CN117426863A - Tissue ablation using high frequency monopole IRE - Google Patents
Tissue ablation using high frequency monopole IRE Download PDFInfo
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- CN117426863A CN117426863A CN202310893879.6A CN202310893879A CN117426863A CN 117426863 A CN117426863 A CN 117426863A CN 202310893879 A CN202310893879 A CN 202310893879A CN 117426863 A CN117426863 A CN 117426863A
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- 238000002679 ablation Methods 0.000 title abstract description 16
- 230000005404 monopole Effects 0.000 title abstract description 4
- 230000002051 biphasic effect Effects 0.000 claims abstract description 24
- 239000000523 sample Substances 0.000 claims abstract description 15
- 230000002107 myocardial effect Effects 0.000 claims abstract description 10
- 238000004520 electroporation Methods 0.000 claims abstract description 7
- 230000002427 irreversible effect Effects 0.000 claims abstract description 6
- 238000003780 insertion Methods 0.000 claims abstract description 5
- 230000037431 insertion Effects 0.000 claims abstract description 5
- 230000000747 cardiac effect Effects 0.000 claims description 2
- 238000000034 method Methods 0.000 abstract description 26
- 210000001519 tissue Anatomy 0.000 description 19
- 238000010586 diagram Methods 0.000 description 3
- 230000006907 apoptotic process Effects 0.000 description 2
- 210000004027 cell Anatomy 0.000 description 2
- 230000005684 electric field Effects 0.000 description 2
- 238000010438 heat treatment Methods 0.000 description 2
- 210000003205 muscle Anatomy 0.000 description 2
- 230000004118 muscle contraction Effects 0.000 description 2
- 210000003492 pulmonary vein Anatomy 0.000 description 2
- 230000002123 temporal effect Effects 0.000 description 2
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 102000010834 Extracellular Matrix Proteins Human genes 0.000 description 1
- 108010037362 Extracellular Matrix Proteins Proteins 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 210000005242 cardiac chamber Anatomy 0.000 description 1
- 230000005779 cell damage Effects 0.000 description 1
- 230000030833 cell death Effects 0.000 description 1
- 208000037887 cell injury Diseases 0.000 description 1
- 210000000170 cell membrane Anatomy 0.000 description 1
- 230000010001 cellular homeostasis Effects 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 230000009977 dual effect Effects 0.000 description 1
- 230000005284 excitation Effects 0.000 description 1
- 210000002744 extracellular matrix Anatomy 0.000 description 1
- 210000002064 heart cell Anatomy 0.000 description 1
- 210000005003 heart tissue Anatomy 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 231100000518 lethal Toxicity 0.000 description 1
- 230000001665 lethal effect Effects 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000017074 necrotic cell death Effects 0.000 description 1
- 210000005036 nerve Anatomy 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 210000004872 soft tissue Anatomy 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000000451 tissue damage Effects 0.000 description 1
- 231100000827 tissue damage Toxicity 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
-
- 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
-
- 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
- A61B2018/00345—Vascular system
- A61B2018/00351—Heart
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00613—Irreversible electroporation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B2018/1405—Electrodes having a specific shape
- A61B2018/1425—Needle
Abstract
The title of the present disclosure is "tissue ablation using high frequency monopole IRE". A method for medical treatment, the method comprising providing a probe configured for insertion into a heart of a living subject, and comprising at least one probe electrode configured to contact myocardial tissue in the heart. At least one body surface electrode is configured to be secured to the skin of the living subject. A biphasic electrical pulse is applied between the at least one probe-electrode and the at least one body-surface electrode, the biphasic electrical pulse having a peak-to-peak amplitude of at least 1kV, a frequency of at least 500kHz, and an electrical current sufficient to cause irreversible electroporation of the myocardial tissue contacted by the at least one probe-electrode.
Description
Cross Reference to Related Applications
The present application claims the benefit of continued application from portions of U.S. provisional patent application No. 63/241,782 filed on 8 of 9 in 2021 and U.S. patent application No. 16/701,989 filed on 3 of 12 in 2019.
Technical Field
The present disclosure relates generally to invasive medical devices and procedures, and in particular, to apparatus and methods for ablating tissue within a body.
Background
Irreversible electroporation (IRE) is a soft tissue ablation technique that applies short pulses of strong electric fields to create permanent and thus lethal nanopores in the cell membrane, disrupting cellular homeostasis (internal physical and chemical conditions). Cell death following IRE is due to apoptosis (apoptosis) rather than necrosis (cell damage, which causes the cells to be destroyed by the action of its own enzymes), as in other heat and radiation based ablation techniques. IRE is commonly used to ablate tumors in areas where the precision and retention of extracellular matrix, blood flow, and nerves are important.
IRE may also be applied to ablate tissue in the heart, for example as described in U.S. patent application publication No. 2021/0161592, the disclosure of which is incorporated herein by reference. As explained in this reference, IRE is primarily a non-thermal process that should result in a rise in tissue temperature of up to a few degrees in a few milliseconds. Thus, it is distinguished from RF (radio frequency) ablation, which raises the tissue temperature by 20 ℃ to 70 ℃ and destroys cells by heating. IRE utilizes a combination of positive and negative pulses applied between a bipolar electrode pair, for example, on a catheter. In order for the IRE pulse to generate the desired nanopore in cardiac tissue, the field strength of the pulse must exceed a tissue-dependent threshold E th The threshold is about 500V/cm for heart cells. The applied voltage may reach up to 2000V. The positive and negative pulses have a pulse width of 0.5 to 5 mus and a spacing between the positive and negative pulses of 0.1 to 5 mus.
As another example, U.S. patent application publication 2021/0177503, the disclosure of which is incorporated herein by reference, describes a medical device that includes a probe configured for insertion into a patient and includes a plurality of electrodes configured to contact tissue within the body. An electrical signal generator applies positive and negative pulse trains having a voltage amplitude of at least 200V and a duration of each of the pulses of less than 20 mus between at least one pair of electrodes in contact with the tissue, thereby causing irreversible electroporation of the tissue between the at least one pair of electrodes. One or more electrical sensors sense energy dissipated between at least one pair of electrodes during a pulse train. The controller is responsive to the one or more electrical sensors to control the electrical and time parameters of the pulse train applied by the electrical signal generator such that the dissipated energy meets predefined criteria.
In the above references, a pair of positive and negative pulses is referred to as a "bipolar pulse" and the pulse applied between a pair of electrodes on the catheter is referred to as bipolar ablation (whether the pulse is positive or negative). To avoid confusion in the specification and claims, a pair of positive and negative pulses is referred to herein as a "biphasic pulse" or biphasic pulse pair.
Disclosure of Invention
Embodiments of the present disclosure described below provide improved devices and methods for ablating tissue in the body.
Drawings
The disclosure will be more fully understood from the following detailed description of examples of the disclosure, taken in conjunction with the accompanying drawings, in which:
FIG. 1 is a schematic illustration of a system for use in IRE ablation procedures according to examples of the disclosure;
FIG. 2A is a diagram schematically illustrating a dual phase IRE pulse according to an example of the present disclosure; and is also provided with
Fig. 2B is a diagram schematically illustrating bursts of dual-phase IRE pulses according to an example of the present disclosure.
Detailed Description
IRE is typically performed by applying a high voltage pulse between pairs of electrodes that are relatively close to each other to produce a high electric field strength. In other words, IRE is typically a bipolar operation and is achieved over a relatively small area. If this type of bipolar IRE is applied to a large tissue area, such as for ablating the entire circumference of a Pulmonary Vein (PV) ostium, for example, multiple ablations must be repeated over different portions of the area. This approach is time consuming and may lead to inconsistent results, such as unstable catheter contact with the ostium due to heart motion.
To this end, some IRE ablation procedures may be advantageously performed in monopolar mode between one electrode inside the patient and another electrode on the surface of the patient's skin. In monopolar ablation, the IRE current is distributed over a larger area around the inner electrode and thus creates a larger lesion at each location where the IRE is applied. However, when operating in IRE monopolar mode, the low equivalent capacitance of the patient may cause high impedance and thus may reduce the efficiency of the procedure and make adjustment of electroporation difficult. Furthermore, because the current is distributed over a larger area, the local current density may drop below the level required for an effective IRE.
Examples of the present disclosure described herein overcome these limitations by applying unipolar IRE at higher voltage and frequency levels than previously thought possible. In the disclosed example, an IRE signal generator applies a biphasic electrical pulse between a probe electrode in a subject's heart and a body surface electrode on the subject's skin, the biphasic electrical pulse having a peak-to-peak amplitude of at least 1kV, a frequency of at least 500kHz, and an electrical current sufficient to cause IRE of myocardial tissue contacted by the probe electrode. In some examples, the peak-to-peak amplitude may be at least 2kV and the frequency may be 1MHz or greater. The high frequency of the electrical excitation counteracts the low capacitance of the patient. The high voltage drives a high current through the patient's body, typically at least 20A, and possibly 30A or more.
Thus, monopolar IRE ablation proceeds effectively and uniformly despite the wide spatial distribution of current within the body. Biphasic pulses are typically applied in bursts having a total duration of less than 1ms, such that the total energy delivered in each burst remains within safe limits.
IRE is applied at a very high frequency in this example, which is also advantageous in reducing muscle contraction due to the applied current. In bipolar IRE where the electrodes are close to each other, the current is localized and thus lower frequencies can be used without causing muscle contraction. For monopole IRE, the inventors have found that higher frequencies above 500kHz are preferred. In order to reduce the current density in the muscles outside the heart, it is also desirable to use large body surface electrodes, or even a plurality of body surface electrodes, which are fixed to the skin at different respective locations, thereby further reducing the current density flowing through the muscles.
Fig. 1 is a schematic illustration of a system 20 for use in an IRE ablation procedure according to an example of the present disclosure. The elements of system 20 may be based on those produced by Biosense Webster, inc. (Irvine, california)Components of the system.
The physician 30 navigates the catheter 22 through the vascular system of the patient 28 via the sheath 23 into the chamber of the patient's heart 26, where the distal end 25 of the catheter is then deployed. The physician 30 uses the manipulator 32 near the proximal end of the catheter 22 to manipulate the distal end 25 so as to bring one or more probe electrodes 40 on the distal end 25 into contact with myocardial tissue at the site to be ablated. Although the electrodes 40 are simply arrayed along the length of the distal end 25 in fig. 1, in alternative examples, the catheter may include a distal structure, such as a basket, balloon, or lasso, along which the electrodes are disposed.
Catheter 22 is connected at its proximal end to console 24. The display 27 on the console 24 may present a map 31 or other image of the heart chamber, wherein the map indicates the location of the distal end 25, in order to assist the physician 30 in positioning the electrode 40 at the target location of the IRE ablation procedure. The console 24 may also receive, process, and utilize other types of signals, such as Electrocardiogram (ECG) signals received from ECG electrodes 39 attached to the patient 28.
Once distal end 25 is properly deployed and positioned in heart 26, physician 30 actuates IRE module 34 in console 24 to apply a sequence of IRE pulses to the electrodes on the basket assembly under the control of processor 36. The circuitry and other components of IRE module 34 are similar to those shown in fig. 1 and 5-9 of the above-mentioned U.S. patent application publication 2021/0161592, and are described in the present disclosure with reference thereto. In particular, IRE module 34 includes IRE signal generator 38 capable of generating biphasic pulses having a frequency of up to at least 1MHz, with a peak-to-peak voltage of at least 2kV and a power sufficient to drive a current of at least 30A through electrode 40. In this example, IRE pulses are applied in a monopolar mode between one or more probe electrodes 40 and a separate common electrode (e.g., one or more conductive back patches 42 applied to the skin of a patient). Alternatively or in addition, IRE pulses may be applied in a bipolar mode between the electrode pairs 40.
Processor 36 instructs IRE module 34 to apply the pulses according to a predefined scheme. The physician 30 may use controls on the console 24 to select the protocol to be applied. For example, a physician or assistant may use the touch screen functionality of the display 27 on the console 24 to interact with the processor 36. Alternatively or in addition, the physician or assistant may operate controls to manually select the pulse parameters and electrodes. In one example, processor 36 instructs IRE signal generator 38 to synchronize the application of IRE pulses with the heart cycle of patient 28, e.g., based on the ECG signals received from electrodes 39.
The system configuration shown in fig. 1 is presented by way of example for conceptual clarity in understanding the operation of examples of the present disclosure. For simplicity, fig. 1 shows only certain elements of system 20 that are relevant to these examples. The remaining elements of the system will be apparent to those skilled in the art, and those skilled in the art will likewise appreciate that the principles of the present disclosure may be implemented in other medical treatment systems using other components. All such alternative implementations are considered to be within the scope of the present disclosure.
Fig. 2A is a schematic illustration of a biphasic IRE pulse 100 according to the examples of the present disclosure. Curve 102 shows the voltage V of pulse 100 over time t during an IRE ablation procedure. This example assumes that IRE signal generator 38 is configured as a voltage source, and thus describes IRE signals in terms of their voltage. Alternatively, IRE signal generator 38 is configured as a current source, in which case IRE pulses will be described in terms of their current. The biphasic IRE pulse comprises a positive pulse 104 and a negative pulse 106, where the terms "positive" and "negative" refer to any selected polarity of electrodes 40 and 42 between which the pulse is applied.
The amplitude of the positive pulse 104 is labeled v+ and the temporal width of the pulse is labeled t+. Similarly, the amplitude of the negative pulse 106 is labeled V-and the temporal width of the pulse is labeled t-. The time width between positive pulse 104 and negative pulse 106 is labeled t Spacing of . The total peak-to-peak voltage of pulse 100 is V pp =v++ V-, wherein for the monopolar IRE scheme described herein V pp >1kV. The period of the biphasic pulse is t pp ＝t++t-+2*t Spacing of Wherein t is pp <2 mus to achieve IRE pulse frequencies of 500kHz or higher.
Fig. 2B is a schematic diagram of a burst 200 of biphasic pulses 100 according to an example of the disclosure. In this example, the IRE signal is applied by IRE module 34 in one or more bursts 200 between electrodes 40 and 42, as shown by curve 202. Burst 200 includes N T A plurality of bursts 204, wherein each burst comprises N P A biphasic pulse 100. The length of each burst 204 is labeled t T And the interval between successive bursts is marked as delta T No signal is applied during this interval. Length t T Typically less than 1ms, to avoid collateral damage to body tissue at the high voltage and power levels of the pulse 100. In a typical IRE ablation procedure, t T ＝100μs，Δ T =0.3-1000 ms, and N T Between 1 and 100.
As an example, N T =20 and Δ T =5 ms such that the total sequence of bursts extends over a duration of about 100 ms. The spacing between the bursts helps to avoid excessive tissue heating. The inventors have found that a sequence of bursts of this type having a total duration of less than 250ms gives good results while minimizing collateral tissue damage.
Examples
Embodiment 1. A method for medical treatment, the method comprising providing a probe (22) configured for insertion into a heart (26) of a living subject (28) and comprising at least one probe electrode (40) configured to contact myocardial tissue in the heart; providing at least one body surface electrode (42) configured to be secured to the skin of the living subject; and applying biphasic electrical pulses between the at least one probe-electrode and the at least one body-surface electrode, the biphasic electrical pulses having a peak-to-peak amplitude of at least 1kV, a frequency of at least 500kHz, and an electrical current sufficient to cause irreversible electroporation of the myocardial tissue contacted by the at least one probe-electrode.
Embodiment 2. The method of embodiment 1 wherein the peak-to-peak amplitude is at least 2kV.
Embodiment 3. The method of embodiment 1 or 2, wherein the frequency is at least 1MHz.
Embodiment 4. The method of any of the preceding embodiments, wherein the current is at least 20A.
Embodiment 5. The method of any of the preceding embodiments, wherein applying the biphasic electrical pulse comprises applying a train of the pulses having a train duration of less than 1 ms.
Embodiment 6. The method of embodiment 5 wherein applying the train of pulses comprises applying a sequence of pulse trains with spaces between the pulse trains.
Embodiment 7. The method of embodiment 6 wherein the sequence of the pulse train has a total duration of less than 250 ms.
Embodiment 8. The method of any of the preceding embodiments, wherein providing the at least one body surface electrode comprises providing a plurality of body surface electrodes that are secured to the skin of the living subject at different respective locations such that the electrical current flows between the at least one probe electrode and the plurality of body surface electrodes.
Embodiment 9. The method of any of the preceding embodiments, wherein applying biphasic electrical pulses comprises synchronizing the application of the biphasic electrical pulses with the cardiac cycle of the living subject.
Embodiment 10. An apparatus (20) for medical treatment, the apparatus comprising a probe (22) configured for insertion into a heart (26) of a living subject (28) and comprising at least one probe electrode (40) configured to contact myocardial tissue in the heart; at least one body surface electrode (42) configured to be secured to the skin of the living subject; and an IRE signal generator (34) configured to apply a biphasic electrical pulse between the at least one probe-electrode and the at least one body-surface electrode, the biphasic electrical pulse having a peak-to-peak amplitude of at least 1kV, a frequency of at least 500kHz, and an electrical current sufficient to cause irreversible electroporation of the myocardial tissue contacted by the at least one probe-electrode.
Various features of the disclosure which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the disclosure that are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.
It should be understood that the above-described embodiments are cited by way of example, and that the present disclosure is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present disclosure includes both combinations and sub-combinations of the various features described hereinabove as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not disclosed in the prior art.
Claims (9)
1. An apparatus for medical treatment, comprising:
a probe configured for insertion into a heart of a living subject and comprising at least one probe electrode configured to contact myocardial tissue in the heart;
at least one body surface electrode configured to be secured to the skin of the living subject; and
an IRE signal generator configured to apply a biphasic electrical pulse between said at least one probe-electrode and said at least one body-surface electrode, said biphasic electrical pulse having a peak-to-peak amplitude of at least 1kV, a frequency of at least 500kHz, and an electrical current sufficient to cause irreversible electroporation of the myocardial tissue contacted by said at least one probe-electrode.
2. The apparatus of claim 1, wherein the peak-to-peak amplitude is at least 2kV.
3. The apparatus of claim 1, wherein the frequency is at least 1MHz.
4. The apparatus of claim 1, wherein the current is at least 20A.
5. The device of claim 1, wherein the IRE signal generator is configured to apply a train of the biphasic electrical pulses having a train duration of less than 1 ms.
6. The apparatus of claim 5, wherein the IRE signal generator is configured to apply a sequence of bursts with spaces between the bursts.
7. The device of claim 6, wherein the sequence of the pulse train has a total duration of less than 250 ms.
8. The apparatus of claim 1, wherein the at least one body surface electrode comprises a plurality of body surface electrodes configured to be secured to the skin of the living subject at different respective locations such that the current flows between the at least one probe electrode and the plurality of body surface electrodes.
9. The apparatus of claim 1, wherein the IRE signal generator is configured to synchronize application of the biphasic electrical pulse with a cardiac cycle of the living subject.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US17/868,945 US20220346857A1 (en) | 2019-12-03 | 2022-07-20 | Tissue ablation using high-frequency unipolar ire |
| US17/868945 | 2022-07-20 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN117426863A true CN117426863A (en) | 2024-01-23 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202310893879.6A Pending CN117426863A (en) | 2022-07-20 | 2023-07-20 | Tissue ablation using high frequency monopole IRE |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN117426863A (en) |
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2023
- 2023-07-20 CN CN202310893879.6A patent/CN117426863A/en active Pending
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