Radio frequency ablation operation electrode and preparation method thereof

Abstract

The invention discloses a radiofrequency ablation operation electrode and a preparation method thereof.The radiofrequency ablation operation electrode comprises an electrode needle and a thermocouple, and a hollow cavity is formed in the electrode needle; the hard sleeve is positioned in the hollow cavity and is arranged outside the thermocouple in a sleeving manner; and the filling body is filled in the hard sleeve and wraps the thermocouple. The hard sleeve is filled with the filling body and the thermocouple is wrapped by the filling body, so that the thermocouple is fixed in the hard sleeve. When the hard sleeve fixed with the thermocouple is inserted into the electrode needle, the hard sleeve is not easy to bend and deform, and the distance between the temperature measuring point of the thermocouple and the top of the inner layer of the needle point of the electrode needle can be accurately determined, so that the temperature measured by the thermocouple can reflect the temperature of the needle point of the electrode needle more accurately.

Description

Technical Field

[0001] The present invention relates to the technical field of ablation devices, and particularly to a radiofrequency ablation surgical electrode and a preparation method thereof. Background Art

[0002] As a minimally invasive thermal ablation technology, surgical electrodes have been widely used in the treatment of neurosurgery and pain medicine. The radiofrequency ablation technology mainly relies on a radiofrequency therapeutic instrument with ablation and cutting functions, and the treatment mechanism is mainly the thermal effect. The radiofrequency electrode includes components such as a temperature sensor, a discharge electrode, and a handle. The radiofrequency electrode is inserted into the relevant nerve site, and by adjusting parameters such as the radiofrequency thermocoagulation temperature, time, pulse width, voltage, and the output mode, the range of the lesion is precisely controlled to avoid unnecessary secondary injuries.

[0003] In the prior art, the thermocouple sensor is directly inserted into the hollow discharge electrode needle. Since the thermocouple wire is relatively soft, it is prone to bending during the process of inserting into the inner layer of the discharge electrode needle, and it is difficult to control the distance from the thermocouple temperature measurement point to the top of the inner layer of the needle tip, resulting in a relatively low accuracy of the detected temperature.

[0004] Therefore, the prior art still needs to be improved and developed. Summary of the Invention

[0005] The technical problem to be solved by the present invention is, in view of the above-mentioned defects of the prior art, to provide a radiofrequency ablation surgical electrode and a preparation method thereof, aiming to solve the problem in the prior art that it is difficult to control the distance from the thermocouple temperature measurement point to the top of the inner layer of the needle tip of the radiofrequency ablation surgical electrode, resulting in a relatively low accuracy of the detected temperature.

[0006] The technical solution adopted by the present invention to solve the technical problem is as follows:

[0007] A radiofrequency ablation surgical electrode includes: an electrode needle and a thermocouple, and a hollow cavity is formed in the electrode needle; wherein, the radiofrequency ablation surgical electrode further includes:

[0008] A rigid sleeve, which is located in the hollow cavity and sleeved outside the thermocouple;

[0009] A filling body, which is filled in the rigid sleeve and wraps the thermocouple.

[0010] The radiofrequency ablation surgical electrode as described above, wherein the electrode needle includes:

[0011] A handle;

[0012] A needle body, which is arranged at the front end of the handle;

[0013] A cable, which is arranged at the rear end of the handle;

[0014] Wherein, the hollow cavity is formed in the needle body;

[0015] The cable is electrically connected to the needle body;

[0016] The first lead of the thermocouple extends outside the filling body and is electrically connected to the cable.

[0017] The radiofrequency ablation surgical electrode described above, wherein the front end of the needle body is an arc-shaped needle tip, and the rear end of the needle body forms an opening;

[0018] The opening allows the rigid sleeve to pass through and insert into the hollow cavity.

[0019] The radiofrequency ablation surgical electrode described above, wherein the rear end of the rigid sleeve extends outside the opening;

[0020] A seal is provided at the opening for sealing the rear end of the rigid sleeve and the needle body.

[0021] The radiofrequency ablation surgical electrode described above, wherein the rear end of the needle body and the seal are wrapped by a wrapping member;

[0022] The rear end of the needle body is connected to a second lead and extends outside the wrapping member;

[0023] The second lead is electrically connected to the cable.

[0024] The radiofrequency ablation surgical electrode described above, wherein the outer wall of the rigid sleeve abuts against the inner wall of the hollow cavity.

[0025] The radiofrequency ablation surgical electrode described above, wherein the handle is made of a biocompatible insulating material;

[0026] The cable is a silicone shielded cable;

[0027] The positive electrode of the thermocouple is made of nickel-chromium alloy, and the negative electrode of the thermocouple is made of nickel-silicon alloy;

[0028] The needle body is made of medical stainless steel;

[0029] The electrode needle further includes:

[0030] A plug, which is electrically connected to the cable.

[0031] The radiofrequency ablation surgical electrode described above, wherein the filling body is made of insulating glue, and the rigid sleeve is made of rigid plastic.

[0032] A preparation method of the radiofrequency ablation surgical electrode according to any one of the above, which includes the steps:

[0033] Insert a thermocouple into a rigid sleeve, fill the rigid sleeve with a filling body, and wrap the thermocouple to obtain a rigid sleeve with a fixed thermocouple.

[0034] Insert the rigid sleeve with the fixed thermocouple into the hollow cavity of the electrode needle to obtain a radiofrequency ablation surgical electrode.

[0035] In the preparation method of the radiofrequency ablation surgical electrode, the distance between the thermocouple and the arc-shaped needle tip is determined according to the length of the rear end of the rigid sleeve extending outside the opening.

[0036] Beneficial effects: By filling the rigid sleeve with a filling body and wrapping the thermocouple, the thermocouple is fixed inside the rigid sleeve. When the rigid sleeve with the fixed thermocouple is inserted into the electrode needle, the rigid sleeve is not easily bent or deformed, and the distance between the temperature measurement point of the thermocouple and the inner top of the needle tip of the electrode needle can be accurately determined. Therefore, the temperature measured by the thermocouple can more accurately reflect the temperature of the needle tip of the electrode needle. Description of the Drawings

[0037] Figure 1 is a schematic structural diagram of a radiofrequency ablation surgical electrode in an embodiment of the present invention.

[0038] Figure 2 is a schematic structural diagram of a thermocouple in an embodiment of the present invention.

[0039] Figure 3 is a schematic structural diagram of a needle body in an embodiment of the present invention.

[0040] Figure 4 is a schematic structural diagram of a rigid sleeve in an embodiment of the present invention.

[0041] Figure 5 is a schematic structural diagram of a rigid sleeve with a fixed thermocouple in an embodiment of the present invention.

[0042] Figure 6 is a schematic structural diagram of a rigid sleeve with a fixed thermocouple installed on a needle body in an embodiment of the present invention.

[0043] Figure 7 is a schematic structural diagram of a needle body in an embodiment of the present invention.

[0044] Description of the Reference Numerals:

[0045] 10. Electrode needle; 11. Handle; 111. Electrode number silk screen; 12. Needle body; 121. Hollow cavity; 122. Opening; 123. Arc-shaped needle tip; 124. Seal; 125. Wrapping; 126. Second lead wire; 13. Cable; 20. Thermocouple; 21. Temperature measurement point; 22. First lead wire; 23. Positive electrode; 24. Negative electrode; 30. Rigid sleeve; 40. Filling body; 50. Plug. Detailed Embodiments

[0046] To make the objectives, technical solutions and advantages of the present invention clearer and more explicit, the following further elaborates on the present invention with reference to the accompanying drawings and by way of examples. It should be understood that the specific embodiments described herein are merely for explaining the present invention and not for limiting the present invention.

[0047] Please refer to Figures 1-7 simultaneously, and some embodiments of a radiofrequency ablation surgical electrode are provided by the present invention.

[0048] As Figure 1 and Figure 6 shown, the radiofrequency ablation surgical electrode of the present invention includes:

[0049] An electrode needle 10, within which a hollow cavity 121 is formed;

[0050] A thermocouple 20;

[0051] A rigid sleeve 30, which is located within the hollow cavity 121 and sleeved outside the thermocouple 20;

[0052] A filling body 40, which is filled within the rigid sleeve 30 and wraps the thermocouple 20.

[0053] Specifically, the electrode needle 10 is used for discharging, and the thermocouple 20 is used for detecting temperature. As Figure 2 shown, the thermocouple 20 includes a positive electrode 23 and a negative electrode 24. The connection point of the positive electrode 23 and the negative electrode 24 serves as a temperature measurement point 21. Usually, the positive electrode 23 and the negative electrode 24 are connected by welding. Both the positive electrode 23 and the negative electrode 24 are slender conductors, and the materials of the positive electrode 23 and the negative electrode 24 are different. Both the positive electrode 23 and the negative electrode 24 are flexible and prone to bending and deformation, while the rigid sleeve 30 is not easily bent and deformed.

[0054] As Figure 4 shown, the rigid sleeve 30 is a hollow tube with openings at both ends through which the thermocouple 20 can pass. The thermocouple 20 is not directly inserted into the electrode needle 10. Instead, a rigid sleeve 30 is sleeved outside the thermocouple 20, and the rigid sleeve 30 and the thermocouple 20 are filled and wrapped with a filling body 40 to fix the thermocouple 20 within the rigid sleeve 30 (as Figure 5 shown). When the rigid sleeve 30 with the thermocouple 20 fixed is inserted into the electrode needle 10, the rigid sleeve 30 is not easily bent and deformed, and the distance between the temperature measurement point 21 of the thermocouple 20 and the inner top of the tip of the electrode needle 10 can be accurately determined. Thus, the temperature measured by the thermocouple 20 can more accurately reflect the temperature of the tip of the electrode needle 10.

[0055] The connection point of the positive electrode 23 and the negative electrode 24 can be located outside the rigid sleeve 30, and the connection point of the positive electrode 23 and the negative electrode 24 does not contact the electrode needle 10. The filling body 40 also wraps the connection point of the positive electrode 23 and the negative electrode 24. The filling body 40 can be an insulating filling body, so that the thermocouple 20 is insulated from the electrode needle 10. The rigid sleeve 30 can also be an insulating sleeve to further improve the insulation effect between the thermocouple 20 and the electrode needle 10.

[0056] In a preferred implementation manner of the embodiment of the present invention, the filling body 40 is made of insulating glue.

[0057] Specifically, the filling body 40 can be made of insulating glue, for example, epoxy resin, polyester resin, etc.

[0058] In a preferred implementation manner of the embodiment of the present invention, the rigid sleeve 30 is made of rigid plastic.

[0059] Specifically, the rigid sleeve 30 is made of rigid plastic, for example, polycarbonate, polyamide, polyimide, polytetrafluoroethylene, acrylonitrile-butadiene-styrene copolymer, etc.

[0060] In a preferred implementation manner of the embodiment of the present invention, as Figure 1 and Figure 6 shown, the electrode needle 10 includes:

[0061] a handle 11;

[0062] a needle body 12 disposed at the front end of the handle 11;

[0063] a cable 13 disposed at the rear end of the handle 11;

[0064] wherein, a hollow cavity 121 is formed in the needle body 12; the cable 13 is electrically connected to the needle body 12; the first lead 22 of the thermocouple 20 extends outside the filling body 40 and is electrically connected to the cable 13.

[0065] Specifically, the needle body 12, the handle 11 and the cable 13 are connected in sequence. A hollow cavity 121 is formed in the needle body 12 to accommodate the rigid sleeve 30 fixed with the thermocouple 20. The handle 11 is for the user to hold by hand and is usually made of an insulator. The needle body 12 is a conductor and has electrical conductivity. The cable 13 has a discharge wire and a compensating wire, and the discharge wire and the compensating wire are independent of each other. The discharge wire is electrically connected to the needle body 12 and transmits electrical energy to the needle body 12. The compensating wire is electrically connected to the thermocouple 20 and transmits electrical energy to the thermocouple 20. The compensating wire is specifically connected to the first lead 22. There are two first leads 22, namely the first lead 22 of the positive electrode 23 and the first lead 22 of the negative electrode 24. The handle 11 adopts a taper design of 6:100 to be compatible with the puncture sleeve of the standard Luer connector. An electrode number silk screen 111 is formed on the handle 11.

[0066] In a preferred implementation of the embodiment of the present invention, the handle 11 is made of a biocompatible insulating material.

[0067] Specifically, the handle 11 is made of a biocompatible insulating material. Using a biocompatible material has the biological properties of not causing obvious clinical reactions and being able to withstand the effects of various host systems while remaining relatively stable, not being damaged or rejected. The biocompatible insulating material can be polyphenylsulfone (PPSU), bioceramics, etc.

[0068] In a preferred implementation of the embodiment of the present invention, the cable 13 is a silicone shielded cable.

[0069] Specifically, the cable 13 is a shielded cable, for example, a silicone shielded cable. The shielded cable includes an outer shield layer and an inner shield layer. The inner shield layer wraps the discharge trace, and the outer shield layer wraps the compensation wire and the inner shield layer.

[0070] In a preferred implementation of the embodiment of the present invention, the positive electrode 23 of the thermocouple 20 is made of nickel-chromium alloy, and the negative electrode 24 of the thermocouple 20 is made of nickel-silicon alloy.

[0071] Specifically, the thermocouple 20 can be a K-type thermocouple. The positive electrode 23 is made of nickel-chromium alloy (NiCr), and the negative electrode 24 is made of nickel-silicon alloy (NiSi).

[0072] In a preferred implementation of the embodiment of the present invention, the needle body 12 is made of medical stainless steel.

[0073] Specifically, the needle body 12 is made of medical stainless steel, for example, medical stainless steel SUS321 (1Cr18Ni9Ti).

[0074] In a preferred implementation of the embodiment of the present invention, as Figure 3 、 Figure 6 and Figure 7 shown, the front end of the needle body 12 is an arc-shaped tip 123, and the rear end of the needle body 12 forms an opening 122; the opening 122 allows the rigid cannula 30 to pass through and insert into the hollow cavity 121.

[0075] Specifically, the needle body 12 is a conductive needle body 12. The front end of the needle body 12 is an arc-shaped tip 123, specifically spherical crown-shaped. The front end of the needle body 12 is closed, and the rear end of the needle body 12 forms an opening 122. The opening 122 serves as the entrance of the hollow cavity 121, and the rigid cannula 30 is inserted into the hollow cavity 121 from the opening 122. For example, the rigid cannula 30 fixed with the electrode needle 10 can be inserted into the hollow cavity 121 from the opening 122.

[0076] In a preferred implementation of the embodiment of the present invention, asFigure 6 and Figure 7 As shown in Figure 7 , the rear end of the rigid cannula 30 extends outside the opening 122; a seal 124 is provided at the opening 122 for sealing the rear ends of the rigid cannula 30 and the needle body 12.

[0077] Specifically, the temperature measurement point 21 of the thermocouple 20 is located at the front end of the rigid cannula 30 and extends outside the rigid cannula 30. The rear end of the rigid cannula 30 extends outside the opening 122, the seal 124 seals the rear ends of the rigid cannula 30 and the needle body 12, and the seal 124 and the filling body 40 seal the entire opening 122.

[0078] In a preferred implementation manner of the embodiment of the present invention, as Figure 1 and Figure 7 shown in Figure 7 , the rear end of the needle body 12 and the seal 124 are wrapped by a wrapping member 125; a second lead wire 126 is connected to the rear end of the needle body 12 and extends outside the wrapping member 125; the second lead wire 126 is electrically connected to the cable 13.

[0079] Specifically, a wrapping member 125 is further disposed outside the rear end of the needle body 12 and the seal 124 to wrap the rear end of the needle body 12, the rear end of the rigid cannula 30, and the seal 124. A second lead wire 126 is connected to the rear end of the needle body 12, the connection position of the second lead wire 126 to the rear end of the needle body 12 is wrapped by the wrapping member 125, the second lead wire 126 extends outside the wrapping member 125, and is electrically connected to the cable 13.

[0080] In a preferred implementation manner of the embodiment of the present invention, as Figure 6 and Figure 7 shown in Figure 7 , the outer wall of the rigid cannula 30 abuts against the inner wall of the hollow cavity 121.

[0081] Specifically, the outer diameter of the rigid cannula 30 is slightly smaller than the inner diameter of the hollow cavity 121, and the rigid cannula 30 can be inserted into the hollow cavity 121 and abut against the inner wall of the hollow cavity 121.

[0082] In a preferred implementation manner of the embodiment of the present invention, as Figure 1 shown in Figure 1 , the electrode needle further includes:

[0083] A plug, electrically connected to the cable.

[0084] Specifically, a plug is connected to the rear end of the cable, and the plug can be inserted into a socket.

[0085] Based on the radiofrequency ablation surgical electrode described in any one of the above embodiments, the present invention further provides a preferred embodiment of a preparation method of a radiofrequency ablation surgical electrode:

[0086] The preparation method of the radiofrequency ablation surgical electrode according to the embodiment of the present invention includes the following steps:

[0087] Step S100: Insert a thermocouple into a rigid sleeve, fill a filler in the rigid sleeve, and wrap the thermocouple to obtain a rigid sleeve with the thermocouple fixed therein.

[0088] Step S200: Insert the rigid sleeve with the thermocouple fixed therein into the hollow cavity of the electrode needle to obtain a radiofrequency ablation surgical electrode.

[0089] Specifically, first insert the thermocouple into the rigid sleeve, and then fill the filler in the rigid sleeve. The filler can be cured, so as to fix the thermocouple in the rigid sleeve, and a rigid sleeve with the thermocouple fixed therein is obtained. Although the thermocouple may be deformed when inserted into the rigid sleeve, when the rigid sleeve with the thermocouple fixed therein is inserted into the hollow cavity, since the thermocouple is fixed in the rigid sleeve by the filler, the inner wall of the hollow cavity will not contact the thermocouple, and the thermocouple will not be deformed by force.

[0090] The distance between the thermocouple and the arc-shaped tip is determined according to the length that the rear end of the rigid sleeve extends outside the opening. Since the rear end of the rigid sleeve extends outside the opening, after the thermocouple is fixed, the position of the temperature measurement point of the thermocouple relative to the rigid sleeve is fixed. The distance between the arc-shaped tip and the thermocouple (for example, the temperature measurement point of the thermocouple) is related to the depth of insertion of the rigid sleeve into the hollow cavity. The more the part of the rigid sleeve inserted into the hollow cavity, the smaller the distance between the arc-shaped tip and the thermocouple. The length that the rear end of the rigid sleeve extends outside the opening can reflect the depth of insertion of the rigid sleeve into the hollow cavity. The longer the length that the rear end of the rigid sleeve extends outside the opening, the less the part of the rigid sleeve inserted into the hollow cavity, and the greater the distance between the arc-shaped tip and the thermocouple. Therefore, the distance between the thermocouple and the arc-shaped tip can be determined according to the length that the rear end of the rigid sleeve extends outside the opening.

[0091] Step S200 specifically includes:

[0092] Step S210: Insert the rigid sleeve with the thermocouple fixed therein into the hollow cavity of the needle body.

[0093] Step S220: Form a seal at the opening to seal the rear ends of the rigid sleeve and the needle body.

[0094] Step S230: Form a wrapping piece at the rear end of the needle body to wrap the rear end of the needle body and the seal.

[0095] Step S240: Connect the cable with the first lead and the second lead.

[0096] Step S250: Assemble the needle body on the handle to obtain a radiofrequency ablation surgical electrode.

[0097] Specifically, after inserting the rigid sleeve fixed with the thermocouple into the hollow cavity of the needle body, determine the length of the rear end of the rigid sleeve extending outside the opening, form a seal at the opening, and further form a wrapper. Connect the cable (the cable can be a cable connected with a plug) to the first lead and the second lead respectively to obtain the needle body connected with the cable. Finally, assemble the needle body connected with the cable in the handle and fix it with insulating glue, then the radiofrequency ablation surgical electrode is obtained.

[0098] It should be understood that the application of the present invention is not limited to the above examples. For those of ordinary skill in the art, improvements or transformations can be made according to the above description, and all such improvements and transformations should fall within the protection scope of the appended claims of the present invention.

Claims

1. A radiofrequency ablation surgical electrode, comprising: An electrode needle and a thermocouple, wherein a hollow cavity is formed in the electrode needle; characterized in that the radiofrequency ablation surgical electrode further comprises: A hard sleeve, the hard sleeve is located in the hollow cavity and sleeved outside the thermocouple; A filling body is filled in the hard sleeve and wraps the thermocouple.

2. The radiofrequency ablation electrode according to claim 1, characterized in that: The electrode needle comprises: handle; A needle body, arranged at the front end of the handle; A cable, disposed at the rear end of the handle; Wherein, the hollow cavity is formed in the needle body; The cable is electrically connected to the needle body; The first lead wire of the thermocouple extends out of the filling body and is electrically connected to the cable.

3. The radiofrequency ablation electrode according to claim 2, characterized in that: The front end of the needle body is an arc-shaped needle tip, and the rear end of the needle body forms an opening; The opening allows the hard sleeve to pass through and be inserted into the hollow cavity.

4. The radiofrequency ablation electrode according to claim 3, characterized in that: The rear end of the hard sleeve extends outside the opening; A sealing member is provided at the opening for sealing the hard sleeve and the rear end of the needle body.

5. The radiofrequency ablation electrode according to claim 4, characterized in that: The rear end of the needle body and the sealing member are wrapped by a wrapping member; The rear end of the needle body is connected to a second lead wire and extends out of the wrapping member; The second lead is electrically connected to the cable.

6. The radiofrequency ablation electrode according to claim 2, characterized in that: The outer wall of the hard sleeve abuts against the inner wall of the hollow cavity.

7. The radiofrequency ablation electrode according to claim 2, characterized in that: The handle is made of biocompatible insulating material; The cable is a silicone shielded cable; The positive electrode of the thermocouple is made of nickel-chromium alloy, and the negative electrode of the thermocouple is made of nickel-silicon alloy; The needle body is made of medical stainless steel; The electrode needle also includes: A plug is electrically connected to the cable.

8. The radiofrequency ablation electrode according to any one of claims 1 to 7, characterized in that: The filler is made of insulating glue, and the hard sleeve is made of hard plastic.

9. A method for preparing a radiofrequency ablation electrode according to any one of claims 1 to 8, characterized in that: Includes steps: Inserting a thermocouple into a hard sleeve, and filling a filling body in the hard sleeve and wrapping the thermocouple to obtain a hard sleeve with a thermocouple fixed thereon; The hard sleeve fixed with the thermocouple is inserted into the hollow cavity of the electrode needle to obtain a radiofrequency ablation electrode.

10. The method for preparing a radiofrequency ablation electrode according to claim 9, characterized in that: The distance between the thermocouple and the arc-shaped needle tip is determined according to the length from the rear end of the hard sleeve to the outside of the opening.

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