United States Patent (19)
`Heilman et al.
`
`54
`
`(75)
`
`73
`
`21
`22
`
`(63)
`
`51
`(52)
`58)
`(56)
`
`PORTABLE DEVICE FOR SENSING
`CARDIAC FUNCTION AND
`AUTOMATICALLY DELIVERING
`ELECTRICAL THERAPY
`Inventors: Marlin S. Heilman, Sarver; Arlan J.
`Brandt, Gibsonia Larry D. Bowling;
`Joseph F. Russial, both of Pittsburgh,
`all of Pa.
`Assignee: Lifecor, Inc., Pittsburgh, Pa.
`Notice:
`The portion of the term of this patent
`subsequent to May 29, 2007 has been
`disclaimed.
`Appl. No.: 528,883
`Fied:
`May 29, 1990
`
`Related U.S. Application Data
`Continuation-in-part of Ser. No. 185,781, Apr. 25,
`1988, Pat. No. 4,928,690.
`Int. Cl. ............................................... A61N 1/00
`U.S. C. ............................... 128/421; 128/419 D;
`128/783; 128/734; 128/696
`Field of Search ............ 128/421,419 D, 419 PG,
`128/696, 702, 734, 783
`References Cited
`U.S. PATENT DOCUMENTS
`3,241,556 3/1966 Zacouto .............................. 28A2
`3,460.542 8/1969 Gemmer ............................. 28/42
`3,702.6l3 11/972 Panico et al. ....................... 28/417
`3,826,245 7/1974 Funfistuck .......................... 28/2.06
`
`34
`
`HHHHHH
`USOO5078134A
`Patent Number:
`5,078,134
`(11)
`(45) Date of Patent:
`"Jan. 7, 1992
`
`
`
`3,942,533 3/1976 Cannon, III ........................ 128/47
`3,961,623 6/1976 Milani et al. ....
`... 28/2.06
`4,002,239 1/1977 Buchalter ........
`..... 206/484
`4,058,127 11/1977 Buchalter ........
`... 128/417
`4,088,138 5/1978 Diack et al. ......................... 28/419
`4,576, 170 3/1986 Bradley et al. .........
`... 28/49
`4,779,630 10/1988 Scharnberg et al. ...
`... 28/783
`4,785,812 1/1988 Pihl et al. ..............
`... 28/734
`4,928,690 5/1990 Heilman et al. ..................... 128/42
`4,974,600 12/1990 Reyes.............................. 128/49 D
`Primary Examiner-Francis Jaworski
`Assistant Examiner-George Manuel
`Attorney, Agent, or Firm-Fleit, Jacobson, Cohn, Price,
`Holman & Stern
`ABSTRACT
`(57)
`A patient-worn harness or vest protects at-risk patients
`from the possibly fatal results of heart arrhythmias. The
`harness or vest incorporates sensing electrodes for mon
`itoring heart condition, a microprocessor and memory
`for processing signals received from the sending elec
`trodes and comparing same with patient's data, and
`skin-contacting pulsing electrodes for applying electri
`cal pulses to the patient's chest wall responsive to sig
`nals received from the microprocessor. The electrodes
`include automatic tightening and electrolyte gel release
`mechanisms for reducing impedance at the electrode
`skin interface. A servicing subsystem is provided for the
`harness or vest and may be used to interface with the
`harness or vest and may be used to interface with the
`harness or vest and also to communicate with renote
`health care personnel through a suitable telephone link.
`
`52 Claims, 28 Drawing Sheets
`
`d
`
`36
`22ff N
`k-16
`
`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`

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`U.S. Patent
`U.S. Patent
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`Jan. 7, 1992
`Jan. 7, 1992
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`Sheet 1 of 28
`Sheet 1 of 28
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`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
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`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
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`U.S. Patent
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`Jan. 7, 1992
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`Sheet 2 of 28
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`22,722
`22.5%
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`54
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`IPR2023-00783
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`U.S. Patent
`U.S. Patent
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`Jan. 7, 1992
`Jan. 7, 1992
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`Sheet 3 of 28
`Sheet 3 of 28
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`5,078,134
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`32
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`FIG.3b
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`
`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
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`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`

`

`U.S. Patent
`U.S. Patent
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`Jan, 7, 1992
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`Sheet 4 of 28
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`5,078,134
`5,078,134
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`
`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
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`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
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`

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`U.S. Patent
`U.S. Patent
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`Jan. 7, 1992
`Jan. 7, 1992
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`Sheet 5 of 28
`Sheet 5 of 28
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`5,078,134
`5,078,134
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`IPR2023-00783
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`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
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`

`

`U.S. Patent
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`Jan. 7, 1992
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`Sheet 6 of 28
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`5,078,134
`
`N88 c
`Sas
`22
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`
`F. G. 3h
`
`92
`
`
`
`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`

`

`U.S. Patent
`U.S. Patent
`
`Jan. 7, 1992
`Jan. 7, 1992
`
`Sheet 7 of 28
`Sheet 7 of 28
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`5,078,134
`5,078,134
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`
`
`
`
`BACKUP
`
`aC
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` al oe
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`CHARGE POWER ON
`
`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`

`

`U.S. Patent
`U.S. Patent
`
`Jan. 7, 1992
`Jan. 7, 1992
`
`Sheet 8 of 28
`Sheet 8 of 28
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`5,078,134
`5,078,134
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`&
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`
`
`202
`
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`
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`
`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`

`

`U.S. Patent
`U.S. Patent
`
`Jan. 7, 1992
`Jan. 7, 1992
`
`Sheet 9 of 28
`Sheet 9 of 28
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`5,078,134
`5,078,134
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`208
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`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`3.
`
`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`

`

`U.S. Patent
`
`Jan. 7, 1992
`
`Sheet 10 of 28
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`5,078,134
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`sessessessee ZZ
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`
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`IPR2023-00783
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`U.S. Patent
`U.S. Patent
`
`Jan. 7, 1992
`Jan. 7, 1992
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`Sheet 11 of 28
`Sheet 11 of 28
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`5,078,134
`5,078,134
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`
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`IPR2023-00783
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`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
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`

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`U.S. Patent
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`Jan. 7, 1992
`
`Sheet 12 of 28
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`5,078,134
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`
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`
`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`

`

`FIG. 3O
`FIG.I3a
`
`
`
`
`
`U.S. Patent
`U.S. Patent
`
`Jan. 7, 1992
`Jan. 7, 1992
`
`Sheet 13 of 28
`Sheet 13 of 28
`
`5,078,134
`5,078,134
`
`FG.3b
`
`FIG.I3b
`
`
`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`

`

`U.S. Patent
`U.S. Patent
`
`Jan. 7, 1992
`Jan. 7, 1992
`
`Sheet 14 of 28
`Sheet 14 of 28
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`5,078,134
`5,078,134
`
`FIG.I5a
`
`FIG.15b
`
`
`
`FIG.15d
`
`FG.50
`
`FIG.15c
`
`
`
`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`

`

`U.S. Patent
`U.S. Patent
`
`Jan. 7, 1992
`Jan. 7, 1992
`
`5,078,134
`5,078,134
`
`Sheet 15 of 28
`Sheet 15 of 28
`
`328
`
`
`
`FIG.16c
`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
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`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`

`

`U.S. Patent
`U.S. Patent
`
`Jan. 7, 1992
`Jan. 7, 1992
`
`Sheet 16 of 28
`Sheet 16 of 28
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`5,078,134
`5,078,134
`
`
`
`400
`
`4OO
`
`FIG .17-
`
`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`

`

`U.S. Patent
`U.S. Patent
`
`Jan. 7, 1992
`Jan. 7, 1992
`
`Sheet 17 of 28
`Sheet 17 of 28
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`5,078,134
`5,078,134
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`
`
`
`
`F. G. 8O
`
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`
`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`a
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`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`

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`U.S. Patent
`U.S. Patent
`
`Jan. 7, 1992
`Jan. 7, 1992
`
`Sheet 18 of 28
`Sheet 18 of 28
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`5,078,134
`5,078,134
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`422
`422
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`FIG. I8e
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`FIG.
`I8q
`
`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
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`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`

`

`U.S. Patent
`U.S. Patent
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`Jan. 7, 1992
`Jan. 7, 1992
`
`Sheet 19 of 28
`Sheet 19 of 28
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`5,078,134
`5,078,134
`
`
`
`
`
`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
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`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`

`

`U.S. Patent
`U.S. Patent
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`Jan. 7, 1992
`Jan. 7, 1992
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`Sheet 20 of 28
`Sheet 20 of 28
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`5,078,134
`5,078,134
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`
`
`
`
`F G. 20
`FIG. 20
`
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`IPR2023-00783
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`IPR2023-00783
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`U.S. Patent
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`Jan. 7, 1992
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`Sheet 21 of 28
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`5,078,134
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`-e) e-
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`
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`IPR2023-00783
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`U.S. Patent
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`Jan. 7, 1992
`
`Sheet 22 of 28
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`5,078,134
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`
`
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`52
`
`F G 23O
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`IPR2023-00783
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`U.S. Patent
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`Jan. 7, 1992
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`Sheet 23 of 28
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`5,078,134
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`46O
`
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`
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`
`484
`
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`
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`IPR2023-00783
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`

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`U.S. Patent
`
`Jan. 7, 1992
`
`Sheet 24 of 28
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`IPR2023-00783
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`U.S. Patent
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`Jan. 7, 1992
`
`Sheet 25 of 28
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`5,078,134
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`472
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`IPR2023-00783
`
`

`

`U.S. Patent
`
`Jan. 7, 1992
`
`Sheet 26 of 28
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`5,078,134
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`44
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`F G 32O
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`58
`
`44
`
`F G 32b
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`U.S. Patent
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`Jan. 7, 1992
`
`Sheet 27 of 28
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`5,078,134
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`440 522 54b
`
`44b. /
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`52O 56
`56
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`
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`

`U.S. Patent
`
`Jan. 7, 1992
`
`Sheet 28 of 28
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`5,078,134
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`
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`
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`
`
`
`
`
`
`CONTINUOUS PATENT MONTORING
`FOR DETECTING TREAABLE
`TACHYARRHYTHMAS
`
`AUTOMAC ELECTRODE/SKN
`NTERFACE ELECTRICAL
`MPEDANCE LOWERING
`
`SIGNALLING THE PAST
`HA ELECTRICAL SHOCK
`TREATMENT IS IMPENDING
`
`PATENT DELAYS OR ABORTS
`ELECTRICAL SHOCK THERAPY
`F ABLE TO RESPOND TO
`THE SIGNAL
`
`
`
`
`
`
`
`F G 350
`
`
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`
`ELECTRICALLY ACTIVATED GAS
`RELEASE FOR CREATNG PRESSURE
`
`PRESSURE ACTS ON ELECTRICALY
`CONDUCTIVE MATERIAL FORCNG SAD
`MATERAL INTO THE ELECTRODE/SKN
`INTERFACE
`
`TRANSMISSION OF CORRECTIVE
`ELECTRIC SHOCK THERAPY HROUGH
`EECIRQRE/SKN INTERFACE AND
`PATENT'S HEART
`
`F G 35b
`
`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`

`

`1.
`
`PORTABLE DEVICE FOR SENSING CARDAC
`FUNCTION AND AUTOMATICALLY
`DELIVERING EECTRICAL THERAPY
`
`CROSS REFERENCE TO RELATED
`APPLICATION
`This application is a Continuation in Part of applica
`tion Ser. No. 07/185,781 filed Apr. 25, 1988, now U.S.
`Pat. No. 4,928,690 issued May 29, 1990, the entire con
`tents of which is expressly incorporated herein by refer
`eCe.
`
`O
`
`5,078,134
`2
`a practical means to protect them from life threatening
`arrhythmias. There are also numerous patients awaiting
`implantation of an automatic defibrillator who require
`an external defibrillator to be close at hand in case they
`experience a life-threatening tachyrhythmia. Addition
`ally, there are patients in need of an implantable defibril
`lator who are placed at inordinate risk due to the sur
`gery required for implanting such a device.
`It is evident from the above that there is a real need
`for providing an effective means whereby susceptible
`patients can be protected on a relatively long-term basis
`against the dangerous consequences of an electrical
`heart malfunction without having to undergo an in
`plant procedure and without having to remain hospital
`ized.
`
`20
`
`FIELD OF THE INVENTION
`This invention relates generally to the treatment of
`human defects, particularly heart defects, by the admin
`istration of electrical therapy. More particularly, the
`invention relates to a system and means for protecting
`susceptible or at-risk patients from sudden death due to
`excessively fast or slow heart rates.
`BACKGROUND OF THE INVENTION
`For several years, technology has been available for
`correcting excessively slow heart rates (bradycardia) by
`implantable devices, commonly referred to as pacemak
`25
`ers, which deliver microjoule electrical pulses to a
`slowly beating heart in order to speed the heart rate up
`to an acceptable level. Also, it is well known to deliver
`high energy shocks (180 to 360 joules) via external
`paddles applied to the chest wall in order to correct
`excessively fast heart rates and prevent the possible fatal
`outcome of ventricular fibrillation or certain ventricular
`tachycardias. Bradycardia, ventricular fibrillation and
`ventricular tachycardia are all electrical malfunctions
`(arrhythmias) of the heart and each may lead to death
`within minutes unless corrected by the appropriate
`electrical stimulation.
`Because time delays in applying the corrective elec
`trical treatment may result in death, implantable pace
`makers and defibrillators have significantly improved
`the ability to treat these otherwise life threatening con
`ditions. Being implanted within the patient, the device
`continuously monitors the patient's heart for treatable
`arrhythmias and when such is detected, the device ap
`plies corrective electrical pulses directly to the heart.
`45
`Pacemakers and defibrillators that apply corrective
`electrical pulses externally to the patient's chest wall
`also are used to correct such life-threatening arrhyth
`mias but suffer from a drawback insofar as it may not be
`possible to apply the device in time during an acute
`50
`arrhythmic emergency to save the patient's life. Such
`treatment is needed within a few minutes to be effective.
`Consequently, when a patient is deemed at high risk of
`death from such arrhythmias, the electrical devices are
`implanted so as to be readily available when treatment is
`needed. Alternatively, such patients are kept in a hospi
`tal where corrective electrical therapy is generally
`close at hand. Long term hospitalization, however, is
`frequently impractical due to its high cost or due to the
`requirements for patients to engage in normal daily
`activities.
`There are also many patients susceptible to heart
`arrhythmias who are at temporary risk of sudden death.
`For example, patients undergoing a coronary artery
`occlusion and myocardial infarction are at substantial
`risk of tachyrhythmia for several weeks following the
`coronary artery occlusion. Such patients are generally
`hospitalized but could be discharged earlier if there was
`
`30
`
`35
`
`55
`
`65
`
`SUMMARY OF THE INVENTION
`It is an object of the invention to provide a system
`and means as referred to above, whereby a patient sus
`ceptible to certain heart arrhythmias can be effectively
`protected against harmful consequences resulting there
`from without having to undergo an implant procedure
`and without having to remain hospitalized.
`Another object of the invention is to provide an effec
`tive form of externally applied electrical therapy which
`can provide relatively long-term protection to a patient
`against the consequences of heart arrhythmias without
`the patient having to forego normal everyday activities.
`A further object is to provide treatment apparatus
`which can be comfortably worn by a patient on a rela
`tively long term basis and which is adapted both to
`detect a treatable condition in the patient and, in re
`sponse thereto, provide electrical therapy to the patient.
`The present invention provides a system and means
`whereby susceptible patients may be substantially pro
`tected from arrhythmic death including a portable pa
`tient-worn external pacemaker/defibrillator that is
`comfortable to wear yet has the capability of continu
`ously monitoring the patient for potentially lethal ar
`rhythmias and delivering corrective electrical pulses
`quickly and appropriately in the event that such ar
`rhythmia occurs. The invention also provides a support
`ive non-patient-worn system and means to optimize the
`operational readiness and reliability of the patient-worn
`device. Emphasis in the present inventive system and
`means is placed on optimizing reliable operation and
`further on maximizing patient compliance in wearing
`such a device by making the device comfortable and
`user compatible.
`Further, according to the present invention, there are
`provided a number of means whereby the automatic
`external pacemaker/defibrillator may be worn comfort
`ably by an at-risk patient. Included are means to mini
`mize the weight of the device, means to distribute the
`weight-bearing surfaces over a large body area, means
`to allow the device to be loosely fitting in a standby
`mode, and means to allow a comfortable undergarment
`to be generally positioned between the device and the
`patient's skin. Most importantly, the device also in
`cludes means to cause a low impedance pathway to be
`established for an electrical pulse to the heart when a
`potentially dangerous arrhythmia has been detected by
`the device.
`Correct reliable positive detection of arrhythmias and
`minimal false detections are important to the utility of
`the wearable anti-arrhythmic device. Accordingly. it is
`also preferred that the device continuously nonitor
`
`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`

`

`10
`
`5
`
`5,078,134
`3
`4.
`more than one physiological indicator of a treatable
`dance with the invention, shown in association with an
`arrhythmia. Since various types of patient behavior may
`upper-body garment with which it is worn;
`produce unreliable detection, means may be provided
`FIG. 8 is a view of the second embodiment pacema
`for advising the patient of the status of the detection
`ker/defibriliator device in it in-use position, and shown
`circuits such that the patient may learn behavior pat
`in somewhat more detail;
`terns that optimize reliable device operation. The de
`FIGS. 9a and 9b are sectional plan and sectional
`elevational views respectively of a sensing electrode
`vice may also include means whereby the patient may
`delay the delivery of a high energy shock if conscious,
`assembly used in the second embodiment device;
`indicating that the arrhythmia is not yet life-threaten
`FIGS. Oa and 10b are sectional elevational views of
`ing.
`a pulsing electrode assembly used in the second embodi
`ment device, FIG. 10a showing the assembly in a hold
`It is a further object of the invention to provide dif
`ferent types of system monitoring means to maximize
`ing mode, and FIG. 10a showing the assembly in an
`safety, efficacy and reliability of the patient-worn de
`operational node;
`vice. Such monitoring means may include means to
`FIGS. 10c, 10d and 10e are enlarged sectional eleva
`check operational readiness of the patient-worn device,
`tional views of parts of the pulsing electrode assembly
`when in the holding mode.
`means to check battery status of the device, means to
`FIGS. 11a, 11b and 11c show respective parts of the
`recharge the batteries if necessary, means to record
`puncture mechanism in the operational mode;
`memory contents of the patient-worn device, and means
`FIGS. 11d, 11e and 11.fshow the respective parts in
`to transmit vital data to remote health care personnel
`20
`for problem solving and advising on correct device
`the holding mode;
`operation.
`FIG. 12 is an underneath plan view of the pulsing
`The above and other objects that will hereinafter
`electrode;
`FIGS. 13a and 13b are respective plan views of a
`appear, and the nature of the invention, will be more
`clearly understood by reference to the following de
`voltage controlled heat operated release mechanism,
`25
`scription, the appended claims and the accompanying
`FIG. 13a being shown in the holding mode and FIG.
`drawings.
`13b being shown in the operation mode;
`FIG. 4 is a diagrammatic in-use view of a third em
`BRIEF DESCRIPTION OF THE ORAWINGS
`bodiment pacemaker/defibrillator as worn by a patient;
`FIGS. 15a and 15b are respectively a plan view and
`FIG. 1 is a block diagram of the functional elements
`30
`of a first embodiment wearable automatic pacemaker/-
`an end view of an electrode housing with a gas source
`remotely mounted;
`defibrillator device and maintenance subsystem for the
`FIGS. 15c and 15d are respective bottom views of the
`wearable device;
`FIG. 2a is a diagrammatic sectional elevational view
`electrode housing, with a fluid container, resistive heat
`ing element and retaining member being shown with
`of a first embodiment combination ECG electrode/-
`35
`heart sound microphone used with the pacemaker/defi
`channels being removed in FIG. 15c and being in place
`in FIG. 15d.
`brillator device for heart beat detection;
`FIGS. 16a and 16b are respectively a plan view and
`FIG. 2b is an underneath plan view of the micro
`phone;
`an end view of the electrode housing with a gas source
`locally mounted within the pad housing;
`FIG. 3a is a plan view of a first embodiment sensing
`FIG. 16c is an enlarged end view showing increased
`and pulsing electrode assembly used in the defibrillator
`detail of the electrode housing, including a fluid con
`device;
`tainer, resistive heating element and retaining mem
`FIG. 3b is a side elevational view of the electrode
`assembly;
`brane;
`FIG. 17 is a partly diagrammatic in-use view of a
`FIG. 3c is an end elevational view of the electrode
`45
`assembly;
`third embodiment patient worn heart arrhythmia cor
`FIG. 3d is an enlarged plan view, partly broken
`rection system with a chest belt and a treatment pack
`age worn on the upper left leg;
`away, of the interior of the electrode assembly with the
`FIG. 18a is a partly diagrammatic in-use view of a
`cover removed;
`fourth embodiment patient worn heart arrhythmia cor
`FIG. 3e is an end elevational view of one of the elec
`trode components;
`rection system with a chest belt and a treatment pack
`age worn on the lower right chest;
`FIG. 3f is a side elevational view of the electrode
`assembly with the cover removed;
`FIG. 18b is an in-use view of the front region of a
`FIG. 3g is an underneath plan view of the electrode
`chest belt of the type shown in FIGS. 17 and 18a with
`a full length circumferential elastic member in place;
`assembly with the cover partly removed;
`55
`FIG. 3h is an exploded elevational view of parts of
`FIG. 18c is an in-use view of the front region of the
`chest belt with an elastic member applied to the pa
`the electrode assembly;
`tient's left front quadrant only;
`FIG. 4 is a diagrammatic in-use view of the first em
`bodiment pacemaker/defibrillator as worn by a patient;
`FIG. 18d is an in-use view of a further embodiment of
`FIG. 5a is a diagrammatic plan view of a respiration
`the chest belt with a conductor systern embedded
`within the outer perimeter of the belt and with sensing
`sensor as used in the first embodiment pacemaker/defi
`electrode structures integrated within a discontinuous
`brillator device;
`inner perimeter of the belt, and with elastic tensioning
`FIG. 5b is a diagrammatic elevational view of the
`respiration sensor;
`means interposed between the perimeters;
`F.G. 6 is a diagrammatic perspective view of the
`FIGS. 18e-18g are enlarged views of an electrode
`maintenance subsystem;
`section of the belt structure shown in FIG. 8d.
`FIG. 19 is a plan view of the body-encompassing
`FIG. 7 is a diagrammatic in-use view of a second
`embodiment pacemaker/defibrillator device in accor
`structures shown in FIGS. 17 and 18a, as seen from
`
`65
`
`50
`
`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`

`

`10
`
`15
`
`5,078,134
`6
`5
`ing electrical pulses to the respective electrode assem
`above the patient, with the upper chest belt shown in
`blies 20. Assemblies 20 have respective sensing elec
`section;
`trodes 22 and pulse electrodes 32.
`FIG. 20 is a partly diagrammatic in-use back view of
`In use of the device as thus far described, assemblies
`the third and fourth embodiment chest belt/electrode
`20 are held in comfortable contact with a patient's chest
`structure;
`wall and continuously monitor and detect the heart
`FIGS. 21a to 21c are underneath plan, side, and in-use
`rhythm by means of the respective sensing electrodes
`views respectively of a belt adjustment locking device;
`22. Alternatively, sensing electrodes may be traditional
`FIG. 22a is an enlarged detail view of an area of the
`disposable E.C.G. electrodes placed on the patient's
`belt near a rear treatment electrode and showing a belt
`skin in a location separate from the pulse electrodes 32.
`adjustment means;
`In the event that the sensing electrodes detect a treat
`FIG.22b is a view similar to FIG. 22a and showing a
`able heart arrhythmia, the electrodes will send the
`flexible conductor system folded over the adjustment
`sensed signal via conductors 28 and 30 to the pulse
`means;
`generator, and in response thereto, the pulse generator
`FIG.22c is an opened out view of curved elastomeric
`will return appropriate treatment pulses to the respec
`members forming the adjustment means;
`tive pulse electrodes 32. Moreover, each of the elec
`FIGS. 23a and 23b are front and side views of a
`power spring operated tensioning device;
`trode assemblies further includes means (to be described
`below) for automatically reducing the impedance of
`FIG. 24 is a perspective view of the front treatment
`electrical transmission to the heart upon receipt of the
`electrode;
`appropriate treatment commencing signal from the
`FIG.25 is an underneath plan view of the front treat
`pulse generator. Such impedance reducing means may
`ment electrode partly broken away;
`include, for example, means for automatically tighten
`FIG. 26 is a sectional elevation view of the front
`ing the respective pulsing electrodes 32 against the
`treatment electrode on line 26-26 of FIG. 25;
`patient's skin, and means for automatically releasing an
`FIG. 27 is an enlarged sectional view of a part of the
`electrically conductive electrode gel to the electrode
`front electrode prior to use;
`25
`FIG. 28 is a view similar to FIG. 27 during release of
`skin interface.
`Reverting to FIG. 4, it is seen that device 10 may be
`fluid from the electrode;
`worn over a comfortable undergarment 34, such as a
`FIG. 29 is a sectional view on line 29-29 of FIG.26;
`T-shirt, which may have apertures 36 that receive the
`FIG. 30 is a sectional view on line 30-30 of FIG.26;
`FIG.31 is a perspective view of one layer of the front
`respective electrode assemblies 20. Attachments 38,
`such as patches of loop and pile Velcro-typefabric, may
`electrode structure;
`be provided between belt 14, strap 18 and the undergar
`FIGS. 32a and 32b show an end view and a plan view
`of a leg worn treatment package;
`ent.
`FIGS. 2a and 2b illustrate details of the respective
`FIGS. 33a, 33b and 33c show a plan view (part bro
`sensing electrodes 22. Each sensing electrode, which is
`ken away), a front view, and an end view of one em
`35
`centrally located in its respective assembly 20, com
`bodiment of a segmented chest-worn treatment pack
`prises a plastic, cylindrical housing 40 containing a
`age;
`FIGS. 34a and 34b show broken-away plan views of
`telescoping inner chamber 42 which carries an EGG
`electrode 44, an associated amplifier 46, and an audio
`respective embodiments of the chest-worn package; and
`FIGS. 35a and 35b are block diagrams illustrating
`transducer or microphone 48. The EGG electrode 44
`may be capacitive, conductive carbon, or any other
`respective modes of operation of the afore-illustrated
`design which permits long-term use without skin irrita
`treatment apparatus.
`tion. The microphone is acoustically coupled to a port
`DETAILED DESCRIPTION OF THE
`50 which conducts audio-frequency energy to the mi
`PREFERRED EMBODIMENTS
`crophone diaphragm. The diameter of the inner cham
`ber is typically about 2.5 cm. Installed over the ampli
`Generally stated, in a preferred form of the invention
`fier 46 and microphone 48, and electrically connected
`as illustrated in the drawings, there is provided a pa
`thereto, is a flexible printed circuit 52 supplying power
`tient-wearable automatic electric heart therapy device,
`to and receiving signals from the amplifier and micro
`such as device 10, shown in overal view in FIG. 4, or
`phone. It is understood that the printed circuits of the
`device 200 shown in overall view in FIGS. 7 and 8, and
`50
`respective electrodes are connected to the pulse genera
`a maintenance subsystem or module 12, shown in over
`all view in FIG. 6 on which the respective therapy
`tor 24 through conductors 28 and 30 referred to in
`device 10 or 200 can be mounted when not in use on a
`connection with FIG. 4.
`patient, effectively to service, program and charge the
`The inner chamber 42 telescopes within the outer
`chamber 40 and a synthetic expanded foam pad 54 lo
`device.
`55
`cated beneath a chamber cover 60 applies pressure to
`As shown in FIG. 4, in a first embodiment, the pa
`tient-worn device may include a waist-encompassing
`the top of the inner chamber and thus to the skin sur
`belt 14 of suitable fabric, webbing or the like, which
`face, insuring constant contact between the ECG elec
`may be elasticized, or may incorporate sprung elements
`trode surface and the skin whenever the system is worn.
`the belt having a low-profile connector or buckle 16,
`FIGS. 3a-3c illustrate the overall outer appearance
`and dimensions of the respective electrode assemblies
`and a shoulder strap 18 of like material connected be
`20, showing the placement of the sensing electrode 22
`tween front and rear portions of the belt. First and
`second like sensing and pulse electrode assemblies 20
`within the pulse electrode 32. The electrode assemblies
`are carried respectively on belt 14 and shoulder strap
`each have an outer housing 56 of a flexible, composite
`material having a skin contact area of approximately
`18. Belt 14 also carries a pulse generator 24 which may
`65
`have a supporting strap connection 26 with strap 18 and
`100 square centimeters.
`FIGS. 3d-3g illustrate the interior of the respective
`electrical conductors, diagrammatically indicated at 28
`and 30, for receiving electrical signals from and deliver
`electrode assemblies with the housing removed. The
`
`40
`
`20
`
`30
`
`45
`
`Petitioner Intel Corp., Ex. 1028
`IPR2023-00783
`
`

`

`10
`
`5,078,134
`7
`8
`respective sensing electrode 22 fits centrally within the
`100 is applied over the gauge element which also encap
`respective pulse electrode and has a recess 58 provided
`sulates lead wires 102.
`in the top surface of the central chamber cover 60.
`System operation will now be described with particu
`Recess 58 contains an electrically-operated release or
`lar reference to FIG. 1.
`trigger mechanism, consisting of a heating coil of resis
`A set of sensors (monitoring means) is used to gather
`tance wire 62 wound around a synthetic fiber activator
`information as to the patient's condition. The monitor
`ing means include the respiration sensor 94, previously
`member 64. Member 64 has headed ends 65 which at
`tach to and retain two spring-loaded equalizer bars and
`described, for detecting chest wall movement, the mi
`allowing springs 68 to exert force upon the bars which
`crophone 48 for picking up heart or respiration sounds,
`travel within two cantilevered tubes 70. Contained
`the ECG electrodes 22 to monitor the surface electro
`within tube 70 are synthetic fiber tension members 72,
`cardiogram and a reference ECG electrode 106 (known
`fastened at their ends to washers 74 and at their other
`perse) to establish a "common' potential for electrodes
`ends, not shown, into the structure of belt 14 or strap 18
`22. The signals from the sensors are amplified and con
`as the case may be. Thus, as the equalizer bars travel
`ditioned by respective amplifiers 108, 110, 112 and a
`within the tubes, the tension members 72, by virtue of
`15
`signal processing network 114. The conditioned signals
`their attachment to the washers, are pulled through the
`are applied to a microprocessor 116.
`tubes, applying tension to the ends of the belt 14 or strap
`The microprocessor, in conjunction with a system
`18 to which the respective electrode housing fastens,
`memory 118, performs all functions necessary for pa
`thereby tightening the electrode assembly against the
`tient monitoring, time keeping and background opera
`patient's skin and providing a firm form of impedance
`20
`tion, recording of arrhythmias and system events, com
`reducing means.
`munication with the maintenance subsystem 12, control
`Between the tubes 70 at each side of the electrode
`of treatment sequences, self checks of system and elec
`body, and attached to grooves in central housing 40, are
`trode functioning, and monitoring of status switches 120
`opposite capsules 76 containing a conductive fluid such
`and 122. The microprocessor and memory together
`as an electrolyte gel. Central portions of the equalizer
`25
`constitute essential elements of the pulse generator 24
`bars 66 surround the gel capsules such that when acti
`described