more temperature sensor elements contact brain tissue; and

connecting the heat transfer management unit to said heat pump via a lead bundle;

whereby responsive to signals from one or more activity sensor elements, mathematical algorithms of the heat transfer management unit determine abnormal brain activity, causing the heat pump to transfer heat to the brain tissue from a heat source, thereby heating the patient'"'"'s brain.

17. A method according to claim 16, wherein said heat transfer management unit is surgically implanted into a patient'"'"'s body cavity or is located external to a patient'"'"'s body.

18. A method for control of central nervous system tissue swelling or inflammation by controlled cooling comprising the steps of:

surgically cutting a heat transfer aperture into a patient'"'"'s skull or spine, thereby exposing a predetermined portion of patient'"'"'s brain or spinal cord;

surgically implanting into said heat transfer aperture a heat pump having one or more activity sensor elements and one or more temperature sensor elements;

attaching a heat transfer management unit such that a micro controller of the heat transfer management unit is connected to one or more members of the group consisting of activity sensor elements and temperature sensor elements contacting brain or spinal cord tissue; and

connecting the heat transfer management unit to said heat pump via a lead bundle;

whereby responsive to signals from said one or more activity sensor elements or one or more temperature sensor elements, mathematical algorithms of the heat transfer management unit determine abnormal brain or spinal cord activity, causing the heat pump to transfer heat from the brain or spinal cord tissue to a heat sink, thereby effecting cooling.

19. A method according to claim 18, wherein said central nervous system tissue swelling or inflammation is due to a member selected from the group consisting of trauma, hemorrhage, encephalitis, localized myelitis, mass lesions and intractable migraine headaches.

20. A method of controlling swelling, inflammation or localized pain in a non-central nervous system organ by regionally or locally directed cooling to said organ comprising the steps of:

surgically cutting an incision into a patient'"'"'s musculature, fascia and body cavity linings and skin, thereby exposing a predetermined portion of said organ;

surgically implanting through this incision a heat pump having one or more activity sensor elements and one or more temperature sensor elements;

attaching a heat transfer management unit such that a micro controller of the heat transfer management unit is connected to one or more activity sensor elements and one or more temperature sensor elements in contact with organ tissue; and

connecting the heat transfer management unit to said heat pump via a lead bundle;

whereby responsive to signals from said one or more activity or temperature sensor elements, mathematical algorithms of the heat transfer management unit detect abnormal organ cell activity, causing the heat pump to transfer heat from the organ tissue to a heat sink, thereby cooling the patient'"'"'s organ to reduce or eliminate swelling, inflammation or localized organ pain.

21. A method according to claim 20, wherein said non-central nervous system organ comprises a member selected from the group consisting of thoracic and abdominal organs and skeletal muscle.