Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/02—Details
  • A61N1/04—Electrodes
  • A61N1/0404—Electrodes for external use
  • A61N1/0408—Use-related aspects
• • 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
  • A61B18/1206—Generators therefor
• • 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
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
  • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
  • A61B18/14—Probes or electrodes therefor
  • A61B18/1402—Probes for open surgery
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
  • A61B2018/00345—Vascular system
  • A61B2018/00404—Blood vessels other than those in or around the heart
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
  • A61B2018/00345—Vascular system
  • A61B2018/00404—Blood vessels other than those in or around the heart
  • A61B2018/0041—Removal of thrombosis
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
  • A61B2018/00452—Skin
  • A61B2018/00458—Deeper parts of the skin, e.g. treatment of vascular disorders or port wine stains
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • 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
  • A61B2018/00636—Sensing and controlling the application of energy
  • A61B2018/00696—Controlled or regulated parameters
  • A61B2018/0072—Current
• • 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
  • A61B2018/00636—Sensing and controlling the application of energy
  • A61B2018/00696—Controlled or regulated parameters
  • A61B2018/00732—Frequency
• • 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
  • A61B2018/00636—Sensing and controlling the application of energy
  • A61B2018/00773—Sensed parameters
  • A61B2018/00875—Resistance or impedance
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/02—Details
  • A61N1/04—Electrodes
  • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
  • A61N1/0504—Subcutaneous electrodes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/36014—External stimulators, e.g. with patch electrodes
  • A61N1/36017—External stimulators, e.g. with patch electrodes with leads or electrodes penetrating the skin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/36014—External stimulators, e.g. with patch electrodes
  • A61N1/3603—Control systems
  • A61N1/36031—Control systems using physiological parameters for adjustment
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/36014—External stimulators, e.g. with patch electrodes
  • A61N1/3603—Control systems
  • A61N1/36034—Control systems specified by the stimulation parameters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/362—Heart stimulators
  • A61N1/3625—External stimulators

Definitions

• aspects and embodiments are directed to systems and methods of vascular treatment of a subject.
• An electrical current can be applied to blockages in a subject's blood vessel. This causes the blockages to ablate, fragment, dissolve, or decrease in size or volume. This reduces impedance to blood flow through the circulatory system.
• the electrical stimulation device includes a fiber optic device to guide the first electrode to a first position internal to the subject and proximate to a first portion of an outer surface of the blood vessel, and to guide the second electrode to a second position internal to the subject and proximate to a second portion of the outer surface of the blood vessel.
• the first portion of the outer surface and the second portion of the outer surface can be located proximate to the blockage.
• the electrical current has a value of between approximately 2 and 8 niA, a pulse duration of approximately 2 milliseconds, and the electrical pulses are applied at a frequency between about 50 and 100 pulses per minute for a duration of approximately one to eight hours.
• the device includes at least one of an external defibrillator and a pacing unit.
• electrical current is applied to the blockage and the blockage fragments.
• the first and second electrodes can be removed from the subject after the electrical current has been applied to the subject.
• the electrical current can be applied to the blockage with the first electrode positioned internal to the subject, external to the blood vessel that includes the blockage, and proximate to a first portion of an outer surface of the blood vessel.
• the electrical current can be applied to the blockage with the second electrode positioned internal to the subject, external to the blood vessel that includes the blockage, and proximate to a second portion of the outer surface of the blood vessel.
• the first electrode is positioned external to the subject, proximate to the blockage
• the second electrode is positioned external to the subject, proximate to the blockage
• the electrical current is applied to the blockage.
• the blockage includes plaque or a thrombus
• the electrical current dissolves the plaque or thrombus.
• the controller is configured to ablate a blockage such as a deposit located external to a circulatory system of the subject.
• the deposit can be located in a duct or an organ of the subject.
• instructions to operate the electrical stimulation device are provided. The instructions can include at least one instruction directing a user to identify a location of the portion of the blood vessel that includes the blockage.
• the instructions can also direct the user to position a first electrode and a second electrode proximate to the location of the portion of the blood vessel that includes the blockage, and to control an electrical current to follow a path between the first electrode and the second electrode that includes the blockage.
• the instructions can direct the user to position the first electrode internal to the subject, external to the blood vessel that includes the blockage, and proximate to a first portion of an outer surface of the blood vessel, and to position the second electrode internal to the subject, external to the blood vessel that includes the blockage, and proximate to a second portion of the outer surface of the blood vessel.
• the instructions can also instruct the user to apply the electrical current to the blockage.
• the instructions can direct the user to position the first electrode external to the subject, proximate to the blockage, to position the second electrode external to the subject, proximate to the blockage, and to apply the electrical current to the blockage.
• the instructions can also direct the user to apply the electrical current to the blockage, and to remove the first electrode and the second electrode from the subject subsequent to application of the electrical current.
• Figure 1 is a block diagram depicting an electrical stimulation device for vascular treatment of a subject in accordance with an embodiment
• Figure 4 is a perspective view depicting an electrical stimulation device with external electrodes in accordance with an embodiment
• Figure 5 is a perspective view depicting an electrical stimulation device electrode configured for internal placement proximate to a blood vessel of a subject in accordance with an embodiment
• Figure 8 is a perspective view depicting an electrical stimulation device with internal electrodes in accordance with an embodiment
• At least one electrode is placed proximate to a subject and electrical current is applied to the subject.
• the electrical current passes through a blockage in a blood vessel of the subject, and electrical energy from the applied current ablates the blockage, facilitating circulatory system blood flow.
• two electrodes 105 are placed on the subject, internally or externally, proximate to the blockage.
• Controller 1 10 directs power supply 1 15 to provide electrical current to at least one of the two electrodes 105.
• the current can be applied to the subject via electrodes 105 as a series of pulses, for example, as a square wave.
• the current follows a path between the two electrodes 105.
• the amount of energy delivered to a human subject to ablate the blockage is approximately equal to the amount of energy, in joules, delivered to a human subject during approximately 8 hours of a cardiac pacing procedure.
• This amount of energy applied to the body of a human subject weighing 1751bs and having an impedance of approximately 400 Ohms corresponds to approximately 30 Joules/lb, and is equivalent to the amount of energy that would be applied to the human subject during 8.7 hours of pacing. It should be appreciated that dependent on the size, weight, and health of the subject, the subjec t's sensitivity to the applied energy, whether the subject was conscious or not during the procedure, etc. these values of current, voltage, and time may vary.
• the electrodes 105 may be physically moved to swap position on the subject to reverse the direction of current flow.
• the user holds electrodes 105 in place during application of electric current to blockage 305, or electrodes 105 can be otherwise fixed in their position, for example by wrapping electrodes 105 around a portion of the subject, or by adhering electrodes 105 to a portion of the subject (e.g., an external surface of a blood vessel) with an adhesive.
• Electrodes 105 can be internal electrodes positioned proximate to blockage 305 and coupled to device 100, which may include a defibrillator or pacing machine, by wires 120.
• Power supply 115 may include a battery or AC power source, such as a connection to main lines in an outlet.
• the user initiates application of the electrical current by inputting instructions to device 100 via a user interface with electrodes 105 internally positioned proximate to blockage 305.
• Fragmenting the blockage (ACT 920) may include ablating, dissolving, or breaking up the blockage into sufficiently small particles that can travel freely through the circulatory system. For example, fragmenting the blockage (ACT 920) may reduce the size of individual particles of the blockage to less than the diameter of a red blood cell, or less than the internal diameter of the subject's capillaries. In one embodiment, fragmenting the blockage (ACT 920) includes dissolving at least part of a thrombus attached to an inner surface of a blood vessel.
• method 900 includes an act of removing at least one electrode (ACT 925).
• ACT 925 For example, subsequent to application of controlled electrical current, external electrodes can be removed from the subject's body by the subject or by a user of the electrical stimulation device that applied the current. Any conductive gel or other material that facilitated conduction between the subject's body and the electrodes can be removed from the subject and cleaned from the surfaces of the electrodes.
• internally placed electrodes are removed (ACT 925) by a doctor, surgeon, or other user and the incision that allowed their internal entry into the subject is properly closed.
• method 1000 includes an act of providing instructions to operate the electrical stimulation device (ACT 1010).
• the instructions can be provided (ACT 1010) via a user interface that is part of the device, or separately, such as by written instructions.
• the instructions can be provided audibly, visually, or combinations thereof.
• providing instructions (ACT 1010) directs the user to identify a location of the portion of the blood vessel that includes the blockage.
• the provided (ACT 1010) instructions can also direct the user to position a first electrode and a second electrode proximate to the location of the portion of the blood vessel that includes the blockage, and to control an electrical current to follow a path between the first electrode and the second electrode that includes the blockage.
• the animals of Groups 1 and 2 were treated the same, except one animal of Group 1 (animal number 550) was treated for 105 minutes.
• the animals of Group 3 were all treated slightly different relative to the animals of Groups 1 and 2 to determine when dermal changes occur by changing 10% chloride gel pads every 15 min, to determine the time to thrombolysis by taking angiograms every 15 minutes, to determine the dermal reaction effect of using 3 ⁇ 4% chloride gel electrodes, and to determine the effect of using approximately 50% less total treatment energy.
• Table 1 illustrates the overall test methodology.
• Table 2 below illustrates the test methodology used with the animals of Group 3.
• the animals were housed in rooms of the testing facility where the temperature and the humidity was monitored daily.
• the environmental conditions for swine are typically a room temperature between 61-81°F and a relative humidity between 30-70%.
• the temperature was within range during the entire study and the average relative humidity was within range during the entire study except once in one of the rooms (which was out of range at 77% relative humidity on the fifth day of acclimation).
• the Study Director was notified and determined that there were no notable deviations which had an impact on the study outcome.
• the animals had 12 hours of light followed by a 12 hour dark cycle, and tap water was provided to the animals by an automatic watering system. The system was checked daily to assure it was operating appropriately.
• the hair was clipped from the inguinal area.
• the animal was positioned in dorsal recumbency.
• the operative areas were then cleaned with three alternating scrubs of povidone-iodine surgical solution and 70% alcohol. Once the alternating scrubs were complete, a final application of povidone-iodine surgical solution was applied and allowed to dry. The areas were draped for aseptic surgery.
• Electrodes are solid electrodes that are round in shape, have a diameter of approximately 6 cm, an electrode area of approximately 30 cm 2 and were stored, prior to use, at room temperature (approximately 20- 25°C).
• an electrically conductive hydrogel was used, which contained 10% Chloride (Groups 1 and 2 and one animal in Group 3) or 3 ⁇ 4% Chloride (two animals in Group 3). Standard laboratory precautions and aseptic handling techniques were observed during treatment.
• an angiogram was performed and the thrombus occlusion severity was scored as: l-(0-25% occlusion), 2-(26-50% occlusion), 3-(51-75% occlusion), and 4-(76-100% occlusion).
• electrodes with a 10% chloride gel were placed on the animal and electrical current was applied using pulses of current having an amplitude of 15 mA and a pulse width of 175 ms at a frequency of 170 pulses per minute for a duration of 75 minutes (See Table 1). Given that the impedance between the pair of electrodes was approximately 500 Ohms, the applied voltage was approximately 7.5 volts. After treatment an angiogram was performed and the thrombus occlusion severity scored by angiogram. The animal was then allowed to recover. The treatment for one animal, Number 550, consisted of an additional 30 minutes.
• the clinical investigation described above was used to determine treatment parameters, electrodes, and electrical parameters capable of achieving thrombolytic effects in a swine femoral vein thrombosis model.
• the porcine model used in the clinical testing described herein is an established in vivo animal model having a strong correlation to human subjects. Accordingly, it is believed that the various electrical parameters and setting used in this investigation could be used on human subjects. For example, 15 mA pulses of current having a duration of 80-175 ms could be applied to the body of a human subject using transdermal electrodes having a 3 ⁇ 4% chloride gel at a frequency of between 100 and 175 pulses per minute for a duration of 30 to 75 minutes to ablate a thrombus.
• blockages in the subject's blood vessels include partial blockages, and the subject may or may not be experiencing distress due to the blockage condition.
• the deposit need not be in a blood vessel.
• a circuit can be formed between at least two electrodes and a deposit that is outside a blood vessel, such as in a duct. The subject may also remain conscious during the application of current to the blockage.

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• 2013
  • 2013-09-27 WO PCT/US2013/062257 patent/WO2014055359A1/fr not_active Ceased
  • 2013-09-27 EP EP13843164.8A patent/EP2903684A4/fr not_active Withdrawn

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