WO2022237580A1 - 电切活检针、电切活检针套件及真空辅助乳房活检系统 - Google Patents

电切活检针、电切活检针套件及真空辅助乳房活检系统 Download PDF

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Publication number
WO2022237580A1
WO2022237580A1 PCT/CN2022/090236 CN2022090236W WO2022237580A1 WO 2022237580 A1 WO2022237580 A1 WO 2022237580A1 CN 2022090236 W CN2022090236 W CN 2022090236W WO 2022237580 A1 WO2022237580 A1 WO 2022237580A1
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Prior art keywords
interface
biopsy needle
cutting
electrode
electrocutting
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PCT/CN2022/090236
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English (en)
French (fr)
Inventor
郭毅军
李明轩
Original Assignee
重庆西山科技股份有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Priority claimed from CN202110512924.XA external-priority patent/CN113413172B/zh
Priority claimed from CN202220427922.0U external-priority patent/CN218128600U/zh
Application filed by 重庆西山科技股份有限公司 filed Critical 重庆西山科技股份有限公司
Priority to EP22806548.8A priority Critical patent/EP4338685A1/en
Priority to KR1020237042645A priority patent/KR20240005945A/ko
Publication of WO2022237580A1 publication Critical patent/WO2022237580A1/zh

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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
    • A61B10/0275—Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet
    • 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
    • A61B10/0096—Casings for storing test samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61B10/0283—Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe
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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
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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
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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
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    • A61B18/148—Probes or electrodes therefor having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
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    • A61B2018/00922—Handpieces of the surgical instrument or device with means for switching or controlling the main function of the instrument or device by switching or controlling the treatment energy directly within the hand-piece
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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
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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
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    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
    • A61B2090/034—Abutting means, stops, e.g. abutting on tissue or skin abutting on parts of the device itself
    • A61B2090/035—Abutting means, stops, e.g. abutting on tissue or skin abutting on parts of the device itself preventing further rotation

Definitions

  • the application relates to the technical field of medical devices, in particular to an electrocution biopsy needle, an electrocution biopsy needle set and a vacuum-assisted breast biopsy system.
  • the Vacuum Assisted Breast Biopsy System is a medical device used for the minimally invasive treatment or biopsy of breast masses (tumors).
  • the vacuum-assisted breast biopsy system is mainly composed of a host, a biopsy device, and a vacuum negative pressure system.
  • the system mainly punctures the biopsy needle of the biopsy surgical device to the operation point under the guidance of imaging equipment (such as B-ultrasound), and then uses electrical control to make the biopsy needle perform partial or complete rotary resection of the lesion tissue through mechanical movement. And the rotary cut tissue specimens are finally transported to the outside through negative pressure, and then used for film production, pathological detection, analysis and diagnosis.
  • the rotary cutter head of the biopsy surgical device has weak durability against calcified lesions, and may cause bleeding during the rotary cutting process.
  • the postoperative rotary cutting tissue cavity needs to be pressed for a long time to stop bleeding. Hematoma may also occur during the procedure.
  • an electrocutting biopsy surgical device has appeared in the traditional technology. In this electrocutting biopsy surgical device, the cutting edge part of the cutting part is changed into a surgical electrode, and the high-frequency current passes through the cutting edge of the cutter tube and is conducted to the For the diseased tissue that needs to be cut, stop bleeding while cutting the tissue.
  • a metal plate with a larger area needs to be in contact with the patient's buttocks or thighs as a neutral electrode.
  • the current flows through the human body, and then flows back from the neutral electrode to the host to form a circuit. If the neutral electrode does not fit well with the skin of the human body and is in poor contact, high energy will be generated locally, which is more prone to burns and poor safety; moreover, the metal plate is bulky, heavy, and inconvenient to operate.
  • the present application discloses a high-safety, easy-to-operate electrocution biopsy needle, a electrocution biopsy needle set, and a vacuum-assisted breast biopsy system.
  • an electrocution biopsy needle provided by the present application includes: a puncture assembly, the puncture assembly includes a puncture tube, the puncture tube has a front end and a rear end, and a sampling groove is opened on the tube wall of the puncture tube;
  • the cutting assembly includes a cutting member; the cutting member can move back and forth along the axial direction of the puncture tube; the cutting assembly has a first electrode, and the puncturing assembly has a second electrode;
  • An electrode and a second electrode are respectively electrically connected to a first interface and a second interface, any one of the first interface and the second interface is used to directly or indirectly connect the high-frequency output terminal of the host, Another interface is used to directly or indirectly connect the high-frequency input terminal of the host.
  • the cutting element includes a cutting element body and a cutting edge provided on the front port of the cutting element body, the cutting element body is insulated, and the cutting edge conducts electricity to form the first electrode , the puncture tube conducts electricity to form the second electrode.
  • the cutting edge is circular or arc-shaped extending along the periphery of the front port.
  • the cutting edge is formed by bending a wire.
  • the front port is provided with a closed or non-closed metal sheet extending along the periphery of the front port, the cutting edge is formed at the front end of the metal sheet, and the metal sheet and the The first interface is electrically connected.
  • the cutting edge is directly fixed on the end face of the front port.
  • the cutting edge is arranged opposite to the front side of the front port at a certain interval, at least one conductive leg is arranged between the cutting edge and the front port, and the leg One end is electrically connected to the cutting edge, and the other end is electrically connected to the first interface.
  • the cutting edge is circular, the number of the legs is two, and the line connecting the two legs passes through the center of the circle.
  • the cutting edge is arc-shaped, and the number of the legs is three, wherein one end of two legs is connected to both ends of the arc, and one end of the remaining leg is connected to the arc. Vertices are connected.
  • the main body of the cutting element includes a metal tube body and an insulating layer covering the surface of the tube body, and the tube body is electrically connected to the cutting edge and the first interface.
  • the main body of the cutting element is made of insulating material, and at least one connecting wire is arranged in the tube wall of the main body of the cutting element, one end of the connecting wire is electrically connected to the cutting edge, and the other end of the connecting wire is electrically connected to the cutting edge. One end is electrically connected with the first interface.
  • the puncture assembly further includes a tubular casing, the rear end of the puncture tube is inserted and fixed in the front end of the casing, and the rear end of the cutting member extends out of the puncture tube and into the In the casing, a push rod is fixedly sleeved on the cutting part protruding into the casing, and a first gear is threaded on the push rod, and the rotation of the cutting part relative to the puncture tube is restricted. stop mechanism.
  • the cutting element includes a cutting element main body, an electrode collar is arranged on the cutting element main body, and the first electrode is connected to the first interface through the electrode collar; the first Any one of the interface and the second interface is also used to directly or indirectly connect to the high-frequency output end of the host, and the other interface is also used to directly or indirectly connect to the high-frequency input end of the host.
  • the rear end of the main body of the cutter has a conductive area, the conductive area is electrically connected to the first electrode, the conductive area is passed through the central hole of the electrode collar, and can be Relative to the axial reciprocating movement and rotational movement of the electrode collar, the electrode collar is provided with at least one elastic contact assembly, and the elastic contact assembly includes an elastic spring disposed in the central hole of the electrode collar. A contact, the head of the elastic contact is slidingly fitted with the outer wall of the conductive area, and the elastic contact is directly or indirectly connected to the first interface.
  • the electrode collar further includes a connector provided on the outer peripheral surface of the electrode collar, the connector is connected to the first interface, and the elastic contact is electrically connected to the connector.
  • the cutting element can also rotate relative to the piercing tube.
  • the puncture assembly further includes a tubular casing, the rear end of the puncture tube is inserted and fixed in the front end of the casing, and the rear end of the cutting member extends out of the puncture tube and into the In the housing, the first interface and the second interface are arranged on the housing.
  • the first interface includes a first pin
  • the second interface includes a second pin
  • the first pin is electrically connected to the first electrode
  • the second pin The inner end of the puncture tube is electrically connected to the puncture tube through a wire, and the outer ends of the first pin and the second pin are both exposed from the shell.
  • a set of electrocution biopsy needles provided by the present application includes a handle, the handle includes a housing and a circuit board arranged in the housing, and also includes the electrocution biopsy needle, and the handle also includes It includes a third interface and a fourth interface respectively matched with the first interface and the second interface, the third interface and the fourth interface are electrically connected to the circuit board, and the electrocution biopsy needle Connected to the housing, the first interface and the second interface are electrically connected to the third interface and the fourth interface respectively.
  • the electrocution biopsy needle set provided by the present application includes a handle, the handle includes a housing and also includes the electrocution biopsy needle, and the electrocution biopsy needle is connected with the housing.
  • a vacuum-assisted breast biopsy system includes: the electrocution biopsy needle set; and a host, the host includes a high-frequency transmitting module for generating high-frequency, and the high-frequency transmitting module has The high-frequency output end and the high-frequency input end, the high-frequency output end and the high-frequency input end are connected to the circuit board through cables so as to be indirectly connected to the first interface and the second interface , or the high-frequency output end and the high-frequency input end are directly connected to the first interface and the second interface through cables.
  • the present application discloses an electrocution biopsy needle, an electrocution biopsy needle set and a vacuum-assisted breast biopsy system, which can more effectively crush calcifications compared with the traditional rotary-cut electrosection biopsy needle Foci, and due to the thermal effect, it can play the role of trauma coagulation, effectively avoiding the risk of intraoperative hemorrhage and postoperative hematoma.
  • the puncture component of the electrocution biopsy needle of the present application is provided with a first electrode, and the cutting component is provided with a second electrode, and the high-frequency electric wave between the first electrode and the second electrode is used to Cutting, so that the range of high-frequency electric energy is limited to between the two electrodes, the degree of damage to the body tissue and the range of influence are much smaller than that of the monopolar method, and there is no need to add additional metal plates during work, which can avoid the damage caused by the metal plate If it does not fit well with human skin and burns the human body, it has high safety and is easy to operate.
  • the electrocution biopsy needle has a simple structure and low cost.
  • Fig. 1 is the cross-sectional view of the electrocutting biopsy needle set in the first embodiment of the present application
  • Fig. 2 is a schematic diagram of an exploded structure of the electrocution biopsy needle set shown in Fig. 1;
  • Fig. 3 is a three-dimensional schematic diagram of the puncture assembly of the electrocution biopsy needle set shown in Fig. 1;
  • Fig. 4 is a three-dimensional schematic diagram of the cutting assembly of the electrocutting biopsy needle set shown in Fig. 1;
  • Fig. 5 is a partially enlarged schematic diagram of place A in Fig. 4;
  • Fig. 6 is a partially enlarged schematic diagram of place C in Fig. 1;
  • Fig. 7 is a schematic diagram of the three-dimensional structure of the cutting edge of the second structure
  • Fig. 8 is a schematic diagram of the three-dimensional structure of the cutting edge of the third structure
  • Fig. 9 is a schematic diagram of the three-dimensional structure of the cutting edge of the fourth structure.
  • Fig. 10 is a partially enlarged schematic diagram of place B in Fig. 1;
  • Fig. 11 is a schematic structural view of a vacuum-assisted breast biopsy system having an electrocution biopsy needle set shown in Fig. 1;
  • Fig. 12 is a schematic diagram of the three-dimensional structure of the electrocution biopsy needle set in Example 2 of the present application.
  • FIG. 13 is a schematic structural view of a vacuum-assisted breast biopsy system having an electrosection biopsy needle set shown in FIG. 12;
  • Fig. 14 is a three-dimensional schematic diagram of the cutting assembly of the electrocutting biopsy needle set shown in Fig. 1;
  • FIG. 15 is a perspective view of the electrode collar of the cutting assembly shown in FIG. 14 .
  • 100 electrocution biopsy needle; 110, puncture component; 112, puncture tube; 112a, sampling groove; 112b, tip; 114, shell; 120, cutting component; Cutting edge; 122c, air vent; 122d, front port; 122e, leg; 122f, metal sheet; 1221, conductive area; 124, push rod; 124a, external thread; 124b, limit groove; 130, first gear; 131 , threaded hole; 140, shaft sleeve; 142, limit protrusion; 150, collection box; 162, first interface; 164, second interface; 170, electrode collar; 171, mounting seat; 172, elastic contact assembly ; 172a, elastic contact; 173, connector; 200, handle; 210, housing; 212, slot; 214, motor; 216, second gear; 217, third interface; 218, fourth interface; 300, Host; 410, first cable; 420, second cable; 430, third cable; 500, vacuum tube.
  • FIG. 1 is a cross-sectional view of the electrosecting biopsy needle set in Embodiment 1 of the present application
  • FIG. 2 is a schematic diagram of an exploded structure of the electrosecting biopsy needle set shown in FIG. 1 .
  • the electrocution biopsy needle set in Embodiment 1 of the present application includes a electrotomy biopsy needle 100 and a handle 200 , wherein the electrosection biopsy needle 100 is mainly composed of a puncture assembly 110 and a cutting assembly 120 .
  • the puncture assembly 110 includes a puncture tube 112 and a housing 114, the puncture tube 112 has a front end away from the housing 114 and a rear end close to the housing 114, the front end of the puncture tube 112 is provided with a tip 112b, the tip 112b is ultrasonically Piercing through tissue with the aid of imaging or X-ray imaging equipment.
  • a sampling groove 112 a is provided on the wall of the puncture tube 112 near the front end, and the rear end of the puncture tube 112 is inserted into and fixed in the casing 114 .
  • the puncture tube 112 is made of conductive material (such as stainless steel) to form the second electrode.
  • the cutting assembly 120 includes a cutting part 122, which is installed in the puncture tube 112 and can move back and forth along the axial direction of the puncture tube 112.
  • the cutting part 122 includes an insulating cutting part main body 122a, the cutting part
  • the main body 122a is tubular, or sheet-like, or thin rod-shaped, and the cutting element 122 also includes a cutting edge 122b arranged on the front port 122d of the cutting element main body 122a, and the cutting edge 122b is made of a conductive material to form a first electrode .
  • the electrocution biopsy needle 100 also includes a first interface 162 and a second interface 164, the first interface 162 and the second interface 164 are electrically connected to the cutting edge 122b and the puncture tube 112 respectively, and the first interface 162 and the second interface 164 Any one of the interfaces is used to directly or indirectly connect the high-frequency output terminal of the host 300 , and the other interface is used to directly or indirectly connect the high-frequency input terminal of the host 300 .
  • the cutting edge 122b forms the emitter, and the puncture tube 112 forms the receiver pole; otherwise, if the first interface 162 is connected with the high-frequency input terminal, and the second interface 164 is connected to the high-frequency output terminal, the cutting edge 122b forms a receiving pole, and the piercing tube 112 forms an emitting pole.
  • the cutting edge 122b, the puncture tube 112, the first interface 162 and the second interface 164 form a loop to conduct high-frequency energy.
  • the resistance of the water molecules to the high-frequency electric waves converts the high-frequency electric wave energy into mechanical energy, causing the water molecules to vibrate violently instantaneously, and the water molecules in the cells are transformed from liquid water in an instant Gaseous water, the cells rupture under the condition of water molecule volume expansion, forming tissue separation and cutting; and using its thermal effect, the local cells of the soft tissue are coagulated and protein denatured to achieve effective hemostasis.
  • the electrocution biopsy needle 100 of the present application can more effectively crush the calcified foci, and can play the role of wound blood coagulation due to the thermal effect, effectively avoiding intraoperative bleeding and surgical trauma. Risk of post-hematoma.
  • the electrocution biopsy needle 100 of the present application uses the puncture tube 112 as one pole, and the cutting edge 122b of the cutting member 122 as the other pole, and utilizes the cutting edge 122b and the puncture
  • the high-frequency electric wave between the tubes 112 is used for cutting, and no additional metal plate is needed during work, which can avoid burns to the human body due to poor fit between the metal plate and the human skin, with high safety and convenient operation.
  • the product structure is simple and the cost is low.
  • the cutting edge 122b in this embodiment is a circle extending along the periphery of the front port 122d , the cutting edge 122b is longer and the cutting efficiency is high. Moreover, when the cutting member 122 moves from back to front along the axial direction of the cutting member 122, the tissue cut off by the cutting edge 122b is directly extruded into the front port 122d, and then sucked into the collection box 150 by vacuum.
  • the cutting edge 122b in this embodiment is formed by bending a metal wire (such as stainless steel wire, tungsten wire, etc.), and the cutting edge 122b is directly fixed on the end surface of the front port 122d.
  • the cutting edge 122b with this structure has the advantages of simple structure and good reliability.
  • FIG. 7 is a schematic perspective view of the three-dimensional structure of the cutting edge 122b of the second structure.
  • the cutting edge 122b is relatively arranged on the front side of the front port 122d at a certain interval, at least one conductive leg 122e is arranged between the cutting edge 122b and the front port 122d, and one end of the leg 122e is connected to the cutting edge.
  • the cutting edge 122b is electrically connected, and the other end is electrically connected to the first interface 162 , and the supporting leg 122e simultaneously functions as support and conduction.
  • FIG. 8 is a schematic perspective view of the three-dimensional structure of the cutting edge 122b of the third structure.
  • the cutting edge 122b is arc-shaped, and there are three legs 122e, one end of two legs 122e is connected to the two ends of the arc, and one end of the remaining leg 122e is connected to the apex of the arc.
  • the structure of the cutting edge 122b of this structure is more firm.
  • FIG. 9 is a schematic perspective view of the three-dimensional structure of the cutting edge 122b of the fourth structure.
  • the front port 122d of the cutting member 122 is provided with a closed or non-closed metal sheet 122f extending around the front port 122d
  • the cutting edge 122b is formed on the front end of the metal sheet 122f
  • the metal sheet 122f is connected to the first interface. 162 is electrically connected.
  • This kind of cutting edge 122b has high strength and can also play the role of mechanical cutting.
  • the cutting edge 122b can also have the following structures: the cutting body 122a includes a metal tube body and an insulating layer coated on the surface of the tube body, and the front port 122d of the tube body is exposed and processed into a pointed shape The cutting edge 122b is formed, and the structure of the cutting member 122 is simpler.
  • the cutting element main body 122a includes a metal (such as stainless steel) tube body (not shown in the figure) and an insulating layer (not shown in the figure) coated on the surface of the tube body, and the tube body and the cutting edge 122b It is electrically connected with the first interface 162 .
  • the cutting edge 122b is welded to the front end of the pipe body.
  • the cutting body 122a is made of insulating material (ceramic material, hard plastic), the cutting edge 122b is fixed on the end face of the front port 122d, and at least one connecting wire is arranged in the tube wall of the cutting body 122a (not shown in the figure), one end of the connecting wire is electrically connected to the cutting edge 122 b, and the other end is electrically connected to the first interface 162 .
  • the cutting edge 122b and the connecting wire are integrally formed.
  • At least one vent 122c is opened on the peripheral wall of the front port 122d of the cutting element main body 122a.
  • the first interface 162 in this embodiment includes a first pin
  • the second interface 164 includes a second pin.
  • the first pin and the cutting edge 122b can be electrically connected by a wire
  • the cutting piece main body 122a includes a metal tube body and an insulating layer coated on the surface of the tube body, and the position near the first pin of the tube body is not Apply an insulating coating, the inner end of the first contact pin is in contact with the tube body to realize electrical connection, and the front end of the tube body is electrically connected to the cutting edge 122b, thereby realizing the electrical connection between the first contact pin and the cutting edge 122b .
  • the inner end of the second pin is electrically connected to the puncture tube 112 through a wire (not shown in the figure). Both the outer ends of the first pin and the second pin are exposed from the housing 114 .
  • the TES biopsy needle 100 in this embodiment further includes a transmission mechanism for converting rotational torque into linear motion of the cutting member 122 .
  • the transmission mechanism includes a push rod 124, a first gear 130 and an anti-rotation mechanism.
  • the push rod 124 is fixedly sleeved on the cutting member 122 protruding into the casing 114.
  • the push rod 124 is provided with an external thread 124a.
  • the first The center of the gear 130 is provided with a threaded hole 131 , and the internal thread of the threaded hole 131 cooperates with the external thread 124 a on the push rod 124 .
  • the anti-rotation mechanism is used to limit the rotation of the cutting member 122 relative to the puncture tube 112 .
  • the push rod 124 is moved axially on the axis of the first gear 130 , and the rotational motion is converted into a linear motion to realize the forward and backward movement of the cutting assembly 120 .
  • the end of the push rod 124 near the front end of the puncture tube 112 is provided with at least one axially extending limiting groove 124b, and a shaft sleeve 140 is fixed inside the housing 114, and the shaft sleeve 140 is sleeved on the push rod 112.
  • the inner wall of the sleeve 140 is provided with a limiting protrusion 142 extending in the axial direction.
  • the limiting protrusion 142 cooperates with the limiting groove 124b to form an anti-rotation mechanism to limit the rotation of the cutting member 122 relative to the puncture tube 112 .
  • the electrocutting biopsy needle 100 in this embodiment further includes a collection box 150 , the inlet of the collection box 150 is connected to the rear end of the cutting member 122 , and the severed tissue enters the collection box 150 through the cutting member 122 .
  • An air passage for gas circulation is formed between the outer wall of the cutting part 122 and the inner wall of the puncture tube 112, and the electrocution biopsy needle 100 also includes an air valve for making the rear opening of the air passage conduct or non-conduct with the outside atmosphere Mechanism
  • the air valve mechanism in this embodiment can be the air valve mechanism disclosed in the Chinese patent with publication number CN209285578U.
  • the handle 200 includes a housing 210, a driving device, a circuit board (not shown), a first cable 410, a third interface 217 and a fourth interface 218, and one side of the housing 210
  • a draw-in slot 212 for accommodating the housing 114 of the biopsy needle is provided, and the driving device is accommodated in the casing 210.
  • the driving device includes a motor 214 and a second gear 216, and the second gear 216 is installed on the output shaft of the motor 214.
  • the second gear Part 216 exposes the casing 210 and engages with the first gear 130 of the TES needle 100 .
  • the circuit board is connected with the motor 214 , the first cable 410 , the third interface 217 and the fourth interface 218 .
  • the third interface 217 is a first socket matched with the first pin
  • the fourth interface 218 is a second socket matched with the second pin.
  • the cutting member 122 is also capable of rotational movement relative to the piercing tube 112 .
  • an electrode collar 170 is disposed on the cutter main body 122 a, and the first electrode is connected to the first interface 162 through the electrode collar 170 .
  • Any one of the first interface 162 and the second interface 164 is also used to directly or indirectly connect the high-frequency output terminal of the host 300, and the other interface is also used to directly or indirectly connect the electrical outlet of the host 300. Coagulation input.
  • the cutting edge 122b forms the emitter, and the puncture tube 112 forms the receiver pole; otherwise, if the first interface 162 is connected to the electrocoagulation input terminal, and the second interface 164 is connected to the high-frequency output terminal, the cutting edge 122b forms a receiving pole, and the piercing tube 112 forms an emitting pole.
  • the cutting edge 122b, the piercing tube 112, the first port 162 and the second port 164 form a loop to conduct electric current.
  • the current is conducted from the first interface 162 or the second interface 164 to the first electrode or the second electrode.
  • body fluids, tissues, etc. There are body fluids, tissues, etc., and the conduction of body fluids and tissues connects the first electrode and the second electrode to form a current in the human body, and since the area of the first electrode is smaller than the area of the second electrode, the current energy near the first electrode Dense, release heat in the body, heat the wound tissue, realize the coagulation of the body tissue, so as to achieve the purpose of hemostasis.
  • the electrode collar 170 includes an annular mounting base 171 and at least one elastic contact assembly 172 arranged in the circumferential direction on the mounting base 171 , the elastic contact assembly 172
  • the head assembly 172 includes the elastic contact 172a in the central hole of the mounting seat 171.
  • the rear end of the cutting piece main body 122a has a conductive area 1221, and the head of the elastic contact 172a is in contact with the outer wall of the conductive area 1221. Slip fit.
  • the electrode collar 170 adopts such a structure, so that when the cutting member 122 reciprocates axially back and forth and rotates, the head of the elastic contact 172a is always in reliable contact with the surface of the conductive region 1221 , and the connection reliability is high.
  • the electrode collar 170 also includes a connector 173 disposed on the outer peripheral surface of the mounting base 171 , the connector 173 is electrically connected to the first pin through a wire; the elastic contact 172 a is electrically connected to the connector 173 .
  • the piercing assembly 110 further includes a tubular shell 114 .
  • the rear end of the piercing tube 112 is inserted and fixed in the front end of the housing 114 , and the rear end of the cutting member 122 extends out of the piercing tube 112 and into the housing 114 .
  • the first interface 162 and the second interface 164 are disposed on the housing 114 .
  • the first interface 162 includes a first pin
  • the second interface 164 includes a second pin.
  • the first pin is electrically connected to the electrode collar 170 .
  • the inner end of the second pin is electrically connected to the puncture tube 112 through a wire, and the outer ends of the first pin and the second pin are both exposed from the shell 114 .
  • the cutter main body 122a includes a metal tube body and an insulating layer coated on the surface of the tube body, the rear end of the tube body exposes the insulating layer to form a conductive area 1221, and the conductive area 1221 passes through the electrode collar 170, and Axial reciprocating movement back and forth and rotational movement relative to the electrode collar 170 is possible.
  • Fig. 11 is a schematic diagram of the structure of a vacuum-assisted breast biopsy system with the electrosection biopsy needle set in the above embodiment.
  • the vacuum-assisted breast biopsy system of the present application includes the electrocutting biopsy needle kit and the host 300 in the above-mentioned embodiments, and the host 300 is provided with a high-frequency transmission module (not shown in the figure) and a vacuum generating system (shown in the figure). not shown), the high-frequency output and high-frequency input of the high-frequency transmitting module are connected to the circuit board in the handle 200 through the first cable 410, and the circuit board is electrically connected to the first jack and the second jack.
  • the vent 122c, the air channel between the cutting part 122 and the puncture tube 112 and the inside of the cutting part 122 form an airflow path, which prevents the front end of the cutting part 122 from being blocked.
  • an electrocoagulation module (not shown in the figure) and a vacuum generating system (not shown in the figure) are also provided in the host machine 300, and the high-frequency output end and the electrocoagulation input end of the electrocoagulation module pass through a fourth cable ( (not shown in the figure) is connected to the circuit board in the handle 200, so that the high-frequency output end and the electrocoagulation input end of the electrocoagulation module are indirectly connected to the first pin and the second pin.
  • the vent 122c, the air channel between the cutting part 122 and the puncture tube 112 and the inside of the cutting part 122 form an airflow path, which prevents the front end of the cutting part 122 from being blocked.
  • the user first punctures the front end of the puncture tube 112 to the operation site under the guidance of the ultrasonic equipment. At this time, the front port 122d of the cutting member 122 is located at the position closest to the front end of the puncture tube 112, and the sampling groove 112a is in a closed state.
  • the control button on the top sends a control signal, the circuit board controls the motor 214 to start working, and the negative pressure is turned on.
  • the second gear 216 cooperates with the first gear 130 to drive the cutting part 122 of the electrocution biopsy needle 100 to move backward, and the sampling groove 112a is opened to The required size, when the cutting part 122 moves backward, the air valve is closed, the cutting part 122, the collection box 150, the vacuum tube 500, and the vacuum joint of the electrocution biopsy needle 100 are connected in sequence to form a vacuum channel, and the tissue sample is sucked into the sampling groove 112a;
  • Sampling is started by sending a control signal through the button of the handle 200, or the software automatically controls the start of sampling, and the second gear 216 cooperates with the first gear 130 to drive the cutting part 122 of the electrocution biopsy needle 100 to move forward, so that the cutting edge 122b advances, and at the same time
  • the host 300 outputs high-frequency radio waves, and the high-frequency radio waves are sent to the cutting edge 122b through the first cable 410, the circuit board, the first socket and the first pin, and high-frequency waves are generated between the cutting edge 122b and the puncture tube 112 Radio wave, partial or complete resection of the lesion tissue by high-frequency radio waves, when the cutting part 122 advances to the position closest to the front end of the puncture tube 112, the air valve mechanism is opened, and the outside air passes through the vent 122c and between the cutting part 122 and the puncture tube 112 The air passage between them enters the front port 122d of the cutting part 122, and the interior of the cutting part 122 is a vacuum,
  • the electrocoagulation module sends current to the first electrode through the cable, the circuit board, the first socket and the first pin. Since there is body fluid, tissue, etc. between the first electrode and the second electrode, the body fluid 1. Tissue conduction conducts the first electrode and the second electrode to form an electrocoagulation circuit, and because the area of the first electrode is smaller than the area of the second electrode, the current energy near the first electrode is dense, and heat is released in the body. The wound tissue is heated to realize the coagulation of the body tissue, so as to achieve the purpose of hemostasis.
  • Fig. 12 is a schematic perspective view of the three-dimensional structure of the electrosection biopsy needle set in Example 2 of the present application
  • Fig. 13 is a schematic structural diagram of a vacuum-assisted breast biopsy system having the electrosection biopsy needle set shown in Fig. 12
  • the structure of the electrocution biopsy needle set in this embodiment is generally the same as that in the embodiment, the difference is that the high frequency circuit of the electrocution biopsy needle 100 is directly connected to the host 300, That is, the first pin and the second pin on the puncture assembly 110 are set on the side facing away from the handle 200 , the host 300 is connected to the circuit board of the handle 200 through the second cable 420 , and connected to the first pin through the third cable 430 .
  • the pin is electrically connected with the second pin.
  • the first interface 162 and the second interface 164 of the biopsy needle 100 are directly connected to the host 300, that is, the first needle and the second needle on the puncture assembly 110 are arranged on the side facing away from the handle 200,
  • the host 300 is connected to the circuit board of the handle 200 through a fifth cable (not shown in the figure), and the high-frequency output terminal and the electrocoagulation input terminal of the electrocoagulation module are connected to the first cable through a sixth cable (not shown in the figure).
  • the pin is electrically connected with the second pin.

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Abstract

一种电切活检针(100)、电切活检针(100)套件及真空辅助乳房活检系统，电切活检针(100)包括：穿刺组件(110)，穿刺组件(110)包括穿刺管(112)，穿刺管(112)具有前端和后端，穿刺管(112)的管壁上开设有取样槽(112a)；切割组件(120)，切割组件(120)包括切割件(122)；切割件(122)可沿着穿刺管(112)的轴向前后往复移动；切割组件(120)具有第一电极，穿刺组件(110)具有第二电极；还包括与第一电极和第二电极分别电性连接的第一接口(162)和第二接口(164)，第一接口(162)和第二接口(164)中的任意一接口用于直接或间接地连接主机(300)的高频输出端，另一接口用于直接或间接地连接主机(300)的高频输入端。电切活检针(100)利用切割刃口(122b)和穿刺管(112)之间的高频电波对组织进行切割，具有安全性高、操作方便、结构简单、成本低的优点。

Description

电切活检针、电切活检针套件及真空辅助乳房活检系统 技术领域
本申请涉及医疗器械技术领域，特别是涉及一种电切活检针、电切活检针套件及真空辅助乳房活检系统。
背景技术
真空辅助乳房活检系统是一种用于乳腺肿块(肿瘤)的微创治疗或活检的医疗器械。真空辅助乳房活检系统主要由主机、活检手术装置以及真空负压系统组成。该系统主要是在影像设备(如B超)引导下，将活检手术装置的活检针穿刺到术点位置，然后通过电气控制使活检针通过机械运动的方式对病灶组织进行部分或完全旋切，并将旋切下来的组织标本最终通过负压输送到外部，进而用于制片处理及病理检测分析诊断。
目前，活检手术装置的旋切刀头对于钙化灶的耐用性较弱，并且在旋切的过程中会有可能引起出血，术后的旋切组织空腔需要长久的按压止血，并且在恢复的过程中还有可能会出现血肿。为了解决此问题，传统技术出现了一种电切活检手术装置，该电切活检手术装置将切割件的切割刃口部分改作为手术电极，高频电流通过切割刀管的切割刃口并传导至需切割的病变组织，一边切割组织一边止血。但该电切活检手术装置在手术中，还需将一面积较大的金属板与病人臀部或者大腿接触作为中性电极，电流流经人体，再从中性电极流回主机构成回路。如果中性电极与人体皮肤贴合不好接触不良，会在局部产生高能，比较容易发生烫伤，安全性差；而且，金属板体积大，重量重，操作不方便。
发明内容
有鉴于此，本申请公开一种安全性高、操作简单的电切活检针、电切活检针套件及真空辅助乳房活检系统。
一方面，本申请所提供的一种电切活检针，包括：穿刺组件，该穿刺组件 包括穿刺管，所述穿刺管具有前端和后端，所述穿刺管的管壁上开设有取样槽；切割组件，该切割组件包括切割件；所述切割件可沿着所述穿刺管的轴向前后往复移动；所述切割组件具有第一电极，所述穿刺组件具有第二电极；还包括与第一电极和第二电极分别电性连接的第一接口和第二接口，所述第一接口和所述第二接口中的其中任意一接口用于直接或间接地连接主机的高频输出端，另一接口用于直接或间接地连接所述主机的高频输入端。
在一个实施例中，所述切割件包括切割件主体和设置在所述切割件主体的前端口上的切割刃口，所述切割件主体绝缘，所述切割刃口导电形成所述第一电极，所述穿刺管导电形成所述第二电极。
在一个实施例中，所述切割刃口为沿着所述前端口的周围延伸的圆形或者弧形。
在一个实施例中，所述切割刃口由金属丝弯曲形成。
在一个实施例中，所述前端口处设置有一沿着所述前端口周围延伸的闭合或者非闭合金属片，所述切割刃口形成在所述金属片的前端，所述金属片与所述第一接口电性连接。
在一个实施例中，所述切割刃口直接固定在所述前端口的端面上。
在一个实施例中，所述切割刃口以一定间距相对地设置在所述前端口的前侧，在所述切割刃口与所述前端口之间设置有至少一条导电的支脚，所述支脚的一端与所述切割刃口电性连接，另一端与所述第一接口电性连接。
在一个实施例中，所述切割刃口为圆形，所述支脚的数量为两条，两条所述支脚的连线经过所述圆形的圆心。
在一个实施例中，所述切割刃口为弧形，所述支脚的数量为三条，其中两条支脚的一端与所述弧形的两端连接，剩余一条支脚的一端与所述弧形的顶点连接。
在一个实施例中，所述切割件主体包括金属的管体和包覆在所述管体表面的绝缘层，所述管体与所述切割刃口和所述第一接口电性连接。
在一个实施例中，所述切割件主体采用绝缘材料制成，在所述切割件主体的管壁内设置有至少一连接导线，该连接导线的一端与所述切割刃口电性连接，另一端与所述第一接口电性连接。
在一个实施例中，所述穿刺组件还包括管状的外壳，所述穿刺管的后端插入固定在所述外壳的前端内，所述切割件的后端伸出所述穿刺管并伸入所述外壳内，在伸入所述外壳内的所述切割件上固定套设有推杆，在所述推杆上螺纹配合有第一齿轮，还包括限制所述切割件相对所述穿刺管旋转的止转机构。
在一个实施例中，所述切割件包括切割件主体，所述切割件主体上设置有电极套环，所述第一电极通过所述电极套环与所述第一接口连接；所述第一接口和所述第二接口中的其中任意一接口还用于直接或间接地连接主机的高频输出端，另一接口还用于直接或间接地连接主机的高频输入端。
在一个实施例中，所述切割件主体的后端有导电区域，所述导电区域与所述第一电极电连接，所述导电区域穿设在所述电极套环的中心孔内，且可相对于所述电极套环轴向前后往复移动和旋转运动，所述电极套环设置有至少一个弹性触头组件，所述弹性触头组件包括设置在所述电极套环的中心孔内的弹性触头，所述弹性触头的头部与所述导电区域的外壁滑动配合，且所述弹性触头与所述第一接口直接或间接连接。
在一个实施例中，所述电极套环还包括设置在电极套环外周面上的连接头，所述连接头与所述第一接口连接，所述弹性触头与所述连接头电连接。
在一个实施例中，所述切割件还可相对于所述穿刺管旋转运动。
在一个实施例中，所述穿刺组件还包括管状的外壳，所述穿刺管的后端插入固定在所述外壳的前端内，所述切割件的后端伸出所述穿刺管并伸入所述外壳内，所述第一接口和所述第二接口设置在所述外壳上。
在一个实施例中，所述第一接口包括第一插针，所述第二接口包括第二插针；所述第一插针与所述第一电极电性连接；所述第二插针的内端通过导线与所述穿刺管电性连接，所述第一插针和所述第二插针的外端均露出所述外壳。
另一方面，本申请提供的一种电切活检针套件，包括手柄，所述手柄包括壳体和设置在所述壳体内的电路板，还包括所述的电切活检针，所述手柄还包括分别与所述第一接口和所述第二接口配合的第三接口和第四接口，所述第三接口和所述第四接口与所述电路板电性连接，所述电切活检针与所述壳体连接，所述第一接口和所述第二接口分别与所述第三接口和所述第四接口电性连接。
另一方面，本申请提供的一种电切活检针套件，包括手柄，所述手柄包括 壳体还包括所述的电切活检针，所述电切活检针与所述壳体连接。
另一方面，本申请提供的一种真空辅助乳房活检系统，包括：所述的电切活检针套件；以及主机，该主机包括用于产生高频的高频发射模块，该高频发射模块具有高频输出端和所述高频输入端，所述高频输出端和所述高频输入端通过线缆与所述电路板连接从而间接地与所述第一接口和所述第二接口连接，或者所述高频输出端和所述高频输入端通过线缆与所述第一接口和所述第二接口直接地连接。
从上述的技术方案可知，本申请公开了一种电切活检针、电切活检针套件及真空辅助乳房活检系统，与传统的旋切式电切活检针相比，可以更加有效的击碎钙化灶，并因热效应影响可以起到创伤凝血的功能，有效避免术中出血和术后血肿的风险。而与现有的电切活检针相比，本申请的电切活检针的穿刺组件上设置第一电极，切割组件上设置第二电极，利用第一电极与第二电极之间的高频电波进行切割，使得高频电能的作用范围只限于两电极之间，对机体组织的损伤程度和影响范围远比单极方式要小得多，且工作时无需额外增加金属板，可以避免因金属板与人体皮肤贴合不好而灼伤人体，安全性高，而且操作方便。此外，该电切活检针结构简单、成本低。
附图说明
图1为本申请实施例一中的电切活检针套件的剖视图；
图2为图1中所示电切活检针套件的分解结构示意图；
图3为图1中所示电切活检针套件的穿刺组件的立体结构示意图；
图4为图1中所示电切活检针套件的切割组件的立体结构示意图；
图5为图4中A处的局部放大示意图；
图6为图1中C处的局部放大示意图；
图7为第二种结构的切割刃口的立体结构示意图；
图8为第三种结构的切割刃口的立体结构示意图；
图9为第四种结构的切割刃口的立体结构示意图；
图10为图1中B处的局部放大示意图；
图11为具有图1中所示电切活检针套件的真空辅助乳房活检系统的结构示 意图；
图12为本申请实施例二中的电切活检针套件的立体结构示意图；
图13为具有图12中所示电切活检针套件的真空辅助乳房活检系统的结构示意图；
图14为图1中所示电切活检针套件的切割组件的立体结构示意图；
图15为图14中所示的切割组件的电极套环的立体图。
附图标记说明：
100、电切活检针；110、穿刺组件；112、穿刺管；112a、取样槽；112b、尖部；114、外壳；120、切割组件；122、切割件；122a、切割件主体；122b、切割刃口；122c、通气口；122d、前端口；122e、支脚；122f、金属片；1221、导电区域；124、推杆；124a、外螺纹；124b、限位槽；130、第一齿轮；131、螺纹孔；140、轴套；142、限位凸起；150、收集盒；162、第一接口；164、第二接口；170、电极套环；171、安装座；172、弹性触头组件；172a、弹性触头；173、连接头；200、手柄；210、壳体；212、卡槽；214、电机；216、第二齿轮；217、第三接口；218、第四接口；300、主机；410、第一线缆；420、第二线缆；430、第三线缆；500、真空管。
具体实施方式
下面参考附图并结合实施例对本申请进行详细说明。需要说明的是，在不冲突的情况下，以下各实施例及实施例中的特征可以相互组合。
在本文中，所涉及的前、后、上、下等方位词是以附图中零部件位于图中以及零部件相互之间的位置来定义的，只是为了表达技术方案的清楚及方便。应当理解，所述方位词的使用不应限制本申请请求保护的范围。
图1为本申请实施例一中的电切活检针套件的剖视图，图2为图1中所示电切活检针套件的分解结构示意图。如图1、2所示，本申请实施例一中的电切活检针套件包括电切活检针100和手柄200，其中，电切活检针100主要由穿刺组件110和切割组件120组成。
如图3所示，穿刺组件110包括穿刺管112和外壳114，穿刺管112具有远离外壳114的前端和靠近外壳114的后端，穿刺管112的前端设置有尖部112b，尖部112b在超声影像或X射线影像设备的辅助下刺穿组织。在穿刺管112靠近前端的管壁上设置有取样槽112a，穿刺管112的后端伸入并固定在外壳114内。本实施例中，穿刺管112采用导电材料(比如不锈钢等)制成以形成第二电极。
如图4、5所示，切割组件120包括切割件122，切割件122装于穿刺管112内且可以沿穿刺管112的轴向前后运动，切割件122包括绝缘的切割件主体122a，切割件主体122a为管状、或者片状、或者细杆状，切割件122还包括设置在切割件主体122a的前端口122d上的切割刃口122b，切割刃口122b采用导电材料制成以形成第一电极。
电切活检针100还包括第一接口162和第二接口164，第一接口162和第二接口164分别与切割刃口122b和穿刺管112电性连接，第一接口162和第二接口164中的其中任意一接口用于直接或间接地连接主机300的高频输出端，另一接口用于直接或间接地连接主机300的高频输入端。如果第一接口162与高频输出端连接，第二接口164与高频输入端连接，则切割刃口122b形成发射极，穿刺管112形成接收极，反之，如果第一接口162与高频输入端连接，第二接口164与高频输出端连接，则切割刃口122b形成接收极，穿刺管112形成发射极。切割刃口122b、穿刺管112、第一接口162和第二接口164形成回路以传导高频能量。
如图6所示，当从第一接口162或者第二接口164输入高频波时，在切割刃口122b与穿刺管112的取样槽112a边缘之间产生高频电波，高频电波通过取样槽112a内的组织时，由于组织对高频电波的阻力，使组织本身内部的水分子瞬间产生快速振荡，细胞内水分子蒸发从而破坏细胞或使细胞挥发。当高频电波遇到细胞内的水分子时，水分子对高频电波产生的阻力使高频电波能量转换成机械能量，引起水分子瞬间激烈振荡，细胞内的水分子由液态水在瞬间转化成气态水，细胞在水分子体积膨胀的情况下破裂，形成组织分离，实现切割；并利用其热效应，使软组织局部细胞凝固蛋白质变性，达到有效止血。
本申请的电切活检针100与传统的旋切式电切活检针100相比，可以更加有效的击碎钙化灶，并因热效应影响可以起到创伤凝血的功能，有效避免术中 出血和术后血肿的风险。而与现有的电切活检针100相比，本申请的电切活检针100将穿刺管112作为一极，将切割件122的切割刃口122b作为另一极，利用切割刃口122b与穿刺管112之间的高频电波进行切割，工作时无需额外增加金属板，可以避免因金属板与人体皮肤贴合不好而灼伤人体，安全性高，而且操作方便。此外，产品结构简单、成本低。
进一步参见图5，本实施例中的切割刃口122b为沿着前端口122d的周围延伸的圆形，该切割刃口122b的长度较长，切割效率高。而且，当切割件122沿切割件122的轴向由后向前移动时，被切割刃口122b切断后的组织直接挤入前端口122d内，然后通过真空吸入收集盒150内。本实施例中的切割刃口122b由金属丝(如不锈钢丝、钨丝等)弯曲形成，切割刃口122b直接固定在前端口122d的端面上。此种结构的切割刃口122b具有结构简单、可靠性好的优点。
图7所示为第二种结构的切割刃口122b的立体结构示意图。如图所示，该切割刃口122b以一定间距相对地设置在前端口122d的前侧，在切割刃口122b与前端口122d之间设置有至少一条导电的支脚122e，支脚122e的一端与切割刃口122b电性连接，另一端与第一接口162电性连接，支脚122e同时起到支撑和导电的作用。本实施例中的支脚122e的数量为两条，两条支脚122e的连线经过切割刃口122b的圆心。
图8所示为第三种结构的切割刃口122b的立体结构示意图。如图所示，该切割刃口122b为弧形，支脚122e的数量为三条，其中两条支脚122e的一端与弧形的两端连接，剩余一条支脚122e的一端与弧形的顶点连接。这种结构的切割刃口122b的结构更加牢固。
图9所示为第四种结构的切割刃口122b的立体结构示意图。如图所示，切割件122的前端口122d处设置有一沿着前端口122d周围延伸的闭合或者非闭合金属片122f，切割刃口122b形成在金属片122f的前端，金属片122f与第一接口162电性连接。此种切割刃口122b的强度大，同时还可以起到机械切割的作用。
切割刃口122b除了上述四种结构之外，还可以是以下结构：切割件主体122a包括金属的管体和包覆在管体表面的绝缘层，管体的前端口122d露出且加工成尖状形成切割刃口122b，这种切割件122的结构更加简单。
本实施例中，切割件主体122a包括金属(如不锈钢)的管体(图中未示出)和包覆在管体表面的绝缘层(图中未示出)，管体与切割刃口122b和第一接口162电性连接。优选地，切割刃口122b与管体的前端焊接。作为替代方案，切割件主体122a采用绝缘材料(陶瓷材料、硬质塑料)制成，切割刃口122b固定在前端口122d的端面上，在切割件主体122a的管壁内设置有至少一连接导线(图中未示出)，该连接导线的一端与切割刃口122b电性连接，另一端与第一接口162电性连接。优选地，切割刃口122b和连接导线为一体结构。
为了方便被切割下来的组织进入切割件122内，切割件主体122a的前端口122d的周壁上开设有至少一个通气口122c。
如图1、2所示，本实施例中的第一接口162包括第一插针，第二接口164包括第二插针。第一插针与切割刃口122b可以通过导线电性连接，或者，切割件主体122a包括金属的管体和包覆在管体表面的绝缘层，在管体的靠近第一插针的位置不涂敷绝缘涂层，第一插针的内端与管体接触实现电性连接，而管体的前端与切割刃口122b电性连接，从而实现第一插针与切割刃口122b电性连接。第二插针的内端通过导线(图中未示出)与穿刺管112电性连接。第一插针和第二插针的外端均露出外壳114。
如图1、4、10所示，本实施例中的电切活检针100还包括用于将旋转力矩转换为切割件122直线运动的传动机构。作为示例，传动机构包括推杆124、第一齿轮130和止转机构，推杆124固定地套设在伸入外壳114内的切割件122上，推杆124上设置有外螺纹124a，第一齿轮130的中心设置有螺纹孔131，该螺纹孔131的内螺纹与推杆124上的外螺纹124a配合，止转机构用于限制切割件122相对穿刺管112旋转。第一齿轮130旋转时，使推杆124在第一齿轮130轴线上做轴向运动，将旋转运动转变为直线运动，实现切割组件120的前进后退。如图所示，推杆124靠近穿刺管112的前端侧的一端上设置有至少一条沿轴向延伸的限位槽124b，在外壳114内固定有轴套140，该轴套140套设在推杆124上，轴套140的内壁设置有沿轴向延伸的限位凸起142，限位凸起142与限位槽124b配合形成止转机构，限制切割件122相对穿刺管112旋转。
本实施例中的电切活检针100还包括收集盒150，收集盒150的入口与切割件122的后端连接，被切断的组织经过切割件122进入收集盒150内。
切割件122的外壁与穿刺管112的内壁之间形成有供气体流通的气道，电切活检针100还包括用于使气道的后端开口与外界大气导通或者非导通的空气阀门机构，本实施例中的空气阀门机构可以是公开号为CN209285578U的中国专利公开的空气阀门机构。
如图1、2所示，手柄200包括壳体210、驱动装置、电路板(图中未示出)、第一线缆410、第三接口217和第四接口218，壳体210的一侧设置有用于容纳活检针的外壳114的卡槽212，驱动装置容纳于壳体210内，驱动装置包括电机214和第二齿轮216，第二齿轮216安装在电机214的输出轴上，第二齿轮216部分露出壳体210与电切活检针100的第一齿轮130啮合。电路板连接电机214、第一线缆410、第三接口217和第四接口218。本实施例中的第三接口217为与第一插针配合的第一插孔，第四接口218为与第二插针配合的第二插孔。当电切活检针100安装在卡槽212内时，第一插针和第二插针分别插入第一插孔和第二插孔内。
在一个实施例中，切割件122还可相对于穿刺管112旋转运动。
请参阅图14与图15，在一个实施例中，切割件主体122a上设置有电极套环170，第一电极通过电极套环170与所述第一接口162连接。所述第一接口162和所述第二接口164中的其中任意一接口还用于直接或间接地连接主机300的高频输出端，另一接口还用于直接或间接地连接主机300的电凝输入端。如果第一接口162与高频输出端连接，第二接口164与电凝输入端连接，则切割刃口122b形成发射极，穿刺管112形成接收极，反之，如果第一接口162与电凝输入端连接，第二接口164与高频输出端连接，则切割刃口122b形成接收极，穿刺管112形成发射极。切割刃口122b、穿刺管112、第一接口162和第二接口164形成回路以传导电流。
当需要止血时，向第一接口162或者第二接口164输入电流时，电流从第一接口162或者第二接口164传导至第一电极或者第二电极，由于第一电极与第二电极之间存在体液、组织等，体液、组织导电将第一电极和第二电极导通从而在人体内形成电流，且由于第一电极的面积小于第二电极的面积，因此在第一电极附近的电流能量密集，在体内释放热量，对创面组织进行加热，实现机体组织的凝固，从而达到止血的目的。
请参阅图14与图15，在一个实施例中，电极套环170包括环状的安装座171和设置在安装座171上的圆周方向排布的至少一个弹性触头组件172，所述弹性触头组件172包括所述安装座171的中心孔内的弹性触头172a，具体而言，切割件主体122a的后端有导电区域1221，所述弹性触头172a的头部与导电区域1221的外壁滑动配合。电极套环170采用此种结构，可以实现当切割件122轴向前后往复移动和旋转运动时，所述弹性触头172a的头部始终与导电区域1221的表面可靠接触，连接可靠性高。电极套环170还包括设置在安装座171外周面上的连接头173，连接头173通过导线与第一插针电连接；所述弹性触头172a与连接头173电连接。
请参阅图1与图2，在一个实施例中，所述穿刺组件110还包括管状的外壳114。所述穿刺管112的后端插入固定在所述外壳114的前端内，所述切割件122的后端伸出所述穿刺管112并伸入所述外壳114内。所述第一接口162和所述第二接口164设置在所述外壳114上。
请参阅图1与图2，在一个实施例中，所述第一接口162包括第一插针，所述第二接口164包括第二插针。所述第一插针与电极套环170电性连接。所述第二插针的内端通过导线与所述穿刺管112电性连接，所述第一插针和所述第二插针的外端均露出所述外壳114。作为示例，切割件主体122a包括金属的管体和包覆在管体表面的绝缘层，管体的后端露出绝缘层以形成导电区域1221，导电区域1221穿设在电极套环170内，且可以相对于电极套环170轴向前后往复移动和旋转运动。
图11为具有上述实施例中的电切活检针套件的真空辅助乳房活检系统的结构示意图。如图所示，本申请的真空辅助乳房活检系统包括上述实施例中的电切活检针套件和主机300，主机300内设置有高频发射模块(图中未示出)和真空发生系统(图中未示出)，该高频发射模块的高频输出端和高频输入端通过第一线缆410与手柄200内的电路板连接，而电路板与第一插孔和第二插孔电连接，从而实现高频发射模块的高频输出端和高频输入端与第一插针和第二插针间接地连接。通气口122c、切割件122与穿刺管112之间的气道与切割件122的内部形成气流通路，避免切割件122前端形成封堵。
此外，主机300内还设置有电凝模块(图中未示出)和真空发生系统(图 中未示出)，该电凝模块的高频输出端和电凝输入端通过第四线缆(图中未示出)与手柄200内的电路板连接，从而实现电凝模块的高频输出端和电凝输入端与第一插针和第二插针间接地连接。通气口122c、切割件122与穿刺管112之间的气道与切割件122的内部形成气流通路，避免切割件122前端形成封堵。
本申请实施例中的真空辅助乳房活检系统的工作过程如下：
使用者首先在超声设备的引导下将穿刺管112的前端穿刺到术点位置，此时切割件122的前端口122d位于最靠近穿刺管112前端的位置，取样槽112a处于关闭状态，通过手柄200上的控制按钮发送控制信号，电路板控制电机214开始工作，开启负压，通过第二齿轮216与第一齿轮130配合驱动电切活检针100的切割件122向后运动，打开取样槽112a至需要的大小，当切割件122向后运动时空气阀门关闭，切割件122、收集盒150、真空管500、电切活检针100的真空接头，依次连接形成真空通道，组织标本被吸入取样槽112a；
通过手柄200按键发送控制信号开始取样，或者软件自动控制开始取样，通过第二齿轮216与第一齿轮130配合驱动电切活检针100的切割件122向前运动，使切割刃口122b前进，同时主机300输出高频电波，高频电波通过第一线缆410、电路板、第一插孔和第一插针输送至切割刃口122b，在切割刃口122b和穿刺管112之间产生高频电波，通过高频电波对病灶组织进行部分或完全切除，当切割件122前进至最靠近穿刺管112前端的位置时空气阀门机构打开，外界大气通过通气口122c和切割件122与穿刺管112之间的气道进入切割件122的前端口122d，而切割件122的内部为真空，这样在内外压差下被切割下来的组织标本通过通气口122c进入切割件122内，然后输送到收集盒150内，以便进行制片处理及病理检测分析诊断。一方面可微创取出病变组织标本，做出准确的病理诊断；另一方面可对病灶进行微创手术切除。
此外，当需要止血时，电凝模块通过线缆、电路板、第一插孔和第一插针向第一电极输送电流，由于第一电极与第二电极之间存在体液、组织等，体液、组织导电将第一电极和第二电极导通从而形成电凝回路，且由于第一电极的面积小于第二电极的面积，因此在第一电极附近的电流能量密集，在体内释放热量，对创面组织进行加热，实现机体组织的凝固，从而达到止血的目的。
图12为本申请实施例二中的电切活检针套件的立体结构示意图，图13为 具有图12中所示电切活检针套件的真空辅助乳房活检系统的结构示意图。如图所示，本实施例中的电切活检针套件与实施例中的电切活检针套件的结构大体相同，不同之处在于，电切活检针100的高频电路直接与主机300连接，即穿刺组件110上的第一插针和第二插针设置在背对手柄200的一侧，主机300通过第二线缆420与手柄200的电路板连接，通过第三线缆430与第一插针和第二插针电性连接。
此外，可选地，活检针100的第一接口162和第二接口164直接与主机300连接，即穿刺组件110上的第一插针和第二插针设置在背对手柄200的一侧，主机300通过第五线缆(图中未示出)与手柄200的电路板连接，电凝模块的高频输出端和电凝输入端通过第六线缆(图中未示出)与第一插针和第二插针电性连接。
以上实施例仅表达了本申请的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对本申请专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本申请构思的前提下，还可以做出若干变形和改进，这些都属于本申请的保护范围。

Claims (21)

  1. 一种电切活检针，包括：
    穿刺组件，该穿刺组件包括穿刺管，所述穿刺管具有前端和后端，所述穿刺管的管壁上开设有取样槽；
    切割组件，该切割组件包括切割件；
    其特征在于，所述切割件可沿着所述穿刺管的轴向前后往复移动；
    所述切割组件具有第一电极，所述穿刺组件具有第二电极；还包括与第一电极和第二电极分别电性连接的第一接口和第二接口，所述第一接口和所述第二接口中的其中任意一接口用于直接或间接地连接主机的高频输出端，另一接口用于直接或间接地连接所述主机的高频输入端。
  2. 根据权利要求1所述的电切活检针，其特征在于，所述切割件包括切割件主体和设置在所述切割件主体的前端口上的切割刃口，所述切割件主体绝缘，所述切割刃口导电形成所述第一电极，所述穿刺管导电形成所述第二电极。
  3. 根据权利要求2所述的电切活检针，其特征在于，所述切割刃口为沿着所述前端口的周围延伸的圆形或者弧形。
  4. 根据权利要求3所述的电切活检针，其特征在于，所述切割刃口由金属丝弯曲形成。
  5. 根据权利要求3所述的电切活检针，其特征在于，所述前端口处设置有一沿着所述前端口周围延伸的闭合或者非闭合金属片，所述切割刃口形成在所述金属片的前端，所述金属片与所述第一接口电性连接。
  6. 根据权利要求3所述的电切活检针，其特征在于，所述切割刃口直接固定在所述前端口的端面上。
  7. 根据权利要求3所述的电切活检针，其特征在于，所述切割刃口以一定间距相对地设置在所述前端口的前侧，在所述切割刃口与所述前端口之间设置有至少一条导电的支脚，所述支脚的一端与所述切割刃口电性连接，另一端与所述第一接口电性连接。
  8. 根据权利要求7所述的电切活检针，其特征在于，所述切割刃口为圆形，所述支脚的数量为两条，两条所述支脚的连线经过所述圆形的圆心。
  9. 根据权利要求7所述的电切活检针，其特征在于，所述切割刃口为弧形，所述支脚的数量为三条，其中两条支脚的一端与所述弧形的两端连接，剩余一条支脚的一端与所述弧形的顶点连接。
  10. 根据权利要求2至9中任意一项所述的电切活检针，其特征在于，所述切割件主体包括金属的管体和包覆在所述管体表面的绝缘层，所述管体与所述切割刃口和所述第一接口电性连接。
  11. 根据权利要求2至9中任意一项所述的电切活检针，其特征在于，所述切割件主体采用绝缘材料制成，在所述切割件主体的管壁内设置有至少一连接导线，该连接导线的一端与所述切割刃口电性连接，另一端与所述第一接口电性连接。
  12. 根据权利要求1至9中任意一项所述的电切活检针，其特征在于，所述穿刺组件还包括管状的外壳，所述穿刺管的后端插入固定在所述外壳的前端内，所述切割件的后端伸出所述穿刺管并伸入所述外壳内，在伸入所述外壳内的所述切割件上固定套设有推杆，在所述推杆上螺纹配合有第一齿轮，还包括限制所述切割件相对所述穿刺管旋转的止转机构。
  13. 根据权利要求1至9中任意一项所述的电切活检针，其特征在于，所述切割件包括切割件主体，所述切割件主体上设置有电极套环，所述第一电极通过所述电极套环与所述第一接口连接；所述第一接口和所述第二接口中的其中任意一接口还用于直接或间接地连接主机的高频输出端，另一接口还用于直接或间接地连接主机的高频输入端。
  14. 根据权利要求13所述的电切活检针，其特征在于，所述切割件主体的后端有导电区域，所述导电区域与所述第一电极电连接，所述导电区域穿设在所述电极套环的中心孔内，且可相对于所述电极套环轴向前后往复移动和旋转运动，所述电极套环设置有至少一个弹性触头组件，所述弹性触头组件包括设置在所述电极套环的中心孔内的弹性触头，所述弹性触头的头部与所述导电区域的外壁滑动配合，且所述弹性触头与所述第一接口直接或间接连接。
  15. 根据权利要求14所述的电切活检针，其特征在于，所述电极套环还包括设置在电极套环外周面上的连接头，所述连接头与所述第一接口连接，所述弹性触头与所述连接头电连接。
  16. 根据权利要求1至9中任意一项所述的电切活检针，其特征在于，所述切割件还可相对于所述穿刺管旋转运动。
  17. 根据权利要求1至9中任意一项所述的电切活检针，其特征在于，所述穿刺组件还包括管状的外壳，所述穿刺管的后端插入固定在所述外壳的前端内，所述切割件的后端伸出所述穿刺管并伸入所述外壳内，所述第一接口和所述第二接口设置在所述外壳上。
  18. 根据权利要求17所述的电切活检针，其特征在于，所述第一接口包括第一插针，所述第二接口包括第二插针；所述第一插针与所述第一电极电性连接；所述第二插针的内端通过导线与所述穿刺管电性连接，所述第一插针和所述第二插针的外端均露出所述外壳。
  19. 一种电切活检针套件，包括手柄，所述手柄包括壳体和设置在所述壳体内的电路板，其特征在于，还包括如权利要求1至18中任意一项所述的电切活检针，所述手柄还包括分别与所述第一接口和所述第二接口配合的第三接口和第四接口，所述第三接口和所述第四接口与所述电路板电性连接，所述电切活检针与所述壳体连接，所述第一接口和所述第二接口分别与所述第三接口和所述第四接口电性连接。
  20. 一种电切活检针套件，包括手柄，所述手柄包括壳体，其特征在于，还包括如权利要求1至18中任意一项所述的电切活检针，所述电切活检针与所述壳体连接。
  21. 一种真空辅助乳房活检系统，其特征在于，包括：
    如权利要求19或20所述的电切活检针套件；以及
    主机，该主机包括用于产生高频的高频发射模块，该高频发射模块具有高频输出端和所述高频输入端，所述高频输出端和所述高频输入端通过线缆与所述电路板连接从而间接地与所述第一接口和所述第二接口连接，或者所述高频输出端和所述高频输入端通过线缆与所述第一接口和所述第二接口直接地连接。
PCT/CN2022/090236 2021-05-11 2022-04-29 电切活检针、电切活检针套件及真空辅助乳房活检系统 WO2022237580A1 (zh)

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