EP1001708A1 - Systeme et methode de revascularisation peroperatoire du myocarde au moyen d'energie sonique pulsee - Google Patents

Systeme et methode de revascularisation peroperatoire du myocarde au moyen d'energie sonique pulsee

Info

Publication number
EP1001708A1
EP1001708A1 EP98940826A EP98940826A EP1001708A1 EP 1001708 A1 EP1001708 A1 EP 1001708A1 EP 98940826 A EP98940826 A EP 98940826A EP 98940826 A EP98940826 A EP 98940826A EP 1001708 A1 EP1001708 A1 EP 1001708A1
Authority
EP
European Patent Office
Prior art keywords
heart
sonic energy
patient
probe member
pulsed sonic
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Withdrawn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
EP98940826A
Other languages
German (de)
English (en)
Inventor
Michael Aita
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
Application filed by Cardiogenesis Corp filed Critical Cardiogenesis Corp
Publication of EP1001708A1 publication Critical patent/EP1001708A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B17/2202—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being inside patient's body at the distal end of the catheter
    • 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, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets 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

Definitions

  • This invention generally relates to the field of heart tissue removal, and more particularly to the use of pulsed sonic energy for myocardial revascularization to improve the flow of blood to the heart muscle and cure angina.
  • Myocardial revascularization typically involves formation of one or more channels in a patient's heart wall defining the heart chamber to treat a patient's ischemic myocardial tissue therein.
  • the first trials of the revascularization process was made by Mirhoseini et al. See for example the discussions in Lasers in General Surgery (Williams & Wil ins; 1989), pp 216-223. Another early disclosure of this procedure is found in U.S. Patent 4,658,817 (Hardy). Both of these references describe laser myocardial revascularization (LMR) procedures in which a laser is used to form the revascularization channels through the epicardium, myocardium and endocardium.
  • LMR laser myocardial revascularization
  • LMR low cost yet reliable myocardial revascularization system
  • the present invention generally involves use of a pulsed sonic energy apparatus for the removal of heart tissue, including both the ablation of the tissue and the formation of channels in the tissue.
  • a pulsed sonic energy apparatus for the removal of heart tissue, including both the ablation of the tissue and the formation of channels in the tissue.
  • One aspect of the invention provides a method for ablating tissue of a patient's heart comprising, providing a pulsed sonic energy apparatus with an elongated probe member. The probe member contacts the patient's heart tissue, and transmits bursts of pulsed sonic energy to the heart tissue.
  • a system for forming a channel in a patient's heart wall comprising an elongated probe member connected to a source of bursts of pulsed sonic energy.
  • the transverse dimension, or diameter, of the probe member is essentially the same as the size of the channel to be formed.
  • the energy bursts are delivered in a timed sequence, which may be either dependent or independent of the patient's heart cycle. By providing the sonic energy bursts at a specific frequency and pulse duration, the removal of the heart tissue can be optimally controlled.
  • Fig. 1 is a schematic section of a human heart showing revascularization of the myocardium according to the invention.
  • Fig. 2 is a schematic block diagram of a pulsed sonic energy system synchronized to a heart beat according to the invention.
  • a pulsed sonic energy generator 10 of the invention generally comprises a source of pulsed sonic energy 11 and a transmitting device 12 including an elongated probe member 13.
  • the elongated probe member 13 is inserted into the chest cavity.
  • Elongated probe member 13 is then placed in contact with an area of the heart 16, such as a ventricle 17, having an area 18 in need of increased blood circulation due to cardiovascular disease. Portions of the heart other than ventricles 17 might also be revascularized by this method. Pulsed sonic energy is transmitted in a plurality of bursts through the elongated probe member 13 of the transmitting device 12 to the patient's heart tissue in contact therewith. A number of channels 20 can then be formed by the elongated probe member 13 from the outer wall, or epicardium 21 , and extend through the myocardium 22. The channel can optionally perforate the interior of the heart wall, or endocardium 23.
  • the elongated probe member 13 is shaped to facilitate contact with a region of the patient's heart, e.g. with a bend, into a desired configuration (not shown).
  • One aspect of the invention provides a system for forming a channel of desired transverse dimensions in a wall of a patient's heart.
  • the system comprises an elongated probe member 13, a source of a plurality of bursts of pulsed sonic energy 11 , and means to connect the source 11 to the proximal extremity of the probe member 13.
  • the elongated probe member 13 having a proximal end 14 and a distal end 15, when in contact with tissue, cuts a channel essentially equal to the transverse dimension of the probe member distal end 15.
  • the means to connect the pulsed sonic energy source 11 has a handle means (not shown) to enable an operator to press the distal extremity of the probe member 13 into contact with the patient's heart wall to form a channel.
  • the handle means facilitates pressing the probe member distal extremity perpendicularly against the patient's heart wall.
  • the heart beat is preferably monitored, and the sonic energy source 11 is preferably gated to generate one or more pulses during contractions (systole) of the heart, and to generate no pulses during the rest of the heart cycle.
  • the presently preferred pulse duration is no more than 100 milliseconds.
  • a plurality of bursts of pulsed sonic energy may be required to complete the channel 20 in the heart wall.
  • the presently preferred frequency of the pulsed sonic energy emitted from the pulsed sonic energy source is at least 15,000 Hz.
  • the sonic energy includes, for example, ultrasound, and the presently preferred source of pulsed sonic energy is an ultrasonic generator.
  • the ultrasound generator drives a transducer operating at resonance coupled to the elongated probe member 13.
  • pulsed sonic energy is delivered to the heart tissue in a sequence dependent on the patient's heart beat cycle.
  • the R wave is one of four distinct waveforms that exist in each heart beat cycle.
  • Fig. 2 illustrates a schematic block diagram of a pulsed sonic energy system in which a +5 volt pulse is produced from an ECG monitor 31 for each R wave of a beating heart.
  • the ECG +5 volt pulse is sent to a one shot trigger generator 32, where it triggers a variable width pulse.
  • the variable width pulse is typically no greater than 100 msec, and is sent from the one shot 32 to a NAND gate 33. When the system is turned on, the NAND gate 33 switch will close, in response to the variable width pulse from the one shot.
  • the closed NAND gate sends a signal to a NPN transistor 34, which in turn energizes a reed relay 36, which triggers an ultrasonic generator 38 for a time that approximates the pulse width of the one shot.
  • a foot switch connector may be provided so that the physician may selectively energize the elongated probe member 13 with ultrasonic energy for the formation of channels 20.
  • the ECG monitor 31 may be a standard model, such as is available from Hewlett-Packard Company.
  • the one shot trigger generator 32 and NAND gate 33 may be readily obtainable models, such as National Semiconductor models CD4047 BM, and CD 4011 BM respectively.
  • the ultrasound generator 38 may be, for example, the MISSONIX generator, or another readily obtainable generator.
  • the distal end of the elongated probe member 13 may be maintained in position on the outer heart wall by a gentle pressure that advances the elongated probe member, to insure that the member 13 is not dislodged in the formation of the channel 20 between pulses of the sonic energy.
  • a gentle pressure that advances the elongated probe member, to insure that the member 13 is not dislodged in the formation of the channel 20 between pulses of the sonic energy.
  • as few as one pulse of sonic energy per heartbeat is transmitted to the heart tissue.
  • an energized probe member 13 contacting the heart surface at a non-perpendicular angle has an increased risk of producing a heart arrhythmia.
  • the elongated probe member 13 is held by the operator at an angle of approximately 90° to the heart surface.
  • the elongated probe member is maintained in the perpendicular orientation relative to the surface of the beating heart by an orientation means (not shown).
  • the orientation means comprises for example, a track in which the elongated probe member 13 proximal end 14 slides, wherein the probe member distal end 15 extends beyond the distal end of the tract and into the patient.

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Mechanical Engineering (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)

Abstract

L'invention concerne une méthode permettant de pratiquer l'ablation de tissus au niveau du coeur d'un patient, méthode qui consiste à utiliser un appareil à énergie sonique pulsée pourvu d'une sonde allongée. La sonde allongée vient au contact des tissus du coeur du patient et on pratique l'ablation de ces tissus au moyen de salves d'énergie sonique pulsée transmises via la sonde. L'invention concerne également un système permettant de pratiquer un canal dans la paroi du coeur d'un patient, lequel système comprend une sonde allongée connectée à une source de décharges d'énergie sonique pulsée. Lors de l'ablation ou de la formation de canaux, les salves d'énergie sont appliquées en séquences temporisées, indépendantes ou non du cycle cardiaque du patient.
EP98940826A 1997-08-07 1998-08-07 Systeme et methode de revascularisation peroperatoire du myocarde au moyen d'energie sonique pulsee Withdrawn EP1001708A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US90824697A 1997-08-07 1997-08-07
US908246 1997-08-07
PCT/US1998/016528 WO1999007296A1 (fr) 1997-08-07 1998-08-07 Systeme et methode de revascularisation peroperatoire du myocarde au moyen d'energie sonique pulsee

Publications (1)

Publication Number Publication Date
EP1001708A1 true EP1001708A1 (fr) 2000-05-24

Family

ID=25425439

Family Applications (1)

Application Number Title Priority Date Filing Date
EP98940826A Withdrawn EP1001708A1 (fr) 1997-08-07 1998-08-07 Systeme et methode de revascularisation peroperatoire du myocarde au moyen d'energie sonique pulsee

Country Status (3)

Country Link
EP (1) EP1001708A1 (fr)
AU (1) AU8901598A (fr)
WO (1) WO1999007296A1 (fr)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6254564B1 (en) 1998-09-10 2001-07-03 Percardia, Inc. Left ventricular conduit with blood vessel graft
US6217575B1 (en) 1999-02-24 2001-04-17 Scimed Life Systems, Inc. PMR catheter
US6468271B1 (en) 1999-02-24 2002-10-22 Scimed Life Systems, Inc. Device and method for percutaneous myocardial revascularization
US6669691B1 (en) 2000-07-18 2003-12-30 Scimed Life Systems, Inc. Epicardial myocardial revascularization and denervation methods and apparatus
US6533779B2 (en) 2001-01-16 2003-03-18 Scimed Life Systems, Inc. PMR catheter and associated methods
US6544220B2 (en) 2001-02-14 2003-04-08 Scimed Life Systems, Inc. Fluid jet PMR
US6508783B2 (en) 2001-03-14 2003-01-21 Scimed Life Systems, Inc. Ultrasound method for revascularization and drug delivery
DE102005003632A1 (de) 2005-01-20 2006-08-17 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Katheter für die transvaskuläre Implantation von Herzklappenprothesen
US7896915B2 (en) 2007-04-13 2011-03-01 Jenavalve Technology, Inc. Medical device for treating a heart valve insufficiency
WO2011104269A1 (fr) 2008-02-26 2011-09-01 Jenavalve Technology Inc. Stent pour le positionnement et l'ancrage d'une prothèse valvulaire dans un site d'implantation dans le cœur d'un patient
US9044318B2 (en) 2008-02-26 2015-06-02 Jenavalve Technology Gmbh Stent for the positioning and anchoring of a valvular prosthesis
AU2011257298B2 (en) 2010-05-25 2014-07-31 Jenavalve Technology Inc. Prosthetic heart valve and transcatheter delivered endoprosthesis comprising a prosthetic heart valve and a stent
CN105491978A (zh) 2013-08-30 2016-04-13 耶拿阀门科技股份有限公司 用于假体瓣膜的径向可折叠框架及其制造方法
EP3288495B1 (fr) 2015-05-01 2019-09-25 JenaValve Technology, Inc. Dispositif à débit réduit de stimulateur cardiaque lors d'un remplacement de valvules cardiaques
US11065138B2 (en) 2016-05-13 2021-07-20 Jenavalve Technology, Inc. Heart valve prosthesis delivery system and method for delivery of heart valve prosthesis with introducer sheath and loading system

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4658817A (en) 1985-04-01 1987-04-21 Children's Hospital Medical Center Method and apparatus for transmyocardial revascularization using a laser
US4827911A (en) * 1986-04-02 1989-05-09 Cooper Lasersonics, Inc. Method and apparatus for ultrasonic surgical fragmentation and removal of tissue
US4931047A (en) * 1987-09-30 1990-06-05 Cavitron, Inc. Method and apparatus for providing enhanced tissue fragmentation and/or hemostasis
US4936281A (en) * 1989-04-13 1990-06-26 Everest Medical Corporation Ultrasonically enhanced RF ablation catheter
US5304115A (en) * 1991-01-11 1994-04-19 Baxter International Inc. Ultrasonic angioplasty device incorporating improved transmission member and ablation probe
US5362309A (en) * 1992-09-14 1994-11-08 Coraje, Inc. Apparatus and method for enhanced intravascular phonophoresis including dissolution of intravascular blockage and concomitant inhibition of restenosis
US5630837A (en) * 1993-07-01 1997-05-20 Boston Scientific Corporation Acoustic ablation
US5827203A (en) * 1997-04-21 1998-10-27 Nita; Henry Ultrasound system and method for myocardial revascularization

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9907296A1 *

Also Published As

Publication number Publication date
AU8901598A (en) 1999-03-01
WO1999007296A1 (fr) 1999-02-18
WO1999007296A9 (fr) 1999-04-29

Similar Documents

Publication Publication Date Title
US5380316A (en) Method for intra-operative myocardial device revascularization
US5989274A (en) Methods and devices for improving blood flow to a heart of a patient
US6267757B1 (en) Revascularization with RF ablation
US6156031A (en) Transmyocardial revascularization using radiofrequency energy
US6086534A (en) Apparatus and method of myocardial revascularization using ultrasonic pulse-echo distance ranging
WO1999007296A1 (fr) Systeme et methode de revascularisation peroperatoire du myocarde au moyen d'energie sonique pulsee
US5913853A (en) Laser energy device and procedure for forming a channel within tissue
US5885272A (en) System and method for percutaneous myocardial revascularization
JP2002500523A (ja) 患者の心臓への血流を改善する方法及び装置
US6056742A (en) Revascularization with laser outputs
EP0799604A1 (fr) Appareil à laser pour la revascularisation transmyocardiale
US20040054363A1 (en) Methods and devices for ablation
CA2236958A1 (fr) Dispositif a ultrasons pour telemetrie axiale
CA2305333A1 (fr) Revascularisation transmyocardique au moyen d'energie radiofrequence
WO2022023968A1 (fr) Dispositif médical à émission d'ondes ultrasonores
US6001091A (en) Revascularization with heart pacing
AU8760098A (en) Laser ablation device and control system
US20120086789A1 (en) Imaging system for imaging a viscoelastic medium
JP2001510701A (ja) レーザーアブレーションによる経心筋脈管再生のための装置および方法
US6149649A (en) Radio frequency transmyocardial revascularization channel formation

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20000216

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AT BE CH DE FR GB IT LI NL

RAP1 Party data changed (applicant data changed or rights of an application transferred)

Owner name: ECLIPSE SURGICAL TECHNOLOGIES, INC.

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN

18D Application deemed to be withdrawn

Effective date: 20040303