U.S. patent application number 11/981410 was filed with the patent office on 2008-06-12 for apparatus for detecting and treating ventricular arrhythmia.
Invention is credited to Ward Brown, Stephen D. Heinrich.
Application Number | 20080140139 11/981410 |
Document ID | / |
Family ID | 22957649 |
Filed Date | 2008-06-12 |
United States Patent
Application |
20080140139 |
Kind Code |
A1 |
Heinrich; Stephen D. ; et
al. |
June 12, 2008 |
Apparatus for detecting and treating ventricular arrhythmia
Abstract
A system and method for long-term monitoring of cardiac
conditions such as arrhythmias is disclosed. The invention includes
a pulse generator including means for sensing an arrhythmia. The
pulse generator is coupled to at least one subcutaneous electrode
or electrode array for providing electrical stimulation such as
cardioversion/defibrillation shocks and/or pacing pulses. The
electrical stimulation may be provided between multiple
subcutaneous electrodes, or between one or more such electrodes and
the housing of the pulse generator. In one embodiment, the pulse
generator includes one or more electrodes that are isolated from
the can. These electrodes may be used to sense cardiac signals.
Inventors: |
Heinrich; Stephen D.;
(Rochester, MN) ; Brown; Ward; (La Crosse,
WI) |
Correspondence
Address: |
SHUMAKER & SIEFFERT , P.A
1625 RADIO DRIVE , SUITE 300
WOODBURY
MN
55125
US
|
Family ID: |
22957649 |
Appl. No.: |
11/981410 |
Filed: |
October 31, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10949877 |
Sep 24, 2004 |
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11981410 |
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09990045 |
Nov 21, 2001 |
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10949877 |
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10968889 |
Oct 21, 2004 |
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09990045 |
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10460300 |
Jun 13, 2003 |
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10968889 |
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09990045 |
Nov 21, 2001 |
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10460300 |
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60252811 |
Nov 22, 2000 |
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60252811 |
Nov 22, 2000 |
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Current U.S.
Class: |
607/4 ; 607/5;
607/7 |
Current CPC
Class: |
A61N 1/3962 20130101;
A61N 1/3956 20130101; A61N 1/3925 20130101; A61N 1/36071 20130101;
A61N 1/3629 20170801; A61N 1/3918 20130101; A61N 1/3622 20130101;
A61N 1/365 20130101; A61N 1/3987 20130101; A61N 1/3621 20130101;
A61N 1/39622 20170801; A61N 1/0504 20130101; A61N 1/39624
20170801 |
Class at
Publication: |
607/4 ; 607/5;
607/7 |
International
Class: |
A61N 1/39 20060101
A61N001/39; A61N 1/362 20060101 A61N001/362; A61N 1/365 20060101
A61N001/365 |
Claims
1. A system for providing arrhythmia therapy to a patient,
comprising: an implantable pulse generator; a sensing circuit
coupled to the implantable pulse generator; and a subcutaneous
electrode array coupled to the implantable pulse generator to
deliver electrical stimulation to the patient upon detection by the
sensing circuit of an arrhythmia wherein the system does not
comprise a transvenous, intracardiac, or epicardial electrode.
2. The system of claim 1, wherein the subcutaneous electrode array
is a defibrillation electrode array to deliver relatively
high-voltage electrical stimulation to the patient.
3. The system of claim 1, wherein the sensing circuit includes a
circuit to sense a bradyarrhythmia event, and wherein the
subcutaneous electrode array is configured to deliver at least one
pacing pulse to the patient upon detection of the bradyarrhythmia
event.
4. The system of claim 1, wherein the system is housed within a
can, and wherein the sensing circuit includes at least two sensing
electrodes on at least a first surface of the can to sense cardiac
signals.
5. The system of claim 2, wherein the system is housed within a
can, and wherein the sensing circuit utilizes the defibrillation
electrode array and the can to sense for an arrhythmia.
6. The system of claim 1, wherein the can includes at least one
surface to deliver high-voltage shocks.
7. The system of claim 4, wherein the can includes at least one
surface to deliver high-voltage shocks, and wherein the surface to
deliver high-voltage shocks is different from the at least first
surface of the can.
8. A method for treating patient arrhythmias, with a system that
does not comprise a transvenous, intracardiac, or epicardial
electrode, the method comprising: providing a subcutaneous pulse
generator; providing a monitoring circuit to monitor the patient's
cardiac signals for arrhythmias; and providing a subcutaneous
electrode array to deliver electrical therapy to a patient.
9. A method of using a subcutaneously-placed pulse generator that
is not coupled to a transvenous, intracardiac, or epicardial
electrode to treat arrhythmias, the method comprising: detecting an
arrhythmia; and employing at least one subcutaneous electrode to
deliver therapy based on the detected arrhythmia.
10. The method of claim 9, wherein the detected arrhythmia is a
tachyarrythmia, wherein the at least one subcutaneous electrode
includes a defibrillation electrode, and wherein the therapy that
is delivered is a relatively high-voltage shock.
11. The method of claim 9, wherein the detected arrhythmia is a
bradyarrythmia, and wherein employing at least one subcutaneous
electrode to deliver therapy based on the detected arrhythmia
comprises delivering a pacing pulse in response to the detected
bradyarrythmia.
12. A system for delivering electrical energy to the heart of a
patient, the system comprising: a subcutaneous pulse generator; at
least one sensing electrode disposed on a surface of the pulse
generator and positioned proximate to subcutaneous tissue; and at
least one electrode array coupled to the pulse generator and
positioned subcutaneously on the patients wherein the system does
not comprise a transvenous, intracardiac, or epicardial
electrode.
13. An apparatus for monitoring cardiac signals of a patient,
comprising; a hermetically-sealed housing; sensing means included
within the housing; and first and second electrode sets coupled to
the sensing means, the first electrode set including at least one
electrode adjacent to a surface of the housing positionable
proximate subcutaneous tissue at a first location in the patient's
body, and the second electrode set coupled to a connector on the
housing and forming an electrode array subcutaneously positionable
in the patient's body at a location different from the first
locations wherein the first and second electrode sets do not
comprise a transvenous, intracardiac, or epicardial electrode.
14. A method of implanting a subcutaneous
cardioverter-defibrillator in a patient for treating arrhythmias
without a transvenous, intracardiac or epicardial electrode,
comprising: making a skin incision in the patient's body;
implanting an electrode subcutaneously in the patient; and placing
an electrically active canister subcutaneously in the patient,
wherein the canister contains a source of electrical energy and
operational circuitry that senses the presence of potentially fatal
heart rhythms and has means for delivering electrical
cardioversion-defibrillation energy using the canister as either
the anode or the cathode and using the electrode as the opposite
electrode from the canister, and wherein the canister is
electrically connected to the electrode; and closing the skin
incision.
15. A method for providing anti-arrhythmia therapy via a
subcutaneous cardioverter-defibrillator and without a transvenous,
intracardiac or epicardial electrode, comprising: implanting a
canister comprising a biocompatible housing subcutaneously in a
patient, the biocompatible housing enclosing and containing
cardioversion-defibrillation circuitry and defining at least one
electrically conductive surface on an outer surface of the
biocompatible housing and electrically connected to the
cardioversion-defibrillation circuitry; implanting an electrically
inert lead subcutaneously, the electrically inert lead comprising a
substantially pliant and directable cannula adaptably connected to
the canister with a lead electrode formed on a distal end of the
electrically inert lead and electrically interfaced to the
cardioversion-defibrillation circuitry; and delivering an
electrical therapy comprising an anti-arrhythmia waveform from the
lead electrode to the at least one electrically conductive
surface.
16. A subcutaneous implantable cardioverter-defibrillator
comprising: an electrically active canister that serves as either
an anode or a cathode of the cardioverter-defibrillator wherein the
canister houses a source of electrical energy, a capacitor, and
operational circuitry that senses the presence of potentially fatal
heart rhythms; a subcutaneous electrode that serves as the opposite
electrode from the canister (either the anode or the cathode); a
lead system electrically attaching the electrode to the canister;
means for delivering electrical cardioversion-defibrillation energy
when the operational circuitry senses a potentially fatal heart
rhythm; and the absence of a transvenous, intracardiac, or
epicardial electrode.
17. A cardioverter-defibrillator for subcutaneous implantation,
comprising: a canister comprising a biocompatible housing enclosing
and containing cardioversion-defibrillation circuitry and defining
at least one electrically conductive surface on an outer surface of
the biocompatible housing and electrically connected to the
cardioversion-defibrillation circuitry; an electrically inert lead
connected to the canister comprising a substantially pliant and
directable cannula adaptably connected to the canister; and a lead
electrode formed on a distal end of the electrically inert lead and
electrically interfaced to the cardioversion-defibrillation
circuitry to deliver an electrical therapy with the at least one
electrically conductive surface to the heart of a patient without a
transvenous, intracardiac or epicardial electrode.
18. A subcutaneous cardioverter-defibrillator with electrically
active canister for minimally invasive implantation, comprising: a
subcutaneously implantable, canister comprising a sterilizable
biocompatible housing enclosing and containing
cardioversion-defibrillation circuitry interfaceable through the
biocompatible housing via an electrically isolated connector block,
the biocompatible housing defining at least one electrically
conductive surface on the outer surface of the biocompatible
housing and electrically connected to the
cardioversion-defibrillation circuitry; an electrically inert lead
comprising a substantially pliant and directable cannula enclosing
and guiding one or more conductors adaptably connected to the
electrically isolated connector block; and a lead electrode formed
on a distal end of the electrically inert lead and electrically
interfaced via the one or more conductors to the
cardioversion-defibrillation circuitry to deliver an electrical
therapy with the at least one electrically conductive surface to
the heart of a patient without a transvenous, intracardiac or
epicardial electrode.
19. A cardioversion-defibrillation device with electrically
conductive housing means for subcutaneous implantation, comprising:
means for housing and hermetically containing
cardioversion-defibrillation circuitry, the housing means
comprising electrically isolated means for externally interfacing
to the cardioversion-defibrillation circuitry and defining at least
one electrically conductive surface on an outer surface of the
housing means that is electrically connected to the
cardioversion-defibrillation circuitry through internal interfacing
means; means for guiding and enclosing one or more conductors
connected to the cardioversion-defibrillation circuitry via the
external interfacing means, the enclosing means being substantially
pliant and directable; and means for delivering an electrical
therapy to a patient's heart between a distal end of the guiding
means and the at least one electrically conductive surface without
a transvenous, intracardiac or epicardial electrode, the electrical
therapy delivering means being responsive to an autonomously
detected arrhythmic condition and being electrically connected via
the one or more conductors to the cardioversion-defibrillation
circuitry.
20. An implantable subcutaneous cardioverter-defibrillator with
electrically active canister, comprising: an implantable canister
providing a housing enclosing and containing
cardioversion-defibrillation circuitry externally interfaceable via
an electrically isolated connector block on a proximal end of the
housing, the housing defining a discrete electrically conductive
surface on an outer surface and internally connecting electrically
to the cardioversion-defibrillation circuitry; a substantially
pliant and directable lead enclosing and guiding one or more
conductors adaptably connected to the electrically isolated
connector block, the lead being electrically inert; and a lead
electrode circumferentially formed on a distal end of the lead and
electrically interfaced via the one or more conductors to the
cardioversion-defibrillation circuitry to deliver an electrical
therapy responsive to an autonomously detected arrhythmic condition
without a transvenous, intracardiac or epicardial electrode.
21. An implantable subcutaneous cardioverter-defibrillator
providing antiarrhythmia therapy, comprising: an implantable
canister providing a housing enclosing and containing
cardioversion-defibrillation circuitry externally interfaceable via
an electrically isolated connector block on a proximal end of the
housing, the housing defining an electrically conductive surface on
an outer surface and internally connecting electrically to the
cardioversion-defibrillation circuitry, the
cardioversion-defibrillation circuitry monitoring cardiac
physiological conditions; a substantially pliant and directable
lead enclosing and guiding one or more conductors adaptably
connected to the electrically isolated connector block, the lead
being electrically inert; and a lead electrode circumferentially
formed on a distal end of the lead and electrically interfaced via
the one or more conductors to the cardioversion-defibrillation
circuitry to deliver an anti-arrhythmic waveform responsive to an
arrhythmic condition autonomously detected by the
cardioversion-defibrillation circuitry without a transvenous,
intracardiac or epicardial electrode.
22. An implantable subcutaneous cardioverter-defibrillator
monitoring cardiac physiological conditions, comprising: an
implantable canister providing a housing enclosing and containing
cardioversion defibrillation circuitry externally interfaceable via
an electrically isolated connector block on a proximal end of the
housing, the housing defining an electrically conductive surface on
an outer surface and internally connecting electrically to the
cardioversion-defibrillation circuitry; a substantially pliant and
directable lead enclosing and guiding one or more conductors
adaptably connected to the electrically isolated connector block,
the lead being electrically inert; a sensing electrode
circumferentially formed on a distal end of the lead and
electrically interfaced via the one or more conductors to sensing
circuitry within the cardioversion-defibrillation circuitry to
deliver an electrical therapy responsive to an autonomously
detected arrhythmic condition without a transvenous, intracardiac
or epicardial electrode; and monitoring circuitry integral to the
cardioversion-defibrillation circuitry and deriving cardiac
physiological measures.
23. An implantable subcutaneous cardioverter-defibrillator
detecting cardiopulmonary physiological conditions, comprising: an
implantable canister providing a housing enclosing and containing
cardioversion defibrillation circuitry externally interfaceable via
an electrically isolated connector block on a proximal end of the
housing, the housing defining an electrically conductive surface on
an outer surface and internally connecting electrically to the
cardioversion-defibrillation circuitry; a substantially pliant and
directable lead enclosing and guiding one or more conductors
adaptably connected to the electrically isolated connector block,
the lead being electrically inert; a sensing electrode
circumferentially formed on a distal end of the lead and
electrically interfaced via the one or more conductors to sensing
circuitry within the cardioversion-defibrillation circuitry to
deliver an electrical therapy responsive to an autonomously
detected arrhythmic condition without a transvenous, intracardiac
or epicardial electrode; and detection circuitry integral to the
cardioversion-defibrillation circuitry and deriving physiological
measures.
24. A subcutaneous implantable cardioverter-defibrillator
comprising: a housing including a source of electrical energy, a
capacitor, and operational circuitry that senses the presence of
potential fatal heart rhythms; at least one
cardioversion/defibrillation electrode located on the housing;
means for delivering electrical cardioversion-defibrillation energy
when the operational circuitry senses a potentially fatal heart
rhythm; and the absence of a transvenous, intracardiac, or
epicardial electrode.
25. The subcutaneous implantable cardioverter-defibrillator of
claim 24, wherein the electrical cardioversion-defibrillating
energy is equal to the energy required to terminate the potentially
fatal heart rhythm.
26. The subcutaneous implantable cardioverter-defibrillator of
claim 24, further comprising at least two sensing electrodes
located on the housing.
27. The subcutaneous implantable cardioverter-defibrillator of
claim 26, wherein the sensing electrodes are spaced apart from each
other.
28. The subcutaneous implantable cardioverter-defibrillator of
claim 24, wherein the operational circuitry is programmable.
29. The subcutaneous implantable cardioverter-defibrillator of
claim 24, wherein the operational circuitry can detect
tachycardia.
30. The subcutaneous implantable cardioverter-defibrillator of
claim 29, further comprising means for delivering antitachycardia
therapy when the operational circuitry senses a tachycardia
rhythm.
31. The subcutaneous implantable cardioverter-defibrillator of
claim 24, wherein the operational circuitry can detect tachycardia
and fibrillation.
32. The subcutaneous implantable cardioverter-defibrillator of
claim 31, wherein the operational circuitry can deliver
defibrillation energy to treat the detected fibrillation.
33. The subcutaneous implantable cardioverter-defibrillator of
claim 24, wherein the electrical cardioversion-defibrillating
energy is delivered in a biphasic wave form.
34. The subcutaneous implantable cardioverter-defibrillator of
claim 24, wherein the capacitance is the capacitance required to
terminate the potentially fatal heart rhythm.
35. The subcutaneous implantable cardioverter-defibrillator of
claim 24, wherein the housing is provided with at least one sensing
electrode.
36. The subcutaneous implantable cardioverter-defibrillator of
claim 24, wherein the housing is provided with one or more sensing
electrodes, and wherein said cardioverter-defibrillator is further
provided with a subcutaneous electrode with one or more sensing
electrodes, and means for selecting two sensing electrodes from the
sensing electrodes located on the housing and the sensing electrode
located on the subcutaneous electrode that provide adequate QRS
wave detection.
37. A method of implanting an implantable subcutaneous
cardioverter-defibrillator in a patient comprising: making a skin
incision in the patient's body; implanting a subcutaneous
cardioverter-defibrillator, the subcutaneous
cardioverter-defibrillator including a housing enclosing and
containing cardioversion-defibrillation circuitry and defining at
least one electrode electrically interfaced to the
cardioversion-defibrillation circuitry to deliver an electrical
therapy to the heart of a patient without a transvenous,
intracardiac or epicardial electrode; and closing the skin
incision.
38. A cardioverter-defibrillator for subcutaneous implantation,
comprising: a canister comprising a biocompatible housing enclosing
and containing cardioversion-defibrillation circuitry; at least one
electrode formed on the biocompatible housing and electrically
interfaced to the cardioversion-defibrillation circuitry to deliver
an electrical therapy to the heart of a patient; and the absence of
a transvenous, intracardiac, or epicardial electrode.
39. The cardioverter-defibrillator according to claim 38, further
comprising: at least one sensing electrode formed on, and
electrically insulated from, the biocompatible housing and
electrically interfaced to the cardioversion-defibrillation
circuitry.
40. The cardioverter-defibrillator according to claim 38, further
comprising: at least one electrically insulated surface defined on
an outer surface of the biocompatible housing and juxtaposed to the
at least one electrode.
41. The cardioverter-defibrillator according to claim 40, further
comprising: at least one sensing electrode formed on the at least
one electrically insulated surface and electrically interfaced to
the cardioversion-defibrillation circuitry.
42. The cardioverter-defibrillator according to claim 40, further
comprising: an insulated margin around the at least one electrode
along the at least one electrically insulated surface and defining
a concentrated electrically conductive surface.
43. The cardioverter-defibrillator according to claim 38, further
comprising: monitoring circuitry integral to the
cardioversion-defibrillation circuitry and deriving physiological
measures.
44. The cardioverter-defibrillator according to claim 38, further
comprising: a pulse generator integral to the
cardioversion-defibrillation circuitry and producing an
anti-arrhythmia waveform for anti-arrhythmia therapy via the at
least one electrode responsive to the cardioversion-defibrillation
circuitry.
45. The cardioverter-defibrillator according to claim 44, further
comprising: the pulse generator generating the anti-arrhythmia
waveform as a biphasic waveform.
46. The cardioverter-defibrillator according to claim 45, further
comprising: the cardioversion-defibrillation circuitry initiating
the anti-arrhythmia therapy upon detection of a certain event.
47. The cardioverter-defibrillator according to claim 45, further
comprising: the cardioversion-defibrillation circuitry terminating
the anti-arrhythmia therapy upon detection of a certain event.
48. The cardioverter-defibrillator according to claim 45, further
comprising: power supply components integral to the
cardioversion-defibrillation circuitry for providing power
sufficient to generate the anti-arrhythmia waveform.
49. The cardioverter-defibrillator according to claim 38, wherein
the housing is any shape suitable for implantation.
50. The cardioverter-defibrillator according to claim 38, wherein
the at least one electrode interfaces with high voltage and low
impedance circuitry.
51. The cardioverter-defibrillator according to claim 50, further
comprising: a plurality of sensing electrodes formed on the
biocompatible housing, each sensing electrode interfacing with low
voltage and high impedance circuitry.
52. The cardioverter-defibrillator according to claim 38, wherein
the at least one electrode faces the heart when implanted.
53. A method for providing anti-arrhythmia therapy via a
subcutaneous cardioverter-defibrillator and without a transvenous,
intracardiac or epicardial electrode, comprising: implanting a
canister comprising a biocompatible housing subcutaneously in a
patient, the biocompatible housing enclosing and containing
cardioversion-defibrillation circuitry and defining at least one
electrode on the outer surface of the biocompatible housing that
faces the heart and electrically connected to the
cardioversion-defibrillation circuitry; and delivering an
electrical therapy comprising an anti-arrhythmia waveform to the
heart of a patient from the at least one electrode.
54. The method according to claim 53, the method further
comprising: providing a plurality of sensing electrodes formed on
the canister, electrically isolated from the at least one
electrode, each sensing electrode interfacing with sensing
circuitry to the cardioversion-defibrillation circuitry; and
monitoring and deriving cardiac physiological measures via the
sensing electrodes.
55. The method of claim 14, wherein the electrode can be
subcutaneously implanted at various locations in the body.
56. The method of claim 14, wherein the canister can be
subcutaneously implanted at various locations in the body.
57. The subcutaneous implantable cardioverter-defibrillator of
claim 16, wherein the operational circuitry comprises an impedance
detection means for measuring impedance.
58. The subcutaneous implantable cardioverter-defibrillator of
claim 16, wherein the operational circuitry can measure cardiac
output.
59. A cardioverter-defibrillator according to claim 17, further
comprising: at least one further electrically inert lead comprising
a substantially pliant and directable cannula connected to the
canister; at least one further lead electrode formed on a distal
end of the at least one further electrically inert lead and
electrically interfaced to the cardioversion-defibrillation
circuitry; and switching circuitry to selectively deliver an
electrical therapy between the at least one electrically conductive
surface and one or more of the lead electrodes on the electrically
inert leads.
60. A cardioverter-defibrillator according to claim 17, further
comprising: providing a plurality of sensing electrodes formed on
the electrically inert lead, each sensing electrode interfacing
with sensing circuitry in the cardioversion-defibrillation
circuitry; and monitoring and deriving cardiac physiological
measures via the sensing electrodes.
61. The subcutaneous implantable cardioverter-defibrillator of
claim 16, wherein the electrical cardioversion-defibrillating
energy is equal to the energy required to terminate the potentially
fatal heart rhythm.
62. The subcutaneous implantable cardioverter-defibrillator of
claim 16, wherein the subcutaneous electrode is a composite
electrode comprising: a cardioversion-defibrillation electrode a
first sensing electrode; and a second sensing electrode
electrically insulated and spaced apart from the first sensing
electrode.
63. The subcutaneous implantable cardioverter-defibrillator of
claim 62, wherein the first sensing electrode, the second sensing
electrode, and the cardioversion-defibrillation electrode are
located near each other.
64. The subcutaneous implantable cardioverter-defibrillator of
claim 16, wherein the operational circuitry is programmable.
65. The subcutaneous implantable cardioverter-defibrillator of
claim 16, wherein the operational circuitry can detect
tachycardia.
66. The subcutaneous implantable cardioverter-defibrillator of
claim 65, further comprising means for delivering antitachycardia
pacing when the operational circuitry senses a tachycardia
rhythm.
67. The subcutaneous implantable cardioverter-defibrillator of
claim 16, wherein the operational circuitry can detect tachycardia
and fibrillation.
68. The subcutaneous implantable cardioverter-defibrillator of
claim 67, wherein the operational circuitry can deliver
defibrillation energy to treat the detected fibrillation.
69. The subcutaneous implantable cardioverter-defibrillator of
claim 16, wherein the electrical cardioversion-defibrillating
energy is delivered in a biphasic waveform.
70. The subcutaneous implantable cardioverter-defibrillator of
claim 16, wherein the capacitor has a capacitance equal to the
capacitance required to terminate the potentially fatal heart
rhythm.
71. The subcutaneous implantable cardioverter-defibrillator of
claim 16, wherein the canister is provided with at least one
sensing electrode.
72. The subcutaneous implantable cardioverter-defibrillator of
claim 16, wherein the canister is provided with one or more sensing
electrodes, the subcutaneous electrode is provided with one or more
sensing electrodes, and means for selecting two sensing electrodes
from the one or more sensing electrodes located on the canister and
the one or more sensing electrodes located on the subcutaneous
electrode that provide adequate QRS wave detection.
73. The subcutaneous implantable cardioverter-defibrillator of
claim 16, comprising an additional subcutaneous electrode that
serves as the opposite electrode from the canister (either the
anode or the cathode) and the same polarity as the original
subcutaneous electrode.
74. The subcutaneous implantable cardioverter-defibrillator of
claim 16, comprising an additional subcutaneous electrode that
serves as the opposite electrode from the original subcutaneous
electrode (either the anode or the cathode) and the same polarity
as the canister.
75. The cardioverter-defibrillator according to claim 16, wherein
the canister is any shape suitable for subcutaneous
implantation.
76. A cardioverter-defibrillator according to claim 17, further
comprising: at least one sensing electrode formed on and
electrically insulated from the at least one electrically
conductive surface and electrically interfaced to the
cardioversion-defibrillation circuitry.
77. A cardioverter-defibrillator according to claim 17, further
comprising: at least one electrically insulated surface defined on
the outer surface of the biocompatible housing and juxtaposed to
the at least one electrically conductive surface.
78. A cardioverter-defibrillator according to claim 77, further
comprising: at least one sensing electrode formed on the at least
one electrically insulated surface and electrically interfaced to
the cardioversion-defibrillation circuitry.
79. A cardioverter-defibrillator according to claim 77, further
comprising: a margin bounding the at least one electrically
conductive surface from the at least one electrically insulated
surface and defining a concentrated electrically conductive surface
within the at least one electrically insulated surface.
80. A cardioverter-defibrillator according to claim 17, further
comprising: monitoring circuitry integral to the
cardioversion-defibrillation circuitry and deriving physiological
measures.
81. A cardioverter-defibrillator according to claim 17, further
comprising: a pulse generator integral to the
cardioversion-defibrillation circuitry and producing an
anti-arrhythmia waveform for anti-arrhythmia therapy via the at
least one electrically conductive surface and the lead electrode
responsive to the cardioversion-defibrillation circuitry.
82. A cardioverter-defibrillator according to claim 81, further
comprising: the pulse generator generating the anti-arrhythmia
waveform as a biphasic waveform.
83. A cardioverter-defibrillator according to claim 82, further
comprising: the cardioversion-defibrillation circuitry initiating
the anti-arrhythmia therapy upon detection of a certain event.
84. A cardioverter-defibrillator according to claim 82, further
comprising: the cardioversion-defibrillation circuitry terminating
the anti-arrhythmia therapy upon detection of a certain event.
85. A cardioverter-defibrillator according to claim 17, wherein the
housing is any shape suitable for implantation.
86. A cardioverter-defibrillator according to claim 17, further
comprising: the lead electrode formed non-circumferentially on the
electrically inert lead.
87. A cardioverter-defibrillator according to claim 17, further
comprising: at least one sensing electrode formed on the
electrically inert lead.
88. A cardioverter-defibrillator according to claim 87, wherein the
at least one sensing electrode is formed distal to the lead
electrode.
89. A cardioverter-defibrillator according to claim 87, wherein the
at least one sensing electrode is formed near the lead
electrode.
90. A cardioverter-defibrillator according to claim 87, wherein the
at least one sensing electrode is formed non-circumferentially on
the electrically inert lead.
91. A cardioverter-defibrillator according to claim 17, further
comprising: at least one further electrically inert lead comprising
a substantially pliant and directable cannula connected to the
canister; at least one further lead electrode formed on a distal
end of the at least one further electrically inert lead and
electrically interfaced to the cardioversion-defibrillation
circuitry; and switching circuitry to selectively deliver an
electrical therapy between the at least one electrically conductive
surface and one or more of the lead electrodes on the electrically
inert leads.
92. A subcutaneous cardioverter-defibrillator according to claim
18, further comprising: the lead electrode further interfacing with
sensing circuitry and providing a sensing function to the
cardioversion-defibrillation circuitry.
93. A subcutaneous cardioverter-defibrillator according to claim
18, further comprising: a concentrated electrically conductive
surface defined about a surface of the biocompatible housing
adapted to face the heart.
94. A subcutaneous cardioverter-defibrillator according to claim
18, further comprising: at least one electrically insulated surface
defined about a surface of the biocompatible housing adapted to
face away from the heart and juxtaposed to the at least one
electrically conductive surface.
95. A subcutaneous cardioverter-defibrillator according to claim
94, further comprising: an insulating area substantially interposed
between the at least one electrically conductive surface and the at
least one electrically insulated surface.
96. A subcutaneous cardioverter-defibrillator according to claim
18, further comprising: at least one sensing electrode formed on
and electrically insulated from the at least one electrically
conductive surface and electrically interfaced to the
cardioversion-defibrillation circuitry, each sensing electrode
interfacing with sensing circuitry and providing a sensing function
to the cardioversion-defibrillation circuitry.
97. A subcutaneous cardioverter-defibrillator according to claim
96, further comprising: an electrically insulated surface about
each at least one sensing electrode abutting the biocompatible
housing and marginal to the at least one electrically conductive
surface.
98. A subcutaneous cardioverter-defibrillator according to claim
18, further comprising: at least one sensing electrode formed on
the electrically inert lead and electrically interfaced via the one
or more conductors to the cardioversion-defibrillation circuitry,
the sensing electrode interfacing with sensing circuitry and
providing a sensing function to the cardioversion-defibrillation
circuitry.
99. A subcutaneous cardioverter-defibrillator according to claim
98, wherein the at least one sensing electrode is formed near the
lead electrode.
100. A subcutaneous cardioverter-defibrillator according to claim
98, wherein the at least one sensing electrode is formed
non-circumferentially on the electrically inert lead.
101. The cardioverter-defibrillator according to claim 18, wherein
the housing is any shape suitable for implantation.
102. A subcutaneous cardioverter-defibrillator according to claim
18, further comprising: at least one further electrically inert
lead comprising a substantially pliant and directable cannula
enclosing and guiding one or more conductors adaptably connected to
the electrically isolated connector block; at least one further
lead electrode formed on a distal end of the at least one further
electrically inert lead and electrically interfaced via the one or
more conductors to the cardioversion-defibrillation circuitry to
deliver an electrical therapy to the at least one electrically
conductive surface; and switching circuitry controllable via the
cardioversion-defibrillation circuitry to selectively deliver an
electrical therapy between the at least one electrically conductive
surface and one or more of the lead electrodes on the electrically
inert leads.
103. A subcutaneous cardioverter-defibrillator according to claim
18, further comprising: a pulse generator integral to the
cardioversion-defibrillation circuitry and generating an
anti-arrhythmia biphasic waveform.
104. A subcutaneous cardioverter-defibrillator according to claim
18, further comprising: the cardioversion-defibrillation circuitry
comprising at least one of: monitoring circuitry deriving
physiological measures; and a pulse generator producing an
anti-arrhythmia waveform for anti-arrhythmia therapy via the at
least one electrically conductive surface and the lead electrode
responsive to the cardioversion-defibrillation circuitry.
105. A cardioversion-defibrillation device according to claim 19,
further comprising: means for monitoring and deriving physiological
measures; and means for producing an anti-arrhythmia waveform for
anti-arrhythmia therapy via the at least one electrically
conductive surface and the electrical therapy delivering means
responsive to the cardioversion-defibrillation circuitry.
106. A cardioversion-defibrillation device according to claim 19,
further comprising: sensing means provided via the electrical
therapy delivering means, the sensing means being electrically
connected via the one or more conductors to the
cardioversion-defibrillation circuitry to interface with sensing
circuitry.
107. A cardioversion-defibrillation device according to claim 19,
further comprising: sensing means provided abutting and
electrically insulated from the housing means, the sensing means
being electrically connected via the internal interfacing means to
the cardioversion-defibrillation circuitry to interface with
sensing circuitry.
108. A cardioversion-defibrillation device according to claim 19,
further comprising: sensing means provided on the guiding means
adjunctively to the electrical therapy delivering means, the
sensing means being electrically connected via the one or more
conductors to the cardioversion-defibrillation circuitry to
interface with sensing circuitry.
109. A subcutaneous cardioverter-defibrillator according to claim
19, further comprising: sensing means formed near the electrical
therapy delivering means.
110. A cardioversion-defibrillation device according to claim 19,
further comprising: at least one electrically insulated surface
defined about a surface of the housing means adapted to face the
heart and juxtaposed to the at least one electrically conductive
surface, an insulating area being substantially interposed between
the at least one electrically conductive surface and the at least
one electrically insulated surface.
111. A cardioversion-defibrillation device according to claim 19,
further comprising: pulse generating means integral to the
cardioversion-defibrillation circuitry and generating an
anti-arrhythmia biphasic waveform.
112. A cardioversion-defibrillation device according to claim 19,
wherein the housing means is any shape suitable for
implantation.
113. An implantable subcutaneous cardioverter-defibrillator
according to claim 20, further comprising: an electrically
insulated surface juxtaposed to the discrete electrically
conductive surface and substantially interposed therefrom by an
electrically insulated area.
114. An implantable subcutaneous cardioverter-defibrillator
according to claim 20, further comprising: at least one sensing
electrode circumferentially formed on the lead and electrically
connected with the one or more conductors via the isolated
connector block to the cardioversion-defibrillation circuitry, the
at least one sensing electrode interfacing with sensing circuitry
within the cardioversion-defibrillation circuitry and providing a
sensing function.
115. An implantable subcutaneous cardioverter-defibrillator
according to claim 114, wherein the at least one sensing electrode
is formed near the lead electrode.
116. An implantable subcutaneous cardioverter-defibrillator
according to claim 20, further comprising: at least one sensing
electrode formed on and electrically insulated from the
electrically conductive surface and internally electrically
connected to the cardioversion-defibrillation circuitry, the at
least one sensing electrode interfacing with sensing circuitry
within the cardioversion defibrillation circuitry and providing a
sensing function.
117. An implantable subcutaneous cardioverter-defibrillator
according to claim 20, further comprising: an anti-arrhythmic pulse
generator integral to the cardioversion-defibrillation circuitry
and generating an anti-arrhythmia biphasic waveform to the
electrically conductive.
118. An implantable subcutaneous cardioverter-defibrillator with
discrete electrically active canister, comprising: an implantable
canister providing a housing enclosing and containing
cardioversion-defibrillation circuitry externally interfaceable via
an electrically isolated connector block on a proximal end of the
housing, the housing defining a discrete electrically conductive
surface on an outer surface and internally connecting electrically
to the cardioversion-defibrillation circuitry, the housing further
defining an electrically insulated surface juxtaposed to the
discrete electrically conductive surface and substantially
interposed therefrom by an electrically insulated area; a
substantially pliant and directable lead enclosing and guiding one
or more conductors adaptably connected to the electrically isolated
connector block, the lead being electrically inert; and a lead
electrode circumferentially formed on a distal end of the lead and
electrically interfaced via the one or more conductors to the
cardioversion-defibrillation circuitry to deliver an electrical
therapy responsive to an autonomously detected arrhythmic condition
without a transvenous, intracardiac or epicardial electrode.
119. An implantable subcutaneous cardioverter-defibrillator
according to claim 118, further comprising: at least one sensing
electrode formed on at least one of the discrete electrically
conductive surface and the electrically insulated surface, the at
least one sensing electrode being electrically insulated from the
discrete electrically conductive surface and internally
electrically connected to the cardioversion-defibrillation
circuitry, each sensing electrode interfacing with sensing
circuitry within the cardioversion-defibrillation circuitry and
providing a sensing function.
120. An implantable subcutaneous cardioverter-defibrillator
according to claim 21, wherein the anti-arrhythmia waveform is a
biphasic waveform.
Description
[0001] This application is a continuation of U.S. application Ser.
No. 10/949,877, filed Sep. 24, 2004, which is a continuation of
U.S. application Ser. No. 09/990,045, filed Nov. 21, 2001, which
claims the benefit of U.S. Provisional Application No. 60/252,811,
filed Nov. 22, 2000. This application is also a continuation of
U.S. application Ser. No. 10/968,889, filed Oct. 21, 2004, which is
a continuation of U.S. application Ser. No. 10/460,300, filed Jun.
13, 2003, which is a continuation of U.S. application Ser. No.
09/990,045, filed Nov. 21, 2001, which claims the benefit of U.S.
Provisional Application No. 60/252,811, filed Nov. 22, 2000. The
entire content of each of these Applications is incorporated herein
by reference.
FIELD OF THE INVENTION
[0002] This invention relates to a method and apparatus for
treating ventricular arrhythmias; and more particularly, relates to
a method and apparatus for long-term monitoring of arrhythmias, and
for the delivery of acute tachyarrhythmia and bradyarrhythmia
therapy using a subcutaneous stimulation device.
DESCRIPTION OF THE PRIOR ART
[0003] It has long been known to use implantable systems to protect
patients that are at risk for life-threatening arrhythmias. For
example, rapid heart rhythms commonly referred to as
tachyarrhythmias are generally treated using implantable devices
such as the Medtronic Model 7273 GEM II DR or the 7229 GEM II SR,
both commercially available from the Medtronic Corporation. These
systems detect the presence of tachyarrhythmia conditions by
monitoring the electrical and mechanical heart activity (such as
intra-myocardial pressure, blood pressure, impedance, stroke volume
or heart movement) and/or the rate of the electrocardiogram. These
devices require that one or more defibrillation electrodes be
positioned within the atrium and/or ventricle of a patient's heart
using current endocardial lead placement techniques. The use of
such systems provides consistent long-term monitoring capabilities,
and relatively good protection against life-threatening
tachyarrhythmias.
[0004] Similarly, bradyarrhythmias, which are heart rhythms that
are too slow, are generally treated using implantable pulse
generators. Such devices are described in U.S. Pat. Nos. 5,158,078,
4,958,632, and 5,318,593, for example. As with devices to treat
tachyarrhythmias, most implantable pulse generators that treat
these types of conditions generally require leads that are
implanted within one or more cardiac chambers.
[0005] Although the use of endocardial leads placed within the
cardiac chambers of a patient's heart provides the capability to
deliver a relatively reliable, long-term arrhythmia therapy, there
are disadvantages associated with such treatments. The placement of
these leads requires a relatively time-consuming, costly procedure
that is not without risks to the patient including infection, the
possibility of vascular perforation, and tamponade.
[0006] Moreover, some people are not candidates for endocardial
leads. For example, patients with artificial mechanical tricuspid
valves are generally not candidates for leads that extend from the
right atrium, through this valve, to the right ventricle, as is the
case with most right ventricular endocardial leads. This is because
the use of such leads interfere with the proper mechanical
functioning of the valves. Other patients that are not candidates
for endocardial lead placement include those with occluded venous
access, or patients with congenital heart defects.
[0007] Patients that are contraindicated for endocardial lead
placement must often undergo a procedure to attach the lead to the
external surface of the heart. This type of epicardial lead
placement involves a more invasive procedure that requires a longer
recovery time, makes follow-up procedures very difficult, and is
also associated with increased patient risk, including an increased
chance of contracting an infection.
[0008] Another problem associated with both endocardial and
epicardial leads involves patient growth. More specifically, a lead
placed within a child's cardiac vasculature will likely need to be
re-positioned or replaced as the child matures. Such lead
replacement procedures can be dangerous, especially when
previously-placed leads are extracted rather than left in position
within the body.
[0009] One alternative to endocardial and epicardial leads involves
subcutaneously-placed electrode systems. For example, in U.S. Pat.
No. Re 27,652 by Mirowski, et al., a defibrillation system employs
a ventricular endocardial electrode and a plate electrode mounted
to the heart directly, subcutaneously, or to the skin to deliver
high-voltage therapy to the patient. A similar lead system
disclosed in U.S. Pat. No. 5,314,430 to Bardy includes a coronary
sinus/great vein electrode and a subcutaneous plate electrode
located in the left pectoral region which may optionally take the
form of a surface of the defibrillator housing.
[0010] What is needed, therefore, is a system and method that can
provide long-term monitoring for various types of arrhythmias,
provide patient therapy when needed, and also overcome the problems
associated with both endocardial and epicardial lead placement.
SUMMARY OF THE INVENTION
[0011] The current invention provides a system and method for
long-term monitoring for arrhythmias. The invention includes a
pulse generator including means for sensing an arrhythmia. The
pulse generator is coupled to at least one electrode or electrode
array for providing electrical stimulation to a patient. The
stimulation may include cardioversion/defibrillation shocks and/or
pacing pulses. The electrical stimulation may be provided between
multiple electrodes, or between one or more electrodes and the
housing of the pulse generator. In one embodiment, the pulse
generator includes one or more electrodes that are isolated from
the can. These electrodes may be used to sense cardiac signals.
[0012] According to one embodiment of the invention, an apparatus
is provided for monitoring cardiac signals of a patient. The
apparatus includes a hermetically-sealed housing, sensing means
included within the housing, and first and second electrode sets
coupled to the sensing means. The first electrode set includes at
least one electrode adjacent to a surface of the housing
positionable proximate subcutaneous tissue at a first location in
the patient's body. The second electrode set is coupled to a
connector on the housing and forms an electrode array
subcutaneously-positionable in the patient's body at a location
different from the first location.
[0013] According to another embodiment of the invention, a method
of therapy is provided. This method includes monitoring the
patient's cardiac signals for a condition such as an arrhythmia,
and thereafter delivering a electrical therapy to a patient via a
subcutaneous electrode array is the condition is detected. Other
aspects of the invention will become apparent from the drawings and
the accompanying description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 illustrates an exemplary subcutaneous electrode and
pulse generator as may be used in accordance with the current
invention.
[0015] FIG. 2 is a block functional diagram of an illustrative
embodiment of a pulse generator that may be employed according to
the present invention.
[0016] FIG. 3 is a top view of an electrode array 300 as may be
used with the current invention.
[0017] FIG. 4A is a side view of a pulse generator illustrating the
orientation of electrodes A, B and C disposed on the device
housing.
[0018] FIG. 4B is a side view of a pulse generator wherein at least
one of the electrodes extends away from the pulse generator via a
lead extension.
[0019] FIG. 4C is a side view of a pulse generator wherein at least
one of the electrodes is located at a proximal end of a lead.
[0020] FIG. 4D is a side view of a pulse generator wherein multiple
electrodes are located on an edge of a device housing.
[0021] FIG. 4E is a side view of yet another embodiment of a device
housing including an array of electrodes.
[0022] FIG. 4F is a side view of a device having a first
alternative shape.
[0023] FIG. 4G is a side view of a device having a second
alternative shape.
[0024] FIG. 5 is a timing diagram illustrating one embodiment of a
detection method used during bradyarrhythmia monitoring.
[0025] FIG. 6 is a block diagram illustrating an electrode array
positioned around a patient's side, with electrode coils extending
to the patient's back.
[0026] FIG. 7 is a block diagram illustrating an electrode array
positioned on patient's back in a more superior position.
[0027] FIG. 8 is a block diagram illustrating an electrode array
positioned around a patient's side, with coil electrodes extending
to the patient's back in a more posterior position.
[0028] FIG. 9 is a block diagram illustrating an electrode array
positioned on a patient's back, and a second subcutaneous disk
electrode positioned on a patient's chest.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0029] The current invention provides a system and method for
long-term monitoring for arrhythmias. The invention also provides
acute therapy delivery in the event an arrhythmia episode is
detected. According to one embodiment of the invention, a
subcutaneous pulse generator is provided. This pulse generator may
be a transthoracic Implantable Cardioversion/Defibrillator (ICD)
such as the GemDR.TM. Model 7271 or the GEM II VR Model 7229, both
commercially available from the Medtronic Corporation. The pulse
generator is coupled to at least one subcutaneously-placed
electrode or electrode array. Cardioversion/defibrillation pulses
and/or pacing pulses may be delivered between the electrode and the
can of the device, or between two subcutaneously-placed
electrodes.
[0030] FIG. 1 illustrates an implantable pulse generator 10 and an
exemplary associated lead system according to the current
invention. Pulse generator 10 includes a device housing 12, and is
further coupled to a lead 14 which may be implanted subcutaneously
in the left chest or on the back as discussed below. Lead 14 may
include a subcutaneous plate electrode 16, which may be any of the
various known subcutaneous plate electrodes. This type of
subcutaneous electrode may be located proximal the left ventricular
cavity on the patient's chest, on the patient's side or back, or
any other portion of the body appropriate for providing electrical
stimulation to the heart. Similar electrodes are disclosed in U.S.
Pat. Nos. 4,932,407, 5,261,400, and 5,292,338, all incorporated
herein by reference. During use, electrical stimulation may be
delivered to heart 18 between electrode 16 and device housing
12.
[0031] FIG. 2 is a block functional diagram of an illustrative
embodiment of a pulse generator that may be employed according to
the present invention. As illustrated, the device is embodied as a
microprocessor-based stimulator. However, other digital circuitry
embodiments and analog circuitry embodiments are also believed to
be within the scope of the invention. For example, devices having
general structures as illustrated in U.S. Pat. No. 5,251,624 issued
to Bocek et al., U.S. Pat. No. 5,209,229 issued to Gilli, U.S. Pat.
No. 4,407,288, issued to Langer et al, U.S. Pat. No. 5,662,688,
issued to Haefner et al., U.S. Pat. No. 5,855,593 issued to Olson
et al., U.S. Pat. No. 4,821,723, issued to Baker et al. or U.S.
Pat. No. 4,967,747, issued to Carroll et al., all incorporated
herein by reference in their entireties, may also be usefully
employed in conjunction with the present invention. FIG. 1 should
thus be considered illustrative, rather than limiting with regard
to the scope of the invention.
[0032] The primary elements of the apparatus illustrated in FIG. 2
are a microprocessor 100, read-only memory (ROM) 102, random-access
memory (RAM) 104, a digital controller 106, an input amplifier
circuit 110, two output circuits 108 and 109, and a
telemetry/programming unit 120. Read-only memory stores software
and/or firmware for the device, including the primary instruction
set defining the computations performed to derive the various
timing intervals employed by the device. RAM 104 generally serves
to store variable control parameters, such as programmed pacing
rate, programmed cardioversion/defibrillation intervals, pulse
widths, pulse amplitudes, and so forth which are programmed into
the device by the physician. Random-access memory 104 also stores
derived values, such as the stored time intervals separating
tachyarrhythmia pulses and the corresponding high-rate pacing
interval.
[0033] Controller 106 performs all of the basic control and timing
functions of the device. Controller 106 includes at least one
programmable timing counter, which is used to measure timing
intervals within the context of the current invention. On time-out
of the pacing escape interval or in response to a determination
that a cardioversion, defibrillation, or pacing pulse is to be
delivered, controller 106 triggers the appropriate output pulse
from high-voltage output stage 108, as discussed below. In one
embodiment, controller may also control the amplitude of pacing
pulses, as well as the energy associated with defibrillation and
cardioversion shocks.
[0034] Following generation of stimulus pulses, controller 106 may
be utilized to generate corresponding interrupts on control lines
132 to microprocessor 100, allowing it to perform any required
mathematical calculations, including all operations associated with
evaluation of return cycle times and selection of
anti-tachyarrhythmia therapies according to the present invention.
The timing/counter circuit in controller 106 also may control
timing intervals such as ventricular refractory periods, as is
known in the art. The time intervals may be determined by
programmable values stored in RAM 104, or values stored in ROM.
[0035] Controller 106 may also generate interrupts for
microprocessor 100 on the occurrence of sensed ventricular
depolarizations or beats. The timing and morphology of sensed
cardiac waveforms may also be used by microprocessor 100 to
determine whether an arrhythmia is occurring so that therapy may be
delivered as discussed further below.
[0036] Output stage 108 contains a high-output pulse generator
capable of generating cardioversion/defibrillation pulses.
According to the current invention, these pulses may be applied
between a subcutaneous electrode or electrode array coupled to
terminal 134 and the can of the pulse generator. Alternatively, the
pulses may be provided between an electrode coupled to terminal 134
and a second subcutaneous electrode or electrode array coupled to
terminal 136. Typically the high-output pulse generator includes
one or more high-voltage capacitors, a charging circuit, and a set
of switches to allow delivery of monophasic or biphasic
cardioversion or defibrillation pulses to the electrodes employed.
Output circuit 108 may further provide pacing pulses to the heart
under the control of controller 106. These pacing pulses, which may
be between 50 and 150 volts in amplitude, are provided via one or
more of the subcutaneously-located electrodes.
[0037] Sensing of ventricular depolarizations (beats) is
accomplished by input circuit 110, which is coupled to electrode
138 and one of electrodes 140 and 142. This circuitry may include
amplification, and noise detection and protection circuitry. In one
embodiment, signal sensing is disabled during periods of excessive
noise. Noise rejection filters and similar circuitry may also be
included, as is known in the art. Input circuit 110 provides
signals indicating both the occurrence of natural ventricular beats
and paced ventricular beats to the controller 106 via signal lines
128. Controller 106 provides signals indicative of the occurrence
of such ventricular beats to microprocessor 100 via signal lines
132, which may be in the form of interrupts. This allows the
microprocessor to perform any necessary calculations or to update
values stored in RAM 104.
[0038] Optionally included in the device may be one or more
subcutaneously or cutaneously-positioned physiologic sensors 148,
which may be any of the various known sensors for use in
conjunction with implantable stimulators. Any sensor of this type
known in the art may be employed within the context of the current
invention. Additionally, if desired, sensors positioned within the
cardiovascular system may be utilized. For example, sensor 148 may
be a hemodynamic sensor such as an impedance sensor as disclosed in
U.S. Pat. No. 4,865,036, issued to Chirife or a pressure sensor as
disclosed in U.S. Pat. No. 5,330,505, issued to Cohen, both of
which are incorporated herein by reference in their entireties.
Alternatively, sensor 148 may be a demand sensor for measuring
cardiac output parameters, such as an oxygen saturation sensor
disclosed in U.S. Pat. No. 5,176,137, issued to Erickson et al. or
a physical activity sensor as disclosed in U.S. Pat. No. 4,428,378,
issued to Anderson et al., both of which are incorporated herein by
reference in their entireties.
[0039] Sensor processing circuitry 146 transforms the sensor output
into digitized values for use in conjunction with detection and
treatment of arrhythmias. These digitized signals may be monitored
by controller 106 and microprocessor 100 and used alone or in
combination with sensed electrical cardiac signals to provide
diagnostic information used to determine the onset of an arrhythmia
or other cardiac conditions. These signals may also be used to
determine an optimal time for shock delivery. For example, an
impedance sensor may be used to determine when a patient has
exhaled so that shock delivery may occur when the lungs are
relatively deflated, since this may result in lower defibrillation
thresholds (DFTs). Sensor signals may also be stored in RAM 104 for
later diagnostic use.
[0040] External control of the implanted cardioverter/defibrillator
is accomplished via telemetry/control block 120 that controls
communication between the implanted cardioverter/pacemaker and an
external device 121. Any conventional programming/telemetry
circuitry is believed workable in the context of the present
invention. Information may be provided to the
cardioverter/pacemaker from the external device and passed to
controller 106 via control lines 130. Similarly, information from
the cardioverter/pacemaker may be provided to the telemetry block
120 via control lines 130 and thereafter transferred to the
external device.
[0041] In one embodiment, the external device 121 is a programmer
that may be utilized to diagnose patient conditions and to provide
any necessary re-programming functions. In another embodiment, the
external device may be a patient interface used to provide
information to, and/or receive commands from, the patient. For
example, the patient interface may be an externally-worn device
such as a wrist band that provides a warning to a patient
concerning an impending shock. The patient may be allowed to cancel
the shock if the patient believes the shock was prescribed
erroneously. This may be accomplished, for example, by pushing a
button, or issuing a voice command. The patient interface may
provide additional information, including a warning that medical
attention is required, and/or an indication concerning a low power
source. If desired, the patient interface could automatically place
an emergency telephone call via a wireless link, and/or could issue
patient positional information via a global positioning system
(GPS).
[0042] Any other system and method used for the detection and
treatment of tachyarrhythmias may be incorporated within the
current invention. Such systems and methods are described in U.S.
Pat. Nos. 5,849,031, 5,193,535, and 5,224,475. In one embodiment,
the system may include "tiered therapies" for delivering treatment
based on the type of arrhythmia detected by the device. According
to this approach, arrhythmias are differentiated by analyzing the
rate and morphology of a sensed cardiac signal. Those arrhythmias
considered less dangerous such as ventricular tachycardias (VTs)
may be treated by delivering a series of low-power, relatively
high-rate, pacing pulses to the heart. This therapy is often
referred to as anti-tachyarrhythmia pacing therapy (ATP). In
contrast, more perilous arrhythmias such as ventricular
fibrillations (VFs) may be treated by immediately delivering more
aggressive shock therapy. This type of system is described in U.S.
Pat. Nos. 5,193,536, issued to Mehra, 5,458,619 to Olson, 6,167,308
to DeGroot, and 6,178,350 to Olson, et al., all incorporated herein
by reference. Within the context of the current invention, ATP
therapy is delivered using one or more subcutaneous electrodes in
the manner discussed below. In one embodiment of the invention, a
separate electrode may be provided within a subcutaneous electrode
array for delivering the ATP therapy.
[0043] According to another aspect of the inventive system, the
device may include means for decreasing discomfort associated with
high-voltage shocks. It is well known that high-voltage shocks are
painful for the patient. This discomfort can be minimized by
decreasing the amount of energy associated with the shock. One
mechanism for accomplishing this involves delivering a pre-shock
pulse waveform, as described in U.S. Pat. No. 5,366,485 issued to
Kroll. In one embodiment, this type of waveform could be a
programmable feature that is controlled by controller 106 via
parameters stored in RAM 104.
[0044] In yet another embodiment of the invention, the implantable
device includes a drug pump 150 as shown in FIG. 2. This pump may
be used to deliver a biologically-active agent such as an analgesic
drug to the patient prior to shock delivery to reduce discomfort.
The drug delivery may be accomplished via a catheter 152 that is
implanted subcutaneously or within the patient's vascular system. A
similar system is described in U.S. Pat. No. 5,893,881 to Elsberry,
incorporated herein by reference. Alternatively, or in addition,
this pump may deliver an agent such as D-salotol, Procainamide or
Quinidine to reduce the defibrillation threshold of the required
shock, thereby serving to reduce pain. In a more complex
embodiment, two separate drug pumps might be employed to allow
delivery of the threshold reducing agent alone or in conjunction
with an analgesic.
[0045] Pain control may also be accomplished by providing spinal
cord stimulation (SCS). For example, the Medtronic Itrel II
implantable neurostimulation system is widely implanted for
treatment and alleviation of intractable pain. Clinical reports and
studies have shown that SCS can reduce the discomfort associated
with high-voltage shocks. This type of system may utilize a lead
system of the type described in U.S. Pat. No. 5,119,832, 5,255,691
or 5,360,441. These leads, as well as the Medtronic Model 3487A or
3888 leads, include a plurality of spaced apart distal electrodes
that are adapted to be placed in the epidural space adjacent to
spinal segments T1-T6 to provide SCS stimulation for pain
reduction. In this embodiment, initial detection and verification
of fibrillation is followed by epidural neural stimulation to
produce paraesthesia. Thereafter, a shock may be delivered. Should
the cardioversion shock prove unsuccessful, the process is repeated
until the cardioversion therapies prove successful or are
exhausted. When successful defibrillation is confirmed, the
epidural SCS stimulation is halted.
[0046] In addition to SCS therapy, other types of stimulation such
as Transcutaneous Neurological Stimulators (TENs) may be provided
via electrode patches placed on the surface of a patient's body.
Subcutaneously-placed electrodes may also be positioned in the
T1-T6 area or in other areas of the body to deliver subcutaneous
electrical stimulation to reduce pain. In the context of the
current invention, the subcutaneously-placed electrode arrays may
include specialized electrodes to deliver the subcutaneous
stimulation prior to shock delivery to reduce patient
discomfort.
[0047] Turning now to a more detailed discussion of the electrode
systems used with the current invention, the electrode may be of a
type shown in FIG. 1. Alternatively, this electrode array may be
similar to the Model 6996 SQ commercially-available from the
Medtronic Corporation.
[0048] FIG. 3A is a top view of an electrode array 300 as may be
used with the current invention. Electrode array 300 is coupled to
distal end of lead 302. The array includes multiple finger-like
structures 304A through 304E. More or fewer of these finger-like
structures may be provided. Each finger includes a defibrillation
coil electrode shown as 306A through 306E. When connector 308 is
coupled to a pulse generator, a cardioversion/defibrillation pulse
may be provided via one or more of the electrodes 306A through
306E. In one embodiment, the electrodes that are activated may be
selected via a switch provided by the lead.
[0049] Electrode array 300 may include one or more sensing
electrodes such as electrode 310 provided for sensing cardiac
signals. This electrode may be used in a unipolar mode wherein
signals are sensed between an electrode and the device housing.
Alternatively, sensing may be performed between electrode 310 and
one of the coil electrodes 306 or another sensing electrode.
[0050] In use, the fingers 304 of electrode array are positioned
under the skin on a patient's chest, side, back, or any other point
of the body as required. Insulative spacers may be located between
the fingers, if desired, to prevent the coil electrodes 306A-E from
shorting together. If desired, multiple such electrode arrays may
be used in conjunction with the current invention. For example, one
electrode array may be positioned on the chest over the left
ventricle, while another electrode array is positioned behind the
left ventricle on the back. Cardioversion/defibrillation shocks or
pacing pulses may be delivered between the two electrode arrays.
Alternatively, electrical stimulation may be provided between one
or more electrode arrays and the device housing. As noted above,
sensing of the patient's cardiac signals may be performed between a
subcutaneous electrode array and the device can.
[0051] FIG. 3B is a top view of an alternative embodiment of
electrode array, shown as array 300A. In this embodiment, fingers
320A through 320C have a serpentine shape. More or fewer such
fingers may be provided. This shaped array directs current provided
by coiled electrodes 322A through 322C through a larger tissue
area, thereby decreasing defibrillation thresholds in some
instances. This embodiment may also include one or more sensing
electrodes 322. Any other shape may be utilized for the electrode
array.
[0052] The electrodes used with the current invention may be any of
the electrode types now known or known in the future for
subcutaneous delivery of electrical stimulation. Such electrodes
may be coated with a biologically-active agent such as
glucocorticoids (e.g. dexamethasone, beclamethasone), heparin,
hirudin, tocopherol, angiopeptin, aspirin, ACE inhibitors, growth
factors, oligonucleotides, and, more generally, antiplatelet
agents, anticoagulant agents, antimitotic agents, antioxidants,
antimetabolite agents, and anti-inflammatory. Such coating may be
useful to prevent excessive tissue in-growth. Such electrodes may
further include a low-polarization coating such as TiN.
Alternatively, the electrodes may be coated with an antibiotic or
other biologically-active agent used to prevent infections and
inflammation.
[0053] In another embodiment, the can itself may include a
subcutaneous electrode array of the type described in U.S. Pat. No.
5,331,966, which is incorporated herein by reference in its
entirety. This type of array, which is provided by the Medtronic
Model 9526 Reveal Plus Implantable Loop Recorder, includes at least
two sensing electrodes on the can for sensing of cardiac signals.
In all such systems, it will be understood that the electrodes A,
B, C on the surface of the housing are electrically isolated from
one another and the conductive surface of the pulse generator
housing 10 through suitable insulating bands and electrical
feedthroughs as described in U.S. Pat. No. 4,310,000, incorporated
herein by reference. Examples of possible electrode orientations
and configurations of a three electrode system comprising the
electrodes are set forth in FIGS. 4A through 4G.
[0054] FIG. 4A is a side view of a pulse generator illustrating the
orientation of orthogonally-disposed electrodes A, B and C with two
electrodes on the connector block 418 and one electrode on the
pulse generator case 410. The spacing of the electrodes A, B and C
on each of the illustrated orientations of FIG. 4A through 4G may
be on the order of about one inch but can be larger or smaller
depending on the exact size of the device. Smaller devices and
closer spacing will require greater amplification.
[0055] FIG. 4B is a side view of a pulse generator wherein at least
one of the electrodes extends away from the pulse generator by a
lead extension member 420 to achieve a greater inter-electrode
spacing, if desirable.
[0056] FIG. 4C is a side view of a pulse generator wherein at least
one of the electrodes 230 is located at a proximal end of a lead
432, which may be a lead coupled at a distal end to a subcutaneous
electrode or electrode array.
[0057] FIG. 4D is a side view of a pulse generator wherein multiple
electrodes are located of an edge of a device housing. It will be
understood that the electrodes placed on the edge of the pulse
generator case could constitute insulated pins of feedthroughs
extending through the wall of the case. As illustrated in FIGS. 4C
and 4D, the relative orientation of the electrodes may vary
somewhat from the orthogonal orientation depicted in FIGS. 4A and
4B.
[0058] FIG. 4E is a side view of yet another embodiment of a device
housing including an array of electrodes.
[0059] FIG. 4F is a side view of a device having a first
alternative "T" shape. This shape allows at least two of the
electrodes A and C to be positioned at a maximum distance from one
another, optimizing signal reception between the two
electrodes.
[0060] FIG. 4G is a side view of a device having a second
alternative "boomerang" shape which may be used to optimize
electrode positioning so that better signal reception is
achieved.
[0061] It will be appreciated that the shapes, sizes, and electrode
configurations of the devices shown in FIGS. 4A through 4G are
exemplary only, and any other shape, size or electrode
configuration imaginable is within the scope of the current
invention. As will be appreciated by those skilled in the art,
those configurations allowing for greater inter-electrode distances
will generally provide better signal reception. As such, it is
usually desirable to provide electrodes on at least two quadrants
of the device.
[0062] As described above, in one embodiment, the current invention
provides a pulse generator coupled to one or more subcutaneous
electrodes or electrode arrays. The electrodes provide electrical
stimulation to a patient based on sensed cardiac signals. The
sensed signals may be obtained using a selected pair of sensing
electrodes, which may reside on one or more of the leads coupled to
pulse generator 10, or on the device housing itself, as indicated
by FIGS. 4A through 4G.
[0063] Although all of the foregoing examples illustrate a housing
including three electrodes, more than three electrodes may be
provided. In one embodiment, four or more electrodes may be coupled
or adjacent to the device, and the physician may select which of
the electrodes will be activated for a given patient. In one
embodiment, cardiac signals are sensed between a selected pair of
the electrodes based on a signal optimization method. One
embodiment of this type of method is disclosed in U.S. patent
application Ser. No. 09/721,275 filed Nov. 22, 2000, now U.S. Pat.
No. 6,505,067, and incorporated herein by reference in its
entirety.
[0064] Regardless of which one or more electrodes or electrode
pairs are selected for monitoring purposes, the sensed cardiac
signals may be analyzed to detect the presence of an arrhythmia.
The arrhythmia detection system and method could be, for example,
that employed by the Medtronic Model 9526 Reveal Plus device
commercially available from Medtronic Corporation. Alternatively, a
detection method such as described in U.S. Pat. No. 5,354,316 or
5,730,142 could be employed. If an arrhythmia is detected,
appropriate therapy may be administered. As described above, one
embodiment of the invention includes at least one subcutaneous
defibrillation electrode array. If monitoring indicates the
presence of a tachyarrhythmia or ventricular fibrillation, a
high-voltage shock may be delivered between one or more
subcutaneous defibrillation electrode(s) and a shocking surface of
the can, or one or more electrodes on the can. The shock may
alternatively be delivered between multiple defibrillation
electrodes. The monitoring system would then determine whether the
arrhythmia or fibrillation has terminated. If not, another shock
will be administered. This therapy will continue until normal
rhythm has been restored. In one embodiment, signals indicative of
sensed cardiac waveforms may be stored in RAM 104 and later
transferred to an external device via a communication system such
as telemetry circuitry 120.
[0065] According to another aspect of the invention, the sensing
electrodes may be placed on a surface of the can that is different
from the shocking surface of the can. Preferably, the shocking
surface is adjacent to muscle tissue, whereas the sensing
electrodes are placed adjacent to subcutaneous tissue.
[0066] As described above, therapy for bradyarrhythmia may be
provided in addition to, or instead of, the tachyarrhythmia
therapy. In this embodiment, output circuit 108 includes the
capability to deliver lower-voltage pulses for transthoracic pacing
therapy for bradyarrhythmias, as described above in reference to
FIG. 1. These lower-voltage pulses could be on the order of between
50 and 150 volts, for example. In one embodiment, these pulses have
an amplitude of around 100 volts. Monitoring for a bradyarrhythmia
could be accomplished using the sensing electrodes discussed above.
For example, the device may be programmed to detect a period of
asystole that is greater than a predetermined period, such as three
seconds. When a period greater than this length is detected, the
output circuit of the device is charged to the pacing voltage. A
transthoracic, monophasic pacing pulse may then be delivered
between the shocking surface of the can and a subcutaneous
electrode or electrode array, or between two such electrode or
electrode arrays. The sensing electrodes monitor the cardiac
waveform to ensure that the pacing pulse is only delivered during
predetermined periods of the cardiac cycle. For example, delivery
of the pulse should not occur during the occurrence of a
T-wave.
[0067] Following delivery of a pacing pulse, the output circuit
begins charging in preparation for delivery of another pulse while
monitoring of the cardiac signals continues. For example,
monitoring of the patient's heart rate may be performed to
determine whether it is less than some predetermined rate such as
forty beats per minute. If so, another transthoracic, monophasic
pacing pulse is delivered. This process of pulse delivery followed
by charging of the output circuit is repeated until an intrinsic
heart rate of greater than the predetermined minimum rate is
detected.
[0068] The transthoracic pacing provided by the current invention
will likely be uncomfortable for the patient. Thus, this function
is not intended to provide chronic therapy. Once therapy delivery
has occurred for a bradyarrhythmic episode, a more traditional
device should be implanted to provide long-term therapy. In one
embodiment, the device may record whether any ACC/AHA class I
pacing indications has been met by the detected bradyarrhythmic
event. For example, if asystole greater than three seconds and/or
an escape rate less than forty beats per minute has been detected,
these indications are recorded. This data may then be transferred
to an external device to generate a physician notification. Other
actions may be taken, such as sounding an alarm, for example.
[0069] FIG. 5 is a timing diagram illustrating one embodiment of a
detection method used during bradyarrhythmia monitoring. If
asystole is detected for greater than, or equal to, a first
predetermined time period 500 such as three seconds, charging of
output capacitors occurs to a predetermined voltage such as 100
volts. This charging occurs during time period 502. At time 504, a
first pacing pulse is delivered, and recharging of the capacitors
begins at time 506. Monitoring for an escape rate longer than a
predetermined rate occurs during time period 508, which in one
embodiment is 1500 milliseconds. Thereafter, a second pacing pulse
is delivered at time 510 if an intrinsic beat does not occur. At
time 512, recharging occurs, and monitoring for the escape rate
again proceeds. If such therapy is not discontinued because of the
re-occurrence of the patient's intrinsic normal heart beat, the
patient will be required to seek immediate emergency attention,
since such therapy will be uncomfortable for the patient. The times
utilized to provide therapy as shown in FIG. 5 may be
programmable.
[0070] It may be appreciated from the foregoing discussion that
providing repeated therapy, and in particular, repeated
high-voltage pacing stimulation, will deplete a system power source
such as a battery relatively quickly. Therefore, in one embodiment,
the power source is rechargeable. For example, the pulse generator
may include rechargeable nickel cadmium batteries. Such batteries
may be recharged over a period of several hours using a radio
frequency link. Alternatively, a rechargeable capacitive energy
source such as disclosed in U.S. Pat. No. 4,408,607 to Maurer may
be utilized. In yet another embodiment, the pulse generator may
include both an implanted radio frequency (RF) receiving unit
(receiver) incorporating a back-up rechargeable power supply and a
non-rechargeable battery, as described in U.S. Pat. No. 5,733,313
incorporated herein by reference. The rechargeable power supply is
charged by an external RF transmitting unit worn by the patient.
Any other type of rechargeable power supply known in the art for
use with implantable medical devices may be used in the
alternative.
[0071] In one embodiment, the power source selected for use in the
current invention is capable of delivering up to ten therapy
shocks, with additional power being available for threshold
testing. However, compromises will exist since the power source
capacity will determine device size. In yet another embodiment, the
device is a 75-joule device having a volume of no more than 75
cubic centimeters. Preferably, the device includes a power source
and associated charge circuitry that provides a charge time of no
more than three minutes during the useful life of the device. In
another embodiment, the device should be capable of delivering a
35-joule shock after a one-minute charge time over the useful life
of the device.
[0072] FIGS. 6 through 9 illustrate various exemplary electrode
configurations as may be used with the current invention.
[0073] FIG. 6 is a block diagram illustrating an electrode array
300 positioned around a patient's side, with fingers 304 extending
to the patient's back. Electrical stimulation is delivered between
the electrode array and the device can 10, which is positioned over
the left ventricle. In one embodiment, sensing electrodes 600 are
positioned substantially facing toward subcutaneous tissue.
[0074] FIG. 7 is a block diagram illustrating an electrode array
positioned on a patient's back in a more superior position than is
shown in FIG. 6. Electrical stimulation is delivered between the
electrode array and the device can 10, which is positioned in the
abdominal cavity.
[0075] FIG. 8 is a block diagram illustrating an electrode array
positioned around a patient's side, with fingers 304 extending to
the patient's back in a more posterior position than is shown in
FIG. 6 or 7. Electrical stimulation is delivered between the
electrode array and the device can, which is positioned proximal
the right side of the heart.
[0076] FIG. 9 is a block diagram illustrating an electrode array
with fingers 304 positioned on a patient's back, and a second
subcutaneous disk electrode 306 such as electrode 16 (FIG. 1)
positioned on a patient's chest. Electrical stimulation may be
delivered from one of electrodes 304 or 306 to the other electrode
and/or the device housing 10. Alternatively, stimulation may be
provided from both electrode assemblies to the device housing. In
yet another embodiment, one or more additional subcutaneous
electrode or electrode arrays may be coupled to the device for
providing high-voltage shocks, for sensing cardiac signals, and/or
for delivering SCS, TENs, or subcutaneous low-voltage stimulation
as discussed above. If desired, the device may include programmable
logic to selectably enable those electrode and/or electrode arrays
to be activated during a given therapy delivery session. For
example, switching networks may be incorporated into output
circuitry 108 and/or input circuitry 110 (FIG. 2) such that this
type of programmably selected therapy may be provided. In one
instance, it may be desirable to activate one electrode
configuration to optimize sensing of cardiac signals, while
utilizing another configuration to provide optimal therapy
delivery.
[0077] The above-described inventive system and method provides a
therapy that avoids the risks of transvenous lead delivery. Such a
system may be used for patients that are at-risk for arrhythmias,
but have not yet experienced a confirmed arrhythmic episode. The
device may therefore provide a needed long-term monitoring
function, as well as any interventional therapy that is required.
Preferably, after an episode is detected and therapy is delivered
for a first time, the current system would be replaced with a more
conventional implantable defibrillator.
[0078] As discussed above, the inventive system provides many
important benefits over other conventional systems for some
patients. The procedure is faster because there is no need for
venous or epicardial access, and therefore the procedure is less
invasive, and would not require procedures needing sophisticated
surgical facilities and devices. Additionally, the implant
procedure can be accomplished without exposing the patient to
potentially-harmful radiation that accompanies fluoroscopy. The
risk of infection is reduced, and the procedure may be provided to
patients that are contraindicated for a more traditional device.
Additionally, one hundred percent patient compliance is achieved,
and the system is more comfortable than externally-worn devices.
The system is well suited for pediatric use, since the placement of
the electrodes allows lead length to be easily extended as a
patient grows. The system may also be employed in parts of the
world where more long-term therapies and treatments are not
available, and where sophisticated surgical skills and equipment
cannot be readily obtained.
* * * * *