Patent Application
20220095947
The present application relates generally to electronic circuitry, and specifically to electronic circuitry of magnetic field sensors. The present application further relates to catheters including magnetic field sensors.
A magnetic field can be sensed by positioning a conductive coil in the magnetic field and observing electrical current and/or voltage induced in the coil by a change in the magnetic field that is aligned with an axis of the conductive coil. Because electrical current is induced in the conductive coil, such a coil is also referred to as an inductive coil. Relative position of a sensor including one or more inductive coils can be determined in relation to a known magnetic field source by monitoring the induced electric current and/or voltage.
Navigation sensors which include three coil arrangements aligned along three orthogonal axes to determine position and orientation of the navigation sensor in three dimensions within a known induced magnetic field are disclosed for instance in U.S. Pat. Nos. 10,330,742 and 10,677,857, each of which are hereby incorporated herein by reference in its entirety into this application as if set forth in full herein and which are attached in the Appendix to priority application U.S. 63/084,674.
Integrating a navigation sensor into a catheter suitable for intravascular and/or intracardiac treatments can involve crafting the sensor by hand, which can result in significant manufacturing time and labor costs. Navigation sensor components can account for a significant percentage of catheter material costs.
A catheter is presented herein which includes inductive coils which conform to the curved surface of a tubular catheter body and collectively can function as a three axis sensor during an intravascular treatment. The inductive coils can be fabricated on a flexible circuit substrate and affixed to the tubular catheter body. The catheter can include a distal portion that can be moved into a circular shape (“lasso”) when within vasculature or the heart. The inductive coils can be positioned around the circular shape such that a position and orientation of the distal portion can be determined in three dimensions when the distal portion is within a known magnetic field.
An example catheter can have a tubular body and a circuit. The tubular body can have a proximal shaft and a distal portion. The tubular body can have a delivery configuration in which the distal portion and proximal shaft are aligned along a longitudinal axis. The proximal shaft can be manipulated to deliver the distal portion through vasculature. The distal portion can have a cylindrical surface with a curvature that curves around the longitudinal axis when the tubular body is in the delivery configuration. The circuit can include a first inductive sensor, a second inductive sensor, and a third inductive sensor. The sensors, collectively, can be used to determine position and orientation of the distal portion in three dimensions when the distal portion is within a known magnetic field. In other words, the sensors, collectively, can function as a three-axis sensor. The circuit can be affixed to the cylindrical surface such that the first inductive sensor, the second inductive sensor, and the third inductive sensor each conform to the curvature of the cylindrical surface.
The tubular body can have a deployed configuration in which the distal portion has a generally circular shape. The circular shape can be generally orthogonal to the longitudinal axis defined by the proximal shaft of the tubular body. The tubular body can be movable from the delivery configuration to the deployed configuration via manipulation of the proximal shaft. When the distal portion is in the generally circular shape, the first inductive sensor, second inductive sensor, and third inductive sensor can be spaced approximately equidistant from each other around the generally circular shape. The generally circular shape can have a circumference measuring approximately 50 millimeters.
The catheter can further include a support member extending through a tubular lumen within the distal portion of the tubular body. The tubular body can include a flexible polymeric material. The support member can include a memory shape material. The memory shape material can have a predetermined shape that is shaped approximately the same as the generally circular shape. The catheter can further include a contraction wire extending through the tubular lumen of the tubular body within the distal portion. The contraction wire can be moved to cause the distal portion to become shaped into the generally circular shape.
The first inductive sensor, the second inductive sensor, and the third inductive sensor can each lack any inductive coil circumscribing the cylindrical surface.
The first inductive sensor can include first inductive coils spiraling substantially parallel to the cylindrical surface such that the first inductive coils conform to the cylindrical surface. The second inductive sensor can include second inductive coils spiraling substantially parallel to the cylindrical surface such that the second inductive coils conform to the cylindrical surface. The third inductive sensor can include third inductive coils spiraling substantially parallel to the cylindrical surface such that the third inductive coils conform to the cylindrical surface.
The first inductive coils can include a first coil, a second coil, a third coil, and a fourth coil arranged in a particular arrangement. The second and/or third inductive sensors can respectively include four coils arranged in a similar manner. The first, second, third, and fourth coils can be arranged as follows. The first coil can be positioned on a first side of the cylindrical surface and include a central termination. The second coil can be positioned on a second side of the cylindrical surface, about 180° around the cylindrical surface from the first side and also include a central termination. The first coil can spiral oppositely from the second coil. The third coil can be positioned on the first side of the cylindrical surface. The first coil and third coil can be positioned such that a majority of the first coil overlaps a majority of the third coil. The third coil can include a central termination in immediate electrical contact with the central terminal of the first coil. The third coil can spiral oppositely from the first coil. The fourth coil can be positioned on the second side of the cylindrical surface. The second coil and the fourth coil can be positioned such that a majority of the second coil overlaps a majority of the fourth coil. The fourth coil can include a central termination in immediate electrical contact with the central terminal of the second coil. The fourth coil can spiral oppositely from the second coil. The third coil can spiral oppositely from the fourth coil. The third coil and the fourth coil can be confined between two electrically insulative, substantially parallel, arcuate surfaces.
The catheter can further include conductive traces to the coils. A first conductive trace can be in immediate electrical contact with the first coil and extend from the first coil to the proximal shaft. A second conductive trace can be in immediate electrical contact with the second coil and extend from the second coil to the proximal shaft. A third conductive trace can be in immediate electrical contact with the third coil and extend from the third coil to the proximal shaft. The first and third conductive traces can be positioned such that a majority of the first conductive trace overlaps a majority of the third conductive trace. A fourth conductive trace can be in immediate electrical contact with the fourth coil and can extend from the fourth coil to the proximal shaft. The second and fourth conductive traces can be positioned such that a majority of the second conductive trace overlaps a majority of the fourth conductive trace. The fourth conductive trace can be electrically connected to the third conductive trace near the proximal shaft. Similarly, the catheter can include conductive traces to the coils of the second inductive sensor and/or the third inductive sensor.
The circuit can include an insulative substrate, a lower layer, an insulating mid layer, and an upper layer. The insulative substrate can be affixed to the cylindrical surface. The lower layer can be above the insulative substrate and can include the third coil, third conductive trace, fourth coil, and fourth conductive trace. The insulating mid layer can be above the lower layer and can include vias therethrough. The vias can facilitate immediate electrical contact between the central termination of the first coil and the central termination of the third coil and can facilitate immediate electrical contact between the central termination of the second coil and the central termination of the fourth coil. The upper layer above the insulating mid layer can include the first coil, first conductive trace, second coil, and second conductive trace. The circuit can further include an insulative top layer above the upper layer. Similarly, corresponding coils and traces of the second inductive sensor and/or third inductive sensor can be positioned in the lower layer and upper layer of the circuit.
The catheter can further include contact pads and wires connecting to the coils. A first contact pad connected to the first conductive trace can be positioned in the upper layer of the circuit at or near the proximal shaft. A first wire can be soldered to the first contact pad and can extend through the proximal shaft to a proximal end of the tubular body. A second contact pad connected to the second conductive trace can be positioned in the upper layer of the circuit at or near the proximal shaft. A second wire can be soldered to the second contact pad and can extend through the proximal shaft to the proximal end of the tubular body. Similarly, the catheter can include contact pads and wires to the second inductive sensor and/or third inductive sensor.
The inductive coils of the first inductive sensor, the second inductive sensor, and the third inductive sensor can each respectively spiral around a respective coil axis such that each respective coil axis is approximately orthogonal to the cylindrical surface. Each of the inductive coils can have a respective height, measured in a direction of the respective coil axis, and a respective width, measured orthogonal to the respective coil axis. The width can measure at least ten times greater than the height.
An example method for designing, constructing, or assembling a catheter can include one or more of the following steps executed in various orders as understood by a person skilled in the pertinent art according to the teachings herein. The method can include fabricating a multi-layer flexible circuit having a first coil arrangement, a second coil arrangement, and a third coil arrangement. The fabrication can result in the first, second, and third coil arrangements being linearly arranged to define a longitudinal axis of the multi-layer flexible circuit. Each of the first, second, and third coil arrangements can each respectively include four coils. For each of the coil arrangements, the four coils can each include a respective central termination. The four coils can be arranged such that each of the four coils is next to an adjacently stacked coil and an adjacent coplanar coil. The four coils can be arranged such that the central termination of each of the four coils is in immediate electrical contact with its adjacently stacked coil.
The method can include affixing the multi-layer flexible circuit to a cylindrical surface of a tubular catheter body. As a result of affixing, the longitudinal axis of the multi-layer flexible circuit can be aligned lengthwise with the tubular catheter body. The flexible circuit can have arcuate cross sections through each of the first, second, and third coil arrangements, where the cross sections are orthogonal to the longitudinal axis.
The method can include affixing the multi-layer flexible circuit to the cylindrical surface such that each of the four coils is centered about 180° around a circumference of the tubular body from its adjacent coplanar coil.
The method can include forming a distal portion of the tubular catheter body in a substantially circular shape.
The method can include affixing the multi-layer flexible circuit to the cylindrical surface such that each of the first, second, and third coil arrangements are spaced approximately equidistant from each other around the generally circular shape when the distal portion is in the substantially circular shape.
The method can include configuring a proximal shaft of the tubular catheter body such that the distal portion of the tubular catheter is movable from a substantially straight configuration to the substantially circular shape through manipulation of the proximal shaft.
The method can include forming the distal portion of the tubular catheter body in the substantially circular shape such that the substantially circular shape has a circumference measuring approximately 50 millimeters.
The method can include extending a support member through a tubular lumen of the tubular catheter within the distal portion.
The method can include shaping memory shape material of the support member to have a predetermined shape that approximates the generally circular shape.
The method can include extending a contraction wire through the tubular lumen within the distal portion such that the contraction wire is movable to modify a shape of the distal portion to the generally circular shape.
The method can include affixing the multi-layer flexible circuit to the cylindrical surface such that the first coil arrangement, the second coil arrangement, and the third coil arrangement each lack any inductive coil circumscribing the cylindrical surface.
The method can include affixing the multi-layer flexible circuit to the cylindrical surface such that the first inductive coil arrangement has first inductive coils spiraling substantially parallel to the cylindrical surface so that the first inductive coils conform to the cylindrical surface. The method can include affixing the multi-layer flexible circuit to the cylindrical surface such that the second coil arrangement has second inductive coils spiraling substantially parallel to the cylindrical surface so that the second inductive coils conform to the cylindrical surface. The method can include affixing the multi-layer flexible circuit to the cylindrical surface such that the third inductive coil arrangement has third inductive coils spiraling substantially parallel to the cylindrical surface so that the third inductive coils conform to the cylindrical surface.
The method can include affixing the multi-layer flexible circuit to the cylindrical surface such that the first inductive coil arrangement has coils arranged in a particular arrangement. A first coil can be positioned on a first side of the cylindrical surface. A second coil can be positioned on a second side of the cylindrical surface, about 180° around the cylindrical surface from the first side, the first coil and the second coils being adjacent coplanar coils (e.g. coplanar when the circuit was flat prior to affixing to the cylindrical surface). A third coil can be positioned on the first side of the cylindrical surface such that a majority of the first coil overlaps a majority of the third coil so that the first coil and the third coil are adjacently stacked coils joined electrically at their respective central terminations. The third coil can spiral oppositely from the first coil. A fourth coil can be positioned on the second side of the cylindrical surface such that a majority of the second coil overlaps a majority of the fourth coil so that the second coil and the fourth coil are adjacently stacked coils joined electrically at their respective central terminations. The fourth coil can spiral oppositely from the second coil. The third and fourth coils can be adjacent coplanar coils.
The method can include affixing the multi-layer flexible circuit to the cylindrical surface such that the first coil spirals oppositely from the second coil and the third coil spirals oppositely from the fourth coil.
The method can include confining the third coil and the fourth coil between two electrically insulative, substantially parallel, arcuate surfaces.
The method can include fabricating the multi-layer flexible circuit such that a first conductive trace is in immediate electrical contact with the first coil and the first conductive trace extends from the first coil to the proximal shaft. The method can include fabricating the multi-layer flexible circuit such that a second conductive trace is in immediate electrical contact with the second coil and the second conductive trace extends from the second coil to the proximal shaft. The method can include fabricating the multi-layer flexible circuit such that a third conductive trace is in immediate electrical contact with the third coil, the third conductive trace extends from the third coil to the proximal shaft, and a majority of the first conductive trace overlaps a majority of the third conductive trace. The method can include fabricating the multi-layer flexible circuit such that a fourth conductive trace is in immediate electrical contact with the fourth coil, the fourth conductive trace extends from the fourth coil to the proximal shaft, a majority of the second conductive trace overlaps a majority of the fourth conductive trace, and the fourth conductive trace is in electrical contact with the third conductive trace approximate the proximal shaft.
The method can include fabricating the multi-layer flexible circuit such that the multi-layer flexible circuit includes an insulative substrate, a lower layer above the insulative substrate, an insulating mid layer above the lower layer, and an upper layer above the insulating mid layer. The lower layer can include the third coil, third conductive trace, fourth coil, and fourth conductive trace. The insulating mid layer can include vias therethrough which facilitate immediate electrical contact between the central termination of the first coil and the central termination of the third coil and facilitate immediate electrical contact between the central termination of the second coil and the central termination of the fourth coil. The upper layer can include the first coil, first conductive trace, second coil, and second conductive trace.
The method can include affixing the insulative substrate of the multi-layer flexible circuit to the cylindrical surface of the tubular catheter body.
The method can include affixing an insulative top layer above the upper layer of the multi-layer flexible circuit.
The method can include fabricating the multi-layer flexible circuit such that the multi-layer flexible circuit includes a first contact pad and a second contact pad each positioned in the upper layer near the proximal shaft. The method can include soldering a first wire to the first contact pad. The method can include extending the first wire through the tubular catheter body to a proximal end of the tubular catheter body. The method can include soldering a second wire to the second contact pad. The method can include extending the second wire through the tubular catheter body to a proximal end of the tubular catheter body.
An example method for intracardiac diagnostics can include one or more of the following steps executed in various order as understood by a person skilled in the pertinent art according to the teachings herein. The method can include manipulating a proximal shaft of a catheter to position a distal portion of the catheter within a heart. The method can include receiving position signals from inductive coil arrangements affixed to a cylindrical surface of the distal portion. The coil arrangements can be shaped to have an arcuate cross-section as a result of being affixed to the cylindrical surface. The method can include determining position and orientation of the distal portion based at least in part, or solely on the position signals. The method can include determining a three-dimensional position and a three-dimensional orientation of the distal portion based at least in part, or solely on the position signals.
The method can include forming a distal portion of the catheter into a substantially circular shape such that each of the inductive coil arrangements are positioned around a circumference of the circular shape. An example multi-layer flexible circuit can include three coil arrangements each having four coils, where each of the coils has a central termination. The three coil arrangements can be linearly arranged to define a longitudinal axis of the multi-layer flexible circuit. In each coil arrangement, the four coils of that arrangement can be arranged such that each of the four coils is next to an adjacently stacked coil and an adjacent coplanar coil. The central termination of each of the four coils can be in immediate electrical contact with its adjacently stacked coil.
While the specification concludes with claims, which particularly point out and distinctly claim the subject matter described herein, it is believed the subject matter will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which:
As used herein, the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, “about” or “approximately” may refer to the range of values ±20% of the recited value, e.g. “about 90%” may refer to the range of values from 71% to 99%.
The catheter 100 can include a control handle 101 affixed to a proximal end 102 of the tubular body 103 that can be moved to push the tubular body 103 distally through vasculature. In some examples, the control handle 101 can also be used to move the distal portion 108 from the delivery configuration illustrated in
As illustrated in
The proximal shaft 106 can have an elongated tubular construction. The proximal shaft 106 can have a single, axial, or central lumen. The proximal shaft 106 can be flexible, i.e., bendable, but substantially non-compressible along its length. The proximal shaft 106 can be of any suitable construction and made of any suitable material. In some examples, the proximal shaft 106 has an outer polymer wall having an interior braided metal mesh. The proximal shaft 106 can have sufficient structural integrity such that when the control handle 101 is rotated, the tubular body 103, including the proximal shaft 106 and distal portion 108, rotate in a corresponding manner. The outer diameter of the proximal shaft 106 is preferably about 8 French or about 7 French.
The useful length of the catheter 100, i.e., that portion that can be inserted into the body, can vary as appropriate based on treatment procedure and anatomy of a patient. For most treatments, the useful length can be about 110 centimeters (cm) to about 120 cm. The length of the distal portion 108 is a relatively small portion of the useful length and preferably is about 3.5 cm to about 10 cm, and more preferably about 5 cm to about 6.5 cm.
In some examples, the distal portion 108 can have a section aligned with the longitudinal axis L-L, when the distal portion 108 is in the substantially circular shape, measuring about 3 millimeters (mm) to about 12 mm. The distal end 104 of the tubular body 103 may or may not overlap the distal portion 108 when in the circular shape (e.g. comparing
The proximal shaft 106 and distal portion 108 can be joined with glue or the like. In some examples, the junction 105 can include a spacer similar to as describe in U.S. Pat. No. 5,964,757 incorporated herein by reference in its entirety into this application as if set forth in full herein and which is attached in the Appendix to priority application U.S. 63/084,674.
Although not illustrated in
The support member 184 can include a memory shape material. The memory shape material can have a predetermined shape that is shaped approximately the same as the generally circular shape of the distal portion in the deployed configuration as illustrated in
The coils can spiral around a radial axis (r) that is orthogonal to the cylindrical surface 183. When in the deployed configuration as illustrated in
The substrate 114 can be affixed to the cylindrical surface 183 (
The first and second coils 121, 122 are positioned 180° apart from each other around the cylindrical surface 183 of the distal portion 108 when the circuit 110 is affixed to the catheter 100 as illustrated in
The third coil 123 can spiral oppositely from the first coil 121. The first coil 121 and third coil 123 can be positioned such that a majority of the first coil 121 overlaps a majority of the third coil 123. The fourth coil 124 can spiral oppositely from the second coil 122. The second coil 122 and the fourth coil 124 can be positioned such that a majority of the second coil 122 overlaps a majority of the fourth coil 124. The first coil 121 can spiral oppositely from the second coil 122. The third coil 123 can spiral oppositely from the fourth coil 124. The third coil 123 and the fourth coil 124 can be confined between two electrically insulative, substantially parallel, arcuate surfaces 114, 116.
The circuit 110 can further include conductive traces 131-134 to the coils 121-124. A first conductive trace 131 can be in immediate electrical contact with the first coil 121 and extend from the first coil 121 to the proximal shaft 106 (i.e. near a junction 105 between the distal portion 108 and proximal shaft 106 or further toward the proximal end 102 of the tubular body 103). A second conductive trace 132 can be in immediate electrical contact with the second coil 122 and extend from the second coil 122 to the proximal shaft 106. A third conductive trace 133 can be in immediate electrical contact with the third coil 123 and extend from the third coil 123 to the proximal shaft 106. The first and third conductive traces 131, 133 can be positioned such that a majority of the first conductive trace 131 overlaps a majority of the third conductive trace 133. A fourth conductive trace 134 can be in immediate electrical contact with the fourth coil 124 and can extend from the fourth coil 124 to the proximal shaft 106. The second and fourth conductive traces 132, 134 can be positioned such that a majority of the second conductive trace 132 overlaps a majority of the fourth conductive trace 134. The fourth conductive trace 134 can be electrically connected to the third conductive trace 133 near the proximal shaft 106. By extending the third and fourth conductive traces 133, 134 to run near the first and second conductive traces 131, 132, the traces can act similar to a twisted pair to reduce noise in the electrical signal from the first inductive sensor 120 compared to a configuration where the third and fourth traces 133 are foreshortened or otherwise routed in the circuit 110.
Geometry of the coils 121-124 and circuit 110 can be described in relation to a cylindrical coordinate system having a radial axis (r), z-axis (z), and azimuth (0). The radial axis (r) is aligned with the coils 121-124 similarly to as illustrated in
The circuit 110 includes a distal segment 119 that lacks conductive traces. The distal segment can be shaped and otherwise configured to help anchor the circuit 110 to the cylindrical surface 183 of the distal portion 108. The distal segment 119 of the circuit 110 can have a width W1 measuring about 0.6 mm and a length L1 of about 25 mm. Each of the sensors 120, 140, 160 can respectively be positioned on portions of the circuit 110 each having a width W2 of about 3.2 mm and a length L2 of about 5 mm. The coil arrangements can occupy a majority of the area of those portions. The sensors 120, 140, 160 can be separated by intermediate segments 138, 158 having a width about equal to that of the distal segment 119 and a length L3, L4 of about 11 mm to about 13 mm. In one example, the length L4 between the third sensor 160 and the second sensor 140 can be about 13 mm and the length L3 between the second sensor 140 and first sensor 120 can be about 11 mm. The circuit 110 can include a proximal segment 178 between the third sensor 160 and a contact pad arrangement 180. The proximal segment 178 can have a length L5 measuring about 105 mm and a width measuring about the same as the distal segment 119 and intermediate segments 138, 158. The length L5 of the proximal segment 178 can be sufficient to position the contact pad arrangement 180 in the proximal shaft 106. The contact pad arrangement 180 can be positioned on a segment of the circuit 110 having a length L6 measuring about 9.25 mm and a width W3 measuring about 0.8 mm. The circuit 110 can include a proximal segment 117 with no conductive traces. The proximal segment 117 can have a length L7 measuring about 25 mm and a width W3 measuring about equal to the width of the segment of the circuit 110 including the contact pad arrangement 180 or can be narrower, about 0.6 mm.
The catheter 100b illustrated in
The mapping electrodes 188 can be made of a suitable conductive material, such as platinum or gold, preferably a combination of platinum and iridium. The mapping electrodes 188 include a series of ring electrodes mounted over the polymeric tube 182 of the distal portion 108 of the tubular body 103 of the catheter 100b. The mapping electrodes 188 can be mounted over the circuit 110 and over the sensors 120, 140, 160. The distal portion 108b can optionally include a non-conductive cover positioned over the circuit 110 and under the mapping electrodes 188. The mapping electrodes 188 can be affixed to the distal portion 108b with glue, weld, crimp, or the like. Alternatively, the mapping electrodes 188 can be formed by coating the distal portion 108b with an electrically conducting material, like platinum, gold and/or iridium. The coating can be applied using sputtering, ion beam deposition or an equivalent technique. In some examples, each mapping electrode 188 is mounted by forming a hole in the polymeric tube 182, an electrode lead wire (not illustrated) is fed through the hole, and the mapping electrode 188 is welded in place over the lead wire and polymeric tube 182. The lead wires extend through the polymeric tube 182 and into the proximal shaft 106. The proximal end of each lead wire is electrically connected to a suitable connector (not shown), which is connected an appropriate monitor or other device for receiving and displaying the information received from the mapping electrodes 188. Alternatively, the mapping electrodes 188 can be formed by adding an upper layer on top of the flexible circuit 110, for instance by patterning conductors on top of the insulative top 118 layer (see
In order to perform the investigation, the professional 14 inserts the catheter 100 into a sheath 21 that has been pre-positioned in a lumen of the patient. The sheath 21 is positioned so that the distal portion 108 of the catheter 100 enters the heart of the patient 18. The distal portion 108 include a position sensor 24 including three inductive sensors 120, 140, 160 as illustrated herein, disclosed herein, or a variation thereof as understood by a person skilled in the pertinent art according to the teachings herein. The position sensor 24 can enable tracking location and orientation of the distal portion 108 of the catheter 100. The distal portion 108 can also include mapping electrodes 188 as illustrated herein, disclosed herein, or a variation thereof as understood by a person skilled in the pertinent art according to the teachings herein. The mapping electrodes 188 can be used to acquire electropotentials of the myocardium 16.
The position sensor 24 includes inductive sensors 120, 140, 160 which respectively include a plurality of coils 121-124, 141-144, 161-164. While the description herein describes using the coils for sensing magnetic fields, the coils may also be used to produce magnetic fields.
The system 12 can include a console 48 having a system processor 46. The console 48 can include controls 49 which can be usable by the professional 14 to communicate with the processor 46. The software for the processor 46 can be downloaded to the processor in electronic form, over a network, for example. Alternatively, or additionally, the software can be provided on non-transitory tangible media, such as optical, magnetic, or electronic storage media. Tracking (e.g. position and orientation) of distal portion 108 of the catheter 100 can be displayed on a three-dimensional representation 60 of the heart of patient 18 that is displayed on a screen 62.
In order to operate the system 12, the processor 46 communicates with a memory 50, which has a number of modules used by the processor 46 to operate the system 12. Thus, the memory 50 can include an electrocardiograph (ECG) module 56 which acquires and analyzes signals from the mapping electrodes 188. The memory 50 can also include a tracking module 52, which receives signals from the position sensor 24, and which analyzes the signals in order to generate the location and orientation of distal portion 108. An ECG module 56 and the tracking module 52 can include hardware and/or software components. The memory 50 can include other software modules, such as a force module for measuring the force on the distal portion 108, and/or an irrigation module allowing the processor 46 to control irrigation provided for the distal portion 108. For simplicity, such other modules are not illustrated in
In addition to receiving and analyzing signals from the position sensor 24, the tracking module 52 can also control radiators 3032, 34. The radiators can be positioned in proximity to myocardium 16 and can be configured to radiate alternating magnetic fields into a region in proximity to the myocardium 16. The position sensor 24 can be configured to produce electrical signals which can be transmitted to the console 48 to be interpreted by the tracking module 52 to determine a three-dimensional position and orientation of the distal portion 108 of the catheter 100. Each of the inductive sensors 120, 140, 160 can be configured to generate the electrical signals of the position sensor 24 in response to the radiated magnetic fields traversing coils 121-124, 141-144, 161-164 of the inductive sensors 120, 140, 160, thereby enabling the console 48 to track the distal portion 108. The Carto® system produced by Biosense Webster uses such a magnetic tracking system.
In many known magnetic tracking systems, three inductive sensors of a position sensor are aligned orthogonal to each other, i.e. coils of each of the respective inductive sensors are each aligned along a respective coil axis and each coil axis of an inductive sensor is orthogonal to the coil axis of the other two inductive sensors. In many known magnetic systems, coils are either planar (spiraling in a flat plane at an expanding radius from a central terminal) or cylindrically helical (spiraling along a length of a cylindrical shape at a constant radius from a central axis of the cylindrical shape). As presented herein, the sensors 120, 140, 160 of example catheters 100, 100a-b need not be orthogonal to each other. The coils 121-124, 141-144, 161-164 of the sensors 120, 140, 160 need not be planar nor cylindrically helical. The tracking module 52 can therefore be configured to determine a three-dimensional position of the distal portion 108 of the catheter 100 based on electrical signals from non-orthogonal sensors 120, 140, 160 and/or coils that are neither planar nor cylindrically helical.
The descriptions contained herein are examples of embodiments of the invention and are not intended in any way to limit the scope of the invention. As described herein, the invention contemplates many variations and modifications of the catheter 100, 100a-b, circuit 110, 100a, and methods for manufacturing and using the same. Additional modifications that are apparent to those having skill in the art to which this invention pertains and are intended to be within the scope of the claims which follow.
The present application claims benefit of priority to U.S. Provisional Patent Application No. 63/084,674 filed Sep. 29, 2020. The entire contents of which are hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63084674 | Sep 2020 | US |
