WO2020253632A1 - 一种脊柱经皮穿刺等离子体手术刀头及其操作方法 - Google Patents

一种脊柱经皮穿刺等离子体手术刀头及其操作方法 Download PDF

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WO2020253632A1
WO2020253632A1 PCT/CN2020/095876 CN2020095876W WO2020253632A1 WO 2020253632 A1 WO2020253632 A1 WO 2020253632A1 CN 2020095876 W CN2020095876 W CN 2020095876W WO 2020253632 A1 WO2020253632 A1 WO 2020253632A1
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Prior art keywords
plasma scalpel
plasma
scalpel head
ablation
electrode
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PCT/CN2020/095876
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English (en)
French (fr)
Inventor
卢艳丽
李永磊
王元利
王庆普
田志军
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北京市隆福医院
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Priority to US17/596,761 priority Critical patent/US20220313339A1/en
Publication of WO2020253632A1 publication Critical patent/WO2020253632A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/042—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating using additional gas becoming plasma
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00059—Material properties
    • A61B2018/00089—Thermal conductivity
    • A61B2018/00101—Thermal conductivity low, i.e. thermally insulating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00339—Spine, e.g. intervertebral disc
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A61B2018/00583—Coblation, i.e. ablation using a cold plasma
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00964—Features of probes

Definitions

  • This application relates to the technical field of plasma scalpels, in particular to a spinal percutaneous puncture plasma scalpel head and an operating method thereof.
  • the low-temperature plasma surgery system uses the electric field and the knife head to excite the conductive liquid at the front end of the knife head to the plasma state, and applies a corresponding voltage to the plasma according to different working conditions.
  • the charged particles in it have a certain kinetic energy to interrupt the target tissue and make it in Cracking at the molecular level produces vaporization, cutting, ablation and hemostasis effects. Since the electric field does not directly act on the tissue, excess heat can be avoided, thereby minimizing the thermal damage to the surrounding normal tissues.
  • the current plasma surgical blade still has the defect that it cannot continuously generate a large amount of plasma. This defect increases the difficulty of nucleus pulposus ablation, which will bring great uncertainty to the operation and increase the risk of the operation. hardly produce complications and so on.
  • the plasma scalpel heads in the prior art are mostly made of platinum, and most of the plasma scalpel heads have complex structures and high costs; in addition, many plasma scalpel heads There is a one-time restriction, which causes the high price of the plasma surgical blade and the limited number of uses.
  • the embodiments of the present application aim to provide a spinal percutaneous puncture plasma scalpel head and its operating method to solve the problem that the existing spinal percutaneous puncture plasma scalpel head and plasma scalpel use expensive Technical problems such as the platinum material blade, the complicated structure of the scalpel, and the high cost.
  • the plasma scalpel head includes a needle core; the needle core includes a main ablation electrode and a needle core body; the main ablation electrode is arranged on the plasma scalpel head Ablation end; the needle core body is provided with a first insulating layer of the same length as the needle core body; the first insulating layer is provided with a reflow electrode layer; the length of the reflow electrode layer is less than the length of the first insulating layer, on the first insulating layer The part that is not covered with the reflow electrode layer is to form an ablation electrode protection insulating ring;
  • the reflow electrode layer is provided with a second insulating layer smaller than its length, and the portion of the reflow electrode layer that is not covered with the second insulating layer forms a reflow electrode.
  • the length of the main ablation electrode protection insulating ring is 1 to 1.5 mm; the angle between the main ablation electrode and the needle core body is 10 to 15°.
  • the core material of the plasma scalpel head is stainless steel; the shape of the ablation end of the main ablation electrode is cylindrical.
  • the core material of the plasma scalpel head is tungsten steel; the shape of the ablation end of the main ablation electrode is a cylinder.
  • the surface area ratio of the main ablation electrode and the return electrode of the plasma scalpel is 1:3 to 1:7.
  • both the first insulating layer and the second insulating layer are made of plastic insulating layers.
  • a plasma scalpel kit for spinal percutaneous puncture is characterized in that the plasma scalpel kit is used in conjunction with the plasma scalpel head of any one of claims 1 to 6, and the plasma scalpel kit includes a puncture A needle core and a puncture needle sheathed on the outside of the puncture needle core; the puncture component is used for puncturing and inserting into the diseased part of the spine.
  • the application also discloses an operating method of a plasma scalpel head for spinal percutaneous puncture, using the above-mentioned plasma scalpel head and plasma scalpel kit, and the operation method of the plasma scalpel head includes the following step:
  • Step S1 Use the puncture assembly to insert the diseased disc, and then introduce the plasma scalpel head into the nucleus pulposus from the puncture needle;
  • Step S2. Lock the plasma scalpel head and the puncture needle, and rotate the core of the plasma scalpel head 360° to form a first cone ablation zone; the first ablation zone and surrounding nucleus pulposus tissue are vaporized and ablated by the main ablation electrode , To achieve disc decompression and disc formation.
  • the operation method of the plasma scalpel head for percutaneous spinal puncture further includes step S3.
  • step S3 the puncture needle and the plasma scalpel head are retracted by 1 to 2 mm, and the needle core of the plasma scalpel head is rotated 360 °, forming a second cone ablation zone; the second ablation zone and surrounding nucleus pulposus tissue are vaporized and ablated by the main ablation electrode to achieve disc decompression and disc formation.
  • step S4 the puncture needle and the plasma scalpel head are returned by 1 to 2 mm again, and the core of the plasma scalpel head is rotated. 360°, a third cone ablation zone is formed. The third cone ablation zone and surrounding nucleus pulposus tissue are ablated and vaporized by the main ablation electrode to realize disc decompression and disc formation.
  • the first insulating layer is directly arranged outside the needle core, and the return electrode layer is arranged outside the first insulating layer.
  • the first insulating layer and the return electrode form a main ablation electrode protection insulating ring near the ablation end.
  • the main ablation electrode isolates the main ablation electrode and the return electrode to form a certain protective distance, thereby ensuring that the main ablation electrode emits plasma normally;
  • the existing plasma scalpel is provided with a first insulating layer and a second insulating layer outside the needle core And a third insulating layer, and an insulating ring and a heating part need to be separately arranged between the main ablation electrode and the reflow electrode, which results in a very complicated structure and high cost, which is not conducive to mass production.
  • This application controls the angle between the main ablation electrode and the needle core body to be between 10 and 15°.
  • the plasma scalpel head is rotated 360°, and the plasma scalpel The rotation trajectory of the head can form a conical plasma ablation zone.
  • This design can not only increase the ablation range of the cervical nucleus pulposus and reduce the pressure in the cervical nucleus pulposus, but also avoid multiple introduction of plasma scalpel heads in different directions and reduce
  • the operation time also reduces the patient's pain, and at the same time can ensure the efficient work of the spinal percutaneous plasma surgery.
  • FIG. 1 is a front view of the plasma scalpel head for spinal percutaneous puncture provided in Example 1 of the application;
  • Fig. 2 is a schematic diagram of the structure of the spinal percutaneous plasma scalpel blade provided in Example 1 of the application.
  • the plasma scalpel head includes a needle core; the needle core includes a main ablation electrode 1 and a needle core body; the main ablation electrode 1 is the ablation end of the plasma scalpel head; the needle core body is provided with a first insulating layer 4 of the same length as the needle core body; the first insulating layer 4 is provided with 5 reflow electrode layers; 5 reflow electrode layers The length is smaller than the length of the first insulating layer 4.
  • the part of the first insulating layer 4 that is not covered with the reflow electrode layer 5 is the main ablation electrode protection insulating ring 2; the reflow electrode layer 5 is provided with a second insulating layer smaller than its length 6. The part of the reflow electrode layer 5 that is not covered with the second insulating layer 6 is the reflow electrode layer 5.
  • the plasma scalpel head includes a needle core and a three-layer structure arranged outside the needle core.
  • the needle core includes an integrally formed main ablation electrode 1 and a needle core body.
  • the main ablation electrode 1 is the ablation end of the plasma scalpel head.
  • the three-layer structure is the first insulating layer 4, the reflow electrode layer 5 and the second insulating layer 6; among them, the needle core body is provided with the same length of the first insulating layer 4, and the first insulating layer 4 is provided There are 5 reflow electrode layers less than its length.
  • the part of the first insulating layer 4 that is not covered by the reflow electrode layer 5 is the main ablation electrode protection insulating ring 2, and the main ablation electrode protection insulating ring 2 is used to make the main ablation electrode A certain insulation protection distance is formed between 1 and the return electrode layer 5, so that the main ablation electrode 1 can generate plasma.
  • the plasma scalpel head is introduced into the nucleus pulposus, the plasma can vaporize the nucleus pulposus tissue at low temperature. Then ablate the nucleus pulposus tissue to achieve disc decompression and disc formation.
  • this application adopts the first insulating layer 4 to be directly arranged outside the needle core, and the reflow electrode layer 5 is arranged outside the first insulating layer 4.
  • the first insulating layer 4 and the reflow electrode layer 5 are formed in A main ablation electrode protection insulating ring 2 is formed near the ablation end, and the main ablation electrode 1 separates the main ablation electrode 1 and the return electrode layer 5 to form a certain protection distance, thereby ensuring that the main ablation electrode 1 normally emits plasma; while the prior art
  • the insulating structure of the plasma scalpel head in China is very complicated.
  • the existing plasma scalpel head is provided with a first insulating layer 4, a second insulating layer 6 and a third insulating layer outside the needle core, and the main ablation electrode 1 and the reflow
  • An insulating ring and a heating part need to be separately arranged between the electrode layers 5, so the structure is very complicated and expensive, which is not conducive to mass production.
  • the length of the main ablation electrode protection insulating ring 2 is 1 to 1.5 mm; the length of the main ablation electrode protection insulating ring 2 is controlled to be 1 to 1.5 mm. It can prevent the main ablation electrode 1 from contacting the return electrode layer 5, and can ensure that the main ablation electrode 1 normally generates plasma.
  • the plasma breaks the molecular bonds of the tissue at a lower temperature, so that the molecules are split, and then vaporizes the cervical nucleus or Lumbar nucleus pulposus, decompression of the cervical spine or intervertebral disc.
  • the angle between the main ablation electrode 1 and the core body is controlled to be between 10 and 15°; specifically, the main ablation electrode 1 and the core body
  • the plasma scalpel head is rotated 360°.
  • the plasma scalpel head’s rotating trajectory can form a cone plasma ablation zone, and the main ablation electrode 1 Controlling the angle between the main body of the needle core and the body of the needle between 10-15° can not only increase the ablation range of the cervical nucleus pulposus and reduce the pressure in the cervical nucleus pulposus, but also avoid multiple introduction of plasma scalpel heads in different directions.
  • the operation time is reduced and the patient's pain is relieved, and at the same time, it can ensure the efficient work of the spinal percutaneous plasma surgery.
  • the needle core of the plasma scalpel head is made of stainless steel; the needle core is designed to be stainless steel, on the one hand because stainless steel is resistant to ablation and ionization The characteristics of high temperature resistance and high temperature resistance meet the requirements of being able to excite a large amount of plasma.
  • the needle core of the existing plasma scalpel is mostly made of platinum, which makes the plasma scalpel head expensive, while the needle core made of stainless steel can The production cost of plasma surgical blades is greatly reduced, thereby reducing the cost of plasma surgery. From an economic perspective, more patients can receive plasma surgery treatment.
  • the shape of the ablation end of the main ablation electrode 1 is a cylindrical shape.
  • the main ablation electrode 1 is set in a cylindrical shape mainly because: using the tip effect, the curvature of the tip and the higher the charge density, the stronger the field strength near it. Therefore, the field strength near the main ablation electrode 1 is higher than the current one.
  • the electric field of the plasma scalpel head must be large, so it can excite a large amount of plasma; it should be noted that the plasma emitted by the cylindrical main ablation electrode 1 can form a cluster-type plasma cluster, which can be The most appropriate kinetic energy breaks the molecular bonds of the target tissue, so that the target tissue is broken at the molecular level, which can accurately vaporize, cut, ablate, and stop bleeding. Since the electric field generated by the three-dimensional does not directly act on the tissue, it can avoid the generation of excess heat , So as to minimize the thermal damage to the surrounding normal tissues.
  • the core material of the plasma scalpel head is tungsten steel.
  • the needle core is designed to be made of tungsten steel, on the one hand, because tungsten steel has the characteristics of resistance to ablation, ionization and high temperature, and the melting point of tungsten steel reaches 6000 °C, which meets the requirement of exciting a large amount of plasma; on the other hand,
  • Existing plasma scalpel needle cores are mostly made of platinum, which makes the plasma scalpel head expensive, while the use of tungsten steel needle cores can greatly reduce the production cost of plasma scalpel heads, thereby reducing the cost of plasma surgery. From an economic perspective, more patients can be treated with plasma surgery.
  • the shape of the ablation end of the main ablation electrode 1 is cone-shaped, and the use of a cone-shaped needle core is not only easy to process, but also low in cost.
  • the surface area ratio of the main ablation electrode 1 and the return electrode layer 5 of the plasma scalpel head is 1:3 to 1:7. Specifically, the larger the surface area of the main ablation electrode 1 and the return electrode layer 5, the smaller the voltage intensity across their surfaces, the easier it is to form a voltage current.
  • the main ablation electrode 1 The surface area ratio of the electrode 1 to the return electrode layer 5 is in the range of 1:3 to 1:7.
  • the main ablation electrode 1 can ensure the plasma emission range and ensure the ablation effect of the main ablation electrode 1; on the other hand, from a safety perspective, If the area ratio of the main ablation electrode 1 to the return electrode layer 5 exceeds 1:3, the pressure of the main ablation electrode 1 is likely to be too high, which is likely to adversely affect the main ablation electrode 1 in the province, and also adversely affect the surgical target. .
  • both the first insulating layer 4 and the second insulating layer 6 are made of material insulating layers.
  • the first insulating layer 4 and the second insulating layer 6 in this embodiment are made of insulating plastics, wherein the first insulating layer 4 uses a plastic insulating layer to replace the existing silicone insulating material, and the silicone insulating material is used in the main ablation electrode
  • the field strength formed by 1 and the reflow electrode layer 5 is easily ablated, and the use of a plastic insulating layer can effectively solve the problem of ablation of the insulating ring, and provide an effective guarantee for the multiple use of the plasma surgical knife; in addition, from the medical care Considering the safety of personnel operation and the cost of use, designing the first insulating layer 4 and the second insulating material to be plastic insulation can not only save costs, but also meet the safety of the operation.
  • the first insulating layer 4 is thickened and expanded. By expanding the first insulating layer 4, the effective insulation time can be exchanged for volume.
  • This embodiment provides an operating method of the plasma scalpel head for spinal percutaneous puncture, using the plasma scalpel head and plasma scalpel kit provided in Example 1.
  • the spine percutaneous puncture plasma scalpel head is used for
  • the operation method of the cervical spine includes the following steps:
  • Step S1 Use the puncture assembly to insert the diseased cervical intervertebral disc, and then introduce the plasma scalpel into the nucleus pulposus from the puncture needle;
  • Step S2. Lock the plasma scalpel head and the puncture needle, and rotate the core of the plasma scalpel head 360° to form a first cone ablation zone; the first ablation zone and the surrounding nucleus pulposus tissue are vaporized and ablated at low temperature;
  • Step S3. Retract the puncture needle and the plasma scalpel head by 1 to 2 mm, and rotate the core of the plasma scalpel head 360° to form a second cone ablation zone; the second ablation zone and surrounding nucleus pulposus tissue are obtained at low temperature Vaporization and ablation
  • Step S4 Retract the puncture needle and plasma scalpel head again by 1 to 2 mm, rotate the core of the plasma scalpel head 360° to form the third cone ablation zone, press the ablation pedal to ablate the third cone ablation Area and surrounding nucleus pulposus tissue.
  • step S1 insert the puncture needle in the center of the intervertebral disc, and the front and side fluoroscopy is at the midpoint; pull out the puncture needle core, insert and push the plasma scalpel head forward, pay attention to the plasma scalpel head Do not extend the puncture needle at the front end, keep the plasma knife head still, withdraw the puncture needle, monitor the main ablation electrode 1 of the plasma scalpel head under fluoroscopy, and lock the plasma scalpel head with the puncture needle, and confirm the plasma again
  • step S2 rotate the core of the plasma scalpel head 360° to form a first cone ablation zone; the first ablation zone and surrounding nucleus pulposus tissue are vaporized and ablated at low temperature
  • the spinal percutaneous puncture plasma operation method of the present application only needs to introduce the cervical nucleus pulposus once.
  • the plasma scalpel is rotated
  • the blade head is 360°, and the rotation track of the plasma scalpel head can form the first cone ablation zone.
  • the puncture needle and the plasma scalpel head are retracted by 1 to 2 mm, and the needle core of the plasma scalpel head is rotated 360° to form the first cone ablation zone.
  • Second cone ablation zone retract the puncture needle and plasma scalpel head again by 1 to 2mm, and rotate the core of the plasma scalpel head 360° again to form the third cone ablation zone; by placing the main ablation electrode 1 in Different positions are rotated 360° to form different ablation zones, which can avoid multiple introduction of plasma scalpel heads in different directions, reduce operation time and relieve the pain of patients, while ensuring the efficient work of spinal percutaneous plasma surgery .
  • This embodiment provides an operation method for lumbar spine surgery performed by percutaneous spine puncture plasma scalpel head.
  • the plasma scalpel head and plasma scalpel kit provided in embodiment 1 are used.
  • the operation method when the blade is used in the lumbar spine includes the following steps:
  • Step S1 Use the puncture assembly to insert the diseased lumbar intervertebral disc, and then introduce the plasma scalpel into the nucleus pulposus from the puncture needle;
  • Step S2. Lock the plasma scalpel head and the puncture needle, and rotate the core of the plasma scalpel head 360° to form a first cone ablation zone; the first ablation zone and the surrounding nucleus pulposus tissue are vaporized and ablated at low temperature;
  • Step S3. Retract the puncture needle and the plasma scalpel head by 1 to 2 mm, and rotate the core of the plasma scalpel head 360° to form a second cone ablation zone; the second ablation zone and surrounding nucleus pulposus tissue are obtained at low temperature Vaporization and ablation
  • Step S4 Retract the puncture needle and plasma scalpel head again by 1 to 2 mm, rotate the core of the plasma scalpel head 360° to form the third cone ablation zone, press the ablation pedal to ablate the third cone ablation Area and surrounding nucleus pulposus tissue.
  • the Kirschner needles need to be fluoroscopically positioned in the prone position to locate the diseased lumbar intervertebral space, and mark the table.
  • the special puncture needle is 35-45 mm from the midline of the affected side to the skin.
  • the puncture needle should be located in the middle of the nucleus pulposus and puncture in the front position
  • the needle is located in the center of the spine, and the lateral puncture needle is located in the center of the intervertebral space; the puncture needle core is pulled out, and the plasma scalpel head is inserted into the lumbar nucleus pulposus; among them, the tip of the plasma scalpel inserted is longer than the tip of the puncture needle.
  • step S2 after the plasma scalpel head and the puncture needle are locked, the needle core of the plasma scalpel head is rotated 360° to form a first cone ablation zone; the first ablation zone and surrounding nucleus pulposus tissue are obtained at low temperature Vaporization and ablation; in step S3, retract the puncture needle and the plasma scalpel head by 1 to 2 mm, and rotate the core of the plasma scalpel head 360° to form a second cone ablation zone; the second ablation zone and surrounding nucleus pulposus The tissue is vaporized and ablated at low temperature; in step S4, the puncture needle and the plasma scalpel head are retracted again by 1 to 2 mm, and the needle core of the plasma scalpel head is rotated 360° to form the third cone ablation zone, and press The ablation pedal, ablate the third cone ablation zone and surrounding nucleus pulposus tissue.
  • the spine percutaneous puncture plasma operation method of the present application only needs to introduce the lumbar nucleus pulposus once.
  • the rotary plasma operation The blade head is 360°, and the rotation track of the plasma scalpel head can form the first cone ablation zone.
  • the puncture needle and the plasma scalpel head are retracted by 1 to 2 mm, and the needle core of the plasma scalpel head is rotated 360° to form the first cone ablation zone.
  • Second cone ablation zone retract the puncture needle and plasma scalpel head again by 1 to 2mm, and rotate the core of the plasma scalpel head 360° again to form the third cone ablation zone; by placing the main ablation electrode 1 in Different positions are rotated 360° to form different ablation zones, which can avoid multiple introduction of plasma scalpel heads in different directions, reduce operation time and relieve the pain of patients, while ensuring the efficient work of spinal percutaneous plasma surgery .

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Abstract

一种脊柱经皮穿刺等离子体手术刀头及其操作方法，属于等离子体手术刀技术领域，解决了现有等离子体手术刀头绝缘结构复杂、生产成本高、限制一次性使用且加工困难的技术问题。脊柱经皮穿刺等离子体手术刀头包括针芯；针芯包括主消融电极（1）和针芯主体；主消融电极（1）设于等离子体手术刀头的消融端；针芯主体外设有与针芯主体等长的第一绝缘层（4）；第一绝缘层（4）外设有回流电极层（5）；回流电极层（5）的长度小于第一绝缘层（4）的长度，第一绝缘层（4）上未覆盖回流电极层（5）的部分形成主消融电极保护绝缘环（2）；回流电极层（5）上设有小于其长度的第二绝缘层（6），回流电极层（5）上未覆盖第二绝缘层（6）的部分形成回流电极。脊柱经皮穿刺等离子体手术刀头能够导入髓核并直接汽化髓核组织，在微创状态下实现椎间盘减压。

Description

一种脊柱经皮穿刺等离子体手术刀头及其操作方法 技术领域
本申请涉及等离子体手术刀技术领域，尤其涉及一种脊柱经皮穿刺等离子体手术刀头及其操作方法。
背景技术
低温等离子手术系统，通过电场和刀头，将刀头前端的导电液体激发至等离子状态，根据不同工作条件向等离子体上施加相应电压，是其中的带电粒子一定动能打断靶组织，使其在分子水平裂解，从而产生汽化、切割、消融和止血的效果，由于电场并不直接作用于组织，所以可以避免多余的热量，从而最大程度的减轻对周边正常组织的热损伤。现阶段的等离子体手术刀头还存在不能够持续产生大量的等离子体的缺陷，该缺陷加大了髓核消融的难度，这会给手术带来很大的不确定性，增加手术的风险，极易产生并发症等。
从现有等离子体手术刀头的结构上考虑，现有技术中的等离子体手术刀头多采用铂金材质且大部分等离子体手术刀头的结构复杂和成本高；另外，很多等离子体手术刀头存在一次性的限制，造成等离子体手术刀头的价格昂贵、使用次数受限。
从现有等离子体手术刀头的操作方法方面考虑，现有等离子体手术刀头在治疗时，需要多次朝不同方位导入等离子体手术刀头，手术时间比较长，增加了患者承受的痛苦，也导致脊柱经皮穿刺等离子体手术的工作效率较低。
发明内容
鉴于上述的分析，本申请实施例旨在提供一种脊柱经皮穿刺等离子 体手术刀头及其操作方法，用以解决现有脊柱经皮穿刺等离子体手术刀头及等离子体手术刀采用昂贵的铂金材料刀头、且手术刀结构复杂和造价昂贵等技术问题。
本申请的目的主要是通过以下技术方案实现的：
一方面，本申请公开了一种脊柱经皮穿刺等离子体手术刀头，等离子体手术刀头包括针芯；针芯包括主消融电极和针芯主体；主消融电极设于等离子体手术刀头的消融端；针芯主体外设有与针芯主体等长的第一绝缘层；第一绝缘层外设有回流电极层；回流电极层的长度小于第一绝缘层的长度，第一绝缘层上未覆盖回流电极层的部分为形成消融电极保护绝缘环；
回流电极层上设有小于其长度的第二绝缘层，回流电极层上未覆盖第二绝缘层的部分形成回流电极。
在一中可能的设计中，主消融电极保护绝缘环长度为1～1.5mm；主消融电极与针芯主体的夹角为10～15°。
在一中可能的设计中，等离子体手术刀头的针芯材质为不锈钢；主消融电极的消融端的形状为圆柱体状。
在一中可能的设计中，等离子体手术刀头的针芯材质为钨钢；主消融电极的消融端形状为圆柱体状。
在一中可能的设计中，等离子体手术刀的主消融电极与回流电极的表面积比为1:3～1:7。
在一中可能的设计中，第一绝缘层和第二绝缘层的材质均采用塑料绝缘层。
另一方面，一种脊柱经皮穿刺等离子体手术刀套件，其特征在于，等离子体手术刀套件与权利要求1至6任一项的等离子体手术刀头配合使用，等离子体手术刀套件包括穿刺针芯以及套设于穿刺针芯外侧的穿 刺针；穿刺组件用于穿刺并置入脊柱的病变部位。
再一方面，本申请还公开了一种脊柱经皮穿刺等离子体手术刀头的操作方法，采用上述的等离子体手术刀头和等离子体手术刀套件，该等离子体手术刀头的操作方法包括以下步骤：
步骤S1.利用穿刺组件置入病变间盘，然后将等离子体手术刀头从穿刺针内导入髓核；
步骤S2.将等离子体手术刀头和穿刺针锁定，旋转等离子体手术刀头的针芯360°，形成第一圆锥体消融区；第一消融区及周边髓核组织通过主消融电极得到汽化消融，实现椎间盘减压和椎间盘成形。
进一步地，上述脊柱经皮穿刺等离子体手术刀头的操作方法还包括步骤S3，在步骤S3中，将穿刺针及等离子体手术刀头退回1～2mm，旋转等离子体手术刀头的针芯360°，形成第二圆锥体消融区；第二消融区及周边髓核组织通过主消融电极得到汽化消融，实现椎间盘减压和椎间盘成形。
进一步地，上述脊柱经皮穿刺等离子体手术刀头的操作方法还包括步骤S4，在步骤S4中，将穿刺针及等离子体手术刀头再次退回1～2mm，旋转等离子体手术刀头的针芯360°，形成第三圆锥体消融区，第三圆锥体消融区及周边髓核组织通过主消融电极得到消融汽化，实现椎间盘减压和椎间盘成形。
与现有技术相比，本申请至少可实现如下有益效果之一：
(1)本申请采用第在针芯外直接设置第一绝缘层，并在第一绝缘层外设置回流电极层，第一绝缘层和回流电极成在靠近消融端形成主消融电极保护绝缘环，主消融电极将主消融电极和回流电极隔离开，形成一定的保护距离，进而保证主消融电极正常发射等离子体；现有等离子体手术刀头在针芯外设置第一绝缘层、第二绝缘层和第三绝缘层，且在主 消融电极与回流电极之间需要单独设置绝缘环和加热部分，因此造成其结构十分复杂并且成本昂贵，不利于批量生产。
(2)本申请将主消融电极与针芯主体的夹角控制在10～15°之间，当将等离子体手术刀导入颈椎髓核后，旋转等离子体手术刀头360°，等离子体手术刀头的旋转轨迹能够形成圆锥体等离子体消融区，该设计不仅能够增大颈椎髓核的消融范围并减小颈椎髓核内压力，还可以避免多次朝不同方位导入等离子体手术刀头，减少手术时间并且减轻了患者的痛苦，同时能够保证脊柱经皮穿刺等离子体手术的高效工作。
(3)从经济层面上考虑，现有等离子体手术刀的针芯多采用铂金材质，造成等离子体手术刀头价格昂贵；而本申请采用不锈钢材质或者钨钢的针芯能够大大降低等离子体手术刀头的生产成本和手术成本，有利于促使更多的患者接受等离子体手术的治疗。
本申请中，上述各技术方案之间还可以相互组合，以实现更多的优选组合方案。本申请的其他特征和优点将在随后的说明书中阐述，并且，部分优点可从说明书中变得显而易见，或者通过实施本申请而了解。本申请的目的和其他优点可通过说明书实施例以及附图中所特别指出的内容中来实现和获得。
附图说明
附图仅用于示出具体实施例的目的，而并不认为是对本申请的限制，在整个附图中，相同的参考符号表示相同的部件。
图1为本申请实施例1提供的脊柱经皮穿刺等离子体手术刀头的主视图；
图2为本申请实施例1提供的脊柱经皮穿刺等离子体手术刀头结构 示意图。
附图标记：
1-主消融电极；2-主消融电极保护绝缘环；3-回流电极；4-第一绝缘层；5-回流电极层；6-第二绝缘层。
具体实施方式
下面结合附图来具体描述本申请的优选实施例，其中，附图构成本申请一部分，并与本申请的实施例一起用于阐释本申请的原理，并非用于限定本申请的范围。
实施例1
本实施例公开了一种脊柱经皮穿刺等离子体手术刀头，如图1和图2所示，等离子体手术刀头包括针芯；针芯包括主消融电极1和针芯主体；主消融电极1为等离子体手术刀头的消融端；针芯主体外设有与针芯主体等长的第一绝缘层4；第一绝缘层4外设有回流电极层5层；回流电极层5层的长度小于第一绝缘层4的长度，第一绝缘层4上未覆盖回流电极层5层的部分为主消融电极保护绝缘环2；回流电极层5层上设有小于其长度的第二绝缘层6，回流电极层5层上未覆盖第二绝缘层6的部分为回流电极层5。
具体地，等离子体手术刀头包括针芯和设于针芯外部的三层结构，针芯包括一体成型的主消融电极1和针芯主体，主消融电极1为等离子体手术刀头的消融端；三层结构分别为第一绝缘层4、回流电极层5层和第二绝缘层6；其中，针芯主体上设有与其等长的第一绝缘层4，第一绝缘层4上设有小于其长度的回流电极层5层，其中，第一绝缘层4上未覆盖回流电极层5层的部分为主消融电极保护绝缘环2，该主消融电极保护绝缘环2用于使主消融电极1与回流电极层5之间形成一定的绝缘保 护距离，使主消融电极1能够产生等离子，当将等离子体手术刀头导入髓核内时，该等离子体能够在低温下使髓核组织汽化，进而消融髓核组织，实现椎间盘减压和椎间盘成形。
与现有技术相比，本申请采用第在针芯外直接设置第一绝缘层4，并在第一绝缘层4外设置回流电极层5层，第一绝缘层4和回流电极层5成在靠近消融端形成主消融电极保护绝缘环2，主消融电极1将主消融电极1和回流电极层5隔离开，形成一定的保护距离，进而保证主消融电极1正常发射等离子体；而现有技术中的等离子体手术刀头的绝缘结构十分复杂，现有等离子体手术刀头在针芯外设置第一绝缘层4、第二绝缘层6和第三绝缘层，且在主消融电极1与回流电极层5之间需要单独设置绝缘环和加热部分，因此造成其结构十分复杂和成本昂贵，不利于批量生产。
为了使主消融电极1和回流电极层5间形成一定的绝缘保护距离，主消融电极保护绝缘环2长度为1～1.5mm；将主消融电极保护绝缘环2的长度控制在1～1.5mm不仅能够避免主消融电极1与回流电极层5接触，而且可以确保主消融电极1正常的产生等离子体，等离子体在在较低温度下打断组织分子键，使分子裂解，然后汽化颈椎髓核或腰椎髓核，为颈椎或椎间盘减压。
为了增大消融髓核的范围和减小髓核内压力，将主消融电极1与针芯主体的夹角控制在10～15°之间；具体地，将主消融电极1与针芯主体之间设置为10～15°，当将等离子体手术刀导入颈椎髓核后，旋转等离子体手术刀头360°，等离子体手术刀头的旋转轨迹能够形成圆锥体等离子体消融区，将主消融电极1与针芯主体的夹角控制在10～15°之间不仅能够增大颈椎髓核的消融范围并减小颈椎髓核内压力，还可以避免多次朝不同方位导入等离子体手术刀头，减少手术时间并且减轻了患者的痛苦， 同时能够保证脊柱经皮穿刺等离子体手术的高效工作。
为了降低生产成本且保证等离子体手术刀头能够产生大量的等离子体，等离子体手术刀头的针芯材质为不锈钢；将针芯设计成不锈钢材质，一方面是因为，不锈钢具有耐消融、耐电离和耐高温的特点，满足能够激发大量等离子体的要求；另一方面，现有等离子体手术刀的针芯多采用铂金材质，造成等离子体手术刀头价格昂贵，而采用不锈钢材质的针芯能够大大降低等离子体手术刀头的生产成本，进而降低等离子体手术成本，从经济层面上考虑，可以使更多的患者接受等离子体手术的治疗。
需要强调的是，为保证等离子体手术刀头能够持续产生大量的等离子，主消融电极1的消融端形状为圆柱体形形。具体地，将主消融电极1设置成圆柱体形主要是因为：利用尖端效应，尖端的曲率答，电荷密度高，其附近场强也就越强，因此，主消融电极1附近场强要比现有等离子体手术刀头的电场要大，所以能够激发出持续大量的等离子体；需要说明的是，圆柱体形主消融电极1发射的等离子体能够形成簇型的等离子团，该等离子体团能够以最恰当的动能打断靶组织的分子键，使靶组织在分子水平裂解，能够精确汽化、切割、消融和止血，由于等立体产生的电场并不直接作用于组织，所以可以避免产生多余的热量，从而最大程度的减轻对周边正常组织的热损伤。
同样地，为了降低生产成本且保证等离子体手术刀头能够产生大量的等离子体，等离子体手术刀头的针芯材质为钨钢。将针芯设计成钨钢材质，一方面是因为，钨钢具有耐消融、耐电离和耐高温的特点，且钨钢的熔点达到6000℃，满足能够激发大量等离子体的要求；另一方面，现有等离子体手术刀的针芯多采用铂金材质，造成等离子体手术刀头价格昂贵，而采用钨钢材质的针芯能够大大降低等离子体手术刀头的生产成本，进而降低等离子体手术成本，从经济层面上考虑，可以使更多的 患者接受等离子体手术的治疗。
需要说明的是，当针芯材质采用钨钢时，主消融电极1的消融端形状为圆锥体状，采用圆锥体状的针芯不仅加工容易，且成本较低。
为了使主消融电极1发射的等离子体控制在一定距离以内，等离子体手术刀头的主消融电极1与回流电极层5的表面积比为1:3～1:7。具体地，主消融电极1和回流电极层5的表面积越大，通过其表面的电压强度越小，也就越容易形成电压流势，为了控制主消融电极1的等离子体发射范围，将主消融电极1与回流电极层5的表面积比在1:3～1:7范围内，一方面，能够保证等离子体的发射范围，保证主消融电极1的消融效果；另一方面，从安全角度考虑，主消融电极1与回流电极层5的面积比如果超过1：3时，容易造成主消融电极1的压强过大，容易对主消融电极1本省产生不利影响，同时对手术对象也会造成不利影响。
为了实现等离子体手术刀头多次使用和保证操作人员的安全，第一绝缘层4和第二绝缘层6均采用料绝缘层。
具体地，本实施例中的第一绝缘层4和第二绝缘层6均采用绝缘塑料，其中，第一绝缘层4采用塑料绝缘层代替现有的硅胶绝缘材料，硅胶绝缘材料在主消融电极1和回流电极层5形成的场强中很容易被消融掉，而采用塑料绝缘层能够有效解决绝缘环被消融的问题，为等离子体手术刀头多次使用提供了有效保证；另外，从医护人员操作安全性以及使用成本的角度考虑，将第一绝缘层4和第二绝缘的材质设计成塑料绝缘，不仅能够节省成本，而且也能满足手术的安全性。
为了使针芯尽可能粗一些，本实施例将第一绝缘层4进行加粗膨大处理，通过将第一绝缘层4进行膨大处理，能够以体积换取有效绝缘时长。
实施例2
本实施例提供了一种脊柱经皮穿刺等离子体手术刀头的操作方法，采用实施例1提供的等离子体手术刀头和等离子体手术刀套件，该脊柱经皮穿刺等离子体手术刀头用于颈椎时的操作方法包括以下步骤：
步骤S1.利用穿刺组件置入病变颈椎间盘，然后将等离子体手术刀头从穿刺针内导入髓核；
步骤S2.将等离子体手术刀头和穿刺针锁定，旋转等离子体手术刀头的针芯360°，形成第一圆锥体消融区；第一消融区及周边髓核组织在低温下得到汽化消融；
步骤S3.将穿刺针及等离子体手术刀头退回1～2mm，旋转等离子体手术刀头的针芯360°，形成第二圆锥体消融区；第二消融区及周边髓核组织在低温下得到汽化消融；
步骤S4.将穿刺针及等离子体手术刀头再次退回1～2mm，旋转等离子体手术刀头的针芯360°，形成第三圆锥体消融区，踩压消融脚踏，消融第三圆锥体消融区及周边髓核组织。
具体地，在步骤S1前需要先仰卧位，颈部轻度过伸，透视下体外克氏针定位病变间隙，标记病变间隙后进行局部麻醉，并在C臂引导下前外侧入路于动脉鞘和内脏鞘间，在步骤S1中，在椎间盘正中置入穿刺针，正侧位透视均位于中点；拔出穿刺针芯，插入并向前推动等离子体手术刀头，注意等离子体手术刀头前端不要伸出穿刺针，保持等离子刀头不动，将穿刺针回抽，透视下监视等离子体手术刀头的主消融电极1暴露出来，将等离子体手术刀头与穿刺针锁定，再次确认等离子体手术刀头位置，在步骤S2中，旋转等离子体手术刀头针芯360°，形成第一圆锥体消融区；第一消融区及周边髓核组织在低温下得到汽化消融；在步骤S3中，将穿刺针及等离子体手术刀头退回1～2mm，旋转等离子体手术刀头的针芯360°，形成第二圆锥体消融区；第二消融区及周边髓核组织在低 温下得到汽化消融；在步骤S4中，将穿刺针及等离子体手术刀头再次退回1～2mm，旋转等离子体手术刀头的针芯360°，形成第三圆锥体消融区，踩压消融脚踏，消融第三圆锥体消融区及周边髓核组织；消融完毕后拔出穿刺针和等离子体手术刀头，完成颈椎髓核消融操作。
与现有等离子体手术刀头的操作方法相比，本申请的脊柱经皮穿刺等离子体手术操作方法只需要导入颈椎髓核一次，当将等离子体手术刀导入颈椎髓核后，旋转等离子体手术刀头360°，等离子体手术刀头的旋转轨迹能够形成第一圆锥体消融区，将穿刺针及等离子体手术刀头退回1～2mm，旋转等离子体手术刀头的针芯360°，形成第二圆锥体消融区；将穿刺针及等离子体手术刀头再次退回1～2mm，并再次旋转等离子体手术刀头的针芯360°，形成第三圆锥体消融区；通过将主消融电极1在不同位置分别旋转360°以形成不同的消融区，可以避免多次朝不同方位导入等离子体手术刀头，减少手术时间并且减轻了患者的痛苦，同时能够保证脊柱经皮穿刺等离子体手术的高效工作。
实施例3
本实施例提供了一种脊柱经皮穿刺等离子体手术刀头进行的腰椎手术的操作方法，采用实施例1提供的等离子体手术刀头和等离子体手术刀套件，该脊柱经皮穿刺等离子体手术刀头用于腰椎时的操作方法包括以下步骤：
步骤S1.利用穿刺组件置入病变腰椎间盘，然后将等离子体手术刀头从穿刺针内导入髓核；
步骤S2.将等离子体手术刀头和穿刺针锁定，旋转等离子体手术刀头的针芯360°，形成第一圆锥体消融区；第一消融区及周边髓核组织在低温下得到汽化消融；
步骤S3.将穿刺针及等离子体手术刀头退回1～2mm，旋转等离子体手术刀头的针芯360°，形成第二圆锥体消融区；第二消融区及周边髓核组织在低温下得到汽化消融；
步骤S4.将穿刺针及等离子体手术刀头再次退回1～2mm，旋转等离子体手术刀头的针芯360°，形成第三圆锥体消融区，踩压消融脚踏，消融第三圆锥体消融区及周边髓核组织。
具体地，在步骤S1之前，需要俯卧位透视下克氏针体外定位病变腰椎间隙，并作表表标记，C臂引导下于患侧距中线8-10mm以专用穿刺针与皮肤成35-45°，通过“安全三角”刺入椎间盘，腰椎间盘纤维环的后外侧部即位于此区内，且表面无骨性结构遮挡；在步骤S1中，将穿刺针头应位于髓核正中，正位穿刺针头位于脊柱正中，侧位穿刺针头位于椎间隙正中；拔出穿刺针芯，将等离子体手术刀头腰椎髓核；其中，插入等离子体手术刀头的顶端要比穿刺针的顶端长些，以确保等离子体手术刀头的主消融电极1在腰椎髓核内而与穿刺针无接触；将离子体手术刀头穿过穿刺针，轻轻向前推，直至标记线到达穿刺针尾，此点即为消融起始点；将离子体手术刀头和穿刺套管固定，并将穿刺套管远端退回纤维环内，将离子体手术刀头向前轻推近至推不动，说明达到对侧纤维环内层边缘，透视下可证实；此时将卡环移至穿刺针尾，此点即为消融最远点；将刀头退到消融起始点标记处即可进行消融及成型操作。
在步骤S2中，将等离子体手术刀头和穿刺针锁定后，旋转等离子体手术刀头的针芯360°，形成第一圆锥体消融区；第一消融区及周边髓核组织在低温下得到汽化消融；在步骤S3中，将穿刺针及等离子体手术刀头退回1～2mm，旋转等离子体手术刀头的针芯360°，形成第二圆锥体消融区；第二消融区及周边髓核组织在低温下得到汽化消融；在步骤S4中，将穿刺针及等离子体手术刀头再次退回1～2mm，旋转等离子体手术刀头 的针芯360°，形成第三圆锥体消融区，踩压消融脚踏，消融第三圆锥体消融区及周边髓核组织。
与现有等离子体手术刀头的操作方法相比，本申请的脊柱经皮穿刺等离子体手术操作方法只需要导入腰椎髓核一次，当将等离子体手术刀导入腰椎髓核后，旋转等离子体手术刀头360°，等离子体手术刀头的旋转轨迹能够形成第一圆锥体消融区，将穿刺针及等离子体手术刀头退回1～2mm，旋转等离子体手术刀头的针芯360°，形成第二圆锥体消融区；将穿刺针及等离子体手术刀头再次退回1～2mm，并再次旋转等离子体手术刀头的针芯360°，形成第三圆锥体消融区；通过将主消融电极1在不同位置分别旋转360°以形成不同的消融区，可以避免多次朝不同方位导入等离子体手术刀头，减少手术时间并且减轻了患者的痛苦，同时能够保证脊柱经皮穿刺等离子体手术的高效工作。
以上所述，仅为本申请较佳的具体实施方式，但本申请的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本申请揭露的技术范围内，可轻易想到的变化或替换，都应涵盖在本申请的保护范围之内。

Claims (10)

  1. 一种脊柱经皮穿刺等离子体手术刀头，其特征在于，所述等离子体手术刀头包括针芯；所述针芯包括主消融电极和针芯主体；
    所述主消融电极设于等离子体手术刀头的消融端；所述针芯主体外设有与针芯主体等长的第一绝缘层；所述第一绝缘层外设有回流电极层；所述回流电极层的长度小于第一绝缘层的长度，所述第一绝缘层上未覆盖回流电极层的部分为形成消融电极保护绝缘环；
    所述回流电极层上设有小于其长度的第二绝缘层，所述回流电极层上未覆盖第二绝缘层的部分形成回流电极。
  2. 根据权利要求1所述的脊柱经皮穿刺等离子体手术刀头，其特征在于，所述主消融电极保护绝缘环长度为1～1.5mm；
    所述主消融电极与针芯主体的夹角为10～15°。
  3. 根据权利要求1所述的脊柱经皮穿刺等离子体手术刀头，其特征在于，所述等离子体手术刀头的针芯材质为不锈钢；所述主消融电极的消融端的形状为圆柱体状。
  4. 根据权利要求1所述的脊柱经皮穿刺等离子体手术刀头，其特征在于，所述等离子体手术刀头的针芯材质为钨钢；所述主消融电极的消融端形状为圆锥体状。
  5. 根据权利要求1所述的脊柱经皮穿刺等离子体手术刀头，其特征在于，所述等离子体手术刀的主消融电极与回流电极的表面积比为1:3～1:7。
  6. 根据权利要求1所述的脊柱经皮穿刺等离子体手术刀头，其特征在于，所述第一绝缘层和第二绝缘层的材质均采用塑料绝缘层。
  7. 一种脊柱经皮穿刺等离子体手术刀套件，其特征在于，所述等离子体手术刀套件与权利要求1至6任一项所述的等离子体手术刀头配合使用，所述等离子体手术刀套件包括穿刺针芯以及套设于穿刺针芯外侧的 穿刺针；所述穿刺组件用于穿刺并置入脊柱的病变部位。
  8. 一种脊柱经皮穿刺等离子体手术刀头的操作方法，其特征在于，采用权利要求7所述的等离子体手术刀头和等离子体手术刀套件，所述等离子体手术刀头的操作方法包括以下步骤：
    步骤S1.利用穿刺组件置入病变间盘，然后将等离子体手术刀头从穿刺针内导入髓核；
    步骤S2.将等离子体手术刀头和穿刺针锁定，旋转等离子体手术刀头的针芯360°，形成第一圆锥体消融区；第一消融区及周边髓核组织通过主消融电极得到汽化消融，实现椎间盘减压和椎间盘成形。
  9. 根据权利要求8所述的脊柱经皮穿刺等离子体手术刀头的操作方法，其特征在于，还包括步骤S3，在所述步骤S3中，将穿刺针及等离子体手术刀头退回1～2mm，旋转等离子体手术刀头的针芯360°，形成第二圆锥体消融区；第二消融区及周边髓核组织通过主消融电极得到汽化消融，实现椎间盘减压和椎间盘成形。
  10. 根据权利要求9所述的脊柱经皮穿刺等离子体手术刀头的操作方法，其特征在于，还包括步骤S4，在所述步骤S4中，将穿刺针及等离子体手术刀头再次退回1～2mm，旋转等离子体手术刀头的针芯360°，形成第三圆锥体消融区，第三圆锥体消融区及周边髓核组织通过主消融电极得到消融汽化，实现椎间盘减压和椎间盘成形。
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