CN120814897B - Device and system for performing electric field treatment on digestive tract - Google Patents
Device and system for performing electric field treatment on digestive tractInfo
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
- A61B1/018—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
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- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/273—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the upper alimentary canal, e.g. oesophagoscopes, gastroscopes
- A61B1/2736—Gastroscopes
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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
- A61B18/1206—Generators therefor
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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
- A61B18/14—Probes or electrodes therefor
- A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
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- 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
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00482—Digestive system
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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
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00482—Digestive system
- A61B2018/00494—Stomach, intestines or bowel
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
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- A—HUMAN NECESSITIES
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- 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
- A61B2018/00613—Irreversible electroporation
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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
- 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
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Abstract
The invention discloses a device and a system for carrying out electric field treatment on a digestive tract, wherein the device for carrying out electric field treatment on the digestive tract comprises an elongated catheter, a supporting body positioned at the far end part of the catheter, an electrode array film arranged on the supporting body and a pulse generator, the output end of the pulse generator is coupled with electrode pairs on the electrode array film, a sequence pulse wave output by the pulse generator comprises a plurality of groups of nanosecond pulse strings, the time interval between every two adjacent nanosecond pulse strings is 1us-10000us, the time interval between every two adjacent nanosecond pulse strings is 50ns-10000ns, the nanosecond pulse strings comprise positive pulses and negative pulses which alternately appear, and the pulse width of the positive pulses and the negative pulses is 10 ns-1000 ns and the time interval is 10 ns-1000 ns. The invention can obviously improve the permeability of cell membranes and the cell death efficiency, and breaks through the limitation of the traditional IRE technology.
Description
Technical Field
The invention relates to the technical field of pulse generation and medical appliances, in particular to a device and a system for performing electric field treatment on a digestive tract.
Background
In recent years, as the research on biological effects of pulsed electric fields is continued, more and more technologies and devices based on the principle of biological effects of electric pulses are coming into clinical application. An electric field therapy device based on cell ablation is a minimally invasive therapy device that uses electrodes to provide a pulsed electric field under image guidance to destroy the cellular activity of the target tissue.
Research in the field of cytoelectric ablation shows that a single pulse of nanoseconds or microseconds disclosed in Chinese patent applications with publication numbers of CN117159123A and CN221654541U has poor effect of ablating tumor cells. In particular, conventional microsecond-level pulses, while capable of producing sufficiently large cell membrane perforations, are highly sensitive in their perforation efficiency to cell size. When the difference of the cell radius to be perforated exceeds 1.55 times, large cells are easy to die due to excessive perforation, and small cells are easy to be perforated insufficiently, so that the overall fusion rate is obviously reduced.
Nanosecond pulse has no sensitivity to cell size, is hardly affected by the cell size, and can induce nanometer micropores on the membrane. However, such microwells are often fully closed on the order of microseconds due to their extremely small dimensions and rapid membrane elastic recovery, and cannot support the sustained open time (in milliseconds) required for cell fusion, and thus fusion success rates are likewise limited.
In order to solve the technical problem that the ablation effect of a single pulse on tumor cells is poor, a Chinese patent application with publication number of CN113824431A proposes a collaborative pulse generation circuit, a collaborative pulse generation device and a collaborative pulse generation method, and microsecond pulses and nanosecond pulses are respectively excited in different time periods, so that the microsecond pulses and the nanosecond pulses are used in a combined mode, and the ablation effect of the tumor cells is improved.
The foregoing background is only for the purpose of providing an understanding of the principles and concepts of the application and is not necessarily related to the prior art or is not necessarily taught by the present application, but is not intended to be used for the purposes of assessing the novelty and creativity of the present application without express evidence that such matter has been disclosed prior to the filing date of the present application.
Disclosure of Invention
The invention aims to provide a device and a system for performing electric field treatment on the alimentary canal, which can obviously improve the permeability and the cell death efficiency of cell membranes and break through the limitations of the traditional IRE technology.
In order to achieve the above purpose, the invention adopts the following technical scheme:
An apparatus for performing electric field therapy on a digestive tract, comprising:
An elongate catheter;
A support body positioned at a distal end portion of the catheter, the support body having a contracted operating state and an expanded operating state;
The electrode array film is arranged on the support body, and is stretched on the support body when the support body is in an expanding working state, and is contracted on the support body when the support body is in a contracting working state, and a plurality of pairs of electrode pairs consisting of a first electrode and an adjacent second electrode are arranged on the electrode array film;
The pulse generator is provided with a pulse signal output end, the pulse signal output end is coupled to the electrode pair and is used for generating ablation current on the electrode pair when the pulse generator outputs a sequence pulse wave, the sequence pulse wave comprises a plurality of groups of nanosecond pulse strings, the time interval between two adjacent groups of nanosecond pulse strings is 1 mu s-10000 mu s, the nanosecond pulse strings are composed of a plurality of nanosecond pulse pairs, the time interval between two adjacent nanosecond pulse pairs is 50ns-10000ns, the nanosecond pulse pairs are composed of positive pulses and negative pulses which alternately appear, the pulse width of each positive pulse or negative pulse is 10ns-1000ns, and the time interval between the positive pulse and the negative pulse is 10ns-1000ns.
Further, the nanosecond pulse pair releases 10-100kV/cm of electric field energy at each electrode pair in combination with any one or more of the foregoing aspects.
Further, any one or a combination of the foregoing, each set of nanosecond pulse trains is composed of a plurality of nanosecond pulse pairs, and a time interval between two adjacent nanosecond pulse pairs is 100ns-1000ns.
Further, in any one or a combination of the foregoing aspects, each nanosecond pulse pair is composed of positive pulses and negative pulses that alternately appear, a pulse width of each positive pulse or negative pulse is 50ns-500ns, and a time interval between the positive pulse and the negative pulse is 50ns-500ns.
Further, in any one or a combination of the foregoing aspects, the period of time during which the pulse generator outputs the sequence pulse wave includes a first period of time from first to last to an nth period of time, N being a positive integer not less than 2;
And determining that the time interval between two adjacent nanosecond pulse trains in the pulse wave sequence in the ith time period is T i, and taking an integer from 1 to N-1 by T i＜Ti+1.
Further, the pulse generator outputs the sequence pulse wave for a period of time including a first period of time, a second period of time, and a third period of time from first to last;
T 1 is 1 mu s-2000 mu s, T 2 is 10 mu s-5000 mu s, T 3 is 50 mu s-10000 mu s, T j represents the time interval between two adjacent nanosecond pulse trains in the sequence pulse wave in the j-th time period, and j is 1 or 2 or 3.
Further, any one or a combination of the foregoing, wherein the positive pulse and the negative pulse are square waves, and/or,
The absolute value of the voltage amplitude of the negative pulse is equal to the absolute value of the voltage amplitude of the positive pulse.
Further, the combination of any one or more of the foregoing, wherein the time interval between two adjacent nanosecond pulse trains is 10 μs to 1000 μs.
Further, any one or a combination of the foregoing, each set of nanosecond pulse trains consists of 1-1000 nanosecond pulse pairs.
Further, in any one or a combination of the foregoing aspects, the sequential pulse wave is composed of 1-1000 nanosecond pulse trains, and a time interval between two sequential pulse waves is 0.1s-10s.
Further, the combination of any one or more of the foregoing aspects, further comprising an operating handle at a proximal end of the catheter for manipulating the support body between the contracted working state and the expanded working state, and/or,
The pulse generator comprises pulse discharging modules, the number of the pulse discharging modules is 1, the pulse discharging modules are configured to output the sequence pulse waves, and/or,
The pulse generator includes an electrode selection module configured to control some or all of the electrodes on the electrode array membrane to generate the ablation current.
According to another aspect of the present invention, there is provided a system for performing ablation treatment on an alimentary canal, comprising a device for performing electric field treatment on an alimentary canal according to any one or a combination of the above aspects, and further comprising a gastroscopic device comprising a gastroscopic body having a surgical instrument channel disposed thereon, the support body and the electrode array membrane being disposed within the surgical instrument channel.
The technical scheme provided by the invention has the following beneficial effects:
a. The device for treating the digestive tract by the electric field provided by the invention generates millisecond-level sequence pulse waves through the pulse generator, the sequence pulse waves comprise microsecond-level nanosecond pulse trains formed by compounding and nesting a plurality of nanosecond pulses, the nanosecond pulses in the nanosecond pulse trains can form wide but shallow electroporation on target cells, local electric field intensity is ensured to reach the standard through the intensive nanosecond pulses in the nanosecond pulse trains, and the inter-train time interval allows the dynamic recovery of tissue conductivity, so that the uniformity of electric field distribution can be regulated while the effect of the electric field can be continuously carried out on cells with various sizes, a more continuous and transmural ablation area can be finally formed, the permeability and the cell death efficiency of cell membranes can be remarkably improved, the limitation of the traditional IRE technology is broken through, and the device has remarkable value in the aspects of curative effect improvement, safety optimization, indication expansion and the like;
b. the pulse generator provided by the invention can generate a sequence pulse wave of nanosecond, microsecond and millisecond composite nested pulses only by one pulse discharge module, can reduce the electric field intensity threshold value of irreversible electroporation of tissues, can form effective ablation damage in target tissues by lower total energy input, reduces non-effective energy consumption, improves the ablation efficiency and has low cost.
Drawings
In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings that are required to be used in the embodiments or the description of the prior art will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments described in the present application, and other drawings may be obtained according to the drawings without inventive effort to those skilled in the art.
FIG. 1 is a schematic view of an apparatus for performing electric field therapy on the digestive tract in a human body according to an exemplary embodiment of the present invention;
FIG. 2 is a schematic view of a gastroscope body provided with an electrode array film according to an exemplary embodiment of the present invention;
FIG. 3 is a schematic view of a support and electrode array film according to an exemplary embodiment of the present invention;
FIG. 4 is a block diagram of an apparatus for performing electric field therapy on the alimentary canal, in accordance with an exemplary embodiment of the present invention;
FIG. 5 is a schematic diagram of an apparatus for performing electric field therapy on the digestive tract according to an exemplary embodiment of the present invention;
FIG. 6 is a schematic diagram of the electrical circuit of an apparatus for performing electric field therapy on the alimentary canal according to an exemplary embodiment of the present invention;
FIG. 7 is a schematic workflow diagram of an apparatus for performing electric field therapy on the alimentary canal according to an exemplary embodiment of the present invention;
FIG. 8 is a schematic diagram of the composition of a pulse train provided by an exemplary embodiment of the present invention;
Fig. 9 is a schematic diagram showing the composition structure of a sequential pulse wave according to an exemplary embodiment of the present invention.
The device comprises a catheter 1, a supporting body 2, an electrode array film 3, a first electrode 4, a second electrode 5, an electrode pair 6, an electrode pair 7, a pulse generator 10, a gastroscope display screen 11, an operating handle 12, a stomach 13, a duodenum 14, a gastroscope body 15, a surgical instrument channel 16, a luminous body 17 and a knob.
Detailed Description
In order that those skilled in the art will better understand the present invention, a technical solution in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in which it is apparent that the described embodiments are only some embodiments of the present invention, not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the present invention without making any inventive effort, shall fall within the scope of the present invention.
It should be noted that the terms "first," "second," and the like in the description and the claims of the present invention and the above figures are used for distinguishing between similar objects and not necessarily for describing a particular sequential or chronological order. It is to be understood that the data so used may be interchanged where appropriate such that the embodiments of the invention described herein may be implemented in sequences other than those illustrated or otherwise described herein. Furthermore, the terms "comprises," "comprising," and "having," and any variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, apparatus, article, or device that comprises a list of steps or elements is not necessarily limited to those steps or elements expressly listed or inherent to such process, method, article, or device.
The technical proposal proposed by the Chinese patent application with publication number of CN113824431A can improve the ablation effect on tumor cells to a certain extent by using microsecond pulses and nanosecond pulses. However, the technical scheme still has the advantages of time-sharing multiplexing microsecond pulse and nanosecond pulse, and not achieving the same time and achieving the advantages of cell ablation by microsecond pulse and nanosecond pulse and avoiding the disadvantages of cell ablation by microsecond pulse and nanosecond pulse. Specifically, according to the technical scheme provided by the patent application, in the period of performing cell ablation by adopting microsecond pulse, the problem of insufficient overall fusion rate caused by easy death of large cells due to excessive perforation and insufficient perforation of small cells still exists, and in the period of performing cell ablation by adopting nanosecond pulse, the technical problem of limited fusion success rate caused by rapid recovery of nanoscale micropores still exists.
To solve the deficiencies of the prior art, the present application proposes a device for electric field treatment of the digestive tract, see fig. 1 to 3 and 5, comprising an elongated catheter 1, a support body 2, an operating handle 11, an electrode array membrane 3 and a pulse generator 7.
Wherein the support body 2 is located at the distal end of the catheter 1, and the support body 2 has a contracted working state and an expanded working state. Before the distal end of the catheter 1 has reached the target site, the support body 2 is configured to be in a contracted working state in order to facilitate movement of the catheter 1 and support body 2 and reduce damage to the human body. When the distal end of the catheter 1 reaches the target location, the support body 2 is configured to expand in operation to control the device to release the pulsed electric field to the target location.
The operating handle 11 is located at the proximal end of the catheter 1, and the operating handle 11 is used for operating the support body 2 to switch between a contracted working state and an expanded working state. Specifically, as shown in fig. 5, the operating handle 11 is provided with a knob 17, and the knob 17 is rotated to operate the support body 2 to switch between the contracted operation state and the expanded operation state.
The electrode array film 3 is arranged on the support body 2, the electrode array film 3 is stretched on the support body 2 when the support body 2 is in an expanding working state, the electrode array film 3 is contracted on the support body 2 when the support body 2 is in a contracting working state, and a plurality of pairs of electrode pairs 6 consisting of a first electrode 4 and an adjacent second electrode 5 are arranged on the electrode array film 3.
The pulse generator 7 has a pulse signal output coupled to the electrode pair 6 for generating an ablation current at the electrode pair 6 when the pulse generator 7 outputs a sequence of pulse waves. As shown in fig. 8 and 9, the sequence pulse wave includes a plurality of groups of nanosecond pulse trains, and the time interval between two adjacent groups of nanosecond pulse trains is 1 μs-10000 μs. More preferably, the time interval between the two adjacent nanosecond pulse trains is 10 mu s to 1000 mu s.
The nanosecond pulse train consists of a plurality of nanosecond pulse pairs, and the time interval between two adjacent nanosecond pulse pairs is 50ns-10000ns. More preferably, the time interval between two adjacent nanosecond pulse pairs is 100ns-1000ns, and each group of nanosecond pulse trains consists of 1-1000 nanosecond pulse pairs.
The nanosecond pulse pair consists of positive pulses and negative pulses which alternately appear, the pulse width of each positive pulse or negative pulse is 10-1000ns, and the time interval between the positive pulse and the negative pulse is 10-1000ns. More preferably, the pulse width of each positive or negative pulse is 50-500ns, and the time interval between the positive and negative pulses is 50-500ns. Preferably, the positive pulse and the negative pulse are square waves, and the absolute value of the voltage amplitude of the negative pulse is equal to that of the positive pulse.
The invention forms extensive but shallow electroporation on target cells by nanosecond pulses with pulse width of 10-1000ns and time interval between positive pulse and negative pulse of 10-1000 ns. The nanosecond pulse trains formed by the nanosecond pulse pairs form nanosecond pulse trains with the time length reaching microsecond level, the time interval between the nanosecond pulse trains is microsecond level (optionally 1 mu s-10000 mu s, preferably 10 mu s-1000 mu s), the nanosecond pulse trains are used for carrying out microsecond-level continuous electric field action, initial micropores formed by the nanosecond pulse pairs are expanded into irreversible transmembrane channels, and cell osmotic pressure imbalance and apoptosis are finally caused. Therefore, the technical scheme not only has the advantage that nanosecond pulse is insensitive to the cell size, but also can solve the technical problem that the nanoscale micropores are easy to close rapidly.
It should be noted that the core role of the pulse interval is to provide a time window for the biological system (from microscopic ions to macroscopic tissues) to respond and recover between two high voltage electric shocks, which are distinct on the microsecond and nanosecond scale. The main target of action of microsecond pulses (typically with pulse widths >1 μs) is the cell membrane, which is destroyed by irreversible electroporation (IRE) to double lipid layers, leading to cell death. As described in the background, cell ablation using the microsecond pulses has the disadvantage of being too sensitive to size. The time interval between microsecond pulses has effects including heat dissipation and protection from thermal damage, and stabilization of cell membrane state and electric field distribution. The nanosecond pulse (usually with the pulse width of <1000 ns) has extremely short pulse width and extremely high voltage, and has the core effect of generating nanoscale holes on cell membranes, and simultaneously, the nano-scale holes can directly act on intracellular organs (such as mitochondria and nuclear membranes) to cause cell death by inducing apoptosis signals and the like. As described in the background, the use of a single nanosecond pulse has the disadvantage that the perforation heals in time, which affects the ablation effect. The core function of the time interval between nanosecond pulses is to maintain a long-lived permeabilized state of the cell membrane to ensure that the pores on the membrane do not close immediately and avoid thermal and electrolytic effects. The application combines the unique biological effect of nanosecond pulse (the nanosecond pulse in the nanosecond pulse train is insensitive to the cell size) with the physical regulation effect of microsecond interval (the short interval can cause the bubble or electrolysis product generated by the last pulse to change the local conductivity to influence the electric field distribution of the next pulse, and the microsecond pulse train time interval is favorable for the electric field distribution of the next pulse train), thereby realizing more efficient, safer and more controllable cell ablation. Without the microsecond time interval between nanosecond pulse trains provided by the application, nanosecond pulses are simply energy superposition and repeatedly circulate in the process of perforation-perforation healing-perforation. With this microsecond interval, a "biological synergy" is created between the bursts and the time intervals of the bursts, achieving the 1+1>2 effect, so that a more effective treatment can be achieved with lower total energy.
In this embodiment, the nanosecond pulse pairs preferably release 10-100kV/cm of electric field energy at each electrode pair. More preferably, the nanosecond pulse pairs release electric field energy at each electrode pair of preferably 10-50kV/cm. In the prior art, cell ablation is performed using a single nanosecond pulse, the electric field energy released on each electrode pair is typically 1-10kV/cm, and cell ablation is performed using a single microsecond pulse, the electric field energy released on each electrode pair is typically 10-30kV/cm. The application instantaneously induces the cell membrane to generate high-density nano holes through nanosecond pulse with extremely high electric field intensity, and simultaneously, the nano holes penetrate the cell membrane to directly act on cell organelles such as a cell nuclear membrane, mitochondria and the like to trigger an intracellular electroporation effect.
As shown in FIG. 9, the sequence pulse wave consists of 1-1000 nanosecond pulse trains, and the time interval between two sequence pulse waves is 0.1s-10s. The pulse train interval and the sequence pulse wave interval provided by the application can enable the cell membrane pore part to be impacted by subsequent pulses after being closed, exacerbate ion unbalance, realize irreversible membrane damage and further improve the apoptosis rate of cancer cells.
In an embodiment of the present invention, unlike the equal-length time interval in which the time interval between two adjacent nanosecond pulse trains in the above embodiment is in the order of microseconds, in this embodiment, the period during which the pulse generator outputs the sequence pulse wave includes a first period from first to last to an nth period, N is a positive integer not less than 2, and it is determined that the time interval between two adjacent nanosecond pulse trains in the sequence pulse wave in the ith period is T i, then T i＜Ti+1, i is an integer from 1 to N.
For example, the period of time in which the pulse generator outputs the sequence pulse wave includes a first period of time, a second period of time and a third period of time from first to last, preferably, T 1 has a value ranging from 1 μs to 2000 μs, T 2 has a value ranging from 10 μs to 5000 μs, T 3 has a value ranging from 50 μs to 10000 μs, T j represents a time interval between two adjacent sets of nanosecond pulse trains in the sequence pulse wave in the j-th period of time, and j is 1 or 2 or 3.
According to the embodiment, the whole treatment time is divided into a plurality of time periods from first to last, and the time interval between two adjacent nanosecond pulse trains is larger in the later time period compared with the earlier time period, so that the healing probability of the nanometer micropores can be further reduced, the requirement of dynamic recovery of tissue conductivity can be met, the local temperature rise condition can be improved, and adjacent blood vessels, bile ducts and nerve tissues can be better protected.
Preferably, the time interval between two sequential pulse waves in different treatment phases is also adapted to achieve a better treatment effect. For example, the period of time during which the pulse generator outputs the sequential pulse wave (i.e., the full period of time of electric field treatment) is divided into a first period of time (front), a second period of time (middle) and a third period of time (rear) from front to back, t j represents a time interval between two adjacent sequential pulse waves in the sequential pulse wave in the j-th period, j is 1 or 2 or 3, preferably, t 2＞t1 and t 2＞t3, optionally, t 1=t3 or t 1≠t3.
In one embodiment of the present invention, as shown in fig. 4, the pulse generator 7 includes a display of the pulse generator, a main controller, an electrical isolation module, a microprocessor, a high voltage power supply, a pulse discharging module, and an electrode selecting module, wherein the display of the pulse generator is electrically connected to the main controller and configured to display an operation state of the pulse generator. The main controller is electrically connected with the microprocessor through the electrical isolation module, and is configured to run a main control program, coordinate and command all other modules (microprocessor, high voltage power supply, etc.) to work cooperatively. The display and/or the main controller are configured to input control parameters of the pulse generator.
The microprocessor is configured to receive control instructions from the main controller and convert the received control instructions into accurate, high-speed timing control signals, generating accurate pulse trigger signals (PWM signals). The microprocessor controls the starting time, width, interval, quantity and the like of the pulse generated by the pulse discharging module.
The main controller and the microprocessor realize electric isolation through the electric isolation module (such as optical coupling isolation, magnetic coupling isolation, optical fiber isolation and the like) so as to ensure the safety isolation of the low-voltage side and the high-voltage side and good model transmission. A barrier with high insulation strength is established between a low-voltage control side (a main controller and a display) and a high-voltage side (a microprocessor, pulse discharge, electrode selection and a high-voltage power control end) through the electric isolation module, so that high voltage is prevented from entering a circuit, and operators and patients are protected from electric shock risks.
The high voltage power supply is electrically connected with the microprocessor and is configured to provide high voltage for the pulse discharging module of the subsequent stage.
The pulse discharging module is a core power component for generating actual high-voltage pulse and receives accurate time sequence signals sent by the microprocessor. The pulse discharging module can adopt a magnetic compression resonant circuit (shown in figure 6) or a Marx Bank circuit and the like which are formed by power switches (such as IGBT, MOSFET, siC or special high-voltage solid-state switches).
The electrode selection module is configured to be electrically connected to the pulse discharge module and the electrode array film, respectively. The electrode selection module is configured to flexibly distribute the high-voltage pulses generated by the pulse discharge module to the designated one or more first electrodes and/or second electrodes according to the setting and control of the main controller to achieve different ablation modes. The electrode selection module is typically composed of a series of high voltage relays or an array of solid state switches.
The workflow is shown in fig. 7, the catheter is controlled to the target position, and the ablation operation is started. Under the control of the main controller and the microprocessor, the pulse generator outputs nanosecond pulses with preset pulse width and preset time interval, and when the number of the nanosecond pulses reaches a preset first number threshold value, the output of a group of nanosecond pulse trains is completed, and the output of the nanosecond pulses is paused. When the pause duration reaches a preset pulse train interval (namely, the time interval between two adjacent nanosecond pulse trains), the next group of nanosecond pulse trains are output, when the number of the output nanosecond pulse trains reaches a preset second number threshold, the output nanosecond pulse is paused, and when the pause duration reaches a preset sequence pulse wave interval (namely, the time interval between two adjacent sequence pulse waves), the next sequence pulse wave is output. Repeating the steps to output a plurality of sequential pulse waves until stopping pulse wave output and ending the ablation.
The device for performing ablation treatment on the alimentary canal outputs nanosecond, microsecond and millisecond composite nested pulses based on the mode, can reduce the electric field intensity threshold of irreversible electroporation of tissues, and can form effective ablation damage in the target tissues at lower total energy input, thereby reducing non-effective energy consumption and improving ablation efficiency. The nanosecond pulse penetrates through the cell membrane to form extensive but shallow electroporation, the membrane permeability is increased, the impedance is reduced, and the microsecond pulse train acts on the enlarged pore to penetrate into the cell, so that stronger electrolytic effect and ion imbalance are induced, and irreversible membrane damage is caused. While avoiding the localized temperature rise (> 42 ℃) that may be caused by microsecond pulses in conventional IREs, thereby protecting adjacent vascular, biliary and neural tissue. By ablating corresponding digestive tract tissues, the treatment of some digestive tract diseases can be realized, as shown in fig. 1, by adopting the device for treating digestive tract by electric field provided by the invention, the distal end part of the catheter extends into the duodenum 13 through the stomach 12 and outputs the sequential pulse wave, so that higher-efficiency cell ablation can be carried out on the villus tissue of the duodenum, the surface of the duodenum is repaired again, and diabetes can be treated.
In addition, the device for performing ablation treatment on the alimentary canal provided by the invention can output the nanosecond, microsecond and millisecond composite nested pulse by adopting only 1 pulse discharge module, and at least two groups of pulse discharge modules are not required to be adopted like the Chinese patent application with the publication number of CN113824431A, wherein one group of pulse discharge modules is used for generating nanosecond pulses, and the other group of pulse discharge modules is used for generating microsecond pulses. Therefore, compared with the prior art, the technical scheme not only can obtain better cell ablation effect, but also has low cost and easy realization.
In one embodiment of the invention, a system for performing ablation therapy on an alimentary canal is provided, comprising a gastroscopic device and a device for performing electric field therapy on an alimentary canal as described in any one or a combination of the above embodiments. The gastroscope device comprises a gastroscope display screen 10, a gastroscope catheter and a gastroscope body 14, wherein the gastroscope body 14 is arranged at the distal end part of the gastroscope catheter, a surgical instrument channel 15 and a luminous body 16 are arranged on the gastroscope body 14, and the luminous body 16 is used for providing illumination. The support body 2 and the electrode array membrane 3 in the apparatus for electric field treatment of the digestive tract are disposed within the surgical instrument channel 15. The gastroscopic catheter is internally provided with a channel for receiving the catheter 1 in a device for electric field treatment of the digestive tract. The gastroscope display screen 10 is disposed at the proximal end of the gastroscope catheter, and is electrically connected to the gastroscope body 14, for displaying information such as a photographed image and/or a working state of the gastroscope body 14.
The system for performing ablation treatment on the alimentary canal provided by the invention has the same inventive concept as the embodiment of the device for performing ablation treatment on the alimentary canal, and the whole content of the embodiment of the device for performing ablation treatment on the alimentary canal is incorporated into the embodiment of the system for performing ablation treatment on the alimentary canal by introducing the content of the embodiment of the device for performing ablation treatment on the alimentary canal.
It is noted that relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises an element.
The foregoing is merely illustrative of the embodiments of this application and it will be appreciated by those skilled in the art that variations and modifications may be made without departing from the principles of the application, and it is intended to cover all modifications and variations as fall within the scope of the application.
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| US12485279B2 (en) * | 2020-11-25 | 2025-12-02 | Virginia Tech Intellectual Properties, Inc. | Methods for modulating temporal infrastructure of pulsed electric fields |
| US11389234B1 (en) * | 2021-02-11 | 2022-07-19 | Boston Scientific Scimed, Inc. | Systems, apparatuses, and methods for pre-ablation pulses in pulsed field ablation applications |
| CN113100918A (en) * | 2021-04-15 | 2021-07-13 | 杭州维纳安可医疗科技有限责任公司 | Pulse control method, device, and ablation device, system, and storage medium |
| CN114271931B (en) * | 2021-12-23 | 2023-09-12 | 心航路医学科技(广州)有限公司 | Pulse ablation system |
| CN115040233B (en) * | 2022-05-19 | 2024-06-18 | 杭州维纳安可医疗科技有限责任公司 | Irreversible electroporation tissue ablation system and control method thereof |
| CN117159123A (en) * | 2023-08-08 | 2023-12-05 | 杭州维纳安可医疗科技有限责任公司 | Ablation system for alimentary canal, control method, control device and medium thereof |
| CN117503324A (en) * | 2023-12-18 | 2024-02-06 | 上海微创电生理医疗科技股份有限公司 | pulse ablation circuit |
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