Patent Application
20230210433
Cardiac arrhythmia, such as atrial fibrillation, occurs when regions of cardiac tissue abnormally conduct electric signals to adjacent tissue, thereby disrupting the normal cardiac cycle and causing asynchronous rhythm. Sources of undesired signals can be located in tissue of an atria or a ventricle. Unwanted signals are conducted elsewhere through heart tissue where they can initiate or continue arrhythmia.
Procedures for treating arrhythmia include surgically disrupting the origin of the signals causing the arrhythmia, as well as disrupting the conducting pathway for such signals. More recently, it has been found that by mapping the electrical properties of the endocardium and the heart volume, and selectively ablating cardiac tissue by application of energy, it is possible to cease or modify the propagation of unwanted electrical signals from one portion of the heart to another. The ablation process destroys the unwanted electrical pathways by formation of non-conducting lesions.
In this two-step procedure, which includes mapping followed by ablation, electrical activity at points in the heart is typically sensed and measured by advancing a catheter containing one or more electrical sensors into the heart and acquiring data at multiple points. These data are then utilized to select the target areas at which ablation is to be performed.
For greater mapping resolution, it is desirable for a mapping catheter to provide high-density signal maps through the use of several electrodes sensing electrical activity of tissue in an area on the order of a square centimeter. For mapping within an atria or a ventricle (for example, an apex of a ventricle), it is desirable for a catheter to collect larger amounts of data signals within shorter time spans. It is also desirable for such a catheter to be adaptable to different tissue surfaces, for example, flat, curved, irregular or nonplanar surface tissue and be collapsible for atraumatic advancement and withdrawal through a patient's vasculature.
Example apparatuses disclosed herein are generally usable with catheter-based systems to measure or provide electrical signals within the heart and surrounding vasculature. Example apparatuses generally include an end effector with one or more spines that can rotate about a longitudinal axis such that the spines are aligned in a plane in a first configuration and the one or more spines are rotated out of the plane in a second configuration. The end effector can include features which provide improved and/or alternative diagnostic or treatment options compared to existing end effectors. In some example treatments utilizing some example apparatuses presented herein, an end effector can map a wall within the heart in the first configuration and a lumen of a vein in the second configuration.
An example end effector for use with a catheter can include a tubular shaft and a plurality of spines. The tubular shaft can extend along a longitudinal axis. The plurality of spines can be disposed on a plane contiguous to the plurality of spine and the longitudinal axis in a first configuration. At least one spine can be configured for rotation about the longitudinal axis such that the at least one spine is disposed outside of the plane in a second configuration.
Each spine can extend generally parallel to the longitudinal axis. Alternatively, each spine can extend at angle with reference to the longitudinal axis.
Another example apparatus can include an elongated shaft, a handle, and an end effector. The elongated shaft can include a proximal portion and a distal portion. The elongated shaft can be configured to be manipulated at the proximal portion to position the distal portion into a heart of a patient. The elongated shaft can define a longitudinal axis of the apparatus. The handle can be affixed to the proximal portion of the shaft. The end effector can be disposed proximate the distal portion of the elongated shaft. The end effector can include a plurality of spine pairs. Each spine includes electrodes disposed thereon. The plurality of spine pairs can include an outer pair of spines and an inner pair of spines such that in a first configuration, the outer pair of spines are contiguous to a plane with the inner pair of spines, such that in a second configuration, one of the inner pair of spines or the outer pair of spines are rotated about the longitudinal axis so that the one pair of spines is out of alignment with the other pair of spines.
Each pair of spines includes a connecting member to define a spine loop so that the plurality of spine pairs define a plurality of spine loops. At least one of the plurality of spine loops can be rotatable about the longitudinal axis.
Each of the spine loops can include a substantially rectangular shape. Alternatively, each of the spine loops can include a substantially trapezoidal shape having a distal width wider than a proximal width.
The plurality of spine loops can include three spine loops. At least two of the three spine loops can be rotatable about the longitudinal axis by manipulation of the handle.
The end effector can include a first spine loop including the outer pair of spines. The first spine loop can define an outer perimeter of the end effector when the plurality of spines are in the first configuration. A second spine loop can include the inner pair of spines. The inner pair of spines can be positioned between the outer pair of spines when the plurality of spines are in the first configuration. A third spine loop can include a central pair of spines of the plurality of spines. The central pair of spines can be positioned between the inner pair of spines when the plurality of spines are in the first configuration.
The first spine loop can be configured to rotate between 30° and 90° about the longitudinal axis. The second spine loop can be configured to rotate between −30° and −45° about the longitudinal axis. In the second configuration, the first spine loop can be at an angle of approximately 60° to the second spine loop, the second spine loop can be at an angle of approximately 60° to the third spine loop, and the third spine loop can be at an angle of approximately 60° to the first spine loop.
The end effector can further include a flexible linkage affixed to the plurality of spine loops at a distal end of the end effector along the longitudinal axis.
The end effector can further include a support linkage affixed to a distal end of at least one of the spine loops of the plurality of spine loops, extending along the longitudinal axis, and affixed to the distal portion of the elongated shaft.
The spines can be positioned in the second configuration when the end effector is in free space. The spines can be movable to the first configuration when the end effector is pressed against a planar surface.
The apparatus can further include a pull wire extending from the handle to the distal portion of the elongated shaft such that manipulation of the handle moves the pull wire and causes the plurality of spines to move between the second configuration and the first configuration. A pull wire can be made from any suitable materials that can endure tight bends while still allowing for movement. For example, high molecular weight polymer or ultra-high molecular weight polymer (e.g., Vectran, Spectra) can be used as well as nylon for a wire.
The apparatus can further include a first rotating frame disposed in the distal portion of the elongated shaft and affixed to a first spine of the plurality of spines. The first rotating frame and the first spine can be configured to rotate about the longitudinal axis in response to movement of the pull wire.
The first rotating frame can be affixed to proximal ends of a first spine loop. The first spine loop can include the first spine and a second spine of the outer pair of spines. The first rotating frame and the first spine loop can be configured to rotate about the longitudinal axis in response to movement of the pull wire.
The apparatus can further include a second rotating frame disposed in the distal portion of the elongated shaft and affixed to proximal ends of a second spine loop. The second spine loop can include the inner pair of spines. The second rotating frame and the second spine loop can be configured to rotate about the longitudinal axis in response to movement of the pull wire. The first rotating frame and the first spine loop can be configured to rotate oppositely about the longitudinal axis in relation to rotation of the second rotating frame and the second spine loop about the longitudinal axis. The first spine loop can include a first support frame affixed to the first rotating frame. The second spine loop can include a second support frame affixed second rotating frame.
The apparatus can further include a distal cap affixed at the distal portion of the elongated shaft, distal of the first rotating frame and the second rotating frame. A distal end of the pull wire can be affixed to the distal cap. The pull wire can be threaded through a first pull wire lumen of the first rotating frame. The pull wire can be threaded through a second pull wire lumen of the second rotating frame. Tension in the pull wire can move the first pull wire lumen and the second pull wire lumen into alignment.
The apparatus can further include a plurality of pull wires each affixed to the distal cap and each threaded through a first respective pull wire lumen of the first rotating frame and a second respective pull wire lumen of the second rotating frame. The plurality of pull wires can be configured to move the plurality of spines from the planar shape to the second configuration and from the second configuration to the first configuration.
The apparatus can further include a center column disposed in the distal portion of the elongated shaft and affixed to proximal ends of a third spine loop. The third spine loop can include a central pair of spines. The first rotating frame and/or the second rotating frame can be movable to rotate about the center column in response to movement of the pull wire.
The apparatus can further include a plurality of electrical conductors extending through the elongated shaft, through the center column, and electrically connected to the electrodes.
The distal portion of the elongated shaft can be configured to deflect in relation to longitudinal axis in response to manipulation of the handle.
An example method can include one or more of the following steps presented in no particular order. A distal portion of an elongated shaft and an end effector extending distally from the distal portion of the elongated shaft can be moved, through a catheter to a heart. The end effector can include a plurality of spines with electrodes thereon. The plurality of spines can include an outer pair of spines and an inner pair of spines. The elongated shaft can define a longitudinal axis. The end effector can be moved from a distal end of the catheter via manipulation of a proximal portion of the elongated shaft. The end effector can be positioned against a wall within the heart such that a majority of a length of each spine of the plurality of spines conforms to the wall. At least a portion of the end effector can be positioned within a vein. A portion of the length of each spine of the plurality of spines can be apposed to the vein.
The method can further include rotating, about the longitudinal axis, the inner pair of spines and/or the outer pair of spines such that the inner pair of spines is non-coplanar to the outer pair of spines.
The method can further include manipulating a handle at a proximal end of the elongated shaft to thereby rotate a spine loop including the inner pair of spines or the outer pair of spines about the longitudinal axis.
The method can further include rotating the spine loop between 30° and 90° about the longitudinal axis.
The method can further include twisting a flexible linkage affixed to a plurality of spine loops at a distal end of the end effector along the longitudinal axis as the spine loop is rotated.
The method can further include positioning the spines in a basket shape when the end effector is in free space within the heart. The method can further include pressing the end effector against the wall to move the spines to a planar shape.
The method can further include manipulating a handle at the proximal portion of the elongated shaft to move a pull wire extending from the handle to the distal portion of the elongated shaft to thereby cause the plurality of spines to move between a basket shape and a planar shape.
The method can further include rotating, about the longitudinal axis, in response to movement of the pull wire, a first rotating frame disposed in the distal portion of the elongated shaft and affixed to a first spine of the plurality of spines.
The method can further include rotating, about the longitudinal axis, a first spine loop including the first spine and a second spine, the first rotating frame being affixed to proximal ends of a first spine loop.
The method can further include rotating, about the longitudinal axis, in response to movement of the pull wire, a second rotating frame and a second spine loop, the second rotating frame being disposed in the distal portion of the elongated shaft and affixed to proximal ends of the second spine loop, the second spine loop including a third spine and a fourth spine.
The method can further include rotating the first rotating frame and the first spine loop oppositely about the longitudinal axis in relation to rotation of the second rotating frame and the second spine loop about the longitudinal axis.
The method can further include providing tension to the pull wire to move a first pull wire lumen of the first rotating frame into alignment with a second pull wire lumen of the second rotating frame, the pull wire being threaded through the first pull wire lumen and the second pull wire lumen.
The method can further include manipulating a plurality of pull wires to move the plurality of spines from the planar shape to the basket shape and from the basket shape to the planar shape, each of the plurality of pull wires being affixed to a distal cap and each threaded through a first respective pull wire lumen of the first rotating frame and a second respective pull wire lumen of the second rotating frame.
The method can further include rotating the first rotating frame and/or the second rotating frame about a center column disposed in the distal portion of the elongated shaft and affixed to proximal ends of a third spine loop, the third spine loop comprising a fifth spine and a sixth spine.
The method can further include mapping electrical signals of the wall with the electrodes, and mapping electrical signals of the vein with the electrodes.
The method can further include deflecting the distal portion of the elongated shaft in relation to longitudinal axis in response to manipulation of the handle.
The above and further aspects of this invention are further discussed with reference to the following description in conjunction with the accompanying drawings, in which like numerals indicate like structural elements and features in various figures. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating principles of the invention. The figures depict one or more implementations of the inventive devices, by way of example only, not by way of limitation.
The following description of certain examples of the invention should not be used to limit the scope of the present invention. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the pertinent art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different or equivalent aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.
Any one or more of the teachings, expressions, versions, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, versions, examples, etc. that are described herein. The following-described teachings, expressions, versions, examples, etc. should therefore not be viewed in isolation relative to each other. Various suitable ways in which the teachings herein may be combined will be readily apparent to those skilled in the pertinent art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.
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 ±25% of the recited value, e.g. “about 90%” may refer to the range of values from 65% to 115%.
As used herein, the terms “patient,” “host,” “user,” and “subject” refer to any human or animal subject and are not intended to limit the systems or methods to human use, although use of the subject invention in a human patient represents a preferred embodiment.
Examples illustrated herein generally relate to catheters with end effectors which can be shaped in a first configuration to map electrical signals of a substantially planar surface such as a wall within a heart and shaped in a second configuration to map electrical signals around a bodily lumen such as within a vein.
The elongated shaft 9 has a proximal portion 12 in the shape of an elongated catheter body, an intermediate deflection section 14, and distal portion 14A. The deflection control handle 16 is attached to the proximal end of the catheter body 12. Suitable control handles are disclosed in U.S. Pat. Nos. 6,123,699; 6,171,277; 6,183,435; 6,183,463; 6,198,974; 6,210,407 and 6,267,746, the entire disclosures of which are incorporated herein by reference and attached in the Appendix of priority application U.S. 63/295,702. The distal portion 14A of the shaft is coupled to the end effector 100 via a connector tubing 46. The elongated shaft 9 forms a tubular catheter body sized and otherwise configured to traverse vasculature. The end effector 100 has a plurality of spine loops 101, 102, 103. The spine loops can be joined at a distal vertex of the end effector 100 with a mechanical linkage 50. The end effector 100 can include a support linkage 104 extending along the longitudinal axis L-L, affixed to a distal end of at least one of the spine loops and affixed to the distal portion 14A of the elongated shaft 9.
When the device is unconstrained and aligned, the proximal portion 12, intermediate section 14, distal portion 14A, and end effector 100 are generally aligned along the longitudinal axis L-L. The intermediate section 14 can be configured to bend to deflect the distal portion 14A and end effector 100 from the longitudinal axis L-L.
The end effector 100 can be collapsed (compressed toward the longitudinal axis L-L) to fit within a guiding sheath or catheter (not illustrated). The shaft 9 can be pushed distally to move the end effector 100 distally through the guiding sheath. The end effector 100 can be moved to exit a distal end of the guiding sheath via manipulation of the shaft 9 and/or control handle 16. An example of a suitable guiding sheath for this purpose is the Preface Braided Guiding Sheath, commercially available from Biosense Webster, Inc. (Irvine, Calif., USA).
The end effector 100 has first, second and third spine loops 101, 102, and 103. Each spine loop 101, 102, 103 has two spines 101A, 101B, 102A, 102B, 103A, 103B and a connector 101C, 102C, 103C that connects the two spines of the respective spine loop 101, 102, 103. Spines 101A, 101B of a first spine loop 101 are connected by a first connector 101C; spines 102A, 102B of a second spine loop 102 are connected by a second connector 102C; and spines 103A, 103B of a third spine loop 103 are connected by a third connector 103C. Each spine loop 101, 102, 103 further includes proximal segments 101D, 101E, 102D, 102E, 103D, 103E joining to the distal portion 14A of the shaft 9.
For each spine loop 101, 102, 103, the spines 101A, 101B, 102A, 102B, 103A, 103B in the respective pair of spines can be substantially parallel to each other along a majority of their respective lengths when the end effector 100 is expanded in an unconstrained configuration as illustrated in
The end effector 100 can optionally include a flexible linkage 50 joining the spine loops 101, 102, 103 at a distal vertex of the end effector aligned with the longitudinal axis L-L. The flexible linkage 50 can function to maintain spatial relation of the spine loops 101, 102, 103 at the distal vertex and be flexible to allow rotation of one or more of the spine loops 101, 102, 103.
The end effector 100 can optionally include a support linkage 104 affixed to a distal end of at least one of the spine loops 101, 102, 103, extend along the longitudinal axis L-L, and affixed at a distal portion of the elongated shaft. The support linkage 104 can provide additional structural support to the end effector 100.
Each spine 101A, 101B, 102A, 102B, 103A or 103B can have a length ranging between about 5 and 50 mm, preferably about 10 and 35 mm, and more preferably about 28 mm. The parallel portions of each spine 101A, 101B, 102A, 102B, 103A, 103B can be spaced apart from each other by a distance ranging between about 1 mm and 20 mm, preferably about 2 and 10 mm, and more preferably about 4 mm. Each spine 101A, 101A, 101B, 102A, 102B, 103A, 103B preferably carries at least eight electrodes per spine member. The end effector preferably includes six spines as illustrated. With eight electrodes on six spines, the end effector 100 includes forty-eight electrodes.
A distal electrode 38D and a proximal electrode 38P are positioned near the distal portion 14A of the shaft 9. The electrodes 38D and 38P can be configured to cooperate (e.g. by masking of a portion of one electrode and masking a different portion on the other electrode) to define a referential electrode (an electrode that is not in contact with tissues). One or more impedance sensing electrodes 38R can be configured to allow for location sensing via impedance location sensing technique, as described in U.S. Pat. Nos. 5,944,022; 5,983,126; and 6,445,864, which are incorporated by reference herein and attached to the Appendix of priority application U.S. 63/295,702.
The catheter body 12 can be flexible, i.e., bendable, but substantially non-compressible along its length. The catheter body 12 can be of any suitable construction and made of any suitable material. In some embodiments, the catheter body 12 has an outer wall made of polyurethane or PEBAX. The outer wall may include an imbedded braided mesh of stainless steel or the like to increase torsional stiffness of the catheter body 12 so that, when the control handle 16 is rotated, the intermediate section 14 will rotate in a corresponding manner. The outer diameter of the catheter body 12 is preferably no more than about 8 French, more preferably about 7 French.
The catheter body 12 can include, extending therethrough: a plurality of lead wires for ring electrodes 37 carried on the spines 101A, 101B, 102A, 102B, 103A, 103B; one or more puller wires to bend the intermediate portion 14; a cable for an electromagnetic position sensor positioned within the distal portion 14A; and lead wires for distal and proximal ring electrodes 38D, 38P carried on the catheter proximally of the end effector 100. Electromagnetic location sensing technique is described in U.S. Pat. Nos. 5,391,199; 5,443,489; 5,558,091; 6,172,499; 6,590,963; and 6,788,967 which are incorporated by reference herein and attached to the Appendix of priority application U.S. 63/295,702. The magnetic location sensor can be utilized with impedance sensing electrode 38R in a hybrid magnetic and impedance position sensing technique known as ACL described in U.S. Pat. Nos. 7,536,218; 7,756,567; 7,848,787; 7,869,865; and 8,456,182, which are incorporated by reference herein and attached to the Appendix of priority application U.S. 63/295,702.
The useful length of the catheter shaft 9, i.e., that portion of the apparatus 10 that can be inserted into the body excluding the end effector, can vary as desired. Preferably the useful length ranges from about 110 cm to about 120 cm. The length of the intermediate section 14 is a relatively smaller portion of the useful length, and preferably ranges from about 3.5 cm to about 10 cm, more preferably from about 5 cm to about 6.5 cm.
The distal portion 14A of the shaft 9 can be substantially contiguous with the intermediate section 14 such that the intermediate section comprises the distal portion 14A; the distal portion being distinguished from the intermediate section 14 by the positioning of one or more (optional) ring electrodes 38R. As referred to herein, the distal portion 14A of the shaft 9 can therefore correspond to a distal portion of the intermediate section 14.
The distal portion 14A of the shaft 9 can be coupled to the end effector 100 with a connector tubing 46. The connector tubing 46 includes an insert for connection of spine loops 101, 102, 103 to provide electrical connection through the intermediate portion 14 of the catheter body. The connector tubing 46 can be affixed to the distal portion 14A of the catheter by glue or the like.
As shown in
The end effectors 100, 200 illustrated in
The distal portion 14A of the shaft 9 can include a distal cap 60 with openings 61D, 61E, 62D, 62E, 63D, 63D as illustrated in
The distal portion can further include a first rotating frame 71 and a second rotating frame 72. The first rotating frame 71 includes openings 71D, 71E for a support frame that extends through a first pair of spines. In one example, a support frame of an outer spine loop is received by the openings 71D, 71E. In another example, support frames through spines having free ends are received by the openings 71D, 71E. The second rotating frame 72 includes openings 72D, 72E for a support frame that extends through a second pair of spines. In one example, a support frame of an inner spine loop is received by the openings 72D, 72E. In another example, support frames through spines having free ends are received by the openings 72D, 72E.
The distal portion 14A can further include a center column 73. The first and second rotating frames 71, 72 can be configured to rotate about the center column 73. The center column 73 can include openings 73D, 73E for a support frame. In one example, a support frame of a central spine loop is received by the openings 73D, 73E. In another example, support frames through spines having free ends are received by the openings 73D, 73E.
The distal portion 14A as illustrated, is configured to receive an end effector having six spines. In one example, one or more of the support frame openings 71D, 71E, 72D, 72E, 73D, 73E are left empty, for instance to accommodate an end effector having fewer than six spines. In another example, the first rotating frame 71, second rotating frame 72, or center column 73 are omitted to accommodate an end effector having four or fewer spines; in such an example, the non-omitted features can be modified as understood by a person skilled in the pertinent art. For instance, a rotating frame and the distal end cap 60 can be modified to allow spines to rotate through a larger angle of rotation about the longitudinal axis.
The catheter 10 can include additional pull wires which extend through additional pull wire openings illustrated in
The center column 73 can include one or more lumens 73A to accommodate electrical conductors which make electrical contact to the electrodes 37 of the end effector.
At step 404, the end effector can be moved from a distal end of the catheter via manipulation of a proximal portion of the elongated shaft.
At step 406, the end effector can be positioned against a wall within the heart such that a majority of a length of each spine conforms to the wall. The end effector can be positioned similar to as illustrated in
At step 408, the end effector can be positioned such that at least a portion of the end effector is within a vein and a portion of the length of each spine is positioned apposed to the vein. The end effector can be positioned similar to as illustrated in
The method 400 can further include additional steps as otherwise disclosed herein.
This application claims benefit of priority to prior filed U.S. Provisional Patent Application No. 63/295,702 filed Dec. 31, 2021 which is hereby incorporated by reference in full herein.
| Number | Date | Country | |
|---|---|---|---|
| 63295702 | Dec 2021 | US |
