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WO2019121328A1 - Applicateur en forme d'aiguille - Google Patents

Applicateur en forme d'aiguille Download PDF

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Publication number
WO2019121328A1
WO2019121328A1 PCT/EP2018/084782 EP2018084782W WO2019121328A1 WO 2019121328 A1 WO2019121328 A1 WO 2019121328A1 EP 2018084782 W EP2018084782 W EP 2018084782W WO 2019121328 A1 WO2019121328 A1 WO 2019121328A1
Authority
WO
WIPO (PCT)
Prior art keywords
applicator
ablation
spreading
living
section
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.)
Ceased
Application number
PCT/EP2018/084782
Other languages
German (de)
English (en)
Inventor
Enrico Pannicke
Urte Kägebein
Frank Wacker
Bennet Hensen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medizinische Hochschule Hannover
Otto Von Guericke Universitaet Magdeburg
Original Assignee
Medizinische Hochschule Hannover
Otto Von Guericke Universitaet Magdeburg
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Medizinische Hochschule Hannover, Otto Von Guericke Universitaet Magdeburg filed Critical Medizinische Hochschule Hannover
Publication of WO2019121328A1 publication Critical patent/WO2019121328A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • A61B18/1477—Needle-like probes
    • 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
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/1815—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
    • 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
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00029—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids open
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00184—Moving parts
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/00267—Expandable means emitting energy, e.g. by elements carried thereon having a basket shaped structure
    • 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
    • A61B2018/00577—Ablation
    • 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

Definitions

  • the invention relates to a needle-shaped applicator for carrying out minimally invasive tissue ablations in the body of a living being, wherein the applicator has a needle-shaped ablation-active section in a distal region, from which the tissue ablation is feasible by irradiation of an energy signal, and one from the distal Area remote proximal region for handling the applicator has.
  • ablation For the therapeutic removal of tumors the so-called ablation is used.
  • thermal ablation destruction of the tumor occurs, e.g. through the targeted guidance of heat, which can be introduced, inter alia, by microwave radiation.
  • a so-called applicator is used, which has a distal needle-shaped portion from which the microwave radiation is emitted.
  • Such a microwave applicator is known, for example, from EP 2 664 358 B1.
  • Tissue ablation can also be performed by IRE (Irreversible Electroporation).
  • IRE irreversible Electroporation
  • the energy signal emitted by the applicator can be emitted in the form of a low-frequency or high-frequency field.
  • the object of the invention is to improve the function and range of use of such an applicator.
  • the applicator has at least one hollow channel extending at least from the ablation-active section to the proximal region, which channel is for transporting at least one gaseous, liquid or solid medium or a mixture thereof out of the animal to an analyzer and / or is set up by a therapy device into the living being, b) the applicator has at least one spreading section, in which by means of a spreading mechanism of the applicator, the diameter of the applicator can be increased arbitrarily with respect to the end-side diameter of the distal region and reduced again to the original diameter.
  • the additional hollow channel proposed in the applicator makes it possible to expand the function of the applicator, which was hitherto restricted to the pure emission of the energy signal, by further additional medical functions.
  • gaseous, liquid or solid media or mixtures thereof can be taken from the living organism through the hollow channel.
  • gases released by the ablation can be reliably removed so that they can no longer disturb the further performance of the ablation. Otherwise it may happen that, due to the unequipped gases, bulky ablation areas are formed and thus more tissue is removed than is necessary for the complete treatment of the tumor.
  • the media transported through the hollow channel can be analyzed after aspiration, which, for example, can give additional information about the composition of the tumor.
  • detection and differentiation of healthy and diseased tissue is possible.
  • the hollow channel can also be used to introduce media into the subject from a therapy device, e.g. medical agents.
  • the applicator can also have a plurality of the aforementioned hollow channels, for example a hollow channel for transporting a medium out of the living organism and a hollow channel separate therefrom for transporting a medium into the living organism.
  • the respective hollow channel can, for example, be connected via a hose to an analysis device or a therapy device.
  • the analyzer may e.g. to be a gas chromatograph.
  • the hollow channel is suitable, for example, for the application of fluids for the preparation of the treatment, for example saturation of the tumor with particles which increase the ablation effect. Another possibility is the introduction of gases to break up the tumor.
  • the heat generated by the emission of the energy signal in the tissue is only used to trigger the ablation process and an additional chemical introduced thereby initiates an exothermic chemical reaction.
  • the applicator also has the aforementioned spreading with the Sp Drurmecha- mechanism. This allows additional functionality of the applicator both for the radiation of the energy signal and for additional therapeutic approaches. For example, elements of the spreading mechanism or components mounted thereon may be used to perform a biopsy.
  • the diameter of the ablation-active portion of the applicator can be dynamically adjusted to the particular application, i. the dimensions of the tumor, to be adjusted. It is also possible to ablate larger tumors than with known applicators.
  • the energy signal may be applied by the applicator, for example, in the form of continuous low frequency (e.g., radio frequency) or high frequency (e.g., microwave) fields. Another option is the use of pulsed
  • tissue beabing can be carried out by any desired thermal or non-thermal method.
  • the spreading section is arranged between the distal end of the applicator and the proximal region, in particular in the ablation-active section or at a small distance therefrom.
  • the distance between the expansion section and the ablation-active section may, for example, be less than three times the diameter of a portion of the applicator adjacent to the expansion section.
  • the distal end of the applicator is understood to be the end of the distal region.
  • the spreading mechanism thus causes the increase in diameter not at the distal end of the applicator, but in the ablation-active region, which is not arranged at the outermost distal end of the applicator.
  • the Spreading improve the functionality of the applicator in the emission of the energy signal and additionally support.
  • the delivery of the energy signal in the expansion section it can be designed to cut mechanically and / or thermally.
  • the spreading mechanism prefferably has a plurality of spreading arms distributed over the circumference of the applicator, which are radially extendable.
  • the spreading arms may in particular be designed as rigid spreading arms, i. as substantially rigid spreading arms. In this way, the multifunctional applicability of the applicator according to the invention is further promoted.
  • the applicator in the spreading section has at least one tool which can be extended in the radial direction by means of the spreading mechanism.
  • the tool may e.g. a cutting tool, e.g. a blade or a knife such as a hydraulic knife.
  • samples can be taken by biopsy.
  • the tumor tissue can be cut open or broken up as a preparatory measure for the ablation.
  • the applicator has at least one outer sleeve and an electrical inner conductor guided through the outer sleeve for guiding the energy signal to the ablation-active section, wherein at least one longitudinal section of the outer sleeve is longitudinally displaceable relative to the inner conductor , This also makes it possible to further improve the application possibilities of the applicator.
  • the longitudinally displaceable portion of the outer sleeve is coupled to the spreading mechanism such that upon actuation of the spreading mechanism at the same time a longitudinal displacement of the longitudinally displaceable portion of the outer sleeve is carried out against the inner conductor.
  • This can be realized, for example, by the fact that the longitudinally displaceable portion is coupled via the spreading mechanism with a further subsection of the outer sleeve, which is coupled to the inner conductor and, accordingly, is not longitudinally displaceable relative to the inner conductor. In this way, the spreading mechanism has sufficient freedom of movement at the same time stable coupling of the longitudinally displaceable part section.
  • the applicator has antenna elements that can be extended by the spreading mechanism in the expansion section, by means of which the energy signal can be emitted for carrying out the tissue beabing. In this way, the energy signal can be emitted in an enlarged volume region near the tumor tissue to be ablated. The local area of application of the applicator is thereby increased.
  • the hollow channel is connected to a plurality of ablation-active section, the outer shell of the applicator perforating openings is connected.
  • the openings may be e.g. annularly disposed on the outer surface of the applicator, e.g. in the form of a fine-meshed net or sieve. This makes it possible to apply gases or liquids or fine-grained solids in the living organism or to remove them from the tissue. In particular, a large-scale gas extraction is possible.
  • the applicator is designed as a multi-function applicator, which is adapted to carry out at least one therapeutic and / or diagnostic additional medical function in addition to tissue ablation. This also further improves the applicability of the applicator, which is accompanied by improved protection of the treated living being. In this way, the invention allows extended possibilities for diagnosis and therapy, without the applicator having to be removed from the living being during a treatment in the meantime.
  • an additional function is the introduction of a therapeutic medium through the applicator into the living being and / or the sampling of at least one medium by the applicator from the living being.
  • the one or more hollow channels can be used.
  • the applicator has a substantially cylindrical body, which tapers to a tip at the distal end.
  • Figure 1 shows an ablation device
  • FIG. 1 Figures 2 to 4 embodiments of an applicator in an enlarged side view.
  • the ablation device shown in FIG. 1 has an applicator 1, which is connected via lines 10, 11, 12 to further components 13, 14, 15 of the ablation device.
  • the applicator 1 has a proximal region 5, which serves for manual handling of the applicator 1.
  • a grip area for manual gripping of the applicator 1 may be present.
  • the applicator 1 also has a distal region 2, which serves to emit an energy signal for performing a tissue ablation and is accordingly to be introduced into a patient.
  • the applicator 1 ends in the distal region 2 with the distal end 6.
  • the distal region 2 is connected to the proximal region 5 via a connection region 4.
  • the distal region 2 can also connect directly to the proximal region 5.
  • the distal region 2 has an ablation-active section 3, in which the energy signal is emitted.
  • the applicator 1 is needle-shaped at least in this ablation-active section 3, ie pointed and with a small diameter.
  • the needle-shaped portion may have a circular cross section, so that a total of approximately one cylinder shape results in this range.
  • an electrical inner conductor 7 is arranged, which may be formed, for example, as a waveguide to give this inner conductor 7 a certain mechanical stability.
  • the inner conductor 7 serves to guide the energy signal to be emitted by an energy signal generator 14, e.g. a microwave generator, ablation-active section 3.
  • the output signal of the energy signal generator 14 may, for example, be connected to the inner conductor 7 via a coaxial cable 10.
  • the applicator 1 additionally has at least one hollow channel, in which case two hollow channels 8, 9 are shown in the game.
  • a hollow channel 8, 9 advantageously extends from the ablation-active section 3 in the direction of the proximal region 5, wherein the extent of the hollow channel 8, 9 does not have to extend completely to the proximal region 5, but also in advance, for example. binding section 4, branch off and can be led out of the applicator 1.
  • hollow channels 8, 9 extending completely through to the proximal region 5 are assumed, and the lines 11, 12 formed on the proximal end of the applicator 1 via, for example, hoses are connected to the components 13, 15 could be.
  • the hollow channel 8 can be used to transport gaseous, liquid or solid media or a mixture thereof from the ablation-active section 3 of the applicator 1 to an analytical device, e.g. a gas chromatograph, trained component 15 serve.
  • the hollow channel 9 can serve for the implantation of media into the patient, e.g. by introducing such a medium from a therapy device 13 via the hollow channel 9 into the applicator 1 and discharging it from the hollow channel 9 in the ablation-active section 3.
  • FIG. 2 shows only a part of the distal region 2 of the applicator 1.
  • the applicator 1 has a spreading mechanism in the distal region 2 16 on.
  • the spreading mechanism 16 has spreading arms 17, which are connected to one another via joints 18 and to parts 19, 21 of the applicator 1.
  • each pair of spreader arms 17 can be connected to one another via a joint 18.
  • the one spreading arm 17 of this pair is then connected via a hinge 18 to the part 19, the other spreading arm 17 of this pair is connected via a hinge 18 to the part 21.
  • the part 19 is designed as a part of the outer sleeve of the applicator 1 which is displaceable in the longitudinal direction in relation to the inner conductor 7.
  • the part 21 is fixedly coupled to the inner conductor 7 and can be moved closer to the sub-section 19 via the spreading mechanism 16 when it is extended.
  • the partial section 19 has a filling made of a dielectric 20.
  • the outer sleeve of the applicator can be made of electrically conductive material, for example a metal.
  • FIG. 3 shows the arrangement according to FIG. 2, wherein the spreading mechanism 16 is actuated, so that the diameter of the distal region 2 is increased.
  • the spreader arms 17, which are connected to one another via a joint 18, are no longer in alignment with the outer contour of the applicator 1, but instead are exposed to the outside at an angle.
  • a tool 22 can be attached to one or more spreading arms.
  • FIG. 4 shows an embodiment of the distal region 2 of the applicator 1, in which a perforation section 23 is present in the ablation-active section 3.
  • the perforation section 23 has a multiplicity of openings 24 which perforate the outer shell of the applicator 1 and which can be connected to one of the hollow channels 8, 9 or also to both hollow channels 8, 9. Alternatively, a part of the openings 24 may be connected to one hollow channel 8, another part of the openings 24 to the other hollow channel 9.

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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

L'invention concerne un applicateur en forme d'aiguille pour la réalisation d'ablations tissulaires minimalement invasives dans le corps d'un être vivant, l'applicateur présentant, dans une zone distale, une section active en ablation en forme d'aiguille, qui permet de réaliser l'ablation tissulaire par émission d'un signal d'énergie, et une zone proximale, éloignée de la zone distale, pour la manipulation de l'applicateur. Selon l'invention, l'applicateur présente l'une ou les deux des caractéristiques suivantes a), b) : a) l'applicateur présente au moins un canal creux s'étendant au moins depuis la section active en ablation vers la zone proximale, qui est conçu pour le transport d'au moins un milieu gazeux, liquide ou solide ou d'un mélange correspondant depuis l'être vivant vers un dispositif d'analyse et/ou depuis un dispositif de thérapie dans l'être vivant, b) l'applicateur présente au moins une section d'écartement, dans laquelle le diamètre de l'applicateur peut être agrandi de manière quelconque par rapport au diamètre côté extrémité de la zone distale et de nouveau réduit en taille au moyen d'un mécanisme d'écartement de l'applicateur.
PCT/EP2018/084782 2017-12-19 2018-12-13 Applicateur en forme d'aiguille Ceased WO2019121328A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102017130526.2 2017-12-19
DE102017130526.2A DE102017130526A1 (de) 2017-12-19 2017-12-19 Nadelförmiger Applikator

Publications (1)

Publication Number Publication Date
WO2019121328A1 true WO2019121328A1 (fr) 2019-06-27

Family

ID=65013647

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2018/084782 Ceased WO2019121328A1 (fr) 2017-12-19 2018-12-13 Applicateur en forme d'aiguille

Country Status (2)

Country Link
DE (1) DE102017130526A1 (fr)
WO (1) WO2019121328A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12076071B2 (en) 2020-08-14 2024-09-03 Kardium Inc. Systems and methods for treating tissue with pulsed field ablation

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000066021A1 (fr) * 1999-05-04 2000-11-09 Curon Medical, Inc. Systemes et methodes de traitement du cardia de l'estomac et de zones voisines de tissu de l'oesophage
WO2001082814A2 (fr) * 2000-05-03 2001-11-08 C.R. Bard, Inc. Appareil et procedes permettant d'effectuer des cartographies et des ablations lors d'interventions d'electrophysiologie
US20140025054A1 (en) * 2012-07-19 2014-01-23 Vihar Surti Endoscopic Ultrasound Ablation Needle
US20140039491A1 (en) * 2012-08-02 2014-02-06 Ethicon Endo-Surgery, Inc. Flexible expandable electrode and method of intraluminal delivery of pulsed power
EP2664358B1 (fr) 2010-01-29 2016-04-27 Covidien LP Dispositif d'ablation à micro-ondes avec un dispositif d'imagerie intégré
EP3069654A1 (fr) * 2015-03-20 2016-09-21 Otto-von-Guericke-University Cathéter d'ablation

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140257262A1 (en) * 2013-03-11 2014-09-11 Alexandre Carpentier Interstitial ultrasonic disposable applicator and method for tissue thermal conformal volume ablation and monitoring the same
GB2551117A (en) * 2016-05-31 2017-12-13 Creo Medical Ltd Electrosurgical apparatus and method

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000066021A1 (fr) * 1999-05-04 2000-11-09 Curon Medical, Inc. Systemes et methodes de traitement du cardia de l'estomac et de zones voisines de tissu de l'oesophage
WO2001082814A2 (fr) * 2000-05-03 2001-11-08 C.R. Bard, Inc. Appareil et procedes permettant d'effectuer des cartographies et des ablations lors d'interventions d'electrophysiologie
EP2664358B1 (fr) 2010-01-29 2016-04-27 Covidien LP Dispositif d'ablation à micro-ondes avec un dispositif d'imagerie intégré
US20140025054A1 (en) * 2012-07-19 2014-01-23 Vihar Surti Endoscopic Ultrasound Ablation Needle
US20140039491A1 (en) * 2012-08-02 2014-02-06 Ethicon Endo-Surgery, Inc. Flexible expandable electrode and method of intraluminal delivery of pulsed power
EP3069654A1 (fr) * 2015-03-20 2016-09-21 Otto-von-Guericke-University Cathéter d'ablation

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12076071B2 (en) 2020-08-14 2024-09-03 Kardium Inc. Systems and methods for treating tissue with pulsed field ablation

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