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WO2008098300A1 - Procédé et système de contrôle de procédure thérapeutique - Google Patents

Procédé et système de contrôle de procédure thérapeutique Download PDF

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Publication number
WO2008098300A1
WO2008098300A1 PCT/AU2008/000192 AU2008000192W WO2008098300A1 WO 2008098300 A1 WO2008098300 A1 WO 2008098300A1 AU 2008000192 W AU2008000192 W AU 2008000192W WO 2008098300 A1 WO2008098300 A1 WO 2008098300A1
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WO
WIPO (PCT)
Prior art keywords
patient
laser
operator
cnv
therapeutic procedure
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.)
Ceased
Application number
PCT/AU2008/000192
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English (en)
Inventor
Jarbas Caiado De Castro Neto
Mario Antonio Stefani
Giuliano Rossi
Alessandro Damiani Mota
Rogerio Alves Costa
Jose Augusto Cardillo
Jairo Kerr Azevedo
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Opto Global Holdings Pty Ltd
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Opto Global Holdings Pty Ltd
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Filing date
Publication date
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Publication of WO2008098300A1 publication Critical patent/WO2008098300A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F9/00821—Methods or devices for eye surgery using laser for coagulation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F2009/00844—Feedback systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F2009/00855—Calibration of the laser system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F2009/00861—Methods or devices for eye surgery using laser adapted for treatment at a particular location
    • A61F2009/00863—Retina
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0613—Apparatus adapted for a specific treatment
    • A61N5/062—Photodynamic therapy, i.e. excitation of an agent
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection

Definitions

  • the present invention relates to medical treatment and diagnostic procedures.
  • the present invention relates to a control system and method for use in a therapeutic procedure that combines the introduction of external substances to a patient with the use of an application device.
  • a number of medical treatment and diagnostic procedures involve the combined effect of a substance which is introduced into a patient which in turn promotes the therapeutic or diagnostic effectiveness of a separate application device whose use forms part of the procedure.
  • a procedure involves the introduction of a radioactive substance into a patient's body which is subsequently detected by an X-ray machine. The distribution of the radioactive substance throughout the areas being examined allows the clinician to determine the extent of conditions such as cancer and the like.
  • This procedure can also be applied in reverse where the introduced substance is a contrast or dye material which preferentially blocks X-ray photons as they pass through the body after emission from an X-ray machine.
  • the introduced substance is a contrast or dye material which preferentially blocks X-ray photons as they pass through the body after emission from an X-ray machine.
  • contrast dyes and MRI machines where the application of the dye modifies the magnetic properties of the area being examined.
  • i-MP Indocyanine-Green Mediated Photothrombosis
  • CNV choroidal neovascularisation
  • ICG-mediated photothrombosis is a procedure that relies on the photo- activation of Indocyanine Green (ICG) in the targeted tissue by the application of a continuous low irradiance 805 nm laser to achieve selective vascular occlusion with minimal or no damage to adjacent neural structures or tissues.
  • ICG Indocyanine Green
  • the therapeutic effect arises from the photochemical reactions between pathologic tissues with increased ICG uptake and the laser energy causing selective necrosis of the CNV.
  • the therapy may result in restoration or stabilisation of visual acuity and control of the disease.
  • treatment or diagnostic methodologies such as i-MP suffer from a number of significant issues which can make their use both overly complicated and costly.
  • the most significant disadvantage is that these methodologies rely on the complex interplay between a chemical introduced into a patient and an application device such as a laser, X-ray machine or the like. Because of the complexity of the procedure there is greater scope for error either in the introduction of the relevant chemical to the patient and/ or the use of what is often extremely sophisticated equipment in the course of the procedure.
  • a computer- implemented method of controlling a therapeutic procedure performed on a patient comprising: detem ⁇ ig at least one dosage parameter and at least one application parameter of the therapeutic procedure dependent on patient-related data; displaying one or more prompts instructing an operator to introduce at least one external substance into the patient in accordance with the at least one dosage parameter; and presenting one or more instructions to the operator to apply an output of an application device to a treatment area of the patient in accordance with the at least one application parameter.
  • a computer- implemented method of controlling a therapeutic procedure performed on a patient comprising: determining, dependent on patient-related data, a dosage of an external substance to be introduced into the patient; calculating, dependent on the patient-related data, a desired output of an application device to be applied to a treatment area of the patient; displaying prompts instructing an operator to introduce the external substance into the patient in accordance with a timing schedule of the therapeutic procedure; and presenting instructions to the operator to apply the output of the application device to the treatment area, the instructions being presented according to the timing schedule.
  • a computer- implemented method of controlling a procedure for treating macular degeneration in a patient's eye comprising: receiving data relating to the patient; determining a quantity of an external substance to be introduced into the patient dependent on the received data; calculating a desired power output of a laser to be applied to a treatment area in the patient's eye; displaying prompts instructing an operator to introduce the external substance into the patient in a plurality of doses, wherein the prompts are displayed according to a liming schedule; and presenting instructions to the operator to apply the laser beam to the treatment area in a plurality of applications, the instructions being presented according to the timing schedule.
  • a system for controlling a therapeutic procedure performed on a patient comprising: means for determining at least one dosage parameter and at least one application parameter of the therapeutic procedure dependent on patient-related data; means for displaying one or more prompts instructing an operator to introduce at least one external substance into the patient in accordance with the at least one dosage parameter; and means for presenting one or more instructions to the operator to apply an output of an application device to a treatment area of the patient in accordance with the at least one application parameter.
  • a system for controlling a therapeutic procedure performed on a patient comprising: data storage for storing patient-related information; a display for displaying information to an operator; and a processor in communication with the data storage and the display and arranged to: determine at least one dosage parameter and at least one application parameter of the therapeutic procedure dependent on the patient-related data; cause the display of one or more prompts instructing an operator to introduce at least one external substance into the patient in accordance with the at least one dosage parameter; and cause the display of one or more instructions to the operator to apply an output of an application device to a treatment area of the patient in accordance with the at least one application parameter.
  • a computer program product comprising machine-readable program code recorded on a machine- readable recording medium, for controlling the operation of a data processing apparatus on which the program code executes to perform a method of controlling a therapeutic procedure performed on a patient, the method comprising: determining at least one dosage parameter and at least one application parameter of the therapeutic procedure dependent on patient-related data; displaying one or more prompts instructing an operator to introduce at least one external substance into the patient in accordance with the at least one dosage parameter; and presenting one or more instructions to the operator to apply an output of an application device to a treatment area of the patient in accordance with the at least one application parameter.
  • a computer program product comprising machine-readable program code recorded on a machine- readable recording medium, for controlling the operation of a data processing apparatus on which the program code executes to perform a method of controlling a therapeutic procedure performed on a patient, the method comprising: determining, dependent on patient-related data, a dosage of an external substance to be introduced into the patient; calculating, dependent on the patient-related data, a desired output of an application device to be applied to a treatment area of the patient; displaying prompts instructing an operator to introduce the external substance into the patient in accordance with a timing schedule of the therapeutic procedure; and presenting instructions to the operator to apply the output of the application device to the treatment area, the instructions being presented according to the timing schedule.
  • a computer program comprising machine-readable program code for controlling the operation of a data processing apparatus on which the program code executes to perform a method of controlling a therapeutic procedure performed on a patient, the method comprising: determining at least one dosage parameter and at least one application parameter of the therapeutic procedure dependent on patient-related data; displaying one or more prompts instructing an operator to introduce at least one external substance into the patient in accordance with the at least one dosage parameter; and presenting one or more instructions to the operator to apply an output of an application device to a treatment area of the patient in accordance with the at least one application parameter.
  • a method of controlling a therapeutic procedure performed on a patient including determining and/or inputting at least one dosage parameter dependent on patient-related data; determining and/or inputting at least one application parameter dependent on patient-related data; providing instructions to administer at least one external substance into the patient; and providing instructions to apply an output of an application device to a treatment area of the patient.
  • the the therapeutic procedure may be a procedure for treating choroidal neovascularisation (CNV) and at least one of the steps is a computer-implemented step.
  • CNV choroidal neovascularisation
  • a computer program product comprising machine readable program code recorded on a machine readable recording medium, for controlling the operation of a data processing apparatus on which the program code executes to perform a method of controlling a therapeutic procedure performed on a patient including determining and/or inputting at least one dosage parameter; determining and/or inputting at least one application parameter of the therapeutic procedure dependent on patient-related data; providing instructions to an operator to administer at least one external substance into the patient in accordance with the at least one dosage parameter; and providing instructions to the operator to apply an output of a laser to a treatment area of the patient in accordance with the at least one application parameter.
  • the therapeutic procedure may be a procedure for treating choroidal neovascularisation (CNV) and the external substance is indocyanine green (ICG) in solution that is introduced into the patient by injection.
  • At least one of the steps may be a computer-implemented step. In embodiments, all of the steps may be computer-implemented steps or at least one of the steps may be a manually implemented step.
  • the method may be used to treat at least one of the following: CNV secondary to wet AMD, Angioid Streaks, Pathologic Myopia, Central Serous Retinopathy, or other choroidal diseases resulting from inflammatory conditions and idiopathic causes as compared to conventional systems.
  • wet AMD may include any one of classic CNV, occult CNV, mixed forms of CNV, predominantly classic CNV, predominantly occult CNV, Polypoidal CNV and combinations of any of the above.
  • the therapeutic procedure may have a timing sequence and providing steps may display prompts and present instructions according to the timing sequence.
  • the method may also include interrupting the therapeutic procedure if at least one specified action is not completed within a specified time and/or requesting the operator to enter the patient-related data.
  • the method may also include adjusting at least one setting of the application device dependent on the at least one application parameter, and the output of the application device may be dependent on the at least one setting.
  • the application device may be a laser and the adjusting step may adjust a power output of the laser.
  • the method may also include providing instructions for the operator to operate the application device according to a predetermined calibration procedure to calibrate the application device for the therapeutic procedure.
  • the method may also include displaying safety information related to the therapeutic procedure, the safety information being displayed at one or more predetermined stages of the therapeutic procedure.
  • the application device may be a laser.
  • the patient-related data may include at least one of: a weight of the patient; a maximum dimension of a lesion in an eye of the patient; and a level of pigmentation in the eye of the patient.
  • the dosage parameter may be a quantity of the external substance to be administered into the patient.
  • a method of reducing medication error including utilizing a computer to control at least a portion of a therapeutic procedure.
  • a dosage may be admistered from a single vial to reduce the medication error, hi some embodiments, the dosage from a single vial may be admisistered as one or two injections.
  • the computer controlled portion of the therapeutic procedure may be more precise and require less operator intervention and/or discretion as compared with conventional systems.
  • the medication error may be reduced by any of the following amounts: between about 5% to about 25%; between about 10% to about 35%; between about 25% to about 60%; or between about 25% to about 90% as compared with conventional methods.
  • the medication error may be reduced by any of the following amounts: greater than about 5%; greater than about 15%; greater than about 25%; greater than about 35%; greater than about 60%; greater than about 80%; or greater than about 95% as compared with conventional methods.
  • a method of treating CNV secondary to wet AMD e.g., wet AMD with classic subretinal CNV ("wet classic AMD"), wet AMD with occult subretinal CNV (“wet occult AMD”), or wet AMD with classic and occult subretinal CNV (“mixed wet AMD”) (including, but not limited to, predominantly classic CNV and predominantly occult CNV) in a patient (e.g., a human), using the system and/or computer program product described herein.
  • wet AMD with classic subretinal CNV wet AMD with classic subretinal CNV
  • wet occult AMD wet AMD with classic and occult subretinal CNV
  • mixed wet AMD including, but not limited to, predominantly classic CNV and predominantly occult CNV
  • a system for treating CNV secondary to wet AMD e.g., wet classic CNV, wet occult CNV, or mixed CNV
  • CNV secondary to wet AMD e.g., wet classic CNV, wet occult CNV, or mixed CNV
  • a patient e.g., a human
  • CNV secondary to wet AMD e.g., wet classic CNV, wet occult CNV, or mixed CNV
  • a patient e.g., a human
  • a system and method for that provides one or more of the following: additional safety, reduction in medication error, higher efficacy, fewer side effects, less damage to a healthy retina, and suitable treatment for all kinds of CNV secondary to AMD, Angioid Streaks, Pathologic Myopia, Central Serous Retinopathy, and other choroidal diseases resulting from inflammatory conditions and idiopathic causes as compared to conventional systems.
  • a system and method that reduces surgical and/or medication error that can adversely affect a group, sampling, and/or population of patients.
  • the automation introduced by the methods and systems disclosed allow for a broader range of physicians/operators with varying levels of skill and experience to treat patients and these treatments may generally be more effective as a whole.
  • the methods and systems disclosed allows doctors or operators to perform the disclosed treatments without having to use specialized diagnostic equipment such as ICG angiography imaging systems and similar equipment.
  • FIGURE IA shows schematically a laser system that includes a laser unit and an optical delivery path for delivering laser energy to a patient's eye;
  • FIGURE IB shows a laser system having a detector positioned at the end of the optical delivery path and providing a feedback signal for calibrating the laser unit;
  • FIGURE 1C is a schematic diagram of an application device including the laser unit of Figure IA having a control system, display and user inputs enabling operator interaction with the laser unit;
  • FIGURE ID is a schematic diagram showing more detail of the system of Figure 1C;
  • FIGURE 2 is a flowchart diagram of a mode selection process in the system of
  • Figures 1 A-ID used as an i-MP application device
  • FIGURE 3 is a flowchart diagram of steps performed in the AUTO-CALIBRA ⁇ ON mode
  • FIGURE 4 is a flowchart diagram of a first set of steps performed in SET PARAMETER mode
  • FIGURE 5 is a flowchart diagram of a second set of steps performed in SET PARAMETER mode
  • FIGURE 6 is a flowchart diagram of a third set of steps performed in SET PARAMETER mode
  • FIGURE 7 is a flowchart diagram of a first set of steps performed in USER
  • FIGURE 8 is a flowchart diagram of a second set of steps performed in USER PREFERENCES mode
  • FIGURE 9 is a flowchart diagram of a first set of steps performed in TREATMENT mode
  • FIGURE 10 is a flowchart diagram of a second set of steps performed in TREATMENT mode
  • FIGURE 11 is a flowchart diagram of a third set of steps performed in TREATMENT mode
  • FIGURE 12 is a flowchart diagram of a fourth set of steps performed in
  • FIGURE 13 is a flowchart providing an overview of the therapeutic procedure.
  • like reference characters designate like or corresponding parts throughout the several views of the drawings.
  • the systems and methods disclosed herein may be used in the application of any suitable therapeutic procedures, such as those described in WO 2006/125280 and in WO 02/094260. Specifically, for example, the systems and methods disclosed herein can be used to treat CNV secondary to wet AMD, including but not limited to, classic CNV, wet occult CNV, mixed forms of CNV, predominantly classic CNV, predominantly occult CNV, and/or combination of any of the above.
  • the laser system illustrated in Figure IA is an example of a photo-coagulator laser system and may be used in the application of a therapeutic procedure such as that described in WO 02/094260 "New use of Indocyanine Green as a Photosensitive Agent", published on 28 November 2002.
  • the photo-coagulator laser system includes a photo-coagulator laser unit 10 followed by an optical delivery path.
  • the laser beam travels through the optical delivery path, which prepares and delivers the laser beam to a delivery point at a distal end of the optical delivery path.
  • the optical delivery system generally includes fibre optic cable 20, slit lamp adaptor 30, slit lamp microscope 40, beam splitter 50, and a delivery end (contact lens 60).
  • the contact lens 60 (during treatment) usually contacts the area of the eye that requires treatment, and allows the laser beam to pass through to the eye.
  • Other types of optical delivery path may be used, including an endo-ocular probe, a laser indirect ophthalmoscope and a surgical microscope adapter.
  • Figure IB shows an overview of a laser system incorporating an auto- calibration system.
  • Detector 70 is placed behind the contact lens 60 so as to measure the power of the laser beam at the end of the delivery path.
  • Detector 70 converts the measure of the power of the laser beam to an electrical signal which is then fed via communication link 71 to an input 11 of laser console 10. This electrical signal is converted into a digital signal (unless the signal is already a digital signal) which is then provided to a processor in laser console 10.
  • the measurement of the power of the beam made by the detector at the delivery end is then compared with the desired or required power level for delivery. This information is used to adjust a calibration factor associated with the optical delivery path.
  • the calibration factor is used in controlling the power of the laser beam generated by laser console 10. Accordingly the power generation compensates for the effect of the optical delivery path.
  • the auto-calibration also accounts for power deviations caused by component variation and degradation in the delivery path, as well as within the laser console itself.
  • the laser system calibration method is carried out at the practitioner's discretion, but preferably prior to use for each patient.
  • the laser system locks to prevent more than ten procedures being performed without an auto- calibration.
  • the detector 70 is removed from the delivery point to allow treatment of the patient's eye 100.
  • the present invention provides one or more of the following advantages: additional safety, higher efficacy, reduction in medication error, fewer side effects, less damage to a healthy retina, and is suitable treatment for all kinds of CNV secondary to AMD, Angioid Streaks, Pathologic Myopia, Central Serous Retinopathy, and other choroidal diseases resulting from inflammatory conditions and idiopathic causes as compared to conventional systems, hi contrast to the method and system disclosed herein, conventional systems were operated in a substantially manual fashion. Typically, calculations needed to determine treatment parameters were performed manually and the person performing the treatment had to manually control the steps and timing of the procedure. Such systems were more susceptible to error.
  • the present invention reduces surgical and/or medication error that can adversely affect the patient since the systems and methods of the present invention are more precise than conventional systems and requires less operator intervention and/or discretion.
  • the present invention also reduces surgical and/or medication error that can adversely affect a group, sampling, and/or population of patients since the systems and methods of the present invention are more precise than conventional systems and requires less operator intervention and/or discretion.
  • the treatment parameters that the operator is required to provide in certain embodiments of the present invention are easier to determine.
  • conventional lasers systems require the operator to determine parameters such as laser power, laser duration, ICG dosage, and laser spot size.
  • the present invention discussed herein requires the operator to make fewer adjustments, or in some embodiments no adjustments, to the laser power and laser duration.
  • the present invention will select for the operator the ICG dosage and laser spot size to use. Therefore, the patient is subjected to fewer opportunities for operator error using the present invention.
  • an error in these calculations may cause over or under treatment of the patient which may result in greater chance for unwanted side effects, damage to the patient's retina, and/or an ineffective treatment.
  • the automation introduced by the methods and systems of the present invention create an added level of safety, require a reduced number of calculations and less control to be performed by hand, and furthermore, the parameters that are measured by the operator are simpler to determined (for example, lesion size, weight, and pigmentation level). Therefore, the present invention may allow for a broader range of physicians/operators with varying levels of skill and experience to treat patients and these treatments may generally be more effective as a whole. Furthermore, the present invention also allows doctors or operators to perform the disclosed treatments without having to use specialized diagnostic equipment such as ICG angiography imaging systems and similar equipment.
  • the present invention reduces or eliminates this additional cost factor and allows a wider range of doctors or operators to perform the disclosed treatments.
  • doctors can perform the disclosed treatments using i-MP without having specific clinical training for these procedures and the supervision of another doctor.
  • the present invention reduces the need for supervision, training, and provides a system that is much easier for a wider range of doctors or operators to use. Much of the decisions that a doctor would have to make with conventional i-MP systems is now subsumed in the automation that comes with the present invention.
  • Embodiments of the present invention use the photo-activation of Indocyanine Green (ICG) in the targeted tissue by the application of a continuous low irradiance laser to achieve selective vascular occlusion with minimal or no damage to adjacent neural structures or tissues.
  • ICG Indocyanine Green
  • the dose of ICG and the dosing regiment can be varied if desired.
  • the total dosage of ICG used per treatment session is typically either about lOOmg or about 150 mg based upon the weight of the patient.
  • the total dosage can be varied to about 60 mg to about 170 mg per treatment session, about 70mg to about 160mg per treatment session, or can be about 90 mg, about 95 mg per treatment session, about 105 mg per treatment session, about 110 mg per treatment session , about 140 mg , per treatment session about 145 mg per treatment session, about 155 mg per treatment session about 160 mg per treatment session .
  • the solution concentration used can also vary. In certain preferred embodiments the concentration will be about 25 mg/ml. This can be varied either as more concentrated or less concentrated if desired. In certain embodiments the solution could range from about 10 mg/ml to about 40 mg/ml, about 15 mg/ml to about 35mg/ml, or about 20mg/ml to about 35 mg/ml.
  • each subject received a 2 ml loading dose of a solution of ICG (25 mg/ml, approximately 1 mg/kg body weight) in the form of an IV bolus, followed by a 5.0-ml saline flush. 20-40 minutes after the loading dose, a second IV injection of 50 mg of ICG in 2 ml of solution is administered to each subject, followed by another saline flush.
  • ICG has typically been provided as a powder in a tube in the amounts of 25mg and 50mg per tube. This has required use of multiply tubes which added to the potentially for medication error.
  • the ICG powder is provided as a freeze dried powder in a tube so the solution can be mixed in one tube and used as one dose amount.
  • Embodiments of the present invention contemplate providing the ICG as a freeze dry powder in 5 ml tubes with lOOmg and in 10ml tubes with 150mg. It is believed providing the dosage to be used in a single vial will contribute to the reduction of medication error. Of course the amounts of ICG and the size of the tubes could be varied.
  • the present invention includes varying of degrees of automation in the computer-implemented method of controlling a therapeutic procedure. Certain embodiments will be substantially automated whereas other embodiments will be less automated. The degree of automation may vary. One skilled in the art will appreciate that one or more of the steps, data determinations, patient-related data determinations, dosage levels, calculations, desired outputs, treatment parameters, displays, prompts, instructions, and timing issues disclosed herein to some extent can be done manually. Embodiments of the present invention permit varying degrees of automation. For example, in some embodiments of the present invention the dosage level of indocyanine green (ICG) will be either lOOmg or 150mg based on the weight of the patient being treated.
  • ICG indocyanine green
  • the dosage level of ICG is lOOmg and if the patients weight is 75 Kg or greater than the dosage level is 150mg.
  • the selection of the dosage level could be done manually in certain embodiments of the present invention.
  • the spot size could be manually determined by the doctor and manually selected by the doctor.
  • the doctor could use a stopwatch to manually control and prompt the thirty minute wait after the first injection of ICG to inject the second ICG dose, and/or the two minute wait to apply the laser after the second injection of ICG.
  • the medication error may be reduced by between about 5% to about 25%, about 10% to about 35%, about 25% to about 60%, or about 25% to about 90% as compared with medication errors in conventional treatment systems. In certain embodiments, the medication error may be reduced by greater than about 5%, greater than about 15%, greater than about 25%, greater than about 35%, greater than about 60%, greater than about 80% greater than about 95% as compared with medication errors in conventional treatment systems.
  • the percentage of successful treatments may increase by between about 1.05 to about 2 times, 1.25 and about 4 times, greater than about 1.05 times, greater than about 1.1 times, greater than about 1.2 times, greater than about 1.3 times, greater than about 1.4 times, greater than about 1.5 times, greater than about 1.7 times, greater than about 2 times, between about 1.05 and about 1.4 times, between about 1.25 times and about 1.6 times, or between about 1.3 times and about 2 times the current number of successful treatments.
  • the percentage of errors during treatment may be reduced by between about 20% and about 100%, greater than about 5%, greater than about 15%, greater than about 25%, greater about 35%, greater than about 50%, greater than about 75%, between about 5% and about 15%, between about 10% and about 25%, between about 10% and about 30% as compared with conventional treatments.
  • the present invention allows a broader range of physicians/operators to treat patients.
  • the percentage of physicians treating patients may increase by between about 1.1 times and about 4 times, greater than about 1.1 times, greater than about 1.2 times, greater than about 1.25 times, greater than about 1.4 times, between about 1.2 times and about 1.4 times, between about 1.3 and about 2 times, or between about 1.4 and about 1.8 times the current number of physicians treating patients.
  • the percentage of physicians treating patients may be increased. If the population of ophthalmologist is defined as physicians who treat retina diseases and you randomly select 10 of these physicians from a city or urban setting with a population of over 2 million people, then in certain embodiments, by using the present invention, the percentage of physicians treating patients may increase by between about 1.1 times and about 4 times, greater than about 1.1 times, greater than about 1.2 times, greater than about 1.25 times, greater than about 1.4 times, between about 1.2 times and about 1.4 times, between about 1.3 and about 2 times, or between about 1.4 and about 1.8 times the current number of physicians treating patients.
  • the percentage of physicians treating patients may be increased. If the population of ophthalmologist is defined as physicians who treat retina diseases but have treated less than 10 patients with AMD using available treatment modalities and you randomly select 10 of these physicians from a city or urban setting with a population of over 2 million people, then in certain embodiments, by using the present invention, the percentage of physicians treating patients may increase by between about 1.1 times and about 4 times, greater than about 1.1 times, greater than about 1.2 times, greater than about 1.25 times, greater than about 1.4 times, between about 1.2 times and about 1.4 times, between about 1.3 and about 2 times, or between about 1.4 and about 1.8 times the current number of physicians treating patients.
  • FIG. 1C there is shown a system overview of the application device, laser unit 10, which may be employed in a therapeutic procedure according to an illustrative embodiment of the present invention.
  • the treatment or diagnostic system is the i-MP procedure described previously. Whilst this illustrative embodiment is described with reference to the i-MP procedure the described arrangement may be applied to other medical procedures involving an application device used with externally introduced substances which when used together facilitate the medical procedure.
  • Application device 10 includes a control system 90, laser assembly 80, slit lamp adaptor (SLA) 30, display 117, keyboard 116 and foot pedal 121.
  • Laser assembly 80 is a laser photocoagulator system which delivers controlled pulses of continuous wave 805 ran wavelength laser.
  • the laser assembly 80 can deliver a maximum of 2.5 W of power which is continuously monitored by redundant safety systems.
  • the laser console 10 includes a laser, a laser power supply, an electronics control board, an electronics power supply board, a control panel with display, keypad and buttons, a control panel board and a microcontroller board.
  • any laser assembly with similar power specifications e.g., about 2.5W, less than about 3W, less than about 5W, about 2.75 W, about 2W, about 1.5W
  • any laser assembly with similar power specifications e.g., about 2.5W, less than about 3W, less than about 5W, about 2.75 W, about 2W, about 1.5W
  • SLA 30 performs the function of delivering the laser beam to the patient's eye. It is an optical device including a fibre optic cable, a Galileo type microscope and a mechanical system which permits the device to be attached to a slit lamp microscope. SLA 30 is positioned coaxially with the optical path of the slit lamp microscope and allows the physician to apply the laser whilst viewing the back of the patient's eye (retina).
  • control system 90 In one arrangement control system 90, keyboard 116, display 121 and laser assembly 80 are integrated into the same enclosure.
  • Control system 90 is a microprocessor-based electronic circuit which runs the operational software and is responsible for controlling the operation of the laser assembly 80, aspects of the laser safety monitoring and interaction with the user interface including keyboard 116, display 117, user controls and foot pedal 121.
  • Control system 90 also runs the routines which control the delivery of the treatment procedure.
  • Control system 90 includes a microprocessor, memory, software, power supplies and other related electronics.
  • FIG. 1 shows the laser console 10 in greater detail and illustrates the system components included in the laser assembly 80 and control system 90.
  • the main laser power supply 101 supplies the required current to produce the laser beam.
  • the main laser power controller 102 is a module that controls the current to the main laser so that the output power is equivalent to the desired power.
  • the laser diode 103 is used to generate the laser beam for the procedure.
  • the wavelength of the laser is 805 nm, which is in the infrared range and is invisible to the human eye.
  • the laser preferably has a tolerance of +/- 3 nm.
  • the laser produced by diode 103 passes through the main laser collimator lens set 104, which shapes the laser beam so that the beam can be focused onto the fibre-optic cable.
  • the beam passes through beam splitter 105, which is a partially reflective mirror that splits the laser beam, providing a percentage of the laser beam to a photo sensor 112 that forms part of a safety system.
  • beam splitter 105 is a partially reflective mirror that splits the laser beam, providing a percentage of the laser beam to a photo sensor 112 that forms part of a safety system.
  • the part of the beam that is not diverted by the beam splitter 105 reaches the aiming beam combiner 106, which is a special mirror that combines the main laser beam from diode 103 with an aiming laser beam received from laser diode 113.
  • the aiming laser beam has a visible beam (red) that is used by the physician to aim the laser.
  • the aiming beam laser has a wavelength of 630nm and a maximum power of ImW.
  • the main beam has a maximum power of 2.5W.
  • Laser cavity 111 is a metal box which contains the main laser diode 103, and the optical components 104, 105, 106 and 107 used to adjust the shape, focus and direction of the laser.
  • the aiming laser diode 113 may also be included in the laser cavity.
  • the optical delivery path 110 is connected to an output nozzle of the laser cavity 111.
  • the cavity 111 is sealed to protect the optical system from dust and humidity.
  • At the output nozzle of the laser cavity 111 there is an optically-coupled fibre lock sensor 108 that indicates to the controller whether there is a fibre optic cable connected to the laser console 10.
  • a mechanical laser shutter 109 is connected by a hinge to the laser console 10 to cover the output nozzle when no delivery device is connected to the laser console 10.
  • the laser console 10 may be connected to an optical delivery path 110 which includes a fibre optic cable used to deliver the laser beam to the patient's eye. Examples of optical delivery paths include an endo-ocular probe, a slit lamp adaptor, a laser indirect ophthalmoscope and a surgical microscope adapter.
  • Some of the beam split by beam splitter 105 is provided to the main laser safety photo-sensor 112, which is a photodiode that reads the power level and provides an electronic signal used to ensure safe laser operation.
  • Processor 114 controls the functioning of all the laser equipment, and is in electronic communication with most of the components of the laser console 10.
  • the processor 114 includes a microprocessor from the 8032 family, flash memory, e2prom and a watchdog unit.
  • the processor 114 has access to data storage in which parameters of the therapeutic procedure may be stored.
  • a buzzer 115 connected to the processor 114 is used to generate alarms, beeps and other audible signals.
  • Keyboard 116 is used as an interface for the physician or operator to control the operating mode and parameters of the treatment
  • the alphanumeric display 117 is used as an interface to show the treatment data and parameters to the physician using the laser console 10.
  • the visual and audio outputs of the laser unit 10 may be used to guide an operator through the i-MP procedure.
  • a laser power knob 118 is preferably a rotary knob allowing the physician to set the main laser power.
  • the power knob includes an encoder from which output signals are read and interpreted by the processor 114 and displayed to the physician.
  • the pulse-duration-select dial button 119 is a rotary knob allowing the physician to set the duration of a laser shot.
  • the button 119 includes an encoder from which output signals are read and interpreted by the processor 114 and displayed to the physician, for example, on display 117.
  • the pulse interval select dial button 120 is a rotary knob which allows the physician to set the repeat interval.
  • Diode button 120 includes an encoder from which output signals are read and interpreted by the processor board 114.
  • Foot switch 121 is used to fire the laser beam.
  • the foot pedal 121 is optically coupled to the laser console 10 to provide electrical safety.
  • Interlock unit 122 is an optional device for additional laser safety.
  • the interlock input 122 allows a switch to be connected to the laser console 10 to disable the laser when an external door is opened inadvertently. If the user chooses not to use the remote interlock, then a by-pass connector must be inserted into the interlock unit
  • the "autokey" connector 123 contains electrical circuitry used to provide information to the laser console 10 that indicates what optical delivery path has been connected to the laser console 10.
  • Each optical delivery path 110 has different transmission properties which affect the laser power that reaches the patient's eye
  • 114 can calculate a transmission factor to compensate for the attenuation of laser power along the optical delivery path 110.
  • An electronic power supply 124 supplies the required power to the circuits of the power controller 102 and the processor board 114.
  • EMI/EMC line filter 125 is a module that filters the electrical noise from the mains line to protect the laser from malfunction and damage due to possible power surges.
  • Mains cable 126 connects the laser console 10 to an electric outlet.
  • Switch 127 is an on/off switch allowing the user to turn the laser console 10 on or off.
  • Keyboard 116 includes a number of buttons for the operation of application device 10 and adjustment of the treatment parameters by an operator.
  • the buttons include: • ⁇ Treat> Activates TREATMENT mode directly;
  • the treatment system has four modes of operation including: • AUTO-CALIBRATION mode 200: This mode is selected to calibrate the output power of laser unit 10. This calibration is necessary due to the precision required for the i-MP procedure. Auto-calibration is designed to compensate for any output power deviation arising either from accumulation of dust on the mirrors and lenses of the SLA 30, wearing out of the fibre optic, misalignment or aging of the laser diode 103. The adjustment range of the auto-calibration is 20% of the factory calibration thereby preventing the accidental use of the equipment out of the power tolerance specification. In some embodiments, auto-calibration may not be performed before each procedure.
  • the calibration may be a manual procedure or it may be performed after, for example, every two procedures, every five procedures, or every ten procedures. Additionally, in embodiments, the adjustment range of the auto calibration may be about 20 % (e.g., about 15-20%, about 10-20%, about 10-30%).
  • This mode includes a sequence of screens displayed on display 117 where the user is prompted to adjust the fundamental parameters of the treatment procedure including: o Lesion greatest linear dimension (GLD); o Patient's weight; o Lens magnification; and o Pigment concentration.
  • LFD Lesion greatest linear dimension
  • USER PREFERENCES mode 400 In this mode auxiliary parameters such as aiming beam intensity and sound intensity of buzzer 115 are adjusted by the operator.
  • TREATMENT mode 500 Mode in which the treatment laser 103 is applied to the patient using previously selected parameters.
  • Mode selection is accomplished by the operator pressing the ⁇ M0DE> button 5 repeatedly until the desired mode is displayed on display 117. Once a mode is shown on the display, pressing the ⁇ SEL/YES> button will commence the associated sequence of steps to be performed for that mode.
  • Prompts are displayed to the operator on display 117 and the operator interacts with
  • the software by pressing a button on keyboard 116 or pressing foot pedal 121.
  • the operator is prompted to perform an action, for example putting on safety goggles or injecting the patient.
  • the software procedure in general does not proceed until the operator has confirmed (by pressing a button on keyboard 116) that the action has been performed.
  • the following text does not mention every point
  • FIG. 3 there is shown a flowchart diagram of the steps involved in guiding an operator through the auto-calibration of laser unit 10 with a
  • AUTO-CALIBRATION mode 200 is used to fine tune the system's power control and compensate for any degradation and aging of the components.
  • Dust on the mirrors, lenses and filters, micro-cracks in the fibre optical cable or misalignment of the fibre optic coupling are the most common causes of deviation of the output power of the laser. Additionally, the laser diode also ages and although this is
  • the auto-calibration process involves the use of a purpose- designed power meter 70, which is placed in a position that corresponds to the location of the patient's eye 100 to measure laser power.
  • the auto-calibration procedure is automatic, however the operator is required to position the power meter, connect the power meter cable 71 to the input 11 of the laser console 10 and activate the auto- calibration routine.
  • the laser console 10 prompts the user to perform the necessary actions.
  • a commercial off-the-shelf power meter may be replaced for power meter 70.
  • the operator then confirms that he or she wishes to complete the auto-calibration procedure and is then prompted 210 to position the power meter or detector 70 at which point the software running on processor 114 activates the aiming laser diode 113 to assist in the positioning.
  • the controlling software After the operator has confirmed (by pressing the CAN/NO or SEL/YES buttons) that the detector 70 is positioned, the controlling software then prompts 220 the operator to wear his or her safety glasses before proceeding with the auto-calibration procedure.
  • the first part of the procedure involves setting 230 a spot size to 1.5 mm. This is performed manually by the operator turning the thumb wheel on the SLA 30 to the 1.5 mm position at which point the operator is prompted 260 to either cancel the auto- calibration or press the foot pedal 121 thereby activating the laser diode 103 which will be fired for a period of time long enough to complete the internal calibration performed by software running on processor 114.
  • the laser will be turned off and the user will then be prompted 240 to adjust the spot size to 2.5 mm and repeat the laser firing procedure.
  • the software then prompts 250 the operator to adjust the spot size to 4.3 mm and once again activate the laser by pressing the foot pedal (prompt 260).
  • calibration may be performed using other spot sizes (for example, 0.8 mm, 1.0 mm, 1.5 mm, 2.5 mm, and 4.3 mm.). It is also possible to have systems that have a continuous spot size adjustment that are sometimes referred to as zoom magnification systems. It is also possible to have other spots sizes selected from the range of 0.5mm to 6 mm.
  • the operator will be informed of a successful calibration procedure or alternatively in the event of failure be prompted to take remedial action such as replacing the fibre 20 and/or cleaning the optics at which stage the auto-calibration procedure can be repeated.
  • the parameters include at least one dosage parameter, namely a quantity of ICG to be injected into the patient, and at least one application parameter such as the laser power to be used in the procedure.
  • PARAMETER mode 300 guides the operator in entering the clinical parameters in order to determine the output power for the laser.
  • the power setting of the laser is calculated by software running on processor 114 using the following equations:
  • Mag magnification of the retina laser lens 60 (typically 1.5);
  • Ki OSeT 155.03875 W/mm 2 (Constant of Irradiance);
  • P2 output power in Watts for use in a second laser application.
  • Pigment factors 1 and 2 are based on an examination of the pigmentation of the patient's eye. In one arrangement the following values are used:
  • the power Pl used in the first laser application for low assessed pigmentation can be about 0.5%, 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, or 5% (e.g., about 0.25-5%, 0.5-4%, 0.5-3%, or 1-2%) higher than the power Pl used in the first laser applications for medium or high assessed pigmentation.
  • the power Pl used in the first laser application for low assessed pigmentation is about 1-2% higher than the power Pl used in the first laser applications for medium or high assessed pigmentation. In some embodiments, in this regard, the same power Pl can be used for the first laser application for medium and for high assessed pigmentations.
  • the power Pl used in the first laser application for high assessed pigmentation can be about 0.5%, 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, or 5% (e.g., about 0.25-5%, 0.5-4%, 0.5-3%, or 1-2%) lower than the power Pl used in the first laser applications for medium or low assessed pigmentation.
  • the power Pl used in the first laser application for high assessed pigmentation is about 1-2% lower than the power Pl used in the first laser applications for medium or low assessed pigmentation.
  • the power Pl used in the first laser application is preferred to be lower than the power P2 used in the second laser application. This is applicable, in some embodiments, for low, medium, and high assessed pigmentation. In other embodiments, in the case of medium and high pigmentation, the power P2 used in the second laser application is higher than the power Pl used in the first laser application. In some embodiments, for example, the power P2 used in the second laser application is about 0.5%, 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, or 5% (e.g., about 0.25-5%, 0.5- 4%, 0.5-3%, or 1 -2%) higher than the power Pl used in the first laser application. In one preferred embodiment, the power P2 used in the second laser application is about 1-2% higher than the power Pl used in the first laser application.
  • the output power is recalculated when the first and the second laser applications are started or when a fundamental parameter is changed.
  • the output power is calculated by software running on processor 114.
  • one or more subsequent laser applications are performed to complete treatment. Such additional one or more laser applications may follow an assessment (e.g., via ICG angiography or other means) of the degree of completion of photo-activation of ICG or the presence of a complete photo bleaching (usually judged by the formation on the ICG angiography of an absolute dark spot at the irradiated area) in the targeted tissue and/or the presence of remaining non-activated ICG in the tissue.
  • the one or more subsequent laser applications can comprise any suitable output power and duration. In one embodiment, for example, a single subsequent laser application (i.e., a third laser application) is administered at an output power that is similar or higher than the output power of the second laser application.
  • the one or more subsequent laser applications can have an output power that is about the same or 0.5%, 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 5.5%, or even 6% (e.g., about 0.5-5%, 1-4%, 1.5-3.5%, or 2-3%) higher than the output power of the second laser application.
  • a single subsequent laser application i.e., a third laser application
  • the duration of the third and subsequent laser application will typically be shorter than the first and second laser application.
  • the third application will typically be about 15-60 seconds in duration (for example, about 15 to about 30 seconds, about 30 to about 45 seconds, about 45 to about 60 seconds, about 20 seconds, about 25 seconds, about 30 seconds, about 35 seconds, about 40 seconds, about 45 seconds, about 50 seconds, or about 55 seconds).
  • the operator may step between these alternatives by pressing the INC and DEC buttons. The operator may then vary each of these options according to patient characteristics.
  • the lesion size mode 310 the operator is presented with three options to set the Lesion GLD. The choice between these options is based on an examination of the lesions in the patient's eye 100. The first of these options 311 corresponds to a lesion size less than 1.5 mm in which case the spot size (SZ) is to be set 312 to 1.5 mm. If this is appropriate as determined by examination of the patient, the operator is prompted 312 to turn the thumb wheel on SLA 30 to the appropriate spot size as indicated. The system will then return to mode selection level 200.
  • an operator can instruct the system to increase the lesion size parameter to be in the range 1.5 mm to 3.0 mm 313 in which case the spot size parameter stored in memory is set to 2.5 mm and the operator is prompted 314 to adjust the SLA 30 to a spot size of 2.5 mm. If the lesion size is indicated 315 as being greater than 3.0 mm, the spot size is set to 4.3 mm and a displayed message prompts 316 the operator to adjust the spot size at SLA 30.
  • the spot size values can be varied (e.g., less than lmm, between 1 and 3 mm, between 1.6mm and 6mm, more than 1.6 mm, 3mm, 4 mm, 1.75mm, 2.5mm, 3.5mm, or 4.5mm).
  • Keyboard 116 allows the operator to move between the various options for lesion size by using the ⁇ INC> or ⁇ DEC> buttons as appropriate. Once the operator has selected the appropriate lesion size and confirmed this by pressing the SEL/YES button, the appropriate prompt 312, 314, 316 is displayed on display 117.
  • ICG indocyanine green
  • prompt 320 the operator has the choice of entering the patient's weight. After selection of patient's weight mode by pressing the SEL/YES button, the operator may enter whether the patient's weight is either under 75 kg 321 or over 75 kg 323 by pressing the INC or DEC buttons. If the patient's weight is over 75 kg then the operator is instructed (by prompt 322 displayed on display 117) to prepare 150 mg of ICG in two syringes of 3 ml each.
  • additional weights may be presented to the operator for selection (e.g., above or below 65kg, 70kg, 80kg, and 100Kg). Additionally, more than two values for patient weight may be presented (e.g., 3, 4, or 5).
  • Prompt 331 asks the operator to confirm that a Mainster Wide Field 1.5X magnification lens is used. In other embodiments, the operator may be presented with a potential choice of retinal laser lens types.
  • the final parameter to be selected in the SET PARAMETER mode is the pigment content of the eye that is to be treated.
  • prompt 340 is displayed on display 117
  • the operator is able to choose between a high pigment level 341, normal pigment level 342 and low pigment level 343 as determined by examination of the patient.
  • the operator may step between prompts 341, 342 and 343 by pressing the INC and/or DEC buttons.
  • the appropriate pigment level is displayed on display 117, the operator selects the pigment level by pressing the SEL/YES button. Once this has been completed the process flow returns to the top level menu 200.
  • the parameters set in the SET PARAMETER mode are stored for use during the TREATMENT mode.
  • the display changes to the next mode (TREATMENT MODE).
  • the operator enters the USER PREFERENCES mode by pressing the SEL/YES button, the operator is presented with a set of parameters to vary. The operator may step between these parameters by pressing the INC and/or DEC buttons on keyboard 116.
  • Prompt 410 enables the operator to adjust the sound intensity level. By pressing the INC or DEC buttons, the sound intensity may be adjusted to a number ranging between 4 and 9. Displayed message 411 indicates the current setting of the sound intensity.
  • prompts 420 and 421 allow the operator to adjust the aiming beam intensity in a range of 2 to 9.
  • the aiming beam is a visible laser of relatively low power output that is used to position and aim the laser subsequently used in the therapeutic procedure.
  • FIG 13 provides an overview 900 of the treatment protocol. More detail is shown in Figures 9 to 12.
  • the treatment protocol has a timing sequence.
  • the control software described herein guides the operator in executing the treatment according to the timing sequence.
  • step 904 information 901 saved during the SET PARAMETER mode is displayed on display 117 in order for the operator to check that the parameters have been selected appropriately.
  • step 906 the operator injects a first syringe of ICG into the patient.
  • step 910 the operator injects a second syringe of ICG into the patient (step 910).
  • Software running on processor 114 guides the operator through steps 906 - 908 by providing prompts and instructions at appropriate times during the procedure.
  • step 912 laser power Pl is applied to a treatment area in the patient's eye for 100 seconds.
  • the operator applies the laser power by pressing foot pedal 121.
  • the power setpoint of the laser is determined by software running on microprocessor 114 dependent on the information 901 entered in the SET PARAMETER mode.
  • the control system 90 times the wait and alerts the operator near the end of the wait.
  • step 916 laser power P2 is applied to the treatment area for 100 seconds.
  • the procedure is then complete and the controlling software returns (step 918) to higher-level selection menus.
  • the system initially prompts the operator to confirm that a number of important actions have been performed before the treatment can commence. In this manner, the system makes use of the various parameters that have already been entered into the system to ensure that the correct treatment protocol is being followed.
  • TREATMENT mode 500 may be activated directly by pressing the ⁇ Treat> button on keyboard 116.
  • hi TREATMENT mode 500 the operator is first asked (by means of prompt 510 displayed on display 117) to confirm that an auto-calibration has been recently performed, hi one arrangement the system requires that an auto-calibration is performed at least once every 10 treatments.
  • the system confirms the weight of the patient and the amount of ICG that is to be delivered.
  • prompt 520 indicates that 2 syringes of 3ml each are to be used, and asks the operator to confirm this.
  • the operator responds by pressing the CAN/NO button or the SEL/YES button, as appropriate.
  • the selected lesion size is displayed 530 and the operator is prompted to confirm that the lesion size agrees with the spot size selected on SLA 30.
  • the system then prompts 540 the operator to confirm which contact lens 60 is used. In the described example, a Mainster WF lens is used as the contact lens 60.
  • the system also prompts 550 the operator to confirm that the pigment concentration parameter is correctly set. Prompts 510, 520, 530, 540, 550 are part of a final safety check to ensure that the system is parameterised correctly with regard to the patient to be treated.
  • the system next prompts 560 the operator to inject the first dose of ICG into the patient's blood circulation.
  • the operator confirms the injection by pressing the SEL/YES button. Alternatively, the operator may halt the procedure by pressing the CAN/NO button. If the injection is confirmed, software running on processor 114 sets a count down timer to 1680 seconds. The current value of the timer is displayed 610 on display 117. The operator may cancel the timer by pressing the CAN/NO button.
  • the controlling software When the timer has finished the count-down, the controlling software resets the timer to 120 seconds and causes the buzzer 115 to sound a continuous beep (step 615).
  • the system continues counting down and prompts 620 the operator to put on safety glasses and confirm that this has been done. If the operator presses the SEL/YES button to confirm use of the safety glasses, processor 114 switches off the buzzer 115 and switches on the aiming laser diode 113.
  • a prompt 640 is then displayed instructing the operator to place lens 60 on the patient's eye and confirm that this has been done.
  • Prompt 650 then instructs the operator to position the aiming laser beam on the lesion and to confirm that this action has been performed.
  • the display 117 continues to display 660 the status of timer Tl.
  • the timer After the timer has completed the 120 second countdown (during which time the operator has put on safety glasses, positioned lens 60 and aimed the laser), the timer is reset to 60 seconds (step 675). Prompt 670 is displayed instructing the operator to inject the second syringe into the patient. The operator is required to confirm, by pressing the SEL/YES button, that the second syringe has been injected into the patient. If this confirmation has not occurred within 60 seconds the treatment will automatically time out and display 117 presents the message Treatment time-out 676.
  • step 685 starts a 90 second countdown timer.
  • Screen display 680 displays the timer and also the calculated power parameter P, the lens magnification and the spot size.
  • P 375mW
  • L I.5
  • the spot size is 1.5 mm.
  • the timer reaches the last 30 seconds of the countdown period, 3 long beeps are sounded.
  • the timer reaches the last 20 seconds 2 long beeps are sounded and at the last 10 seconds one long beep will be emitted.
  • the system displays a prompt 710 instructing the user to press the foot pedal 121. If the operator does not press the foot pedal within 60 seconds (set in step 705), the procedure times out and an error signal is displayed. The operator also has the option of cancelling the procedure by pressing the CAN/NO button.
  • a sound signal is emitted by buzzer 115 and the main laser diode 103 is activated (step 720).
  • the patient is positioned and the lens is in place.
  • a 100 second countdown timer is started in step 725.
  • the power, lens magnification and spot size are displayed 730 and an indicator of delivered energy dosage is also displayed.
  • the display 730 also includes an indication that the first laser application is underway.
  • the foot pedal 121 must be kept pressed. If the foot pedal 121 is released the laser diode 103 and countdown are paused (step 735). The countdown and laser treatment can be resumed (step 736) by pressing foot pedal 121 again. In the event of foot pedal 121 not being pressed for more than 30 seconds, the system will display the time-out message. The operator may also cancel the procedure by pressing the CAN/NO button.
  • the controlling software running on processor 114 deactivates the treatment laser diode 103 and aiming laser diode 113 (step 740).
  • a 1680 second countdown timer is then started in step 745.
  • the delivered energy (DE) dose indicator remains on display 750 whilst the laser assembly 80 is in standby mode. In the example shown the delivered energy is 4205 J.
  • the timer is reset to 120 seconds in step 765, providing an overall delay of 1800 seconds.
  • the buzzer 115 sounds a continuous beep 760 to alert the operator. If the operator presses the SEITYES button, the processor 114 acts (in step 770) to turn off the beep and turn on the aiming laser diode 113. The operator is then prompted 775 again to place the lens 60 on the eye 100 to be treated and to confirm that the lens 60 is in place.
  • the software displays prompt 780 to instruct the operator once again to position the aiming laser on the treatment area including the lesion. If the operator confirms that this has been done (by pressing the SEIVYES button), then prompt 790 is displayed, prompting the operator to prepare for the second laser application.
  • the timer is reset to 60 seconds in step 816 and prompt 810 is displayed instructing the operator to press the foot pedal.
  • the settings of power P, lens magnification and spot size are also displayed.
  • step 815 the buzzer 115 sounds an alert.
  • the main laser diode 103 is activated in step 820 and a countdown period of 100 seconds commences (step 830).
  • An indicator of energy dosage is displayed 840 along with power, lens magnification and spot size and an indication that this is the second application of the laser assembly 80.
  • the power P2 used in the second laser application may be higher than the power Pl used in the previous laser application.
  • the relative strength of Pl and P2 is determined by the pigmentation parameter Kpi g .
  • the foot pedal 121 must be kept pressed down. If the foot pedal 121 is released the laser and countdown are paused (step 845). These can be resumed (step 846) by pressing the foot pedal 121 again. If the foot pedal 121 is not pressed for more than 30 seconds, application device 10 will sound a continuous beep until the foot pedal 121 is pressed again.
  • the treatment laser diode 103 and aiming laser diode 113 are deactivated in step 847.
  • the delivered energy dose indicator remains on the display 117 (step 850) and the operator is given the option to return to the top level menu display 200.
  • the treatment may be cancelled explicitly by the operator or alternatively if a time out period has been exceeded.
  • a typically procedure that could be used is as follows. Subjects, ranging in age from 50 to 75 years in age, would be treated with one of the embodiments of the present invention disclosed. The test subjects would exhibit positive signs for the following forms of neovascular age-related macular degeneration (AMD):
  • AMD neovascular age-related macular degeneration
  • Pre-treatment pigmentation levels would be assessed for each subject. Additionally, pre-treatment visual acuity for each subject would be assessed by the measurement of the best corrected visual acuity (BCVA), according to Early Treatment Diabetic Retinopathy Study (ETDRS) scoring, by means of counting the number of correct recognized letters, through the use of backlit Ferris-Bailey charts. On average, patients would expected to have a baseline best-corrected visual acuity (BCVA) between 20/100 and counting fingers with a mean of 20/400. Fundus photography, fluorescein angiography, and Indocyanine Green (ICG) angiography would also be conducted to collect additional information as to the effectiveness of the treatment using a fundus camera.
  • EDRS Early Treatment Diabetic Retinopathy Study
  • each subject would then undergo a treatment protocol using the automated i-MP. Following the computer generated protocol certain data such as, patient weight, lesion size, and pigment level would be entered into the i-MP system.
  • the following the prompts provided each subject would be administered an intravenous injection of ICG dye.
  • each subject received a 2 ml loading dose of a highly concentrated solution of ICG (25 mg/ml, approximately 1 mg/kg body weight) in the form of an IV bolus, followed by a 5.0-ml saline flush. 20-40 minutes after the loading dose, a second IV injection of 50 mg of ICG in 2 ml of solution would be administered to each subject, followed by another saline flush.
  • a laser light from an 805 ran diode laser, as described in the present application, with a slit lamp delivery system, and an automated laser calibration system would then be directed to the center of choroidal neovascularization (CNV) ingrowths site of each subject at a laser energy of about 30 W/cm 2 for 80-100 seconds.
  • a second laser application with an increased laser energy of approximately 30.6 W/cm 2 would be applied.
  • fluorescein angiography could be performed approximately 30 minutes after the second laser application. If it was determined via angiography that ICG dye remained in the retina of any subjects following the second laser application, a third laser application of a 1-2% greater power level (as compared to the power level of the second laser application) could be administered. Using the present invention it is believed that the need for the use of additional equipment would be mininirnized.
  • each subject would be observed at 1-, 12-, 24-, and 48-week intervals.
  • subjects' best-corrected visual acuity would be determined and 'they may undergo complete ophthalmic examinations, color fundus photography, fluorescein and ICG angiography, and optical coherence testing utilizing the macular thickness standardized acquisition protocol.
  • For the macular thickness map analysis an ETDRS-like map could be generated, and center foveal thickness and total macular volume could be determined.
  • Post-treatment assessments of visual acuity and average reduction in mean macular thickness would be collected as follows:
  • Using the present invention will result in improvement in visual acuity and in reduction in mean macular thickness for the subjects in each of the five treatment groups as well as provide one or more of the following: additional safety, reduction in medication error, higher efficacy, fewer side effects, less damage to a healthy retina, and suitable treatment for all kinds of CNV secondary to AMD, Angioid Streaks, Pathologic Myopia, Central Serous Retinopathy, and other choroidal diseases resulting from inflammatory conditions and idiopathic causes as compared to conventional systems.
  • WO 02/094260 describes a range of laser wavelengths from 700 to 900 nm (preferably 805 run) and an exposure time from 40 to 150 seconds (preferably 100 seconds).
  • the laser wavelength may be about 790nm, about 795nm, about 800nm, about 805nm, about 810nm, about 815nm, about 820, nm, about 825 nm, about 830nm, or any other wavelength that would suitably excite the ICG or any derivative of ICG.
  • the treatment times may be, for example, about 50sec, about 45 sec, about 60 sec, about 75 sec, about 90 sec, about 100 sec, about 110 sec, about 125 sec, about 150 sec, etc.
  • the dosage of ICG used may also vary, and different lenses may be placed in the path of the laser beam.
  • the control system described above is implemented by software running on a processor preferably included within the laser unit 10. However, some or all of the software-implemented tasks such as calculating the treatment parameters and displaying instructions to the operator may be run on other computational devices, which may be in electronic communication with one another and/or the laser unit.
  • the software instructions may be stored on a computer-readable medium, for example floppy disks, magnetic tape, CD-ROM, DVD, a hard disk drive, a magneto-optic disk, or a computer- readable card such as a PCMCIA card and the like.
  • a computer-readable medium having software or a computer program recorded on it is a computer program product.
  • One or more aspects of the described system may also be performed in dedicated hardware, for example an application-specific integrated circuit.

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Abstract

La présente invention concerne un procédé et un système de contrôle de procédure thérapeutique réalisée sur un patient. En fonction d'une information associée au patient, un système de contrôle (90) détermine au moins un paramètre de dosage et au moins un paramètre d'application de la procédure thérapeutique. Un écran d'affichage (117) affiche une ou des invites de commande indiquant à un opérateur d'introduire au moins une substance externe dans l'organisme du patient selon ledit paramètre de dosage et affiche une ou des instructions pour l'opérateur concernant l'application d'une sortie d'un dispositif d'application (80) à la zone de traitement (100) du patient selon ledit paramètre d'application. La procédure thérapeutique peut être un traitement par photothrombose par l'intermédiaire de vert d'indocyanine pour la dégénération maculaire liée à l'âge.
PCT/AU2008/000192 2007-02-14 2008-02-14 Procédé et système de contrôle de procédure thérapeutique Ceased WO2008098300A1 (fr)

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000047107A1 (fr) * 1999-02-15 2000-08-17 Avimo Group Limited Procede et appareil pour traiter la neovascularisation
US6491715B1 (en) * 1999-11-17 2002-12-10 Pulsion Medical Systems Ag Device for treating growing, dilated or malformed blood vessels and method for treating biological material
US20030135388A1 (en) * 2002-01-11 2003-07-17 James Martucci Medication delivery system
WO2006012752A1 (fr) * 2004-08-06 2006-02-09 John Kennedy Dispositif therapeutique et accessoires connexes, compositions et methodes de traitement
US20060088530A1 (en) * 2000-01-12 2006-04-27 Chen James C Photodynamic therapy treatment for eye disease
US20070010746A1 (en) * 2003-08-06 2007-01-11 Michael Forman Treatment of age-related macular degeneration
WO2007016749A1 (fr) * 2005-08-11 2007-02-15 Opto Global Holdings Pty Ltd Procede et systeme de reglage d'une intervention therapeutique

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000047107A1 (fr) * 1999-02-15 2000-08-17 Avimo Group Limited Procede et appareil pour traiter la neovascularisation
US6491715B1 (en) * 1999-11-17 2002-12-10 Pulsion Medical Systems Ag Device for treating growing, dilated or malformed blood vessels and method for treating biological material
US20060088530A1 (en) * 2000-01-12 2006-04-27 Chen James C Photodynamic therapy treatment for eye disease
US20030135388A1 (en) * 2002-01-11 2003-07-17 James Martucci Medication delivery system
US20070010746A1 (en) * 2003-08-06 2007-01-11 Michael Forman Treatment of age-related macular degeneration
WO2006012752A1 (fr) * 2004-08-06 2006-02-09 John Kennedy Dispositif therapeutique et accessoires connexes, compositions et methodes de traitement
WO2007016749A1 (fr) * 2005-08-11 2007-02-15 Opto Global Holdings Pty Ltd Procede et systeme de reglage d'une intervention therapeutique

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