USOORE42933E

(19) United States (12) Reissued Patent

(10) Patent Number:

Tang et a]. (54)

(45) Date of Reissued Patent:

METHOD AND APPARATUS FOR AVOIDING

(56)

Nov. 15, 2011

References Cited

UNWANTED SENSING IN A CARDIAC RHYTHM MANAGEMENT DEVICE

U~S~ PATENT DOCUMENTS 5,275,621 A *

(75) Inventors: Zhengnian JlllIO C. Spinelli, Tang, Lakewood ShorevieW,Ranch, MN (UFL S); (US); Jeffrey E. Stahmann, Ramsey,

MN (DE); Andrew ReneP.HI Kramer, Wentkowski’ MarineBerlin on St.

Creix, MN (Us); PaulA- Haefller, Circle Pines, MN (US) MN (Us)

1/1994

Mehra ............................. .. 607/5

536433326 A 2 >ix<

7/1997 Weiner giieet'éi et al‘ N

5,735,881 A

4/1998

*

Routh et a1.

607/14

.......

. . . .. 607/14

FOREIGN * PATENT Legay DOCUMENTS et al' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' "

EP EP

(73) Assignee: Cardiac Pacemakers, Inc., St. Paul,

0318304 A2 0562237 A1

5/1989 9/1993

EP

0594957 A1

5/1994

EP_

_0705620 A2

4/1996

* cited by examlner Primary Examiner * Georg e Manuel

_

(21)

US RE42,933 E

Appl' NO" 11/900’901

Assistant Examiner * Robert N Wieland

_

(74) Attorney, Agent, or Firm * Schwegman, Lundberg &

(22) Flled:

Sep. 13, 2007

Woessner’ p_A_

Related U.S. Patent Documents Reissue Of: _ (64) patent NO"

(57)

A cardiac rhythm management device that utilizes blanking or refracto W P eriods to avoid misidenti?cation of artifacts

69441499

Issued? Appl. No.: Filed:

ABSTRACT

seP- 13, 2005 10/066,989 Feb. 4, 2002

and evoked potentials, Wherein the refractory periods are discontinuous and may be dependent upon sensed events, expiration of a prede?ned timing interval, or stimulation events in the same or other chambers of the heart. The dis

(51) Int, Cl,

continuous refractory periods enhance the ability of the

A61N1/00 (52)

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device to sense intrinsic events. The present invention includes seP arate refractoI'Y and ?oating refracto W P eriods . . . .

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incorporated W1th1n the sens1ng protocol for each selected

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cycle, thereby increasing the time period for normal sensing.

See application ?le for complete search history.

70 Claims, 4 Drawing Sheets

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ENSE REFRACTORY/ BLANKING PERIODS TRIGGERED BY V2 SENSE

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US RE42,933 E 1

2

METHOD AND APPARATUS FOR AVOIDING UNWANTED SENSING IN A CARDIAC RHYTHM MANAGEMENT DEVICE

The effective delivery of stimulation pulses is further dependent upon the normal pacing cycle of the heart. The delivery of the stimulation pulse must be delivered at a proper time during the cardiac cycle or the stimulation pulse may not be effective, may not be as effective, or may be undesirable.

Matter enclosed in heavy brackets [ ] appears in the original patent but forms no part of this reissue speci?ca

The determination of the proper timing of the delivery of the stimulation pulse is further dependent upon proper detection of intrinsic activity in the heart. Polarization voltages and after potentials, which develop at the heart tissue electrode interface following the application of a stimulation pulse, affects the ability of the rhythm management device to accu

tion; matter printed in italics indicates the additions made by reissue. BACKGROUND OF THE INVENTION

rately detect intrinsic activity. As pacemakers have evolved, the pacing modes and con?gurations have become more intri cate and complex, generating an increasing array of polariza

1. Field of the Invention This invention relates generally to a cardiac rhythm man agement device suitable for delivering stimulation pulses to a patient’s heart and more particularly relates to a cardiac

tion voltages and after potentials. Blanking or refractory peri ods, which may be considered as a means for avoiding

unwanted sensing in the cardiac rhythm management

rhythm management device that utilizes a sensing protocol which avoids misidenti?cation of artifacts and evoked poten tials enhancing the ability of the device to sense intrinsic events.

20

upon sensing an intrinsic activity or delivering a stimulation

ll. Discussion of the PriorArt

pulse and last until the end of all predictable artifacts and evoked potentials associated with the event. The blanking or

Over the years, cardiac rhythm management devices have been utilized for supplanting some or all of an abnormal

heart’s natural pacing functions. These devices have rem

25

edied abnormalities including total or partial heart block,

arrhythmias, congestive heart failure, congestive heart disor

refractory period, in effect, causes the pacing logic of the device to “ignore”, for example, detected intrinsic activity. Thus, the typical cardiac rhythm management device runs “blind” even if there is a period of time during this preset period for which no artifact or evoked potential is present and response to a detected intrinsic activity may be desirable.

ders and other various rhythm disturbances within the heart. Typically, the rhythm management device includes a power

supply and pulse generator for generating electrical stimulus

devices, are frequently used to prevent artifacts and after potentials from being improperly detected as intrinsic events. Such blanking or refractory periods are typically initiated

30

pulses delivered to a pre-selected area of the heart. An elec

For example, when pacing in the ventricles and sensing in the atrium, an atrial channel of a sensing circuit of the present

trode lead arrangement (either uni-polar or bi-polar) posi

day cardiac rhythm management devices may have to be

tioned adjacent or within a pre-selected heart chamber is

refractory most of the time because of a long retrograde conduction time. Consequently, a P-wave resulting from intrinsic depolarization may easily fall into a refractory or blanking period, in which case the intrinsic atrial events will not be detected by the device. This reduces the effectiveness of the stimulation protocol of the device. US. Pat. No. 5,735,

electrically coupled to the pulse generator for delivering stimulation pulses to the desired chamber. More recently, electrode lead arrangements have included multiple electrode leads positioned within a single chamber of the heart. Regardless of the type of stimulation device employed to

35

restore the heart’s natural rhythm (i.e. de?brillators, Conges tive Heart Failure (CHE) devices or other devices having logic and timing dependent on sensing of intrinsic heart events), each type operates to stimulate excitable heart tissue cells,

881 to Andre Routh et al. provides a method for increased 40

sensing of intrinsic depolarizations by bifurcating the blank ing period with an atrial sensing period. The Routh et al patent teaches the use of a ?xed blanking period during the post ventricular atrial refractory period (PVARP) and a program mable blanking period to prevent the mischaracterization of a

which may or may not result in evoked response by the heart. Myocardial evoked response to stimulation or “capture” is a

function of the positive and negative charges found in each myocardial cell within the heart. The selective permeability of each myocardial cell works to retain potassium and

far ?eld R-wave as an atrial depolarization event. However, the Routh et al patent does not teach or suggest a method for

exclude sodium such that, when the cell is at rest, the concen tration of sodium ions outside of the cell membrane are sig

potentials generated by multiple site pacing. Multiple site

ni?cantly greater than the concentration of sodium ions inside the cell membrane, while the concentration of potassium ions

accounting for the complex polarization voltages and after pacing may include at least one pacing/sensing site in an 50

atrium and several pacing/sensing sites in one or more ven

tricles. Each intrinsic and each paced event in each of these

outside the cell membrane are signi?cantly less than the con

sites may introduce one or more unwanted potentials in car

centration of potassium ions inside the cell membrane. When a stimulus is applied to the cell membrane, the selective permeability of the cell membrane is disturbed and no longer

diac signals associated with the pacing/sensing sites. Each unwanted potential may have a relatively ?xed temporal rela 55

tionship with at least one intrinsic or paced event in one of the

sites. Because whether such unwanted potentials will be present for an individual patient and how they are temporally

blocks the in-?ow of sodium ions from outside the cell mem brane. The in-?ow of sodium ions at the stimulation site causes the adjacent portions of the cell membrane to lose its

related to any of the intrinsic and paced events are not neces

selective permeability, thereby causing a chain reaction

sarily known before device implantation, applying a pro

across the cell membrane until the cell interior is ?ooded with sodium ions. This process, referred to as “depolarization”, causes the myocardial cell to have a net positive charge due to the in-?ow of sodium ions and an out-?ow of potassium ions. The success of a pacing stimulus in depolarizing or “captur

grammable blanking period, as suggested by Routh et al., will require numerous blanking refractory periods. The number of such blanking or refractory periods will grow exponentially

ing” the selected chamber of the heart is dependent upon whether the amplitude and/or duration of the stimulus as delivered to the myocardium exceeds a required threshold.

65

with the number of pacing/sensing sites in a multiple site pacing system, eventually to a point that requires a system size that cannot be accommodated by an implantable device and, moreover, this causes signi?cant dif?culties and poten

tial for confusion to the physician programming the implant

US RE42,933 E 3

4

able device. What is, therefore, needed is one or more blank

refractory periods associated with the atrium, dependent

ing or refractory periods that do not require excessive system

upon events occurring in the ventricles. Further, the second refractory period may be initiated by an event sensed in an

resources and which are easy to program by a physician who

atrial channel and this refractory period may apply to the

observes the cardiac signals during or after a device implan tation. The present invention meets these and other needs that will become apparent from a review of the description of the

same and/or different atrial channel. Likewise, the second refractory period may be initiated by an event sensed in a

ventricular channel and this refractory period may apply to

present invention.

the same and/ or different ventricular channel.

The controller may be implemented in any of several

SUMMARY OF THE INVENTION

forms, including a dedicated state device or a microprocessor

with code, and may include Read Only Memory (ROM) for

The present invention includes pro grammable refractory or

blanking periods and ?oating refractory or ?oating blanking

storing programs to be executed by the controller and Ran

periods, which are incorporated within the sensing protocol for each selected cycle, thereby increasing the time period for

dom Access Memory (RAM) for storing operands used in carrying out the computations by the controller. The control ler is electrically coupled to the power supply and manipu lates the electrical circuitry for the sensing and tracking and the circuitry for determining and generating stimulation

normal sensing. The ?oating refractory period is initiated by a predetermined (preprogrammed) triggering event and may be retriggerable if a triggering event is detected during the

?oating refractory period.

pulses, during each cardiac cycle. The prede?ned sensing

The present invention provides a single- or multi-chamber

cardiac rhythm management device having multiple pacing

20

electrodes positioned at a plurality of sites within selected

chamber(s) of the heart. The cardiac rhythm management

The circuitry for sensing includes one or more channels for

device of the present invention stimulates the heart in a pre

selected stimulation mode, and increases the time period dur ing a selected cardiac cycle for normal sensing. The cardiac rhythm management device of the present invention includes a power supply, a controller, circuitry for sensing intrinsic

cardiac events, timing circuitry, a prede?ned sensing proto col, and circuitry for determining and generating stimulation pulses. The controller and circuitry for sensing are capable of

sensing events associated with the atrium and/or one or more 25

these sensed events. The transmitted signals may be utilized

by the controller, for example and without limitation, to there 35

utilizes the timing and sensing circuitry for determining and generating stimulation pulses to selectively stimulate pre 40

refractory or blanking periods that may follow a shortened

“conventional” programmed refractory or blanking period. The ?oating refractory or blanking periods are initiated by

observing all of the cardiac signals sensed from different sites in the heart and then ascertaining a temporal relationship between the unwanted potential and a known, repeatable intrinsic or paced event. The device is then pro grammed with the known repeatable intrinsic or paced event employed as a

50

period, the event may be detected and “marked” by the

device, with the pacing logic ignoring the event. The trigger ing event for the ?oating refractory period may be de?ned, for example, by an arbitrary pace, sense, and/or timing interval expiration event. The ?oating refractory period may be asso

initiated automatically if intrinsic conduction from the ven tricle is sensed. In use, the cardiac rhythm management device of the present invention may be utilized to stimulate pre-selected chambers of a patient’s heart in accordance with a prede?ned stimulation sequence. The present invention provides a method for assisting a physician in avoiding an unwanted

potential by ?rst identifying the unwanted potential by 45

?xed in duration or may be retriggerable if a triggering event

occurs during the ?oating refractory period. Also, if a trigger ing event occurs during the ?oating refractory or blanking

intrinsic conduction from the atrium is sensed. In another

alternative embodiment, the second refractory period may be

selected chambers of the patient’s heart. As described below in greater detail, in the preferred

prede?ned or programmed triggering events. Those skilled in the art will appreciate that the ?oating refractory or blanking period may be implemented in ?xed hardware and/or soft ware of the device. The ?oating refractory period may be

refractory period, thereby potentially inhibiting a response in accordance with the pacing logic. The second or ?oating refractory period may be initiated a predetermined amount of time after the end of the ?rst refractory period. Alternatively, the second refractory period may be initiated automatically if

transmitting signals containing information corresponding to

embodiment, the controller initiates one or more ?oating

channels for sensing events associated with the ventricles. The controller, in accordance with a preset sensing protocol, manipulates the sensing channels to create, for example, the ?rst and second refractory periods. Without limitation, the controller may blank a portion of the signal sensed from either the atrium or ventricles that is sensed during the second

30

detecting and identifying atrial and/ or ventricular events and

after track, over time, the sensed events. The controller also

protocol may be stored in the controller and is utilized by the controller to increase the time period during a cardiac cycle for normal sensing of intrinsic events.

trigger event that triggers a blanking or refractory period. A sensing channel where the unwanted potential is identi?ed is then programmed as the channel to which the blanking or

refractory period is to be applied. Further, a delay value is 55

pro grammed that starts with the trigger event and that extends to a point in time before which the unwanted potential is

ciated with one or more device channels, and one triggering

believed not to occur. Finally, a duration of the blanking or

event can simultaneously trigger ?oating refractory periods

refractory period that starts with the end of the delay and

for one or more or a combination of other device sensing

extends to cover a period of time during which the unwanted

channels. In one embodiment of the present invention, the sensing protocol utilized by the controller includes a ?rst and a second

potential is believed to have occurred is programmed. It is accordingly a principal object of the present invention to provide an enhanced blanking or refractory period that

60

refractory period for sensed events in pre-selected chambers during the cardiac cycle. The controller may initiate ?rst and second refractory periods associated with the ventricles,

reduces the likelihood of failure to identify intrinsic events. Another object of the present invention is to provide a

rhythm management device having a sensing protocol that

provided for between the ?rst and second refractory periods.

avoids misidenti?cation of artifacts and evoked potentials while enhancing the ability of the device to sense intrinsic

Alternatively, the controller may initiate ?rst and second

events by increasing the time period for normal sensing.

dependent upon events occurring in the atrium. A time gap is

65

US RE42,933 E 6

5 Still another object of the present invention is to provide a

to include the sensing protocol of the present invention as

cardiac rhythm management device that increases the ability

described below in greater detail. In particular, the refractory/ blanking periods may be implemented in hardware and/or

of the device to detect tachyarrhythmias. Yet another object of the present invention is to provide a cardiac rhythm management device that may include separate

software in a known manner.

Referring next to FIG. 2, one embodiment of the sensing

refractory and ?oating refractory periods for each selected

protocol which utilizes a refractory period 44 and ?oating refractory period 46 is shown. In this embodiment, electro

cardiac cycle which may be utilized to increase the time

period for normal sensing.

gram signals 38 and 40 are sensed over time by respective

These and other objects and advantages of the present

atrial and ventricular sensing channels comprising sensing

invention will become readily apparent to those skilled in the art from a review of the following detailed description of the invention especially when considered in conjunction with the claims and accompanying drawings in which like numerals in the several views refer to corresponding parts.

refractory period 44 having a predetermined duration and then later initiates a ?oating refractory period 46 also having

circuit 34 in FIG. 1. The sensing protocol initiates a ?rst

a predetermined duration. The initiation of the ?rst refractory

period 44 and the ?oating refractory period is dependent upon the timing of sensed signals exceeding a predetermined

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram depicting a cardiac rhythm man

agement device in accordance with the present invention; FIG. 2 is a plot showing retrograde conduction sensed by an atrial sensing channel of the sensing circuit and associated

20

refractory and ?oating refractory periods in comparison with a conventional Post Ventricular Atrial Refractory Period; FIG. 3 is a plot showing an intrinsic event sensed by the atrial and ventricular sensing channels of the sensing circuit

25

threshold. The ?oating refractory period 46 is initiated a preset time following a triggering event and lasts for a prede termined amount of time. The ?oating refractory period 46 is used in combination with the ?rst refractory period 44 to increase the time available for normal sensing. In the embodiment shown in FIG. 2, the triggering event is de?ned by the expiration of a predetermined timing interval. It should be appreciated that the triggering event is program mable and may alternately include for example, without limi

and associated refractory and ?oating refractory periods in

tation, a paced event or a sensed event in either the atrium or

conjunction with atrial stimulation and associated ventricular

ventricles. Further, the ?oating/blanking or refractory period

refractory and ?oating refractory periods;

may be implemented in a sensing protocol for either the atrium or ventricles. Also, the amount of time required for the

FIG. 4 is a plot showing several pacing and intrinsic events in relation to the timing and occurrence of a ?rst refractory

30

refractory period 44 and ?oating refractory period 46 may be varied through physician programming, depending upon the

and second refractory or ?oating refractory/blanking period; FIG. 5 is a plot showing retrograde conduction sensed by

particular patient’s needs.

an atrial sensing channel of the sensing circuit and an asso

As further seen in FIG. 2, following a ventricular pace or ventricular intrinsic event the atrial electrogram 38 includes a

ciated non-retriggerable ?oating refractory period and a son; and FIG. 6 shows a progression of modi?cations to the conven

potential artifact 48 later followed by a retrograde conducted P-wave 50 occurring several milliseconds after the end of the sensed potential artifact and the end of the sensed ventricular

tional refractory period to derive a preferred ?rst shortened “conventional” refractory period and a second ?oating refrac tory period, which may be utilized to automatically program

46 blank the sensing circuit 34 from reacting to the artifact 48 and retrograde P-wave 50, but allows for sensing events

retriggerable ?oating refractory period shown for compari

35

event. The refractory period 44 and ?oating refractory period 40

occurring between the artifact 48 and retrograde 50, thus maximizing the time available for normal sensing. This increased time for sensing may be particularly relevant in

the refractory and ?oating refractory periods. DETAILED DESCRIPTION OF THE INVENTION

treating CHF patients having conduction defects, since arti

The present invention represents broadly applicable

45

especially long PVARP) than experienced by patients having

management device. The embodiments detailed herein are intended to be taken as representative or exemplary of those in

which the improvements of the invention may be incorpo rated and are not intended to be limiting. Referring ?rst to

FIG. 1, the cardiac rhythm management device 10 of the present invention is shown including a housing 12, atrial lead 14, and ventricular lead 16. The distal end of the atrial lead shown positioned in the right atrium includes electrodes 18 and 20. The distal end of the ventricular lead 16 shown posi tioned in the right ventricle includes ventricular electrodes 22 and 24. The atrial lead 14 and ventricular lead 16 are engaged to header 26 a?ixed to the housing and may be electrically coupled to the power supply 28 and controller 30 contained within the housing 12 in a known fashion. It should be appre

ciated that other lead con?gurations of known construction may be utilized, dependent upon the particular desired stimu lation and particular placement of the lead. Without limita tion, the controller 30 includes a pulse generator 32, sensing circuit 34, stimulation circuit 36 and timing circuit 37. The

facts and/or evoked potentials may occur a signi?cantly

longer time after the triggering event (thereby requiring an

improvements to the sensing protocol of a cardiac rhythm

50

55

normal conduction times. Further, in left ventricular pacing of a CHF patient, when the lead is in a uni-polar con?guration and placed near the base of the ventricle, signals associated with left atrium activity may also be sensed by the left ven tricular lead. Those skilled in the art will appreciate that the ?oating/blanking refractory period 46 may be used to blank signals corresponding to the left atrial P-wave with minimum

interruption of left ventricular sensing. In bi-ventricular or other multi-site pacing, additional arti

fact and evoked potentials are expected which consequently

require longer refractory periods, thereby further reducing the normal sensing time. For example, in the case of bi 60

ventricular pacing, the ventricular refractory period must be long enough to blank out far-?eld sensing and/or retrograde conduction from both the right ventricle and the left ventricle.

These long ventricular refractory periods may be required to

pulse generator 32, sensing circuit 34, stimulation circuits 36,

prevent the right ventricular channel from sensing left ven tricular activities and vice versa. The ?oating blanking refrac tory/period will extend the normal sensing time and may also

and timing circuit 37 of known construction may be modi?ed

be implemented in other multi-channel stimulation con?gu

65

US RE42,933 E 7

8

rations, ensuring successful implementation of brady and

blanking/refractory periods in a pacemaker, de?brillator,

tachy therapy algorithms by maximizing the normal sensing

CHF device, and/or atrial ?brillation devices or any other

time.

device whose logic and timing depend on sensing events. Use

FIG. 3 illustrates refractory and ?oating refractory periods,

of the ?rst refractory and ?oating refractory periods maxi

44 and 46 respectively, in both the atrial and ventricular channels when pacing 54 occurs in the atrium. A pacing event is identi?ed by numeral 54 in FIG. 3. In this embodiment, the

mizes the normal sensing time for each sensing channel. Those skilled in the art will appreciate that the procedure for

triggering event for the ?oating refractory period 46' in the

may also be utilized manually by a programmer. This invention has been described herein in considerable detail in order to comply with the patent statutes and to provide those skilled in the art with the information needed to apply the novel principles and to construct and use such specialized components as are required. However, it is to be understood that the invention can be carried out by speci?

automatically implementing the ?oating refractory period

ventricular channel is a paced event 54 in the atrium. lmple

menting refractory and ?oating refractory periods for each sensing channel increases the total time for normal sensing. FIG. 4 illustrates implementation of refractory and ?oating

refractory periods 44 and 46 respectively for multiple sensing channels identi?ed as A1, A2, V1, and V2, wherein the ?oat

ing refractory periods 46 are triggered by paced and intrinsic events. Three pacing/ sensing sequences divided by dotted

cally different equipment and devices, and that various modi ?cations, both as to the equipment and operating procedures, can be accomplished without departing from the scope of the

vertical lines 56 and 58 may each occur independently. Although the pacing/sensing sequences are shown sequen tially, the representation should not be construed as sequen

tially limited, but, rather, those skilled in the art will appreci

invention itself. 20

What is claimed is:

ate that each sequence may occur independently of the other.

1. A cardiac rhythm management device capable of detect

With reference to the ?rst of the three pacing/ sensing

ing intrinsic depolarization events, comprising:

sequences, a pacing stimulus 60 is delivered to an atrium

associated with sensing channel A1. A refractory period 44 is initiated in each channel A1, A2, V1, and V2 at the time the

a pulse generator for selectively stimulating a plurality of 25

pacing stimulus 60 is delivered. A ?oating refractory period 46 is initiated for each sensing channel A2, V1, and V2. As

illustrated, the ?oating refractory period 46 may blank sensed events occurring during the refractory period. Referring to the next pacing/ sensing sequence shown in FIG. 4, a pacing

tioned within a sensing channel for an atrium of the 30

stimulus 62 is delivered to a ventricle associated with the

sensing channel V1 . A refractory period 44 is initiated on each

channel A1, A2, V1, andV2 at the time the pacing stimulus 62 is delivered. A ?oating refractory period 46 is then initiated for each sensing channel A1, A2, and V1. A subsequent event sensed in channel V1 triggers a ?oating refractory period 46 in channel A2. The third pacing/ sensing sequence shown in

depolarization events during a plurality of program mable refractory periods in timed relation relative to a

sensed triggering event [in] programmably selected ?om one of a plurality of programmably selectable sens

ing channels. 40

nels A1 and A2.

The start and duration of the ?oating refractory period 46 for a given sensing channel may also be programmed as a function of the heart rate or pacing rate. Also, the ?oating refractory period may be programmed to restart upon occur

patient’s heart and a second electrode positioned within a sensing channel for a ventricle of the patient’s heart; and a controller con?gured to receive data from the sensing circuit and to control the pulse generator, wherein the controller prevents the use of data to detect intrinsic

35

FIG. 4 shows an intrinsic event 64 sensed by channel V2 which initiates a refractory period 44 in channels V1 and V2.

Floating refractory periods 46 are initiated in channels A1 and A2 which blanks sensing of intrinsic events detected in chan

sites in at least one chamber of a patient’s heart;

a sensing circuit con?gured to receive signals indicative of the depolarization events from a ?rst electrode posi

2. The cardiac rhythm management device, as in claim 1, wherein one of the plurality of refractory periods is a ?oating refractory period that may selectively be applied to said at least one sensing channel for the atrium and said at least one

45

sensing channel for the ventricle. 3. The cardiac rhythm management device, as in claim 1, wherein at least one of the programmable refractory periods

rence of a triggering event during ?oating refractory period

is initiated a predetermined amount of time after the end of a

(see FIG. 5).

?rst refractory period, the ?rst refractory period being initi

In use, under certain circumstances the timing and duration

of the ?oating refractory period may be automated. For

ated coincidental with sensing an intrinsic event. 50

4. The cardiac rhythm management device, as in claim 1, wherein at least one of the programmable refractory periods is triggered by a stimulation of a pre-selected chamber of the heart. 5. The cardiac rhythm management device, as in claim 1,

55

wherein the triggering event is a sensed intrinsic event.

example, with reference to FIG. 6, the device may start by

using a maximum conventional refractory period (PVARP). The refractory period is then shortened to the minimum con ventional refractory period 70. A window 72 in the shortened conventional PVARP is created and then the window 72 is

6. The cardiac rhythm management device, as in claim 1,

extended or maximized.

Alternatively, the device may gradually shorten the refrac tory period until a potential is sensed. The duration for the ?rst refractory period may then be de?ned a predetermined amount greater than the elapsed time until the potential was

wherein the triggering event includes a paced event.

7. The cardiac rhythm management device, as in claim 1, wherein the triggering event includes an intrinsic atrial event. 60

8. The cardiac rhythm management device, as in claim 1,

sensed. A window of time that “interrupts” a conventional

wherein the triggering event includes an intrinsic ventricular

refractory period may expand from the end of the ?rst refrac tory period to cover the time during which nothing is sensed. As described above, this window may expand by a prede?ned

event.

amount, may terminate when a pace occurs or when an intrin

9. The cardiac rhythm management device, as in claim 1, wherein the triggering event includes a paced atrial event. 65

10. The cardiac rhythm management device[of], as in

sic event is sensed. As recognized above, the various embodi

claim 1, wherein the triggering event includes a paced ven

ments of this invention include using one or more ?oating

tricular event.

US RE42,933 E 9

10

11. The cardiac rhythm management device, as in claim 1, Wherein preprogrammed sensed triggering events from the atrium are blanked during a ?oating refractory period. 12. The cardiac rhythm management device, as in claim 1, Wherein preprogrammed sensed triggering events from the ventricle are blanked during a ?oating refractory period. 13. The cardiac rhythm management device, as in either claim 11 or claim 12, Wherein the ?oating refractory period is

[(a)] a controller; [(b)] means for stimulating at least one of an atrium or

ventricle of a heart, said means being electrically

coupled to said controller; [(c)] sensing means for sensing a cardiac electrogram, said sensing means electrically coupled to the controller; [(d)] an atrial lead having an atrial electrode electrically coupled to the controller;

retriggerable. 14. The cardiac rhythm management device, as in claim 1, Wherein the controller initiates ?rst and second refractory periods associated With the ventricle dependent upon sensed triggering events occurring in the atrium. 15. The cardiac rhythm management device, as in claim 1, Wherein the controller initiates ?rst and second refractory periods associated With the atrium dependent upon sensed triggering events occurring in the ventricle. 16. A multi-chamber cardiac rhythm management device functioning in a pre- selected stimulation mode and capable of atrial and ventricular tracking, said device comprising:

[(e)] a ventricular lead having a ventricular electrode elec

trically coupled to the controller; and [(f)] said controller having means for de?ning a refractory period and a ?oating refractory period for a predeter mined cardiac cycle for a [programmable] programma bly selectable chamber of the heart that is programmably

selectable for applying the refractory period and the

?oating refractory period thereto. 26. The cardiac rhythm management device recited in claim 25, Wherein the sensing means includes a programma 20

tricular events and transmitting signals containing infor mation corresponding to sensed events; stimulation means for selectively stimulating pre-selected chambers of the patient’s heart; and

bly designate sensing channel for the atrium and a program

mably designated sensing channel of the ventricle Wherein the controller selects the sensing channel in creating the

sensing means for sensing at least one of atrial and ven

refractory period and ?oating refractory period. 27. The cardiac rhythm management device as recited in 25

a programmable controller coupled to said means for sens

claim 25, Wherein the ?oating refractory period is initiated a preprogrammed amount of time after the end of the refractory

ing and said stimulation means, Wherein during a cardiac

period.

cycle said controller manipulates the means for sensing

[28. The cardiac rhythm management device as recited in claim 26, Wherein the ?oating refractory period is initiated a preprogrammed amount of time after the end of the refractory

to thereby create [a] ?rst and second refractory [period] periods of sensed events for programmably [pre-se

30

period.]

lected chambers] selected sites in the patient’s heart

during the cardiac cycle, wherein the programmably

29. The cardiac rhythm management device as recited in

selected sites are programmably selected for applying

claim 25, Wherein the ?oating refractory period is initiated if

the ?rst and second refractory periods thereto. 17. The cardiac rhythm management device as recited in

intrinsic events from the atrium are sensed. 35

30. The cardiac rhythm management device as recited in

claim [15] 16, Wherein the second refractory period is initi

claim 25, Wherein the ?oating refractory period is initiated if

ated a predetermined amount of time after the end of the ?rst

intrinsic events from the ventricle are sensed.

refractory period.

31. The cardiac rhythm management device as recited in claim 25, Wherein sensed events from the atrium are blanked

[18. The cardiac rhythm management device as recited in claim 15, Wherein the second refractory period is initiated a predetermined amount of time after the end of the ?rst refrac

40

32. The cardiac rhythm management device as recited in claim 25, Wherein sensed events from the ventricles are

tory period.]

blanked during the ?oating refractory period.

19. The cardiac rhythm management device as recited in

claim [15] 1 6, Wherein the controller is programmed such that the second refractory period is initiated if intrinsic events

during the ?oating refractory period.

45

33. The cardiac rhythm management device as recited in claim 25, Wherein the controller initiates a refractory period

and ?oating refractory period associated With the ventricles

from the atrium are sensed.

20. The cardiac rhythm management device as recited in

dependent upon preprogrammed triggering vents occurring

claim [15] 1 6, Wherein the controller is programmed such that the second refractory period is initiated if intrinsic events

in the atrium. 34. The cardiac rhythm management device as recited in

from the ventricle are sensed.

50

claim 25, Wherein the controller initiates a refractory period

21. The cardiac rhythm management device as recited in claim [15] 16, Wherein sensed events from the atrium are

and ?oating refractory period associated With the atrium

blanked during the second refractory period.

in the ventricles. 35. The cardiac rhythm management device as in any one

22. The cardiac rhythm management device as recited in claim [15] 16, Wherein sensed events from the ventricles are

dependent upon preprogrammed triggering events occurring 55

of claims 25-34 Wherein the ?oating refractory period is

blanked during the second refractory period.

retriggerable.

23. The cardiac rhythm management device as recited in claim [15] 1 6, Wherein the controller initiates ?rst and second

patient’s heart using a cardiac rhythm management device of

36. A method for stimulating a pre-selected chamber of a

refractory periods associated With the ventricles dependent upon events occurring in the atrium. 24. The cardiac rhythm management device as recited in claim [15] 1 6, Wherein the controller initiates ?rst and second

60

of pro grammed timing and stimulation intervals, said method comprising the steps of: [a)] sensing cardiac electrograms and detecting an intrinsic events occurring in pre-selected chambers of the

refractory periods associated With the atrium dependent upon events occurring in the ventricle. 25. A cardiac rhythm management device capable of uni polar or bipolar atrial and ventricular stimulation, said cardiac

rhythm management device including:

the type Which senses and determines independently atrial and ventricular depolarization events and includes a plurality

65

patient’s heart; then [b)] identifying [a time] times at Which unwanted poten tials of the intrinsic events are sensed;

US RE42,933 E 11

12

[c)] initiating a ?rst interval for blanking detected events for a ?rst predetermined portion of a cardiac cycle; [d)] initiating a second interval for blanking detected events for a second predetermined portion of the cardiac

periods is a ?oating refractory period that is initiated a pro

grammable amount of time after the end of a ?rst refractory

period, the?rst refractory period being initiated coincidental with the sensed triggering event. 46. The cardiac rhythm management device, as in claim 44,

cycle; [and]

comprising a pulse generator con?gurable to selectively

programming a sensing channel to which the?rst interval and the second interval are applied;

stimulate a plurality ofsites in at least one chamber ofthe

programming timing ofthe second interval using the iden ti?ed times; and [e)] stimulating pre-selected chambers in accordance with

patient ’s heart, and wherein the controller is con?gured to control the pulse generator and prevent the use of data to

a predetermined stimulation protocol so long as an

programmable refractory periods in controlling the pulse

intrinsic cardiac event having an amplitude exceeding a predetermined amount is not [sense] sensed between the

generator.

detect intrinsic depolarization events during the plurality of 47. The cardiac rhythm management device, as in claim 46, wherein at least one of the programmable refractory periods is triggered by a stimulation ofa pre-selected chamber ofthe

?rst and second intervals. 37. The method as recited in claim 36, wherein the second

heart 48. The cardiac rhythm management device, as in claim 46,

interval is initiated a predetermined amount of time after an

end of the ?rst interval. 38. The method as recited in claim 36, wherein the second interval is initiated when an intrinsic event from the atrium is sensed. 39. The method as recited in claim 36, wherein the second

wherein the triggering event is a sensed intrinsic event.

49. The cardiac rhythm management device, as in claim 46, 20

50. The cardiac rhythm management device, as in claim 46,

interval is initiated when an intrinsic event from the ventricle

is sensed. 40. The method as recited in claim 36 wherein the blanked event is associated with the atriums. 41. The method as recited in claim 36, wherein the blanked event is associated with the ventricle. 42. A method for pro gramming a cardiac rhythm manage ment device to enhance its ability to sense intrinsic depolar ization events while avoiding detection of artifacts and after

wherein the triggering event includes an intrinsic atrial event.

5]. The cardiac rhythm management device, as in claim 46, wherein the triggering event includes an intrinsic ventricular 25 event.

52. The cardiac rhythm management device, as in claim 46, wherein the triggering event includes a paced atrial event.

53. The cardiac rhythm management device, as in claim 46, wherein the triggering event includes a paced ventricular 30 event.

potentials comprising[the step of]:

54. The cardiac rhythm management device, as in claim 45,

[(a)] examining cardiac electrogram data originating from

wherein preprogrammed sensed triggering events from the atrium are blanked during the ?oating refractory period.

programmably selectable sites in a heart to identify

unwanted potentials; [(b)] determining a temporal relationship between the

55. The cardiac rhythm management device, as in claim 45, 35

unwanted potentials and a known, repeatable, intrinsic

of claims 45, 54, and 55, wherein the ?oating refractory period is retriggerable.

paced event as a trigger event that initiates a blanking or 40

[(d)] pro gramming a delay value that starts with the trigger event and extends to a point in time before which the

unwanted potential is predicted not to occur; and [(e)] programming a duration of the blanking or refractory

45

period that begins with the end of the delay value and extends to cover a period of time during which the unwanted potential is predicted to occur. 43. The cardiac rhythm management device as in any one

[claim 16 or 17-24] ofclaims 16, 17 and 19-24 wherein the

44. A cardiac rhythm management device capable of detecting intrinsic depolarization events, comprising:

coupled to the controller; a ventricular lead having a ventricular electrode electri 55

patient ’s heart and a second electrode positioned within

a sensing channelfor a ventricle ofthe patient’s heart; 60

45. The cardiac rhythm management device, as in claim 44,

selectable for applying the refractory period and the 60. The cardiac rhythm management device as recited in claim 59, wherein the sensing means includes aprogramma

refractory periods in timed relation relative to a sensed triggering event programmably selected from one of a

wherein one of the one or more programmable refractory

cally coupled to the controller; and said controller having means for de?ning a refractory periodanda?oating refractoryperiod in a cardiac cycle for aprogrammably selectable site in a heart, wherein the programmably selectable site is programmably

?oating refractory period thereto.

larization events during one or more programmable

plurality of sensing channels.

sensing means for sensing a cardiac electrogram, said sensing means electrically coupled to the controller; an atrial lead having an atrial electrode electrically

tioned within a sensing channel for an atrium of a

and a controller con?gured to receive data from the sensing circuit and prevent use of data to detect intrinsic depo

57. The cardiac rhythm management device, as in claim 46, wherein the controller initiates ?rst and second refractory periods associated with the ventricle dependent upon sensed triggering events occurring in the atrium. 58. The cardiac rhythm management device, as in claim 46, wherein the controller initiates ?rst and second refractory periods associated with the atrium dependent upon sensed triggering events occurring in the ventricle. 59. A cardiac rhythm management device, comprising: a controller;

50

second refractory period is retriggerable. a sensing circuit con?gured to receive signals indicative of the depolarization events from a ?rst electrode posi

wherein preprogrammed sensed triggering events from the ventricle are blanked during the ?oating refractory period. 56. The cardiac rhythm management device as in any one

or paced event;

[(c)] programming the known, repeatable, intrinsic or refractory period in a sensing channel exhibiting the unwanted potential;

wherein the triggering event includes a paced event.

65

bly designated sensing channelfor the atrium andaprogram mably designated sensing channelfor the ventricle wherein the controller selects the sensing channel in creating the

refractory period and?oating refractory period.

US RE42,933 E 14

13

70. A multi-chamber cardiac rhythm management device

6]. The cardiac rhythm management device as recited in claim 59, wherein the?oating refractoryperiod is initiated a

functioning in apre-selectedstimulation mode andcapable of

preprogrammed amount oftime after the end ofthe refractory

atrial and ventricular tracking, said device comprising:

period. 62. The cardiac rhythm management device as recited in

sensing meansfor sensing at least one ofatrial and ven 5

claim intrinsic 59,events wherein from the?oating the atriumrefractoryperiod are sensed. is initiated 63. The cardiac rhythm management device as recited in

claim intrinsic 59,events wherein from the?oating the ventricle refractoryperiod are sensed. is initiated

10

periods ofsensed eventsfor programmably pre-selected

during the ?oating refractory period.

chambers ofthe patient ’s heart during the cardiac cycle,

65. The cardiac rhythm management device as recited in claim 59, wherein sensed events from the ventricles are

wherein the second refractory period is initiated a pre

determined amount of time after the end of the ?rst

blanked during the ?oating refractory period.

refractory period.

66. The cardiac rhythm management device as recited in claim 59, wherein the controller initiates a refractory period

7]. A cardiac rhythm management device capable of detecting intrinsic depolarization events, comprising: 20

in the atrium. 67. The cardiac rhythm management device as recited in

tioned within a sensing channel for an atrium of a

and ?oating refractory period associated with the atrium dependent upon preprogrammed triggering events occurring in the ventricles. 68. The cardiac rhythm management device as recited in

larization events during one or more programmable

any one of claims 59-67 wherein the ?oating refractory

refractory periods in timed relation relative to a sensed triggering event programmably selected from one of a plurality ofsensing channels, wherein one ofthe one or

period is retriggerable. 69. A cardiac rhythm management device capable of

detecting intrinsic depolarization events, comprising: a pulse generator for selectively stimulating a plurality of

more programmable refractory periods is a ?oating refractory period that is initiated a programmable amount of time after the end of a ?rst refractory period,

sites in at least one chamber ofa patient’s heart; a sensing circuit con?gured to receive signals indicative of

the ?rst refractory period being initiated coincidental

the depolarization events from a ?rst electrode posi

with the sensed triggering event.

tioned within a sensing channelfor an atrium of the patient ’s heart and a second electrode positioned within

72. A cardiac rhythm management device, comprising: a controller;

a sensing channelfor a ventricle ofthe patient’s heart;

depolarization events during a plurality ofprogram mable refractory periods in timed relation relative to a

sensed triggering event programmably selected from one ofa plurality ofprogrammably selectable sensing channels, wherein at least one of the programmable refractory periods is initiated a predetermined amount

of time after the end of a ?rst refractory period, the ?rst refractory period being initiated coincidental with sens ing an intrinsic event.

a sensing circuit con?gured to receive signals indicative of the depolarization events from a ?rst electrode posi patient ’s heart and a second electrode positioned within a sensing channel for a ventricle of the patient’s heart; and a controller con?gured to receive data from the sensing circuit and prevent use of data to detect intrinsic depo

claim 59, wherein the controller initiates a refractory period

and a controller con?gured to receive data from the sensing circuit and to control the pulse generator, wherein the controller prevents the use of data to detect intrinsic

a programmable controller coupled to said meansforsens ing and said stimulation means, wherein during a car

diac cycle said controller manipulates the means for sensing to thereby create ?rst and second refractory

64. The cardiac rhythm management device as recited in claim 59, wherein sensed events from the atrium are blanked

and?oating refractory period associated with the ventricles dependent upon preprogrammed triggering events occurring

tricular events and transmitting signals containing information corresponding to sensed events; stimulation means for selectively stimulating pre-selected chambers of a patient’s heart; and

40

sensing means for sensing a cardiac electrogram, said sensing means electrically coupled to the controller; an atrial lead having an atrial electrode electrically

coupled to the controller; a ventricular lead having a ventricular electrode electri

cally coupled to the controller; and said controller having means for de?ning a refractory periodanda?oating refractoryperiod in a cardiac cycle for aprogrammably selectable site in a heart, wherein the ?oating refractory period is initiated a prepro

grammed amount oftime after the end ofthe refractory

period.

UNITED STATES PATENT AND TRADEMARK OFFICE

CERTIFICATE OF CORRECTION PATENT NO.

I RE42,933 E

APPLICATION NO.

DATED

: 11/900901 : November 15, 2011

INVENTOR(S)

: Zhengnian Tang et a1.

Page 1 ofl

It is certified that error appears in the above-identi?ed patent and that said Letters Patent is hereby corrected as shown below:

In column 9, line 25, in Claim 16, delete “the” and insert -- a --, therefor. In column 10, line 2, in Claim 25, after “or” insert -- a --.

In column 10, line 47, in Claim 33, delete “vents” and insert -- events --, therefor.

In column 10, line 63, in Claim 36, after “detecting” delete “an”. In column 11, line 50, in Claim 43, delete “17” and insert -- 17, --, therefor.

Signed and Sealed this

David J. Kappos Director 0fthe United States Patent and Trademark O?ice

J

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