RU2740699C2 - Sterile disposable bipolar ablation needle, associated system, and method of use - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: sterile disposable bipolar ablation needle contains an external electrode, an internal electrode which is located inside the external electrode, and insulating layer, which is located between inner and outer electrodes. First open area of the needle is located next to its proximal end, is configured to provide contact with connector and comprises first open part of inner electrode and first open part of outer electrode. Second open area of the needle is located near its distal end, forms an active area and contains the second open part of the internal electrode and the second open part of the external electrode. Second open part of inner electrode has first sharpening angle making 12°±2°.

EFFECT: enabling more reliable and stable electric contact of the needle with working electrodes owing to larger surface area of the contact surface, improved ergonomic and operational characteristics, simplified manufacturing technology, easier piercing procedure, which makes the entire procedure less painful and more tolerable for the patient; in addition, the configuration of the working area of the needle enables to localize the ablation region and thereby minimizing peripheral injuries of the surrounding healthy tissues.

11 cl, 10 dwg

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[001] This application is a partial continuation of the application at serial number 15/188952, entitled "Disposable Bipolar Coaxial Radio Frequency Ablation Needle, System and Method" and filed June 21, 2016, the contents of which are incorporated herein by reference in full.

FIELD OF TECHNOLOGY

[002] Embodiments of the invention generally relate to electrical surgical (or electrosurgical) instruments, and in particular to sterile disposable bipolar ablation instruments (eg, needles), as well as systems and methods for their use.

LEVEL OF TECHNOLOGY

[003] A common treatment for malignant tumors in human organs, such as nodules in the thyroid gland or renal tumors in the kidney, is the surgical removal of most of the corresponding organ tissue. For example, thyroidectomy can be performed to treat thyroid cancers, which, unfortunately, removes most of the thyroid tissue. In addition, having thyroid surgery often presents risks such as nerve damage or damage to the parathyroid glands, and may require the patient to take thyroid hormone supplements after surgery. For non-malignant tumors, alternatives to thyroidectomy are known in the art, including radio frequency (RF) ablation techniques, in which the temperature of the target tissue can be raised to 60 ° C or higher.

[004] For example, Holmer et al. evaluated ablation techniques, as reported in Bipolar Radiofrequency Ablation for Nodular Thyroid Disease - ex Vivo and in Vivo Evaluation of a Dose-Response Relationship, J. Surg. Res. 2009 Oct. 29. A study of percutaneous RF ablation of benign thyroid nodules has also been described by Kim et al. in "Radiofrequency Ablation of Benign Cold Thyroid Nodules: Initial Clinical Experience", Thyroid, 2006 April, 16 (4): 361-7. Kim et al. reported that the ablation electrode used was internally cooled and that most patients required conscious sedation while undergoing the ablation procedure.

[005] While RF devices are known in the art suitable for, for example, ablation applications, most such devices require a long period of use, ranging from five to ten minutes per session. This period of time makes it impractical to use a conventional RF device in the treatment of thyroid nodules, in particular, because the thyroid gland will move with the patient's swallowing movements. There may be a need for an electrosurgical, electrocautery, or percutaneous ablation instrument that can remove cancerous tissue or tumor relatively quickly.

[006] Existing high frequency ablation (HFA) treatments typically involve either monopolar or bipolar treatments. To one degree or another, each of these methods has certain limitations determined by the physical characteristics of the ablation instrument.

[007] For example, in a monopolar method, the patient electrode must have constant reliable electrical contact with the patient's body, which in some cases is not always easy to provide or is not always convenient. Meanwhile, high-frequency currents flowing through the patient's body from the patient's electrode to the active electrode usually pass through large areas of healthy tissues and can have additional undesirable effects on these tissues. In addition, there may be a potential negative effect of these currents, for example on a pacemaker.

[008] Bipolar ablation requires two electrodes located close to each other to affect only the part of the body that is between these electrodes. Unlike monopolar ablation, the bipolar method allows you to limit the effect of electric current only on the “area of interest”, and also significantly reduce the exposure time to achieve the desired result (coagulation area). In general, a bipolar ablation instrument is used to work on a visible surface. Alternatively, special instruments with thin parallel conducting electrodes (needles) are used, which create the possibility of affecting the internal regions, such as, for example, the instrument described in patent BY 19188 C1 2015.06.30 and used in the treatment of thyroid neoplasms. Nevertheless, the relative bulkiness of the instrument and the presence of two needles with a protruding insulator edge on each electrode makes it difficult to penetrate and control their position in the affected area, increase the size of the wound, and can lead to undesirable emotions in the patient.

[009] In addition, the instruments mentioned above may be difficult to sterilize and may not be suitable as a disposable instrument (eg, single use).

SUMMARY OF THE INVENTION

[0010] Some embodiments may include a sterile disposable bipolar ablation needle having an outer conductor and an inner conductor separated by an insulating layer disposed between the inner conductor and the outer conductor, with the outer conductor exposed and not covered with an insulating layer. The sterile disposable bipolar ablation needle may further have a first open area of the sterile disposable bipolar ablation needle located adjacent to the proximal end of the sterile disposable bipolar ablation needle, the first open area comprising a first exposed portion of the inner electrode and a first exposed portion of the outer electrode, the first an open area is configured to provide contact with the connector, and a second open area of the sterile disposable bipolar ablation needle located adjacent to the distal end of the sterile disposable bipolar ablation needle, the second open area forming an active area of the sterile disposable bipolar ablation needle and containing a second open part of the inner conductor and a second exposed part of the outer conductor.

[0011] The sterile disposable bipolar ablation needle may also comprise a connector coupled to the sterile disposable bipolar ablation needle and comprising a first contact contacting the first exposed portion of the outer conductor and a second contact contacting the first exposed portion of the inner conductor. The inner guide and the outer guide can be made of stainless steel, similar to that used for surgical needles and in a similar manner to that used for surgical needles.

[0012] The insulating inner dielectric layer can be formed from medical varnish or other suitable material. The length of the second exposed portion of the inner electrode may be about 7 mm and the length of the second exposed portion of the outer electrode may be about 7 mm.

[0013] The first open portion may comprise an open portion of the first insulating layer. The second open portion may comprise an open portion of the first insulating layer. The inner needle diameter can be about 0.5 mm. The outer needle can be about 0.9 mm in diameter.

[0014] Some embodiments may include a high frequency ablation system comprising an electrosurgical generator and a coaxial bipolar ablation instrument (as described above). The system may also comprise a connecting cable having a first end adapted to connect to an instrument and a second end adapted to connect to an electrosurgical generator; a power supply connected to the electrosurgical generator; and a control switch connected to the electrosurgical generator.

[0015] The system may also comprise a connector coupled to the instrument and having a first contact contacting a first exposed portion of the outer needle and a second contact contacting a first exposed portion of the inner needle. The inner needle and outer needle can be formed from stainless steel surgical needles, similar to those used for lumbar puncture and spinal anesthesia.

[0016] The insulating layer can be formed from a medical varnish. The second open area of the inner needle can be about 7 mm and the second open part of the outer needle can be about 7 mm.

[0017] The first open portion may comprise an open portion of the first insulating layer. The second open portion may comprise an open portion of the first insulating layer.

[0018] The diameter of the inner needle may be about 0.5 mm. The outer needle can be about 0.9 mm in diameter.

[0019] Some embodiments may include a method for removing tissue from a patient, comprising the steps of: obtaining an instrument comprising a first electrode assembly and a second electrode assembly held in a handle, the handle holding a first electrode section generally parallel to a second electrode section, to define a substantially linear bipolar ablation zone between a portion of the first electrode assembly and a portion of the second electrode assembly, the bipolar ablation zone being offset and aligned substantially parallel to the axis of the handle; introducing the bipolar ablation zone into the patient's body near the area containing the tissue; determine that part of the tissue is located within the zone of bipolar ablation; energizing the first electrode assembly and the second electrode assembly for a predetermined period of time to create a predetermined level of ablative RF power in the bipolar ablation zone; and the bipolar ablation zone is removed from the patient's body.

[0020] Additional features and advantages of the disclosed subject matter are set forth in the detailed description that follows and / or becomes apparent to those skilled in the art.

BRIEF DESCRIPTION OF THE GRAPHIC MATERIALS

[0021] FIG. 1 is a schematic diagram of an exemplary sterile disposable bipolar ablation needle with an aspiration needle and a sterile cap in place, in accordance with some embodiments.

[0022] FIG. 2A illustrates a schematic diagram of an exemplary sterile disposable bipolar ablation needle in accordance with some embodiments of the invention.

[0023] FIG. 2B is a schematic diagram of an exemplary sterile disposable bipolar ablation needle showing details of electrodes and a working area in accordance with some embodiments of the invention.

[0024] FIG. 3 is a schematic diagram of an exemplary thin probe for use with a sterile disposable bipolar ablation needle in accordance with some embodiments of the invention.

[0025] FIG. 4 is a schematic diagram of an exemplary sterile coating for a sterile disposable bipolar ablation needle, in accordance with some embodiments of the invention.

[0026] FIG. 5 is a diagram showing details of the working area of an exemplary disposable sterile bipolar ablation needle in accordance with some embodiments of the invention.

[0027] FIG. 6 is a schematic diagram showing an exemplary electrical connection to a sterile disposable bipolar ablation needle, in accordance with some embodiments of the invention.

[0028] FIG. 7 is a schematic diagram showing an exemplary electrical connection to a sterile disposable bipolar ablation needle, in accordance with some embodiments of the invention.

[0029] FIG. 8 is a schematic diagram showing an exemplary electrosurgical environment in accordance with some embodiments of the invention.

[0030] FIG. 9 illustrates a flow diagram of an exemplary electrosurgery method in accordance with some embodiments of the invention.

DETAILED DESCRIPTION OF THE INVENTION

[0031] Some embodiments of the invention may include a bipolar radiofrequency (RF) ablation instrument, an electrosurgical or electrocoagulation instrument (eg, a sterile disposable bipolar ablation needle) capable of percutaneously ablating tissue within a human tissue structure such as a nodular goiter or volumetric kidney formation. A sterile, disposable bipolar ablation needle can be inserted through a patient's skin into a nodular goiter or renal cell carcinoma under the guidance of an imaging system (eg, an ultrasound system). Activating the sterile disposable bipolar ablation needle is designed to rapidly destroy cancerous tissue (eg, neoplasm).

[0032] In some embodiments, an uncoated, 12 ° sharpened, sterile disposable bipolar ablation exit guidewire may be used. According to tests carried out by the inventor of the disclosed subject matter, these features make it much easier for a physician to pierce the skin and thyroid capsule of a patient. As a result, the entire procedure becomes less painful and more bearable for the patient.

[0033] In addition, since no coating is required on the outer lead of the sterile disposable bipolar ablation needle, the manufacturing process becomes simpler and less costly, and is also better suited for batch production.

[0034] The configuration of the working area of the sterile disposable bipolar ablation needle allows localization of the ablation site and thus minimizing peripheral damage to surrounding healthy tissue.

[0035] FIG. illustrated is a schematic diagram of an exemplary sterile disposable bipolar ablation needle system 100 comprising a sterile disposable bipolar ablation needle 102, a protective cap 104 to protect and maintain sterility of a sterile disposable bipolar ablation needle, and a thin probe 106.

[0036] FIG. 2A is a schematic diagram of an exemplary sterile disposable bipolar ablation needle 102 comprising a fine probe adapter 202, a handle 204, and a needle 206. The fine probe adapter 202 is a cannula for connection to a suction syringe.

[0037] FIG. 2B is a schematic diagram of an exemplary sterile disposable bipolar ablation needle 102 showing details of electrodes and working area. In particular, the sterile disposable bipolar ablation needle 102 includes a working area 208 that has a portion of the outer electrode 210, an open portion of the inner electrode 212, and an open portion of the inner dielectric layer 214. The portion of the outer electrode 210 may have a length of about 1-15 mm, the open portion the inner electrode 212 may be about 1-15 mm long and the exposed portion of the dielectric 214 may be about 1-2 mm long. In some embodiments of the invention, the maximum outer diameter of the working area of the tool should be no more than 0.9 mm. The length of the working area can be from 3 to 32 mm. The maximum immersion depth (that is, the distance from the male connector to the end of the needle) can be no more than 60 mm.

[0038] Section 216 can have a length that depends on the length of the working area, and can be from about 46 mm to 75 mm. Section 218 may be about 2 mm long. Section 220 may be about 10 mm long.

[0039] The sterile disposable bipolar ablation needle 102 contains an inner electrode 222, which is a needle-shaped electrode with a hollow inner portion and an inner diameter of about 0.5 mm. The sterile disposable bipolar ablation needle 102 also includes an outer electrode 224 having an inner diameter of about 0.9 mm. The sterile disposable bipolar ablation needle 102 also includes an inner dielectric layer 226 located between the inner electrode 222 and the outer electrode 224. In some embodiments, the dielectric layer 226 may provide an insulation resistance R between the outer and inner needles (electrodes) of at least about 3 kΩ.

[0040] FIG. 3 is a schematic diagram of an exemplary thin probe 106 including a thin probe connector 302 and a needle portion 306 of the thin probe. A thin probe 106 may be used during the procedure to facilitate aspiration of fluid prior to the ablation procedure. The thin probe 106 can be freely inserted into the hole of the inner needle 102 and has a holder for easy removal from the hole of the needle. The thin probe 106 is optional; sterile disposable bipolar ablation needle 102 can be used alone. Typically, the thin probe 106 is removed prior to starting the ablation procedure to aspirate the fluid component of the assembly. The ablation procedure can also be performed with a thin probe 106.

[0041] FIG. 4 is a schematic diagram of an exemplary sterile cover 104 having a first cap portion 402 and a second cap portion 404, the diameter of the first cap portion 402 being greater than the diameter of the second cap portion 404.

[0042] FIG. 5 is a diagram showing details of the working area 208 of an exemplary sterile disposable bipolar ablation needle 206, in accordance with some embodiments of the invention. In particular, in FIG. 5 illustrates an outer needle-shaped electrode 502 (210 in accordance with FIG. 2B), a needle-shaped inner dielectric layer 504 (214 in accordance with FIG. 2B), and an inner electrode 506 (212 in accordance with FIG. 2B). The inner electrode 506 includes a hollow inner space 508 that is configured to receive a thin probe (eg, 106). The working area of the sterile disposable bipolar ablation needle 206 includes a first sharpening angle 510 of the internal electrode. The first sharpening angle 510 can be about 12 ° ± 2 ° for the long-cut embodiment or 18 ° ± 2 ° for the short-cut embodiment. The working area of the sterile disposable bipolar ablation needle 206 includes a second sharpening angle 512 of the internal electrode. The second sharpening angle 512 can be in the range of about 20-90 ° and can be chamfered. In some embodiments of the invention, the maximum diameter of the working area of the tool should be no more than 0.9 mm. In some embodiments of the invention, the length of the working area can be from about 3 mm to 32 mm.

[0043] In some embodiments, the maximum immersion depth (eg, the distance from the male connector to the tip of the needle) may be no more than about 60 mm.

[0044] FIG. 6 is a schematic diagram of an exemplary sterile disposable bipolar ablation needle 206. A sterile disposable bipolar ablation needle 206 may comprise an inner electrode 222, an outer electrode 224, and an inner dielectric (or insulating) layer 226.

[0045] The sterile disposable bipolar ablation needle 206 has two exposed contact areas: 1) a first open contact area near the proximal end of the sterile disposable bipolar ablation needle 206, where a connector 602 connects to a sterile disposable bipolar ablation needle 206 and a connecting cable, connected to an electrosurgical generator. Connector 602 includes an outer electrode contact 604 and an inner electrode contact 606; and 2) a second exposed contact area at the distal end (eg, the working area) that forms the active portion of the instrument, where RF power is radiated into the tissue. As described above, the sterile disposable bipolar ablation needle 206 may also contain a sterile cap 104 to maintain sterility of the sterile disposable bipolar ablation needle 206 when the connector 602 is attached. The cap 104 can be removed immediately prior to the surgical procedure.

[0046] The inner electrodes and outer electrodes can be made of stainless steel (for example, similar to the material and / or shape of the lumbar puncture needles) of appropriate sizes suitable for a given ablation procedure. The insulating material can be a medically safe material such as Mastersilver from Renfert (a German company), where Mastersilver is a varnish used in prosthetic dentistry, or other suitable medically safe insulating material.

[0047] FIG. 7, an embodiment of the invention is illustrated in which a connector 702 is integrated with a sterile disposable bipolar ablation needle 206, and a connector 704 may be connected to a connector 702 in a sterile disposable bipolar ablation needle 206. This can add to the cost of a sterile disposable bipolar ablation needle 206, but can have advantages such as having an instrument manufactured with a factory-attached connector 702.

[0048] FIG. 8 illustrates a schematic diagram of an exemplary electrosurgical system 800 using a sterile disposable bipolar ablation needle 810, in accordance with some embodiments of the invention. Specifically, system 800 includes a power source 802 (e.g., a 220 V, 50 Hz power source), a control unit 804 with a footswitch, an electrosurgical generator 806, a connecting cable 808, a sterile disposable bipolar ablation needle 810 that can generate power 812, which acts on biological material 814 (eg, tissue).

[0049] Some embodiments of the invention may include a sterile disposable bipolar ablation needle 206 having an outer electrode and an inner electrode. The sterile disposable bipolar ablation needle 206 may also include an insulating layer located between the inner electrode and the outer electrode. The sterile disposable bipolar ablation needle 206 may further comprise a first open region of the instrument located adjacent to the proximal end of the sterile disposable bipolar ablation needle 206, the first open region comprising a first open portion of the inner electrode and a first open portion of the external electrode, the first open region being formed with the possibility of providing contact with the connector, and a second open area of the sterile disposable bipolar ablation needle 206 located adjacent to the distal end of the sterile disposable bipolar ablation needle 206, the second open area forming an active area of the sterile disposable bipolar ablation needle 206 and contains a second open part of the inner electrode and a second exposed part of the outer electrode.

[0050] FIG. 9 is a flow chart showing an exemplary method 900 for operating the sterile disposable bipolar ablation needle illustrated in FIG. 1-7, in accordance with some embodiments of the invention. The method begins at block 902 in which a sterile disposable needle or bipolar ablation instrument (eg, 810) is obtained. If a sterile disposable bipolar ablation needle is not yet connected to the electrosurgical generator, a sterile disposable bipolar ablation needle can be connected to the electrosurgical generator via a connecting cable. The method continues at block 904.

[0051] At block 904, a sterile disposable bipolar ablation needle is introduced into the patient. The method continues at block 906.

[0052] At block 906, upon insertion, the sterile disposable bipolar ablation needle is optionally guided to the desired area using an imaging technique such as ultrasound or the like. The method continues at block 908.

[0053] At block 908, RF power is applied to the instrument. The method continues at block 910.

[0054] At block 910, the RF power delivery is stopped or stopped. The RF power supply can be stopped after a predetermined period of time or after a period of time determined based on the condition of the tissue. The method continues at block 912 where a sterile, disposable bipolar ablation needle is removed from the patient. The sterile disposable bipolar ablation needle may optionally be discarded.

[0055] It should be understood that the description herein is given by way of example only and is intended to provide an overview for understanding the nature and nature of the disclosed subject matter. The accompanying drawings are included to provide a further understanding of various features and embodiments of the method and apparatus, which, together with their description, serve to explain the principles and operation of the disclosed subject matter. Thus, while the disclosed subject matter has been described with reference to specific embodiments or applications, it should be understood that the disclosed subject matter is not limited to the specific structures and methods described herein and / or illustrated in the drawings, but includes any modifications or equivalents. within the scope of the disclosed subject matter.

[0056] Therefore, it will be appreciated that in accordance with various embodiments of the invention disclosed herein, a sterile disposable bipolar ablation needle and associated system and method are provided.

[0057] While the disclosed subject matter has been described in conjunction with a number of embodiments, it will be appreciated that many alternatives, modifications, and variations would be obvious or obvious to those skilled in the art. Accordingly, the applicant intends to cover all such alternatives, modifications, equivalents, and variations that fall within the spirit and scope of the disclosed subject matter.

Claims (17)

1. Disposable sterile bipolar ablation needle containing: outer electrode; an inner electrode located inside the outer electrode; an insulating layer located between the inner electrode and the outer electrode; a first open area of a sterile disposable bipolar ablation needle located adjacent to the proximal end of a sterile disposable bipolar ablation needle, the first open area comprising a first open portion of an inner electrode and a first open portion of an external electrode, the first open area being configured to contact the connector ; and a second open area of the sterile disposable bipolar ablation needle located adjacent to the distal end of the sterile disposable bipolar ablation needle, the second open area forming an active area of the sterile disposable bipolar ablation needle and containing a second open portion of the inner electrode and a second open portion of the outer electrode, the second open part of the inner electrode has a first sharpening angle of 12 ° ± 2 °. 2. The sterile disposable bipolar ablation needle of claim 1, further comprising a connector coupled to the sterile disposable bipolar ablation needle and having a first contact contacting the first exposed portion of the outer electrode and a second contact contacting the first exposed portion of the inner electrode. 3. Sterile disposable bipolar ablation needle according to claim 1, characterized in that the inner electrode and the outer electrode are made of stainless steel. 4. The sterile disposable bipolar ablation needle according to claim 1, wherein the insulating layer is formed from a medical varnish. 5. The sterile disposable bipolar ablation needle according to claim 1, characterized in that the length of the second open area of the inner electrode is in the range from 1 mm to 15 mm, and the length of the second open portion of the outer electrode is in the range from 1 mm to 15 mm. 6. The sterile disposable bipolar ablation needle according to claim 1, wherein the first open portion includes an open portion of the insulating layer. 7. A sterile disposable bipolar ablation needle according to claim 1, wherein the second open portion includes an open portion of the insulating layer. 8. The sterile disposable bipolar ablation needle according to claim 1, wherein the inner diameter of the inner electrode is 0.5 mm. 9. A sterile disposable bipolar ablation needle according to claim 1, characterized in that the outer electrode has a diameter of 0.9 mm. 10. A sterile disposable bipolar ablation needle according to claim 10, wherein the second open portion of the outer electrode includes a second sharpening angle ranging from 20 ° to 90 °. 11. A sterile disposable bipolar ablation needle according to claim 11, characterized in that the second sharpening angle is chamfered.

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