WO2003030744A1 - Appareil et methode de pontage coronarien - Google Patents

Appareil et methode de pontage coronarien Download PDF

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Publication number
WO2003030744A1
WO2003030744A1 PCT/GB2001/004484 GB0104484W WO03030744A1 WO 2003030744 A1 WO2003030744 A1 WO 2003030744A1 GB 0104484 W GB0104484 W GB 0104484W WO 03030744 A1 WO03030744 A1 WO 03030744A1
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WO
WIPO (PCT)
Prior art keywords
tube
catheter
imaging
vein
patient
Prior art date
Application number
PCT/GB2001/004484
Other languages
English (en)
Inventor
Robert Dickinson
Joackim Eriksson
Martin Terry Rothman
Original Assignee
Jomed Nv
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 Jomed Nv filed Critical Jomed Nv
Priority to PCT/GB2001/004484 priority Critical patent/WO2003030744A1/fr
Publication of WO2003030744A1 publication Critical patent/WO2003030744A1/fr

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
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1107—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1139—Side-to-side connections, e.g. shunt or X-connections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound
    • A61B2090/3782—Surgical systems with images on a monitor during operation using ultrasound transmitter or receiver in catheter or minimal invasive instrument
    • A61B2090/3784—Surgical systems with images on a monitor during operation using ultrasound transmitter or receiver in catheter or minimal invasive instrument both receiver and transmitter being in the instrument or receiver being also transmitter
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents

Definitions

  • the present invention relates to a coronary bypass apparatus and method.
  • Coronary artery disease is a significant medical problem in the developed world and treatments include pharmaceutical therapies, surgical intervention and percutaneous angioplasty.
  • Surgical intervention uses a vessel harvested from the patient themselves and grafted onto the blocked coronary artery to bypass the obstruction. This is termed Coronary Artery Bypass Grafting (CABG). Usually this is a significant operation which involves opening up the chest cavity.
  • CABG Coronary Artery Bypass Grafting
  • Percutaneous techniques use coronary catheters to open up the obstruction and require the catheter to cross through the obstruction. Such techniques are significantly less traumatic from the patient's point of view.
  • the present invention is concerned with minimally invasive methods of performing CABG, which methods do not require such a major surgical operation as that discussed above.
  • One known technique takes advantage of the fact that many coronary arteries have a vein running parallel to the artery.
  • An example is The Left Anterior Descending Coronary artery which has the Great Cardiac Vein in its vicinity.
  • This known technique diverts arterial blood into the vein by creating a conduit between the two in order to bypass the arterial blockage. Blood passing through the conduit either returns into the artery beyond the blockage or through the vein perfuses the muscle with oxygenated blood. The return of the blood, the so-called venous return, is then via other routes.
  • the advantage of this technique is that it can be performed percutaneously using catheters. Examples of this known technique are disclosed in United States
  • This prior art technique requires a separate ultrasound imaging catheter to enable the puncture to be made in the correct direction, namely towards the neighbouring vessel.
  • the vein which is proximal to the conduit is blocked with a suitable plug in order to divert the high-pressure arterial blood into the distal region.
  • the present invention is concerned with providing an improved apparatus and method for bypassing a coronary blockage utilising the patient's adjacent vein as a bypass to that blockage.
  • apparatus of the kind previously described for effecting an artery bypass utilising an adjacent vein is combined with imaging transducer in order to enable a clinician to accurately position the means for creating a conduit between the artery and the adjacent vein.
  • the apparatus preferably comprises a catheter with an imaging transducer.
  • the imaging transducer may comprise, for example, an intravascular ultrasonic (IVUS) imaging transducer, a phased array IVUS transducer, a rotational or mechanical IVUS transducer, an Optical Coherence Tomography (OCT) transducer, or a Magnetic Resonance
  • IVUS intravascular ultrasonic
  • OCT Optical Coherence Tomography
  • Imaging (MRI) transducer
  • imaging means comprises an imaging catheter
  • imaging catheter the above referred to combination could take a number of forms.
  • the first catheter carrying the ultrasonic transducer array at or near its distal end would be used to make the incision in the wall of the artery and then the incision in the wall of the adjacent vein and the second catheter would then be used subsequently to create the conduit between the artery and the adjacent vein.
  • the first catheter would incorporate a stillette (a wire with a pointed distal end) in order to pierce the wall of the artery and then the wall of the adjacent vein.
  • a stillette a wire with a pointed distal end
  • the second catheter would incorporate means for enlarging the incision made in the walls of the artery and adjacent vein and would incorporate a stent which could then be delivered to the expanded apertures in the artery and the vein in order to create the conduit between the artery and the vein.
  • Figure 1 illustrates a coronary bypass procedure using an adjacent vein
  • Figure 2 is a perspective view showing the distal end of a first catheter incorporating an imaging transducer
  • Figure 3 is a partial cross-sectional view taken along the line A-A in Figure 2;
  • Figure 4 is a diagrammatic representation of the image of the catheter in use;
  • Figure 5 illustrates the use of the imaging catheter for making the incision in the artery and vein walls
  • Figure 6 is a view similar to Figure 4 and illustrating the endpoint of the second stage of the procedure employing the second type of catheter.
  • a patient has a blockage 100 within a coronary artery 101 alongside which runs an existing vein 102.
  • a first passage 103 is formed between the artery 101 and the vein 102 so that blood flowing in the artery 101 (as indicated by the arrows) can pass through the passage 103 and into the vein 102.
  • This blood may then either be allowed to continue its flow through the vein 102 to perfuse the heart muscle with oxygenated blood, the venous return being via other routes within the patient's body, or the blood flow may pass through a second passage 104 formed between the vein 102 and the artery 101 in order to then continue its flow through the vein 101 having bypassed the obstruction 100.
  • this apparatus and method involve the employment of two different and separate catheters that can be introduced into the patient's vascular system typically through an incision made in an artery in the patient's groin.
  • This provides a method which is minimally invasive when compared with the major surgery required in carrying out Coronary Artery Bypass Grafting (CABG).
  • CABG Coronary Artery Bypass Grafting
  • the first step in this minimally invasive method is to insert into the patient's vascular system, and in particular the artery 101, a standard guide wire 201 in the well-known way.
  • the distal end of the guide wire 201 is positioned upstream of the blockage 100 in the vicinity of the location where it is desired to form the first conduit 103.
  • the first catheter 202 is then slid down the guide wire 201 in known manner.
  • the first catheter 202 is an imaging catheter which has near its distal end 202a a imaging transducer 203. As this kind of intravascular ultrasonic catheter is already known it will not be described in any more detail.
  • this intravascular imaging catheter 202 Mounted on this intravascular imaging catheter 202 is a tube 204 which runs substantially the length of the catheter and through which a metal stillette 205 may be threaded.
  • the stillette is a metal wire with a pointed distal end.
  • one aspect of the present invention is the combination of the tube 204 mounted on the outside of an imaging catheter 202.
  • the distal end of the tube 204 is at an angle to the axis of the body of the ultrasound catheter 202 whereas the main part of the tube 204 runs parallel to that axis. This angle to the axis of the catheter 202 is indicated at ⁇ in Figure 2.
  • the purpose of the angling of the distal end 204a of the tube 204 with respect to the axis of the catheter 202 is to enable the distal end of the stillette 205 to traverse the path indicated in Figure 5.
  • a marker 401 can be put on the image illustrated in Figure 4 to indicate the intended route for the distal end of the stillette 205 in order to ensure that it pierces the arterial wall 101 and vein wall 102 at the correct locations.
  • the catheter 202 is rotated so that the opening 204b of the distal end of the tube 204 is pointing at the desired target area of the arterial wall 101 and the marker 401 aligns with both the artery 101 and the vein 102, the stillette 205 being aligned for the proper formation of the passage 103.
  • the stillette 205 which comprises a wire with a sharp tip 205a is then pushed down the tube 204 so that the tip 205a enters the arterial wall 101 and the marker 401 aligns with both the artery 101 and the vein 102, the stillette 205 being aligned for the proper formation of the passage 103. at the desired location of the first conduit 103.
  • the distal tip 205a of the stillette 205 is in the imaging plane of the ultrasound array 203 thus enabling the correct position of the tip 205a to be confirmed from an examination of the image, as indicated in Figure 4.
  • the first imaging catheter 202 can then be and is withdrawn from within the patient's artery by being pulled back along the guide wire 201 in the normal way.
  • the stillette wire 205 has to be rigid enough to puncture the artery wall 101b and the vein wall 102b but flexible enough to bend once the distal end 205a is within the lumen 102a of the vein 102, ie the pointed distal end 205a will not then continue and puncture the opposite wall of the vein 102.
  • One solution is to provide the stillette 205 with a rigid or semi-rigid tip 205a which could be about 3-4mm in length, there then being a flexible portion immediately adjacent the semi-rigid tip. With this arrangement the flexible portion would be constrained within the delivery tube 204a, thus preventing it from bending, with only the semirigid tip protruding from the tube 204.
  • the flexible portion adjacent the semi-rigid tip is now outside the distal end 204a of the delivery tube 204 the distal end of the stillette can bend within the lumen 102a of the vein 102 thus ensuring that there is no danger of the pointed end 205a of the stillette puncturing the far wall of the vein 102.
  • a second way of overcoming the problem referred to is to construct the stillette as a hypodermic tube as is well known to those skilled in the art.
  • a separate flexible guide wire is inserted through the inner lumen of the hypodermic tube, this guide wire being a standard guide wire and therefore flexible and not likely to penetrate the wall of the vein 102.
  • An advantage of using the second solution, namely the hypodermic tube is that contrast liquid can be injected down the hypodermic tube so that once the tube enters the vein lumen 102a the contrast liquid will be seen on the fluoroscopy display to indicate that access from the lumen 101a of the artery 101 into the lumen 102a of the vein 102 has been achieved.
  • the stillette 205 is left within the patient's artery 101 with its proximal end outside the patient and accessible by the clinician and its distal end located within the lumen of the patient's vein 102.
  • the stillette 205 can then be used in effect as a guide wire for introducing the distal end of a second catheter into the conduit 103 formed between the patient's artery 101 and the patient's vein 102.
  • the essence of the second catheter is that it carries an expandable stent at or near its distal end so that the stent 601 can be delivered to its operative position as shown in Figure 6.
  • the stillette is used as a guide wire over which the stent catheter is advanced.
  • the stent is delivered in a collapsed delivery configuration, and then expanded in place to an expanded deployed configuration, for example, with a balloon catheter, or through self-expansion.
  • the second catheter preferably comprises a balloon catheter when a balloon-expandable stent is used, and a self-expandable stent delivery system when a self-expanding stent is used.
  • the stent acts as a conduit between the patient's artery 101 and the patient's vein 102. Additionally, or alternatively the stent may act as a plug or barrier within the lumen 102a of the vein 102 to prevent the flow of blood from the area B to the area C, or vice versa, as indicated in Figure 6.
  • the stent 601 may have a number of known constructions, these all essentially consisting of an expandable lattice or coiled spring-like structure whereby the stent can either have a retracted configuration when it is mounted on the delivery catheter (not shown) or is then capable of being expanded radially outwardly to form what is essentially a latticework tube as indicated in Figure 6.
  • the stent is also provided with a flexible cover (not shown) which would be essentially in the form of a tube coupled to the stent so that the stent will provide an effective lining to the conduit between the lumen of the patient's artery 101 and the lumen of the patient's vein 102.
  • the delivery system for the stent could take a number of forms ie the catheter on which the stent is initially mounted could take a number of forms.
  • the catheter would be provided with a balloon around which the unextended stent is mounted when the second catheter is first inserted into the patient's artery 101.
  • the balloon is expanded in the normal way typically by introducing into it, from the proximal end of the catheter, a saline solution. Expansion of the balloon converts the stent from its retracted to its expanded position as shown in Figure 6.
  • the stent would be provided with a protective sheath to avoid its dislodgement as the distal end of the second catheter is pushed along the patient's artery 101 to bring the stent into the target area shown in Figure 6.
  • the stent is self-expandable and is mounted on a sheath-based stent delivery system in known manner, such as the JOSENT Self-X stent and delivery system marketed by JOMED NV of Amsterdam, The Netherlands.
  • the proximal end of the stent may protrude into the coronary artery 101 by, for example, 0.5 mm, and this protruding portion expanded so that the narrowest cross-section of the stent is located between the patient's artery 101 and the patient's vein 102.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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 un appareil destiné à réaliser un pontage sur une lumière corporelle de la manière la moins invasive possible. Cet appareil comprend un cathéter doté de zones proximale et distale, un transducteur d'imagerie couplé à la zone distale, ainsi qu'un élément de coupe conçu pour former une ouverture dans la lumière corporelle, ledit élément de coupe étant couplé à la zone distale. Le transducteur d'imagerie permet au chirurgien de positionner ledit élément de coupe.
PCT/GB2001/004484 2001-10-09 2001-10-09 Appareil et methode de pontage coronarien WO2003030744A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/GB2001/004484 WO2003030744A1 (fr) 2001-10-09 2001-10-09 Appareil et methode de pontage coronarien

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/GB2001/004484 WO2003030744A1 (fr) 2001-10-09 2001-10-09 Appareil et methode de pontage coronarien

Publications (1)

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WO2003030744A1 true WO2003030744A1 (fr) 2003-04-17

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015108984A1 (fr) * 2014-01-14 2015-07-23 Volcano Corporation Ensemble cathéter pour création de site d'accès vasculaire
US10238816B2 (en) 2014-01-14 2019-03-26 Volcano Corporation Devices and methods for forming vascular access
US10251606B2 (en) 2014-01-14 2019-04-09 Volcano Corporation Systems and methods for evaluating hemodialysis arteriovenous fistula maturation
US10874409B2 (en) 2014-01-14 2020-12-29 Philips Image Guided Therapy Corporation Methods and systems for clearing thrombus from a vascular access site
US11260160B2 (en) 2014-01-14 2022-03-01 Philips Image Guided Therapy Corporation Systems and methods for improving an AV access site
WO2024036258A3 (fr) * 2022-08-10 2024-05-16 Deerfield Catalyst, Llc Navigation de dérivation fémoro-poplitée percutanée

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998046119A1 (fr) * 1997-04-11 1998-10-22 Transvascular, Inc. Catheters et dispositifs associes permettant de former des passages entre des vaisseaux et autres structures anatomiques
WO1999035980A1 (fr) * 1998-01-15 1999-07-22 Lumend, Inc. Dispositif a catheter servant a effectuer un traitement guide d'occlusions arterielles par voie transvasculaire
WO1999049793A1 (fr) * 1998-03-31 1999-10-07 Transvascular, Inc. Catheters de creation de passages, systemes et procedes pour derivation arterio-veineuse in-situ percutanee
US6035856A (en) * 1997-03-06 2000-03-14 Scimed Life Systems Percutaneous bypass with branching vessel
US6190353B1 (en) * 1995-10-13 2001-02-20 Transvascular, Inc. Methods and apparatus for bypassing arterial obstructions and/or performing other transvascular procedures
US6293955B1 (en) * 1996-09-20 2001-09-25 Converge Medical, Inc. Percutaneous bypass graft and securing system
WO2001070133A2 (fr) * 2000-03-20 2001-09-27 Jan Otto Solem Procede et systeme servant a effectuer un pontage arteriel

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6190353B1 (en) * 1995-10-13 2001-02-20 Transvascular, Inc. Methods and apparatus for bypassing arterial obstructions and/or performing other transvascular procedures
US6293955B1 (en) * 1996-09-20 2001-09-25 Converge Medical, Inc. Percutaneous bypass graft and securing system
US6035856A (en) * 1997-03-06 2000-03-14 Scimed Life Systems Percutaneous bypass with branching vessel
WO1998046119A1 (fr) * 1997-04-11 1998-10-22 Transvascular, Inc. Catheters et dispositifs associes permettant de former des passages entre des vaisseaux et autres structures anatomiques
WO1999035980A1 (fr) * 1998-01-15 1999-07-22 Lumend, Inc. Dispositif a catheter servant a effectuer un traitement guide d'occlusions arterielles par voie transvasculaire
WO1999049793A1 (fr) * 1998-03-31 1999-10-07 Transvascular, Inc. Catheters de creation de passages, systemes et procedes pour derivation arterio-veineuse in-situ percutanee
WO2001070133A2 (fr) * 2000-03-20 2001-09-27 Jan Otto Solem Procede et systeme servant a effectuer un pontage arteriel

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015108984A1 (fr) * 2014-01-14 2015-07-23 Volcano Corporation Ensemble cathéter pour création de site d'accès vasculaire
US10238816B2 (en) 2014-01-14 2019-03-26 Volcano Corporation Devices and methods for forming vascular access
US10251606B2 (en) 2014-01-14 2019-04-09 Volcano Corporation Systems and methods for evaluating hemodialysis arteriovenous fistula maturation
US10874409B2 (en) 2014-01-14 2020-12-29 Philips Image Guided Therapy Corporation Methods and systems for clearing thrombus from a vascular access site
US11234649B2 (en) 2014-01-14 2022-02-01 Philips Image Guided Therapy Corporation Systems and methods for evaluating hemodialysis arteriovenous fistula maturation
US11260160B2 (en) 2014-01-14 2022-03-01 Philips Image Guided Therapy Corporation Systems and methods for improving an AV access site
US11426534B2 (en) 2014-01-14 2022-08-30 Koninklijke Philips N.V. Devices and methods for forming vascular access
WO2024036258A3 (fr) * 2022-08-10 2024-05-16 Deerfield Catalyst, Llc Navigation de dérivation fémoro-poplitée percutanée

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