WO2016130844A1 - Procédés et dispositifs de visualisation et modification de tissus - Google Patents

Procédés et dispositifs de visualisation et modification de tissus Download PDF

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Publication number
WO2016130844A1
WO2016130844A1 PCT/US2016/017608 US2016017608W WO2016130844A1 WO 2016130844 A1 WO2016130844 A1 WO 2016130844A1 US 2016017608 W US2016017608 W US 2016017608W WO 2016130844 A1 WO2016130844 A1 WO 2016130844A1
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WO
WIPO (PCT)
Prior art keywords
elongated member
tissue
distal end
visualization
hand
Prior art date
Application number
PCT/US2016/017608
Other languages
English (en)
Inventor
Xiaolong Ouyang
James S. Cybulski
Eric Schultz
Fred R. Seddiqui
Original Assignee
Trice Medical, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US14/622,680 external-priority patent/US20150157387A1/en
Application filed by Trice Medical, Inc. filed Critical Trice Medical, Inc.
Publication of WO2016130844A1 publication Critical patent/WO2016130844A1/fr

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    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
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Definitions

  • FIG. 7 provides a view of the distal end of a device according to one embodiment of the invention.
  • FIG. 8 A is a side view of one embodiment of a portable diagnostic tool.
  • FIG.8B is a section view of the portable diagnostic tool of FIG.8A.
  • FIG. 10F is a section view of the top view of the portable diagnostic tool of FIG. 8A that shows a conduit diagram for a port located at the distal tip of the elongated member and connecting to the port of FIG.8F, according to one embodiment.
  • FIG. 16 is a block diagram showing an embodiment of an electronic control schema for the portable diagnostic device of FIG 8A.
  • FIG. 19A is a side view of one embodiment of a RF tissue modulation device including a elongated member and hand-held control unit.
  • FIG. 22B is a side view of the separated medical device and adapter of FIG. 21A with a removable section of the medical device removed, according to one embodiment.
  • FIG. 29 is a block diagram showing an embodiment of a modulation circuit coupled to the charge accumulator shown for the RF energy source of FIG.26.
  • Tissue modification systems of the invention include both an access device and an elongated tissue modification device.
  • the access device is a device having a proximal end and a distal end and an internal passageway extending from the proximal end to the distal end.
  • the elongated tissue modification device has a proximal end and a distal end and is dimensioned to be slidably moved through the internal passageway of the access device.
  • the longest cross-sectional dimension of the internal passageway e.g., the inner diameter of a tubular shaped access device
  • the access devices ranges in length from 5 to 30 mm, such as 5 to 25 mm, including 5 to 20 mm, e.g., 7 to 18 mm.
  • the access devices are sufficiently rigid to maintain mechanical separation of tissue, e.g., muscle, and may be fabricated from any convenient material. Materials of interest from which the access devices may be fabricated include, but are not limited to: metals, such as stainless steel and other medical grade metallic materials, plastics, and the like.
  • aspects of the access devices of the invention include the presence of one or more illumination elements that are positioned at the distal end of the access device.
  • positioned at the distal end is meant that the illumination element(s) is present at the distal end of the access device, or near the distal end of the access device, e.g., within 10 mm or closer to the distal end, such as within 5 mm or closer to the distal end and including within 3 mm or closer to the distal end of the access device.
  • a variety of different types of lights sources may be employed as illumination elements, so long as their dimensions are such that they can be positioned at the distal end of the access device.
  • dimensioned to access an intervertebral disc is meant that at least the distal end of the device has a longest cross-sectional dimension that is 10 mm or less, such as 8 mm or less and including 7 mm or less, where in certain embodiments the longest cross-sectional dimension has a length ranging from 5 to 10 mm, such as 6 to 9 mm, and including 6 to 8 mm.
  • the elongate member may be solid or include one or more lumens, such that it may be viewed as a catheter.
  • catheter is employed in its conventional sense to refer to a hollow, flexible or semi-rigid tube configured to be inserted into a body.
  • systems of the invention include modified versions of any single port laporascopic device system which may include an access device and an instrument configured to be slidably introduced to a tissue location through the access device.
  • the RF-shielded visualization sensor module of the present device is integrated with the elongated member, it is not a separate device from the elongated member that is merely present in a working channel of the elongated member and which can be removed from the working channel of such an elongated member without structurally compromising the elongated member in any way.
  • the visualization sensor module may be integrated with the elongated member by a variety of different configurations. Integrated configurations include configurations where the visualization sensor of the visualization sensor module is fixed relative to the distal end of the elongated member, as well as configurations where the visualization sensor of the visualization sensor module is movable to some extent relative to the distal end of the elongated member.
  • the elongated member may or may not include one or more lumens that extend at least partially along its length.
  • the lumens may vary in diameter and may be employed for a variety of different purposes, such as irrigation, aspiration, electrical isolation (for example of conductive members, such as wires), as a mechanical guide, etc., as reviewed in greater detail below.
  • such lumens may have a longest cross section that varies, ranging in some instances from 0.5 to 5.0 mm, such as 1.0 to 4.5 mm, including 1.0 to 4.0 mm.
  • the diameter of the wire in such embodiments may be 180 ⁇ m, such as 150 ⁇ m or less, such as 130 ⁇ m or less, such as 100 ⁇ m or less, such as 80 ⁇ m or less.
  • RF electrode configurations suitable for use in tissue modification include, but are not limited to, those described in U.S. Patent Nos. 7,449,019; 7,137,981; 6,997,941; 6,837,887; 6,241,727; 6,112,123; 6,607,529; 5,334,183.
  • the tissue modification device can comprise an irrigation lumen located at the distal end of the elongated member, and the tissue modification device can include an aspiration lumen located at the distal end of the elongated member.
  • the irrigation lumen is operatively connected to a fluid source (e.g., a physiologically acceptable fluid, such as saline) at the proximal end of the device, where the fluid source is configured to introduce fluid into the lumen under positive pressure, e.g., at a pressure ranging from 0 psi to 60 psi, so that fluid is conveyed along the irrigation lumen and out the distal end.
  • a fluid source e.g., a physiologically acceptable fluid, such as saline
  • FIGS. 6A and 6B provide two different side views of a device 2200 according to one embodiment of the invention.
  • Device 2200 includes an elongated member 2210 and an operating handle 2220 at the proximal end of the elongated member 2210.
  • the operating handle has a gun configuration and includes a trigger 2225 and thumbwheel 2230 which provide a user with manual operation over certain functions of the device, e.g., RF electrode positioning and extension.
  • Located at the distal end of the elongated member is an integrated RF- shielded visualization sensor 2240 and tissue modifier 2250.
  • embodiments of such methods include positioning a distal end of a minimally invasive intervertebral disc imaging device of the invention in viewing relationship to an intervertebral disc or portion of there, e.g., nucleus pulposus, internal site of nucleus pulposus, etc.
  • viewing relationship is meant that the distal end is positioned within 40 mm, such as within 10 mm, including within 5mm of the target tissue site of interest.
  • the subject methods are suitable for use with a variety of mammals.
  • Mammals of interest include, but are not limited to: race animals, e.g. horses, dogs, etc., work animals, e.g. horses, oxen etc., and humans.
  • the mammals on which the subject methods are practiced are humans.
  • distal end polarized member is meant a structure or combination of structures that have been polarized in some manner sufficient to achieve the desired purpose of reducing, if not eliminating, light from the integrated illuminator directly reaching the integrated visualization sensor.
  • the light from an LED is polarized by a first polarizer (linearly or circularly) as it enters at lens or prism at the distal tip of the elongated member.
  • a visualization sensor such as CMOS sensor, also has a polarizer directly in front of it, with this second polarizer being complimentary to the first polarizer so that any light reflected by the outer prism surface into the visualization sensor will be blocked by this polarizer.
  • the distal end polarized member may be a cover lens, e.g., for forward viewing elongated members, or a prism, e.g., for off-axis viewing elongated members, such as described in greater detail below and elsewhere in the specification.
  • the internal tissue visualization devices of the invention further include a hand-held control unit to which the elongated member is operably connected.
  • the control unit is hand-held, it is configured to be held easily in the hand of an adult human.
  • the hand-held control unit may have a configuration that is amenable to gripping by the human adult hand.
  • the weight of the hand-held control unit may vary, but in some instances ranges from .5 to 5 lbs, such as .5 to 3 lbs.
  • the hand-held control unit may have any convenient configuration, such as a hand-held wand with one or more control buttons, as a hand-held gun with a trigger, etc., where examples of suitable handle configurations are further provided below.
  • the devices of the invention may be fabricated using any convenient materials or combination thereof, including but not limited to: metallic materials such as tungsten, stainless steel alloys, platinum or its alloys, titanium or its alloys, molybdenum or its alloys, and nickel or its alloys, etc.; polymeric materials, such as polytetrafluoroethylene, polyimide, PEEK, and the like; ceramics, such as alumina (e.g., STEATITETM alumina, MAECORTM alumina), etc.
  • metallic materials such as tungsten, stainless steel alloys, platinum or its alloys, titanium or its alloys, molybdenum or its alloys, and nickel or its alloys, etc.
  • polymeric materials such as polytetrafluoroethylene, polyimide, PEEK, and the like
  • ceramics such as alumina (e.g., STEATITETM alumina, MAECORTM alumina), etc.
  • the devices may include a stereoscopic image module.
  • stereoscopic image module is meant a functional module that provides a stereoscopic image from image data obtained by the device.
  • the module provides a user via the monitor with the perception of a three-dimensional view of an image produced from the image data obtained by the device.
  • the module is described in terms of“images”, and it should be understood that the description applies equally to still images and video. Further details regarding stereoscopic image modules and image recognition modules can be found in U.S. Application Serial Nos. 12/501,336 and 12/269,770; the disclosures of which are herein incorporated by reference.
  • Reference images that make up the reference may differ from each other in a number of ways.
  • any two given reference images may be images of regions of interest of different internal tissue locations.
  • the reference may include first and second pre-determined images that differ from each other with respect to a pre-determined internal tissue location.
  • the reference may include images of at least a first tissue location and a second tissue location.
  • the first and second tissue locations may be locations that a given device may be expected to image during a given procedure, such as during a surgical procedure.
  • the reference includes multiple images of different locations that a given visualization sensor should image during a given procedure if the procedure is performed correctly.
  • the image recognition module compares received image data of an internal tissue site (e.g., obtained during a given procedure of interest) with the reference.
  • the comparison performed by the image recognition module may be achieved using any convenient data processing protocol.
  • Data processing protocols that may be employed in this comparison step may compare the received image data and reference based on color descriptor data and/or anatomical descriptor data.
  • Data comparison protocols of interest include, but are not limited to: mean absolute difference between the descriptors of data and stored values such as mean color intensity, and, the degree of correlation between principle axis of the structure and stored values.
  • the stereoscopic module and image recognition modules may be implemented as software, e.g., digital signal processing software; hardware, e.g., a circuit; or combinations thereof, as desired.
  • the conveyance structure may be configured to transport items, e.g., fluids, medicines, devices, to an internal target site or from an internal target site.
  • the proximal end entry port of the conveyance structure may vary, and may be configured to be operably coupled to a variety of different types of components, such as but not limited to: aspiration units, fluid reservoirs, device actuators, etc.
  • devices of the invention may be configured for wireless data transmission, e.g., to provide for one or more of: transmission of data between various component of the device, transmission of data between components of the device and another device, such as hospital information system, separate monitor, etc. Any convenient wireless communication protocol may be employed, where in some instances wireless communication is implemented as one or more wireless communication modules.
  • the devices of the invention include an updatable control module, by which is meant that the devices are configured so that one or more control algorithms of the device may be updated. Updating may be achieved using any convenient protocol, such as transmitting updated algorithm data to the control module using a wire connection (e.g., via a USB port on the device) or a wireless communication protocol. The content of the update may vary.
  • a hand-held control unit is updated to configure the unit to be used with a particular elongated member. In this fashion, the same hand-held control units may be employed with two or more different elongated members that may differ by function and have different components.
  • FIGS. 8A-8K illustrate one embodiment a self-contained, portable diagnostic imaging device of the invention.
  • the hand-held, self- contained, portable diagnostic imaging device 100 illustrated in these figures includes a hand piece 114 and a removably attached elongated member 111 having a distal end integrated CMOS sensor, which is referred to herein as a“probe piece.” See FIG.8K.
  • a conduit that connects the port 115 to a port 391, as shown in FIGS. 10B and 10D located at the very distal end of the distal tip 120 of the probe piece whereby a material, medicine or implant may be delivered from the hand piece 100.
  • the material, medicine or implant may be aspirated into the port 391 at the distal tip 120 of the probe piece, and be transported through a conduit within the probe piece and hand piece, exiting through the port 115 located on the hand piece.
  • a switch 180 for turning on and off the present device.
  • the switch 180 would allow for power from the battery 195, shown in FIG 8B, to pass to the electronic board 190.
  • an embodiment of the sheath 400 may have connected and sealed to it a rigid and clear monitor cover 420 and a flexible boot 430.
  • the purpose of the monitor cover 420 is to allow for the functionality of the monitor means of the hand piece 112, while maintaining the sealability of the sheath 400.
  • the monitor cover 420 may be comprised of a clear plastic, for example, that has the mechanical features to snap over the monitor means; the purpose of which is to allow for a clear view of the monitor for the practitioner of the present invention.
  • the flexible boot 430 may be comprised of rubber, for example, that has the mechanical features to snap over the control elements, for example switches, of the hand piece 112, while maintaining the sealability of the sheath 400.
  • the hand piece sheath portion 450 may then be sealed over the hand piece 112 at a location 440 as described previously.
  • the flexible portion 500 of the probe piece may be constructed in such a way as to allow for flexion of this portion of the probe piece, in one or more directions.
  • the embodiment as shown in FIGS. 12A-12B shows one example of how to create the flexible portion 500 of the probe piece, by having a series of cut-outs covered with a hydrophobic tube 510.
  • the flexible portion 500 is configured to flex in one direction, that being shown in FIG. 12B.
  • the purpose of the hydrophobic tubing surrounding the cut-outs 510 is to prevent material ingress into the probe piece, for example water, while allowing for the flexion of the flexible portion 500.
  • this flexible portion 500 may be flexible in a plurality of directions and degrees, and may be controlled by a concomitant number of control cables connected to switches or other mechanical controls within the hand piece.
  • FIG. 8 there is shown one embodiment of a deployable sensor 812 incorporated into a device of the present invention 100 by a wired connection 810.
  • a wireless communication module may be employed instead of wired connection 810.
  • the wired connection passes through a port 391, as shown in FIGS.
  • Video processor module 905 may be electrically coupled with camera module 950 via an I2C bus, for example, with camera module 950 configured as the slave and microcontroller 930 as the master.
  • Microcontroller 930 may be configured to send camera control data to the camera module 950.
  • the camera control data may comprise information requests (e.g., for information relating to testing/debugging, for calibration data, etc.) or provide commands for controlling the camera module 950 (e.g., controlling the two or more distinct visualization sensors, etc.).
  • RF electrodes may be shaped in a variety of different formats, such as circular, square, rectangular, oval, etc.
  • the dimensions of such electrodes may vary, where in some embodiments the RF electrode has a longest cross sectional dimension that is 7 mm or less, 6 mm or less 5 mm or less, 4 mm or less, 3 mm or less or event 2 mm or less, as desired.
  • the diameter of the wire in such embodiments may be 180 ⁇ m, such as 150 ⁇ m or less, such as 130 ⁇ m or less, such as 100 ⁇ m or less, such as 80 ⁇ m or less.
  • the plasma generator is configured to generate a plasma between two or more RF electrodes.
  • one or more of the RF electrodes is a grounded conductive member, wherein a plasma is generated between an RF electrode and a grounded RF electrode (e.g., grounded conductive member, such as grounded outer surface of the elongated member, etc.).
  • the RF electrodes are provided with the necessary power and voltage to generate a plasma between the electrodes.
  • the plasma is only generated when the plasma generator is partially or fully submerged in saline solution such that only a portion of the plasma field is exposed to the patient.
  • the surrounding saline solution provides a conductive path between the electrodes as well as the sodium ions required to produce the plasma.
  • the saline solution may also help to disperse the thermal effects generated by the plasma field. Such limited exposure may also help to confine the treated region to the surface surrounding tissue.
  • the plasma may be generated in other mediums, such as air, blood, tissue, etc.
  • the electrical energy source may include one or more power sources— e.g., one or more DC batteries. While the electrical energy source is described as being located within the hand-held control unit or adapter, in some instances, the electrical energy source may be remote from the hand-held control unit or adapter—e.g., in a battery pack configured to be electrically coupled to the hand-held control unit or adapter—e.g., via cables. However, providing the electrical energy source within the hand-held control unit or adapter allows the RF tissue modulation device to remain untethered and more portable, which may be user-friendly for the operator of the device.
  • power sources e.g., one or more DC batteries.
  • the RF signal generator includes an RF power amplifier and an RF clock source.
  • the RF power amplifier receives an RF clock signal generated by the RF clock source and generates an RF signal at an operating frequency based on the RF clock signal.
  • the RF power amplifier may be configured to receive a voltage signal used as a bias voltage input.
  • the bias voltage input may affect , for example, the peak voltage of the signal output by the RF power amplifier.
  • the bias voltage signal may be received by another component such as the charge accumulator, DC to DC converter, or other voltage source.
  • the RF energy source may also include an RF tuner in some embodiments.
  • the RF tuner includes basic electrical elements (e.g., capacitors and inductors) which serve to tailor the output impedance of the RF energy system.
  • the term “tailor” is intended here to have a broad interpretation, including affecting an electrical response that achieves maximum power delivery, affecting an electrical response that achieves constant power (or voltage) level under different loading conditions, affecting an electrical response that achieves different power (or voltage) levels under different loading conditions, etc.
  • the elements of the RF tuner can be chosen so that the output impedance is dynamically tailored, meaning the RF tuner self-adjusts according to the load impedance encountered at the electrode tip.
  • the adapter is configured to operably and removably couple to a hand-held minimally dimensioned medical device.
  • the adapter may be configured to removably couple to a minimally dimensioned visualization device (such as, for example, a tissue visualization device as described in U.S. Application Serial No. 12/501,336, the disclosure of which is hereby incorporated by reference) that has been configured to couple to the adapter.
  • a minimally dimensioned visualization device such as, for example, a tissue visualization device as described in U.S. Application Serial No. 12/501,336, the disclosure of which is hereby incorporated by reference
  • the visualization device may be configured to include a removable section that removes so that the adapter may operably couple in place of the removable section.
  • the adapter of the present invention may be configured to removably couple and operate with a variety of medical devices other than a visualization device.
  • the RF tissue modulation devices further include a visualization sensor integrated at the distal end of the elongated member, such that the visualization sensor is integrated with the elongated member.
  • the visualization sensor is integrated with the elongated member, it cannot be removed from the remainder of the elongated member without significantly compromising the structure and functionality of the elongated member. Accordingly, the devices of the present invention are distinguished from devices which include a“working channel” through which a separate autonomous device is passed through.
  • the RF tissue modulation devices further include a second tissue modifier other than the plasma generator.
  • Tissue modifiers are components that interact with tissue in some manner to modify the tissue in a desired way.
  • the term modify is used broadly to refer to changing in some way, including cutting the tissue, ablating the tissue, delivering an agent(s) to the tissue, freezing the tissue, etc.
  • tissue modifiers are tissue cutters, tissue ablators, tissue freezing/heating elements, agent delivery devices, etc.
  • Tissue cutters of interest include, but are not limited to: blades, liquid jet devices, lasers and the like.
  • the RF tissue modulation devices may include a collimated laser configured to emit collimated laser light from a distal region of the elongated member, such as the distal end of the elongated member.
  • the collimated laser components of these embodiments may be configured for use for a variety of purposes, such as but not limited to: anatomical feature identification, anatomical feature assessment of sizes and distances within the field of view of the visualization sensor, etc.
  • the hand-held control unit 3130 includes RF energy source components as described above.
  • the hand-held control unit 3130 may include, for example, the electrical energy source, a voltage converter, charge accumulator, and RF signal generator (not shown).
  • Example embodiments of the RF energy source are described in further detail in later figures illustrating example block diagrams of the RF energy source. It should be understood that additional circuitry such as wiring, LEDs, control units (e.g., microcontrollers and/or microprocessors), memory units (e.g., volatile and non-volatile memory) may also be included within the hand-held control unit.
  • RF line 3116 provides an electrical connection between the RF energy source (not shown) and the conductive member 3115 such that RF energy (e.g., high voltage modulated RF signals as described above) may be delivered to conductive member 3115 from RF energy source when RF energy is activated.
  • RF energy e.g., high voltage modulated RF signals as described above
  • plasma generator 3111 produces a plasma between the conductive member 3115 and outer surface 3113, for example, as represented by the dotted arrows illustrated in FIGS.2A-2E.
  • FIG. 20C illustrates a cross sectional side view of an elongated member 3110, according to one embodiment.
  • Elongated member 3110 includes an outer surface 3113, distal end opening 3118 within the outer surface 3113, and distal end tip 3112.
  • Conductive member 3115 is positioned within the distal end opening 3118 by insulator 3117.
  • insulator 117 extends from within the elongated member 3110.
  • the distal end of the elongated member 3311 is shown close up in FIG. 21, as represented by the dotted arrow and circled sections. Furthermore, as explained earlier, additional components as well as the visualization sensor may be included in the RF probe 3311—e.g., illuminators, lumens, etc.
  • the RF tissue modulation device may include another number of interface locations—e.g., one.
  • electrical contacts may be included at one or more of the interface locations.
  • the electrical path for delivery of RF energy is not required to be at the same interface location of the electrical path for communication between the hand-held piece and the adapter.
  • FIGS. 22A-22C and FIG. 23 illustrate an RF tissue modulation device 300 including an adapter 3310 and diagnostic device 3350 (also referred to herein as “visualization device”), according to one embodiment.
  • the visualization device may be similar to the visualization devices described in U.S. Application Serial No. 12/501,336, except configured to removably couple to the adapter. More specifically, FIGS. 22A-22C and FIG. 23 illustrate various embodiments where the elongated member (e.g., RF probe) is removably coupled to the adapter.
  • the elongated member e.g., RF probe
  • An RF line (not shown) is positioned within RF probe 3311 to electrically couple the adapter 310 and the plasma generator 3312 positioned at the distal end of the RF probe 3311.
  • the RF line may be, for example, conductive wiring extending within the RF probe 3311 from an RF electrode (not shown) of the plasma generator 3312.
  • RF probe 3311 includes RF shielding as described above.
  • RF tuner 3608 coupled to voltage converter 3607.
  • RF tuner 3608 receives the high voltage modulated RF signal 3650 and outputs a signal 3660 to the plasma generator—e.g., vian RF line.
  • Signal 3660 is a high voltage modulated RF signal that has been tuned as follows.
  • the RF tuner 3608 includes basic electrical elements (e.g., capacitors and inductors) which serve to tailor the output impedance of the RF energy system.
  • the modulation at the modulation frequency comprises attenuating the amplitude of the high voltage signal based on the second clock signal.
  • the modulation waveform i.e., the clock signal from the clock source
  • the modulation waveform may be definable as a sine, square, saw-tooth, triangle, pulse, non-standard, complex, or irregular waveform, or the like, with a well-defined modulation frequency.
  • the modulation frequency can range from 1 Hz to 10 kHz, such as from 1 Hz to 500 Hz, and including from 10 Hz to 100 Hz.
  • the modulation waveform is a square wave with modulation frequency 50 Hz.
  • positive and negative high voltage outputs 820a,820b may range from +/-50 volts (at e.g., approximately 1.4 mA) to +/-1000 volts (at e.g., approximately 28.5 mA), such as from +/-200 volts (at e.g., approximately 5.7 mA) to +/-500 volts (at e.g., approximately 14.2 mA), and including from +/-300 volts (at e.g., approximately 8.5 mA) to +/-400 volts (at e.g., approximately 11.4 mA).
  • Transistors 834a,834b are further configured to receive input signals that turn the transistor on and off.
  • transistors 834a are configured to receive signals B1-B16 at the respective base inputs of BJTs 834a to turn on the respective BJT.
  • transistors 834b are configured to receive signals B’1-B’16 at the respective base inputs of BJTs 834b to turn on the respective BJT.
  • each transistor pair 834a,834b in each stage may be configured to turn on when an activation voltage signal (e.g., B1-B16 and B’1-B’16) is applied to its base.
  • an activation voltage signal e.g., B1-B16 and B’1-B’16
  • an activation voltage signal may be applied to a pair of transistors 834a,834b in a first stage, and then subsequently to a pair of transistors 834a,834b in a second stage, and so on, until all stages have discharged.
  • a modulation circuit (e.g., the one described in FIG. 29) may be implemented to provide the activation voltages signals sequentially to each stage at a modulated rate, as described further in FIG. 29.
  • charge accumulator 803 receives a high voltage signal from voltage converter 802 and outputs a high voltage modulated signal on its output lines.
  • the modulation rate can range from 1 Hz to 10 kHz, such as from 1 Hz to 500 Hz, and including from 10 Hz to 100 Hz.
  • the duty cycle may also vary and range from 5% to 95%, such as from 25% to 75%, and including from 45% to 55%). In some embodiments, the duty cycle is approximately 50%.
  • FIG. 29 illustrates a functional block diagram of a modulation circuit 31100 coupled to charge accumulator 803 shown in FIG. 10, according to one embodiment.
  • Modulation circuit 31100 is coupled to the charge accumulator 803 and outputs activation voltage signals (B1,B1’ to B16-B16’) to turn on the transistors 834a,834b in charge accumulator 803, thus discharging the stored charge in the pairs of capacitors 830a,830b at a modulated rate. More specifically, the activation voltage signals (B1 ,B1’ to B16-816’) from the output of the modulation circuit 3110 are input into the base of the transistor and bias the transistor and turn it on and off accordingly.
  • the RF tissue modulation devices may be configured to deliver RF energy from the RF energy source to the plasma generator for a therapeutic duration.
  • the therapeutic duration may range, for example, from minutes or less, including 30 seconds or less, such as 10 seconds or less. In some instances, the therapeutic duration may range from 1 to 2 seconds.
  • the therapeutic duration may be controlled using a variety of implementations.
  • the RF tissue modulation device may be configured to return switches 831, 835, 31107 to their charging positions after a predetermined amount of time.
  • the methods include generating RF energy, delivering the RF energy to the plasma generator, and generating a plasma at the plasma generator to deliver RF energy to the internal target tissue site of the subject.
  • a plasma may be generated between an RF electrode of the plasma generator and the outer surface of the elongated member, resulting in tissue modification.
  • irrigating conducting fluid is provided.
  • the plasma generator may further be translated and/or rotated while supplying RF energy (and irrigating conducting fluid in some instances)— e.g, resulting in tissue dissection.
  • the entire end of the RF tissue modulation device may be translated proximally and distally until the desired tissue dissection is obtained. When finished with tissue dissection at the first location, the device may be rotated 180 degrees and further tissue removed using the steps described above.
  • the methods of generating RF energy include providing electrical energy from an electrical energy source to a charge accumulator, storing energy in a charge accumulator, and discharging the electrical energy to voltage converter.
  • the methods may further include providing an RF clock signal from an RF clock source to the voltage converter and generating a modulated high voltage signal output.
  • the methods may further include providing the modulated high voltage signal to an RF signal generator to generate a high voltage modulated RF signal output.
  • the methods further include providing the high voltage modulated RF signal to an RF tuner and outputting a tuned high voltage RF signal to a plasma generator.
  • the methods of generating RF energy include providing electrical energy from an electrical energy source to a voltage converter.
  • embodiments of such methods include positioning a distal end of an RF tissue modulation device of the invention in viewing relationship to an intervertebral disc or portion of there, e.g., nucleus pulposus, internal site of nucleus pulposus, etc.
  • viewing relationship is meant that the distal end is positioned within 40 mm, such as within 10 mm, including within 5mm of the target tissue site of interest.
  • Methods of the invention may further include illuminating the internal target tissue site via an illuminator integrated at the distal end of the elongated member.
  • the target tissue e.g., intervertebral disc or portion thereof
  • Image data obtained according to the methods of the invention is output to a user in the form of an image, e.g., using a monitor or other convenient medium as a display means.
  • the image is a still image, while in other embodiments the image may be a video.
  • the methods of assembly include operably coupling a proximal end of an adapter to a hand-held medical device, e.g., a visualization device as described above.
  • the medical device includes a removable section that is removed before the adapter may be operably coupled.
  • this step of operably coupling may include a variety of different attachment mechanisms, such as snapping, hinging, using magnetics, etc.
  • medical device does not include a removable section that is required to be removed before operably coupling adapter to the medical device.
  • the subject devices and methods may find use in other procedures, such as but not limited to ablation procedures, including high-intensity focused ultrasound (HIFU) surgical ablation, cardiac tissue ablation, neoplastic tissue ablation (e.g. carcinoma tissue ablation, sarcoma tissue ablation, etc.), microwave ablation procedures, and the like.
  • ablation procedures including high-intensity focused ultrasound (HIFU) surgical ablation, cardiac tissue ablation, neoplastic tissue ablation (e.g. carcinoma tissue ablation, sarcoma tissue ablation, etc.), microwave ablation procedures, and the like.
  • HIFU high-intensity focused ultrasound
  • cardiac tissue ablation e.g. carcinoma tissue ablation, sarcoma tissue ablation, etc.
  • neoplastic tissue ablation e.g. carcinoma tissue ablation, sarcoma tissue ablation, etc.
  • microwave ablation procedures e.g. carcinoma tissue ablation, sarcoma tissue ablation, etc.
  • Yet additional applications of interest
  • a minimally invasive tissue modification system comprising:
  • tissue modifier is a mechanical tissue modifier.
  • a method of modifying an internal target tissue of a patient comprising: (a) positioning a minimally invasive access device having a proximal end, a distal end and an internal passageway so that the distal end is near the target tissue, wherein the distal end comprises an illumination element; and
  • the illumination element comprises both a LED and a fiber optic light source.
  • the minimally invasive access device according to Claim 32, wherein the illumination element comprises both a LED and a fiber optic light source.
  • the RF-shielded visualization sensor module further comprises an RF-shielded conductive member that connects the visualization sensor to a proximal end location of the elongated member.
  • An internal tissue visualization device comprising:
  • an elongated member having a proximal end and a distal end
  • the RF-shielded visualization sensor module further comprises an RF-shielded conductive member that connects the visualization sensor to a proximal end location of the elongated member.
  • the device further comprises a distal end tissue modifier and the method further comprises modifying tissue with the tissue modifier.
  • the kit according to Claim 172 wherein the charge accumulator is configured to receive a first signal from the voltage converter and to output a second signal to the RF signal generator.
  • the RF probe comprises a first conductive member positioned substantially at a tip of the elongated member.
  • the RF probe comprises a distal end opening positioned over the first conductive member.
  • the kit according to Claim 170 wherein the kit comprises a hand-held device according to Claim 64, an adapter according to Claim 38 and an RF probe according to Claim 57. 179.

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Abstract

L'invention concerne, selon des aspects, des systèmes de modification des tissus à effraction minimale. Certains modes de réalisation des systèmes comprennent un dispositif d'accès à effraction minimale ayant une extrémité proximale, une extrémité distale et un passage interne. Placés parmi les extrémités distales des dispositifs, se trouvent un élément de visualisation et un élément d'éclairage. L'invention concerne également des procédés d'utilisation des systèmes dans des applications de modification de tissu, ainsi que des nécessaires pour mettre en pratique les procédés de l'invention. L'invention concerne également des dispositifs de visualisation de tissus internes ayant des modules de capteurs de visualisation à protection RF. L'invention concerne des dispositifs de modulation de tissus RF à effraction minimale. Selon certains aspects, les dispositifs comprennent une unité de commande portative et un élément allongé. Selon certains aspects, les dispositifs de modulation des tissus RF sont dotés d'un adaptateur qui s'accouple fonctionnellement à un dispositif médical portatif et le comprennent. L'adaptateur produit de l'énergie RF pour distribution à un producteur de plasma sur un élément allongé.
PCT/US2016/017608 2015-02-13 2016-02-11 Procédés et dispositifs de visualisation et modification de tissus WO2016130844A1 (fr)

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