CN117159128B - Ablation device and ablation electrode for steep pulse ablation and/or radio frequency ablation - Google Patents
Ablation device and ablation electrode for steep pulse ablation and/or radio frequency ablation Download PDFInfo
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- CN117159128B CN117159128B CN202311451988.9A CN202311451988A CN117159128B CN 117159128 B CN117159128 B CN 117159128B CN 202311451988 A CN202311451988 A CN 202311451988A CN 117159128 B CN117159128 B CN 117159128B
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Abstract
An ablation device and an ablation electrode usable for steep pulse ablation and/or radio frequency ablation, the electrode comprising at least: an energy delivery unit, an energy application unit, a cold circulation unit, and a sensing member, the energy application unit comprising an electrode needle having at least one first cavity extending along a longitudinal axis of the electrode needle body; a second cavity is arranged in the energy transmission unit, and the distal end part of the second cavity is communicated with the proximal end part of the first cavity; the cold circulation unit is provided with a fluid conveying pipeline which is arranged in the second cavity and is penetrated and extended to a position, close to the tip, of the distal end of the first cavity along the longitudinal axis, and a clearance channel for conveying outflow liquid is arranged between the outer surface of the fluid conveying pipeline and the inner cavity surfaces of the first cavity and the second cavity respectively so as to bring heat energy out of the electrode needle body; the sensing means comprises a temperature and/or position sensor, which is arranged near the distal end of the electrode needle by means of a fluid delivery conduit.
Description
Technical Field
The invention relates to the technical field of medical auxiliary instruments, in particular to an ablation device and an ablation electrode which can be used for steep pulse ablation and/or radio frequency ablation.
Background
In the medical field, steep pulse ablation and radio frequency ablation are two methods widely used for tissue treatment. Steep pulse ablation has high selectivity on the one hand and can accurately ablate target tissues, but the ablation range is usually smaller. On the other hand, radio frequency ablation may cover a wider tissue area, but does not have the ability to selectively ablate.
However, combining both steep pulses and radio frequency ablation on one ablation device (e.g., an electrode or electrode array) can achieve an effect of one plus one to two. By first performing radio frequency ablation, controlling the tissue temperature at a lower level can cause a change in tissue conductivity, providing a wider range of ablation for subsequent steep pulse treatment while maintaining selectivity. The combined design not only improves the treatment effect, but also reduces the medical cost, and brings innovation breakthrough to the medical field.
An energy delivery probe for tissue ablation and method of use is disclosed in U.S. patent No. 9931161B 2. The energy delivery device has at least a first energy delivery member and a second energy delivery member, the first energy delivery member and the second energy delivery member having handle members positioned along a longitudinal axis, each handle member having a proximal end and a distal end. The distal end of the first handle member is releasably coupled to the proximal end of the second handle member, and a portion of each member is defined along the longitudinal axis in coaxially surrounding relation to one another. A method of using the probe includes identifying tissue to be ablated, providing an energy delivery probe, inserting at least a portion of the energy delivery probe into the identified tissue, delivering electrical energy through the energy delivery probe to the identified tissue, and ablating the identified tissue such that at least a first ablation zone is formed. The handle is described in this patent proposal as having a size of about 1 inch to about 2 inches and a diameter of about 0.5 inch to about 0.75 inch, which is not satisfactory for various miniaturized applications of the ablation device.
Disclosure of Invention
A first object of the present invention is to provide an ablation device that can be used for steep pulse ablation and/or radio frequency ablation to solve the prior art problems of dimensions that do not meet the needs of various miniaturized application scenarios of ablation devices.
A second object of the present invention is to provide an ablation electrode.
An ablation device for steep pulse ablation and/or radio frequency ablation comprising at least one electrode comprising at least: an energy delivery unit, an energy application unit, a cold circulation unit, and a sensing member, wherein:
the energy application unit includes an electrode needle having a proximal end and a distal end, the distal end having a tip for applying energy to a target tissue, and the electrode needle having at least one first lumen extending along a longitudinal axis of the electrode needle body;
the energy delivery unit comprising at least a handle member disposed along a longitudinal axis, the handle member having a proximal end and a distal end, the handle member being provided with at least one second lumen disposed along the longitudinal axis, a distal portion of the second lumen being in communication with a proximal portion of the first lumen, the proximal portion being provided with an opening;
the cold circulation unit comprises a fluid conveying pipeline and a fluid outflow channel, wherein the fluid conveying pipeline is arranged in the second cavity, penetrates through the second cavity along the longitudinal axis and extends to a position, close to the tip, of the distal end of the first cavity, a gap channel is arranged between the outer surface of the fluid conveying pipeline and the inner cavity surfaces of the first cavity and the second cavity respectively, the gap channel and the opening form a fluid outflow channel, and fluid is conveyed from the fluid conveying pipeline to the distal end of the first cavity, conveyed out or extracted from the fluid outflow channel so as to carry heat energy generated by applying energy to target tissues out of the electrode needle body;
the sensing member has at least one sensing unit having a distal end with a signal sensing end and a proximal end disposed within the fluid delivery conduit, the distal end extending through the distal end of the fluid delivery conduit along a longitudinal axis, and the signal sensing end disposed proximate the tip.
Preferably, the electrode needle body forms a hollow first cavity, the fluid conveying pipeline is positioned in the first cavity, a first annular gap is formed between the inner wall of the first cavity and the outer wall of the pipeline, a second annular gap is also formed between the inner cavity surface of the second cavity and the outer wall of the fluid conveying pipeline, the gap channel comprises a first annular gap and a second annular gap which are communicated, and the radial size of the second cavity is smaller than 20mm.
Preferably, the fluid delivery tube further comprises a transfer tube and a drainage tube, the transfer tube extends into the second cavity from the proximal side of the second cavity and extends along the longitudinal axis, the drainage tube is connected with the transfer tube in a sealing manner, the transfer tube extends along the longitudinal axis to a position, close to the tip, of the distal end of the first cavity, the second cavity is provided with a liquid outlet tube, and the liquid outlet tube is sleeved on the first cavity formed by the electrode needle body and forms a sealing connection.
Preferably, the handle member further has a driving part attached to at least one outer side of the second cavity, and a power output end of the driving part is connected to the energy application unit and configured to receive an external power input, and the power output end outputs a driving force to drive the energy application unit to slide along a longitudinal axis of a track preset by the energy application unit so as to adjust the energy application execution area to match with the preset energy application area.
Preferably, the energy application unit further comprises an insulating film which is sleeved outside the electrode needle, and the insulating film can be configured for relative movement along the longitudinal axis with respect to the electrode needle.
The driving part may further include a sliding unit fixed to the insulating film, the sliding unit configured to drive the insulating film to relatively move along the longitudinal axis to adjust the working length of the electrode needle, and a limiting unit configured to configure the sliding unit to handle a sliding state or a seizing state.
The electrode comprises an electrode needle array of at least two electrode needles, or the device comprises at least two electrodes and each electrode comprises at least one electrode needle to form the electrode array, the electrode needles of the electrode needle array/the electrode needles of the electrode array are configured to be distributed in parallel to a preset energy application area for energy transfer to the identified tissue to form an ablation area, and a small-spacing needle distribution area can be formed between the electrode needles.
A second object of the present invention is to provide an ablation electrode comprising an energy delivery unit, an energy application unit and a fluid delivery unit, wherein:
the energy application unit includes an electrode needle having a proximal end and a distal end, the distal end having a tip for applying energy to a target tissue, and the electrode needle having at least one first lumen extending along a longitudinal axis of the electrode needle body;
the energy delivery unit comprising at least a handle member disposed along a longitudinal axis, the handle member having a proximal end and a distal end, the handle member being provided with at least one second lumen disposed along the longitudinal axis, a distal portion of the second lumen being in communication with a proximal portion of the first lumen, the proximal portion being provided with an opening;
the fluid conveying unit comprises a fluid conveying pipeline, the fluid conveying pipeline is arranged in the second cavity, penetrates through the second cavity along the longitudinal axis and extends to a position, close to the tip, of the distal end of the first cavity, a gap channel is arranged between the outer surface of the fluid conveying pipeline and the inner cavity surfaces of the first cavity and the second cavity, and fluid is conveyed to the distal end of the first cavity from the fluid conveying pipeline, or flows out of the gap channel or is pumped out from the gap channel.
Compared with the prior art, the invention has at least one of the following technical effects:
the electrode adopts an optimized cold circulation unit, so that the radial size of a handle on the electrode is reduced, and the application range of the electrode is improved. And the electrode can realize two different ablation technologies through one electrode, and the electrode needs to be in a miniaturized design so as to meet the requirement of multi-needle combined ablation. The dimensions of the particular electrodes need to be precisely controlled to achieve a closely spaced parallel arrangement of needles to achieve efficient tissue ablation.
Drawings
In order to more clearly illustrate the technical solution of the embodiments of the present invention, the following description will briefly explain the drawings that are required to be used in the description of the embodiments:
FIG. 1 is an exemplary diagram of an ablation device that may be used for steep pulse ablation and/or radio frequency ablation;
FIG. 2A is an enlarged view of portion II of FIG. 1, FIG. 2B is an enlarged cross-sectional view of portion A-A of FIG. 2A, and FIG. 2C is an enlarged view of portion I of FIG. 1;
FIG. 3 is a schematic illustration of a cold cycle unit;
FIG. 4 is a diagram of an example fluid flow of a cold cycle unit;
FIG. 5 is a diagram showing a partial structural example of an ablation device that may be used for steep pulse ablation and/or radio frequency ablation;
FIG. 6 is an enlarged view of a portion VI of the ablation device of FIG. 5;
FIG. 7 is a side view of a portion of the ablation device VI of FIG. 5;
FIG. 8 is a schematic top view of a portion of an ablation device that may be used for steep pulse ablation and/or radio frequency ablation;
FIG. 9 is a schematic side view of a portion of an ablation device that may be used for steep pulse ablation and/or radio frequency ablation;
FIG. 10 is an enlarged cross-sectional view of a portion V of the ablation device of FIG. 8 that may be used for steep pulse ablation and/or radio frequency ablation;
fig. 11 is a view of a portion IV of the ablation device of fig. 1 that may be used for steep pulse ablation and/or radio frequency ablation.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be further described in detail below with reference to the accompanying drawings and detailed description. It should be understood that the detailed description is presented by way of example only and is not intended to limit the invention.
Ranges may be expressed herein as from "about" to one particular value, and/or to "about" another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms another embodiment. It will also be understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint. The terms "proximal" and "distal" as used herein refer to directions away from and toward, respectively, the tip of the energy delivery probe. The terminology includes the words above specifically mentioned, derivatives thereof and words of similar import.
Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the disclosure are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Furthermore, when ranges of values for the ranges of variation are set forth herein, it is contemplated that any combination of these values, including the recited values, can be used.
The term "radio frequency" or "RF" refers to the current of an ac electrode in the radio frequency range (extending from below 3kHz to about 3kHz gigahertz). In the context of activating a distal structure, such as an electrode, "activating", "activatable" or "activating" refers to applying a stimulus to the structure that is effective to ablate tumor tissue in contact with the structure. Such activation may include RF, microwave or current applied to the electrodes or current applied to the resistive heating element.
The ablation device may be configured for tissue treatment including, but not limited to, pulsed electric field ablation and electroporation ablation. More specifically, the energy delivery electrode needle may be configured to deliver electrical energy to the target tissue in an amount sufficient to ablate the target tissue. In one embodiment, the electrical energy may be radio frequency energy (RF) or an electrical pulse sufficient to reversibly or irreversibly electroporate (IRE) the target tissue.
The inventive process of the present invention will be described first. There is a need in the industry to provide an ablation electrode combining steep pulse and radio frequency ablation, which implements two different ablation techniques by one electrode, and which is required to be of a miniaturized design to accommodate the need of multiple needle combined ablation. The dimensions of the particular electrodes need to be precisely controlled to achieve a closely spaced parallel arrangement of needles to achieve efficient tissue ablation. However, the existing electrode with a handle has a larger radial dimension, and cannot meet the requirements of small focus or irregular focus.
To this end, my company provides an ablation device that can be used for steep pulse ablation and/or radio frequency ablation. Referring to fig. 1 to 3, the electrode includes at least one electrode, the electrode includes: an energy applying unit 10, an energy transporting unit 20, a cold circulation unit, and a sensing member, wherein:
the energy application unit 10 comprises an electrode needle 11, the electrode needle 11 having a proximal end and a distal end, the distal end having a tip 12 for applying energy to a target tissue, and the electrode needle 11 having at least one first cavity 111 extending along a longitudinal axis of the electrode needle body. The distal tip 12 may be sharpened so as to be able to pierce tissue. The tip 12 may have a beveled profile or may have a blunt tip. In other embodiments, the tip 12 may be any shape known in the art such that it is suitably configured to perform energy release, including, but not limited to, minimizing or preventing damage to surrounding cellular structures, and increasing the effectiveness of energy release or the efficiency or accuracy of treatment. In some embodiments, the tip 12 may have a bullet shape or bullet head shape. In other embodiments, the tip 12 may have a circular plane, which may be spherical or non-spherical in nature, or may be oval in shape. Tip 12 may be used with a variety of energy delivery forms and may be used as part of an energy delivery electrode needle 11 for electroporation, thermal or athermal irreversible electroporation, radio frequency ablation, thermoelectric heating, and conventional electrode heating methods using direct or alternating current. The first cavity 111 may be a cavity or channel formed by the electrode needle body, and the distal end of the first cavity 111 is connected to or integrally formed with the tip 12. And, the distal end of the first cavity 111 forms a sealed space near the tip 12. The energy application unit 10 further comprises an insulating film 13, which insulating film 13 is sleeved outside the electrode needle 11, and which insulating film 13 can be configured for a relative movement along the longitudinal axis with respect to the electrode needle 11.
The energy delivery unit 20 comprises at least a handle member 21 arranged along a longitudinal axis, the handle member having a proximal end and a distal end, the handle member 21 being provided with at least one second cavity 211 arranged along the longitudinal axis, the distal end portion of the second cavity 211 being in communication with the proximal end portion of the first cavity 111, the proximal end portion thereof being provided with an opening 35.
The cold circulation unit 30 includes a fluid delivery pipe and a fluid outflow channel, the fluid delivery pipe is provided into the second cavity 211 and extends through along the longitudinal axis to a position where the distal end of the first cavity 111 is close to the tip 12, a gap channel 31 is provided between the outer surface of the fluid delivery pipe and the inner cavity surfaces of the first cavity and the second cavity 211, respectively, the gap channel 31 and the opening 35 form a fluid outflow channel, and fluid is configured to be delivered from the fluid delivery pipe to the distal end of the first cavity 111 and delivered out or extracted from the fluid outflow channel to carry heat energy generated by applying energy to a target tissue out of the electrode needle 11 body. The fluid may be water or the like, which is a liquid capable of heat transfer by flow through a fluid medium.
Referring to fig. 3-4, fig. 3 is a schematic diagram of the cooling circulation unit, and fig. 4 is a schematic diagram of the liquid flow of the cooling circulation unit 30. The electrode needle 11 body itself forms the hollow first cavity 111, the fluid delivery conduit is located in the first cavity 111, and a first annular gap (31 in fig. 2B is a typical first annular gap structure) is formed between the inner wall of the first cavity and the outer wall of the conduit, a second annular gap is also formed between the inner cavity surface of the second cavity 211 and the outer wall of the fluid delivery conduit, and the gap channel includes the first annular gap and the second annular gap which are communicated. The fluid is configured to flow in from the fluid delivery conduit, and because the distal end of the first cavity 111 forms a sealed space near the tip 12, when there is a pressure differential or external force delivery or external force extraction, the fluid easily flows from the first annular gap around to the second annular gap and out through the opening into the external conduit, forming a heat carrying-out channel, and in particular, heat generated during ablation of tissue can be carried out. The flow velocity v of the liquid can be controlled subsequently by controlling the amount of force with which the liquid is delivered or withdrawn. Fig. 3-4 are diagrams of one example of the cooling circulation unit 30. The fluid delivery conduit is a hollow conduit that is positioned in the middle of the first cavity 111 and the first cavity 211, respectively, with its ends fixed to the distal end of the first cavity 111 near the tip 12. Thus, when liquid is delivered from the fluid delivery conduit to the end proximate the tip 12, the liquid can flow or be withdrawn evenly from each annular periphery of the first annular gap, with even force being easier to form better flow rate control, resulting in better cooling.
The fluid delivery tube further comprises a transfer tube 34 and a drainage tube 32, wherein the transfer tube 34 extends into the second cavity 211 from the proximal end side of the second cavity 211 and extends along the longitudinal axis, the drainage tube 32 is in sealing connection with the transfer tube 34, the transfer tube 34 extends along the longitudinal axis to a position, close to the tip 12, of the distal end of the first cavity 111, the second cavity 211 is provided with a liquid outlet tube 33, and the liquid outlet tube 33 is sleeved on the first cavity 111 formed by the electrode needle body 11 and forms sealing connection. In this case, the whole liquid outlet pipe forms the reference pipe body of the handle, the liquid outlet pipe is used as the body of the second cavity 211, the radial length of the liquid outlet pipe is about the basic radial length of the handle of the patent, the arrangement ensures that the ablation electrode of the invention is very small in radial direction and can be smaller than 10mm, and the ablation electrode can be suitable for various small-size application scenes. This is only an example of the invention and, of course, the handle may also comprise a housing, with the associated tube portion of the fluid delivery conduit being disposed therein. In addition, the adaptor tube 34 may extend from the middle of the second cavity 211 (or the liquid outlet tube 33) into the second cavity 211. Only the through holes formed between the adapter tube 34 and the second cavity 211 need be sealed.
In addition, in this example, the fluid delivery pipe and the delivery channel for cooling the liquid with the clearance channel between the inner cavity surfaces of the first cavity 111 and the second cavity 211 are used, and no plastic pipe is required to be added, so that the radial dimension is reduced as much as possible. Moreover, the insulating film 13 may be configured for relative movement along the longitudinal axis with respect to the electrode needle 11 to achieve electrode needle working length adjustability. In this way, the electrode needle is fixed to the cold circulation unit 30, and the positions of the first chamber 111, the second chamber 211 and the fluid transfer pipe are fixed and do not move relatively, so that the electrode with reduced radial dimensions works stably. The radial dimension of the second cavity may be less than 20mm, and in particular implementations, the radial dimension of the second cavity may be 10mm or even less.
The sensing member has at least one sensing unit having a distal end with a signal sensing end and a proximal end disposed within the fluid delivery conduit, the distal end extending through the distal end of the fluid delivery conduit along a longitudinal axis, and the signal sensing end disposed proximate the tip. The sensing unit comprises a temperature sensor 42 and/or a position sensor 41, and if the temperature sensor 42 can acquire real-time temperature, the flow rate is calculated by a formula of Q=AV, wherein Q is the flow rate, A is the inner surface area of the fluid conveying pipeline, V is the flowing speed of the fluid per second, and the unit is cubic meters per second. Q=mc Δt, where Q is heat, m is the mass of the liquid, c is the specific heat of the liquid, and Δt is the change in temperature. According to the delta T required to be achieved in advance, the liquid flow velocity V required by the scheme can be calculated preliminarily, so that the force for conveying liquid or extracting liquid can be controlled adaptively.
Referring to fig. 5-7, in this example, the ablation device for steep pulse ablation and/or radio frequency ablation may further comprise an energy generating unit having a power line 64, the sensing unit including a temperature sensor 42 and a position sensor 41, the power line 64 being in communication with the electrode needle 11, the power line 64 and the temperature sensor 42 being connected by a cable 62 to an electrical terminal, the position sensor 41 being provided with a protective tube 61 near the proximal end of the second cavity to be connected to the electrical terminal.
Referring to fig. 8-11, the handle member further has a driving portion 22, where the driving portion 22 may be attached to at least one outer portion of the second cavity, and a power output end of the driving portion 22 is connected to the energy application unit and configured to receive an external power input from the power input end, and output a driving force from the power output end to drive the energy application unit, so as to slide along a longitudinal axis of a track preset by the energy application unit, so as to adjust the energy application execution area to match with the preset energy application area.
The driving part further comprises a sliding unit 222 and a limiting unit 223, wherein the sliding unit 222 is fixed with the insulating film 13, the sliding unit 222 is configured to drive the insulating film 13 to relatively move along the longitudinal axis so as to adjust the working length of the electrode needle 11, and the limiting unit 223 is used for configuring the sliding unit to process a sliding state or a clamping state.
A cavity outer wall of the second cavity is configured as a joint surface 224, a handle scale groove 225 is disposed on the joint surface 224 along the longitudinal axis, the sliding unit 222 can move along the handle scale groove 225, and a position mark is disposed on the sliding unit 222 to indicate the position of the sliding unit. The sliding unit 222 in this example employs a push button. The handle scale groove 225 may be provided in the handle with a mating surface outside of a cavity of the second cavity. The push button is arranged in the handle, the push button can move along the handle scale groove 225, the push button position mark at the front end of the push button can indicate the position of the push button, the push button limit key (the limit unit 223) at the rear end of the push button can move when being pressed down, and the handle limit groove 226 can be blocked to prevent the push button from moving when being released. The insulating film is fixedly connected with the push button, the insulating film is sleeved outside the electrode needle, and the insulating film can be driven to move by moving the push button, so that the working length of the electrode needle is adjustable. The above is merely a mechanical structure of one implementation, but is not limited thereto.
In summary, the present example implements steep pulse therapy by connecting the electrical connection of the power+temperature sensor to the steep pulse therapy device. The insulating film material with better insulating property can be used in the embodiment, and the working voltage of steep pulse is far greater than the radio frequency working voltage, so that the insulating film material with the insulating property of steep pulse can be met, and the radio frequency requirement can be met at the same time. The improvement of the insulating property of the insulating film can be selected from the materials per se, and generally, a PI material is selected; this can also be achieved by increasing the thickness of the insulating material. In addition, the electrode tip of the steep pulse ablation section integrates the following key elements or key components:
-a cold circulation unit to maintain the electrode operating temperature;
-a thermocouple (a temperature sensor) for monitoring the tissue temperature in real time;
the use of high-voltage-resistant materials, such as silicone high-voltage-resistant cables, ensures that high voltages and high currents can be tolerated.
If the ablation device of the embodiment uses the radio frequency ablation part, the electrical connection end of the power and temperature sensor is connected with the radio frequency treatment equipment, so that radio frequency ablation treatment is realized. The electrode of the radiofrequency ablation part also has the capability of resisting high voltage and high current so as to meet the requirement of radiofrequency ablation. The insulating properties of the electrode material are highly optimized to ensure safe and reliable radiofrequency ablation operation.
Briefly, the ablation device operates in one of the following modes: a steep pulse mode, a radio frequency mode; the steep pulse mode adopts an energy generating unit and a temperature sensor, wherein the power line and the temperature sensor are connected in parallel by a cable to be connected to an electric end, and the electric end is used for connecting steep pulse treatment equipment; the radio frequency mode adopts an energy generating unit and a temperature sensor, the power line and the temperature sensor are connected in a parallel mode through a cable and are connected to an electric end, and the electric end is used for being connected with radio frequency treatment equipment.
Application example
The present application may also include an electrode array. The first type of electrode comprises at least two or more electrodes and each electrode comprises at least electrode pins as shown in fig. 1, which electrodes form an electrode array when the pins are arranged in parallel. The second electrode array is that two electrode needles can be arranged on a handle in parallel, each electrode needle is provided with a corresponding driving part, and each driving part is arranged on the handle.
The electrode pins of the electrode pin array are configured to be deployed in parallel to a predetermined energy application region for energy delivery to the identified tissue to form an ablation region, and closely spaced needle deployment regions may be formed between the electrode pins.
The electrode needles are provided with cloth needle joint surfaces which are arranged opposite to or adjacent to the driving part, the minimum cloth needle distance of the small-space cloth needle area is the shortest distance between the electrode needles in the state of joint or contact of the two cloth needle joint surfaces, and the minimum cloth needle distance between the two electrode needles of the small-space cloth needle area is smaller than 20mm.
The electrode of the invention adopts a miniaturized design so as to meet the requirement of multi-needle combined ablation. The dimensions of the electrodes are precisely controlled to achieve a small pitch parallel needle placement to achieve efficient tissue ablation.
The core of the miniaturised design here is the reduction of the radial dimension of the handle. Multiple needle combined ablation requires parallel needle placement between the needles, and the diameter of the electrode needle body is small, typically < 2mm, so the radial dimension of the handle limits the lower limit of the needle placement distance for small distances. The radial size of the electrode handle with the cold circulation which is conventional in the market is generally about 20mm, so that the distance between parallel needle distribution is more than 20mm; the handle of this scheme design because retrencied the cold cycle overall arrangement, can be about 10mm with the size control of handle, and the interval of parallel cloth needle is less than current product far away. Smaller needle spacing has three benefits: 1. the small-spacing cloth has better adaptability and accuracy for treating smaller focus. 2 for larger focus, the same needle distribution area can distribute more electrode needles in the focus at small intervals, and the effect of simultaneous treatment of more electrode needles can be better. 3. For irregular focus, the smaller needle spacing can better cope with focus conformal treatment, and reduce the damage of benign tissues while ensuring the treatment effect.
Second example
The invention also provides a simplified ablation electrode comprising an energy delivery unit, an energy application unit and a fluid delivery unit, wherein:
the energy application unit includes an electrode needle having a proximal end and a distal end, the distal end having a tip for applying energy to a target tissue, and the electrode needle having at least one first lumen extending along a longitudinal axis of the electrode needle body;
the energy delivery unit comprising at least a handle member disposed along a longitudinal axis, the handle member having a proximal end and a distal end, the handle member being provided with at least one second lumen disposed along the longitudinal axis, a distal portion of the second lumen being in communication with a proximal portion of the first lumen, the proximal portion being provided with an opening;
the fluid conveying unit comprises a fluid conveying pipeline, the fluid conveying pipeline is arranged in the second cavity, penetrates through the second cavity along the longitudinal axis and extends to a position, close to the tip, of the distal end of the first cavity, a gap channel is arranged between the outer surface of the fluid conveying pipeline and the inner cavity surfaces of the first cavity and the second cavity, and fluid is conveyed to the distal end of the first cavity from the fluid conveying pipeline, or flows out of the gap channel or is pumped out from the gap channel.
The present example may employ a simple fluid transfer unit or may be a cold cycle arrangement as shown in the previous example. The fluid delivery conduit further comprises a transfer tube extending into the second cavity from a proximal side of the second cavity and extending along a longitudinal axis, and a drain tube sealingly connected to the transfer tube extending along the longitudinal axis to a position near the tip of the distal end of the first cavity, the second cavity having a drain tube sleeved over the first cavity formed by the electrode needle body and forming a sealed connection.
This example provides an ablation electrode that is simple and compact in structure. Of course, the sensing member may be added as desired in medicine. For example, other components such as a temperature sensor/position sensor and the like are integrated, different pathological tissues can be subjected to conformal ablation, and the treatment requirements of different patients can be better met in clinical application.
Although the present invention has been described in terms of the preferred embodiments, it is not intended to be limited to the embodiments, and any person skilled in the art can make any possible variations and modifications to the technical solution of the present invention by using the methods and technical matters disclosed above without departing from the spirit and scope of the present invention, so any simple modifications, equivalent variations and modifications to the embodiments described above according to the technical matters of the present invention are within the scope of the technical matters of the present invention.
Claims (10)
1. An ablation device for steep pulse ablation and/or radio frequency ablation comprising at least one electrode, characterized in that the electrode comprises at least: an energy delivery unit, an energy application unit, a cold circulation unit, and a sensing member, wherein:
the energy application unit includes an electrode needle having a proximal end and a distal end, the distal end having a tip for applying energy to a target tissue, and the electrode needle having at least one first lumen extending along a longitudinal axis of the electrode needle body;
the energy delivery unit comprising at least a handle member disposed along a longitudinal axis, the handle member having a proximal end and a distal end, the handle member being provided with at least one second lumen disposed along the longitudinal axis, a distal portion of the second lumen being in communication with a proximal portion of the first lumen, the proximal portion being provided with an opening;
the cold circulation unit comprises a fluid conveying pipeline and a fluid outflow channel, wherein the fluid conveying pipeline is arranged in the second cavity, penetrates through the second cavity along the longitudinal axis and extends to a position, close to the tip, of the distal end of the first cavity, a clearance channel is formed between the outer surface of the fluid conveying pipeline and the inner cavity surfaces of the first cavity and the second cavity respectively, the clearance channel and the opening form the fluid outflow channel, and fluid is conveyed from the fluid conveying pipeline to the distal end of the first cavity, conveyed out or extracted from the fluid outflow channel so as to carry heat energy generated by applying energy to target tissues out of the electrode needle body;
the sensing component is provided with at least one sensing unit, the sensing unit is provided with a distal end and a proximal end, the distal end is provided with a signal sensing end, the proximal end of the sensing unit is arranged in the fluid conveying pipeline, the distal end of the sensing unit extends to the distal end of the fluid conveying pipeline along the longitudinal axis in a penetrating way, the signal sensing end is arranged at a position close to the tip, the electrode needle body forms a hollow first cavity, the fluid conveying pipeline is positioned in the first cavity, a first annular gap is formed between the inner wall of the first cavity and the outer wall of the fluid conveying pipeline, a second annular gap is also formed between the inner cavity surface of the second cavity and the outer wall of the fluid conveying pipeline, the gap channel comprises a first annular gap and a second annular gap which are communicated, and the radial dimension of the second cavity is smaller than 20mm;
the second cavity is provided with a liquid outlet pipe, the liquid outlet pipe is sleeved on the first cavity formed by the electrode needle body and forms sealing connection, the whole liquid outlet pipe forms a reference pipe body of the handle member, the liquid outlet pipe is used as the body of the second cavity, and the radial length of the liquid outlet pipe is the basic radial length of the handle member;
the handle member further has a driving part attached to at least one outer side portion of the second cavity, a power output end of the driving part is connected to the energy application unit, and is configured such that the power input end receives an external power input, and the power output end outputs a driving force to drive the energy application unit to slide along a longitudinal axis of a track preset by the energy application unit, so as to adjust the energy application execution area to match with the preset energy application area.
2. The ablation device of claim 1, wherein the fluid delivery conduit further comprises a transition tube extending into the second lumen from a proximal side of the second lumen and disposed along a longitudinal axis, and a drainage tube sealingly connected to the transition tube, the drainage tube disposed along the longitudinal axis extending to a position proximal to the tip of the distal end of the first lumen.
3. The ablation device of claim 1, wherein the energy application unit further comprises an insulating film that is sleeved outside the electrode needle and that is configured for relative movement with respect to the electrode needle along a longitudinal axis.
4. The ablation device of claim 3, wherein the driving portion further comprises a sliding unit fixed to the insulating film and configured to move the insulating film relatively along the longitudinal axis to adjust the working length of the electrode needle, and a limiting unit configured to configure the sliding unit to handle a sliding state or a seizing state.
5. The ablation device of claim 4, wherein a lumen outer wall of the second lumen is configured as a junction surface on which a handle scale groove is disposed along the longitudinal axis, the sliding unit being movable along the handle scale groove, and the sliding unit being provided with position indicia to indicate the position of the sliding unit.
6. An ablation device for steep pulse ablation and/or radio frequency ablation as claimed in claim 1, wherein the electrode comprises an electrode needle array of at least two electrode needles, or the ablation device comprises at least two electrodes and each electrode comprises at least one electrode needle to form an electrode array, the at least two electrode needles of the electrode needle array/the at least two electrode needles of the electrode array being configured to be deployed in parallel to a predetermined energy application zone for energy delivery to the identified tissue to form an ablation zone, a closely spaced deployment zone being formable between the electrode needles.
7. The ablation device of claim 6, wherein the electrode needles have a needle-engaging surface disposed opposite or adjacent to the driving portion, the minimum needle-spacing of the closely spaced needle-engaging surface being the shortest distance between the electrode needles in a two-by-two engaged or contacting state of the needle-engaging surface, the minimum needle-spacing of the closely spaced needle-engaging surface being less than 20mm.
8. The ablation device of claim 1, further comprising an energy generating unit having a power line, the sensing unit including a temperature sensor and a position sensor, the power line in communication with the electrode needle, the power line and the temperature sensor being wired to an electrical terminal, the position sensor having a protective tube connected to the electrical terminal near the proximal end of the second lumen; and the ablation device is configured to operate in one of the following modes: a steep pulse mode, a radio frequency mode; the steep pulse mode adopts an energy generating unit and a temperature sensor, wherein the power line and the temperature sensor are connected in parallel by a cable to be connected to an electric end, and the electric end is used for connecting steep pulse treatment equipment; the radio frequency mode adopts an energy generating unit and a temperature sensor, the power line and the temperature sensor are connected in a parallel mode through a cable and are connected to an electric end, and the electric end is used for being connected with radio frequency treatment equipment.
9. An ablation electrode comprising an energy delivery unit, an energy application unit, and a fluid delivery unit, wherein:
the energy application unit includes an electrode needle having a proximal end and a distal end, the distal end having a tip for applying energy to a target tissue, and the electrode needle having at least one first lumen extending along a longitudinal axis of the electrode needle body;
the energy delivery unit comprising at least a handle member disposed along a longitudinal axis, the handle member having a proximal end and a distal end, the handle member being provided with at least one second lumen disposed along the longitudinal axis, a distal portion of the second lumen being in communication with a proximal portion of the first lumen, the proximal portion being provided with an opening;
the fluid conveying unit comprises a fluid conveying pipeline, the fluid conveying pipeline is arranged in the second cavity, and penetrates through the second cavity along the longitudinal axis to be arranged at a position, close to the tip, of the distal end of the first cavity, a gap channel is arranged between the outer surface of the fluid conveying pipeline and the inner cavity surfaces of the first cavity and the second cavity respectively, fluid is conveyed from the fluid conveying pipeline to the distal end of the first cavity and flows out or is extracted from the gap channel, the electrode needle body forms a hollow first cavity, the fluid conveying pipeline is arranged in the first cavity, a first annular gap is formed between the inner wall of the first cavity and the outer wall of the fluid conveying pipeline, a second annular gap is also formed between the inner cavity surface of the second cavity and the outer wall of the fluid conveying pipe, the gap channel comprises a first annular gap and a second annular gap which are communicated, and the radial dimension of the second cavity is smaller than 20mm;
the second cavity is provided with a liquid outlet pipe, the liquid outlet pipe is sleeved on the first cavity formed by the electrode needle body and forms sealing connection, the whole liquid outlet pipe forms a reference pipe body of the handle member, the liquid outlet pipe is used as the body of the second cavity, and the radial length of the liquid outlet pipe is the basic radial length of the handle member;
the handle member further has a driving part attached to at least one outer side portion of the second cavity, a power output end of the driving part is connected to the energy application unit, and is configured such that the power input end receives an external power input, and the power output end outputs a driving force to drive the energy application unit to slide along a longitudinal axis of a track preset by the energy application unit, so as to adjust the energy application execution area to match with the preset energy application area.
10. An ablation electrode as in claim 9, wherein the fluid delivery conduit further comprises a transition tube extending into the second lumen from a proximal side of the second lumen and disposed along a longitudinal axis, and a drainage tube sealingly connected to the transition tube, the drainage tube disposed along the longitudinal axis extending to a position proximal to the tip of the distal end of the first lumen.
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| CN202311451988.9A CN117159128B (en) | 2023-11-03 | 2023-11-03 | Ablation device and ablation electrode for steep pulse ablation and/or radio frequency ablation |
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| CN202311451988.9A CN117159128B (en) | 2023-11-03 | 2023-11-03 | Ablation device and ablation electrode for steep pulse ablation and/or radio frequency ablation |
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