Catheter frame pieces used as large single axis sensors
11647958 · 2023-05-16
Assignee
Inventors
Cpc classification
A61B5/318
HUMAN NECESSITIES
A61B5/287
HUMAN NECESSITIES
A61B5/05
HUMAN NECESSITIES
A61B18/1492
HUMAN NECESSITIES
A61B5/065
HUMAN NECESSITIES
International classification
A61B5/00
HUMAN NECESSITIES
A61B5/05
HUMAN NECESSITIES
A61B5/06
HUMAN NECESSITIES
A61B5/287
HUMAN NECESSITIES
Abstract
Catheterization of the heart is carried out using a framework formed by a plurality of electrically conducting wire loops. The wire loops are modeled as polygons, each subdivided into a plurality of triangles. The wire loops are exposed to magnetic fluxes at respective frequencies, and signals read from the loops. Theoretical magnetic fluxes in the polygons are computed as sums of theoretical magnetic fluxes in the triangles thereof, The location and orientation of the framework in the heart is determined by relating the computed theoretical magnetic fluxes to the signals.
Claims
1. An apparatus, comprising: a probe adapted for insertion into an organ of a living subject, the probe having a distal end; a framework disposed on the distal end, the framework comprising a plurality of wire loops that are electrically conductive and define a chamber, the plurality of wire loops independently connectable to a receiver, each of the plurality of wire loops functioning independently as a single-axis magnetic location sensor when subjected to a magnetic field produced by field generating coils, each of the plurality of wire loops being connected to a magnetic position tracking system having the field generating coils at respective frequencies disposed around the living subject; and a processor configured to model the plurality of wire loops as respective polygons, identify local coordinates of the polygons in a local coordinate system, transform the local coordinates of the polygons to coordinates of the magnetic position tracking system, read signals from the plurality of wire loops in response to magnetic fluxes of the magnetic field produced by the field generating coils at the respective frequencies, compute theoretical magnetic fluxes in the polygons as respective sums of theoretical magnetic fluxes in the polygons thereof, determine a location and orientation of the framework by relating the computed theoretical magnetic fluxes to the signals from the plurality of wire loops to report a position and orientation of the probe in the organ.
2. The apparatus according to claim 1, wherein the plurality of wire loops comprise three to eight loops.
3. The apparatus according to claim 1, wherein the plurality of wire loops comprise six to seven loops.
4. The apparatus according to claim 1, wherein the plurality of wire loops form spirals about an axis.
5. The apparatus according to claim 1, wherein the plurality of wire loops are deformable for deployment through a catheter lumen.
6. The apparatus according to claim 1, wherein one of the wire loops of the plurality of wire loops contacts at least another wire loop of the plurality of wire loops.
7. The apparatus of claim 1, wherein the processor computes the theoretical magnetic fluxes based on areas and centroids of the polygons.
8. The apparatus of claim 1, wherein the polygons comprise triangles.
9. The apparatus of claim 1, wherein the polygons comprise hexagons.
10. The apparatus of claim 8, wherein the processor applies a first constraint to the model of the polygons, wherein segments of the polygons of adjacent polygons are required to intersect.
11. The apparatus of claim 8, wherein the processor applies a second constraint to the model of the polygons, wherein a vertex of each of one polygon coincides with a vertex of an adjacent polygon.
12. The apparatus of claim 8, wherein the processor applies a third constraint to the model of the polygons, wherein adjacent polygons contact one another at exactly two points.
Description
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
(1) For a better understanding of the present invention, reference is made to the detailed description of the invention, by way of example, which is to be read in conjunction with the following drawings, wherein like elements are given like reference numerals, and wherein:
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
DETAILED DESCRIPTION OF THE INVENTION
(12) In the following description, numerous specific details are set forth in order to provide a thorough understanding of the various principles of the present invention. It will be apparent to one skilled in the art, however, that not all these details are necessarily needed for practicing the present invention. In this instance, well-known circuits, control logic, and the details of computer program instructions for conventional algorithms and processes have not been shown in detail in order not to obscure the general concepts unnecessarily.
(13) Documents incorporated by reference herein are to be considered an integral part of the application except that, to the extent that any terms are defined in these incorporated documents in a manner that conflicts with definitions made explicitly or implicitly in the present specification, only the definitions in the present specification should be considered.
Overview
(14) Turning now to the drawings, reference is initially made to
(15) Areas determined to be abnormal, for example by evaluation of the electrical activation maps, can be ablated by application of thermal energy, e.g., by passage of radiofrequency electrical current through wires in the catheter to one or more electrodes at the distal tip 18, which apply the radiofrequency energy to the myocardium. The energy is absorbed in the tissue, heating it to a point (typically about 50° C.) at which it permanently loses its electrical excitability. When successful, this procedure creates non-conducting lesions in the cardiac tissue, which disrupt the abnormal electrical pathway causing the arrhythmia. The principles of the invention can be applied to different heart chambers to diagnose and treat many different cardiac arrhythmias.
(16) The catheter 14 typically comprises a handle 20, having suitable controls on the handle to enable the operator 16 to steer, position and orient the distal end of the catheter as desired for the ablation. To aid the operator 16, the distal portion of the catheter 14 contains position sensors (not shown) that provide signals to a processor 22, located in a console 24. The processor 22 may fulfill several processing functions as described below.
(17) Ablation energy and electrical signals can be conveyed to and from the heart 12 through one or more ablation electrodes 32 located at or near the distal tip 18 via cable 34 to the console 24. Pacing signals and other control signals may be conveyed from the console 24 through the cable 34 and the electrodes 32 to the heart 12. Sensing electrodes 33, also connected to the console 24 are disposed between the ablation electrodes 32 and have connections to the cable 34.
(18) Wire connections 35 link the console 24 with body surface electrodes 30 and other components of a positioning sub-system for measuring location and orientation coordinates of the catheter 14. The processor 22 or another processor (not shown) may be an element of the positioning subsystem. The electrodes 32 and the body surface electrodes 30 may be used to measure tissue impedance at the ablation site as taught in U.S. Pat. No. 7,536,218, issued to Govari et al., which is herein incorporated by reference. A temperature sensor (not shown), typically a thermocouple or thermistor, may be mounted on or near each of the electrodes 32.
(19) The console 24 typically contains one or more ablation power generators 25. The catheter 14 may be adapted to conduct ablative energy to the heart using any known ablation technique, e.g., radiofrequency energy, ultrasound energy, and laser-produced light energy. Such methods are disclosed in commonly assigned U.S. Pat. Nos. 6,814,733, 6,997,924, and 7,156,816, which are herein incorporated by reference.
(20) In one embodiment, the positioning subsystem comprises a magnetic position tracking arrangement that determines the position and orientation of the catheter 14 by generating magnetic fields in a predefined working volume and sensing these fields at the catheter, using field generating coils 28. The positioning subsystem U.S. Pat. No. 7,756,576, which is hereby incorporated by reference, and in the above-noted U.S. Pat. No. 7,536,218.
(21) As noted above, the catheter 14 is coupled to the console 24, which enables the operator 16 to observe and regulate the functions of the catheter 14. Console 24 includes a processor, preferably a computer with appropriate signal processing circuits. The processor is coupled to drive a monitor 29. The signal processing circuits typically receive, amplify, filter and digitize signals from the catheter 14, including signals generated by the above-noted sensors and a plurality of location sensing electrodes (not shown) located distally in the catheter 14. The digitized signals are received and used by the console 24 and the positioning system to compute the position and orientation of the catheter 14 and to analyze the electrical signals from the electrodes.
(22) Typically, the system 10 includes other elements, which are not shown in the figures for the sake of simplicity. For example, the system 10 may include an electrocardiogram (ECG) monitor, coupled to receive signals from one or more body surface electrodes, in order to provide an ECG synchronization signal to the console 24. As mentioned above, the system 10 typically also includes a reference position sensor, either on an externally-applied reference patch attached to the exterior of the subject's body, or on an internally-placed catheter, which is inserted into the heart 12 maintained in a fixed position relative to the heart 12. Conventional pumps and lines for circulating liquids through the catheter 14 for cooling the ablation site are provided. The system 10 may receive image data from an external imaging modality, such as an MRI unit or the like and includes image processors that can be incorporated in or invoked by the processor 22 for generating and displaying images that are described below.
(23) Reference is now made to
(24) The loops 43 experience electromagnetic fields and function as single-axis magnetic sensors. When the loops are subjected to electromagnetic fields at respective frequencies it has been found that the location of each loop can be determined to within 1 mm by combining signals obtained from the loops using the positioning subsystem of the system 10 (
(25) As noted above, the loops 43 are formed of wires. Any conducting material can be used. Suitable materials include copper, stainless steel, and nitinol. Materials having shape memory may be advantageous in maintaining contact between the electrodes 53 and the endocardial surface of the heart chamber. The inventors have found in simulations that the average field strength over a large loop is the same as the field at the centroid of the loop.
(26) The requisite size of the loops relates inversely to the intensity of the magnetic fields produced by field generating coils 28 (
(27)
(28) Electrodes 53 are typically disposed on the loops 43. While only one electrode is shown on each loop in
Calibration
(29) Reference is now made to
(30) The borders of the hexagons 57 define respective surfaces 59. If one of the loops 43 (
(31)
(32) An electrical prototype of several catheters was constructed, where the external structure comprised six hexagonal shaped loops as shown in
Simulations
(33) It is possible to obtain a more detailed representation of the catheter than provided by the set of locations and orientations of the centroids of the loops 43. This is achieved by exploiting knowledge of the structure of the framework 39: specifically the shape of the loops 43 and the nature of intersections between adjacent loops, whether they cross or are tangent.
(34) In one configuration which has been simulated, the loops are modeled as hexagons with various relative dimensions. A useful feature of hexagons is that they can be subdivided into triangles. That means even when the hexagon is deformed, and its border is no longer planar, the theoretical magnetic flux can be modeled as the sum of theoretical magnetic fluxes over the triangular segments, which are, by definition, planar.
(35)
(36) Reference is now made to
(37)
where dA(x,y,z) represents the surface element over the triangle and
(38)
is the normal to the triangle, and B.sup.CARTO(x,y,z) are the CARTO fields, a set of nine vectors. Each Flux.sub.i is a nine element vector. We can avoid the laborious calculation of surface integrals by applying Equation 1.
(39) Reverting to
(40)
(41) The value of the signal from the hexagon is
(42)
(43) Continuing to refer to
(44) Consider the internal structure of each hexagonal loop. Points 1 of all 6 triangles within a hexagon intersect at the vertex 73.
Tri.sub.i,j.sup.CARTO(1)=Tri.sub.i,k≠j.sup.CARTO(1) Eq. (5).
(45) In local coordinates Equation 5 becomes
Rot.sub.i,j.sup.loc.fwdarw.CARTOTri.sub.i,j.sup.local(1)+T.sub.i,j.sup.loc.fwdarw.CARTO=Rot.sub.i,k≠j.sup.loc.fwdarw.CARTOTri.sub.i,k≠j.sup.local(1)+T.sub.i,k≠j.sup.loc.fwdarw.CARTO Eq. (6).
(46) Another set of constraints on the internal structure is that point 3 of each triangle coincides with point 2 of the adjacent triangle.
Tri.sub.i,{1,2,3,4,5,6}.sup.CARTO(3)=Tri.sub.i,{2,3,4,5,6,1}.sup.CARTO(2) Eq. (7)
(47) We can also define constraints based on the relative disposition of the hexagonal loops. In the present configuration adjacent frames touch each other at two points, best seen in
(48) Reference is now made to
(49) A fit was performed that included the following conditions:
(50) A vertex of each triangle meets at the center of a hexagon;
(51) The other vertices of the triangles meet at points defining the vertices of a hexagon;
(52) The measured flux from each hexagon equals the sum of the estimated fluxes through each triangle; and
(53) There are wire crossing constraints, i.e., the triangles intersect at points, e.g., the intersections of segments 79, 83 and segments 84, 86.
(54) There is more than one way to define this constraint. Distances between two skewed lines may be computed using the formula
(55)
where the differences are all vectors. The vectors x.sub.1 and x.sub.2 are endpoints of one segment, and the vectors x.sub.3 and x.sub.4 are endpoints of the other. This involves the addition of no.sup.1 new parameters. For computational reasons we found it more convenient to define two parameters, v.sub.12 and v.sub.34, the distance along the segments, and define the constraint as follows
x.sub.1+v.sub.12(x.sub.2−x.sub.1)=x.sub.3+v.sub.34(x.sub.4−x.sub.3) Eq. (8).
(56) For calculation purposes each of the terms x.sub.i is expressed in terms of the local triangles and the transformations to the CARTO coordinate system.
(57) Given a set of measurements for an array of hexagons defined by vertices or points, either from experiment or simulations, The parameters are found by optimizing a first cost function, wherein.
(58) meas.sub.i is the i.sup.th measured signal from the system; and
(59) locMeas.sub.i is the location of the i.sup.th point.
(60) The value locMeas.sub.i is determined, mutatis mutandis, by the method, disclosed in detail in commonly assigned U.S. Pat. No. 8,818,486, which is herein incorporated by reference. Briefly, the method involves generating a magnetic field in a predefined volume. A reference model is defined, which models the magnetic field at multiple points in the volume using spherical harmonics. The magnetic field is measured by a field detector, which is coupled to an intra-body probe inserted into an organ of a living body located in the volume. A second cost function is defined by comparing the measured magnetic field with the reference magnetic field model within the volume. The cost function is minimized by a computation over dipole terms in a derivative over the cost function so as to find a position and orientation that matches the measured magnetic field. The found position and orientation is outputted as the position and orientation of a probe in the organ.
(61) The following constraints are incorporated into the cost function:
(62) Centroid Constraint,
(63)
(64) The location of the first point in triangle 1 of each hexagon matches the location found by using the measured signal from the hexagon.
(65) Flux Sum Constraint:
(66) The term B.sup.CARTO(x,y,z) is the estimated field value at a location using a mathematical model such as described in the above-noted U.S. Pat. No. 8,818,486. That implies that the value Signal.sub.i is also a model based value.
(67)
(68) Optimally, the estimated flux in each hexagon matches the measured flux.
(69) Triangle Points 1 for each hexagon meet:
(70)
(71) Point 3 of each triangle in a hexagon meets point 2 of the next triangle:
(72)
(73) Adjacent hexagons meet at a point. The following equations show the meeting of triangle 3 from one hexagon with triangle 4 of the adjacent hexagon, e.g., segments 79, 83.
(74)
(75) The following equations show the meeting of triangle 6 from one hexagon with triangle 1 of adjacent hexagon, e.g., segments 84, 86 (84 and 85 of
(76)
(77) The total cost function to be minimized is
cost.sub.full=w1 cost.sub.centroid+w2 cost.sub.Flux_Hex+w3 cost.sub.vertex1+w4 cost.sub.triangles+w5 cost.sub.cross_top+w6 cost.sub.cross_bottom
(78) The variables w1-w6 are relative weighting terms. In the results presented here they are all set to 1.
(79) The parameters are found by minimizing the above cost function. In simulations, the optimization is begun with the entire structure displaced and deformed by bending at some of the hexagon joints. The reconstruction accuracy was at the sub-millimeter level.
(80) Reference is now made to
(81) At initial step 85 a catheter framework is modeled as a series of hexagons subdivided into triangles.
(82) Next, at step 87 local coordinates of each triangle are defined.
(83) Next, at step 89 the local coordinates of the triangles are transformed into CARTO coordinates. The initial parameters of the transform can be a priori values or can be obtained from a previous solution as shown in step 90.
(84) Next, at step 101 theoretical fluxes and signals for the triangles and hexagons are obtained as described above.
(85) Step 103 applies measured signals to the solution in step 103 for the parameters of the transformations of each triangle to the CARTO coordinate system by optimizing the cost function described above—applying Equation 4 and Equation 5 to the triangles using their areas and centroids (in CARTO coordinates) to compute the flux in each of the hexagons and then to compute the signal obtained from each of the hexagons.
(86) At final step 107 the location of the catheter is reported, using the best values of the transformation parameters and Carto coordinates.
Example
(87) A fit was performed that included the following conditions: a vertex of each triangle meets at the center of a hexagon; the other vertices of the triangles meet at points defining the vertices of a hexagon; the measured flux from each hexagon equals the sum of the estimated fluxes through each triangle; the hexagons are not deformed; and the wire crossing constraint is met using the formula.
(88)
(89) Reference is now made to
(90) Reference is now made to
(91) When the hexagons are allowed to deform by bending at the vertices, which is the case in an actual flexible catheter, simulations show a slight loss of accuracy. Reference is now made to
Alternate Embodiment
(92) The construction of a wire framework is not limited to the embodiment shown in
(93) It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and sub-combinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.