CN121240830A - Electrophysiology catheter insertion components and electrophysiology catheter - Google Patents

Abstract

An insertion component of an electrophysiology catheter and the electrophysiology catheter relate to the field of electrophysiology catheters. The insertion assembly comprises an outer tube body (210), the outer tube body (210) comprises an outer bending section (211) and an outer main body section (212), the outer bending section (211) is located at the distal end of the outer tube body (210), the outer main body section (212) is connected to the proximal end of the outer bending section (211), the inner tube body (220) is used for transmitting torque, the inner tube body (220) is nested in the outer tube body (210), the inner tube body (220) comprises an inner bending section (221) and an inner main body section (222), the inner bending section (221) is located at the distal end of the inner tube body (220), the inner main body section (222) is connected to the proximal end of the inner bending section (221) and used for transmitting torque to the inner bending section (221), the perfusion tube (230) is sleeved outside the inner bending section (221) and forms a fluid channel (250) for enabling fluid to pass through with the inner bending section (221), the fluid channel (250) is led to the outside of the distal end of the insertion assembly, and the insertion assembly further comprises a fluid supply tube (240) and the proximal end of the fluid channel (240) is in fluid communication with the distal end of the fluid channel (250). The insertion assembly enables the catheter to meet fluid infusion requirements in the event that the drive rod is in rotational demand.

Description

Insertion assembly of electrophysiology catheter and electrophysiology catheter

Technical Field

The present application relates to the field of electrophysiology catheters.

Background

Atrial fibrillation, abbreviated as atrial fibrillation, is the most common clinical arrhythmia, and its incidence increases gradually with age. Currently, catheter ablation has become an important treatment modality for atrial fibrillation. The pulse electric field ablation is a new tissue ablation means based on physical energy factors, which mainly uses the irreversible electroporation principle, and the cell membrane is perforated irreversibly by the action of the high-voltage pulse electric field on the cell, so that the cell gradually necroses, and finally the tissue ablation purpose is realized.

The electrophysiological catheters adopted by pulse ablation devices in the market at present are mostly petal-shaped catheters or basket-shaped catheters, namely, the catheters with petal-shaped or basket-shaped electrode assemblies. The distal end of the electrode assembly can be driven to be close to or far away from the proximal end by pushing and pulling the driving rod in the tube body, so that the electrode assembly is folded and unfolded, is approximately columnar when folded so as to enter and exit the sheath tube, and is petal-shaped or basket-shaped when unfolded so as to perform ablation or mapping.

In addition, electrophysiology catheters often require bending through the distal bending section during use, and in such cases, the drive shaft also requires bending. Also, using an electrophysiology catheter may require an irrigation operation, such as delivering saline, through the catheter to the area to be ablated, to help control the temperature during ablation, reduce the formation of scabs and thrombus, and control the extent and depth of ablation.

However, in some designs the drive rod is required to rotate to transmit torque, and consideration is required to how the fluid priming requirements are met in this case.

Disclosure of Invention

In one embodiment, the application provides an insertion assembly for an electrophysiology catheter to enable the catheter to meet fluid infusion requirements in the event that rotation of the drive shaft is required.

An insertion assembly for an electrophysiology catheter, comprising:

The outer tube body comprises an outer bending section and an outer main body section, the outer bending section is positioned at the distal end of the outer tube body, and the outer main body section is connected with the proximal end of the outer bending section;

and an inner tube for transmitting torque, the inner tube being nested in the outer tube;

The inner tube body comprises an inner bending section and an inner main body section, the inner bending section is positioned at the far end of the inner tube body, and the inner main body section is connected with the near end of the inner bending section and is used for transmitting torque to the inner bending section;

The insertion assembly further comprises a perfusion tube for bending along with the inner bending section, the perfusion tube is sleeved outside the inner bending section and forms a fluid channel for fluid to pass through with the inner bending section, and the fluid channel is communicated to the outside of the distal end side of the insertion assembly;

The insert assembly further includes a fluid supply tube having a distal end in communication with the proximal end of the fluid passageway.

In one embodiment, an insertion assembly includes an electrode assembly including:

The spline is of a linear structure, the spline is provided with a first tail end and a second tail end, and electrodes for transmitting electric energy are distributed on the spline;

The spline connecting seat is arranged at the far end side of the spline connecting seat, the spline connecting seat comprises a first seat body and a second seat body, the first seat body and the second seat body are both pipe bodies, the second seat body is embedded into the first seat body, the far end of the second seat body is exposed at the far end of the first seat body, and the second seat body is rotatably arranged at the first seat body;

the first seat body is fixedly connected with the first end of the spline, the second seat body is fixedly connected with the second end of the spline, and one side of the spline, which is far away from the spline connecting seat, is provided with a reverse folding part;

The first base body rotates relative to the second base body, the electrode assembly is in an unfolding state and a folding state, in the unfolding state, each spline forms a petal shape on the radial outer side of the spline connecting base, in the folding state, the first tail end and the second tail end of any spline are staggered along the circumferential direction of the electrode assembly, and the spline has folding amount bent towards the far end direction of the electrode assembly compared with the unfolding state.

In one embodiment, the application provides an electrophysiology catheter comprising an operating handle and an insertion assembly coupled to the operating handle, the insertion assembly being the insertion assembly described above.

The application has the beneficial effects that:

According to the insertion assembly provided by the embodiment of the application, the perfusion tube sleeved outside the inner bending section is arranged, a fluid channel for fluid to pass through is formed between the perfusion tube and the inner bending section, the fluid channel is communicated with the outside of the far end side of the insertion assembly, and the near end of the fluid channel is communicated with the liquid supply tube, so that the perfusion requirement is met, and the perfusion tube bends along with the inner bending section, so that the normal bending of the outer bending section and the inner bending section can be ensured, and the perfusion tube is sleeved outside the inner bending section, so that the position of the rotation axis of the inner bending section is fixed, the rotation axis of the inner tube body is reduced or prevented from changing when the inner tube body rotates and when the outer bending section and the inner bending section bend, the shape adjustment accuracy of the far end part of the electrophysiological catheter is ensured, and the rotation requirement of the driving rod is met.

Drawings

FIG. 1 is a schematic view of the structure of one embodiment of an electrophysiology catheter of the present application;

FIG. 2 is a perspective view of the electrode assembly at the distal end of FIG. 1 in an expanded state;

FIG. 3 is an orthographic view of FIG. 2;

FIG. 4 is a top view of FIG. 3;

FIG. 5 is a schematic illustration of the first and second spring backbones of one of the splines of FIG. 4;

FIG. 6 is a schematic view of the electrode assembly of FIG. 3 without connecting tubes and electrodes;

FIG. 7 is a perspective view of the first housing of FIG. 3 and a first elastomeric armature coupled to the first housing;

FIG. 8 is a schematic illustration of a corresponding use scenario in which an embodiment of an electrophysiology catheter is in a deployed state;

FIG. 9 is a schematic view of the morphology of the electrode assembly of FIG. 8;

FIG. 10 is a schematic illustration of another use scenario corresponding to an embodiment of an electrophysiology catheter in a deployed state;

FIG. 11 is an orthographic view of the electrode assembly of FIG. 10;

FIG. 12 is a schematic illustration of a corresponding use scenario in which an embodiment of the electrophysiology catheter is in an incompletely collapsed state;

FIG. 13 is an orthographic view of the electrode assembly of FIG. 12;

FIG. 14 is a top view of FIG. 13;

FIG. 15 is a schematic illustration of a corresponding use scenario in which an embodiment of the electrophysiology catheter is in a fully collapsed state;

FIG. 16 is a schematic illustration of another use scenario corresponding to one embodiment of an electrophysiology catheter in a fully collapsed state;

Fig. 17 is a perspective view of the electrode assembly of fig. 15 and 16;

FIG. 18 is an orthographic view of FIG. 17;

FIG. 19 is a top view of FIG. 18;

FIG. 20 is a cross-sectional view of a distal portion of one embodiment of an electrophysiology catheter, with a cut plane passing through the axis of the electrophysiology catheter and the first-end center of the corresponding spline;

FIG. 21 is a cross-sectional view of a distal portion of one embodiment of an electrophysiology catheter, with a cut plane passing through the axis of the electrophysiology catheter and the second end center of the corresponding spline;

FIG. 22 is an enlarged view of a portion of FIG. 21;

FIG. 23 is a schematic view of the fluid channel of FIG. 22;

FIG. 24 is a schematic illustration of the connection of a perfusion tube and a supply tube in one embodiment of an electrophysiology catheter;

fig. 25 is a perspective view of a part of fig. 24.

List of feature names corresponding to reference numerals in the figure:

100. an operation handle;

200. A pipe body;

210. Outer tube body, 211, outer bending section, 2111, outer tube body, 2112, inner tube body, 2113, braiding layer, 212, outer main body section;

220. inner tube body 221, inner bending section 2211, tube core 2212, flexible sealing tube 222, inner main body section;

230. the pouring tube, 231, the adapter sleeve, 2311, a first arc-shaped part, 2312, a second arc-shaped part, 2313 and a transition part;

240. a liquid supply pipe;

250. A fluid channel;

300. An electrode assembly;

310. spline 311, first end 312, second end 313, reverse fold;

321. First portion, 322, second portion, 323, intermediate portion;

330. 331, a first base body, 3311, a slot, 332, a second base body;

340. a protective tube;

351. 352, second elastic framework 353, connecting pipe;

361. first electrode 362, second electrode 363, middle electrode;

371. A first sensor; 372, a second sensor;

400. A driving rod;

500. the target tissue.

Detailed Description

The application will be described in further detail below with reference to the drawings by means of specific embodiments. Wherein like elements in different embodiments are numbered alike in association. In the following embodiments, numerous specific details are set forth in order to provide a better understanding of the present application. However, one skilled in the art will readily recognize that some of the features may be omitted, or replaced by other elements, materials, or methods in different situations. In some instances, related operations of the present application have not been shown or described in the specification in order to avoid obscuring the core portions of the present application, and may be unnecessary to persons skilled in the art from a detailed description of the related operations, which may be presented in the description and general knowledge of one skilled in the art.

Furthermore, the described features, operations, or characteristics of the description may be combined in any suitable manner in various embodiments. Also, various steps or acts in the method descriptions may be interchanged or modified in a manner apparent to those of ordinary skill in the art. Thus, the various orders in the description and drawings are for clarity of description of only certain embodiments, and are not meant to be required orders unless otherwise indicated.

The numbering of the components itself, e.g. "first", "second", etc., is used herein merely to distinguish between the described objects and does not have any sequential or technical meaning. The term "coupled" as used herein includes both direct and indirect coupling (coupling), unless otherwise indicated.

In the embodiment of the application, the insertion component of the electrophysiology catheter comprises a perfusion tube and a liquid supply tube, wherein the perfusion tube is sleeved outside the inner bending section and can bend along with the inner bending section, so that the perfusion tube and an inner tube body for transmitting torque are integrated, the perfusion tube can rotate and bend along with the inner tube body, the obstruction on the rotation and bending process of the inner tube body is reduced, meanwhile, a fluid channel for fluid to pass through is formed between the perfusion tube and the inner bending section, and the proximal end of the fluid channel is communicated with the distal end of the liquid supply tube, so that perfusion liquid can be led to the outside of the distal end side of the insertion component through the liquid supply tube and the fluid channel.

Embodiments of electrophysiology catheters in the present application:

Referring to fig. 1, in some embodiments, the electrophysiology catheter includes an operation handle 100, a tube body 200, and an electrode assembly 300, wherein the operation handle 100, the tube body 200, and the electrode assembly 300 are sequentially connected along a proximal end to a distal end of the electrophysiology catheter, and the tube body 200 and the electrode assembly 300 form an insertion assembly for accessing a patient.

Wherein, as shown in fig. 1 and 24, the tube body 200 includes an outer tube body 210 and an inner tube body 220 nested in the outer tube body 210, and the inner tube body 220 is used to transmit torque to the electrode assembly 300, forming a driving rod 400 (as shown in fig. 20). The tube body 200 includes a bending section disposed at a distal end, and the outer tube body 210 and the inner tube body 220 respectively include an outer bending section 211 and an inner bending section 221 disposed at distal ends, and the outer tube body 210 and the inner tube body 220 respectively include an outer body section 212 and an inner body section 222, the outer body section 212 being connected to a proximal end of the outer bending section 211, and the inner body section 222 being connected to a proximal end of the inner bending section 221.

The operating handle 100 can be gripped by an operator and used correspondingly, and its specific operating functions can be designed according to needs, for example, to realize bending adjustment of the distal end of the tube body 200, control the shape of the electrode assembly 300, etc. The tube body 200 is connected to the distal end of the operating handle 100, and can drive the electrode assembly 300 to move, and can provide a layout matrix for corresponding circuits, liquid paths and/or gas paths, etc., so that the corresponding circuits, liquid paths and/or gas paths are led to the electrode assembly 300 by the operating handle 100.

The electrode assembly 300 includes an elastically deformable spline 310, electrodes for transmitting electric power are distributed on the spline 310, and the distribution of the electrodes can be changed by changing the shape of the spline 310, thereby satisfying different use demands.

It should be noted that the electrophysiology catheter in the embodiments of the present application may be an ablation catheter for ablating the target tissue 500, for example, pulsed electric field ablation, radio frequency ablation, etc., and in some other embodiments, the electrophysiology catheter in the embodiments of the present application may be a mapping catheter for acquiring electrophysiology signals of the target tissue 500.

To effect a change in morphology of the electrode assembly 300, in one embodiment of the electrophysiology catheter, the spline 310 is a wire-like structure having a inflection 313, the spline 310 having a first end 311 and a second end 312. Meanwhile, the electrode assembly 300 includes a spline connection holder 330, the spline 310 is disposed on a distal end side of the spline connection holder 330, the spline connection holder 330 includes a first holder 331 and a second holder 332 (as shown in fig. 6), the second holder 332 is embedded in the first holder 331, a distal end of the second holder 332 is exposed to a distal end of the first holder 331, the second holder 332 is rotatably disposed on the first holder 331, the first holder 331 is fixedly connected with a first end 311 of the spline 310, and the second holder 332 is fixedly connected with a second end 312 of the spline 310. As shown in fig. 2, 3 and 7, the electrophysiology catheter may include a protective tube 340, where the protective tube 340 may be sleeved outside the first seat 331, so as to protect and decorate the internal structure. The shield tube 340 may be fixedly coupled, e.g., adhesively secured, to the first housing 331, and the shield tube 340 may be fixed to the tube body 200. In some other embodiments, the protective tube 340 may be omitted, and the outer peripheral surface of the first seat 331 may be used as the outer peripheral surface of the corresponding portion of the electrophysiology catheter.

It should be noted that, the spline 310 having the linear structure with the reverse folded portion 313 may have a corresponding thickness, cross-sectional shape, and profile after being folded, as required. For example, the spline 310 may be circular in cross-section to better abut the target tissue 500 at different orientations. For another example, the profile of the folded spline 310 may be a smooth arcuate profile, such as a drop-like shape, a broken line profile with corners, such as a triangle, or the profile of the spline 310 may include both straight and arcuate portions, such as a fan shape.

In one embodiment, referring to fig. 2-5, spline 310 includes a first portion 321 proximate first end 311, a second portion 322 proximate second end 312, and an intermediate portion 323 connected between first portion 321 and second portion 322. Wherein, in the unfolded state, the projections of the first portion 321 and the second portion 322 along the axis of the spline connection seat 330 may be straight lines, and the first portion 321 and the second portion 322 may be curved in an arc shape, forming an arch shape protruding toward the proximal end side of the electrode assembly 300, for example, fig. 3 and 6.

In some embodiments, the intermediate portion 323 may be "V" shaped, opening toward the splined connection 330. The intermediate portion 323 forms a corner with the first portion 321 and the intermediate portion 323 forms a corner with the second portion 322. The middle part 323 adopts a V shape, and in the process of converting the electrode assembly 300 from the unfolded state to the folded state, the parts on the two sides of the opening of the V shape can form a guide structure, so that the splines 310 can conveniently form a cross, and the stability of the shape of the splines 310 can be ensured. In addition, the use of a "V" shape for the intermediate portion 323 facilitates a smoother transition of the profile surface of the electrode assembly 300 when the spline 310 is in a collapsed state. The portions on both sides of the V-shaped opening may be straight or arc.

In view of the stress at the collapsing of the splines 310 and the morphological control of the splines 310, in some embodiments, the angle at which the "V" shape corresponds is not less than 90 ° in the deployed state. Of course, in some other embodiments, the specific values of the included angles may be adjusted as desired.

In some embodiments, referring to fig. 5 to 7, the spline 310 may include a first elastic skeleton 351, a second elastic skeleton 352, and a connection pipe 353, wherein two ends of the connection pipe 353 are respectively sleeved on the first elastic skeleton 351 and the second elastic skeleton 352, and an intermediate section of the connection pipe 353 between the first elastic skeleton 351 and the second elastic skeleton 352 forms an intermediate portion 323. The connection between the first elastic frame 351, the second elastic frame 352 and the connection pipe 353 is not limited, and may be, for example, adhesive bonding.

With this structure, the initial positions of the first elastic frame 351 and the second elastic frame 352 can be positioned first, and then the connection pipe 353 is installed, thereby facilitating assembly. If the spline 310 is of a unitary structure, the first and second ends 311, 312 are again connected to the spline connection mount 330 at the time of assembly, which may be difficult to operate due to the small size of the spline 310 and the spline connection mount 330.

The materials of the first elastic framework 351 and the second elastic framework 352 can meet the requirement of elastic support, and can be metal materials or nonmetal materials commonly used in the art for forming splines, such as nitinol. The material of the connection tube 353 may be selected according to the need, for example, TPU (Thermoplastic Urethane, thermoplastic polyurethane elastomer rubber), pebax (Polyether BlockAmide ) or PA (Polyamide, polyamide). The connection tube 353 can form a softer section at the end of the spline 310, and the overall safety is greater when the distal end of the electrode assembly 300 is proximate to the target tissue 500. Of course, in some other embodiments, an intermediate elastic skeleton may be disposed between the first elastic skeleton 351 and the second elastic skeleton 352, and the material of the intermediate elastic skeleton may be the same as that of the first elastic skeleton 351 and the second elastic skeleton 352, where the skeleton of the spline 310 may be a single integral skeleton.

In some embodiments, the first seat 331 and the second seat 332 may be both tubes, the first elastic framework 351 is integrally formed with the first seat 331, the second elastic framework 352 is integrally formed with the second seat 332, and the second seat 332 is coaxially sleeved in the first seat 331. By adopting the integral molding mode, the first elastic framework 351 and the second elastic framework 352 can be conveniently positioned. The first elastic skeleton 351 and the first elastic skeleton 351 may be formed by cutting the pipe wall and bending, and in other embodiments, the elastic skeleton and the corresponding seat body may be manufactured separately and fixedly connected, such as welded and fixed.

To facilitate rotation of second end 312, in the deployed state, the location of first portion 321 proximate first end 311 is offset from the location of second portion 322 proximate second end 312 in the axial direction of spline connection 330 to avoid interference between relative rotation of first portion 321 and second portion 322. In one embodiment, referring to fig. 6, the distal end of the second housing 332 protrudes beyond the distal end of the first housing 331 such that the first end 311 and the second end 312 of the spline 310 are axially offset from the spline connection seat 330. In some other embodiments, the distal end of the second housing 332 may be flush with the distal end of the first housing 331 and may be recessed into the first housing 331, at which point the axial misalignment may be achieved by an extension of the second end 312 that extends generally along the axial direction of the spline connection 330.

Of course, it will be appreciated by those skilled in the art that the first end 311 and the second end 312 may be radially offset from the spline connection 330, for example, the second body 332 may have a smaller body diameter than the first body 331, such that the rotational path of the second end 312 about the axis of the spline connection 330 is within the circle defined by the first end 311, thereby achieving radial offset of the first end 311 and the second end 312.

In the above embodiment, the first elastic framework 351 is integrally formed with the first base 331, the first end 311 is connected to the distal end face of the first base 331, the second elastic framework 352 is integrally formed with the second base 332, and the second end 312 is connected to the distal end face of the second base 332. In some other embodiments, the first end 311 may be connected to the outer peripheral surface or the inner wall surface of the first base 331, and the second end 312 may be connected to the outer peripheral surface or the inner wall surface of the second base 332.

Electrodes for transmitting electrical energy are distributed over spline 310 to effect ablation or mapping. In some embodiments, the electrodes include at least two first electrodes 361 disposed on the first portion 321, at least two second electrodes 362 disposed on the second portion 322, and the distribution of the electrodes can be determined by the first portion 321 and the second portion 322 to ablate the target tissue 500. The electrode further comprises a middle electrode 363 arranged on the middle part 323, wherein the middle electrodes 363 are arranged on the part of the middle part 323 corresponding to the two side lines of the V shape, so that more quantity can be formed, and when the electrode assembly 300 is folded to a certain degree, point-shaped ablation can be performed by means of the middle electrode 363 at the far end of the electrode assembly 300.

In some embodiments, the electrode may be a ring-shaped electrode that surrounds the outer perimeter of spline 310, facilitating better abutment of the electrode with target tissue 500 when electrode assembly 300 is in different deployed and collapsed states.

In some embodiments, in the deployed state, the distance from the center of any first electrode 361 to the axis of the spline connection mount 330 on the same spline 310 is different than the distance from the center of any second electrode 362 to the axis of the spline connection mount 330. In one embodiment, three first electrodes 361 may be provided on the first portion 321 and two second electrodes 362 may be provided on the second portion 322. The effect of this structure is that the electrodes can be staggered to form a wider electric field.

By the spline 310 and the spline connection holder 330, the electrode assembly 300 has an expanded state and a collapsed state when the first holder 331 is rotated relative to the second holder 332, and each spline 310 has a petal shape on the radially outer side of the spline connection holder 330 in the expanded state, and the first end 311 and the second end 312 of any spline 310 are offset in the circumferential direction of the electrode assembly 300 in the collapsed state, and the spline 310 has a collapsed amount bent in the distal direction of the electrode assembly 300 compared to the expanded state.

To achieve the relative rotation of the first base 331 and the second base 332, in some embodiments, the first base 331 may be fixed, the second base 332 may be rotated, the first base 331 may be rotated, the second base 332 may be fixed, and both the first base 331 and the second base 332 may be rotated. In view of the complexity of the structure and the fact that the electrophysiology catheter needs to be introduced into the human body, it is preferable in some cases to have the first housing 331 fixed and the second housing 332 rotatable.

In some embodiments, spline 310 is a self-expanding spline 310, i.e., spline 310 is in an expanded state when no external driving force is applied, for elastic deformation into and out of the sheath by itself when subjected to axial push-pull forces. This allows the shape and attitude of spline 310 to be controlled by simply rotating first end 311 and second end 312 of spline 310 relative to each other. It will be appreciated by those skilled in the art that the sheath can be used as the body 200 of the electrophysiology catheter and the electrode assembly 300 to enter and exit the body, and the specific structure thereof can refer to the existing structure in the related art, and it is considered that there is no direct connection with the innovative content of the present application and the technical problem to be solved, and will not be described herein.

It will be appreciated by those skilled in the art that in the illustrated embodiment, in the initial state, since the first end 311 of the spline 310 is fixed, the arrangement of the first end 311 and the second end 312 and the inflection 313 on the spline 310 away from the spline connection seat 330 will substantially determine the shape and position of the spline 310 when the second end 312 and the first end 311 are located on substantially the same side of the spline connection seat 330. When the shape of the spline 310 needs to be adjusted, taking the first base 331 as an example and the second base 332 as an example, the second base 332 rotates, the second end 312 is driven to rotate around the axis of the spline connecting seat 330, and as the second end 312 moves to a side of the spline connecting seat 330 different from the position of the first end 311, the space surrounded by the spline 310 spans at least a part of the spline connecting seat 330, and the spline 310 is closer to the axis of the spline connecting seat 330 than in the unfolded state, so that folding is generated. Referring to fig. 2 and 3, in the unfolded state, the spline 310 is inclined toward the distal end side of the electrode assembly 300 as a whole, which is more advantageous in that the spline 310 is folded.

In some embodiments, the collapsed state includes a configuration where at least one spline 310 enters a space enclosed by another spline 310 (e.g., FIG. 14), which enables a smaller collapsed diameter. In some embodiments, the collapsed state includes a state in which the first end 311 and the second end 312 of the same spline 310 are located on opposite sides of the spline connection base 330, i.e., a state in which a line connecting the first end 311 and the second end 312 intersects with the rotation axis of the second base 332 (e.g., fig. 18), and the state at the time of the spline 310 can be taken as a collapsed limit.

In some embodiments, the first base 331 of the electrode assembly 300 may be fixed on the tube body 200, and the driving rod 400 (as shown in fig. 20, may be the inner tube body 220) of the electrophysiology catheter, the distal end of the driving rod 400 is connected to the second base 332 to drive the second base 332 to rotate, and the operating handle 100 includes a driving module, where the proximal end of the driving rod 400 is connected to the driving module, and the driving module is used to drive the driving rod 400 to rotate. The specific structure of the driving module is not limited, and the driving rod 400 can be rotated forward and backward, and can be driven manually or electrically. For example, a turning wheel may be mounted on the operation handle 100, the proximal end of the driving lever 400 being fixed to the turning wheel, the turning wheel having an operation portion exposed to the outside of the operation handle 100, and the user may rotate the driving lever 400 by rotating the operation portion. The specific structure of the driving rod 400 is not limited, and for example, a solid rod may be used, or a hollow rod may be used.

To obtain the rotation angle of the driving rod 400 when driving the second housing 332 to rotate, in some embodiments, referring to fig. 20 to 23, the electrode assembly 300 further includes a first sensor 371 and a second sensor 372. The first sensor 371 is disposed on the first housing 331, the first sensor 371 is non-coaxial with the second housing 332, the detectable signal of the first sensor 371 includes a spatial position of the first sensor 371 with respect to a rotational axis of the second housing 332, the second sensor 372 is disposed on the second housing 332, the second sensor 372 is disposed coaxially with the second housing 332, and the detectable signal of the second sensor 372 includes a rotational angle of the second housing 332. The fixing manner of the first sensor 371 and the second sensor 372 is not limited, and may be adhesively fixed by, for example, filling glue. In some other embodiments, the second housing 332 and the inner housing 220 may be of unitary construction.

It should be noted that, the first sensor 371 is not coaxial with the second housing 332, so that the rotation axes of the first sensor 371 and the second housing 332 are not coincident, specifically, the first sensor 371 may be parallel to and spaced apart from the second housing 332, and the first sensor 371 may be disposed in such a way that the axes intersect with or spatially intersect with the rotation axis of the second housing 332. For the second sensor 372, the detected rotation angle of the second base 332, that is, the rotation angle of the second sensor 372 itself about the axis of the second base 332.

When in use, the corresponding pose of the second seat 332 can be obtained by the second sensor 372, including the rotation angle around the longitudinal axis of the second seat 332, and the corresponding pose of the second seat 332 can be obtained by the second sensor 372, and the rotation angle of the second sensor 372 relative to the first sensor 371, that is, the rotation angle of the second seat 332 relative to the first seat 331 can be determined by combining the rotation axis position of the second sensor 372.

In some embodiments, the first sensor 371 and the second sensor 372 are columnar structures, and the axes of the first sensor 371 and the second sensor 372 are parallel to the rotation axis of the second base 332, which is beneficial to establishing a coordinate system, saving space and avoiding increasing the diameter of the electrophysiological catheter. In some other embodiments, both the first sensor 371 and the second sensor 372 may be replaced with other configurations, such as a chip configuration.

It will be appreciated by those skilled in the art that the sensor coordinate system may be a Cartesian coordinate system, including three mutually perpendicular axes, and rotational directions about each axis, each of which may correspond to a degree of freedom. In some embodiments, the first sensor 371 is at least a 5 degree-of-freedom magnetic sensing coil, the detectable signal includes coordinates along its axis, two-dimensional coordinates perpendicular to its axis, and rotation about each axis of the two-dimensional coordinates, and/or the second sensor 372 is at least a 6 degree-of-freedom magnetic sensing coil, the detectable signal includes coordinates along its axis, two-dimensional coordinates perpendicular to its axis, rotation about its axis, and rotation about each axis of the two-dimensional coordinates, which facilitates more comprehensive acquisition of pose information of the first sensor 371 and the second sensor 372. Of course, the detectable signal of each sensor may also be varied, depending on the application requirements.

In some embodiments, the first sensor 371 may be a 5-degree-of-freedom magnetic sensor, i.e., a 5Dof magnetic sensor, and the second sensor 372 may be a 6-degree-of-freedom magnetic sensor, i.e., a 6Dof magnetic sensor. The magnetic sensor is a sensor commonly applied in electrophysiological catheters, and can be made of a coil, a magnetic field is established around a patient when the sensor is used, and the magnetic flux can be changed when the pose of the coil is changed, so that position detection can be realized. For a 6-degree-of-freedom magnetic sensor, two 5Dof magnetic sensors may be combined in a non-coaxial manner to detect the angle of rotation about their own axis. The specific structure of the magnetic sensor may refer to the existing structure in the related art, and is not described herein in detail in view of no direct association with the innovative content of the present application and the technical problem to be solved.

In some embodiments, the second sensor 372 is disposed within an interior cavity of the second housing 332 in the form of a tube, while at least a portion of the first sensor 371 is located radially outward of the second sensor 372, facilitating more accurate calculation of the relative positional change between the first sensor 371 and the second sensor 372.

Since the diameter of the electrophysiology catheter tends to be small, in order to meet the space arrangement requirements in the case where the first sensor 371 and the second sensor 372 are provided at the same time, in some embodiments, the projection is performed in a direction parallel to the rotation axis of the second housing 332, and the projection of the first housing 331 and the first sensor 371 at least partially coincides. For example, an accommodating space may be provided on a sidewall of the first housing 331, and at least a portion of the first sensor 371 is disposed in the accommodating space. In one embodiment, for the first base 331 in the form of a tube, a slot 3311 is provided on a sidewall of the tube, and the slot 3311 forms a receiving space. The axis of the sensor may coincide with the side wall of the tube. In some embodiments, the first sensor 371 may also be offset from the first housing 331 along the catheter axis, as well as the projection of the first housing 331 and the first sensor 371 may be at least partially coincident.

The notch 3311 in the first housing 331 may cause the first sensor 371 to be exposed, and in addition, the outer circumferential surface of the first housing 331 may need to be provided with other structures to cause unevenness. In some embodiments, the electrode assembly 300 includes a shield tube 340, the shield tube 340 is fixedly sleeved outside the first housing 331, and the first sensor 371 is entirely located within the shield tube 340. The protection tube 340 and the first seat 331 can be adhered and fixed by filling glue.

The first seat 331 may be fixedly connected to the distal end of the outer tube 210, and the second seat 332 may be fixedly connected to the distal end of the inner tube 220, so that the first seat 331 may be fixed by means of the outer tube 210, and the second seat 332 may rotate with the inner tube 220, and form adjustment of the electrode assembly 300 may be achieved by means of the inner tube 220 as a driving member.

To meet the supply requirements of the perfusate during use of the electrophysiology catheter, the insertion assembly further includes a perfusion tube 230 for bending with the inner bending section 221, the perfusion tube 230 being sleeved outside the inner bending section 221 and forming a fluid channel 250 (shown more clearly in a filled pattern in fig. 23) between the inner bending section 221 and the perfusion tube, the fluid channel 250 opening out of the distal side of the insertion assembly. Meanwhile, the insert assembly further includes a fluid supply tube 240, the distal end of the fluid supply tube 240 being in communication with the proximal end of the fluid channel 250. The fluid supply tube 240 may be routed along the insertion assembly to the operating handle 100 and withdrawn through the operating handle 100, thereby connecting an external perfusate supply device, enabling perfusate to be delivered to the outside of the distal side of the electrode assembly 300.

In some embodiments, referring to fig. 22 and 23, the inner bending section 221 includes a flexible tube core 2211, and a flexible sealing tube 2212 sleeved outside the tube core 2211, wherein the tube core 2211 is made of hard materials and has a flexible structure, the flexible structure forms a gap on the tube wall of the tube core 2211, and the flexible sealing tube 2212 is used for forming a sealing layer outside the tube core 2211. The flexible structure forming the slit in the tube wall of the tube core 2211 can provide better bending performance for the inner bending section 221, and the sealing layer formed outside the tube core 2211 by the flexible sealing tube 2212 can close the slit, so as to lay a foundation for establishing the fluid channel 250.

In some embodiments, the flexible sealing tube 2212 may be a polymer material tube, for example, PI (Polyimide) material. The flexible sealing tube 2212 is not limited in the molding manner on the die 2211, and may be sleeved at the bendable structure by, for example, thermal shrinkage, elastic shrinkage, adhesion, etc. and sealed, or may be directly attached at the bendable structure by, for example, coating, dipping, etc. to form a tubular structure. In some other embodiments, the flexible sealing tube 2212 may also be made of other materials, such as Pebex, TPU, PTFE, silicone, and the like.

Referring to fig. 22, in some embodiments, the outer tuning section 211 may include an outer tube 2111, an inner tube 2112 embedded within the outer tube 2111, and a braid 2113 disposed between the outer tube 2111 and the inner tube 2112, wherein the braid 2113 and the outer tube 2111 may be combined with each other to form a composite layer. For example, after the braiding of the braid 2113 on the inner tube 2112 is completed, the outer tube 2111 may be covered and the outer tube 2111 may be fused with the braid 2113 by hot pressing, or, for example, after the braiding of the braid 2113 on the inner tube 2112 is completed, the braid 2113 may be covered with a heating fluid and cooled to form the outer tube 2111, and the outer tube 2111 may be fused with the braid 2113. The structure is beneficial to improving the structural strength and fatigue resistance of the outer bending section 211 and ensuring the effective transmission of torque. The outer body section 212 of the outer body 210 may be constructed in the same manner as the inner body 2112.

The specific structure of the perfusion tube 230 is not limited, and may be, for example, a bellows, so as to better adapt to the bending of the inner bending section 221, and to ensure the stability of the cross section of the fluid channel 250 during bending. In some other embodiments, the perfusion tube 230 can also be a straight wall tube. In addition, referring to fig. 22, the bellows may include a straight tube section disposed at the distal end to facilitate ensuring smooth fluid discharge from the distal end of the fluid passageway 250, thereby facilitating ensuring a consistent infusion volume and reducing infusion pressure.

In a particular embodiment, the die 2211 may include a plurality of wires arranged side-by-side, the plurality of wires arranged side-by-side being helically coiled to form a tubular structure, similar to a multi-start thread. The wire may be a stainless steel wire, a nitinol wire, or a noble metal wire. The number of the wires can be set according to the needs, and a plurality of wires which are arranged side by side have higher mechanical properties than a single wire, so that the torque at the near end can be more completely transmitted to the far end, and stable rotation in a narrow bent blood vessel can be realized.

Those skilled in the art will appreciate that the bendable structure may be a hypotube structure or a snake bone structure. The specific structure of the hypotube structure or the snake bone structure can refer to the existing structure in the related technology, can realize the bending of the catheter and the sheath tube, and can be used for the bending section of the catheter and the sheath tube.

For the hypotube structure, the hypotube structure may include a first groove body and a second groove body respectively disposed on two opposite sides of a tube wall of the tube core 2211, where a depth of the first groove body and the second groove body is smaller than a radius of the tube core 2211, and the first groove body and the second groove body have a stagger amount along an axial direction of the tube core 2211. In some other embodiments, the first and second slots may also be arranged in alignment. For a serpentine structure, as an example, slots may be formed in the sidewall of the tube by laser cutting, which can provide deformation space for the bending of the tube core 2211. For the snake bone structure, the bendable structure may also be a hinge structure disposed between two adjacent snake bone unit sections, and the hinge structure may refer to an existing structure in the related art, which is not described herein.

In one embodiment, the hard material used for the die 2211 may be a metallic material, such as nitinol, stainless steel, etc., that can provide better mechanical properties and more efficient torque transfer. Similarly, the inner body section 222 may also be a metal tube, likewise of nitinol, stainless steel, or the like, to more effectively transmit torque.

To achieve connection of the fluid supply tube 240 and the perfusion tube 230, in some embodiments, the insertion assembly includes an adapter sleeve 231, the adapter sleeve 231 is sleeved on the inner tube body 220, a distal end of the adapter sleeve 231 is communicated with a proximal end of the perfusion tube 230, a sleeve wall of the adapter sleeve 231 includes a first arc-shaped portion, a second arc-shaped portion and two transition portions, the first arc-shaped portion and the second arc-shaped portion are located at two opposite sides of the circumference of the adapter sleeve 231, an inner wall of the first arc-shaped portion is anastomotic with a corresponding side surface of the inner tube body 220, an inner wall of the second arc-shaped portion is anastomotic with a corresponding side surface of the fluid supply tube 240, and the two transition portions are respectively connected between two side edges of the first arc-shaped portion and corresponding side edges of the second arc-shaped portion. The adapter sleeve 231 with the structure can control the radial dimension of the position of the adapter sleeve 231 while realizing the communication between the liquid supply pipe 240 and the fluid channel 250, thereby being beneficial to the integral rotation of the inner pipe 220, the adapter sleeve 231, the perfusion pipe 230 and the liquid supply pipe 240.

It will be appreciated by those skilled in the art that the proximal end of the adaptor sleeve 231 and the distal end of the inner body section 222 and the distal end of the liquid supply tube 240 have sealing structures, and the specific form of the sealing structures is not limited, for example, the sealing structures may be glue-injected and bonded, for example, the sealing structures may be formed by interference fit, for example, sealing may be formed by providing a sealing ring.

In some embodiments, the liquid supply pipe 240 is parallel to the inner main body section 222, and is disposed at one side of the inner main body section 222, so that the structure is simple, and smooth flow of the fluid in the liquid supply pipe 240 is ensured. In addition, the liquid supply tube 240 may adopt a biasing structure in the tube body 200, and the outer tube body 210, the inner tube body 220, and the filling tube 230 are coaxially arranged, so as to ensure that the inner tube body 220 extends along the axis of the center of the insertion assembly, thereby ensuring the coaxiality of the second seat 332 and the first seat 331 of the electrode assembly 300.

In some embodiments, when the inner tube 220 is a hollow tube, at least a portion of the lead wires on the electrode assembly 300 lead from the inner tube 220, e.g., the lead wires on the second portion 322 of the spline 310 may lead from the inner tube 220. Of course, the lead-out wires on both the first portion 321 and the second portion 322 of the spline 310 may lead out of the inner tubular body 220. In the case where other electronic components, such as a magnetic sensor, are provided on the electrode assembly 300, lead wires to which the magnetic sensor is connected may also be led out from the inner tube 220.

It should be noted that, in some other embodiments, the insertion assembly may also refer to a portion that does not include the electrode assembly 300 described above, i.e., a portion corresponding to the pipe body 200.

Through the irrigation pipe 230 and the fluid supply pipe 240 having the above-described structure, the inner pipe body 220 can realize the transmission of torque and the bending adjustment, and simultaneously realize the delivery of the irrigation fluid through the fluid supply pipe 240 and the fluid passage 250.

Whether the electrode assembly 300 is in the deployed state or the collapsed state, the electrode assembly can be used for ablation or mapping, and the size of the collapsed amount can be suitable for different application scenarios. In the following, several possible application scenarios are described in connection with fig. 8 to 19.

Referring to fig. 8 and 9, when the electrode assembly 300 is in the deployed state, the target tissue 500 to be ablated is the left atrium back wall, the electrode assembly 300 can cover the left atrium back wall, and each spline 310 deforms under the reaction force of the left atrium back wall to be a substantially planar structure, so that the whole left atrium back wall can be ablated, and a plurality of effective large-area sheet-shaped ablation areas can be formed at one time and rapidly, so as to isolate abnormal electrical signals of the target tissue 500. At this time, a desired ablation shape can be achieved by different polarity configurations of the electrodes. For example, the electrodes on the same spline 310 on both sides of the reverse fold 313 may be configured to have different polarities, as well as, for example, the electrodes on the same spline 310 may be configured to have the same polarity while the electrodes on adjacent two splines 310 may be configured to have opposite polarities, as well as, for example, adjacent electrodes on the same spline 310 may be arranged in a staggered polarity.

Referring to fig. 10 and 11, the electrode assembly 300 is also in the deployed state, the target tissue 500 to be ablated is the pulmonary vein vestibule, the pulmonary vein vestibule is covered with the electrode assembly 300, and each spline 310 deforms under the reaction force of the rear wall of the left atrium, and forms a reverse bend toward the proximal end side of the electrode assembly 300, so that the entire pulmonary vein vestibule can be ablated. At this time, one first electrode 361 and one second electrode 362 adjacent to the middle portion 323, and the middle electrode 363 on the middle portion 323 may each be configured as a positive electrode, and the remaining first electrode 361 and second electrode 362 may be configured as a negative electrode.

Referring to fig. 12-14, the electrode assembly 300 is in a collapsed state, but not reaching the collapse limit, and can be used in a scenario where the target tissue 500 to be ablated is the ostium of a pulmonary vein. During the ablation operation, the electrode assembly 300 can be completely folded to enter the pulmonary vein mouth, and then the electrode assembly 300 is opened to form a semi-open state, so that each spline 310 is abutted against the inner wall of the pulmonary vein mouth to perform ablation. At this time, the polarity configuration of the electrodes may be the same as when the vestibule of the pulmonary vein is ablated, and the electrodes on the distal half side, which correspond approximately to the flower buds formed by folding the electrode assembly 300, are each configured as positive electrodes, while the electrodes on the proximal half side are each configured as negative electrodes. Even if the electrodes at the distal ends of the electrode assemblies 300 are touched, the ablation discharge is not affected because the polarities are the same.

Referring to fig. 15-19, the electrode assembly 300 is now in a fully collapsed state, and can be used for spot ablation of the target tissue 500 through the head end or side in the case where the target tissue 500 to be ablated is a posterior wall/isthmus line (an ablation line connecting the anterior inferior edge of the lower left pulmonary vein (LIPV) and the mitral annulus). In this case, the polarity arrangement of the electrodes may be the same as in the previous scenario.

It should be noted that the above-mentioned polarity configuration of the electrodes is only an example, and those skilled in the art may use other polarity configurations as needed. In addition, the number of the splines 310 may be 2, 3, 4, 5, 6, 7, 8, 9 or 10, or more, and each spline 310 may be uniformly distributed along the circumference of the spline connection seat 330 to form a uniform electrode structure.

It will be appreciated by those skilled in the art that the above-described structures of the operating handle 100, the tube body 200, the electrode assembly 300, and the like, except for the modifications related to the present application, may refer to the existing structures in the related art, and are not repeated herein in view of no direct association with the innovative contents of the present application and the technical problems to be solved.

The electrophysiology catheter of the present application controls the shape of the electrode assembly 300 by rotating the first end 311 and the second end 312 of the spline 310 relative to each other, and has the advantages of simple operation, good usability and stable electrode position. In addition, the electrode assembly 300 has an unfolding state and folding states with different folding degrees, when facing a pulmonary vein with a large diameter, the electrode assembly can be used for attaching the pulmonary vein with a petal shape, facing a pulmonary vein with a small diameter, can be used for ablation with a bud shape, can be folded and then stretched into a lumen, and is further unfolded to be attached to the inner wall of the lumen, so that the electrode assembly is flexible in use mode and more in application scene, and can be used for better coping with arrhythmia of different conditions.

In addition, since petal-shaped catheters or basket-shaped catheters currently on the market often require guide wires for guiding, while the respective splines 310 also need to be incorporated at the leading end, and also require different form changes of the electrode assembly 300 to be formed by pushing and pulling the driving rod, the setting of the leading end is difficult to avoid. This results in such products being able to ablate only a single pulmonary vein and not to ablate elsewhere in the heart. In the electrophysiology catheter of the application, the spline 310 is connected by the first tail end 311 and the second tail end 312, so that a guide head structure is not required, the whole distal end is smoother, no protrusion exists in the middle, and the electrophysiology catheter is safer and more free for user operation when being attached to an endocardium.

For basket catheters or petal catheters that are deployed and collapsed by relative movement of the proximal and distal ends along the catheter axis, it is often necessary to provide a sensor at each of the proximal and distal ends of the electrode assembly to obtain the pose of the electrode assembly. In the embodiment of the application, the first sensor and the second sensor can acquire the relative rotation angle of the first seat body and the second seat body so as to determine the unfolding state of the spline, and can also acquire the pose of the electrode assembly at the same time.

Embodiments of the insertion assembly of the electrophysiology catheter in the present application:

the structure of the insertion assembly is the same as that of the embodiment of the electrophysiology catheter described above, and will not be described here again.

The foregoing description of the invention has been presented for the purpose of providing a better understanding of the invention and is not intended to limit the invention. Several simple deductions, modifications or substitutions may also be made by the person skilled in the art to which the invention pertains, according to the inventive idea.

Claims (17)

1. An insertion assembly for an electrophysiology catheter, comprising:

The outer tube body comprises an outer bending section and an outer main body section, the outer bending section is positioned at the distal end of the outer tube body, and the outer main body section is connected with the proximal end of the outer bending section;

and an inner tube for transmitting torque, the inner tube being nested in the outer tube;

The inner tube body comprises an inner bending section and an inner main body section, the inner bending section is positioned at the far end of the inner tube body, and the inner main body section is connected with the near end of the inner bending section and is used for transmitting torque to the inner bending section;

The insertion assembly further comprises a perfusion tube for bending along with the inner bending section, the perfusion tube is sleeved outside the inner bending section and forms a fluid channel for fluid to pass through with the inner bending section, and the fluid channel is communicated to the outside of the distal end side of the insertion assembly;

The insert assembly further includes a fluid supply tube having a distal end in communication with the proximal end of the fluid passageway.

2. The insert assembly of claim 1 wherein the inner deflection section comprises a flexible tube core, a flexible sealing tube surrounding the tube core, the tube core being of a hard material and having a flexible structure forming a gap in a wall of the tube core, the flexible sealing tube being adapted to form a sealing layer outside the tube core.

3. The insert assembly of claim 2, wherein the die comprises a plurality of wires arranged side-by-side, the plurality of wires arranged side-by-side being helically coiled to form a tubular structure.

4. The insert assembly of claim 3, wherein the wire is a stainless steel wire, a nitinol wire, or a precious metal wire.

5. The insert assembly of claim 2, wherein the core is a hypotube structure or a serpentine structure.

6. The insert assembly of claim 5, wherein the hypotube structure comprises a first channel and a second channel disposed on opposite sides of a tube wall of the tube core, respectively, the first channel and the second channel having a depth less than a radius of the tube core, the first channel and the second channel having an offset along an axial direction of the tube core.

7. The insert assembly of any one of claims 2-6, wherein the hard material is a metallic material.

8. The insert assembly as claimed in any one of claims 2 to 6 wherein the flexible sealing tube is a polymeric tube.

9. The insert assembly of any one of claims 1 to 6, wherein the inner body section is a metal tube.

10. The insert assembly of any one of claims 1 to 6, comprising an adapter sleeve, the adapter sleeve being sleeved on the inner tube, a distal end of the adapter sleeve being in communication with a proximal end of the perfusion tube, a sleeve wall of the adapter sleeve comprising a first arcuate portion, a second arcuate portion and two transition portions, the first arcuate portion and the second arcuate portion being located on circumferentially opposite sides of the adapter sleeve, an inner wall of the first arcuate portion being coincident with a respective side of the inner tube, an inner wall of the second arcuate portion being coincident with a respective side of the fluid supply tube, the two transition portions being connected between respective sides of the first arcuate portion and respective sides of the second arcuate portion.

11. The insert assembly of any one of claims 1-6, wherein the fluid supply tube is disposed parallel to the inner body section on one side of the inner body section.

12. The insert assembly of any one of claims 1 to 6, wherein the irrigation tube is a bellows.

13. The insert assembly of any one of claims 12, wherein the bellows comprises a straight tube section disposed at a distal end.

14. The insert assembly according to any one of claims 1 to 6, wherein the inner tube is a hollow tube, the insert assembly comprising an electrode assembly, at least a portion of the lead-out wires on the electrode assembly being led out of the inner tube.

15. The insert assembly of any one of claims 1 to 6, wherein the outer tube, inner tube, and infusion tube are coaxially arranged.

16. The insert assembly of any one of claims 1 to 6, comprising an electrode assembly comprising:

The spline is of a linear structure, the spline is provided with a first tail end and a second tail end, and electrodes for transmitting electric energy are distributed on the spline;

The spline connecting seat is arranged at the far end side of the spline connecting seat, the spline connecting seat comprises a first seat body and a second seat body, the first seat body and the second seat body are both pipe bodies, the second seat body is embedded into the first seat body, the far end of the second seat body is exposed at the far end of the first seat body, and the second seat body is rotatably arranged in the first seat body;

The first seat body is fixedly connected with the distal end of the outer tube body, and the second seat body is fixedly connected with the distal end of the inner tube body;

the first seat body is fixedly connected with the first end of the spline, the second seat body is fixedly connected with the second end of the spline, and one side of the spline, which is far away from the spline connecting seat, is provided with a reverse folding part;

The first base body rotates relative to the second base body, the electrode assembly is in an unfolding state and a folding state, in the unfolding state, each spline forms a petal shape on the radial outer side of the spline connecting base, in the folding state, the first tail end and the second tail end of any spline are staggered along the circumferential direction of the electrode assembly, and the spline has folding amount bent towards the far end direction of the electrode assembly compared with the unfolding state.

17. An electrophysiology catheter comprising an operating handle and an insertion assembly connected to the operating handle, the insertion assembly being as defined in any one of claims 1 to 16.