EP1018961A1 - Revascularisation transmyocardique au moyen d'energie radiofrequence - Google Patents

Revascularisation transmyocardique au moyen d'energie radiofrequence

Info

Publication number
EP1018961A1
EP1018961A1 EP98950873A EP98950873A EP1018961A1 EP 1018961 A1 EP1018961 A1 EP 1018961A1 EP 98950873 A EP98950873 A EP 98950873A EP 98950873 A EP98950873 A EP 98950873A EP 1018961 A1 EP1018961 A1 EP 1018961A1
Authority
EP
European Patent Office
Prior art keywords
energy
patient
heart
distal tip
elongated
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.)
Withdrawn
Application number
EP98950873A
Other languages
German (de)
English (en)
Inventor
Michael Aita
Carl J. Simpson
Randy J. Kesten
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Eclipse Surgical Technologies Inc
Original Assignee
Cardiogenesis Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US08/942,874 external-priority patent/US6267757B1/en
Priority claimed from US09/107,077 external-priority patent/US6156031A/en
Application filed by Cardiogenesis Corp filed Critical Cardiogenesis Corp
Publication of EP1018961A1 publication Critical patent/EP1018961A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00392—Transmyocardial revascularisation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00738—Depth, e.g. depth of ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00839—Bioelectrical parameters, e.g. ECG, EEG

Definitions

  • This invention is directed to the ablation or disruption of tissue in the wall of a
  • TMR transmyocardial revascularization
  • diagnostic agents to various locations in the patient's heart wall or for a variety of
  • TMR involves forming a plurality of channels in a
  • Patent 4,658,817 (Hardy). These early references describe intraoperative TMR
  • peripheral arterial system e.g., the femoral artery
  • the distal end of the optical fiber Within the left ventricle, the distal end of the optical fiber
  • the device is directed toward a desired location on the patient's endocardium and urged
  • the laser based revascularization procedure has been shown to be clinically
  • the present invention is directed to a method and system for the
  • said region with emissions of radiofrequency (RF) energy and is particularly
  • One method includes the step of inserting an elongated shaft having an RF
  • the RF energy emitter is guided to the interior of the left
  • ventricle and positioned against a desired portion of the ventricle's inner wall.
  • the RF energy emitter is activated to remove or otherwise injure tissue.
  • RF energy emitter may be advanced so as to remove tissue until a channel or
  • channel formation include fluoroscopic or ultrasonic visualization or advancing the
  • revascularization means a fixed distance.
  • penetration limitation can be
  • the RF energy emitter is repositioned against another portion of the heart wall and the process is repeated until enough channels or regions of ablated
  • tissue are formed to provide the desired revascularization.
  • tissue is ablated within
  • intervals of about one to about 500 msec and preferably about 30 to about 130
  • a radiofrequency burst may comprise a continuous emission or
  • discontinuous emission i.e. be pulsatile, and, if pulsatile, may involve a plurality or
  • train of pulses which may or may not be of the same width (duration), frequency or
  • the RF emissions are preferably controlled so that heart tissue is exposed to
  • the RF energy source generally should have
  • the channel formation or tissue disruption may be performed
  • the remainder of the procedure may be performed at a lower energy
  • RF energy transmitting member which has a proximal end, and an uninsulated distal tip configured to emit RF energy.
  • the channel formed in the heart wall preferably has an aspect ratio
  • the RF energy emitter includes
  • lumens for perfusion and aspiration to remove the particles from the patient's body are provided.
  • the RF energy emitter is configured to produce particles small enough
  • a flexible RF energy emitter is advanced through the patient's vasculature until a
  • a heart chamber such as the left ventricle.
  • RF energy transmitting member is advanced so that the uninsulated distal tip which
  • At least one burst of RF energy is emitted from the uninsulated
  • Another embodiment of the invention involves a minimally invasive approach where a small incision is made in the patient's chest and with or without the benefit
  • an elongated RF energy transmitting member is advanced into
  • the RF energy emitter preferably includes an RF energy transmitting
  • uninsulated distal tip can have a diameter of about 0.025 to about 0.2 inch (0.64-5.1
  • the distal tip may be solid or
  • the frequency of the RF current should not be less than 100 kHz and preferably is
  • the method and system of the invention effectively ablates or disturbs tissue within the patient's heart wall to revascularize the ablated region and particularly can
  • FIG. 1 is a schematic illustration of a system for revascularizing heart tissue
  • FIG. 2 is a transverse cross-section of the RF energy transmitting member of
  • FIG. 3 is a schematic illustration of the one shot shown in FIG. 1.
  • FIG. 4 is a schematic illustration of a system for generating trigger signals
  • FIG. 5 is an elevational view of a delivery system for the RF energy emitter
  • FIG. 6 is a schematic elevational view, partially in cross-section, of a human
  • FIG. 7 is a schematic longitudinal cross-sectional view of the distal portion of
  • FIGS. 8 and 9 are schematic longitudinal cross-sectional views of RF
  • FIGS. 1 and 2 depict an RF system 10 embodying features of the invention
  • the RF energy transmitting member The RF
  • energy transmitting member 11 includes an electrical conductor 14 which may be
  • a suitable insulating polymeric material is the
  • the output from the RF energy source 12 is pulsed by pulse-trigger system
  • the pulsed output signal 20 from the one-shot 17 actuates the transistor 21 for the
  • the output of the transistor 21 is connected to reed
  • the output of the reed relay 22 is connected in series to the foot switch 23.
  • FIG. 3 illustrates in more detail the one-shot shown in FIG. 1 which has 14
  • pins identified as pins a-n in FIG. 3.
  • the one-shot shown in FIG. 3 has the pins
  • the one-shot model number CD4047 has these pins numbered 1-14.
  • trigger signal 18 from an ECG unit is received by pin h and upon receipt of the
  • pin j is controlled by the resistance R and capacitance C from the RC circuit
  • the resistance R can typically range from about
  • the capacitance can typically range from about 0.08 to
  • FIG. 4 schematically illustrates a system of generating trigger signals 18
  • the signals from the patient's heart 31 are based upon the patient's heart cycle 30.
  • the signals from the patient's heart 31 are
  • trigger generating system 32 which may also be contained in the ECG unit.
  • trigger signal generating system 32 is preprogrammed to emit one or more trigger
  • FIG. 5 illustrates a system for the percutaneous
  • an RF system which has an outer catheter 40, a shaped distal end 41 , a
  • This system also includes an inner catheter
  • catheter 44 which is slidably and rotatably disposed within the inner lumen of the
  • outer catheter 40 which has a shaped distal section 45, a distal end 46, a port
  • An RF energy emitter 50 is slidably disposed within the
  • the distal section 45 of the inner catheter 44 is at an angle with respect to the main shaft section 51 of the inner catheter to orient the
  • the present invention also comprises a method for
  • An RF system 10 including
  • an elongated shaft 60 with an RF energy emitter 50 disposed at the distal end is
  • the RF energy emitter 50 is
  • the RF energy emitter 50 is activated and urged against the muscle 62 to
  • tissue forming the revascularization channel 64.
  • region disturbed or ablated should extend a desired distance through the
  • the RF energy emitter 50 is deactivated, withdrawn from channel 64 and
  • RF energy emitter 50 on the distal end is introduced through a small opening in the patient's chest wall. RF system 10 is advanced until the RF energy emitter 50 is
  • emitter 50 is activated and urged towards the muscle 62. Tissue is removed
  • channels 64 or similar revascularization sites are formed in muscle 62 to
  • the RF energy emitter 50 may be maintained in position on the RF energy emitter 50
  • the RF energy emitter 50 can be maintained in place by applying a vacuum at the
  • the operation may be synchronized
  • the RF energy emitter 50 is subject to
  • the RF energy emitter 50 may operate at two or more energy
  • the initial tissue removal to penetrate the endocardium 66 is
  • the remainder of the tissue removal may be performed at a lower energy level to
  • control lines 70 are
  • Adhesive bonding may utilize any of a variety of adhesives, including
  • control lines 70 are thus axially,
  • a mechanism such as a ring or knob may
  • control lines 70 may be attached to the proximal ends of control lines 70 to allow manipulation of control
  • Control lines 70 are preferably approximately 3-mil stainless steel wire,
  • an outer tubular member 74 preferably encloses control lines 70
  • Outer tubular member 74 is secured at
  • control lines 70 are
  • Channels 76 are preferably constructed of 30 gauge polyamide tubing.
  • Control lines 70 are thus guided to remain both separated and within well controlled
  • the positioning of the device may be viewed by esophageal ultrasound
  • trans-thoracic ultrasound imaging and trans-thoracic fluoroscopic imaging.
  • RF energy emitter 50 may
  • FIG. 8 illustrates the distal portion of an RF system
  • the thermal ablator 78 has an electrode 80
  • the diameter of probe 82 should be from about 1.0 to 5.0 mm.
  • proximal ends of the electrode 80 is are connected to a radiofrequency generating
  • Radiofrequency energy may also provide inductive heating as shown in
  • FIG. 9 The distal portion of an RF system 10 has a ferrite probe 84 on the end.
  • radiofrequency generating means (not shown) irradiates the patient's body with
  • Radiofrequency energy at a frequency to which body tissue is relatively transparent but the ferrite Radiofrequency energy may also provide inductive heating as shown in FIG. 9.
  • distal portion of an RF system 10 has a ferrite probe 84 on the end.
  • radiofrequency generating means (not shown) irradiates the patient's body with
  • Eighteen channels were made in the heart of a live, anesthetized medium
  • distal tip of the RF delivery system were varied to determine the nature of the
  • the revascularization may be performed from

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Plasma & Fusion (AREA)
  • Medical Informatics (AREA)
  • Otolaryngology (AREA)
  • Physics & Mathematics (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un système et un procédé de revascularisation du tissu cardiaque d'un patient par au moins une salve d'énergie radiofréquence dans un intervalle compris entre environ 1 et environ 500 millisecondes, de préférence, entre environ 30 et environ 130 millisecondes. Le dispositif comporte, de préférence, une tige électroconductrice isolée et de forme allongée, dont une extrémité distale non isolée est conçue pour émettre une énergie radiofréquence. L'invention concerne également un procédé de revascularisation myocardique d'un coeur humain pour lequel on utilise un dispositif flexible, allongé, comprenant un dispositif d'ablation par radiofréquences. Dans certains modes de réalisation, ce dispositif est conçu de façon à pouvoir être introduit de manière percutanée. Dans d'autres modes de réalisation, il est conçu de façon à pouvoir être introduit de manière péropératoire. L'émetteur d'énergie radiofréquence est introduit jusqu'à un emplacement adjacent à une zone voulue de la paroi du coeur. Le dispositif est actionné, déplaçant ainsi le tissu en vue de former un canal de revascularisation.
EP98950873A 1997-10-02 1998-10-02 Revascularisation transmyocardique au moyen d'energie radiofrequence Withdrawn EP1018961A1 (fr)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US947290 1992-09-14
US08/942,874 US6267757B1 (en) 1995-08-09 1997-10-02 Revascularization with RF ablation
US942874 1997-10-02
US94729097A 1997-10-07 1997-10-07
US107077 1998-06-29
US09/107,077 US6156031A (en) 1995-08-09 1998-06-29 Transmyocardial revascularization using radiofrequency energy
PCT/US1998/020799 WO1999017671A1 (fr) 1997-10-02 1998-10-02 Revascularisation transmyocardique au moyen d'energie radiofrequence

Publications (1)

Publication Number Publication Date
EP1018961A1 true EP1018961A1 (fr) 2000-07-19

Family

ID=27380246

Family Applications (1)

Application Number Title Priority Date Filing Date
EP98950873A Withdrawn EP1018961A1 (fr) 1997-10-02 1998-10-02 Revascularisation transmyocardique au moyen d'energie radiofrequence

Country Status (5)

Country Link
EP (1) EP1018961A1 (fr)
JP (1) JP2001518345A (fr)
AU (1) AU9680398A (fr)
CA (1) CA2305333A1 (fr)
WO (1) WO1999017671A1 (fr)

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US6254564B1 (en) 1998-09-10 2001-07-03 Percardia, Inc. Left ventricular conduit with blood vessel graft
JP2003524444A (ja) 1998-09-10 2003-08-19 パーカーディア，インコーポレイティド Ｔｍｒシャント
EP1112041A1 (fr) 1998-09-10 2001-07-04 Percardia, Inc. Shunt tmr
US6409697B2 (en) 1999-05-04 2002-06-25 Heartstent Corporation Transmyocardial implant with forward flow bias
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AU1629001A (en) 1999-09-08 2001-04-10 Curon Medical, Inc. Systems and methods for monitoring and controlling use of medical devices
EP1210024A1 (fr) 1999-09-08 2002-06-05 Curon Medical, Inc. Systeme de commande d'une famille de dispositifs de traitements
US6854467B2 (en) 2000-05-04 2005-02-15 Percardia, Inc. Methods and devices for delivering a ventricular stent
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US6949118B2 (en) 2002-01-16 2005-09-27 Percardia, Inc. Encased implant and methods
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Also Published As

Publication number Publication date
CA2305333A1 (fr) 1999-04-15
JP2001518345A (ja) 2001-10-16
WO1999017671A1 (fr) 1999-04-15
WO1999017671A9 (fr) 1999-06-17
AU9680398A (en) 1999-04-27

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