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WO2025128495A1 - Dispositifs médicaux à thérapie focale et procédés pour cibles profondes - Google Patents

Dispositifs médicaux à thérapie focale et procédés pour cibles profondes Download PDF

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Publication number
WO2025128495A1
WO2025128495A1 PCT/US2024/059269 US2024059269W WO2025128495A1 WO 2025128495 A1 WO2025128495 A1 WO 2025128495A1 US 2024059269 W US2024059269 W US 2024059269W WO 2025128495 A1 WO2025128495 A1 WO 2025128495A1
Authority
WO
WIPO (PCT)
Prior art keywords
body member
needles
medical device
electrodes
therapy
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/US2024/059269
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English (en)
Inventor
Timothy O'brien
Ryan C. Abbott
Erasmo Lopez Calleros
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.)
Intuitive Surgical Operations Inc
Original Assignee
Intuitive Surgical Operations 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 Intuitive Surgical Operations Inc filed Critical Intuitive Surgical Operations Inc
Publication of WO2025128495A1 publication Critical patent/WO2025128495A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1477—Needle-like probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00273—Anchoring means for temporary attachment of a device to tissue
    • A61B2018/00291—Anchoring means for temporary attachment of a device to tissue using suction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1425—Needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1425—Needle
    • A61B2018/143—Needle multiple needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1425—Needle
    • A61B2018/1432—Needle curved
    • 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
    • A61B2018/1475—Electrodes retractable in or deployable from a housing

Definitions

  • Disclosed embodiments relate to medical devices, and more specifically, to focal therapy medical devices.
  • Minimally invasive medical techniques are intended to reduce the amount of tissue that is damaged during medical procedures, thereby reducing patient recovery time, discomfort, and harmful side effects.
  • Such minimally invasive techniques may be performed through natural orifices in a patient anatomy or through one or more surgical incisions. Through these natural orifices or incisions, physicians may insert minimally invasive medical instruments (including surgical, diagnostic, therapeutic, and/or biopsy instruments) to reach a target tissue location.
  • minimally invasive robotically-assisted surgery there is a time associated with switching out different instruments and/or end effectors. Reducing this time can advantageously reduce the time a patient is under general anesthesia.
  • a medical device in some examples, includes a first body member and a second body member coupled to the first body member, wherein the second body member has a distal end disposed distally from the first body member.
  • One or more needles are coupled to the first body member and extend distally from the first body member.
  • One or more electrodes are coupled to the distal end of the second body member and each electrode is axially aligned with a respective one of the one or more needles.
  • the first body member and second body member are movable relative to one another between a surface therapy position and a penetrating therapy position.
  • the one or more needles are electrically coupled to the electrodes with distal ends of the one or more needles recessed relative to the clcctrodcs/distal end of the second body member and the electrodes are configured to apply energy to a surface of a target.
  • the one or more needles extend distally relative to the electrodes/the distal end of the second body member and the one or more needles are configured to apply energy to a target.
  • a medical device in some examples, includes a first body member, one or more needles coupled to the first body member and extending distally from the first body member, and a second body member coupled to the first body member.
  • the first body member and the second body member are movable relative to one another between a first position with a distal end of the second body member disposed distally of the one or more needles and a second position with the needles extending distally relative to the distal end of the second body member.
  • the medical device further includes an auto-injection mechanism configured to drive the first body member relative to the second body member at least partially from the first position to the second position.
  • a treatment method includes delivering a medical device to a treatment location with the medical device in a first configuration, wherein the medical device includes a first body member and a second body member movable relative to one another.
  • the first configuration includes one or more needles coupled to the first body member and extending distally from the first body member with the needles being recessed relative to a distal end of the second body member.
  • the method further includes moving the first body member and second body member relative to one another to a second configuration that includes the needles extending distally relative to the distal end of the second body member.
  • a focal therapy delivery treatment method includes delivering a medical device to a treatment location, performing penetrating focal therapy with the medical device, and performing surface focal therapy with the medical device.
  • Performing the penetrating focal therapy includes moving an end wall of the medical device relative to a proximal body member of the medical device, such that needles coupled to the proximal body member move from a retracted position relative to the end wall to an extended position, pressing the needles into tissue, and supplying energy to the needles.
  • Performing the surface focal therapy with the medical device having the needles in the retracted position includes pressing electrodes coupled to the end wall of the medical device against tissue and supplying energy to the electrodes.
  • a medical device that includes a first body member and a second body member coupled to the first body member.
  • the second body member has a distal end disposed distally from the first body member.
  • One or more needles are coupled to the first body member and extending distally from the first body member.
  • the one or more needles are coupled to first wires to electrically couple the needles to one or more power supplies.
  • One or more electrodes are coupled to the distal end of the second body member. Each electrode is axially aligned with a respective one of the one or more needles and the one or more electrodes are coupled to second wires to electrically couple the electrodes to the one or more power supplies.
  • the first body member and second body member are movable relative to one another between a surface therapy position wherein the distal ends of the one or more needles are recessed relative to the distal end of the second body member and the electrodes are supplied with electrical power via the second wires, and a penetrating therapy position with the one or more needles extending distally relative to the one or more electrodes and the distal end of the second body member and the one or more needles are supplied with electrical power via the first wires.
  • FIG. 1 is a schematic diagram for a robotically-assisted manipulator system, according to some examples.
  • FIG. 2A is a schematic diagram of an instrument system according to examples described herein.
  • FIG. 2B illustrates a distal portion of the instrument system of FIG. 2A with an extended example of an instrument according to examples described herein.
  • FIG. 3A is a perspective view of a medical device according to examples described herein.
  • FIG. 3B is a perspective view of a distal end portion of the medical device of FIG. 3A.
  • FIG. 4 is a simplified diagrammatic view of a medical system according to some examples described herein.
  • FIG. 5A is a perspective view of a first example medical device showing needles in a retracted position according to some examples described herein.
  • FIG. 5B is a perspective view of the medical device of FIG. 5A showing the needles in an extended position.
  • FIG. 5C is a perspective view of the medical device of FIG. 5A.
  • FIG. 5D is a cross-sectional view of the medical device of FIG. 5A taken along the line
  • FIG. 5E is a rear perspective view of the medical device of FIG. 5A.
  • FIG. 5F is a view of a medical device depicting needles in an extended position.
  • FIG. 5G is a view of a medical device depicting a needle.
  • FIG. 5H is a view of a medical device depicting needles in an extended position.
  • FIGS. 5I-5J are views of medical devices depicting needles.
  • FIG. 5K is a view of a medical device depicting fluid channels.
  • FIG. 6 is a simplified side view of a second example medical device according to some examples described herein.
  • FIGS. 7A-7C are simplified side views of a first example medical device having a tissue-engaging tool according to some examples described herein.
  • FIGS. 8A-8C are simplified side views of a second example medical device having a tissue-engaging tool according to some examples described herein.
  • FIGS. 9A-9C are simplified side views of a third example medical device having a tissue-engaging tool according to some examples described herein.
  • FIG. 10 is a perspective view of a medical device according to examples described herein.
  • FIGS. 11A-11C are cross-sectional views of example medical devices having locking mechanisms according to some examples described herein.
  • FIGS. 12A and 12B are schematic diagrams of components for medical devices according to some examples described herein.
  • FIG. 13 is a perspective view of a medical device according to examples described herein.
  • FIG. 14 is a perspective view of a medical device according to examples described herein.
  • FIG. 15 A is a perspective view of a medical device according to examples described herein.
  • FIG. 15B is a sectional view of the medical device of FIG. 15A showing internal detail.
  • FIG. 15C is a cross-sectional view of the medical device of FIG. 15A.
  • FIG. 15D is a perspective view of the medical device of FIG. 15 A.
  • FIG. 16 is a schematic diagram of a medical device according to examples described herein.
  • FIG. 17A is a perspective view of a medical device according to examples described herein showing needles in a retracted position.
  • FIG. 17B perspective view of the medical device of FIG. 17A showing the needles in an extended position.
  • FIG. 18 a flowchart for a method of focal therapy delivery according to some embodiments.
  • position refers to the location of an object or a portion of an object in a three-dimensional space (e.g., three degrees of translational freedom along Cartesian x-, y-, and z-coordinates).
  • orientation refers to the rotational placement of an object or a portion of an object (e.g., one or more degrees of rotational freedom such as, roll, pitch, and yaw).
  • the term “pose” refers to the position of an object or a portion of an object in at least one degree of translational freedom and to the orientation of that object or portion of the object in at least one degree of rotational freedom (e.g., up to six total degrees of freedom).
  • the term “shape” refers to a set of poses, positions, and/or orientations measured along an object.
  • distal refers to a position that is closer to a procedural site and the term “proximal” refers to a position that is further from the procedural site. Accordingly, the distal portion or distal end of an instrument is closer to a procedural site than a proximal portion or proximal end of the instrument when the instrument is being used as designed to perform a procedure.
  • a multi-purpose medical device that can provide both surface and deep seated treatments.
  • the medical device enables focal therapy delivery to treat target tissue present on the surface of tissue with surface electrodes at a distal end portion of the medical device, as well as to treat deep seated target tissue with needles selectively extendable distally of a distal end portion of the medical device.
  • the medical device includes a body having a first body member and a second body member that are movable relative to one another to selectively move between desired treatment configurations.
  • the second body member may extend distally relative to the first body member.
  • the first body member may be a proximal body member and the second body member may be a distal body member.
  • the second body member is axially movable relative to the first body member to expose treatment needles.
  • the needles can be coupled to the first (proximal) body member to extend distally from the first body member and surface electrodes can be coupled to the second (distal) body member on a distal end surface of the second body member.
  • the second body member may be drivable forward to expose the needles.
  • the needles can be coupled to the second body member to extend distally from the second body member and the electrodes can be coupled to the first body member.
  • Movement of the first body member and second body member relative to one another causes the needles to be positioned in a retracted position (e.g., relative to the distal end surface of the second body member) or extend into an extended position (e.g., relative to the distal end surface of the second body member) according to a desired treatment option.
  • the needles and electrodes are axially aligned, with the needles engaging the electrodes in the retracted position and with the needles moved distal of the electrodes in the extended position.
  • the needles are electrically connected to a power supply via wires extending proximally to the medical device, such that with the needles in the retracted position, the electrodes are exposed distally of the needles and the electrodes are supplied electrical power or energy from the needles to provide surface therapies to target tissue in a surface therapy position.
  • the needles are supplied power or energy from the power supply and are configured to provide deep seated treatment (e.g., applied beyond a tissue surface) in a penetrating therapy position.
  • the electrodes and needles are separately connected to a power supply via wires extending proximally to the medical device.
  • the medical device can include a biasing mechanism, such as a spring, to bias the first body member and the second body member to the retracted needle position corresponding to the surface therapy position. Biasing to the retracted needle position will ensure that the needles are concealed during delivery and positioning of the medical device and will not inadvertently penetrate tissue.
  • a user may convert the medical device to the extended needle position correspond to the penetrating therapy position. Conversion to the extended needle position can be achieved by any suitable mechanism/method.
  • the medical device may be configured to allow a user to simply push the medical device against tissue to extend the needles to a desired depth and/or the medical device may include an auto-injection mechanism that applies a driving force to at least partially move the needles to the extended position. Further, the medical device can include a lock that prevents the needles from transitioning to the extended position when engaged.
  • the first body member may include a housing with an opening to receive a portion of the second body member.
  • the second body member may be a telescoping member (e.g., internally or externally) relative to the first body member (e.g., in the form of a plunger or piston) that is received in the opening in the first body member with the biasing mechanism between the mating portions of the first body member and the second body member.
  • the first body member may shift distally relative to the first body member and the second body member may press against the biasing mechanism when the medical device is pressed, injected, or inserted into tissue.
  • the needles may be deployed to a desired target depth. A greater amount of force may be applied to drive the needles into a deeper deployment, while a lower amount of force may be applied for a shallower deployment of the needles.
  • the medical device can optionally include a locking mechanism.
  • the locking mechanism can be in the form of a latch that retains the needles in the retracted needle position when locked. While locked, the needles are prevented from moving toward the expanded needle position. The locking mechanism helps to prevent inadvertent deployment of the needles.
  • the medical device may be actuated manually to deploy the needles. For example, a user may press the medical device against tissue (e.g., by hand or with one or more tools) to extend the needles to a desired depth.
  • the medical device may include an auto-injection mechanism to drive individual, group, or full needle deployment into the extended needle position.
  • the auto-injection mechanism may be set such that force of deployment drives the needles to a specific depth of penetration (e.g., 0.5 cm - 1 cm).
  • the auto-injection mechanism may be applied to embodiments containing a common biasing mechanism and may be applied to embodiments containing individually actuatable needles. Following deployment via the auto-injection mechanism, the needles may be extended further into tissue via manual actuation.
  • the medical device may include a plurality of needles and the needles may be deployed together upon actuation into the extended needle position.
  • the medical device may include a common biasing element (e.g., a common spring) that provides a biasing force to bias the plurality of needles together into the retracted needle position. When the biasing force is overcome, the plurality of needles are moved together towards the extended needle configuration.
  • the medical device may include a plurality of needles with one or more of the needles being independently biased (e.g., with a separate biasing element) and may be independently actuated relative to the other needles.
  • each needle of the plurality of needles may be separately biased and separately actuated.
  • the medical device may include a common auto-injection element (e.g., a common spring, actuator, etc.) that provides a force to drive the plurality of needles forward to the extended needle position.
  • the medical device may include a plurality of needles with one or more of the needles being independently driven forward to the extended needle position (e.g., with a separate auto-injection mechanism) and may be independently actuated relative to the other needles.
  • each needle of the plurality of needles may be include a separate auto-injection mechanism. Further in examples with separate biasing members/auto-injection mechanisms, needle deployment may occur one needle at a time, or multiple needles may be actuated simultaneously, or all of the needles may be actuated simultaneously.
  • the electrodes and/or needles may allow for local tissue sensing (impedance, temperature, pH, etc.) at any time during a procedure and/or the needles can be hollow to allow for the local delivery of an adjuvant, such as saline, one or more drugs, a muscle blockade, ionic content, contrast, etc.
  • an adjuvant such as saline, one or more drugs, a muscle blockade, ionic content, contrast, etc.
  • the medical device is drop-in device that can be grasped and manipulated by a grasping tool, such as a laparoscopic or robotic instrument having a gripping end effector.
  • a grasping tool such as a laparoscopic or robotic instrument having a gripping end effector.
  • the medical device may include one or more gasping portions that allow the grasping tool to easily hold the medical device for positioning and treatment.
  • the medical device may be configured as an end effector on a laparoscopic or robotic instrument.
  • the medical device in some embodiments is configured to fit on the end of an instrument, such as by snap-fit connection or the like, or is a standalone instrument.
  • the manipulator system can include one or more manipulators that can be operated with the assistance of an electronic controller (e.g., computer) to move and control functions of one or more instruments when coupled to the manipulators.
  • an electronic controller e.g., computer
  • FIG. 1 illustrates an embodiment of a robotically-assisted manipulator system for use with the medical devices described herein.
  • the manipulator system can be used, for example, in surgical, diagnostic, therapeutic, biopsy, or non-medical procedures, and is generally indicated by the reference numeral 100.
  • a robotically-assisted manipulator system 100 can include one or more manipulator assemblies 102 for operating one or more medical instrument systems 104 in performing various procedures on a patient P positioned on a table T in a medical environment 101.
  • the manipulator assembly 102 can drive catheter or end effector motion, can apply treatment to target tissue, and/or can manipulate control members.
  • the manipulator assembly 102 can be teleoperated, non-teleoperated, or a hybrid teleoperated and nonteleoperated assembly with select degrees of freedom of motion that can be motorized and/or teleoperated and select degrees of freedom of motion that can be non-motorized and/or non- teleoperated.
  • An operator input system 106 which can be inside or outside of the medical environment 101, generally includes one or more control devices for controlling manipulator assembly 102.
  • Manipulator assembly 102 supports medical instrument system 104 and can optionally include a plurality of actuators or motors that drive inputs on medical instrument system 104 in response to commands from a control system 112.
  • the actuators can optionally include drive systems that when coupled to medical instrument system 104 can advance medical instrument system 104 into a naturally or surgically created anatomic orifice.
  • Other drive systems can move the distal end of medical instrument in multiple degrees of freedom, which can include three degrees of linear motion (e.g., linear motion along the X, Y, Z Cartesian axes) and in three degrees of rotational motion (e.g., rotation about the X, Y, Z Cartesian axes).
  • the manipulator assembly 102 can support various other systems for irrigation, treatment, or other purposes.
  • Such systems can include fluid systems (including, for example, reservoirs, heating/cooling elements, pumps, and valves), generators, lasers, interrogators, and ablation components.
  • Robotically-assisted manipulator system 100 also includes a display system 110 for displaying an image or representation of the surgical site and medical instrument system 104 generated by an imaging system 109 which can include an imaging system, such as an endoscopic imaging system.
  • Display system 110 and operator input system 106 can be oriented so an operator O can control medical instrument system 104 and operator input system 106 with the perception of telepresence.
  • a graphical user interface can be displayable on the display system 110 and/or a display system of an independent planning workstation.
  • the endoscopic imaging system components of the imaging system 109 can be integrally or removably coupled to medical instrument system 104.
  • a separate imaging device such as an endoscope, attached to a separate manipulator assembly can be used with medical instrument system 104 to image the surgical site.
  • the endoscopic imaging system 109 can be implemented as hardware, firmware, software, or a combination thereof which interact with or are otherwise executed by one or more computer processors, which can include the processors of the control system 112.
  • Robotically-assisted manipulator system 100 can also include a sensor system 108.
  • the sensor system 108 can include a position/location sensor system (e.g., an actuator encoder or an electromagnetic (EM) sensor system) and/or a shape sensor system (e.g., an optical fiber shape sensor) for determining the position, orientation, speed, velocity, pose, and/or shape of the medical instrument system 104.
  • the sensor system 108 can also include temperature, pressure, force, or contact sensors or the like.
  • Robotically-assisted manipulator system 100 can also include a control system 112.
  • Control system 112 includes at least one memory 116 and at least one computer processor 114 for effecting control between medical instrument system 104, operator input system 106, sensor system 108, and display system 110.
  • Control system 112 also includes programmed instructions (e.g., a non-transitory machine-readable medium storing the instructions) to implement a procedure using the robotically-assisted manipulator system including for navigation, steering, imaging, engagement feature deployment or retraction, applying treatment to target tissue (e.g., via the application of energy), or the like.
  • Control system 112 can optionally further include a virtual visualization system to provide navigation assistance to operator O when controlling medical instrument system 104 during an image-guided surgical procedure.
  • Virtual navigation using the virtual visualization system can be based upon reference to an acquired pre-operative or intra-operative dataset of anatomic passageways.
  • the virtual visualization system processes images of the surgical site imaged using imaging technology such as computerized tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermography, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, and/or the like.
  • CT computerized tomography
  • MRI magnetic resonance imaging
  • fluoroscopy thermography
  • ultrasound ultrasound
  • OCT optical coherence tomography
  • thermal imaging impedance imaging
  • laser imaging laser imaging
  • nanotube X-ray imaging and/or the like.
  • the control system 112 can use a pre-operative image to locate the target tissue (using vision imaging techniques and/or by receiving user input) and create a pre-operative plan, including an optimal first location for performing treatment.
  • the pre-operative plan can include, for example, a planned size to expand an expandable device, a treatment duration, a treatment temperature, and/or multiple deployment locations.
  • FIG. 2A shows a medical instrument system 200 according to some embodiments.
  • medical instrument system 200 can be used in an image-guided medical procedure.
  • medical instrument system 200 can be used for non-teleoperational exploratory procedures or in procedures involving traditional manually operated medical instruments, such as endoscopy.
  • medical instrument system 200 is interchangeable with, or a variation of, medical instrument system 104 of FIG. 1.
  • Medical instrument system 200 includes elongate flexible device 202, such as a flexible catheter or endoscope (e.g., gastroscope, bronchoscope), coupled to a drive unit 204.
  • Elongate flexible device 202 includes a flexible body 216 having proximal end 217 and distal end, or tip portion, 218.
  • flexible body 216 has an approximately 14-20 mm outer diameter. Other flexible body outer diameters can be larger or smaller.
  • Flexible body 216 can have an appropriate length to reach certain portions of the anatomy, such as the lungs, sinuses, throat, or the upper or lower gastrointestinal region, when flexible body 216 is inserted into a patient’s oral or nasal cavity.
  • Tracking system 230 can optionally track distal end 218 and/or one or more of the segments 224 using a shape sensor 222. In some embodiments, tracking system 230 can optionally and/or additionally track distal end 218 using a position sensor system 220, such as an electromagnetic (EM) sensor system. In some examples, position sensor system 220 can be configured and positioned to measure six degrees of freedom, e.g., three position coordinates X, Y, Z and three orientation angles indicating pitch, yaw, and roll of a base point or five degrees of freedom, e.g., three position coordinates X, Y, Z and two orientation angles indicating pitch and yaw of a base point.
  • EM electromagnetic
  • Flexible body 216 includes one or more channels 221 sized and shaped to receive one or more medical instruments 226.
  • flexible body 216 includes two channels 221 for separate instruments 226, however, a different number of channels 221 can be provided.
  • FIG. 2B is a simplified diagram of flexible body 216 with medical instrument 226 extended according to some embodiments.
  • medical instrument 226 can be used for procedures and aspects of procedures, such as surgery, biopsy, ablation, mapping, imaging, illumination, irrigation, or suction. Medical instrument 226 can be deployed through channel 221 of flexible body 216 and used at a target location within the anatomy.
  • Medical instrument 226 can include, for example, image capture devices, biopsy instruments, ablation instruments, catheters, laser ablation fibers, and/or other surgical, diagnostic, or therapeutic tools.
  • Medical tools can include end effectors having a single working member such as a scalpel, a blunt blade, a lens, an optical fiber, an electrode, and/or the like.
  • Other end effectors can include, for example, forceps, graspers, balloons, needles, scissors, clip appliers, and/or the like.
  • Other end effectors can further include electrically activated end effectors such as electrosurgical electrodes, transducers, sensors, imaging devices and/or the like.
  • Medical instrument 226 can be advanced from the opening of channel 221 to perform the procedure and then retracted back into the channel when the procedure is complete. Medical instrument 226 can be removed from proximal end 217 of flexible body 216 or from another optional instrument port (not shown) along flexible body 216.
  • the medical instrument 226 can be used with an image capture device (e.g., an endoscopic camera) also within the elongate flexible device 202. Alternatively, the medical instrument 226 can itself be the image capture device.
  • Medical instrument 226 can additionally house cables, linkages, or other actuation controls (not shown) that extend between its proximal and distal ends to controllably the bend distal end of medical instrument 226.
  • Flexible body 216 can also house cables, linkages, or other steering controls (not shown) that extend between drive unit 204 and distal end 218 to controllably bend distal end 218 as shown, for example, by broken dashed line depictions 219 of distal end 218.
  • at least four cables are used to provide independent “up-down” steering to control a pitch motion of distal end 218 and “left-right” steering to control a yaw motion of distal end 218.
  • drive unit 204 can include drive inputs that removably couple to and receive power from drive elements, such as actuators, of the teleoperational assembly.
  • medical instrument system 200 can include gripping features, manual actuators, or other components for manually controlling the motion of medical instrument system 200.
  • the information from tracking system 230 can be sent to a navigation system 232 where it is combined with information from visualization system 231 and/or the preoperatively obtained models to provide the physician or other operator with real-time position information.
  • FIGS. 3 A and 3B are various views of a medical device 300, according to an embodiment.
  • the medical device 300 or any of the components therein are optionally parts of an instrument for a surgical system that performs surgical procedures, and which surgical system can include a manipulator unit, a series of kinematic linkages, a series of cannulas, or the like.
  • the medical device 300 (and any of the instruments described herein) can be used in any suitable surgical system, such as the manipulator system 100 or the manipulator system 200 shown and described above.
  • the medical device 300 can be used as the medical instrument 226 described above. As shown in FIG.
  • the medical device 300 defines (or is included within) a distal boundary (or footprint) 302 that corresponds to a cannula size, or a size to fit within a working channel of an elongate flexible device (such as a flexible catheter or endoscope), or other size dictated by the surgical environment.
  • the distal boundary 302 can be a cylindrical shape having any suitable nominal diameter (e.g., 8 mm, 5 mm, or any size therebetween).
  • the medical device 300 includes a force transmission mechanism 304, a shaft 306, an optional distal wrist assembly 308, a distal end effector 310, and a set of tension elements 312 (which can be, for example, a cable, band, or the like).
  • the medical device 300 can include multiple tension elements 312.
  • the medical device 300 can include two tension elements 312 with each tension element 312 having two segments extending along the shaft 306 of the instrument, thereby forming four proximal end portions.
  • respective tension elements 312 can be routed through a wrist assembly 314 and wrapped about respective pulleys 316 or 317 of the tool members 318, 319.
  • Each tension element 312 has two tension element segments along the shaft 306 with two proximal end portions that, when moved in opposite directions, can (among other things) cause rotation of the respective tool member 318 or 319 about the axis Al.
  • the medical device 300 can include four separate tension elements 312 with two separate tension elements coupled to the pulley 316 of the tool member 318 and two separate tension elements coupled to the pulley 317 of the tool member 318, thereby creating four proximal tension element end portions.
  • the medical device 300 can include more than two or four tension elements 312 and more than four proximal tension element end portions.
  • the tension elements 312 can be, for example, cables, bands, or the like that couple the force transmission mechanism 304 to the distal wrist assembly 308 and end effector 310.
  • the tension elements 312 can be constructed from a polymer.
  • the medical device 300 is configured such that movement of one or more of the tension elements 312 produces rotation of the end effector 310 about a first rotation axis Al (see FIG. 3B, which functions as a yaw axis, the term yaw is arbitrary), rotation of the wrist assembly 308 about a second rotation axis A2 and/or optionally about a third rotation axis A3 (which functions as a pitch axis, the term pitch is arbitrary), a cutting rotation of the tool members of the end effector 310 about the first rotation axis Al, or any combination of these movements.
  • a first rotation axis Al see FIG. 3B, which functions as a yaw axis, the term yaw is arbitrary
  • rotation of the wrist assembly 308 about a second rotation axis A2 and/or optionally about a third rotation axis A3 (which functions as a pitch axis, the term pitch is arbitrary)
  • Changing the pitch or yaw of the medical device 300 can be performed by manipulating the tension elements 312 in a similar manner as that described with reference to the device 2400 described in copending International Patent Application Serial No. PCT/US2022/039942, entitled “Surgical Instrument Cable Control and Routing Structures,” the disclosure of which is incorporated herein by reference in its entirety.
  • the proximal force transmission mechanism 304 includes a set of drive components such as capstans 322 and 324 that rotate or “wind” a proximal portion of any of the tension elements 312 to produce the desired tension element movement.
  • two proximal ends of a tension element 312, which are associated with opposing directions of a single degree of freedom, are connected to two independent drive capstans 322 and 324.
  • This arrangement which is generally referred to as an antagonist drive system, allows for independent control of the movement of (e.g., pulling in or paying out) each of the ends of the tension elements 312.
  • the force transmission mechanism 304 produces movement of the tension elements 312, which operates to produce the desired articulation movements (pitch, yaw, or grip) at the wrist assembly 308 and end effector 310.
  • the force transmission mechanism 304 includes components to move a first proximal end portion of the tension element 312 via the first capstan 322 in a first direction (e.g., a proximal direction) and to move a second proximal end portion of the tension element 312 via the second capstan 324 in a second opposite direction (e.g., a distal direction).
  • the force transmission mechanism 304 can also move both proximal end portions of the tension element 312 in the same direction. In this manner, the force transmission mechanism 304 can maintain the desired tension within the tension elements 312.
  • the force transmission mechanism 304 can include any of the assemblies or components described in International Patent Application Serial No. PCT/US2022/039942, entitled “Surgical Instrument Cable Control and Routing Structures,” the disclosure of which is incorporated herein by reference in its entirety.
  • any of the medical devices described herein can have the two ends of a tension elements wrapped about a single capstan.
  • This alternative arrangement which is generally referred to as a self-antagonist drive system, operates the two ends of the tension element using a single drive motor.
  • a force transmission mechanism can include one or more linear actuators that produce translation (linear motion) of a portion of the cables.
  • Such force transmission mechanisms can include, for example, a gimbal, a lever, or any other suitable mechanism to directly pull (or release) an end portion of any of the cables.
  • the proximal force transmission mechanism 304 can include any of the proximal force transmission mechanisms or components described in U.S. Patent Application Pub. No. US 2015/0047454 Al (filed Aug. 15, 2014), entitled “Lever Actuated Gimbal Plate,” or U.S. Patent No. US 6,817,974 B2 (filed Jun. 28, 2001), entitled “Surgical Tool Having Positively Positionable Tendon- Actuated Multi-Disk Wrist Joint,” each of which is incorporated herein by reference in its entirety.
  • the shaft 306 can be any suitable elongated shaft that is coupled to the force transmission mechanism 304 and to the optional wrist assembly 308 (when present) or the end effector 310.
  • the shaft 306 includes a proximal portion 326 that is coupled to the force transmission mechanism 304, and a distal portion 328 that is coupled to the optional wrist assembly 308 or to the end effector 310.
  • the shaft 306 defines a passageway or series of passageways through which the tension elements 312 and other components (e.g., electrical wires, ground wires, or the like) can be routed from the force transmission mechanism 304 to the wrist assembly 308.
  • FIG. 4 is a simplified diagram of a medical system 400 according to some embodiments.
  • the medical system 400 includes a medical device 402 capable of performing penetrating focal therapy and surface focal therapy.
  • the medical device 402 includes one or more needles 404 that penetrate tissue to perform the penetrating focal therapy and one or more electrodes 406 that abut the surface of tissue to perform the surface focal therapy.
  • the needles 404 and electrodes 406 are movable with respect to one another, such that the needles 404 can be recessed relative to the electrodes 406 for the surface focal therapy and extended past the electrodes 406 for the penetrating focal therapy.
  • the electrodes 406 are located at a distal end surface of the medical device 402 when the needles 404 are in a retracted position.
  • the medical device 402 can be configured with any suitable number of needles 404 and electrodes 406 to perform a given procedure.
  • the needles 404 and electrodes 406 can be arranged in a suitable array for spacing requirements and needle gauges of a given implementation.
  • the medical device 402 can include between one and thirty six (e.g., a six by six array) of needles 404 and electrodes 406.
  • the needles 404 or electrodes 406 can be utilized to deliver energy-based focal treatment in either a monopolar or bipolar’ fashion (e.g., Radio Frequency ablation (RFA), Electroporation-based energy (PEF/PFA, nsPEF, HFIRE, IRE, E2, ECT, EIT, EGT), Electrolytic-based energy, or any combination.).
  • the medical device 402 can also be configured for cryoablation or microwave ablation. In a cryoablation configuration, one or more of the electrodes 406 have an internal channel for nitrogen circulation. In a microwave ablation configuration, one or more of the electrodes 406 have an antenna provided by two internal conductive components spaced by a suitable insulative material (e.g., Teflon).
  • the antenna can be a triaxial antenna, a choke antenna, or a balun-free antenna.
  • the medical system 400 includes one or more power sources (e.g., power supplies) 408 that are electrically connected to the needles 404 by wires 410 and/or other suitable electrical pathways (e.g., traces, circuit boards, etc.). Each needle 404 is electrically connected to one of the electrodes 406 to provide electrical energy to the electrodes 406 when performing the surface focal therapy.
  • a control system 412 for the medical system 400 is operably coupled to the power supply 408 to control the electrical energy delivered to the medical device 402.
  • the medical device 402 can be configured as a drop-in probe or as an end effector to an instrument 414. In either implementation, the medical device 402 is disposed distally of the instrument 414. In the first instance, the medical device 402 is inserted or dropped at a target location within a patient and the instrument 414 includes an end effector capable of grasping and manipulating the medical device 402, such as an end effector including tool members 318, 319 described above. In the second instance, the medical device 402 can form a distal end of the instrument 414 as an end effector for the instrument 414. In some embodiments, the instrument 414 may have a shaft with a substantially rigid member. In other embodiments, the instrument 414 may have a flexible shaft, and the instrument 414 may be configured to be inserted through a flexible elongate device such as flexible elongate device 202 described above.
  • FIGS. 5A-5E show a medical device 502 capable of performing penetrating focal therapy and surface focal therapy.
  • the medical device 502 may correspond to the medical device 402 of the medical system 400.
  • the medical device 502 includes a first body member 516 and a second body member 518.
  • the second body member 518 is coupled to the first body member 516 and extends distally from the first body member 516.
  • the first body member 516 is a proximal body member and the second body member 518 is a distal body member.
  • the first body member 516 and the second body member 518 may be concentric with each other and each body member may extend along a common longitudinal axis L.
  • One or more needles 504 are coupled to the first body member 516 and extend distally from the first body member 516.
  • Electrodes 506 are electrically coupled to a distal end 520 of the second body member 518. As shown, each electrode 506 is axially aligned with and electrically coupled to a respective one of the needles 504. In an alternative example, one or more of the electrodes 506 can be electrically coupled to a power source via dedicated wiring, separate from the wiring supplying electrical power to the needles 504, as described further below with reference to FIG. 5F.
  • the distal end 520 of the second body member 518 is a wall defining a distal end surface 522 and the electrodes 506 are coupled to the distal end surface 522. As shown, the electrodes 506 can protrude distally outwardly of the distal end surface 522, so that the electrodes 506 provide a first point of contact of the medical device 502 as the medical device 502 is brought into contact with tissue.
  • the electrodes 506 may be surface electrodes.
  • the first body member 516 and the second body member 518 are movable relative to one another along a longitudinal axis L of the medical device 502 between a surface therapy position (FIG. 5A) and a penetrating therapy position (FIG. 5B).
  • the first body member 516 and the second body member 518 arc positioned relative to one another such that distal ends of the needles 504 are recessed relative to the electrodes 506 (e.g., in a retracted needle position) and the electrodes 506 are configured to apply energy to a surface of a target.
  • the needles 504 may be electrically coupled to a power source (e.g., via wires 410) and the needles 504 are energized.
  • the electrodes 506 can be exposed distally of the medical device 502 to be pressed against tissue while the electrodes 506 are supplied with energy via the needles 504 (i.e. , while the needles 504 are recessed relative to the electrodes 506, the needles 504 remain in electrical contact with the electrodes 506).
  • the first body member 516 and the second body member 518 are positioned relative to one another such that the needles 504 extend distally relative to the electrodes 506 (e.g., in an extended needle position) and the needles 504 are configured to apply energy to a target.
  • the needles 504 are exposed distally of the medical device 502 to be moved (e.g., pressed, injected, or inserted) into tissue while the needles are coupled to the wires 410 and are supplied energy via a power source.
  • one or more electrodes 506 may be electrically coupled a power source via separate wires that are distinct from the wires supplying electrical power to the needles 504, as described further below with respect to FIGS. 5F-5H.
  • the medical device 502 can include a single needle 504 and single electrode 506.
  • the medical device 502 can include two, three, or four needles 504 and electrodes 506 disposed in an array (e.g., a line, a triangular array, a square array, etc.).
  • the array can include a central needle/electrode or array surrounded by spaced needles/electrodes. For example, as shown in FIG.
  • the medical device 502 includes seven needles 504 and seven electrodes 506 with a central needle/electrode surrounded by six spaced needles/electrodes.
  • Gauges of the needles 504 and corresponding sizing for the electrodes 506 are selectable for a given implementation.
  • microneedles can be utilized for larger needle arrays.
  • the array can be configured so that adjacent needles/electrodes are spaced at equal distances from one another to aid in particular treatment procedures, as described in more detail below.
  • the needles 504 may each extend along a respective longitudinal axis with the longitudinal axes of the needles 504 being parallel to each other with equal spacing between the needles 504.
  • the needles 504 may extend substantially parallel to a longitudinal axis L of the medical device 502.
  • the needles 504 and electrodes can have any other known fixed spacing relative to one another (e.g., a rectangular configuration).
  • wires 510 are electrically coupled to proximal ends of the needles 504.
  • the proximal ends of the needles 504 are disposed within bores 524 (FIGS. 5D and 5E) extending longitudinally through the first body member 516 and the electrical coupling between each wire 510 and the respective needle 504 can be similarly disposed within the first body member 516.
  • the wires 510 extend proximally through the first body member 516 to exit through proximal openings of the bores 524.
  • the first body member 516 can define one or more radial openings 526 proximal to the bores 524, such that the wires 510 can be fed through the radial openings 526 to a central cavity 528 defined in the first body member 516 that opens rearwardly allowing the wires 510 to extend distally to be coupled to one or more power sources (not shown).
  • the proximal ends of the needles 504 can be secured within the bores 524 of the first body member 516 by any suitable method, including, for example, adhesive, welding, snap-fit, etc.
  • the distal end 520 of the second body member 518 can define through bores 530 (FIGS. 5D and 5E) for the needles 504 to pass therethrough as the first body member 516 and the second body member 518 are moved relative to one another to the penetrating therapy position.
  • the electrodes 506 have an annular configuration and are mounted around the through bores 530 to electrically couple the electrodes 506 to the needles 504. For example, as shown in FIG.
  • the electrodes 506 can have a cylindrical proximal portion 506a that extends partially or entirely through the second body member distal end 520 and a flanged distal end 506b that extends outwardly relative to the cylindrical proximal portion along the distal end surface 522.
  • the needles 504 and the electrodes 506 may be separ ated from each other via one or more insulators when in the penetrating therapy position.
  • the needles 504 may include an insulating region (e.g., an insulating layer or jacket) proximal to a distal end portion of the needle 504 to electrically isolate the electrodes 506 from the needles 504 in the penetrating therapy position.
  • the second body member 518 can be a telescoping member (e.g., a plunger or piston) that can be depressed with respect to the first body member 516.
  • the second body member 518 includes a body portion 532 that extends proximally from the distal end 520 of the second body member 518, and the first body member 516 defines a cavity 534 (FIG. 5D) sized to slidably receive the body portion 532 of the second body member 518 therein.
  • the bores 524 can be arranged around the cavity 534 in a ring.
  • the medical device 502 can further include a biasing mechanism or member 536 (e.g., spring, elastic member, etc.) disposed between the first body member 516 and the second body member 518.
  • the biasing mechanism 536 biases the first body member 516 and the second body member 518 away from one another such that the medical device 502 is held in the surface therapy position and the needles 504 are in the retracted needle position via a holding force of the biasing mechanism 536.
  • the body portion 532 of the second body member 518 can be annular to define a cylindrical interior, such that the biasing member 536 can be received within the interior of the second body member 518 to extend between the distal end 520 of the second body member 518 and a proximal end of the cavity 534 of the first body member 516.
  • the distal end 520 of the second body member 518 can be operated (e.g., pressed against tissue) to thereby overcome the holding force of the biasing mechanism 536 and move the distal end 520 of the second body member 518 proximally relative to the first body member 516 to expose the needles 504 and move the needles 504 into the extended needle position.
  • the medical device 502 can include an autoinjection mechanism (e.g., auto-injection mechanism 750 shown in FIGS. 17A-17B) configured to at least partially drive injection/insertion of the needles 504 into the tissue.
  • the first body member 516 can include a post portion 538 that extends distally within the cavity 534 to provide a central support for the centrally-disposed needle 504 as shown in FIG. 5D.
  • the annular body portion 532 of the second body member 518 is disposed concentrically around the post portion 538 of the first body member 516.
  • the post portion 532 can include one of the bores 524 extending longitudinally therethrough to receive the proximal end of the needle 504, as well as one of the wires 510 (not shown).
  • the medical device 502 can be an end effector for an instrument or be a drop-in probe.
  • one or both of the first body member 516 and the second body member 518 can include one or more grasping portions 540 providing a region for holding and manipulating the medical device 502 with a grasping tool, such as forceps or a jawed instrument.
  • a medical device 502 can include a plurality of grasping portions 540. Several example grasping portions 540 are shown in FIG. 5E.
  • the grasping portion 540 can include an upstanding wall or fin 542 having lateral protrusions or ribs 544 such that tool members (e.g., jaws or clamps) can grasp the upstanding wall 542 and be retained thereon for manipulating the medical device 502.
  • the grasping portion 540 can be defined by recesses or cavities 546 defined in opposite sides of the first body portion 516. As shown, the recesses 546 can be oriented downwardly so that a tool can grasp the medical device from above.
  • the medical device 502 may additionally or alternative include recesses 546 oriented upwardly so that a tool can grasp the medical device from below. Additionally or alternatively, the recesses 546 can be oriented at an angle.
  • the grasping portion 540 can be defined by an annular recess 548 defined in the first body portion 516.
  • the medical device 502 can include a plurality of grasping portions 540, such as one or more fins 542 and/or one or more recesses 546.
  • the grasping portion 540 can include grooves or ribs to provide texture and a better gripping surface.
  • one or more of the needles 504 can have a solid crosssection. Additionally or alternatively, one or more of the needles 504 can define a lumen 550 (FIG. 5D) extending therethrough. If desired, the lumen 550 can be fluidly coupled to a fluid source, such as an adjuvant, to deliver fluid to a treatment location through the needle 504. The delivery of fluid can be performed in conjunction (e.g., before, during, or after) a treatment utilizing the needles 504 in the penetrating position.
  • a fluid source such as an adjuvant
  • adjuvants can include saline, one or more drugs, a muscle blockade, ionic content, contrast, etc.
  • one or more of the needles 504 can include a sensor extending at least partially therethrough.
  • one or more needles 504 can include a visual tool, such as an ultrasound device (e.g., a fiber optic ultrasound device) or an optical coherence tomography device.
  • At least one of the needles 504/electrodes 506 can be a cathode and at least one of the needles 504/electrodes 506 can be an anode while performing the penetrating and/or surface focal therapy. Additionally or alternatively, the two or more needles 504 and electrodes 506 can enable local tissue sensing during a procedure (e.g., before, during, or after focal therapy). The local tissue sensing can provide data regarding the tissue, including, for example, impedance, temperature, pH, etc.
  • one or more of the electrodes 506 can be electrically coupled to a power source 508 via dedicated wiring or conductors, separate from wiring supplying electrical power to the needles 504.
  • the medical system 500 includes one or more power sources (e.g., power supplies) 508 that are electrically connected to the needles 504 by first wires 510a, and the one or more power sources 508 are electrically connected to the electrodes 506 by second wires 510b distinct from the first wires 510a.
  • a control system 512 for the medical system 500 is operably coupled to the power supply 508 to control the electrical energy delivered to the medical device 502.
  • one power source 508 or multiple separate power sources 508 may be provided.
  • the power source 508 supplying electrical power to the needles 504 may be the same power source or a different power from the power source 508 supplying electrical power to the electrodes 506.
  • the needles 504 may be supplied with electrical power without the electrodes 506 being supplied with electrical power, or the electrodes 506 may be supplied with electrical power without the needles 504 being supplied with electrical power, or the needles 504 and the electrodes may be simultaneously supplied with electrical power, or any combination thereof.
  • the various configurations can be utilized for energy-based focal treatment in either a monopolar or bipolar fashion.
  • either the needles 504 or the electrodes 506 may be supplied with electrical power for monopolar energy delivery (e.g., with current passing between the needles 504 or the electrodes 506 and a return pad located spaced apart from the medical device 502 such as outside the body of a patient).
  • multiple needles 504 may be simultaneously supplied with electrical power for bipolar energy delivery between the needles 504 (e.g., with current passing between multiple needles 504).
  • multiple electrodes 506 may be simultaneously supplied with electrical power for bipolar energy delivery between the electrodes 506 (e.g., with current passing between multiple electrodes 506).
  • a needle 504 and an electrode 506 pair may be supplied with electrical power together for bipolar energy delivery along the axial direction (e.g., with current passing between the needle 504 and electrode 506 pair). Further, multiple needle 504 and electrode 506 pairs may be supplied with electrical power for bipolar energy delivery.
  • the control system 512 may selectively control the electrical energy delivered to the medical device 502 at various times during the procedure to energize one or more of the needles 504 without energizing the electrodes 506, energize one or more of the electrodes 506 without energizing the needles 504, and/or simultaneously energize one or more of the needles 504 and one or more of the electrodes 506.
  • the needles 504 and the electrodes 506 may be separated from each other via one or more insulators when in the surface therapy position, when in the penetrating therapy position, and/or in both positions.
  • the needles 504 may include an insulating region (e.g., an insulating layer or jacket) 505 proximal to a distal end portion of the needle 504 to electrically isolate the electrodes 506 from the needles 504 in the penetrating therapy position. Additionally or alternatively, an insulator may be positioned between the needles 504 and the electrodes 506 in the surface therapy position.
  • an insulating region e.g., an insulating layer or jacket
  • an insulator may be positioned between the needles 504 and the electrodes 506 in the surface therapy position.
  • one or more of the needles 504 may include multiple electrodes or electrode portions.
  • the needles 504 may include a first electrode 562 at a distal end portion 560 of the needle 504 and may include a second electrode 564 that is proximal to the first electrode 562 and spaced apart from the first electrode 562.
  • the first electrode 562 and/or the second electrode 564 may be located at other portions of the needle 504.
  • the needle 504 may additionally include further electrodes or electrode portions (e.g., a third electrode, a fourth electrode, etc.).
  • the first electrode 562 of the needle 504 may be electrically coupled to the power source 508 via dedicated wiring, separate from wiring supplying electrical power to the first electrode 562 of the needle 504.
  • the first electrode 562 may be electrically connected to the power source 508 by a first wire 572.
  • the first wire 572 may extend through an inner diameter of the needle 504 and form a conductive central core of the needle 504 to couple to the first electrode 562.
  • a portion of the electrode 562 may extend proximally through an inner diameter of the needle 504 and form the central core of the needle 504.
  • the second electrode 564 may be electrically connected to the power source 508 by a second wire 574 distinct from the first wire 572.
  • the second electrode 564 may extend to a proximal end 566 of the needle 504 with the second wire 574 coupled to a proximal portion of the electrode 564.
  • an insulator (not shown) may be proximal to the second electrode 564 and the second wire 574 may extend through the insulator to electrically couple the second electrode 564 to the power source 508.
  • the first electrode 562 and wire 572 may be spaced apart from the second electrode 564 and wire 574 by one or more insulators and/or spacers that are not electrically conductive.
  • an axial insulating spacer 568 may axially space apart the first electrode 562 from the second electrode 564.
  • a further insulating spacer 570 may circumferentially surround the conductive central core of the needle 504 to radially separate the first electrode 562 and first wire 572 from the second electrode 564 and second wire 574.
  • an insulator may circumferentially surround a proximally extending portion of the second electrode 564 or second wire 574.
  • the first and second electrodes 562, 564 of the needle 504 can be utilized for energy-based focal treatment in either a monopolar or bipolar fashion.
  • first electrode 562 or the second electrode 564 may be supplied with electrical power for monopolar energy delivery (e.g., with current passing first electrode 562 or the second electrode 564 and a return pad located spaced apart from the needle 504 such as outside the body of a patient).
  • first electrode 562 and the second electrode 564 may be supplied with electrical power for bipolar energy delivery (e.g., with current passing between the first electrode 562 and the second electrode 564).
  • the first electrode 562 of the needle 504 may be coupled to the first wire 572
  • the second electrode of the needle 504 may be coupled to the second wire 574
  • the surface electrode 506 may be coupled to a third wire 576, with the first wire 572, the second wire 574, and the third wire 576 separate from each other.
  • the medical system 500 may include only the first wire 572, only the second wire 574, only the third wire 576, only the first and second wires 572, 574 , only the first and third wires 572, 576, or only the second and third wires 574, 576.
  • the medical system can include cooling elements configured to cool the electrodes, needles, and/or the tissue in contact with the needles or electrodes. Such cooling elements can be used to mitigate heating effects due to applied energybased treatment.
  • one or more needles can include internal channels providing a fluid flow path for a cooling fluid to flow within the respective needle.
  • FIG. 51 depicts an example needle 504 with internal channels 578, 579 providing a fluid flow path for a cooling fluid.
  • the cooling fluid may include saline (c.g., sterile saline), deionized water, air, nitrous oxide, etc.
  • One or more first channels 578 provide a path for routing cooling fluid in a first direction through the needles (e.g., a proximal to distal direction) while one or more second channels 579 provide a path for routing cooling fluid in a second direction opposite the first direction through the needles (e.g., a return path in a distal to proximal direction).
  • the one or more first channels 578 and the one or more second channels 579 may be in fluid communication to provide a continuous flow path from the first channels 578 to the second channels 579 (or alternatively from the second channels 579 to the first channels 578). As shown in FIG. 51, the first channels 578 and the second channels 579 may be concentric with each other.
  • the first channels 578 may be positioned concentrically within or alternatively outside of the second channels 579.
  • the first channels 578 and the second channels 579 may be arranged in a side-by-side configuration.
  • the cooling fluid internally cools the needles without the cooling fluid directly contacting tissue.
  • the cooling fluid may circulate through the needles and/or optionally through other portions of the medical system without the cooling fluid being provided to tissue external to the needles.
  • the respective needles may include one or more openings to route cooling fluid from the needle to an area surrounding the needle. For example, as shown in FIG.
  • one or more openings 580 in the needle 504 may intersect with one or more of the first channels 578 and/or one or more of the second channels 579 to allow cooling fluid to exit outside of the needle 504 and be placed in contact with tissue.
  • the medical device may include one or more cooling channels configured to circulate cooling fluid through the device and cool the needles, the electrodes, or both.
  • FIG. 5K depicts cooling channels 582 extending through the medical device 502 to cool the electrodes 506.
  • the cooling channels 582 may include supply channels 582a that receive cooling fluid from one or more fluid sources 584 and return channels 582b that return the cooling fluid back to the fluid sources 584.
  • the cooling channels 582 may extend through the first body member 516, through the second body member 518, or through both of the first body member 516 and the second body member 518. Further, the cooling channels 582 may extend to the electrodes 506 and/or to the needles 504.
  • FIG. 51 depicts cooling channels 582 with a supply channel 582a supplying cooling fluid to the one or more needles 504 and a return channel 582b returning cooling fluid back to the fluid source 584.
  • cooling channels 582 may include one or more supply channels 582a without a return channel 582b.
  • the cooling fluid may be expelled out of the openings 580 to an area surrounding the needles without a return of cooling fluid from the needles 504 to the fluid source 584.
  • some cooling channels may include supply and return channels 582a, 582b while other cooling channels may include a supply channel 582a without a return channel 582b.
  • Any of the above examples can include an external pumping system (e.g., a peristaltic pump) 586 to pump the cooling fluid through the medical device 502 and/or through the channels 578, 579, for example with the cooling fluid being received from the fluid source 584 as shown in FIGS. 5I-5K.
  • the cooling fluid can be delivered at room temperature, a reservoir of cooling fluid can be resting in a cooling medium (e.g., an ice slurry), or the cooling fluid entry line can be run through a heat exchanger system.
  • the needles 504 can have a straight or linear configuration, extending parallel with the longitudinal axis L of the medical device 502.
  • a medical device 602 can include one or more of the needles 604 that are preshaped to increase a treatment volume laterally (e.g., relative to a longitudinal axis L of the medical device 602).
  • the medical device 602 may correspond to the medical devices 402, 502.
  • the medical device 602 can have a configuration similar to the medical devices 402, 502 described above.
  • the medical device 602 includes a first body member 616 and a second body member 618 that are movable relative to one another to selectively expose or deploy the needles 604.
  • the first body member 616 is a proximal body member and the second body member 618 is a distal body member.
  • the needles 604 can be pre-shaped to extend laterally beyond the width of the medical device 602 to expand an area encompassed by the array of needles 604 when the needles 604 are deployed.
  • the needles 604 can be pre-shaped to have an outward cant, tilt, slant, angulation, etc. of a desired degree (e.g., between 0 degrees and 45 degrees) or to have a curve, arch, bend, hook, etc. of a desired degree (e.g., between 0 degrees and 180 degrees).
  • the needles 604 may splay outward away from the longitudinal axis L when the needles 604 are deployed.
  • the pre-shaped needles 604 can be provided as one or more outer needles 604a that arc arrayed around a perimeter of a distal end 620 of the medical device 602 adjacent to a lateral edge of the distal end 620.
  • all of the outer needles 604a can be pre-shaped to extend radially outwardly as the needles 604a are deployed.
  • a select number of the outer needles 604a can be pre-shaped to selectively expand the treatment volume in desired directions, while the remaining outer needles 604a can be straight (e.g., substantially parallel to the longitudinal axis L when deployed). This directed volume expansion can be used to avoid harming adjacent critical structures.
  • the number of outer needles 604a can range from between one to six, or more.
  • the medical device 602 can further include a central needle 604b that is straight.
  • FIGS. 7A-7C A medical device 702 including a tissue-engaging tool 752 is shown in FIGS. 7A-7C. According to some embodiments consistent with FIG. 4, FIGS. 5A-5E, and FIG. 6, the medical device 702 may correspond to the medical device 402, the medical device 502 and/or the medical device 602.
  • the medical device 702 can have a configuration similar to the medical devices 402, 502, 602 described above.
  • the medical device 702 includes a first body member 716 and a second body member 718 that are movable relative to one another along a longitudinal axis L of the medical device 702 between a surface therapy position (FIG. 7A) and a penetrating therapy position (FIGS. 7B and 7C).
  • the second body member 718 is coupled to the first body member 716 and extends distally from the first body member 716.
  • the first body member 718 is a proximal body member and the second body member 718 is a distal body member.
  • One or more needles 704 are coupled to the first body member 716 and extend distally from the first body member 716.
  • the needles 704 can include one or more needles having straight configurations (FIG. 7B) and/or one or more needles having pre-shaped nonstraight configurations (FIG. 7C).
  • One or more electrodes 706 are coupled to a distal end 720 of the second body member 718. As shown, each electrode 706 is axially aligned with and electrically coupled to a respective one of the needles 704.
  • the first body member 716 and the second body member 718 are positioned relative to one another such that distal ends of the needles 704 are recessed relative to the electrodes 706 (e.g., the needles are in a retracted needle position) and the electrodes 706 are configured to apply energy to a surface of a target.
  • the first body member 716 and the second body member 718 are positioned relative to one another such that the needles 704 extend distally relative to the electrodes 706 (c.g., the needles arc in an extended needle position) and the needles 704 are configured to apply energy to a target.
  • the tissue-engaging tool 752 is operable through the distal end 720 of the second body member 718 to hold tissue relative to the medical device 702 (e.g., against the distal end 720).
  • the tissue-engaging tool 752 is configured to removably couple to or engage tissue.
  • the tissue-engaging tool 752 can be used to provide better contact with the target tissue and may additionally allow the medical device 702 to remain coupled with the target tissue without an instrument holding the medical device 702.
  • the tissue-engaging tool 752 includes a suction device having one or more suction ports 754 exposed through the distal end 720 of the second body member 718 and a conduit 756 extending proximally through the second body member 718 and the first body member 716 to connect to a negative pressure source (not shown).
  • the conduit 756 can be collapsible or slidable relative to the body members 716, 718 to allow the body members 716, 718 to move relative to one another between the surface therapy position and the penetrating therapy position.
  • the conduit 756 can extend through aligned bores 758 extending through the first body member 716 and the second body member 718.
  • the tissue-engaging tool 752 may have a plurality of suction ports 754.
  • the plurality of suction ports 754 may be coupled to separate conduits 756 each coupled to a negative pressure source, or the plurality of suction ports 754 may be coupled to a common conduit 756.
  • FIGS. 8A-8C A medical device 802 including a tissue-engaging tool is shown in FIGS. 8A-8C. According to some embodiments consistent with FIG. 4, FIGS. 5A-5E, and FIG. 6, the medical device 802 may correspond to the medical device 402, the medical device 502, and/or the medical device 602.
  • the medical device 802 can have a configuration similar to the medical devices 402, 502, 602 described above.
  • the medical device 802 includes a first body member 816 and a second body member 818 that are movable relative to one another along a longitudinal axis L of the medical device 802 between a surface therapy position (FIG. 8A) and a penetrating therapy position (FIGS. 8B and 8C).
  • the second body member 818 is coupled to the first body member 816 and extends distally from the first body member 816.
  • the first body member 816 is a proximal body member and the second body member 818 is a distal body member.
  • One or more needles 804 are coupled to the first body member 816 and extend distally from the first body member 816.
  • the needles 804 can include one or more needles having straight configurations (FIG. 8B) and/or one or more needles having pre-shaped non-straight configuration (FIG. 8C).
  • One or more electrodes 806 are coupled to a distal end 820 of the second body member 818. As shown, each electrode 806 is axially aligned with and electrically coupled to a respective one of the needles 804.
  • the first body member 816 and the second body member 818 are positioned relative to one another such that distal ends of the needles 804 are recessed relative to the electrodes 806 (e.g., the needles are in a retracted needle position) and the electrodes 806 are configured to apply energy to a surface of a target.
  • the first body member 816 and the second body member 818 are positioned relative to one another such that the needles 804 extend distally relative to the electrodes 806 (e.g., the needles are in an extended needle position) and the needles 804 are configured to apply energy to a target.
  • the tissue-engaging tool 852 is operable through the distal end 820 of the second body member 818 to hold tissue relative to the medical device 802 (e.g., against the distal end 820).
  • the tissue-engaging tool 852 is configured to removably couple to or engage tissue.
  • the tissue-engaging tool 852 can be used to provide better contact with the target tissue and may additionally allow the medical device 802 to remain coupled with the target tissue without an instrument holding the medical device 802.
  • the tissue-engaging tool 852 includes a helix member 854 extendable through an opening 856 in the distal end 820 of the second body member 818.
  • the helix member 854 is rotatable to pierce and corkscrew into tissue distal of the medical device 802 to hold the tissue as the needles 804 are inserted therein and the second body member 818 is moved relative to the first body member 816.
  • the helix member 854 can be operably coupled to a drive (not shown) via a control line 858.
  • the helix member 854 can be configured to be driven forward past the distal end 820 of the second body member 818 to rotate into tissue while the second body member 818 is in the surface therapy position.
  • the helix member 854 can be received within aligned bores 860 extending at least partially through the first body member 816 and the second body member 818.
  • the helix member 854 can also be electrically connected to provide a central electrode in combination with the needles 804 and/or electrodes 806.
  • a plurality of helix members 854 may be provided. The plurality of helix members 854 may be coupled to separate control lines 858, or plurality of helix members 854 may be coupled to a common control line 858.
  • FIGS. 9A-9C A medical device 902 including a tissue-engaging tool is shown in FIGS. 9A-9C. According to some embodiments consistent with FIG. 4, FIGS. 5A-5E, and FIG. 6, the medical device 902 may correspond to the medical device 402, the medical device 502, and/or the medical device 602.
  • the medical device 902 can have a configuration similar to the medical devices 402, 502, 602 described above.
  • the medical device 902 includes a first body member 916 and a second body member 918 that are movable relative to one another along a longitudinal axis L of the medical device 902 between a surface therapy position (FIG. 9A) and a penetrating therapy position (FIGS. 9B and 9C).
  • the second body member 918 is coupled to the first body member 916 and extends distally from the first body member 916.
  • the first body member 916 is a proximal body member and the second body member 918 is a distal body member.
  • One or more needles 904 are coupled to the first body member 916 and extend distally from the first body member 916.
  • the needles 904 can include one or more needles having straight configurations (FIG. 9B) and/or one or more needles having pre-shaped nonstraight configurations (FIG. 9C).
  • One or more electrodes 906 are coupled to a distal end 920 of the second body member 918. As shown, each electrode 906 is axially aligned with and electrically coupled to a respective one of the needles 904.
  • the first body member 916 and the second body member 918 are positioned relative to one another such that distal ends of the needles 904 are recessed relative to the electrodes 906 (e.g., the needles are in a retracted needle position) and the electrodes 906 are configured to apply energy to a surface of a target
  • the first body member 916 and the second body member 918 are positioned relative to one another such that the needles 904 extend distally relative to the electrodes 906 (e.g., the needles are in an extended needle position) and the needles 904 are configured to apply energy to a target.
  • the tissue-engaging tool 952 is operable through the distal end 920 of the second body member 918 to hold tissue relative to the medical device 902 (e.g., against the distal end 920).
  • the tissue-engaging tool 952 is configured to removably couple to or engage tissue.
  • the tissue-engaging tool 952 engaging member can be used to provide better contact with the target tissue and may additionally allow the medical device 902 to remain coupled with the target tissue without an instrument holding the medical device 902.
  • the tissue-engaging tool 952 includes pivotable clamping members 954 that can be actuated to grip tissue therebetween.
  • the pivotable clamping members 954 are extendable through an opening 956 in the distal end 920 of the second body member 918.
  • the clamping members 954 are operable to pivot together or separately to hold the tissue as the needles 904 are inserted therein and the second body member 918 is moved relative to the first body member 916.
  • the pivotable clamping members 954 can be operably coupled to a drive (not shown) via a control line 958.
  • the pivotable clamping members 954 can be configured to be driven forward past the distal end 920 of the second body member 918 to clamp onto tissue while the second body member 918 is in the surface therapy position.
  • the pivotable clamping members 954 can be received within aligned bores 960 extending at least partially through the first body member 916 and the second body member 918.
  • the pivotable clamping members 954 can also be electrically connected to provide a central electrode in combination with the needles 904 and/or electrodes 906.
  • a plurality of clamping members 954 may be provided. The plurality of clamping members 954 may be coupled to separate drives for actuation, or the plurality of clamping members 954 may be coupled to a common drive.
  • a medical device 1002 is shown in FIG. 10 capable of performing penetrating focal therapy and surface focal therapy.
  • the medical device 1002 may correspond to the medical device 402, the medical device 502, the medical device 602, the medical device 702, the medical device 802, and/or the medical device 902.
  • the medical device 1002 can have a configuration similar to the medical devices 402, 502 described above.
  • the medical device 1002 includes a first body member 1016 and a second body member 1018 that are movable relative to one another between a surface therapy position and a penetrating therapy position.
  • the first body member 1016 is a proximal body member and the second body member 1018 is a distal body member.
  • an outer diameter of the medical device 1002 is provided by the second body member 1018, allowing the medical device 1002 to have a reduced outer diameter configuration to fit within the lumen of a medical instrument (e.g., an 8 mm cannula, trocar, or laparoscopic port).
  • a medical instrument e.g., an 8 mm cannula, trocar, or laparoscopic port
  • One or more needles 1004 are coupled to the first body member 1016 and extend distally from the first body member 1016.
  • One or more electrodes 1006 e.g., electrodes 406, 506, 606, 706, 806, 906 are electrically coupled to a distal end 1020 of the second body member 1018. As shown, each electrode 1006 is axially aligned with and electrically coupled to a respective one of the needles 1004.
  • the needles 1004 are coupled to the first body member 1016 in grooves 1024 defined in an outer surface of the first body member 1016.
  • the second body member 1018 has an annular sidewall 1038 configured to shift longitudinally along and be disposed concentrically around the first body member 1016 when transitioning between the surface and penetrating therapy positions. Transitioning to the penetrating therapy position exposes the needles 1004 distally of the second body member 1018 with the needles in an extended needle position.
  • a distal end 1020 of the second body member 1018 is a wall defining a distal end surface 1022 and the electrodes 1006 are coupled to the distal end surface 1022.
  • the electrodes 1006 can protrude distally outwardly of the distal end surface 1022 to provide a first point of contact of the medical device 1002 as the medical device 1002 is brought into contact with tissue with the needles 1004 in the retracted position.
  • the first body member 1016 and the second body member 1018 are positioned relative to one another such that distal ends of the needles 1004 are recessed relative to the electrodes 1006 (e.g., in a retracted needle position) and the electrodes 1006 are configured to apply energy to a surface of a target region.
  • the needles 1004 may be electrically coupled to a power source via wires 1010 and the needles 1004 are energized.
  • the electrodes 1006 can be exposed distally of the medical device 1002 to be pressed against tissue while the electrodes 1006 are supplied with energy via the needles 1004 (i.e., while the needles 1004 are recessed relative to the electrodes 1006, the needles 1004 remain in electrical contact with the electrodes 1006).
  • the first body member 1016 and the second body member 1018 are positioned relative to one another such that the needles 1004 extend distally relative to the electrodes 1006 (e.g., in an extended needle position) and the needles 1004 are configured to apply energy to a target.
  • the needles 1004 are exposed distally of the medical device 1002 to be moved (e.g., pressed, injected, or inserted) into tissue while the needles are coupled to the wires 1010 and are supplied energy via a power source.
  • the medical device 1002 can be an end effector for an instrument or be a drop-in probe.
  • the first body member 1016 and the second body member 1018 can include one or more grasping portions 1040 providing a region for holding and manipulating the medical device 1002 with a grasping tool, such as forceps or a jawed instrument.
  • the grasping portion 1040 can include a wall or fin 1042, or a plurality of fins 1042, that extends proximally from the first body portion 1016 having lateral protrusions or ribs 1044 such that tool members (e.g., jaws or clamps) can grasp the fin 1042 and be retained thereon for manipulating the medical device 1002.
  • the fin 1042 is arranged such that a maximum outer diameter of the first body member 1016 (including the fin 1042) is less than or equal to a maximum outer diameter of the second body member 1018.
  • Any of the medical devices described herein can include one or more locking mechanisms/members (e.g., latches) that are configured to retain the needles in the retracted needle position to prevent inadvertent deployment of the needles.
  • One example locking mechanism 1150 for a medical device 1102 is shown in FIGS. 11 A and 1 IB.
  • the medical device 1102 can have a configuration similar to the medical devices 402, 502 described above.
  • the medical device 1102 includes a first body member 1116 and a second body member 1118 that are movable relative to one another between a surface therapy position and a penetrating therapy position.
  • One or more needles 1104 e.g., needles 404, 504, 604, 704, 804, 904 are coupled to the first body member 1116 and extend distally from the first body member 1116.
  • One or more electrodes 1106 e.g., electrodes 406, 506, 606, 706, 806, 906) are electrically coupled to a distal end 1120 of the second body member 1118. As shown, each electrode 1106 is axially aligned with and electrically coupled to a respective one of the needles 1104.
  • the locking mechanism 1150 can include one or more levers 1152 that are selectively pivotable to dispose an end 1154 of the lever 1152 into a retraction path of the second body member 1118.
  • the end 1154 of the lever 1152 can be selectively pivoted out of the retraction path of the second body member 1118 to allow the second body member 1118 to be retracted as described herein for deployment of the needles 1104.
  • the end 1 154 of the lever 1152 can be selectively pivoted into the retracting path to hold the needles at specified depths.
  • the needles 1104 arc held via the lever 1152 in a retracted needle position.
  • the needles 1104 can alternatively be held at specified depths of penetration by pivoting the end 1154 of the lever 1152 into selective engagement with a series of grooves or notches 1158 as described herein.
  • Actuation of the locking mechanism 1150 can be achieved by any suitable method.
  • the first body member 1116 can be at least partially flexible (e.g., flexible in a portion aligned with the lever 1152) so that a clamp or other tool can be applied to an exterior of the first body member 1116 (e.g., squeeze the first body member 1116) to deflect the housing wall inwardly to thereby engage a second end 1156 of the lever 1152 and pivot the first end 1154 of the lever 1152 out of the retraction path of the second body member 1118.
  • the lever 1152 can be coupled to a solenoid or other actuation mechanism (e.g., a pull wire) that can be selectively actuated to pivot the lever 1152.
  • a control system e.g., control system 112
  • the lever 1152 and the second body member 1118 can be selectively engaged to hold the second body member 1118 at one or more deployment depths.
  • the second body member 1118 can include one or more grooves 1158 extending at least partially therearound and the lever 1152 can include a rib or lip 1160 that extends inwardly to selectively be received within the groove 1158.
  • the user can cause the second body member 1118 to retract to expose one or more of the needles 1104 as described herein. Thereafter, the user can release the lever 1152 to allow the first end 1154 of the lever 1152 to pivot back towards the second body member 1118.
  • the rib 1160 When the rib 1160 is aligned with one of the grooves 1158, the rib 1160 can be pivoted into groove 1158, which will prevent further retraction or extension of the second body member 1118 relative to the first body member 1116 and leave the needles 1104 exposed in a preset corresponding distance.
  • a medical device as described herein can include an inner tubular member in place of the lever 1152, where the inner tubular member is configured to be slid within the interior of the first body member 1116 to engage the second body member 1118.
  • the locking mechanism 1150 can include a spring-loaded latch 1162 that extends through the second body member 1118 to engage the first body member 1116 to prevent relative motion between the second body member 1118 and the first body member 1116 when the latch is engaged.
  • the latch 1162 can include a compression spring 1164 extending across an interior of the second body member 1118 or can include a coil spring 1166 extending along an interior surface of the second body member 1118. The latch 1162 can be depressed against the biasing force of the spring 1164, 1166 to move the latch 1162 out of engagement with the first body member 1116, allowing the second body member 1118 to shift with respect thereto.
  • the medical device 1102 can include one common locking mechanism 1150 for all of the needles 1104 with the locking mechanism 1150 engaging the second body member 1118.
  • the locking mechanism 1150 can include a plurality of mechanism for individual ones, pairs, or other combinations of needles 1104, so that less than all of the needles 1104 can be deployed as desired.
  • one or more needles 1204 for a medical device 1202 can include one or more markers 1205 spaced along a longitudinal length of the needle 1204.
  • the markers 1205 are disposed a predetermined length away from a distal tip 1204a of the needle 1204 to provide an indication of an insertion/deployment depth of the needle 1204 into tissue.
  • the markers 1205 can be configured to be visualized directly with a camera device and/or can be radiopaque for visualization under fluoroscopy or other imaging techniques.
  • a first body member 1216 of the medical device 1202 can be transparent or translucent or include a transparent or translucent portion aligned with the needles 1204 to allow the markers 1205 to be visualized through the first body member 1216. It will be understood that similar markers can be used with any of the embodiments described herein.
  • FIG. 13 Another example medical device 1302 is shown in FIG. 13.
  • the medical device 1302 can have a configuration similar to the medical devices 402, 502 described above.
  • the medical device 1302 includes a first body member 1316 and a second body member 1318 that are movable relative to one another between a surface therapy position and a penetrating therapy position.
  • One or more needles 1304 e.g., needles 404-1204 are coupled to the first body member 1316 and extend distally from the first body member 1316.
  • One or more electrodes (not shown) (e.g., electrodes 406- 1206) are electrically coupled to a distal end 1320 of the second body member 1318.
  • One or more tension or extension springs 1350 extend between the first body member 1316 and the second body member 1318 to bias the body members 1316, 1318 toward each other.
  • the first body member 1316 and the second body member 1318 further include cooperating cam structures to move the second body member 1318 between at least a first position with the needles 1304 being recessed and a second position with the needles 1304 being deployed.
  • the cam structures may provide additional needles positions (e.g., a third position, a fourth position, etc.) having different fixed depths of deployment of the needles 1304.
  • the first body member 1316 includes at least two slots 1352a, 1352b defined in an interior surface of the first body member 1316.
  • the two slots 1352a, 1352b have different longitudinal depths relative to a distal end of the first body member 1316 to provide the first position and the second position for the second body member 1318. Additional slots may be provided with yet further different longitudinal depths.
  • An angled camming surface 1354 extends between the slots 1352a, 1352b with the camming surface 1354 angled towards the deeper slot 1352b corresponding to the second position.
  • the second body member 1318 includes a cam 1356 that extends inwardly into an interior of the second body member 1318.
  • the cam 1356 is sized to be received within the slots 1352 and has an angled camming surface 1358 complementary to the camming surface 1354 of the first body member 1316.
  • An actuation member 1360 e.g., a button
  • the device 1302 can be delivered to a treatment location with the cam 1356 of the second body member 1318 received with the shallower slot 1352, such that the needles 1304 are recessed within the device 1302. Thereafter the actuation member 1360 can be pressed against tissue or pressed with another instrument to drive the cam 1356 out of the shallower slot 1352.
  • the tension spring 1350 pulls the cam 1356 along the camming surface 1354 of the first body member 1316 to rotate the second body member 1318 relative to the first body member 1316.
  • the actuation member 1360 can be released and spring 1350 pulls the cam 1356 into the deeper slot 1352 to shift the second body member 1318 to a fixed depth of deployment relative to the first body member 1316.
  • the first body member 1316 can include a plurality of camming surfaces 1354 spanning between three or more slots 1352 having different longitudinal positions that can be sequentially engaged as the second body member 1318 is shifted to provide different, sequential depths of deployment.
  • FIG. 14 Another example medical device 1402 is shown in FIG. 14.
  • the medical device 1402 can have a configuration similar to the medical devices 402, 502 described above.
  • the medical device 1402 includes a first body member 1416 and a second body member 1418 that are movable relative to one another between a surface therapy position and a penetrating therapy position.
  • One or more needles 1404 e.g., needles 404-1304.
  • One or more electrodes (not shown) (e.g., electrodes 406-1206) are electrically coupled to a distal end 1420 of the second body member 1418.
  • the medical device 1402 includes a torsion spring 1450 that engages both the first body member 1416 and the second body member 1418 to prevent movement of the second body member 1418 relative to the first body member 1416.
  • the torsion spring 1450 has a baseline state compressed around the second body member 1418, such that the second body member 1418 is prevented from moving relative to the torsion spring 1450.
  • the torsion spring 1450 further includes ends 1452 that extend outwardly through an opening 1454 defined through the first body member 1416.
  • the ends 1452 of the torsion spring 1450 abut a side of the opening 1454 in the first body member 1416 to effectively prevent the second body member 1418 from moving relative to the first body member 1416 with the torsion spring 1450 in the baseline state.
  • a user can engage the ends 1452 of the torsion spring 1450 to loosen the torsion spring 1450 and disengage the torsion spring 1450 from the second body member 1418.
  • the inner diameter of the torsion spring 1450 expands allowing the second body member 1418 to slide in and out relative to the torsion spring 1450 and the first body member 1416.
  • FIGS. 1 A-l 5D Another example medical device 1502 is shown in FIGS. 1 A-l 5D.
  • the medical device 1502 can have a configuration similar to the medical devices 402, 502 described above.
  • the medical device 1502 includes a first body member 1516 and a second body member 1518 that are movable relative to one another between a surface therapy position and a penetrating therapy position.
  • One or more needles 1504 are coupled to the first body member 1516 and extend distally from the first body member 1516.
  • One or more electrodes (not shown) (e.g., electrodes 406-1206) are electrically coupled to a distal end 1520 of the second body member 1518.
  • the medical device 1502 includes a shift lever 1550 to rotate the second body member 1518 relative the longitudinal axis of the device 1502 and, with sufficient longitudinal movement, lock the second body member 1518 into one of a plurality of axial deployment positions that have corresponding deployment depths for needle exposure.
  • the first body member 1516 and the second body member 1518 each include grasping portions 1552 providing regions for holding and manipulating the medical device 1502 with one or more grasping tools, such as forceps or a jawed instrument that allows the second body member 1518 to manipulated (e.g., rotated and moved proximally and distally along the longitudinal axis of the device 1502) relative to the first body member 1516.
  • the second body member 1518 further includes a radial protrusion 1553 that mates with internal slots 1554 defined along an interior surface of the first body member 1516.
  • the medical device 1502 includes one or more tension springs 1556 extending between the first body member 1516 and the second body member 1518 to pull the second body member 1518 proximally with respect to the first body member 1516.
  • Ends 1558 of the slots 1554 are notches having rear and side surfaces to receive the radial protrusion 1552 and restrict lateral/rotational movement of the radial protrusion 1553 when the radial protrusion 1553 is received in the end 1558 relative to the first body member 1516.
  • the ends 1558 of the slots 1554 correspond to predetermined deployment depths for the needles 1504.
  • a user can pull the first body member 1516 and the second body member 1518 longitudinally away from one another via the grasping portions 1552 to unseat the radial protrusion 1553 from the end 1558 of the current slot 1554.
  • the user can rotate the second body member 1518 relative to the first body member 1516 to longitudinally align the radial protrusion 1552 with another desired slot 1554 and allow the biasing force of the spring 1556 to pull the radial protrusion 1553 into the end 1558 of the desired slot 1554.
  • openings 1530 through the distal end 1520 of the second body member 1518 can have an arcuate, elongate shape to allow the second body member 1518 to rotate relative to the needles 1504 coupled to the first body member 1516.
  • a medical device 1602 is shown schematically in FIG. 16 capable of performing penetrating focal therapy and surface focal therapy.
  • the above-described medical devices e.g., medical device 402-1502 may include one or more features of the medical device 1602.
  • the medical device 1602 can have a configuration similar to the medical devices 402, 502 described above.
  • the medical device 1602 includes a first body member 1616 and a second body member 1618 that are movable relative to one another between a surface therapy position and a penetrating therapy position.
  • One or more needles 1604 e.g., needles 404-1504
  • One or more electrodes 1606 are electrically coupled to a distal end 1620 of the second body member 1618.
  • each electrode 1606 is axially aligned with and electrically coupled to a respective one of the needles 1604.
  • the electrodes 1606 may be electrically coupled a power source via separate wires that are distinct from the wires supplying electrical power to the needles 1604, as described further above.
  • the second body member 1618 can be a plunger or piston that can be depressed with respect to the first body member 1616.
  • the second body member 1618 includes a body portion 1632 that extends proximally from the distal end 1620 of the second body member 1618.
  • the medical device 1602 can further include a biasing mechanism or member 1636 (e.g., spring, elastic member, etc.) disposed between the first body member 1616 and the second body member 1618 to bias the first body member 1616 and the second body member 1618 away from one another such that the medical device 1602 is held in the surface therapy position and the needles 1604 are in the retracted needle position.
  • a biasing mechanism or member 1636 e.g., spring, elastic member, etc.
  • the first body member 1616 can define a cavity 1634 sized to receive biasing member 1636 therein. As shown, the biasing member 1636 can be received within an interior of the second body member 1618 to extend between the distal end 1620 of the second body member 1618 and a proximal end of the cavity 1634 of the first body member 1616.
  • the medical device 1602 includes an outer housing 1650 that defines an interior 1652 to receive the first body member 1616 and the second body member 1618 therein and a distal opening 1654.
  • the outer housing 1650 is sized so that the distal end 1620 of the second body member 1618 extends through the distal opening 1654. So configured, the electrodes 1606 are exposed distally of the outer housing 1650 for surface therapy.
  • the medical device 1602 includes a second biasing mechanism or member 1656 disposed between the first body member 1616 and the outer housing 1650.
  • the second biasing mechanism 1656 is configured to bias the first body member 1616 toward the distal opening 1654 of the outer housing 1650.
  • a release mechanism 1658 holds the first body member 1616 relative to the outer housing 1650 so that the second biasing mechanism 1656 is held in a compressed, primed state.
  • the body portion 1632 of the second body member 1618 extends proximally along the first body member 1616.
  • a user can press the distal end 1620 of the second body member 1618 against tissue at the treatment location, which shifts the second body member 1618 proximally with respect to the first body member 1616 and outer housing 1650.
  • the body portion 1632 engages the release mechanism 1658 to disengage the first body member 1616 from the release mechanism 1658. This allows the second biasing mechanism 1656 to drive the first body member 1616, and the needles 1304 coupled to the first body member 1616, distally.
  • the second biasing mechanism 1656 drives the needles 1604 forward to insert the needles 1604 into tissue.
  • the depth of insertion can be set according to the size of the second body portion 1616 relative to the distal end 1620 of the second body member 1618 and the configuration of the first biasing mechanism 1636. If further insertion is desired, the user can further press the second body member 1618 against tissue to compress the first biasing mechanism 1636 further.
  • the second biasing mechanism 1656 can include a plurality of biasing mechanisms, such as one for each needle 1604 to allow a user to choose which of the needles 1604 to be inserted. For example, the user can choose or more needles 1604 to insert or could cause groups or all of the needles 1604 to be inserted in concert.
  • a medical device 1702 is shown in FIGS. 17 A and 17B capable of performing penetrating focal therapy and surface focal therapy.
  • the above-described medical devices e.g., medical device 402-1602 may include one or more features of the medical device 1702.
  • the medical device 1702 includes a first body member 1716 and a second body member 1718 that are movable relative to one another between a surface therapy position and a penetrating therapy position.
  • the first body member 1716 is a proximal body member and the second body member 1718 is a distal body member.
  • One or more needles 1704 are coupled to a distal end 1720 of the first body member 1716 and extend distally from the first body member 1716 and one or more electrodes 1706 are electrically coupled to a distal end 1721 of the second body member 1718.
  • each electrode 1706 is axially aligned with and electrically coupled to a respective one of the needles 1704.
  • the first body member 1716 is operatively coupled to an auto-injection mechanism 1750 configured to drive the first body member 1716 and the needles 1704 coupled thereto distally relative to the second body member 1718.
  • the auto-injection mechanism 1750 allows deploying and driving the needles 1704 with greater force into target tissue.
  • the auto-injection mechanism 1750 is configured to partially or fully drive the needles 1704 to an extended needle position.
  • the auto-injection mechanism 1750 includes a bias member 1752 (e.g., one or more springs) coupled to the first body member 1716 and configured to drive the first body member 1716 distally with respect to the second body member 1718.
  • the auto-injection mechanism 1750 includes a control element 1754 that is configured to hold the bias member 1752 in a primed state, such that the needles 1704 are held in the retracted state.
  • the control element 1754 is actuatable to release the bias member 1752, which can then drive movement of the first body member 1716 and needles 1704 distally.
  • the control element 1754 includes a shaft 1756 having a spiral groove 1758 and the first body member 1716 defines an opening 1760 sized to receive the shaft 1756 therethrough.
  • the first body member 1716 engages the groove 1758 and, due to the spiral configuration of the groove 1758, rotation of the shaft 1756 drives or allows longitudinal travel of the first body member 1716.
  • the shaft 1756 extends proximally from the first body member 1716 to an actuator (e.g., motor) (not shown) that restricts or otherwise controls rotation of the shaft 1756. So configured, the medical device 1702 can be delivered to a treatment location as described herein with the control element 1754 holding the needles 1704 in the retracted position.
  • the actuator can allow rotation of the shaft 1756, such that the bias member 1752 is enabled to drive movement of the first body member 1716 to cause the needles 1704 to protrude through the distal end 1721 of the second body member 1718.
  • the actuator can be configured to drive the needles a predetermined deployed distance past the end surface of the second body member. Thereafter, the second body member can be manually depressed by pressing the device against the tissue in accordance with the above-described examples.
  • the medical device can include a plurality of biasing mechanisms/auto-injector mechanisms that are each configured to drive individual needles or groups of needles less than the full array of needles.
  • the user can actuate the mechanisms simultaneously or independently to deploy a desired number of needles. This also allows a user to determine locations for needle insertion/areas to avoid. Pursuant to this, some or all of the needles can be locked via separate locking mechanisms to prevent deployment. This allows a user to unlock desired needles are unlocked.
  • the devices can include an auto-injection mechanism configured to drive deployment of the needles to increase a deployment speed of the needles relative to pressing the device against tissue to get better piercing of the tissue via dynamic friction.
  • Any of the medical device embodiments described herein can be an end effector for an instrument (e.g., instrument 414) or be a drop-in probe.
  • the medical device can include one or more grasping portions (e.g., grasping portions 540) to provide a region for holding and manipulating the medical device with a grasping tool, such as forceps.
  • FIG. 18 illustrates a method 1800 for focal therapy delivery treatment according to some embodiments.
  • the method 1800 is illustrated as a set of operations or processes 1802 through 1814. Not all of the illustrated processes may be performed in all embodiments of the method 1800. Additionally, one or more processes that are not expressly illustrated in FIG. 18 may be included before, after, in between, or as part of the processes 1802 through 1814. Processes may also be performed in different orders.
  • one or more of the processes 1802 through 1814 may be implemented, at least in part, in the form of executable code stored on non- transitory, tangible, machine-readable media that when run by one or more processors (e.g., the processors of a controller) may cause the one or more processors to perform one or more of the processes.
  • the processes 1802 through 1814 may be performed by a controller.
  • a medical device e.g., medical device 402-1602 is delivered to a treatment location.
  • an end wall e.g., distal end 520-1620 of the medical device is biased away from a proximal body member (e.g., first body member 516-1616) with a biasing mechanism (e.g., spring 536) to bias needles (e.g., needles 404-1604) to a retracted needle position relative to the end wall.
  • a distal body member e.g., second body member 518-1618 having the distal end is biased away from the proximal body member to bias the needles into the retracted needle position.
  • tissue of a patient is engaged with a tissueengaging tool (e.g., tissue-engaging tool 752, 852, 952) operable through the end wall to hold tissue relative to the medical device.
  • tissueengaging tool e.g., tissue-engaging tool 752, 852, 952
  • penetrating focal therapy is performed with the medical device.
  • the penetrating focal therapy can be performed by moving the end wall of the medical device relative to the proximal body member of the medical device, such that the needles coupled to the proximal body member move from the retracted needle position relative to the end wall to an extended needle position, pressing/inserting/injecting the needles into tissue, and supplying energy to the needles.
  • process 1810 surface focal therapy is performed with the medical device having the needles in the retracted needle position by pressing electrodes (e.g., electrodes 406-1606) coupled to the end wall of the medical device against tissue and supplying energy to the electrodes via the needles.
  • electrodes e.g., electrodes 406-1606
  • an adjuvant is delivered through one of the one or more needles while performing the penetrating focal therapy.
  • local tissue sensing is performed with at least one of the needles or electrodes.
  • only surface focal therapy is performed or only penetrating focal therapy is performed for treatment (i.e., either process 1808 or process 1810 is omitted), while in other embodiments, both surface focal therapy and penetrating focal therapy are performed (both process 1808 and process 1810 are performed).
  • control system 112, 412 may be implemented in software for execution on one or more processors of a computer system.
  • the software may include code that when executed by the one or more processors, configures the one or more processors to perform various functionalities as discussed herein.
  • the code may be stored in a non-transitory computer readable storage medium (e.g., a memory, magnetic storage, optical storage, solid-state storage, etc.).
  • the computer readable storage medium may be part of a computer readable storage device, such as an electronic circuit, a semiconductor device, a semiconductor memory device, a read only memory (ROM), a flash memory, an erasable programmable read only memory (EPROM); a floppy diskette, a CD-ROM, an optical disk, a hard disk, or other storage device.
  • the code may be downloaded via computer networks such as the Internet, Intranet, etc. for storage on the computer readable storage medium.
  • the code may be executed by any of a wide variety of centralized or distributed data processing architectures.
  • the programmed instructions of the code may be implemented as a number of separ ate programs or subroutines, or they may be integrated into a number of other aspects of the systems described herein.
  • wireless connections may use wireless communication protocols such as Bluetooth, near-field communication (NFC), Infrared Data Association (IrDA), home radio frequency (HomeRF), IEEE 802.11, Digital Enhanced Cordless Telecommunications (DECT), and wireless medical telemetry service (WMTS).
  • wireless communication protocols such as Bluetooth, near-field communication (NFC), Infrared Data Association (IrDA), home radio frequency (HomeRF), IEEE 802.11, Digital Enhanced Cordless Telecommunications (DECT), and wireless medical telemetry service (WMTS).

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Abstract

Un dispositif médical comprend des éléments de corps mobiles l'un par rapport à l'autre pour fournir des traitements de thérapie focale de surface et de pénétration. Le dispositif médical comprend des électrodes pour proposer des traitements de thérapie focale de surface et des aiguilles qui peuvent être sélectivement étendues de manière distale d'une partie d'extrémité distale du dispositif médical pour fournir des traitements de thérapie focale pénétrants.
PCT/US2024/059269 2023-12-11 2024-12-10 Dispositifs médicaux à thérapie focale et procédés pour cibles profondes Pending WO2025128495A1 (fr)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6817974B2 (en) 2001-06-29 2004-11-16 Intuitive Surgical, Inc. Surgical tool having positively positionable tendon-actuated multi-disk wrist joint
US20090076497A1 (en) * 2001-02-28 2009-03-19 Angiodynamics, Inc. Tissue surface treatment apparatus and method
US20150047454A1 (en) 2013-08-15 2015-02-19 Intuitive Surgical Operations, Inc. Lever actuated gimbal plate
US20200390430A1 (en) 2018-03-07 2020-12-17 Intuitive Surgical Operations, Inc. Low-friction, small profile medical tools having easy-to-assemble components
WO2022271469A1 (fr) * 2021-06-22 2022-12-29 Pulse Biosciences, Inc. Embouts de traitement avec fonction d'aspiration
US20230218335A1 (en) * 2020-06-02 2023-07-13 Pulse Biosciences, Inc. High-voltage minimally invasive applicator devices for sub-microsecond pulsing

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090076497A1 (en) * 2001-02-28 2009-03-19 Angiodynamics, Inc. Tissue surface treatment apparatus and method
US6817974B2 (en) 2001-06-29 2004-11-16 Intuitive Surgical, Inc. Surgical tool having positively positionable tendon-actuated multi-disk wrist joint
US20150047454A1 (en) 2013-08-15 2015-02-19 Intuitive Surgical Operations, Inc. Lever actuated gimbal plate
US20200390430A1 (en) 2018-03-07 2020-12-17 Intuitive Surgical Operations, Inc. Low-friction, small profile medical tools having easy-to-assemble components
US20230218335A1 (en) * 2020-06-02 2023-07-13 Pulse Biosciences, Inc. High-voltage minimally invasive applicator devices for sub-microsecond pulsing
WO2022271469A1 (fr) * 2021-06-22 2022-12-29 Pulse Biosciences, Inc. Embouts de traitement avec fonction d'aspiration

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