Active can emulator and method of use
First Claim
1. A pulse generator emulator operable as a subcutaneous electrode for use with at least one remote electrode in testing the efficacy of electrical stimulation of a body organ with an implantable pulse generator, comprising:
- an emulator housing, configured to emulate the characteristics of a hermetically sealed housing of an implantable pulse generator of the type having a connector block attached thereto, said emulator housing having an electrode on a surface thereof and first connector means attached to the emulator housing for making electrical connection to the electrode; and
an elongated lead including a conductor extending from a proximal end to a distal end thereof, a second connector means for coupling to a defibrillator, located at the proximal end and coupled to said conductor, a header permanently mounted to the distal end of the lead configured to emulate the connector block of the implantable pulse generator and third connector means mounted to said header and coupled to said conductor, for removably connecting with said first connector means.
1 Assignment
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Accused Products
Abstract
An active can emulator for emulating the electrical and dimensional characteristics of an implantable pulse generator of the type having a hermetically sealed housing configured to operate as an active electrode and a connector block for receiving and connecting with a lead extending to a second active electrode. The emulator comprises a reusable, sterilizable, conductive can conforming to the dimensional characteristics of the hermetically sealed housing of the implantable pulse generator and having a first electrical and mechanical connector and a disposable lead having a second electrical and mechanical connector for mating attachment with the first connector formed as part of a header configured to conform to the dimensional characteristics of the connector block of the emulated pulse generator. In use, the testing of defibrillation thresholds and system performance is conducted by implanting a transvenous lead bearing an electrode disposed in the patient'"'"'s heart, creating the surgical pocket opening to receive the pulse generator, using the active can emulator to enlarge the surgical pocket while positioning it therein, coupling the transvenous lead and the lead of the active can emulator to an external cardioverter, inducing a tachyarrythmia in the patient'"'"'s heart, and operating the external cardioverter to deliver one or more cardioverting pulses to the patient'"'"'s heart through the two electrodes to determine whether or not the patient'"'"'s heart can be satisfactorily cardioverted. The testing may be repeated with variations in the positioning of the active can emulator to locate a position providing a satisfactory safety factor. After testing is completed, the lead may be disposed of, but the can may be cleaned and resterilized conventionally and reused on other patients.
305 Citations
13 Claims
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1. A pulse generator emulator operable as a subcutaneous electrode for use with at least one remote electrode in testing the efficacy of electrical stimulation of a body organ with an implantable pulse generator, comprising:
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an emulator housing, configured to emulate the characteristics of a hermetically sealed housing of an implantable pulse generator of the type having a connector block attached thereto, said emulator housing having an electrode on a surface thereof and first connector means attached to the emulator housing for making electrical connection to the electrode; and an elongated lead including a conductor extending from a proximal end to a distal end thereof, a second connector means for coupling to a defibrillator, located at the proximal end and coupled to said conductor, a header permanently mounted to the distal end of the lead configured to emulate the connector block of the implantable pulse generator and third connector means mounted to said header and coupled to said conductor, for removably connecting with said first connector means. - View Dependent Claims (2, 3, 4, 5)
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6. A method of testing a patient for suitability of implantation of a defibrillator pulse generator having a housing and an active housing surface electrode on its housing for use with at least a first lead bearing a remote electrode, wherein the testing is conducted by:
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implanting the first lead with the remote electrode in an intended position for permanent implantation; implanting a reusable, dummy housing shaped electrode, with a detachable and disposable connector and second lead attached thereto, the dummy housing shaped electrode having dimensional characteristics corresponding to those of the defibrillator pulse generator housing, in an expected position for permanent implantation of the pulse generator housing; coupling the first and second lead to an external cardioverter; inducing a tachyrhythmia in the patient'"'"'s heart; and
operating the external cardioverter to deliver one or more cardioverting pulses to the patient'"'"'s heart through the dummy housing shaped electrode and the remote electrode to determine pulse characteristics sufficient to effect cardioversion. - View Dependent Claims (7, 8, 9, 10, 11)
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12. A method of testing defibrillation thresholds and system performance of an implantable defibrillator pulse generator and electrode system of the type having a hermetically sealed housing surface configured to operate as a first active electrode and a connector block for receiving and connecting with an implantable lead comprising a second active electrode comprising the steps of:
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providing an active can emulator for emulating the electrical and dimensional characteristics of the implantable pulse generator and comprising a reusable, sterilizable, conductive can conforming to the dimensional characteristics of the hermetically sealed housing surface of the implantable pulse generator and having a first electrical and mechanical connector and a disposable lead having a second electrical and mechanical connector for mating attachment with the first connector formed as part of a header configured to conform to the dimensional characteristics of the connector block of the implantable pulse generator; implanting the implantable lead with the remote electrode disposed in relation to a patient'"'"'s heart; creating a surgical pocket to receive the implantable pulse generator; implanting the active can emulator in the surgical pocket; inducing a tachyrhythmia in the patient'"'"'s heart; and delivering one or more cardioverting pulses to the patient'"'"'s heart through the first and second active electrodes to determine whether or not the patient'"'"'s heart can be satisfactorily cardioverted. - View Dependent Claims (13)
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Specification