WO2008061528A1 - Medical device for substantially uniform ablation of animal or human surface tissue - Google Patents

Medical device for substantially uniform ablation of animal or human surface tissue Download PDF

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Publication number
WO2008061528A1
WO2008061528A1 PCT/DK2006/000652 DK2006000652W WO2008061528A1 WO 2008061528 A1 WO2008061528 A1 WO 2008061528A1 DK 2006000652 W DK2006000652 W DK 2006000652W WO 2008061528 A1 WO2008061528 A1 WO 2008061528A1
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Prior art keywords
electrodes
polarity
medical device
ablation
electrode
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PCT/DK2006/000652
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French (fr)
Inventor
Kamran Behzadian
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Kamran Behzadian
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Priority to PCT/DK2006/000652 priority Critical patent/WO2008061528A1/en
Publication of WO2008061528A1 publication Critical patent/WO2008061528A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/14Probes or electrodes therefor
    • A61B18/1477Needle-like probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/14Probes or electrodes therefor
    • A61B18/148Probes or electrodes therefor having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1467Probes or electrodes therefor using more than two electrodes on a single probe

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Otolaryngology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Plasma & Fusion (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

The present invention relates to a medical device for substantially uniform ablation of animal or human surface tissue, the device comprising a generator for generating radio frequency energy, an applicator probe comprising a cluster of at least three electrodes, said cluster of at least three electrodes being arranged in a substantially planar manner on a substantially planer member of the applicator probe, and a polarity alternator operatively connected to the generator and the at least three electrodes, the polarity alternator being adapted to automatically change polarity of at least one of the electrodes during ablation so as to form lesions about at least two electrodes, the polarity alternator further being adapted to repeatedly cycling lesion formation over a length of the electrode cluster during ablation so as to create a substantial and uniform ablation about at least two electrodes.

Description

MEDICAL DEVICE FOR SUBSTAISTFTALLY UNIFORM ABLATION OF ANIMAL OR HUMAN SURFACE TISSUE
FIELD OF THE INVENTION
The present invention relates generally to a method and apparatus for utilizing bipolar radio frequency energy for creating a uniform ablation zone suitable for treating superficial malignant and benign lesions on human or animal organ tissue.
BACKGROUND OF THE INVENTION
Radio frequency electrical energy has been used in medical procedures for many years for the treatment of soft tissue. Radio frequency (RF) ablation occurs from a high frequency alternating electrical current flowing from a high voltage applicator or catheter electrode(s) to return electrode(s) through the electric field set up between the two polarities within the surrounding tissue. The objective of RF-ablation is to heat tissues to 50 - 100 degrees centigrade for 4 - 6 minutes without causing charring or vaporization. Under these conditions there is almost instantaneous cellular protein denaturation, melting of lipid bilayers and destruction of DNA, RNA and key cellular enzymes. This is commonly known as cell necrosis. However, encountered difficulties with such applicator probes or catheters are that when applied to a surface, it is difficult to achieve a uniform zone of ablation that only treats the surface tissue to a uniform depth.
When a lesion is encountered on the surface of human or animal organs, surface tissue is dissected or another method is used to cause lesion cell necrosis such as freezing the surface tissue.
US 6,447,506 discloses a device for creating lesions in body tissue. The device suggested in US 6,447,506 involves a support element having an electromagnetic energy emitting region. During emission of electromagnetic energy the region creates a long and thin continuous lesion having a length that is substantially greater than its width. The device suggested in US 6,447,506 is intended for ablation of heart inner surface tissue or non-surface body tissue only in that the probe of the device is adapted to be inserted into the body tissue by penetrating the skin of the patient or the device is adapted to be placed into the heart through the vascular pathways. The device of US 6,447,506 is, due to its geometry, not suitable for treatment of wide surface tissue and can only produce linear ablation zones. It is an object of the present invention to provide a bipolar apparatus and method for ablating a substantially wide surface lesion uniformly and to a uniform depth with radiofrequency electrical energy.
SUMMARY OF THE INVENTION
The above-mentioned object is complied with by providing, in a first aspect, a medical device for substantially uniform ablation of animal or human surface tissue, the device comprising:
- a generator for generating radio frequency energy;
- an applicator probe comprising a cluster of at least three electrodes, said cluster of at least three electrodes being arranged in a substantially planar manner on a substantially planer member of the applicator probe; and
- a polarity alternator operatively connected to the generator and the at least three electrodes, the polarity alternator being adapted to automatically change polarity of at least one of the electrodes during ablation so as to form lesions about at least two electrodes, the polarity alternator further being adapted to repeatedly cycling lesion formation over a length of the electrode cluster during ablation so as to create a substantial and uniform ablation about at least two electrodes
The applicator probe may further comprise a handle to ease handling of the applicator probe. The electrodes may be electrically insulated from each other. This implies that the electrodes may be operated in an independent manner. The at least three electrodes may be spaced evenly along a width of the substantially planar member, or alternatively, the at least three electrodes may be spaced unevenly along a width of the substantially planar member.
The generator may be adapted to generate radio frequency energy in the frequency range 200 kHz - 1.2 MHz.
The at least three electrodes may have dissimilar outer surface areas, said outer surface areas being adapted to be exposed to animal or human surface tissue. In addition, the at least three electrodes may comprise an electrically conductive matter or precious metal- plated material.
Each of the at least three electrodes may be shaped to form a substantially linear electrode. The substantially linear electrodes may be arranged in a substantially parallel manner on a substantially planar and rigid member. Alternatively, the substantially planar member may be a flexible member that is allowed to follow contours of the human or animal body.
The substantially planar member may support a first, a second and a third group of substantially linearly shaped electrodes. Each group of electrodes may comprise at least three electrically connected electrodes.
In a second aspect, the present invention relates to a method for substantially uniform ablation of animal or human surface tissue, the method comprising the steps of:
- placing a substantially planer member adjacent to the surface tissue, said substantially planar member supporting a cluster of at least three electrodes arranged in a substantially planar manner;
- applying a dissimilar polarity to the at least three electrodes such that a total surface area of electrodes carrying a first voltage polarity is unequal to a total surface area of an electrode or electrodes carrying a second voltage polarity, thereby creating a higher current density about the electrode or electrodes with the smallest total surface area, said higher current density being sufficient to cause ablation of tissue;
- automatically changing the polarity of at least one of the electrodes so as to spatially shift the higher current density from a first electrode to a second electrode; and
- repeatedly changing polarity of at least one of the electrodes during ablation so as to create a substantially wide and uniform ablation about at least two electrodes.
According to the second aspect, the changing of the polarity of at least one of the electrodes may involve changing from a positive voltage polarity to a neutral or negative voltage polarity. Alternatively or in addition, the changing of the polarity of at least one of the electrodes may involve changing from a neutral voltage polarity to a positive or negative voltage polarity. Alternatively or in addition, the changing of the polarity of at least one of the electrodes may involve changing from a negative voltage polarity to a neutral or positive voltage polarity.
According to the second aspect of the present invention, a time period to ablate tissue exposed to the higher current density is within the range 0.5 to 10 seconds, such as within the range 2 to 5 seconds. BRIEF DESCRIPTION OF THE INVENTION
The present invention will now be explained with reference to the accompanying figures, wherein
Figure 1 shows an ablation system,
Figure 2 shows a front view of the electrodes on a flat applicator face with wiring diagram and a polarity alteration table,
Figure 3A, B, C show a cross- section A-A of electrodes in Figure 2 during ablation,
Figure 4 shows the surface of an example lesion in muscle tissue, and
Figure 5 shows the cross section of the example lesion.
While the invention is susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and will be described in detail herein. It should be understood, however, that the invention is not intended to be limited to the particular forms disclosed. Rather, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.
DETAILED DESCRIPTION OF THE INVENTION
In general, the present invention relates to a device for radio frequency ablation of a surface lesion on human or animal organs.
Figure 1 shows a bipolar ablation system according to the present invention. As seen, the system comprises a bipolar radio frequency generator 1, a polarity alternator 2, and a bipolar applicator probe 3 with a substantially flat or planar surface supporting a cluster 6 of electrodes. The bipolar generator 1 may be a conventional general purpose electrosurgical power supply operating at a frequency in the range of about 200 kHz to about 1.2 MHz, with a conventional sinusoidal or non-sinusoidal wave form.
The bipolar generator 1 has a high voltage polarity 4 and a return polarity 5. Such power supplies, which are commercially available, are capable of controlling power output in response to measured temperature, current, voltage, or impedance from an applicator probe. In addition such power supplies may be activated in responds to a set time period or time interval. The polarity alternator 2 provides electrical connection to individual electrodes in the cluster 6. Furthermore, the polarity alternator 2 is capable of altering electrode potentials from high voltage polarity to return polarity or neutral and from return polarity to high voltage polarity or neutral. The altering of polarity can be done dynamically and automatically by repeating the polarity alterations during ablation.
The applicator probe 3 shown in Figure 1 comprises a handle 7 with a substantially flat surface 8 supporting a cluster 6 of substantially flat electrodes (item 9 in Figure 2). The number of electrodes can be adjusted to match specific applications. The substantially fiat surface 8 is made of an electrically non-conductive material so as to provide electrical insulation between the electrodes. The substantially flat surface 8 may be rigid or flexible.
The polarity alternator 2 shown in Figure 2 is depicted as a stand- alone instrument. However, it may optionally form an integral part of the generator 1, or form an integral part of the applicator handle 7.
Figure 2 shows a bottom view of an example of an applicator probe. The applicator probe depicted in Figure 2 comprises a cluster 6 of substantially flat electrodes 9. The electrodes are placed in a substantially parallel manner on the substantially flat surface 8 of the applicator 3. The electrodes are wired in series as shown in Figure 2 so as to form three groups of electrodes El, E2, and E3. In the example shown in Figure 2 each group of electrodes El, E2, and E3 consists of five electrodes, but the number of electrodes per group can be different from five.
Figure 2 also shows a table illustrating polarity alteration. It is appreciated that the polarity alteration table in Figure 2 is one possible method of dynamically repeating lesion formation about a substantially flat array of electrodes and cycling lesion formation over the width of the cluster during ablation. It is appreciated that there are many formats for dynamically changing polarities to repeatedly cycle lesion formation over the length of a cluster of electrodes.
Figure 3A through 3C show an A-A cross-sectional view of the applicator surface 8 in Figure 2. In addition, the resulting electric field formation when the polarity of electrodes is arranged and altered by the polarity alternator 2 is depicted in Figure 3A through 3C. Tissue ablation takes place about electrodes with higher current density about them. Alteration of polarity is dynamically and automatically repeated to cycle lesion formation through sets of electrodes during ablation and will ultimately result in a lesion of uniform depth covering the area of tissue that is adjacent to the electrodes. Figure 3A shows dissimilar polarity by electrode group El being energized with high voltage 4 which is denoted by a "+" sign, while electrode groups E2 and E3 are being energized with return polarity 5 which is denoted by a "-" sign. Dissimilar surface areas between electrodes El, that are charged with + polarity, and E2 and E3, which are charged with - polarity, allows the electric field and therefore electric current density to be higher about electrodes El 11 and lower about electrodes E2 and E3 12. Therefore, by producing a higher current density in some regions 11 and lower current density in other regions 12 the ablation heat generation is greatest about electrode group El resulting in lesion generation 13 in tissue 14 for a time period, T.
The next step is depicted in Figure 3B. Figure 3B shows dissimilar polarity by electrode groups El and E2 being energized with high voltage, +, and electrode group E3 being energized with return polarity, -. Dissimilar surface areas allow the electric field and therefore the electric current density to be higher about electrode group E3 11 and lower about electrode groups El and E2 12. Therefore, by producing a higher current density in some regions 11 and lower current density in other regions 12 the ablation heat generation is greatest about electrode group E3 resulting in lesion generation 13 in tissue 14 for a time period, T.
The next step is depicted in Figure 3C. Figure 3C shows dissimilar polarity by electrode groups El and E3 being energized with high voltage, +, and electrode group E2 being energized with return polarity, -. Dissimilar surface areas allow the electric field and therefore electric current density to be higher about electrode group E2 11 and lower about electrode groups El and E3 12. Therefore, by producing a higher current density in some regions 11 and lower current density in other regions 12 the ablation heat generation is greatest about electrode group E2 resulting in lesion generation 13 in tissue 14 for a time period, T.
Lesion formation is independent of polarity in that it forms where a higher current density is present. Furthermore, the current density is independent of polarity and only a function of active surface area. Ablation lesion will form about the electrodes with the higher current density around them and irrespective of a particular polarity. Therefore, electrodes with high voltage polarity or return polarity in Figure 3A through 3C may have their polarities altered in order to shift high current density to the tissue adjacent to a different set of electrodes.
The polarity alteration is dynamically and automatically repeated to cycle lesion formation through the cluster of substantially flat electrodes as shown in table in Figure 2 at a time interval T. The polarity alternator will then automatically and rhythmically change the polarity of the electrodes at a time interval of 0.5 to 10 seconds. A lesion is initiated by power input to the electrode cluster. The software in the generator determines a power setting for each applicator. Determination of lesion formation and completion is accomplished by monitoring electrical current and voltage to electrodes in circuitry embedded within the generator 1 or polarity alternator 2. The electrical characteristics, such as impedance, of the tissue under treatment are calculated by the circuitry based on the monitored voltage and current characteristics of the lesion that is being formed around the electrodes.
A lesion is formed as tissue cell necroses takes place. As cells change composition while the tissue is heated, the average electrical impedance of the volume of tissue where electric current is contained continuously increases until full necroses of all cells in the volume of tissue where electric field is present takes place. A lesion grows to the size of the electric field because that is where electrons responsible for ablation are present. As lesion is formed and grows to the size of the electric field, the average impedance of tissue where electric energy is present increases until full lesion formation. Average impedance measured between electrodes does not increase any further when a lesion of the size of the electric field about a linear array of electrodes is formed.
Lesion formation may be verified on the surface of various animal organs such as muscle tissue, liver tissue, kidney tissue, lung tissue, etc.
Figure 4 shows the surface of muscle tissue after an example lesion. In this example the lesion is approximately 2cm by 2cm. Example lesion is in muscle tissue and was made with about 5 watts at T= 2 second lesion formation intervals in table in Figure 2 in about 1.5 minutes.
Figure 5 is a picture of the example lesion of Figure 4 sectioned in half. The uniform lesion is about 1.5 to 2mm deep. Figure 5 shows the uniform nature of the formed lesion.

Claims

1. A medical device for substantially uniform ablation of animal or human surface tissue, the device comprising:
- a generator for generating radio frequency energy;
- an applicator probe comprising a cluster of at least three electrodes, said cluster of at least three electrodes being arranged in a substantially planar manner on a substantially planer member of the applicator probe; and
- a polarity alternator operatively connected to the generator and the at least three electrodes, the polarity alternator being adapted to automatically change polarity of at least one of the electrodes during ablation so as to form lesions about at least two electrodes, the polarity alternator further being adapted to repeatedly cycle lesion formation over a length of the electrode cluster during ablation so as to create a substantially wide and uniform ablation about at least two electrodes
2. The medical device according to claim 1, wherein the applicator probe further comprises a handle.
3. The medical device according to claim 1 or 2, wherein the electrodes are electrically insulated from each other.
4. The medical device according to any of claims 1-3 wherein the generator is adapted to generate radio frequency energy in the frequency range 200 kHz - 1.2 MHz.
5. The medical device according to any of claims 1-4, wherein the at least three electrodes are spaced evenly along a width of the substantially planar member.
6. The medical device according to any of claims 1-4, wherein the at least three electrodes are spaced unevenly along a width of the substantially planar member.
7. The medical device according to any of claims 1-6, wherein the at least three electrodes have dissimilar outer surface areas, said outer surface areas being adapted to be exposed to animal or human surface tissue.
8. The medical device according to any of claims 1-7, wherein each of the at least three electrodes comprises an electrically conductive matter or precious metal-plated material.
9. The medical device according to any of claims 1-8, wherein each of the at least three electrodes is shaped to form a substantially linear electrode, and wherein the substantially linear electrodes are arranged in a substantially parallel manner.
10. A medical device according to any of the claims 1-9, wherein the substantially planar member is a substantially rigid member.
11. A medical device according to any of the claims 1-9, wherein the substantially planar member is a flexible member.
12. A medical device according to any of the claims 1-11, wherein the substantially planar member supports a first, a second and a third group of substantially linearly shaped electrodes, and wherein each group of electrodes comprises at least one electrically connected electrode.
13. A method for substantially uniform ablation of animal or human surface tissue, the method comprising the steps of:
- placing a substantially planer member adjacent to the surface tissue, said substantially planar member supporting a cluster of at least three electrodes arranged in a substantially planar manner;
- applying a dissimilar polarity to the at least three electrodes such that a total surface area of electrodes carrying a first voltage polarity is unequal to a total surface area of an electrode or electrodes carrying a second voltage polarity, thereby creating a higher current density about the electrode or electrodes with the smallest total surface area, said higher current density being sufficient to cause ablation of tissue;
- automatically changing the polarity of at least one of the electrodes so as to spatially shift the higher current density from a first electrode to a second electrode; and
- repeatedly changing polarity of at least one of the electrodes during ablation so as to create a substantial and uniform ablation about at least two electrodes.
14. The method according to claim 13, wherein the changing of the polarity of at least one of the electrodes involves changing from a positive voltage polarity to a neutral or negative voltage polarity.
15. The method according to claim 13, wherein the changing of the polarity of at least one of the electrodes involves changing from a neutral voltage polarity to a positive or negative voltage polarity.
16. The method according to claim 13, wherein the changing of the polarity of at least one of the electrodes involves changing from a negative voltage polarity to a neutral or positive voltage polarity.
17. The method according to any of claims 13-16, wherein a time period to ablate tissue exposed to the higher current density is within the range 0.5 to 10 seconds, such as within the range 2 to 5 seconds.
PCT/DK2006/000652 2006-11-22 2006-11-22 Medical device for substantially uniform ablation of animal or human surface tissue WO2008061528A1 (en)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3045134A1 (en) * 2015-01-14 2016-07-20 Covidien LP Arrangement of multi-channel bipolar electrode zones to minimize leakage and edge effects
US9743981B2 (en) 2013-10-25 2017-08-29 Covidien Lp Unfurling electrode devices with spring
US9763733B2 (en) 2013-10-25 2017-09-19 Covidien Lp Unfurling electrode devices with the multiple longitudinal electrode segments
US10149716B2 (en) 2015-02-02 2018-12-11 Covidien Lp Self-sizing catheter features to prevent over-tightening of the electrode
US10278776B2 (en) 2004-01-09 2019-05-07 Covidien Lp Devices and methods for treatment of luminal tissue

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US5562720A (en) * 1992-05-01 1996-10-08 Vesta Medical, Inc. Bipolar/monopolar endometrial ablation device and method
US6156060A (en) * 1998-07-31 2000-12-05 Surx, Inc. Static devices and methods to shrink tissues for incontinence
US20030069573A1 (en) * 2001-10-09 2003-04-10 Kadhiresan Veerichetty A. RF ablation apparatus and method using amplitude control
EP1459695A1 (en) * 2003-03-21 2004-09-22 Ethicon Endo-Surgery, Inc. Medical device with improved wall construction

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5562720A (en) * 1992-05-01 1996-10-08 Vesta Medical, Inc. Bipolar/monopolar endometrial ablation device and method
US6156060A (en) * 1998-07-31 2000-12-05 Surx, Inc. Static devices and methods to shrink tissues for incontinence
US20030069573A1 (en) * 2001-10-09 2003-04-10 Kadhiresan Veerichetty A. RF ablation apparatus and method using amplitude control
EP1459695A1 (en) * 2003-03-21 2004-09-22 Ethicon Endo-Surgery, Inc. Medical device with improved wall construction

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10278776B2 (en) 2004-01-09 2019-05-07 Covidien Lp Devices and methods for treatment of luminal tissue
US10856939B2 (en) 2004-01-09 2020-12-08 Covidien Lp Devices and methods for treatment of luminal tissue
US9743981B2 (en) 2013-10-25 2017-08-29 Covidien Lp Unfurling electrode devices with spring
US9763733B2 (en) 2013-10-25 2017-09-19 Covidien Lp Unfurling electrode devices with the multiple longitudinal electrode segments
US9918789B2 (en) 2013-10-25 2018-03-20 Covidien Lp Unfurling electrode devices with the protection element
US10898263B2 (en) 2013-10-25 2021-01-26 Covidien Lp Unfurling electrode devices
EP3045134A1 (en) * 2015-01-14 2016-07-20 Covidien LP Arrangement of multi-channel bipolar electrode zones to minimize leakage and edge effects
CN105769330A (en) * 2015-01-14 2016-07-20 柯惠有限合伙公司 Arrangement Of Multi-channel Bipolar Electrode Zones To Minimize Leakage And Edge Effects
AU2015249116B2 (en) * 2015-01-14 2017-08-17 Covidien Lp Arrangement of multi-channel bipolar electrode zones to minimize leakage and edge effects
US10368934B2 (en) 2015-01-14 2019-08-06 Covidien Lp Arrangement of multi-channel bipolar electrode zones to minimize leakage and edge effects
US10631910B2 (en) 2015-01-14 2020-04-28 Covidien Lp Arrangement of multi-channel bipolar elecrode zones to minimize leakage and edge effects
US10149716B2 (en) 2015-02-02 2018-12-11 Covidien Lp Self-sizing catheter features to prevent over-tightening of the electrode

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