System for use in draining fluid from a brain or spinal fluid cavity unto another body cavity of a human being

• US 7,967,771 B2
• Filed: 10/24/2008
• Issued: 06/28/2011
• Est. Priority Date: 07/21/2004
• Status: Expired due to Fees

• Current Assignee: Dpcom As
• Original Assignee: Dpcom As
• Inventors: Eide, Per Kristian
• Primary Examiner(s): Deak; Leslie R
• Application Number:
  US12/258,380
• Publication Number:
  US 20090054827A1
• Time in Patent Office: 977 Days
• Field of Search: 604 7- 10, 600/561
• US Class Current: 604/9
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/02108 from analysis of pulse wave characteristics
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves

Abstract

This invention describes a method for processing pressure signals derivable from locations inside or outside a human or animal body or body cavity. Different aspects of the invention relate to a method for optimal differentiating between cardiac beat- and artifact-induced pressure waves and a method for obtaining new and improved information from said pressure signals. In particular, this invention describes a system for draining fluid from a brain or spinal fluid cavity according to the inventive method of processing pressure signals.

Claims

1. A system for use in draining fluid from a brain or spinal fluid cavity unto another body cavity of a human being, comprising:

a first drainage tube having an inlet thereof configured to be located in said brain or spinal fluid cavity, said first drainage tube connected to the inlet of a fluid flow controllable valve,

one or more sensor(s) configured to measure fluid pressure in one of;

the brain cavity, the spinal cavity and said another body cavity, when located in such cavity or attached to said first drainage tube inside or outside such cavity,

a pressure transducer linked to said sensor(s) and capable of transforming continuous pressure-related signals derivable from said sensor(s) into processable signals,

a processing unit configured to receive said processable signals,

a valve-opening regulator having an input linked to output means of the processing unit via a regulator unit and a control unit and having its output operatively connected to said valve to control fluid flow mass rate through said valve,

a second drainage tube from an outlet of said valve, said second drainage tube at a downstream end having a distal outlet configured to be located in said another human body cavity, and

a power supply to power said pressure transducer, said processing unit, said valve opening regulator, said control unit, and said regulator unit,

wherein said processing unit comprises;

sampling means configured to sample said pressure-related signals at specific intervals,

converter means configured to convert the sampled signals into pressure related digital data with a time reference,

identifying means capable of identifying from said digital data single pressure waves related to cardiac beat-induced pressure waves, related to artifacts, or a combination of cardiac beat-induced waves and artifacts,

computing means configured to compute time sequence (TS.x)-related parameters of said single pressure waves during individual time sequence windows,

analyzing means configured to establish an analysis output of said time sequence (TS.x)-related parameters for a selectable number of said time sequence windows, and

output means for delivering said analysis output as parameter signals to said regulator unit.

2. A system according to claim 1, wherein said system further comprises an information transfer means linked to the processor and configured to communicate with external processing equipment, and wherein an assembly of said fluid flow controllable valve, said valve-opening regulator, said control unit, said regulator unit, said processing unit, said pressure transducer, said power supply, said information transfer means, and said first and second drainage tubes are located below a skin surface of said human body.

3. A system according to claim 2, wherein said assembly configured to be located below a skin surface of said human body in a thoracic or abdominal body area thereof and with part of said first and second drainage tubes thereat.

4. A system according to claim 1, wherein said first and second drainage tubes are configured to be located below said skin surface of said human body partly in a thoracic or abdominal body area.

5. A system according to claim 1, wherein said inlet of said first drainage tube configured to be located inside dura mater of a brain, within one or more of said brain fluid cavities, said first drainage tube being able to drain fluid from said brain fluid cavity to the inlet of said fluid flow controllable valve.

6. A system according to claim 1, wherein said inlet of said first drainage tube configured to be located inside dura mater of a spinal cord, within said spinal fluid cavity, said drainage tube being able to drain fluid from said spinal fluid cavity to the inlet of said fluid flow controllable valve.

7. A system according to claim 1, wherein location of said sensor provides for sensing pressure-related signals from said human brain or spinal fluid cavity.

8. A system according to claim 7, wherein said sensor is located on or coupled to said first drainage tube providing for sensing pressure-related signals from said fluid within said first drainage tube.

9. A system according to claim 1, wherein said an analysis output based on said time sequence (TS.x)-related parameters for a selectable number of said time sequence windows, said parameters selected from the group of:

mean wave amplitude (TS.MeanWavedP), mean wave latency (TS.MeanWavedT), mean wave rise time coefficient (TS.MeanWaveRT), mean amplitude (TS.MeandP), mean latency (TS.MeandT), and mean rise time coefficient (TS.MeanRT).

10. A system according to claim 1, wherein said processing unit is configured to deliver a first control signal to the regulator, said first control signal being a function of one or more selectable criteria for said analysis output of said time sequence (TS.x)-related parameters.

11. A system according to claim 10, wherein said one or more selectable criteria for said analysis output relate to criteria for regulating a mode of function of opening of a shunt valve.

12. A system according to claim 10, wherein said selectable criteria are a function of selectable thresholds for time sequence (TS.x)-related parameters, said parameters selected from the group of:

mean wave amplitude (TS.MeanWavedP), mean wave latency (TS.MeanWavedT), mean wave rise time coefficient (TS.MeanWaveRT), mean amplitude (TS.MeandP), mean latency (TS.MeandT), and mean rise time coefficient (TS.MeanRT).

13. A system according to claim 10, wherein said selectable criteria are a function of analysis output of a selectable number of individual time sequence windows in a continuous series of said time sequence windows.

14. A system according to claim 1, wherein features of said first control signal are selectable when said analysis output from the analyzing means meets one or more of selectable criteria.

15. A system according to claim 1, wherein said processing unit delivers a first control signal to said regulator unit, and wherein a second control signal output from the regulator unit unto the control unit is a function of said first control signal.

16. A system according to claim 1, wherein a second control signal output from the regulator unit to the control unit is configured to modify a mode by which said control unit controls adjustment of said valve-opening regulator.

17. A system according to claim 1, wherein any control signal level of a second deliverable control signal output from the control unit is related to said analysis output for a selectable number of said time sequence windows, said control signal level determining the function mode or a valve-opening regulator.

18. A system according to claim 1, wherein fluid flow rate through said valve is adjustable by said valve-opening regulator being controlled by a first control signal output from said processing unit.

19. A system according to claim 1, wherein said distal opening of said second drainage tube within said another body cavity, constitutes a drainage outlet of fluid into an abdominal body cavity, the second drainage tube thus enabling drainage of cavity fluid from said cavity via said first drainage tube and said valve into said abdominal body cavity.

20. A system according to claim 1, wherein said distal opening of said second drainage tube within said another body cavity, constitutes a drainage outlet of fluid into a thoracic body cavity, the second drainage tube thus enabling drainage of cavity fluid from said cavity via said first drainage tube and said valve into said thoracic body cavity.

21. A system according to claim 1, wherein said information transfer means is configured to enables information transferal through skin of said human being, said information being deliverable unto an external processing unit.

22. A system according to claim 1 or 20, wherein information from said power supply to the information transfer means relates to residual power.

23. A system according to claim 1, wherein said information from said processing unit to the information transfer means relates to analysis output of processing of continuous pressure related signals.

24. A system according to claim 1, wherein information deliverable unto said processing unit via said information transfer means relates to adjustment interaction between analysis output of said processing unit and the level of a first control signal deliverable therefrom to the control unit via the regulator unit.

25. A system according to anyone of claims 1 and 9-13, wherein said control means on basis of said parameter signals enabling control of drainage fluid flow rate from a first body cavity to a second body cavity in one said human, and wherein parameter signals are related to time sequence windows selectable from the group of:

mean wave amplitude (TS.MeanWavedP),

mean wave latency (TS.MeanWavedT),

mean wave rise time coefficient (TS.MeanWaveRT),

mean amplitude (TS.MeandP),

mean latency (TS.MeandT),

mean rise time coefficient (TS.MeanRT),

mean single wave pressure (TS.Mean_SWP), and

wherein said regulator unit is connectable to said output means for receiving at least one of said parameter signals, said regulator unit being capable of establishing a system performance modifying signal by means of one of said pressure parameter signals or a combination effect obtained from using at least two of said pressure parameter signals, said performance modifying signal deliverable from said regulator unit being capable of controlling said drainage fluid flow rate through said valve device by input to the valve-opening regulator.