EP1006916A4 - Procedes et dispositifs de revascularisation transmyocardique coronarienne directe - Google Patents

Procedes et dispositifs de revascularisation transmyocardique coronarienne directe

Info

Publication number
EP1006916A4
EP1006916A4 EP97940595A EP97940595A EP1006916A4 EP 1006916 A4 EP1006916 A4 EP 1006916A4 EP 97940595 A EP97940595 A EP 97940595A EP 97940595 A EP97940595 A EP 97940595A EP 1006916 A4 EP1006916 A4 EP 1006916A4
Authority
EP
European Patent Office
Prior art keywords
passageway
transmyocardial
coronary
blood
heart
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Withdrawn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
EP97940595A
Other languages
German (de)
English (en)
Other versions
EP1006916A1 (fr
Inventor
Joshua Makower
Timothy Machold
Christopher J Flaherty
Jason Brian Whitt
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.)
Transvascular Inc
Original Assignee
Transvascular 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 Transvascular Inc filed Critical Transvascular Inc
Publication of EP1006916A1 publication Critical patent/EP1006916A1/fr
Publication of EP1006916A4 publication Critical patent/EP1006916A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A61F2/94—Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart 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
    • A61F2/2412—Heart 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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart 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
    • A61F2/2493—Transmyocardial revascularisation [TMR] devices
    • 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
    • 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
    • A61B2017/00252—Making holes in the wall of the heart, e.g. laser Myocardial revascularization for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00392—Transmyocardial revascularisation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body

Definitions

  • the present invention pertains generally to medical treatment methods and devices, and more particularly to methods and devices for transluminal direct coronary revascularization .
  • Coronary artery disease continues to be one of the leading causes of morbidity and mortality, throughout the world.
  • the typical etiology of coronary artery disease is characterized by the build-up of atherosclerotic plaque within the coronary arteries. Such deposits of atherosclerotic plaque tend to fully or partially block the flow of blood through the affected coronary arteries, and if untreated can result in myocardial ischemica, infarction and death.
  • coronary artery bypass surgery For many years, the traditional surgical treatment of coronary artery disease has been coronary artery bypass surgery.
  • traditional coronary artery bypass surgery the patient is generally anesthetized and placed on cardiopul onary bypass. A thoracotomy is performed and the obstructed coronary blood vessels are exposed by surgical dissection.
  • One or more segments of the patient's saphenous vein or internal mammary artery is/are harvested for use as bypass graft(s).
  • the harvested segment (s) of vein or artery is/are then anastomosed to the obstructed coronary artery (ies) to form bypass conduit (s) around the arterial obstruction (s) .
  • Such traditional coronary artery bypass surgery is expensive, extremely invasive, and is associated with significant operative and perioperative complications.
  • balloon angioplasty One alternative to traditional coronary artery bypass surgery is balloon angioplasty.
  • a flexible guide catheter is percutaneously inserted into a peripheral artery (e.g., the femoral artery) and is transluminally advanced through the vasculature- until the distal tip of the catheter is within an obstructed coronary artery.
  • a balloon catheter is passed through the guide catheter and into the obstructive lesion.
  • the balloon of the balloon catheter is inflated one or more times to dilate coronary artery in the region of the obstructive lesion.
  • restenosis has generally been attributed to either a) an increase in the mass of the artery wall (e.g., neointima formation) , b) a thickening of the artery wall without substantial change in it's mass (e.g., vascular remodeling) and/or c) radial contraction of the balloon- dilated artery wall upon healing of cracks and fissures that have been created by the balloon dilation process.
  • an increase in the mass of the artery wall e.g., neointima formation
  • a thickening of the artery wall without substantial change in it's mass
  • vascular remodeling e.g., vascular remodeling
  • transluminal atheroectomy or ablation of the obstructive matter within the coronary artery Another alternative to traditional coronary artery bypass surgery is transluminal atheroectomy or ablation of the obstructive matter within the coronary artery.
  • These taranslu inal atheroectomy or ablation procedures are performed by passing a catheter-mounted ablation apparatus through the vasculature to the site of the coronary obstruction. the catheter-mounted ablative apparatus is then utilized to cut, shave, sonicate, pulverize or otherwise ablate the obstructive matter from the lumen of the coronary artery.
  • These atheroectomy or ablative procedures must be performed with caution to avoid abrasion or damage to the artery wall, as such abrasion or damage can result in excessive scaring and subsequent reocclusion of the artery lumen.
  • Atheroectomy or ablative procedures may, in some cases at least, be confounded by the need to meticulously contain and remove the severed fragments of obstructive matter in order to prevent such fragments of obstructive matter from escaping into the patient's circulatory system.
  • atheroectomy catheters and other catheter-mounted ablative apparatus are described in United States Patent Nos.
  • EP0347098A2 (Shiber) , O87-05739 (Cooper), O89-06515
  • EP316789 (Don Michael, et al . ) , DE 3,821,836 (Schubert), DE2438648 (Pohlman) , and EP 0443256A1 (Baruch) .
  • TMDCR Transmyocardial Direct Coronary Revascularization
  • a stent is required to be positioned within the transmyocardial passageway.
  • Such i ⁇ ntramyocardial stent is constructed to perform a one-way valving function (i.e., to open and close the transmyocardial passageway in accordance with changes in the systolic-diastolic cardiac cycle) .
  • 5,287,861 (Wilk), 5,409,019 (Wilk) and 5,429,114 (Wilk)
  • Wilk 5,287,861
  • 5,409,019 (Wilk)
  • 5,429,114 (Wilk)
  • any stent which is positioned solely within the transmyocardial passageway may be subject to repetitive flexing and/or stressing as the myocardium undergoes its normal contraction and relaxation. Such repeated flexing and/or stressing of the intramyocardial stent may lead to unwanted migration, dislodgement or damage of the stent.
  • the present invention provides new TMDCR methods, as well as certain valving devices which are usable in conjunction with these TMDCR methods. i. TMDCR Procedures Using Coronary Vein
  • a transmyocardial passageway is formed between a chamber of the heart (e.g., left ventricle) and a coronary vein .
  • blood may pass from the cardiac chamber, through the transmyocardial passageway, and into the coronary vein for the purpose of improving blood flow to the myocardium and/or to equalize or normalize pressures within the coronary venous vasculature by draining blood from the vein into the cardiac chamber.
  • the coronary vein of this embodiment may be situated next to an obstructed coronary artery, and one or more secondary blood flow passageways may be created between the coronary vein and the adjacent artery, at site(s) which is/are downstream of the coronary artery obstruction.
  • the lumen (s) of the coronary vein and/or adjacent coronary artery may be blocked or embolized at appropriate positions to facilitate the flow of blood in the desired direction (s) through the man-made blood flow passageway (s) , the coronary vein and/or the coronary artery.
  • one or more valving apparatus may be positioned within the coronary vein and/or within the cardiac chamber, to control or intermittently block the flow of blood through the transmyocardial passageway. ii.
  • an unstented transmyocardial passageway e.g., a puncture tract, bore, tunnel, or other passageway
  • a chamber of the heart e.g., the left ventricle
  • a coronary vessel e.g., a) an endogenous coronary artery; b) an endogenous coronary vein; c) a man-made passageway which has been formed in the heart, and which leads to an endogenous coronary vein; d) a man-made passageway which has been formed in the heart, and which leads to an endogenous coronary artery; and/or e) a man-made passageway which has been formed in the heart between an endogenous coronary artery and an endogenous coronary vein) .
  • an unstented transmyocardial passageway e.g., a puncture tract, bore, tunnel, or other passageway
  • the unstented transmyocardial passageway (s) created in accordance with this embodiment of the invention may be utilized to improve perfusion of the myocardium by shunting blood from the chamber of the heart (e.g., left ventricle) into the coronary vessel (e.g., vein artery or man-made passageway) , or may alternatively be utilized to equalize or normalize flow or pressure within the cardiac vasculature by draining blood from one or more cardiac vessels (e.g., vein, artery or man-made passageway), into the chamber of the heart. iii.
  • intraluminal valving apparatus Positionable in Coronary Vessels Still further in accordance with the present invention, there are provided several types of intraluminal valving apparatus which may be positioned within the lumen (s) of the coronary blood vessel (s) (i.e., artery, vein or man-made passageway) which intersect with the transmyocardial passageway, to intermittently block bloodflow, in at least one direction, through the transmyocardial passageway.
  • s coronary blood vessel
  • These intraluminal valving devices generally comprise tubular bodies having at least one occluder member positioned therein, said occluder member (s) being alternately moveable between i) open position (s) whereby bloodflow is permitted to pass through the transmyocardial bloodflow passageway in a desired direction, and ii) closed position (s) whereby blood is prevented from flowing through the transmyocardial bloodflow passageway, in an undesired direction.
  • the present invention also includes endogenous tissue valve (s) which are formed in the transmyocardial passageway to perform a desired one-way valving function whereby blood is permitted to flow through the transmyocardial bloodflow passageway in a first direction, but is prevented from backflowing or regurgitating in a second direction.
  • tissue valve s
  • Intracardiac Valving Devices for TMDCR Passageway
  • intracardiac valving devices which are mountable within a chamber of the heart (e.g., left ventricle) immediately adjacent to an opening into a transmyocardial passageway which extends from the cardiac chamber to a coronary vessel (e.g., artery, vein or man- made passageway) .
  • Such intracardiac valving device may be constructed such that it will open in response to hemodynamic pressure generated during systole and/or in response to mechanical contraction (i.e., shortening and thickening) of the myocardium during systole.
  • the intracardiac valving device When open, the intracardiac valving device permits blood to flow through the transmyocardial bloodflow passageway. Thereafter, the valving device may be constructed to close when diastolic pressures are present in the cardiac chamber or when the myocardium undergoes mechanical relaxation (i.e., lengthening and thinning during diastole. When closed, the valving device will prevent blood from backflowing or regurgitating from the transmyocardial bloodflow passageway, into the cardiac chamber.
  • stents and stented grafts which are positionable within the transmyocardial passageway, and which protrude into the adjacent coronary vessel (e.g., vein, artery or man-made passageway).
  • These protrusive stents and/or protrusive stented grafts may be self -expanding or pressure- expandable.
  • one or more valves or occluder members may be positioned within such protrusive stents and/or stented grafts to facilitate valving or directed movement of bloodflow in accordance with the diastolic/systolic cardiac cycle.
  • Figure 1 is a perspective view of a human heart showing the typical anatomical positioning of the coronary arteries and coronary veins of the left heart.
  • Figure la is a partial cut-away sectional view of a human heart wherein a transmyocardial passageway has been created between the left ventricle and a coronary vein, in accordance with the present invention.
  • Figure lb is a partial longitudinal sectional view through an obstructed coronary artery and adjacent coronary vein, showing a transmyocardial passageway of the present invention, extending between the chamber of the left ventricle and the coronary vein.
  • Figure lc is a partial longitudinal sectional view through an obstructed coronary artery and adjacent coronary vein, showing a transmyocardial passageway of the present invention extending between the chamber of the left ventricle to the coronary vein, and a secondary bloodflow passageway extending from the coronary vein to the adjacent coronary artery, downstream of the obstruction.
  • Figure Id is a partial longitudinal sectional view through a portion of the myocardium of a human heart, adjacent the left ventricle, showing an alternative embodiment of the present invention wherein a transmyocardial bloodflow passageway extends from the chamber of the left ventricle to a secondary passageway which has been created between the obstructed coronary artery and the adjacent coronary vein.
  • Figure 2 is a longitudinal sectional view showing a first embodiment of an intravascular valving apparatus of the present invention operatively positioned within a coronary blood vessel (artery, vein or man-made passageway) .
  • Figure 2a is a perspective view of the intravascular valving apparatus of Figure 2.
  • Figure 2b is an elevational view of a variant of the intravascular valving apparatus shown in Figures 2 and 2a, wherein a bloodflow blocking bulkhead is formed on the upstream end of the apparatus.
  • Figure 3 is a longitudinal sectional view of a second embodiment of an intravascular valving apparatus of the present invention operatively positioned in a coronary blood vessel (artery, vein or man-made passageway) .
  • Figure 3a is longitudinal sectional view showing variant of the second intravascular valving apparatus embodiment shown in Figure 3, wherein two (2) separate valving apparatus are respectively positioned upstream and downstream of the junction between the transmyocardial bloodflow passageway and the coronary blood vessel (artery, vein or man-made passageway) .
  • Figure 3b is a longitudinal sectional view of another variant of the second intravascular valving apparatus embodiment shown in Figure 3, wherein three (3) valves are incorporated within a single tubular body to accomplish valving of bloodflow through a transmyocardial bloodflow passageway and coronary blood vessel (artery, vein or man- made passageway) .
  • Figure 4 is a longitudinal sectional view showing a third embodiment of an intravascular valving apparatus of the present invention operatively positioned within a coronary blood vessel (artery, vein or man-made passageway) .
  • a coronary blood vessel artery, vein or man-made passageway
  • Figure 5 is a longitudinal sectional view showing an intracardiac valving apparatus of the present invention along with an optional retainer assembly (dotted lines) useable to mount such intracardiac valving apparatus on the inner wall of the heart.
  • Figure 5a is a perspective view of the intracardiac valving apparatus of Figure 4 having the optional retainer assembly affixed thereto.
  • Figures 6a and 6b are longitudinal sectional views of a human heart wherein a bloodflow passageway has been created between the left ventricle and a coronary blood vessel (artery, vein or man-made passageway) , and a valving tissue valve has been created in the wall of the blood vessel, in accordance with the present invention.
  • a bloodflow passageway has been created between the left ventricle and a coronary blood vessel (artery, vein or man-made passageway)
  • a valving tissue valve has been created in the wall of the blood vessel, in accordance with the present invention.
  • Figures 7a- 7b are longitudinal sectional views of a human heart wherein a blood vessel passageway has been created between the left ventricle and a coronary blood vessel (artery, vein or man-made passageway) , and wherein an elastic suture has been positioned, in accordance with the present invention.
  • Figure 8a is a longitudinal sectional view showing a protrusive stent apparatus of the present invention implanted within a transmyocardial passageway and extending into a coronary blood vessel (e.g., artery, vein or man- made passageway) .
  • a coronary blood vessel e.g., artery, vein or man- made passageway
  • Figure 8b is a longitudinal sectional view showing an alternative embodiment of the protrusive stent apparatus shown in Figure 5a.
  • Figure 8c is a longitudinal sectional view showing another alternative embodiment of the protrusive stent apparatus shown in Figure 5a, having an optional tubular covering and/or optional valve (s) incorporated therein.
  • the present invention includes methods for improving perfusion of regions of the myocardium M which are ischemic or otherwise affected by the existence of an obstruction OB within a coronary artery CA, by forming a transmyocardial passageway 10 which extends from a chamber of the heart, (e.g., left ventricle LV) , to a coronary vein CV.
  • a transmyocardial passageway 10 which extends from a chamber of the heart, (e.g., left ventricle LV) , to a coronary vein CV.
  • the transmyocardial passageway 10 will simply provide a flow of blood from the chamber of the heart and into the coronary vein CV, such that the blood will pass in retrograde fashion through the coronary vein CV to perfuse the ischemic portion of the myocardium through the coronary vein, as sheen in Figure lb.
  • a secondary bloodflow passageway 12 may be created between the coronary vein CV into which the transmyocardial passageway 10 extends and the obstructed coronary artery CA, at a location which is downstream of the obstruction OB, as shown in Figure lc.
  • this secondary bloodflow passageway 12 allows blood from the chamber of the heart (e.g., the left ventricle LV) to initially flow through the transmyocardial passageway 10, through a segment of the coronary vein lumen CVL, through the secondary bloodflow passageway 12, and into the coronary artery lumen CAL, at a location downstream of the coronary artery obstruction OB, as shown in Figure 2b.
  • the secondary bloodflow passageway 12 which extends between the coronary vein CV and the coronary artery CA may optionally be stented or internally supported by a stent, sleeve or coating (e.g., a polymer coating) to maintain patency of the secondary passageway 12.
  • the coronary vein lumen CVL may be purposely blocked (e.g., ligated, embolized, fused, welded, clamped, etc.) at site(s) upstream and/or downstream of the transmyocardial passageway 10.
  • a proximal embolization member 14a may be positioned within the coronary vein lumen CVL, immediately upstream of transmyocardial passageway 10, to ensure that the shunted blood will flow, in the desired retrograde direction through the coronary vein CV.
  • a distal e bolization member 14b may be positioned within the coronary vein lumen CVL immediately downstream of the secondary bloodflow passageway 12, to divert the flow of blood through the secondary bloodflow passageway.12.
  • the proximal embolization member 14a and/or distal 14b embolization member may comprise any suitable type of lumen blocking matter or apparatus, examples of which are the embolization coils described in United States Patent Nos. 5,382,260 (Dormandy, Jr. et al . ) , 5,108,407 (Geremia et al . ) , and 5,256,146 (Ensminger, et al . ) .
  • the coronary vein lumen CVL may be closed off at the sites of the proximal 14a and/or distal 14b embolization members by any suitable alternative means, such as clamping, clipping, ligating, fusing, welding or adhesively conjoining the inner walls of the coronary vein lumen CVL so as to provide the desired blocking of bloodflow therethrough.
  • Figure Id shows an alternative embodiment of the method of the present invention wherein a secondary bj-oodflow passageway 12 of the above-described type has been created between the coronary vein CV and coronary artery CA, and wherein the transmyocardial bloodflow passageway 10a extends from the chamber of the heart (e.g., left ventricle) such secondary bloodflow passageway 12. ii.
  • the present invention also includes alternative TMDCR methods wherein a transmyocardial passageway 10 is formed between a chamber of the heart and a coronary vessel (i.e., a) an endogenous coronary vein, b) an endogenous coronary artery, c) a man-made passageway in the heart which connects to an endogenous coronary vein; d) a- man-made passageway in the heart which connects to an endogenous coronary or e) a man-made passageway which extends between an endogenous coronary artery and an endogenous coronary vein) , and such transmyocardial passageway 10 is allowed to remain non-stented (e.g., devoid of any stent or internal support member positioned therewith) .
  • a coronary vessel i.e., a) an endogenous coronary vein, b) an endogenous coronary artery, c) a man-made passageway in the heart which connects to an endogenous coronary vein; d
  • the non-stented transmyocardial passageway 10 of the present invention When the non-stented transmyocardial passageway 10 of the present invention is intended to provide bloodflow from the chamber of the heart (e.g., left ventricle) into the coronary vessel (e.g., vein, artery or man-made passageway) , the non-stented transmyocardial passageway 10 must remain open during systolic contraction of the myocardium. If the non-stented passageway 10 is permitted to substantially occlude or close-off during systolic contraction of the myocardium, such could prevent or deter the desired blood flow from passing through the transmyocardial passageway 10.
  • the coronary vessel e.g., vein, artery or man-made passageway
  • the passageway 10 in embodiments of the invention which utilize the non-stented transmyocardial passageway 10, it may be desirable to debulk, core or otherwise enlarge the diameter of the passageway 10 during it's formation so as ensure that the passageway 10 will remain patent and open, even during systolic contraction of the myocardium.
  • Such coring, debulking or other enlargement of the passageway 10 may be accomplished by any suitable means, including the use of a hollow coring needle, laser, electrosurgical probe, or other tissue removing/ablating device capable of debulking and removing tissue so as to create a transmyocardial passageway 10 of the desired diameter.
  • the non-stented transmyocardial passageway preferably should not fill-in with granulation tissue or otherwise close-off as a result of any scarring or healing process of the myocardium.
  • the coring, de-bulking or other enlargement of the non-stented passageway 10 and/or the continuing passage of blood, therethrough may be sufficient to prevent or deter such scarring or natural closing of the non-stented passageway 10.
  • the transmyocardial passageway 10, 10a may function in it's intended manner without the inclusion of any valving apparatus, for intermittently blocking the flow of blood therethrough. However, in at least some applications, it may be desired to prevent the backflow of blood through the transmyocardial passageway 10, 10a during certain phase (s) of the cardiac cycle when the relative hemodynamic pressures would tend to cause such backflow.
  • the present invention includes intravascular valving apparatus 20, 30, 31, 33, 40, examples of which are shown in Figures 2-4.
  • These intravascular valving apparatus 20, 20, 31, 33, 40 are positionable within the lumen of the coronary blood vessel CBV (e.g., vein, artery or man-made passageway) , and operate to prevent backflow of blood into the transmyocardial bloodflow passageway 10, 10a.
  • CBV coronary blood vessel
  • each of the intravascular- valving apparatus 20, 30, 31, 33, 40 of the present invention comprise a radially expandable cylindrical or tubular body which is transluminally advanceable into the lumen of the coronary blood vessel CBV (e.g., artery, vein or man-made passageway) , and which is then radially expandable so as to become implanted at a location which is adjacent or near to the intersection of that coronary vessel CBV with a transmyocardial bloodflow passageway 10, 10a.
  • the valving apparatus 20, 30, 31, 33, 40 has an axial bore 24, 34, 42 through which blood may pass as it flows through the lumen of the coronary blood vessel CBV or secondary passageway 12 in which the apparatus 20, 30, 31, 33, 40 is positioned.
  • One or more occluder members 26, 36, 46 are formed within the apparatus 20, 30, 31, 33, 40. Such occluder member(s) 26, 36, 46 are alternately moveable between a first (e.g., open) position whereby blood is permitted to flow from the transmyocardial bloodflow passageway into the coronary blood vessel CBV or secondary passageway 12, and a second (e.g., closed) position whereby blood is prevented or deterred from backflowing or regurgitating from the coronary blood vessel CBV or secondary passageway 12, into the transmyocardial bloodflow passageway.
  • a first e.g., open
  • second e.g., closed
  • each of the intravascular valving apparatus 20, 30, 31, 33, 40 of the present invention offer advantages over the intramyocardial stenting/valving apparatus described in United States Patent Nos. 5,248,861 (Wilk), 5,409,019 (Wilk) and 5,429,144 (Wilk) in that they are operatively situated entirely within the lumen of the coronary blood vessel CBV of secondary passageway 12 and do not extend into the transmyocardial passage way (e.g., the first passageway 10, 10a) which emanates from the chamber (e.g., left ventricle) of the heart.
  • the transmyocardial passage way e.g., the first passageway 10, 10a
  • the valving apparatus 20, 30, 31, 33, 40 of the present invention do not require precise measurement or precise cutting-to- length, as is purportedly required of the intramyocardial stenting/valving apparatus described in U.S. Patent Nos. 5,248,861 (Wilk), 5,409,019 (Wilk) and 5,429,144 (Wilk).
  • the valving apparatus 20, 30, 31, 33, 40 of the present invention be initially disposable in a first radially compact diameter which is small enough to be mounted upon or inserted into an intravascular delivery catheter.
  • intravascular delivery catheter having the valving apparatus 20, 30, 31, 33, 40 mounted thereon or therewithin, is transluminally passable through the vasculature and into the lumen of the coronary blood vessel CBV wherein the apparatus 20, 30, 31, 33, 40 is to be implanted.
  • the apparatus 20, 30, 31, 33, 40 is radially expanded (by self -expansion or pressure-expansion) to a second radially expanded diameter, wherein the outer surface of the apparatus 20, 30, 31, 33, 40 frictionally engages the surrounding wall of the coronary blood vessel CBV such that the apparatus 20, 30, 31, 33, 40 is thereby implanted and retained in a stationary position.
  • the valving apparatus 20, 30, 31, 33, 40 is so implanted within the coronary blood vessel CBV, blood may flow through the axial bore 24, 34, 42 of the apparatus 20, 30, 31, 33, 40, as described in more detail herebelow.
  • the valving apparatus 20, 30, 31, 33, 40 may be either self -expanding or pressure- expandable.
  • the cylindrical body of the apparatus 20, 30, 31, 33, 40 may be formed of a shape memory alloy or resilient material (e.g., spring metal) which is inherently biased to it's second radially expanded diameter.
  • the cylindrical body of the apparatus 20, 30, 31, 33, 40 may be formed of plastically deformable material which is initially formed it's first radially compact diameter, and which may be pressure deformed to it's second radially expanded diameter by the exertion of outward force from an internally positioned balloon or other radial expansion device.
  • the potential useability and applicability of the intravascular valving apparatus 20, 30, 31, 33, 40, 50 described herebelow is not limited only to uses in connection with the improved TMDCR methods of the present invention, but may also be useable as a modification of the previously described TMDCR methods, such as those of United States Patent Nos. 5, 287, 816 (Wilk) , 5 , 409 , 019 (Wilk) , and 5,429,144 (Wilk).
  • FIGS 2, 2a and 2b show a first embodiment of an intravascular valving apparatus 20 which is positioned within the lumen of a coronary blood vessel CBV (artery, vein or man-made passageway) , at a location which is adjacent it's intersection with the transmyocardial passageway 10.
  • This embodiment of the valving apparatus 20 has a cylindrical body having an axial bore 24 which extends longitudinally therethrough, and a side aperture 22 formed in the sidewall thereof.
  • the side aperture 22 is preferably the same size or larger than the diameter of the adjacent end of the transmyocardial passageway 10, such that blood flowing from the cardiac chamber (e.g., left ventricle LV) through the transmyocardial passageway 10 will pass directly through the side aperture 22 and into the bore 24 of the valving apparatus 20.
  • An occluder member 26, such as a hinged obturator or pliable elastomeric leaflet is affixed to the cylindrical body of the valving apparatus 20, and extends over and substantially blocks the side aperture 22 so as to prevent the flow of blood out of the side aperture .22.
  • the occluder member 26 is alternately moveable between a first position wherein it blocks blood from flowing out of the side aperture 22, and a second position wherein it permits blood to flow into the bore 24 through the side aperture 22.
  • This first embodiment of the valving apparatus 20 may be implanted in the lumen of the coronary blood vessel CBV such that the side aperture 22 is in alignment with the adjacent end of the bloodflow passageway 10.
  • the relatively high pressure within the left ventricle will force the occluder member 26 to its second (open) position, allowing blood to flow from the left ventricle, through the transmyocardial passageway 10, through the side aperture 22, through the bore 24 and into the lumen of the coronary blood vessel CBV in the perfusive direction PD, as shown.
  • the relatively low filling pressure within the left ventricle LV will draw the occluder member 26 to its first (closed) position whereby the occluder member 26 will prevent blood from regurgitating or moving in the backflow direction BD from the lumen of the coronary blood vessel CBV , out of the side aperture 22, and into the bloodflow passageway 10.
  • the first embodiment of the valving apparatus 20 serves to facilitate efficient pumping of oxygenated blood from the left ventricle and into the lumen of the coronary blood vessel CBV, to improve the flow of oxygenated blood to an ischemic or blood- flow-deprived region of the myocardium M.
  • a closure member 21, in the nature of an end cap, may be formed on the upstream end of the apparatus 20 so as to completely or substantially block the flow of blood through the coronary blood vessel CBV and into the upstream end of the bore 24 of the apparatus 20.
  • the optional inclusion of the end closure member .21 in the apparatus 20 may serve to obviate any need for the placement of a proximal embolization member 14a within the lumen of the coronary blood vessel CBV, upstream of the valving apparatus 20.
  • Figure 3 shows a second embodiment of the intravascular valving apparatus 30 which comprises a generally cylindrical body having an axial bore 34 extending longitudinally therethrough and a pair of occluder members 46 positioned therewithin, and a side aperture 32 formed in the cylindrical sidewall of the apparatus 30, behind the occluder members 36.
  • Each occluder member 36 is affixed at least one point to the cylindrical body of the apparatus 30, and may comprise any suitable structure or openable and closeable passage, such as a self -sealing slit or hole, or a hinged leaflet or pliable elastomeric member.
  • the occluder members 46 are alternately moveable between first positions wherein the occluder members 36 directly contact one another so as to prevent blood from backflowing in the backflow direction BD through the axial bore 34 of the apparatus 30, and second positions wherein the occluder members 36 move out of contact with one another such that blood may flow through the axial bore 34 of the apparatus 30 in the perfusion direction PD.
  • the side aperture 32 is preferably as large as or larger than the diameter of the bloodflow passageway 10 which extends through the myocardium M from the left ventricle LV to the lumen of the coronary blood vessel CBV.
  • This embodiment of the apparatus 30 is implanted in the lumen of the coronary blood vessel CBV such that its side aperture 32 is directly aligned with the bloodflow passageway 10 so that blood may flow through the bloodflow passageway 10, into the axial bore 34 of the apparatus 30.
  • the relatively high pressures created in the left ven ⁇ ricle LV will force blood to flow through the passageway 10 into the axial bore 34 of the valving apparatus 30.
  • Such systolic bloodflow will move the occluder members 36 to their second (i.e., open) positions, thereby allowing the blood to flow through the lumen of the coronary blood vessel in the perfusion direction PD.
  • this second embodiment of the intravascular valving apparatus 30 serves to facilitate efficient pumping of oxygenated blood from the left ventricle LV and through the lumen of the coronary blood vessel CBV, in order to provide improved bloodflow to an ischemic or blood- flow-deprived region of the myocardium M.
  • secondary occluder members 38 may be formed or mounted within the bore 34 of the apparatus 30, upstream of the side opening 32. These optional secondary occluder members 38 may be of the same type and construction as the above-described downstream occluder members 36. If present, such additional occluder members 38 will assume their first (e.g., closed) position when the pressure of blood within the bore 34 of the apparatus 30 downstream of such secondary occluder members 38 is greater than the pressure of blood within the coronary blood vessel CBV upstream of the such secondary occluder member 38.
  • Figure 3a shows one variant of the second embodiment wherein two (2) separate intravascular valving apparatus 31a, 31b are respectively positioned upstream and downstream of the transmyocardial bloodflow passageway.
  • the above-described occluder members 36 are formed in the apparatus 31b which is positioned downstream of the transmyocardial bloodflow passageway 10 and the above- described secondary occluder members 38 are formed within the apparatus 31a which is positioned upstream of the transmyocardial bloodflow passageway 10.
  • these separate intravascular valving apparatus 31a, 31b will function in the same manner as the apparatus 30 shown in Figure 3, when it is equipped with the optional secondary occluder members 38.
  • FIG. 3b shows another variant of the second embodiment wherein a single intravascular valving apparatus 33, in the nature of a tubular stent or tubular body, is provided with three (3) separate valves 26, 36, 38 at locations which are a) at the junction of the transmyocardial passageway 10 and the coronary blood vessel CBV, b) upstream of the transmyocardial passageway 10 and c) downstream of the transmyocardial passageway 10, respectively.
  • These valves 26, 36, 38 may comprise self- sealing pliable slit openings, elastomeric leaflets, hinged occluder members or any other suitable type of structure or apparatus which will intermittently open and close, to permit bloodflow in the desired direction therethrough.
  • the first valve 26 will operate to open during systole to permit blood to flow from the transmyocardial passageway 10 into the coronary blood vessel CBV, but will close during diastole to prevent backflow or regurgitation into the cardiac chamber.
  • the second (upstream valve 38 will close during systole to prevent backflow of blood through the proximal end opening of the valving apparatus 33.
  • the third (downstream) valve 36 will open during systole to permit the desired flow of blood entering through the transmyocardial passageway 10, to continue on downstream through the coronary blood vessel CBV in the desired perfusion direction.
  • Figure 4 shows a third embodiment of the intravascular valving apparatus 40 which comprises a generally cylindrical body having an axial bore 42 extending longitudinally therethrough and a plurality of occluder members 46 formed therewithin.
  • the cylindrical body and occluder members 46 of this third embodiment of the apparatus 40 are the same as those of the above described second embodiment, except that the cylindrical body of this third embodiment is devoid of any side aperture (s) or openings in the cylindrical sidewall.
  • this third embodiment of the apparatus 40 is implanted in the lumen of the coronary blood vessel CBV at a location which is downstream of the junction between the coronary blood vessel CBV and the first bloodflow passageway 10.
  • Figures 5 and 5a show examples of intracardiac valving apparatus 80 which may be utilized to prevent backflow of blood through the transmyocardial passageway 10, or to otherwise control the flow of blood through the transmyocardial passageway 10 in accordance with the systolic/diastolic cardiac cycle.
  • the intracardiac valving apparatus 80 is positionable within the cardiac chamber (e.g., left ventricle) immediately adjacent the opening of the transmyocardial passageway 10 thereinto.
  • the intracardiac valving apparatus 80 may comprise any suitable type of hinged, pliable or moveable occlusion member or self- sealing slit which will operate to intermittently block or unblock the flow of blood in at least one direction through the transmyocardial passageway 10.
  • the intracardiac valving apparatus 80 comprises a generally annular body having a central aperture formed therein and an occluder member 81, such as a pliable elastomeric flap, mounted within the aperture.
  • the occluder member 81 will move, in relation to hemodynamic bloodflow and/or contraction of the myocardium M, between an open position whereby blood is permitted to pass in at least one direction through the transmyocardial passageway 10, and a closed position whereby blood is prevented from flowing in at least one direction through the transmyocardial passageway 10.
  • the intracardiac valving apparatus 80 may be implanted within the cardiac chamber by any suitable surgical or non- surgical technique.
  • the intracardiac Valving apparatus 80 is initially positioned within or upon a delivery catheter, and the delivery catheter is advanced through the coronary blood vessel CBV, and through the transmyocardial passageway 10. Thereafter, the intracardiac valving apparatus 80 is released or ejected from the delivery catheter, and is caused to radially expand to it's operative configuration. the expanded valving apparatus 80 is then retracted into abutting contact with the myocardial wall, as shown.
  • the intracardiac valving apparatus 80 may be attached to the myocardial wall by any suitable attachment such as hooks, sutures, adhesives or a retaining assembly which is operative to hold the intracardiac valving apparatus 80 in its desired fixed position upon the myocardial wall.
  • a retaining apparatus shown in Figures 5 and 5a, comprises an annular retaining ring 82 which is positionable within the coronary blood vessel CBV and a plurality of elastomeric tether members 84 which extend between the retainer ring 82 and the intracardiac valving apparatus 80.
  • the elastomeric tethers 84 will resiliently draw the retaining ring 82 and intracardiac valving apparatus 80 toward one another, so as to hold the intracardiac valving apparatus 80 in fixed abutment with the myocardium M as shown.
  • the occluder member 81 will be designed to move in response to changes in hemodynamic pressure, such that when the hemodynamic pressure within the cardiac chamber (e.g., left ventricle) exceeds that within the transmyocardial passageway 10, the occluder member 81 will move to it's open position, and when the pressure within the transmyocardial passageway 10 exceeds that- within the cardiac chamber (e.g., left ventricle) the occluder member 81 will move to it's closed position.
  • the cardiac chamber e.g., left ventricle
  • the occluder member 81 may be designed to move in relation to contractile changes in the myocardial muscle.
  • the occluder member 81 will be mechanically linked or coupled to the body of the intracardiac valving apparatus 80 such that, when the myocardium undergoes contraction (e.g., shortening and thickening) , the occluder member 81 will be propelled to it's open position, and when the myocardium undergoes relaxation (e.g., lengthening and narrowing) the occluder member 81 will move to it's closed position.
  • contraction e.g., shortening and thickening
  • relaxation e.g., lengthening and narrowing
  • the intracardiac valving apparatus 80 of the present invention serves to control the desired bloodflow through the transmyocardial passageway 10, without the need for customizing or precise cutting- to- size of any intramyocardial stent, as has been described in the prior art.
  • v. Tissue Valve for Preventing Backflow into the Transmyocardial Bloodflow Passageway An alternative to the use of the above-described intravascular valving apparatus 20, 30, 31, 33, 40 and/or the intracardiac valving apparatus 80, is an endogenous tissue valve which may be formed within the transmyocardial passageway 10 or at either end thereof.
  • Figures 6a- 6b show an endogenous tissue valve 50 which is formed at the junction of the transmyocardial bloodflow passageway 10 and a coronary blood vessel CBV (e.g., artery vein or man-made passageway) .
  • CBV coronary blood vessel
  • the endogenous tissue valve 50 may comprise one or more segment (s) 54 of the wall of the coronary blood vessel CBV, along with one or more tapered segment (s) of underlying myocardial tissue 52.
  • This endogenous tissue valve 50 is formed such that the segment (s) of blood vessel wall 54 and underlying portion (s) of myocardial tissue 52 will receive sufficient blood supply so as not to become necrotic or infarcted.
  • the thickness and mass of the tissue valve 50 is preferably defined so that, when the heart undergoes systolic contraction the elevated pressure created within the left ventricle LV and transmyocardial bloodflow passageway 10 will force the tissue valve 50 to an open position, as illustrated in Figure 5a, thereby creating an opening 56 through which blood may flow into the lumen of the coronary blood vessel CBV, in the profusion direction PD.
  • the tissue valve 50 will return to a second or closed position, as illustrated in Figure 5b.
  • the tissue valve 50 will substantially or completely close off the transmyocardial bloodflow passageway 10, so as to prevent blood from backflowing or regurgitating in the backflow direction BD, from the lumen of the coronary blood vessel CBV into the transmyocardial bloodflow passageway 10.
  • the tissue valve 50 may be created by any suitable means, including a procedure whereby the tissue penetrating, cutting or boring device used to create the transmyocardial bloodflow passageway is provided with a tapered distal end having a configuration analogous to that of the inner edge(s) 55 of the wall segment (s) 54 so as to form the desired tissue valve (s) or segment (s) when form the endogenous tissue valve 50, or by another catheter- based device which is equipped to form such tissue valve (s) or segment (s) . It will be appreciated that the tissue valve 50 may be formed in various configuration.
  • tissue valve 50 shown in Figures 6a and 6b hereof consists of a single flap
  • various alternative configurations may be utilized wherein multiple tissue protrusions, multiple tissue flaps, or annularly tapered or funnel shapped tissue flaps are formed to perform the desired valving function. Any and all such configurations of endogenous tissue are intended to be included within the scope of the term "tissue valve" 50 as used herein.
  • the elastic closure member 60 may comprise one or more sutures formed of stretchable or elastic material such as latex or other elastomeric polymer materials.
  • Such elastic closure member (s) 60 are preferably passed through adjacent portions of myocardial tissue next to the opening 66 between the transmyocardial bloodflow passageway 10 and the lumen of the coronary blood vessel CBV (or secondary bloodflow passageway 12) .
  • the elastic closure member (s) 60 is the elastically biased to a retracted state whereby the closure member (s) 60 will draw the adjacent portions of myocardium M together so as to close off the opening 66 between the transmyocardial bloodflow passageway 10 and the lumen of the coronary bloodflow CBV, as shown in Figure 7b.
  • the relatively high pressures created within the left ventricle LV and transmyocardial bloodflow passageway 10 will cause the elastic closure member (s) 60 to stretch or expand, thereby forming opening 66 through which blood may flow from the transmyocardial bloodflow passageway 10 into the lumen of the coronary blood vessel CBV (or secondary bloodflow passageway 12) in the perfusion direction PD, as shown in Figure 7a.
  • the elastic closure member 60 may be installed in any suitable method, such as by way of an appropriate suturing or stapling device which operates to attach the elastic closure member 60 at its desired location.
  • Such installation of the elastic closure member 60 may be accomplished by open surgical technique or by way of catheter-based, transluminal methodology.
  • a catheter having a suturing or stapling device positioned therewithin may be advanced to a position adjacent the opening 66.
  • negative pressure or other suitable drawings means may be utilized to draw adjacent segments of the myocardial tissue, from either side of the transmyocardial passageway 10, into the catheter.
  • the desired elastic closure member 60 may be penetrated and threaded through the adjacent sides of the myocardial tissue so as to form the desired elastic closure member 60, as shown. vii. Protrusive Stents and Stented Grafts for Stenting of the Transmyocardial Passageway
  • protrusive stents or stented grafts may be positioned within the transmyocardial passageway 10, and may extend into one or more adjacent coronary vessels including a) an endogenous coronary vein, b) an endogenous coronary artery, c) a man-made passageway in the heart which connects to an endogenous coronary vein, d) a man- made passageway in the heart which connects "to an endogenous coronary artery and/or e) a man-made passageway which extends between an endogenous coronary vein and an endogenous coronary artery.
  • the protrusive stent apparatus 90, 90a, 90b of the present invention may incorporate one or more valving apparatus to intermittently block or direct bloodflow in accordance with various stages of the systolic/diastolic cardiac cycle. Furthermore, such protrusive stent apparatus may optionally be covered or juxtapositioned to a tubular graft or sheath so as to form a discrete tubular passageway.
  • Figure 8a shows a non-valved, non-covered protrusive stent apparatus 90 of the present invention positioned partially within a transmyocardial passageway 10, and extending into the coronary vessel CV (e.g., artery, vein or man-made passageway) to which such transmyocardial passageway 10 extends.
  • the protrusive stent apparatus 90 is curved or bent at the junction of the transmyocardial passageway 10 and the coronary vessel CV, and preferably extends into the coronary vessel CV in the desired bloodflow direction.
  • the protrusive stent apparatus 90 may be formed of any suitable material, such as wire mesh or other metal or polymeric material, and may be self -expanding or pressure- expandable.
  • Figure 8b shows a variant of the protrusive stent apparatus 90a positioned partially within a transmyocardial passageway 10, extending through a coronary vein CV, through a secondary passageway 12, and into a coronary artery CA. As shown the protrusive stent apparatus 90a is curved or bent at the junction of the secondary passageway 12 and the coronary artery CA and preferably extends into the coronary artery CA in the desired bloodflow direction.
  • Figure 8c shows alternative variations of the protrusive stent apparatus 90b wherein an optional tabular covering 92 is formed on the protrusive stent 90b.
  • Such optional covering 92 may be any suitable tubular covering such as woven polyester or expanded, sintered polytetrafluoroethylene (PTFE) .
  • PTFE polytetrafluoroethylene
  • one or more valves such as hinged occluder members or pliable elastomeric leaflets may be located within the protrusive stent apparatus 90b with or without covering 92, at locations h. and/or L 2 and/or L 3 to facilitate control and valving of bloodflow through the transmyocardial passageway 10, coronary vein CV, secondary passageway 12 and/or coronary artery CA.
  • embodiments of the protrusive valving apparatus 90b which incorporates such valves at locations L. and/or L 2 and/or L 3 may be provided with appropriate openings or apertures in any covering 92 formed thereon to facilitate the desired inflow or outflow of blood at specific locations thereon.
  • protrusive stent apparatus 90, 90a, 90b with or without the optional covering 92 and/or without the optional valves at locations h. and/or L 2 and/or L 3 offer advantages over previously known intramyocardial stents in that they do not require precise cutting to length or precise positioning within the myocardial passageway 10.
  • the protrusive stent apparatus 90, 90a, 90b of the present invention are intended to protrude into a coronary blood vessel CBV (e.g., artery, vein and/or man-made passageway) and the length of the portion of the stent apparatus 90, 90a, 90b which extends into such coronary blood vessel CBV is typically not critical. In this regard, there will exist no need for custom- fitting or precise precutting of the stent apparatus 90, 90a, 90b prior to implantation within the patient.
  • CBV coronary blood vessel
  • such covering may be formed of any suitable material including but not necessarily limited to polyester, woven polyester, polytetrafluroethylene, expanded polytetraflouroethylene, polyurethane; silicone, polycarbonate, autologous tissue and, xenograft tissue.

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Abstract

Cette invention concerne des procédés et dispositifs destinés à une revascularisation coronarienne directe dans laquelle on forme un passage (10) transmyocardique entre une cavité cardiaque (LV) et un vaisseau sanguin coronarien (CBV) afin de permettre au sang de circuler entre ceux-ci. Dans quelques modes de réalisation, on forme ce passage (10) entre une cavité cardiaque (LV) et une veine coronaire (CV). L'invention comprend passage (10) transmyocardique effectué par extenseur, de même que des passages transmyocardiques (10) dans lesquels des dispositifs extenseurs saillants (90) s'étendent dudit passage (10) dans un vaisseau coronarien adjacent (CBV) ou dans une cavité cardiaque (LV). Le dispositif de l'invention comprend des extenseurs saillants (90), destinés à l'extension de passages transmyocardiques (10), des dispositifs endoluminaux à valvule (40) pour munir d'une valvule des passages transmyocardiques (10), des dispositifs intracardiaques à valvule (80) pour munir d'une valvule des passages transmyocardiques (10), des valvules tissulaires endogènes (50) pour munir d'une valvule un passage transmyocardique (10), ainsi qu'un dispositif annexe utile pour être utilisé conjointement avec les dispositifs de l'invention.
EP97940595A 1996-08-26 1997-08-25 Procedes et dispositifs de revascularisation transmyocardique coronarienne directe Withdrawn EP1006916A4 (fr)

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US2892296P 1996-08-26 1996-08-26
PCT/US1997/014801 WO1998008456A1 (fr) 1996-08-26 1997-08-25 Procedes et dispositifs de revascularisation transmyocardique coronarienne directe
US2892 1998-01-05

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JP2001500401A (ja) 2001-01-16
CA2263672A1 (fr) 1998-03-05
WO1998008456A1 (fr) 1998-03-05
EP1006916A1 (fr) 2000-06-14
AU4234097A (en) 1998-03-19

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