Stroke treatment utilizing extravascular circulation of oxygenated synthetic nutrients to treat tissue hypoxic and ischemic disorders

• US 4,451,251 A
• Filed: 09/30/1982
• Issued: 05/29/1984
• Est. Priority Date: 03/03/1982
• Status: Expired due to Fees

• Current Assignee: Thomas Jefferson University (Main Line Health System)
• Original Assignee: Thomas Jefferson University (Main Line Health System)
• Inventors: Osterholm, Jewell L.
• Primary Examiner(s): Lesmes, George F.
• Assistant Examiner(s): Swisher, Nancy A. B.
• Application Number:
  US06/428,899
• Time in Patent Office: 607 Days
• Field of Search: 128/1 R, 128/207.19, 604/27, 604/26, 604/24, 604/31, 604/66, 424/355
• US Class Current: 604/24
• CPC Class Codes: A61M 2202/0464 Cerebrospinal fluid
• CPC Class Codes: A61M 2202/0476 Oxygenated solutions
• CPC Class Codes: A61M 2205/3653 by Joule effect, i.e. electric resistance
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 3/02 Enemata; Irrigators
• CPC Class Codes: A61M 3/0212 after use

Abstract

A novel acute care cerebral support system and method for treating severly ischemic brains is disclosed wherein an oxygenated nutrient emulsion is circulated through at least a portion of the ventriculo-subarachnoid spaces. The nutrient emulsion contains an oxygenatable non-aqueous component, an aqueous nutrient component, an emulsification component, and other components which render physiologic acceptability to the nutrient emulsion. The disclosed system and method have been shown to effectively exchange oxygen, carbon dioxide, glucose, and other metabolites in severely stroked brains. Significant restoration of oxidative metabolism and electrographic activity result from the disclosed treatment. Methods for producing the nutrient emulsion and a system for delivering that emulsion to the cerebrospinal pathway are also disclosed. Additionally, novel diagnostic methods for diagnosing the physiologic state of hypoxic-ischemic and other diseased neurologic tissue during treatment are provided.

Claims

1. An apparatus for treating patients suspected of having hypoxic-ischemic central nervous system tissue, comprising:

(a) a reservoir containing an oxygenatable fluorocarbon emulsion for treating hypoxic-ischemic neurologic tissue;

(b) oxygenator means disposed in fluid communication with said reservoir for oxygenating said emulsion, to produce an oxygenated liquid;

(c) cerebrospinal injection means disposed in fluid communication with said oxygenator means for injecting said oxygenated liquid into an extravascular cerebrospinal body pathway;

(d) cerebrospinal withdrawal means for withdrawing liquid from said extravascular cerebrospinal pathway to create, in combination with said injection means, a circulation of said oxygenated liquid within said pathway; and

(e) monitoring means in communication with said pathway for monitoring a physical/chemical characteristic of said withdrawn liquid.

2. The invention of claim 1 wherein said withdrawal means comprises means for withdrawing liquid from a subarachnoid space.

3. The invention of claim 1 wherein said monitoring means comprises means for monitoring the temperature of said oxygenated liquid.

4. The invention of claim 1 wherein said monitoring means comprises means for monitoring the osmolarity of said oxygenated liquid.

5. The invention of claim 1 wherein said monitoring means comprises means for monitoring the concentrations of compounds comprising said withdrawn liquid.

6. The invention of claim 1 wherein said apparatus comprises output analysis means for monitoring at least one chemical characteristic of said withdrawn fluid.

7. The invention of claim 6 wherein said apparatus comprises means for comparing at least one of said output characteristics with corresponding characteristics of the oxygenated liquid, and for selectively altering said oxygenated liquid characteristics in response thereto.

8. The invention of claim 6 wherein said chemical compounds include at least one compound selected from the group consisting of:

oxygen;

carbon dioxide;

sodium;

calcium;

lactic acid;

carbohydrates;

magnesium;

potassium;

fluoride;

chloride;

GABA;

amino acids;

catabolic enzyme;

ammonia;

neurotransmitter;

metabolites;

cellular organelles;

myelin fragments;

protein;

polypeptides;

lipids.

9. The invention of claim 6 wherein said monitoring means comprises means for monitoring the concentration of glucose.

10. The invention of claim 6 wherein said monitoring means comprises means for monitoring the concentration of dextrose.

11. The invention of claim 6 wherein said monitoring means comprises means for monitoring the concentration of LDH.

12. The invention of claim 7 wherein said injection means further comprises a cerebral catheter means for insertion into at least a brain ventricle for injecting a liquid therein, said cerebral catheter having an arrangement of outlet holes disposed as a series of slits radially spaced around the tip thereof.

13. The invention of claim 1 wherein said withdrawal means further comprises a catheter having a tip with multiple perforations disposed therein, said catheter further comprising means for attaching at least a portion thereof to tissue in the region of said subarachnoid space.

14. The invention of claim 13 wherein said means for attaching comprises a staple for attaching a noncollapsable portion of said catheter to a lumbar region of the skin.

19. The invention of claim 1 wherein said monitoring means comprises means for monitoring at least the oxygen content of said oxygenated liquid.

20. The invention of claim 1 wherein said monitoring means comprises means for monitoring the CO₂ content of said oxygenated liquid.

21. The invention of claim 1 wherein said monitoring means comprises means for monitoring the pressure under which said oxygenated liquid is injected.

15. An apparatus for treating patients suspected of having hypoxic-ischemic central nervous system tissue, comprising:

(a) a reservoir containing an oxygenatable fluorocarbon emulsion for treating hypoxic-ischemic neurologic tissue;

(b) oxygenator means disposed in fluid communication with said reservoir for oxygenating said emulsion, to produce an oxygenated liquid;

(c) cerebrospinal injection means disposed in fluid communication with said oxygenator means for injecting said oxygenated liquid into an extravascular cerebrospinal body pathway said injection means comprising a spinal catheter means for injecting said liquid into a spinal subarachnoid space; and

(d) cerebrospinal withdrawal means for withdrawing liquid from said extravascular cerebrospinal pathway to create, in combination with said injection means, a circulation of said oxygenated liquid within said pathway.

16. An apparatus for treating patients suspected of having hypoxic-ischemic central nervous system tissue, comprising:

(a) a reservoir containing an oxygenatable fluorocarbon emulsion for treating hypoxic-ischemic neurologic tissue;

(b) oxygenator means disposed in fluid communication with said reservoir for oxygenating said emulsion, to produce an oxygenated liquid;

(c) cerebrospinal injection means disposed in fluid communication with said oxygenaor means for injecting said oxygenated liquid into an extravascular cerebrospinal body pathway said injection means comprising a cerebral catheter means for insertion into at least a brain ventricle for injection of liquid therein, and means for preventing the portion of the catheter located within said ventricle from damaging tissues surrounding said ventricle; and

(d) cerebrospinal withdrawal means for withdrawing liquid from said extravascular cerebrospinal pathway to create, in combination with said injection means, a circulation of said oxygenated liquid within said pathway.

17. The invention of claim 16 wherein said means for preventing comprises an inflatable balloon tip.

18. The invention of claim 16 wherein said cerebral catheter means further comprises means for fixing at least a portion thereof with respect to the skull to thereby ensure catheter stability.