EP1204384A1 - Procedes et appareils de revascularisation coronarienne directe - Google Patents

Procedes et appareils de revascularisation coronarienne directe

Info

Publication number
EP1204384A1
EP1204384A1 EP00952369A EP00952369A EP1204384A1 EP 1204384 A1 EP1204384 A1 EP 1204384A1 EP 00952369 A EP00952369 A EP 00952369A EP 00952369 A EP00952369 A EP 00952369A EP 1204384 A1 EP1204384 A1 EP 1204384A1
Authority
EP
European Patent Office
Prior art keywords
conduit
wall
heart
coronary artery
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.)
Withdrawn
Application number
EP00952369A
Other languages
German (de)
English (en)
Inventor
Marvin Guiles
Gerald Mlesky
Margaret Mccabe
Mark Bowen
Stephen Evans
Fernando Alvarez De Toledo
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.)
Percardia Inc
Original Assignee
Percardia 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 Percardia Inc filed Critical Percardia Inc
Publication of EP1204384A1 publication Critical patent/EP1204384A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2493Transmyocardial revascularisation [TMR] devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/94Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958Inflatable balloons for placing stents or stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/821Ostial stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0067Three-dimensional shapes conical
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0073Quadric-shaped
    • A61F2230/0078Quadric-shaped hyperboloidal

Definitions

  • the present invention relates to an apparatus for bypassing a blocked or stenosed blood vessel segment, and more particularly, to an apparatus and method for delivering a conduit or stent between the coronary artery and the left ventricle of the heart.
  • Coronary artery disease is a major problem in the U.S. and throughout the world. Coronary arteries as well as other blood vessels frequently become clogged with plaque which, at the very least, can reduce blood and oxygen flow to the heart muscle (myocardium), and may impair the efficiency of the heart's pumping action, and can lead to heart attack (myocardial infarction) and death. In some cases, these coronary arteries can be unblocked through non-invasive techniques such as balloon angioplasty. In more difficult cases, a surgical bypass of the blocked vessel is necessary.
  • one or more venous segments are inserted between the aorta and the coronary artery, or, alternatively, the distal end of an internal mammary artery is anastomosed to the coronary artery at a site distal to the stenosis or occlusion.
  • the inserted venous segments or transplants act as a bypass of the blocked portion of the coronary artery and thus provide for a free or unobstructed flow of blood to the heart. More than 500,000 bypass procedures are performed in the U.S. every year.
  • CABG coronary artery bypass graft
  • PTCA percutaneous transluminal coronary angioplasty
  • vascular treatments are not always indicated due to the type or location of the blockage or stenosis, or due to the risk of emboli.
  • the methods and apparatus described and illustrated herein generally relate to direct coronary revascularization, wherein a conduit or opening is provided from the left ventricle to the coronary artery, oftentimes the left anterior descending (LAD), to provide blood flow directly therethrough.
  • LAD left anterior descending
  • the methods and apparatus described herein accomplish one or more of the following goals, namely: (1 ) to accurately engage and align a conduit with the coronary artery; (2) to deliver a conduit into position in the heart wall; (3) to increase net forward flow through an opening or conduit from the left ventricle to the coronary artery; (4) to increase long term patency of a conduit between the left ventricle and coronary artery; (5) to accommodate wall thickness changes of the heart: and (6) to prevent migration of the conduit.
  • FIGURE 1 is a schematic, cross-sectional view of a human heart, showing a conduit in the myocardium of the heart for forming a bypass shunt between the left ventricle and a coronary artery.
  • FIGURE 2 is a schematic view of a hinged conduit.
  • FIGURE 3 is a schematic view of another embodiment of a hinged conduit.
  • FIGURE 4A is a schematic side view of a bell shape stent having a web flange and an axially expandable region.
  • FIGURE 4B is a schematic side view of the distal end of the stent of FIGURE 4A showing more particularly the web flange in the coronary artery.
  • FIGURE 4C is a schematic side view of the stent and web flange of FIGURE 4A, showing a stylet holding the web flange closed.
  • FIGURE 5A is a schematic side view of an expandable device using a stylet down the center, and an outer catheter sleeve to keep the device compressed.
  • FIGURE 5B is a schematic side view of the device of FIGURE 5A, showing the device deployed.
  • FIGURE 6 is a schematic side view of a flange of a delivery tool to locate the, inner wall of the coronary artery.
  • FIGURE 7 is a schematic side view of a conduit having an expandable flange and external sleeve for delivering the device.
  • FIGURE 8 is a schematic side view of a device having an expansion chamber within the myocardium.
  • FIGURE 9 is a schematic side view of a device having an autologous valve made from an arterial flap.
  • FIGURE 10 is a schematic side view of a bypass opening between the left ventricle and the coronary artery, with the coronary artery cut and its proximal end inserted into the distal end over the bypass opening.
  • FIGURE 11 is a schematic side view of a bypass opening between the left ventricle and the coronary artery, with the coronary artery cut away from the heart and doubled back inside itself to create a valve with interior wall exposure only.
  • FIGURE 12 is a schematic side view of a bypass opening between the left ventricle and the coronary artery, showing a compliant restriction downstream in the artery.
  • FIGURE 13 is a schematic side view of a bypass opening between the left ventricle and the coronary artery, showing a device within the opening having a toroidal balloon therein.
  • FIGURES 14A-14B are schematic side views of a device having a fluidic valve between the left ventricle and the coronary artery.
  • FIGURE 15 is a schematic view of an active valve connected to the heart pacing function in the right atrium.
  • FIGURE 16 is a schematic side view of a bypass opening between the left ventricle and the coronary artery, showing a section of artery removed and inserted into the bypass opening.
  • FIGURES 16A-16B are schematic side view of the bypass opening of FIGURE 16, showing insertion of a spring embedded in the myocardium.
  • FIGURE 17 is a schematic side view of a device having a flattened diameter at the coronary artery end.
  • FIGURES 18-19 are schematic side views of a device having an inside surface made of a porous material through which heparin, or other non-clotting drug, can be infused.
  • FIGURE 20 is a schematic side view of a compliant tubing reinforced with rings or a spring.
  • FIGURE 21 is a schematic side view of a flexible conduit between the coronary artery and the left ventricle.
  • FIGURE 22 is a schematic side view a conduit having annular grooves. Detailed Description of the Preferred Embodiment
  • the coronary artery branches off the aorta and is positioned along the external surface of the heart wall. Oxygenated blood that has returned from the lungs to the heart then flows from the heart to the aorta. Some blood in the aorta flows into the coronary arteries, and the remainder of blood in the aorta flows on to the rest of the body.
  • the coronary arteries are the primary blood supply to the heart muscle and are thus critical to life. In some individuals, atherosclerotic plaque, aggregated platelets, and/or thrombi build up within the coronary artery, blocking the free flow of blood and causing complications ranging from mild angina to heart attack and death. The presence of coronary vasospasm. also known as “variant angina” or "Prinzmetal's angina,” compounds this problem in many patients.
  • the principles of the present invention are not limited to left ventricular conduits, and include conduits for communicating bodily fluids from any space within a patient to another space within a patient, including any mammal.
  • fluid communication through the conduits is not limited to any particular direction of flow and can be antegrade or retrograde with respect to the normal flow of fluid.
  • the conduits may communicate between a bodily space and a vessel or from one vessel to another vessel (such as an artery to a vein or vice versa).
  • the conduits can reside in a single bodily space so as to communicate fluids from one portion of the space to another.
  • the conduits can be used to achieve a bypass within a single vessel, such as communicating blood from a proximal portion of an occluded coronary artery to a more distal portion of that same coronary artery.
  • the conduits and related methods can preferably traverse various intermediate destinations and are not limited to any particular flow sequence.
  • the conduit communicates from the left ventricle, through the myocardium, into the pericardial space, and then into the coronary artery.
  • other preferred embodiments are disclosed, including direct transmyocardial communication from a left ventricle, through the myocardium and into the coronary arter ⁇ '.
  • transmyocardial should not be narrowly constmed in connection with the preferred fluid communication conduits, and other non-myocardial and even noncardiac fluid communication are preferred as well.
  • the preferred conduits and related methods are capable of fluid communication through all such walls including, without limitation, the pericardium, epicardium, myocardium, endocardium, septum, etc.
  • bypass which is achieved with certain preferred embodiments and related methods is not limited to a complete bypass of bodily fluid flow, but can also include a partial bypass which advantageously supplements the normal bodily blood flow.
  • occlusions which are bypassed may be of a partial or complete nature, and therefore the terminology "bypass" or "occlusion” should not be constmed to be limited to a complete bypass or a complete occlusion but can include partial bypass and partial occlusion as described.
  • conduits and related methods disclosed herein can also provide complete passages or partial passages through bodily tissues.
  • the conduits can comprise stents. shunts, or the like, and therefore provide a passageway or opening for bodily fluid such as blood.
  • the conduits are not necessarily stented or lined with a device but can comprise mere tunnels or openings formed in the tissues of the patient.
  • the conduits of the present invention preferably comprise both integral or one-piece conduits as well as plural sections joined together to form a continuous conduit.
  • the present conduits can be deployed in a variety of methods consistent with sound medical practice including vascular or surgical deliveries, including minimally invasive techniques.
  • various preferred embodiments of delivery rods and associated methods may be used.
  • the delivery rod is solid and trocarlike. It may be rigid or semi-rigid and capable of penetrating the tissues of the patient and thereby form the conduit, in whole or in part, for purposes of fluid communication.
  • the delivery rods may be hollow so as to form the conduits themselves (e.g., the conduits are preferably self-implanting or self-inserting) or have a conduit mounted thereon (e.g., the delivery rod is preferably withdrawn leaving the conduit installed).
  • the preferred conduit device and method for installation is preferably determined by appropriate patient indications in accordance with sound medical practices.
  • a coronary artery bypass is accomplished by disposing a left ventricular conduit 10 in a heart wall or myocardium MYO of a patient's heart PH.
  • the conduit 10 preferably extends from the left ventricle LV of heart PH to a clogged coronary artery CA at a point downstream of a blockage BL.
  • Conduit 10 is preferably made of a biocompatible material such as stainless steel or nitinol, although other materials such as Ti, Ti alloys, Ni alloys, Co alloys and biocompatible polymers may also be used. Conduit 10 may also be coated. Engagement and Alignment with Artery
  • the embodiments described below relate to methods and apparatus for engaging and aligning a conduit between the left ventricle and coronary artery in a patient's heart.
  • FIGURE 2 illustrates a conduit 20 for connecting the left ventricle LV to the coronary artery CA.
  • the conduit 20 comprises a solid tube that has a cut section 22 that can be bent over to align with the artery CA.
  • FIGURE 3 illustrates a conduit 24 similar to the conduit of FIGURE 2, which is more preferably a nitinol stent having a short hinged section 26 to align with the coronary artery.
  • a conduit provided between the left ventricle and coronary artery further includes a flange, either rigid or flexible, that seats against the interior wall of the artery.
  • FIGURES 4A and 4B illustrate a conduit 28 between the left ventricle and coronary artery which is preferably a nitinol stent.
  • the proximal end 30 of the stent opening into the left ventricle preferably is heat set to have a bell shape to hold to the interior heart wall and to introduce flow.
  • the distal end 32 preferably has small heat set fingers 34 which extend outward to anchor the stent against the interior wall of the coronary artery.
  • a web flange 36 on the distal end 32 preferably comprises two or more rings which, when placed in the heart, open in the coronary artery to position the conduit while allowing blood flow. These rings are preferably shaped to extend outward in a curved configuration as shown in FIGURE 4A when deployed. Between the proximal and distal ends is an axially expandable region 38, provided by slots 40 cut in the region.
  • FIGURE 4C illustrates a stylet 42 used for inserting a conduit 28 having the web flange shown in FIGURES 4A and 4B. More particularly, the stylet is inserted through the rings of the web flange to bring the rings together or closed for insertion. Removal of the stylet after the conduit is placed in the heart allows the rings to expand outward to the shape shown in FIGURES 4A and 4B. Delivery of Device
  • the embodiments described below relate to methods and apparatus for delivering a device between the left ventricle and the coronary artery.
  • a coring knife is used to remove a plug or piece of the myocardium prior to insertion of a device or conduit therein.
  • FIGURES 5A-5B illustrate a conduit 44, which is preferably a nitinol device, using a stylet 46 down the center of the device.
  • a conduit such as shown in FIGURE 4A
  • an outer catheter sleeve 48 is used to keep the device compressed for insertion.
  • a flange 50, or other protruding feature such as a step, on the stylet pushes the devices into the heart wall, and a flange 52 on the sleeve controls the depth of insertion.
  • FIGURE 5B illustrates the conduit 44 after it is inserted by removing the stylet and sleeve.
  • a threaded device is provided for insertion into the myocardium as it is turned.
  • the threaded device can be either the conduit itself between the left ventricle and coronary artery, or an insertion tool which holds the myocardium open for insertion of a nonthreaded conduit therethrough.
  • a guidewire, catheter, conduit or other device is inserted from the left ventricle to the coronary artery.
  • a radiopaque marker is placed on the end of the device to be inserted into the coronary artery.
  • a second radiopaque marker is placed on the coronary artery, preferably on the outside of the heart over the coronary artery. In one embodiment, this second marker is preferably tubular in shape.
  • the catheter, guidewire or other device can be brought through the myocardium into an appropriate position inside or through the coronary artery by aligning the first marker with the second marker.
  • a delivery tool for inserting a conduit between the left ventricle and the coronary artery is provided.
  • the tool 60 is preferably hollow to allow insertion of a conduit 62 therethrough.
  • a flange 64 is provided on the tool 60 which is used to locate the inner wall of the artery when the tool is inserted. After the tool is inserted into the heart, the conduit can be inserted through the delivery tool into the myocardium. The flange on the delivery tool makes it easier to deliver the conduit to an appropriate location when there are differences in the exterior arterial wall thickness.
  • a conduit 66 is provided between the left ventricle and the coronary artery.
  • an expandable flange or cage 68 is provided, used to locate the artery. More particularly, the conduit 66 is delivered using an external sleeve 70 which is placed through the outer wall of the artery and held stationary. The conduit 66 is inserted through the sleeve, with the end opposite the end having the cage inserted first. The cage is collapsible within the sleeve. The conduit exits the sleeve into the coronary artery and through the myocardium. Upon the release of the cage 68 from the sleeve, the cage expands to its expanded configuration to position itself in the artery and to maintain patency.
  • a conduit having a flange or a bell shape is held in a compressed configuration for delivery using sutures to hold the flange or bell shape in a small diameter until deployment. This prevents the need for an external sleeve through the myocardium. After the ' conduit is positioned, the sutures can be pulled off to deploy the device. Increase Net Forward Flow
  • the embodiments described below relate to methods and apparatuses for increasing net forward flow in a conduit from the left ventricle to the coronary artery.
  • FIGURE 8 illustrates a device 102 to be placed in the myocardium between the left ventricle and coronary artery having an expansion chamber 104 within the myocardium.
  • the chamber is designed to expand during systole, then flow during systole.
  • One way valves 106, 108 are preferably provided at each end of the device to control flow.
  • FIGURE 9 illustrates the use of an arterial flap to form an autologous valve.
  • An opening or conduit 112 is provided through the myocardium from the left ventricle to the coronary artery, downstream of blockage BL.
  • a flap of arterial wall 1 10 is placed over the opening in the conduit facing the coronary artery to form the valve.
  • FIGURE 10 illustrates another embodiment using a cut portion of artery to form a valve over a bypass opening 112 between the left ventricle and coronary artery.
  • the artery is cut at 114, and the portion 116 of the artery proximal to the cut is inserted into the portion 118 of the artery distal to the cut, over the bypass opening.
  • FIGURE 11 illustrates another embodiment when the artery is cut to form an autologous valve over a bypass opening, but wherein the portion of the artery forming the valve includes the inner wall of the artery. As shown, the artery is cut away from the heart, and doubled back inside to create a valve 1 10 over the bypass opening with interior wall exposure only.
  • a conduit between the left ventricle and coronary artery has a conical or funnel shape, with one end larger than the other. This forms a passive valve.
  • a compliant restriction 120 is placed in the coronary artery downstream of a bypass opening 112 between the left ventricle and coronary artery.
  • the site of the compliant restriction depends on the pressure of blood flow through the coronary artery CA. When flow pressure is low, for instance during diastole, the restriction blocks more flow to prevent backflow into the opening 1 12. During high pressure flow, i.e., systole, the restriction does not impede flow and blood from the opening flows downstream past the compliant restriction.
  • a bypass opening or conduit 112 between the left ventricle and coronary artery is provided with a compressible material, more preferably a toroidal balloon 122.
  • the balloon acts as a type of valve which increases the flow under systolic pressure. Under the high pressure flow of systole, the balloon compresses as shown in FIGURE 13B to increase blood flow. During low pressure diastolic flow, the balloon is decompressed to fill the opening and prevent blood flow. The balloon need not be the full length of the device. When the balloon is part of a conduit, the balloon preferably lines the inside of the conduit.
  • a fluidic valve 124 is provided within a conduit 126 between the left ventricle and coronary artery.
  • the conduit 126 is divided, preferably into three regions. Reducing the effective inner diameter of the regions of the conduit decreases the low pressure (diastole) flow through each region due to the increased resistance.
  • a valve 128 for controlling blood flow through an opening or conduit 112 from the left ventricle to the coronary artery is provided.
  • the valve is preferably an active valve connected to the heart pacing function of the right atrium.
  • a ball valve is provided to control flow through an opening or conduit from the left ventricle to the coronary artery.
  • the embodiments described below relate to methods and apparatus for increasing long term patency of a conduit placed between the left ventricle and coronary artery.
  • the conduit is an absorbable scaffold or stent seeded with the patient's epithelial cells.
  • a section of artery 130 proximal to a bypass opening or conduit 112 and distal to a blockage BL in the coronary artery is removed and inserted into the bypass opening.
  • the section of artery 130 can either be lined with a bioabsorbable scaffold 132, or a permanent scaffold or stent can be placed on the outside of the section prior to inserting the section into the bypass hole or opening.
  • RF energy is used to kill growth on the conduit and to keep the conduit open.
  • a conduit can be made open by burning a bypass hole with laser, electrosurgery or other ablation device, or by removing a core with a coring device. This hole can then be supported, as shown in FIGURE 16A, with a spring 160' embedded in the myocardium, which prevents the hole from closing during systolic contraction.
  • a conduit 134 is provided between the coronary artery and left ventricle having a proximal opening 132 to the left ventricle that is preferably round and a distal opening 138 to the coronary artery that is preferably a flattened bell.
  • This flattened bell is formed by taking a larger diameter tube and flattening the distal end into a long oval.
  • a conduit 140 is provided between left ventricle and coronary artery having an inner surface 142 made of a porous material, preferably either metal or ceramic or a porous membrane.
  • the wall of the conduit can be infused with heparin from a heparin reservoir 144 attached to a port 146 that may be located outside of the patient. This heparin is released through the porous surface 142 at a set rate.
  • FIGURE 19 illustrates another embodiment wherein a heparin reservoir 144 is provided within the conduit 140 itself surrounded by outer case 148. This reservoir 144 can also be infused with additional heparin from outside the body. Heparin is released through porous core 142.
  • An ingrowth coating 150 is also provided on the outside of the conduit 140 to promote scar tissue growth to form a biornechanical bond to the surrounding myocardium, thereby preverlting movement of the conduit.
  • the coating may be a ceramic material to which the body has a tendency to bond.
  • a similar porous layer for promoting ingrowth is shown in FIGURE 18 as outer layer 152.
  • FIGURE 19 also illustrates flange 154 for securing the conduit 140 to the coronary artery. Accommodate Wall Thickness Changes
  • the embodiments described below relate to methods and apparatus for accommodating the wall thickness changes of the heart, for example, during systole and diastole.
  • a conduit 156 between the left ventricle and coronary artery is provided as a compliant, axially flexible tubing 158.
  • Reinforcing rings 160 or a spring may be used to keep the tubing open. This is similar to a flexible duct, and allows the conduit to accommodate wall thickness changes while the rings keep the conduit open.
  • conduit or stent is preferably cut to create axial expansion.
  • a flexible conduit 162 is provided between the left ventricle and coronary artery.
  • the flexibility of the conduit accommodates the changes in wall thickness of the heart.
  • the conduit is preferably sized to be larger toward the coronary artery CA than the left ventricle LV.
  • the conduit between the left ventricle and coronary artery is preferably a woven sleeve, like a Chinese finger trap.
  • the embodiments described below relate to methods and apparatus for preventing migration of the conduit when placed between the left ventricle and coronary artery.
  • the conduit is a mesh or stent type device.
  • annular or isolated barbs are provided on the conduit.
  • rigid or flexible flanges are provided on the conduit.
  • sutures are used to hold the conduit in place.
  • a porous outer layer is provided on the conduit to promote ingrowth with the surrounding heart muscle.
  • the conduit is provided with an hourglass, curved or fluted shape to prevent migration.
  • FIGURE 22 illustrates an embodiment where the conduit is provided with annular grooves. Grooves may also be provided longitudinally along the conduit. In another embodiment, not shown, glue may be used to prevent migration of the conduit.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Prostheses (AREA)

Abstract

On décrit des procédés et un appareil relatifs à un conduit placé dans la paroi cardiaque entre le ventricule gauche et l'artère coronaire. De manière plus spécifique, les procédés et l'appareil visent un ou plusieurs des objectifs suivants, à savoir, (1) placer et aligner avec précision un conduit sur une artère coronaire; (2) positionner un conduit à sa place dans la paroi cardiaque; (3) augmenter le flux avant net par une ouverture ou un conduit situé entre le ventricule gauche et l'artère coronaire; (4) augmenter la perméabilité à long terme d'un conduit situé entre le ventricule gauche et l'artère coronaire; (5) composer avec les modifications de l'épaisseur de la paroi du coeur; et (6) empêcher le déplacement du conduit.
EP00952369A 1999-08-04 2000-08-02 Procedes et appareils de revascularisation coronarienne directe Withdrawn EP1204384A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US14720299P 1999-08-04 1999-08-04
US147202P 1999-08-04
PCT/US2000/020973 WO2001010348A1 (fr) 1999-08-04 2000-08-02 Procedes et appareils de revascularisation coronarienne directe

Publications (1)

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EP1204384A1 true EP1204384A1 (fr) 2002-05-15

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EP00952369A Withdrawn EP1204384A1 (fr) 1999-08-04 2000-08-02 Procedes et appareils de revascularisation coronarienne directe

Country Status (5)

Country Link
EP (1) EP1204384A1 (fr)
JP (1) JP2003510143A (fr)
AU (2) AU777443B2 (fr)
CA (1) CA2381192A1 (fr)
WO (1) WO2001010348A1 (fr)

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AU2001296796A1 (en) * 2000-10-11 2002-04-22 Heartstent Corporation Transmyocardial implant with anchor element
US6620122B2 (en) * 2001-04-26 2003-09-16 Scimed Life Systems, Inc. Gastric pseudocyst drainage and stent delivery system for use therein
WO2003020338A2 (fr) * 2001-09-04 2003-03-13 Broncus Technologies, Inc. Conduits a structure de cage distale pour le maintien de canaux collateraux dans des tissus et procedes associes
AU2003901345A0 (en) * 2003-03-21 2003-04-03 Ventracor Limited Improved cannula
IES20030531A2 (en) 2003-07-17 2005-09-21 Medtronic Vascular Connaught Methods and devices for placing a fistula device in fluid communication with a target vessel
IES20030539A2 (en) 2003-07-22 2005-05-18 Medtronic Vascular Connaught Stents and stent delivery system
WO2006044890A2 (fr) * 2004-10-13 2006-04-27 Medtronic, Inc. Squelettes autofixants
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
CN103002833B (zh) 2010-05-25 2016-05-11 耶拿阀门科技公司 人工心脏瓣及包括人工心脏瓣和支架的经导管输送的内假体
WO2015028209A1 (fr) 2013-08-30 2015-03-05 Jenavalve Technology Gmbh Cadre radialement repliable pour valvule prothétique et procédé de fabrication dudit cadre
WO2016130991A1 (fr) * 2015-02-13 2016-08-18 Millipede, Inc. Remplacement de valvule à l'aide d'ancrages rotatifs
EP3632378B1 (fr) 2015-05-01 2024-05-29 JenaValve Technology, Inc. Dispositif à faible débit de stimulateur cardiaque dans le remplacement de valvule cardiaque
EP4183371A1 (fr) 2016-05-13 2023-05-24 JenaValve Technology, Inc. Système de pose de prothèse de valvule cardiaque et procédé de pose de prothèse de valvule cardiaque avec gaine d'introduction et système de chargement
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Also Published As

Publication number Publication date
CA2381192A1 (fr) 2001-02-15
WO2001010348A1 (fr) 2001-02-15
AU2004242527A1 (en) 2005-01-27
AU777443B2 (en) 2004-10-14
WO2001010348A9 (fr) 2001-08-16
JP2003510143A (ja) 2003-03-18
AU6508300A (en) 2001-03-05

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