Source: http://www.docstoc.com/docs/55072466/Implantable-Cardioverter-defibrillator-Having-Two-Spaced-Apart-Shocking-Electrodes-On-Housing---Patent-6988003
Timestamp: 2013-12-12 12:02:23
Document Index: 44712939

Matched Legal Cases: ['art.\n3', 'art.\n5', 'art.\n6', 'art.\n7', 'art.\n8', 'art.\n11', 'art.\n12', 'art.\n13', 'art.\n16', 'art.\n17', 'art.\n18', 'art.\n19', 'art.\n23', 'art.\n31', 'art.\n32', 'art.\n33', 'art.\n36', 'art.\n37']

Implantable Cardioverter-defibrillator Having Two Spaced Apart Shocking Electrodes On Housing - Patent 6988003
United States Patent: 6988003
Implantable cardioverter-defibrillator having two spaced apart shocking
electrodes on housing
cardioverter-defibrillator for subcutaneous positioning over a patient&#39;s
ribcage, the implantable cardioverter-defibrillator includes a housing
having a first end and a second end; a first electrode disposed upon the
first end of the housing; a second electrode disposed upon the second end
of the housing; an electrical circuit located within the housing, wherein
the electrical circuit is electrically coupled to the first electrode and
the second electrode; and a lead electrode electrically coupled to the
electrical circuit located within the housing.
Bardy; Gust H. (Seattle, WA), Cappato; Riccardo (Ferrara, IT), Rissmann; William J. (Coto de Caza, CA), Sanders; Gary H. (Margarita, CA)
10/011,566
09940599Aug., 2001
09633607Sep., 20006721597
607/36  ; 607/4; 607/5; 607/9
607/4-6,9,17-20,22-26,36
Fayan et al.
US. Appl. No. 09/663,607 to Bardy et al., filed Sep. 18, 2000. cited by other
application entitled &quot;CANISTER DESIGNS FOR IMPLANTABLE
CARDIOVERTER-DEFIBRILLATORS,&quot; having Ser. No. 09/940,599 filed Aug. 27,
2001, which is a continuation-in-part of U.S. patent application entitled
&quot;SUBCUTANEOUS ONLY IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR AND OPTIONAL
PACER,&quot; having Ser. No. 09/663,607, filed Sep. 18, 2000, now U.S. Pat.
No. 6,721,597 and U.S. patent application entitled &quot;UNITARY SUBCUTANEOUS
Ser. No. 09/663,606, filed Sep. 18, 2000, now U.S. Pat. No. 6,647,292 of
which both applications are assigned to the assignee of the present
application, and the disclosures of both applications are hereby
1.  A method of forming a plurality of depolarization vectors for an implantable cardioverter-defibrillator, the method comprising the steps of: providing a
cardioverter-defibrillator canister having a first electrode and a second electrode disposed upon a portion of the cardioverter-defibriflator canister, and an electrical circuit contained within the cardioverter-defibrillator canister that electrically
couples to the first electrode and the second electrode, the electrical circuit being adapted to provide an output pulse for cardiac stimulation using one of the first electrode and the second electrode as an anode and the other as a cathode;  providing
a lead electrode that is electrically coupled to the electrical circuit contained within the cardioverter-defibrillator canister;  and positioning the cardioverter-defibrillator canister and the lead electrode subcutaneously over a patient&#39;s ribcage.
2.  The method of claim 1, wherein the first electrode and the second electrode form a depolarization vector with respect to a patient&#39;s heart.
3.  The method of claim 2, wherein the electrical circuit is configured to receive sensory information via at least one pair of electrodes including the first electrode, second electrode or lead electrode.
4.  The method of claim 1, wherein the first electrode and the lead electrode form a depolarization vector with respect to a patient&#39;s heart.
5.  The method of claim 1, wherein the first electrode and second electrode form a depolarization vector with the lead electrode with respect to a patient&#39;s heart.
6.  The method of claim 1, wherein the first electrode and the lead electrode form a depolarization vector with the second electrode with respect to a patient&#39;s heart.
7.  The method of claim 1, wherein the first electrode, second electrode and lead electrode can emit an energy for shocking a patient&#39;s heart.
8.  The method of claim 1, wherein the electrical circuit is programmed prior to implantation into the patient.
9.  The method of claim 8, wherein the electrical circuit is capable of being further programmed after implantation into the patient.
10.  The method of claim 1, wherein the electrical circuit can provide a cardioversion-defibrillation energy to a patient&#39;s heart.
11.  The method of claim 10, wherein the electrical circuit can further provide multiphasic waveform cardiac pacing for the patient&#39;s heart.
12.  The method of claim 10, wherein the electrical circuit can further provide monophasic waveform cardiac pacing for the patient&#39;s heart.
13.  An implantable cardioverter-defibrillator for subcutaneous positioning over a patient&#39;s ribcage, the implantable cardioverter-defibrillator comprising: a housing having a first end and a second end;  a first electrode disposed upon the
first end of the housing;  a second electrode disposed upon the second end of the housing;  and an electrical circuit located within the housing, wherein the electrical circuit is electrically coupled to the first electrode and the second electrode such
that the electrical circuit provides a cardiac stimulus output to the patient using one of the first electrode and the second electrode as an anode and the other as a cathode;  wherein the first and second electrodes are spaced apart such that a
depolarization vector is formed with respect to a patient&#39;s heart between the first and second electrodes.
14.  The implantable cardioverter-defibrillator of claim 13, further comprising a lead electrode electrically coupled to the electrical circuit located within the housing.
15.  The implantable cardioverter-defibriulator of claim 14, wherein the first electrode and the lead electrode form a depolarization vector with respect to a patient&#39;s heart.
16.  The implantable cardioverter-defibrillator of claim 14, wherein the first electrode and second electrode form a depolarization vector with the lead electrode with respect to a patient&#39;s heart.
17.  The izuplantable cardioverter-defibrillator of claim 14, wherein the first electrode and the lead electrode form a depolarization vector with the second electrode with respect to a patient&#39;s heart.
18.  The implantable cardioverter-defibriflator of claim 14, wherein the first electrode, second electrode and lead electrode can emit a energy for shocking a patient&#39;s heart.
19.  The implantable cardioverter-defibrillator of claim 14, wherein the first electrode, second electrode and lead electrode can receive sensory information.
20.  An implantable cardioverter-defibrillator for subcutaneous positioning over a patient&#39;s ribcage, the implantable cardioverter-defibrillator comprising: a housing having a first end and a second end;  a first electrode disposed upon the
first end of the housing;  a second electrode disposed upon the second end of the housing;  an electrical circuit located within the housing, the electrical circuit adapted to provide a depolarization output pulse sufficient to cause depolarization of
cardiac tissue from an implanted position, wherein the electrical circuit is electrically coupled to the first electrode and the second electrode such that one of the first electrode and second electrode is the anode and the other is the cathode for a
depolarization output pulse of the electrical circuit;  and a lead electrode electrically coupled to the electrical circuit located within the housing;  wherein the spacing between the first and second electrodes is such that a depolarization vector is
formed with respect to a patient&#39;s heart between the first and second electrodes when a depolarization output pulse from the electrical circuit is output through the first electrode and the second electrode.
21.  The implantable cardioverter-defibrillator of claim 20, wherein the lead electrode is coupled to the electrical circuit located within the housing through a connection port.
22.  The implantable cardioverter-defibrillator of claim 20, wherein the first electrode, second electrode and lead electrode can emit an energy for shocking a patient&#39;s heart.
23.  The implantable cardioverter-defibrillator of claim 20, wherein the electrical circuit is further adapted to receive sensory information.
24.  The implantable cardioverter-defibrillator of claim 23, wherein the sensory information that is receivable concerns a patient&#39;s blood glucose level.
25.  The implantable cardioverter-defibrillator of claim 23, wherein the sensory information that is receivable concerns a patient&#39;s respiratory rate.
26.  The implantable cardioverter-defibrillator of claim 23, wherein the sensory information that is receivable concerns a patient&#39;s blood oxygen content.
27.  The implantable cardioverter-defibrillator of claim 23, wherein the sensory information that is receivable concerns a patient&#39;s blood pressure.
28.  The implantable cardioverter-defibrillator of claim 23, wherein the sensory information that is receivable concerns a patient&#39;s activity.
29.  The implantable cardioverter-defibrillator of claim 20, wherein the electrical circuit is configured to receive sensory information from at least one pair of electrodes chosen from the lead electrode and the first and second electrodes, the
sensory information concerning a patient&#39;s cardiac output.
30.  The implantable cardioverter-defibrillator of claim 20, wherein the first electrode and the lead electrode form a depolarization vector with respect to a patient&#39;s heart.
31.  The implantable cardioverter-defibrillator of claim 20, wherein the first electrode and second electrode form a depolarization vector with the lead electrode with respect to a patient&#39;s heart.
32.  The implantable cardioverter-defibrillator of claim 20, wherein the first electrode and the lead electrode form a depolarization vector with the second electrode with respect to a patient&#39;s heart.
33.  The implantable cardioverter-defibrillator of claim 20, wherein the electrical circuit is programmed prior to implantation into the patient.
34.  The implantable cardioverter-defibrillator of claim 33, wherein the electrical circuit is capable of being further programmed after implantation into the patient.
35.  The implantable cardioverter-defibrillator of claim 20, wherein the electrical circuit can provide a cardioversion-defibrillation energy to a patient&#39;s heart.
36.  The implantable cardioverter-defibrillator of claim 35, wherein the electrical circuit can further provide multiphasic waveform cardiac pacing for the patient&#39;s heart.
37.  The implantable cardioverter-defibrillator of claim 35, wherein the electrical circuit can further provide monophasic waveform cardiac pacing for the patient&#39;s heart.  Description
in U.S.  Pat.  No. 5,476,503, the disclosure of which is incorporated herein by reference.
One embodiment of the present invention provides an implantable cardioverter-defibrillator for subcutaneous positioning over a patient&#39;s ribcage, the implantable cardioverter-defibrillator includes a housing having a first end and a second end; a
first electrode disposed upon the first end of the housing; a second electrode disposed upon the second end of the housing; an electrical circuit located within the housing, wherein the electrical circuit is electrically coupled to the first electrode
and the second electrode; and a lead electrode electrically coupled to the electrical circuit located within the housing.
Cardioverter and Defibrillator,&quot; Computers in Cardiology (1986) pp.  167 170.  Detection can be provided via R--R Cycle length instability detection algorithms.  Once atrial fibrillation has been detected, the operational circuitry will then provide QRS
and specificity by examining QRS beat-to-beat uniformity, QRS signal frequency content, R--R interval stability data, and signal amplitude characteristics all or part of which can be used to increase or decrease both sensitivity and specificity of S-ICD
disclosures a composite electrode with a coil cardioversionldefibrillation electrode and sense electrodes.  Modifications to this arrangement are 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
onset of atrial fibrillation.  In an alternative embodiment of a detection algorithm, the ventricular detection rate could be monitored for stability of the R--R coupling interval.  In the examination of the R--R interval sequence, atrial fibrillation
can be recognized by providing a near constant irregularly irregular coupling interval on a beat-by-beat basis.  A R--R interval plot during AF appears &quot;cloudlike&quot; in appearance when several hundred or thousands of R--R intervals are plotted over time
when compared to sinus rhythm or other supraventricular arrhythmias.  Moreover, a distinguishing feature compared to other rhythms that are irregularly irregular, is that the QRS morphology is similar on a beat-by-beat basis despite the irregularity in
the R--R coupling interval.  This is a distinguishing feature of atrial fibrillation compared to ventricular fibrillation where the QRS morphology varies on a beat-by-beat basis.  In yet another embodiment, atrial fibrillation may be detected by seeking
to compare the timing and amplitude relationship of the detected P-wave of the electrocardiogram to the detected QRS (R-wave) of the electrocardiogram.  Normal sinus rhythm has a fixed relationship that can be placed into a template matching algorithm
that can be used as a reference point should the relationship change.
arrhythmias, one may be able to use different electrode systems than what is used to treat ventricular arrhythmias.  Another embodiment, would be to allow for different types of therapies (amplitude, waveform, capacitance, etc.) for atrial arrhythmias
FIGS. 19 27 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
thoracic sizes and shapes.  More particularly, FIGS. 19 27 detail various material constructions, dimensions and curvatures that are incorporated within the numerous S-ICD canister designs detailed in FIGS. 19 27.
will generally use voltages in the range of 700 V to 3150 V, requiring energies of approximately 40 J to 210 J. These energy requirements will vary, however, depending upon the form of treatment, the proximity of the canister from the patient&#39;s heart,
significant portion of a patient&#39;s thorax.  The compliant material in this embodiment may comprise a portion of the canister housing, or alternatively, may comprise the canister housing in its entirety.  The correct material selection (or combination
reduction in surface friction also continues on long after implantation through a significant reduction in inflammation and soreness, lending to an overall heightened feeling of wearability and comfort.
reduction in surface friction also continue on long after implantation through a significant reduction in inflammation and soreness, lending to an overall heightened feeling of wearability and comfort.
surface between approximately 100 square millimeters and approximately 2000 square millimeters in area.  As with the size of the canister housing 192, the size of the electrically conductive surface may vary to accommodate the particular patient
extend perpendicular with a recipient&#39;s rib cage, can have their conductive surface&#39;s length 207 being greater than their conductive surface&#39;s width 205.  The appropriate S-ICD canister 190 alignment, and subsequently the appropriate electrode 204
190 and the second vector end point comprises the proximal end 202 of the SICD canister 190.  In particular embodiments, the curvature vector .theta.  possesses a degree of separation between 30 degrees and 180 degrees.  For example, a canister housing
In certain embodiments of the present invention, the electronic components (e.g., circuitry, batteries and capacitors) of the S-ICD canister 220, are generally absent from the distal housing member 230.  As such, the depth of the distal housing
depicted in FIG. 26A, 26B and 26C specifically have a distal segment 282 and a proximal segment 284 hinged, or otherwise coupled, together.
Referring now to FIG. 27, a US-ICD canister 310 embodiment is shown.  In this embodiment, the US-ICD canister 310 comprises a proximal end 312, a distal end 314 and two electrodes--a first electrode 316 and a second electrode 318.  The first
electrode 316 is shown as having a thumbnail shape and is located near the distal most end of the US-ICD canister 310.  Although a thumbnail shape is depicted for the first electrode 316, alternative shapes (described in detail above) are also suitable
The second electrode 318 depicted in FIG. 27 is disposed at the proximal end 312 of the US-ICD canister 310.  More specifically to the illustrated embodiment, the second electrode 318 is positioned just distally from the proximal-most end of the
US-ICD canister 310.  This positioning of the second electrode 318 permits the accommodation of a connection port 320 on the US-ICD canister 310.  Similar to the first electrode 316, however, the second electrode 318 is also depicted as generally
following the contours of the canister housing.
The connection port 320 couples the operational circuitry housed within the US-ICD canister 310 to ancillary devices.  In particular embodiments, the connection port 320 couples the operational circuitry to a lead 328, and ultimately to a lead
electrode 330; of which the electrode portion 332 is shown in phantom in FIG. 27.  Although FIG. 27 depicts the connection port 320 at the proximal-most end of the US-ICD canister 310, connection ports 320 may be positioned anywhere along the canister
housing.  In particular embodiments, however, the connection ports 320 are located at the distal end 314 or proximal end 312 of US-ICD canisters 310.  In yet additional embodiments, connection ports 320 may be positioned at both the distal end 314 and
the proximal end 312 of the US-ICD canister 310.
In the connection port 320 embodiment depicted in FIG. 27, the connection port 320 comprises, in part, of a socket 322.  The socket 322 of the connection port 320 acts as a receptacle for ancillary devices.  More specifically, the socket 320
mates with a portion of the ancillary device to enable the flow of electrical information between the US-ICD canister 310 and the ancillary device.  In the embodiment depicted in FIG. 27, a portion of the lead 328 mates within the socket 322 of the
connection port 320.
In particular embodiments, the mating of the lead 328 to the socket 322 forms a friction fit hermetic seal.  In many instances, this friction fit seal prevents unintentional uncoupling of the ancillary device from the socket 322.  In alternative
embodiments, however, additional mechanical means may be utilized to insure against such an accidental uncoupling.  An example of an additional means for securing the connection between the ancillary device and the socket 322 is through a set screw.  A
set screw, when properly advanced against an object, applies a positive pressure that prevents the displacement of that object.  In the present invention, the set screw is utilized to provide a positive pressure against an ancillary device once properly
inserted within the connection port&#39;s socket 322.  Additional securing means, being known in the art, are additionally incorporated herein as being within the spirit and scope of the present invention.
To further form a hermetic seal between the ancillary device and the US-ICD canister 310, certain embodiments further comprise a shell 324 encased over a portion of the socket 322.  The shell 324 includes an aperture 326 that aids in guiding the
ancillary device into the connection port&#39;s socket 322.  In certain embodiments, the aperture 326 also forms a seal around the ancillary device when the ancillary device passes through the shell&#39;s aperture 326.  More specifically, the shell 324 provides
a hermetic seal that prevent bodily fluids from entering through the aperture 326 and into the connection port 320.
In particular embodiments, the material forming the shell 324 of the connection port 320 is translucent.  By utilizing a translucent material for the shell 324, a physician may visually assess whether a proper connection is made between the
ancillary device and the socket 322.  As such, materials suitable for forming the connection port&#39;s shell 324 generally include polymeric materials.  Polymeric materials suitable for the connection port&#39;s shell 324 of the present invention include
polyurethanes, polyamides, polyetheretherketones (PEEK), polyether block amides (PEBA), polytetrafluoroethylene (PTFE), polyetheylene, silicones, and mixtures thereof.
The utilization of ancillary devices in conjunction with a US-ICD canister 310 enables a physician to enhance the care provided to their patient recipients.  In particular, the use of a US-ICD canister 310 with an additional ancillary device
(e.g., lead electrode 330) allows the operational circuitry in the US-ICD canister 310 to utilize multiple electrodes and sensors.  This permits the physician to best regulate and treat the particular condition experienced by a patient recipient.  For
example, a physician may utilize the first electrode 316 and the second electrode 318 on the US-ICD canister 310 for shocking and pacing, while utilizing the lead electrode 330 for sensing.  In particular, the lead electrode 330 may be utilized for
monitoring the patient&#39;s blood glucose level, respiration, blood oxygen content, patient activity, blood pressure and/or cardiac output, and as an accelerometer while the first electrode 316 and the second electrode 318 are utilized in pacing.
Since the length between each electrode is different in the embodiment depicted in FIG. 27, at least three depolarization vectors may be formed.  In illustration, the first electrode 316 and the second electrode 318 on the US-ICD canister 310
form a first depolarization vector; the first electrode 316 and the lead electrode 330 form a second depolarization vector; and the second electrode 318 and the lead electrode 330 form a third depolarization vector.  Moreover, all the electrodes may be
used for shocking at the same time.  In these embodiments, two of the electrodes form an additional depolarization vector with the third electrode.  As a result, three more depolarization vectors are additionally created.  If multiple ancillary devices
are connected to the US-ICD canister 310, the number of depolarization vectors increase accordingly.  Moreover, the electronic circuitry of the US-ICD may utilize the two electrodes forming the most effective depolarization vector for shocking, while
utilizing the remaining electrode for sensing functions.  In these arrangements, all electrodes are capable of sensing and shocking functions, and these functions may alternate as the programming of the US-ICD determines the best arrangement for the
particular needs of the patient recipient.
The electronic circuitry contained within the US-ICD canister 310 may utilize these multiple depolarization vectors when attempting to recapture a patient&#39;s heart rate, or in other cardioversion-defibrillation therapies.  The electronic circuitry
may be programmed either before implantation, or in follow-up examination.  If the electronic circuitry is programmed before implantation, the physician may indicate which depolarization vectors may be used, or alternatively, what array of depolarization
vectors the electronic circuitry should utilize when treating the patient recipient&#39;s particular condition.  The physician would also identify what sensing functions, and in what arrangement, should be used in monitoring the condition of the patient
In an alternate method of treatment, the physician may improve upon the initial programming of the electronic circuitry in a follow-up examination.  During follow-up examinations, the physician may reprogram the electronic circuitry externally
through devices known in the art (e.g., a programmer).  These devices permit the physician to adjust the US-ICD&#39;s programming to better treat the particular needs of the patient.  For example, this follow-up reprogramming procedure may involve the
physician utilizing new depolarization vectors in the treatment of the patient&#39;s condition.  Alternatively, the physician may wish to monitor particular physiological activities.  Reprogramming the electronic circuitry permits the US-ICD to adjust the
sensing and detection of these physiological activities and the corresponding shocking/pacing response.
In yet an alternative method of treatment, the electronic circuitry is programmed to detect particular physiological conditions, and automatically respond to these conditions.  For example, if for instance, one depolarization vector fails to
recapture the patient&#39;s heart rate, the US-ICD programming would automatically initiate the utilization of one of the alternative depolarization vectors to perform this recapturing function.  Such programming would permit the US-ICD to sense and shock in
an array of patterns to best serve the needs of a particular patient.  Thus, the programming could sense the difference between AF and VF, and utilize the most appropriate depolarization vector (or array of depolarization vectors) to treat the particular
condition.  Thus, the inclusion of an ancillary device to a US-ICD canister permits great flexibility in the programming of the US-ICD, and ultimately in the thoroughness of possible treatments and responses from an implanted US-ICD.
Implantable cardioverter-defibrillator having two spaced apart shocking electrodes on housing, Bardy, et al., Gust H. Bardy, Riccardo Cappato, William J. Rissmann, Gary H. Sanders, Application number 10 011-566, Surgery: LightThermal And Electrical Application, implantable cardioverter-defibrillator, electrode system, implantable defibrillator, pulse generator, implantable electrodes, preferred embodiment, present invention relates, Health, Patent Search, implantable cardioverter defibrill
Defibrillation/cardioversion is a technique employed to counter arrhythmic heart conditions including some tachycardias in the atria and/or ventricles. Typically, electrodes are employed to stimulate the heart with electrical impulses or shocks,of a magnitude substantially greater than pulses used in cardiac pacing. Because current density is a key factor in both defibrillation and pacing, implantable devices may improve what is capable with the standard waveform where the current and voltagedecay over the time of pulse deliver. Consequently, a waveform that maintains a constant current over the duration of delivery to the myocardium may improve defibrillation as well as pacing.Defibrillation/cardioversion systems include body implantable electrodes that are connected to a hermetically sealed container housing the electronics, battery supply and capacitors. The entire system is referred to as implantablecardioverter/defibrillators (ICDs). The electrodes used in ICDs can be in the form of patches applied directly to epicardial tissue, or, more commonly, are on the distal regions of small cylindrical insulated catheters that typically enter thesubclavian venous system, pass through the superior vena cava and, into one or more endocardial areas of the heart. Such electrode systems are called intravascular or transvenous electrodes. U.S. Pat. Nos. 4,603,705, 4,693,253, 4,944,300, 5,105,810,the disclosures of which are all incorporated herein by reference, disclose intravascular or transvenous electrodes, employed either alone, in combination with other intravascular or transvenous electrodes, or in combination with an epicardial patch orsubcutaneous electrodes. Compliant epicardial defibrillator electrodes are disclosed in U.S. Pat. Nos. 4,567,900 and 5,618,287, the disclosures of which are incorporated herein by reference. A sensing epicardial electrode configuration is disclosedin U.S. Pat. No. 5,476,503, the disclosure of which is incorporated herein