Apparatus and method for detecting lead adequacy and quality

• US 7,610,091 B2
• Filed: 11/16/2006
• Issued: 10/27/2009
• Est. Priority Date: 07/31/1998
• Status: Expired due to Fees

• Current Assignee: Harbinger Medical, Inc.
• Original Assignee: Harbinger Medical, Inc.
• Inventors: Ryan, Stephen J., Hoium, Harold H.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US11/600,355
• Publication Number:
  US 20070093871A1
• Time in Patent Office: 1,076 Days
• Field of Search: 607 1- 2, 607/27, 607 36- 38, 607115-116, 600/515, 439/506, 439/909
• US Class Current: 607/27
• 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 package for enclosing a lead set, the lead set optimized to induce Wedensky phenomena by sub-threshold transcutaneous stimulation for acute, short term use external to a body 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 each lead termination being associated with one of the plurality of leads, 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 operably coupled to a testing apparatus 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 electromagnetically isolated lead pad interposed between the lead termination and the package interface, thereby facilitating the testing of the lead set for conformance with known desired electromagnetic characteristics;

in which the electromagnetically isolated lead pads are fixated in space relative to one another in a remanufactured fixture and the connector is releasably fixated in space relative to the electromagnetically isolated lead pads in the premanufactured fixture; and

in which the fixture is altered by the removal of the leads such that the known electromagnetic transmission characteristics of the electromagnetically 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.

2. The package 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 package as claimed in claim 1, in which the fixture is altered by removal of the leads such that the leads cannot be reattached.