CN115337054A - Plasma-assisted rotary-cut biopsy needle for breast tumors - Google Patents
Plasma-assisted rotary-cut biopsy needle for breast tumors Download PDFInfo
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- CN115337054A CN115337054A CN202211276280.XA CN202211276280A CN115337054A CN 115337054 A CN115337054 A CN 115337054A CN 202211276280 A CN202211276280 A CN 202211276280A CN 115337054 A CN115337054 A CN 115337054A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/0233—Pointed or sharp biopsy instruments
- A61B10/0266—Pointed or sharp biopsy instruments means for severing sample
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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
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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
- 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
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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
- 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
- A61B2018/00589—Coagulation
Abstract
The invention relates to the technical field of medical instruments and discloses a plasma-assisted rotary-cut biopsy needle for breast tumors. The invention provides a composite blade head of a plasma piercing cutting edge, which is combined with a mechanical piercing cutting edge, point discharge and low excitation voltage. The invention provides a biopsy needle with an ablation hemostasis function, which takes a puncture blade seat with the same outer diameter and an outer needle tube as two electrodes of the ablation hemostasis, so that plasma is closer to a damaged tissue, and the ablation hemostasis is performed on the tissue in a safer low-voltage mode.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a plasma-assisted rotary-cut biopsy needle for breast tumors.
Background
The biopsy needle is a medical instrument for rotary cutting tissue operation, and generally comprises a needle body, a handle, a collection bin and a vacuum pipeline; the needle body generally comprises a puncture blade, an outer needle tube and an inner needle tube; the puncture blade at the front end of the outer needle tube is used for mechanically puncturing and cutting human tissues, the inner needle tube is provided with a rotary cutting edge, the outer needle tube is provided with a radial sampling notch, the inner needle tube can rotate, advance and retreat in the outer needle tube, and the vacuum pipeline is communicated with the outer needle tube.
The rotary cut tissue operation process comprises: under the guidance of the radiography technology, a puncture blade is opened, a biopsy needle is inserted to a preset depth, a vacuum pipeline is used for providing a vacuum environment for an outer needle tube, under the negative pressure, a tissue to be biopsied enters a sampling notch, an inner needle tube rotates, moves forwards and backwards to cut the tissue to be biopsied off in a rotary mode, and the cut tissue is conveyed to a collection bin through the negative pressure.
The breast tumor is a female high-incidence tumor disease, and in order to improve the survival rate, the female is generally recommended to be screened by regular breast tumor biopsy, so that a breast tumor early-stage report is obtained in advance.
When the biopsy needle is applied to breast tumor biopsy, a puncture blade needs to be inserted into a breast to obtain tissues. The macroscopic tissue structure of the breast is usually composed of the nipple, areola, mammary gland, fat and supporting structures (the cubital ligament), which are all subcutaneous tissues.
Because the breast is different from other parts of the tissue structure, the breast and the supporting structure are very tough, the resistance is larger during puncture, especially the breast tissue has the characteristics of large quantity and high toughness, when mechanical puncture is adopted, puncture can be carried out by large force, but too large puncture force is easy to cause too deep puncture depth, so that the work can be carried out by skillful doctors, and the adaptability of the biopsy needle is lower.
When in biopsy, rotary cutting is needed to take tissues for detection, so that tissue defects are caused, bleeding often occurs on the damaged section, at present, hemostasis is performed by adopting medicines and a postoperative pressurization mode, but hematoma is easy to occur.
At present, in order to break open hard skin surfaces while achieving skin surface hemostasis; application No. 201822235388.X proposes a biopsy needle in which a puncture blade is used as an electrode and a neutral electrode is provided on the skin surface, wherein the cutting edge portion of a cutting member is changed to be an operation electrode, and a high-frequency current is conducted to a lesion tissue to be cut through the cutting edge of a cutting knife tube, thereby cutting the tissue and stopping bleeding. The biopsy needle needs to use a metal plate with a large area to contact the buttocks or thighs of a patient as a neutral pole, and when the neutral pole is in poor contact with the skin of the human body, high energy can be generated locally, and scalding is easy to occur, so that the safety is poor. The biopsy needle is a radio frequency knife taking human tissues as impedance, utilizes the function of a puncture blade as a radio frequency electrode when breaking the human tissues, still adopts mechanical cutting when breaking the inside of the tissues, and starts a hemostasis mode when exiting.
At present, in order to solve the bleeding caused by rotary cutting, application number 202121002482.6 proposes a technical scheme that an outer needle tube and an inner needle tube are simultaneously used as electrodes, and the specific description is as follows: when high-frequency waves are input from the first interface or the second interface, high-frequency radio waves are generated between the cutting edge (equivalent to an inner needle tube) and the edge of the sampling groove of the puncture tube (equivalent to an outer needle tube), and when the high-frequency radio waves pass through tissues in the sampling groove, water molecules in the tissues are instantaneously rapidly oscillated due to the resistance of the tissues to the radio waves, and water molecules in cells are evaporated so as to destroy the cells or volatilize the cells. When high-frequency electric waves encounter water molecules in cells, the resistance of the water molecules to the electric waves enables the energy of the electric waves to be converted into mechanical energy, the water molecules are caused to oscillate fiercely instantly, the water molecules in the cells are converted into gaseous water instantly from liquid water, and the cells are broken under the condition of expansion of the volume of the water molecules to form tissue separation and realize cutting; and the heat effect is utilized to denature the local cell coagulation protein of the soft tissue so as to achieve effective hemostasis. The technical scheme is equivalent to that two cutting edges of the scissors are set to be electrodes, the electrodes are described to be radio-frequency knives, and the radio-frequency knives are different from the radio-frequency knives described in the previous patent in that the radio-frequency knives are monopolar radio-frequency knives and the radio-frequency knives are bipolar radio-frequency knives, and the radio-frequency knives directly act on tissues to enable the inside of the tissues to oscillate, so that the cutting and the hemostasis are realized.
Referring to fig. 7 and 8, fig. 7 and 8 show the rotary cutting process of application No. 202121002482.6. In the state of fig. 7, the inner needle tube 15 and the outer needle tube 14 are respectively used as 2 electrodes, and the negative pressure makes the tissue 50 protrude downwards by a tissue rotary-cut area 51; in the state of fig. 8, the inner needle tube 15 and the outer needle tube 14 must be simultaneously contacted with the rotary-cut tissue region 51, so that the rotary-cut tissue region 51 is used as an impedance object, and the tissue inside the rotary-cut tissue region is denatured, thereby achieving the purposes of rotary-cut and hemostasis. This atherectomy procedure may denature the atherectomy area 51 and may not be used for biopsy. The rotary cutting process makes the inner needle tube 15 as an electrode, and the inner needle tube 15 needs to perform hemostatic rotation, advance, retreat, and other actions at the same time, so that the inner needle tube is difficult to conduct electricity when being added with an electrode function, and a complex mechanical design is caused.
Currently, there is a need for a biopsy needle that provides smooth cutting and hemostasis of the resected portion of the breast without compromising the viability of the resected tissue.
Disclosure of Invention
The invention aims to provide a plasma-assisted rotary-cut biopsy needle for breast tumors, and provides a biopsy needle with smoother puncture and cutting during breast biopsy and a biopsy needle with good ablation hemostasis effect after rotary cutting.
In order to solve the technical problem, the invention adopts the following scheme:
the plasma-assisted rotary-cut biopsy needle for the breast tumor comprises a needle body, wherein the needle body comprises an outer needle tube, an insulator seat, a puncture blade seat and a puncture blade;
the insulator seat is inserted into the front end of the outer needle tube and is used for assembling the puncture blade seat;
the puncture blade seat is inserted into the front end of the insulator seat and is used for assembling the puncture blade;
the puncture blade is inserted into the front end of the puncture blade seat and used for mechanical puncture cutting;
the puncture blade seat is insulated and isolated from the puncture blade by an insulating coating;
the puncture blade seat and the outer needle tube are insulated and isolated by the insulator seat;
the puncture blade seat and the puncture blade form a group of conducting electrodes which are used as plasma auxiliary puncture cutting electrodes and are used for the puncture blade to perform mechanical puncture cutting and simultaneously enable a saline medium between the puncture blade seat and the puncture blade to form plasma for auxiliary mechanical puncture cutting;
the puncture blade seat and the outer needle tube form another group of conducting electrodes which are used as plasma ablation hemostasis electrodes and used for enabling a saline medium between the puncture blade seat and the outer needle tube to form plasma for ablation hemostasis.
The design principle of the invention is as follows: the puncture blade seat is additionally arranged at the front end of the outer needle tube and the rear end of the puncture blade, the puncture blade seat, the puncture blade and the puncture blade seat are all electric conductors, and the puncture blade seat is used as a common electrode so as to obtain the functions of assisting mechanical puncture and cutting and ablation hemostasis.
The auxiliary mechanical piercing and cutting functions are explained as follows:
when the puncture blade seat and the puncture blade form a group of conducting electrodes, the conducting electrodes have the function of assisting mechanical puncture cutting, alternating voltage with certain frequency can be loaded on the puncture blade seat and the puncture blade, an electric field can be formed by the puncture blade seat and the puncture blade, a pointed cone-shaped electric field pointing to the front is formed by the electric field on the basis of the tip of the puncture blade and the circumferential surface of the puncture blade seat, the electric field wraps the puncture blade and ionizes a saline medium near the tip of the puncture blade, the ionized saline medium can influence the molecular bond fracture of tough cells of mammary gland tissues and promote the cells to disintegrate, the toughness of the influenced mammary gland tissues is reduced, the mammary gland tissues are easier to be cut by mechanical puncture, the mammary gland tissues can be conveniently punctured by the puncture blade, the puncture process is smooth, the resistance is reduced, and the mechanical strength is easier to control by doctors. Compared with a high-frequency knife and a radio-frequency knife, the plasma knife is composed of the puncture blade seat and the puncture blade and is characterized in that the forward puncture blade is used as an electrode, the annular puncture blade seat is used as another electrode, and finally a plasma region with a specific forward pointed cone shape is formed. It does not act directly on the tissue structure but on the saline medium. The high-frequency knife and the radio-frequency knife take the tissue structure as an impedance object, an electric field is applied to the tissue structure, the temperature is high, the control is not easy, and the normal sampling tissue is easily influenced. The plasma knife of the invention has the characteristic of low-temperature cutting, is not used as a main cutting knife but only used as an auxiliary effect, and aims to enable the tissue in front of the puncture blade to be under the influence of a plasma saline medium, so that the tissue is easier to be punctured and cut mechanically. The puncture blade mechanically punctures and cuts the broken tissue in the front, the plasma continuously separates the auxiliary broken tissue, the mechanical function of the puncture blade has the guiding function at the moment, and the plasma function of the puncture blade has the auxiliary cutting function.
The ablation hemostasis function is electrocoagulation hemostasis ablation, which is specifically explained as follows:
when the puncture blade seat and the outer needle tube form another group of conducting electrodes, another alternating voltage with a certain frequency is loaded on the puncture blade seat and the outer needle tube, an electric field is formed by the puncture blade seat and the outer needle tube, and the puncture blade seat and the outer needle tube are designed to have the same outer diameter. The puncture blade seat and the outer needle tube are used at the following time: after rotary cutting operation, namely mechanical rotary cutting of a rotary cutting area of the tissue is taken out, a tissue cavity is formed at the original position of the rotary cutting area of the tissue, the tissue cavity is provided with a rotary cutting surface, the rotary cutting surface is a bleeding surface, at the moment, the biopsy needle can retreat for a certain distance under the guidance of an imaging technology, so that the tissue cavity is just positioned in an effective plasma area of a puncture blade seat and an outer needle tube, power supply under an ablation mode is executed at the moment, a plasma saline medium can be filled in the tissue cavity, cells on the surface of the tissue cavity are ablated, the process is regarded as electrocoagulation hemostasis ablation, and the purpose of hemostasis after rotary cutting is achieved. Meanwhile, the outer needle tube is used as an electrode, so that the electrode is closer to a damaged tissue surface which is concave in a tissue cavity, and the ablation hemostasis effect is improved. Therefore, the invention does not need to start negative pressure in the ablation process, so that the rotary cut damaged tissue surface sinks, thereby reducing the complexity of operation and accelerating the operation process. The operation process of the invention is roughly as follows: forming negative pressure operation, rotary cutting operation, negative pressure releasing operation, section taking out and ablation operation.
Preferably, the piercing blade includes a base body section inserted into a front end of the piercing blade holder, and a blade section provided at a front end of the base body section; the land section comprises at least 2 intersecting lands; the blade face comprises a conductive exposed area and an insulating coated area, the width of the blade face is M by taking the intersecting line of the blade face as a base line, the occupied range of M is defined as the conductive exposed area, the rest range of the blade face is defined as the insulating coated area, the insulating coated area and the substrate section are coated and shielded by the insulating coating, and the conductive exposed area of the blade face is used as an exposed electrode of the piercing edge.
In the prior art, since the conventional plasma knife is provided with 2 side-by-side electrodes at the front end of the knife, i.e. 2 electrodes are simultaneously arranged on the front end surface, the distance between the 2 electrodes is relatively low, and therefore, the plasma knife can work with relatively low breakdown voltage, and the plasma knife is not provided with a cutting edge for mechanical piercing cutting.
In the present invention, since the auxiliary piercing and cutting function is realized on the basis of the biopsy needle having the piercing blade, it is necessary to retain the piercing blade instead of replacing the piercing blade with a conventional leading-end two-electrode plasma blade. Therefore, in the present invention, 2 technical difficulties need to be faced, first how to select the electrode for forming the plasma, and second how to achieve a lower operating voltage.
In the present invention, the piercing blade of the electrical conductor is selected, the piercing blade itself is used as the mechanical piercing and cutting blade and also as the electrode, and since the piercing blade itself is an electrical conductor and occupies the front section of the cutter, the second electrode cannot be mounted at the front end. In order to solve the problem, the invention adopts a puncture blade seat additionally provided with an electric conductor as a second electrode. However, the two are required to be insulated and isolated, and the distance between the two is undoubtedly increased, so that the breakdown voltage is required to be increased, and the safety problem is easily caused. Therefore, in order to reduce the breakdown voltage, the distance between the piercing blade seat and the piercing blade needs to be reduced as much as possible, for this reason, the invention is realized by adopting the insulating coating, the thickness of the insulating coating is extremely small, the small distance between the piercing blade seat and the piercing blade can be ensured as much as possible, and in order to increase the plasma forming effect, the invention provides the limitation on the coating range of the insulating coating, and the limitation can enable only partial area of the blade section to be a discharge area so as to form a point discharge effect in the air.
To summarize, the piercing edge is divided into a base section and a cutting edge section, and the piercing edge is provided with an insulating coating on its surface. Because the puncture blade seat and the puncture blade are both electric conductors, the puncture blade seat and the puncture blade need to be insulated and isolated, generally, a mounting seat is adopted between the puncture blade seat and the puncture blade for insulation and isolation, but by adopting the isolation mode, the distance between the puncture blade seat and the puncture blade can be increased, an electric field required by plasma is not easy to form, and in order to reduce breakdown voltage, the invention adopts an insulation coating as a technical means of insulation and isolation. In order to increase the breakdown effect, the invention adopts a point discharge means, and the insulating coating is required to coat all the puncture blades as much as possible, and only a discharge area near the base line is reserved for the puncture blades, so that the point discharge is formed. The so-called base line is the intersection of 2 facets, which also means that the base line is a tip. Therefore, the technical means of the invention forms a composite blade head which is combined with a mechanical piercing cutting blade, a point discharge and a low excitation voltage plasma piercing cutting blade.
Preferably, M is equal to the width dimension of the facet itself or M is between 0.1mm and 0.2mm. When M is 0.1mm to 0.2mm, the effect of point discharge can be achieved.
Preferably, the electrical parameters of the radio frequency power supply for assisting mechanical puncture cutting are as follows: frequency: 100kHz, voltage: more than or equal to 175V; therefore, the voltage of the puncture blade seat and the puncture blade can be as low as 175V, namely, plasma can be realized at 175V, and the voltage is lower and safer.
Preferably, the edge section may be a four-sided edge or a two-sided edge.
Preferably, when the edge section is a four-sided edge, the edge section includes 4 intersecting edge faces, and the 4 intersecting edge faces are respectively:
a left upper edge surface, a right upper edge surface, a left lower edge surface and a right lower edge surface;
the left upper edge surface and the right upper edge surface are intersected on an upper edge line;
the left lower edge surface and the right lower edge surface are intersected at a lower edge line;
the left upper edge surface and the left lower edge surface are intersected at a left edge line;
the right upper edge surface and the right lower edge surface are intersected on a right edge line;
the upper edge line, the lower edge line, the left edge line and the right edge line are intersected at an original point;
the upper edge line, the lower edge line, the left edge line and the right edge line are all in inclined relation with the front-back axis of the outer needle tube;
and at least 1 of the upper edge line, the lower edge line, the left edge line and the right edge line is used as a base line of the conductive bare area.
Preferably, when the cutting edge section is a double-sided cutting edge, the cutting edge section comprises 2 intersecting cutting faces, and the 2 intersecting cutting faces are respectively: a left edge face and a right edge face; the left blade face and the right blade face are intersected at a blade line, the blade line is perpendicular to the front-back axis of the outer needle tube, and the blade line is used as a base line of the conductive exposed area.
Although the present invention is described with respect to a four-sided edge, a two-sided edge, any other edge segment having intersecting facets should fall within the scope and range of equivalents of the present invention.
Preferably, the insulating coating is a ceramic coating or a teflon coating.
Preferably, when the puncture blade seat and the puncture blade form a group of conducting electrodes, the puncture blade seat and the puncture blade are loaded with an auxiliary radio frequency power supply for mechanical puncture cutting, and a radio frequency electric field is formed between the puncture blade seat and the puncture blade so that a saline medium between the puncture blade seat and the puncture blade is converted into plasma; when the puncture blade seat and the outer needle tube form a group of conducting electrodes, the puncture blade seat and the outer needle tube are loaded with a radio frequency power supply for ablation hemostasis, and a radio frequency electric field is formed between the puncture blade seat and the outer needle tube so that saline medium between the puncture blade seat and the outer needle tube is converted into plasma.
Preferably, the electrical parameters of the radio frequency power supply for assisting mechanical puncture and cutting are as follows: frequency: 100kHz, voltage: more than or equal to 175V.
Preferably, the inner part of the outer needle tube is provided with a partition plate, and the partition plate divides the outer needle tube into: the vacuum channel at the upper layer, the saline water and the conducting wire channel at the lower layer; an inner needle tube which is connected with a driver and executes rotation, forward movement and backward movement is assembled in the vacuum channel; a lead A and a lead B are arranged in the saline and lead channel; the lead A is electrically connected with the puncture blade, and the lead B is electrically connected with the puncture blade seat; the puncture blade seat is radially provided with a saline water gap, and the saline water and lead channels are communicated with the saline water gap.
Preferably, the outer needle tube is radially slotted with a sampling slot.
The invention has the following beneficial effects: the invention provides a composite blade head of a plasma puncture cutting blade combined with a mechanical puncture cutting blade, point discharge and low excitation voltage, which is used for cutting tough mammary tissue by plasma and mechanical combination. The biopsy needle with the ablation hemostasis function is provided, the puncture blade seat with the same outer diameter and the outer needle tube are used as two electrodes of ablation hemostasis, so that plasma is closer to damaged tissues, and ablation hemostasis is performed on the tissues in a safer low-voltage mode.
Drawings
Fig. 1 is an overall schematic view of a biopsy needle.
Fig. 2 is a schematic structural view of the needle body.
Fig. 3 is a side sectional view of the needle body.
FIG. 4 is a schematic view of the structure of the needle cannula.
Fig. 5 is a schematic view of the structure of the piercing blade.
Fig. 6 is a front schematic view of the piercing edge.
Fig. 7 is a schematic diagram of a rotary cutting operation according to the prior art.
Fig. 8 is a schematic diagram of the hemostatic action of the prior art.
Fig. 9 is a schematic diagram of the rotary cutting operation of the present invention.
Fig. 10 is a schematic view of the hemostatic action of the present invention.
Fig. 11 is a schematic diagram of the present invention.
The reference numerals are illustrated below:
10. a needle body 20, a handle 30, a collection bin 40 and a vacuum pipeline;
11. a piercing edge, 111, an insulating coating,
12. a puncture blade seat 121, a saline water gap 122, an extension clamp body,
13. an insulator seat is arranged on the base body,
14. an outer needle tube 141, a sampling notch 142, a vacuum channel 143, a saline and lead channel 144, a clapboard 145 and a buckle;
15. an inner needle tube 151, a rotary cutting edge 152, an air outlet 153 and a tissue channel,
16. the length of the conducting wires A,17 and B,
11A, a left upper blade surface, 11A1, a left upper insulation coating area, 11A2, a left upper conductive exposed area,
11B, a right upper blade surface, 11B1, a right upper insulation coating area, 11B2, a right upper conductive exposed area,
11C, a left lower blade surface, 11C1, a left lower insulation coating area, 11C2, a left lower conductive exposed area,
11D, a right lower blade surface, 11D1, a right lower insulation coating area, 11D2, a right lower conductive exposed area,
11M, the left side surface of the base body, 11N, the right side surface of the base body,
50. tissue 51, tissue atherectomy area 52, tissue cavity.
Detailed Description
The present invention will be described in further detail with reference to examples and drawings, but the present invention is not limited to these examples.
Example 1
Referring to fig. 1, a biopsy needle generally comprises a needle body 10, a handle 20, a collection chamber 30, and a vacuum line 40. Referring to fig. 2, a needle body 10 generally comprises a piercing blade 11, an outer needle cannula 14, and an inner needle cannula 15.
Referring to fig. 9 and 10, the piercing blade 11 at the front end of the outer needle tube 14 is used for mechanically piercing and cutting the tissue 50 of the human body, the inner needle tube 15 has a rotary cutting edge 151, the outer needle tube 14 has a radial sampling notch 141, the inner needle tube 15 can rotate, advance and retreat in the outer needle tube 14, and the vacuum line 40 is communicated with the outer needle tube 14.
Referring to fig. 9, the puncturing operation process is as follows: guided by the imaging technique, the biopsy needle is inserted to a predetermined depth by opening the puncture blade 11.
Referring to fig. 10, the rotary cutting operation process is: the vacuum tube 40 is used to provide a vacuum environment for the outer needle tube 14, the tissue 50 to be biopsied enters the sampling notch 141 under negative pressure, the inner needle tube 15 rotates, advances and retreats to rotary cut the tissue 50 to be biopsied, and the rotary cut tissue 50 is sent to the collection bin 30 through negative pressure.
The design schemes of the handle 20, the collection chamber 30 and the vacuum pipeline 40 are all the prior art, and are not described herein again, the focus of the discussion of the present embodiment is on the needle body 10, and the present embodiment is directed to design a plasma-assisted rotary-cut biopsy needle for breast tumor with plasma-assisted mechanical puncture cutting and ablation hemostasis.
Referring to fig. 1, the plasma-assisted rotary-cut biopsy needle for breast tumors comprises a needle body 10. Referring to fig. 2, the needle body 10 includes an outer needle tube 14, an insulator base 13, a piercing blade base 12, and a piercing blade 11, referring to fig. 3, the insulator base 13 is inserted into the front end of the outer needle tube 14 for assembling the piercing blade base 12, the piercing blade base 12 is inserted into the front end of the insulator base 13 for assembling the piercing blade 11, the piercing blade 11 is inserted into the front end of the piercing blade base 12 for mechanical piercing and cutting, the piercing blade base 12 is insulated from the piercing blade 11 by an insulating coating 111, and the piercing blade base 12 is insulated from the outer needle tube 14 by the insulator base 13.
Referring to fig. 11, the piercing blade seat 12 and the piercing blade 11 constitute a set of conductive electrodes, which are used as plasma-assisted piercing and cutting electrodes for the piercing blade 11 to perform mechanical piercing and cutting and simultaneously make the saline medium between the piercing blade seat 12 and the piercing blade 11 form plasma for assisting mechanical piercing and cutting.
Referring to fig. 11, the piercing blade holder 12 and the outer needle tube 14 constitute another set of conductive electrodes, which are used as plasma ablation hemostasis electrodes for enabling the saline medium between the piercing blade holder 12 and the outer needle tube 14 to form plasma for ablation hemostasis.
The puncture blade 11, the puncture blade seat 12 and the outer needle tube 14 are all electric conductors. Piercing blade holder 12 and outer cannula 14 are of uniform outer diameter construction, typically cylindrical, e.g., cylindrical, elliptical, cylindrical. The piercing blade 11 is a cutter having a blade face, and a conical piercing needle is not within the scope of the present invention, that is, the piercing blade 11 of the present invention needs to have piercing and cutting functions, whereas the conical piercing needle has only a piercing function and does not have a cutting function. The invention therefore requires the provision of a tool with at least 2 intersecting edge faces as piercing edges, for example a double-sided wedge.
The design principle of the invention is as follows: the invention is additionally provided with 1 puncture blade seat 12 which is arranged at the front end of an outer needle tube 14 and the rear end of a puncture blade 11, wherein the puncture blade seat 12, the puncture blade 11 and the puncture blade seat 12 are all electric conductors, and the puncture blade seat 12 is used as a common electrode so as to obtain the functions of auxiliary mechanical puncture cutting and ablation hemostasis.
Referring to fig. 9, 10 and 11, the auxiliary mechanical lancing and cutting function is explained as follows:
when the puncture blade seat 12 and the puncture blade 11 form a group of conducting electrodes, the conducting electrodes have the function of assisting mechanical puncture cutting, alternating voltage with certain frequency is loaded on the puncture blade seat 12 and the puncture blade 11, an electric field is formed by the puncture blade seat 12 and the puncture blade 11, a pointed cone-shaped electric field pointing to the front is formed by the electric field based on the tip of the puncture blade 11 and the circumferential surface of the puncture blade seat 12, the electric field wraps the puncture blade 11 and ionizes a saline medium near the tip of the puncture blade 11, the ionized saline medium can affect the molecular bond fracture of tough mammary gland tissue cells and promote cell disintegration, the toughness of the affected mammary gland tissue is reduced, the mammary gland tissue is easier to be cut by mechanical puncture, the puncture blade 11 can conveniently puncture the mammary gland tissue, the puncture process is smooth, the resistance is reduced, and the mechanical strength is easier to be controlled by doctors. Compared with a high-frequency knife and a radio-frequency knife, the plasma knife is composed of the puncture blade seat 12 and the puncture blade 11, and is characterized in that the forward puncture blade 11 is used as an electrode, the annular puncture blade seat 12 is used as another electrode, and finally a plasma region with a specific forward pointed cone shape is formed. It does not act directly on the tissue 50 but on the saline medium. The high-frequency knife and the radio-frequency knife take the tissue 50 as an impedance object, an electric field is applied to the tissue 50, the temperature is high, the control is not easy, and the normal tissue collection 50 is easily influenced. The plasma knife of the present invention has the characteristic of low temperature cutting, and is not used as a main cutting knife but only used as an auxiliary knife, and the purpose of the present invention is to make the tissue 50 in front of the piercing blade 11 under the influence of the plasma saline medium, so that the tissue 50 is easier to be pierced and cut mechanically.
Referring to fig. 9, 10 and 11, the ablation hemostasis function is electrocoagulation hemostasis ablation, which is explained as follows:
when the piercing blade seat 12 and the outer needle tube 14 form another set of conductive electrodes, the piercing blade seat 12 and the outer needle tube 14 will load another ac voltage with a certain frequency. Since the puncture blade holder 12 and the outer needle tube 14 form an electric field and the puncture blade holder 12 and the outer needle tube 14 are designed to have the same outer diameter, the electric field forms an annular electric field with reference to the outer peripheral surfaces of the puncture blade holder 12 and the outer needle tube 14. The area near the annular electric field is regarded as a plasma area, and the saline medium nearby is plasmatized, so that the purpose of hemostasis and ablation is achieved. The puncture blade holder 12 and the outer needle tube 14 are used when the rotary-cut operation is performed, that is, after the rotary-cut tissue section 51 is mechanically rotary-cut and taken out, a tissue cavity 52 is formed in the original position of the rotary-cut tissue section 51, and the tissue cavity 52 has a rotary-cut surface, which is a bleeding surface. At this time, the biopsy needle of the present invention is retracted a certain distance under the guidance of the contrast technique, so that the tissue cavity 52 is exactly located in the effective plasma region of the piercing blade holder 12 and the outer needle cannula 14, and at this time, the power supply in the ablation mode is executed, and the plasma saline medium is filled in the tissue cavity 52, so as to ablate the cells on the surface of the tissue cavity 52, thereby achieving the purpose of hemostasis during the rotary cutting. The ablation of the invention is not carried out simultaneously with the rotary cutting, and meanwhile, the outer needle tube 14 is used as an electrode, so that the electrode is closer to the concave damaged tissue surface of the tissue cavity 52, and the ablation hemostasis effect is improved. The operation process of the invention is roughly as follows: forming negative pressure operation, rotary cutting operation, negative pressure releasing operation, section taking out and ablation operation.
Referring to fig. 5 and 6, the piercing edge 11 includes a base body segment inserted into the front end of the piercing-edge holder 12, and a cutting edge segment disposed at the front end of the base body segment, the cutting edge segment includes at least 2 intersecting cutting faces, the cutting faces include an electrically conductive exposed region and an insulating coated region, a region extending from an intersecting line of the cutting faces to the cutting faces by a width M is defined as the electrically conductive exposed region, the remaining regions of the cutting faces are defined as insulating coated regions, and the insulating coated regions of the base body segment and the cutting faces are coated and shielded by an insulating coating 111; the electrically conductive exposed region of the blade face serves as the exposed electrode of the piercing edge 11.
In the prior art, since the conventional plasma knife is provided with 2 side-by-side electrodes at the front end of the knife, i.e. 2 electrodes are simultaneously arranged on the front end surface, the distance between the 2 electrodes is relatively low, and therefore, the plasma knife can work with relatively low breakdown voltage, and the plasma knife is not provided with a cutting edge for mechanical piercing cutting.
In the present embodiment, since the auxiliary piercing and cutting function is realized on the basis of the biopsy needle having the piercing blade, it is necessary to retain the piercing blade instead of replacing the piercing blade with the conventional leading end two-electrode plasma blade. Therefore, in the present invention, 2 technical difficulties need to be faced, first how to select the electrode for forming the plasma, and second how to achieve a lower operating voltage.
In this embodiment, the piercing blade itself of the electrical conductor is selected as both the mechanical piercing and cutting blade and the electrode, and since the piercing blade itself is an electrical conductor and occupies the entire front section of the cutter, the second electrode cannot be attached to the front end. To solve this problem, the present invention employs a piercing blade holder 12 with an additional electrical conductor as the second electrode. However, the two are required to be insulated and isolated, and the distance between the two is undoubtedly increased, so that the breakdown voltage is required to be increased, and the safety problem is easily caused. Therefore, in order to reduce the breakdown voltage, the distance between the two needs to be reduced as much as possible, for this reason, the invention is realized by adopting the insulating coating 111, the thickness of the insulating coating 111 is extremely small, the distance between the piercing blade seat 12 and the piercing blade can be ensured to be small as much as possible, and in order to increase the plasma forming effect, the invention makes the coating range of the insulating coating 111 limited as above, the limitation can be that only partial area of the blade section is a discharging area, so as to form the point discharging effect in the air.
In the above technical means, the piercing blade 11 is divided into a base body section and a cutting edge section, the piercing blade 11 is required to be provided with the insulating coating 111 on the surface thereof, since the piercing blade holder 12 and the piercing blade 11 are both conductive bodies and both of them need to be insulated and isolated, generally, a mounting holder is used for insulating and isolating the two, but by adopting the isolation method, the distance between the piercing blade holder 12 and the piercing blade 11 is increased, an electric field required by plasma is not easily formed, and in order to reduce the breakdown voltage, the invention adopts the insulating coating 111 as the technical means of insulating and isolating. In order to increase the breakdown effect, the present invention employs a point discharge means, which requires the insulating coating 111 to coat all the piercing edges 11 as much as possible, leaving only a discharge region near the base line for the piercing edges 11, to which point discharge is formed. The so-called base line is the intersection of 2 facets, which also means that the base line is a tip.
Under the technical means, a composite blade head which is combined with a mechanical piercing cutting edge, a point discharge and a low excitation voltage plasma piercing cutting edge is formed. Referring to fig. 11, the present invention has 3 electrodes, which are respectively an outer needle tube 14, a piercing blade seat 12, and a piercing blade 11, wherein the piercing blade seat 12 is used as a common electrode, and respectively forms a set of electrode pairs with the piercing blade 11 and the outer needle tube 14. The provision of piercing-blade holder 12 and insulating coating 111 simplifies the design complexity of the 2 functions described above. The puncture blade 11 and the puncture blade seat 12 form an electric field with a pointed cone pointing to the front end, and the puncture blade 11 is matched to realize puncture cutting together, and particularly has the effect of low resistance on cutting tough mammary tissue. The outer needle tube 14 and the outer needle tube 14 form an annular electric field, which is closer to a damaged tissue surface after rotary cutting, and ablation hemostasis can be realized without negative pressure support.
The further implementation mode is as follows: m is equal to the width dimension of the facet itself or M is 0.1mm to 0.2mm. When M is 0.1mm to 0.2mm, a point discharge effect can be achieved. The electrical parameters of the radio frequency power supply for assisting mechanical puncture and cutting are as follows: frequency: 100kHz, voltage: more than or equal to 175V; therefore, the voltage of the piercing blade holder 12 and the piercing blade 11 can be as low as 175V, that is, plasma can be realized at 175V, and the voltage is lower and safer.
The further implementation mode is as follows: the insulating coating 111 is a ceramic coating or a teflon coating.
The further implementation mode is as follows: when the puncture blade base 12 and the puncture blade 11 form a group of conducting electrodes, the puncture blade base 12 and the puncture blade 11 are loaded with an auxiliary radio frequency power supply for mechanical puncture cutting, and a radio frequency electric field is formed between the puncture blade base 12 and the puncture blade 11 so that saline medium between the puncture blade base 12 and the puncture blade 11 is converted into plasma.
The further implementation mode is as follows: when the puncture blade seat 12 and the outer needle tube 14 form a group of conducting electrodes, the puncture blade seat 12 and the outer needle tube 14 are loaded with a radio frequency power supply for ablation hemostasis, and a radio frequency electric field is formed between the puncture blade seat 12 and the outer needle tube 14 so that saline medium between the puncture blade seat 12 and the outer needle tube 14 is converted into plasma.
The further implementation mode is as follows: the electrical parameters of the radio frequency power supply for assisting mechanical puncture and cutting are as follows: frequency: 100kHz, voltage: more than or equal to 175V; specifically, voltage: can be set to 175V or 180V.
The further implementation mode is as follows: referring to fig. 4, the outer tube 14 is provided with a partition 144 inside, the partition 144 divides the outer tube 14 into: a vacuum passage 142 of the upper layer, and a saline and conducting line passage 143 of the lower layer, the inner needle tube 15 connected to the driver and performing rotation, forward and backward movements is installed in the vacuum passage 142, and the saline and conducting line passage 143 is installed with: the lead A16 is electrically connected with the puncture blade 11, and the lead B17 is electrically connected with the puncture blade seat 12; the piercing blade seat 12 is provided with a saline notch 121 along the radial direction, and the saline and lead passage 143 is communicated with the saline notch 121.
Referring to fig. 4, the saline introduction is also matched, so that the saline and the wire share one passage, namely the saline and the wire passage 143, wherein the saline flows out from the saline notch 121, and the saline notch 121 is arranged on the puncture blade base 12, so that the saline can be forwards spread to the puncture cutting area and backwards spread to the ablation hemostasis area on the basis of one notch.
The further implementation mode is as follows: referring to FIG. 4, the outer tube 14 is provided with a sampling notch 141 at the forward end thereof in the radial direction.
The further implementation mode is as follows: referring to fig. 4, the inner wall of the forward end of the outer needle cannula 14 may also be provided with a snap 145, whereby the mounting of the insulator seat 13 is facilitated by the snap 145.
The further implementation mode is as follows: referring to fig. 4, the inner needle tube 15 is provided with a rotary cutting edge 151 at the front end thereof, and the pattern of the rotary cutting edge 151 is not limited to that shown in fig. 3. Meanwhile, the inner needle tube 15 is further provided with an exhaust port 152, and the inner channel of the inner needle tube 15 is a tissue channel 153.
It should be noted that: the tip of the present invention is defined as the end away from the handle 20, and in the case of the outer needle tube 14, the outer needle tube 14 is generally mounted on the handle 20, the end of the outer needle tube 14 mounted on the handle 20 is the rear end, and the end of the outer needle tube 14 away from the handle 20 is the tip, and similarly, the tips of the inner needle tube 15, the piercing blade 11, and the piercing blade holder 12 are all the ends away from the handle 20. Note that the outer needle cannula 14 and the piercing blade holder 12 are not the aforementioned front end surface and rear end surface, but the outer needle cannula 14 and the piercing blade holder 12 are provided with discharge surfaces, i.e., the front end surface, i.e., the cutting edge surface, and specifically, two intersecting cutting edge surfaces.
Example 2
On the basis of the above embodiments, referring to fig. 5 and 6, the present embodiment provides a cutting tool with four edges as the cutting edge sections. The piercing blade 11 includes a base body section having at least a left base body side 11M and a right base body side 11N, and a blade section having a block structure in which the left base body side 11M, the right base body side 11N, and others are coated with an insulating coating 111, and particularly, the side inserted into the piercing blade holder 12 is coated with the insulating coating 111. In order to reinforce the piercing blade 11, the piercing blade holder 12 is further provided with an extension holder 122, and the extension holder 122 holds the left base body side surface 11M and the right base body side surface 11N.
The edge section comprises 4 intersecting edge faces, the 4 intersecting edge faces being: the cutting edge comprises a left upper cutting surface 11A, a right upper cutting surface 11B, a left lower cutting surface 11C and a right lower cutting surface 11D, wherein the left upper cutting surface 11A and the right upper cutting surface 11B are intersected on an upper cutting line, the left lower cutting surface 11C and the right lower cutting surface 11D are intersected on a lower cutting line, the left upper cutting surface 11A and the left lower cutting surface 11C are intersected on a left cutting line, the right upper cutting surface 11B and the right lower cutting surface 11D are intersected on a right cutting line, and the upper cutting line, the lower cutting line, the left cutting line and the right cutting line are intersected on an origin. The upper edge line, the lower edge line, the left edge line and the right edge line are all in inclined relation with the front-back axis of the outer needle tube 14. And at least 1 of the upper edge line, the lower edge line, the left edge line and the right edge line is used as a base line of the conductive bare area.
Referring to fig. 5 and 6, the upper edge line and the lower edge line are used as base lines of the conductive exposed area, and then the conductive exposed area is set, specifically: the left upper facet 11A is divided into: upper left insulation coating area 11A1, upper left electrically conductive bare area 11A2, upper right flank 11B is divided into: upper right insulating coating area 11B1, upper right conductive bare area 11B2, left lower blade face 11C is divided into: lower left insulating coating district 11C1, lower left electrically conductive naked district 11C2, right lower blade face 11D is divided into: the upper edge line of the upper left conductive bare area 11A2 and the upper right conductive bare area 11B2 is a symmetrical line and is adjacent to the upper edge line, and the lower edge line of the lower left conductive bare area 11C2 and the lower right conductive bare area 11D2 is a symmetrical line and is adjacent to the lower edge line.
The piercing blade 11 may be manufactured by: firstly, the whole base body section and the cutting edge section are coated with insulating coating layers integrally, and then the insulating coating layers in the area are ground by taking the conductive exposed area as a range in a grinding mode, so that the electric conductors in the area are exposed.
Example 3
On the basis of the above embodiments, the present embodiment provides a cutting tool with a cutting edge section being a double-sided edge. Schematic diagrams are not given, and reference can be made to fig. 5 and 6. The piercing blade 11 includes a base body section having at least a left base body side 11M and a right base body side 11N, and a cutting edge section, wherein the left base body side 11M, the right base body side 11N, and the other sides are coated with an insulating coating 111 if the base body section has a block structure, and particularly, the side inserted into the piercing blade holder 12 is coated with the insulating coating 111. In order to reinforce the piercing blade 11, the piercing blade holder 12 is further provided with an extension holder 122, and the extension holder 122 holds the base body left side surface 11M and the base body right side surface 11N.
The cutting edge section comprises 2 intersecting facets, the 2 intersecting facets being: a left edge face and a right edge face; the left and right blade faces intersect at a blade line which is perpendicular to the forward and backward axis of the outer needle tube 14 and serves as a base line of the conductive exposed area.
Examples 2 and 3 although only four-sided, two-sided edge illustrations are provided, any other edge segment having intersecting edge faces should fall within the intended and equivalent scope of the present invention.
The foregoing is only a preferred embodiment of the present invention, and the present invention is not limited thereto in any way, and any simple modification, equivalent replacement and improvement made to the above embodiment within the spirit and principle of the present invention still fall within the protection scope of the present invention.
Claims (10)
1. Plasma-assisted rotary-cut biopsy needle for breast tumors, which comprises a needle body (10) and is characterized in that: the needle body (10) comprises an outer needle tube (14), an insulator seat (13), a puncture blade seat (12) and a puncture blade (11);
the insulator seat (13) is inserted into the front end of the outer needle tube (14) and is used for assembling the puncture blade seat (12);
the puncture blade seat (12) is inserted into the front end of the insulator seat (13) and is used for assembling the puncture blade (11);
the puncture blade (11) is inserted into the front end of the puncture blade seat (12) and is used for mechanical puncture cutting;
the puncture blade seat (12) and the puncture blade (11) are insulated and isolated by an insulating coating (111);
the puncture blade seat (12) and the outer needle tube (14) are insulated and isolated by the insulator seat (13);
the puncture blade seat (12) and the puncture blade (11) form a group of conducting electrodes which are used as plasma auxiliary puncture cutting electrodes and are used for the puncture blade (11) to perform mechanical puncture cutting and simultaneously enable a saline medium between the puncture blade seat (12) and the puncture blade (11) to form plasma for auxiliary mechanical puncture cutting;
the puncture blade seat (12) and the outer needle tube (14) form another group of conducting electrodes which are used as plasma ablation hemostasis electrodes and are used for enabling a saline medium between the puncture blade seat (12) and the outer needle tube (14) to form plasma for ablation hemostasis.
2. The plasma-assisted rotational atherectomy biopsy needle of claim 1, wherein: the puncture blade (11) comprises a base body section inserted into the front end of the puncture blade seat (12) and a blade edge section arranged at the front end of the base body section;
the edge section comprises at least 2 intersecting edge faces; the blade face comprises a conductive exposed area and an insulating coated area, the width of the blade face is M by taking the intersecting line of the blade face as a base line, the range occupied by M is defined as the conductive exposed area, the rest range of the blade face is defined as the insulating coated area, the insulating coated area and the substrate section are coated and shielded by an insulating coating (111), and the conductive exposed area of the blade face is used as an exposed electrode of the piercing edge (11).
3. The plasma-assisted rotational atherectomy biopsy needle of claim 2, wherein: m is equal to the width dimension of the facet itself or M is 0.1mm to 0.2mm.
4. The plasma-assisted rotational atherectomy biopsy needle of claim 2, wherein: the edge section comprises 4 intersecting edge faces, the 4 intersecting edge faces being: a left upper edge surface (11A), a right upper edge surface (11B), a left lower edge surface (11C) and a right lower edge surface (11D);
the left upper edge surface (11A) and the right upper edge surface (11B) are intersected on an upper edge line;
the left lower edge surface (11C) and the right lower edge surface (11D) are intersected at a lower edge line;
the left upper edge surface (11A) and the left lower edge surface (11C) are intersected on a left edge line;
the right upper edge surface (11B) and the right lower edge surface (11D) are intersected on a right edge line;
the upper edge line, the lower edge line, the left edge line and the right edge line are intersected at an origin;
the upper edge line, the lower edge line, the left edge line and the right edge line are all in inclined relation with the front-back axis of the outer needle tube (14);
at least 1 of the upper edge line, the lower edge line, the left edge line and the right edge line is used as a base line of the conductive exposed area.
5. The plasma-assisted rotational atherectomy biopsy needle of claim 2, wherein: the blade section includes 2 crossing planes, and 2 crossing planes are respectively: a left edge face and a right edge face; the left edge face and the right edge face are intersected at an edge line, the edge line is perpendicular to the forward and backward axis of the outer needle tube (14), and the edge line is used as a base line of the conductive exposed area.
6. The plasma-assisted rotational atherectomy biopsy needle of claim 1, wherein: the insulating coating (111) is a ceramic coating or a Teflon coating.
7. The plasma-assisted rotational atherectomy biopsy needle of claim 1, wherein: when the puncture blade seat (12) and the puncture blade (11) form a group of conducting electrodes, the puncture blade seat (12) and the puncture blade (11) are loaded with a radio frequency power supply for assisting mechanical puncture cutting, and a radio frequency electric field is formed between the puncture blade seat (12) and the puncture blade (11) to ensure that saline medium between the puncture blade seat (12) and the puncture blade (11) is converted into plasma;
when the puncture blade seat (12) and the outer needle tube (14) form a group of conducting electrodes, a radio frequency power supply for ablation hemostasis is loaded on the puncture blade seat (12) and the outer needle tube (14), and a radio frequency electric field is formed between the puncture blade seat (12) and the outer needle tube (14) to ensure that saline medium between the puncture blade seat (12) and the outer needle tube (14) is converted into plasma.
8. The plasma-assisted rotational atherectomy biopsy needle of claim 7, wherein: the electrical parameters of the radio frequency power supply for assisting mechanical puncture and cutting are as follows: frequency: 100kHz, voltage: more than or equal to 175V.
9. The rotational atherectomy biopsy needle of any one of claims 1-8, wherein: the inside baffle (144) that is provided with of outer needle tubing (14), baffle (144) divide into outer needle tubing (14): a vacuum channel (142) at the upper layer, and a saline and lead channel (143) at the lower layer; an inner needle tube (15) connected to a driver and performing rotation, forward movement and backward movement is installed in the vacuum passage (142); a lead A (16) and a lead B (17) are arranged in the saline and lead channel (143); the lead A (16) is electrically connected with the puncture blade (11), and the lead B (17) is electrically connected with the puncture blade seat (12); the radial direction of the puncture blade seat is provided with a saline water gap (121), and the saline water and lead passage (143) is communicated with the saline water gap (121).
10. The plasma-assisted rotational atherectomy biopsy needle of any one of claims 1-8, wherein: the outer needle tube (14) is radially provided with a sampling notch (141).
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| CN115337054B (en) | 2023-01-10 |
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