CN112294431A - Ultrasonic developable electrode needle for irreversible electroporation equipment - Google Patents
Ultrasonic developable electrode needle for irreversible electroporation equipment Download PDFInfo
- Publication number
- CN112294431A CN112294431A CN201910696724.7A CN201910696724A CN112294431A CN 112294431 A CN112294431 A CN 112294431A CN 201910696724 A CN201910696724 A CN 201910696724A CN 112294431 A CN112294431 A CN 112294431A
- Authority
- CN
- China
- Prior art keywords
- electrode needle
- developable
- region
- ultrasonically
- cancer
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000004520 electroporation Methods 0.000 title claims abstract description 29
- 230000002427 irreversible effect Effects 0.000 title claims abstract description 27
- 230000005684 electric field Effects 0.000 claims abstract description 20
- 239000000463 material Substances 0.000 claims description 20
- 206010028980 Neoplasm Diseases 0.000 claims description 18
- 239000011810 insulating material Substances 0.000 claims description 9
- 239000004020 conductor Substances 0.000 claims description 8
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims description 6
- 238000009413 insulation Methods 0.000 claims description 6
- 201000011510 cancer Diseases 0.000 claims description 5
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 4
- 229920000052 poly(p-xylylene) Polymers 0.000 claims description 4
- PNEYBMLMFCGWSK-UHFFFAOYSA-N aluminium oxide Inorganic materials [O-2].[O-2].[O-2].[Al+3].[Al+3] PNEYBMLMFCGWSK-UHFFFAOYSA-N 0.000 claims description 3
- 208000015634 Rectal Neoplasms Diseases 0.000 claims description 2
- 201000010536 head and neck cancer Diseases 0.000 claims description 2
- 208000014829 head and neck neoplasm Diseases 0.000 claims description 2
- 206010020718 hyperplasia Diseases 0.000 claims description 2
- 239000007769 metal material Substances 0.000 claims description 2
- 210000002307 prostate Anatomy 0.000 claims description 2
- 206010038038 rectal cancer Diseases 0.000 claims description 2
- 239000000377 silicon dioxide Substances 0.000 claims description 2
- 206010004593 Bile duct cancer Diseases 0.000 claims 1
- 206010005003 Bladder cancer Diseases 0.000 claims 1
- 206010006187 Breast cancer Diseases 0.000 claims 1
- 206010006256 Breast hyperplasia Diseases 0.000 claims 1
- 208000026310 Breast neoplasm Diseases 0.000 claims 1
- 208000000461 Esophageal Neoplasms Diseases 0.000 claims 1
- 208000022072 Gallbladder Neoplasms Diseases 0.000 claims 1
- 208000005016 Intestinal Neoplasms Diseases 0.000 claims 1
- 208000008839 Kidney Neoplasms Diseases 0.000 claims 1
- 206010058467 Lung neoplasm malignant Diseases 0.000 claims 1
- 206010030155 Oesophageal carcinoma Diseases 0.000 claims 1
- 206010033128 Ovarian cancer Diseases 0.000 claims 1
- 206010061535 Ovarian neoplasm Diseases 0.000 claims 1
- 206010061902 Pancreatic neoplasm Diseases 0.000 claims 1
- 206010060862 Prostate cancer Diseases 0.000 claims 1
- 208000000236 Prostatic Neoplasms Diseases 0.000 claims 1
- 206010038389 Renal cancer Diseases 0.000 claims 1
- 208000005718 Stomach Neoplasms Diseases 0.000 claims 1
- 208000007097 Urinary Bladder Neoplasms Diseases 0.000 claims 1
- 208000026900 bile duct neoplasm Diseases 0.000 claims 1
- 208000006990 cholangiocarcinoma Diseases 0.000 claims 1
- 201000004101 esophageal cancer Diseases 0.000 claims 1
- 201000010175 gallbladder cancer Diseases 0.000 claims 1
- 206010017758 gastric cancer Diseases 0.000 claims 1
- 201000002313 intestinal cancer Diseases 0.000 claims 1
- 201000010982 kidney cancer Diseases 0.000 claims 1
- 201000007270 liver cancer Diseases 0.000 claims 1
- 208000014018 liver neoplasm Diseases 0.000 claims 1
- 201000005202 lung cancer Diseases 0.000 claims 1
- 208000020816 lung neoplasm Diseases 0.000 claims 1
- 230000036210 malignancy Effects 0.000 claims 1
- 208000015486 malignant pancreatic neoplasm Diseases 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 201000002528 pancreatic cancer Diseases 0.000 claims 1
- 208000008443 pancreatic carcinoma Diseases 0.000 claims 1
- 201000001275 rectum cancer Diseases 0.000 claims 1
- 201000011549 stomach cancer Diseases 0.000 claims 1
- 201000005112 urinary bladder cancer Diseases 0.000 claims 1
- 239000011248 coating agent Substances 0.000 description 10
- 238000000576 coating method Methods 0.000 description 10
- 238000002604 ultrasonography Methods 0.000 description 10
- 210000001519 tissue Anatomy 0.000 description 8
- 230000000694 effects Effects 0.000 description 7
- 238000000034 method Methods 0.000 description 7
- 238000002679 ablation Methods 0.000 description 4
- 238000011161 development Methods 0.000 description 4
- 239000010963 304 stainless steel Substances 0.000 description 3
- 239000004696 Poly ether ether ketone Substances 0.000 description 3
- 229910000589 SAE 304 stainless steel Inorganic materials 0.000 description 3
- 210000000170 cell membrane Anatomy 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 229920002530 polyetherether ketone Polymers 0.000 description 3
- 239000000523 sample Substances 0.000 description 3
- 210000004027 cell Anatomy 0.000 description 2
- 229910010272 inorganic material Inorganic materials 0.000 description 2
- 239000011147 inorganic material Substances 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 230000004118 muscle contraction Effects 0.000 description 2
- 239000011368 organic material Substances 0.000 description 2
- 230000002441 reversible effect Effects 0.000 description 2
- 230000007480 spreading Effects 0.000 description 2
- 238000002560 therapeutic procedure Methods 0.000 description 2
- 206010004446 Benign prostatic hyperplasia Diseases 0.000 description 1
- 102000008186 Collagen Human genes 0.000 description 1
- 108010035532 Collagen Proteins 0.000 description 1
- 210000000013 bile duct Anatomy 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 210000000481 breast Anatomy 0.000 description 1
- 230000030833 cell death Effects 0.000 description 1
- 230000010001 cellular homeostasis Effects 0.000 description 1
- 231100000045 chemical toxicity Toxicity 0.000 description 1
- 229920001436 collagen Polymers 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 238000007599 discharging Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 210000003238 esophagus Anatomy 0.000 description 1
- 210000000232 gallbladder Anatomy 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 210000000936 intestine Anatomy 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 230000002147 killing effect Effects 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 210000005075 mammary gland Anatomy 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 210000001672 ovary Anatomy 0.000 description 1
- 210000000496 pancreas Anatomy 0.000 description 1
- 150000003904 phospholipids Chemical class 0.000 description 1
- 238000000554 physical therapy Methods 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 239000004408 titanium dioxide Substances 0.000 description 1
- 210000003932 urinary bladder Anatomy 0.000 description 1
Images
Classifications
-
- 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
- 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 application belongs to the field of medical equipment. The present application relates to an electrode needle of an irreversible electroporation apparatus, an array of electrode needles, and an irreversible electroporation apparatus including the electrode needle. The present application relates to an electrode needle for an irreversible electroporation apparatus, the electrode needle including an electrode needle body adapted to receive an electric pulse and apply an electric field to a predetermined direction, and including a conductive region and an ultrasonically developable region on a surface of the electrode needle body.
Description
Technical Field
The application belongs to the field of medical equipment. More particularly, the present application relates to an electrode needle of a non-reversible electroporation apparatus, an array of electrode needles, and a non-reversible electroporation apparatus including the electrode needle.
Background
Tumors, especially malignant tumors, are major diseases that endanger human health. Traditional and more recently developed therapies for tumors are thermal ablation physiotherapy characterized by minimally invasive ablation. The clinical application of the traditional Chinese medicine composition has certain limitations due to the limitation of factors such as indications, contraindications, side effects of treatment, heat effect and the like. In recent years, with the continuous development of pulsed bioelectricity, the electric field pulse attracts the attention of researchers due to the non-thermal and minimally invasive biomedical effects thereof, and the irreversible electroporation therapy of tumors among them attracts the extensive attention of researchers in the bioelectricity field at home and abroad due to the advantages and characteristics of rapidness, controllability, visibility, selectivity, non-thermal mechanism and the like, and is gradually applied to the clinical treatment of tumors.
The irreversible electroporation technology is a technology which is characterized in that an electrode needle is inserted into a diseased part of a patient, a pulse electric field is applied to the periphery of a cell, nanometer-scale micropores are generated on the surface of a cell membrane, so that the material exchange inside and outside the cell is caused, the cell homeostasis is further destroyed, the cell membrane is permanently damaged, and finally the cell death is caused. The technology has excellent application value in the treatment of tumors. The pulse electric field can generate non-thermal energy and no chemical toxicity killing effect. Moreover, the pulse electric field only acts on the cell membrane phospholipid double-layer membrane structure and does not act on components such as protein, collagen and the like, so that the important structures of blood vessels in the ablation area are protected, and the ablation boundary is clear.
Generally, when irreversible electroporation is used for treatment, the affected part is identified by ultrasound, and then an electrode needle is inserted for treatment. The electrode needle used in conjunction with ultrasound and inserted into the body is one or more long needles. Currently, the electrode needle is not visible in ultrasound after being inserted into the human body. This makes it impossible to accurately measure the size of the electrode needle actually inserted into the human body (and the actual discharge size).
Currently, the size of the electrode needle (and the actual discharge size) actually inserted into the human body is determined entirely by the clinical experience of the doctor. This is not only highly demanding on the clinical experience of the physician, but also has inaccuracies.
There is a need to design an electrode needle for an irreversible electroporation apparatus and a method of using the same that overcome the above-mentioned disadvantages.
Disclosure of Invention
An electrode needle is provided that is ultrasonically developable.
The electrode needle includes an electrode needle body adapted to receive an electrical pulse and apply an electric field in a predetermined direction. The electrode needle body includes a conductive region and an ultrasonically developable region on a surface thereof. The conductive region is adapted to apply an electric field in a predetermined direction for irreversible electroporation. The ultrasound developable area is suitable for accurately determining the size of an electrode needle actually inserted into a human body and the actual discharge size. The conductive region is formed of a conductive material. The ultrasonically developable region is formed of an ultrasonically developable material, for example by coating with an ultrasonically developable material. Alternatively, the ultrasonic development can be realized by changing the surface structure of the electrode needle.
In another embodiment, the electrode needle body further comprises an insulation region on a surface thereof. The insulating region has an area/width that is shorter than, equal to, or less than the area/width of the ultrasonically developable region. Optionally, the area/width of the insulating region overlaps or partially overlaps the area/width of the ultrasonically developable region. The insulating region can inhibit the electric field from spreading to the direction far away from the target biological tissue, and relieve the side effects of muscle contraction and the like. Preferably, the insulating region is formed of an insulating material, for example by coating with a coatable insulating material. The insulating material includes various coatable materials of organic materials and inorganic materials having insulating properties, heat resistance, and biocompatibility, for example, parylene and the like (for example, see WO 2018050025). WO2018050025 is herein incorporated by reference in its entirety.
Another aspect of the present application relates to an irreversible electroporation apparatus comprising: a pulse forming device configured to generate an electrical pulse; and one or more electrode needles according to the present application configured to receive electrical pulses from the pulse forming device to generate an electric field.
The present application provides, in another aspect, a method of treating a tumor using an irreversible electroporation apparatus including the electrode needle.
This application electrode needle can accurate definite actual electrode needle size and the actual size of discharging of inserting human when using, has avoided because of the inaccuracy that the operating personnel experience is not enough to bring. Further, since the size of the electrode needle actually inserted into the human body and the actual discharge size can be accurately determined, the irreversible electroporation apparatus including the electrode needle according to the present application can accurately apply an electric field to a diseased part (e.g., a tumor), improving the treatment effect.
Drawings
Fig. 1 is a schematic view of an electrode needle according to an embodiment of the present application.
Fig. 2 is a schematic view of an electrode needle according to an embodiment of the present application.
Fig. 3 is a schematic view of an electrode needle according to an embodiment of the present application.
Fig. 4 is a schematic view of an electrode needle according to an embodiment of the present application.
Description of the reference numerals
1: insulating region
2: ultrasonically developable areas
3: conductive region
4: electrode needle body
Detailed Description
Ultrasound visualizable means are commonly used in ultrasound guided catheter intervention procedures (see, for example, CN107335099A, CN103623493A, CN 204352312U). CN107335099A, CN103623493A, CN204352312U are incorporated herein by reference in their entirety.
At present, in an electrode needle of an irreversible electroporation apparatus, the use of an ultrasonic developable means has not been seen. The inventor of the application innovatively uses an ultrasonic developing means for the electrode needle of the irreversible electroporation equipment, and solves the technical problem that the size of the electrode needle inserted into the body of a patient and the actual discharge size cannot be accurately determined.
The electrode needle described herein includes an electrode needle body adapted to receive an electrical pulse and apply an electric field in a predetermined direction (e.g., a tumor direction). The electrode needle body includes a conductive region and an ultrasonically developable region on a surface thereof. The conductive region is adapted to apply an electric field in a predetermined direction for irreversible electroporation. The ultrasound developable area is suitable for accurately determining the size of an electrode needle actually inserted into a human body and the actual discharge size. The conductive region is formed of a conductive material. The ultrasonically developable region is formed of an ultrasonically developable material, for example by coating with an ultrasonically developable material, such as a polymeric developable material. When the ultrasonically developable region is formed by coating an ultrasonically developable material, the ultrasonically developable region may also be referred to as an ultrasonically developable coating. Alternatively, the ultrasonic development can be realized by changing the surface structure of the electrode needle.
In another embodiment, the electrode needle body further comprises an insulation region on a surface thereof. The insulating region has an area/width greater than, equal to, or less than the area/width of the ultrasonically developable region. Optionally, the area/width of the insulating region overlaps or partially overlaps the area/width of the ultrasonically developable region. The insulating region can inhibit the electric field from spreading to the direction far away from the target biological tissue, and relieve the side effects of muscle contraction and the like. Preferably, the insulating region is formed of, for example by coating, a coatable insulating material. The coatable insulating material includes coatable materials of various organic and inorganic materials having insulation properties, heat resistance and biocompatibility, for example, parylene, Polyetheretherketone (PEEK), and the like. When the insulating region is formed by coating an insulating material, the insulating region may also be referred to as an insulating coating.
In a preferred embodiment, the electrode needle described herein includes a conductive region, an ultrasonically developable region, and an insulating region.
One skilled in the art will appreciate that the electrode needles described herein may be fabricated/constructed in any manner so long as the surface thereof has the conductive regions, ultrasonically developable regions, and optionally insulating regions described herein.
In some embodiments, the terms "electrode needle" and "electrode needle body" described herein may be used interchangeably. In one embodiment, the electrode needle body may be entirely formed of a conductive material. The conductive material may be any conductive material as would occur to one skilled in the art, particularly a conductive material suitable for applying irreversible electroporation pulses, e.g., a conductive metallic material or the like, such as (304) stainless steel.
In one embodiment, a portion of the surface of the electrode needle body has an ultrasonically developable region and an insulating region. The insulating region has an area/width greater than, equal to, or less than the area/width of the ultrasonically developable region. Optionally, the area/width of the insulating region overlaps or partially overlaps the area/width of the ultrasonically developable region.
Preferably, the electrode needle described herein comprises one or more ultrasonically developable regions. The number of ultrasonically developable regions may be 1, 2, 3, 4, 5, 6 or more, preferably 2. When a plurality of the ultrasonically developable regions are contained, it is preferable that one ultrasonically developable region overlap with the insulating region and the area/width of the ultrasonically developable region is smaller than the area/width of the insulating region. The area/width of the remaining ultrasonically developable regions is greater than, less than, or equal to the area/width of the insulating region, and the remaining ultrasonically developable regions partially overlap, abut, or are spaced a suitable distance from the insulating region. Further, one end of one ultrasonically developable region may coincide with one end of the insulating region, and the coinciding end of the one ultrasonically developable region and the insulating region may abut the conductive region. The ultrasonically developable region may be insulating.
When the insulating region overlaps or partially overlaps with the ultrasound developable region, the insulating region is located above or below the ultrasound developable region in a radial direction of the electrode needle body. Preferably, the insulating region is located above the ultrasonically developable region in the radial direction of the electrode needle body, and this arrangement can avoid the risk of the ultrasonically developable material falling off.
The conductive area is located on top of the electrode needle, which may also be referred to as the exposed end. The size of the conductive area is also referred to as the actual discharge size. The insulating region and/or the ultrasound developable region are located at the bottom of the electrode needle. The tip of the electrode needle may have various shapes, such as a bevel shape inclined with respect to the axis of the electrode needle, or a needle tip shape converging to the axis of the electrode needle. The length of the conductive end is not particularly limited, and may be 1 to 20 cm, preferably 1 to 15 cm, more preferably 1 to 10 cm, for example 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 cm.
The length of the electrode needle described herein is not particularly limited. For example, the length of the electrode needle of the present application may be 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, or 70 centimeters. When in use, the electrode needle with a proper length can be selected by a person skilled in the art according to actual conditions, or the electrode needle can be cut into a proper length and then used. The surface of the electrode needle may be smooth or rough, preferably smooth.
The width of the insulating region is not particularly limited, for example, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65 cm. The insulating region is configured to inhibit propagation of the electric field away from the target biological tissue. The width of the insulation region refers to the width of the insulation region in the axial direction of the electrode needle.
The width of the ultrasonically developable region is not particularly limited. Preferably, the width of the ultrasonically developable region may be 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 millimeters. The number of ultrasonically developable regions may be 1, 2, 3, 4, 5, 6 or more, preferably 2. Further, when a plurality of the ultrasonically developable regions are contained, it is preferable that one ultrasonically developable region overlap with the insulating region, and the area/width of the ultrasonically developable region is smaller than that of the insulating region. The area/width of the remaining ultrasonically developable regions is greater than, less than, or equal to the area/width of the insulating region, and the remaining ultrasonically developable regions overlap, abut, or are spaced a suitable distance from the insulating region. The width of the ultrasonic developable area refers to the width of the ultrasonic developable area in the axial direction of the electrode needle.
Still further preferably, the electrode needle of the present application has two ultrasonically developable regions each having a width of 5 to 15 mm. The 1 st ultrasonic developable area overlaps with the insulating area, wherein one end of the 1 st ultrasonic developable area coincides with one end of the insulating area, the width of the 1 st ultrasonic developable area is smaller than the width of the insulating area, and the 1 st ultrasonic developable area and the overlapped end of the insulating area are adjacent to the conductive area. The 2 nd ultrasonically developable region also overlaps the insulating region. The 1 st ultrasonically developable area is spaced a suitable distance, for example 5-10 cm, such as 5, 6, 7, 8, 9, 10 cm, from the 2 nd ultrasonically developable area.
The ultrasonically developable region is formed of an ultrasonically developable material. The ultrasonically developable material comprises a material having a high acoustic impedance (greater than acoustic impedance), such as one or more of alumina, titania, and silica. Alternatively, the ultrasonic development may be realized by changing the surface structure of the electrode needle, for example, a part of the surface of the electrode needle may be configured to have a shape different from the surface shape of other parts, such as a recess, a thread, a step, etc.
Due to the existence of the ultrasonic developable area, the size of the electrode needle actually inserted into the human body and the actual discharge size can be easily determined by a person skilled in the art, and inaccuracy caused by insufficient experience of an operator is avoided, so that the irreversible electroporation equipment comprising the electrode needle can accurately apply an electric field to a diseased part (such as a tumor), so that medical staff can better execute a treatment plan, and the treatment effect is finally improved. Furthermore, the insulating region is located above the ultrasonically developable region, which can circumvent the risk of the ultrasonically developable material falling off.
The target biological tissue in the present application includes benign or malignant tumor, for example, the malignant tumor includes cancer of rectum, head and neck, lung, breast, esophagus, stomach, intestine, liver, pancreas, bile duct, gall bladder, kidney, ovary, bladder, or prostate, and the benign tumor includes hyperplasia of prostate or hyperplasia of mammary glands, etc. Those skilled in the art know that, when irreversible electroporation is performed on a target biological tissue (e.g., a tumor, etc.), the electric field application direction of the electrode needle is opposite to the target biological tissue to apply the electric field to the target biological tissue to ablate the target biological tissue (e.g., the tumor, etc.).
The electrode needles described herein may be used in irreversible electroporation devices, such as the irreversible electroporation devices described in CN106388932B, WO 2018050025. In use, a portion or the entire length of the electrode needle described herein is inserted into the patient, provided that the ultrasonically-developable region is inserted into the patient.
The present application also provides a method of preparing the electrode needle:
1) providing a commercially available electrode needle; and
2) disposing an ultrasonically developable structure or coating an ultrasonically developable material and/or an insulating material to form an ultrasonically developable region and/or an insulating region.
Another aspect of the present application relates to an irreversible electroporation apparatus comprising: a pulse forming device configured to generate an electrical pulse; and one or more electrode needles according to the present application configured to receive electrical pulses from the pulse forming device to generate an electric field.
The present application provides, in another aspect, a method for treating tumors using an irreversible electroporation apparatus including the electrode needle, including the step of detecting a size of the electrode needle inserted into a patient and an actual discharge size using an ultrasonic probe, wherein the detecting of the size of the electrode needle inserted into the patient and the actual discharge size using the ultrasonic probe is performed by detecting an ultrasonically developable region on the electrode needle inserted into the patient using the ultrasonic probe.
The present application provides, in another aspect, a use of the electrode needle in preparing an irreversible electroporation apparatus for treating tumor.
The present application provides in another aspect an electrode needle array, comprising: one or more electrode needles, the axes of the bodies of the one or more electrode needles being parallel to each other, wherein at least one of the one or more electrode needles is an electrode needle according to the present application.
Detailed Description
The following examples are given to facilitate a better understanding of the invention, but do not limit the invention. The methods in the following examples are conventional methods unless otherwise specified; the materials are commercially available, unless otherwise specified.
The electrode needle having an ultrasonically developable region according to the example was prepared according to the following method
1) Providing a commercially available electrode needle;
2) disposing an ultrasonically developable structure or coating an ultrasonically developable material to form an ultrasonically developable region; and
3) an insulating material is optionally applied to form an insulating region.
Example 1
The electrode needle is a 304 stainless steel electrode needle with the length of 30 centimeters. The top conductive area has a width of 10 cm. The electrode needle had an ultrasonically developable region with a width of 20 mm. The ultrasonically developable region is formed by providing a recessed shape in the region of the electrode needle surface. One end of the ultrasonically developable region abuts the top conductive region. The bottom region adjacent to the other end of the ultrasonically developable region may also serve as the second conductive region.
Example 2
The electrode needle is a 304 stainless steel electrode needle with the length of 40 cm. The top conductive area is 5 cm in length. The electrode needle also has an ultrasonically developable region and an insulating region. The ultrasonically developable region is formed by using a coatable material containing alumina at the region of the electrode needle surface. The insulating region is formed of parylene. The width of the ultrasonically developable region was 10 mm. The length of the insulating region is 35 cm. The ultrasonically developable region overlaps the insulating region, and one end of the ultrasonically developable region coincides with one end of the insulating region, the coinciding end being adjacent to the conductive region. The insulating region is located above the ultrasonically developable region in a radial direction of the electrode needle body.
Example 3
The electrode needle is a 304 stainless steel electrode needle with the length of 40 cm. The top conductive area is 5 cm in length. The length of the insulating region is 35 cm. The ultrasonically developable region is formed by using a coatable material containing titanium dioxide at the region of the electrode needle surface. The insulating region is formed of PEEK. The electrode needle also had two ultrasonically developable regions each having a width of 10 mm. The first ultrasonically developable region overlaps the insulating region, and one end of the first ultrasonically developable region coincides with one end of the insulating region, and the ultrasonically developable region and the coinciding end of the insulating region abut the conductive region. A second ultrasonically developable region also overlaps the insulating region. The 1 st ultrasonically developable area and the 2 nd ultrasonically developable area are spaced 5 cm from each other. The insulating region is located above the ultrasonically developable region in a radial direction of the electrode needle body.
Equivalents of
The foregoing examples are provided merely to illustrate the invention and are not to be construed as limiting the scope of the invention in any way. Obviously, many modifications and variations may be made to the embodiments and examples of the present invention described above without departing from the principles of the present invention. All such modifications and variations are intended to be covered by this application.
Claims (17)
1. An electrode needle for an irreversible electroporation apparatus, the electrode needle comprising an electrode needle body adapted to receive an electric pulse and apply an electric field to a predetermined direction, and comprising a conductive region and an ultrasonically developable region on a surface of the electrode needle body.
2. The electrode needle according to claim 1, wherein the electrode needle body further includes an insulation region on a surface thereof.
3. The electrode needle according to claim 2, wherein the insulating region is formed of an insulating material, such as parylene.
4. The electrode needle according to any one of claims 1 to 3, wherein the conductive region is formed of a conductive material (e.g., a conductive metal material).
5. The electrode needle according to any one of claims 1 to 3, wherein the ultrasonically developable region is formed by:
1) formed by ultrasonically developable materials, such as one or more of alumina, titania, and silica; or
2) Is formed by providing a portion of the surface of the electrode needle with a shape different from the surface shape of the other portion, such as a recess, a thread, a step, etc.
6. The electrode needle according to claim 5, wherein the number of the ultrasonically developable regions is 1 to 6, preferably 2.
7. The electrode needle according to any one of claims 1 to 3, wherein the electrode needle body is entirely formed of a conductive material.
8. The electrode needle according to any one of claims 2 to 3, wherein a width of the insulating region in the electrode needle axis direction is larger than, equal to, or smaller than a width of the ultrasonically developable region in the electrode needle axis direction.
9. The electrode needle according to any one of claims 2 to 3, wherein a width of the insulating region in the electrode needle axis direction overlaps or partially overlaps with a width of the ultrasonically developable region in the electrode needle axis direction.
10. The electrode needle according to claim 9, wherein the insulating region is located above or below the ultrasonically developable region in a radial direction from the electrode needle body; preferably, the insulating region is located above the ultrasonically developable region in a radial direction of the electrode needle body.
11. The electrode needle according to claim 6, wherein: the conductive area is positioned at the top of the electrode needle; the width of the ultrasonic developable area in the axial direction of the electrode needle is smaller than that of the insulating area in the axial direction of the electrode needle; the 1 st ultrasonic developable area is overlapped with the insulating area, one end of the 1 st ultrasonic developable area is overlapped with one end of the insulating area, and the overlapped ends of the 1 st ultrasonic developable area and the insulating area are adjacent to the conductive area; the remaining ultrasonically developable regions also overlap the insulating region.
12. An irreversible electroporation device, comprising: a pulse forming device configured to generate an electrical pulse; and one or more electrode needles according to the present application configured to receive electrical pulses from the pulse forming device to generate an electric field.
13. An electrode needle array, comprising: one or more electrode needles, the axes of the bodies of which are parallel to each other, wherein at least one of the one or more electrode needles is an electrode needle according to any one of claims 1 to 11.
14. Use of an electrode needle according to any one of claims 1 to 11 for the manufacture of an irreversible electroporation device for the treatment of tumors.
15. The use of claim 14, wherein the tumor comprises a benign or malignant tumor.
16. The use of claim 15, wherein the malignancy comprises rectal cancer, head and neck cancer, lung cancer, breast cancer, esophageal cancer, gastric cancer, intestinal cancer, liver cancer, pancreatic cancer, bile duct cancer, gallbladder cancer, renal cancer, ovarian cancer, bladder cancer, or prostate cancer.
17. The use of claim 15, wherein the benign tumor comprises prostate hyperplasia or breast hyperplasia.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910696724.7A CN112294431A (en) | 2019-07-30 | 2019-07-30 | Ultrasonic developable electrode needle for irreversible electroporation equipment |
| PCT/CN2020/105584 WO2021018217A1 (en) | 2019-07-30 | 2020-07-29 | Electrode needle for irreversible electroporation device, electrode needle array and device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910696724.7A CN112294431A (en) | 2019-07-30 | 2019-07-30 | Ultrasonic developable electrode needle for irreversible electroporation equipment |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN112294431A true CN112294431A (en) | 2021-02-02 |
Family
ID=74228820
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201910696724.7A Pending CN112294431A (en) | 2019-07-30 | 2019-07-30 | Ultrasonic developable electrode needle for irreversible electroporation equipment |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN112294431A (en) |
| WO (1) | WO2021018217A1 (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113907869A (en) * | 2021-10-08 | 2022-01-11 | 杭州维纳安可医疗科技有限责任公司 | Electrode needle assembly and ablation apparatus |
| CN113907868A (en) * | 2021-10-08 | 2022-01-11 | 杭州维纳安可医疗科技有限责任公司 | Electrode needle assembly and ablation apparatus |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10245098B2 (en) * | 2008-04-29 | 2019-04-02 | Virginia Tech Intellectual Properties, Inc. | Acute blood-brain barrier disruption using electrical energy based therapy |
| CN204352312U (en) * | 2014-12-04 | 2015-05-27 | 上海市同济医院 | A kind of myoelectricity guiding entry needle strengthening ultrasonic development |
| CN106388933B (en) * | 2016-09-14 | 2017-10-10 | 上海睿刀医疗科技有限公司 | Electrode for irreversible electroporation device |
| CN107095718A (en) * | 2017-06-06 | 2017-08-29 | 日照天生物医疗科技有限公司 | Radio-frequency ablation electrode and RF ablation device |
| CN107260300A (en) * | 2017-07-20 | 2017-10-20 | 常州朗合医疗器械有限公司 | Radio frequency ablation catheter and system |
| CN109833091A (en) * | 2017-11-28 | 2019-06-04 | 杭州诺诚医疗器械有限公司 | Melt needle assemblies and ablation system |
| CN109846548A (en) * | 2019-04-01 | 2019-06-07 | 浙江大学 | A kind of ultrasound and the two-in-one conduit of RF ablation of real-time monitoring |
-
2019
- 2019-07-30 CN CN201910696724.7A patent/CN112294431A/en active Pending
-
2020
- 2020-07-29 WO PCT/CN2020/105584 patent/WO2021018217A1/en active Application Filing
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113907869A (en) * | 2021-10-08 | 2022-01-11 | 杭州维纳安可医疗科技有限责任公司 | Electrode needle assembly and ablation apparatus |
| CN113907868A (en) * | 2021-10-08 | 2022-01-11 | 杭州维纳安可医疗科技有限责任公司 | Electrode needle assembly and ablation apparatus |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2021018217A1 (en) | 2021-02-04 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US20220265343A1 (en) | Radio-Frequency Electrical Membrane Breakdown for the Treatment of High Risk and Recurrent Prostate Cancer, Unresectable Pancreatic Cancer, Tumors of the Breast, Melanoma or Other Skin Malignancies, Sarcoma, Soft Tissue Tumors, Ductal Carcinoma, Neoplasia, and Intra and Extra Luminal Abnormal Tissue | |
| US6582426B2 (en) | Needle kit and method for microwave ablation, track coagulation, and biopsy | |
| EP2907464A1 (en) | Methods and systems for treating nerve structures | |
| US20170119465A1 (en) | Electrical ablation devices comprising an injector catheter electrode | |
| ES2240954T3 (en) | APPARATUS FOR THE THERAPEUTIC CAUTERIZATION OF DEFAULT VOLUMES OF BIOLOGICAL FABRIC. | |
| US9572623B2 (en) | Reusable electrode and disposable sheath | |
| US10376674B2 (en) | System and method for targeted delivery of therapeutic agents to tissue | |
| US9662165B2 (en) | Device and method for heat-sensitive agent application | |
| JP2017527395A5 (en) | ||
| JPH08510148A (en) | Medical probe with stylet | |
| US20180028267A1 (en) | Radio-frequency electrical membrane breakdown for the treatment of benign prostatic hyperplasia | |
| CA3147592A1 (en) | Treatment of the reproductive tract with pulsed electric fields | |
| CN112294431A (en) | Ultrasonic developable electrode needle for irreversible electroporation equipment | |
| CN212788678U (en) | Electrode needle for irreversible electroporation device, electrode needle array | |
| JP6663461B2 (en) | Endoscopic cancer treatment system | |
| Malyško-Ptašinskė et al. | Invasive and non-invasive electrodes for successful drug and gene delivery in electroporation-based treatments | |
| Cindrič et al. | Electrodes and electric field distribution in clinical practice | |
| Wei et al. | The interventional therapeutics of irreversible electroporation for pancreatic cancer | |
| RU2231991C2 (en) | Method for treating unresectable primary and metastatic hepatic tumors | |
| US20230338081A1 (en) | System and method for minimally invasive treatment with injectable electrodes | |
| CA3195583A1 (en) | System and method for minimally invasive treatment with injectable electrodes | |
| Steinke | Radiofrequency ablation (RFA) | |
| Melodelima et al. | 5A-4 Thermal Ablation by Ultrasound: Increasing the Coagulated Volume | |
| Steinke | 5.1 Radiofrequency Ablation (RFA) | |
| Melodelima et al. | Thermal Ablation by High‐Intensity‐Focused Ultrasound Using a Toroid Transducer Increases the Coagulated Volume and Allows Coagulation Near Portal and Hepatic veins in Pigs |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| CB02 | Change of applicant information |
Address after: 200135 3rd floor, 2123 Pudong Avenue, Pudong New Area pilot Free Trade Zone, Shanghai Applicant after: Shanghai RuiDao Medical Technology Co.,Ltd. Address before: 200135 3rd floor, 2123 Pudong Avenue, Pudong New Area pilot Free Trade Zone, Shanghai Applicant before: SHANGHAI REMEDICINE Co.,Ltd. |
|
| CB02 | Change of applicant information |