WO2000056230A2 - Systeme de commande d'energie pour atherectomie - Google Patents

Systeme de commande d'energie pour atherectomie Download PDF

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Publication number
WO2000056230A2
WO2000056230A2 PCT/US2000/006259 US0006259W WO0056230A2 WO 2000056230 A2 WO2000056230 A2 WO 2000056230A2 US 0006259 W US0006259 W US 0006259W WO 0056230 A2 WO0056230 A2 WO 0056230A2
Authority
WO
WIPO (PCT)
Prior art keywords
power
drive shaft
speed
ablation
burr
Prior art date
Application number
PCT/US2000/006259
Other languages
English (en)
Other versions
WO2000056230A3 (fr
Inventor
Paul A. Hirst
Tom Hiblar
David Wentzel
Original Assignee
Scimed Life Systems Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Scimed Life Systems Inc filed Critical Scimed Life Systems Inc
Priority to EP00914904A priority Critical patent/EP1087704A2/fr
Priority to CA002332431A priority patent/CA2332431A1/fr
Priority to JP2000606139A priority patent/JP2002538927A/ja
Publication of WO2000056230A2 publication Critical patent/WO2000056230A2/fr
Publication of WO2000056230A3 publication Critical patent/WO2000056230A3/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B2017/320004Surgical cutting instruments abrasive
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03Automatic limiting or abutting means, e.g. for safety
    • A61B2090/031Automatic limiting or abutting means, e.g. for safety torque limiting

Definitions

  • the present invention relates to medical devices in general, and in particular to atherectomy devices for removing deposits from a patient's vessel.
  • Vascular disease is one of the leading causes of death in the United States.
  • One form of vascular disease occurs when a patient's artery walls become occluded with growth or deposits. Left untreated, these blockages can cause heart attacks, high blood pressure, strokes, or even death.
  • One promising technique used to treat vascular occlusions is described in
  • the present invention is an atherectomy system that includes a power controller which monitors the speed and torque characteristics of a prime mover that rotates an ablating burr. From the speed and torque applied by the prime mover, the power controller determines the power dissipated under no-load conditions when the bun- has not engaged an occlusion. During ablation, the torque present in the no-load condition is subtracted from the torque measured during ablation and a power signal equal to the power dissipated at the burr is produced. This power is compared with a maximum ablation power. The power controller then adjusts the speed of the prime mover such that the total power dissipated does not exceed the maximum ablation power.
  • the prime mover comprises an electric motor.
  • the power controller receives signals indicative of the speed of the electric motor as well as the electric current supplied to the motor in order to determine its torque. From the torque and speed, the power dissipated at the burr is calculated and the power controller adjusts the speed of the motor to maintain the power dissipated at a level that is at or below the maximum ablation power.
  • the prime mover comprises a gas turbine.
  • the power controller determines the speed of the turbine as well as the pressure of gas used to drive the turbine in order to determine the torque provided. From the speed and torque, the power dissipated is calculated. The power controller adjusts the pressure to the turbine to maintain the power dissipated at a level that is at or below the maximum ablation power.
  • FIGURE 1 illustrates a constant power atherectomy device that includes an electric motor according to a first embodiment of the present invention
  • FIGURE 2 is a block diagram of a power controller that controls the speed of the electric motor shown in FIGURE 1 such that the power dissipated during ablation remains below a predetermined threshold;
  • FIGURE 3 illustrates a constant power atherectomy device that includes a turbine according to a second embodiment of the present invention.
  • FIGURE 4 illustrates a flow chart showing the steps performed by the constant power atherectomy devices according to the present invention.
  • the present invention is a constant power atherectomy system that maintains the power dissipated in a patient during an ablation procedure at or below a predefined level.
  • FIGURE 1 illustrates a constant power atherectomy system according to a first aspect of the present invention.
  • the present invention includes an ablation burr 12 that is secured to the distal end of a drive shaft 14.
  • the ablation burr 12 is positioned within a patient's vessel 15 and advanced to a site that is just proximal to an occlusion 16.
  • the burr is then rotated at high speed and an abrasive surface 18 on the burr engages the occlusion 16 and removes particles that are sufficiently small such that they will not reembolize downstream of the burr. Passing the rotating burr over the occlusion increases the size of and/or creates a new lumen in the vessel, thereby restoring blood flow.
  • the present invention utilizes a power control system that limits the amount of power dissipated in the vessel.
  • Rotating the drive shaft 14 is a prime mover 20 which, in accordance with a presently preferred embodiment of the invention, comprises an electric motor. In general, most electric motors are not capable of rotating at the high speeds required to cause the differential cutting at the ablation burr.
  • the present invention utilizes a D.C. brushless motor capable of producing speeds up to 100,000 rpm.
  • the motor drives a friction wheel 21 A, which engages a smaller drive wheel 21 B that is coupled to the drive shaft 14.
  • the size ratio between the friction wheel 21 A and the drive wheel 21B was selected to be 4.24: 1. Therefore, the motor can be driven at speeds of 37,000 to 38,000 m in order to produce a burr speed of 160,000 ⁇ m.
  • the larger friction wheel and drive wheel are spring loaded to ensure the two wheels remain engaged and to compensate for wear. With the larger friction wheel and smaller drive wheel, the motor is capable of maintaining rotational burr speeds of between 100,000-200,000 ⁇ m. Controlling the speed of the motor is a conventional motor controller 22. As with traditional motors, the motor controller 22 adjusts the current delivered to the motor 20 to maintain its speed at some desired level.
  • the present invention includes a power controller 24 that adjusts the operating characteristics of the motor 20 such that the power delivered by the burr at the ablation site does not exceed the predetermined threshold.
  • the power controller 24 monitors the torque provided by the motor 20 as well as its speed of rotation in order to calculate the power dissipated by the drive shaft and the ablation burr.
  • the speed of rotation may be received from an external tachometer 26 or may be determined from the commutation signals provided by the motor controller 22.
  • the torque provided by the motor which is a function of the current delivered to the motor, may be determined from an external ammeter 28 disposed in line with the leads that provide current to the motor or may be determined from the motor controller 22.
  • FIGURE 2 illustrates a block diagram of the power controller 24 shown in
  • the power controller includes a resistor 40 that is positioned in line with a lead that delivers the driving current to the motor 20.
  • a differential amplifier 42 measures a voltage across the resistor 40 in order to produce a signal having a magnitude that is proportional to the electrical current that drives the motor.
  • the current signal from the differential amplifier 42 is applied to a low pass filter 44 having a 3dB frequency of 20 Hz that removes high frequency components from the current signal. As will be appreciated by those skilled in the art, the particular 3dB frequency used may be adjusted to alter the response time of the control system and its stability.
  • the output of the low pass filter 44 is applied to a sample and hold circuit 46.
  • the sample and hold circuit Upon activation of the platform switch 30 shown in FIGURE 1, the sample and hold circuit maintains a sample of the filtered current signal and applies it to a first input 48a of a differential amplifier 48. Applied to a second input 48b of the differential amplifier 48 is the filtered current signal produced at the output of the low pass filter 44.
  • a frequency to voltage converter 50 receives the commutation signals that are applied to the motor and converts these signals to a corresponding voltage that is proportional to the speed of the motor.
  • the output of the frequency-to-voltage converter 50 is applied to a low pass filter 52 having a 3dB frequency of 7 Hz.
  • the output of the low pass filter 52 is applied to a first input 54a of a multiplier circuit 54.
  • Applied to another input 54b of the multiplier 54 is the output of the differential amplifier 48.
  • a switch 60 that is opened or closed in order to selectively connect the output of the differential amplifier 48 to the input 54b of the multiplier 54. Prior to calibration by pressing the platform switch, the switch 60 remains open to avoid erroneous signals produced by the multiplier 54.
  • the multiplier 54 produces a signal that is proportional to the power dissipated at the burr in watts.
  • the power dissipated is a function of the torque expended by the motor (which is related to the current delivered to the motor) and its speed. -o-
  • the multiplier 54 calculates the power dissipated at the burr according to the equation:
  • is the rotational speed of the burr in the radians/sec and ⁇ is the torque in newton-millimeters.
  • the relationship between the current delivered to the motor and the torque produced is generally obtained from a motor's specifications or may be determined experimentally.
  • the output of the differential amplifier 42 is therefore calibrated to produce a signal that is proportional to the torque of the motor in the appropriate units to calculate the power of the burr in watts.
  • the sample and hold circuit 46 causes the differential amplifier 48 to subtract the torque expended by the motor during no-load conditions such that the value of the power signal produced by the multiplier 54 is only proportional to the power dissipated at the burr.
  • the output of the multiplier 54 is applied to a power meter 62 that provides a visual indication of the power dissipated at the ablation site.
  • the output of the multiplier 54 is also fed through a switch 64 to one input 66a of a differential amplifier 66.
  • the switch 64 has two positions such that the output of the multiplier 54 can be selectively connected to the input 66a of the differential amplifier 66.
  • the switch 64 When the switch 64 is closed, the power controller operates to maintain the power dissipated at the burr below a predetermined threshold. With the switch open, no feedback control is present.
  • Applied to a second input 66b of the differential amplifier 66 is a voltage that is proportional to a threshold or maximum ablation power to be delivered by the burr during ablation.
  • the differential amplifier 66 produces a positive going signal, which is applied to a summation circuit 68.
  • the output of the differential amplifier 66 is prevented from going negative by a diode 70 such that the differential amplifier 66 only contributes to the output of the summation circuit 68 when the power dissipated by the atherectomy burr exceeds the power threshold.
  • the summation circuit 68 adds the output of the differential amplifier 66 and the output of the low pass filter 52.
  • the output of the summation circuit 68 is applied to the first input 72a of an error amplifier 72. Applied to a second input 72b of the error amplifier is a voltage that is proportional to a desired RPM of the motor.
  • the output of the error amplifier 72 drives a speed control input of the motor controller 22. shown in FIGURE 1. to adjust the speed of the motor.
  • the output of the differential amplifier 66 is greater than zero, meaning that the power dissipated at the burr is greater than the predetermined threshold, the output of the summation circuit increases. This causes the output of the error amplifier 72 to decrease and reduce the speed of the motor such that the power dissipated at the bun- decreases.
  • FIGURE 4 is a flow chart showing the steps to be performed by a digital controller/microprocessor in accordance with the present invention to maintain the power dissipated during ablation at or below a predefined maximum level.
  • the prime mover typically an electric motor as shown in FIGURE 1 or a turbine shown in FIGURE 3
  • differential cutting of the bun- occurs most readily when the bun is rotated at speeds between 140,000 and 200,000 ⁇ m.
  • the power controller determines whether the platform switch was pressed. As indicated above, the platform switch causes the power controller to compensate for the power dissipated by the drive shaft and burr under no-load conditions. If the platform switch has not been pressed, processing returns to step 122 until the switch is pressed.
  • step 124 the power controller determines the torque expended by the prime mover. From the speed of the bun and the torque, the no-load power is determined at step 126 using Equation 1 described above.
  • the physician begins ablating an occlusion in a patient's vessel.
  • the power controller determines the total power being dissipated by the atherectomy device. The no-load power is subtracted from the total power at a step 130 to compute the power dissipated at the bun.
  • step 132 it is determined if the power being dissipated at the burr during ablation exceeds the predetermined threshold.
  • the power controller reduces the speed of the prime mover at step 134.
  • the processing then returns to step 129 and the monitoring of the dissipated power continues until the ablation procedure is complete.
  • the power threshold is set at approximately one watt. However, this threshold may vary depending on the location of the occlusion in the body, blood flow, etc.
  • a second embodiment of the invention uses a turbine 150 to rotate the drive shaft.
  • a pressure control unit 152 controls the speed and power of the turbine.
  • a power controller 154 interfaces with the pressure control unit 152 in order to control the maximum power delivered at the ablation site.
  • the power controller- 154 may interface with an external tachometer 156 that monitors the speed of rotation of the drive shaft.
  • the power controller may receive an indication of the pressure used and/or the flow rate of the gas to drive the turbine from a pressure sensor 158.
  • a platform switch 160 that causes the power controller to compensate for the power dissipated by the burr and drive shaft under no-load conditions.
  • the torque is not as straightforward to obtain.
  • One method is to characterize the performance of the turbine by employing a dynamometer to generate a family of torque-speed curves. At each pressure input to the turbine, a unique torque-speed relationship (curve) exists. Once this family of curves is experimentally generated (one curve for each input pressure selected), the information can be charted in a "look-up" table. During operation, speed can be determined with a tachometer, pressure can be determined with a pressure transducer, and with these two values know, torque can be found in the "look-up" table. With speed and torque now known, power can be calculated.
  • the power controller 154 adjusts the pressure and/or flow rate of the gas applied to the turbine through a high speed solenoid valve (not shown) to slow its speed and maintain the level of power dissipated at the burr at or below a predetermined threshold.
  • the present invention therefore operates to automatically control the level of power dissipated in a patient's vessel during an ablation procedure. Because the speed of the prime mover is automatically adjusted, the physician does not have to monitor the operating characteristics of the device and is free to focus his or her attention on positioning and advancing the bun within a vessel.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Dental Tools And Instruments Or Auxiliary Dental Instruments (AREA)
  • Control Of Eletrric Generators (AREA)

Abstract

Ce système de commande d'énergie pour athérectomie maintient à une valeur de seuil prédéterminée ou en dessous de celle-ci l'énergie dissipée par une fraise d'athérectomie durant une ablation. Un circuit de commande d'énergie contrôle la vitesse et le couple d'un moteur premier faisant tourner la fraise servant à l'ablation et ce, afin de calculer l'énergie dissipée en situation de charge nulle. Durant l'ablation, l'énergie dissipée est déterminée et l'énergie de charge nulle soustraite afin de calculer l'énergie d'ablation. Le circuit de commande adapte la vitesse du moteur premier de façon à maintenir l'énergie d'ablation à une valeur de seuil prédéterminée ou en dessous de celle-ci.
PCT/US2000/006259 1999-03-19 2000-03-09 Systeme de commande d'energie pour atherectomie WO2000056230A2 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP00914904A EP1087704A2 (fr) 1999-03-19 2000-03-09 Systeme de commande d'energie pour atherectomie
CA002332431A CA2332431A1 (fr) 1999-03-19 2000-03-09 Systeme de commande d'energie pour atherectomie
JP2000606139A JP2002538927A (ja) 1999-03-19 2000-03-09 アテレクトミーパワー制御システム

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US27331199A 1999-03-19 1999-03-19
US09/273,311 1999-03-19

Publications (2)

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WO2000056230A2 true WO2000056230A2 (fr) 2000-09-28
WO2000056230A3 WO2000056230A3 (fr) 2001-01-25

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JP (1) JP2002538927A (fr)
CA (1) CA2332431A1 (fr)
WO (1) WO2000056230A2 (fr)

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007109422A2 (fr) 2006-03-22 2007-09-27 Revascular Therapeutics Inc. Systeme de commande pour le franchissement d'occlusions vasculaires
WO2011106053A1 (fr) 2010-02-26 2011-09-01 Cardiovascular Systems, Inc. Dispositif d'athérectomie rotatif ayant un moteur électrique
US10052122B2 (en) 2014-01-17 2018-08-21 Cardiovascular Systems, Inc. Spin-to-open atherectomy device with electric motor control
US10226276B2 (en) 2015-06-26 2019-03-12 Covidien Lp Tissue-removing catheter including operational control mechanism
WO2019168784A1 (fr) * 2018-02-27 2019-09-06 Boston Scientific Scimed, Inc. Système d'athérectomie à commande de moteur
WO2020146517A1 (fr) * 2019-01-09 2020-07-16 Boston Scientific Scimed, Inc. Système de commande de moteur pour l'athérectomie
WO2020210238A1 (fr) * 2019-04-08 2020-10-15 Boston Scientific Scimed, Inc. Système d'athérectomie à protection contre une torsion élevée
US10869689B2 (en) 2017-05-03 2020-12-22 Medtronic Vascular, Inc. Tissue-removing catheter
US11357534B2 (en) 2018-11-16 2022-06-14 Medtronic Vascular, Inc. Catheter
US11690645B2 (en) 2017-05-03 2023-07-04 Medtronic Vascular, Inc. Tissue-removing catheter
US11819236B2 (en) 2019-05-17 2023-11-21 Medtronic Vascular, Inc. Tissue-removing catheter
US11931063B2 (en) 2021-03-24 2024-03-19 Medtronic Vascular, Inc. Tissue-removing catheter with torque control

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CN106388878A (zh) * 2016-08-30 2017-02-15 苏州品诺维新医疗科技有限公司 一种动力控制装置及其控制方法、手术操作系统
CN106264674A (zh) * 2016-08-30 2017-01-04 苏州品诺维新医疗科技有限公司 一种手术器械及其操作方法
CN106236197A (zh) * 2016-08-30 2016-12-21 苏州品诺维新医疗科技有限公司 一种手术器械、操作方法及手术系统
WO2019140121A1 (fr) * 2018-01-10 2019-07-18 Boston Scientific Scimed, Inc. Dispositif médical rotatif

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Cited By (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007109422A2 (fr) 2006-03-22 2007-09-27 Revascular Therapeutics Inc. Systeme de commande pour le franchissement d'occlusions vasculaires
EP2001375A4 (fr) * 2006-03-22 2015-03-11 Revascular Therapeutics Inc Systeme de commande pour le franchissement d'occlusions vasculaires
WO2011106053A1 (fr) 2010-02-26 2011-09-01 Cardiovascular Systems, Inc. Dispositif d'athérectomie rotatif ayant un moteur électrique
EP2538857A1 (fr) * 2010-02-26 2013-01-02 Cardiovascular Systems, Inc. Dispositif d'athérectomie rotatif ayant un moteur électrique
EP2538857A4 (fr) * 2010-02-26 2014-03-12 Cardivascular Systems Dispositif d'athérectomie rotatif ayant un moteur électrique
US9050126B2 (en) 2010-02-26 2015-06-09 Cardiovascular Systems, Inc. Rotational atherectomy device with electric motor
JP2016073683A (ja) * 2010-02-26 2016-05-12 カーディオバスキュラー システムズ, インコーポレイテッド 電気モータを有する回転式アテローム切除術用デバイス
US10052122B2 (en) 2014-01-17 2018-08-21 Cardiovascular Systems, Inc. Spin-to-open atherectomy device with electric motor control
US11426193B2 (en) 2015-06-26 2022-08-30 Covidien Lp Tissue-removing catheter including operational control mechanism
US10226276B2 (en) 2015-06-26 2019-03-12 Covidien Lp Tissue-removing catheter including operational control mechanism
US11690645B2 (en) 2017-05-03 2023-07-04 Medtronic Vascular, Inc. Tissue-removing catheter
US11986207B2 (en) 2017-05-03 2024-05-21 Medtronic Vascular, Inc. Tissue-removing catheter with guidewire isolation liner
US11896260B2 (en) 2017-05-03 2024-02-13 Medtronic Vascular, Inc. Tissue-removing catheter
US10869689B2 (en) 2017-05-03 2020-12-22 Medtronic Vascular, Inc. Tissue-removing catheter
US10925632B2 (en) 2017-05-03 2021-02-23 Medtronic Vascular, Inc. Tissue-removing catheter
US10987126B2 (en) 2017-05-03 2021-04-27 Medtronic Vascular, Inc. Tissue-removing catheter with guidewire isolation liner
US11051842B2 (en) 2017-05-03 2021-07-06 Medtronic Vascular, Inc. Tissue-removing catheter with guidewire isolation liner
US11871958B2 (en) 2017-05-03 2024-01-16 Medtronic Vascular, Inc. Tissue-removing catheter with guidewire isolation liner
WO2019168784A1 (fr) * 2018-02-27 2019-09-06 Boston Scientific Scimed, Inc. Système d'athérectomie à commande de moteur
US11478270B2 (en) 2018-02-27 2022-10-25 Boston Scientific Scimed, Inc. Atherectomy motor control system
US11357534B2 (en) 2018-11-16 2022-06-14 Medtronic Vascular, Inc. Catheter
US11737779B2 (en) 2019-01-09 2023-08-29 Boston Scientific Scimed, Inc. Atherectomy motor control system
CN113271878A (zh) * 2019-01-09 2021-08-17 波士顿科学国际有限公司 斑块切除电机控制系统
WO2020146517A1 (fr) * 2019-01-09 2020-07-16 Boston Scientific Scimed, Inc. Système de commande de moteur pour l'athérectomie
WO2020210238A1 (fr) * 2019-04-08 2020-10-15 Boston Scientific Scimed, Inc. Système d'athérectomie à protection contre une torsion élevée
US11819236B2 (en) 2019-05-17 2023-11-21 Medtronic Vascular, Inc. Tissue-removing catheter
US11931063B2 (en) 2021-03-24 2024-03-19 Medtronic Vascular, Inc. Tissue-removing catheter with torque control

Also Published As

Publication number Publication date
EP1087704A2 (fr) 2001-04-04
CA2332431A1 (fr) 2000-09-28
JP2002538927A (ja) 2002-11-19
WO2000056230A3 (fr) 2001-01-25

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