CN113907868A - Electrode needle assembly and ablation apparatus - Google Patents
Electrode needle assembly and ablation apparatus Download PDFInfo
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- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B18/1477—Needle-like probes
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- 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
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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- A61B90/06—Measuring instruments not otherwise provided for
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- 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
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- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B2018/1405—Electrodes having a specific shape
- A61B2018/1425—Needle
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/06—Measuring instruments not otherwise provided for
- A61B2090/062—Measuring instruments not otherwise provided for penetration depth
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Abstract
The embodiment of the application provides an electrode needle assembly and an ablation device. The electrode needle assembly includes: the needle head part of the electrode needle is provided with a conductive area for outputting high-voltage pulse for electroporation ablation; the depth probe is used for acquiring depth information of the electrode needle inserted into the target biological tissue; the insulating sleeve is fixedly sleeved outside the electrode needle and the depth probe and is used for penetrating into target biological tissues; part of the needle head part of the electrode needle is exposed out of the puncture end of the insulating sleeve, and/or part of the needle head part of the depth probe is exposed out of the puncture end of the insulating sleeve; and the developing layer is arranged at least one of the electrode needle, the depth probe and the insulating sleeve and is used for developing in cooperation with the detection device. The embodiment of the application realizes that the depth probe can accurately measure the size of the electrode needle inserted into the human body after the electrode needle is inserted into the patient body, and the developer is convenient for clearly acquiring the appearance image of the tumor tissue.
Description
Technical Field
The application relates to the technical field of medical instruments, in particular to an electrode needle assembly and ablation equipment.
Background
Irreversible electroporation ablation is a new ablation mode in the field of tumor ablation. Irreversible electroporation ablation uses high voltage pulses to act on the focal site, causing permanent perforation of the cell membrane at nanometer scale, resulting in tumor cell apoptosis. The range of high-voltage electric pulses released by the existing irreversible electroporation ablation technology is mostly 500-5000V, and the current is 20-50A.
In the treatment of tumors by irreversible electroporation, the affected part is usually determined by ultrasound, nuclear magnetic resonance or CT (computed tomography), and then two or more electrode needles are inserted into the patient for action.
At present, the size of the electrode needle actually inserted into a human body cannot be accurately measured, and the size of the electrode needle actually inserted into the human body is determined completely by the clinical experience of a doctor. This is not only highly demanding on the clinical experience of the physician, but also has inaccuracies. Meanwhile, the ablation electrode needle is metal, so that artifacts exist on an image under CT, the judgment of the specific direction of the electrode needle is interfered, and the electrode needle cannot be accurately positioned. For some tumors of key organs, such as the location of the brain, a slight deviation may cause death of a patient, and in order to ensure complete ablation of the brain tumor, the location of the ablation electrode needle is very important, however, in the prior art, no good solution is provided for the precise location of the electrode needle.
Disclosure of Invention
The utility model provides an electrode needle subassembly and ablation equipment to the shortcoming of current mode for there is the electrode needle actual size of inserting the human body to be difficult to the precision measurement, can't clearly observe the position of electrode needle or be difficult to clearly acquire the technical problem of tumour tissue's outward appearance image in prior art.
In a first aspect, embodiments of the present application provide an electrode needle assembly, including:
the needle head part of the electrode needle is provided with a conductive area for outputting high-voltage pulse for electroporation ablation;
the depth probe is used for acquiring depth information of the electrode needle inserted into the target biological tissue;
the insulating sleeve is fixedly sleeved outside the electrode needle and the depth probe and is used for penetrating into target biological tissues; the needle head part of a part of the electrode needle is exposed out of the puncture end of the insulating sleeve, and/or the needle head part of a part of the depth probe is exposed out of the puncture end of the insulating sleeve;
and the developing layer is arranged at least one position of the electrode needle, the depth probe and the insulating sleeve and is used for developing in cooperation with the detection device.
Optionally, the end face of the piercing end of the insulating sleeve is a plane and forms an angle α with the direction of the insulating sleeve on the axis, where 0 < α < 90 °.
Optionally, the end surface of the piercing end of the insulating sleeve is a conical surface.
Optionally, the electrode needle comprises: an electrical conductor and an insulating layer.
The insulating layer covers part of the surface of the electric conductor in a mode of exposing part of the needle head part of the electrode needle, and is used for shielding high-voltage pulse output by the electric conductor.
The developing layer is disposed in a layered relationship with at least a portion of the insulating layer.
The surface of the conductor not covered by the insulating layer forms a conductive region.
Optionally, at least a portion of the development layer is disposed in a layer overlying the insulating layer proximate the conductive region.
Optionally, the electrode needle comprises: an electrical conductor and an insulating layer.
The insulating layer covers part of the surface of the electric conductor in a mode of exposing part of the needle head part of the electrode needle, and is used for shielding high-voltage pulse output by the electric conductor.
At least part of the developing layer is fused with the insulating layer.
The surface of the conductor not covered by the insulating layer forms a conductive region.
Optionally, the development layer is disposed at a tip portion of the depth probe.
Optionally, the developing layer is disposed on an inner wall or an outer wall of the puncture end of the insulating sleeve.
Optionally, the visualization layer is integrated with the wall of the puncture end of the insulating sleeve.
In a second aspect, embodiments of the present application provide an ablation device, comprising: an electrode needle assembly as provided in the first aspect, and a host machine.
The host computer is electrically connected with the electrode needle and the depth probe in the electrode needle assembly respectively.
The beneficial technical effects brought by the technical scheme provided by the embodiment of the application comprise:
in the electrode needle assembly provided by the embodiment of the application, the electrode needle and the depth probe are sleeved in the insulating sleeve at the same time, so that the depth probe can be used for accurately measuring the size of the electrode needle inserted into a human body. Meanwhile, the developing layer is arranged on the electrode needle assembly, so that when the electrode needle acts on a human body, the appearance image of the tumor tissue region can be observed in real time through the cooperation of the detection device and the developing layer. Therefore, the size and specific orientation of the electrode needle assembly actually inserted into the human body can be more accurately measured by the dual functions of the developer and the depth probe.
Additional aspects and advantages of the present application will be set forth in part in the description which follows and, in part, will be obvious from the description, or may be learned by practice of the present application.
Drawings
The foregoing and/or additional aspects and advantages of the present application will become apparent and readily appreciated from the following description of the embodiments, taken in conjunction with the accompanying drawings of which:
FIG. 1 is a cross-sectional view of a first embodiment of an electrode needle assembly provided by an example of the present application;
FIG. 2 is an enlarged view of a portion of FIG. 1 at A;
FIG. 3 is a cross-sectional view of a second embodiment of an electrode needle assembly provided in accordance with an example of the present application;
FIG. 4 is a cross-sectional view of a third embodiment of an electrode needle assembly according to an example of the present application;
fig. 5 is a sectional view of a fourth embodiment of an electrode needle assembly according to an example of the present application.
In the figure, the position of the upper end of the main shaft,
1-electrode needle; 11-an electrical conductor; 12-an insulating layer; 111-tip portion of electrode needle; 1111-conductive region;
2-depth probe; 21-the tip section of the depth probe;
3-an insulating sleeve;
4-a development layer;
100-electrode needle assembly.
Detailed Description
Reference will now be made in detail to the present application, examples of which are illustrated in the accompanying drawings, wherein like reference numerals refer to the same or similar parts or parts having the same or similar functions throughout. In addition, if a detailed description of the known art is not necessary for illustrating the features of the present application, it is omitted. The embodiments described below with reference to the drawings are exemplary only for the purpose of explaining the present application and are not to be construed as limiting the present application.
It will be understood by those within the art that, unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the prior art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
As used herein, the singular forms "a", "an", "the" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, integers, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, elements, components, and/or groups thereof. It will be understood that when an element is referred to as being "connected" or "coupled" to another element, it can be directly connected or coupled to the other element or intervening elements may also be present. Further, "connected" or "coupled" as used herein may include wirelessly connected or wirelessly coupled. As used herein, the term "and/or" includes all or any element and all combinations of one or more of the associated listed items.
The inventor of the present application has found that the size of the electrode needle inserted into the human body is mainly determined by the clinical experience of the doctor, which not only has higher requirements on the clinical experience of the doctor, but also greatly increases the risk that the electrode needle cannot accurately act on the lesion area when inserted into the human body. Therefore, most of the time, the patient needs to be punctured for many times to determine the position of the tumor cells, which can increase the pain of the patient and is not favorable for wound repair after the operation. Meanwhile, the existing electrode needle is usually made of metal materials, and after the electrode needle is inserted into a human body, a strong magnetic field can be locally formed, so that the uniformity of a main magnetic field is disturbed, and displayed images have artifacts, so that the electrode needle cannot be accurately positioned.
The present application provides an electrode needle assembly and an ablation apparatus, which aim to solve the above technical problems of the prior art.
The following describes the technical solutions of the present application and how to solve the above technical problems with specific embodiments.
The embodiment of the present application provides an electrode needle assembly 100, and a schematic structural diagram of the electrode needle assembly 100 is shown in fig. 1, and the electrode needle assembly 100 includes:
an electrode needle 1, wherein a needle head part 111 of the electrode needle is provided with a conductive region 1111 for outputting high-voltage pulse for electroporation ablation;
the depth probe 2 is used for acquiring depth information of the electrode needle 1 inserted into the target biological tissue;
the insulating sleeve 3 is fixedly sleeved outside the electrode needle 1 and the depth probe 2 and is used for penetrating into target biological tissues; part of the needle head part 111 of the electrode needle is exposed out of the puncture end of the insulating sleeve 3, and/or part of the needle head part 21 of the depth probe is exposed out of the puncture end of the insulating sleeve 3;
and the developing layer 4 is arranged at least one position of the electrode needle 1, the depth probe 2 and the insulating sleeve 3 and is used for developing in cooperation with the detection device.
In this application embodiment, the depth probe 2 and the electrode needle 1 are both fixed in the insulating sleeve 3, so that after the electrode needle assembly 100 is inserted into a human body, the electrode needle 1 and the depth probe 2 synchronously act on a lesion area, and the depth probe 2 can accurately measure the depth data of the electrode needle 1 in the human body. The electrode needle 1 can adjust the specific position of the conductive region 1111 according to the depth data fed back by the depth probe 2, so that the discharge region of the electrode needle 1 can be determined more accurately.
Optionally, part of the tip segment 111 of the electrode needle and part of the tip segment 21 of the depth probe are exposed at the piercing end of the insulating sleeve 3. Therefore, the depth probe and the electrode needle are relatively close to each other in length when extending into the human tissue, and the depth probe can also more accurately detect the depth of the electrode needle extending into the human tissue.
Optionally, the tip portion 111 of a portion of the electrode needle is exposed from the piercing end of the insulating sleeve 3, while the tip portion of the depth probe is not exposed from the piercing end of the insulating sleeve. Thus, the needle head part of the puncture end exposed out of the insulating sleeve can be reduced, thereby reducing the stimulation to biological tissues and further reducing the pain to patients
In the present embodiment, the development layer 4 is provided in a partial region of the electrode needle assembly 100, and an external image of tumor tissue around the electrode needle 1 can be displayed in cooperation with the detection device. Thereby more accurately judging the position of the tumor cells.
Alternatively, the detection means may employ ultrasound, nuclear magnetic resonance, CT (computed tomography), or the like.
Optionally, the electrode needle 1 in this embodiment is a single-pole needle, and when performing irreversible electroporation ablation, an electric field is output to tumor tissue by inserting one positive electrode needle 1 and one negative electrode needle 1 into human tissue in parallel, and a distance between the two electrode needles 1 is not less than 1 cm and not more than 5 cm.
The inventors of the present application consider that the insulating sleeve 3 is required for piercing human tissue. To this end, as shown in fig. 1, the present application provides one possible implementation manner for the electrode needle assembly 100 as follows:
the end face of the puncture end of the insulating sleeve 3 is a plane, and forms an alpha angle with the direction of the insulating sleeve 3 on the axis, wherein alpha is more than 0 and less than 90 degrees.
In the present embodiment, the end surface of the piercing end of the insulating sleeve 3 is inclined, which facilitates easier insertion of the electrode needle assembly 100 into the human tissue and less trauma to the skin surface.
In one example, the end face of the piercing end of the insulating sleeve 3 is planar and is at 15 ° to the direction of the insulating sleeve 3 on the axis.
In one example, the end face of the piercing end of the insulating sleeve 3 is planar and is oriented at 30 ° to the insulating sleeve 3 in the axial direction.
In one example, the end face of the piercing end of the insulating sleeve 3 is planar and is oriented at 45 ° to the insulating sleeve 3 in the axial direction.
The inclination angle of the end surface of the puncture end of the insulating sleeve 3 can be designed according to the hardness of human tissue to be punctured, and as can be seen from P ═ F/S (F is the applied pressure and S is the area of the puncture end), the smaller the inclination angle, the smaller S, the greater the pressure, and the easier the puncture.
The inventor of the present application considers that, since the depth probe 2 and the electrode needle 1 are both sleeved in the insulating sleeve 3 and the needle head is at least partially slightly exposed out of the needle head of the insulating sleeve 3, in order to reduce the stimulation of the needle head to the human tissue, as shown in fig. 4, the present application provides one possible implementation manner for the electrode needle assembly 100 as follows:
the end face of the piercing end of the insulating sleeve 3 is a conical surface.
In this embodiment, when the end surface of the piercing end of the insulating sleeve 3 is a tapered surface, the needle head portion 21 of the electrode needle 1 or the depth probe can be used as the needle head portion of the insulating sleeve 3 to pierce the human tissue. Therefore, the number of the tips which can stimulate human tissues can be reduced, and the pain of patients can be relieved.
In one example, the end face of the puncture end of the insulating sleeve 3 is a cone, the needle head 111 of the electrode needle is the needle head of the insulating sleeve 3, and the needle head 21 of the depth probe is arranged inside the side face of the cone.
In one example, the end face of the puncture end of the insulating sleeve 3 is a pyramid, the needle head 21 of the depth probe is the needle head of the insulating sleeve 3, and the needle head 111 of the electrode needle is arranged inside any one side face of the pyramid.
It should be noted that the number of the pyramid sides may be 3, 4, 5, 6, etc., and is not limited herein.
The inventor of the present application considers that the electrode needle 1 needs to have the conductive region 1111, and outputs the high voltage electric pulse for electroporation ablation, so that there is a potential difference between the two electrode needles 1, thereby forming an electric field. To this end, the present application provides one possible implementation manner for the electrode needle assembly 100 as follows:
the electrode needle 1 of the embodiment of the present application includes: an electrical conductor 11 and an insulating layer 12;
the insulating layer 12 covers part of the surface of the electric conductor 11 in a manner of exposing the needle head part 111 of part of the electrode needle, and is used for shielding high-voltage pulses output by the electric conductor 11;
the developing layer 4 is laminated with at least part of the insulating layer 12;
the surface of the conductive body 11 not covered with the insulating layer 12 forms a conductive region 1111.
In this embodiment, the partial area of the surface of the electrode needle 1 is coated with an insulating material, so that the actual conductive region 1111 of the electrode needle 1 can be limited. Meanwhile, the coating area of the developer can be designed with the area covered with the insulating layer 12 as a reference surface.
Alternatively, the development layer 4 is located on the side of the insulating layer 12 away from the conductive body 11 as viewed in the radial direction of the electrode needle 1.
Alternatively, the development layer 4 is located on the side of the insulating layer 12 close to the conductive body 11 as viewed in the radial direction of the electrode needle 1. Alternatively, the developing layer 4 and the insulating layer 12 are provided mixedly.
The lamination relationship of the developing layer 4 and the insulating layer 12 may be set according to the specific requirements of the manufacturing process of the electrode needle 1. If it is technically more economical and simple to apply the developing layer 4 first and then the insulating layer 12, the developing layer 4 can be designed on the side of the insulating layer 12 close to the conductor 11. If it is technically more economical and simple to apply the insulating layer 12 first and then the developing layer 4, the developing layer 4 can be designed on the side of the insulating layer 12 remote from the conductor 11. If the development layer 4 and the insulating layer 12 are applied to the conductor 11 as a single body in a more economical and simple manner in terms of process, the development layer 4 and the insulating layer 12 may be provided in a mixed manner.
In one example, the length of the electrode needle 1 is 25 mm, and the diameter of the conductive body 11 is 0.3 mm; the development layer 4 is located on the side of the insulating layer 12 away from the conductive body 11 as viewed in the radial direction of the electrode needle 1. The area of the region of the development layer 4 is half the area of the region of the insulating layer 12. The thickness of the insulating layer 12 was 0.1 mm, and the thickness of the developing layer 4 was 0.05 mm.
In one example, the length of the electrode needle 1 is 37 mm, and the diameter of the conductive body 11 is 0.4 mm; the developing layer 4 is located on the side of the insulating layer 12 close to the conductive body 11 as viewed in the radial direction of the electrode needle 1. The area of the region of the development layer 4 is one third of the area of the region of the insulating layer 12. The thickness of the insulating layer 12 was 0.15 mm, and the thickness of the developing layer 4 was 0.1 mm.
In one example, the length of the electrode needle 1 is 50 mm, and the diameter of the conductive body 11 is 0.5 mm; the developing layer 4 is located on the side of the insulating layer 12 close to the conductive body 11 as viewed in the radial direction of the electrode needle 1. The area of the region of the development layer 4 is two thirds of the area of the region of the insulating layer 12. The thickness of the insulating layer 12 was 0.15 mm, and the thickness of the developing layer 4 was 0.1 mm.
In one example, the length of the electrode needle 1 is 75 mm, and the diameter of the conductive body 11 is 0.6 mm; the developing layer 4 is located on the side of the insulating layer 12 close to the conductive body 11 as viewed in the radial direction of the electrode needle 1. The developer is blended in the insulating layer 12 to be mixed with the insulating layer 12. The thickness of the insulating layer 12 mixed with the developer was 0.2 mm.
The inventor of the present application considers that the position of the conduction region 1111 of the electrode needle 1 is the closest region to the tumor tissue, and if the developing layer 4 is provided to the entire insulation layer 12 of the electrode needle 1, the electrode needle cannot be directly positioned to the tumor tissue by the detection means. Furthermore, too large a coating area of the developer layer 4 increases the risk of the developer layer falling off and remaining in the body tissue, and the components in the developer may cause a slight amount of radiation damage to the patient. To this end, the present application provides one possible implementation manner for the electrode needle assembly 100 as follows:
as shown in fig. 1, at least a portion of the developing layer 4 is disposed in a layer stack with the insulating layer 12 adjacent to the conductive region 1111.
In this embodiment, the developing layer 4 is disposed near the conduction region 1111, so that an accurate and clear image of the tumor tissue can be visually observed. Meanwhile, the area of the developing layer 4 is reduced, so that the using amount of the developer is reduced, the risk that the developer possibly falls off and remains in the body of a patient is reduced, and the manufacturing cost of the electrode needle 1 is saved.
In one example, the length of the electrode needle 1 is 50 mm, the conductive region 1111 is located at the needle head portion 111 of the electrode needle and has a length of 5 mm in the axial direction of the electrode needle 1, and the developing layer 4 is located on the side of the insulating layer 12 away from the conductive body 11 as viewed in the radial direction of the electrode needle 1. The length of the insulating layer 12 in the axial direction of the electrode needle 1 is 45 mm, one side of the developing layer 4 close to the needle head part is overlapped with one side of the conductive region 1111 far away from the needle head part, and the length of the developing layer 4 in the axial direction of the electrode needle 1 is 10 mm.
The inventors of the present application considered that the setting area of the development layer 4 is variable since the depth probe 2 and the electrode needle 1 are both housed in the insulating sleeve 3. To this end, as shown in fig. 2, the present application provides one possible implementation manner for the electrode needle assembly 100 as follows:
the development layer 4 is provided to the tip portion 21 of the depth probe.
In this embodiment, since the tip portion 21 of the depth probe and the tip portion 111 of the electrode needle are located relatively close to each other, it is considered that the imaging layer 4 is provided on the tip portion 21 of the depth probe, and the appearance image around the tumor tissue region can be reflected relatively accurately.
In one example, the developing layer 4 is provided on the surface of the depth probe 2, and has a thickness of 0.1 mm in the radial direction and a length of 5 mm in the axial direction of the depth probe 2.
The inventors of the present application considered that, since the depth probe 2 and the electrode needle 1 are both sheathed in the insulating sleeve 3, the process operation is more facilitated by directly coating the developer on the insulating sleeve 3 than by coating the electrode needle 1 and the depth probe 2 with the developer. To this end, as shown in fig. 3, the present application provides one possible implementation manner for the electrode needle assembly 100 as follows:
the developing layer 4 is provided on the inner wall or the outer wall of the puncture end of the insulating sleeve 3.
In this embodiment, when the developing layer 4 is disposed on the inner wall or the outer wall of the insulating sleeve 3, the diameter of each needle tube is not increased by coating the developer on the electrode needle 1 or the depth probe 2, and the process operation is more convenient.
In one example, the development layer 4 is provided on the inner wall of the piercing end of the insulating sleeve 3, and has a thickness of 0.1 mm in the radial direction and a length of 5 mm in the axial direction of the insulating sleeve 3.
In one example, the development layer 4 is provided on the outer wall of the piercing end of the insulating sleeve 3, and has a thickness of 0.1 mm in the radial direction and a length of 10 mm in the axial direction of the insulating sleeve 3.
The inventors of the present application considered that the developing layer itself has a certain thickness, and the design and processing of other members are affected to some extent. To this end, the present application provides one possible implementation manner for the electrode needle assembly 100 as follows:
the development layer 4 is integrated with the wall of the puncture end of the insulating sleeve 3.
In the present embodiment, directly blending the material of the development layer 4 into the tube wall of the insulation sleeve 3 when designing the insulation sleeve 3 can reduce the influence of the additionally increased thickness of the development layer 4 on the overall thickness of the tube wall of the insulation sleeve 3.
Based on the same inventive concept, the embodiments of the present application provide an ablation apparatus, including but not limited to: any one of the electrode needle assemblies 100 and the main machine as set forth in the above embodiments.
The main machine is electrically connected with the electrode needle 1 and the depth probe 2 in the electrode needle assembly 100, respectively.
Optionally, the host includes, but is not limited to, a pulse voltage generator for generating high voltage electrical pulses to be transmitted to the electrode needle 1, and the electrode needle 1 then sends the high voltage electrical pulses to the tumor tissue of the patient, so as to promote apoptosis.
The pulse voltage generator is divided into two types, namely a general type and a special type. The general pulse voltage generator is usually used in laboratories to perform general scientific experiments, and is characterized in that parameters such as repetition frequency, pulse width, amplitude, polarity and logic level of the generated pulse signal can be adjusted. Especially, the variation range of the repetition frequency is wide so as to meet the test requirement for experiments. The pulse signal generator is used for developing, testing, producing and maintaining special equipment. Such pulse generators are either complex in waveform or require special specifications. Optionally, the host computer includes, but is not limited to, a depth detector for connecting the depth probe 2 and measuring the depth information of the electrode needle 1 extending into the human tissue in real time.
In this embodiment, since the ablation device employs any one of the electrode needle assemblies 100 provided in the foregoing embodiments, the principle and technical effects thereof refer to the foregoing embodiments, and are not described herein again.
For convenience of understanding, the present application further provides a specific example of the technical solution as follows:
in the treatment of a 3 cm renal malignancy, physicians often opt to use irreversible electroporation to overcome the difficulties associated with tumor size because of the limited efficacy of conventional radiofrequency and cold ablation techniques in treating such tumors. In the case of tumor electric field therapy using irreversible electroporation, the electrode needle assembly 100 of the present embodiment is used in conjunction with a pulsed electric field generator to simultaneously apply to the tumor region of a patient. In the embodiment of the present application, an electrode needle assembly 100 is provided, in which the length of an electrode needle 1 is 50 mm, and the diameter of an electric conductor 11 is 0.4 mm. The length of the needle head part 111 of the electrode needle is 10 mm, a conductive region 1111 is arranged on the needle head part 111 of the electrode needle, the length of the conductive region 1111 along the axial direction of the electrode needle 1 is 5 mm, the other parts of the conductive body 11 except the conductive region 111 are coated with an insulating layer 12, and the thickness of the insulating layer 12 is 0.1 mm. The depth probe 2 has a length of 45 mm and a diameter of 0.2 mm. The insulating sleeve 3 in the electrode needle assembly 100 is fixedly sleeved outside the electrode needle 1 and the depth probe 2, and the thickness of the pipe wall of the insulating sleeve 3 is 0.2 mm. The end face of the piercing end of the insulating sleeve 3 is a plane and forms 15 degrees with the direction of the insulating sleeve 3 on the axis. The conductive region 1111 of the needle portion 111 of the electrode needle is entirely exposed from the puncture end of the insulating sleeve 3, and the portion of the needle portion of the depth probe 2 exposed from the puncture end of the insulating sleeve 3 has a length of 2 mm in the axial direction. The outer wall surface of the puncture end of the insulating sleeve 3 is coated with a developing layer 4, the thickness of the developing layer 4 in the radial direction of the insulating sleeve 3 is 0.1 mm, and the length in the axial direction of the insulating sleeve is 2 mm. During operation, a doctor inserts a positive electrode needle assembly 100 and a negative electrode needle assembly 100 into the approximate range of two sides of tumor tissue in parallel, an electrode needle 1 is connected with a pulse voltage generator, a depth probe 2 is connected with a depth detector, and a CT analyzer is used for imaging and scanning the tumor tissue area of a patient. The visualization layer 4 on the surface of the insulating sleeve 3 will show the appearance of the surrounding tumor tissue under CT. At this time, according to the accurate depth data transmitted to the depth detector by the depth probe 2, the electrode needle assembly 100 is adjusted to a proper position, then the switch of the pulse voltage generator is turned on, so that the electrode needle 1 releases high-voltage electric pulses to the tumor tissue area, a plurality of nanoscale irreversible pore canals are formed on the surface of a cell membrane, the cell homeostasis is destroyed, the cell apoptosis is promoted, cell fragments after the cell apoptosis can be phagocytized by phagocytes in vivo, and meanwhile, the organism immune reaction occurs, so that the effect of controlling the tumor is achieved.
By applying the embodiment of the application, at least the following beneficial effects can be realized:
1. the depth probe 2 and the electrode needle 1 are fixed in the insulating sleeve 3, so that the electrode needle 1 and the depth probe 2 synchronously act on a focus area after the electrode needle assembly 100 is inserted into a human body, and the depth probe 2 can accurately measure the depth data of the electrode needle 1 in the human body. The electrode needle 1 can adjust the specific position of the conductive region 1111 according to the depth data fed back by the depth probe 2, so that the discharge region of the electrode needle 1 can be determined more accurately.
2. The electrode needle assembly 100 is provided with a developing layer 4 in a partial region thereof, and can display an external image of tumor tissue around the electrode needle 1 in cooperation with a detection device. Thereby more accurately judging the position of the tumor cells.
3. The end surface of the piercing end of the insulating sleeve 3 is inclined to facilitate the electrode needle assembly 100 to be inserted into the human tissue more easily and to form a smaller wound on the skin surface.
4. When the end face of the puncture end of the insulating sleeve 3 is a conical surface, the needle head portion 21 of the electrode needle 1 or the depth probe can be used as the needle head portion of the insulating sleeve 3 to puncture the human tissue. Therefore, the number of the tips which can stimulate human tissues can be reduced, and the pain of patients can be relieved.
5. The actual conductive region 1111 of the electrode needle 1 can be limited by coating a partial region of the surface of the electrode needle 1 with an insulating material. Meanwhile, the coating area of the developer can be designed with the area covered with the insulating layer 12 as a reference surface.
6. The developing layer 4 is disposed at a position close to the conduction region 1111, so that an accurate and clear appearance image of the tumor tissue can be observed more intuitively. Meanwhile, the area of the developing layer 4 is reduced, so that the using amount of the developer is reduced, the risk that the developer possibly falls off and remains in the body of a patient is reduced, and the manufacturing cost of the electrode needle 1 is saved.
7. Since the tip portion 21 of the depth probe and the tip portion 111 of the electrode needle are located relatively close to each other, it is considered that the imaging layer 4 is provided on the tip portion 21 of the depth probe, and the external image around the tumor tissue region can be reflected relatively accurately.
8. When the developing layer 4 is provided on the inner wall or the outer wall of the insulating sleeve 3, the influence of the diameter of each needle tube increased by coating the developer on the electrode needle 1 or the depth probe 2 is not caused, and the process operation is more convenient.
9. Directly blending the material of the development layer 4 into the wall of the insulating sleeve 3 when designing the insulating sleeve 3 can reduce the effect of the additionally increased thickness of the development layer 4 on the overall thickness of the wall of the insulating sleeve 3.
In the description of the present application, it is to be understood that the terms "center", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", and the like indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience in describing the present application and simplifying the description, but do not indicate or imply that the referred device or element must have a particular orientation, be constructed in a particular orientation, and be operated, and thus should not be construed as limiting the present application.
The terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present application, "a plurality" means two or more unless otherwise specified.
In the description of the present application, it is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present application can be understood in a specific case by those of ordinary skill in the art.
In the description herein, particular features, structures, materials, or characteristics may be combined in any suitable manner in any one or more embodiments or examples.
The foregoing is only a partial embodiment of the present application, and it should be noted that, for those skilled in the art, several modifications and decorations can be made without departing from the principle of the present application, and these modifications and decorations should also be regarded as the protection scope of the present application.
Claims (10)
1. An electrode needle assembly, comprising:
the needle head part of the electrode needle is provided with a conductive area for outputting high-voltage pulse for electroporation ablation;
the depth probe is used for acquiring depth information of the electrode needle inserted into target biological tissue;
the insulating sleeve is fixedly sleeved outside the electrode needle and the depth probe and is used for penetrating into target biological tissues; part of the needle head part of the electrode needle is exposed out of the puncture end of the insulating sleeve, and/or part of the needle head part of the depth probe is exposed out of the puncture end of the insulating sleeve;
and the developing layer is arranged at least one of the electrode needle, the depth probe and the insulating sleeve and is used for developing in cooperation with the detection device.
2. The electrode needle assembly according to claim 1, wherein the end surface of the penetration end of the insulating sleeve is planar and makes an angle α with the direction of the insulating sleeve on the axis, 0 < α < 90 °.
3. The electrode needle assembly according to claim 1, wherein the end surface of the penetration end of the insulating sleeve is tapered.
4. The electrode needle assembly according to claim 1, wherein the electrode needle includes: an electrical conductor and an insulating layer;
the insulating layer covers part of the surface of the electric conductor in a mode of exposing part of the needle head part of the electrode needle and is used for shielding high-voltage pulses output by the electric conductor;
the developing layer is arranged in a laminating mode with at least part of the insulating layer;
the surface of the conductive body not covered by the insulating layer forms the conductive region.
5. The electrode needle assembly of claim 4, wherein at least a portion of the developer layer is disposed in a layer overlying the insulating layer proximate the conductive region.
6. The electrode needle assembly according to claim 1, wherein the electrode needle includes: an electrical conductor and an insulating layer;
the insulating layer covers part of the surface of the electric conductor in a mode of exposing part of the needle head part of the electrode needle and is used for shielding high-voltage pulses output by the electric conductor;
at least part of the developing layer is fused with the insulating layer into a whole;
the surface of the conductive body not covered by the insulating layer forms the conductive region.
7. The electrode needle assembly of claim 1, wherein the visualization layer is disposed at a tip portion of the depth probe.
8. The electrode needle assembly according to claim 1, wherein the visualization layer is disposed on an inner wall or an outer wall of the puncture end of the insulating sleeve.
9. The electrode needle assembly according to claim 1, wherein the visualization layer is integrated with a wall of the puncture tip of the insulating sleeve.
10. An ablation device, comprising: the electrode needle assembly of any one of claims 1-9, and a host machine;
the host is respectively electrically connected with the electrode needle and the depth probe in the electrode needle assembly.
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| CN202111171837.9A CN113907868A (en) | 2021-10-08 | 2021-10-08 | Electrode needle assembly and ablation apparatus |
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