JP2021512771A - Medical probe with staggered microelectrode arrays - Google Patents

Abstract

The disclosed electrophysiological catheter comprises a distal microelectrode assembly with a covered spine carrying multiple microelectrodes. Microelectrode assemblies are first spines that radiate away from the longitudinal axis and are adjacent to a first spine having a plurality of first microelectrodes disposed on it and a first spine. Includes a second spine that radially separates from the longitudinal axis. The second spine has a plurality of second microelectrodes disposed on it, and a first virtual circle intersecting one of the plurality of first microelectrodes is a second microelectrode. It is designed so that it does not intersect with any of the electrodes.

Description

(priority)
This application was previously filed on February 6, 2018, "CATHETER WITH INCREASED ELECTRODE DENSITY SPINE ASSEMBLY HAVING REINFORCED SPINE COVERS (" Catheter with reinforced spine cover, high electrode density spine assembly "). As a partial continuation of US Patent Application No. 15/890318 (agent reference number BIO5891USNP), claiming interests under 35 USC 120, by reference, fully described in this application. It is incorporated into this application as if it were.

Electrode catheters have been commonly used in medical practice for many years. Electrode catheters are used to stimulate and map electrical activity in the heart and to ablate areas of abnormal electrical activity.

Upon use, the microelectrode catheter is inserted into a major vein or artery, such as the femoral vein, and then guided into the atrium / ventricle of interest. After the catheter is placed in the heart, the location of abnormal electrical activity in the heart is identified.

One locating technique involves an electrophysiological mapping procedure that systematically monitors electrical signals originating from conductive intracardiac tissue and forms a map of those signals. Physicians can identify interfering electrical paths by analyzing the map. A conventional method for mapping electrical signals from conductive cardiac tissue is to percutaneously introduce an electrophysiological catheter (electrode catheter) with mapping microelectrodes mounted on its distal tip. The catheter is manipulated to place these microelectrodes in contact with the endocardium. By monitoring electrical signals in the endocardium, it is possible to pinpoint the abnormal conductive tissue site that is responsible for the arrhythmia.

For sensing by the ring microelectrodes mounted on the catheter, a lead that transmits signals from the ring microelectrodes is electrically connected to a suitable connector at the distal end of the catheter control handle, which is an ECG monitoring system. And / or a suitable 3-D electrophysiological (EP) mapping system, such as CARTO, CARTO XP, or CARTO 3 available from Biosense Webster in Irwindale, California.

Smaller, but closer to each other, microelectrode pairs allow for more accurate detection of short-range potentials with respect to long-range signals, which allows when attempting to treat specific areas of the heart. Can be very important to. For example, the pulmonary vein potential in the short range is a very small signal, while the atrium is very close to the pulmonary vein and provides a much larger signal. Therefore, even if the catheter is placed within the area of the pulmonary vein, the signal is either at a small, near (from the pulmonary vein) potential or at a larger, farther (from the atrium) potential. It can be difficult for an electrophysiologist to determine if it is. Dipoles that are smaller and placed closer to each other allow physicians to more accurately remove long-range signals and more accurately read electrical activity in local tissues. Therefore, by having microelectrodes that are smaller and placed in close proximity to each other, it is possible to accurately target the location of myocardial tissue with pulmonary artery potential, allowing clinicians to accurately target that particular tissue. Can be treated. Furthermore, the smaller and closer to each other microelectrodes allow the physician to determine the exact anatomical location of the pore / plurality of pores by electrical signals.

Increasing the microelectrode density (eg, increasing the number of microelectrodes supported on the catheter) also improves detection accuracy. However, as more microelectrodes are carried on the catheter, the risk of contact or short circuit between the microelectrodes increases, especially as the density of the microelectrodes increases. In addition, microelectrodes and tissue can be reliably contacted, but the microelectrode-holding structure behaves in a controllable and predictable manner without perforating or damaging the tissue. It is always desired to improve the contact between the microelectrodes and the tissue by using a microelectrode assembly structure with high flexibility. As the materials used to build these structures become more flexible and more delicate, smaller ring microelectrodes and their supporting structures during catheter assembly. There is an increased risk of body deformation, especially stretching. Moreover, as the microelectrode assembly structure becomes more delicate, the risk of components dislodging, kinking, and tangling increases.

Therefore, there is a need for an electrophysiological catheter that has microelectrodes placed close to each other and achieves a high microelectrode density. There is also a need for electrophysiological catheters that are delicate in construction and have microelectrode-holding structures that provide the desired flexibility while predicting movement upon contact with tissue. Constructed to minimize the risk of components coming off, kinking, and tangling, it reinforces the spine structure and deforms (including stretching the soft spine cover and microelectrodes supported on it). Further electrophysiological catheters, which are constructed to be minimized, are needed.

The present invention provides multiple radial spines that can flexibly spread over tissue surface regions to detect signals simultaneously at multiple locations with minimal detection of unwanted noise, including long-range signals. The present invention relates to an electrophysiological catheter having a distal microelectrode assembly carrying microelectrodes that are very small and placed in close proximity to each other. The distal microelectrode assembly is configured to fit a variety of different anatomical structures of tissue within the atrial cavity of the heart. Spine has curved segments or curved segments along with linear segments to accommodate a wide range of different tissue surfaces. Spine, on the other hand, offers mechanical advantages in separate segments to obtain improved flexibility and rigidity that facilitate better contact with the tissue. Each spine has a stronger and stiffer proximal base and a more flexible distal end to improve flexibility properties while minimizing the risk of contact or entanglement between spines. I will provide a. To that end, each spine has a generally tapered shape from its proximal end to its distal end.

In some embodiments, the electrophysiological catheter has an elongated body and a distal microelectrode assembly. The distal microelectrode assembly has a proximal stem, multiple spines emanating from the stem, and multiple non-conductive spine covers, each surrounding a corresponding spine, with each spine cover on the side wall of the cover. It has a plurality of embedded tension members.

In some embodiments, the tension member extends longitudinally.

In some embodiments, the tension member has a longitudinally extending portion.

In some embodiments, the tension member comprises a wire.

In some embodiments, the tension member comprises fibers.

In some embodiments, the electrophysiological catheter has an elongated body and a distal microelectrode assembly. The distal microelectrode assembly has a proximal stem and multiple spines, each spine having an enlarged distal portion and the enlarged distal portion having a through hole. The distal microelectrode assembly also has multiple non-conductive spine covers, each surrounding a corresponding spine. The distal microelectrode assembly further has a cap cover that encloses an enlarged distal portion, which has a portion that extends through a through hole.

In some embodiments, the electrophysiological catheter has an elongated body and a distal microelectrode assembly. The distal microelectrode assembly has a proximal stem and a plurality of at least eight spines, each spine having a first preformed curvature defined by a first radius. It has an area and a linear area. The distal microelectrode assembly also has a plurality of non-conductive spine covers and a plurality of microelectrodes, with at least one microelectrode on each spine.

In some embodiments, each spine comprises a second area with a second preformed curve defined by a second radius that is different from the first radius and is preformed with a second. The second area with a curve is on the distal side of the first area with a first preformed curve.

In some embodiments, the first radius is smaller than the second radius.

In some embodiments, the second preformed curve is on the opposite side of the first preformed curve.

In some embodiments, the second area with the second preformed curvature is distal to the first area with the first preformed curvature.

In some embodiments, the linear area is between a first area with a first preformed curve and a second area with a second preformed curve.

In some embodiments, the second area with the linear area is on the distal side of the second area with the second preformed curve.

In some embodiments, each covered spine has an outer circumference of less than 3 French.

In some embodiments, the perimeter is about 2.6 French.

In some embodiments, the electrophysiological catheter has an elongated body and a distal microelectrode assembly. The distal microelectrode assembly has a proximal portion and multiple spines, each spine having a linear taper with a wider proximal end and a narrower distal end. The distal microelectrode assembly also has a plurality of non-conductive spine covers, each of which surrounds a corresponding spine.

In some embodiments, the linear taper is continuous.

In some embodiments, the linear taper is discontinuous.

In some embodiments, the discontinuous linear taper includes a recess having a width narrower than the width of the more proximal stem and the width of the more distal portion.

In some embodiments, the spine is configured for in-plane deflection of the spine and has a hinge along the lateral edge.

In some embodiments, the electrophysiological catheter has an elongated body and a distal microelectrode assembly. The distal microelectrode assembly has a proximal stem and a plurality of at least eight spines, each spine having a linear taper with a wider proximal end and a narrower distal end. The distal electrode assembly also has a plurality of non-conductive spine covers, each non-conductive cover surrounding a corresponding spine. The distal microelectrode assembly further comprises a plurality of microelectrodes, the number of which is at least about 48, and each microelectrode has a length of about 480 μm.

In some embodiments, the microelectrodes on each spine are separated by a distance in the range of about 1 mm to 3 mm when measured between the front edges of the microelectrodes.

In some embodiments, the distance is about 2 mm.

In some embodiments, the microelectrodes on each spine are arranged as dipole pairs, and the front edges of the microelectrodes in one pair are separated by a first distance in the range of about 1 mm to 3 mm and paired. The front edges of the front microelectrodes between them are separated by a second distance in the range of 1 mm to 6 mm.

In some embodiments, the first distance is about 2 mm and the second distance is about 6 mm.

In some embodiments, the number of microelectrodes is equal to about 64.

In some embodiments, the number of microelectrodes is equal to about 72.

In some embodiments, a first ring microelectrode is carried on the proximal stem of the distal microelectrode assembly, and a second ring microelectrode and a third ring microelectrode are distal to the elongated body. It is carried on a portion.

In some embodiments, the electrophysiological catheter has an elongated body and a distal microelectrode assembly. The distal microelectrode assembly has a proximal stem that defines the perimeter around the longitudinal axis. The distal microelectrode assemblies also have multiple spines that emerge from the proximal stem and radiate out at their distal ends, with the multiple spines surrounding the stem and the first spine and the first. The two spines alternate. The distal microelectrode assembly further comprises a plurality of non-conductive spine covers and a plurality of microelectrodes. Each spine cover surrounds the corresponding spine, and the plurality of microelectrodes are staggered on the first spine and the second spine. The most proximal microelectrodes on each first spine are located at a greater distance from the proximal stem, and the most proximal microelectrodes on each second spine are from the proximal stem. Is positioned at a shorter distance.

In some embodiments, the distal microelectrode assembly comprises at least four first spines and four second spines, each spine carrying eight microelectrodes.

In some embodiments, each microelectrode has a length of about 480 μm.

In some embodiments, the microelectrodes on each spine are separated by a distance in the range of about 1 mm to 3 mm when measured between the front edges of the microelectrodes.

In some embodiments, the distance is about 2 mm.

In some embodiments, the microelectrodes on each spine are arranged as dipole pairs, and the front edges of the microelectrodes in one pair are separated by a first distance in the range of about 1 mm to 3 mm and paired. The front edges of the front microelectrodes between them are separated by a second distance in the range of 1 mm to 6 mm.

In some embodiments, the first distance is about 2 mm and the second distance is about 6 mm.

In some embodiments, the electrophysiological catheter has an elongated body and a distal microelectrode assembly. The distal microelectrode assembly has a proximal stem with side walls. The side wall has an inner surface defining the lumen and has an opening. The distal microelectrode assembly is also a plurality of spines emanating from the proximal stem, having a plurality of spines radiating at their distal ends and a plurality of non-conductive covers, each non-conductive. Each cover surrounds the corresponding spine. The distal microelectrode assembly further has multiple microelectrodes on each spine and a housing insert that is received in the lumen of the stem, the housing insert having an outer surface, the outer surface and the inner surface of the stem. A gap is left between and. The adhesive fills the gap between the inner surface of the proximal stem and the outer surface of the housing insert, and the adhesive has a portion that passes through the opening in the side wall of the proximal stem.

In some embodiments, the adhesive has a second layer that coats the outer surface of the stem and seals the openings in the sidewalls of the proximal stem.

In some embodiments, the housing insert has a lumen with a cross section having an elongated bean shape.

In some embodiments, the housing insert has a lumen with a cross section having a C-shape.

These features and advantages of the present invention, as well as other features and advantages, will be better understood by considering the following detailed description in conjunction with the accompanying drawings. It should be understood that some selected structures and mechanisms are not shown in some particular drawings for the sake of clarity of the rest of the structures and mechanisms.
It is a perspective view of the catheter of this invention by one Embodiment. FIG. 5 is a cross-sectional view of the end of the catheter body of the catheter of FIG. It is an end sectional view of the deflection section of the catheter of FIG. It is a perspective view of the integrated support member by one Embodiment. It is a side view of the integrated support member by one Embodiment. It is a detailed view of the integrated support member of FIG. 5A. FIG. 5C is an end sectional view of the integrated indicator member of FIG. 5A taken along line CC. FIG. 5A is a detailed view of the enlarged distal portion of the spine of FIG. 5A. It is a detailed view of the end cross section of the spine of FIG. 5A. It is a side view of the integrated support member by one Embodiment. It is a detailed view of the integrated support member of FIG. 6A. FIG. 6B is a detailed view of the distal portion of the instrument of FIG. 6B. FIG. 6A is a detailed view of the enlarged distal portion of the spine of FIG. 6A. FIG. 6B is an end sectional view of the integrated support member of FIG. 6B taken along lines EE. FIG. 6B is a detailed cross section of an end portion of the proximal portion of the spine of FIG. 6B. FIG. 6B is a detailed cross section of an end portion of the distal portion of the spine of FIG. 6B. It is a side view of the integrated support member by one Embodiment. It is a side view of the integrated support member of FIG. 7A in contact with a tissue. It is a side view of the integrated support member according to another embodiment. It is a side view of the integrated support member of FIG. 8A in contact with a tissue. It is a side view of the integrated support member according to still another embodiment. 9 is a side view of the integrated support member of FIG. 9A in contact with the tissue. FIG. 5 is a side view of an integrated support member according to one embodiment, exemplified to show different parameters. FIG. 5 is an upper plan view of a spine having a hinged structure according to one embodiment. FIG. 3 is an upper plan view of a spine having a hinged structure according to another embodiment. It is a side view of the covered spine according to one Embodiment. It is a side view of the covered spine according to another embodiment. It is a front view of the distal microelectrode assembly according to one embodiment. FIG. 5 is a side view showing the assembly of FIG. 13A in contact with a flat surface. FIG. 3 shows two variants of the assembly of FIG. 13A when viewed along a longitudinal axis orthogonal to the flat surface T of FIG. 13B. FIG. 13C shows a scenario in which the spines of the assembly are compressed into the same line shape. FIG. 3 shows two variants of the assembly of FIG. 13A when viewed along a longitudinal axis orthogonal to the flat surface T of FIG. 13B. A modified example of the assembly of FIG. 13C is shown. More modifications of the assembly of FIG. 13C are shown. More modifications of the assembly of FIG. 13C are shown. More modifications of the assembly of FIG. 13C are shown. A cross-sectional view of one exemplary electrode with respect to one spine is shown, indicating that each electrode on the spine is eccentric or laterally offset. FIG. 5 is a side sectional view of a junction between a deflection compartment and a distal microelectrode assembly according to an embodiment. 14A is a cross-sectional view of the end of the housing insert of FIG. 14A. FIG. 5 is a side sectional view of a junction between a deflection compartment and a distal microelectrode assembly according to another embodiment. 15A is a cross-sectional view of the end of the housing insert of FIG. 15A. FIG. 5 is a perspective side view of a covered spine having a reinforced tension member according to one embodiment. It is a detailed side sectional view of a part of a joint with a reinforcing tension member according to one embodiment. FIG. 5 is a cross-sectional view of an end of a housing insert through which a reinforced tension member passes through according to one embodiment. FIG. 5 is an end sectional view of a deflection section through which a reinforced tension member passes through according to an embodiment. FIG. 5 is a cross-sectional view of an end of a catheter body through which a reinforcing tension member passes through according to an embodiment. FIG. 5 is a schematic representation of a catheter of the invention arranged in contact with the heart and tissues according to various embodiments. FIG. 5 is a schematic representation of a distal microelectrode assembly in contact with tissue within a pulmonary vein according to one embodiment. FIG. 5 is a schematic representation of a distal microelectrode assembly in contact with tissue on the side wall of the heart, according to one embodiment. FIG. 5 is a schematic representation of a distal microelectrode assembly in contact with tissue at the lower wall or apex of the heart, according to one embodiment. FIG. 15A is a cross-sectional view of the distal end of the distal microelectrode assembly of FIG. 15A taken along line AA.

The following detailed description should be read with reference to the drawings, and similar elements in different drawings are similarly numbered. The drawings are not necessarily on scale and show selected embodiments and are not intended to limit the scope of the invention. The detailed description does not limit the principle of the present invention, but illustrates it as an example. This description clearly allows one of ordinary skill in the art to make and use the invention, and some embodiments of the invention, including those currently considered to be the best embodiments of the invention. Applications, modifications, alternatives, and uses are described.

The term "about" or "approximately" as used herein for any number or range of numbers means that a component part or set of components functions in line with its intended purpose as described herein. It shows a suitable dimensional tolerance that makes it possible. More specifically, "about" or "approximately" can refer to a range of values ± 10% of the listed values, for example "about 90%" refers to a range of values 81-99%. obtain. Further, as used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject, limiting the system or method to human use. Although not intended, the use of the present invention in human patients is representative of preferred embodiments. Similarly, the term "proximal" refers to a position closer to the operator, while "distal" refers to a position further away from the operator or physician.

Referring to FIG. 1, in some embodiments of the invention, the catheter 10 comprises a catheter body 12, an intermediate deflection compartment 14, a distal microelectrode assembly 15, and a control handle 16 located proximal to the catheter body 12. Including. The distal microelectrode assembly 15 includes a plurality of spines 17, each spine supporting a plurality of microelectrodes 18.

In some embodiments, the catheter body 12 comprises an elongated tubular structure having a single, axial or central lumen 19, as shown in FIG. The catheter body 12 is flexible, in other words flexible, but is substantially incompressible along its length. The catheter body 12 can have any suitable structure and can be made of any suitable material. One of the preferred structures in the present invention comprises an outer wall 20 made of polyurethane or PEBAX. Since the torsional rigidity of the catheter body 12 is increased by embedding a braided mesh of high-strength steel, stainless steel, or the like in the outer wall 20, when the control handle 16 is rotated, the deflection section 14 of the catheter 10 becomes It rotates accordingly.

The outer diameter of the catheter body 12 is not important. Similarly, although the thickness of the outer wall 20 is not important, the central lumen 19 contains components including, for example, one or more tow wires, microelectrode lead wires, perfusion tubes, and any other wire and / or cable. It is thin enough to accommodate. In some embodiments, the inner surface of the outer wall 20 is lined with a reinforcing tube 21, which can be made from any suitable material, such as polyimide or nylon. The stiffening tube 21, along with the braided outer wall 20, improves torsional stability while at the same time minimizing the thickness of the catheter wall and maximizing the diameter of the central lumen 19. As will be appreciated by those skilled in the art, the structure of the catheter body can be modified as desired. For example, the reinforcing pipe can be omitted.

In some embodiments, the intermediate deflection compartment comprises a shorter compartment of the tubing 30 having a plurality of lumens 31, as shown in FIG. In some embodiments, the tube material 30 is made of a suitable biocompatible material that is more flexible than the catheter body 12. A suitable material for the pipe material 19 is braided polyurethane, that is, polyurethane in which a mesh such as braided high-strength steel or stainless steel is embedded. The outer diameter of the deflection compartment 14 is the same as the outer diameter of the catheter body 12. The number and size of the lumen is not necessarily important and can be changed according to the particular application.

Various components extend through the catheter 10. In some embodiments, the components include a lead 22 for the distal microelectrode assembly 15, one or more traction wires 23A and 23B for deflecting the deflection compartment 14, and a distance of the deflection compartment 14. A cable 24 for an electromagnetic position sensor 26 (see FIGS. 14A and 15A) housed at or near the terminal end is included. In some embodiments, the catheter comprises an irrigation tube 27 for passing fluid through the distal end of the deflection compartment 14. These components pass through the central lumen 19 of the catheter body 12, as shown in FIG.

As shown in FIG. 3, in the deflection compartment 14, different components pass through different lumens 31 of the tubing 30. In some embodiments, the lead wire 22 passes through one or more lumens 31A, the first traction wire 23A passes through the lumen 31B, the cable 24 passes through the lumen 31C, and the second. The tow wire 23B passes through the lumen 31D and the irrigation tube 27 passes through the lumen 31E. The lumens 31B and 31D are opposite to each other in the radial direction so that the intermediate deflection compartment 14 can be deflected in both directions. Additional components may, if desired, pass through additional lumens or share the lumen with other aforementioned components.

Distal side of the deflection compartment 14 is a distal microelectrode assembly 15 that includes an integrated support member 40, as shown in FIG. In some embodiments, the integrated support member 40 is a superelastic material with shape memory, i.e., when a force is applied, it is temporarily stretched or bent away from its original shape in a straight line. It comprises a superelastic material that can and is capable of substantially returning to its original shape when its force is not applied or removed. One of the suitable materials for the support member is a nickel / titanium alloy. Such alloys typically contain about 55% nickel and about 45% titanium, but may contain from about 54% to about 57% nickel, with the balance being titanium. One of the nickel / titanium alloys is nitinol, which has excellent shape memory as well as durability, strength, corrosion resistance, electrical resistance, and temperature stability.

In some embodiments, the member 40 is constructed and molded from, for example, an elongated hollow cylindrical member, but the portion is cut (eg, by laser cutting) or otherwise removed and proximal. A portion, ie, the stem 42, and an elongated body of the spine 17 that emanates longitudinally from the stem and extends outward from the stem are formed. The stem 42 defines a lumen 43 passing through it, which receives the distal end portion 30D of the deflecting compartment 14 of the multiluminal tube 30 (see FIG. 14A). And, as further discussed below, it accepts various components that are housed within the stem 42 or extend through the lumen 43.

Each spine 17 of the member 40 has an enlarged distal portion 46, each spine having a wider proximal end and a narrower distal end. In some embodiments, the spine is along its length, including increasing flexibility towards the distal end 48, as shown in FIGS. 5A, 5B, 5C, 5D, and 5E. It is linearly tapered to provide varying "out-of-plane" flexibility (see arrow A1 in FIG. 5E). In some embodiments, the one or more spines 17 have a proximal portion 17P having a uniform width W1 and a distal portion 17D1 having a continuous linear taper defined by a taper line T1 (FIG. 5B). (See) and a more distally located portion 17D2 having a uniform width W2 (narrower than W1). The distal portion 17D1 is continuously increasing in flexibility so that the spine can take a predetermined shape or curvature when the distal portion 46 comes into contact with tissue. The resulting spine has a relatively stiffer proximal portion and a relatively more flexible distal portion, although such spines may cross or cross spines during use. Helps prevent them from overlapping each other.

In some embodiments, the one or more spines 17 are between the ends 41 and 46, as shown in FIGS. 6A, 6B, 6C, 6D, 6E, 6F, and 6G. Has a discontinuous linear taper. The discontinuous linear taper includes one or more narrows or recesses 50, which are strategically placed along the spine and taper between the stem 42 and the enlarged distal portion 46. It is designed to interrupt the linear taper defined by T2, which would otherwise be continuous. Each recess 50 has a width W (see FIG. 6C), where the width W is less than the width WD of the more distal portion and the width of the more proximal portion greater than the width WD. It is smaller than WP. Thus, advantageously, each recess 50 allows the region of the spine to have different flexibility than the directly adjacent (distal and proximal) portions 51 of the spine. It makes it possible to provide some degree of independent flexibility between the portions separated by 50 (see FIG. 6B). Thus, these spines are significantly more flexible in the area of the recess 50, and thus steeper, in other words, more, when the distal portion 46 comes into contact with the tissue, as compared to the portion 51 of the spine. It is possible to exhibit a tight curvature of angle.

In some embodiments, each spine (between the distal end of the stem 42 and the distal end of the spine) has a length in the range of about 1.0 cm to 2.5 cm, or about 1.50 cm to 2.0 cm. It has a width in the range of about 0.009 inch to 0.02 inch. In some embodiments, the recess 50 has a length in the range of about 10% to 20% of the length of the spine and a width W in the range of about 50% to 80% of the width of the directly adjacent location. Although having, the anterior proximal edge of the recess 50 is located approximately 55% to 65% of the spine length as measured from the distal end of the stem 42.

To further facilitate contact of the microelectrodes with the tissue along the entire length of the spine, each spine 17 has a preformed shape or curvature realized, for example, by a heating and forming jig. One or more spines 17 have at least two different preformed curves C1 and C2, as shown in FIG. 7A. The segment S1 has a preformed curve C1 defined by a radius R1 and the segment S2 has a preformed curve C2 defined by a radius R2. Here, R1 is smaller than R2, and the curves C1 and C2 are oriented in substantially opposite directions so that the spine of the integrated support member 40 has a substantially forward concave surface similar to an open umbrella. It has become. As shown in FIG. 7B (only two spines are shown for clarity), when the distal end of the spine comes into contact with the exemplary surface SF, the preformed spines are neutral to them. The transition from the target shape N (the shape shown by the dashed line) to its adaptive or temporarily "deformed" shape A. This shape A may include a "bent" profile (compared to their neutral shape), which may be more suitable for areas of heart tissue with undulations. Advantageously, the integrated support member 40 maintains its generally forward concave shape upon contact with the tissue and flips inside out as if the umbrella were turned up by a strong wind. Never.

In some embodiments, the one or more spines 17 have at least curved and linear segments. In some embodiments, the one or more spines have at least two different preformed curves along their length. For example, as shown in FIG. 8A, one or more spines 17 have a first segment SA having a preformed curved CA defined by a radius RA and a preformed curved CB defined by a radius RB. It has a second segment SB having a radius and a third segment SC which is linear, and the radius RA is smaller than the radius RB. As shown in FIG. 8B (only two spines are shown for clarity), when the distal end of the spine contacts the exemplary surface SF, the preformed spines are neutral to them. The transition from the shape N to its adaptive or temporarily "deformed" shape A. This shape A may include a deeper concave surface (compared to their neutral shape), which may be more suitable for areas of cardiac tissue with convex surfaces.

As another example, as shown in FIG. 9A, one or more spines 17D have a first segment SJ having a preformed curved CJ defined by a radius RJ and a second segment SK that is linear. And a third segment SL having a preformed curved CL defined by a radius RL, the radius RJ being smaller than the radius RL. As shown in FIG. 9B (only two spines are shown for clarity), when the distal ends of the spines come into contact with the exemplary surface SF, the preformed spines are neutral to them. The transition from the shape N to its adaptive or temporarily "deformed" shape A. This shape A may contain a lower profile (compared to their neutral shape), which may be more suitable for flatter areas of heart tissue.

Referring to FIG. 10, in some embodiments, the integrated support member 40 and its spine 17 can be defined by a plurality of parameters, including, for example:
a (height of the second curve) = range of about 0.00 inches to 0.050 inches b (distal length of the second curve) = range of about 0.302 inches to 0.694 inches c (Proximal length of the second curve) = range of about 0.00 inches to 0.302 inches d (distance between the first curve and the second curve) = about 0.00 inches to 0 .170 inch range e (radius of first curve) = about 0.075 inch to 0.100 inch range f (uniform width segment length) = about 0.100 inch g (depth of recess) = Approximately 0.123 inch to 0.590 inch range

In particular, in some embodiments of the integral support member 40, the proximal (or first) preformed curvature is on the opposite side of the distal (or second) preformed curvature. As a result, the spine 17 of the distal microelectrode assembly 15 retains its general concave surface upon contact with tissue and remains in a forward-looking state without inversion. On the other hand, the highly flexible spine allows the assembly to have flexibility or "bending" so that the distal tip of the spine punctures the tissue upon contact with the tissue or another. It prevents the method from causing damage to the tissue and ensures that each of the spines 17 is in contact with the tissue when the distal microelectrode assembly is pressed against the tissue surface. Further, in some embodiments, the recess 50 can extend between the proximal preformed curvature and the distal preformed curvature, resulting in three portions of the spine ( Proximal, recess, and distal parts) each behave differently with respect to tissue contact and the associated pressure exerted by the user operating the catheter, and different degrees of flexibility from each other. It is possible to have.

The above figure exaggerates the deformation and curvature of the spine to facilitate the development and explanation of the theory, but the actual deformation and curvature are much more subtle and as steep as the figure. Please understand that it may not be the case.

In some embodiments, the one or more spines 17 are also configured with hinges 90 for in-plane (lateral) deflection. As shown in FIGS. 11A and 11B, the spine 17 can have a plurality of notches or depressions along side edges facing each other. These notches or recesses include an expandable recess 80 (eg, provided in the form of a slit 81 and a circular opening 82) along one edge 85a and an opposite edge 85b. Along, compressible depressions 83 (eg, those provided in the form of slots 84 and circular openings 82) can be mentioned. These notches or depressions form hinges 90 along their edges for further in-plane deflection. In the embodiments of FIGS. 11A and 11B, a unidirectional deflection occurs towards the edge 85b of the spine 17. However, it is understood that if the compressible depression 83 is formed along both the edges 85a and 85b, the spine 17 has a bidirectional deflection towards either edge 85a or 85b. .. Suitable hinges are described in US Pat. No. 7,276,062, and the entire disclosure of that patent is incorporated herein by reference.

As shown in FIGS. 12A and 12B, each spine 17 of the distal microelectrode assembly 15 is surrounded by a non-conductive spine cover or tube 28 along its length. In some embodiments, the non-conductive spine cover 28 comprises a highly flexible and highly flexible biocompatible plastic such as PEBAX or PELLATHane, and the spine cover 28 comprises a stem 42 and an enlarged distal portion. It has a length with the same spread as the spine between 46 and is mounted on the spine. A suitable material for constructing the spine cover 28 is one that is sufficiently soft and flexible so as not to generally interfere with the flexibility of the spine 17.

In some embodiments, each covered spine 17 has a diameter D of less than 3 French, preferably a diameter of less than 2.7 French, more preferably a diameter of 2 French, along its length (eg,). , Approximately 0.025 "to 0.035" in diameter).

Each spine 17 includes a non-traumatic distal cover or cap 45 (see FIG. 12A) that encloses the enlarged distal portion 46. In some embodiments, the cover 45 comprises a biocompatible adhesive or sealant, such as polyurethane, to minimize damage to the tissue upon contact with the tissue or when pressure is applied to the tissue. Has a spherical shape. The composition of the cover 45 includes a cross-linked portion 63 of the adhesive or sealant that passes through the through hole 47 of the enlarged distal portion 46, which is advantageously a mechanical lock. The cover 45 is secured onto the distal portion 46 to minimize the risk of the cover 45 coming off the enlarged distal portion 46.

Each spine 17 carries a plurality of microelectrodes 18. The number and arrangement of microelectrodes can vary depending on the intended use. In some embodiments, the number ranges from about 48 to 72, but it will be appreciated that the number may be higher or lower. In some embodiments, each microelectrode has a length L of less than 800 μm, eg, in the range of about 600 μm to 300 μm, and has measurements of, for example, about 480 μm, 460 μm, or about 450 μm. In some embodiments, the distal microelectrode assembly 15 has an area coverage of more than about 7.1 per square centimeter, eg, about 7.2-12.6 per square centimeter. In some embodiments, the distal microelectrode assembly 15 about microelectrodes 2.5 / cm ^2, such as more than, the microelectrodes density in the range of microelectrode about 4 / ^cm 2 to 7-pieces / cm ² Have.

In some embodiments, the distal microelectrode assembly 15 has eight spines, each spine having a length of about 1.5 cm and carrying eight microelectrodes, for a total of 48. Each microelectrode has a length of about 460 μm. Assembly 15 has an area coverage of about 7.1 per square centimeter and a microelectrode density of ^{about 7 microelectrodes / cm 2.}

In some embodiments, the distal microelectrode assembly 15 has eight spines, each spine having a length of about 2.0 cm and carrying six microelectrodes, for a total of 48. Each microelectrode has a length of about 460 μm. Assembly 15 has an area coverage of about 12.6 per square centimeter and a microelectrode density of ^{about 4 microelectrodes / cm 2.}

The microelectrodes 18 on the spine 17 may be arranged as either monopoles or dipoles with various spacing between them, the spacing being between adjacent microelectrodes or microelectrodes. Refers to what is measured as the separation width between the respective tip edges of a pair. Referring to FIG. 12A, as a monopole, the microelectrodes 18 can be separated by a distance S1 in the range of about 1 mm to 3 mm. Referring to FIG. 12B, as a dipole, the pair of adjacent microelectrodes 18 can be separated by a distance S2 in the range of 1 mm to 6 mm.

Referring to FIG. 12B, in some embodiments, the six microelectrodes are arranged as three dipole pairs with a 2.0 mm spacing S1 between the proximal edges within one dipole pair. A 6.0 mm spacing S2 is secured between the proximal edges of adjacent dipole pairs, and such a configuration can be commonly referred to as a "2-6-2" configuration. Is. Another configuration, referred to as the "2-5-2-2-5-2" configuration, has three dipole pairs with a distance of 2.0 mm between the proximal edges within one dipole pair. A distance S2 of 5.0 mm is secured between the proximal edges of the adjacent dipole pairs of S1.

Referring to FIG. 12A, in some embodiments, the six microelectrodes are arranged as monopoles, ensuring a 2.0 mm spacing S1 between the proximal edges of adjacent monopoles. Such a configuration can be called a "2-2-2-2-2" configuration. In some embodiments, the spacing S1 is about 3.0 mm and is therefore referred to as the "3-3-3-3-3" configuration.

In some embodiments, the most proximal microelectrode 18P of each spine is supported on the spine at a location different from the most proximal microelectrode 18P of the adjacent spine. As shown in FIG. 13A of the end probe 400, the spacing between the microelectrodes on any one spine may be uniform throughout the distal microelectrode assembly and is along any one spine. The microelectrodes are staggered with respect to the microelectrodes along adjacent spines. For example, in the case of spines 17A, 17C, 17E, and 17G, the distance D1 between the most proximal microelectrode 18P and the end of the stem 42 is that in the case of spines 17B, 17D, 17G, and 17G. It is larger than the distance D2 between the most proximal microelectrode 18P and the end of the stem 42. This staggered configuration minimizes the risk of microelectrodes contacting and shorting between adjacent spines, especially when the operator swipes the distal microelectrode assembly against tissue.

US Pat. No. 7,089,045, the structural components and assemblies of the junction between the distal microelectrode assembly and the distal end portion of the deflection compartment 14, are incorporated herein by reference in their entirety. It is described in the same No. 7,155,270, the same No. 7,228,164, and the same No. 7,302,285.

FIG. 13B shows a side view of the end probe assembly 400 of FIG. 13A, in which the spine of the assembly is in contact with the flat surface T. In this shape in which the longitudinal axis LL (defined by the stem 42) is approximately orthogonal to the flat surface T, the stem 42 includes a tubular member 27, which has a reference microelectrode 67A. It can be seen that it can be attached to the distal portion of the tubular member 27, leaving a gap G to avoid contact with the tissue represented by the surface T.

In certain use cases, it was recognized that microelectrodes of spines adjacent to each other could come into contact with each other. Therefore, the inventor has devised to arrange microelectrodes on each spine so that microelectrodes of spines adjacent to each other do not come into contact with each other. Specifically, in FIG. 13B, there are eight spines 17A, 17B, 17C, 17D, 17E, 17F, 17G, and 17H, and each spine has a corresponding spine 17A, 17B, 17C, 17D, 17E. , 17F, 17G, and 17H, respectively, corresponding six microelectrodes 17A1 to 17A6, 17B1 to 17B6, 17C1 to 17C6, 17D1 to 17D6, 17E1 to 17E6, 17F1 to 17F6, 17G1 to 17G6, and 17H1 to 17H6. It can be seen that it has. Using the spine 17A as reference data, when the end effector 400 is placed against a flat, transparent surface (eg, glass), the microelectrodes on the spine 17A are longitudinal axis LL (or tube material 27). It can be seen that various virtual circles can be defined based on. For example, the first microelectrode 17A1 defines the first virtual circle VC1, the second microelectrode 17A2 defines the second virtual circle VC2, and the third microelectrode 17A3 defines the third virtual circle VC2. The circle VC3 is defined, the fourth microelectrode 17A4 defines the fourth virtual circle VC4, the fifth microelectrode 17A5 defines the fifth virtual circle VC5, and the sixth microelectrode 17A6 defines the fifth microelectrode 17A6. A sixth virtual circle VC6 is defined, and if more microelectrodes are present on the spine 17A, the microelectrodes also define the virtual circle. Virtual circles indicate that microelectrodes are arranged "alternately" on one spine with respect to its adjacent adjacent devices. As used herein, staggering indicates that one microelectrode on the reference spine is not in contact with different microelectrodes on its adjacent spines. In FIG. 13C, microelectrodes 17A1, 17A2, 17A3, 17A4, 17A5, or even when the reference spine 17A can rotate clockwise about the axis LL by 45 degrees towards the spine 17B. None of 17A6 can contact the microelectrodes 17B1 to 17B6 of the spine 17B. Similarly, in FIG. 13C, even when the spine 17A can rotate 45 degrees counterclockwise about the axis LL, all of the microelectrodes 17A1 to 17A6 are the microelectrodes 17H1 to 17H of the spine 17H. Cannot contact 17H6.

Similarly, even in situations where the spine is integrally compressed by the tissue so that the spine is compressed in the same line with respect to the axis LL, the microelectrodes of one spine are adjacent adjacent spines thereof. Cannot contact microelectrodes. This is exemplified in FIG. 13D, in which the spine 17A is compressed on the same line as the spines 17H, 17G, 17F, and 17E. It can be seen that the staggered arrangement distance Dstagger1 is set between the corresponding front edges of the microelectrodes 17A1 and 17H1 respectively. The staggered arrangement distances can be the same between each of the microelectrodes 17A1-17A6 on the spine 17A and the corresponding adjacent microelectrodes 17H1-17H6 on the adjacent spine 17H, but for example, the spines 17A and 17A adjacent to each other. Other staggered array distances such as Dstagger4 for the corresponding fourth microelectrodes 17A4 and 17H4 on 17H can be used. The staggered array distance can be any distance from about 0.1 mm to about 6 mm.

With reference to FIG. 13C again, it can be seen that each microelectrode of the spine is configured to have the same clearance distance D1 = D2 = D3 = D4 = D5 between the microelectrodes on each spine. .. The gap distance can be measured between the front edges of the microelectrodes or between the centers of the microelectrodes. Although the gap distances are the same, the microelectrode sets 1-6 on each spine (eg 17A) have the same staggered array distance Dstager1 and the microelectrode sets 1-6 on adjacent spines (eg 17H and 17B). Is offset against. FIG. 13E shows an embodiment in which the gap distances are not the same value but may be different. For example, the gap distance D1 can be smaller than the gap distance D2, and the gap distance D1 can be equal to the gap distances D3 and D5, while the gap distance D4 can be equal to the gap distance D2. As long as the microelectrodes set on each spine (eg, 17A) are offset or staggered (eg, Dstager1) with respect to their adjacent spines (eg, 17H and 17B), the gap distances D1, D2, D3, D4, and D5 may not be equal.

The configurations shown in the embodiments of FIGS. 13A-13E are ray-like configurations using spines with free ends, but the same principle for ray-like configurations defines a basket as shown in FIG. 13F. It can be applied to the closed-end type spine configuration. Specifically, in FIG. 13F, there are spines 17A-17L joined to a common center 270 so as to define a basket-shaped assembly. Each spine can carry multiple microelectrodes. For example, the microelectrodes 17A1 to 1710 are arranged so that a virtual circle intersecting one of the microelectrodes 17A1 to 17A10 does not intersect the microelectrodes on adjacent spines (eg, 17L or 17B).

Similarly, the same principle as for these embodiments applies to the planar spine arrays shown here in FIGS. 13G, 13H, and 13I (instead of the conical configuration of FIGS. 13A-13E). Can be applied.

In FIGS. 13G-13H, embodiments are arranged such that the stem 42 and spines 170A, 170B, 170C, 170D are on a single floor plan (FIGS. 13G and 13H) or multiple floor plans (FIG. 13I). However, it follows the same naming scheme as shown above. Each spine 170A, 170B, 170C, and 170D has microelectrodes 170A1-170A6, 170B1-170B6, 170C1-170C6, and 170D1-170D6. The microelectrode sets 170A1-170A6 are staggered or offset from the microelectrode sets 170B1-170B6 on adjacent spines 170B. The microelectrode sets 170B1 to 170B6 are offset from both their adjacent microelectrode sets 170A1 to 170A6 and 170C1 to 170C6. The end probe assembly 400, which includes at least a plurality of spines and a set of microelectrodes for each spine, can be configured as shown in FIGS. 13G and 13H so that the spines are in contact with a single contact surface. In FIG. 13H, the spine 170A can be connected to the spine 170D by the connector 170AD, and the spine 170B is connected to the spine 170C by the connector 170BC. Contact in two or more planes can be used with the configuration of FIG. 13I. In that configuration, the spine 170A is connected to the spine 170C via the connector 170AC to define a first contact surface for the microelectrode sets of these spines, and the spines 170B and 170D are connected to each other by the connector 170BD. A second contact surface is defined.

In the embodiment of FIGS. 13A to 13F, 13H, and 13I, the electrode of one spine has the longitudinal axis L- (of each spine) with respect to the electrode on the adjacent spine (s). along the L is or offset is staggered array, and the center line or center of mass L-L _A1 of each electrode, to be noted that indicates that coincides with the longitudinal axis L-L of each spine Is. We also have yet another staggered arrangement in which the centerline of each electrode on one spine is eccentrically offset from the longitudinal axis in the first direction T1 of the spine to which the electrode is mounted. Invented. This characteristic of eccentric offset can be seen in FIGS. 13G and 13J. In FIG. 13J, the center line LL _A1 of the electrode 170A1 is approximately the transverse direction T1 with respect to the axis LL of the spine 170A. Is offset by the eccentric distance "e". Similarly, the electrode 170B1 on the spine 170B is eccentrically offset in the transverse direction T2 substantially opposite to the electrode 170A1 on the spine 170A of FIG. 13G. Electrodes on one spine may be offset longitudinally only with respect to adjacent electrodes on adjacent spines (s) (FIGS. 13A-13F, 13H, and 13I), but only eccentrically. It is intended that they may be staggered (FIG. 13J) or, as shown in FIG. 13G, they may be staggered both longitudinally and eccentrically.

In summary, we have devised certain common features for the embodiments of FIGS. 13A-13J. Specifically, various embodiments of the medical probe include at least the following features: an elongated member 14 extending along the longitudinal axis, the elongated member 14 to which the distal microelectrode assembly 400 is connected. A member 14, a proximal stem 42 extending along the longitudinal axis LL, and a first spine (eg, 17A or 170A) radiating from the longitudinal axis LL, which owns. Adjacent to and longitudinal of a first spine (17A or 170A) having a plurality of first microelectrodes (17A1-17A6 or 170A1-170A6) disposed above and a first spine (17A or 170A). A second spine (17B or 170B) that radiates away from the directional axis LL and has a plurality of second microelectrodes (17B1-17B6 or 170B1-170B6) disposed on itself. A first virtual circle (eg, VC1 or VC2) that includes a spine (eg, 17B or 170B) and intersects one of a plurality of first microelectrodes does not intersect with any of the second microelectrodes. .. As a further improvement, a third spine may be provided adjacent to the first spine and radially away from the longitudinal axis. The third spine has a plurality of third microelectrodes disposed on it, and a first virtual circle intersecting one of the plurality of first microelectrodes is a second and a second. It is designed so that it does not intersect with any of the microelectrodes of 3. It should be noted that the first virtual circle may have its longitudinal axis approximately at its center and may be approximately orthogonal to the longitudinal axis. For the purpose of defining the shape of the spine, the proximal stem is arranged approximately orthogonal to the flat surface, with the first, second, and third spines in contact with the flat surface and radial of the spine. The shape is defined. The plurality of spines may include 5 to 8 or more spines arranged in an isometric configuration around the longitudinal axis.

Another common feature of the embodiments is that the plurality of spines 17A, 17B, 17C, 17D, 17E. .. .. A plurality of first microelectrodes (for example, 17A1 to 17A6) are arranged on the first spine 17A including 17N, and on the second spine (17H) adjacent to the first spine (17A). Is that a plurality of second microelectrodes (17H1 to 17H6) are arranged. The plurality of first microelectrodes (17A1 to 17A6) are spaced apart along the first spine, and the first microelectrodes are spaced apart from the second microelectrodes (17H1 to 17H2) by the staggered distance Dstager1. It is designed to be offset. In a further improvement, a plurality of third microelectrodes are disposed on the third spine adjacent to the first spine, and the first microelectrodes are the second and third microelectrodes for the staggered array distance Dstager1 only. It is offset with respect to the microelectrodes. The staggered alignment distance is about 0.1 mm to about 0.1 mm as measured between the front edge of one microelectrode on one spine and the front edge of the closest microelectrode on the adjacent spine. Includes any distance of 5 mm.

As shown in FIG. 14A, the stem 42 of the integrated support member 40 receives the narrow distal end 30D of the flexible compartment 14 of the tube member 30 having the plurality of lumens. A non-conductive sleeve 68 having the same spread as the stem 42 between its proximal end and its distal end surrounds the stem 42 in the circumferential direction. The distal end 68D of the sleeve 68 extends over the proximal end 28P of the non-conductive spine tubing 28 to help secure the tubing 28 onto the spine 17.

Proximal to the distal end 30D is a housing insert 60, which is also received and positioned within the lumen 43 of the stem 42 of the integrated support member 40. Since the length of the housing insert 60 in the longitudinal direction is shorter than the length of the stem 42, the housing insert 60 does not protrude beyond the distal end of the stem 42. The housing insert 60 is configured to include one or more lumens. One lumen 71 may have a non-circular cross section, eg, a cross section generally similar to a "C" or elongated kidney bean, and another lumen 72 may have a circular cross section as shown in FIG. 14B. May have. As a result, the lumens are nested together, maximizing the size of the lumens and increasing the spatial efficiency within the housing insert 60. Components that pass through more lumen 71 are not trapped in any one place or position and therefore move more freely and risk breakage, especially when torque is applied to the segment of the catheter and the component is twisted. It has less sex.

In some embodiments, the electromagnetic position sensor 26 (at the distal end of the cable 24) is received within the lumen 72. For example, the irrigation tube 27 and the lead 22 for the microelectrode 18 on the distal microelectrode assembly 15 (and the lead 25 for any ring microelectrodes 67, 69, and 70 proximal to the spine 17). Other components, including and, pass through the lumen 71. In that regard, the housing insert 60 performs multiple functions, including aligning and positioning the various components within the stem 42 of the integrated support member 40, spacing these various components apart. And further serve as a mechanical lock that reinforces the junction between the distal end of the deflection compartment 14 and the distal microelectrode assembly 15. With respect to the latter, the joint may be subject to various forces that can torque or attract the joint during assembly and use of the catheter. The torque force can, for example, pinch the irrigation tube material 27 and obstruct the flow, or cause breakage of the leads 22 and 25. As such, the joints are advantageously assembled in a configuration with a housing insert 60 to form a mechanical lock, as described below.

The housing insert 60 may be selectively configured with an outer diameter smaller than the inner circumference of the lumen 43 of the stem 42 by a predetermined amount. This creates a perceptible void in the cavity 43 filled with a suitable adhesive 61 such as polyurethane, which minimizes, if not prevents, relative movement between the housing insert 60 and the stem 42. The insert 60 is firmly attached to the inside of the lumen 43 and to the distal end of the tube material 30 having the plurality of lumens so as to hold it down. The housing insert 60 protects the components it surrounds, including electromagnetic position sensors 26 (and attachments to cables 24), irrigation tubing 27, and leads 22 and 25. Is done. Also, the housing insert 60 provides a larger and more rigid structure to which the stem 42 is attached. To that end, the housing insert 60 may have a non-circular / polygonal outer cross section and / or textured surface to improve adhesion between the housing insert 60 and the adhesive 61.

To facilitate application of the adhesive into the voids, the stem 42 is formed with an opening 65 in its side wall, where the housing insert 60 is formed in the lumen 43 of the stem 42. A position that allows visual and mechanical access to the housing insert 60 after it has been inserted into it. During assembly of the joint, a visual inspection of the lumen 43 and the components therein is provided through the opening 65. Any adhesive applied to the outer surface of the housing insert 60 prior to insertion into the lumen 43 can be ejected out of the stem 42 during insertion, but advantagefully additional adhesive opens. It is applied into the lumen 43 through the portion 65 to fill the void and firmly attach the housing insert 60 to the stem 42 and the distal end portion of the tube material 30 having the plurality of lumens. The combination of the housing insert 60 and the lumen 71 that spatially accommodates it provides a more integrated and less fragile junction between the distal microelectrode assembly 15 and the deflection compartment 14. To.

In some embodiments, the catheter 10 comprises an irrigation tube 27, the distal end 27D of the irrigation tube 27 having approximately the same extent as the distal end of the stem 42 of the integrated support member 40. Thus, the irrigation fluid, such as saline, extends through the control handle 16 from a remote fluid source that provides the irrigation fluid via the lumen hub 100 (FIG. 1) into the irrigation tube material 27 and the center of the catheter body 12. It is delivered to the distal microelectrode assembly 15 via lumen 19 (FIG. 2) and lumen 31E (FIG. 3) of the tube material 30 of the deflection compartment 14. The irrigation fluid exits from the distal end of the irrigation tube 27 at the distal end of the stem 42 of the integrated support member 40, as shown in FIGS. 15A and 25. A suitable adhesive 90, such as polyurethane, closes and seals the lumen 43 around the distal end of the irrigation tube 27. In some embodiments, as shown in FIG. 14A, the catheter is unirrigated and the distal end of the stem 42 of the integrated support member 40 is entirely sealed by an adhesive such as polyurethane or a sealant 90. Will be done.

FIG. 16 shows an embodiment in which the non-conductive spine tube member 28 includes a reinforcing tension member 53. As will be appreciated by those skilled in the art, microelectrodes 18 are mounted on a spine cover or spine tube 28, with an elongated tubular mandrel (not shown) placed within the lumen of the spine cover 28. However, the microelectrode 18 is supported while being rotationally fitted onto the spine cover 28. Microelectrode 18 may have a circular cross section, including a circular or elliptical shape. It is not desirable for the microelectrodes 18 and spine cover 28 to deform (including extending in the longitudinal direction) during the sinking process, but to prevent or at least minimize such deformations, the microelectrodes do. The supported and seated spine cover 28 includes a reinforcing tension member 53, as shown in FIG. A tension member 53, such as a wire or fiber (used interchangeably herein), is embedded within the side wall 54 of the tube (eg, during extrusion of the tension member). The tension member 53 may be embedded in the non-conductive cover extruded part in a uniaxial or braided pattern and has a longitudinally extending or at least longitudinally extending portion. Although it is not desirable for the spine cover 28 and the microelectrode 18 to be particularly flexible and flexible to extend in the longitudinal direction, the tension member as described above functions to resist this extension. Examples of suitable tension members include VECTRAN, Dacron, KEVLAR, or other materials with low elongation properties. The number of reinforcing tension members is not important. In some embodiments, the number may be in the range of 2-6, but they are arranged at equal intervals in the radial direction. In the illustrated embodiment, the spine cover 28 comprises four tension members at 0, 90, 180, and 270 degree positions around the side wall 54.

In some embodiments, the distal end of the tension member 53 is clamped within a spherical cover 45 and / or ring 99D that encloses the enlarged distal portion of the spine 17, as shown in FIG. , May be compressed or clamped onto the spine cover 28 and above the spine 17. In some embodiments, the proximal end of the tension member 53 has the same extent as the proximal end of the spine cover 28, and the proximal end of the tension member 53 may also be secured by the ring 99P ( See FIGS. 14A and 15A).

In some embodiments, the tension member 53 has a much longer length than described above. With reference to FIGS. 17, 18, 19, and 20, the tension member 53 extends into the lumen 43 of the stem 42 through an opening 44 formed in the stem 42 of the integrated support member 40. To do. The tension member 53 then extends into the control handle 16 through the lumen 71 of the housing insert 60, the lumen 31F of the tube member 30 of the deflection compartment 14, and the central lumen 19 of the catheter body 12. The proximal end of the tension member 53 is configured to be operated by an operator to deflect the spines 17 of the distal microelectrode assembly 15, so that the spines 17 can function individually as "fingers". it can. In that regard, the tension member may be formed within the side wall of the tubing 28 in a manner that allows longitudinal movement with respect to the tubing 28, thereby pulling any one or more tension members proximally. And, each spine is bent or deflected toward the side where those tension members extend along it. Thus, the operator can operate one or more spines for individual deflections as needed or desired. In such cases, the distal microelectrode assembly may come into contact with an uneven tissue surface, such as one or more spines requiring adjustment for better tissue contact. Is done.

With reference to FIGS. 21, 22, 23, and 24, the catheter 10 of the present invention is used in all four atriums and ventricles of the heart, namely the left and right atriums, and the left and right ventricles. It is shown in the state of being. The spine of the distal microelectrode assembly 15 includes, for example, the interior of the pulmonary vein, the posterior wall of the right atrium, and the anterior wall, inferior wall and / or side wall of the left and right ventricle, and even the apex. Easily adapts and adapts to various contours and surfaces of the anatomy. Advantageously, the preformed shape of the spine facilitates contact between the microelectrodes carried on the spine and the tissue, regardless of the anatomy of its surface.

In some embodiments, the catheter 10 has a plurality of ring microelectrodes proximal to the distal microelectrode assembly 15. As shown in FIG. 1, in addition to the ring microelectrode 67, the catheter has another ring microelectrode 69 proximal to the ring microelectrode 67 and another ring microelectrode 69 proximal to the ring microelectrode 69. Supports the electrode 70. Lead wires 25 are provided for these ring microelectrodes. In some embodiments, the ring microelectrode 69 is located near the distal end 30D of the multiluminal tube 30 in the deflection compartment 14, and the ring microelectrode 70 is in the range of about 1 mm to 3 mm. It is separated from the ring microelectrode 69 by a distance S. Each lead wire 25 is connected to the ring microelectrode 67 via an opening 75 formed in the stem 42 and sleeve 68 of the integrated support member 40. Lead wires 25 for each of the ring microelectrodes 69 and 70 are connected to via openings (not shown) formed in these side walls of the pipe material 30 of the deflection section 14.

Each portion of the tow wires 23A and 23B extending through the catheter body 12 is circumferentially surrounded by compression coils 101A and 101B, respectively, as will be appreciated in the art. Each portion of the tow wire 23A and 23B extending through the tube material 30 having a plurality of lumens in the deflection compartment is circumferentially provided by a sheath that prevents the tow wire from biting into the tube material when the tow wire is deflected. being surrounded. The distal end of the tow wire may be secured to the side wall of the tubing 30 at or near the distal end of the tubing 30, as will be appreciated in the art. The proximal end of the tow wire is secured within the control handle 16 for operation by the operator of the catheter, as will be appreciated in the art.

The above description is presented in connection with a preferred embodiment of the present invention. It will be appreciated that those skilled in the art to which the present invention relates may be able to modify and modify the structures described without significantly deviating from the principles, gist and scope of the invention. Let's do it. Any feature or configuration disclosed in one embodiment can be incorporated, as needed or as appropriate, in place of or in addition to the other features of any other embodiment. Drawings are not always to scale, as will be appreciated by those skilled in the art. Therefore, the above description should not be read as relating only to the exact configuration described and illustrated in the accompanying drawings, but rather the claims that have the most complete and fair scope below. Should be read as consistent with and in support of this.

[Implementation mode]
(1) An elongated member extending along the longitudinal axis and a distal electrode assembly connected to the elongated member.
With the proximal stem extending along the longitudinal axis,
A first spine that is radially separated from the longitudinal axis and has a plurality of first microelectrodes disposed on the first spine.
A second spine that is adjacent to the first spine and radially separates from the longitudinal axis and has a plurality of second microelectrodes disposed on the second spine. With spines
With, with a distal electrode assembly,
A medical probe in which a first virtual circle that intersects one of the plurality of first microelectrodes does not intersect any of the second microelectrodes.
(2) Further provided with a third spine adjacent to the first spine and radially separated from the longitudinal axis.
A first virtual circle in which the third spine has a plurality of third microelectrodes disposed on the third spine and intersects one of the plurality of first microelectrodes. The medical probe according to the first embodiment, which does not intersect with any of the second microelectrode and the third microelectrode.
(3) The medical probe according to the first embodiment, wherein the first virtual circle is substantially centered on the longitudinal axis.
(4) The medical probe according to the first embodiment, wherein the first virtual circle is substantially orthogonal to the longitudinal axis.
(5) The proximal stem is arranged approximately orthogonal to the flat surface, and the first spine, the second spine, and the third spine come into contact with the flat surface. The medical probe according to embodiment 1, which defines the radial shape of the spine.

(6) The medical probe according to the first embodiment, wherein the plurality of spines include eight spines arranged in an isometric configuration arranged around the longitudinal axis.
(7) Proximal stem defining the longitudinal axis and
With a plurality of spines extending along the longitudinal axis,
A plurality of first microelectrodes disposed on the first spine,
A plurality of second microelectrodes disposed on the second spine adjacent to the first spine, and
With a distal electrode assembly
The plurality of first microelectrodes are spaced apart along the first spine, and the first microelectrodes are staggered by the stagger distance measured along the longitudinal axis. An electrophysiological medical probe offset with respect to a second microelectrode.
(8) Multiple spines, each defining a longitudinal axis,
A plurality of first microelectrodes arranged on the first spine, each of which is an eccentric distance with respect to the longitudinal axis of the first spine and is approximately relative to the longitudinal axis. A plurality of first microelectrodes having a centerline arranged in a first direction across them.
A plurality of second microelectrodes arranged on a second spine adjacent to the first spine, each of which is an eccentric distance with respect to the longitudinal axis from the first direction. A plurality of second microelectrodes having centerlines disposed in a second direction away from each other.
An electrophysiological medical probe with a distal electrode assembly.
(9) The plurality of first microelectrodes are spaced apart along the first spine, and the first microelectrodes are said to have the staggered arrangement distance measured along the longitudinal axis. The probe according to embodiment 8, which is offset with respect to the microelectrodes of 2.
(10) Each of the first microelectrodes is an eccentric distance with respect to the longitudinal axis of the first spine, and a center arranged in a first direction substantially crossing the longitudinal axis. Including lines,
A plurality of second microelectrodes are arranged on the second spine adjacent to the first spine, and each of the second microelectrodes is at an eccentric distance with respect to the longitudinal axis, and the first. 7. The probe according to embodiment 7, having a centerline disposed in a second direction away from the direction of.

(11) A plurality of third microelectrodes arranged on the third spine adjacent to the first spine are further provided.
The plurality of first microelectrodes are spaced apart along the first spine, and the first microelectrodes are attached to the second microelectrode and the third microelectrode by the staggered arrangement distance. Offset against,
The probe according to embodiment 7 or 8.
(12) The staggered alignment distance is measured between the front edge of one electrode on one spine and the front edge of the closest electrode on the adjacent spine, from about 0.1 mm to about 5 mm. 11. The medical probe according to embodiment 11, wherein the medical probe comprises any distance of the above.
(13) The medical treatment according to the eleventh embodiment, wherein the microelectrodes on each spine are separated by a distance in the range of about 1 mm to 3 mm when measured between the front edges of the microelectrodes. probe.
(14) The medical probe according to embodiment 11, wherein the distance includes a distance of about 2 mm.
(15) The microelectrodes on each spine are arranged as dipole pairs.
The front edges of one pair of microelectrodes are separated by a first distance in the range of about 1 mm to 3 mm.
The medical probe according to embodiment 11, wherein the front edges of the anterior microelectrodes between the pairs are separated by a second distance in the range of 1 mm to 6 mm.

(16) The medical probe according to embodiment 15, wherein the first distance comprises about 2 mm and the second distance comprises about 6 mm.
(17) The medical probe according to embodiment 11, wherein the number of the plurality of microelectrodes is equal to about 64.
(18) The medical probe according to embodiment 11, wherein the number of the plurality of microelectrodes is equal to about 72.
(19) A first ring microelectrode carried on the proximal stem of the distal electrode assembly, and a second ring microelectrode and a third ring supported on the distal portion of the elongated body. Microelectrode,
The medical probe according to embodiment 11, further comprising.
(20) The medical probe according to embodiment 11, wherein each microelectrode has a length in the range of any value from about 300 μm to 500 μm.

(21) The medical treatment according to embodiment 11, wherein the microelectrodes on each spine are separated by a distance in the range of about 1 mm to 3 mm when measured between the front edges of the microelectrodes. probe.
(22) The medical probe according to embodiment 21, wherein the distance comprises about 2 mm.
(23) The microelectrodes on each spine are arranged as a dipole pair.
The front edges of one pair of microelectrodes are separated by a first distance in the range of about 1 mm to 3 mm.
The medical probe according to embodiment 11, wherein the front edges of the anterior microelectrodes between the pairs are separated by a second distance in the range of 1 mm to 6 mm.
(24) The medical probe according to embodiment 23, wherein the first distance comprises about 2 mm and the second distance comprises about 5 mm.

Claims (24)

An elongated member extending along the longitudinal axis and a distal electrode assembly connected to the elongated member.
With the proximal stem extending along the longitudinal axis,
A first spine that is radially separated from the longitudinal axis and has a plurality of first microelectrodes disposed on the first spine.
A second spine that is adjacent to the first spine and radially separates from the longitudinal axis and has a plurality of second microelectrodes disposed on the second spine. With spines
With, with a distal electrode assembly,
A medical probe in which a first virtual circle that intersects one of the plurality of first microelectrodes does not intersect any of the second microelectrodes. Further comprising a third spine adjacent to the first spine and radially away from the longitudinal axis.
A first virtual circle in which the third spine has a plurality of third microelectrodes disposed on the third spine and intersects one of the plurality of first microelectrodes. The medical probe according to claim 1, which does not intersect with any of the second microelectrode and the third microelectrode. The medical probe according to claim 1, wherein the first virtual circle is substantially centered on the longitudinal axis. The medical probe according to claim 1, wherein the first virtual circle is substantially orthogonal to the longitudinal axis. The proximal stem is disposed approximately orthogonal to the flat surface, with the first spine, the second spine, and the third spine in contact with the flat surface to radiate the spine. The medical probe according to claim 1, which defines the shape. The medical probe according to claim 1, wherein the plurality of spines include eight spines arranged in an isometric configuration arranged around the longitudinal axis. Proximal stems that define the longitudinal axis and
With a plurality of spines extending along the longitudinal axis,
A plurality of first microelectrodes disposed on the first spine,
A plurality of second microelectrodes disposed on the second spine adjacent to the first spine, and
With a distal electrode assembly
The plurality of first microelectrodes are spaced apart along the first spine, and the first microelectrodes are the second microelectrode by the staggered array distance measured along the longitudinal axis. Electrophysiological medical probe offset with respect to electrodes. With multiple spines, each defining a longitudinal axis,
A plurality of first microelectrodes arranged on the first spine, each of which is an eccentric distance with respect to the longitudinal axis of the first spine and is approximately relative to the longitudinal axis. A plurality of first microelectrodes having a centerline arranged in a first direction across them.
A plurality of second microelectrodes arranged on a second spine adjacent to the first spine, each of which is an eccentric distance with respect to the longitudinal axis from the first direction. A plurality of second microelectrodes having centerlines disposed in a second direction away from each other.
An electrophysiological medical probe with a distal electrode assembly. The plurality of first microelectrodes are spaced apart along the first spine, and the second microelectrodes are staggered by the staggered alignment distance measured along the longitudinal axis. The probe according to claim 8, which is offset with respect to the electrode. Each of the first microelectrodes includes a centerline disposed in a first direction approximately intersecting the longitudinal axis at an eccentric distance with respect to the longitudinal axis of the first spine. ,
A plurality of second microelectrodes are arranged on the second spine adjacent to the first spine, and each of the second microelectrodes is at an eccentric distance with respect to the longitudinal axis, and the first The probe according to claim 7, which has a center line disposed in a second direction away from the direction of the above. Further comprising a plurality of third microelectrodes disposed on a third spine adjacent to the first spine.
The plurality of first microelectrodes are spaced apart along the first spine, and the first microelectrodes are attached to the second microelectrode and the third microelectrode by the staggered arrangement distance. Offset against,
The probe according to claim 7 or 8. The staggered alignment distance is measured between the leading edge of one electrode on one spine and the leading edge of the closest electrode on the adjacent spine, any of about 0.1 mm to about 5 mm. The medical probe of claim 11, including distance. The medical probe according to claim 11, wherein the microelectrodes on each spine are separated by a distance in the range of about 1 mm to 3 mm when measured between the front edges of the microelectrodes. The medical probe of claim 11, wherein the distance comprises a distance of about 2 mm. The microelectrodes on each spine are arranged as dipole pairs and
The front edges of one pair of microelectrodes are separated by a first distance in the range of about 1 mm to 3 mm.
The medical probe according to claim 11, wherein the front edges of the front microelectrodes between the pairs are separated by a second distance in the range of 1 mm to 6 mm. The medical probe according to claim 15, wherein the first distance comprises about 2 mm and the second distance comprises about 6 mm. The medical probe according to claim 11, wherein the number of the plurality of microelectrodes is equal to about 64. The medical probe according to claim 11, wherein the number of the plurality of microelectrodes is equal to about 72. A first ring microelectrode mounted on the proximal stem of the distal electrode assembly, and a second ring microelectrode and a third ring microelectrode supported on the distal portion of the elongated body.
11. The medical probe according to claim 11. The medical probe of claim 11, wherein each microelectrode has a length in the range of any value from about 300 μm to 500 μm. The medical probe according to claim 11, wherein the microelectrodes on each spine are separated by a distance in the range of about 1 mm to 3 mm when measured between the front edges of the microelectrodes. 21. The medical probe of claim 21, wherein the distance comprises about 2 mm. The microelectrodes on each spine are arranged as dipole pairs and
The front edges of one pair of microelectrodes are separated by a first distance in the range of about 1 mm to 3 mm.
The medical probe according to claim 11, wherein the front edges of the front microelectrodes between the pairs are separated by a second distance in the range of 1 mm to 6 mm. 23. The medical probe of claim 23, wherein the first distance comprises about 2 mm and the second distance comprises about 5 mm.

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