Source: http://www.google.com/patents/US6285898?dq=3657699
Timestamp: 2017-11-25 10:33:55
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Matched Legal Cases: ['art.\n8', 'art.\n9', 'art.\n16', 'art.\n19', 'application No. 08', 'art 20', 'art 20', 'art 20', 'art 20', 'art 20', 'art 20', 'art 20', 'art 20', 'art 20', 'art 20', 'art 20', 'art 20', 'art 20', 'art 20']

Patent US6285898 - Cardiac electromechanics - Google Patents
A method of constructing a cardiac map of a heart having a heart cycle including; bringing an invasive probe into contact with a location on a wall of the heart; determining, at at least two different phases of the heart cycle, a position of the invasive probe; and determining a local non-electrical...http://www.google.com/patents/US6285898?utm_source=gb-gplus-sharePatent US6285898 - Cardiac electromechanics
Publication number US6285898 B1
Application number US 09/111,317
Also published as US6751492, US20020045809
Publication number 09111317, 111317, US 6285898 B1, US 6285898B1, US-B1-6285898, US6285898 B1, US6285898B1
Patent Citations (31), Referenced by (235), Classifications (85), Legal Events (5)
US 6285898 B1
A method of constructing a cardiac map of a heart having a heart cycle including; bringing an invasive probe into contact with a location on a wall of the heart; determining, at at least two different phases of the heart cycle, a position of the invasive probe; and determining a local non-electrical physiological value at the location. The method is repeated for a plurality of locations in the heart The positions are combined to form a time-dependent map of at least a portion of the heart and local relationships between changes in positions of the invasive probe and determined local non-electrical physiological values are determined. Preferably, local electrical activity at the plurality of locations is also acquired.
1. A method of constructing a cardiac map of a heart having a heart cycle comprising:
3. A method according to claim 1, comprising determining a trajectory of the probe as a function of the cardiac cycle.
4. A method according to claim 3, comprising analyzing the trajectory.
5. A method according to claim 1, wherein the map comprises a plurality of maps, each of which correspondes to a different phase of the cycle of the heart.
constructing a first map of a heart prior to a treatment;
constructing a second map of the heart, after the treatment; and
comparing the first and second maps to diagnose the effect of the treatment.
7. A method according to claim 1 comprising: analyzing the map to assess the viabilty of portions of the heart.
8. A method of constructing a cardiac map of a heart having a heart cycle comprising:
(e) combining the positions to form a map of at least a portion of the heart.
9. A method according to claim 8, comprising determining at least a second position of the invasive probe at a phase at which the local non-electrical value is found, which position is different from the position determined in (b).
10. A method according to claim 9, comprising determining at least one local relationship between changes in positions of the invasive probe and determined local non-electrical physiological values.
11. A method to claim 8, comprising determining a movement of the location on the heart wall relative to the movement of neighboring locations.
12. A method according to claim 11, including determining a relative motion profile of the location on the heart wall relative to neighboring locations.
13. A method according to claim 12, including detecting differences changes in the motion profile for different heart cycles.
14. A method according to claim 13, including detecting differences in positions of the probe at the same phase for different heart cycles.
15. A method according to claim 8, comprising, determining a local change in the geometry of the heart.
16. A method according to claim 15, wherein the local change comprises a change in a size of an area surrounding the location.
17. A method according to claim 15, wherein the local change comprises a change in a local radius of the heart at the location.
18. A method according to claim 8, comprising, determining an intra-cardiac pressure of the heart.
19. A method of analysis, comprising:
bringing a probe into contact with a location on a wall of a heart;
determining a position of the probe at the location;
generating a map of electrical activation of the heart with the probe at the location;
generating a map of mechanical activation of the heart with the probe at the location; and
determining local relationships between the local electrical activation and mechanical activation.
20. A method according to claim 19, wherein the mechanical activation comprises a profile of movement.
the electrical activation comprises an activation time.
This patent application is a continuation of International Patent Application PCT/IL97/00010, filed Jan. 8, 1997, which designated the United States and is now abandoned, which is a continuation-in-part application of U.S. patent application No. 08/595,365, filed Feb. 1, 1996, now issued as U.S. Pat. No. 5,738,096, issued Apr. 14, 1998, which claims the benefit of Ser. No. 60/009,769, filed Jan. 11, 1990, which is a 371 of PCT/US95/01103, filed Jan. 24, 1995; which is a CIP of Ser. No. 08/293,859, filed Aug. 19, 1994, now abandoned, and a CIP of Ser. No. 08/311,593, filed Sep. 23, 1994, now U.S. Pat. No. 5,546,951; which is a Division of Ser. No. 08/094,539, filed Jul. 20, 1993 now U.S. Pat. No. 5,391,199.
FIG. 1E shows a fourth phase called atrial systole which indicates the end of the diastole and the start of the systole of the atria. During this phase, the atria contract and inject blood into the ventricles. Although there are no valves guarding the veins entering the atria, there are some mechanisms to prevent backflow during atrial systole. In left atrium 26, sleeves of atrial muscle extend for one or two centimeters along the pulmonary veins and tend to exert a sphincter-like effect on the veins. In right atrium 22, a crescentic valve forms a rudimentary valve called the eustachian valve which covers the inferior vena cave In addition, there may be muscular bands which surround the vena cava veins at their entrance to right atria 22.
When heart 20 contracts (during systole), the ventricle does not contract in a linear fashion, such as shortening of one dimension or in a radial fashion. Rather, the change in the shape of the ventricle is progressive along its length and involves a twisting effect which tends to squeeze out more blood. FIG. 2 shows an arrangement of a plurality of muscle fibers 44 around left ventricle 28 which enables this type of contraction. When muscle fibers 44 are arranged in a spiral manner as shown in FIG. 2 and the activation of muscle fibers 44 is started from an apex 46 of left ventricle 28, left ventricle 28 is progressively reduced in volume from the bottom up. The spiral arrangement of muscle fibers 44 is important because muscle fibers typically contract no more than 50% in length. A spiral arrangement results in a greater change of left ventricular volume than is possible with, for example, a flat arrangement in which the fibers are arranged in bands around the heart. An additional benefit of the spiral arrangement is a leverage effect. In a flat arrangement, a contraction of 10% of a muscle fiber translates into a reduction of 10% of the ventricular radius. In a spiral arrangement with, for example, a spiral angle 48 of 45°, a 10% contraction translates into a 7.07% contraction in ventricular radius and a 7.07% reduction in ventricular length. Since the ventricular radius is typically smaller than the ventricular length the net result is that, depending on spiral angle 48, a tradeoff is effected between a given amount of contraction and the amount of force exerted by that contraction.
Cardiac muscle cells usually exhibit a binary reaction to an activation signal; either the cell responds normally to the activation signal or it does not respond at all. FIG. 4 is a graph showing changes in the voltage of a single cardiac muscle cell in reaction to the activation signal. The reaction is generally divided into five stages. A rapid depolarization stage 62 occurs when the muscle cell receives an activation signal. During this stage, which lasts a few milliseconds, the potential of the cell becomes rapidly positive. After depolarization, the muscle fiber rapidly repolarizes during a rapid repolarization stage 64 until the cell voltage is approximately zero. During a slow repolarization stage 66, also known as the plateau, the muscle cell contracts. The duration of stage 66, the plateau duration, is directly related to the amount of work performed by the muscle cell. A relatively fast repolarization stage 68 follows, where the muscle cell repolarizes to its original potential. Stage 66 is also known as the refractory period, during which the cell cannot be activated by another activation signal During stage 68, the cell is in a relative refractory period, during which the cell can be activated by an exceptionally strong activation signal. A steady state 70 follows in which the muscle cell is ready for another activation.
A very common cause of damage to the heart is ischemia of the heart muscle. This condition, especially when manifesting itself as an acute myocardial inaction (heart attack), can create dead zones in the heart which do not contain active muscle. An additional, and possibly more important effect, is the non-conducting nature of these dead zones which may upset the natural activation sequence of the heart. In some cases, damaged heart tissue continues to conduct the activation signal, albeit at a variable or lower velocity, which may cause arrhythmias.
Xavier Jeanrenaud, Jean-Jacques Goy and Lukas Kappenberger, in “Effects Of Dual Chamber Pacing In Hypertrophic Obstructive Cardiomyopathy”, The Lancet Vol. 339, pp. 1318-1322, May 30, 1992, the disclosure of which is incorporated herein by reference, teaches that to ensure success of DDD pacing in HCM diseased hearts, an optimum AV interval (between atrial activation and ventricular activation) is required. In addition, it is suggested that this optimal AV interval is modified by performing exercise.
R. S. Reneman, F. W. Prinzen, E. C. Cheriex, T. Arts and T. Delhass, in “Asymmetrical Changes in Left Ventricular Diastolic Wall Thickness Induced by Chronic Asynchronous Electrical Activation in Man and Dogs”, FASEB J., 1993;7;A752 (abstract), abstract number 4341, the disclosure of which in incorporated herein by reference, describe results of studies in paced hearts and which show that earlier activated ventricular wall portions were thinner than later activated wall portions, showing an asymmetrical hypertrophy as a result of the pacing.
C. Daubert, PH. Mabo, Veronique Berder, D. Gras and C. LeClercq, in “Atral Tachyarrhythmias Associated with High Degree Interatrial Conduction Block: Prevention by Permanent Atrial Resynchronisation”, European Journal of C.P.E, Vol. 4, No. 1, pp. 35-44, 1994, the disclosure of which is incorporated herein by reference, describes a method of treating atrial fibrillation by implanting pacemaker electrodes in various locations in the heart, including two electrodes in the right atrium.
When used herein, the terms “physiological variable” and “cardiac parameter” do not include electrical activity, rate, arrhythmia or sequencing of the heart. The term “local physiological value” does not include electrical activity, per se, rather it refers to a local physiological state, such as contraction of local heart muscle, perfusion or thickness. The term “location” refers to a location on or in an object, such as the heart muscle. For example, a valve or an apex of the heart. “Position” refers to a position in space, usually relative to a known portion of the heart, for example, 1.5 inches perpendicular from the apex of the heart. The term “local information” includes any information associated with the location on the heart wall, including position and electrical activity.
Preferably the catheter comprises a pressure sensor which measures the intracardiac pressure. Further preferably, the forces on the heart wall are calculated using the local radius and/or the determined pressure, preferably using Laplace's law.
(b) determining a pacing regime which will change the distribution of the value at the plurality of location and
There is also provided in accordance with a preferred embodiment of the invention, a method including constructing a map of a heart, and analyzing the map to assess the viability of portions of the heart.
FIG. 1B-1E are schematic cross-section diagrams showing the heart in each of four phases of a cardiac cycle;
A first preferred embodiment of the invention relates to mapping the geometry of the heart and time related changes in the geometry of the heart FIG. 6 is a schematic side view of a preferred apparatus for performing the mapping. FIG. 7 is a flowchart showing a preferred method for performing a mapping.
Referring to FIG. 6, a distal tip 74 of a mapping catheter 72 is inserted into heart 20 and brought into contact with heart 20 at a location 75. Preferably, the position of tip 74 is determined using a position sensor 76. Sensor 76 is preferably a position sensor as described in PCT application US95/01103, “Medical diagnosis, treatment and imaging systems”, filed Jan. 24, 1995, in U.S. Pat. No. 5,391,119 or in U.S. Pat. No. 5,443,489, all assigned to the same assignee as the instant application and the disclosures of which are incorporated herein by reference, and which typically require an external magnetic field generator 73. Alternatively, other position sensors as known in the art are used, for example, ultrasonic, RF and rotating magnetic field sensors. Alternatively or additionally, tip 74 is marked with a marker whose position can be determined from outside of heart 20, for example, a radio-opaque marker for use with a fluoroscope. Preferably, at least one reference catheter 78 is inserted into heart 20 and placed in a fixed position relative to heart 20. By comparing the positions of catheter 72 and catheter 78, the position of tip 74 relative to the heart can be accurately determined even if heart 20 exhibits overall motion within the chest. Preferably the positions are compared at least once every cardiac cycle, more preferably, during diastole. Alternatively, position sensor 76 determines the position of tip 74 relative to catheter 78, for example, using ultrasound, so no external sensor or generator 73 is required. Alternatively, catheter 78 is outside the heart, such as outside the body or in the esophagus.
As can be appreciated, contact between tip 74 and heart 20 must be assured. In particular, it is important to know when tip 74 comes into contact with heart 20 after repositioning of tip 74 and the stability of tip 74 at a location, such as whether tip 74 moves from location 75 without operator intervention as a result of motion of heart 20 must be known. One method of monitoring the contact between tip 74 and location 75 is through analysis of the trajectory of tip 74. The inner wall of heart 20 has many crevices and tip 74 typically lodges in one of these crevices, such that tip 74 moving together with location 75. It can be expected that tip 74 will return to the same spatial position each cardiac cycle. Thus, if tip 74 does not return to the same position each diastole, contact between tip 74 and location 75 is not stable. Further, some types of slippage can be detected by determining, whether the entire trajectory of tip 74 substantially repeats itself. Furthermore, some types of slippage add artifacts to the trajectory which can be detected by comparing the trajectory against trajectories of nearby segments of the heart or against a model of the motion of the heart.
Alternatively or additionally, a perfusion meter is mounted on tip 74 to determine the amount of perfusion. Examples of perfusion meters include: a Doppler ultrasound perfusion meter or a Doppler laser perfusion meter, such as disclosed in “Design for an ultrasound-based instrument for measurement of tissue blood flow”, by Burns, S. M. and Reid, M. H., in Biomaterials, Artificial Cells and Artificial Organs, Volume 17, Issue 1 page 61-68, 1989, the disclosure of which is incorporated herein by reference. Such a perfusion meter preferably indicates the flow volume and/or the flow velocity.
Aneurysms are readily detectable on a geometric map, as bulges during systole. Furthermore, potential aneurysms can be detected soon after an AMI (acute myocardial infraction) from local reactions to an activation signal and local reactions to changes in intra-cardiac pressure, even if they are not visible to the naked eye. Automatic detection may be based on paradoxical movement, in which an over-stressed portion of the heart expands (and bulges out) when heart contracts and contracts when the heart expands.
A general property of muscle tissue, including cardiac muscle, is that muscle tissue hypertrophies in reaction to increased stress and atrophies in reaction to reduced stress. According to a preferred embodiment of the invention, the stress and/or workload in the heart are redistributed to affect the distribution of cardiac muscle mass. Preferably, redistribution of stress and/or workload is achieved by changing the location of pacing in the heart. Muscle tissue that is acted sooner has a longer plateau, and as a result has a longer working time. Muscle which is activated later has a greater initial contractile force (due to its longer initial length caused by the raise in intra-cardiac pressure), but has a shorter plateau and a shorter working time, which mean lower workload. Thus, workload can be redistributed by changing the pacing location.
FIG. 12A shows a heart 20′ having a hypertrophied ventricular septum 109. The activation of the left ventricle of heart 20′ typically starts from a location 108 at the apex of heart 20′, with the result that the activation times of a location 110 in an external wall 111 is substantially the same as the activation time of a location 112 in septum 109. If the initial activation location is moved from location 108 to location 112, e.g. by external pacing, septum 109 will be more efficiently utilized, while wall 111 will be activated later in the systole, resulting in a shorter plateau duration of wall 111. As a result, wall 111 will hypertrophy and septum 109 will atrophy, which is a desired result. It should be appreciated, that not all pathological chances in muscle-mass distribution are reversible, especially if slippage of muscle fibers and/or formation of scar tissue are involved.
In an additional embodiment of the invention, the activation profile of the heart is changed to reduce the maximum intracardiac pressure. Although such a reduction typically reduces the heart output, it may be lifesaving in case of an aortic or cardiac aneurysm.
Another preferred embodiment of the invention provides a pacemaker utilizing one of the above described pacing methods. In such an embodiment, the pacemaker includes sensors for determining the state of global or local cardiac parameters. For example, the intra-cardiac pressure can be monitored, and if it exceeds a certain amount, the pacing regime is changed to effect a change in the activation profile, which in turn affects the intra-cardiac pressure. In another example, the pacemaker measures the stress in certain segments of the heart, and if the stress in one of segments exceeds a certain limit, the pacing regime is changed so that the stress in the segment is reduced.
In a preferred embodiment of the invention, the pacemaker determines local ischemic conditions, by measuring an injury current. As is known in the art, when the activity of a segment of muscle tissue is impaired, such as by oxygen starvation, the local voltage at rest is higher than in normal muscle. This change in voltage can be directly measured using local sensors. Alternatively, isotonic currents caused by the voltage difference can be measured Further alternatively, the effect of the voltage changes on an ECG, which are well known in the art, can be utilized to diagnose an ischemic condition.
In an additional embodiment of the invention, the pacing regime is changed, so that the stress is temporally redistributed between different segments of the heart. This type of distribution may be required if a high cardiac output is required and most of the heart is chronically ischemic. By cycling the workload, each portion of the heart gets a recuperation period. A temporal redistribution may also be required if it is not possible to efficiently activate two portions of the heart simultaneously, but activation of both is desired so that neither one atrophies as result of non-use.
In a further preferred embodiment of the invention, an electrode is test-implanted, or simulated by pacing from a catheter, in each of a plurality of electrode locations and the heart output associated with each pacing location is measured. After determining the pacing location which yields the highest cardiac output, the electrode is implanted in that location. Preferably, the electrode is mounted on a position sensing catheter to aid in repositioning of the electrode. Preferably, the catheter comprises a peelable sheath enclosing the electrodes, where the sheath contains at least one position sensor. Further preferably, a steerable catheter is used. Preferably, the operation of the heart is reevaluated after one or two weeks to determine the effect of the cardiac-adaptation mechanisms on the position of the optimal pacing position. If necessary, one or more electrodes are moved. Alternatively or additionally, when a multi-electrode pacemaker is used, the pacing location can be changed by activating alternative electrodes.
Cardiac mapping in accordance with preferred embodiments of the invention, is preferably performed using the Carto system (for electrical mapping) and the Noga system (for electromechanical mapping), both available form Biosense (Israel) Ltd., Tirat HaCarmel, Israel. Some preferred types of mapping catheters are described in a PCT application filed in Israel on Jan. 8, 1997, by applicant “Biosense”and titled “Mapping Catheter”, the disclosure of which is incorporated herein by reference.
It should also be appreciated that once the position of the catheter is known, external sensors can be used to provide local physiological values of heart tissue adjacent to the tip of the sensor. For example. if the tip of the catheter caries an ultra-sound marker, an ultrasound image including the marker can be used to determine the local wall thickness. Another example is a combination with SPECT (single photon emission tomography). If the catheter incorporates a radioactive marker suitable for SPECT, local functional information can be gleaned from a SPECT image. Yet another example is determining local perfusion from Doppler-ultrasound images of the coronaries, from nuclear medicine images or from X-ray or CT angiography and overlaying the perfusion map on the geometrical map. In general, a map in accordance with the present invention may be overlaid on or combined with many types of medical data, for example three-dimensional CT data and the like.
It should be appreciated that a two dimensional angiogramn can be aligned, in a clinically useful manner, with a two-dimensional projection of a map of the heart. The appropriate projection direction can be determined from the relative positions of the patient and the angiographic system during the angiography. Preferably, a bi-plane angiogram is aligned with two two-dimensional projections of a map of the heart, alternatively, other types of angiogams or perfusion maps are used. Alignment may be automatic, using fiduciary marks or reference locations as described above. Alternatively, manual alignment or analysis is performed.
The present invention has been described in a plurality of preferred embodiments, each of which has been separately described. It should be appreciated that the present invention contemplates combining various aspects of different embodiments, for example, various types of mappings and various types of pacing may be combined in accordance with preferred embodiments of the invention. Further, many different types of mapable local physiological variables have been described. In various preferred embodiments of the invention, any number of these variables may be mapped and their coupling analyzed to yield information about the activity of a heart. The scope of the invention also includes a pacemaker designed to or programmed to perform any of the above described pacing regimes. Further, the scope of the present invention also encompasses the act of programming g a pacemaker to perform any of the above described pacing regimes and the act of modifying pulse parameters in accordance with any embodiment of the present invention. Also, the scope of the invention should be construed to include analyzing such maps, as described herein and apparatus, such as a computer workstation with software, for performing such analyses. In addition the scope of the invention should be construed to include apparatus for acquiring maps as described herein, and in particular software suitable for converting individual local positions, sensed physiological values and electrical activity into such maps. Also such apparatus preferably displays such maps to an operator, either as a snap shot or as a dynamic map.
Another aspect of the present invention relates to computer aided diagnosis. A library of maps representing different types of pathologies, from many patients may be stored on a computer. Since the maps are typically acquired using a computerized system, inputting the maps is easy. When a patient is diagnosed, the diagnosis is stored along with the map. as well as any additional information, such as history, development of the disease, effects of various drugs (with maps to show these effects), effect of new pacing regimes and the like. When a new map is made, this map may be correlated with the maps in the library to more easily diagnose the patient. Maps may be correlated using anatomical landmarks, fiduciary marks inputted by the user, or geometrical alignment. In addition a map may be correlated with a previous map of the same patient to asses the success of a treatment. In a preferred embodiment of the invention, the computer system include an expert system which helps with the diagnosis and/or suggests an appropriate treatment. It should be appreciated, that even though each person may have a different anatomy and different cardiac disorders, there will be many similarities between maps of different people having similar disorders, such as ischemia due to the blockage of a particular coronary artery.
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U.S. Classification 600/374, 600/508, 128/922, 128/899, 600/407, 600/424
International Classification A61N1/32, A61B18/14, A61B18/02, A61N1/365, A61B5/0456, A61N1/362, A61B8/08, A61N1/368, A61N1/06, A61B18/24, A61B17/00, A61M25/01, A61B5/06, A61B18/00, A61B18/20, A61B5/0215, A61B5/042, A61B5/00, A61N1/40, A61B5/029, A61B19/00, A61B18/18
Cooperative Classification A61B5/068, A61B5/066, A61B2090/3958, A61B34/20, A61B2034/105, A61B2034/2051, Y10S128/922, A61B18/1492, A61N1/403, A61B5/6852, A61B5/6859, A61B2017/00247, A61B18/02, A61N1/3621, A61N1/06, A61N1/36564, A61B18/24, A61B5/06, A61B2017/00243, A61N1/3627, A61B5/145, A61B5/0215, A61B2018/00869, A61B5/0456, A61B18/00, A61B18/18, A61B5/0422, A61M25/0133, A61B5/029, A61B18/14, A61B2018/00392, A61M2025/0166, A61B5/6843, A61N1/32, A61B8/0833, A61B5/6885, A61N1/368, A61B18/20
European Classification A61B5/145, A61B5/68D5, A61B5/68D1H6, A61B19/52H12, A61B5/68B5, A61B5/68D1H, A61M25/01C10, A61B5/0215, A61B18/14V, A61B5/029, A61B18/20, A61N1/06, A61B5/042D, A61N1/365B9, A61B5/06, A61N1/32, A61N1/40T, A61N1/362C, A61B8/08H
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