Systems and methods for lumbar cerebrospinal fluid access and treatment

• US 10,478,555 B2
• Filed: 08/16/2010
• Issued: 11/19/2019
• Est. Priority Date: 08/17/2006
• Status: Active Grant

• Current Assignee: Agathos Holdings LLC
• Original Assignee: Agathos Holdings LLC
• Inventors: Radojicic, Milan
• Primary Examiner(s): Lee, Brandy S
• Application Number:
  US12/857,555
• Publication Number:
  US 20100312084A1
• Time in Patent Office: 3,382 Days
• Field of Search: 604151, 604154, 604432
• CPC Class Codes: A61B 5/032 Spinal fluid pressure
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/7214 using signal cancellation, e.g. based on input of two identical physiological sensors spaced apart, or based on two signals derived from the same sensor, for different optical wavelengths
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2210/1003 Spinal column
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 5/1428 with manual pumping action
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

A system and method for accessing and treating the cerebrospinal fluid with a multilumen catheter configured for placement along a cerebrospinal fluid pathway and a subcutaneous, dual reservoir/pump. The subcutaneous dual reservoir/pump allows simultaneous, bidirectional cerebrospinal fluid access and cerebrospinal fluid exchange. The two chambers prevent mixing of newly treated and discardable cerebrospinal fluid. The subcutaneous dual reservoir/pump can be used inline with other cerebrospinal fluid devices. The catheter may be coupled with a medical probe that sends a wire to a computational device, which can then send wireless data and receive wireless instructions. A method of assessing cerebrospinal fluid infections is provided, whereby monitoring of the cerebrospinal glucose concentrations with a cerebrospinal glucose sensor and analysis of the data by a computational device can notify a patient or medical provider of an impending infection. This assembly can help better diagnose and treat injury and disease.

Claims

1. An implantable system for chronic access to cerebrospinal fluid, said system comprising:

A multilumen bidirectional fluid flow catheter configured for chronic implantation and placement along a cerebrospinal fluid pathway, wherein said multilumen bidirectional fluid flow catheter comprises a plurality of fluid outlets, and a plurality of fluid inlets

said multilumen bidirectional fluid flow catheter configured to connect, via tunneling, to an assembly comprising at least one finger pumpable dome configured for chronic subcutaneous implantation, each said at least one finger pumpable dome having dual functions of fluid reservoir and pump;

wherein said multilumen bidirectional fluid flow catheter and said at least one finger pumpable dome are further configured to allow simultaneous, bidirectional, cerebrospinal fluid access and cerebrospinal fluid exchange.

2. The system of claim 1, wherein the multilumen bidirectional fluid flow catheter is configured to be chronically implanted in a lumbar interspace.

3. The system of claim 1, wherein said assembly further comprises a fastener to an anatomic surface that is further configured to be chronically implanted by subcutaneous fastening to a patient'"'"'s pelvis.

4. The system of claim 1, wherein said multilumen bidirectional fluid flow catheter further comprises a medical sensor.

5. The system of claim 4, wherein said medical sensor is configured to measure intrathecal pressure.

6. The system of claim 1, wherein said assembly further comprises a computational device.

7. The system of claim 6, wherein said computational device is configured to wirelessly transmit physiological data and warning signals to a patient or provider.

8. The system of claim 6, wherein said computational device is further configured to wirelessly accept commands from a medical provider.

9. The system of claim 1, wherein said multilumen bidirectional fluid flow catheter further comprises, between said plurality of fluid outlets and said plurality of fluid inlets, a medical instrument for transmitting or receiving energy;

said energy comprising any of acoustic, radiofrequency, ultrasonic, high frequency ultrasound, photoacoustic, and infrared energy.

10. The system of claim 1, wherein said assembly is further configured in a needle impervious base to form a unit configured for subcutaneous implantation, and;

wherein said at least one finger pumpable dome is further configured to enable, while positioned subcutaneously, for chronic access by needle.

11. The system of claim 10, wherein said needle impervious base further comprises a wireless transmitter and computational circuitry.

12. A system of cerebrospinal fluid diversion comprising:

a multilumen bidirectional fluid flow catheter coupled to a medical sensor for measuring pressure of cerebral spinal fluid;

said multilumen bidirectional fluid flow catheter configured to connect, via tunneling, and via an internal subcutaneous valve to an assembly comprising at least one finger pumpable dome configured for chronic subcutaneous implantation, each said at least one finger pumpable dome having dual functions of fluid reservoir and pump;

said assembly further comprising a computational device;

wherein said internal subcutaneous valve is also coupled to said computational device, and wherein said computational device is configured to receive said pressure measurements from said medical sensor, identify components of pulsatile pressure, and modulate said internal subcutaneous valve to prevent overdrainage of the cerebrospinal fluid.

13. The system of claim 12, wherein said medical sensor is further configured to measure volume.

14. The system of claim 12, wherein said medical sensor is further configured to analyze a fluid composition of said cerebrospinal fluid.

15. The system of claim 12, wherein said valve is programmable.