Pacemaker with improved shelf storage capacity

• US 5,522,856 A
• Filed: 09/20/1994
• Issued: 06/04/1996
• Est. Priority Date: 09/20/1994
• Status: Expired due to Term

• Current Assignee: Vitatron Medical BV
• Original Assignee: Vitatron Medical BV
• Inventors: Reineman, Henk
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US08/309,070
• Time in Patent Office: 623 Days
• Field of Search: 607/9, 607/27, 607/34, 607/16
• US Class Current: 607/9
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37254 Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals
• CPC Class Codes: A61N 2001/37294 Means for testing medical devices within the package prior to implantation

Abstract

A pacemaker has logic incorporated for holding the pacemaker circuitry, or at least a portion of such circuitry, in a low current drain "standby" mode of operation from time of fabrication until time of implantation or preparation for implantation, in order to minimize battery depletion during shelf life. In one embodiment, the pacemaker detects when a lead has been connected to the pulse generator output so as to present an impedance below a predetermined threshold, and such detection is used to take the pacemaker out of the "standby" mode and place it in a fully operational mode. The pacemaker is further provided for sensing an externally generated signal in response to which the pacemaker is placed in an operational mode for a predetermined time duration, following which it reverts to the standby mode.

Claims

1. A pacemaker system having an implantable pacemaker with a battery for providing energy, and pacemaker circuitry powered by said battery for carrying out pacemaker functions, said functions including generating pace pulses for delivery to a patient'"'"'s heart, at least some portion of said pacemaker circuitry having a low current standby mode of operation and a normal operational mode of operation, said system further comprising, when said pacemaker is implanted in a patient, a lead for providing an electrical connection between said pacemaker and said patient, further comprising:

means for initially holding said portion of pacemaker circuitry in said standby mode when said lead is not operatively connected thereto;

detecting means for detecting when said pacemaker and said lead are operatively connected, and response means responsive to said detected connection to place said portion of pacemaker circuitry in said normal operational mode; and

wherein said pacemaker circuitry comprises a pace generator which cyclically produces pace pulses in both said standby and operational modes, and wherein said detecting means comprises means for detecting when there is a current above a predetermined threshold associated with pace pulses generated by said pulse generator, thereby sensing when a load has been placed across said pacemaker output.

2. A pacemaker system having an implantable pacemaker with a battery for providing energy, an output, and pacemaker circuitry powered by said battery for carrying out pacemaker functions including generating pace pulses for delivery to said output, at least some portion of said pacemaker circuitry having a low current standby mode of operation and a normal operational mode of operation, said system further comprising, when said pacemaker is implanted in a patient, a lead connected to said output for providing an electrical connection between said pacemaker and said patient, said lead having an impedance in a range less than a predetermined maximum value, said system having standby control means for initially holding said portion of pacemaker circuitry in said standby mode when said lead is not operatively connected to said output, detecting means for detecting a condition which indicates that said pacemaker and said lead are operatively connected, and response means responsive to said detected connection for placing said portion of pacemaker circuitry in said normal operational mode;

and said detecting means having a monitoring resistance in series between said battery and said output, said monitoring resistance having an impedance value greater than said predetermined maximum value, and wherein said detecting means detects when a load having an impedance value less than said predetermined maximum value is connected to said output, said pacemaker further comprising temporary means for temporarily responding to an external signal and placing said portion of pacemaker circuitry in said normal operational mode for a temporary time duration.

3. The pacemaker system as described in claim 2, wherein said temporary means further includes a timer and means for triggering said timer with an external signal.

4. The pacemaker as described in claim 2, further comprising latch means for latching said portion of pacemaker circuitry in said normal operational mode after said response means has placed said pacemaker circuitry in said normal operational mode.

5. A pacemaker system having an implantable pacemaker with a battery for providing energy, an output, and pacemaker circuitry powered by said battery for carrying out pacemaker functions including generating pace pulses for delivery to said output, at least some portion of said pacemaker circuitry having a low current standby mode of operation and a normal operational mode of operation, said system further comprising, when said pacemaker is implanted in a patient, a lead connected to said output for providing an electrical connection between said pacemaker and said patient, said lead having an impedance in a range less than a predetermined maximum value, said system having standby control means for initially holding said portion of pacemaker circuitry in said standby mode when said lead is not operatively connected to said output, detecting means for detecting a condition which indicates that said pacemaker and said lead are operatively connected, and response means responsive to said detected connection for placing said portion of pacemaker circuitry in said normal operational mode;

and said detecting means having a monitoring resistance in series between said battery and said output, said monitoring resistance having an impedance value greater than said predetermined maximum value, and wherein said detecting means detects when a load having an impedance value less than said predetermined maximum value is connected to said output, said pacemaker further comprising temporary means for temporarily responding to an external signal and placing said portion of pacemaker circuitry in said normal operational mode for a temporary time duration, wherein said pacemaker circuitry comprises a pace generator which cyclically produces pace pulses in both said standby and operational modes, and wherein said detecting means comprises means for detecting when there is a current above a predetermined threshold associated with pace pulses generated by said pulse generator, thereby sensing when a load has been placed across said pacemaker output.

6. The pacemaker system as described in claim 5, wherein said monitoring resistance impedance value is at least twice said predetermined maximum value.

7. The pacemaker system as described in claim 5, wherein said packemaker circuitry produces pace pulses at a predetermined low rate when in said stanby mode, and

said standby control means holds said portion of said pacemaker circuitry in a standby mode whenever said pacemaker circuitry produces pace pulses at said low rate and in the operational mode whenever said pacemaker circuitry is controlled to produce pace pulses at said normal rate.