Apparatus and method for detecting lead adequacy and quality

• US 20020128685A1
• Filed: 09/20/2001
• Published: 09/12/2002
• Est. Priority Date: 07/31/1998
• Status: Active Grant

• Current Assignee: Harbinger Medical, Inc.
• Original Assignee: Harbinger Medical, Inc.
• Inventors: Hoium, Harold H., Ryan, Stephen J.
• Granted Patent: US 7,171,265 B2
• Time in Patent Office: Days
• US Class Current: 607/1
• CPC Class Codes: A61B 5/303 Patient cord assembly, e.g. cable harness
• CPC Class Codes: A61B 5/339 Displays specially adapted therefor
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/366 Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 2001/37294 Means for testing medical devices within the package prior to implantation
• CPC Class Codes: Y10S 439/909 Medical use or attached to human body

Abstract

A system and method for detecting lead adequacy and quality is disclosed. The system includes leads attached to a package having known electrical or optical characteristics. The package is adapted to interface with a testing device that allows the operator to ascertain whether the leads are appropriate for the desired task. This allows the testing of the lead set without the need to remove it from the package. The system of the present invention generally includes packaging of known electrical or optical characteristics, a package testing interface, and a lead testing assembly including hardware and/or software to determine whether the leads in question fulfill the desired characteristics. The lead testing assembly may be freestanding or may be incorporated into an existing testing instrument.

Claims

1. A method for verifying that a lead set is appropriate for use with a medical device that senses or delivers electromagnetic energy, the lead set being adapted for used external to the body of the subject for acute, short term testing, the method comprising the steps of:

supplying a lead set including a connector and lead terminations, the lead set being packaged such that the set of lead terminations are each releasably secured to an isolated lead pad of specific, known electromagnetic transmission characteristics in electromagnetic connection with said isolated lead pad thereby creating a lead-isolated lead pad combination;

releasably attaching said connector to a mating connector incorporated into a testing apparatus;

releasably attaching said isolated lead pads as a unit to a set of corresponding lead pad connectors incorporated into said testing apparatus;

administering via said testing apparatus to said lead set appropriate tests of electromagnetic characteristics to determine the electromagnetic characteristics of said lead-isolated lead pad combination;

adjusting test results thus acquired to account for the known electromagnetic transmission characteristics of said isolated lead pads to create adjusted test results;

comparing said adjusted test results to a desired set of electromagnetic characteristics; and

reporting the compliance of the lead set to the desired set of electromagnetic characteristics.

2. The method as claimed in claim 1, in which the electromagnetic characteristics tested are selected from a group consisting of:

impedance, inductance, capacitance, electrical spectral range or a combination thereof.

3. The method of claim 1, in which said testing apparatus employs an algorithm to administer said tests.

4. The method as claimed in claim 1, in which said testing apparatus employs an algorithm that includes the capacity to determine if the lead has been previously used and to forbid reuse.

5. The method as claimed in claim 1, in which the lead set test ascertains a circumstance selected from a group consisting of:

the lead set is a specific intended lead set, the lead set is of a specific lead quality and the lead set is an acceptable alternative having acceptable characteristics for a desired task.

6. The method as claimed in claim 1, further comprising a premanufactured fixture supporting said lead pads, in which said premanufactured fixture is altered by the removal of said leads such that the known electromagnetic transmission characteristics of said isolated lead pads are altered in a way that is identifiable by said testing apparatus thereby enabling said testing apparatus to deny reuse of said lead set.

7. A system for testing lead set adequacy and quality, the lead set for use with a medical device that senses or delivers electromagnetic energy, the lead set comprising a connector, a plurality of leads and a plurality of lead terminations, the system comprising:

a package comprising a fixture to which said lead terminations and said connector are releasably attachable, said fixture being further adapted to be engagable to a testing interface, said package further including a plurality of isolated lead pads each adapted to engage one of said lead terminations and to be in electromagnetic communication with said lead termination, each said isolated lead pad having specific known electromagnetic transmission characteristics; and

a testing apparatus including a connector interface, a package interface and a testing algorithm such that said package may be operably engaged to said package interface and, said connector being operably selectably engagable with said connector interface whereby said lead set may be tested and compared to a desired set of electromagnetic characteristics without the need to remove the lead set from the package.

8. The system as claimed in claim 7, in which the electromagnetic characteristics tested are selected from a group consisting of:

impedance, inductance, capacitance, electrical spectral range or a combination thereof.

9. The system of claim 7, in which said testing apparatus employs an algorithm to administer said testing.

10. The system as claimed in claim 7, in which said testing apparatus employs an algorithm to administer said testing that includes the capacity to determine if the lead has been previously used and to forbid reuse.

11. The system as claimed in claim 7, in which said isolated lead pads are fixated in space relative to one another in a premanufactured fixture and said connector is releasably fixated in space relative to said isolated lead pads in a premanufactured fixture.

12. The system as claimed in claim 7, further comprising a premanufactured fixture which is altered by the removal of said leads such that said leads cannot be reattached.

15. The system as claimed in claim 12, in which said premanufactured fixture is altered by the removal of said leads such that the known electromagnetic transmission characteristics of said isolated lead pads are altered in a way that is identifiable by said testing system thereby enabling said testing apparatus to deny reuse of said lead set.

17. The package as claimed in claim 16, in which the electromagnetic characteristics tested are selected from a group consisting of:

impedance, inductance, capacitance, electrical spectral range or a combination thereof.

18. The package as claimed in claim 16, in which said isolated lead pads are fixated in space relative to one another in a premanufactured fixture and said connector is releasably fixated in space relative to said isolated lead pads said premanufactured fixture.

19. The package as claimed in claim 18, in which said fixture is altered by the removal of said leads such that said leads cannot be reattached.

20. The package as claimed in claim 18, in which said fixture is altered by the removal of said leads such that the known electromagnetic transmission characteristics of said isolated lead pads are altered in a way that is identifiable by said testing apparatus thereby enabling said testing apparatus to deny reuse of said lead set.

16. A package for enclosing a lead set, the lead set for acute, short term use with a medical device that senses or delivers electromagnetic energy, the lead set comprising a connector, a plurality of leads and a plurality of lead terminations, said package comprising:

a fixture for supporting said lead terminations and said connector in a fixed geometric configuration relative to one another such that said fixture is engagable to a package interface so that said lead set is in electromagnetic communication with said package interface via said connector and said lead terminations thereby facilitating the testing of said lead set for conformance with known desired electromagnetic characteristics.