WO2020020205A1 - Endoscopic ultrasonography flexible microwave ablation needle - Google Patents

Endoscopic ultrasonography flexible microwave ablation needle Download PDF

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Publication number
WO2020020205A1
WO2020020205A1 PCT/CN2019/097425 CN2019097425W WO2020020205A1 WO 2020020205 A1 WO2020020205 A1 WO 2020020205A1 CN 2019097425 W CN2019097425 W CN 2019097425W WO 2020020205 A1 WO2020020205 A1 WO 2020020205A1
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WO
WIPO (PCT)
Prior art keywords
tube
handle
ablation needle
microwave ablation
inner tube
Prior art date
Application number
PCT/CN2019/097425
Other languages
French (fr)
Chinese (zh)
Inventor
于春生
江荣华
杨小唤
隆龙
Original Assignee
南京康友医疗科技有限公司
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
Application filed by 南京康友医疗科技有限公司 filed Critical 南京康友医疗科技有限公司
Publication of WO2020020205A1 publication Critical patent/WO2020020205A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/1815Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/1815Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
    • A61B2018/1869Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves with an instrument interstitially inserted into the body, e.g. needles

Definitions

  • the present disclosure relates to the field of microwave therapeutic medical devices, and in particular, to a flexible microwave ablation needle under ultrasound endoscope configured to perform microwave ablation treatment of tumors and diseased tissues inside the abdominal cavity.
  • Microwave ablation as a minimally invasive surgery, is becoming more and more widely used. Microwave ablation is using the thermal effect of microwave biological tissues to treat lesions. Tissues perform hemostasis, coagulation, burning, anti-inflammatory, swelling, analgesia, or improve local tissue blood circulation to achieve the effect of treating diseases. It has the advantages of less trauma, quick effect and strong penetrating ability, and is accepted by more and more patients.
  • microwave ablation minimally invasive surgery use ultrasound or X-ray imaging equipment to locate the lesion, and then use an external ablation needle to percutaneously puncture the microwave ablation after reaching the lesion.
  • This minimally invasive microwave ablation is limited by external conditions such as the patient's physical conditions, the location of the lesion, and the length of the ablation antenna.
  • the puncture needle path cannot completely ensure that the lesion can be safely and accurately reached.
  • endoscopic microwave needle has improved the microwave ablation technology to a new level, and the new technology is more intuitive with the help of endoscopes. Direct the microwave radiation antenna to the tumor and diseased tissue.
  • the purpose of the present disclosure includes, for example, providing an ablation needle with good flexibility, which can effectively solve the problems of difficult puncture and positioning of the ablation needle, and can reach more lesions, and has strong penetrability.
  • An embodiment of the present disclosure provides a flexible microwave ablation needle under ultrasound endoscope, including a handle, a radio frequency coaxial connector, and a microwave radiation antenna.
  • the radio frequency coaxial connector is disposed on the handle, and the radio frequency coaxial
  • the connector is connected to the microwave radiation antenna through a radio frequency coaxial cable, and a capillary tube and an inner tube are sequentially arranged on the periphery of the radio frequency coaxial cable.
  • the radio frequency coaxial cable is placed in the capillary tube, and the capillary tube is disposed.
  • the capillary tube communicates with a water inlet pipe as a cooling water passage
  • the capillary outer wall and the inner pipe inner wall form a drainage pipe
  • the drainage pipe communicates with a water outlet pipe, and water entering the cooling water passage passes through the water pipe.
  • the drainage pipe is discharged, the inner pipe includes a first end portion and a second end portion, the first end portion extends to the microwave radiation antenna, the second end portion is far from the microwave radiation antenna, and the inner tube It tapers from the second end to the first end.
  • the inner tube is made of a material that can withstand high temperatures and can be bent, such as poly (phenylene ether ether ketone), polyimide, nickel-titanium alloy tube, PTFE tube, or medical composite material composite braided tube.
  • poly (phenylene ether ether ketone) polyimide
  • nickel-titanium alloy tube nickel-titanium alloy tube
  • PTFE tube or medical composite material composite braided tube.
  • the capillary is made of a material that can withstand high temperatures and can be bent, such as a nickel-titanium alloy tube, a 304 stainless steel tube, a PTFE tube, a medical composite multilayer braided tube, poly (phenylene ether ether ketone), or polyimide,
  • the capillary is covered outside the microwave radiation antenna.
  • it further includes a first temperature sensor connected to the capillary tube and configured to detect a temperature of the microwave radiation antenna.
  • it further comprises an outer tube connected to the handle, and the outer tube is sleeved outside the inner tube.
  • the outer tube is tapered from an end far from the microwave radiation antenna to an end closer to the microwave radiation antenna.
  • the outer tube is made of a material that can withstand high temperatures and can be bent, such as poly (phenylene ether ether ketone), a nickel-titanium alloy tube, a PTFE tube, a medical composite multilayer braided tube, or a polyimide.
  • the connecting member includes a sliding portion and a plurality of deformed portions connected to the sliding portion.
  • the plurality of deformed portions are along the sliding portion.
  • the sliding members are arranged at intervals in the circumferential direction, and the slider is connected to the sliding portion, and the sliding portion is located between the inner tube and the outer tube, and slides with the inner tube in the axial direction of the inner tube. Fit; the sliding member slides with the handle, and when the connecting member slides relative to the inner tube, the deformed portion can extend out of the inner tube and the outer tube and along the inner tube.
  • the deformed portion Open radially outward, or the deformed portion can be retracted between the inner tube and the outer tube; the plurality of the second temperature sensors correspond to the plurality of the deformed portions one by one and are configured to detect The temperature around the ablation tissue to determine the size of the ablation area.
  • the sliding portion is sleeved outside the inner tube.
  • the sliding portion is provided with a braided tube, and a plurality of the deformed portions are integrally knitted with the braided tube.
  • the handle includes a first handle, a telescopic handle, and a second handle connected in sequence, and the telescopic handle and the first handle or / and the second handle are along the axis of the radio frequency coaxial cable.
  • the RF coaxial connector is disposed on the first handle, a first through hole penetrating through both ends of the length direction of the telescopic handle is provided in the telescopic handle, and the second handle is provided with A second through hole penetrating through both ends in the length direction of the second handle, one end of the radio frequency coaxial cable, the capillary tube, and the inner tube is connected to the first handle, and the radio frequency coaxial cable
  • the other ends of the capillary tube and the inner tube pass through the first through hole and the second through hole in sequence and protrude from the end of the second through hole away from the first through hole.
  • the telescopic handle is slidably connected to the first handle.
  • a locking device is provided between the telescopic handle and the first handle to prevent the two from sliding relative to each other.
  • the locking device includes a snap ring connected to the first handle, the snap ring is provided with a protrusion, the outer peripheral surface of the telescopic handle is provided with a snap groove, and the snap ring can be along a diameter To deform to engage the protrusion in the slot, thereby restricting the first handle from sliding relative to the telescopic handle; or to separate the protrusion from the slot, thereby causing the The first handle and the telescopic handle can slide relative to each other.
  • the first handle is provided with a hollow area, and the telescopic handle is inserted in the hollow area and can slide relative to the first handle.
  • the handle is provided with an isolation cavity, the isolation cavity includes a water inlet cavity and a water outlet cavity separated from each other, the capillary tube communicates with the water inlet pipe through the water inlet cavity, and the drainage channel passes through the water inlet The water outlet cavity communicates with the water outlet pipe.
  • the microwave radiation antenna is a triangular pyramid antenna, a bevel antenna, or a cone antenna.
  • the inner tube in the present disclosure adopts a tapered diameter to make the front end thin and thick. Under the condition of ensuring the required strength of the inner tube, the front end can be bent to reach more lesions, and the design increases the inner tube.
  • the present disclosure makes full use of the pipe between the inner tube and the capillary tube as a cooling water drainage channel, so that the cooling water in the capillary tube flows to the microwave radiation antenna and is discharged by the drainage channel, so that the cooling water channel and drainage The channels are separated from each other to ensure the cooling efficiency; 3.
  • the inlet and outlet pipes in the present disclosure are arranged on the same side, which facilitates the management of the inlet and outlet cooling water; 4.
  • the outer tube in the present disclosure is arranged outside the inner tube, and
  • the thickness of the inner tube changes in the same direction.
  • it not only protects the microwave radiation antenna and the reduced diameter inner tube from external force damage, but also acts as a freely retractable passage for the reduced diameter inner tube.
  • it can isolate the microwave radiation antenna and prevent damage to the inner wall of the ultrasonic endoscope;
  • the design of the present disclosure using a telescopic handle can change the length of the microwave radiation antenna deep into the body by changing the relative position of the first handle and the telescopic handle to achieve extensibility.
  • Function; 6 the present disclosure isolation chamber such that the inlet chamber and the outlet chamber separated rod designs can effectively reduce the temperature, thus reducing energy consumption during microwave ablation of normal tissue damage, and endoscopy.
  • FIG. 1 is a schematic structural diagram of a flexible microwave ablation needle in an embodiment of the present disclosure
  • FIG. 2 is a schematic cross-sectional view taken along the A-A direction in FIG. 1;
  • FIG. 3 is a partially enlarged schematic diagram at C in FIG. 1; FIG.
  • FIG. 4 is a partially enlarged schematic diagram at B in FIG. 1; FIG.
  • FIG. 5 is a schematic cross-sectional structure diagram of a flexible microwave ablation needle in an embodiment of the present disclosure.
  • the flexible microwave ablation needle under ultrasound endoscope in the present disclosure includes a handle 01, a radio-frequency coaxial connector 7, a radio-frequency coaxial cable 8, a microwave radiation antenna 9, a capillary 10, an inner tube 11, and an outer tube. 12.
  • the RF coaxial connector 7 is disposed on the handle 01.
  • One end of the RF coaxial cable 8 is connected to the RF coaxial connector 7.
  • the other end of the RF coaxial cable 8 is connected to a microwave radiation antenna 9.
  • the microwave radiation antenna 9 includes energy transmission.
  • the device is configured to emit the ablated microwaves, and its structure can be designed according to different requirements.
  • the microwave radiation antenna 9 can use a triangular pyramid antenna, a bevel antenna, or a conical antenna, and has excellent puncture function.
  • a radio-frequency coaxial cable 8 passes through the lumen of the capillary tube 10 and protrudes from the capillary 10 at one end.
  • the radio-frequency coaxial cable 8 has a microwave radiation channel.
  • the radio-frequency coaxial cable 8 is configured to connect the microwave radiation antenna 9 and the radio-frequency coaxial cable.
  • the connector 7 and the radio frequency coaxial cable 8 have a high dielectric constant and prevent microwave leakage.
  • the RF coaxial cable 8 includes an outer layer, an intermediate layer, and an inner core which are arranged in order from the outside to the inside.
  • the outer layer is provided as a copper shielding sheath
  • the middle layer is provided as a PTFE dielectric layer
  • the inner core is provided. It is silver-clad steel, and the RF coaxial cable 8 adopts double-layer protection, and the protection effect is good.
  • the capillary tube 10 is arranged in the inner tube 11 and extends from one end of the handle 01 to the microwave radiation antenna 9.
  • the capillary tube 10 is covered by the RF coaxial cable 8.
  • the lumen of the capillary tube 10 is used as the cooling water channel 15, and the cooling water channel 15 is connected.
  • cooling water can enter the capillary tube 10 from the end of the capillary tube 10 far from the microwave radiation antenna 9 to reduce the temperature of the radio frequency coaxial cable 8 and ensure that the temperature of the radio frequency coaxial cable 8 is not excessively high.
  • the inner tube 11 is covered by the capillary tube 10, and a drainage channel 16 is formed between the inner peripheral wall of the inner tube 11 and the outer peripheral wall of the capillary tube 10.
  • the end of the capillary tube 10 that is far from the microwave radiation antenna 9 projects the drain channel 16, and the drain channel 16 and the outlet
  • the water pipe 5 communicates, and the cooling water enters from the end of the capillary tube 10 away from the microwave radiation antenna 9, flows out from the other end of the capillary tube 10 near the microwave radiation antenna 9, enters the drainage channel 16, and is then discharged from the water outlet pipe 5.
  • the outer tube 12 covers the outside of the inner tube 11.
  • the inner tube 11 is provided in a reduced diameter form. Both ends of the inner tube 11 along the length direction thereof extend to the handle 01 and the microwave radiation antenna 9, respectively. One end of the inner tube 11 connected to the microwave radiation antenna 9 is provided. It is designated as the first end portion 110, and the end of the inner tube 11 connected to the handle 01 is set as the second end portion 111.
  • the pipe diameter (including the inner diameter and the outer diameter) of the inner tube 11 is directed from the second end portion 111 along its length direction.
  • the first end portion 110 gradually becomes smaller, and the minimum diameter of the inner tube 11 is 1 mm. This design enables the thin end of the inner tube 11 to be bent, can reach more lesions, and improves the flexibility and success rate of the operation.
  • the inner tube 11 is made of a material that is resistant to high temperatures and can be bent freely, such as PEEK (Polyetheretherketone polyphenylene ether ketone), PI (Polyimide polyimide), nickel-titanium alloy tube, PTFE Polytetrafluoroethylene) tube or medical composite material combined braided tube, these materials have good flexibility, and the bending of the inner tube 11 is more flexible.
  • the inner tube 11 not only protects the capillary tube 10 and the radio-frequency coaxial cable 8, but also the drainage channel 16 formed between the inner peripheral wall of the inner tube 11 and the outer peripheral wall of the capillary tube 10 and the cooling channel 15 formed by the lumen of the capillary tube 10 itself. They are independent from each other, that is, the cooling water channel 15 and the drainage channel 16 are separated from each other, and the cooling water channel 15 is closer to the RF coaxial cable 8 than the drainage channel 16, which improves the cooling efficiency.
  • the capillary 10 is made of a material that is resistant to high temperatures and can be bent freely, such as a nickel-titanium alloy tube, a 304 stainless steel tube, a PTFE (Polytetrafluoroethylene) tube,
  • a nickel-titanium alloy tube a nickel-titanium alloy tube
  • a 304 stainless steel tube a PTFE (Polytetrafluoroethylene) tube
  • the medical composite material multi-layer braided tube PEEK (Poly Ether Ketone Polyphenylene Ether Ketone) or PI (Polyimide Polyimide) makes the capillary 10 have the function of free bending and recoverable deformation, preventing the needle rod from being deformed.
  • PI Polyimide Polyimide
  • FIG. 2 shows a schematic cross-sectional view in the direction A-A in FIG. 1.
  • the needle bar in the present disclosure includes an outer tube 12, an inner tube 11 covered with the outer tube 12, a capillary tube 10 covered with the inner tube 11, and a radio frequency coaxial cable 8 covered with the capillary tube 10.
  • the lumen of the capillary tube 10 serves as the cooling water channel 15.
  • a drainage channel 16 is formed between the outer peripheral wall of the capillary tube 10 and the inner peripheral wall of the inner tube 11.
  • the diameter of the outer tube 12 is the same, and the diameter of the outer tube 12 is gradually tapered from one end to the other along its length.
  • the outer tube 12 is made of materials that can withstand high temperatures and can be bent freely, such as PEEK (Polyetheretherketone), PI (Polyimide), nickel-titanium alloy tubes, PTFE (Polytetrafluoroethylene) Tube or medical composite material multi-layer braided tube.
  • the outer diameter of the outer tube 12 is a maximum of 3.7mm.
  • the outer tube 12 has a good bendability and double protection. On the one hand, it protects the microwave radiation antenna 9 and the inner tube 11 from being damaged. Damaged by external force also serves as a freely retractable channel for the inner tube 11; on the other hand, it can isolate the microwave radiation antenna 9 to prevent damage to the inner wall of the ultrasonic endoscope. Both ends of the outer tube 12 along the length direction thereof extend to the handle 01 and the microwave radiation antenna 9, respectively, and the length of the outer tube 12 is more than 1.5 m.
  • the microwave radiation antenna 9 adopts a triangular pyramid antenna, a bevel antenna, or a cone antenna, and has excellent puncture function.
  • a first temperature sensor 13 is installed on the needle bar, and the first temperature sensor 13 extends to the front end of the microwave radiation antenna 9 to accurately monitor the temperature of the needle bar in real time to prevent the temperature of the needle bar from being too high and causing damage to normal tissue and internal damage.
  • the first temperature sensor 13 can feedback the detected temperature to the control system, and then cut off the microwave output.
  • the first temperature sensor 13 is connected to the capillary tube 10 and is disposed near the microwave radiation antenna 9.
  • FIG. 4 shows a partially enlarged schematic diagram at B in FIG. 1.
  • An isolation cavity 6 is provided in the handle 01.
  • the isolation cavity 6 includes a water inlet cavity 601 and a water outlet cavity 602 that are separated from each other.
  • the water inlet cavity 601 and the water outlet cavity 602 are sequentially arranged along the length direction of the needle rod.
  • the isolation cavity 6 A partition 60 is provided in the partition, and the partition 60 separates the isolation chamber 6 into an independent water inlet chamber 601 and a water outlet chamber 602.
  • the end of the capillary tube 10 far from the microwave radiation antenna 9 protrudes from the port corresponding to the drainage channel 16.
  • the capillary tube 10 passes through the partition plate 60 and communicates with the water inlet cavity 601.
  • the corresponding end of the drainage channel 16 extends into the water outlet cavity 602 and communicates with the water outlet cavity 602. After the circuit is formed, the cooling water after the cold and heat exchange is led out, thereby reducing the temperature of the needle bar.
  • the water inlet chamber 601 is connected to the water inlet pipe 4 and the water outlet chamber 602 is connected to the water outlet pipe 5.
  • the structural design of the isolation chamber 6 makes the water inlet and the water phase isolated, which can effectively reduce the temperature of the needle bar.
  • the capillary tube 10 and the inner tube 11 are independently connected to the isolation cavity 6 as circulating cooling paths, which can save space.
  • the endoscopic ablation needle can be designed thinner, ensure good cornering performance, and can freely switch directions in the endoscope.
  • the handle 01 in the present disclosure includes a first handle 1, a telescopic handle 2, and a second handle 3.
  • the telescopic handle 2 is connected to the first handle 1 and the second handle 3.
  • the first handle 1 is provided with a radio-frequency coaxial connector 7 and an isolation cavity 6.
  • the telescopic handle 2 is provided with a first through-hole 17, and the first through-hole 17 extends along the telescope.
  • the length direction of the handle 2 runs through both ends of the telescopic handle 2.
  • a second through hole 18 is provided in the second handle 3, and the second through hole 18 penetrates both ends of the second handle 3 along the length direction of the second handle 3.
  • the RF coaxial cable 8 passes through the first through hole 17 and the second through hole 18 in sequence from the first handle 1 and extends out of the second handle 3.
  • the length extension direction of the capillary tube 10 is consistent with the length extension direction of the inner tube 11.
  • the length of the capillary tube 10 extends from the water inlet cavity 601 of the isolation cavity 6 to the microwave radiation antenna 9, and the length of the inner tube 11 extends from the water outlet cavity 602 of the isolation cavity 6 to the microwave radiation antenna 9.
  • the outer tube 12 is fixed at an end of the second handle 3 away from the telescopic handle 2.
  • the outer tube 12 communicates with the second through hole 18, and the outer tube 12 may be integrated with the second handle 3.
  • the diameter of the outer tube 12 is connected along its length.
  • One end of the second handle 3 is gradually tapered toward the other end, and the length of the outer tube 12 may be set to be more than 1.5m.
  • the telescopic handle 2 is slidably connected to the first handle 1.
  • one end of the first handle 1 connected to the telescopic handle 2 is hollow, one end of the telescopic handle 2 extends into the hollow area of the first handle 1, and the length of the telescopic handle 2 extending into the first handle 1 is changed by sliding the telescopic handle 2 That is, the distance between the first handle 1 and the second handle 3 is changed, and finally the depth of the microwave radiation antenna 9 protruding into the human body is adjusted.
  • the first handle 1 and the telescopic handle 2 are connected by a locking device.
  • the telescopic handle 2 and the first handle 1 are fixed by using a structure in which the guide rail and the guide groove are engaged with each other to prevent the telescopic handle 2 and the first handle 1 from rotating relatively.
  • the locking device includes a snap ring 14 connected to the first handle 1 and located at an end of the first handle 1 connected to the telescopic handle 2. The telescopic handle 2 passes through the snap ring 14 and extends into the first handle 1 Hollow area.
  • a slot is provided on the outer peripheral wall of the telescopic handle 2, and a protrusion corresponding to the slot is provided on the inner peripheral wall of the snap ring 14. After the protrusion is snapped into the slot, the position between the telescopic handle 2 and the first handle 1 is provided. Relatively fixed, the telescopic handle 2 and the first handle 1 cannot slide relative to each other. In order to clearly understand the depth of the needle shaft, a scale is provided on the telescopic handle 2, and the scale can clearly indicate the depth of the ablation needle.
  • the specific operation of the length adjustment of the handle 01 is: pressing the snap ring 14, the first handle 1 can slide together with the isolation cavity 6, the reducing inner tube 11 and the microwave radiation antenna 9; loosening the snap ring 14, the telescopic handle 2 has The zigzag-shaped clamping grooves and the elastic buckles are embedded in the clamping grooves of the telescopic handle 2 so as to fix the telescopic handle 2 to prevent it from moving back and forth relative to the first handle 1.
  • the snap ring 14 has a built-in elastic buckle. Press the snap ring 14 to release the snap slot to release the snap ring. The snap ring 14 is loosened. The elastic snap catches the snap slot of the telescopic handle 2 by itself.
  • the structure is similar to a lock. End quick plug connector structure.
  • the microwave ablation needle further includes a slider 19, a connecting member 20, a plurality of second temperature sensors 21, and a controller 22.
  • the slider 19 is slidably connected to the first handle 1, and the sliding of the slider 19 The direction is parallel to the axis direction of the first handle 1, and the slider 19 and the first handle 1 are relatively fixed in the radial direction of the first handle 1, that is, the slider 19 does not fall off from the first handle 1, and the use is safe and reliable.
  • the sliding member 19 may be a slider, and the surface of the sliding member 19 may be provided with a non-slip pattern, which increases the friction between the operator's hand and the sliding member 19, facilitates the sliding of the sliding member 19, and is not easy to slip.
  • the connecting member 20 includes a tubular sliding portion 201 and a plurality of deforming portions 202 connected to the sliding portion 201.
  • the plurality of deforming portions 202 are evenly spaced along the circumferential direction of the sliding portion 201.
  • Each deforming portion 202 may be provided as an elastic piece.
  • the sliding portion 201 is sleeved outside the inner tube 11 and is located inside the outer tube 12. In other words, the sliding portion 201 is located between the inner tube 11 and the outer tube 12.
  • the sliding portion 201 can slide back and forth along the axial direction of the inner tube 11 relative to the inner tube 11 or the outer tube 12.
  • the multiple deformed portions 202 may be retracted between the outer tube 12 and the inner tube 11, or the multiple deformed portions 202 may also extend from between the outer tube 12 and the inner tube 11.
  • the deformed portions 202 are deformed outward in the radial direction of the inner tube 11 after being extended, so that the deformed portions 202 are opened.
  • the plurality of second temperature sensors 21 are in one-to-one correspondence with the plurality of deformation portions 202, or, in other embodiments, a plurality of second temperature sensors 21 are provided on each deformation portion 202.
  • a second temperature sensor 21 is installed on each deformed portion 202, and each second temperature sensor 21 opens or retracts following the corresponding deformed portion 202.
  • the sliding member 19 is pushed so that the deformed portion 202 protrudes from the inner tube 11 and is opened by a certain angle ⁇ , for example, 0 ° ⁇ 150 °.
  • the plurality of second temperature sensors 21 are uniformly arranged around the sliding portion 201 in a dispersed manner, and the plurality of second temperature sensors 21 are distributed around the microwave radiation antenna 9.
  • Each of the second temperature sensors 21 is configured to detect a tissue temperature.
  • the open range of the second temperature sensor 21 is proportional to the distance pushed by the slider 19, so that the size of the ablation area can be accurately confirmed.
  • the plurality of second temperature sensors 21 are all communicatively connected to the controller 22, for example, the plurality of second temperature sensors 21 and the controller 22 may be connected by a conductor in a braided layer.
  • the controller 22 is connected to the handle 01 and is located inside the handle 01.
  • the controller 22 is configured to obtain the temperature detected by the second temperature sensor 21 and can display the temperature to the terminal, so that the operator can perform corresponding operations according to the obtained temperature value.
  • the sliding portion 201 is an annular braided tube
  • the deformed portion 202 is an elastic strip
  • the deformed portion 202 is integrally knitted with the annular braided tube.
  • the present disclosure adopts a combined structure of a reduced inner tube and a reduced outer tube.
  • the outer tube 12 is sleeved outside the inner tube 11, and a channel is formed between the outer tube 12 and the inner tube 11 to isolate the outside.
  • heat is isolated during ablation.
  • the inner tube 11 is in contact with the endoscope clamp channel, which effectively protects the endoscope.
  • the triangular pyramid structure of the microwave radiation antenna 9 and the thicker and thinner inner tube 11 at the front end effectively reduce puncture resistance and are more conducive to puncture. Lesion tissue, internal ablation.
  • the outer tube 12 and the inner tube 11 are both provided with a reducing structure made of the materials listed above, which can restore the curved flexible ablation needle to its original state without affecting the cooling ablation effect.
  • the present disclosure can effectively solve the problems of difficult puncture and positioning of the needles. It can be positioned endoscopically, can reach the location of the lesion intuitively and clearly, and then use ultrasonic endoscopic clamping to make the flexible
  • the microwave ablation needle is delivered to the location of the lesion.
  • the unique isolated multi-cavity structure of the invention can effectively reduce the temperature of the needle rod and reduce the damage to the endoscope and normal tissue by the energy consumption during the microwave ablation process.
  • the present disclosure can more accurately estimate the size of the ablation area and achieve more accurate ablation treatment.
  • the working principle of the present disclosure is: power signal: microwave output device ⁇ via RF coaxial connector 7 ⁇ RF coaxial cable 8 ⁇ through handle 01 ⁇ into isolation cavity 6 ⁇ inner tube 11 ⁇ microwave radiation antenna 9 to radiate energy;
  • Protection circuit return water temperature in the drainage pipe 16 ⁇ temperature measurement by the first temperature sensor 13 ⁇ the temperature of the needle rod exceeds the set value ⁇ feedback microwave output device ⁇ cut off the microwave output.
  • Cooling loop water inlet pipe 4 ⁇ water inlet chamber 601 in isolation chamber 6 ⁇ capillary 10 ⁇ inner tube 11 ⁇ first temperature sensor 13 detects the temperature of the needle rod ⁇ water outlet chamber 602 in isolation chamber 6 ⁇ return water after heat exchange ⁇ 5 ⁇ Water pipe 5.
  • the present disclosure provides a flexible microwave ablation needle under ultrasound endoscope, which has strong penetrability and good treatment effect.

Abstract

An endoscopic ultrasonography flexible microwave ablation needle, comprising a handle (01), a radio frequency coaxial connector (7) and a microwave radiation antenna (9), the radio frequency coaxial connector (7) being arranged on the handle (01), the radio frequency coaxial connector (7) being connected to the microwave radiation antenna (9) via a radio frequency coaxial cable (8), a capillary tube (10) and an inner tube (11) being sequentially arranged around the radio frequency coaxial cable (8), the radio frequency coaxial cable (8) being arranged within the capillary tube (10), the capillary tube (10) being arranged within the inner tube (11), the inner tube (11) comprising a first end portion (110) and a second end portion (111), the first end portion (110) extending to the microwave radiation antenna (9), the second end portion (111) being away from the microwave radiation antenna (9), the inner tube (11) gradually thinning from the second end portion (111) to the first end portion (110). The ablation needle is capable of reaching more lesions, and has strong penetrability.

Description

一种超声内镜下柔性微波消融针Flexible microwave ablation needle under ultrasound endoscope
相关申请的交叉引用Cross-reference to related applications
本公开要求于2018年07月26日提交中国专利局的申请号为201810833418.9、名称为“一种超声内镜下柔性微波消融针”的中国专利申请的优先权。This disclosure claims the priority of a Chinese patent application filed on July 26, 2018 with the application number of 201810833418.9 and the name "A Flexible Microwave Ablation Needle Under Ultrasound Endoscope" filed with the China Patent Office.
技术领域Technical field
本公开涉及微波治疗医疗器械领域,具体而言,涉及一种配置成对腹腔内部肿瘤及病变组织进行微波消融治疗的一种超声内镜下柔性微波消融针。The present disclosure relates to the field of microwave therapeutic medical devices, and in particular, to a flexible microwave ablation needle under ultrasound endoscope configured to perform microwave ablation treatment of tumors and diseased tissues inside the abdominal cavity.
背景技术Background technique
目前,我国医疗行业正在突飞猛进的发展,同时对产品的需求细化程度越来越高,微波消融作为一种微创手术的应用越来越广泛,微波消融是利用微波生物组织的热效应,对病变组织进行止血、凝固、灼除、消炎、消肿、止痛或者改善局部组织血液循环等,达到治疗疾病的作用。它具有创伤小,见效快,穿透能力强等优点,被越来越多的患者所接受。At present, China's medical industry is developing by leaps and bounds, and at the same time, the demand for products is becoming more and more fine. Microwave ablation, as a minimally invasive surgery, is becoming more and more widely used. Microwave ablation is using the thermal effect of microwave biological tissues to treat lesions. Tissues perform hemostasis, coagulation, burning, anti-inflammatory, swelling, analgesia, or improve local tissue blood circulation to achieve the effect of treating diseases. It has the advantages of less trauma, quick effect and strong penetrating ability, and is accepted by more and more patients.
现有的微波消融微创手术大多采用超声或者X射线成像设备等定位病灶,然后采用外置消融针经皮穿刺,到达病灶后微波消融。这种微创微波消融受到病人身体条件,病灶位置,消融天线长度等外部条件限制,同时对穿刺针道也不能完全确保安全、准确地到达病灶位置。随着微波消融技术日益成熟,微波消融针的需求也越来越精细化,一种借助内镜微波针出现,更是将微波消融技 术提高到一个新台阶,新的技术借助于内镜更直观的将微波辐射天线直接引导至肿瘤及病变组织。这就需要一种柔性消融针杆,可自由的穿过内镜,同时也要求这种消融针具有一定穿刺力。针对不同部位选择不同消融针也势在必行。由于胸腔、腹腔部位一些器官借助超声内镜能够直接到达病变部位,而市场上较短的硬针就显得无能为力,柔性内镜下消融针出现,为医生和患者又多了一个优选治疗方案,在临床上已经得到了市场认可。由于人们对健康的日益重视,社会上肺癌、肝癌以及胰腺癌增多,柔性内镜下消融针具有广阔市场前景。Most of the existing microwave ablation minimally invasive surgery use ultrasound or X-ray imaging equipment to locate the lesion, and then use an external ablation needle to percutaneously puncture the microwave ablation after reaching the lesion. This minimally invasive microwave ablation is limited by external conditions such as the patient's physical conditions, the location of the lesion, and the length of the ablation antenna. At the same time, the puncture needle path cannot completely ensure that the lesion can be safely and accurately reached. With the increasing maturity of microwave ablation technology, the demand for microwave ablation needles is becoming more and more refined. The emergence of an endoscopic microwave needle has improved the microwave ablation technology to a new level, and the new technology is more intuitive with the help of endoscopes. Direct the microwave radiation antenna to the tumor and diseased tissue. This requires a flexible ablation needle that can pass freely through the endoscope, and also requires that the ablation needle has a certain puncture force. It is also imperative to choose different ablation needles for different parts. Because some organs in the thoracic cavity and abdominal cavity can reach the lesion directly with the help of ultrasound endoscopy, and short hard needles on the market appear to be helpless, flexible endoscopic ablation needles have emerged, providing an additional preferred treatment plan for doctors and patients. It has been clinically recognized by the market. As people pay more and more attention to health, lung cancer, liver cancer and pancreatic cancer increase in society, and flexible endoscopic ablation needles have broad market prospects.
发明内容Summary of the Invention
本公开的目的包括,例如,提供一种柔性良好的消融针,其能够有效解决消融针穿刺难,进针定位难的问题,同时可达到更多的病变部位,且具有强穿透性。The purpose of the present disclosure includes, for example, providing an ablation needle with good flexibility, which can effectively solve the problems of difficult puncture and positioning of the ablation needle, and can reach more lesions, and has strong penetrability.
本公开的实施例是这样实现的:The embodiments of the present disclosure are implemented as follows:
本公开的实施例提供了一种超声内镜下柔性微波消融针,包括手柄、射频同轴连接器和微波辐射天线,所述射频同轴连接器设置于所述手柄上,所述射频同轴连接器与所述微波辐射天线通过射频同轴线缆连接,所述射频同轴线缆外围依次设有毛细管和内管,所述射频同轴线缆置于所述毛细管内,所述毛细管置于所述内管内,所述毛细管作为冷却水通道连通进水管,所述毛细外壁与所述内管内壁形成排水管道,所述排水管道连通出水管,进入所述冷却水通道的水经所述排水管道排出,所述内管包括第一端部和第二端部,所述第一端部延伸至所述微波辐射天线,所述第二端部远离所述微波辐射天线,所述内管由所述第二端部至所述第一端部逐渐变细。An embodiment of the present disclosure provides a flexible microwave ablation needle under ultrasound endoscope, including a handle, a radio frequency coaxial connector, and a microwave radiation antenna. The radio frequency coaxial connector is disposed on the handle, and the radio frequency coaxial The connector is connected to the microwave radiation antenna through a radio frequency coaxial cable, and a capillary tube and an inner tube are sequentially arranged on the periphery of the radio frequency coaxial cable. The radio frequency coaxial cable is placed in the capillary tube, and the capillary tube is disposed. In the inner pipe, the capillary tube communicates with a water inlet pipe as a cooling water passage, the capillary outer wall and the inner pipe inner wall form a drainage pipe, and the drainage pipe communicates with a water outlet pipe, and water entering the cooling water passage passes through the water pipe. The drainage pipe is discharged, the inner pipe includes a first end portion and a second end portion, the first end portion extends to the microwave radiation antenna, the second end portion is far from the microwave radiation antenna, and the inner tube It tapers from the second end to the first end.
可选的,所述内管采用耐高温且可以弯曲的材料制成,如聚苯醚醚酮、聚酰亚胺、镍钛合金管、PTFE管或医用复合材料复合编织管。Optionally, the inner tube is made of a material that can withstand high temperatures and can be bent, such as poly (phenylene ether ether ketone), polyimide, nickel-titanium alloy tube, PTFE tube, or medical composite material composite braided tube.
可选的,所述毛细管采用耐高温且可以弯曲的材料制成,如镍钛合金管、304不锈钢管、PTFE管、医用复合材料多层编织管、聚苯醚醚酮或聚酰亚胺,所述毛细管包覆于所述微波辐射天线外。Optionally, the capillary is made of a material that can withstand high temperatures and can be bent, such as a nickel-titanium alloy tube, a 304 stainless steel tube, a PTFE tube, a medical composite multilayer braided tube, poly (phenylene ether ether ketone), or polyimide, The capillary is covered outside the microwave radiation antenna.
可选的,还包括第一温度传感器,所述第一温度传感器与所述毛细管连接,配置成检测所述微波辐射天线的温度。Optionally, it further includes a first temperature sensor connected to the capillary tube and configured to detect a temperature of the microwave radiation antenna.
可选的,还包括外管,所述外管与所述手柄连接,所述外管套设于所述内管外。Optionally, it further comprises an outer tube connected to the handle, and the outer tube is sleeved outside the inner tube.
可选的,所述外管由远离所述微波辐射天线的一端向靠近所述微波辐射天线的一端逐渐变细。Optionally, the outer tube is tapered from an end far from the microwave radiation antenna to an end closer to the microwave radiation antenna.
可选的,所述外管采用耐高温且可以弯曲的材料制成,如聚苯醚醚酮、镍钛合金管、PTFE管、医用复合材料多层编织管或聚酰亚胺。Optionally, the outer tube is made of a material that can withstand high temperatures and can be bent, such as poly (phenylene ether ether ketone), a nickel-titanium alloy tube, a PTFE tube, a medical composite multilayer braided tube, or a polyimide.
可选的,还包括滑动件、连接件以及多个第二温度传感器,所述连接件包括滑动部和与所述滑动部连接的多个变形部,多个所述变形部沿所述滑动部的周向间隔排布,所述滑动件与所述滑动部连接,所述滑动部位于所述内管与所述外管之间,且与所述内管沿所述内管的轴线方向滑动配合;所述滑动件与所述手柄滑动配合,当所述连接件相对于所述内管滑动时,所述变形部能够伸出所述内管与所述外管且沿所述内管的径向向外张开,或者所述变形部能够缩回至所述内管与所述外管之间;多个所述第二温度传感器与多个所述变形部一一 对应,配置成检测消融组织周围温度,以确定消融面积大小。Optionally, it further includes a sliding member, a connecting member, and a plurality of second temperature sensors. The connecting member includes a sliding portion and a plurality of deformed portions connected to the sliding portion. The plurality of deformed portions are along the sliding portion. The sliding members are arranged at intervals in the circumferential direction, and the slider is connected to the sliding portion, and the sliding portion is located between the inner tube and the outer tube, and slides with the inner tube in the axial direction of the inner tube. Fit; the sliding member slides with the handle, and when the connecting member slides relative to the inner tube, the deformed portion can extend out of the inner tube and the outer tube and along the inner tube. Open radially outward, or the deformed portion can be retracted between the inner tube and the outer tube; the plurality of the second temperature sensors correspond to the plurality of the deformed portions one by one and are configured to detect The temperature around the ablation tissue to determine the size of the ablation area.
可选的,所述滑动部套设于所述内管外。Optionally, the sliding portion is sleeved outside the inner tube.
可选的,所述滑动部设置有编织管,多个所述变形部与所述编织管编织为一体。Optionally, the sliding portion is provided with a braided tube, and a plurality of the deformed portions are integrally knitted with the braided tube.
可选的,所述手柄包括依次连接的第一手柄、伸缩柄和第二手柄,所述伸缩柄与所述第一手柄或者/和所述第二手柄沿所述射频同轴线缆的轴向滑动配合;所述射频同轴连接器设置于所述第一手柄上,所述伸缩柄内设置有贯穿所述伸缩柄的长度方向的两端的第一通孔,所述第二手柄设置有贯穿所述第二手柄的长度方向的两端的第二通孔,所述射频同轴线缆、所述毛细管和所述内管的一端与所述第一手柄连接,所述射频同轴线缆、所述毛细管以及所述内管的另一端依次穿过所述第一通孔和所述第二通孔且伸出所述第二通孔远离所述第一通孔的一端。Optionally, the handle includes a first handle, a telescopic handle, and a second handle connected in sequence, and the telescopic handle and the first handle or / and the second handle are along the axis of the radio frequency coaxial cable. Sliding cooperation; the RF coaxial connector is disposed on the first handle, a first through hole penetrating through both ends of the length direction of the telescopic handle is provided in the telescopic handle, and the second handle is provided with A second through hole penetrating through both ends in the length direction of the second handle, one end of the radio frequency coaxial cable, the capillary tube, and the inner tube is connected to the first handle, and the radio frequency coaxial cable The other ends of the capillary tube and the inner tube pass through the first through hole and the second through hole in sequence and protrude from the end of the second through hole away from the first through hole.
可选的,所述伸缩柄滑动连接所述第一手柄。Optionally, the telescopic handle is slidably connected to the first handle.
可选的,所述伸缩柄与所述第一手柄之间设有防止二者相对滑动的锁紧装置。Optionally, a locking device is provided between the telescopic handle and the first handle to prevent the two from sliding relative to each other.
可选的,所述锁紧装置包括与所述第一手柄连接的卡环,所述卡环上设置有凸块,所述伸缩柄的外周面设置有卡槽,所述卡环能够沿径向变形,以使所述凸块卡接于所述卡槽中,进而限制所述第一手柄与所述伸缩柄相对滑动;或者使所述凸块与所述卡槽分离,进而使所述第一手柄与所述伸缩柄能够相对滑动。Optionally, the locking device includes a snap ring connected to the first handle, the snap ring is provided with a protrusion, the outer peripheral surface of the telescopic handle is provided with a snap groove, and the snap ring can be along a diameter To deform to engage the protrusion in the slot, thereby restricting the first handle from sliding relative to the telescopic handle; or to separate the protrusion from the slot, thereby causing the The first handle and the telescopic handle can slide relative to each other.
可选的,所述第一手柄设置有中空区,所述伸缩柄插接于所述中空区且能够相对于所述第一手柄滑动。Optionally, the first handle is provided with a hollow area, and the telescopic handle is inserted in the hollow area and can slide relative to the first handle.
可选的,所述手柄上设有隔离腔,所述隔离腔包括相互分离的进水腔和出水腔,所述毛细管通过所述进水腔连通所述进水管,所述排水通道通过所述出水腔连通所述出水管。Optionally, the handle is provided with an isolation cavity, the isolation cavity includes a water inlet cavity and a water outlet cavity separated from each other, the capillary tube communicates with the water inlet pipe through the water inlet cavity, and the drainage channel passes through the water inlet The water outlet cavity communicates with the water outlet pipe.
可选的,所述微波辐射天线采用三棱锥型天线、斜面型天线或圆锥型天线。Optionally, the microwave radiation antenna is a triangular pyramid antenna, a bevel antenna, or a cone antenna.
本公开所产生的有益效果包括,例如:The beneficial effects of this disclosure include, for example:
1、本公开中的内管采用渐变直径,使得前端细后端粗,在保证内管所需要的强度情况下,使得前端可弯曲,以达到更多的病灶部位,且该设计增加了内管的穿透性;2、本公开充分利用内管与毛细管之间的管道,作为冷却水排水通道,使得毛细管内的冷却水流动至微波辐射天线后由该排水通道排出,使得冷却水通道和排水通道相互分离,保证了冷却效率;3、本公开中的进水管和出水管均设置在同一侧,便于对进出冷却水的管理;4、本公开中的外管设置在内管外,且与内管粗细变化趋势一致,一方面既保护微波辐射天线和变径内管受到外力损伤,也作为变径内管自由伸缩通道,另一方面能够隔离微波辐射天线,防止损伤超声内镜内壁;5、本公开采用伸缩柄的设计可通过改变第一手柄与伸缩柄的相对位置改变微波辐射天线深入体内的长度,实现可伸缩功能;6、本公开中的隔离腔使得进水腔和出水腔分离设计能有效降低杆温,进而减少微波消融过程中能耗对内镜和正常组织损伤。1. The inner tube in the present disclosure adopts a tapered diameter to make the front end thin and thick. Under the condition of ensuring the required strength of the inner tube, the front end can be bent to reach more lesions, and the design increases the inner tube. 2. The present disclosure makes full use of the pipe between the inner tube and the capillary tube as a cooling water drainage channel, so that the cooling water in the capillary tube flows to the microwave radiation antenna and is discharged by the drainage channel, so that the cooling water channel and drainage The channels are separated from each other to ensure the cooling efficiency; 3. The inlet and outlet pipes in the present disclosure are arranged on the same side, which facilitates the management of the inlet and outlet cooling water; 4. The outer tube in the present disclosure is arranged outside the inner tube, and The thickness of the inner tube changes in the same direction. On the one hand, it not only protects the microwave radiation antenna and the reduced diameter inner tube from external force damage, but also acts as a freely retractable passage for the reduced diameter inner tube. On the other hand, it can isolate the microwave radiation antenna and prevent damage to the inner wall of the ultrasonic endoscope; The design of the present disclosure using a telescopic handle can change the length of the microwave radiation antenna deep into the body by changing the relative position of the first handle and the telescopic handle to achieve extensibility. Function; 6, the present disclosure isolation chamber such that the inlet chamber and the outlet chamber separated rod designs can effectively reduce the temperature, thus reducing energy consumption during microwave ablation of normal tissue damage, and endoscopy.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
为了更清楚地说明本公开实施例的技术方案,下面将对实施例中所需要使用的附图作简单地介绍,应当理解,以下附图仅示出了本公开的某些实施例,因此不应被看作是对范围的限定,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他相关的附图。In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present disclosure, and therefore are not It should be regarded as a limitation on the scope. For those of ordinary skill in the art, other related drawings can be obtained based on these drawings without paying creative work.
图1为本公开实施例中的柔性微波消融针的结构示意图;1 is a schematic structural diagram of a flexible microwave ablation needle in an embodiment of the present disclosure;
图2为图1中A-A向的剖面示意图;2 is a schematic cross-sectional view taken along the A-A direction in FIG. 1;
图3为图1中C处的局部放大示意图;FIG. 3 is a partially enlarged schematic diagram at C in FIG. 1; FIG.
图4为图1中B处的局部放大示意图;FIG. 4 is a partially enlarged schematic diagram at B in FIG. 1; FIG.
图5为本公开实施例中的柔性微波消融针的剖面结构示意图。5 is a schematic cross-sectional structure diagram of a flexible microwave ablation needle in an embodiment of the present disclosure.
图中:In the picture:
01-手柄;1-第一手柄;2-伸缩杆,3-第二手柄;4-进水管;5-出水管;6-隔离腔;60-隔板;601-进水腔;602-出水腔;7-射频同轴连接器;8-射频同轴线缆;9-微波辐射天线;10-毛细管;11-内管;110-第一端部;111-第二端部;12-外管;13-第一温度传感器;14-卡环;15-冷却水通道;16-排水通道;17-第一通孔;18-第二通孔;19-滑动件;20-连接件;201-滑动部;202-变形部;21-第二温度传感器;22-控制器。01-handle; 1-first handle; 2-telescopic rod, 3-second handle; 4-water inlet pipe; 5-water outlet pipe; 6-isolation cavity; 60-partition; 601- water inlet cavity; 602- water outlet Cavity; 7-RF coaxial connector; 8-RF coaxial cable; 9-microwave radiation antenna; 10- capillary; 11- inner tube; 110- first end; 111- second end; 12- outer 13-first temperature sensor; 14-ring; 15-cooling water channel; 16-drain channel; 17-first through hole; 18-second through hole; 19-slider; 20-connecting member; 201 -Sliding part; 202-deformation part; 21-second temperature sensor; 22-controller.
具体实施方式detailed description
为使本公开实施例的目的、技术方案和优点更加清楚,下面将结合本公开 实施例中的附图,对本公开实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例是本公开一部分实施例,而不是全部的实施例。通常在此处附图中描述和示出的本公开实施例的组件可以以各种不同的配置来布置和设计。In order to make the objectives, technical solutions, and advantages of the embodiments of the present disclosure more clear, the technical solutions in the embodiments of the present disclosure will be described clearly and completely in combination with the drawings in the embodiments of the present disclosure. Obviously, the described embodiments These embodiments are part of, but not all of, the embodiments of the present disclosure. The components of embodiments of the present disclosure, which are generally described and illustrated in the drawings herein, may be arranged and designed in a variety of different configurations.
因此,以下对在附图中提供的本公开的实施例的详细描述并非旨在限制要求保护的本公开的范围,而是仅仅表示本公开的选定实施例。基于本公开中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例,都属于本公开保护的范围。Accordingly, the following detailed description of embodiments of the present disclosure provided in the accompanying drawings is not intended to limit the scope of the claimed disclosure, but merely to indicate selected embodiments of the present disclosure. Based on the embodiments in the present disclosure, all other embodiments obtained by a person of ordinary skill in the art without making creative efforts fall within the protection scope of the present disclosure.
应注意到:相似的标号和字母在下面的附图中表示类似项,因此,一旦某一项在一个附图中被定义,则在随后的附图中不需要对其进行进一步定义和解释。It should be noted that similar reference numerals and letters indicate similar items in the following drawings, so once an item is defined in one drawing, it need not be further defined and explained in subsequent drawings.
在本公开的描述中,需要说明的是,若出现术语“中心”、“上”、“下”、“左”、“右”、“竖直”、“水平”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系,或者是该发明产品使用时惯常摆放的方位或位置关系,仅是为了便于描述本公开和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本公开的限制。In the description of this disclosure, it should be noted that if the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside" appear The azimuth or positional relationship indicated by "" is based on the azimuth or positional relationship shown in the drawings, or the azimuth or positional relationship commonly used when the invention product is used, and is only for the convenience of describing the present disclosure and simplifying the description, rather than indicating Or it implies that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as a limitation on the present disclosure.
此外,若出现术语“第一”、“第二”、“第三”等仅用于区分描述,而不能理解为指示或暗示相对重要性。In addition, if the terms "first", "second", "third", etc. appear only to distinguish descriptions, they cannot be understood as indicating or implying relative importance.
此外,若出现术语“水平”、“竖直”、“悬垂”等并不表示要求部件绝对水平或悬垂,而是可以稍微倾斜。如“水平”仅仅是指其方向相对“竖直”而言 更加水平,并不是表示该结构一定要完全水平,而是可以稍微倾斜。In addition, the appearance of the terms "horizontal", "vertical", "overhang", etc. does not mean that the component is absolutely horizontal or overhanging, but may be slightly inclined. For example, “horizontal” simply means that its direction is more horizontal than “vertical”, which does not mean that the structure must be completely horizontal, but it can be tilted slightly.
在本公开的描述中,还需要说明的是,除非另有明确的规定和限定,若出现术语“设置”、“安装”、“相连”、“连接”等应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或一体地连接;可以是机械连接,也可以是电连接;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通。对于本领域的普通技术人员而言,可以具体情况理解上述术语在本公开中的具体含义。In the description of the present disclosure, it should also be noted that, unless otherwise specified and limited, the terms "setup", "installation", "connected", "connected", etc. should be understood in a broad sense, for example, it may be A fixed connection can also be a detachable connection or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, or it can be the internal connection of two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present disclosure may be understood on a case-by-case basis.
需要说明的是,在不冲突的情况下,本公开的实施例中的特征可以相互结合。It should be noted that, in the case of no conflict, the features in the embodiments of the present disclosure may be combined with each other.
如图1所示,本公开中的超声内镜下柔性微波消融针包括手柄01、射频同轴连接器7、射频同轴线缆8、微波辐射天线9、毛细管10、内管11和外管12。射频同轴连接器7设置在手柄01上,射频同轴线缆8的一端连接射频同轴连接器7,射频同轴线缆8的另一端连接微波辐射天线9,微波辐射天线9包括能量发射器,配置成将消融的微波发射出去,其结构可根据不同需求设计,例如,微波辐射天线9可以采用三棱锥型天线、斜面型天线或圆锥型天线,具有优良的穿刺功能。射频同轴线缆8穿设于毛细管10的管腔中且一端伸出毛细管10,射频同轴线缆8具有微波辐射通道,射频同轴线缆8配置成连接微波辐射天线9与射频同轴连接器7,射频同轴线缆8具有高介电常数起到防微波泄露的作用。射频同轴线缆8包括由外至内排布且依次套接的外层、中间层以及内芯,外层设置为铜质屏蔽鞘管,中间层设置为聚四氟介质层,内芯设置为银包钢,射频同轴线缆8采用双层防护,防护效果好。毛细管10设置于内 管11内且从手柄01的一端一直延伸至微波辐射天线9,毛细管10包覆在射频同轴线缆8外,毛细管10的管腔作为冷却水通道15,冷却水道15连接进水管4,冷却水能够从毛细管10远离微波辐射天线9的一端进入毛细管10以降低射频同轴线缆8的温度,保证射频同轴线缆8的温度不致过高。内管11包覆在毛细管10外,内管11的内周壁与毛细管10的外周壁之间形成排水通道16,毛细管10远离微波辐射天线9的端部伸出排水通道16,排水通道16与出水管5连通,冷却水由毛细管10远离微波辐射天线9的一端进入,由毛细管10靠近微波辐射天线9的另一端流出后进入排水通道16,而后由出水管5排出。外管12包覆在内管11外部。As shown in FIG. 1, the flexible microwave ablation needle under ultrasound endoscope in the present disclosure includes a handle 01, a radio-frequency coaxial connector 7, a radio-frequency coaxial cable 8, a microwave radiation antenna 9, a capillary 10, an inner tube 11, and an outer tube. 12. The RF coaxial connector 7 is disposed on the handle 01. One end of the RF coaxial cable 8 is connected to the RF coaxial connector 7. The other end of the RF coaxial cable 8 is connected to a microwave radiation antenna 9. The microwave radiation antenna 9 includes energy transmission. The device is configured to emit the ablated microwaves, and its structure can be designed according to different requirements. For example, the microwave radiation antenna 9 can use a triangular pyramid antenna, a bevel antenna, or a conical antenna, and has excellent puncture function. A radio-frequency coaxial cable 8 passes through the lumen of the capillary tube 10 and protrudes from the capillary 10 at one end. The radio-frequency coaxial cable 8 has a microwave radiation channel. The radio-frequency coaxial cable 8 is configured to connect the microwave radiation antenna 9 and the radio-frequency coaxial cable. The connector 7 and the radio frequency coaxial cable 8 have a high dielectric constant and prevent microwave leakage. The RF coaxial cable 8 includes an outer layer, an intermediate layer, and an inner core which are arranged in order from the outside to the inside. The outer layer is provided as a copper shielding sheath, the middle layer is provided as a PTFE dielectric layer, and the inner core is provided. It is silver-clad steel, and the RF coaxial cable 8 adopts double-layer protection, and the protection effect is good. The capillary tube 10 is arranged in the inner tube 11 and extends from one end of the handle 01 to the microwave radiation antenna 9. The capillary tube 10 is covered by the RF coaxial cable 8. The lumen of the capillary tube 10 is used as the cooling water channel 15, and the cooling water channel 15 is connected. In the water inlet pipe 4, cooling water can enter the capillary tube 10 from the end of the capillary tube 10 far from the microwave radiation antenna 9 to reduce the temperature of the radio frequency coaxial cable 8 and ensure that the temperature of the radio frequency coaxial cable 8 is not excessively high. The inner tube 11 is covered by the capillary tube 10, and a drainage channel 16 is formed between the inner peripheral wall of the inner tube 11 and the outer peripheral wall of the capillary tube 10. The end of the capillary tube 10 that is far from the microwave radiation antenna 9 projects the drain channel 16, and the drain channel 16 and the outlet The water pipe 5 communicates, and the cooling water enters from the end of the capillary tube 10 away from the microwave radiation antenna 9, flows out from the other end of the capillary tube 10 near the microwave radiation antenna 9, enters the drainage channel 16, and is then discharged from the water outlet pipe 5. The outer tube 12 covers the outside of the inner tube 11.
本公开中,可选的,内管11设置为变径形式,内管11沿其长度方向的两端分别延伸至手柄01以及微波辐射天线9,内管11与微波辐射天线9连接的一端设定为第一端部110,内管11与手柄01连接的一端设定为第二端部111,内管11的管径(包括内径和外径)沿其长度方向由第二端部111向第一端部110逐渐变小,内管11的最小管径为1mm,该设计使得内管11的细端能够弯曲,可到达更多的病变部位,提高手术的灵活性以及成功率。为了保证内管11的柔性,内管11采用耐高温且可以自由弯曲的材料,如PEEK(Polyetheretherketone聚苯醚醚酮)、PI(Polyimide聚酰亚胺)、镍钛合金管、PTFE(聚四氟乙烯Poly tetra fluoroethylene)管或者医用复合材料组合编织管,这些材料具有良好的柔性,内管11的弯曲更加灵活。内管11不仅起到保护毛细管10和射频同轴线缆8的作用,而且内管11的内周壁与毛细管10的外周壁之间形成的排水通道16与毛细管10自身管腔形成的冷却通道15相互独立,也即冷却水通道15和排水通道16的相互分离,且冷却水道 15相较于排水通道16更加靠近射频同轴线缆8,提高了冷却效率。In the present disclosure, optionally, the inner tube 11 is provided in a reduced diameter form. Both ends of the inner tube 11 along the length direction thereof extend to the handle 01 and the microwave radiation antenna 9, respectively. One end of the inner tube 11 connected to the microwave radiation antenna 9 is provided. It is designated as the first end portion 110, and the end of the inner tube 11 connected to the handle 01 is set as the second end portion 111. The pipe diameter (including the inner diameter and the outer diameter) of the inner tube 11 is directed from the second end portion 111 along its length direction. The first end portion 110 gradually becomes smaller, and the minimum diameter of the inner tube 11 is 1 mm. This design enables the thin end of the inner tube 11 to be bent, can reach more lesions, and improves the flexibility and success rate of the operation. In order to ensure the flexibility of the inner tube 11, the inner tube 11 is made of a material that is resistant to high temperatures and can be bent freely, such as PEEK (Polyetheretherketone polyphenylene ether ketone), PI (Polyimide polyimide), nickel-titanium alloy tube, PTFE Polytetrafluoroethylene) tube or medical composite material combined braided tube, these materials have good flexibility, and the bending of the inner tube 11 is more flexible. The inner tube 11 not only protects the capillary tube 10 and the radio-frequency coaxial cable 8, but also the drainage channel 16 formed between the inner peripheral wall of the inner tube 11 and the outer peripheral wall of the capillary tube 10 and the cooling channel 15 formed by the lumen of the capillary tube 10 itself. They are independent from each other, that is, the cooling water channel 15 and the drainage channel 16 are separated from each other, and the cooling water channel 15 is closer to the RF coaxial cable 8 than the drainage channel 16, which improves the cooling efficiency.
本公开中可选的,为了保证毛细管10的柔性,毛细管10采用耐高温且可以自由弯曲的材料制成,如镍钛合金管、304不锈钢管、PTFE(聚四氟乙烯Poly tetra fluoroethylene)管、医用复合材料多层编织管、PEEK(Poly ether ether ketone聚苯醚醚酮)或者PI(Polyimide聚酰亚胺),使得毛细管10具有自由折弯且可恢复形变的功能,防止针杆不变形。Optional in this disclosure, in order to ensure the flexibility of the capillary 10, the capillary 10 is made of a material that is resistant to high temperatures and can be bent freely, such as a nickel-titanium alloy tube, a 304 stainless steel tube, a PTFE (Polytetrafluoroethylene) tube, The medical composite material multi-layer braided tube, PEEK (Poly Ether Ketone Polyphenylene Ether Ketone) or PI (Polyimide Polyimide) makes the capillary 10 have the function of free bending and recoverable deformation, preventing the needle rod from being deformed.
如图2所示,图2中示出了图1中A-A向的剖视示意图。本公开中的针杆包括外管12、被外管12包覆的内管11、被内管11包覆的毛细管10以及被毛细管10包覆的射频同轴线缆8。毛细管10的管腔作为冷却水通道15,毛细管10的外周壁与内管11的内周壁之间形成排水通道16,本公开中的外管12的管径设置为变径形式,与内管11的管径一致,外管12的管径沿其长度方向也是由一端向另一端逐渐变细。外管12选用耐高温且可以自由弯曲的材料制成,如PEEK(Polyetheretherketone聚苯醚醚酮)、PI(Polyimide聚酰亚胺)、镍钛合金管、PTFE(聚四氟乙烯Poly tetra fluoroethylene)管或者医用复合材料多层编织管,外管12的外径最大为3.7mm,外管12具有良好的过弯性,具有双重防护作用,一方面既保护微波辐射天线9和内管11不会受到外力损伤,也作为内管11自由伸缩的通道;另一方面能够隔离微波辐射天线9以防止损伤超声内镜的内壁。外管12的沿其长度方向的两端分别延伸至手柄01和微波辐射天线9,且外管12的长度在1.5m以上。As shown in FIG. 2, FIG. 2 shows a schematic cross-sectional view in the direction A-A in FIG. 1. The needle bar in the present disclosure includes an outer tube 12, an inner tube 11 covered with the outer tube 12, a capillary tube 10 covered with the inner tube 11, and a radio frequency coaxial cable 8 covered with the capillary tube 10. The lumen of the capillary tube 10 serves as the cooling water channel 15. A drainage channel 16 is formed between the outer peripheral wall of the capillary tube 10 and the inner peripheral wall of the inner tube 11. The diameter of the outer tube 12 is the same, and the diameter of the outer tube 12 is gradually tapered from one end to the other along its length. The outer tube 12 is made of materials that can withstand high temperatures and can be bent freely, such as PEEK (Polyetheretherketone), PI (Polyimide), nickel-titanium alloy tubes, PTFE (Polytetrafluoroethylene) Tube or medical composite material multi-layer braided tube. The outer diameter of the outer tube 12 is a maximum of 3.7mm. The outer tube 12 has a good bendability and double protection. On the one hand, it protects the microwave radiation antenna 9 and the inner tube 11 from being damaged. Damaged by external force also serves as a freely retractable channel for the inner tube 11; on the other hand, it can isolate the microwave radiation antenna 9 to prevent damage to the inner wall of the ultrasonic endoscope. Both ends of the outer tube 12 along the length direction thereof extend to the handle 01 and the microwave radiation antenna 9, respectively, and the length of the outer tube 12 is more than 1.5 m.
如图3所示,图3中示出了图1中C处的局部放大示意图。微波辐射天线9采用三棱锥型天线、斜面型天线或圆锥型天线,具有优良的穿刺功能。在针 杆上安装有第一温度传感器13,且第一温度传感器13一直延伸到微波辐射天线9的前端,实时精准监测针杆的温度,防止针杆的温度过高而损伤正常组织以及损坏内镜,当第一温度传感器13检测得到的温度超过设定值时,第一温度传感器13能够将检测得到的温度反馈至控制系统,进而断开微波输出。可选的,第一温度传感器13与毛细管10连接,且靠近微波辐射天线9设置。As shown in FIG. 3, a partially enlarged schematic diagram at C in FIG. 1 is shown in FIG. 3. The microwave radiation antenna 9 adopts a triangular pyramid antenna, a bevel antenna, or a cone antenna, and has excellent puncture function. A first temperature sensor 13 is installed on the needle bar, and the first temperature sensor 13 extends to the front end of the microwave radiation antenna 9 to accurately monitor the temperature of the needle bar in real time to prevent the temperature of the needle bar from being too high and causing damage to normal tissue and internal damage. Mirror, when the temperature detected by the first temperature sensor 13 exceeds a set value, the first temperature sensor 13 can feedback the detected temperature to the control system, and then cut off the microwave output. Optionally, the first temperature sensor 13 is connected to the capillary tube 10 and is disposed near the microwave radiation antenna 9.
如图4所示,图4示出了图1中B处的局部放大示意图。手柄01内设置有隔离腔6,隔离腔6包括相互分离的进水腔601与出水腔602,进水腔601和出水腔602沿针杆的长度方向依次排布,可选的,隔离腔6中设置有隔板60,隔板60将隔离腔6分隔形成独立的进水腔601和出水腔602。毛细管10远离微波辐射天线9的端部伸出排水通道16对应的端口,毛细管10穿过隔板60后与进水腔601相连通。排水通道16对应的端部伸入出水腔602内与出水腔602相连通,形成回路后导出冷热交换后的冷却水,从而降低针杆温度。进水腔601连接进水管4,出水腔602连接出水管5,隔离腔6的结构设计使得进水与出水相隔离,能有效降低针杆的温度。毛细管10与内管11作为循环冷却通路分别与隔离腔6独立连接,能够节省空间,内镜消融针能够设计的更细,保证良好的过弯性,能够在内镜内自由的转换方向。As shown in FIG. 4, FIG. 4 shows a partially enlarged schematic diagram at B in FIG. 1. An isolation cavity 6 is provided in the handle 01. The isolation cavity 6 includes a water inlet cavity 601 and a water outlet cavity 602 that are separated from each other. The water inlet cavity 601 and the water outlet cavity 602 are sequentially arranged along the length direction of the needle rod. Optionally, the isolation cavity 6 A partition 60 is provided in the partition, and the partition 60 separates the isolation chamber 6 into an independent water inlet chamber 601 and a water outlet chamber 602. The end of the capillary tube 10 far from the microwave radiation antenna 9 protrudes from the port corresponding to the drainage channel 16. The capillary tube 10 passes through the partition plate 60 and communicates with the water inlet cavity 601. The corresponding end of the drainage channel 16 extends into the water outlet cavity 602 and communicates with the water outlet cavity 602. After the circuit is formed, the cooling water after the cold and heat exchange is led out, thereby reducing the temperature of the needle bar. The water inlet chamber 601 is connected to the water inlet pipe 4 and the water outlet chamber 602 is connected to the water outlet pipe 5. The structural design of the isolation chamber 6 makes the water inlet and the water phase isolated, which can effectively reduce the temperature of the needle bar. The capillary tube 10 and the inner tube 11 are independently connected to the isolation cavity 6 as circulating cooling paths, which can save space. The endoscopic ablation needle can be designed thinner, ensure good cornering performance, and can freely switch directions in the endoscope.
如图5所示,图5示出了消融针的剖视示意图。本公开中的手柄01包括第一手柄1、伸缩柄2和第二手柄3。伸缩柄2连接第一手柄1和第二手柄3,第一手柄1内设置射频同轴连接器7和隔离腔6,伸缩柄2内设有第一通孔17,第一通孔17沿伸缩柄2的长度方向贯穿伸缩柄2的两端。第二手柄3内设有第二通孔18,第二通孔18沿第二手柄3的长度方向贯穿第二手柄3的两端。射频同轴线缆8由第一手柄1出发依次穿过第一通孔17和第二通孔18并伸出 第二手柄3,毛细管10的长度延伸方向与内管11的长度延伸方向一致,毛细管10的长度由隔离腔6的进水腔601向微波辐射天线9延伸,内管11的长度由隔离腔6的出水腔602向微波辐射天线9延伸。外管12固定在第二手柄3远离伸缩柄2的一端,外管12连通第二通孔18,外管12可以与第二手柄3一体设置,外管12的管径沿其长度方向由连接第二手柄3的一端向另一端逐渐变细,外管12的长度可以设置为1.5m以上。As shown in FIG. 5, a schematic cross-sectional view of an ablation needle is shown. The handle 01 in the present disclosure includes a first handle 1, a telescopic handle 2, and a second handle 3. The telescopic handle 2 is connected to the first handle 1 and the second handle 3. The first handle 1 is provided with a radio-frequency coaxial connector 7 and an isolation cavity 6. The telescopic handle 2 is provided with a first through-hole 17, and the first through-hole 17 extends along the telescope. The length direction of the handle 2 runs through both ends of the telescopic handle 2. A second through hole 18 is provided in the second handle 3, and the second through hole 18 penetrates both ends of the second handle 3 along the length direction of the second handle 3. The RF coaxial cable 8 passes through the first through hole 17 and the second through hole 18 in sequence from the first handle 1 and extends out of the second handle 3. The length extension direction of the capillary tube 10 is consistent with the length extension direction of the inner tube 11. The length of the capillary tube 10 extends from the water inlet cavity 601 of the isolation cavity 6 to the microwave radiation antenna 9, and the length of the inner tube 11 extends from the water outlet cavity 602 of the isolation cavity 6 to the microwave radiation antenna 9. The outer tube 12 is fixed at an end of the second handle 3 away from the telescopic handle 2. The outer tube 12 communicates with the second through hole 18, and the outer tube 12 may be integrated with the second handle 3. The diameter of the outer tube 12 is connected along its length. One end of the second handle 3 is gradually tapered toward the other end, and the length of the outer tube 12 may be set to be more than 1.5m.
本公开中,为了保证微波辐射天线9在人体内可伸缩,伸缩柄2与第一手柄1滑动连接。可选的,第一手柄1连接伸缩柄2的一端中空,伸缩柄2的一端伸入第一手柄1的中空区内,通过滑动伸缩柄2改变伸缩柄2伸入第一手柄1内的长度即改变第一手柄1与第二手柄3之间的间距,最终调整微波辐射天线9伸入人体的深度。In the present disclosure, in order to ensure that the microwave radiation antenna 9 is retractable in the human body, the telescopic handle 2 is slidably connected to the first handle 1. Optionally, one end of the first handle 1 connected to the telescopic handle 2 is hollow, one end of the telescopic handle 2 extends into the hollow area of the first handle 1, and the length of the telescopic handle 2 extending into the first handle 1 is changed by sliding the telescopic handle 2 That is, the distance between the first handle 1 and the second handle 3 is changed, and finally the depth of the microwave radiation antenna 9 protruding into the human body is adjusted.
为了便于在调整好伸缩柄2伸入第一手柄1内的长度后固定两者的相对位置,第一手柄1和伸缩柄2通过锁紧装置连接。可选的,伸缩柄2和第一手柄1之间采用导轨与导槽卡接配合的结构实现固定,以防止伸缩柄2和第一手柄1相对转动。可选的,锁紧装置包括卡环14,卡环14与第一手柄1连接,且位于第一手柄1连接伸缩柄2的一端,伸缩柄2穿过卡环14后伸入第一手柄1的中空区。伸缩柄2的外周壁上设置卡槽,在卡环14的内周壁设置有与卡槽相对应的凸块,当凸块卡入卡槽后,伸缩柄2与第一手柄1之间的位置相对固定,伸缩柄2和第一手柄1不能够相对滑动。为了便于清楚的得知针杆深入长度,伸缩柄2上设置有刻度线,刻度线能够清晰的指示消融针的进针深度。In order to facilitate fixing the relative positions of the telescopic handle 2 after adjusting the length that the telescopic handle 2 extends into the first handle 1, the first handle 1 and the telescopic handle 2 are connected by a locking device. Optionally, the telescopic handle 2 and the first handle 1 are fixed by using a structure in which the guide rail and the guide groove are engaged with each other to prevent the telescopic handle 2 and the first handle 1 from rotating relatively. Optionally, the locking device includes a snap ring 14 connected to the first handle 1 and located at an end of the first handle 1 connected to the telescopic handle 2. The telescopic handle 2 passes through the snap ring 14 and extends into the first handle 1 Hollow area. A slot is provided on the outer peripheral wall of the telescopic handle 2, and a protrusion corresponding to the slot is provided on the inner peripheral wall of the snap ring 14. After the protrusion is snapped into the slot, the position between the telescopic handle 2 and the first handle 1 is provided. Relatively fixed, the telescopic handle 2 and the first handle 1 cannot slide relative to each other. In order to clearly understand the depth of the needle shaft, a scale is provided on the telescopic handle 2, and the scale can clearly indicate the depth of the ablation needle.
手柄01长度调节的具体的操作为:压下卡环14,第一手柄1能够带着隔 离腔6、变径内管11以及微波辐射天线9一起滑动;松开卡环14,伸缩柄2具有锯齿形的卡槽,弹性卡扣嵌入伸缩柄2的卡槽内,实现固定伸缩柄2以防止其相对于第一手柄1前后移动。该卡环14内置弹性卡扣,按下卡环14内置弹性卡扣脱开卡槽,松开卡环14,弹性卡扣通过自身弹性卡住伸缩柄2的卡槽,该结构类似于带锁止的快速插拔连接器结构。The specific operation of the length adjustment of the handle 01 is: pressing the snap ring 14, the first handle 1 can slide together with the isolation cavity 6, the reducing inner tube 11 and the microwave radiation antenna 9; loosening the snap ring 14, the telescopic handle 2 has The zigzag-shaped clamping grooves and the elastic buckles are embedded in the clamping grooves of the telescopic handle 2 so as to fix the telescopic handle 2 to prevent it from moving back and forth relative to the first handle 1. The snap ring 14 has a built-in elastic buckle. Press the snap ring 14 to release the snap slot to release the snap ring. The snap ring 14 is loosened. The elastic snap catches the snap slot of the telescopic handle 2 by itself. The structure is similar to a lock. End quick plug connector structure.
本公开中,可选的,微波消融针还包括滑动件19、连接件20、多个第二温度传感器21以及一个控制器22,滑动件19与第一手柄1滑动连接,滑动件19的滑动方向平行于第一手柄1的轴线方向,且滑动件19与第一手柄1在第一手柄1的径向上相对固定,即滑动件19不会从第一手柄1上脱落,使用安全可靠。可选的,滑动件19可以是滑块,滑动件19的表面可以设置防滑纹,增大操作者手部与滑动件19之间的摩擦力,便于滑动件19的滑动,不易打滑。连接件20包括管状的滑动部201以及与滑动部201连接的多个变形部202,多个变形部202沿滑动部201的周向均匀间隔排布,每个变形部202可以设置为弹片。滑动部201套设在内管11外,且位于外管12内,换句话说,滑动部201位于内管11和外管12之间。滑动部201能够相对于内管11或者外管12沿内管11的轴向往复滑动。在连接件20滑动过程中,多个变形部202可以缩回到外管12与内管11之间,或者,多个变形部202也可以从外管12与内管11之间伸出,每个变形部202伸出后沿内管11的径向向外发生形变,使变形部202呈张开状。多个第二温度传感器21与多个变形部202一一对应,或者,在其他实施例中,每个变形部202上设置有多个第二温度传感器21。每个变形部202上安装有一个第二温度传感器21,每个第二温度传感器21跟随对应的变形部202张开或者回缩。消融过程中,推动滑动件19使变形部202 伸出内管11且张开一定角度α,例如,0°<α≤150°。多个第二温度传感器21呈散开状均匀排布在滑动部201的四周,且多个第二温度传感器21分布在微波辐射天线9的四周,每个第二温度传感器21配置成检测组织温度,且第二温度传感器21张开的范围与滑动件19推动的距离呈比例关系,进而能够精确确认消融面积的大小。多个第二温度传感器21均与控制器22通信连接,例如,多个第二温度传感器21均与控制器22可以通过编织层内导体连接。控制器22与手柄01连接,位于手柄01内部,配置成获取第二温度传感器21检测得到的温度,且能够显示至终端,便于操作人员根据获取的温度值进行相应操作。In the present disclosure, optionally, the microwave ablation needle further includes a slider 19, a connecting member 20, a plurality of second temperature sensors 21, and a controller 22. The slider 19 is slidably connected to the first handle 1, and the sliding of the slider 19 The direction is parallel to the axis direction of the first handle 1, and the slider 19 and the first handle 1 are relatively fixed in the radial direction of the first handle 1, that is, the slider 19 does not fall off from the first handle 1, and the use is safe and reliable. Optionally, the sliding member 19 may be a slider, and the surface of the sliding member 19 may be provided with a non-slip pattern, which increases the friction between the operator's hand and the sliding member 19, facilitates the sliding of the sliding member 19, and is not easy to slip. The connecting member 20 includes a tubular sliding portion 201 and a plurality of deforming portions 202 connected to the sliding portion 201. The plurality of deforming portions 202 are evenly spaced along the circumferential direction of the sliding portion 201. Each deforming portion 202 may be provided as an elastic piece. The sliding portion 201 is sleeved outside the inner tube 11 and is located inside the outer tube 12. In other words, the sliding portion 201 is located between the inner tube 11 and the outer tube 12. The sliding portion 201 can slide back and forth along the axial direction of the inner tube 11 relative to the inner tube 11 or the outer tube 12. During the sliding process of the connecting member 20, the multiple deformed portions 202 may be retracted between the outer tube 12 and the inner tube 11, or the multiple deformed portions 202 may also extend from between the outer tube 12 and the inner tube 11. The deformed portions 202 are deformed outward in the radial direction of the inner tube 11 after being extended, so that the deformed portions 202 are opened. The plurality of second temperature sensors 21 are in one-to-one correspondence with the plurality of deformation portions 202, or, in other embodiments, a plurality of second temperature sensors 21 are provided on each deformation portion 202. A second temperature sensor 21 is installed on each deformed portion 202, and each second temperature sensor 21 opens or retracts following the corresponding deformed portion 202. During the ablation process, the sliding member 19 is pushed so that the deformed portion 202 protrudes from the inner tube 11 and is opened by a certain angle α, for example, 0 ° <α≤150 °. The plurality of second temperature sensors 21 are uniformly arranged around the sliding portion 201 in a dispersed manner, and the plurality of second temperature sensors 21 are distributed around the microwave radiation antenna 9. Each of the second temperature sensors 21 is configured to detect a tissue temperature. In addition, the open range of the second temperature sensor 21 is proportional to the distance pushed by the slider 19, so that the size of the ablation area can be accurately confirmed. The plurality of second temperature sensors 21 are all communicatively connected to the controller 22, for example, the plurality of second temperature sensors 21 and the controller 22 may be connected by a conductor in a braided layer. The controller 22 is connected to the handle 01 and is located inside the handle 01. The controller 22 is configured to obtain the temperature detected by the second temperature sensor 21 and can display the temperature to the terminal, so that the operator can perform corresponding operations according to the obtained temperature value.
本公开中,可选的,滑动部201为环形编织管,变形部202为弹性条,变形部202与环形编织管编织为一体。In the present disclosure, optionally, the sliding portion 201 is an annular braided tube, the deformed portion 202 is an elastic strip, and the deformed portion 202 is integrally knitted with the annular braided tube.
本公开采用变径的内管和变径的外管组合的结构,外管12套设在内管11外部,外管12和内管11之间形成通道与外界隔离,一方面隔离消融时发热的内管11与内镜钳道接触,有效的保护内镜,另一方面,微波辐射天线9的三棱锥结构以及前端由粗变细的内管11,有效减少穿刺阻力,更有利于刺穿病变组织,进行内部消融。同时,外管12和内管11均设置为采用上述所列举的材料制成的变径结构,能让弯曲的柔性消融针恢复原态且不影响冷却消融效果。The present disclosure adopts a combined structure of a reduced inner tube and a reduced outer tube. The outer tube 12 is sleeved outside the inner tube 11, and a channel is formed between the outer tube 12 and the inner tube 11 to isolate the outside. On the one hand, heat is isolated during ablation. The inner tube 11 is in contact with the endoscope clamp channel, which effectively protects the endoscope. On the other hand, the triangular pyramid structure of the microwave radiation antenna 9 and the thicker and thinner inner tube 11 at the front end effectively reduce puncture resistance and are more conducive to puncture. Lesion tissue, internal ablation. At the same time, the outer tube 12 and the inner tube 11 are both provided with a reducing structure made of the materials listed above, which can restore the curved flexible ablation needle to its original state without affecting the cooling ablation effect.
本公开与现有的微波消融针相比可有效解决消融针穿刺难,进针定位难的问题,能够借助内镜定位,可直观清楚地到达病灶位置,然后通过超声内镜钳道,将柔性微波消融针送到病灶位置,同时该发明独特的隔离多腔结构能有效 降低针杆的温度,减少微波消融过程中能耗对内镜和正常组织的损伤。同时本公开通过在微波辐射天线9的四周布置多个第二温度传感器21,能够更精确的估算出消融区域大小,实现更加精准的消融治疗。Compared with the existing microwave ablation needles, the present disclosure can effectively solve the problems of difficult puncture and positioning of the needles. It can be positioned endoscopically, can reach the location of the lesion intuitively and clearly, and then use ultrasonic endoscopic clamping to make the flexible The microwave ablation needle is delivered to the location of the lesion. At the same time, the unique isolated multi-cavity structure of the invention can effectively reduce the temperature of the needle rod and reduce the damage to the endoscope and normal tissue by the energy consumption during the microwave ablation process. At the same time, by arranging a plurality of second temperature sensors 21 around the microwave radiation antenna 9, the present disclosure can more accurately estimate the size of the ablation area and achieve more accurate ablation treatment.
本公开的工作原理为:功率信号:微波输出设备→通过射频同轴连接器7→射频同轴线缆8→穿过手柄01→进入隔离腔6→内管11→微波辐射天线9辐射能量;The working principle of the present disclosure is: power signal: microwave output device → via RF coaxial connector 7 → RF coaxial cable 8 → through handle 01 → into isolation cavity 6 → inner tube 11 → microwave radiation antenna 9 to radiate energy;
保护回路:排水管道16内回水温度→第一温度传感器13测温→针杆温度超出设定值→反馈微波输出设备→切断微波输出。Protection circuit: return water temperature in the drainage pipe 16 → temperature measurement by the first temperature sensor 13 → the temperature of the needle rod exceeds the set value → feedback microwave output device → cut off the microwave output.
冷却循环回路:进水管4→隔离腔6中的进水腔601→毛细管10→内管11→第一温度传感器13探测针杆温度→隔离腔6中的出水腔602→交换热量后回水→出水管5。Cooling loop: water inlet pipe 4 → water inlet chamber 601 in isolation chamber 6 → capillary 10 → inner tube 11 → first temperature sensor 13 detects the temperature of the needle rod → water outlet chamber 602 in isolation chamber 6 → return water after heat exchange →出水管 5。 Water pipe 5.
预判断消融面积大小原理:滑动件19前推→滑动部201前进→变形部202张开→第二温度传感器21测温→滑动部201编织管内部导体传输→手柄处的控制器22→反馈给设备显示→根据反馈温度判断消融大小。Principle of pre-determining the size of the ablation area: Slide 19 forwards → Slide 201 advances → Deformation section 202 opens → Temperature measurement of the second temperature sensor 21 → Transmission of the inner conductor of the braided tube of Slide 201 → Controller 22 at the handle → Feedback to Device display → judge ablation size based on feedback temperature.
上述仅为本公开的优选实施例,本公开并不仅限于实施例的内容。对于本领域中的技术人员来说,在本公开的技术方案范围内可以有各种变化和更改,所作的任何修改、等同替换或者改进等,均在本公开保护范围之内。The above are only preferred embodiments of the disclosure, and the disclosure is not limited to the content of the embodiments. For those skilled in the art, there can be various changes and modifications within the scope of the technical solution of the present disclosure, and any modification, equivalent replacement, or improvement made is within the protection scope of the present disclosure.
工业实用性:Industrial applicability:
综上所述,本公开提供了一种超声内镜下柔性微波消融针,穿透性强,治疗效果好。In summary, the present disclosure provides a flexible microwave ablation needle under ultrasound endoscope, which has strong penetrability and good treatment effect.

Claims (20)

  1. 一种超声内镜下柔性微波消融针,其特征在于:包括手柄、射频同轴连接器和微波辐射天线,所述射频同轴连接器设置于所述手柄上,所述射频同轴连接器与所述微波辐射天线通过射频同轴线缆连接,所述射频同轴线缆外围依次设有毛细管和内管,所述射频同轴线缆置于所述毛细管内,所述毛细管置于所述内管内,所述毛细管作为冷却水通道连通有进水管,所述毛细管的外壁与所述内管的内壁形成排水管道,所述排水管道连通有出水管,进入所述冷却水通道的水经所述排水管道排出,所述内管包括第一端部和第二端部,所述第一端部延伸至所述微波辐射天线,所述第二端部远离所述微波辐射天线,所述内管由所述第二端部至所述第一端部逐渐变细。A flexible microwave ablation needle under an ultrasound endoscope, comprising a handle, a radio-frequency coaxial connector and a microwave radiation antenna. The radio-frequency coaxial connector is disposed on the handle, and the radio-frequency coaxial connector is connected with the radio-frequency coaxial connector. The microwave radiation antenna is connected by a radio frequency coaxial cable, and a capillary tube and an inner tube are sequentially arranged at the periphery of the radio frequency coaxial cable. The radio frequency coaxial cable is placed in the capillary tube, and the capillary tube is placed in the capillary tube. In the inner pipe, the capillary tube communicates with a water inlet pipe as a cooling water passage, and an outer wall of the capillary tube and an inner wall of the inner pipe form a drainage pipe, and the drainage pipe communicates with a water outlet pipe, and water entering the cooling water passage passes through The drainage pipe is discharged, the inner pipe includes a first end portion and a second end portion, the first end portion extends to the microwave radiation antenna, the second end portion is far from the microwave radiation antenna, and the inner portion The tube tapers from the second end to the first end.
  2. 根据权利要求1所述的超声内镜下柔性微波消融针,其特征在于:所述内管采用耐高温且可以弯曲的材料制成。The flexible microwave ablation needle under ultrasound endoscope according to claim 1, wherein the inner tube is made of a material that is resistant to high temperatures and can be bent.
  3. 根据权利要求1或者2所述的超声内镜下柔性微波消融针,其特征在于:所述内管采用聚苯醚醚酮、聚酰亚胺、镍钛合金管、PTFE管或医用复合材料组合编织管制成。The flexible microwave ablation needle under ultrasound endoscope according to claim 1 or 2, characterized in that: the inner tube is made of poly (phenylene ether ether ketone), polyimide, nickel-titanium alloy tube, PTFE tube or medical composite material combination Made of braided tube.
  4. 根据权利要求1-3中任一项所述的超声内镜下柔性微波消融针,其特征在于:所述毛细管采用耐高温且可以弯曲的材料制成。The flexible microwave ablation needle under ultrasound endoscope according to any one of claims 1-3, characterized in that the capillary is made of a material that is resistant to high temperatures and can be bent.
  5. 根据权利要求1-4中任一项所述的超声内镜下柔性微波消融针,其特征在于:所述毛细管采用镍钛合丝管、聚苯醚醚酮、聚酰亚胺、304不锈钢管、镍钛合金管、PTFE管或医用复合材料多层编织管制成。The flexible microwave ablation needle under ultrasound endoscope according to any one of claims 1-4, wherein the capillary tube is a nickel-titanium wire tube, poly (phenylene ether ether ketone), polyimide, or 304 stainless steel tube. , Nickel-titanium alloy tube, PTFE tube or medical composite multilayer braided tube.
  6. 根据权利要求1-5中任一项所述的超声内镜下柔性微波消融针,其特征在于:还包括第一温度传感器,所述第一温度传感器与所述毛细管连接,配置成检测所述微波辐射天线的温度。The ultrasonic endoscopic flexible microwave ablation needle according to any one of claims 1-5, further comprising a first temperature sensor, the first temperature sensor being connected to the capillary tube and configured to detect the capillary tube. Microwave radiation antenna temperature.
  7. 根据权利要求1-6中任一项所述的超声内镜下柔性微波消融针,其特征在于:还包括外管,所述外管与所述手柄连接,所述外管套设于所述内管外。The flexible microwave ablation needle under ultrasound endoscope according to any one of claims 1-6, further comprising an outer tube, the outer tube is connected to the handle, and the outer tube is sleeved on the Outer tube.
  8. 根据权利要求7所述的超声内镜下柔性微波消融针,其特征在于:所述外管由远离所述微波辐射天线的一端向靠近所述微波辐射天线的一端逐渐变细。The flexible microwave ablation needle under ultrasound endoscope according to claim 7, wherein the outer tube is tapered from an end far from the microwave radiation antenna to an end closer to the microwave radiation antenna.
  9. 根据权利要求7或8所述的超声内镜下柔性微波消融针,其特征在于:所述外管采用耐高温且可以弯曲的材料制成。The flexible microwave ablation needle under ultrasound endoscope according to claim 7 or 8, wherein the outer tube is made of a material that is resistant to high temperatures and can be bent.
  10. 根据权利要求7-9中任一项所述的超声内镜下柔性微波消融针,其特征在于:所述外管采用聚苯醚醚酮、聚酰亚胺、镍钛合金管、PTFE管或医用复合材料多层编织管制成。The flexible microwave ablation needle under ultrasound endoscope according to any one of claims 7-9, wherein the outer tube is made of poly (phenylene ether ether ketone), polyimide, nickel-titanium alloy tube, PTFE tube or Made of medical composite multilayer braided tube.
  11. 根据权利要求7-10中任一项所述的超声内镜下柔性微波消融针,其特征在于:还包括滑动件、连接件以及多个第二温度传感器,所述连接件包括滑动部和与所述滑动部连接的多个变形部,多个所述变形部沿所述滑动部的周向间隔排布,所述滑动件与所述滑动部连接,所述滑动部位于所述内管与所述外管之间,且与所述内管沿所述内管的轴线方向滑动配合;所述滑动件与所述手柄滑动配合,当所述连接件相对于所述内管滑动时,所述变形部能够伸出所述内管与所述外管且沿所述内管的径向向外张开,或者所述变形部能够缩回至所述内管与所述外管之间;每个所述变形部上设置有至少一个第二温度传感器。The flexible microwave ablation needle under ultrasound endoscope according to any one of claims 7 to 10, further comprising a sliding member, a connecting member, and a plurality of second temperature sensors, wherein the connecting member includes a sliding portion and a connecting portion. A plurality of deformed parts connected by the sliding part, the plurality of deformed parts are arranged at intervals along the circumferential direction of the sliding part, the sliding part is connected with the sliding part, and the sliding part is located between the inner tube and the inner tube; The outer tube slides and cooperates with the inner tube along the axial direction of the inner tube; the slide member slides with the handle, and when the connecting member slides relative to the inner tube, The deformed portion can extend from the inner tube and the outer tube and open outward in the radial direction of the inner tube, or the deformed portion can be retracted between the inner tube and the outer tube; Each said deformation part is provided with at least one second temperature sensor.
  12. 根据权利要求11所述的超声内镜下柔性微波消融针,其特征在于:所述滑动部套设于所述内管外。The flexible microwave ablation needle under ultrasound endoscope according to claim 11, wherein the sliding portion is sleeved outside the inner tube.
  13. 根据权利要求11或者12所述的超声内镜下柔性微波消融针,其特征在于:所述滑动部设置编织管,多个所述变形部与所述编织管编织为一体。The flexible microwave ablation needle under ultrasound endoscope according to claim 11 or 12, characterized in that: the sliding portion is provided with a braided tube, and a plurality of the deformed portions are knitted with the braided tube as a whole.
  14. 根据权利要求1-13中任一项所述的超声内镜下柔性微波消融针,其特征在于:所述手柄包括依次连接的第一手柄、伸缩柄和第二手柄,所述伸缩柄与所述第一手柄或者/和所述第二手柄沿所述射频同轴线缆的轴向滑动配合;所述射频同轴连接器设置于所述第一手柄上,所述伸缩柄内设置有贯穿所述伸缩柄的长度方向的两端的第一通孔,所述第二手柄设置有贯穿所述第二手柄的长度方向的两端的第二通孔,所述射频同轴线缆、所述毛细管和所述内管的一端与所述第一手柄连接,所述射频同轴线缆、所述毛细管以及所述内管的另一端依次穿过所述第一通孔和所述第二通孔且伸出所述第二通孔远离所述第一通孔的一端。The flexible microwave ablation needle under ultrasound endoscope according to any one of claims 1-13, wherein the handle comprises a first handle, a telescopic handle, and a second handle connected in sequence, and the telescopic handle and the The first handle or / and the second handle slide along the axial direction of the radio-frequency coaxial cable; the radio-frequency coaxial connector is disposed on the first handle, and the telescopic handle is provided with a through hole. A first through hole at both ends in the length direction of the telescopic handle, a second handle provided with a second through hole penetrating through both ends in the length direction of the second handle, the RF coaxial cable, the capillary tube And one end of the inner tube is connected to the first handle, and the radio frequency coaxial cable, the capillary tube, and the other end of the inner tube pass through the first through hole and the second through hole in order. An end of the second through-hole far from the first through-hole is extended.
  15. 根据权利要求14所述的超声内镜下柔性微波消融针,其特征在于:所述伸缩柄滑动连接所述第一手柄。The flexible microwave ablation needle under ultrasound endoscope according to claim 14, wherein the telescopic handle is slidably connected to the first handle.
  16. 根据权利要求14或者15所述的超声内镜下柔性微波消融针,其特征在于:所述伸缩柄与所述第一手柄之间设置有防止二者相对滑动的锁紧装置。The flexible microwave ablation needle under ultrasound endoscope according to claim 14 or 15, wherein a locking device is provided between the telescopic handle and the first handle to prevent the two from sliding relative to each other.
  17. 根据权利要求16所述的超声内镜下柔性微波消融针,其特征在于:所述锁紧装置包括与所述第一手柄连接的卡环,所述卡环上设置有凸块,所述伸缩柄的外周面设置有卡槽,所述卡环能够沿径向变形,以使所述凸块卡接于所述卡槽中,进而限制所述第一手柄与所述伸缩柄相对滑动;或者使所述凸块与所述卡槽分离,进而使所述第一手柄与所述伸缩柄能够相对滑动。The flexible microwave ablation needle under ultrasound endoscope according to claim 16, wherein the locking device comprises a snap ring connected to the first handle, a bump is provided on the snap ring, and the telescopic A snap groove is provided on the outer peripheral surface of the handle, and the snap ring can be deformed in a radial direction so that the projection is engaged in the snap groove, thereby restricting the first handle from sliding relative to the telescopic handle; or The protrusion is separated from the card slot, so that the first handle and the telescopic handle can slide relative to each other.
  18. 根据权利要求15-17中任一项所述的超声内镜下柔性微波消融针,其特征在于:所述第一手柄设置有中空区,所述伸缩柄插接于所述中空区且能够相对于所述第一手柄滑动。The flexible microwave ablation needle under ultrasound endoscope according to any one of claims 15-17, wherein the first handle is provided with a hollow area, and the telescopic handle is inserted into the hollow area and can be opposite to each other. Sliding on the first handle.
  19. 根据权利要求1-18中任一项所述的超声内镜下柔性微波消融针,其特征在于:所述手柄上设有隔离腔,所述隔离腔包括相互分离的进水腔和出水 腔,所述毛细管通过所述进水腔连通所述进水管,所述排水通道通过所述出水腔连通所述出水管。The flexible microwave ablation needle under ultrasound endoscope according to any one of claims 1 to 18, characterized in that: the handle is provided with an isolation cavity, and the isolation cavity comprises a water inlet cavity and a water outlet cavity separated from each other, The capillary tube communicates with the water inlet pipe through the water inlet cavity, and the drainage channel communicates with the water outlet pipe through the water outlet cavity.
  20. 根据权利要求1-19中任一项所述的超声内镜下柔性微波消融针,其特征在于:所述微波辐射天线采用三棱锥型天线、斜面型天线或圆锥型天线。The flexible microwave ablation needle under ultrasound endoscope according to any one of claims 1 to 19, wherein the microwave radiation antenna is a triangular pyramid antenna, a bevel antenna, or a conical antenna.
PCT/CN2019/097425 2018-07-26 2019-07-24 Endoscopic ultrasonography flexible microwave ablation needle WO2020020205A1 (en)

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