Source: https://patents.google.com/patent/US7149575B2/en
Timestamp: 2019-05-26 17:58:24
Document Index: 252381840

Matched Legal Cases: ['art.\n3', 'art.\n14', 'art.\n24', 'art.\n26', 'art.\n38', 'art 1']

US7149575B2 - Subcutaneous cardiac stimulator device having an anteriorly positioned electrode - Google Patents
Subcutaneous cardiac stimulator device having an anteriorly positioned electrode Download PDF
US7149575B2
US7149575B2 US10/150,434 US15043402A US7149575B2 US 7149575 B2 US7149575 B2 US 7149575B2 US 15043402 A US15043402 A US 15043402A US 7149575 B2 US7149575 B2 US 7149575B2
Active, expires 2022-01-31
US10/150,434
US20050267537A9 (en
US20030036778A1 (en
Paul Erlinger
2001-08-27 Priority to US09/940,599 priority patent/US6950705B2/en
2001-11-05 Priority to US10/011,956 priority patent/US7120495B2/en
2002-05-17 Application filed by Cameron Health Inc filed Critical Cameron Health Inc
2002-05-17 Priority to US10/150,434 priority patent/US7149575B2/en
2002-10-30 Assigned to CAMERON HEALTH, INC. reassignment CAMERON HEALTH, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BARDY, GUST H, ERLINGER, PAUL, OSTROFF, ALAN H
2003-02-20 Publication of US20030036778A1 publication Critical patent/US20030036778A1/en
2005-12-01 Publication of US20050267537A9 publication Critical patent/US20050267537A9/en
2006-12-12 Publication of US7149575B2 publication Critical patent/US7149575B2/en
2012-12-28 Assigned to CAMERON HEALTH, INC. reassignment CAMERON HEALTH, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: OSTROFF, ALAN H.
2012-12-28 Assigned to CAMERON HEALTH, INC. reassignment CAMERON HEALTH, INC. AFFIRMATION OF ASSIGNMENT OF PAUL ERLINGER FOR US 7,149,575 AND RELATED CASES Assignors: ERLINGER, PAUL
2022-01-31 Adjusted expiration legal-status Critical
This application is a continuation-in-part of application Ser. No. 10/011,956, filed Nov. 5, 2001, which is a continuation-in-part of application Ser. No. 09/940,599, filed Aug. 27, 2001, now U.S. Pat. No. 6,950,705, which is a continuation-in-part of application Ser. No. 09/663,607, filed Sep. 18, 2000, now U.S. Pat. No. 6,721,597, and application Ser. No. 09/663,606, filed Sep. 18, 2000, now U.S. Pat. No. 6,647,292.
The present invention relates to a device and method for performing electrical cardiac stimulation, including: cardioversion, defibrillation and, optionally, pacing of the heart using subcutaneous electrodes. More specifically, the present invention relates to implantable cardioverter-defibrillator having at least one subcutaneous electrode, wherein the electrode is positioned generally in the frontal portion of the thorax, thereby creating a substantially uniform electric field across a patient's heart.
The heart is a mechanical pump that is stimulated by electrical impulses. The mechanical action of the heart results in blood flow through a person's body. During a normal heartbeat, the right atrium (RA) of the heart fills with blood from veins within the body. The RA then contracts and blood is moved into the heart's right ventricle (RV). When the RV contracts, blood held within the RV is then pumped into the lungs. Blood returning from the lungs moves into the heart's left atrium (LA) and, after LA contraction, is pumped into the heart's left ventricle (LV). Finally, with the contraction of the left ventricle, blood from the LV is pumped throughout the body. Four heart valves keep the blood flowing in the proper directions during this process.
Tachycardia often progresses to cardiac fibrillation, a condition in which synchronization of cell depolarizations is lost, and instead, there are chaotic, almost random electrical stimulations of the heart. Tachycardia often results from isehemic heart disease in which local myocardium performance is compromised and coordinated contraction of heart tissue is lost which leads to a loss of blood flow to the rest of the body. If fibrillation is left untreated, brain death can occur within several minutes, followed by complete death several minutes later.
There are two kinds of conventional cardioversion/defibrillation systems: internal cardioversion/defibrillation devices, or ICDs, and external automatic defibrillators, or AEDs. An ICD generally includes a housing containing a pulse generator, electrodes and leads connecting the electrodes to the housing. Traditionally, the electrodes of the ICD are implanted transvenously in the cardiac chambers, or alternatively, are attached to the external walls of the heart. Various structures of these types are disclosed in U.S. Pat. Nos. 4,603,705, 4,693,253, 4,944,300, 5,105,810, 4,567,900 and 5,618,287, all incorporated herein by reference.
In addition, U.S. Pat. Nos. 5,342,407 and 5,603,732, incorporated herein by reference, disclose an ICD with a pulse generator implanted in the abdomen and two electrodes. In one embodiment (FIG. 22), the two electrodes 188,190 are implanted subcutaneously and disposed in the thoracic region, outside of the ribs and on opposite sides of the heart. In another embodiment (FIG. 23), one electrode 206 is attached to the epicardial tissues and another electrode 200 is disposed inside the rib cage. In a third embodiment (FIG. 24), one electrode 208 is disposed away from the heart and the other electrode 210 is disposed inside the right ventricle. This system is very complicated and it is difficult to implant surgically.
One embodiment of the present invention provides a subcutaneous cardiac stimulator device adapted to generate an electric field across the heart using at least one subcutaneous electrode positioned at a location selected to minimize the degree of surgical intervention.
The present invention provides a device which, in one embodiment, has a curvilinear electrode that is positioned subcutaneously in the frontal or chest area of the body such that it overlaps a peripheral region of the heart. The term ‘curvilinear electrode’ is used herein to designate an electrode baying an elongated configuration with a substantially uniform cross-section along its length and having a cross-sectional diameter that is much smaller than its length by at least an order of magnitude.
FIG. 1 shows a block diagram of a subcutaneous cardiac device having one or two subcutaneous electrodes constructed in accordance with this invention;
FIGS. 14A–14D show frontal view configuration of an active housing with an electrode positioned on either side of the sternum;
FIGS. 15A–15D show an active housing, a segmented electrode and various stimulations applied therebetween;
Referring now to the drawings, FIG. 1 shows an implantable cardiac device 10 constructed in accordance with one embodiment of the present invention. The device 10 includes a housing 12 containing a pulse generator (not shown), an electrode 14 and a lead 16. The electrode 14 is connected to the pulse generator through a header 18 disposed on the housing 12.
The housing 12 can be a conventional defibrillator housing used for programmable electronic circuitry that senses intrinsic cardiac activity and generates antiarrhythmic therapy (defibrillation shocks and/or pacing pulses) in the usual manner. To facilitate implantation, the circuitry, contained within the housing can also induce ventricular fibrillation for the purposes of resting the defibrillation threshold (DFT). DFT testing can be accomplished by delivering a shock during the vulnerable period of the cardiac cycle (T-wave) or by rapid pacing approximately 20 to 100 Hz for several seconds or by the application of direct current for several seconds or by the alternating current between 20 and 100 Hz for several seconds.
The housing 12 generally comprises a footprint in the range of 30–50 cm2 and may be about 1.2 cm deep.
Electrode 14 is a subcutaneous electrode that is positioned under the skin and refrains from directly contacting the patient's heart. The subcutaneous electrode 14 may embody numerous shapes and sizes. For example, the electrode 14 may be planar, or may have a cross section of other shapes, e.g. circular. The electrode could be made from a coil, it could be braided or woven, or could be made by other similar means. In particular embodiments of the present invention, the electrode 14 is a curvilinear electrode. The term ‘curvilinear electrode’ is used herein to designate an electrode having an elongated rod-shaped configuration which could be straight or could be somewhat curved, and have a substantially uniform cross-section along its length and having a cross-sectional diameter that is much smaller than its length by at least an order of magnitude. Generally, the electrode 14 has a length of about 2–10 cm and a diameter of about 1–5 mm.
The tissues bounded by these four electrode positions are generally fatty tissues and/or comprise bony material—both having a relatively high electrical resistivity as compared to the resistivity of the cardiac tissues. Positioning the electrodes in the frontal or anterior chest area allow the naturally forming resistivity differential to better force electric current through the patient's heart, rather than shunting into surrounding tissue.
In the configurations described so far, an electric field is generated between a first electrode disposed horizontally or vertically along a front portion of the rib cage and either the housing or a second electrode disposed on an opposite side of the heart. However, other configurations may also be used in which the second electrode or housing is disposed along the front portion of the rib cage at a right angle with respect to a longitudinal axis of the first electrode. One such configuration is shown in FIGS. 10A and 10B. In this configuration, the first electrode 14A is disposed in the septum position A and the housing 12 is disposed in the inframammary position Y. As seen in FIGS. 10C and 10D (FIG. 10D being a top view), when a voltage is applied to between these two elements, an electric field is generated through the heart. However, the linear distance between the two elements generating the field has to be sufficiently large to insure that a substantial portion of the electric current passes through the heart and is not shunted directly between the first electrode and the housing. For this reason, the electrode in FIGS. 10A and 10B is shorter than the electrodes in the previous embodiments. For example, the electrode 14A may have half the length of the other electrodes 14, 14′. In addition, the electrode 14A is positioned as far as possible from the housing 12 while still being superimposed on a peripheral region of the heart.
In FIG. 13A the active housing is in the side position and the electrodes 14A and 14A′ are in the upper and lower positions, respectively. Similar to FIG. 12A, the active housing 12 may generate at least three distinct electric fields—with electrode 14A alone, with electrode 14A′ alone, and with both electrode 14A and electrode 14A′.
1. A method of implanting a cardiac device, the method comprising:
implanting an electrode subcutaneously within a frontal region of a patient's chest; and
implanting an active housing within the frontal region of the patient's chest, the housing and the subcutaneous electrode cooperating to provide selective antiarrhythmic, sensing and induction therapy between the housing and the subcutaneous electrode, wherein all electrodes are implanted subcutaneously.
2. The method of claim 1, wherein the subcutaneous electrode is positioned within the frontal region of the patient's chest such that is selected to overlap a peripheral region of a patient's heart.
3. The method of claim 1, wherein the subcutaneous electrode is substantially curvilinear in shape.
4. The method of claim 1, further comprising implanting a second subcutaneous electrode.
5. The method of claim 4, wherein the second subcutaneous electrode is positioned within the frontal region of the patient's chest.
6. The method of claim 4, wherein the second subcutaneous electrode is positioned within the lateral region of the patient's chest.
7. The method of claim 4, wherein the housing is active, further comprising applying selective antiarrhythmic, sensing and induction therapy between the subcutaneous electrode, the housing, and the second subcutaneous electrode.
8. The method of claim 4, wherein the housing is active, further providing selective antiarrhythmic, sensing and induction therapy between the subcutaneous electrode and the housing and selective antiarrhythmic, sensing and induction therapy between the second subcutaneous electrode and the housing.
9. The method of claim 4, wherein the subcutaneous electrode further comprises a first part and a second part, wherein the subcutaneous electrode senses intrinsic cardiac activity between the first subcutaneous electrode pan and the second subcutaneous electrode.
10. A method of implanting a cardiac device, the method comprising:
implanting a housing within the frontal region of the patient's chest, the housing and the subcutaneous electrode cooperating to provide selective antiarrhythmic, sensing and induction therapy, wherein all electrodes are implanted subcutaneously;
wherein the subcutaneous electrode further comprises a first part and a second part, wherein the subcutaneous electrode senses intrinsic cardiac activity between the first subcutaneous electrode part and the housing and applies shocks between the subcutaneous electrode and the housing.
11. The method of claim 10, wherein the subcutaneous electrode includes a first segment and a second segment, the first segment and the second segment being collinear.
12. The method of claim 10, wherein the subcutaneous electrode includes a first element and a second element, the first element and the second element being spaced from each other and substantially parallel.
13. A method of implanting a cardiac device, the method comprising:
implanting a housing within the frontal region of the patient's chest, the housing and the subcutaneous electrode cooperating to provide selective antiarrhythmic, sensing and induction therapy, wherein all electrodes are implanted subcutaneously; wherein the subcutaneous electrode further comprises a first part and a second part, wherein the subcutaneous electrode senses intrinsic cardiac activity between the first subcutaneous electrode part and the second subcutaneous electrode part.
14. The method of claim 13, further comprising implanting a second subcutaneous electrode, wherein the housing is inactive, further comprising applying selective antiarrhythmic, sensing and induction therapy between the subcutaneous electrode and the second subcutaneous electrode.
15. A method of applying therapy to a patient's heart comprising:
implanting at least a first electrode in a first subcutaneous electrode position within a patient's chest;
implanting a housing within the patient's chest;
selectively applying antiarrhythmic, sensing and induction therapy between the first subcutaneous electrode and the housing;
wherein the first subcutaneous electrode position is disposed in a frontal region of the patient's chest, the first subcutaneous electrode position being selected from one of a sternum, a lateral, an upper and a lower position;
wherein all electrodes are implanted subcutaneously.
16. The method of claim 15, wherein the housing is implanted in a position that is selected fern our of a side, an inframammary and a pectoral position.
17. The method of claim 15, wherein the first subcutaneous electrode position is selected on one side of the patient's heart and the housing position is selected on the other side of the heart in the frontal region of the patient.
18. The method of claim 15, wherein the first subcutaneous electrode position and the housing positions are selected perpendicular to each other.
19. The method of claim 15, the method further comprising implanting a second electrode in a second subcutaneous electrode position in the frontal region of the patient.
20. The method of claim 19, wherein the first subcutaneous electrode position and the second subcutaneous electrode position are selected on opposite sides of the patient's heart in the frontal region of the patient.
21. The method of claim 19, wherein selective antiarrhythmic, sensing and induction therapy is applied between the first electrode and the second electrode.
22. The method of claim 19, wherein selective antiarrhythmic, sensing and induction therapy is applied between the first electrode and the housing and selective antiarrhythmic, sensing and induction therapy is applied between the second electrode and the housing.
23. A method of implanting a cardiac device, the method comprising:
implanting an electrode subcutaneously within a frontal region of a patient's chest, the subcutaneous electrode including a first part and a second part; and
implanting an active housing within the frontal region of the patient's chest, the housing and the subcutaneous electrode cooperating to provide selective antiarrhythmic, sensing and induction therapy between the housing and the subcutaneous electrode, wherein the subcutaneous electrode senses intrinsic cardiac activity between the first subcutaneous electrode part and one of the housing or the second subcutaneous electrode part.
24. A cardiac device adapted to provide therapy to a patient with a frontal region defined in the chest area, said cardiac device comprising:
a subcutaneous electrode adapted to be disposed in the frontal region;
an active housing; and
a lead electrically coupling the subcutaneous electrode and the housing, wherein the subcutaneous electrode and active housing are adapted to generate an electrical field therebetween, the subcutaneous electrode and the housing configured to cooperate in providing selective antiarrhythmic, sensing and induction therapy between the housing and the subcutaneous electrode; wherein all electrodes are implanted subcutaneously.
25. The device of claim 24, wherein the subcutaneous electrode is adapted to be implanted in the frontal region of the patient's chest in a position selected to overlap a peripheral region of the heart.
26. The device of claim 24, wherein the subcutaneous electrode is adapted to be implanted in one of a sternum, a lateral, an upper and at lower position selected in the frontal region.
27. The device of claim 24, wherein the housing is adapted to be implanted in one of a side, an inframammary and a pectoral position.
28. The device of claim 24, further comprising a second subcutaneous electrode.
29. The device of claim 28, wherein the second subcutaneous electrode is configured to be positioned within the frontal region of the patient's chest.
30. The device of claim 28, wherein the second subcutaneous electrode is configured to be positioned within the lateral region of the patient's chest.
31. The device of claim 28, wherein the housing is active and wherein the subcutaneous electrode and the second subcutaneous electrode are configured to apply selective antiarrhythmic, sensing and induction therapy between the subcutaneous electrode and the second subcutaneous electrode.
32. The device of claim 28, wherein the housing and the second subcutaneous electrode are configured to apply selective antiarrhythmic, sensing and induction therapy between the second subcutaneous electrode and the housing.
33. The device of claim 28, wherein the subcutaneous electrode further comprises a first part and a second part, wherein the subcutaneous electrode senses intrinsic cardiac activity between the first subcutaneous electrode part and the second subcutaneous electrode.
34. A cardiac device adapted to provide therapy to a patient with a frontal region defined in the chest area, said cardiac device comprising:
a lead electrically coupling the subcutaneous electrode and the housing to generate an electrical field therebetween, the subcutaneous electrode and the housing providing selective antiarrhythmic, sensing and induction therapy; wherein all electrodes are implanted subcutaneously;
35. The device of claim 34, wherein the subcutaneous electrode includes a first segment and a second segment, the first segment and the second segment being collinear.
36. The device of claim 34, wherein the subcutaneous electrode includes a first element and a second element, the first element and the second element being spaced from each other and substantially parallel.
37. A cardiac device adapted to provide therapy to a patient with a frontal region defined in the chest area, said cardiac device comprising:
wherein the subcutaneous electrode further comprises a first part and a second part, wherein the subcutaneous electrode senses intrinsic cardiac activity between the first subcutaneous electrode part and the second subcutaneous electrode part.
38. The device of claim 37, further comprising a second subcutaneous electrode, wherein the housing is inactive and wherein the subcutaneous electrode and the second subcutaneous electrode are configured to apply selective antiarrhythmic, sensing and induction therapy between the subcutaneous electrode and the second subcutaneous electrode.
US10/150,434 2000-09-18 2002-05-17 Subcutaneous cardiac stimulator device having an anteriorly positioned electrode Active 2022-01-31 US7149575B2 (en)
US09/940,599 US6950705B2 (en) 2000-09-18 2001-08-27 Canister designs for implantable cardioverter-defibrillators
US10/011,956 US7120495B2 (en) 2000-09-18 2001-11-05 Flexible subcutaneous implantable cardioverter-defibrillator
US10/150,434 US7149575B2 (en) 2000-09-18 2002-05-17 Subcutaneous cardiac stimulator device having an anteriorly positioned electrode
US11/555,459 US7774059B2 (en) 2000-09-18 2006-11-01 Anterior positioning inactive housing
US11/555,424 US7835790B2 (en) 2000-09-18 2006-11-01 Anterior active housing subcutaneous positioning methods
US11/555,436 US7349736B2 (en) 2000-09-18 2006-11-01 Active housing dual lead assembly
US11/555,447 US7774058B2 (en) 2000-09-18 2006-11-01 Anterior positioning on opposing sides of sternum
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US11/555,459 Continuation US7774059B2 (en) 2000-09-18 2006-11-01 Anterior positioning inactive housing
US11/555,424 Continuation US7835790B2 (en) 2000-09-18 2006-11-01 Anterior active housing subcutaneous positioning methods
US11/555,436 Continuation US7349736B2 (en) 2000-09-18 2006-11-01 Active housing dual lead assembly
US11/555,447 Continuation US7774058B2 (en) 2000-09-18 2006-11-01 Anterior positioning on opposing sides of sternum
US20030036778A1 US20030036778A1 (en) 2003-02-20
US20050267537A9 US20050267537A9 (en) 2005-12-01
US7149575B2 true US7149575B2 (en) 2006-12-12
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US10/150,434 Active 2022-01-31 US7149575B2 (en) 2000-09-18 2002-05-17 Subcutaneous cardiac stimulator device having an anteriorly positioned electrode
US11/555,447 Active 2022-08-08 US7774058B2 (en) 2000-09-18 2006-11-01 Anterior positioning on opposing sides of sternum
US11/555,436 Active US7349736B2 (en) 2000-09-18 2006-11-01 Active housing dual lead assembly
US11/555,459 Active 2022-08-13 US7774059B2 (en) 2000-09-18 2006-11-01 Anterior positioning inactive housing
US11/555,424 Active 2022-05-19 US7835790B2 (en) 2000-09-18 2006-11-01 Anterior active housing subcutaneous positioning methods
US12/945,853 Active US8014862B2 (en) 2000-09-18 2010-11-13 Anterior active housing subcutaneous positioning methods
US13/225,517 Active US8145305B2 (en) 2000-09-18 2011-09-05 Subcutaneous defibrillator implantation without fluoroscopy
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