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WO2024188748A1 - Pointes de traitement avec un bloc de support poreux - Google Patents

Pointes de traitement avec un bloc de support poreux Download PDF

Info

Publication number
WO2024188748A1
WO2024188748A1 PCT/EP2024/055822 EP2024055822W WO2024188748A1 WO 2024188748 A1 WO2024188748 A1 WO 2024188748A1 EP 2024055822 W EP2024055822 W EP 2024055822W WO 2024188748 A1 WO2024188748 A1 WO 2024188748A1
Authority
WO
WIPO (PCT)
Prior art keywords
backing block
flexible circuit
treatment
treatment electrode
substrate
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
PCT/EP2024/055822
Other languages
English (en)
Inventor
Craig Robert Bockenstedt
Gregory T. Wing
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.)
Solta Medical Ireland Ltd
Original Assignee
Solta Medical Ireland Ltd
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 Solta Medical Ireland Ltd filed Critical Solta Medical Ireland Ltd
Publication of WO2024188748A1 publication Critical patent/WO2024188748A1/fr
Anticipated expiration legal-status Critical
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
    • A61B18/1402—Probes for open surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/40—Applying electric fields by inductive or capacitive coupling ; Applying radio-frequency signals
    • A61N1/403—Applying electric fields by inductive or capacitive coupling ; Applying radio-frequency signals for thermotherapy, e.g. hyperthermia
    • 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
    • A61B2018/00023—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids closed, i.e. without wound contact by the fluid
    • 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
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00452—Skin
    • A61B2018/0047—Upper parts of the skin, e.g. skin peeling or treatment of wrinkles
    • 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
    • A61B2018/00589—Coagulation

Definitions

  • the disclosure generally relates to energy delivery devices used to treat tissue with electromagnetic energy.
  • Certain types of energy delivery devices are capable of treating the skin tissue of a patient with electromagnetic energy in order to change the outward appearance at the skin surface.
  • the energy delivery device may subcutaneously treat skin tissue with high frequency electromagnetic energy in the radio-frequency (RF) band of the electromagnetic spectrum.
  • the high frequency energy may be transferred through the skin surface to the dermis.
  • the high frequency energy may heat the dermis to a temperature sufficient to cause collagen to contract and shrink and, thereby, tighten the tissue.
  • Treatment with high frequency energy may also cause mild inflammation.
  • the inflammatory tissue response may cause new collagen to be generated over time following treatment.
  • An energy delivery device may include a treatment tip that is placed in contact with the patient’s skin surface during treatment.
  • the treatment tip may include a flexible circuit with an electrode from which electromagnetic energy is emitted during operation.
  • the non-patient contacting side of the flexible circuit may be directly sprayed with a cryogen spray.
  • heat is conducted from the warmer skin tissue to the cooler flexible circuit, which cools the skin tissue immediately beneath the skin surface and establishes a temperature gradient in the skin tissue.
  • a treatment gel may be applied to the skin surface to improve the efficiency of the energy transfer. The temperature gradient may prevent or limit damage to the epidermis.
  • an apparatus comprises an energy delivery device including a flexible circuit.
  • the flexible circuit includes a substrate and a treatment electrode on the substrate.
  • the apparatus further comprises a backing block disposed adjacent to the treatment electrode.
  • the backing block comprises a porous material.
  • FIG. 1 is a diagrammatic view of a treatment system in accordance with embodiments of the invention.
  • FIG. 2 is a perspective view of the handpiece and treatment tip of FIG. 1 with the treatment tip detached from the handpiece.
  • FIG. 3 is an exploded view of the treatment tip in which the flexible circuit is shown in a folded condition.
  • FIG. 4 is a rear view of the flexible circuit of FIG. 3 in an unfolded condition.
  • FIG. 5 is a front view of the treatment tip with the flexible circuit absent for purposes of illustration of the backing block.
  • FIG. 6 is a perspective view in partial cross section of the support member and backing block of the treatment tip.
  • FIG. 7 is a front view of a flexible circuit and backing block in accordance with embodiments of the invention.
  • FIG. 8 is an enlarged view of a portion of FIG. 7.
  • FIG. 9 is a perspective view of a flexible circuit in accordance with alternative embodiments of the invention.
  • a treatment system 10 includes a handpiece 12, a treatment tip 14 that may be coupled in a removable and releasable manner with the handpiece 12, a console generally indicated by reference numeral 16, and a system controller 18.
  • the treatment tip 14 includes a flexible circuit 30, a support member 32, and a backing block 34, as subsequently described in connection with FIGS. 3-6.
  • the system controller 18, which may be disposed at the console 16, orchestrates the global operation of the different individual components of the treatment system 10. Under the control of the system controller 18 and operator interaction with controls at the system controller 18 and handpiece 12, the treatment system 10 is configured to deliver electromagnetic energy from a treatment electrode 20 (FIGS.
  • the treatment tip 14 in a high frequency band of the electromagnetic spectrum, such as the radiofrequency (RF) band, to tissue at a treatment site on a patient.
  • the electromagnetic energy which may be non-invasively and non-ablatively delivered from the treatment electrode 20 to the tissue, heats the tissue at the treatment site.
  • the heating which elevates the tissue temperature, may produce a therapeutic effect.
  • the heating may target the dermis with the intent of modifying collagen to remove or reduce wrinkles and otherwise tighten the skin for improving the outward appearance of a patient receiving the treatment procedure.
  • the handpiece 12 may be manipulated to position the treatment tip 14 for treating multiple treatment sites with electromagnetic energy.
  • the system controller 18 may be coupled to a generator 22 that is configured to generate the electromagnetic energy used in the treatment procedure.
  • the generator 22 which may have the form of a high frequency power supply, may be equipped with an electrical circuit operative to generate high frequency drive signals that are supplied to the treatment electrode 20.
  • the drive signals have parameters, such as energy content and duty cycle, appropriate for the amount of power and the treatment mode selected by the treating clinician.
  • the system controller 18 includes digital and/or analog circuitry that interfaces the system controller 18 with the generator 22 for regulating the power delivered from the generator 22 to an electrical/fluid interface 44 inside the handpiece 12.
  • the system controller 18 and generator 22 at the console 16 may be electrically coupled to circuitry inside the handpiece 12 and the electrical/fluid interface 44 by wiring inside an electrical/fluid cable 24.
  • the system controller 18 may be coupled to a cryogen supply 26 that is configured to pump cryogen, or another type of refrigerant medium, under pressure through a conduit to a control valve inside the handpiece 12 and to activate a control valve to deliver cryogen to the backing block 34 of the treatment tip 14 for cooling the treatment electrode 20.
  • the system controller 18 includes digital and/or analog circuitry that interfaces the system controller 18 with the cryogen supply 26, and the cryogen supply 26 may pump the cryogen from a replaceable canister that is prefilled with a volume of cryogen.
  • the cryogen supply 26 may be fluidically coupled to the electrical/fluid interface 44 inside the handpiece 12 by a fluid line inside the electrical/fluid cable 24.
  • the flexible circuit 30, support member 32, and backing block 34 are arranged inside a rigid outer shell 36 of the treatment tip 14.
  • the flexible circuit 30 is wrapped about the support member 32 and backing block 34, and the backing block 34 may be disposed inside a receptacle in the support member 32.
  • the treatment electrode 20 is disposed on a substrate 25 of the flexible circuit 30, and the flexible circuit 30 includes conductive leads or traces 38 that couple the treatment electrode 20 with one or more contact pads 40.
  • the treatment electrode 20 is electrically coupled through the traces 38 and contact pads 40 with electrical contacts 42 (FIG. 2), such as pogo pins, of the electrical/fluid interface 44 of the handpiece 12.
  • Electromagnetic energy may be transmitted from the treatment electrode 20 through the thickness of substrate 25 over the surface area of the treatment electrode 20 to tissue beneath the skin surface by capacitive coupling, multiple treatment electrodes 20 may be disposed on the non-contact side 45 of the substrate 25 of the flexible circuit 30.
  • a pair of treatment electrodes 20 may be disposed with a side-by-side arrangement on the non-contact side 45 of the substrate 25.
  • the treatment electrode 20 is arranged inside a window 46 defined in a forward open end of the outer shell 36.
  • the backing block 34 may be disposed between the treatment electrode 20 of the flexible circuit 30 and the support member 32.
  • the support member 32 includes a lumen 48 defining a fluid path from an inlet 47 coupled to the electrical/fluid interface 44 at the handpiece 12 to an outlet 49 adjacent to the backing block 34.
  • the outlet 49 from the lumen 48 may be disposed proximate to a centerline of the backing block 34.
  • the handpiece 12 may include a control valve (not shown) operated by the system controller 18 to deliver a cryogen spray or stream through the lumen 48 to the backing block 34.
  • a bonding agent such as an adhesive, such as a dry film adhesive, may be used to bond the substrate 25 to the backing block 34.
  • the substrate 25 may be ultrasonically welded to the backing block 34.
  • the substrate 25 may be ultrasonically welded to the backing block 34 and bonded to the backing block 34 by an adhesive, such as a dry film adhesive.
  • Direct contact between the front surface 50 of the backing block 34 and the treatment electrode 20 may provide an efficient conductive heat path from the patient’s skin through the flexible circuit 30 to the backing block 34.
  • the direct contact conforms the shape of the flexible circuit 30 to the shape of the front surface 50, which provides flexibility to impart a specific shape (e.g., curvature) to the treatment electrode 20 that may benefit a specific type of treatment procedure.
  • the backing block 34 may be comprised of a porous material that is thermally conductive.
  • the backing block 34 may be comprised of an opencell metal foam characterized by a given pore size and pore density.
  • the metal foam which may be structural rigid, includes interconnected cells with open pores and a given porosity (e.g., 20%) creating an internal surface area inside the backing block 34.
  • the metal foam contained in the backing block 34 may be comprised of aluminum, copper, nickel, silver, gold, or an alloy of these metals.
  • the metal foam may be comprised of aluminum, which is characterized by a low density and a high thermal conductivity.
  • the backing block 34 may be comprised of an open-cell aluminum foam with a pore size ranging from about 50 microns to about 350 microns.
  • the backing block 34 may be comprised of a porous material that is thermally conductive and electrically insulating such as a ceramic.
  • the backing block 34 may be comprised of an open-cell polymer foam characterized by a given pore size and pore density.
  • the backing block 34 may be comprised of an open-cell polymer foam with a pore size ranging from about 50 microns to about 350 microns.
  • the backing block 34 may be comprised of an open mesh of polymer fibers.
  • Cryogen is introduced from the lumen 48 in the support member 32 into the porous material of the backing block 34 and flows with a given permeability through the pathways defined by the open cells of the porous material of the backing block 34.
  • cryogen may be exhausted at the peripheral edges of the backing block 34, which may enable the portion of the flexible circuit 30 between the treatment electrode 20 and the skin surface to be imperforate.
  • the cryogen inside the backing block 34 efficiently cools the backing block 34 and treatment electrode 20, which is on the non-contact side 45 of the substrate 25.
  • the relatively high thermal mass of the backing block 34 allows the backing block 34 to be used as a heat sink that efficiently absorbs heat transferred across the treatment electrode 20 and the portion of the substrate 25 between the treatment electrode 20 and the skin surface.
  • the backing block 34 effectively functions as a heat exchanger that extracts heat from the patient’s tissue by conduction across the treatment electrode 20 and the portion of the substrate 25 between the treatment electrode 20 and the skin surface.
  • the cooling of the treatment electrode 20 by the backing block 34 creates a reverse thermal gradient in the tissue heated by the electromagnetic energy such that the temperature of the tissue at and near the skin surface is cooler than the temperature of the tissue deeper within the epidermis or dermis.
  • the reverse thermal gradient results in the flow of heat from the skin surface through the substrate 25 and treatment electrode 20 into the backing block 34.
  • the reverse thermal gradient may be used to protect portions of the skin at and near the skin surface, such as the epidermis, against significant thermal damage. Depths of tissue that are not significantly cooled will warm up to a temperature associated with a therapeutic effect during the treatment procedure.
  • Various duty cycles of cooling and heating may be utilized contingent upon the type of treatment and the desired type of therapeutic effect.
  • the cooling and heating duty cycles may be controlled and coordinated by the system controller 18.
  • Evaporative cooling from the phase transition of the cryogen occurs on the surfaces within the interior of the backing block 34 and causes the bulk temperature of the backing block 34 to decrease, which provides an efficient mechanism for capturing the energy of the phase change and keeping the energy concentrated in the backing block 34.
  • the backing block 34 may also exhibit a temperature gradient resulting from heat flow away from the treatment electrode 20 in which the temperature of the backing block 34 may decrease with increasing distance from the treatment electrode 20.
  • the temperature of the backing block 34 may be simple to control, which may provide more stable temperatures during a treatment procedure. In the interval between consecutive treatment sites, cryogen may be supplied to the backing block 34 in order to restore the bulk temperature of the backing block 34 after treatment at the current treatment site and before treatment at the next treatment site.
  • Cryogen capture within the porous material inside the backing block 34 may reduce the extraneous incidental cooling of adjacent portions of the treatment tip 14, such as the outer shell 36, that does not contribute to creating the reverse thermal gradient.
  • the capture of the cryogen by the porous material of the backing block 34 may reduce the consumption of cryogen needed to create the reverse thermal gradient in comparison with conventionally spraying cryogen directly onto the treatment electrode 20.
  • the direct attachment of the flexible circuit 30 to the backing block 34 may inherently create a seal with the skin surface.
  • the seal may promote control over the flow of the cryogen and the efficient capture of the thermal energy from the phase change of the cryogen, and prevent the ingress of treatment gel.
  • the substrate 25 may include openings 55 that are distributed over the surface area of the treatment electrode 20.
  • the openings 55 may penetrate fully through the flexible circuit 30.
  • the openings 55 may penetrate fully through the substrate 25 and treatment electrode 20 of the flexible circuit 30.
  • cryogen may be sprayed onto the treatment electrode 20 at the non-contact side 45 of the substrate 25 and exhausted from the contact side 35 of the flexible circuit 30 through the openings 55.
  • the openings 55 may be configured to provide a dielectrically- bound passage through the flexible circuit 30.
  • the conductor of the treatment electrode 20 surrounds each passage 52 and is separated from each passage 54 by a disk comprised of the dielectric material of the substrate 25.
  • the openings 55 may include multiple passages 52, 54 in which the passages 52 extending through the treatment electrode 20 have a significantly larger diameter than the passages 54 penetrating through the substrate 25.
  • the passages 52 may have a diameter of about 0.75mm and the passages 54 may have a diameter of about 0.07mm.
  • the openings 55 may penetrate partially through the flexible circuit 30. In an alternative embodiment, the openings 55 may penetrate through the thickness of the substrate 25 and/or treatment electrode 20 of the flexible circuit 30.
  • multiple treatment electrodes 20 may be disposed on the substrate 25 of the flexible circuit 30.
  • a pair of treatment electrodes 20 may be disposed with a side-by-side arrangement on the substrate 25.
  • the flexible circuit 30 with multiple treatment electrodes 20 may be wrapped about the backing block 34.
  • the flexible circuit 30 with multiple treatment electrodes 20 may further include the openings 55 (FIGS. 7, 8).
  • references herein to terms such as “vertical,” “horizontal,” etc. are made by way of example, and not by way of limitation, to establish a frame of reference. It is understood that various other frames of reference may be employed for describing the invention without departing from the spirit and scope of the invention. It is also understood that features of the invention are not necessarily shown to scale in the drawings. Furthermore, to the extent that the terms “comprised of’, “includes”, “having”, “has”, “with”, or variants thereof are used in either the detailed description or the claims, such terms are intended to be inclusive and open-ended in a manner similar to the term “comprising”.
  • references herein to terms modified by language of approximation, such as “about”, “approximately”, and “substantially”, are not to be limited to the precise value specified.
  • the language of approximation may correspond to the precision of an instrument used to measure the value and, unless otherwise dependent on the precision of the instrument, may indicate a range of +/- 10% of the stated value(s).
  • a feature “connected” or “coupled” to or with another feature may be directly connected or coupled to or with the other feature or, instead, one or more intervening features may be present.
  • a feature may be “directly connected” or “directly coupled” to or with another feature if intervening features are absent.
  • a feature may be “indirectly connected” or “indirectly coupled” to or with another feature if at least one intervening feature is present.
  • a feature “on” or “contacting” another feature may be directly on or in direct contact with the other feature or, instead, one or more intervening features may be present.
  • a feature may be “directly on” or in “direct contact” with another feature if intervening features are absent.
  • a feature may be “indirectly on” or in “indirect contact” with another feature if at least one intervening feature is present.
  • Different features “overlap” if a feature extends over, and covers a part of, another feature.

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

Abstract

L'invention concerne des dispositifs de distribution d'énergie avec un circuit souple. L'appareil comprend un dispositif de distribution d'énergie comprenant un circuit souple. Le circuit souple comprend un substrat et une électrode de traitement sur le substrat. L'appareil comprend en outre un bloc de support disposé adjacent à l'électrode de traitement. Le bloc de support comprend un matériau poreux.
PCT/EP2024/055822 2023-03-13 2024-03-06 Pointes de traitement avec un bloc de support poreux Pending WO2024188748A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363451778P 2023-03-13 2023-03-13
US63/451,778 2023-03-13

Publications (1)

Publication Number Publication Date
WO2024188748A1 true WO2024188748A1 (fr) 2024-09-19

Family

ID=90362098

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2024/055822 Pending WO2024188748A1 (fr) 2023-03-13 2024-03-06 Pointes de traitement avec un bloc de support poreux

Country Status (1)

Country Link
WO (1) WO2024188748A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030216728A1 (en) * 1996-01-05 2003-11-20 Stern Roger A. RF electrode assembly for handpiece
EP1158919B1 (fr) * 1999-03-09 2005-06-29 Thermage, Inc. Appareil destine au traitement de tissus
US20090018628A1 (en) * 2007-07-10 2009-01-15 Thermage, Inc. Treatment apparatus and methods for delivering high frequency energy across large tissue areas
US20140188099A1 (en) * 2013-01-03 2014-07-03 Solta Medical, Inc. Patterned electrodes for tissue treatment systems
US20220409256A1 (en) * 2018-08-31 2022-12-29 Bausch Health Ireland Limited Methods and apparatus for pumping coolant to an energy delivery device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030216728A1 (en) * 1996-01-05 2003-11-20 Stern Roger A. RF electrode assembly for handpiece
EP1158919B1 (fr) * 1999-03-09 2005-06-29 Thermage, Inc. Appareil destine au traitement de tissus
US20090018628A1 (en) * 2007-07-10 2009-01-15 Thermage, Inc. Treatment apparatus and methods for delivering high frequency energy across large tissue areas
US20140188099A1 (en) * 2013-01-03 2014-07-03 Solta Medical, Inc. Patterned electrodes for tissue treatment systems
US20220409256A1 (en) * 2018-08-31 2022-12-29 Bausch Health Ireland Limited Methods and apparatus for pumping coolant to an energy delivery device

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