Apparatus and method for detecting lead adequacy and quality

• US 7,171,265 B2
• Filed: 09/20/2001
• Issued: 01/30/2007
• Est. Priority Date: 07/31/1998
• Status: Expired due to Fees

• Current Assignee: Harbinger Medical, Inc.
• Original Assignee: Harbinger Medical, Inc.
• Inventors: Hoium, Harold H., Ryan, Stephen J.
• Primary Examiner(s): Pezzuto; Robert E.
• Assistant Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US09/957,657
• Publication Number:
  US 20020128685A1
• Time in Patent Office: 1,958 Days
• Field of Search: 607 1- 11, 607/27, 607 36- 38, 607/63, 607/64, 607115-116, 607/119, 607/142, 607/37, 600/372, 600/373, 600/515, 439/506, 439/909
• US Class Current: 607/2
• 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 method and system for detecting lead adequacy and quality for leads used in devices that sense or deliver low levels of electromagnetic energy. The system includes leads attached to a package substrate having known electrical or optical characteristics. The package is adapted to interface with a testing device that allows an operator to ascertain whether the leads are appropriate for a desired task. The operator need not remove the leads from the package to perform the test. The lead testing system may be freestanding or integrated into a lead utilizing instrument.

Claims

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

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

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

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

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

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

comparing the adjusted test results to a desired set of electromagnetic characteristics associated with the lead set;

in response reporting the compliance of the lead set to the desired set of electromagnetic characteristics; and

in which the testing apparatus employs an algorithm that includes a capacity to determine if the lead set has been previously used and to forbid reuse.

2. The method as claimed in claim 1, in which the desired set of electromagnetic characteristics 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 the testing apparatus employs an algorithm to administer the tests of electromagnetic characteristics.

4. The method as claimed in claim 1, in which the compliance of the lead set test ascertains whether the lead set meets a condition selected from a group consisting of:

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

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

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

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

supporting the lead pads on a premanufactured fixture, in which the premanufactured fixture is altered by the removal of the lead terminations such that the known electromagnetic transmission characteristics of the isolated lead pads are altered in a way that is identifiable by the testing apparatus thereby enabling the testing apparatus to deny reuse of the lead set;

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

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

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

comparing the adjusted test results to a desired set of electromagnetic characteristics associated with the lead set;

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

6. A system for testing lead set adequacy and quality, the lead set for use with a medical device that senses and delivers low levels of electromagnetic energy to the human body for the purpose of identifying patients at high risk for life threatening cardiac arrhythmias, and optimized to induce Wedensky phenomena by sub threshold transcutaneous stimulation, 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 the lead terminations and the connector are releasably attachable, the fixture including a plurality of isolated lead pads each adapted to releasably engage one of the lead terminations and to be in electromagnetic communication with the lead termination, each 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 the package is operably selectably engagable to the package interface and, the connector is operably selectably engagable with the connector interface such that the lead set may be tested and a test result compared to a desired set of electromagnetic characteristics without the need to remove the lead set from the package, in which the testing apparatus employs an algorithm to administer the testing such that the algorithm includes the capacity to determine if the lead has been previously used and to forbid reuse.

7. The system as claimed in claim 6, in which the isolated lead pads are fixated in space relative to one another in a premanufactured fixture and the connector is releasably fixated in space relative to the isolated lead pads in the premanufactured fixture.

8. The system as claimed in claim 6, further comprising a premanufactured fixture which is altered by the removal of the lead terminations such that the lead terminations cannot be reattached.

9. A system for testing lead set adequacy and quality, the lead set for use with a medical device that senses and delivers low levels of electromagnetic energy to the human body for the purpose of identifying patients at high risk for life threatening cardiac arrhythmias, and optimized to induce Wedensky phenomena by sub threshold transcutaneous stimulation, 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 the lead terminations and the connector are releasably attachable, the fixture including a plurality of isolated lead pads each adapted to releasably engage one of the lead terminations and to be in electromagnetic communication with the lead termination, each 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 the package is operably selectably engagable to the package interface and, the connector is operably selectably engagable with the connector interface such that the lead set may be tested and a test result compared to a desired set of electromagnetic characteristics without the need to remove the lead set from the package;

a premanufactured fixture which is altered by the removal of the lead terminations such that the lead terminations cannot be reattached; and

in which the premanufactured fixture is altered by a removal of the lead terminations such that the known electromagnetic transmission characteristics of the isolated lead pads are altered in a way that is identifiable by the testing apparatus thereby enabling the testing apparatus to sense the removal and to deny reuse of the lead set.

10. The system as claimed in claim 9, in which the electromagnetic characteristics tested are selected from a group consisting of:

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

11. The system as claimed in claim 9, in which the isolated lead pads are fixated in space relative to one another in a premanufactured fixture and the connector is releasably fixated in space relative to the isolated lead pads in the premanufactured fixture.

12. The system as claimed in claim 11, in which the fixture is altered by the removal of the leads such that the leads cannot be reattached.

13. A package for enclosing a lead set, the lead set optimized to induce Wedensky phenomena by sub threshold transcutaneous stimulation 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, the package comprising:

a fixture for supporting the lead terminations and the connector in a fixed geometric configuration relative to one another such that the fixture is engagable to a package interface such that the lead set is in electromagnetic communication with the package interface via the connector and the lead terminations and the lead terminations are each releasably connected to an isolated lead pad thereby facilitating the testing of the lead set for conformance with known desired electromagnetic characteristics;

in which the fixture is altered by the removal of the leads such that the known electromagnetic transmission characteristics of the isolated lead pads are altered in a way that is identifiable by the testing apparatus thereby enabling the testing apparatus to deny reuse of the lead set.