Source: http://www.google.com/patents/US7039465?dq=6,621,746
Timestamp: 2015-05-22 13:52:03
Document Index: 202720418

Matched Legal Cases: ['art.\n22', 'art.\n23', 'art.\n24', 'art.\n25', 'art.\n44', 'art.\n45', 'art.\n46', 'art.\n47', 'art.\n51', 'art.\n62', 'art.\n63']

Patent US7039465 - Ceramics and/or other material insulated shell for active and non-active S ... - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsAn implantable cardioverter-defibrillator for subcutaneous positioning between the third rib and the twelfth rib within a patient, the implantable cardioverter-defibrillator including a housing, wherein at least a portion of the housing is curved; an electrical circuit; and at least one electrically...http://www.google.com/patents/US7039465?utm_source=gb-gplus-sharePatent US7039465 - Ceramics and/or other material insulated shell for active and non-active S-ICD canAdvanced Patent SearchPublication numberUS7039465 B2Publication typeGrantApplication numberUS 09/940,371Publication dateMay 2, 2006Filing dateAug 27, 2001Priority dateSep 18, 2000Fee statusPaidAlso published asUS20020042634, US20050107835, WO2003018119A1Publication number09940371, 940371, US 7039465 B2, US 7039465B2, US-B2-7039465, US7039465 B2, US7039465B2InventorsGust H. Bardy, Riccardo Cappato, William J. Rissmann, Alan H. OstroffOriginal AssigneeCameron Health, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (111), Non-Patent Citations (71), Referenced by (3), Classifications (12), Legal Events (6) External Links: USPTO, USPTO Assignment, EspacenetCeramics and/or other material insulated shell for active and non-active S-ICD can
US 7039465 B2Abstract
a housing including a first segment and a second segment, each segment having an insulating plate at an end thereof and a conductive plate coupled to the insulating plate, wherein the conductive plate of the first segment is coupled to the conductive plate of the second segment to form a unitary implantable device;
an electrode disposed on the housing; wherein the insulating plates separate the conductive plates from the electrode; and
cardioversion-defibrillation circuitry located within the housing and coupled to the electrode.
2. A subcutaneous cardioverter-defibrillator comprising:
a housing comprising a mixture of conductive and nonconductive materials, the housing having a top surface and a bottom surface;
an electrode integrally positioned on a portion of the housing, wherein the electrode couples to the electrical circuit, and further wherein the electrode can provide an effective electric field to treat the myocardium;
wherein the housing further comprises a first segment and a second segment, each segment having an insulating plate at an end thereof and a conductive plate coupled to the insulating plate, wherein the conductive plate of the first segment is coupled to the conductive plate of the second segment to form a unitary implantable device; wherein the insulating plates separate the conductive plates from the electrode.
3. A cardioverter-defibrillator comprising:
a housing comprising a mixture of conductive and nonconductive materials wherein the electrode is integrally disposed in the housing such that the electrode is maintained in a predetermined relationship subcutaneously over a patient's ribs; and
cardioversion-defibrillation circuitry located within the housing and coupled to the electrode;
wherein the housing comprises a mixture of ceramic materials and titanium; and
4. A subcutaneous cardioverter-defibrillator comprising:
a housing having a top surface and a bottom surface, wherein at least a portion of the bottom surface of the housing is non planar, wherein the housing further comprises a first segment and a second segment, each segment having an insulating plate at an end thereof and a conductive plate coupled to the insulating plate, wherein the conductive plate of the first segment is coupled to the conductive plate of the second segment to form a unitary implantable device;
an electrode integrally positioned on a portion of the housing, wherein the insulating plates separate the conductive plates from the electrode, wherein the electrode couples to the electrical circuit, and further wherein the electrode can provide an effective electric field for myocardial cardioversion and defibrillation.
5. The subcutaneous cardioverter-defibrillator of claim 4, wherein the housing comprises an electrically insulated material.
6. The subcutaneous cardioverter-defibrillator of claim 4, wherein the housing comprises a ceramic material.
7. The subcutaneous cardioverter defibrillator of claim 6, wherein the ceramic material is selected from the group consisting essentially of zirconia, alumina, silicon nitride, silicon carbide, titanium carbide, tungsten carbide, titanium nitride, silicon-aluminum oxy-nitride (sialon), graphite, titanium di-boride, boron carbide, zirconia toughened alumina, and molybdenum disilicide.
8. The cardioverter-defibrillator of claim 7, wherein the zirconia is selected from the group consisting essentially of stabilized zirconia, partially stabilized zirconia, tetragonal zirconia, yttria-stabilized zirconia, magnesia-stabilized zirconia, ceria-stabilized zirconia, and calcia-stabilized zirconia.
9. The subcutaneous cardioverter-defibrillator of claim 4, wherein the housing comprises a mixture of ceramic and titanium.
10. The subcutaneous cardioverter-defibrillator of claim 4, wherein the portion of the bottom surface of the housing being non planar comprises a circular arc.
11. The subcutaneous cardioverter-defibrillator of claim 4, wherein the portion of the bottom surface of the housing being non planar comprises an elliptical arc.
12. The subcutaneous cardioverter-defibrillator of claim 4, wherein the portion of the bottom surface of the housing being non planar comprises a nonsymmetrical arc.
13. The subcutaneous cardioverter-defibrillator of claim 4, wherein the bottom surface of the housing is substantially smooth.
14. The subcutaneous cardioverter-defibrillator of claim 4, wherein a portion of the top surface of the housing is substantially non planar.
15. The subcutaneous cardioverter-defibrillator of claim 14, wherein the portion of the top surface of the housing being non planar comprises a circular arc.
16. The subcutaneous cardioverter-defibrillator of claim 14, wherein the portion of the top surface of the housing being non planar comprises an elliptical arc.
17. The subcutaneous cardioverter-defibrillator of claim 14, wherein the portion of the top surface of the housing being non planar comprises a nonsymmetrical arc.
18. The subcutaneous cardioverter-defibrillator of claim 4, wherein the top surface of the housing is substantially smooth.
19. The subcutaneous cardioverter-defibrillator of claim 4, wherein the bottom surface further comprises a proximal end and a distal end, wherein the electrode is integrally positioned at the proximal end of the bottom surface.
20. The subcutaneous cardioverter-defibrillator of claim 19, wherein a second electrode is integrally positioned at the distal end of the bottom surface.
21. The subcutaneous cardioverter-defibrillator of claim 4, wherein the electrical circuit can provide cardioversion-defibrillation energy for the patient's heart.
22. The subcutaneous cardioverter-defibrillator of claim 21, wherein the electrical circuit further provides biphasic waveform cardiac pacing for the patient's heart.
23. The subcutaneous cardioverter-defibrillator of claim 4, wherein the electrical circuit provides biphasic waveform cardiac pacing for the patient's heart.
24. The subcutaneous cardioverter-defibrillator of claim 4, wherein the electrode emits an energy for treating the patient's heart.
25. The subcutaneous cardioverter-defibrillator of claim 24, wherein the electrode further receives sensory information.
26. The subcutaneous cardioverter-defibrillator of claim 4, wherein the electrode receives sensory information.
27. An implantable cardioverter-defibrillator for subcutaneous positioning between the third rib and the twelfth rib within a patient, the implantable cardioverter-defibrillator comprising:
a housing, wherein at least a portion of the housing is curved, wherein the housing further comprises a first segment and a second segment, each segment having an insulating plate at an end thereof and a conductive plate coupled to the insulating plate, wherein the conductive plate of the first segment is coupled to the conductive plate of the second segment to form a unitary implantable device;
an electrically conductive surface integrally positioned on a portion of the housing, wherein the electrically conductive surface is coupled to the electrical circuit; wherein the insulating plates separate the conductive plates from the conductive surface.
28. The implantable cardioverter-defibrillator of claim 27, wherein the housing comprises an electrically insulated material.
29. The implantable cardioverter-defibrillator of claim 27, wherein the housing comprises a ceramic material.
30. The implantable cardioverter-defibrillator of claim 29, wherein the ceramic material is selected from the group consisting essentially of zirconia, alumina, silicon nitride, silicon carbide, titanium carbide, tungsten carbide, titanium nitride, silicon-aluminum oxy-nitride (sialon), graphite, titanium di-boride, boron carbide, zirconia toughened alumina, and molybdenum disilicide.
31. The implantable cardioverter-defibrillator of claim 30, wherein the zirconia is selected from the group consisting essentially of stabilized zirconia, partially stabilized zirconia, tetragonal zirconia, yttria-stabilized zirconia, magnesia-stabilized zirconia, ceria-stabilized zirconia, and calcia-stabilized zirconia.
32. The implantable cardioverter-defibrillator of claim 27, wherein the housing comprises a mixture of ceramic materials and titanium.
33. The implantable cardioverter-defibrillator of claim 27, wherein at least a portion of the first segment is curved.
34. The implantable cardioverter-defibrillator of claim 27, wherein at least a portion of the second segment is curved.
35. The implantable cardioverter-defibrillator of claim 27, wherein the curved portion of the housing comprises a circular arc.
36. The implantable cardioverter-defibrillator of claim 27, wherein the curved portion of the housing comprises an elliptical arc.
37. The implantable cardioverter-defibrillator of claim 27, wherein the curved portion of the housing comprises a nonsymmetrical arc.
38. The implantable cardioverter-defibrillator of claim 34, wherein the curved portion of the second segment comprises a circular arc.
39. The implantable cardioverter-defibrillator of claim 34, wherein the curved portion of the second segment comprises an elliptical arc.
40. The implantable cardioverter-defibrillator of claim 34, wherein the curved portion of the second segment comprises a nonsymmetrical arc.
41. The implantable cardioverter-defibrillator of claim 27, wherein the second segment of the housing is substantially straight.
42. The implantable cardioverter-defibrillator of claim 27, wherein the first segment of the housing is contiguous with the second segment of the housing.
43. The implantable cardioverter-defibrillator of claim 27, wherein the electrical circuit provides cardioversion-defibrillation energy for the patient's heart.
44. The implantable cardioverter-defibrillator of claim 43, wherein the electrical circuit further provides biphasic waveform cardiac pacing for the patient's heart.
45. The implantable cardioverter-defibrillator of claim 27, wherein the electrical circuit provides biphasic waveform cardiac pacing for the patient's heart.
46. The implantable cardioverter-defibrillator of claim 27, wherein the electrically conductive surface emits an energy for shocking the patient's heart.
47. The implantable cardioverter-defibrillator of claim 46, wherein the electrically conductive surface further receives sensory information.
48. The implantable cardioverter-defibrillator of claim 27, wherein the electrically conductive surface can receive sensory information.
49. A cardioverter-defibrillator comprising:
a housing having a curved portion, wherein the electrode is integrally disposed in the curved portion of the housing such that the electrode is maintained in a predetermined relationship subcutaneously over a patient's ribs, and wherein the housing further comprises a first segment and a second segment, each segment having an insulating plate at an end thereof and a conductive plate coupled to the insulating plate, wherein the conductive plate of the first segment is coupled to the conductive plate of the second segment to form a unitary implantable device, and wherein the insulating plates separate the conductive plates from the electrode; and
50. The cardioverter-defibrillator of claim 49, wherein the electrode emits energy for shocking a patient's heart.
51. The cardioverter-defibrillator of claim 50, wherein the electrode further receives sensory information.
52. The cardioverter-defibrillator of claim 49, wherein the electrode receives sensory information.
53. The cardioverter-defibrillator of claim 49, wherein the housing comprises a ceramic material.
54. The cardioverter-defibrillator of claim 53, wherein the ceramic material is selected from the group consisting essentially of zirconia, alumina, silicon nitride, silicon carbide, titanium carbide, tungsten carbide, titanium nitride, silicon-aluminum oxy-nitride (sialon), graphite, titanium di-boride, boron carbide, zirconia toughened alumina, and molybdenum disilicide.
55. The cardioverter-defibrillator of claim 54, wherein the zirconia is selected from the group consisting essentially of stabilized zirconia, partially stabilized zirconia, tetragonal zirconia, yttria-stabilized zirconia, magnesia-stabilized zirconia, ceria-stabilized zirconia, and calcia-stabilized zirconia.
56. The cardioverter-defibrillator of claim 55, wherein the housing comprises a mixture of ceramic materials and titanium.
57. The cardioverter-defibrillator of claim 49, wherein the curved portion of the housing comprises a circular arc.
58. The cardioverter-defibrillator of claim 57, wherein the circular arc is approximately 1 radians to approximately 180 radians in length.
59. The cardioverter-defibrillator of claim 49, wherein the curved portion of the housing comprises an elliptical arc.
60. The cardioverter-defibrillator of claim 49, wherein the curved portion of the housing comprises a nonsymmetrical arc.
61. The cardioverter-defibrillator of claim 49, wherein the predetermined relationship is with respect to the patient's heart.
62. The cardioverter-defibrillator of claim 49, wherein the cardioversion-defibrillation circuitry further provides waveform cardiac pacing for a patient's heart.
63. An implantable cardioverter-defibrillator for subcutaneous positioning between the third rib and the twelfth rib within a patient, the implantable cardioverter-defibrillator comprising:
a housing comprising a mixture of conductive and nonconductive materials wherein at least a portion of the housing is curved;
an electrode integrally positioned on a portion of the housing, wherein the electrode is coupled to the electrical circuit;
wherein the housing further comprises a first segment and a second segment, each segment having an insulating plate at an end thereof and a conductive plate coupled to the insulating plate, wherein the conductive plate of the first segment can be coupled to the conductive plate of the second segment to form a unitary implantable device; wherein the insulating plates separate the conductive plates from the electrode.
64. The implantable cardioverter-defibrillator of claim 63, wherein at least a portion of the first segment is curved.
65. The implantable cardioverter-defibrillator of claim 63, wherein at least a portion of the second segment is curved.
66. The implantable cardioverter-defibrillator of claim 65, wherein the curved portion of the second segment comprises a circular arc.
67. The implantable cardioverter-defibrillator of claim 65, wherein the curved portion of the second segment comprises an elliptical arc.
68. The implantable cardioverter-defibrillator of claim 65, wherein the curved portion of the second segment comprises a nonsymmetrical arc.
69. The implantable cardioverter-defibrillator of claim 63, wherein the second segment of the housing is substantially straight.
70. The implantable cardioverter-defibrillator of claim 63, wherein the first segment of the housing is contiguous with the second segment of the housing.
The present application is a continuation-in-part of U.S. patent application entitled “SUBCUTANEOUS ONLY IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR AND OPTIONAL PACER,” having Ser. No. 09/663,606, filed Sep. 18, 2000, now U.S. Pat. No. 6,647,292, and U.S. patent application entitled “UNITARY SUBCUTANEOUS ONLY IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR AND OPTIONAL PACER,” having Ser. No. 09/663,607, filed Sep. 18, 2000, now U.S. Pat. No. 6,721,597, of which both applications are assigned to the assignee of the present application, and the disclosures of both applications are hereby incorporated by reference.
In addition, the present application is filed concurrently herewith U.S. patent application entitled “DUCKBILL-SHAPED IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR AND METHOD OF USE,” U.S. patent application entitled “CERAMICS AND/OR OTHER MATERIAL INSULATED SHELL FOR ACTIVE AND NON-ACTIVE S-ICD CAN,” U.S. patent application entitled “SUBCUTANEOUS ELECTRODE FOR TRANSTHORACIC CONDUCTION WITH IMPROVED INSTALLATION CHARACTERISTICS,” U.S. patent application entitled “SUBCUTANEOUS ELECTRODE WITH IMPROVED CONTACT SHAPE FOR TRANSTHORACIC CONDUCTION,” U.S. patent application entitled “SUBCUTANEOUS ELECTRODE FOR TRANSTHORACIC CONDUCTION WITH HIGHLY MANEUVERABLE INSERTION TOOL,” U.S. patent application entitled “SUBCUTANEOUS ELECTRODE FOR TRANSTHORACIC CONDUCTION WITH LOW-PROFILE INSTALLATION APPENDAGE AND METHOD OF DOING SAME,” U.S. patent application entitled “SUBCUTANEOUS ELECTRODE FOR TRANSTHORACIC CONDUCTION WITH INSERTION TOOL,” U.S. patent application entitled “METHOD OF INSERTION AND IMPLANTATION FOR IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR CANISTERS,” U.S. patent application entitled “CANISTER DESIGNS FOR IMPLANTABLE CARDIOVERTER-DEFIBRILLATORS,” U.S. patent application entitled “RADIAN CURVED IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR CANISTER,” U.S. patent application entitled “CARDIOVERTER-DEFIBRILLATOR HAVING A FOCUSED SHOCKING AREA AND ORIENTATION THEREOF,” U.S. patent application entitled “BIPHASIC WAVEFORM FOR ANTI-BRADYCARDIA PACING FOR A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR,” U.S. patent application entitled “BIPHASIC WAVEFORM FOR ANTI-TACHYCARDIA PACING FOR A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR,” and “POWER SUPPLY FOR A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR,” the disclosures of which applications are hereby incorporated by reference.
The most distal electrode on the composite subcutaneous electrode is a coil electrode 27 that is used for delivering the high voltage cardioversion/defibrillation energy across the heart. The coil cardioversion/defibrillation electrode is about 5–10 cm in length. Proximal to the coil electrode are two sense electrodes, a first sense electrode 25 is located proximally to the coil electrode and a second sense electrode 23 is located proximally to the first sense electrode. The sense electrodes are spaced far enough apart to be able to have good QRS detection. This spacing can range from 1 to 10 cm with 4 cm being presently preferred. The electrodes may or may not be circumferential with the preferred embodiment. Having the electrodes non-circumferential and positioned outward, toward the skin surface, is a means to minimize muscle artifact and enhance QRS signal quality. The sensing electrodes are electrically isolated from the cardioversion/defibrillation electrode via insulating areas 29. Similar types of cardioversion/defibrillation electrodes are currently commercially available in a transvenous configuration. For example, U.S. Pat. No. 5,534,022, the entire disclosure of which is herein incorporated by reference, disclosures a composite electrode with a coil cardioversion/defibrillation electrode and sense electrodes. Modifications to this arrangement is contemplated within the scope of the invention. One such modification is illustrated in FIG. 2 where the two sensing electrodes 25 and 23 are non-circumferential sensing electrodes and one is located at the distal end, the other is located proximal thereto with the coil electrode located in between the two sensing electrodes. In this embodiment the sense electrodes are spaced about 6 to about 12 cm apart depending on the length of the coil electrode used. FIG. 3 illustrates yet a further embodiment where the two sensing electrodes are located at the distal end to the composite electrode with the coil electrode located proximally thereto. Other possibilities exist and are contemplated within the present invention. For example, having only one sensing electrode, either proximal or distal to the coil cardioversion/defibrillation electrode with the coil serving as both a sensing electrode and a cardioversion/defibrillation electrode.
The two cardioversion/defibrillation electrodes on the housing are used for delivering the high voltage cardioversion/defibrillation energy across the heart. In the preferred embodiment, the cardioversion/defibrillation electrodes are coil electrodes, however, other cardioversion/defibrillation electrodes could be used such as having electrically isolated active surfaces or platinum alloy electrodes. The coil cardioversion/defibrillation electrodes are about 5–10 cm in length. Located on the housing between the two cardioversion/defibrillation electrodes are two sense electrodes 1425 and 1427. The sense electrodes are spaced far enough apart to be able to have good QRS detection. This spacing can range from 1 to 10 cm with 4 cm being presently preferred. The electrodes may or may not be circumferential with the preferred embodiment. Having the electrodes non-circumferential and positioned outward, toward the skin surface, is a means to minimize muscle artifact and enhance QRS signal quality. The sensing electrodes are electrically isolated from the cardioversion/defibrillation electrode via insulating areas 1423. Analogous types of cardioversion/defibrillation electrodes are currently commercially available in a transvenous configuration. For example, U.S. Pat. No. 5,534,022, the entire disclosure of which is herein incorporated by reference, discloses a composite electrode with a coil cardioversion/defibrillation electrode and sense electrodes. Modifications to this arrangement is contemplated within the scope of the invention. One such modification is to have the sense electrodes at the two ends of the housing and have the cardioversion/defibrillation electrodes located in between the sense electrodes. Another modification is to have three or more sense electrodes spaced throughout the housing and allow for the selection of the two best sensing electrodes. If three or more sensing electrodes are used, then the ability to change which electrodes are used for sensing would be a programmable feature of the US-ICD to adapt to changes in the patient physiology and size over time. The programming could be done via the use of physical switches on the canister, or as presently preferred, via the use of a programming wand or via a wireless connection to program the circuitry within the canister.
FIGS. 19–26 refer generally to alternative S-ICD/US-ICD canister embodiments. Although the following canister designs, various material constructions, dimensions and curvatures, discussed in detail below, may be incorporated into either S-ICD or US-ICD canister embodimens, hereinafter, these attributes will be discussed solely with respect to S-ICDs.
Ideally, the emitted energy from the S-ICD device will be directed into the patient's anterior mediastinum, through the majority of the heart, and out to the coupled lead electrode positioned in the posterior, posterolateral and/or lateral thoracic locations. Furthermore, it is desirable that the S-ICD canister 190 be capable of delivering this directed energy, as a general rule, at an adequate effective field strength. In the case of a typical biphasic waveform, an effective field strength is about 3–5 V/cm over approximately 90 percent of a patient's ventricular myocardium. This delivered effective field strength should be adequate for defibrillation of the patient's heart—an intended application of an embodiment of the present invention.
Maintaining the weight and size within the above identified parameters is primarily for patient comfort depending upon the shape and location of the device. The implantation of a S-ICD canister 190 is a long-term solution to heart dysfunction, and as such, will ideally remain in the patient until the device's batteries need replacement or an alternative therapy eventually leads to its removal. Accordingly, a considerable amount of engineering is devoted to minimizing discomfort associated with the installed device.
A “spade” shaped electrode 236 is depicted in FIG. 23A. The distal end of the spade shaped electrode also generally follows the outline of the rounded distal end 234 of the canister housing 220. As the spade shaped electrode 236 moves proximally along the length of the canister housing 220, the conductive surface terminates in a rounded proximal end. Similar to the thumbnail embodiment described above, the spade shaped electrode's conductive surface is generally contained within the distal end 234 of the canister housing 220. In alternate embodiments, the spade shape electrode's conductive surface may extend proximally further within the canister housing 220. In yet another spade shaped electrode 236 embodiment, the margins of the spade shaped electrode's conductive surface refrain from following the exact rounded contour of the canister housing 220, but substantially form a spade shaped configuration.
In certain embodiments of the present invention, an associated feature of the electrode 236 at the distal end is the presence of a margin of insulated material 237 around the active electrode 236. The margin of insulated material 237 may aid in directing emitted energy from the electrode 236 inwardly toward the patient's heart instead of dispersing energy outward toward the patient's chest wall. This margin of insulated material 237 typically ranges from 1–5 mm in width and may extend to the margin of the housing. Moreover, in certain embodiments, the margin of insulated material 237 comprises a ceramic material or other non-conductive material designed to facilitate focusing of current inward toward the heart.
FIGS. 26A–26C illustrate another embodiment of a S-ICD canister having a multi-segment canister housing 280. The multi-segment canister housing 280 includes at least two canister housing segments that are coupled together. The S-ICD canister depicted in FIG. 26A, 26B and 26C specifically have a distal segment 282 and a proximal segment 284 hinged, or otherwise coupled, together.
Because of its inherent nonconductive properties, a housing made of ceramic materials allows an electrode to be integrally disposed therein as described above. Fusing of an electrode to the housing can be accomplished via known processes involving a combination of temperature and pressure. For example, one such process is described in U.S. Pat. No. 6,221,513, entitled “Methods for Hermetically Sealing Ceramic to Metallic Surfaces and Assemblies Incorporating Such Seals.”
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