CN108236500B - Electrophysiology catheter - Google Patents

Abstract

The invention provides an electrophysiology catheter, which comprises a catheter body, an electrode and a force application mechanism, wherein the catheter body comprises a main body section and an annular section which are connected, the electrode is arranged on the annular section, one part of the force application mechanism is arranged in the main body section, the other part of the force application mechanism extends out of the main body section and is used for being in contact with the annular section to apply pressure to the annular section, so that the electrode on the far end of the catheter not only has the axial force from the catheter, but also has the axial force from the force application mechanism, the axial force of the electrode on the far end of the catheter is increased integrally, and the contact property and the contact force of the electrode and tissues are improved.

Description

Electrophysiology catheter

Technical Field

The invention relates to the technical field of medical instruments, in particular to an electrophysiology catheter.

Background

In recent years, catheter ablation pulmonary vein isolation has been widely used to treat atrial arrhythmias, particularly atrial fibrillation, and has been accepted by various macroarrhythmia centers. However, the recurrence rate, particularly the long term recurrence rate, of atrial fibrillation pulmonary vein isolation therapy remains high. Therefore, how to reduce the recurrence rate of atrial fibrillation treatment becomes an urgent problem to be solved.

There are many factors that affect the therapeutic effect of atrial fibrillation, and the contact force of tissues during ablation is an important factor. In a certain range, the larger the ablation tissue attaching force is, the deeper the ablation depth is, the larger the injury area is, and the better the treatment effect is. Currently, there are many ablation catheters available on the market for treating atrial fibrillation, such as a monopolar ablation catheter, a cryoballoon, a thermoballoon, a ring-shaped multipolar ablation catheter, etc., but there are some problems. In particular, monopolar ablation catheters suffer from long ablation times, long radiation exposure times, and high operator specifications. The freezing saccule has the problems of complicated preparation work and suitability for paroxysmal atrial fibrillation ablation only. In addition, poor ablation effectiveness of thermal balloons has long been a problem. However, the advent of annular multi-polar ablation catheters has largely overcome the above-described deficiencies and has provided significant advantages. However, due to the special structure of the pulmonary veins and the individual variability, the ablation effect of the annular multi-polar ablation catheter still needs to be further improved.

The inventor finds that the ablation effect of the annular multi-polar ablation catheter is greatly dependent on the abutting force between the distal electrode and the tissue. Therefore, how to obtain good contact force of the annular multi-polar tube is critical. However, in the prior art, there is no report on how to obtain a good contact force between the distal electrode and the tissue.

Disclosure of Invention

The invention aims to provide an electrophysiology catheter, which applies pressure to the distal end of the catheter by introducing a force application mechanism, so that the adhesion force between a distal electrode and tissues is improved, and the ablation effect is improved.

To achieve the above and other related objects, the present invention provides an electrophysiology catheter comprising a catheter body including a main body segment and an annular segment joined thereto, a force applying mechanism disposed on the annular segment, and an electrode, a portion of the force applying mechanism disposed within the main body segment and another portion extending out of the main body segment for contacting and applying pressure to the annular segment.

Preferably, the number of the electrodes is multiple, the multiple electrodes are arranged on the annular section at intervals, and the contact position of the force application mechanism and the annular section is located between the electrodes.

Preferably, the force applying mechanism comprises a support wire extending through the lumen of the body segment, obliquely penetrating the sidewall of the body segment, and connected to the ring segment.

Preferably, the number of the supporting wires is multiple, and the supporting wires penetrate through the inner cavity of the main body section and penetrate out of the side wall of the main body section to be connected with different parts of the annular section.

Preferably, the support wire comprises a proximal portion and a distal portion connected, the distal portion having a stiffness greater than the stiffness of the proximal portion.

Preferably, the material of the supporting wire is a metal material.

Preferably, the force applying mechanism comprises a guide wire and a support member, the guide wire passes through the inner cavity of the main body segment, obliquely penetrates through the side wall of the main body segment and is connected with the annular segment, the support member also passes through the inner cavity of the main body segment and obliquely penetrates through the side wall of the main body segment, and the support member is movably sleeved on the guide wire; the support is used for contacting the annular section along the extending direction of the guide wire so as to apply pressure to the annular section.

Preferably, the number of the supporting members is matched with the number of the guide wires, the number of the guide wires is multiple, and the guide wires penetrate through the inner cavity of the main body section and penetrate out of the side wall of the main body section to be connected with different parts of the annular section.

Preferably, the material of guide wire is the macromolecular material, the material of support piece is the metallic material.

Preferably, the electrophysiology catheter further comprises a locking element and a handle, wherein the handle is connected with the proximal end of the catheter body, and the locking element is detachably connected with the handle and the force applying mechanism so as to fix the force applying mechanism and the handle.

Preferably, a developing member made of a developing material is provided on the force application mechanism.

Preferably, the side wall of the main body section is provided with an inclined hole, the force application mechanism penetrates through the main body section and penetrates out of the inclined hole, and the central line of the inclined hole and the axis of the main body section form an included angle of 5-45 degrees.

Preferably, one or more of a temperature sensor, a force sensor and a position sensor are provided on the ring segment to obtain one or more of temperature, abutment force and position information relating to the electrophysiology catheter.

Preferably, the electrophysiology catheter further comprises a connecting piece fixed on the annular section, and the connecting piece is connected with the force application mechanism.

Preferably, the annular section is provided with a mounting hole, and the annular section is connected with the force application mechanism through the mounting hole.

In summary, the electrophysiology catheter of the present invention has the force applying mechanism contacting with the annular section at the distal end of the catheter, and applies additional axial force to the annular section through the force applying mechanism, so that the electrode at the distal end of the catheter has not only the axial force from the catheter itself, but also the axial force from the force applying mechanism, thus increasing the axial force of the electrode at the distal end of the catheter as a whole, and improving the contact force of the electrode and the tissue, therefore, the electrophysiology catheter has short time for electrotherapy and good treatment effect.

Drawings

FIG. 1 is a schematic structural diagram of an electrophysiology catheter according to a first embodiment of the present invention;

FIG. 2a is a schematic view of the distal end of the EP catheter shown in FIG. 1, wherein the distal end of the support wire is connected to the connector on the loop segment;

FIG. 2b is a schematic view of the distal end of the EP catheter shown in FIG. 1, wherein the distal end of the support wire is received and secured within the mounting hole of the ring segment;

FIG. 2c is a schematic view of the distal end of the EP catheter according to one preferred embodiment of the present invention;

FIG. 2d is a schematic view of the distal end of the EP catheter according to another preferred embodiment of the present invention;

FIG. 2e is a schematic view of the distal end of the electrophysiology catheter according to another preferred embodiment of the present invention;

FIG. 3a is a schematic view of an electrophysiology catheter entering a heart to perform ablation according to a first embodiment of the present invention;

FIG. 3b is a schematic view of an electrophysiology catheter ablating a pulmonary vein according to a first embodiment of the present invention;

FIG. 4 is a schematic structural diagram of an electrode according to a first embodiment of the present invention;

FIG. 5 is a schematic cross-sectional view of an annular segment of a catheter body according to one embodiment of the invention;

FIG. 6 is a schematic cross-sectional view of a deflectable segment of a catheter body according to a first embodiment of the invention;

FIG. 7 is a schematic structural view of an electrophysiology catheter according to a second embodiment of the present invention;

fig. 8 is a schematic structural view of an electrophysiology catheter according to a second preferred embodiment of the present invention.

The reference numerals in the figures are explained below:

10. 20-an electrophysiology catheter;

11-a catheter body;

11 a-a body segment; 11 b-a ring segment;

111-proximal segment; 112-a bendable section;

112 a-straight line segment; 112 b-a transition section; 112 c-a deflectable segment;

1111-a first chamber of the ring segment; 1112-a second chamber of the ring segment; 1113-third chamber of the ring segment; 1114-a fourth chamber of the ring segment; 1115-perfusion holes;

1121-a first chamber of the deflectable section; 1122-a second chamber of the deflectable segment; 1123-a third chamber of the deflectable segment; 1124-a fourth chamber of the deflectable segment;

12-an electrode;

121-exhaust holes;

13-a force application mechanism;

131-support wires; 132-a guide wire; 133-a support;

14-a developing member;

151-connecting piece; 152-mounting holes;

16-a locking element;

17-a handle;

18-a straightener;

191-an adaptor; 192-a guidewire;

1-an introducer sheath; 2-inferior vena cava; 3-the right atrium; 4-left atrium; 5-pulmonary vein ostia; 6-melting focus;

s1-sensor wire; s2 — electrode lead; s3-shaping silk; s4-adjustable pull ring wire; s5-protection tube; s6-deflection line.

Detailed Description

The core idea of the present invention is to provide an electrophysiology catheter, which includes a force application mechanism for contacting with the distal end of the catheter, and the force application mechanism can apply pressure to the distal end of the catheter, so as to make the electrode on the distal end of the catheter and the tissue well attached, thereby improving the using effect of the electrophysiology catheter.

In order to make the contents of the present invention more clear and understandable, the electrophysiology catheter of the present invention is further described below with reference to the accompanying drawings 1-8 of the specification. The invention is of course not limited to this particular embodiment, and general alternatives known to those skilled in the art are also covered by the scope of the invention.

The present invention is described in detail with reference to the drawings, but these drawings are only for convenience of describing the present invention in detail and should not be construed as limiting the present invention. As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. The term "proximal" generally refers to the end closer to the operator, and "distal" refers to the end further from the operator. The same or similar reference numbers in the drawings identify the same or similar elements.

< example one >

Fig. 1 is a schematic structural view of an electrophysiology catheter 10 according to a first embodiment of the invention. As shown in FIG. 1, the electrophysiology catheter 10 includes a catheter body 11, an electrode 12, and a force application mechanism 13. The catheter body 11 includes a main body section 11a and an annular section 11b connected. The electrodes 12 are arranged on the ring segment 11b for realizing monopolar or bipolar discharge ablation, the number of which may be one or more. If the number of the electrodes 12 is plural, the plural electrodes 12 are disposed on the annular section 11b at intervals along the extending direction of the annular section 11 b. The electrophysiology catheter of the present invention is illustrated in detail with the plurality of electrodes 12 as an illustration, but should not be limited thereto.

In operation, the force application mechanism 13 is used for contacting with the annular section 11b to apply pressure to the annular section 11b, so that the electrode 12 on the annular section 11b has not only the axial force from the main body section 11a, but also the axial force from the force application mechanism 13, so that the axial force applied to the electrode 12 is integrally increased, and thus the contact force of the electrode 12 and the tissue is correspondingly increased, and the increase of the contact force is beneficial to realizing good contact between the electrode 12 and the tissue, so as to improve the ablation effect, and the increase of the contact force also reduces the ablation time, thereby saving the operation time.

As shown in fig. 1, the force applying mechanism 13 in this embodiment includes a supporting wire 131, when assembled, the supporting wire 131 passes through the inner cavity of the main body 11a, and then obliquely passes through the sidewall of the main body 11a to be directly connected to the ring segment 11b, and the connecting portion of the supporting wire 131 and the ring segment 11b is located between the electrodes 12, so as to prevent the supporting wire 131 from contacting the electrodes 12 and affecting the operation of the electrodes 12, especially when the supporting wire 131 is made of metal material, the supporting wire 131 can be prevented from conducting with the electrodes 12 and reducing the safety of the operation.

The range of the oblique angle is greater than 0 ° and less than 90 °, specifically, an included angle between a direction in which the supporting wire 131 penetrates out from the side wall of the main body segment 11a and the axial direction of the main body segment 11a is an acute angle. In the present invention, the direction in which the proximal end of the main body segment 11a extends to the distal end of the main body segment 11a is defined as the axial direction of the main body segment 11 a. The supporting wire 131 penetrates through the main body segment 11a at an acute angle to connect with the ring segment 11b, so that the supporting wire 131 can provide a certain amount of axial force to the ring segment 11b, and normal operation of the force application mechanism 13 is ensured. It will be appreciated that the support wires 131 of this embodiment, like the two-force rods, are capable of withstanding a certain axial force in order to apply pressure to the ring segment 11 b.

In this embodiment, the annular segment 11b is made of a polymer material, and may be TPU (thermoplastic polyurethane elastomer) or PEBAX (block polyether amide resin).

Next, FIG. 2a is a schematic view of the distal end of the EP catheter 10 shown in FIG. 1. Referring to fig. 2a and 1, the distal end of the support wire 131 is preferably welded or bonded to the ring segment 11b, and the proximal end of the support wire 131 extends beyond the proximal end of the main segment 11a (best shown in fig. 1), and may or may not be fixed, preferably fixed to an external mechanism, to drive the proximal end of the support wire 131 to apply pressure to the ring segment 11b via the external mechanism.

The supporting wires 131 may be made of metal, such as nitinol or stainless steel with good flexibility. The diameter of the supporting wire 131 is preferably 0.08-1.0 mm, and if the diameter is too small, the supporting wire is easy to deform and cannot effectively apply pressure to the annular section 11b, and if the diameter is too large, the size of the catheter body 11 is increased, and the use cost is increased.

As shown in fig. 2a, the distal end of the supporting wire 131 is preferably provided with a ring-shaped developing member 14, and the developing member 14 is made of developing material for identifying the position of the distal end of the supporting wire 131 in the rf ablation treatment. The developing member 14 may be made of platinum-iridium alloy or other materials having a developing function. The developing member 14 may form an integrated structure with the supporting wire 131, or may form a separate structure with the supporting wire 131. The shape of the developing member 14 includes, but is not limited to, a ring shape, and may be other shapes such as dots, lines, etc. If the developing member 14 is integrally formed with the supporting wire 131, one or more sections of the supporting wire 131 are made of a developing material.

In a preferred embodiment, the distal end of the support wire 131 is connected to the connecting member 151 sleeved on the ring segment 11 b. For example, the distal end of the support wire 131 is welded to the connection member 151, and preferably, the material of the connection member 151 is the same as that of the support wire 131, so that a good welding can be achieved. The material of the connecting member 151 may be selected from medical stainless steel. In this context, the connecting surface of the supporting wire 131 to the ring segment 11b can be enlarged by the connecting element 151, so as to increase the force, and ultimately improve the contact and contact force between the distal electrode 12 and the tissue.

In other embodiments, as shown in fig. 2b, the ring segment 11b is provided with a mounting hole 152, and the distal end of the supporting wire 131 is received in the mounting hole 152 and fixed by a material such as glue.

The support wire 131 preferably comprises a proximal portion and a distal portion connected to each other, and the proximal portion has a hardness less than that of the distal portion, so that flexibility and a certain support strength are ensured.

In one embodiment, the number of the electrodes 12 is ten, and the distal end of one of the support wires 131 is fixed between the fourth electrode 12 and the fifth electrode 12 (as shown in fig. 2a and 2 b). In another embodiment, as shown in fig. 2c, the number of the electrodes 12 is seven, and the distal end of one of the support wires 131 is fixed between the first electrode 12 and the second electrode 12 to improve the contact and contact force of the electrodes 12 near the end of the ring segment 11 b. Here, the end connecting the ring segment 11b and the main segment 11a is defined as a first end, the end opposite to the first end is defined as a second end, and the tenth electrode 12 is defined as first, second, and third … in this order, counting from the second end toward the first end. Of course, as the number of the electrodes 12 is different, the fixing position of the distal end of one of the support wires 131 to the ring segment 11b is different, and is set according to the actual situation.

In this embodiment, the number of the supporting wires 131 is one or more, the number of the supporting wires 131 shown in fig. 2a to 2c is one, the number of the supporting wires 131 shown in fig. 2d is two, and the number of the supporting wires 131 shown in fig. 2e is three, or in other embodiments, the number of the supporting wires 131 may be more than three.

In the embodiment disclosed in fig. 2d, two support wires 131 are extended from the same position on the main body segment 11a and connected to different portions of the ring segment 11 b. However, the angle between the direction in which the two support wires 131 penetrate out of the main body segment 11a and the positive direction of the axis of the main body segment 11a may be the same or different, and the present invention is not particularly limited. If the number of the electrodes 12 is ten as shown in fig. 2d, in a preferred embodiment, one supporting filament 131 is connected between the second electrode 12 and the third electrode 12, and another supporting filament 131 is connected between the fifth electrode 12 and the sixth electrode 12.

Furthermore, according to the embodiment disclosed in fig. 2e, three support wires 131 are also threaded out from the same position on the main segment 11a and connected to different portions of the ring segment 11 b. For ten electrodes 12, one supporting filament 131 is connected between the second electrode 12 and the third electrode 12, another supporting filament 131 is connected between the fifth electrode 12 and the sixth electrode 12, and the remaining supporting filament 131 is connected between the eighth electrode 12 and the ninth electrode 12. Of course, the present invention also does not specifically limit the connecting positions of the plurality of support wires 131 and the ring segment 11b, as long as the support wires are positioned between the electrodes 12, and does not specifically limit the positions where the support wires 131 extend out from the main body segment 11 a. In addition, in the case of the multiple supporting wires 131, other embodiments not described in detail may refer to a single supporting wire 131.

Next, referring to fig. 3a and fig. 3b, fig. 3a is a schematic diagram of the electrophysiology catheter 10 according to the first embodiment of the present invention entering the heart to perform ablation, and fig. 3b is a schematic diagram of the electrophysiology catheter 10 according to the first embodiment of the present invention after performing ablation on the pulmonary veins. Specifically, during operation, the electrophysiology catheter 10 is firstly inserted into the guiding sheath 1, then the guiding sheath 1 enters the right atrium 3 through the femoral vein and the inferior vena cava 2, then the guiding sheath 1 enters the left atrium 4 through interatrial puncture, further the electrophysiology catheter 10 enters the left atrium 4 through the guiding sheath 1, and under the help of X-rays, the distal end of the electrophysiology catheter 10 is placed at the pulmonary vein ostium 5 through operation to perform ablation, in the ablation process, the annular section 11b is pressed through the supporting wire 131 to realize good adhesion of the electrode 12 and human tissues, finally the annular ablation focus 6 is formed, and further, the other pulmonary vein ostia are sequentially ablated, so that the isolation of the pulmonary veins is obtained.

Further, the number of the electrodes 12 is preferably 4-15, more preferably 10, the length is 2-4 mm, and the interval between the adjacent electrodes 12 is 3-10 mm. Furthermore, the sidewall of the main body section 11a is provided with an inclined hole for the supporting wire 131 to pass through, and the central line of the inclined hole and the axis of the main body section 11a form an acute angle, and the acute angle is preferably between 5 ° and 45 °, so that the axial action effect of the supporting wire 131 is better. The diameter of the inclined hole is 0.50-0.10 mm, and is 5-50 mm, preferably 40mm, from the distal end of the main body section 11 a.

With continued reference to fig. 1, the proximal end of the support wire 131 is removably attached to the locking element 16, the locking element 16 is located at the proximal end of the handle 17 and is removably attached to the proximal end of the handle 17, and the distal end of the handle 17 is attached to the proximal end of the body segment 11 a. Specifically, the proximal end of the support wire 131 extends beyond the proximal end of the handle 17 and is fixedly connected to the locking member 16, and when the support wire 131 applies pressure to the annular section 11b, the locking member 16 is connected to the handle 17, so that the support wire 131 is fixed to the handle 17, whereas the support wire 131 is released by releasing the connection between the locking member 16 and the handle 17, in such a manner that the operation of the urging mechanism 13 is facilitated.

The locking member 16 is a tubular body in this embodiment, and is sleeved on the supporting wire 131 and fixedly connected to the supporting wire 131. The locking element 16 is preferably removably attached to the proximal end of the handle 17 by means of a snap, or the like.

Continuing to refer to fig. 1, the main body segment 11a is formed by connecting a plurality of segments. Specifically, the main body segment 11a includes a proximal segment 111 and a bendable segment 112 connected to each other, and the ring segment 11b connects the bendable segment 112, wherein the bendable segment 112 is used for performing a bending function to facilitate the performance of a surgical operation.

The bendable section 112 includes a straight section 112a, a transition section 112b and a deflectable section 112c connected in sequence, wherein the straight section 112 is connected to the annular section 11b, and the deflectable section 112c is connected to the proximal section 111 and acts as a bend to control the bending of the distal end of the catheter body 11 via the deflectable section 112 c. And the straight line segment 112a is provided with the inclined hole, so that the supporting wire 131 can conveniently penetrate through the inclined hole on the straight line segment 112.

In addition, the handle 17 is connected to the end section 111 and is used to control the bending of the deflectable section 112c, for example, by a pull wire (also called deflection wire) to control the bending of the deflectable section 112c, and also to control the loop diameter of the loop section 11b, for example, by an adjustable pull wire to control the loop diameter of the loop section 11b, wherein the diameter of the loop section 11b is preferably 10-40 mm.

The electrophysiology catheter 10 further includes a straightening device 18 that is disposed on the main body segment 11a and can slide relative to the main body segment 11 a. In application, the straight device 18 is used for assembling the ring segment 11b, so that the ring segment 11b is pressed and held in the inner cavity of the straight device 18 for smooth delivery into the body. The length of the straight device 18 is 50-30 mm, preferably 120mm, the outer diameter of the straight device 18 can be 2.5-4.0 mm, preferably 3.5mm, and the inner diameter is 2-3.5 mm, preferably 3.0 mm.

The electrophysiology catheter 10 further comprises an adapter 191, such as a standard luer, located at the proximal end of the handle 17 for connection with an external device for providing perfusion medium, enabling perfusion cooling of the electrodes and the tissue. Specifically, the catheter body 11 is provided with a medium conveying channel having an input end communicating with the adaptor 191 and an output end communicating with the electrode 12 on the ring segment 11b, and at the same time, the electrode 12 is provided with a discharge hole 121 (shown in fig. 4) penetrating the electrode. After the perfusion medium flows into the electrode 12 through the medium delivery channel, the perfusion medium flows out of the electrode 12 through the discharge hole 121, and the outflow perfusion medium can realize the circulating cooling of the electrode 12 on one hand and can reduce the temperature of tissues in the ablation process on the other hand.

The perfusion medium is for example saline at 20 ℃. The number of the discharge holes 121 is preferably plural and arranged alternately on the surface of the electrode 12. The diameter of the discharge holes 121 is 0.03 to 0.3mm, preferably 0.08mm, and the number is 5 to 100, more preferably 20.

FIG. 5 is a cross-sectional view of an annular segment 11b of an electrophysiology catheter 10 according to an embodiment of the present invention. As shown in FIG. 5, the annular segment 11b is a multi-lumen tube, preferably a four-lumen tube. When the ring segment 11b is a four-lumen tube, it includes a first chamber 1111, a second chamber 1112, a third chamber 1113, and a fourth chamber 1114; the first chamber 1111 of the ring-shaped segment 11b is used for placing an infusion tube to establish a medium conveying channel for electrode infusion; the second chamber 1112 of the ring segment 11b is preferably adapted to receive one or more sensor wires S1, such as magnetic sensor wires, for identifying the position of the catheter body 11 during treatment; the third chamber 1113 of the annular segment 11b is preferably adapted to receive one or more electrode leads S2; the fourth chamber 1114 of the ring segment 11b is preferably adapted to receive, for example, a set wire S3, an adjustable pull ring wire S4, etc.; the material of the shaping wire S3 is preferably nitinol, which is used to pre-shape the catheter body into a ring shape, such as a crescent, a spiral, etc., so as to make the distal end of the catheter body 11 into a ring shape after being placed in the fourth chamber 1114; the sizing wire S3 and the adjustable garter wire S4 may be further contained in a protective tube S5, the material of the protective tube S5 being PI (polyimide) or PTFE (polytetrafluoroethylene).

The first chamber 1111 is communicated with the outside through the perfusion hole 1115, the electrode 12 is sleeved on the annular section 11b, the discharge hole 121 is arranged corresponding to the perfusion hole 1115, and the perfusion medium flowing out of the perfusion hole 1115 directly flows out through the discharge hole 121 on the electrode 12. The diameter of first cavity 1111 is 0.5 ~ 1.0mm, preferably 0.8mm, and the diameter of three other cavities satisfies the requirement of placing the space of the required cable of each cavity can.

Fig. 6 is a schematic cross-sectional view of a deflectable segment 112c of the electrophysiology catheter 10 in accordance with a first embodiment of the present invention. As shown in fig. 6, the deflectable segment 112c is a multi-lumen tube, preferably a four-lumen tube, and the first lumen 1121 of the deflectable segment 112c is configured to receive an irrigation tube for introducing an irrigation medium to establish the medium delivery channel; the second chamber 1122 of the deflectable segment 112c is configured to receive the force applying mechanism 13; the third chamber 1123 of the deflectable segment 112c is adapted to receive, for example, an electrode lead S2, TC lead; the fourth chamber 1124 of the deflectable segment 112c is configured to receive a deflection wire S6, an adjustable pull ring wire S4, and a sensor wire S1; the deflection wire S5 may be nitinol or stainless steel, and the deflection wire S6, the adjustable pull ring wire S4 and the sensor wire S1 are all disposed on the protection tube S5. The present invention does not require any particular diameter for each chamber of the deflectable segment 112c, and preferably provides space for placing corresponding components.

The length of the transition section 112b is preferably between 5mm and 20mm, more preferably 10mm, and the material can be a polymer material such as PEBAX, nylon and the like. The transition section 112b may be a single lumen or multi-lumen tube, preferably a single lumen tube. The transition section 112b can be used to realize the dislocation of the cavity materials in the conduit, and can also be used to place the head end of the deflection wire S6.

Preferably, the electrodes 12 have the functions of mapping and positioning, radiofrequency nerve ablation, temperature induction and the like; when the electrode 12 is used to perform radiofrequency ablation, for example, the electrode 12 may implement a single bipolar discharge to achieve an optimal ablation area.

In the preferred embodiment, at least one of the following sensors is distributed in the vicinity of the electrode 12: the temperature sensor, the mechanical sensor and the position sensor are used for enabling the catheter to obtain information in the aspects of ablation temperature, adhesion force, position and the like in real time when the radiofrequency ablation is carried out, so that the safety and effectiveness of the operation are improved, and efficient radiofrequency ablation is obtained.

< example two >

The difference from the first embodiment is that the force applying mechanism 13, the force applying mechanism 13 of the present embodiment includes a guide wire 132 and a support member 133, the guide wire 132 is used for connecting with the ring segment 11b, and the support member 133 is used for contacting with the ring segment 11b along the extending direction of the guide wire 132 to apply pressure to the ring segment 11 b.

Fig. 7 is a schematic structural view of an electrophysiology catheter 20 according to a second embodiment of the present invention. The distal end of the guidewire 132 passes through the lumen of the body segment 11a and then is also obliquely threaded through the sidewall of the body segment 11a to join the ring segment 11 b. Then, the supporting element 133 is sleeved on the guiding wire 132 along the extending direction of the guiding wire 132 and can slide relative to the guiding wire 132, and the user can operate the supporting element 133 to move along the extending direction of the guiding wire 132 until contacting the annular section 11b, so that a certain force is applied to the supporting element 133, and the electrode 12 on the annular section 11b not only has the axial force from the main body section 11a itself, but also has the axial force from the supporting element 133.

Of course, in other embodiments, the supporting member 133 may be fixedly connected to the main body segment 11a, and the invention is not limited thereto.

In this embodiment, the guiding wire 132 is different from the supporting wire 131 in that it can bear a tensile force and has a certain elasticity or flexibility. The material of the guide wire 132 is preferably a medical polymer material, such as a high molecular polymer, to ensure the flexibility of the guide wire 132. More preferably, the guide wire 132 is a medical suture with good flexibility and the diameter is between 0.02 mm and 0.10 mm.

The supporting member 133 can be selected from a spring tube, but not limited to a spring tube, as long as it has an inner cavity for penetrating the guiding wire 132 and has a certain strength and flexibility. The support 133 is preferably a spring tube made of medical stainless steel, the inner diameter is 0.05-0.40 mm, the outer diameter is 0.20-0.90 mm, the pitch of the far end is 0.5-9.0 mm, and the pitch of the near end is 0.1-6.0 mm. Similarly, the connection position of the distal end of the guide wire 132 and the ring segment 11b is located between the electrodes 12, for example, the number of the electrodes 12 is ten, and the guide wire 132 is connected to the region between the fourth electrode and the fifth electrode.

The guide wire 132 of the present embodiment may be similar in structure to the support wire 132 of the first embodiment, such as the guide wire 132 is correspondingly provided with the developing member 14, and is connected to the ring segment 11b by the connecting member 151, or connected to the ring segment 11b by the mounting hole 152. In addition, the number of the guide wires 132 is not limited to one, and as with the support wires 131, a plurality of guide wires 132 may be provided and connected to different portions of the ring segment 11b, and a support member 133 may be provided on each guide wire 132.

Further, the distal ends of both the guide wire 132 and the support wire 131 are perpendicular to a section of the ring segment 11b passing through the connection point. Further, similar to the first embodiment, the proximal end of the support member 133 is detachably connected to the locking member 16. The locking element 16 is located at the proximal end of the handle 17 and is removably or fixedly connected to the proximal end of the handle 17. As shown in fig. 7, the proximal end of the supporting member 133 is fixedly connected to the locking member 16 and the locking member 16 is connected to the handle 17 when the supporting member 133 applies pressure to the ring segment 11b, so as to fix the supporting member 133 to the handle 17, except that the supporting member 133 is disposed in the tubular locking member 16 and fixed, but the proximal end of the guide wire 132 may be fixed or not fixed, but not limited.

As shown in fig. 8, the transition section 112b has a guidewire lumen for receiving a guidewire 192 for guiding the catheter body 11 into a desired location in the body (e.g., the heart). The guidewire 192 may be placed into the second chamber 1122 of the deflectable segment 112c so that the catheter body 11 may more easily reach the pulmonary vein tissue for effective rf ablation. The guide wire 192 is made of medical metal material, and the head end of the guide wire is flexible. The diameter of the guide wire 192 is variable, the diameter of the minimum section is 0.02-0.10 mm, and the diameter of the maximum section is 0.08-0.20 mm.

Here, it should be noted that the electrophysiology catheter 10, 20 of the present invention can be either a mapping catheter, an ablation catheter, or a catheter for both ablation and mapping, which is not limited by the present invention. At the same time, it can be understood that: when the electrophysiology catheter 10, 20 is a mapping catheter, the electrode 12 is a mapping electrode; and when the electrophysiology catheter 10, 20 is an ablation catheter, the electrode 12 is an ablation electrode; the electrode 12 is then a dual-ablation and mapping electrode when the electrophysiology catheter 10, 20 is a dual-mapping and ablation catheter. The support wire in the urging mechanism 13 is not limited to a wire structure, and may be a wire having a certain elasticity and capable of receiving an axial force. The guide wire in the urging mechanism 13 is not limited to a wire, and may be a string, a belt, or the like.

Compared with the prior art, the electrophysiology catheter has the advantages that the force application mechanism which is in contact with the annular section at the far end of the catheter is arranged, and the force application mechanism applies additional axial force to the annular section, so that the electrode at the far end of the catheter not only has the axial force from the catheter, but also has the axial force from the force application mechanism, the axial force of the electrode at the far end of the catheter is integrally increased, the contact force of the electrode and tissues is improved, the electrotherapy time is short, and the treatment effect is good.

The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the appended claims.

Claims (13)

1. An electrophysiology catheter comprising a catheter body and an electrode, the catheter body comprising a main body segment and an annular segment which are connected, the electrode being disposed on the annular segment, characterized in that the electrophysiology catheter further comprises a force applying mechanism, one part of the force applying mechanism being disposed within the main body segment and the other part extending out of the main body segment for contacting the annular segment to apply pressure to the annular segment to increase the axial force experienced by the electrode;

the force applying mechanism comprises a support wire passing through the lumen of the body segment, obliquely penetrating the sidewall of the body segment, and connected with the ring segment to apply pressure to the ring segment; or the force application mechanism comprises a guide wire and a support piece, the guide wire penetrates through the inner cavity of the main body section, obliquely penetrates through the side wall of the main body section and is connected with the annular section, the support piece also penetrates through the inner cavity of the main body section and obliquely penetrates through the side wall of the main body section, and the support piece is movably sleeved on the guide wire; the support is used for contacting the annular section along the extending direction of the guide wire so as to apply pressure to the annular section.

2. The electrophysiology catheter of claim 1, wherein the number of the electrodes is multiple, the multiple electrodes are arranged on the ring-shaped section at intervals, and the contact position of the force application mechanism and the ring-shaped section is located between the electrodes.

3. The electrophysiology catheter of claim 1, wherein the number of support wires is a plurality, and the plurality of support wires pass through the lumen of the main body segment and exit through the sidewall of the main body segment to connect to different portions of the ring segment.

4. The electrophysiology catheter of claim 1, wherein the support wire comprises a proximal portion and a distal portion that are connected, the distal portion having a stiffness that is greater than a stiffness of the proximal portion.

5. The electrophysiology catheter of claim 1, wherein the support wire is made of a metal material.

6. The electrophysiology catheter of claim 1, wherein the number of support members matches the number of guide wires, the number of guide wires being a plurality, the plurality of guide wires all passing through the lumen of the body segment and out the sidewall of the body segment to connect to different portions of the ring segment.

7. The electrophysiology catheter of claim 1, wherein the guidewire is made of a polymer material, and the support member is made of a metal material.

8. The electrophysiology catheter of claim 1, further comprising a lock and a handle, the handle coupled to the proximal end of the catheter body, the lock configured to removably couple the handle and the force applying mechanism to secure the force applying mechanism to the handle.

9. The electrophysiology catheter of claim 1, wherein the force application mechanism is provided with a visualization member made of a visualization material.

10. The electrophysiology catheter of claim 1, wherein the sidewall of the main body section is provided with an inclined hole, the force application mechanism passes through the main body section and penetrates out of the inclined hole, and the central line of the inclined hole and the axis of the main body section form an included angle of 5-45 degrees.

11. The electrophysiology catheter of claim 1, wherein one or more of a temperature sensor, a force sensor, and a position sensor are provided on the ring segment to obtain one or more of temperature, abutment force, and position information relating to the electrophysiology catheter.

12. The electrophysiology catheter of claim 1, further comprising a connector affixed to the loop segment, the connector being coupled to the force application mechanism.

13. The electrophysiology catheter of claim 1, wherein the loop segment defines a mounting hole, and the loop segment is coupled to the force application mechanism via the mounting hole.

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