WO2020232849A1 - 一种可协同给药的电脉冲消融装置 - Google Patents

一种可协同给药的电脉冲消融装置 Download PDF

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Publication number
WO2020232849A1
WO2020232849A1 PCT/CN2019/101269 CN2019101269W WO2020232849A1 WO 2020232849 A1 WO2020232849 A1 WO 2020232849A1 CN 2019101269 W CN2019101269 W CN 2019101269W WO 2020232849 A1 WO2020232849 A1 WO 2020232849A1
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Prior art keywords
drug delivery
delivery tube
electrodes
lumen
interventional catheter
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PCT/CN2019/101269
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English (en)
French (fr)
Inventor
陈永刚
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杭州睿笛生物科技有限公司
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Publication of WO2020232849A1 publication Critical patent/WO2020232849A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/327—Applying electric currents by contact electrodes alternating or intermittent currents for enhancing the absorption properties of tissue, e.g. by electroporation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00702—Power or energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00982—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe

Definitions

  • the invention relates to the field of medical equipment, in particular to an electric pulse ablation device capable of cooperating drug delivery.
  • the existing application number 2016100163436 "Umbrella-shaped radiofrequency ablation electrode needle for endoscope” discloses a medical device for performing radiofrequency ablation of electrodes and injection of liquid medicine treatment on patients.
  • the medical device can be inserted through the natural cavity of the human body.
  • the catheter like a common endoscope, penetrates into the patient's body for ablation and liquid injection of diseased tissues at specific locations.
  • the electrode needle adopts a retractable/expandable umbrella-shaped electrode needle to perform thermal ablation of diseased tissues after heating, and assists injecting physiological saline or liquid medicine to expand the ablation range or local chemotherapy. This kind of electrode needle can only ablate with a single fever.
  • the shape effect is to expand the range of thermal ablation and damage normal tissues; it is difficult to inject the liquid medicine, and the loss of the liquid medicine attached along the infusion channel causes the final injection of liquid medicine to be insufficient.
  • the aforementioned loss problem can only be solved by injecting more liquid medicine.
  • this type of device can only be used for percutaneous puncture intervention and applied to tissues or cells close to the skin. Internally, the diseased organs and tissues must be exposed through traditional surgery, that is, a hole is inserted into the patient's body. The patient is traumatized and the postoperative recovery is slow, which brings inconvenience to both doctors and patients.
  • the technical problem to be solved and the technical task proposed by the present invention are to overcome the limited effect of radiofrequency ablation using an interventional catheter in the body disclosed in the previous application, the difficulty of injecting the liquid medicine, and the high loss along the way; the existing pulsed electric field treatment equipment can only be applied close to Skin tissues or cells need to make open wounds deep into the human body, which brings many inconveniences and other problems.
  • the present invention provides an electric pulse ablation device that can be coordinated for drug delivery.
  • the ablation device can use an interventional catheter to enter the human body non-invasively , And perform pulse ablation on the tumor tissue of the patient, and then use the aforementioned ablation to reduce the density of the tumor tissue and increase the cell permeability. After the drug is delivered to the tumor tissue, it is easier to penetrate into the tumor cells, which improves the therapeutic effect of the tumor.
  • an electric pulse ablation device capable of coordinating drug delivery, comprising an interventional catheter with open ends at both ends and an operating handle connected to the rear end of the catheter, and is characterized in that the interventional catheter is in the lumen
  • Two electrodes and/or drug delivery tubes are provided.
  • the two electrodes are both thin needles made of nickel-titanium memory alloy.
  • the thin needles form a discharge working section with a length of T2 from the front end to the back.
  • the discharge of the two electrodes is The working section can be stretched out elastically after pushing out the front port of the interventional catheter and facing each other in parallel.
  • the parallel distance between the two discharge working sections is D2.
  • the surface of the thin needle behind the self-discharge working section is wrapped with an insulating layer, and the two electrode tail ends penetrate the intervention backward.
  • the catheter is connected to an operating handle, the operating handle can be externally connected to the pulse generator, the operating handle can drive the two electrodes forward to extend or retract the interventional catheter; the operating handle can drive the drug delivery tube forward to extend or retract the interventional catheter And administering drugs; the front end of the drug delivery tube is provided with a drug storage area.
  • the invention can be used for non-invasive or minimally invasive intervention on the patient, directly using the existing endoscope working channel to make the interventional catheter penetrate into the body through the natural cavity of the human body, and then use high-voltage pulse to ablate the tumor part, and use the electric pulse to act on the tumor cell , So that the original hard tissue becomes softer and the cell permeability increases, and then the drug in the drug storage area is delivered to the tumor cells after pulse ablation, the drug is easier to enter the tumor cells, thereby improving the tumor treatment effect; the drug is located in the interventional
  • the front end of the catheter is the drug storage area at the end of the extension, the delivery distance is short, and there is no massive loss caused by the delivery along the intervention catheter.
  • the two electrodes are made of nickel-titanium memory alloy. Use the operating handle to drive the two electrodes forward and push out the interventional catheter.
  • the shape memory effect of the memory alloy is used to elastically expand and maintain a certain gap in parallel. The strength can be formed after the two parallel electrodes are energized.
  • the uniform electric field completes the pulse ablation, effectively shortens the ablation time, increases the ablation area of a single insertion, and has a good treatment effect.
  • the two electrodes need to be connected to a high-voltage electric pulse generator during operation.
  • the high-voltage electric pulse generator is an existing technology.
  • the drug can be placed in the drug storage area at the front end of the drug delivery tube in advance, after the ablation is completed.
  • the two electrodes withdraw the interventional catheter, the drug delivery tube is moved forward to push out the interventional catheter, the drug storage area is moved to the position of the ablated tumor tissue to administer the drug, where the front end of the drug delivery tube where the drug storage area is located is defined as the distal end of the drug delivery tube , The rear end of the drug delivery tube is defined as the proximal end.
  • the drug enters the human body with the interventional catheter directly in the drug storage area at the far end.
  • the subsequent delivery to the tumor site is short and the delivery distance is short to avoid the loss and waste caused by the drug delivery along the way.
  • the operating handle is at the proximal end Work drives the drug delivery tube forward to push out or withdraw the interventional catheter.
  • the present invention adopts the following technical measures: the ends of the discharge working section of the two electrodes are both pointed ends; the drug storage area is an adsorption port formed by the open end of the drug delivery tube , The drug delivery tube is provided with a guide wire capable of piercing the capsule shell, the guide wire is inserted backwards through the guide wire interface on the operating handle, and the operating handle is provided with an air pump interface connected to the drug delivery tube.
  • the ends of the discharge working section of the two electrodes are both sharp, it is convenient to penetrate the human cavity wall and penetrate into the tumor tissue next to the wall with the assistance of imaging equipment, and perform pulse ablation inside the tumor tissue, which has a better ablation effect; through the air pump interface
  • the air in the drug delivery tube is drawn out to generate negative pressure, and the drug stored here is sucked at the suction port, so that the drug can be pushed out of the drug delivery tube to the tumor tissue site.
  • the air pump interface can also be directly connected to the syringe for pumping; here
  • the medicine needs to adopt a capsule structure.
  • the capsule can store solid powder or liquid medicine. When the medicine is applied, the medicine can be applied by pushing the guide wire forward from the guide wire interface of the operating handle to puncture the capsule.
  • the suction opening is a bell mouth with a large outer diameter and a small inner diameter.
  • the bell mouth with a large outside and a small inside can increase the contact area with the capsule medicine, improve the stability of the capsule adsorption, and prevent the capsule from falling off early and affecting normal use due to the small adsorption contact area of the two.
  • the ends of the discharge working section of the two electrodes are both pointed ends;
  • the drug delivery tube is provided with a guide wire that can pierce the capsule shell, and the guide wire is inserted backward through the guide wire interface on the operating handle, and the operating handle is provided
  • Connect the air pump interface of the drug delivery tube the front end of the drug delivery tube is provided with a tip, the tip is provided with a hole connected to the drug delivery tube, the small diameter end of the tip is opened to form a drug delivery port and communicates with the hole, and the large diameter end of the tip is connected to the drug delivery tube It is connected with the pores, and the lumen of the drug delivery tube butted with the tip serves as the drug storage area.
  • the ends of the discharge working section of the two electrodes are sharp, which is good for piercing into the tumor tissue.
  • Pulse ablation inside the tumor tissue has a better ablation effect; the tip of the drug delivery tube also penetrates the tumor tissue and then passes through the tip The internal pores directly send the drug in the drug delivery tube into the tumor tissue.
  • the guide wire is used to pierce the capsule to release the internal drug powder, and then use an air pump to infuse the drug delivery tube to blow the drug powder out into the tumor tissue.
  • the drug needs to adopt a capsule structure. Push the guide wire forward at the guide wire interface to extend or retract the drug delivery tube; the drug can be stored in the lumen of the drug delivery tube.
  • the tip and the drug delivery tube are integrally formed, and the tube section on the side of the corresponding tip is provided with a radial hole communicating with the lumen, and the radial hole extends outward to the outer surface of the tube section and forms a charge hole;
  • the tip is an independent component that is threaded or bonded to the drug delivery tube, and the drug delivery tube is provided with a release channel radially communicating with the lumen on the tube section on the side of the corresponding tip, and the release channel extends outward to The outer surface of the pipe section.
  • the radial channel can store drugs, and the loading hole is used to fill the drug capsule into the aforementioned radial channel.
  • the tip and the drug delivery tube adopt an integrated structure, and the drug flows from the tip channel and the drug delivery hole to the drug delivery tube.
  • External application; or the tip is a separate independent component, fixed on the front end of the drug delivery tube by threaded connection or bonding, the drug is inserted into the drug delivery tube port in advance before the tip and the drug delivery tube are docked, and the drug is simultaneously from the tip hole And the release channel of the drug delivery tube is released outward.
  • the lumen of the interventional catheter is divided into three mutually independent compartments, two electrodes and a drug delivery tube are respectively penetrated.
  • the lumen of the interventional catheter is divided into three independent compartments.
  • the two electrodes and the drug delivery tube are respectively penetrated into these three compartments. Only one interventional catheter can be used to penetrate the human body once to complete the pulse electric field ablation of the tumor Organization and subsequent administration of treatment.
  • the lumen of the interventional catheter is a single-lumen structure, and the two electrodes or the drug delivery tube are selectively inserted into the lumen.
  • the interventional catheter has a single-lumen structure, and can only penetrate two electrodes at a time, or a drug delivery tube. When in use, an interventional catheter needs to be penetrated twice to complete ablation and drug delivery, of which two electrodes are penetrated for the first time , And withdraw after use; the second time through the drug delivery tube for administration.
  • the lumen of the interventional catheter has a single-lumen structure, and the two electrodes or the drug delivery tube are alternatively inserted into the lumen;
  • the operation handle is provided with an air pump interface communicating with the drug delivery tube, and the front end of the drug delivery tube is sleeved
  • An inflatable airbag the drug delivery tube is provided with an opening on the side wall of the tube section passing through the airbag, and the outer wall of the airbag can be adhered to the drug as a drug storage area;
  • the front ends of the discharge working sections of the two electrodes are fixed at On a tapered guide, the large-diameter end of the guide matches the diameter of the interventional catheter, and the two electrodes are provided with an electrode fixing member behind the guide so that they abut against the limit.
  • the two The discharge working section of each electrode is located between the guide member and the electrode fixing member.
  • the interventional catheter still adopts a single-lumen structure, and only two electrodes or a drug delivery tube can be inserted at a time, and the pulse ablation and drug delivery are completed in two backwards; the drug delivery tube is pushed out first, and the air pump is used to the drug delivery tube
  • the balloon is inflated, the drug adhered to the outer surface of the balloon is applied to the tumor tissue.
  • the drug delivery tube is inflated, and the balloon returns to its original state and is withdrawn into the interventional catheter along with the drug delivery tube; due to the two electrodes
  • the two ends of the discharge working section are respectively connected to the guide and the electrode holder.
  • the two discharge working sections between the guide and the electrode holder can fit the tumor tissue, which is suitable for the ablation treatment of the tumor tissue on the wall around the pathway channel.
  • the electrode has an insulating layer on the electrode surface at both ends of the discharge working section.
  • the invention can be used for non-invasive or minimally invasive intervention on the patient, directly using the existing endoscope working channel to make the interventional catheter penetrate into the body through the natural cavity of the human body, and then use high-voltage pulse to ablate the tumor part, and use the electric pulse to act on the tumor cell ,
  • the original hard tissue becomes softer to increase cell permeability, and then the drug in the drug storage area is delivered to the tumor cells after pulse ablation, so that the drug can easily enter the tumor cells, thereby improving the tumor treatment effect.
  • Figure 1 Schematic diagram of the structure of Example 1.
  • Figure 2 Cross-sectional view of the interventional catheter in Example 1.
  • Figure 3 A schematic diagram of the radial cross-section of the interventional catheter body in Embodiment 1.
  • Figure 4 Schematic diagram of the positive electrode of Example 1.
  • Figure 5 Working schematic diagram of Example 1.
  • Figure 6 Schematic diagram 1 of the drug delivery tube in Example 2.
  • Figure 7 Schematic diagram of the second embodiment of the second embodiment of the drug delivery tube.
  • Figure 8 Schematic diagram of embodiment 2 electrode delivery.
  • Figure 10 Schematic diagram of Example 3.
  • Interventional catheter 2. Operating handle, 3. Electrode, 4. Electrode, 5. Drug delivery tube, 51. Radial channel, 6. Air pump interface, 7. Adsorption port, 8. Guide wire, 9. Tip, 91. Orifice, 92. Drug delivery port, 10. Airbag, 11. Guide, 12. Electrode fixture, 13. Insulation layer, 14. Electrode cavity, 15. Drug delivery cavity, 16. Drug capsule, 17 . Human cavity wall, 18. Tumor tissue, 19. Guide wire interface, 20. Loading hole, 21. Application hole.
  • an electric pulse ablation device capable of coordinating drug delivery includes an interventional catheter 1 with open ends and an operating handle 2 connected to the rear end of the catheter.
  • the lumen of the interventional catheter 1 is separated
  • the electrodes 3 and 4 and the drug delivery tube 5 are penetrated into three independent compartments.
  • the three compartments are respectively two electrode cavities 14 and a drug delivery cavity 15; the two electrodes are both nickel-titanium memory
  • the fine needle forms a discharge working section with a length of T2 from the front end to the back.
  • the discharge working section ends of the two electrodes are both pointed ends.
  • the discharge working section of the two electrodes can be pushed out of the intervention catheter 1
  • the front port is elastically expanded and parallel to each other.
  • the parallel distance between the two discharge working sections is D2.
  • the surface of the fine needle behind the self-discharge working section is wrapped with an insulating layer 13, and the two electrode tail ends pass through the intervention catheter 1 to the operating handle 2 backwards ,
  • the operating handle 2 can be connected to an external pulse generator, the operating handle 2 can drive the two electrodes to move forward to extend or retract the interventional catheter 1; the operating handle 2 can drive the drug delivery tube 5 to move forward to extend or retract the interventional catheter
  • the catheter 1 and drug delivery; the drug delivery tube 5 is provided with a drug storage area at the front end.
  • the drug storage area in this embodiment is a trumpet-shaped adsorption port 7 with a large outer diameter and a small inner diameter formed at the front end of the drug delivery tube 5.
  • the tube 5 is provided with a guide wire 8 capable of piercing the capsule shell.
  • the guide wire 8 is inserted backwards through the guide wire interface 19 on the operating handle 2, and the operating handle 2 is provided with an air pump interface 6 connected to the drug
  • the invention only needs to use an interventional catheter to penetrate the human body once to complete the pulse electric field ablation of tumor tissue and subsequent drug delivery treatment.
  • the interventional catheter is penetrated into the human body from the working channel of the endoscope to close to the tumor tissue, and the operation handle is used to drive the two electrodes forward to push out the interventional catheter.
  • the two electrodes are elastically expanded in parallel according to the set shape memory. Then pierce the tumor tissue, keep a certain gap and energize the tumor tissue and pulse ablate the tumor tissue.
  • the thin metal needles of the two electrodes are connected to the high-voltage electric pulse generator.
  • the high-voltage electric pulse generator is the existing technology.
  • the operating handle After the ablation is completed, use the operating handle to re Withdraw the two electrodes back into the interventional catheter, and use the lumen of the interventional catheter to confine the two electrodes to their original shape;
  • the drug is a drug capsule 16 that is placed in the adsorption port in advance, and the air pump or syringe is used to pump air into the drug delivery tube. Press and suck the drug capsules stored here, push out the drug delivery tube to send the capsule to the position of the tumor tissue after ablation, use the guide wire to pierce the capsule and apply the medicine powder or liquid inside to the tumor tissue after the ablation.
  • the entire interventional catheter enters the human body, and the subsequent delivery to the tumor site has a short delivery distance, avoiding wastage and waste caused by drug delivery along the way; the air pump interface is used to connect an air pump or a syringe to pump the drug delivery tube to generate negative pressure.
  • the interventional catheter described in this embodiment can also adopt a single-lumen structure, and only two electrodes or one drug delivery tube can be inserted at a time. When in use, an interventional catheter needs to be inserted twice to complete ablation and drug delivery. For the first time, two electrodes are inserted for pulse ablation. After use, the two electrodes are drawn out and then inserted into the drug delivery tube for drug delivery treatment.
  • Example 2 As shown in Figures 6-9, an electric pulse ablation device capable of coordinating drug delivery.
  • the difference from Example 1 is that the ends of the discharge working section of the two electrodes are both pointed ends; the drug delivery tube 5 is provided with a guide wire 8 that can pierce the capsule shell.
  • the guide wire 8 is inserted backwards through the guide wire interface 19 on the operating handle 2, and the operating handle 2 is provided with an air pump interface 6 connected to the drug delivery tube 5.
  • a tip 9 is provided at the front end of the delivery tube 5, the tip 9 is provided with a hole 91 connected to the drug delivery tube 5, the small diameter end of the tip 9 is opened to form a drug delivery port 92 and communicates with the hole 91, and the large diameter end of the tip 9 is connected to the drug delivery tube 5 and communicate with the hole 91, and the lumen of the drug delivery tube 5 butted with the tip 9 serves as the drug storage area.
  • the tip 9 and the drug delivery tube 5 are integrally formed.
  • the drug delivery tube 5 is provided with a radial channel 51 communicating with the lumen on the tube section on the side corresponding to the tip 9, and the radial channel 51 is outwards.
  • a release channel 21 radially connected to the lumen is arranged around the pipe section of, and the release channel 21 extends outward to the outer surface of the pipe section; the remaining parts are basically the same as the first embodiment.
  • the lumen of the interventional catheter described in this embodiment can also adopt a single-lumen structure.
  • the same interventional catheter needs to be inserted twice into the two electrodes and the drug delivery tube to complete ablation and drug delivery.
  • the two electrodes penetrate the interventional catheter Shown in Figure 8.
  • Example 2 the difference between Example 2 and Example 1 is that the drug delivery method is different.
  • the interventional catheter enters the human body close to the tumor tissue, and two electrodes push out the interventional catheter to penetrate the human cavity wall and penetrate into the tumor next to the wall. Pulse ablation is performed inside the tissue.
  • the tip of the drug delivery tube is set to facilitate the penetration of the tumor tissue, and then the drug in the drug delivery tube is directly delivered into the tumor tissue through the internal hole of the tip.
  • the guide wire punctures the capsule to release the internal drug
  • the medicine in the capsule is then delivered to the medicine delivery tube by an air pump to assist the powder/medicine liquid to be blown out into the tumor tissue, where the medicine also needs to use a medicine capsule;
  • the medicine shown in Figure 6 and Figure 7 has two different storage and delivery methods The first is that the drug capsule is inserted into the radial hole from the loading hole, and the drug is discharged from the loading hole and the drug delivery port.
  • the second is the drug capsule from the drug delivery tube port before the tip is connected to the drug delivery tube Insertion, the medicine is discharged from the medicine delivery port and the application hole.
  • Embodiment 3 is shown in FIG. 10, an electric pulse ablation device capable of co-administration.
  • the difference from Embodiment 1 is that the lumen of the interventional catheter is a single-lumen structure, and the two electrodes 3 and 4 Or the drug delivery tube 5 is alternatively inserted into the lumen; the operating handle 2 is provided with an air pump interface 6 connected to the drug delivery tube 5, and an inflatable balloon 10 is sleeved at the front end of the drug delivery tube 5, and there is no guide wire in the delivery tube
  • the drug delivery tube 5 is provided with an opening on the side wall of the tube section passing through the airbag 10, and the outer wall of the airbag 10 can be adhered to the drug as a drug storage area; the front ends of the discharge working sections of the two electrodes are fixed in a cone
  • the large-diameter end of the guide 11 matches the diameter of the interventional catheter 1, and the two electrodes are provided with an electrode fixing member 12 behind the guide 11 so that they are close to the limit.
  • This embodiment is suitable for ablation treatment of tumor tissue on the wall around the pathway channel.
  • the tapered guide guides the interventional catheter 4 along the human cavity wall 7 to the position of the tumor tissue 8, and then withdraws the interventional catheter and simultaneously pushes out two electrodes. After the interventional catheter is pushed out, the two electrodes are elastically expanded and face in parallel. The two discharge working sections between the guide and the electrode holder are attached to the tumor tissue. After the ablation is completed, the two electrodes are drawn back to the interventional catheter and constricted in the lumen of the interventional catheter; then the drug delivery tube is pushed out, and the air pump is used to The drug delivery tube is used to infuse air.
  • the gas in the drug delivery tube enters the airbag through the openings on the side wall to inflate the airbag.
  • the airbag can store drugs through folds when the airbag is in a dry state before inflation. When the airbag is inflated, the drug sticks to the airbag Shake off to the ablated tumor tissue. After the drug delivery is completed, the drug delivery tube is evacuated, and the balloon returns to its original state and is withdrawn into the interventional catheter along with the drug delivery tube.

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Abstract

一种可协同给药的电脉冲消融装置，包括两端敞口的介入导管（1）和接在介入导管（1）后端的操作手柄（2），介入导管（1）的管腔内设置两个电极（3，4）和/或药物输送管（5），两个电极（3，4）均为镍钛记忆合金制成，并自前端部向后形成长度为T2的放电工作段，两个电极（3，4）的放电工作段可在推出介入导管（1）前端口后弹性展开并平行相对。该电脉冲消融装置解决了现有使用介入导管深入体内射频消融存在效果有限，注射药液损耗大等问题，其可以利用介入导管（1）无创进入人体内部，并对病患的肿瘤组织（18）做脉冲消融，使肿瘤组织（18）致密度降低，细胞渗透性增强，给药到肿瘤组织（18）后更易渗透进入肿瘤细胞，治疗效果更好。

Description

一种可协同给药的电脉冲消融装置 技术领域
本发明涉及医疗器械领域，特别是一种可协同给药的电脉冲消融装置。
背景技术
现有申请号2016100163436“内窥镜用伞形射频消融电极针”公开了一种对患者实施电极射频消融与注射药液治疗的医疗装置，所述医疗装置可通过经人体自然腔道插入的介入导管如常见的内窥镜深入病人体内对特定位置的疾病组织作消融和药液注射。所述电极针采用可收拢/展开的伞形电极针通电后发热对疾病组织进行热消融，并辅助注射生理盐水或药液扩大消融范围或局部化疗，这种电极针仅能单一发热消融，伞形作用是扩大热消融范围，而且对正常组织有损伤；注射药液难度大，输液通道沿途附着药液产生损耗导致最后注射药液量不足，只能通过注入更多的药液解决前述损耗问题，保证足量药液到达治疗位置。现在虽有采用两个电极接脉冲发生器作正、负电极形成脉冲电场治疗的医疗设备，但是这类设备只能进行经皮穿刺介入，应用于靠近皮肤的组织或细胞上，如果要深入人体内部必须借助传统手术暴露出病变器官组织，即在病人身体上开孔放入，病人创伤大、术后恢复慢，由此给医生和病患都带来不便。
发明内容
本发明要解决的技术问题和提出的技术任务是克服在先申请公开的使用介入导管深入体内射频消融治疗效果有限，注射药液难度大、沿途损耗高；现有脉冲电场治疗设备只能应用靠近皮肤的组织或细胞，深入人体内部需要做开放性创口，带来诸多不便等问题，本发明提供了一种可协同给药的电脉冲消融装置，所述消融装置可以利用介入导管无创进入人体内部，并对病患的肿瘤组织做脉冲消融，然后利用前述消融使肿瘤组织致密度降低，细胞渗透性增强，药物送到肿瘤组织后更易渗透进入肿瘤细胞，提高对肿瘤的治疗效果。
本发明解决技术问题采用的技术方案：一种可协同给药的电脉冲消融装置，包括两端敞口的介入导管和接在导管后端的操作手柄，其特征是所述介入导管的管腔内设置两个电极和/或药物输送管，所述两个电极均为镍钛记忆合金制成的细针，细针自前端部向后形成长度为T2的放电工作段，两个电极各自的放电工作段可在推出介入导管前端口后弹性展开并平行相对，两放电工作段的平行间距为D2，自放电工作段向后的细针表面包裹绝缘层，两个电极尾端向后穿出介入导管接操作手柄，所述操作手柄可外接脉冲发生器，操作手柄可驱动两个电极前移伸出或缩回介入导管；所述操作手柄可驱动药物输送管前移伸出或缩回介 入导管以及施放药物；所述药物输送管前端设药物存放区。
本发明可以在病人身上无创或微创介入，直接借助现有内窥镜工作通道使介入导管经人体自然腔道深入体内，然后用高压脉冲对肿瘤部位进行消融，利用电脉冲作用在肿瘤细胞上，使原来的坚硬组织变的较为松软，细胞渗透性增大，然后将药物存放区的药物送到前述脉冲消融后的肿瘤细胞，药物更易进入肿瘤细胞内，进而提高肿瘤治疗效果；药物位于介入导管前端即伸入端的药物存放区，送药距离短，没有沿介入导管一路输送造成的大量损耗。两个电极均采用镍钛记忆合金制成，使用操作手柄驱动两个电极前移推出介入导管后利用记忆合金的形状记忆效应弹性展开保持一定间隙平行相对，两平行电极之间通电后可形成强度均匀的电场完成脉冲消融，有效缩短消融时间，增加单次插入的消融面积，治疗效果好，两个电极在工作中需要接高压电脉冲发生器，高压电脉冲发生器为现有技术，放电完成后使用操作手柄再将两个电极抽回介入导管中，利用介入导管的管腔束缚收纳两个电极到初始形状；药物可以提前放置在药物输送管前端的药物存放区，前述消融完成后两个电极抽回介入导管，药物输送管前移推出介入导管，药物存放区移至消融后的肿瘤组织所在位置施放药物，这里药物存放区所在的药物输送管前端定义为药物输送管的远端，定义药物输送管后端为近端，药物直接在远端的药物存放区随介入导管进入人体内部，后续送达肿瘤部位输送距离短，避免药物沿途输送造成的损耗浪费，操作手柄在近端工作驱动药物输送管前移推出或抽回介入导管。
作为对上述技术方案的进一步完善和补充，本发明采用如下技术措施：所述两个电极的放电工作段端部均为尖端；所述药物存放区为药物输送管前端部敞口形成的吸附口，药物输送管内设有可刺破胶囊外壳的导丝，所述导丝向后穿设于操作手柄上的导丝接口，操作手柄上设连通药物输送管的气泵接口。由于两个电极的放电工作段端部均为尖端，方便在影像设备辅助下穿透人体腔壁刺入隔壁的肿瘤组织内部，在肿瘤组织内部进行脉冲消融，消融效果更好；通过气泵接口可以将药物输送管内空气抽出，以产生负压，在吸附口吸住存放于此的药物，方便药物随药物输送管推出送至肿瘤组织部位，这里气泵接口也可以直接连针筒进行抽气；这里药物需采用胶囊结构，胶囊可以存储固态粉末或液态药液，施放药物时只要在操作手柄的导丝接口推动导丝向前伸出药物输送管刺破胶囊就能施放药物。
所述吸附口为外大内小的喇叭口。外大内小的喇叭口可以增大和胶囊药物的接触面积，提高胶囊吸附的稳定性，避免两者吸附接触面积过小造成胶囊提前脱落影响正常使用。
所述两个电极的放电工作段端部均为尖端；药物输送管内设有可刺破胶囊外壳的导丝，所述导丝向后穿设于操作手柄上的导丝接口，操作手柄上设连通药物输送管的气泵接 口，药物输送管前端设尖端，所述尖端内设孔道连通药物输送管，尖端小径端开孔形成药物投送口并连通所述孔道，尖端大径端对接药物输送管并连通所述孔道，与尖端对接的药物输送管管腔作为所述药物存放区。两个电极的放电工作段端部均为尖端，利于刺入肿瘤组织内部，在肿瘤组织内部进行脉冲消融，消融效果更好；药物输送管前端设置的尖端作用也是刺入肿瘤组织，然后通过尖端内部孔道将药物输送管里的药物直接送入肿瘤组织内部，导丝用于刺破胶囊释放内部药粉，然后用气泵向药物输送管输气使药粉吹出进入肿瘤组织，这里药物需采用胶囊结构，在导丝接口推动导丝前移伸出或缩回药物输送管；药物可以存放在药物输送管的管腔内。
所述尖端与药物输送管一体成型，所述药物输送管在对应尖端一侧的管段上设置连通管腔的径向孔道，所述径向孔道向外延伸至管段外表面并形成装药孔；或者所述尖端为独立构件，与药物输送管螺纹连接或粘结，所述药物输送管在对应尖端一侧的管段上环绕设置径向连通管腔的施放孔道，所述施放孔道向外延伸至管段外表面。径向通道可以存储药物，装药孔用于向前述径向通道内填塞药物胶囊，此时尖端和药物输送管采用一体成型的结构，药物同时从尖端的孔道和药物输送管的装药孔向外施放；或者尖端是分体的独立构件，通过螺纹连接或粘结固定在药物输送管前端，在尖端和药物输送管对接前将药物预先从药物输送管端口塞入，药物同时从尖端的孔道和药物输送管的施放孔道向外施放。
所述介入导管的管腔分隔成三个相互独立的隔腔分别穿设两个电极和药物输送管。介入导管的管腔分隔成三个独立隔腔，两个电极和药物输送管三者分别穿入这三个隔腔中，只需使用一根介入导管一次穿入人体就能完成脉冲电场消融肿瘤组织和后续给药治疗。
所述介入导管的管腔为单腔结构，所述两个电极或药物输送管择一穿设在管腔中。介入导管为单腔结构，一次只能穿入两个电极，或者一个药物输送管，使用时一根介入导管要分两次先后穿入完成消融和给药，其中第一次穿入两个电极，用完以后抽出；第二次穿入药物输送管进行给药。
所述介入导管的管腔为单腔结构，所述两个电极或药物输送管择一穿设在管腔中；所述操作手柄上设连通药物输送管的气泵接口，药物输送管前端套置一可膨胀的气囊，所述药物输送管在穿过气囊的管段侧壁设开孔，所述气囊外壁上可粘附药物作为药物存放区；所述两个电极的放电工作段前端部固定在一锥形的引导件上，所述引导件的大径端和介入导管管径相配，所述两个电极在引导件后方设置一使两者紧靠限位的电极固定件，所述两个电极各自的放电工作段位于引导件和电极固定件之间。介入导管仍然采用单腔结构，一次只能穿入两个电极，或者一个药物输送管，分两次向后完成脉冲消融和给药；给药时先推出药物输 送管，用气泵向药物输送管输气，当气囊鼓起后粘附于气囊外表面的药物贴服于肿瘤组织上，给药完成后药物输送管抽气，气囊恢复原状随药物输送管抽回介入导管内；由于两个电极的放电工作段两端分别接引导件和电极固定件，引导件和电极固定件之间两个放电工作段可以贴合肿瘤组织，适用于肿瘤组织在途径通道周围壁上的消融治疗，两个电极在放电工作段两头的电极表面都有绝缘层。
本发明可以在病人身上无创或微创介入，直接借助现有内窥镜工作通道使介入导管经人体自然腔道深入体内，然后用高压脉冲对肿瘤部位进行消融，利用电脉冲作用在肿瘤细胞上，使原来的坚硬组织变的较为松软以增大细胞的渗透性，然后将药物存放区的药物送到前述脉冲消融后的肿瘤细胞，药物更易进入肿瘤细胞内，进而提高肿瘤治疗效果。
附图说明
图1：实施例1结构示意图。
图2：实施例1介入导管剖视图。
图3：实施例1介入导管本体径向截面示意图。
图4：实施例1正电极示意图。
图5：实施例1工作示意图。
图6：实施例2药物输送管示意图一。
图7：实施例2药物输送管示意图二。
图8：实施例2电极输送示意图。
图9：实施例2工作示意图。
图10：实施例3示意图。
图中：1.介入导管、2.操作手柄、3.电极、4.电极、5.药物输送管、51.径向孔道、6.气泵接口、7.吸附口、8.导丝、9.尖端、91.孔道、92.药物投送口、10.气囊、11.引导件、12.电极固定件、13.绝缘层、14.电极腔、15.送药腔、16.药物胶囊、17.人体腔壁、18.肿瘤组织、19.导丝接口、20.装药孔、21.施放孔道。
具体实施方式
下面结合附图说明和具体实施方式对本发明做进一步的说明。
实施例1如图1～5所示，一种可协同给药的电脉冲消融装置，包括两端敞口的介入导管1和接在导管后端的操作手柄2，其中介入导管1的管腔分隔成三个相互独立的隔腔分别穿设电极3和电极4以及药物输送管5，三个隔腔分别是两个电极腔14和一个送药腔15；所述两个电极均为镍钛记忆合金制成的细针，细针自前端部向后形成长度为T2的放电 工作段，两个电极的放电工作段端部均为尖端，两个电极各自的放电工作段可在推出介入导管1前端口后弹性展开并平行相对，两放电工作段的平行间距为D2，自放电工作段向后的细针表面包裹绝缘层13，两个电极尾端向后穿出介入导管1接操作手柄2，所述操作手柄2可外接脉冲发生器，操作手柄2可驱动两个电极前移伸出或缩回介入导管1；所述操作手柄2可驱动药物输送管5前移伸出或缩回介入导管1以及施放药物；所述药物输送管5前端设药物存放区，本实施例中的药物存放区为药物输送管5前端部敞口形成的外大内小的喇叭状吸附口7，药物输送管5内设有可刺破胶囊外壳的导丝8，所述导丝8向后穿设于操作手柄2上的导丝接口19，操作手柄2上设连通药物输送管5的气泵接口6。
本发明只需使用一根介入导管一次穿入人体就能完成脉冲电场消融肿瘤组织和后续给药治疗。工作时，借助影像设备的帮助，介入导管由内窥镜工作通道深入人体内部靠近肿瘤组织，使用操作手柄驱动两个电极前移推出介入导管，两个电极按照设定形状记忆弹性展开平行相对，然后刺入肿瘤组织，保持一定间隙通电后对肿瘤组织脉冲消融，两个电极的金属细针接高压电脉冲发生器，高压电脉冲发生器为现有技术，消融完毕后使用操作手柄再将两个电极抽回介入导管中，利用介入导管的管腔束缚收纳两个电极到初始形状；药物为提前放在吸附口的药物胶囊16，利用气泵或针筒抽气在药物输送管内产生负压，吸住存放于此的药物胶囊，推出药物输送管将胶囊送至消融后的肿瘤组织位置，使用导丝刺破胶囊施放内部的药粉或药液于消融后的肿瘤组织上，药物无需穿过整个介入导管进入人体内部，后续送达肿瘤部位输送距离短，避免药物沿途输送造成的损耗浪费；气泵接口用于连接气泵或针筒对药物输送管抽气产生负压。此外，本实施例所述的介入导管也可以采用单腔结构，一次只能穿入两个电极或者一个药物输送管，使用时一根介入导管要分两次先后穿入完成消融和给药，其中第一次穿入两个电极做脉冲消融，用完以后抽出两个电极，再穿入药物输送管进行给药治疗。
实施例2如图6～9所示，一种可协同给药的电脉冲消融装置，和实施例1的区别之处在于所述两个电极的放电工作段端部均为尖端；药物输送管5内设有可刺破胶囊外壳的导丝8，所述导丝8向后穿设于操作手柄2上的导丝接口19，操作手柄2上设连通药物输送管5的气泵接口6，药物输送管5前端设尖端9，所述尖端9内设孔道91连通药物输送管5，尖端9小径端开孔形成药物投送口92并连通所述孔道91，尖端9大径端对接药物输送管5并连通所述孔道91，与尖端9对接的药物输送管5管腔作为所述药物存放区。
如图6所示，所述尖端9与药物输送管5一体成型结构，药物输送管5在对应尖端9一侧的管段上设置连通管腔的径向孔道51，所述径向孔道51向外延伸至管段外表面并形成 装药孔20；或者如图7所示，所述尖端9为独立构件，与药物输送管5螺纹连接或粘结，所述药物输送管5在对应尖端9一侧的管段上环绕设置径向连通管腔的施放孔道21，所述施放孔道21向外延伸至管段外表面；其余部分与实施例1基本相同。本实施例所述的介入导管管腔也可采用单腔结构，同一根介入导管要分两次先后穿入两个电极和药物输送管完成消融和给药，两个电极穿入介入导管时如图8所示。
工作时，实施例2和实施例1的区别之处在于药物施放方式不同，同样在影像设备帮助下介入导管进入人体靠近肿瘤组织，两个电极推出介入导管穿透人体腔壁刺入隔壁的肿瘤组织内部进行脉冲消融，药物输送管前端设置的尖端也是为了方便刺入肿瘤组织，然后通过尖端内部孔道将药物输送管里的药物直接送入肿瘤组织内部，具体是导丝刺破胶囊施放内部药物胶囊里的药物，再用气泵向药物输送管输气，辅助药粉/药液吹出深入肿瘤组织内部，这里药物也需要采用药物胶囊；图6和图7所示药物有两种不同存放和施放方式，第一种是药物胶囊从装药孔塞入径向孔道内，药物从装药孔和药物投送口向外施放，第二种是药物胶囊在尖端对接药物输送管之前从药物输送管端口塞入，药物从药物投送口和施放孔道向外施放。
实施例3如图10所示，一种可协同给药的电脉冲消融装置，和实施例1的区别之处在于所述介入导管的管腔为单腔结构，所述两个电极3和4或药物输送管5择一穿设在管腔中；所述操作手柄2上设连通药物输送管5的气泵接口6，药物输送管5前端套置一可膨胀的气囊10，输送管内没有导丝，所述药物输送管5在穿过气囊10的管段侧壁设开孔，所述气囊10外壁上可粘附药物作为药物存放区；所述两个电极的放电工作段前端部固定在一锥形的引导件11上，所述引导件11的大径端和介入导管1管径相配，所述两个电极在引导件11后方设置一使两者紧靠限位的电极固定件12，引导件11和电极固定件12之间的电极段包含两个电极各自的放电工作段，放电工作段两头的电极表面都有绝缘层。
本实施例适用于肿瘤组织在途径通道周围壁上的消融治疗。工作时锥形引导件沿着人体腔壁7引导介入导管4到达肿瘤组织8所在位置，然后抽回介入导管同时推出两个电极，两个电极在推出介入导管后弹性展开并平行相对，锥形引导件和电极固定件之间的两个放电工作段贴合肿瘤组织，通电消融完毕后两个电极抽回介入导管重新收拢约束于介入导管的管腔中；然后推出药物输送管，用气泵向药物输送管输气，药物输送管内的气体经侧壁开孔进入气囊中使气囊鼓起，气囊在鼓起之前干瘪状态下可以通过褶皱等存储药物，当气囊鼓起后粘在气囊上的药物抖落到消融后的肿瘤组织上，给药完成后药物输送管抽气，气囊恢复原状随药物输送管抽回介入导管内。

Claims (8)

  1. 一种可协同给药的电脉冲消融装置，包括两端敞口的介入导管(1)和接在导管后端的操作手柄(2)，其特征是所述介入导管(1)的管腔内设置两个电极(3,4)和/或药物输送管(5)，所述两个电极(3,4)均为镍钛记忆合金制成的细针，细针自前端部向后形成长度为T2的放电工作段，两个电极(3,4)各自的放电工作段可在推出介入导管(1)前端口后弹性展开并平行相对，两放电工作段的平行间距为D2，自放电工作段向后的细针表面包裹绝缘层(13)，两个电极(3,4)尾端向后穿出介入导管(1)接操作手柄(2)，所述操作手柄(2)可外接脉冲发生器，操作手柄(2)可驱动两个电极(3,4)前移伸出或缩回介入导管(1)；所述操作手柄(2)可驱动药物输送管(5)前移伸出或缩回介入导管(1)以及施放药物；所述药物输送管(5)前端设药物存放区。
  2. 根据权利要求1所述的可协同给药的电脉冲消融装置，其特征是所述两个电极(3,4)的放电工作段端部均为尖端；所述药物存放区为药物输送管(5)前端部敞口形成的吸附口(7)，药物输送管(5)内设有可刺破胶囊外壳的导丝(8)，所述导丝(8)向后穿设于操作手柄(2)上的导丝接口(19)，操作手柄(2)上设连通药物输送管(5)的气泵接口(6)。
  3. 根据权利要求2所述的可协同给药的电脉冲消融装置，其特征是所述吸附口(7)为外大内小的喇叭口。
  4. 根据权利要求1所述的可协同给药的电脉冲消融装置，其特征是所述两个电极(3,4)的放电工作段端部均为尖端；药物输送管(5)内设有可刺破胶囊外壳的导丝(8)，所述导丝(8)向后穿设于操作手柄(2)上的导丝接口(19)，操作手柄(2)上设连通药物输送管(5)的气泵接口(6)，药物输送管(5)前端设尖端(9)，所述尖端(9)内设孔道(91)连通药物输送管(5)，尖端(9)小径端开孔形成药物投送口(92)并连通所述孔道(91)，尖端(9)大径端对接药物输送管(5)并连通所述孔道(91)，与尖端(9)对接的药物输送管(5)管腔作为所述药物存放区。
  5. 根据权利要求4所述的可协同给药的电脉冲消融装置，其特征是所述尖端(9)与药物输送管(5)一体成型，所述药物输送管(5)在对应尖端(9)一侧的管段上设置连通管腔的径向孔道(51)，所述径向孔道(51)向外延伸至管段外表面并形成装药孔(20)；
    或者所述尖端(9)为独立构件，与药物输送管(5)螺纹连接或粘结，所述药物输送管(5)在对应尖端(9)一侧的管段上环绕设置径向连通管腔的施放孔道(21)，所述施放孔道(21)向外延伸至管段外表面。
  6. 根据权利要求1至5之一所述的可协同给药的电脉冲消融装置，其特征是所述介入导管(1)的管腔分隔成三个相互独立的隔腔分别穿设两个电极(3，4)和药物输送管(5)。
  7. 根据权利要求1至5之一所述的可协同给药的电脉冲消融装置，其特征是所述介入导管(1)的管腔为单腔结构，所述两个电极(3，4)或药物输送管(5)择一穿设在管腔中。
  8. 根据权利要求1所述的可协同给药的电脉冲消融装置，其特征是所述介入导管(1)的管腔为单腔结构，所述两个电极(3，4)或药物输送管(5)择一穿设在管腔中；所述操作手柄(2)上设连通药物输送管(5)的气泵接口(6)，药物输送管(5)前端套置一可膨胀的气囊(10)，所述药物输送管(5)在穿过气囊(10)的管段侧壁设开孔，所述气囊(10)外壁上可粘附药物作为药物存放区；所述两个电极(3，4)的放电工作段前端部固定在一锥形的引导件(11)上，所述引导件(11)的大径端和介入导管(1)管径相配，所述两个电极(3，4)在引导件(11)后方设置一使两者紧靠限位的电极固定件(12)，所述两个电极(3，4)各自的放电工作段位于引导件(11)和电极固定件(12)之间。
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