Bipolar ablation device

Abstract

The utility model belongs to the technical field of human body cavity energy ablation, and provides a bipolar ablation device which comprises an outer sheath tube, a first electrode and a second electrode. The insulating part is connected with the first ablation electrode at one end of the outer sheath tube; the puncture needle is arranged at one end of the insulating part, a second ablation electrode is arranged on the puncture needle, the polarity of the second ablation electrode is opposite to that of the first ablation electrode, and the outer sheath tube, the insulating part and the puncture needle are coaxially arranged. The first ablation electrode and the second ablation electrode which are opposite in polarity are arranged at one end of the outer sheath tube, ablation can be carried out without the help of a back polar plate, the situation that arc burn is caused due to the fact that the back polar plate is instably attached to the human body is avoided, meanwhile, the outer sheath tube, the insulating part and the puncture needle which are coaxially arranged do not need assistance of an endoscope, and the ablation efficiency is improved. In-vitro puncture can be directly achieved, operation is easy, and practicability is high.

Description

Technical Field

[0001] The utility model belongs to the technical field of human cavity energy ablation, in particular to a bipolar ablation device. Background Art

[0002] The existing ablation technique uses temperature ablation, which makes the tumor close to important tissues such as the gastrointestinal tract, bile duct, urethra, and nerves become ablation restricted areas, and the large blood vessels also affect the efficacy due to the heat sink effect. As a new treatment method, the only non-thermal ablation treatment technology, irreversible electroporation ablation technology, avoids the embarrassment of irreversible damage to adjacent tissue structures and the "heat sink effect" during surgery.

[0003] In the clinical treatment method of tumors using irreversible electroporation technology, electric pulses are used to ablate biological tissues. This is done by sending electric field pulses to the target cells, causing ions inside and outside the cells to move and gather on both sides of the outer membrane, causing a sharp change in the transmembrane potential. The cells undergo irreversible electroporation, breaking the balance inside and outside the cells and ultimately causing cell death.

[0004] Traditional ablation technologies are all monopolar designs. During the operation, a negative electrode plate needs to be attached to the patient's exposed skin to form a circuit. During the operation, the energy will pass through the diseased tissue and then through the human muscle tissue to reach the negative electrode plate. If the negative electrode plate is not firmly attached, resulting in insufficient contact, there will be a risk of arc burns. Utility Model Content

[0005] The utility model provides a bipolar ablation device, which not only avoids thermal damage to healthy tissue near the tumor tissue caused by traditional thermal ablation, but also does not need to set a back pole plate forming a loop outside the human body to prevent the risk of arc burns caused by loose bonding of the back pole plate and insufficient contact.

[0006] In order to achieve the above purpose, the utility model adopts the following technical solutions:

[0007] A bipolar ablation device, comprising:

[0008] An outer sheath tube has a first through passage, the outer sheath tube is a rigid structure, and a first ablation electrode is disposed at one end of the outer sheath tube;

[0009] An insulating member connected to a first ablation electrode at one end of the outer sheath;

[0010] A puncture needle is arranged at one end of the insulating member, and a second ablation electrode is arranged on the puncture needle, wherein the polarity of the second ablation electrode is opposite to that of the first ablation electrode, wherein the outer sheath, the insulating member and the puncture needle are coaxially arranged.

[0011] In some embodiments, the insulating member is made of ceramic material.

[0012] In some embodiments, the puncture needle is provided with a needle head and has conductive properties to form the second ablation electrode.

[0013] In some embodiments, the insulating member is provided with a first through hole, and the first through hole passes through two ends of the insulating member.

[0014] In some embodiments, the outer sheath has a conductive property, and a first insulating layer is provided on the outer sheath to cover the outer sheath, wherein a side of the outer sheath close to the insulating member is partially exposed to form the first ablation electrode.

[0015] In some embodiments, the outer surface area of ​​the first ablation electrode on the outer sheath is larger than the outer surface area of ​​the second ablation electrode on the puncture needle.

[0016] In some embodiments, a first wire is further included, wherein the first wire is disposed in the first channel, a second insulating layer is disposed on an outer surface of the first wire, and a first end of the first wire passes through the first through hole and is electrically connected to the second ablation electrode.

[0017] In some embodiments, a developing marker ring is further included, and the developing marker ring is located on the puncture needle.

[0018] In some embodiments, scale markings are further included, and the scale markings are evenly distributed from the puncture needle to the outer sheath.

[0019] In some embodiments, it further includes a limit block disposed on the outer sheath tube, the limit block is tightly fitted with the outer sheath tube, and the limit block can move axially relative to the outer sheath tube.

[0020] In some embodiments, an operating handle is further included, on which a grip is provided, and the outer sheath is fixedly connected to the operating handle.

[0021] In some embodiments, a second wire is further included, one end of which is connected to the outer sheath, and the other end of the second wire and one end of the first wire pass through the operating handle and are connected to an external energy generator.

[0022] Compared with the prior art, the beneficial effects brought by the utility model are:

[0023] The present application sets a first ablation electrode at one end of the outer sheath and a second ablation electrode on the puncture needle, wherein an insulating member is set between the first ablation electrode and the second ablation electrode for insulation to avoid short circuit, and the outer sheath, the insulating member and the puncture needle are coaxially arranged. During the operation, the tumor tissue is directly punctured without the need to attach a back plate to the human body to form a closed loop, thereby avoiding the risk of arc burns caused by insufficient contact between the back plate and the human body. At the same time, compared with traditional ablation catheters, the present application does not require the assistance of an endoscope for auxiliary operation, the product structure is simple and practical, and the operation process is not cumbersome.

[0024] Additional aspects and advantages of the present application will be partially given in the following description, which will become apparent from the following description, or will be understood through the practice of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 This is a general structural diagram of a bipolar ablation device of the utility model;

[0026] Figure 2 This is a schematic diagram of the connection structure of an outer sheath and a puncture needle of a bipolar ablation device of the utility model;

[0027] Figure 3 This is a three-dimensional structural diagram of a puncture needle of a bipolar ablation device of the utility model;

[0028] Figure 4 A schematic diagram of scale markings on an outer sheath of a bipolar ablation device of the utility model;

[0029] Figure 5 This is a schematic diagram of the puncture depth of a bipolar ablation device of the utility model;

[0030] Figure 6 It is a schematic diagram of the current flow direction of a bipolar ablation device of the utility model;

[0031] Figure 7 It is a cross-sectional view of a bipolar ablation device of the utility model. DETAILED DESCRIPTION

[0032] The present application is further described in detail below in conjunction with specific drawings. In the description of this embodiment, unless otherwise specified, the terms "left", "right", etc. indicate directions or positional relationships based on the directions or positional relationships shown in the drawings, which are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the present application must have a specific direction, be constructed and operated in a specific direction, and therefore cannot be understood as limiting the present application.

[0033] like Figure 1-2As shown, a bipolar ablation device provided by the utility model mainly includes an outer sheath 1, an insulating member 3 and a puncture needle 2. The outer sheath 1 has a first channel 12 that runs through both ends of the outer sheath 1, which has rigid characteristics and cannot be bent. A first ablation electrode 11 is arranged at one end of the outer sheath 1; the insulating member 3 is arranged at one end of the first ablation electrode 11 of the outer sheath 1, and is fixedly connected to the first ablation electrode 11 on the outer sheath 1; the puncture needle 2 is arranged at the end of the insulating member 3 away from the first ablation electrode 11, and a second ablation electrode 21 is arranged on the puncture needle 2, wherein it should be particularly noted that the polarities of the first ablation electrode 11 and the second ablation electrode 21 are opposite, that is, when the first ablation electrode 11 is in contact with the outer sheath 1, the second ablation electrode 21 is in contact with the outer sheath 1. When the first ablation electrode 11 is connected to the positive pole of the external energy generator, the second ablation electrode 21 is connected to the negative pole of the external energy generator. Conversely, when the first ablation electrode 11 is connected to the negative pole of the external energy generator, the second ablation electrode 21 is connected to the positive pole of the external energy generator. Since the ablation device in the present application directly enters the tumor tissue for ablation through extracorporeal puncture, in order to ensure that the puncture incision is small and the puncture process is smooth, the puncture needle 2, the insulating member 3 and the outer sheath 1 are coaxially arranged. At the same time, as a preferred embodiment, the outer diameters of the outer sheath 1, the insulating member 3 and the puncture needle 2 are the same.

[0034] The present invention provides a first ablation electrode 11 and a second ablation electrode 21 at one end of the outer sheath tube 1, and performs insulation treatment between the two through an insulating member 3 to form a pulse electric field. The puncture needle 2 penetrates into the tumor tissue, and the current forms a loop around the lesion. Figure 6 As shown, there is no need to flow through the human muscle tissue, which reduces the energy consumption caused by the impedance of the human body and improves the efficiency of the operation. At the same time, there is no need to stick a negative electrode plate on the exposed skin of the human body, which reduces the risk of burns on the patient's skin.

[0035] In one embodiment, the insulating member 3 is a ceramic member, which ensures good insulation performance between the first ablation electrode 11 and the second ablation electrode 21. On the one hand, since ceramic is a hard material, it can ensure the rigidity of the connection structure between the puncture needle 2 and the outer sheath 1 without affecting the puncture performance of the puncture needle 2. On the other hand, the ceramic material is harmless to the human body and does not affect the health of the operator. Optionally, the insulating member 3 can also be made of hard plastic, such as polyurethane material, unsaturated polyurethane or propylene resin.

[0036] In one embodiment, in order to facilitate the production and manufacture of the ablation device, reduce the difficulty of processing, and simplify the structure, in this embodiment, the puncture needle 2 has conductive properties and is provided with a needle head 22, which is made of metal material, thereby directly forming the second ablation electrode 21. At the same time, the puncture needle 2 made of metal material can ensure its puncture ability. Optionally, the puncture needle 2 can be made of hard plastic. In this case, it is necessary to separately set the second ablation electrode 21 on the puncture needle 2 for discharge to form a pulsed electric field.

[0037] In one embodiment, Figure 2 As shown, a first through hole is provided on the insulating member 3, and the first through hole 31 passes through both ends of the insulating member 3, thereby realizing energy transmission of the second ablation electrode 21. Specifically, in this embodiment, the external energy generator is connected to the second ablation electrode through the first wire 51, and one end of the first wire 51 is connected to the second ablation electrode 21 through the first channel 12 and the first through hole 31. In this embodiment, since the puncture needle 2 is made of metal material, the puncture needle 2 itself is a hollow structure, and a welding point 511 is provided inside it to realize the electrical connection between the second ablation electrode 21 and the first wire 51.

[0038] Furthermore, if Figure 2 and Figure 3 As shown, the insulating member 3 is embedded in the outer sheath 1 and the puncture needle 2, a snap-fit ​​notch 23 is provided on the puncture needle 2, and a snap-fit ​​boss is provided on the insulating member 3, so as to realize the connection between the puncture needle 2 and the insulating member 3. Furthermore, the outer diameter of the insulating member 3 is the same as that of the puncture needle 2, which ensures the structural strength and the smoothness of the puncture. The puncture needle 2 and the insulating member 3 can be fixed by gluing or interference fit. Similarly, the fixing method of the insulating member 3 and the outer sheath 1 is the same, so it will not be described in detail here.

[0039] In one embodiment, the outer sheath tube 1 has the performance of a conductor, and the outer sheath tube 1 is a pipe made of metal material. A first insulating layer 15 is provided on the outer sheath tube 1, and the first insulating layer 15 covers the outer sheath tube 1, wherein the portion of the outer sheath tube 1 close to the insulating member 3 is exposed to the outside to directly form the first ablation electrode 11. Preferably, the first insulating layer adopts a heat shrinkable tube, and the heat shrinkable tube can be fixed to the surface of the outer sheath tube by heat shrinking. Optionally, the outer sheath tube 1 can also be made of hard plastic, in which case an additional conductive metal material needs to be provided on the outer sheath tube 1 to form the first ablation electrode 11.

[0040] Furthermore, in order to ensure that the first ablation electrode 11 is in full contact with human tissue to form a stable circuit, the exposed portion of the first ablation electrode 11 needs to be larger, that is, the surface of the first ablation electrode 11 needs to be much larger than the surface of the second ablation electrode 21, so as to facilitate better contact with human tissue. At the same time, since in the present application, the puncture needle 2 is directly formed of a conductive metal material to form the second ablation electrode 21, in order to avoid the puncture needle 2 being too long, the surface area of ​​the second ablation electrode 21 needs to be reduced, so the length of the puncture needle 2 is correspondingly reduced, and when the tumor tissue is small, the puncture needle 2 is prevented from excessive puncture.

[0041] In one embodiment, it also includes the first wire 51 as mentioned above, and a second insulating layer is arranged on the outside of the first wire 51. Since the first wire 51 needs to pass through the first channel 12 of the outer sheath tube 1, and in the present application, the outer sheath tube 1 is made of metal material, a short circuit is avoided by setting a second insulating layer.

[0042] In one embodiment, in order to allow the operator to know the position of the puncture needle 2, a developing marker ring 24 is provided on the puncture needle 2. By providing the developing marker ring 24, the operator can observe the position of the puncture needle 2 in real time in combination with CT, thereby determining whether the puncture is in place. Specifically, the developing marker ring 24 is made of a platinum-iridium ring or barium sulfate.

[0043] Furthermore, when the device is used, a CT scan is first performed to determine the puncture layer and puncture point, and then the CT cursor is used to measure the straight-line distance (or the shortest distance) between the skin needle entry point and the lesion to determine the puncture depth and angle. Figure 4 As shown, the scale mark 14 on the outer sheath extends from the puncture needle 2 to one side of the outer sheath 1 and is evenly distributed, so that the operator can accurately puncture the puncture needle 2 into the tumor tissue to avoid excessive puncture or inadequate puncture. After multiple CT scans to confirm that the puncture needle 2 is in the lesion, the connecting line 5 of the ablation device is connected to the external energy generator, and then the energy is stimulated for ablation. The number of ablations is planned according to the size of the lesion. Do not perform ablation twice on the same site.

[0044] Further, in order to make the puncture depth 15 more accurate, as Figure 5 As shown, a limit block 13 is provided on the surface of the outer sheath tube 1, and the limit block 13 and the outer sheath tube 1 are tightly matched. When there is no external force, the limit block 13 is fixed. Under the action of external force, the limit block 13 can move axially relative to the outer sheath tube 1. When the operator determines the needle insertion depth and the needle insertion angle, the limit block 13 is adjusted to a preset position so that the measured needle insertion depth corresponds to the puncture depth 15 on the outer sheath tube, and the puncture position of the ablation device can be further fixed. Preferably, the limit block is made of an elastic rubber body. The length of the puncture needle 2 is fixed, and the length of the exposed part of the outer sheath tube 1 is also fixed. When the size of the tumor tissue is large, the puncture needle 2 cannot achieve one-time complete ablation during ablation. At this time, the needle must be withdrawn or inserted, and the position of the puncture needle 2 must be adjusted to achieve multiple ablations. The puncture depth 15 can be determined by moving the limit block 13.

[0045] In one embodiment, the ablation device further includes an operating handle 4 , on which a grip is provided. The outer sheath 1 is fixedly connected to the operating handle 4 , and the operator performs puncture by gripping the outer sheath 1 .

[0046] In one embodiment, Figure 7As shown, it also includes a second wire 52, one end of which is connected to the outer sheath tube 1. Specifically, a connecting ring 521 is provided on the second wire 52, and the connecting ring 521 is made of a conductive material. The second wire 52 is connected to the outer sheath tube 1 through the connecting ring 521 to increase the contact area and avoid virtual connection or missing connection. The other end of the second wire 52 passes through the operating handle 4 and is connected to the external energy generator. Specifically, the first wire 51 and the second wire 52 are formed into a connecting wire 1 by sheathing a thicker insulating sleeve, and are plugged and connected with the external energy generator.

[0047] The above is only a preferred embodiment of the present invention. It should be noted that a person skilled in the art can make several improvements and modifications without departing from the principle of the present invention. These improvements and modifications should also be considered as the protection scope of the present invention.

Claims

1. A bipolar ablation device, characterized in that: include: An outer sheath tube has a first through passage, the outer sheath tube is a rigid structure, and a first ablation electrode is disposed at one end of the outer sheath tube; An insulating member connected to a first ablation electrode at one end of the outer sheath; A puncture needle is arranged at one end of the insulating member, and a second ablation electrode is arranged on the puncture needle, wherein the polarity of the second ablation electrode is opposite to that of the first ablation electrode, wherein the outer sheath, the insulating member and the puncture needle are coaxially arranged.

2. A bipolar ablation device according to claim 1, characterized in that: The insulating member is made of ceramic material.

3. A bipolar ablation device according to claim 1, characterized in that: The puncture needle is provided with a needle head and has conductive properties to form the second ablation electrode.

4. A bipolar ablation device according to claim 2, characterized in that: The insulating member is provided with a first through hole, and the first through hole passes through two ends of the insulating member.

5. A bipolar ablation device according to claim 4, characterized in that: The outer sheath tube has a conductive property, and a first insulating layer is arranged on the outer sheath tube to cover the outer sheath tube, wherein a part of the outer sheath tube close to the insulating member is exposed to form the first ablation electrode.

6. A bipolar ablation device according to claim 5, characterized in that: The outer surface area of ​​the first ablation electrode on the outer sheath is larger than the outer surface area of ​​the second ablation electrode on the puncture needle.

7. A bipolar ablation device according to claim 4, characterized in that: It also includes a first wire, which is arranged in the first channel, a second insulating layer is provided on the outer surface of the first wire, and a first end of the first wire passes through the first through hole and is electrically connected to the second ablation electrode.

8. A bipolar ablation device according to claim 5, characterized in that: It also includes a developing marker ring, which is located on the puncture needle.

9. A bipolar ablation device according to claim 8, characterized in that: It also includes scale marks, which are evenly distributed from the puncture needle to the outer sheath tube.

10. A bipolar ablation device according to claim 9, characterized in that: It also includes a limit block arranged on the outer sheath tube, the limit block is tightly matched with the outer sheath tube, and the limit block can move relatively axially along the outer sheath tube.

11. A bipolar ablation device according to claim 7, characterized in that: It also includes an operating handle, on which a hand grip is provided, and the outer sheath is fixedly connected to the operating handle.

12. A bipolar ablation device according to claim 11, characterized in that: It also includes a second wire, one end of which is connected to the outer sheath tube, and the other end of the second wire and one end of the first wire pass through the operating handle and are connected to an external energy generator.

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