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EP4395674A1 - Dispositifs et méthodes d'ablation de tissus par tamis sphérique - Google Patents

Dispositifs et méthodes d'ablation de tissus par tamis sphérique

Info

Publication number
EP4395674A1
EP4395674A1 EP22865375.4A EP22865375A EP4395674A1 EP 4395674 A1 EP4395674 A1 EP 4395674A1 EP 22865375 A EP22865375 A EP 22865375A EP 4395674 A1 EP4395674 A1 EP 4395674A1
Authority
EP
European Patent Office
Prior art keywords
conductive
distal
wire
spheroid
ablation
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
EP22865375.4A
Other languages
German (de)
English (en)
Other versions
EP4395674A4 (fr
Inventor
Robert F. Rioux
Alyssa Bailey
Thomas Kurth
Zachary Rzeszutek
Giovanni Meier
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
Priority claimed from US17/463,216 external-priority patent/US12207863B2/en
Application filed by Innoblative Designs Inc filed Critical Innoblative Designs Inc
Publication of EP4395674A1 publication Critical patent/EP4395674A1/fr
Publication of EP4395674A4 publication Critical patent/EP4395674A4/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
    • 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
    • A61B18/148—Probes or electrodes therefor having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
    • A—HUMAN NECESSITIES
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    • 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
    • A61B18/1485—Probes or electrodes therefor having a short rigid shaft for accessing the inner body through natural openings
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    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/50—Supports for surgical instruments, e.g. articulated arms
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    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/0016—Energy applicators arranged in a two- or three dimensional array
    • A—HUMAN NECESSITIES
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    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022—Balloons
    • A—HUMAN NECESSITIES
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    • A61B2018/0022—Balloons
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    • A—HUMAN NECESSITIES
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    • A61B2018/00333—Breast
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    • A61B2018/00505—Urinary tract
    • A61B2018/00517—Urinary bladder or urethra
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2018/00547—Prostate
    • A—HUMAN NECESSITIES
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    • A61B2018/00559—Female reproductive organs
    • A—HUMAN NECESSITIES
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    • 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
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    • 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
    • A61B18/1206—Generators therefor
    • A61B2018/124—Generators therefor switching the output to different electrodes, e.g. sequentially
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    • 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
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    • 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
    • A61B2018/1465—Deformable electrodes
    • 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
    • A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • 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
    • A61B2018/1475—Electrodes retractable in or deployable from a housing
    • A—HUMAN NECESSITIES
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    • 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

  • 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. Electrosurgical methods, for example, can be used to destroy these abnormal tissue growths. However, in some instances, surgery alone is insufficient to adequately remove all cancerous tissue from a local environment.
  • treatment of early stage breast cancer typically involves a combination of surgery and adjuvant irradiation.
  • a lumpectomy removes only the tumor and a small rim (area) of the normal tissue around it.
  • Radiation therapy is given after lumpectomy in an attempt to eradicate cancer cells that may remain in the local environment around the removed tumor, so as to lower the chances of the cancer returning.
  • radiation therapy as a post-operative treatment suffers various shortcomings. For example, radiation techniques can be costly and time consuming, and typically involve multiple treatments over weeks and sometimes months. Furthermore, radiation often results in unintended damage to the tissue outside the target zone. Thus, rather than affecting the likely residual tissue, typically near the original tumor location, radiation techniques often adversely affect healthy tissue, such as short and long-term complications affecting the skin, lungs, and heart.
  • This design also enables the ablation device to function in a bipolar mode because a first conductive wire (or combination of conductive wires) can deliver energy to the surrounding tissue through its electrical connection with an ablation generator while a second conductive wire (or combination of conductive wiress) can function as a ground or neutral conductive member.
  • the even distribution is independent of probe orientation.
  • the insert also serves as a fluid flow resistance, preventing all of the fluid from pooling out of the irrigation ports too quickly.
  • the distal portion may generally include a plurality of ports or apertures configured to allow the fluid to pass therethrough, or weep, from the interior chamber to an external surface of the distal portion.
  • the spacer member is shaped and sized so as to maintain the hydrophilic insert in contact with the interior surface of the distal tip wall, and specifically in contact with the one or more perforations, such that the hydrophilic insert provides uniformity of fluid distribution to the perforations. Accordingly, upon positioning the distal portion within a target site (e.g., tissue cavity to be ablated), the electrode array can be activated.
  • the fluid weeping through the perforations to the outer surface of the distal portion is able to carry energy from electrode array, thereby creating a virtual electrode. Accordingly, upon the fluid weeping through the perforations, a pool or thin film of fluid is formed on the exterior surface of the distal portion and is configured to ablate surrounding tissue via the RF energy carried from the electrode array.
  • the conductive distal ends of each wire are preformed loops. Looping the conductive distal end of a wire may include disposing a preformed loop along the exterior surface of the spheroid body and fastening the anchor to a distal portion of the spheroid body. In certain aspects, looping the conductive distal end of a wire includes passing the conductive distal end from the interior space of an elongate body half to an exterior side, distally along the exterior surface of the spheroid body, around the anchor member, proximally along the exterior surface, and through the body into the interior space.
  • Certain methods of the invention include seating a hydrophilic insert in at least one spheroid body.
  • the hydrophilic insert may be a spheroid.
  • the hydrophilic insert may have a unique shape to fit the interior surface of the complimentary halves, which may include structural ridges or mating features.
  • the hydrophilic insert may also include a spherical spacer ball disposed within an interior of the insert.
  • the hydrophilic insert may be provided as two complementary halves that are joined around the spacer prior to seating.
  • the hydrophilic insert may be attached to the spacer ball.
  • the distal spheroid bodies include a plurality of support members, each member extending from a proximal portion of the spheroid body to the distal portion, wherein a distal end of each member is attached to the distal portion of the spheroid body via one of the anchor members.
  • the method may further include passing each of the two conductive wire portions of each wire along a lateral surface of one of the support members.
  • Certain methods of the invention include passing each of the two conductive wire portions of each wire underneath a one or the support members.
  • the support members are conductive.
  • the controller may be powered by a battery and the battery may be held in place using an overlay.
  • the overlay may contain a perforated section that allows the user to tear away a portion of the overlay in order to remove the battery after use.
  • the overlay may have a foam backing which prevents fluid ingress from seeping into the battery slot.
  • the overlay’s perforation may be located outside of the battery window in order to prevent fluid ingress.
  • FIG. l is a schematic illustration of an ablation system consistent with the present disclosure.
  • FIGS. 3 A, 3B, and 3C are perspective views of the ablation device tip of FIG. 2 in greater detail
  • FIG. 5A is a side view and FIG. 5B is a cross-sectional view of one embodiment of a deployable distal portion of the ablation device illustrating transitioning of the distal portion from a delivery configuration to a deployed configuration;
  • FIG. 6 illustrates a method of deploying the distal portion of FIGS. 5A and 5B into an expanded configuration for delivery of RF energy to a target site for ablation of marginal tissue;
  • FIG. 7 is a cross-sectional view of the deployable distal portion of FIGS. 5A and 5B illustrating the inclusion of an internal balloon member within an interior chamber of the distal portion.
  • the internal balloon is configured to receive a fluid from a fluid source and thereby expand, which, in turn, causes the distal portion to transition from the delivery configuration to the deployed configuration, and further supply the fluid to an exterior surface of the distal portion, via weeping of the fluid through one or more perforations on the distal portion wall, to create a virtual electrode arrangement with the electrode array;
  • FIG. 8 is an exploded view of an ablation device consistent with the present disclosure, including a hydrophilic insert provided within an interior chamber of the distal portion and configured to receive a fluid from a fluid source and evenly distribute the fluid to an exterior an exterior surface of the distal portion, via weeping of the fluid through one or more perforations on the distal portion wall, to create a virtual electrode arrangement with the electrode array;
  • a hydrophilic insert provided within an interior chamber of the distal portion and configured to receive a fluid from a fluid source and evenly distribute the fluid to an exterior an exterior surface of the distal portion, via weeping of the fluid through one or more perforations on the distal portion wall, to create a virtual electrode arrangement with the electrode array;
  • FIG. 9 is an exploded view of the ablation device of FIG. 8 illustrating the hydrophilic insert in more detail
  • 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.
  • FIG. 2 is a perspective view of the distal portion or tip 16 of the ablation device 14.
  • the distal tip 16 may include a neck portion 24 and a generally spheroid body 26 extending distally from the neck 24.
  • the spheroid body 26 may be generally rigid and may maintain a default shape.
  • the spheroid body 26 may be configured to transition between a collapsed state and an expanded state, as will be described in greater detail herein, particular with respect to FIGS. 5A-5B and 6-7.
  • the spheroid body 26 may be collapsible to a delivery configuration having a reduced size (e.g., equatorial diameter) relative to the deployed configuration size (e.g., equatorial diameter) of the spheroid body 26.
  • the catheter shaft 17 can be configured as a handle adapted for manual manipulation.
  • the catheter shaft 17 is additionally or alternatively 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 catheter shaft 17 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 device in place while the ablation or other procedure takes place, eliminating the need for a user to manually hold the device for the duration of the treatment.
  • an electrical line 34 may be provided for coupling the conductive wires 28 to the controller 18 and ablation generator 20 and a fluid line 38 may be provided for providing a fluid connection between the irrigation pump or drip 22 to the distal tip 16 so as to provide a conductive fluid (e.g., saline) to the tip 16.
  • the electrical line 34 and/or the fluid delivery line 38 can be supported by a stabilizing element 62 within the device lumen. In some cases, the stabilizing element 62 may be integral with the neck 24 of the distal tip 16.
  • conductive members 28 extend through a first port (e.g., the distal port 44), run along an external surface of the spheroid body 26 (e.g. within the groove 47) before re-entering the lumen of the distal tip 16 through another port (e.g., the proximal port 46).
  • a conductive fluid such as saline, may be provided to the distal tip 16 via the fluid line 38, wherein the saline may be distributed through the ports (e.g., to the distal ports 44, the proximal ports 46, and/or medial ports 45).
  • one or more conductive wires 28c can extend from along the external surface of the distal tip 16 at an angle (e.g., non-parallel to the longitudinal axis of the device), as shown in an angled configuration in FIG. 10C.
  • One or more conductive wires 28d, 28e, and 28f can also form a pattern along the external surface in which the conductive wires extend in various directions, as shown in a combined configuration in FIG. 10D.
  • one or more conductive wires 28g can extend a reduced length of the external surface an alternative configuration in FIG. 10E.
  • FIGS. 12A-12D are side and perspective views of the distal tip of the application device illustrating the different clinical axes or sides of FIG. 9.
  • each clinical axis can include multiple independently connected conductive wires.
  • clinical axis/side 66 can include three independently connected conductive wires 76
  • clinical axis/side 68 can include three independently connected conductive wires 78
  • clinical axis/side 70 can include three independently controlled conductive wires 80
  • clinical axis/side 72 can include three independently connected conductive wires 82
  • clinical axis/side 74 can include three independently controlled conductive wires 84
  • clinical axis/side 75 can include three independently controlled conductive wires 86.
  • FIGS. 13 and 14 are perspective and exploded perspective views, respectively, of one embodiment of a device controller 19 consistent with the present disclosure.
  • the controller 19 may include a first halve or shell 88a and a second halve or shell 88b for housing a PC board 90 within, the PC board 90 comprising circuitry and hardware for controlling various parameters of the device 14 during an ablation procedure.
  • an electrical line 34 may be provided for coupling the conductive wires 28 to the controller 18 and ablation generator 20 and a fluid line 38 may be provided for providing a fluid connection between the irrigation pump or drip 22 to the distal tip 16 so as to provide a conductive fluid (e.g., saline) to the tip 16.
  • the electrical line 34 and/or the fluid delivery line 38 can be supported by a stabilizing element 62 within the device lumen. In some cases, the stabilizing element 62 may be integral with the neck 24 of the distal tip 16.
  • each of the four conductive wires 28(l)-28(4) remain electrically isolated and independent from one another such that, each, or one or more sets of a combination of, the conductive wires, can independently receive an electrical current from the ablation generator and independently conduct energy, the energy including RF energy.
  • This allows energy to be selectively delivered to a designated conductive wire or combination of conductive wires.
  • This design also enables the ablation device to function in a bipolar mode because a first conductive wire (or combination of conductive wires) can deliver energy to the surrounding tissue through its electrical connection with an ablation generator while a second conductive wire (or combination of conductive wiress) can function as a ground or neutral conductive member.
  • each wire or sets of wires allows for activation (e.g., emission of RF energy) of corresponding portions of the electrode array.
  • the electrode array may be partitioned into specific portions which may correspond to clinical axes or sides of the distal portion of the device.
  • the electrode array may include at least four distinct portions (i.e., individual or sets of conductive wires) corresponding to four clinical axes or sides of the distal portion (e.g, four sides or quadrants around spheroid body).
  • FIG. 20 is a schematic illustration of the ablation device 14a illustrating delivery of fluid from the irrigation pump 22, as controlled by the controller 19, to the hydrophilic inserts 98a, 98b within the interior chamber of the distal tip 16, wherein the fluid can be subsequently distributed to an exterior surface of the spheroid body 26 resulting in a virtual electrode arrangement upon activation of one or more portions of the electrode array.
  • the saline may be distributed through at least the medial ports 45, such that the weeping saline is able to carry electrical current from electrode array, such that energy is transmitted from the electrode array to the tissue by way of the saline weeping from the ports, thereby creating a virtual electrode.
  • a pool or thin film of fluid is formed on the exterior surface of the spheroid body 26 and is configured to ablate surrounding tissue via the electrical current carried from the electrode array.
  • FIGS. 21 and 22 are perspective and plan views of a detachable mount 100 for holding and maintaining a temperature probe 102 (or any other separate monitoring device) at a desired position, as indicated by arrow 106, relative to the spheroid body 26 of the distal tip of the ablation device 14.
  • the mount 100 allows for an operator (e.g., surgeon) to releasably couple a temperature probe 102, or other measurement device, to the ablation device 14a and further position the working end 104 of the probe 102 in close proximity to the spheroid body 2 for the collection of temperature data during an RF ablation procedure.
  • the second end 114 may include a bore or channel configured to receive and retain a portion of the temperature probe 102 within.
  • the second end 114 may further allow for the temperature probe 102 to translate along the bore or channel, as indicated by arrow 116, to thereby adjust the distance of the temperature probe tip 104 relative to the spheroid body of the device tip.
  • the arm 112 and/or second end 114 may articulate relative to one another and/or the first end 108. Accordingly, the angle of the temperature probe 102 may also be adjusted as desired.
  • tissue ablation devices particularly the applicator heads described herein, may be well suited for treating hollow body cavities, such as cavities in breast tissue created by a lumpectomy procedure.
  • the devices, systems, and methods of the present disclosure can help to ensure that all microscopic disease in the local environment has been treated. This is especially true in the treatment of tumors that have a tendency to recur.
  • the proximal shaft/handle portion 2380 can be configured as a handle adapted for manual manipulation by a medical professional.
  • the handle/ shaft 2380 can include a textured gripping surface 2383 to prevent the device from slipping in the hand.
  • the proximal shaft/handle portion 2380 is additionally or alternatively 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.
  • FIG. 24 provides an exploded perspective of probe 2316.
  • the distal portion can comprise two complementary, elongate body halves 2326a, 2326b. These body halves act as the major structural feature of the probe 2316 and serve as a chassis on which the remaining components of the portion are seated and secured. The two halves can be coupled or joined to form a unitary distal portion.
  • one or more of the stabilizing elements 2362 provide functions, alternatively or additionally, to joining the elongate body halves 2316a, 2316b.
  • one or more of the stabilizing elements 2362 may serve to provide the probe 2316 with structural rigidity and integrity.
  • the conductive distal end 2382 of each wire is passed around an anchor element 2384 affixed to the spheroid body.
  • the conductive distal end 2382 of each wire is positioned on the spheroid body 2326 as a loop, and an anchor element 2384 is affixed to the spheroid body to secure the loop.
  • each anchor element is permanently secured or integral to one spheroid body half 2326a, 2326b.
  • each anchor element is secured or affixed to a spheroid body half during manufacturing.
  • Each anchor element may be made from, or secured using, a joining element, e.g., a screw or snap.
  • the anchoring element may be conductive or nonconductive, and it may be formed onto the end of the wire.
  • affixing the anchor element 2384 to the spheroid body secures the looped conductive distal ends 2382 of a wire to the spheroid body.
  • the conductive distal ends are looped around an anchor element and secured by manipulating the anchor element 2384, e.g., via tightening a fastening element such as a screw.
  • the anchor element 2384 is made from a non-conductive material to ensure that RF energy is only transmitted from the conductive elements 2328 disposed on the spheroid body. In certain aspects, the anchor element 2384 is made using a conductive material such that it can transmit RF energy during an ablation procedure.
  • each wire harness 2381a, 2381b includes a central portion 2385 that is seated during manufacturing in the interior space of one of the elongate body halves 2316a, 2316b.
  • the interior space of each elongate body half includes one or more wire channels or guides 2386 that secure the wires of each harness to an elongate body half.
  • one or more of the stabilizing elements 2362 can be used to position the wires of the harness within the device. The channels, guides, and/or stabilizing elements can assure that, not only are the wires of each harness positioned correctly and secured within the device, but that they also remain electrically isolated from one another.
  • each wire harness includes a proximal end 2387.
  • the wires at the proximal end 2387 can be connected to the central electrical line 2334, which can in turn be connected to a device controller 18 and/or an ablation energy generator 20.
  • the connection between the proximal end 2387 of a wire harness can be made or secured using, for example, clips or wire fasteners 2388.
  • the clips/fasteners 2388 are integral to the elongate body halves.
  • the clips/fasteners can be seated into the elongate body halves during manufacturing. These clips/fasteners may be made using conductive components that mate when the two halves come together. The wires may terminate in these conductive components and may complete the electrical connection between the distal electrodes and the cable which leads to the energy source.
  • one or more of a wire channel/guide 2386, a stabilizing element 2362, and/or the fastener/clip 2388 are used to provide a tensioning force on the wire harness towards the proximal end of the device. This helps ensure that the conductive distal tips 2382 remain flat along the exterior surface of the spheroid body.
  • one or more of the conductive wires 2328 can be electrically isolated from one or more of the remaining conductive wires 2328.
  • This electrical isolation enables various operation modes for the ablation device.
  • ablation energy may be supplied to one or more conductive wires 2328 in a bipolar mode, a unipolar mode, or a combination bipolar and unipolar mode.
  • unipolar mode ablation energy is delivered between one or more conductive wires 2328 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 2328, while at least one conductive wire 2328 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 2328.
  • the conductive wires can independently receive an electrical current from the ablation generator and independently conduct RF energy. This allows energy to be selectively delivered to a designated conductive wire or combination of conductive wires.
  • This design also enables the ablation device to function in a bipolar mode because a first conductive wire (or combination of conductive wires) can deliver energy to the surrounding tissue through its electrical connection with an ablation generator while a second conductive wire (or combination of conductive wiress) can function as a ground or neutral conductive member.
  • each wire or sets of wires allows for activation (e.g., emission of RF energy) of corresponding portions of the electrode array.
  • the electrode array may be partitioned into specific portions which may correspond to clinical axes or sides of the distal portion of the device. While various conductive wires 2328 have generally been described such that individual conductive members are energized or that the desired combination of conductive members is energized for a pre-selected or desired duration, in some cases, the desired combination of conductive members can be based on desired contact region of the spheroid body 2326.
  • the conductive elements 2328 can be arranged and controlled in the same manner as those in FIGS. 18-19.
  • the preformed wire harnesses 2381 can be used.
  • the harnesses can have electrically isolated wires already bundled and cut to the proper lengths such that they can be easily seated and secured within the elongate body halves 2316a, 2316b.
  • the distal conductive tips of each wire in a harness can be looped around an anchor member, such that two resulting conductive members are formed and disposed on the spheroid body in a desired conformation.
  • these devices of the disclosure can be manufactured faster and cheaper than prior devices. Moreover, as the methods of manufacturing are simple and involve fewer steps, there is less likelihood that mistakes will occur during production. This not only provides more consistency across the manufactured devices, but also provides the ability to employ a less skilled, and consequently less costly labor force.
  • these simple-to-manufacture devices can be configured to receive a flow of conductive and/or irrigation fluid, for example, from an irrigation or pump 22 as described herein.
  • the fluid can be provided to a fluid line 2338, which is fluidically connected with the interior of the device.
  • the fluid e.g., saline
  • the spheroid body 2326 includes distal ports/slots, proximal ports/slots, and/or medial ports/slots from which fluid is delivered to the exterior of the spheroid body.
  • the fluid flowing to the outer surface of the probe 2316 may carry electrical current from the electrode array, such that energy is promoted from the electrode array to the tissue by way of the fluid, thereby creating a virtual electrode. Accordingly, upon the fluid weeping through the ports, a pool or thin film of fluid is formed on the exterior surface of the probe 2316 and is configured to ablate surrounding tissue via the electrical current carried from the electrode array.
  • the fluid line 2338 may be fluidically connected to, or is a part of, a proximal lumen 2389.
  • the proximal lumen 2389 which may be a flexible tube, can be easily seated and secured into an elongate body half using one or more stabilizing structures 2362 and/or channels 2366.
  • the proximal lumen 2389 may be fluidically connected to a distal lumen 2390 to provide fluid to the spheroid body 2326.
  • the distal lumen 2390 can be seated and secured using channels and/or stabilizing structures.
  • the two lumens can be joined using a fluidic connector 2391 seated between the lumens.
  • the fluidic connector may be or may include, for example, a nozzle, flange, valves and the like.
  • the fluidic connector may create a leak tight or air tight seal between the two halves, with or without the aid of adhesive or liquid silicone, to prevent liquid from traveling up the handle.
  • the fluidic connector 2391 may include wire guides 2392 that receive the wires during manufacturing.
  • the device includes one or more hydrophilic inserts 2398a, 2398b that are seated within the spheroid body 2326.
  • the hydrophilic insert(s) aligns with the distal lumen 2390.
  • the hydrophilic insert is configured to distributed fluid from the distal lumen to the exterior of the spheroid body, for example, by wicking the fluid against gravity. By using a wicking action, the hydrophilic insert(s) provides a more uniform distribution of saline.
  • the hydrophilic insert(s) is formed using a hydrophilic foam material (e.g., hydrophilic polyurethane).
  • the hydrophilic insert is spherical and provided as two halves 2398a, 2398b. During manufacturing, one half of the insert can be seated in the spheroid body 2326a, 2326b of an elongate body half 2316a, 2316b. Each insert half may include one or more structures, such as slot 2397. Slot 2397 can seat around a corresponding structure 2396 in the spheroid body 2326a, 2326b of an elongate body half. In certain aspects, the structures, such as slot 2397, facilitate an even distribution of fluid, despite the orientation of the probe, and provide some resistance to the fluid to prevent it from flowing too quickly. Similarly, in certain aspects, the hydrophilic insert includes one or more passages or ports 2360 that facilitate fluid distribution.
  • the probe 2316 including the spheroid body 2326, may generally include a plurality of ports or apertures configured to allow the fluid to pass therethrough, or weep, from an interior space of the spheroid body to an external surface of the distal portion 2316.
  • all of the ports e.g., proximal ports, medial ports, and distal ports
  • only the medial ports may allow for fluid passage, while the proximal and distal ports may be blocked via a heat shrink or other occlusive material.
  • the hydrophilic insert(s) surround a spacing member.
  • the spacing member may, for example, help keep the hydrophilic insert flush against the interior space of the spheroid body.
  • the hydrophilic insert may be adhered to the spacer ball.
  • the spacing member 2372 may be formed from a nonconductive material and may be shaped and sized so as to maintain the hydrophilic inserts 2398a, 2398b in sufficient contact with the interior surface of the distal spheroid body wall, and specifically in contact with the one or more fluid ports, such that the hydrophilic inserts 2398a, 2398b provide uniform fluid distribution to the ports.
  • the spacing member 2372 may have a generally spherical body, corresponding to the interior contour the spheroid body 2326.
  • the spacer member includes structural components 2371 that facilitate fluid distribution to the hydrophilic inserts.
  • the structural components may align, for example, with a passage or port 2360 on the inserts to facilitate fluid distribution.
  • the spacing member 2372 is seated between two halves of a spherical hydrophilic insert 2398a, 2398b.
  • the spacer member may include one or more joining members 2373, e.g., clips or snaps.
  • the joining members can be used, for example, to attach the halves of the hydrophilic insert to the spacer member such that insert halves surround the spacer member.

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Abstract

La présente invention concerne un dispositif d'ablation ayant une configuration de tamis sphérique pour l'ablation de tissu marginal entourant une cavité tissulaire. Le dispositif comporte une sonde équipée d'une tige allongée non conductrice comprenant au moins une lumière à travers cette dernière et une partie distale non conductrice se déployant à partir de la tige. La partie distale non conductrice comprend une pluralité d'orifices distaux et une pluralité d'orifices proximaux en communication avec ladite au moins une lumière de tige. Le dispositif comprend en outre un réseau d'électrodes comprenant une pluralité de fils conducteurs indépendants se déployant à travers la lumière et positionnée le long d'une surface externe de la partie distale non conductrice, chaque fil de la pluralité de fils passe dans au moins un des orifices proximaux associés et dans au moins un des orifices distaux correspondants.
EP22865375.4A 2021-08-31 2022-08-29 Dispositifs et méthodes d'ablation de tissus par tamis sphérique Pending EP4395674A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US17/463,216 US12207863B2 (en) 2015-10-29 2021-08-31 Screen sphere tissue ablation devices and methods
PCT/US2022/041881 WO2023034207A1 (fr) 2021-08-31 2022-08-29 Dispositifs et méthodes d'ablation de tissus par tamis sphérique

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EP4395674A1 true EP4395674A1 (fr) 2024-07-10
EP4395674A4 EP4395674A4 (fr) 2025-06-25

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US8097926B2 (en) * 2008-10-07 2012-01-17 Mc10, Inc. Systems, methods, and devices having stretchable integrated circuitry for sensing and delivering therapy
JP6933857B2 (ja) * 2015-10-29 2021-09-08 イノブレイティブ デザインズ， インコーポレイテッド 網球状組織アブレーションデバイスおよび方法
US20170215947A1 (en) * 2016-02-02 2017-08-03 Innoblative Designs, Inc. Cavitary tissue ablation system
WO2020236689A1 (fr) * 2019-05-20 2020-11-26 Innoblative Designs, Inc. Dispositifs et procédés d'ablation tissulaire

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EP4395674A4 (fr) 2025-06-25
WO2023034207A1 (fr) 2023-03-09

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