CSF shunt flow enhancer, method for generating CSF flow in shunts and assessment of partial and complete occlusion of CSF shunt systems

• US 9,138,568 B2
• Filed: 05/19/2011
• Issued: 09/22/2015
• Est. Priority Date: 05/21/2010
• Status: Active Grant

• Current Assignee: Children's Medical Center Corporation, ShuntCheck, Inc.
• Original Assignee: Children's Medical Center Corporation, ShuntCheck, Inc.
• Inventors: Swoboda, Marek, Hochman, Matias Gabriel, Mattiucci, Mark Evan, Fritz, Frederick J., Madsen, Joseph R.
• Primary Examiner(s): Wiest, Philip R
• Assistant Examiner(s): KLEIN, BENJAMIN JACOB
• Application Number:
  US13/698,477
• Publication Number:
  US 20130102951A1
• Time in Patent Office: 1,587 Days
• Field of Search: 604 8- 10, 604131-155
• US Class Current: 1/1
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves

Abstract

An apparatus capable of generating flow in cerebrospinal fluid (CSF) shunt systems by vibrating the shunt, tubing or shunt valve dome, or applying cyclical pressure to the various parts of the shunt system. A method of generating flow and method of using the apparatus in shunt patency assessment, for example, hydraulic resistance assessment, is also disclosed. The apparatus allows, in conjunction with a thermal dilution method or radionuclide method, a quick CSF shunt patency assessment based upon CSF shunt resistance and not upon CSF flow or intracranial pressure (ICP) separately. This provides a more objective measure of shunt obstruction compared to other methods. Furthermore, the apparatus can be used to enhance flow in shunts, identify partial occlusion before symptoms occur, differentiate between patent, partially-occluded and occluded shunts. The apparatus can be used to generate flow in shunts if there is a need to lower ICP or move drugs administered via an injection chamber or a shunt dome.

Claims

1. An apparatus for detecting the degree of occlusion in an implanted cerebrospinal fluid (CSF) shunt having a shunt valve in symptomatic or asymptomatic, said apparatus comprising:

a pad that is adapted to be placed against the skin of a patient over the location of the CSF shunt, said pad comprising a plurality of temperature sensors that are aligned in a first direction and wherein one of said plurality of temperature sensors is aligned with the CSF shunt, each of said temperature sensors generating respective temperature data;

a vibrating device that applies pulsation energy against the shunt valve for a predetermined period when said vibrating device is positioned against the skin over said shunt valve; and

a sensor processing device that is electrically coupled to said pad for receiving temperature data from each of said temperature sensors, said sensor processing device using said temperature data to determine the degree of occlusion of said CSF shunt when a temperature source is applied to said pad for said predetermined period of time.

2. A method for detecting the degree of occlusion in an implanted cerebrospinal fluid (CSF) shunt having a shunt valve in symptomatic or asymptomatic patients, said method comprising:

applying a plurality of temperature sensors against the skin over the location of the CSF shunt and aligned in a first direction, and wherein only one of said plurality of temperature sensors is aligned with the CSF shunt;

applying a temperature source over the CSF shunt and upstream of said plurality of temperature sensors for a predetermined period;

applying a vibrating device against the skin positioned over the shunt valve for applying a pulsation procedure for said predetermined period of time;

collecting temperature data from said plurality of temperature sensors during said predetermined period of time;

determining the degree of occlusion in said CSF shunt based on said collected data.

3. The method of claim 2 wherein said step of determining the degree of occlusion in said CSF shunt comprises:

(a) detecting no change of temperature in said collected data over said predetermined period; and

(b) establishing said degree of occlusion to be obstructed.

4. The method of claim 2 wherein said step of determining the degree of occlusion comprises:

(a) detecting a change of temperature in said collected data over said predetermined period; and

(b) establishing said degree of occlusion to be unobstructed.

5. The method of claim 4 wherein said temperature source is a cold source and wherein said step of detecting a change in temperature comprises detecting a transcutaneous change in temperature as cooled CSF flows through said CSF shunt.

6. The method of claim 2 wherein said step of determining said degree of occlusion comprises:

(a) detecting changes of temperature in said collected data;

(b) correlating said changes of temperature with CSF shunt resistance; and

(c) defining a plurality of CSF shunt resistance levels comprising full patency, partial occlusion and complete occlusion based upon said correlation.

7. The method of claim 6 wherein said degree of occlusion is determined for symptomatic patients.

8. The method of claim 6 wherein said degree of occlusion is determined for asymptomatic patients.

9. The method of claim 6 wherein said step of correlating said changes of temperature with CSF shunt resistance comprises activating said vibrating device at two distinct times using respective frequencies.

10. The method of claim 6 wherein said step of correlating said changes of temperature with CSF shunt resistance comprises:

(a) activating said vibrating device;

(b) monitoring CSF flow rates generated by said vibrating device activation using said temperature data; and

(c) assessing changes in said CSF flow rates with said CSF shunt resistance.

11. The method of claim 6 further comprising the step of tracking CSF shunt resistance to detect possible shunt obstruction early.

12. A method for tracking shunt resistance in order to detect possible cerebrospinal fluid (CSF) shunt obstruction in a CSF shunt, having a shunt valve, implanted within a patient, said method comprising:

applying a plurality of temperature sensors against the skin over the location of the CSF shunt and aligned in a first direction, and wherein only one of said plurality of temperature sensors is aligned with the CSF shunt;

applying a temperature source over the CSF shunt and upstream of said plurality of temperature sensors for a predetermined period;

applying a vibrating device against the skin positioned over the shunt valve for applying a pulsation procedure for said predetermined period of time;

collecting temperature data from said plurality of temperature sensors during said predetermined period of time;

identifying a maximum temperature drop; and

comparing said maximum temperature drop to a look up table that correlates shunt resistance therewith.