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EP4274499A1 - Ablation d'un tissu cavitaire - Google Patents

Ablation d'un tissu cavitaire

Info

Publication number
EP4274499A1
EP4274499A1 EP22737041.8A EP22737041A EP4274499A1 EP 4274499 A1 EP4274499 A1 EP 4274499A1 EP 22737041 A EP22737041 A EP 22737041A EP 4274499 A1 EP4274499 A1 EP 4274499A1
Authority
EP
European Patent Office
Prior art keywords
medical device
balloon
fluid
tissue
outer balloon
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
Application number
EP22737041.8A
Other languages
German (de)
English (en)
Other versions
EP4274499A4 (fr
Inventor
Zachary Rzeszutek
Tyler Wanke
Robert F. Rioux
Alyssa Bailey
Thomas Kurth
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.)
Innoblative Designs Inc
Original Assignee
Innoblative Designs Inc
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 Innoblative Designs Inc filed Critical Innoblative Designs Inc
Publication of EP4274499A1 publication Critical patent/EP4274499A1/fr
Publication of EP4274499A4 publication Critical patent/EP4274499A4/fr
Pending 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
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022—Balloons
    • 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
    • A61B2018/0022—Balloons
    • A61B2018/00232—Balloons having an irregular shape
    • 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
    • A61B2018/0022—Balloons
    • A61B2018/0025—Multiple balloons
    • A61B2018/00255—Multiple balloons arranged one inside another
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00333—Breast
    • 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
    • A61B2018/144—Wire
    • 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
    • A61B2018/1472—Probes or electrodes therefor for use with liquid electrolyte, e.g. virtual electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/002—Irrigation

Definitions

  • the present disclosure relates generally to medical devices, and, more particularly, to a tissue ablation device having a deployable applicator head configured to be delivered to a tissue cavity and ablate marginal tissue surrounding the tissue cavity.
  • Cancer is a group of diseases involving abnormal cell growth with the potential to invade or spread to other parts of the body. Cancer generally manifests into abnormal growths of tissue in the form of a tumor that may be localized to a particular area of a patient's body (e.g., associated with a specific body part or organ) or may be spread throughout. Tumors, both benign and malignant, are commonly treated and removed via surgical intervention, as surgery often offers the greatest chance for complete removal and cure, especially if the cancer has not spread to other parts of the body. However, in some instances, surgery alone is insufficient to adequately remove all cancerous tissue from a local environment.
  • a tissue ablation device consistent with the present disclosure includes a dual-balloon design.
  • the tissue ablation device includes a probe including a nonconductive elongated shaft having a proximal end and a distal end and at least one lumen extending therethrough, and an expandable balloon assembly coupled to the distal end of the probe shaft.
  • the expandable balloon assembly includes an expandable inner balloon having an inner balloon wall having an exterior surface, an interior surface and a lumen defined therein and in fluid connection with at least one lumen of the probe.
  • the inner balloon is configured to inflate into an expanded configuration in response to delivery of a first fluid from at least one lumen of the probe into the lumen of the inner balloon.
  • the expandable balloon assembly further includes an expandable outer balloon surrounding the inner balloon and configured to transition to an expanded configuration in response expansion of the inner balloon.
  • the tissue ablation device of the invention includes a probe having a deployable applicator member or head that has a non-spherical shape when in its expanded configuration.
  • the member or head may have, as non-limiting exemplary embodiments, an ellipsoid, conical, cylindrical, or polyhedron shape.
  • a tissue ablation device consistent with the present disclosure may be well suited for treating hollow body cavities, such as irregularly-shaped cavities in breast tissue created by a lumpectomy procedure.
  • body cavity may include non-surgically created cavities, such as natural body cavities and passages, such as the ureter (e.g., for prostate treatment), the uterus (e.g. for uterine ablation or fibroid treatment), fallopian tubes (e.g. for sterilization), and the like.
  • tissue ablation devices of the present disclosure may be used for the ablation of marginal tissue in various parts of the body and organs (e.g., skin, lungs, liver, pancreas, etc.) and is not limited to treatment of breast cancer.
  • a tissue ablation device of the invention includes an applicator head and/or outer balloon that, when in the expanded configuration, has one of: an ellipsoid shape; a prolate ellipsoid shape an oblate ellipsoid shape; a cylindrical shape; a right cylindrical shape; an oblique cylindrical shape; a conical shape; a pyramidal shape; a polyhedron shape; and a regular polyhedron shape (such as a tetrahedron, a cuboid, an octahedron, a dodecahedron, and an icosahedron).
  • the outer balloon includes an outer balloon wall having an interior surface, an exterior surface, and a chamber defined between the interior surface of the outer balloon and the exterior surface of the inner balloon.
  • the exterior surface of the inner balloon wall has an irregular surface defined thereon.
  • the inner balloon wall may include a plurality of bumps, ridges, or other features arranged on an outer surface thereof configured to maintain separation between the outer surface of the inner balloon wall and the interior surface of the outer balloon wall, thereby ensuring the chamber is maintained.
  • the chamber defined between the inner surface of the outer balloon wall and the outer surface of the inner balloon wall is in fluid connection with at least one lumen of the probe, so as to receive a second fluid therefrom.
  • the outer balloon wall further includes a plurality of perforations configured to allow the passage of the second fluid from the chamber to the exterior surface of the outer balloon upon delivery of the second fluid from at least one lumen of the probe into the chamber.
  • each of the plurality of conductive wires is independent from one another.
  • each of the plurality of conductive wires, or one or more sets of a combination of conductive wires is configured to independently receive an electrical current from an energy source and independently conduct energy.
  • each of the plurality of conductive wires is configured to conduct energy upon receipt of the electrical current, the energy including RF energy.
  • the present invention also provides methods for manufacturing the ablation devices disclosed herein.
  • An exemplary method includes, adding a heat shrink sleeve or tubing to an end of each wire of the plurality of conductive wires to act as a strain relief.
  • FIG. 6 is an exploded view of the applicator head of FIG. 5;
  • FIGS. 11 A and 1 IB are sectional views of a portion of the applicator head of FIG. 10 illustrating the arrangement of components of the applicator head;
  • FIG. 12 is a schematic illustration of the delivery of the applicator head of FIG. 4 into a tissue cavity and subsequent ablation of marginal tissue according to methods of the present disclosure
  • FIG. 13 is a perspective view of another embodiment of an applicator head compatible with the tissue ablation device of FIG. 1;
  • FIG. 14 illustrates a method of deploying the applicator head of FIG. 13 into an expanded configuration for delivery of RF energy to a target site for ablation of marginal tissue;
  • FIG. 15 illustrates different embodiments of the outer surface of the applicator head of FIG. 13.
  • FIG. 16 is a schematic illustration of the delivery of the applicator head of FIG. 13 into a tissue cavity and subsequent ablation of marginal tissue according to methods of the present disclosure.
  • FIGS. 17A and 17B show a perspective view and exploded view of a device of a two- balloon ablation device of the present disclosure.
  • FIG. 18 shows the adjustable parameters used to create differently shaped balloons in accordance with the present disclosure.
  • FIG. 19 exemplifies the use of Mol ex connectors during the manufacture of the device shown in FIGS. 17A and 17B.
  • FIGS. 20 A, 20B, 20C, and 20D exemplify the use of a heat shrink sleeve/tubing on the electrodes of the two-balloon ablation device of FIGS. 17A and 17B.
  • FIGS. 21 A, 21B, 21C, 21D, and 21E show exemplary steps used in manufacturing the device shown in FIGS. 17A and 17B.
  • FIGS. 22A, 22B, and 22C show an exemplary controller used with the ablation devices of the invention.
  • the present disclosure is generally directed to a tissue ablation device having a deployable applicator head configured to be delivered into a tissue cavity and ablate marginal tissue surrounding the tissue cavity.
  • the tissue ablation device of the invention includes a probe having a deployable applicator member or head that has a non-spherical shape when in its expanded configuration.
  • the applicator member or head may have, as non-limiting exemplary embodiments, an ellipsoid, conical, cylindrical, or polyhedron shape.
  • the tissue ablation system of the present disclosure can be used during an ablation procedure to destroy the thin rim of marginal tissue around the cavity in a targeted manner.
  • the present disclosure is generally directed to a cavitary tissue ablation system including an ablation device to be delivered into a tissue cavity and configured to emit non ionizing radiation, such as radiofrequency (RF) energy, in a desired shape or pattern so as to deliver treatment for the ablation and destruction of a targeted portion of marginal tissue around the tissue cavity.
  • RF radiofrequency
  • the ablation device generally includes a probe having a deployable applicator head coupled thereto and configured to transition between a collapsed configuration, in which the applicator head can be delivered to and maneuvered within a previously formed tissue cavity (e.g., formed from tumor removal), and an expanded configuration, in which the applicator head is configured to ablate marginal tissue (via RF) immediately surrounding the site of a surgically removed tumor in order to minimize recurrence of the tumor.
  • tissue ablation device of the present disclosure is configured to allow surgeons, or other medical professionals, to deliver precise, measured doses of RF energy at controlled depths to the marginal tissue surrounding the cavity.
  • the device controller 18 may be used to control the emission of energy from one or more conductive elements of the device 14 to result in ablation, as well as controlling the delivery of fluid to or from the deployable applicator head 16 so as to control the expansion and collapse of the head 16.
  • the device controller 18 may be housed within the ablation device 14.
  • the ablation generator 20 may also connected to a return electrode 15 that is attached to the skin of the patient 12.
  • the tissue ablation devices 14 of the invention include devices with a head or balloon(s) of a non-spherical shape when in an expanded configuration.
  • the present Inventors made the discovery that, depending on the shape of a given tissue cavity, a head with a spherical or spheroidal shape will not be in sufficient proximity to, or in adequate contact with, all marginal tissue in a cavity. Therefore, the present inventors designed the devices exemplified herein that include non-spherical heads and balloons, which are configured to make sufficient contact with (or be in adequate proximity to) marginal tissue in differently- or irregularly-shaped tissue cavities.
  • the member or head may have a longer or prolate shape, such that it is able to penetrate into a deep, narrow cavity.
  • the member or head may have a broad or oblate shape to ablate wider, shallower cavities.
  • an ablation device of the present disclosure with a sphere-shaped head or balloon 301 is able to make sufficient contact with, or come in adequate proximity to, all marginal tissue a tissue cavity 311.
  • a sphere-shaped head may not be able to come into contact/proximity with certain areas 321 of marginal tissue.
  • FIG. 3C many tissue cavities have crevices 331 or other irregularities that cannot be reached using a sphere-shaped head.
  • the present Inventors have designed ablation probes, and methods for their manufacture, with heads or balloons of non-spherical shapes when in their expanded configurations.
  • using devices of the invention, with non-spherical heads (302 and 303) allows the devices to treat all marginal tissue in a tissue cavity.
  • FIGS. 2A-2C one embodiment of an exemplary tissue ablation device configured to ablate marginal tissue is shown.
  • the tissue ablation devices of the present disclosure generally include a probe including a shaft 17 having a proximal end and a distal end, wherein the applicator head 16 is positioned at the distal end.
  • the device exemplified in FIGS 2A-2C and other drawings of the present disclosure show a spherical head, the teachings also apply to the devices disclosed herein with non-spherical heads when in the expanded configuration.
  • the shaft 17 of the probe may generally resemble a catheter and thus may further include at least one lumen for providing a pathway from the proximal end of the shaft to the distal end of the shaft and the applicator head so as to allow various components to be in fluid communication with the applicator head.
  • the applicator head includes at least one balloon configured to transition from a collapsed configuration to an expanded configuration in response to delivery of a fluid thereto.
  • FIGS. 2A-2C illustrate the applicator head 16 transitioning from a collapsed configuration (FIG. 2A) to an expanded configuration (FIG. 2B) via delivery of a fluid to the head 16 and activated to emit energy for ablation of tissue (FIG. 2C).
  • the at least one lumen of the shaft 17 may provide a fluid pathway from the proximal end, which may be coupled to a fluid source (i.e., irrigation pump or drip 22), and the interior volume of the balloon 16.
  • one or more of the conductive wires can be electrically isolated from one or more of the remaining conductive wires.
  • This electrical isolation enables various operation modes for the ablation device 14.
  • ablation energy may be supplied to one or more conductive wires in a bipolar mode, a unipolar mode, or a combination bipolar and unipolar modes.
  • unipolar mode ablation energy is delivered between one or more conductive wires on the ablation device 14 and the return electrode 15, as described with reference to FIG. 1.
  • bipolar mode energy is delivered between at least two of the conductive wires, while at least one conductive wire remains neutral.
  • at least, one conductive wire functions as a grounded conductive wire (e.g., electrode) by not delivering energy over at least one conductive wire.
  • one or more control wires or other components may be coupled to the mesh-like conductive element to control the retraction and expansion (e.g., via pushing and pulling) of the mesh-like conductive element from the shaft of the probe, as well as electrical wiring for electrically coupling the conductive element and RF generator, wherein such control and electrical wires may be housed within the at least one lumen of the shaft of the probe.
  • the shaft 17 of the probe may be configured as a handle adapted for manual manipulation.
  • the shaft may be configured for connection to and/or interface with a surgical robot, such as the Da Vinci® surgical robot available from Intuitive Surgical, Inc., Sunnyvale, California.
  • the shaft may be configured to be held in place by a shape lock or other deployment and suspension system of the type that is anchored to a patient bed and which holds the probe in place while the ablation or other procedure takes place, eliminating the need to a user to manually hold the device for the duration of the treatment.
  • the applicator head 16 includes a non-conductive material (e.g., a polyamide) as a layer on at least a portion of an internal surface, an external surface, or both an external and internal surface. In other examples, the applicator head 16 is formed from a non- conductive material. Additionally or alternatively, the applicator head 16 material can include an elastomeric material or a shape memory material.
  • a non-conductive material e.g., a polyamide
  • the applicator head 16 is formed from a non- conductive material.
  • the applicator head 16 material can include an elastomeric material or a shape memory material.
  • FIG. 4 is a perspective view, partly in section, of one embodiment of an applicator head 100 compatible with the tissue ablation device 14 of FIG. 1.
  • the applicator head 100 includes an inflatable balloon 102 having a plurality of perforations 104, holes, or micropores, so as to allow a fluid provided within the balloon 102, such as saline, to pass therethrough, or weep, from the balloon 102 when the balloon 102 is inflated.
  • the perforations 104 may be sized, shaped, and/or arranged in such a pattern so as to allow a volume of fluid to pass from the interior volume of the balloon to an exterior surface of the balloon at a controlled rate so as to allow the balloon to remain inflated and maintain its shape.
  • the probe further includes a conductive element 106, such as an electrode, positioned within the balloon, wherein the electrode 106 is coupled to an RF energy source 20.
  • a conductive element 106 such as an electrode
  • the balloon When in the collapsed configuration (e.g., little or no fluid within the interior volume) (shown in FIG. 2A), the balloon has a smaller size or volume than when the balloon is in the expanded configuration.
  • the target site e.g., tissue cavity
  • fluid may then be delivered to the balloon so as to inflate the balloon into an expanded configuration (shown in FIG. 2B), at which point, ablation of marginal tissue can occur.
  • an operator may initiate delivery of RF energy from the conductive element 106 by using the controller 18, and RF energy is transmitted from the conductive element 106 to the outer surface of the balloon 102 by way of the fluid weeping from the perforations 104. Accordingly, ablation via RF energy is able to occur on the exterior surface (shown in FIG. 2C). More specifically, upon activating delivery of RF energy from the conductive element (electrode), the RF energy is transmitted from the conductive element to the outer surface of the balloon by way of the fluid weeping from the perforations, thereby creating a virtual electrode.
  • the fluid within the interior of the balloon 102 and weeping through the perforations 104 to the outer surface of the balloon 102 is a conductive fluid (e.g., saline) and thus able to carry electrical current from the active electrode 106.
  • a conductive fluid e.g., saline
  • a pool or thin film of fluid is formed on the exterior surface of the balloon 102 and is configured to ablate surrounding tissue via the electrical current carried from the active electrode 106. Accordingly, ablation via RF energy is able to occur on the exterior surface of the balloon in a controlled manner and does not require direct contact between tissue and the electrode 106.
  • the inner balloon 202 may include an irregular outer surface 208, which may include a plurality of bumps, ridges, or other features, configured to maintain separation between the outer surface of the inner balloon 202 and an interior surface of the outer balloon 204, thereby ensuring that a chamber is maintained between the inner and outer balloons.
  • the outer balloon 204 may be coupled to a second fluid source (or the first fluid source) via a second fluid line 24b.
  • the outer balloon 204 may further include a plurality of perforations or holes 210 so as to allow fluid from the second fluid source to pass therethrough, or weep, from the outer balloon 204.
  • the perforations may be sized, shaped, and/or arranged in such a pattern so as to allow a volume of fluid to pass from the chamber to an exterior surface of the outer balloon at a controlled rate.
  • the present Inventors have designed applicator heads with both a single and double balloon configuration, using non-spherical balloons.
  • FIG. 7 shows a spherical balloon 701 used in an applicator head of a tissue ablation device, as it is inflated from 2 cm in diameter, to 2.5 cm, and to 3 cm in an exemplary tissue cavity 705.
  • the balloon When the balloon is placed into a tissue cavity 705, highlighted by the dashed lines, and inflated to 2 cm, the balloon makes contact with some of the marginal tissue 703 of the cavity 705.
  • other areas 707a remain distant from the balloon. Even inflating the balloon past the diameter of the tissue cavity would leave areas (707b and 707c) beyond the reach of the balloon.
  • the exemplified applicator heads with an elongate cylindrical balloon 801 and a cylindrical balloon 802 are able to contact far more surface area of the tissue cavity without requiring inflating the balloon beyond the natural diameter of the tissue cavity. Not only does this help provide more comprehensive ablation of marginal tissue in a single pass, but the more complementary shape allows for less traumatic inflation requirements to adequately contact all marginal tissue in a cavity.
  • a tissue ablation device of the invention includes a head and/or outer balloon that, when in the expanded configuration, has one of: an ellipsoid shape; a prolate ellipsoid shape an oblate ellipsoid shape; a cylindrical shape; a right cylindrical shape; an oblique cylindrical shape; a conical shape; a pyramidal shape; a polyhedron shape; and a regular polyhedron shape (such as a tetrahedron, a cuboid, an octahedron, a dodecahedron, and an icosahedron), a prismatic shape, and a rhombohedral shape.
  • a tissue ablation device of the invention includes a head and/or outer balloon that, when in the expanded configuration a prolate ellipsoid shape 903 or an oblate ellipsoid shape 905.
  • a prolate ellipsoid 903 may be particularly effective at treating deeper tissue cavities.
  • an oblate ellipsoid shape is effective at treating wider, shallow tissue cavities.
  • the head and/or outer balloon may be designed to take a polyhedral or cylindrical shape (909, 907).
  • the heads or balloons may be designed with similar shapes, but different lengths suitable for treating either shallow 907 or deep 909 tissue cavities.
  • the balloon or head has a shape with tapered or rounded vertices 919 and/or edges. In certain aspects, the balloon or head has a shape useful for targeting tissue cavities with sloped walls 921, such as a conical or pyramidal shape 911.
  • FIG. 10 is a perspective view, partly in section, of the components of an exemplary applicator head 200 of a device 14 of FIG. 1, which includes two balloons. Although shown as a sphere, the components of the applicator head 200 are generally applicable to applicator heads of a non-spherical shape as described herein.
  • FIGS. 11 A and 1 IB are sectional views of a portion of the applicator head 200 illustrating the arrangement of components relative to one another.
  • the inner and outer balloons include a chamber 214 defined there between.
  • the plurality of bumps or ridges 208 arranged on an outer surface of the inner balloon 202 are configured to maintain separation between the outer surface of the inner balloon 202 and an interior surface of the outer balloon 204, thereby ensuring the chamber 214 is maintained.
  • a first fluid may be delivered to a lumen 212 of the inner balloon 202, which inflates the inner balloon 202 into an expanded configuration, at which point, the outer balloon 204 further expands.
  • a second fluid may then be delivered to the outer balloon 204, such that the second fluid flows within the chamber 214 between the inner and outer balloons 202, 204 and weeps from the outer balloon 204 via the perforations 210.
  • the fluid weeping through the perforations 210 creates a pool or thin film of fluid formed on the exterior surface of the outer balloon 204.
  • This embodiment is particularly advantageous in that the dual-balloon design does not require a syringe pump, and can be supplied with gravity-fed fluid source 22.
  • the volume of fluid required within the chamber is significantly less (when compared to a single balloon design), thus less wattage is required to achieve RF ablation.
  • Another advantage of the dual-balloon design of applicator head 200 is that it is not limited to placement within tissue cavities. Rather, when in a collapsed state, the applicator head 200 is shaped and/or sized to fit through working channels of scopes or other access devices, for example, and thus be used for ablation in a plurality of locations within the human body.
  • the device 14 of the present disclosure may further be equipped with feedback capabilities.
  • the head 200 may be used for the collection of initial data (e.g., temperature and conductivity measurements (impedance measurements) from one or more of the conductive elements 206.
  • initial data e.g., temperature and conductivity measurements (impedance measurements) from one or more of the conductive elements 206.
  • saline flow may be stopped (controlled via controller 18), and subsequent impedance measurements may be taken.
  • the collection of data prior and during an ablation procedure may be processed by the controller 18 so as to provide an estimation of the state of the tissue during an RF ablation procedure, thereby providing an operator (e.g., surgeon) with an accurate indication success of the procedure.
  • the applicator head may include a silicone-webbed mesh body composed of an electrically conductive material.
  • the mesh body may be self-expanding such that it is able to transition from a collapsed configuration, in which the mesh body is retracted within a portion of the shaft of the probe, to an expanded configuration upon deployment from the shaft of the probe.
  • FIG. 16 is a schematic illustration of the delivery of the applicator head of FIG. 13 into a tissue cavity and subsequent ablation of marginal tissue according to methods of the present disclosure.
  • the device also includes a fluid lumen 1706 for the inner balloon, shown in FIG. 17B with a female-to-barb luer fitting.
  • the device includes a second fluid lumen 1708 for the outer balloon, also shown with female-to-barb luer fitting.
  • the device further includes wire(s) 1705 to transmit RF energy to the device.
  • the Inventors have not only developed balloons of different sizes, but also improved methods for manufacturing and manufacturing-focused design aspects.
  • FIGS. 21 A-21E show certain steps of an exemplary method for manufacturing two- balloon devices of the invention.
  • the device exemplified in FIGS. 21A-21E has a spherical head/balloons, these manufacturing steps can be applied to devices with non-spherical heads/balloons, as described herein.
  • Step 1 the conductive electrode wires are cut, bent, and loaded onto a plastic neck hub.
  • Step 2 the distal ends of the wires are cut to an appropriate length, depending on the dimensions of the balloon to be used.
  • the cut wires are bent into the hook shape shown in FIGS.
  • Step 3 the components are affixed to the neck hub using an adhesive.
  • Step 4 heat shrink sleeve or tubing is applied to the proximal end of the wire bundles.
  • the heat shrink sleeve or tubing with a cutout, as described above, is applied to the distal end of the wires.
  • Step 5 the inner balloon is inflated, and ridges of UV glue ridges are added to isolate each electrode wire.
  • Step 6 the proximal end of the balloon is stretched and adhered to the plastic neck hub. The distal end of the balloon is flipped inside out and pressed onto the shaft and glued, preferably using a UV glue.
  • Step 9 the fluid tubes (lumens) are affixed to the plastic neck hub.
  • Step 10 a heat shrink sleeve or tubing is applied to cover the tubes and wire bundles.
  • Step 11 alligator or Molex connectors are applied to the proximal ends of the wire bundles, and Luer-to-barb connectors are fitted to the proximal ends of the tubes.
  • any of the operations described herein may be implemented in a system that includes one or more storage mediums having stored thereon, individually or in combination, instructions that when executed by one or more processors perform the methods.
  • the processor may include, for example, a server CPU, a mobile device CPU, and/or other programmable circuitry.
  • various embodiments may be implemented using hardware elements, software elements, or any combination thereof.
  • hardware elements may include processors, microprocessors, circuits, circuit elements (e.g., transistors, resistors, capacitors, inductors, and so forth), integrated circuits, application specific integrated circuits (ASIC), programmable logic devices (PLD), digital signal processors (DSP), field programmable gate array (FPGA), logic gates, registers, semiconductor device, chips, microchips, chip sets, and so forth.

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Abstract

L'invention concerne un système d'ablation d'un tissu cavitaire comprenant un dispositif d'ablation ayant un applicateur déployable, de préférence avec une tête non sphérique, conçu pour être amené dans une cavité tissulaire et procéder à l'ablation de tissu marginal entourant la cavité tissulaire. La tête d'applicateur déployable est conçue pour être amenée dans une cavité tissulaire lorsqu'elle est dans une configuration repliée, et procéder à l'ablation de tissu marginal entourant la cavité tissulaire lorsqu'elle est dans une configuration déployée.
EP22737041.8A 2021-01-05 2022-01-05 Ablation d'un tissu cavitaire Pending EP4274499A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202163133944P 2021-01-05 2021-01-05
PCT/US2022/011296 WO2022150374A1 (fr) 2021-01-05 2022-01-05 Ablation d'un tissu cavitaire

Publications (2)

Publication Number Publication Date
EP4274499A1 true EP4274499A1 (fr) 2023-11-15
EP4274499A4 EP4274499A4 (fr) 2024-11-20

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP22737041.8A Pending EP4274499A4 (fr) 2021-01-05 2022-01-05 Ablation d'un tissu cavitaire

Country Status (3)

Country Link
EP (1) EP4274499A4 (fr)
JP (1) JP2024501763A (fr)
WO (1) WO2022150374A1 (fr)

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5893847A (en) * 1993-03-16 1999-04-13 Ep Technologies, Inc. Multiple electrode support structures with slotted hub and hoop spline elements
US5755704A (en) * 1996-10-29 1998-05-26 Medtronic, Inc. Thinwall guide catheter
US6923754B2 (en) * 2002-11-06 2005-08-02 Senorx, Inc. Vacuum device and method for treating tissue adjacent a body cavity
US7371231B2 (en) * 2004-02-02 2008-05-13 Boston Scientific Scimed, Inc. System and method for performing ablation using a balloon
US9750565B2 (en) * 2011-09-30 2017-09-05 Medtronic Advanced Energy Llc Electrosurgical balloons
US20140018794A1 (en) * 2012-07-13 2014-01-16 Boston Scientific Scimed, Inc. Off-wall electrode devices and methods for nerve modulation
EP2879576A4 (fr) * 2012-07-30 2016-07-13 Univ Northwestern Sonde de radiofréquence pour ablation circonférentielle d'une cavité creuse
US10314649B2 (en) * 2012-08-02 2019-06-11 Ethicon Endo-Surgery, Inc. Flexible expandable electrode and method of intraluminal delivery of pulsed power
WO2016176567A1 (fr) 2015-04-29 2016-11-03 Innoblative Designs, Inc. Ablation d'un tissu cavitaire

Also Published As

Publication number Publication date
WO2022150374A1 (fr) 2022-07-14
EP4274499A4 (fr) 2024-11-20
JP2024501763A (ja) 2024-01-15

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