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WO1982004388A1 - Instrument d'incision et de dilatation de l'artere coronaire - Google Patents

Instrument d'incision et de dilatation de l'artere coronaire Download PDF

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Publication number
WO1982004388A1
WO1982004388A1 PCT/US1981/000792 US8100792W WO8204388A1 WO 1982004388 A1 WO1982004388 A1 WO 1982004388A1 US 8100792 W US8100792 W US 8100792W WO 8204388 A1 WO8204388 A1 WO 8204388A1
Authority
WO
WIPO (PCT)
Prior art keywords
cannula
artery
cutting
balloon
coronary
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/US1981/000792
Other languages
English (en)
Inventor
Banning G Lary
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Priority to PCT/US1981/000792 priority Critical patent/WO1982004388A1/fr
Priority to AU73792/81A priority patent/AU7379281A/en
Publication of WO1982004388A1 publication Critical patent/WO1982004388A1/fr
Anticipated expiration legal-status Critical
Ceased 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
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/104—Balloon catheters used for angioplasty
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1093—Balloon catheters with special features or adapted for special applications having particular tip characteristics

Definitions

  • TECHNICAL FIELD This invention relates generally to coronary artery surgery and is directed particularly to an improved method and means for the surgical treatment of stenotic or occluded major coronary vessels while the heart is beating and without the use of the heart and lung machine, although it can also be used with these modalities with the heart in fibrillation or arrest.
  • an inflatable balloon carried at the end of a catheter or the like is passed through the affected artery to the site of the stenosis as observed in cine-coronary arteriography, and then inflated to compact the stenotic plaque and thereby increase the lumen size by dilation.
  • a distinct advantage of this technique is that the catheter can be inserted through a peripheral artery, thereby obviating surgical opening of the chest wall to expose the heart.
  • This, technique has limited application be ⁇ cause of major problems in its use in the treatment of sten ⁇ oses associated with coronary artery rigidity, obstruction, and with single severe and multiple stenoses.
  • the principal object of this invention to provide a novel and improved coronary artery incision and dilation instrument that allows for both cutting and immediately successive dilation of the coronary artery from within the lumen of the vessel.
  • Another object of the invention is to provide a surgical in ⁇ strument of the character described which is adaptable for surgical use either at the site of the coronary artery after opening of the chest wall, or which, in appropriate cases, can be combined with a catheter for introduction to the coronary artery site through peripheral artery without the necessity for opening the chest wall.
  • Figure 1 is a side view of the coronary artery cutting and dilating instrument embodying the invention
  • Figure 2 is a fragmentary enlarged view of the cutting knife and dilating balloon portion of the instrument illustrated in Figure 1, with portions broken away to illustrate con ⁇ structional details;
  • Figure 3 is a partial side view of the instrument as illus ⁇ trated in Figure 2, but showing a modified form thereof where ⁇ in a pair of diametrically opposed cutting blades are used instead of a single blade;
  • Figure 4 illustrates pictorially a human heart with a mag ⁇ nified zone showing a typical stenosis in the anterior de ⁇ scending coronary artery;
  • Figure 5 illustrates how the coronary artery cutting and dilating instrument, in use, is passed through a purse-string sutured cut in the coronary artery to approach the stenosis from the distal side;
  • Figure 6 illustrates a fragmentary cross-sectional view of the stenonic zone of the artery illustrated in Figure 5 show ⁇ ing the cutting of the arterial wall extending into the peri- arterial tissues;
  • Figure 7 illustrates how deeper insertion of the instrument places the balloon section of the site of the stenotic con ⁇ striction just prior to inflation
  • Figure 8 illustrates, on an enlarged scale as compared with
  • Figure 7 how inflation of the balloon serves to dilate and spread the incised stenonic artery zone to enlarge its lumen
  • Figure 9 illustrates, schematically, how a coronary cutting and dilating instrument comprising the invention can be com ⁇ bined with a catheter introduced through a peripheral artery for performing the surgical procedure without the necessity for opening the chest wall;
  • Figure 10 illustrates the distal end portion of the peripheral artery catheter assemblage schematically illustrated in Figure 9, showing how the cutting and dilating instrument is pushed forward and outwardly of the catheter after the catheter is placed at the site of an arterial obstruction.
  • reference numeral 10 designates one form of coronary artery cutting and dilating in ⁇ strument embodying the invention.
  • the instrument 10 comprises a standard vacuum syringe connector fitting device 11 at one end, communicating with a slightly flexible length of tubing or cannula 12, the distal end of which has secured thereto a coaxial, outwardly-extending, flexible wire probe member 13 terminating in a blunt, ovoid tip 14 of increased diametric size.
  • the probe wire 13 will preferably be secured to the cannula 12 by having a short, proximal end portion telescop- ically received within said cannula and soldered or welded in place, thereby blocking the tube opening.
  • Welded, soldered or otherwise securely affixed at the distal end of the cannula 12, and extending radially outward thereof, is an arcuate
  • OMTI knife blade 15 Circumjacently fitted on the cannula 12, directly behind the knife blade 15,is an elongated balloon member 16, the ends thereof being circumjacently secured to said cannula by a suitable cement, and/or an outer wrapping or a suitably thin wire or plastic filament(not illustrated).
  • the cannula 12, along that portion within the elongated balloon member 16, is provided with a plurality of side wall through openings or apertures 17 through which balloon inflating fluid can flow as controlled by use of an inflating syringe during use of the instrument, as is herein- below more particularly described.
  • the normal, collapsed condition of the expansible balloon 16 is illustrated by full-line representation thereof, whereas the "inflated" condition thereof is illustrated in broken lines, indicated at 18.
  • the coronary artery cutting and dilating instrument in the surgical treatment of stenotic coronary artery insufficiency, the heart will be exposed at the site of the affected coronary artery and, as illustrated in Figure 5, a longitudinal incision will be made distal of the stenotic obstruction and spaced there ⁇ from by a distance somewhat less than the length of the instru ⁇ ment cannula 12.
  • the arterial incision will be purse-string sutured, as indicated at 19, after which the probe wire will be passed upstream into the artery through the incision to the position in which the cutting knife blade 15 will have entered the arterial stenosis S.
  • the instrument may also be introduced proximal and passed distalward.
  • Figure 6 illustrates further advancement of the instrument through the artery, causing the knife blade 15 to cut through the arterial wall at the stenosis and into the peri-arterial tissues.
  • the depth of cut is predetermined by the particular width of the knife blade comprising the instrument.
  • the instrument is inserted further into the artery so as to place the balloon member 16 within the zone of the incised stenotic constriction, whereafter a surgical syringe 20 (partially illustrated in Figure 7) will be actuated to force hydraulic fluid through the instrument cannula 12 and openings 17 therein to inflate the balloon.
  • Figure 8 illustrates how inflation of the balloon services to dilate and spread the incised stenotic artery zone, thereby to effect immediate normal distal blood flow and pressure upon completion of the procedure.
  • the lumen need only be in ⁇ creased to a diameter of between one and two millimeters to effect such normal blood flow pressure in the stenotic or com ⁇ pletely occluded artery.
  • Bleeding is controlled by ligation of the purse-string suture after completion of the cutting and dilating procedure, or by ligation of a segment of vein which has been sutured circumferentially to the epicardial opening.
  • the radial position of the knife blade 15 will be indicated, for example, by an indexing pin 11a projecting radially outwardly of the syringe connector fitting device 11 at a position diametrically opposed to that of said cutting blade. It is thus possible for the surgeon to know precisely the direction of the incision being made through the artery wall and into the peri-arterial tissues. While Figures 1, 2 and 5 through 8 illustrate a. coronary cutting and dilating instrument having a single cutting blade 15, it is contemplated that a plurality of blades could also be used to bi-valve or tri-valve, selectively, the stenotic zone of an artery.
  • Figure 3 is a partial view, on an enlarged scale, of a coronary cutting and dilating instru ⁇ ment which, while otherwise the same as the instrument illus ⁇ trated in Figure 1, has a pair of diametrically-opposed knife blades 15a, 15b. If the blades 15a, 15b are made shallower or of lesser radial extent, so as to cut the arterial wall but not to perforate the epicardium, the direction of the blades will be of lessor signi icance. This permits incision and immediate dilation of the coronary artery via a peripheral artery without the necessity of opening the chest wall of the patient in a procedure similar to that heretofore used in the decompression of stenoses by use of an inflatable balloon without cutting. As illustrated in Figures 9 and 10, the cannula 12 of the balloon and knife blade assemblage 22, which is otherwise the same as that of the embodiment of Figure 1, but with two dia ⁇ metrically-opposed blades as illustrated in the embodiment of
  • Figure 3 is of such length as to permit feeding from the out-
  • the external end of the catheter 23 will be provided with appropriate fittings for connection with surgical syringe 20a for hydraulic inflation of the dilating balloon 16, and for introduction of medical fluid through an auxiliary surgical syringe 20b.
  • surgical syringe 20a for hydraulic inflation of the dilating balloon 16
  • auxiliary surgical syringe 20b for introduction of medical fluid through an auxiliary surgical syringe 20b.
  • the instrument blades 15a, 15b will be shallow enough not to cut through the arterial wall at the stenosis, while nevertheless “valving" the stenotic mass to facilitate smooth introduction of the balloon 16 through the approximate center of the stenosis.
  • a plurality of symmetrically opposed knife blades will preferably be employed in this procedure.
  • two diametrically-opposed, shallow knife blades 15a, 15b are

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Surgery (AREA)
  • Public Health (AREA)
  • Vascular Medicine (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Child & Adolescent Psychology (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Surgical Instruments (AREA)

Abstract

Instrument chirurgical pour le traitement du retrecissement et de l'occlusion de l'artere coronaire, permettant d'inciser longitudinalement et subepicardialement le canal de l'artere coronaire au travers d, une zone de retrecissement ou d'obstruction immediatement apres avoir effectue une dilatation du canal arteriel a l'endroit du blocage stenotique et de l'incision arterielle par expansion sous pression d'un ballon (16) que l'on fait passer a cet endroit au travers de l'artere. L'instrument d'incision et de dilatation (10) de l'artere coronaire possede une sonde flexible (13) a l'extremite distale pour en faciliter le guidage au travers de l'artere coronaire, la sonde etant suivie d'une ou plusieurs lames s'etendant radialement (15) permettant d'effectuer l'incision coronaire et d'un ballon gonflable (16) de dilatation de la zone stenotique de l'artere immediatement apres l'incision. Un tube flexible de gonflage et de commande (13) s'etend depuis le ballon (16) jusqu'a l'extremite proximale, ou une seringue chirurgicale (20) peut etre connectee pour effectuer le gonflage hydraulique du ballon (16). L'extension proximale tubulaire (12) de l'instrument est soit courte lorsqu'elle est utilisee en chirurgie a coeur ouvert en la faisant passer au travers de l'artere coronaire sous une incision en bourse effectuee dans l'epicarde au-dessus de l'artere affectee a quelques centimetres du blocage, soit relativement longue lorsqu'elle est appliquee au travers d'un catheter (23) introduit via une artere peripherique.
PCT/US1981/000792 1981-06-10 1981-06-12 Instrument d'incision et de dilatation de l'artere coronaire Ceased WO1982004388A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/US1981/000792 WO1982004388A1 (fr) 1981-06-12 1981-06-12 Instrument d'incision et de dilatation de l'artere coronaire
AU73792/81A AU7379281A (en) 1981-06-10 1981-06-12 Coronary cutting and dilating instrument

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PCT/US1981/000792 WO1982004388A1 (fr) 1981-06-12 1981-06-12 Instrument d'incision et de dilatation de l'artere coronaire
WOUS81/00792810612 1981-06-12

Publications (1)

Publication Number Publication Date
WO1982004388A1 true WO1982004388A1 (fr) 1982-12-23

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1981/000792 Ceased WO1982004388A1 (fr) 1981-06-10 1981-06-12 Instrument d'incision et de dilatation de l'artere coronaire

Country Status (2)

Country Link
AU (1) AU7379281A (fr)
WO (1) WO1982004388A1 (fr)

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0254414A1 (fr) * 1986-06-16 1988-01-27 Samuel Shiber Cathéter rotatoire pour enlever une obstruction d'un vaissee sanguin
DE3737121A1 (de) * 1987-11-02 1989-05-11 Alexander Staeblein Steuerbares abdichtsystem fuer katheter- und instrumenten-einfuehrbestecke
EP0379786A3 (fr) * 1989-01-23 1991-07-17 Interventional Technologies Inc Dispositif coupant pour l'arthérectomie muni d'un fil excentrique
US6139557A (en) * 1997-11-07 2000-10-31 Prolifix Medical, Inc. Apparatus for making wire with radial expansible guide section and methods of manufacturing the same
US6371928B1 (en) 1997-11-07 2002-04-16 Prolifix Medical, Inc. Guidewire for positioning a catheter against a lumen wall
US6406442B1 (en) 1996-11-07 2002-06-18 Prolifix Medical, Inc. Guidewire for precision catheter positioning
DE102004015639A1 (de) * 2004-03-31 2005-10-27 Siemens Ag Vorrichtung zum Durchführen einer "Cutting-Balloon"-Intervention mit IVUS-Überwachung
DE102004015640A1 (de) * 2004-03-31 2005-10-27 Siemens Ag Vorrichtung zum Durchführen einer "Cutting-Balloon"-Intervention mit OCT-Überwachung
US8529450B2 (en) 2006-01-20 2013-09-10 Siemens Aktiengesellschaft Device for performing a cutting-balloon intervention
WO2019157604A1 (fr) * 2018-02-19 2019-08-22 Vesalius Cardiovascular Inc. Appareils destinés à être utilisés pour remplacer des valvules mitrales et leurs procédés d'utilisation
CN111166431A (zh) * 2019-12-27 2020-05-19 昆山金泰医疗科技有限公司 一种具有封堵功能的血栓快速切割回收装置
US11083484B2 (en) 2016-07-03 2021-08-10 Sinusafe Medical Ltd. Medical device for treatment of a sinus and/or an ear and methods of use thereof
US11213308B2 (en) 2015-01-08 2022-01-04 Sinusafe Medical Ltd Paranasal sinus medical device and uses thereof

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB678098A (en) * 1949-10-18 1952-08-27 Savory And Moore Ltd Improvements in instruments for use in veterinary sphincterotomy and analogous purposes
US2730101A (en) * 1954-02-23 1956-01-10 Roy D Hoffman Teat bistoury with expansible cutter knives
US3336927A (en) * 1964-04-06 1967-08-22 Sklar Mfg Co J Surgical instrument for bile duct explorations
US3435826A (en) * 1964-05-27 1969-04-01 Edwards Lab Inc Embolectomy catheter
US3506010A (en) * 1968-01-29 1970-04-14 Berkeley Tonometer Co Uterine evacuator
DE2804015A1 (de) * 1978-01-31 1979-08-02 Erich Wintermantel Vorrichtung zur lumenerweiterung von gefaessen, insbesondere blutgefaessen im menschlichen kopfbereich

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB678098A (en) * 1949-10-18 1952-08-27 Savory And Moore Ltd Improvements in instruments for use in veterinary sphincterotomy and analogous purposes
US2730101A (en) * 1954-02-23 1956-01-10 Roy D Hoffman Teat bistoury with expansible cutter knives
US3336927A (en) * 1964-04-06 1967-08-22 Sklar Mfg Co J Surgical instrument for bile duct explorations
US3435826A (en) * 1964-05-27 1969-04-01 Edwards Lab Inc Embolectomy catheter
US3506010A (en) * 1968-01-29 1970-04-14 Berkeley Tonometer Co Uterine evacuator
DE2804015A1 (de) * 1978-01-31 1979-08-02 Erich Wintermantel Vorrichtung zur lumenerweiterung von gefaessen, insbesondere blutgefaessen im menschlichen kopfbereich

Cited By (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0254414A1 (fr) * 1986-06-16 1988-01-27 Samuel Shiber Cathéter rotatoire pour enlever une obstruction d'un vaissee sanguin
DE3737121A1 (de) * 1987-11-02 1989-05-11 Alexander Staeblein Steuerbares abdichtsystem fuer katheter- und instrumenten-einfuehrbestecke
EP0379786A3 (fr) * 1989-01-23 1991-07-17 Interventional Technologies Inc Dispositif coupant pour l'arthérectomie muni d'un fil excentrique
US6406442B1 (en) 1996-11-07 2002-06-18 Prolifix Medical, Inc. Guidewire for precision catheter positioning
US6139557A (en) * 1997-11-07 2000-10-31 Prolifix Medical, Inc. Apparatus for making wire with radial expansible guide section and methods of manufacturing the same
US6371928B1 (en) 1997-11-07 2002-04-16 Prolifix Medical, Inc. Guidewire for positioning a catheter against a lumen wall
DE102004015640B4 (de) * 2004-03-31 2007-05-03 Siemens Ag Vorrichtung zum Durchführen einer "Cutting-Balloon"-Intervention mit OCT-Überwachung
DE102004015640A1 (de) * 2004-03-31 2005-10-27 Siemens Ag Vorrichtung zum Durchführen einer "Cutting-Balloon"-Intervention mit OCT-Überwachung
DE102004015639A1 (de) * 2004-03-31 2005-10-27 Siemens Ag Vorrichtung zum Durchführen einer "Cutting-Balloon"-Intervention mit IVUS-Überwachung
DE102004015639B4 (de) * 2004-03-31 2007-05-03 Siemens Ag Vorrichtung zum Durchführen einer "Cutting-Balloon"-Intervention mit IVUS-Überwachung
US7637885B2 (en) 2004-03-31 2009-12-29 Siemens Aktiengesellschaft Catheter device for applying a medical cutting balloon intervention
US8109951B2 (en) 2004-03-31 2012-02-07 Siemens Aktiengesellschaft Device for implementing a cutting balloon intervention with IVUS monitoring
US8529450B2 (en) 2006-01-20 2013-09-10 Siemens Aktiengesellschaft Device for performing a cutting-balloon intervention
US11213308B2 (en) 2015-01-08 2022-01-04 Sinusafe Medical Ltd Paranasal sinus medical device and uses thereof
US11925371B2 (en) 2015-01-08 2024-03-12 Sinusafe Medical Ltd Paranasal sinus medical device and uses thereof
US11083484B2 (en) 2016-07-03 2021-08-10 Sinusafe Medical Ltd. Medical device for treatment of a sinus and/or an ear and methods of use thereof
WO2019157604A1 (fr) * 2018-02-19 2019-08-22 Vesalius Cardiovascular Inc. Appareils destinés à être utilisés pour remplacer des valvules mitrales et leurs procédés d'utilisation
US12268597B2 (en) 2018-02-19 2025-04-08 Vesalius Cardiovascular Inc. Apparatus for use in replacing mitral valves and methods of use thereof
CN111166431A (zh) * 2019-12-27 2020-05-19 昆山金泰医疗科技有限公司 一种具有封堵功能的血栓快速切割回收装置

Also Published As

Publication number Publication date
AU7379281A (en) 1983-01-04

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