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Patent US6751492 - System for mapping a heart using catheters having ultrasonic position sensors - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsA system for mapping a heart comprises a mapping catheter having an ultrasonic position sensor for insertion into the heart. The system also comprises at least one reference catheter having an ultrasonic position sensor placeable in a fixed position relative to the heart. The position of the mapping...http://www.google.com/patents/US6751492?utm_source=gb-gplus-sharePatent US6751492 - System for mapping a heart using catheters having ultrasonic position sensorsAdvanced Patent SearchPublication numberUS6751492 B2Publication typeGrantApplication numberUS 09/783,111Publication dateJun 15, 2004Filing dateFeb 14, 2001Priority dateJul 20, 1993Fee statusPaidAlso published asUS6285898, US20020045809Publication number09783111, 783111, US 6751492 B2, US 6751492B2, US-B2-6751492, US6751492 B2, US6751492B2InventorsShlomo Ben-HaimOriginal AssigneeBiosense, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (48), Referenced by (28), Classifications (80), Legal Events (2) External Links: USPTO, USPTO Assignment, EspacenetSystem for mapping a heart using catheters having ultrasonic position sensors
US 6751492 B2Abstract
A system for mapping a heart comprises a mapping catheter having an ultrasonic position sensor for insertion into the heart. The system also comprises at least one reference catheter having an ultrasonic position sensor placeable in a fixed position relative to the heart. The position of the mapping catheter is determined relative to the at least one reference catheter. The ultrasonic position sensor of the mapping catheter is located at the tip of the mapping catheter. The ultrasonic position sensor for the at least one reference catheter is located at the tip of the at least one reference catheter.
What is claimed is: 1. A system for mapping a heart, the system comprising:
a mapping catheter having a tip and a first ultrasonic position sensor for insertion into the heart; and at least one reference catheter having a second ultrasonic position sensor placeable in a fixed position relative to the heart; an imaging apparatus for acquiring images of the heart for construction of a perspective image thereof; an ultrasound transmitter for actuating the first ultrasonic position sensor and the second ultrasonic position sensor; and a location processor for iteratively processing sensed information from the first ultrasonic position sensor and the second ultrasonic position sensor to create a plurality of geometric snapshots of the heart, each of the geometric snapshots comprising one or more data points, the geometric snapshots being superimposed on the perspective image of the heart; wherein a position of the mapping catheter is determined relative to the at least one reference catheter and the plurality of geometric snapshots of the heart are made based on a position of the tip of the mapping catheter on a surface of the heart at a point in time of a cardiac cycle, the plurality of the geometric snapshots defining a map. 2. The system according to claim 1, wherein the first ultrasonic position sensor of the mapping catheter is located at the tip of the mapping catheter.
3. The system according to claim 2, wherein the second ultrasonic position sensor of the at least one reference catheter is located at the tip of the at least one reference catheter.
4. The system according to claim 3, wherein the at least one reference catheter is insertable into the heart.
5. The system according to claim 4, wherein the at least one reference catheter is placeable outside of the heart.
6. The system according to claim 1, wherein the mapping catheter comprises a multi-head catheter.
7. The system according to claim 1, wherein the mapping catheter includes at least one electrode thereon.
8. The system according to claim 7, wherein the map includes electrical activity of the surface of the heart.
9. The system according to claim 7, wherein the map includes impedance measured of the surface of the heart.
10. The system according to claim 1, wherein the map includes mechanical information of the surface of the heart.
11. The system according to claim 10, wherein the mechanical information includes movement of the surface of the heart.
This patent application is a continuation of U.S. patent application Ser. No. 09/111,317, filed on Jul. 7, 1998, now issued U.S. Pat. No. 6,285,898, which is a continuation of Application No. PCT/IL97/00010, filed on Jan. 8, 1997 (published in English), now abandoned, which is a Continuation-in-Part of U.S. patent application Ser. No. 08/595,365, filed on Feb. 1, 1996, now issued U.S. Pat. No. 5,738,096, which claims the benefit of Ser. No. 60/009,769, filed on Jan. 11, 1990, which is a �371 filing of PCT/US95/01103, filed on Jan. 24, 1995; which is a CIP of U.S. application Ser. No. 08/293,859, filed on Aug. 19, 1994, now abandoned, and a CIP of U.S. application Ser. No. 08/311,593, filed on Sep. 23, 1994, now issued U.S. Pat. No. 5,546,951; which is a Division of U.S. application Ser. No. 08/094,539, filed on Jul. 20, 1993 now issued U.S. Pat. No. 5,391,199.
The present invention relates to the field of cardiac medicine and more particularly to diagnosing and treating diseased hearts based on the interaction between cardiac electro-physiological and cardiac bio-mechanical activity.
Cardiovascular diseases accounted for approximately 43 percent of the mortality in the United States of America in 1991 (923,000 persons). However, many of these deaths are not directly caused by an acute myocardial infraction (AMI). Rather, many patients suffer a general decline in their cardiac output known as heart failure. Once the overt signs of heart failure appear, half the patients die within five years. It is estimated that between two and three million Americans suffer from heart failure and an estimated 200,000 new cases appear every year. In many cases heart failure is caused by damage accumulated in the patient's heart, such as damage caused by disease, chronic and acute ischemia and especially (�75%) as a result of hypertension.
A short discussion of the operation of a healthy heart is useful in order to appreciate the complexity of the functioning of the heart and the multitude of pathologies which can cause heart failure. FIG. 1A is a schematic drawing of a cross-section of a healthy heart 20. In general heart 20 comprises two independent pumps. One pump comprises a right atrium 22 and a right ventricle 24 which pump venous blood from an inferior and a superior vena cava to a pair of lungs (not shown) to be oxygenated. Another pump comprises a left atrium 26 and a left ventricle 28, which pump blood from pulmonary veins (not shown) to a plurality of body systems, including heart 20 itself. The two ventricles are separated by a ventricular septum 30 and the two atria are separated by an atrial septum 32.
It should be appreciated that the contraction of cardiac muscle cells is delayed in time from their activation. In addition the duration of the contraction is generally equal to the duration of the plateau.
One of the most common cardiovascular diseases is hypertension. A main effect of hypertension is increased cardiac output demand, which causes hypertrophy since the blood must be pumped against a higher pressure. Furthermore, hypertension usually aggravates other existing cardiac problems.
Heart muscle which is stressed before it is activated, heart muscle which is weakened (such as by ischemia) and portions of the heart which have turned into scar tissue, may form aneurysms. As can be appreciated from Laplace's law, portions of the ventricle wall which do not generate enough tension to offset the tension induced by the intra-cardiac pressure must increase their local radius in response to the pressure overload. The stretched wall portion thins out and may burst, resulting in the death of the patient. The apex of the left ventricle is especially susceptible to aneurysms since it may be very thin. In addition, the total pressure in the ventricle and the flow from the ventricle are reduced as the aneurysm grows, so the heart output is also reduced. Although weak muscle should be expected to hypertrophy in response to the greater need, in some cases, such as after an AMI, hypertrophy may not occur before irreversible tissue changes are caused by the stretching.
Perfusion of the heart muscle usually occurs during diastole. However, if the diastole is very long, such as when the activation signal is propagated slowly, some portions of the heart may not be oxygenated properly, resulting in functional ischemia.
As mentioned above, one of the adaptation mechanisms of the heart is hypertrophy, in which the size of the heart increases to answer increased demand. However, hypertrophy increases the danger of arrhythmias, which in some cases reduce heart output and in others, such as VF (ventricular fibrillation) are life threatening. Arrhythmias are also caused by damaged heart tissues which generate erroneous activation signals and by blocks in the conduction system of the heart.
Several methods may be used to treat heart failure. One method is to connect assist pumps to the patient's circulatory system, which assist the heart by circulating the blood. To date, no satisfactory long-term assist pump has been developed. In some cases, a diseased heart is removed and replaced by another human heart. However, this is an expensive, complicated and dangerous operation and too few donor hearts are available. Artificial hearts suffer from the same limitations as assist pumps and, like them, are not yet practical.
Some cases of heart failure can be helped by medicines which either strengthen the heart, correct arrhythmias or reduce the total volume of blood in the body (which reduces blood pressure). However, many cases of heart failure can only be treated by reducing the activity of the patient. Ultimately, once the cardiac reserve is used up, most cases of heart failure cannot be treated and result in death.
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.
It is an object of some aspects of the present invention to provide methods of augmenting the compensatory mechanisms of the heart.
Yet another object of some aspects of the present invention is to control the adaptation mechanisms in the heart so that the heart output or some other parameter of the heart is optimized. Alternatively or additionally, the adaptation mechanisms of the heart are utilized to effect change in the morphology of the heart, such as by redistributing muscle mass.
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 is in contact with the heart wall through the entire cardiac cycle. It should be appreciated that contact with the heart wall can be achieved either from the inside or from the outside of the heart, such as outside contact being achieved by inserting the catheter into the coronary arteries and/or veins. Alternatively, the catheter is directly inserted into the body (not through the vascular system), such as through a throactoscope or during surgery.
A preferred embodiment of the invention provides for changing the distribution of muscle-mass in the heart from an existing muscle-mass distribution to a desired muscle-mass distribution. This is achieved by adjusting the pacing of the heart to achieve an activation profile which affects such change. Preferably, portions of the heart which are relatively atrophied are activated so that relatively more effort is required of them than previously. Alternatively or additionally, portions of the heart which are hypertrophied are activated so that less effort is required of them than previously. Preferably, the decision how to change the activation profile of the heart is based on a map of the heart, further preferably, using a map which shows the local energy expenditure and/or the local work performed by each portion of the heart. Alternatively or additionally, a map which shows the ratio between local perfusion and local energy expenditure is used. Preferably, the activation profile of the heart is changed when the heart approaches the desired muscle mass distribution. Typically, the heart is paced using an implanted pacemaker. Preferably, a map is used to determine the optimal location for the pacing electrode(s). Additionally or alternatively, a treatment course of pharmaceuticals for affecting the activation of the heart, may be designed using such a map and a model of the reaction of the heart to the pharmaceuticals.
In a preferred embodiment of the invention, the method includes reconstructing a surface of a portion of the heart. Alternatively or additionally, the method includes binning local information according to characteristics of the cycle of the heart. Preferably, the characteristics include a heart rate. Alternatively or additionally, the characteristics include a morphology of an ECG of the heart. Preferably, the ECG is a local electrogram. Alternatively or additionally, the method includes separately combining the information in each bin into a map. Preferably, the method includes determining differences between the maps.
There is also provided in accordance with a preferred embodiment of the invention, a method of determining the effect of a treatment including constructing a first map of a heart, prior to the 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.
There is also provided in accordance with a preferred embodiment of the invention, a pacemaker including a plurality of electrodes; a source of electricity for electrifying the electrodes; and a controller which changes the electrification of the electrodes in response to a stored map of values of local information of a heart at different locations, to achieve an optimization of a cardiac parameter of the heart.
FIG. 1A is a schematic cross-section diagram of a heart;
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.
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.
In a preferred embodiment of the invention electrode 79 is used to measure the impedance between tip 74 and a ground outside the patient. The impedance between tip 74 and the ground is affected by the distance of tip 74 from the wall of heart and by the quality of contact therebetween. The effect can be explained in the following manner. Long cells such as muscle cells and nerves exhibit electrical conductivities which are non-isotropic and frequency dependent. Blood, which fills heart 20, exhibits conduction which is relatively frequency independent and isotropic, and its resistance is approximately half the average resistance of muscle tissue. The greatest amount of frequency dependence of body structures is found between 30 and 200 Hz. However, frequencies in the range 30 Hz-10 MHz are useful. For example, at 50 KHz, contact can be most easily determined from changes in the impedance and at 0.5 MHz, accumulation of residue on the catheter from charring of heart muscle during ablation can be determined from changes in the impedance.
FIG. 9B shows another way of determining the reaction of muscle tissue to an activation signal. A first location 92 is located a distance D1 from a second location 94 and a distance D2 from a third location 96. In a normal heart D1 and D2 can be expected to contract at substantially the same time by a substantially equal amount. However, if the tissue between location 92 and location 94 is non-reactive, D1 might even grow when D2 contracts (Laplace's law). In addition a time lag between the contraction of D1 and of D2 is probably due to blocks in the conduction of the activation signal. A map of the reaction of the heart to an activation signal may be as important as an activation map, since it is the reaction which directly affects the cardiac output, not the activation.
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.
Alternatively or additionally, a cold-tip catheter is used to map the effect of ablating a portion of the heart. It is known in the art that hypothermic cardiac muscle does not initiate or react to electrical signals. Cold-tip catheters, such as disclosed in PCT publication WO 95/19738 of Jul. 27, 1995, the disclosure of which is incorporated herein by reference, can be used to inhibit the electrical activity of a local wall segment while simultaneously mapping the local geometrical effects of the inhibition.
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 lacation 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 changes in muscle-mass distribution are reversible, especially if slippage of muscle fibers and/or formation of scar tissue are involved.
FIG. 12D shows heart 20″ having a substantially inactive muscle segment 126 which is closer to natural pacing location 108 of the left ventricle and a healthy muscle segment 130 which is further away from pacing location 108. Muscle segment 130 is not called upon to perform as much work as it can because of its late activation time, on the other hand, segment 126 cannot perform as much work as it should since it is infarcted. Pacing the left ventricle from location 128 transfers the demand from segment 126 to segment 130, which is able to answer the demand. As a result, the output and efficiency of heart 20″ increase. If heart 20″ hypertrophied to compensate for its reduced output, the hypertrophy may be reversed. Other compensatory mechanisms, such as increased heart rate may also be reversed, resulting in less stress on heart 20″.
Other cardiac physiological variables can also be optimized using the methods of the present invention. For example, by changing the activation profile of the heart, the pressure gradient of the heart can be matched to the impedance of the circulatory system. For example, hypertrophy is an adaptive mechanism for hardening arteries. The increase in size of the left ventricle results in a less pulsile flow which more readily enters the hardened arteries. By changing the activation profile of the heart, the pulse can be made less pulsile without hypertrophy. Other variables which may be optimized include, but are not limited to, heart rate, diastolic interval, long axis and/or short axis shortening, ejection fraction, valvular cross-sectional area, and parameters of the vascular system, such as blood volume and velocity, blood-vessel cross-sectional area and blood pressure. It should be appreciated that such a variable may have a single value or a have a continually changing value whose profile is to be optimized.
Pacing the heart in the above described embodiments of the invention can be performed in many ways. One pacing method does not require implanting a cardiac pacemaker. Rather, the conduction pathways in the heart are mapped and several of the pathways are disconnected to permanently change the activation profile of the heart. Disconnecting the pathways can be achieved by surgically removing portions of pathways or by ablating those portions, using methods known in the art. Alternatively, new conduction pathways can be formed in the heart, by surgically connecting pathways, by implanting conductive tissues or by implanting electrical conductors. For example, an electrical lead having a distal end and a proximal end, which are both highly conductive, and which can act as a conduction pathway. Optionally, the lead includes a miniature circuitry which charges a capacitor with the plateau voltage from the proximal end and discharges the voltage as an activation signal at the distal end.
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.
There are several ways in which an optimal activation profile and its optimal pacing regime can be determined. In one preferred embodiment of the invention, a map of the heart is constructed and analyzed to determine an optimal activation profile. Such determination is usually performed using a model of the heart, such as a finite-element model. It should be appreciated that a relatively simple map is sufficient in many cases. For example, an activation-time map is sufficient for determining some portions of the heart which are activated too late in the cardiac cycle and are, thus, under utilized. In another example, A map of thickness changes is sufficient to determine portions of the heart which are inactive and/or to detect aneurysms.
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A61N1/403, A61B2019/5251, A61B18/00, A61B5/06, A61B18/18, A61B5/029, A61B2019/5458, A61B18/02, A61B5/6843, A61B18/20, A61B2018/00869, A61N1/32, A61M2025/0166, A61B18/24, A61B2017/00243, A61N1/36564, A61B18/14, A61B2017/00247, A61B5/0422, A61B2018/00392, A61B5/6852, A61B2019/505, A61M25/0133, A61B5/145European ClassificationA61B5/145, A61B5/68B5, A61B5/68D1H, A61B5/68D1H6, A61B18/14V, A61N1/40T, A61N1/06, A61M25/01C10, A61B5/68D5, A61B19/52H12, A61B8/08H, A61B18/20, A61B5/0215, A61N1/32, A61N1/365B9, A61B5/06, A61B5/042D, A61N1/362C, A61B5/029Legal EventsDateCodeEventDescriptionSep 21, 2011FPAYFee paymentYear of fee payment: 8Nov 26, 2007FPAYFee paymentYear of fee payment: 4RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services