Apparatus for the exchange of cerebrospinal fluid and a method of treating brain and spinal cord injuries

• US 4,904,237 A
• Filed: 05/16/1988
• Issued: 02/27/1990
• Est. Priority Date: 05/16/1988
• Status: Expired due to Fees

• Current Assignee: Woodrow W. Janese
• Original Assignee: Woodrow W. Janese
• Inventors: Janese, Woodrow W.
• Primary Examiner(s): Jaworski, Francis
• Application Number:
  US07/194,363
• Time in Patent Office: 652 Days
• Field of Search: 604/27-28, 604/30-31, 604/32, 604/51-53, 604/65-67, 604/158, 604/246, 604/280
• US Class Current: 604/28
• CPC Class Codes: A61M 1/30 Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/302 having a reservoir for withdrawn untreated blood
• CPC Class Codes: A61M 1/303 having a reservoir for treated blood to be returned
• CPC Class Codes: A61M 1/361 before treatment
• CPC Class Codes: A61M 2202/0464 Cerebrospinal fluid
• CPC Class Codes: A61M 2205/126 with incorporated membrane filters
• CPC Class Codes: A61M 2205/3606 cooled
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves

Abstract

Disclosed is an apparatus and method for exchanging cerebrospinal fluid. The apparatus withdraws cerebrospinal fluid from the lumbar subarachnoid space, filters, cools, pH adjusts and performs diagnostic/monitoring functions on the fluid. It then returns purified and/or artificial spinal fluid to the subarachnoid space. The apparatus monitors fluid temperature and core body temperature. Furthermore, it detects increased subarachnoid hemorrhage or repeat subarachnoid hemorrhage. The apparatus is attached to an indwelling spinal cannula, and can continually exchange cerebrospinal fluid and monitor the patient. The apparatus can be completely controlled by computer with technician supervision for the treatment of patients needing purification of their spinal fluid.

Claims

1. An apparatus for the exchange of cerebrospinal fluid comprising:

a collection means for obtaining cerebrospinal fluid, wherein said collection means includes a catheter for indwelling in the subarachnoid compartment of a spinal canal, said catheter having a flange for retarding cerebrospinal fluid leakage from said spinal canal and a cannula for puncturing the spinal canal and providing a conduit for said catheter;

a processing means, attached to said collection means, for monitoring the exchange of cerebrospinal fluid; and

a regulation means for controlling the processing means and regulating the exchange of cerebrospinal fluid; and

an interface for connecting the processing means to the regulation means.

2. The apparatus of claim 1, wherein, more particularly, said catheter and said flange are silicone elastomers and said flange is attached to the external surface of said catheter and engages the spinal canal at the puncture site.

3. The apparatus of claim 2, wherein, more particularly, said catheter has an outside diameter of about 1.22 mm and an internal diameter of about 0.97 mm.

4. The apparatus of claim 1 wherein, more particularly, the processing means comprises:

a first container for holding untreated cerebrospinal fluid;

a filtration means for removing particulate matter from said untreated cerebrospinal fluid;

a second container for storing filtered cerebrospinal fluid;

a means for moving said cerebrospinal fluid, wherein said means for moving removes fluid from said spinal canal, passing said cerebrospinal fluid through said first container, said filtration means, said second container and back into said spinal canal;

a temperature regulating means for controlling the temperature of said cerebrospinal fluid; and

a means for monitoring physical and chemical characteristics of said cerebrospinal fluid.

5. The apparatus of claim 4, wherein, more particularly, the means for moving includes:

a peristaltic pump, wherein said pump is reversible, has a volume range of about 0.07 to 25 liters per hour, an operating pressure of less than about 30 PSI and is attached to said regulating means through said interface;

a three port valve means connected to said regulating means through said interface for synchronous control with said pump; and

a fluid loop connecting said collection means and said processing means;

wherein said fluid loops transport cerebrospinal fluid from said spinal canal through said processing means and back to said spinal canal.

6. The apparatus of claim 5, wherein, more particularly, the fluid loop includes:

a main fluid loop comprising a first tube between said collection means and said three port valve means;

an untreated fluid loop comprising a second tube for carrying said cerebrospinal fluid from said three port valve means to said first container, a third tube for carrying said cerebrospinal fluid from said first container to said filtration means, a fourth tube for carrying unfiltered cerebrospinal fluid from said filtration means back to said first container;

a treated fluid loop comprising a fifth tube for carrying filtered cerebrospinal fluid from said filtration means to said second container and a sixth tube for carrying filtered cerebrospinal fluid from said second container to said three port valve means;

wherein said loops pass through said temperature regulating means and said reversible peristaltic pump and wherein said regulating means controls the direction of flow of said cerebrospinal fluid by regulating the direction of said peristaltic pump and the open ports of said three port valve means such that cerebrospinal fluid flows from said spinal canal through the main fluid loop, the untreated fluid loop, the treated fluid loop and back through the main fluid loop to said spinal canal.

7. The apparatus of claim 4, wherein, more particularly, the filtration means includes a hollow fiber cartridge for micro-filtration of said cerebrospinal fluid by tangential flow filtration, said cartridge having a pore size of about 0.2 m, a membrane surface area of at least about 450 cm², wherein said cartridge is configured to allow said fluid flows at right angles through wall of said cartridge.

8. The apparatus of claim 4, wherein, said means for monitoring includes:

a pH electrode for measuring the pH of said cerebrospinal fluid;

a temperature probe for measuring the temperature of said cerebrospinal fluid;

a flow meter for measuring the volume of said cerebrospinal fluid flowing between the three port valve means and said spinal canal;

bi-directional pressure transducers for monitoring cerebrospinal fluid pressure; and

a spectrophotometer for monitoring spectrophotometric transmittance in the cerebrospinal fluid,

wherein said pH electrode, temperature probe, flow meter, pressure transducer and spectrophotometer are connected to said regulating means through said interface.

9. The apparatus of claim 1, wherein, more particularly, the regulation means comprises:

a computer; and

a technician station connected to said computer for providing results, including a monitor, a printer and a warning means.

10. The apparatus of claim 9, wherein, more particularly the computer is an IBM compatible micro-computer.

11. An apparatus for the exchange of cerebrospinal fluid comprising:

an extra-thin walled stainless steel cannula for puncturing a spinal canal, a said cannula having an outside diameter of about 1.47 mm and an internal diameter of about 1.25 mm;

a silicone elastomer catheter for inserting into said cannula and for indwelling in the subarachnoid compartment of said spinal canal, said catheter having an outside diameter of about 1.22 mm and an inside diameter of about 0.97 mm;

a flange for retarding leakage of said cerebrospinal fluid from said spinal canal by engaging said spinal canal at the puncture site, said flange being attached to the external surface of said catheter;

a first container for holding cerebrospinal fluid;

a fiber cartridge for micro-filtration of cerebrospinal fluid by tangential flow filtration, said fiber cartridge having a pore size of about 0.2 mμ and

a membrane surface area of at least about 450 cm² ;

a second container for storing filtered cerebrospinal fluid;

a means for moving said cerebrospinal fluid, including, a reversible peristaltic pump with a volume range of about 0.07 to 25 liters per hour and an operating pressure of less than about 30 PSI, a three port valve means for regulating the direction of flow of said cerebrospinal fluid, and a fluid loop for carrying said cerebrospinal fluid,

wherein said fluid loop connects said catheter to said three port valve means;

said three port valve means to said first container and said second container; and

said filtration device to said first container and said second container; and

a temperature probe for measuring the temperature of said cerebrospinal fluid;

a temperature regulating means connect to said temperature probe for controlling the temperature of said cerebrospinal fluid;

a flow meter for measuring the volume of cerebrospinal fluid;

bi-directional pressure transducers for monitoring cerebrospinal fluid pressure;

a spectrophotometer for monitoring transmittance of the cerebrospinal fluid;

a computer for regulating the exchange of said cerebrospinal fluid and for controlling the treatment and flow of said cerebrospinal fluid;

a computer station connected to said computer for displaying results, said computer station includes a monitor, a printer and a warning means; and

an interface for connecting said computer to said peristaltic pump, said three port valve means, said pH electrode, said temperature probe, said flow meter, said pressure transducers, said spectrophometer and said temperature regulating means.

12. The method of exchanging cerebrospinal fluid in a vertebrate comprising the steps of:

collecting cerebrospinal fluid from said vertebrate;

treating the collected cerebrospinal fluid;

monitoring the physical and chemical parameters of the cerebrospinal fluid;

returning the treated cerebrospinal fluid to said vertebrate; and

regulating the collecting, treating, monitoring and returning of said cerebrospinal fluid.

13. The method of claim 12, comprising the further step of cooling the cerebrospinal fluid.

14. A method for continuously removing blood, blood byproducts and other impurities from cerebrospinal fluid comprising the steps of:

collecting said cerebrospinal fluid with a catheter inserted into the subarachnoid compartment, said catheter having an outside diameter of about 1.22 mm and an internal diameter of about 0.97 mm;

micro-filtering said cerebrospinal fluid with a hollow fiber cartridge and tangential flow filtration;

monitoring physical and chemical parameters of said cerebrospinal fluid with a monitoring means including means for measuring pH, pressure, temperature, volume and percent transmission;

returning said filtered cerebrospinal fluid to said vertebrate; and

regulating the collecting, filtering, monitoring and returning of the cerebrospinal fluid with a computer interfaced to said collecting, filtering and monitoring means, wherein said computer receives signals from the monitoring means and sends signals to the collecting filtering and returning means.

15. The method of claim 14 for the diagnosis, management and treatment of brain and spinal cord injuries and diseases.

16. The method of claim 15, wherein said injuries and diseases are selected from the group consisting of intracranial arterial vasospasm, subarachnoid hemorrhage, trauma and fetal intracranial hemorrhage.

17. The method of treating brain and spinal cord injury including the steps of:

continuously collecting cerebrospinal fluid from an injured vertebrate;

cooling said cerebrospinal fluid;

filtering said cerebrospinal fluid;

monitoring physical and chemical parameters of said cerebrospinal fluid; and

returning treated or artificial cerebrospinal fluid to said vertebrate.