RADIOFREQUENCY ABLATION CATHETER HAVING MESHED TUBULAR STENT STRUCTURE AND AN APPARATUS THEREOF
20170224415 · 2017-08-10
Inventors
- Yonghua DONG (Shanghai, CN)
- Meijun SHEN (Shanghai, CN)
- Liang JI (Shanghai, CN)
- Zhengmin SHI (Shanghai, CN)
Cpc classification
A61B2018/00916
HUMAN NECESSITIES
A61B2018/1467
HUMAN NECESSITIES
A61B2018/00214
HUMAN NECESSITIES
International classification
Abstract
A radiofrequency ablation catheter having a meshed tubular stent structure and an apparatus thereof, include a meshed tubular stent disposed at a front end of the catheter. The meshed tubular stent comprises and including a meshed tube (1). Both ends of the meshed tube are tapered to form a distal end and a proximal end of the meshed tubular stent. The intermediate segment of the meshed tubular stent has a contracted state and an expanded state. One or more electrodes (2) are fixed onto the intermediate segment. The radiofrequency ablation catheter has improved flexibility and provides great coverage for the blood vessels with different thicknesses and curves. When the meshed tubular stent expands in the blood vessels having different thicknesses of 4-12 mm, all of the electrodes (2) contact the walls. Moreover, when the meshed tubular stent expands in the curved blood vessels, all of the electrodes are ensured to contact the walls.
Claims
1. A radiofrequency ablation catheter having a meshed tubular stent structure, comprising: a meshed tubular stent disposed at a front end of the catheter and including a meshed tube, wherein both ends of the meshed tube are tapered to form a distal end and a proximal end of the meshed tubular stent, an intermediate segment of the meshed tubular stent has a contracted state and an expanded state, and one or more electrodes are fixed on at least one filament of the intermediate segment of the meshed tubular stent.
2. The radiofrequency ablation catheter as claimed in claim 1, wherein before assembly, the meshed tube is shaped to have an intermediate cylinder, both ends of which are tapered; and after assembly, the meshed tube is shaped into an cylinder.
3. The radiofrequency ablation catheter as claimed in claim 1, wherein before assembly, the meshed tube is shaped into an cylinder; and after assembly, the meshed tube is shaped into a round drum body which has an intermediate convex and both naturally tapered ends.
4. The radiofrequency ablation catheter as claimed in claim 1, further comprising: a radiofrequency line and a thermocouple wire disposed inside each of the electrodes, wherein the radiofrequency line, the thermocouple wire and the filament are independent wire materials; or a portion of the filament has a function of the radiofrequency line; or the radiofrequency line and the thermocouple wire are made into one wire.
5. The radiofrequency ablation catheter as claimed in claim 1, wherein axial projections of a plurality of the electrodes in an axial direction of the meshed tubular stent do not overlap each other.
6. The radiofrequency ablation catheter as claimed in claim 1, wherein a plurality of the electrodes are arranged in a straight line or staggered in a plurality of straight lines on an expansion diagram of a circumferential surface of the meshed tube.
7. The radiofrequency ablation catheter as claimed in claim 1, wherein the both ends of the meshed tube are provided with a first connecting tube and a second connecting tube; the meshed tubular stent further includes a central drawing filament disposed along a central axis thereof, wherein one end of the central drawing filament is fixed on the first connecting tube disposed at the distal end of the meshed tubular stent, or the central drawing filament penetrates through the first connecting tube and is confined outside the first connecting tube; the other end of the central drawing filament penetrates through an inside of the meshed tubular stent and then through a center of the second connecting tube disposed at the proximal end of the meshed tubular stent; the central drawing filament is configured to axially draw the meshed tubular stent relative to the second connecting tube, and the central drawing filament is configured to slide toward the distal end of the meshed tubular stent relative to the second connecting tube.
8. The radiofrequency ablation catheter as claimed in claim 7, wherein the proximal end of the meshed tubular stent is connected to a multi-hole tube, wherein one end of the central drawing filament is fixed on the distal end of the meshed tubular stent, or the central drawing filament is confined outside the distal end of the meshed tubular stent, and thus configured to freely slide relative to the distal end of the meshed tubular stent; wherein the other end of the central drawing filament penetrates through a central hole of the multi-mole tube; a radiofrequency line, a thermocouple wire and the filament are disposed inside each of the electrodes; both ends of the electrodes are fixed on the meshed tubular stent; one end of the thermocouple wire and one end of the radiofrequency line are fixed inside the electrode; and the other end of the thermocouple wire and the other end of the radiofrequency line penetrate through a corresponding hole in the multi-hole tube and then are connected to an external device.
9. The radiofrequency ablation catheter as claimed in claim 1, wherein an opening is disposed on a circumference of each of the electrode.
10. The radiofrequency ablation catheter as claimed in claim 1, wherein the meshed tube is woven and formed by one single of the filament or a plurality of the filaments; or the meshed tube is processed and formed by a metal material or a polymer material.
11. A radiofrequency ablation apparatus, comprising a radiofrequency ablation catheter as claimed in claim 1, and a control handle and a radiofrequency ablation main machine, both connected to the radiofrequency ablation catheter.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0038] The technical contents of the present invention are described in detail with reference to the accompanying drawings and the specific examples. For convenience, the end close to the operator (away from the ablation site) is referred to as the proximal end, and the end away from the operator (close to the ablation site) is referred to as the distal end.
[0039] As shown in
[0040] In the following, two meshed tubular stents, in which a meshed tube 1 first undergoes a shaping process and subsequently is assembled, are taken as examples. The structures of the meshed tubular stents of the radiofrequency ablation catheters provided in the present invention and the contact thereof with the walls are described. In the first embodiment, before the meshed tubular stent is assembled, the meshed tube is shaped to have an intermediate cylinder, the both ends of the meshed tube are tapered, and the intermediate segment and the ends are connected at an oblique angle between 10° and 90°, and have arc transition, as shown in
First Embodiment
[0041] As shown in
[0042]
[0043] The radiofrequency ablation catheter also includes thermocouple wires 6 and radiofrequency lines 7 disposed inside each electrode 2. When meshed tube 1 is woven using a single filament, a single nickel-titanium filament, a stainless steel filament, or other filamentary material (e.g., medical polymer material) can be used to independently weave a scaffold, and the thermocouple wires 6 and the radiofrequency lines 7 are disposed on the scaffold. The filaments, the radiofrequency lines 7 and the thermocouple wires 6 can be separate wire materials, and the thermocouple wire 6 and the radiofrequency lines 7 are respectively wound with the meshed tubular stent. The mesh filaments, the radiofrequency lines 7 and the thermocouple wire 6 have their own functions. Alternatively, the thermocouple wires 6 and the radiofrequency lines 7 can also be made into a single wire. The radiofrequency line 7 and thermocouple wire 6 are integrated, and subsequently wounded with the meshed tubular stent.
[0044] When the meshed tube 1 is woven using multiple filaments, the meshed tube 1 can be directly woven using multiple filaments as described above, and the thermocouple wire 6 and the radiofrequency line 7 are disposed on the meshed tube 1, or some of the filaments (i.e. the mesh filaments used for fixing the electrodes 2) are replaced with the radiofrequency lines 7 (or the same wire materials including the radiofrequency lines 7 and the thermocouple wires 6), so that some of the filaments have the function of the radiofrequency lines, and the meshed tube 1 is woven and formed using the multiple radiofrequency lines 7 and the remaining multiple filaments together. When the meshed tube 1 is woven using multiple radiofrequency lines 7 and multiple filaments, after the meshed tube 1 is woven, the thermocouple wires 6 can be wound with the radiofrequency line 7, and the multiple electrodes 2 are fixed to the radiofrequency lines 7 in the meshed tube 1. Certainly, when the meshed tube 1 is woven using multiple filaments, multiple radiofrequency lines 7 and multiple filaments may be wound together as a single braided wire, and the meshed tube 1 is woven and formed using the aforementioned braided wires and other filaments together, that is to say, the meshed tubular stent is not limited to the structure of the meshed tube woven by a single filament, and other structural alternations are possible.
[0045] In the practical manufacture of the meshed tubular stent, it is required for each mesh filament (or radiofrequency line) to be insulated. An insulation layer is directly formed on the mesh filament. Alternatively, after the electrodes are fixed on the mesh filaments, the rest parts of the filaments excluding the electrodes are insulated. One or more electrodes may or may not be fixed on each filament used to form the meshed tubular stents. For example, when the meshed tube, whose cross section includes 24 filaments, is woven using 12 filaments, by respectively disposing an electrode on 6 filaments thereof, the meshed tubular stent having a high strength can be formed, and the distribution of 6 electrodes on the meshed tubular stent does not cause excessive ablation. For another example, when the meshed tube whose cross section includes 6 filaments is woven using 2 filaments, by respectively disposing 6 electrodes on each filament, the meshed tubular stent in which 12 electrodes are evenly distributed on the outer surface of the meshed tube. For preventing the electrodes from excessively ablating the walls of the blood vessels, during disposing the multiple electrodes on the meshed tubular stent, the projections of a plurality of the electrodes in the axial direction of the meshed tubular stent preferably do not overlap each other.
[0046]
[0047]
[0048] As shown in
[0049] In addition, for controlling the contraction or the expansion of the meshed tubular stent in the blood vessels, a central drawing filament 3 is also disposed in the meshed tubular stent. In the first embodiment, one end of the central drawing filament 3 is fixed on the first connecting tube disposed at the distal end of the meshed tubular stent, and the other end penetrates through the inside of the meshed tubular stent and then through the second connecting tube 5 disposed at the proximal end of the meshed tubular stent. Moreover, the central drawing filament 3 extends through the central hole of the multi-hole tube 8 connected with the proximal end of the meshed tubular stent to the control handle disposed at the end of the catheter. The central drawing filament 3 is configured to draw the meshed tubular stent in the axial direction relative to the second connecting tube 5 and the multi-hole tube 8 under an external force. When the meshed tubular stent in the blood vessel is compressed by the wall of the blood vessel to undergo contractive deformation, the central drawing filament 3 automatically slides, the length of the meshed tube 1 is lengthened, and the outer diameter is reduced. When the central drawing filament 3 is drawn back from the outside of the catheter, the meshed tubular stent expands, the length of the meshed tube 1 is shortened, and the outer diameter is increased, so that a plurality of electrodes contact the wall of the blood vessel having a large diameter. When the central drawing filament 3 is pushed forward from the outside of the catheter, the meshed tubular stent contracts, thereby moving the location of the meshed tubular stent within the blood vessel or withdrawing the meshed tubular stent from the blood vessel to the outside of the body. During the movement, damage caused by the meshed tubular stent to the walls of the blood vessels is avoided.
[0050] The flexibility of the meshed tubular stent in the first embodiment provided by the present invention is now described with reference to
[0051] As the collapsed meshed tubular stent after protruding from the sheath naturally expands, as shown in
[0052] Furthermore, the radiofrequency ablation catheter further includes a multi-hole tube 8. The multi-hole tube 8 is connected with the proximal end of the meshed tubular stent (i.e., connected with the second connecting tube 5). One end of the central drawing filament 3 disposed in the meshed tubular stent is fixed at the distal end of the meshed tubular stent. The other end penetrates through the proximal end of the meshed tubular stent and the central hole of the multi-mole tube 8, extends to the outside of the catheter and is connected with the control handle. A thermocouple wire 6, a radiofrequency line 7, and a filament are disposed inside each electrode 2, both ends of the electrodes 2 are fixed on the filaments of the meshed tube, one end of the thermocouple wire and one end of the radiofrequency line are fixed inside the electrode 2, and the other end of the thermocouple wire 6 and the other end of the radiofrequency line 7 penetrate through a corresponding hole in the multi-hole tube 8 and then are connected to an external device. Since the coverage of the meshed tubular stent for the blood vessels having different diameter is improved, the same radiofrequency ablation catheter having the aforementioned meshed tubular stent can be used for radiofrequency ablation in different patients.
[0053] Meanwhile, the meshed tubular stent provided in the present invention has excellent adaptability to the curved blood vessels. After the meshed tubular stent is expanded and contacts the wall of the curved blood vessel, the whole meshed tubular stent is configured to be bent and adapted to the shape of the blood vessel. A plurality of electrodes disposed on the intermediate segment simultaneously contact the wall. In this embodiment, the effect of contact with the wall of the curved blood vessel is not shown, but the adaptability of the meshed tubular stent provided by the present invention can be understood in accompaniment with the effect diagram of the second embodiment.
Second Embodiment
[0054] As shown in
[0055] In this embodiment, the central drawing filament is disposed in a manner different from that in the first embodiment. As shown in
[0056] Moreover, in the second embodiment, as shown in
[0057] Since the shape of the meshed tube before assembly and the arrangement of the central drawing filament in the second embodiment are different from those of the meshed tube in the first embodiment, and the rest of the configurations are the same as those in the first embodiment, the specific configurations are not described in detail herein. In the following, the flexibility of the meshed tubular stent provided in the second embodiment in the blood vessels having different diameters and in the curved blood vessels is described based upon the specific simulation experiment.
[0058]
[0059] When the meshed tubular stent is expanded within the thin blood vessel, a plurality of electrodes disposed on the intermediate segment ensure the effective contact with the wall during the natural expansion process, as shown in
[0060] It is explained herein that
Third Embodiment
[0061] In the meshed tubular stent provided in the first embodiment and the second embodiment, the meshed tube undergoes a shaping process before assembly. In the third embodiment provided in the present invention, the meshed tube does not undergo any specific shaping process before the meshed tube is assembled into the meshed tubular stent. When the radiofrequency ablation catheter protrudes from the sheath, the meshed tubular stent cannot expand spontaneously, but it is ensured that a plurality of electrodes disposed on the intermediate segment simultaneously contact the wall by drawing the central drawing filament. Furthermore, after the meshed tubular stent is expanded and contacts the wall, the axial projections of a plurality of electrodes in the axial direction of the meshed tubular stent do not overlap each other, and the circumferential projections of a plurality of electrodes are evenly distributed over the circumferential cross section of the meshed tubular stent.
[0062] The radiofrequency ablation catheter provided in the present invention is described above. The present invention also provides a radiofrequency ablation apparatus including the radiofrequency ablation catheter described above. In addition to the radiofrequency ablation catheter described above, the radiofrequency ablation apparatus includes a control handle and a radiofrequency ablation catheter main machine, both connected to the radiofrequency ablation catheter. The central drawing filament in the meshed tubular stent is connected to the control handle through the multi-hole tube, and the control handle may control the radiofrequency ablation catheter to move forward, move backward, and turn. The radiofrequency lines and the thermocouple wires in the meshed tubular stent are connected to the corresponding circuit in the radiofrequency ablation catheter main machine respectively via the multi-hole tube, thereby realizing the radiofrequency control and the temperature monitoring of the radiofrequency ablation catheter main machine for a plurality of electrodes. The setting of the control handle and the setting of the radiofrequency ablation catheter main machine can be seen in the patents previously applied for and filed by the applicant, and the specific structure thereof is not described in detail herein.
[0063] In actual clinical treatment, the radiofrequency ablation catheter and the radiofrequency ablation apparatus provided in the present invention can be applied to nerve ablation in different parts, the blood vessels, or the trachea having different diameters: for example, nerve ablation in the renal artery for treating patients with refractory hypertension, nerve ablation in the celiac artery for treating patients with diabetes, for example, the ablation of the tracheal / bronchial vagal nerve branch for treating patients with asthma, the ablation of the duodenum vagus nerve branch for treating patients with duodenal ulcer, and, in addition, nerve ablation in other blood vessels in the renal pelvis, the pulmonary artery or the trachea. It should be noted that the radiofrequency ablation catheter provided in the present invention is not limited to the aforementioned applications in clinical treatments, but can also be used for nerve ablation at other sites.
[0064] In summary, since in the radiofrequency ablation catheter provided in the present invention, a meshed tube woven by a single filament or multiple filaments is used, and the electrodes, which have a plurality of arrangement forms in the expanded state to meet specific requirements, are disposed on the circumferential surface of the meshed tube, when the meshed tubular stent is expanded in the blood vessels having different diameters, a plurality of electrodes all effectively contact the wall. The meshed tubular stent has improved flexibility and wide coverage for the blood vessels having different diameters, which can meet the requirements of the radiofrequency ablation for the blood vessels of at least 4-12 mm. Moreover, the meshed tubular stent also has effective coverage for the curved blood vessels. Therefore, the radiofrequency ablation catheter provided in the present invention and the radiofrequency ablation apparatus including the aforementioned radiofrequency ablation catheter have wide coverage for nerve ablation operations in different patients.
[0065] The radiofrequency ablation catheter having meshed tubular stent structure and the device thereof provided by the present invention have been described in detail. A person of ordinary skill in the art who makes any obvious change to this invention without departing from the substantial spirit of the present invention will commit a violation of the patent rights of this prevent invention, and will take the corresponding legal responsibilities.