Source: http://www.google.es/patents/US20040225329
Timestamp: 2017-11-22 18:46:05
Document Index: 490829654

Matched Legal Cases: ['art.\n17', 'art.\n18', 'art.\n35', 'art;\n51', 'art.\n56', 'art.\n58', 'art 510', 'art 610', 'art 610', 'art 610', 'art 610', 'art 610', 'art 610', 'art 610', 'art 610']

Patente US20040225329 - Electrode placement determination for subcutaneous cardiac monitoring and ... - Google Patentes
Methods and devices of cardiac electrode placement involve locating electrodes on a thorax of a patient. Surface pacing levels are determined relative to a pacing limit. Surface electrode locations are selected or rejected based on the level being within a limit. Electrodes may be relocated to new locations,...http://www.google.es/patents/US20040225329?utm_source=gb-gplus-sharePatente US20040225329 - Electrode placement determination for subcutaneous cardiac monitoring and therapy
Número de publicación US20040225329 A1
Número de solicitud US 10/804,476
También publicado como US7389138
Número de publicación 10804476, 804476, US 2004/0225329 A1, US 2004/225329 A1, US 20040225329 A1, US 20040225329A1, US 2004225329 A1, US 2004225329A1, US-A1-20040225329, US-A1-2004225329, US2004/0225329A1, US2004/225329A1, US20040225329 A1, US20040225329A1, US2004225329 A1, US2004225329A1
Inventores Darrell Wagner, Adam Cates, Curtis Lindstrom
Cesionario original Wagner Darrell Orvin, Cates Adam W., Lindstrom Curtis Charles
Citas de patentes (99), Citada por (12), Clasificaciones (11), Eventos legales (5)
US 20040225329 A1
locating a plurality of surface electrodes on a thorax of a patient at initial locations;
selecting or rejecting one or more surface electrode locations based on the surface pacing level being within the pacing limit, the selected one or more surface electrode locations corresponding to one or more acceptable subcutaneous electrode locations.
3. The method of claim 1, further comprising relocating at least one of the plurality of surface electrodes on the thorax of the patient until a new surface pacing level falls within the pacing limit.
4. The method of claim 1, wherein selecting or rejecting the one or more surface electrode locations comprises selecting a location suitable for implantation of a subcutaneous cardiac stimulation electrode.
5. The method of claim 4, further comprising implanting the subcutaneous cardiac stimulation electrode at the selected location.
6. The method of claim 1, wherein selecting or rejecting the one or more surface electrode locations comprises selecting locations suitable for implantation of a plurality of subcutaneous cardiac stimulation electrodes.
7. The method of claim 6, further comprising implanting the plurality of subcutaneous cardiac stimulation electrodes at the selected locations.
8. The method of claim 1, wherein locating the plurality of surface electrodes comprises locating an array of electrode elements.
9. The method of claim 1, wherein locating the plurality of surface electrodes comprises locating an array of surface electrode elements, and wherein selecting or rejecting the one or more electrode locations comprises scanning the array of surface electrode elements for their associated pacing levels.
10. The method of claim 9, wherein selecting or rejecting the one or more electrode locations further comprises selecting one or more electrode element locations having the lowest pacing levels.
14. The method of claim 2, further comprising rejecting the patient for implantation of a subcutaneous cardiac stimulation system based on the new surface pacing level exceeding the pacing limit.
15. The method of claim 1, wherein selecting or rejecting the one or more surface electrode locations comprises:
16. The method of claim 1, wherein selecting or rejecting the one or more surface electrode locations comprises locating at least one surface electrode substantially parallel to a ventricular free wall of the patient's heart.
17. The method of claim 1, wherein selecting or rejecting the one or more surface electrode locations comprises locating at least one surface electrode parallel to a ventricular free wall of the patient's heart and extending a predetermined distance beyond the apex of the patient's heart.
18. An electrode placement method, comprising:
selecting one or more surface electrode locations as a function of a surface cardiac pacing level; and
19. The method of claim 18, further comprising implanting one or more subcutaneous cardiac stimulation electrodes at the determined one or more subcutaneous electrode implant locations.
20. The method of claim 18, wherein determining the one or more subcutaneous electrode implantation locations comprises selecting locations for implantation of a plurality of subcutaneous cardiac stimulation electrodes.
21. The method of claim 20, further comprising implanting the plurality of subcutaneous cardiac stimulation electrodes at the selected implantation locations.
22. The method of claim 18, wherein determining the one or more subcutaneous electrode implantation locations comprises selecting locations for implantation of a subcutaneous cardiac stimulation electrode and a cardiac stimulation system housing.
23. The method of claim 22, further comprising implanting the subcutaneous cardiac stimulation electrode and cardiac stimulation system housing at the selected implant locations.
24. The method of claim 18, wherein selecting the one or more surface electrode locations comprises:
25. The method of claim 18, wherein selecting the one or more surface electrode locations comprises locating at least one surface electrode substantially parallel to a ventricular free wall.
26. The method of claim 18, wherein selecting the one or more surface electrode locations comprises locating at least one surface electrode parallel to a ventricular free wall and extending a predetermined distance beyond the apex of the heart.
a plurality of surface electrodes coupled to the pulse generator and to the detection circuitry, the plurality of surface electrodes configured for positioning on a thorax of a patient relative to a patient's heart; and
a controller coupled to the pulse generator and detection circuitry, the controller determining acceptable subcutaneous electrode locations based at least in part on detection of capture or non-capture resulting from delivery of the pacing stimulus at the stimulus level.
28. The system of claim 27, wherein the controller determines acceptable subcutaneous electrode locations based at least in part on a pre-established proportionality relationship between the stimulus level of the pacing stimulus and a subcutaneous defibrillation level.
29. The system of claim 28, wherein the subcutaneous defibrillation level comprises a level of subcutaneous defibrillation energy above which a particular subcutaneous defibrillation device is not suited to deliver.
30. The system of claim 28, wherein the subcutaneous defibrillation level comprises a level of subcutaneous defibrillation energy below which a particular subcutaneous defibrillation device is suited to deliver.
31. The system of claim 27, comprising a recording arrangement coupled to the controller and configured to record capture threshold data or non-capture data determined for selected thoracic locations of the plurality of surface electrodes.
32. The system of claim 27, comprising a user interface coupled to the controller and configured to present capture threshold data or non-capture data determined for selected thoracic locations of the plurality of surface electrodes.
33. The system of claim 27, further comprising a cardioversion/defibrillation device configured for performing induction testing.
34. The system of claim 27, wherein the pulse generator is configured to deliver cardioversion/defibrillation stimulation to the patient's heart.
35. The system of claim 27, further comprising a housing, the plurality of surface electrodes supported by or coupled to the housing.
36. The system of claim 35, wherein the housing comprises a handle and is configured for hand-held portability.
37. The system of claim 27, further comprising a housing, the pulse generator and detection circuitry provided in the housing, and the plurality of surface electrodes coupled to the housing.
38. The system of claim 27, further comprising a housing, the pulse generator, detection circuitry, and controller provided in the housing, respectively, and the plurality of surface electrodes coupled to the housing.
39. The system of claim 31, further comprising a housing, the pulse generator, detection circuitry, controller, and recording arrangement supported by the housing, respectively, and the plurality of surface electrodes coupled to the housing.
40. The system of claim 32, further comprising a housing, the pulse generator, detection circuitry, controller, and user interface supported by the housing, respectively, and the plurality of surface electrodes coupled to the housing.
41. The system of claim 27, further comprising an electrode array structure configured to support the plurality of surface electrodes in an array arrangement, the electrode array structure configured to be positionable on the patient's thorax.
42. The system of claim 41, wherein the controller is configured to coordinate scanning of selected combinations of the plurality of surface electrodes.
43. The system of claim 41, wherein the controller is configured to coordinate scanning of combinations of the plurality of surface electrodes and identify surface electrode combinations associated with the lowest pacing levels that effect cardiac capture.
a plurality of surface electrodes configured for positioning on a thorax of a patient relative to a patient's heart;
means for selecting or rejecting one or more surface electrode locations based on the surface pacing level being within the pacing limit, the selected one or more surface electrode locations corresponding to one or more acceptable subcutaneous electrode locations.
45. The system of claim 44, further comprising means for selecting one or more electrodes of the plurality of surface electrodes associated with the lowest pacing levels that effect cardiac capture.
46. The system of claim 44, further comprising means for scanning combinations of the plurality of surface electrodes and means for identifying surface electrode combinations associated with the lowest pacing levels that effect cardiac capture.
47. The system of claim 44, wherein the means for selecting or rejecting comprises means for determining the one or more acceptable subcutaneous electrode locations based at least in part on a pre-established proportionality relationship between a surface pacing level and a subcutaneous defibrillation level.
means for selecting one or more surface electrode locations as a function of a surface cardiac pacing level; and
means for determining one or more subcutaneous electrode implant locations using the selected one or more surface electrode locations.
49. The system of claim 48, further comprising means for determining suitability of the one or more subcutaneous electrode implant locations based at least in part on a pre-established proportionality relationship between the surface cardiac pacing level and a subcutaneous defibrillation level.
a plurality of surface electrodes coupled to the pulse generator and supported by the electrode support assembly, the plurality of electrodes having a fixed spatial relationship relative to one another and configured for positioning on a thorax of a patient relative to the patient's heart;
51. The system of claim 50, wherein the controller determines acceptable subcutaneous electrode locations based at least in part on a pre-established proportionality relationship between the pacing level of the pacing stimulus and a subcutaneous defibrillation level.
52. The system of claim 50, wherein the controller determines acceptable subcutaneous electrode locations based at least in part on inducing an arrhythmia in the patient and determining the defibrillation level that terminates the arrhythmia.
53. An electrode placement method, comprising:
55. The method of claim 53, wherein the first surface electrode is located relative to an apex of the patient's heart and the second surface electrode is located in relation to a superior aspect of the patient's heart.
56. The method of claim 53, further comprising rotating the second surface electrode relative to the first surface electrode location while maintaining the fixed spatial relationship.
57. The method of claim 53, wherein the first surface electrode is located in relation to an inferior aspect of the patient's heart and the second surface electrode is located in relation to a superior aspect of the patient's heart.
58. The method of claim 53, further comprising relocating the first surface electrode and the second surface electrode to respective new locations on the thorax of the patient.
59. The method of claim 53, further comprising inducing an arrhythmia in the patient using the first and second surface electrodes.
60. The method of claim 59, further comprising delivering defibrillation energy to the patient at first and second surface electrode locations in response to the induced arrhythmia.
[0024]FIGS. 1A and 1B are views of a transthoracic cardiac sensing and/or stimulation device as implanted in a patient in accordance with an embodiment of the present invention;
[0025]FIG. 1C is a block diagram showing various components of a transthoracic cardiac sensing and/or stimulation device in accordance with an embodiment of the present invention;
[0026]FIG. 1D is a block diagram illustrating various processing and detection components of a transthoracic cardiac sensing and/or stimulation device in accordance with an embodiment of the present invention;
[0027]FIGS. 2A-2C are diagrams illustrating various components of a transthoracic cardiac sensing and/or stimulation device located in accordance with embodiments of the invention;
[0028]FIGS. 3A-3C are diagrams illustrating electrode subsystem placement relative to a heart in accordance with embodiments of the invention;
[0029]FIG. 3D illustrates electrode placement and an electrode testing system in accordance with an embodiment of the present invention;
[0030]FIG. 4A is a graph of proportionality relationships between surface pacing and subcutaneous defibrillation stimulus levels;
[0031]FIG. 4B is a flow-chart of a method for performing patient stratification in accordance with the present invention;
[0032]FIG. 4C is a flow-chart of another method for performing patient stratification in accordance with an embodiment of the present invention; and
[0033]FIGS. 5A and 5B are side and bottom views respectively of a hand-held device in accordance with an embodiment of the present invention.
[0053]FIG. 1C is a block diagram depicting various components of an ITCS device in accordance with one configuration. According to this configuration, the ITCS device incorporates a processor-based control system 205 which includes a micro-processor 206 coupled to appropriate memory (volatile and non-volatile) 209, it being understood that any logic-based control architecture may be used. The control system 205 is coupled to circuitry and components to sense, detect, and analyze electrical signals produced by the heart and deliver electrical stimulation energy to the heart under predetermined conditions to treat cardiac arrhythmias. In certain configurations, the control system 205 and associated components also provide pacing therapy to the heart. The electrical energy delivered by the ITCS device may be in the form of low energy pacing pulses or high-energy pulses for cardioversion or defibrillation.
[0066]FIG. 1D illustrates a configuration of detection circuitry 302 of an ITCS device that includes one or both of rate detection circuitry 310 and morphological analysis circuitry 312. Detection and verification of arrhythmias may be accomplished using rate-based discrimination algorithms as known in the art implemented by the rate detection circuitry 310. Arrhythmic episodes may also be detected and verified by morphology-based analysis of sensed cardiac signals as is known in the art. Tiered or parallel arrhythmia discrimination algorithms may also be implemented using both rate-based and morphologic-based approaches. Further, a rate and pattern-based arrhythmia detection and discrimination approach may be employed to detect and/or verify arrhythmic episodes, such as the approach disclosed in U.S. Pat. Nos. 6,487,443; 6,259,947; 6,141,581; 5,855,593; and 5,545,186, which are hereby incorporated herein by reference in their respective entireties.
[0072]FIG. 2A illustrates the housing 501 and can electrode 502 placed subcutaneously, superior to the heart 510 in the left pectoral region, which is a location commonly used for conventional pacemaker and defibrillator implants. The second electrode subsystem 504 may include a coil electrode mounted on the distal end of a lead body 506, where the coil is approximately 3-15 French in diameter and 5-12 cm in length. The coil electrode may have a slight preformed curve along its length. The lead may be introduced through the lumen of a subcutaneous sheath, through a common tunneling implant technique, and the second electrode subsystem 504, e.g., comprising a coil electrode, may be placed subcutaneously, deep to any subcutaneous fat and adjacent to the underlying muscle layer.
[0078]FIGS. 3A-3C provide additional detailed views of subcutaneous electrode subsystem placement considered particularly useful in patient implant stratification in accordance with embodiments of the present invention. FIG. 3A illustrates first and second electrode subsystems configured as a can electrode 602 and a coil electrode 604, respectively. FIG. 3A illustrates the can electrode 602 located superior to the heart 610 in the left pectoral region and the coil electrode 604 located inferior to the heart 610, parallel to the right ventricular free wall of the heart 610.
[0081]FIG. 3B illustrates a cross sectional area 605 formed by the lines drawn between active elements of the can electrode 602 and the coil electrode 604. Lines drawn between active areas of the electrodes 602, 604, may be defined by a medial edge and a lateral edge of the can electrode 602, and a proximal end and a distal end of a coil electrode utilized as the second electrode subsystem 604. The coil electrode 604 extends a predetermined distance beyond the apex of the heart 610, e.g. less than about 3 cm.
[0082]FIG. 3C illustrates a configuration wherein the pulse generator housing 601 does not include an electrode. In this implementation two electrode subsystems are positioned about the heart so that a majority of ventricular tissue is included within a volume defined between the electrode subsystems. According to this embodiment, the first and second electrodes are configured as first and second coil electrodes 608, 609. The first coil electrode 608 is located superior to the heart 610 and may be located relative to a superior aspect of the heart, e.g., the left ventricular free wall. The second coil electrode 609 is located inferior to the heart 610. The second electrode 609 may be located in relation to an inferior aspect of the heart 610. In one configuration, the second electrode 609 is positioned parallel to the right ventricular free wall with a tip of the electrode 609 extending less than about 3 cm beyond the apex of the heart 610. As illustrated in FIG. 3C, the volume defined between the electrodes may be defined by the cross sectional area 605 bounded by lines drawn between active areas of the electrodes 608, 609.
Embodiments of the present invention exploit this relationship for verifying that the implantable systems operate as intended in a particular patient, making that patient a candidate for implantation of the particular defibrillation system.
Embodiments of the present invention also use this proportionality relationship for determining proper placement of components of a given implantable defibrillation system. Embodiments of the present invention further use this proportionality relationship for determining stimulus levels useful for individual patient stratification. In other embodiments of the present invention, this proportionality relationship is useful for stratifying patients. Examples of patient stratification include determining that a patient is not a candidate for implantation of a 40-Joule defibrillator, but is a candidate for implantation of an 80-Joule defibrillator, or determining that a smaller implantable device is suitable for a patient, thereby saving that patient from the increased bulk of a larger system. It is understood that these examples are for illustration only, and not limitation.
The electrodes 800 may be individually placed and relocated, or may be provided in one or more groups attached to a substrate such as an adhesive backed polymeric sheet. The electrodes may be large electrodes, such as having an active surface area of about 32 cm2, or may include one or more smaller electrodes, such as standard surface EKG electrodes, that may be used individually or in combination For example, an array of standard EKG surface electrodes may be used, and adjacent pairs or combinations of electrodes may be used simultaneously for pacin and/or defibrillation.
It is also contemplated by the inventors that an automated stratification system may be built into an implantable ITCS device, to further stratify patients during the continued lifetime of the implant. For example, patient stratification may be an automated process post-implant, or performed routinely at patient follow-ups. This periodic stratification may identify patients who may need to have a device upgrade because of, for example, increased body weight, progression of heart disease, or other pathological or physiological conditions. As described earlier, results of such routine stratifications may be communicated via an advanced patient management system. Implantable systems that detect capture and that may be useful with embodiments of the present invention that perform routine patient stratification are further described in U.S. Pat. No. 5,683,431; and 5,331,966, hereby incorporated herein by reference.
[0109]FIG. 5A illustrates a side view of the device 99. The device 99 may include a handle 55, a body 60, a user interface 70, and one or more electrodes 75, 80, 85, and 90. The handle 55 may be grasped by a clinician, and the body 60 may be placed over the thorax of a patient. The device 99 may then perform one or more of the methodologies described above to stratify the patient for purposes of implanting a subcutaneous defibrillation device and/or to assist the clinician in determining suitable or optimal subcutaneous electrode implant locations.
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Clasificación internacional A61N1/365, A61N1/05, A61N1/39
Clasificación cooperativa A61N1/36542, A61N1/36585, A61N1/05, A61N1/3962, A61N1/3956
Clasificación europea A61N1/39M2, A61N1/365C