CN105615991B

CN105615991B - Ablation catheter

Info

Publication number: CN105615991B
Application number: CN201410619961.0A
Authority: CN
Inventors: 张清淳; 谭家宏; 梁波; 王铮; 孙毅勇; 吴常生
Original assignee: Shanghai Microport EP MedTech Co Ltd
Current assignee: Shanghai Microport EP MedTech Co Ltd
Priority date: 2014-11-05
Filing date: 2014-11-05
Publication date: 2021-04-16
Anticipated expiration: 2034-11-05
Also published as: CN105615991A

Abstract

The invention provides an ablation catheter, which comprises an operating handle, a catheter main body and an ablation electrode which are connected from near to far, wherein a stopper is detachably connected to the far end of the ablation electrode, and the operating handle controls the stopper to be separated from the ablation electrode; after the occluder is used for occluding, the occluder is separated from the ablation electrode, the ablation electrode is exposed and then ablated, so that occlusion and ablation can be simultaneously realized in one operation, the ablation catheter is simple in processing technology, low in cost and simple and convenient to operate, and the operation mode, the operation time and the like are not greatly influenced.

Description

Ablation catheter

Technical Field

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

Background

Today, there are two main ways of treating atrial fibrillation, one is to restore sinus rhythm, such as by catheter ablation, and the other is to control heart rate in combination with thrombus prevention. Embolism caused by atrial fibrillation, the thrombus source of the embolism mainly comes from the left atrial appendage, and even if the sinus rhythm is recovered through treatment, the left atrial appendage is shrunk and stopped, thrombus can still be formed, and the risk of ischemic stroke is caused. Therefore, the left auricle is blocked, and the risk of stroke can be greatly reduced. At present, the left auricle can be plugged in an intracardiac intervention mode, a plugging device with a special structural design is used, a channel which enters the left auricle through the skin is established by utilizing a guiding technology, and then the plugging device is conveyed by a conveyor and further placed in the left auricle to plug the left auricle.

At present, atrial fibrillation is mainly treated by radio frequency ablation to restore sinus rhythm, and thrombus is prevented by thrombus-preventing medicines after operation. Patients need to be administered continuously after surgery, increasing the economic burden on the patients and reducing the quality of life of the patients. It is desirable to design an apparatus that can simultaneously perform catheter ablation and occlusion of the left atrial appendage, and that is simple to operate, easy to use, and does not significantly affect the manner and duration of the procedure.

Disclosure of Invention

The invention aims to provide an ablation catheter, which can simultaneously realize catheter ablation and occlusion of left atrial appendage, and has simple processing technology and low cost.

To achieve the above and other related objects, the present invention provides an ablation catheter: the catheter comprises an operating handle, a catheter main body and an ablation electrode which are connected from near to far, wherein a stopper is detachably connected to the far end of the ablation electrode, and the operating handle controls the stopper to be separated from the ablation electrode.

Optionally, the occluder comprises: the device comprises a seal head, a metal mesh grid and a connecting cap; the end socket and the connecting cap are respectively used for fixing two ends of the metal woven net to form a closed body.

Optionally, the end socket and the connecting cap are arranged on the same axis.

Optionally, the occluder is connected with the distal end of the ablation electrode through the connecting cap, and the operating handle is connected with the connecting cap to control the connecting cap to be separated from the ablation electrode.

Optionally, the connection cap is connected with the ablation electrode through a thread, an internal thread is arranged on the connection cap, and an external thread is arranged on the ablation electrode.

Optionally, the internal thread and the external thread are rectangular, saw-toothed, triangular or trapezoidal.

Optionally, the length of the ablation electrode is 3mm to 6mm, and the length of the external thread on the ablation electrode is 1mm to 4 mm.

Optionally, the connecting cap is connected with the ablation electrode through a buckle.

Optionally, the buckle is arranged in an i-shape, a spherical shape or a peanut shape.

Optionally, a knob is arranged on the operating handle, and the knob is a hollow cylinder.

Optionally, the proximal end of the catheter main body is introduced into the operating handle, the outer surface of the catheter main body is bonded with the inner surface of the knob, and the catheter main body and the ablation electrode are driven to rotate by rotating the knob, so that the occlusion device is separated.

Optionally, the catheter further comprises a deflectable segment connected between the ablation electrode and the catheter body, the deflectable segment comprising a multi-lumen tube.

Optionally, a first lead and a second lead are respectively arranged in two symmetrical lumens in the multi-lumen tube, and distal ends of the first lead and the second lead are both connected with the proximal end of the ablation electrode.

Optionally, the first guide wire and the second guide wire respectively pass through the catheter main body and extend into the operating handle; the first lead is fixed at the far end of a sliding block in the operating handle, and the second lead passes through a through hole at one side of the sliding block and is fixed at the near end of the sliding block after surrounding a leather pulley; the sliding block can slide up and down in the sliding groove, so that the first lead or the second lead is tensioned, and the bilateral bending of the ablation catheter is realized.

Compared with the prior art, the ablation catheter provided by the invention has the beneficial effects that:

1. the distal end of the ablation electrode is detachably connected with the stopper, after the stopper performs the blocking, the operation handle controls the stopper to be separated from the ablation electrode, the ablation electrode is exposed and then ablation is performed, and therefore the blocking and the ablation can be simultaneously realized in one operation;

2. the occluder is connected with the ablation electrode through threads or buckles, the knob is arranged in the operating handle, the inner surface of the knob is adhered to the outer surface of the catheter main body, and the catheter main body and the ablation electrode are rotated while the knob is rotated, so that the occluder is separated from the ablation electrode.

Drawings

Fig. 1 is a schematic structural diagram of an ablation catheter according to an embodiment of the present invention.

Fig. 2 is a schematic view of the connection between the occluder and the ablation electrode in the ablation catheter provided in an embodiment of the present invention.

Fig. 3a to 3b are schematic views illustrating connection between an occluder and an ablation electrode in an ablation catheter according to another embodiment of the present invention.

FIG. 4 is a cross-sectional view of an ablation electrode, a deflectable segment, and a catheter body in an ablation catheter in accordance with an embodiment of the invention.

Fig. 5a and 5B are cross-sectional views of fig. 4 at a and B, respectively.

Fig. 6 is a cross-sectional view of an operating handle of an ablation catheter in accordance with an embodiment of the present invention.

Fig. 7 a-7 c are schematic views illustrating the use of an ablation catheter according to an embodiment of the present invention.

Detailed Description

In order to make the contents of the present invention more clearly understood, the contents of the present invention will be further described with reference to the accompanying drawings. 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, and for convenience of explanation, the drawings are not enlarged partially according to the general scale, and should not be construed as limiting the present invention.

The core idea of the invention is as follows: the occluder is connected to the ablation electrode and can be separated from the ablation electrode, and after occlusion is performed, the occluder falls off from the ablation electrode to expose the ablation electrode for ablation, so that occlusion and ablation can be simultaneously realized in one operation.

Please refer to fig. 1, which is a schematic structural diagram of an ablation catheter according to an embodiment of the present invention. As shown in fig. 1, the ablation catheter comprises an operation handle 15, a catheter main body 14 and an ablation electrode 12 which are connected from the near to the far, an occluder 11 is detachably connected at the far end of the ablation electrode 12, and the operation handle 15 controls the occluder 11 to be detached from the ablation electrode 12. The ablation catheter further includes a deflectable section 13 connected between the ablation electrode 12 and the catheter body 14.

The main function of the occlusion device 11 is to perform occlusion, and in this embodiment, the occlusion device is mainly used for occluding the left atrial appendage. The stopper 11 comprises a sealing head 111, a metal mesh grid 112 and a connecting cap 113, as shown in fig. 2. The metal mesh grid 112 is woven from memory metal wires, such as nickel titanium wires; or the woven net can be cut by laser; the metal mesh grid 112 is preset to a certain shape, such as a disc shape, according to actual needs. The end sockets 111 and the connecting caps 113 are respectively used for fixing two ends of the metal mesh grid 112, so that the mesh grid forms a closed body; the sealing head 111 is arranged on the outer side of the closing body, the connecting cap 113 is arranged on the inner side of the closing body, namely, the near end of the metal mesh grid 112 is embedded in the connecting cap 113, and the sealing head 111 and the connecting cap 113 are arranged on the same axis.

The diameter D of the occluder 11 is 5mm to 60mm, and is adjusted according to the form of the tissue to be occluded, for example, the form of the left atrial appendage. The occluder 11 is connected with the distal end of the ablation electrode 12 through the connecting cap 113, and the operating handle 15 is connected with the connecting cap 113 to control the connecting cap 113 to be separated from the ablation electrode 12. In this embodiment, the connecting cap 113 is connected to the ablation electrode 12 through a thread, specifically referring to fig. 2, an internal thread is disposed on the connecting cap 113, an external thread is disposed on the ablation electrode 12, and the external thread can be obtained by a threading method of a die, a thread rolling machine, or a lathe; the internal thread and the external thread are both rectangular, the external diameter of the thread is less than 3mm, the thread pitch is 0.05 mm-1 mm, the groove width is 0.5 multiplied by the thread pitch + (0.02-0.04) mm, the tooth height is 0.5 multiplied by the thread pitch + (0.1-0.2) mm, the tooth width is pitch-groove width, and the internal diameter is external diameter-2 multiplied by the tooth height; it should be noted that the sizes of the internal thread and the external thread are not limited to the above data, and may be determined according to the specific sizes of the occluding device 11 and the ablation electrode 12 and the actual surgical conditions; in other embodiments, the internal thread and the external thread may also be saw-toothed, triangular or trapezoidal.

The ablation electrode 12 is made of a metal material, such as copper, stainless steel, platinum, gold or platinum alloy, and has a length of 3mm to 6mm, the length of the external thread on the ablation electrode 12 is 1mm to 4mm, such as 2mm and 3mm, and the preferred length of the external thread is 3 mm; the surface of the ablation electrode 12 without external threads is provided with a plurality of small holes which are connected with an infusion tube in the catheter main body 14, so that the ablation electrode 12 can be infused in the ablation process to reduce the temperature of the ablation electrode 12. The length of the connecting cap 113 is 1mm to 4mm, such as 2mm and 3mm, and the preferred length is 2 mm; the diameter of the connecting cap 113 is larger than that of the ablation electrode 12, and is generally 3 mm-5 mm; the connecting cap 113 is made of metal, for example: stainless steel, copper, etc., and also engineering plastics, such as: nylon, ABS (Acrylonitrile butadiene Styrene copolymers), POM (Polyoxymethylene), PES (polyethersulfone resin), and the like.

In another embodiment of the present invention, the connecting cap 113 is connected to the ablation electrode 12 by a snap, which may be i-shaped, spherical or peanut-shaped, as shown in fig. 3a and 3 b. In fig. 3a, the distal end of the ablation electrode 12 is provided with an i-shape, the connecting cap 113 is provided with a hollow structure corresponding to the i-shape, and the distal end of the ablation electrode 12 is embedded in the connecting cap 113; fig. 3b shows another shape of the connection, in which the distal end of the ablation electrode 12 is provided with a spherical shape and embedded in the connection cap 113; the distal end of the ablation electrode 12 may also be provided in other shapes that are easily attachable, such as a peanut shape. In the above-described connection mode. The connecting cap 113 is preferably made of medical silicon rubber, and the hardness of the connecting cap is at least greater than 75D.

Referring to fig. 4 and 5, fig. 4 is a cross-sectional view of an ablation electrode, a deflectable section and a catheter body in an ablation catheter according to an embodiment of the present invention, fig. 5a and 5B are cross-sectional views of fig. 4 at a and B, and as shown in fig. 4 and fig. 5a and 5B, a temperature sensor 121 and a position sensor 122 are fixed in the ablation electrode 12, and the fixing manner may be gluing or welding. The outer wall of the deflectable segment 13 is made of a polymer material, preferably a polyurethane material with a woven metal mesh, and may be formed as a single or multi-lumen tube, in this embodimentA four-lumen tube; wherein the hardness of the outer wall pipe is about 55D. The four-lumen tube contains four chambers, and a plurality of wires 133, including wires of the ablation electrode 12, the temperature sensor 121, and the position sensor 122, are placed in the first chamber 100; placing an irrigation tube 134 in the third chamber 300, and saline entering the ablation electrode 12 through the irrigation tube 134 to reduce the temperature of the ablation electrode 12 during the ablation process; the first pull wire 131 and the second pull wire 132 are respectively disposed in the second chamber 200 and the fourth chamber 400, and distal ends of the first pull wire 131 and the second pull wire 132 are connected to a proximal end of the ablation electrode 12, wherein the connection manner includes welding, gluing, and the like. The second lumen 200 and the fourth lumen 400 are symmetrical about the ablation catheter axis, thus ensuring that asymmetrical deflection occurs in the same plane when the ablation catheter is deflected. The first and

second wires

131, 132 are made of metal material, such as stainless steel, nitinol or copper alloy, or polymer material, such as

(polyarylate fiber). The first wire 131 and the second wire 132 may be single-stranded or may be wound by multiple strands. The diameter of the pull wire is about 0.1mm to 0.3 mm.

The ablation electrode 12 and the deflectable section 13, and the deflectable section 13 and the catheter body 14 are connected by glue or epoxy. To effect deflection of the deflectable segment 13, the catheter body 14 is stiffer than the deflectable segment 13, preferably around 75D, and is preferably formed of a TPU (Thermoplastic polyurethane elastomer rubber) plastic tube with a metal mesh. Thus, upon tightening of the first pull wire 131 or the second pull wire 132, the bending point begins near the junction, the softer deflectable segment 13 deflects, while the stiffer catheter body 14 remains unchanged. In the catheter main body 14, the second chamber 200 and the fourth chamber 400 are bonded to the inner surface of the catheter main body 14 by glue 141.

The catheter main body 14 extends into the operating handle 15, the rotation knob 151 on the operating handle 15 is used to control the separation and screwing of the occluder 11 and the ablation electrode 12, the push button 152 on the operating handle 15 is used to control the deflection of the deflectable section 13, please refer to fig. 1 and 6, fig. 6 is a cross-sectional view of the operating handle in the ablation catheter provided by an embodiment of the present invention, the rotation knob 151 is a hollow cylinder, the catheter main body 14 is inserted into the hollow section of the cylinder, the outer surface of the catheter main body 14 is bonded to the inner surface of the rotation knob 151, so that the catheter main body 14 rotates along with the rotation knob 151 and drives the ablation electrode 12 to rotate, and since the occluder 11 is in a fixed state at this time, the rotation of the ablation electrode 12 separates the occluder 11 from the ablation electrode 12. The guide wire 133 is divided into two parts at the proximal end of the catheter main body 14 extending into the operating handle 15, fixed at both sides near the outer wall of the operating handle, and provided with a sliding groove 155 and a sliding block 153 capable of sliding on the sliding groove 155 at the middle thereof, and provided with a stopper 158 at both sides of the sliding block 153 for preventing the sliding block 153 from moving left and right; the lead 133 is ultimately secured to the tail socket 156 and the irrigation tube 134 exits through an irrigation port 157 at the proximal end of the operating handle 15. The first pulling wire 131 is fixed to the distal end of the sliding block 153 by glue after entering the operating handle 15, and the second pulling wire 132 is fixed to the proximal end of the sliding block 153 by glue after entering the operating handle 15, passing through the through hole on the right side of the sliding block 153, and wrapping around the pulley 154. Thus, when the sliding block 153 moves downwards along the sliding groove 155, the first pulling wire 131 is pulled to generate a side bending shape, and when the sliding block 153 slides upwards along the sliding groove 155, the leather pulley 154 drives the second pulling wire 132 to tighten the second pulling wire 132 to generate another side bending shape, so that the double-side bending of the ablation catheter is realized. The length of the sliding groove 155 determines the stroke of the first and

second wires

131 and 132, and the bending degree of the bending type can be controlled.

The use method of the ablation catheter comprises the following steps: the operation handle 15 is controlled to enable the occluder 11, the ablation electrode 12, the deflectable section 13 and the catheter main body 14 to enter the human body and reach the tissue to be occluded; the tissue is blocked by using the blocking device 11; the knob 151 on the operation handle 15 is rotated to separate the occluder 11 from the ablation electrode 13, exposing the ablation electrode 11 and performing the ablation operation.

Referring to fig. 7a to 7c, a method for using the ablation catheter of the present invention is described in detail, as shown in fig. 7a, a left atrium 31 of a heart 30 is established by a puncture needle 20 and an introducer sheath 21 and is placed at the end of a left atrial appendage 32; as shown in fig. 7b, the ablation catheter enters the left atrium 31 through the guiding sheath 31 and further enters the left auricle 32, and gradually retreats from the guiding sheath 21 to release the occluder 11, thereby completing the occlusion of the left auricle 32; as shown in figure 7c, the ablation catheter and the occluder 11 are separated by rotating the operating handle, and the ablation electrode 12 is exposed, and the ablation operation can be continued by the ablation electrode 12.

In conclusion, the distal end of the ablation electrode is detachably connected with the occluder, after the occluder performs occlusion, the operation handle controls the occluder to be separated from the ablation electrode, the ablation electrode is exposed and then ablation is performed, so that occlusion and ablation can be simultaneously realized in one operation, and the ablation catheter has the advantages of simple processing technology, low cost, simple and convenient operation, and no great influence on the operation mode, the operation time and the like; the occluder is connected with the ablation electrode through threads or buckles, the knob is arranged in the operating handle, the inner surface of the knob is adhered to the outer surface of the catheter main body, and the catheter main body and the ablation electrode are rotated while the knob is rotated, so that the occluder is separated from the ablation electrode.

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

1. The utility model provides an ablation catheter, its characterized in that includes by near-to-far connected operating handle, catheter main part and ablation electrode, at the separable plugging device that is connected with of ablation electrode's distal end, the plugging device is including connecting the cap, the plugging device passes through connect the cap with ablation electrode distal end is connected, just operating handle with connect the cap and connect, control connect the cap follow break away from on the ablation electrode.

2. The ablation catheter of claim 1, wherein the occluder further comprises: sealing heads and metal woven meshes; the end socket and the connecting cap are respectively used for fixing two ends of the metal woven net to form a closed body.

3. The ablation catheter of claim 2, wherein the closure head and the connecting cap are disposed on the same axis.

4. The ablation catheter of claim 3, wherein said connecting cap is threadably connected to said ablation electrode, said connecting cap having internal threads and said ablation electrode having external threads.

5. The ablation catheter of claim 4, wherein the internal and external threads are each rectangular, serrated, triangular, or trapezoidal.

6. The ablation catheter of claim 4, wherein said ablation electrode has a length of 3mm to 6mm and said external thread has a length of 1mm to 4mm on said ablation electrode.

7. The ablation catheter of claim 3, wherein said connection cap is connected to said ablation electrode by a snap fit.

8. The ablation catheter of claim 7, wherein said snap is configured as an i-shape, a spherical shape, or a peanut shape.

9. The ablation catheter of claim 1, wherein said operating handle is provided with a knob, said knob being a hollow cylinder.

10. The ablation catheter as in claim 9, wherein the proximal end of the catheter body is passed into the operating handle, the outer surface of the catheter body is bonded to the inner surface of the knob, and the rotation of the knob drives the catheter body and the ablation electrode to rotate, so that the occluder is separated.

11. The ablation catheter of claim 1, further comprising a deflectable segment connected between said ablation electrode and said catheter body, said deflectable segment comprising a multi-lumen tube.

12. The ablation catheter of claim 11, wherein a first wire and a second wire are disposed in two symmetrical lumens of the multi-lumen tube, respectively, and distal ends of the first and second wires are connected to a proximal end of the ablation electrode.

13. The ablation catheter of claim 12, wherein said first and second leads each extend through the catheter body and into said operating handle; the first lead is fixed at the far end of a sliding block in the operating handle, and the second lead passes through a through hole at one side of the sliding block and is fixed at the near end of the sliding block after surrounding a leather pulley; the sliding block can slide up and down in the sliding groove, so that the first lead or the second lead is tensioned, and the bilateral bending of the ablation catheter is realized.