EP0429629A4 - Aortic graft and method for repairing aneurysm - Google Patents

Aortic graft and method for repairing aneurysm

Info

Publication number
EP0429629A4
EP0429629A4 EP19900909889 EP90909889A EP0429629A4 EP 0429629 A4 EP0429629 A4 EP 0429629A4 EP 19900909889 EP19900909889 EP 19900909889 EP 90909889 A EP90909889 A EP 90909889A EP 0429629 A4 EP0429629 A4 EP 0429629A4
Authority
EP
European Patent Office
Prior art keywords
aortic graft
aortic
aorta
graft
cephalic
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Withdrawn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
EP19900909889
Other languages
English (en)
Other versions
EP0429629A1 (fr
Inventor
Hugh H. Trout, Iii
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP0429629A1 publication Critical patent/EP0429629A1/fr
Publication of EP0429629A4 publication Critical patent/EP0429629A4/en
Withdrawn legal-status Critical Current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
    • 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
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • 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
    • A61F2/848—Devices 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
    • 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
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • 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
    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • the invention is an aortic graft, and a device and method of using that devic for repair and treatment of arterial aortic aneurysms.
  • An aneurysm is a ballooning o the wall of an artery resulting from the weakening of the artery due to disease or othe conditions. Left untreated, the aneurysm will frequently rupture resulting in loss of bloo through the rupture.
  • Aortic aneurysms are the most common form of arterial aneurysm and are lif threatening.
  • the aorta is the main artery which supplies blood to the circulatory system
  • the aorta arises from the left ventricle of the heart, passing upward and bending ove behind the heart and passing down through the thorax and abdomen.
  • the abdomina aorta supplies two side vessels to the kidneys, the renal arteries.
  • the abdominal aorta continues to about the level of the fourth lumba vertebrae where it divides into the iliac arteries.
  • the iliac arteries in turn, supply bloo to the lower extremities and perineal region.
  • an aortic aneurysm It is common for an aortic aneurysm to occur in that portion of the abdominal aorta between the renal arteries and the iliac arteries. This portion of the abdominal aorta is particularly susceptible to weakening, resulting in an aortic aneurysm.
  • An aortic aneurysm larger than about 4 cm. in diameter in this section of the aorta is ominous. Left untreated, the aneurysm may rupture, resulting in rapid and usually fatal hemorrhaging.
  • Aneuiysms in the abdominal aorta are associated with a particularly high mortality rate. Accordingly, current medical standards call for urgent operative repair of abdominal aortic aneurysms. Abdominal surgery itself is a major procedure resulting in substantial stress to the body. Although the mortality rate for an aortic aneurysm is extremely high, there is also considerable mortality and morbidity associated with surgical intervention to repair an aortic aneurysm. This intervention involves going through the abdominal wall to the location of the aneurysm to bypass or replace the diseased section of the aorta at the aneurysm. A prosthetic device, typically a synthetic tube, is used for this purpose. This graft serves to exclude the aneurysm from the circulatory system, thus relieving pressure and stress on the weakened section of the aorta at the aneurysm.
  • Kornberg discloses an aortic graft comprising a flexible tubular material havin a plurality of struts to lend the graft stability and resiliency.
  • the struts have angle hooks with barbs at their upper ends which are securely attached to the inside of th aorta above the aneurysm.
  • Kornberg's graft is inserted using a tubular device als disclosed in his patent.
  • Kornberg anchors only the proximal end of the graft in the aorta Kornberg claims that the downward flow of blood holds the distal graft securely in plac so that no mechanical attachment is necessary distally.
  • the blood pressure in the abdominal aorta i typically in the magnitude of 130 mm of mercury.
  • SUBSTITUTE SHEET will result unless the distal end is also mechanically attached. Without distal attachment, the device of Kornberg will not effectively exclude the weakened arterial wall at the site of the aneurysm from the forces and stress associated with the blood pressure.
  • Lazarus discloses a grafting system that employs a plurality of staples mounted in the proximal end of the graft. Lazarus's staples are forced through the aorta wall by means of a balloon catheter. As does Kornberg, however, Lazarus discloses staples mounted only in the proximal end of the graft. There is no teaching or suggestion in Lazarus, U.S. Patent No. 4,787,899 as to the desirability or means for mechanically attaching the graft to the distal aorta below the level of the aneurysm.
  • Lazarus U.S. Patent No. 4,787,899 also discloses various means for repairing the aorta. Among them are surgical techniques, the use of nitinol coil, and various graft systems that are implaced by the use of a balloon catheter system.
  • a further object of the invention is to provide a means for repairing an aortic aneurysm in patients who cannot tolerate major abdominal surgery.
  • a further object of the invention is to reduce the risk of morbidity and mortality associated with extensive surgical procedures.
  • Another object of the invention is to provide a means to quickly stabilize patients suffering from an aortic aneurysm as an emergency procedure.
  • SUBSTITUTE SHEET Yet a further object of the invention is to provide a means for treatment of abdominal aortic aneurysm without major surgical intervention.
  • a further object of the invention is to provide a device for repair of abdominal aortic aneurysms while reducing the morbidity and mortality associated with surgical procedures for repair of abdominal aortic aneurysms.
  • An additional object of the invention is to provide a procedure and system for repairing abdominal aortic aneurysms at greatly reduced cost in terms of medical resources relative to intraabdominal surgical repair of the aneurysm.
  • an additional object of the invention is to provide a procedure and system for repairing abdominal aortic aneurysms at greatly reduced cost to the patient in terms of medical expenses, rehabilitation, morbidity, and recovery time.
  • the invention is an aortic graft for performing an aortic anastomosis on a section of aorta, comprising, aortic graft means, having cephalic and caudal ends, and having an axis, a plurality of attachment means attached to said cephalic and caudal ends of said aortic graft means for securing said aortic graft means to the aorta, said attachment means having base means, oriented in substantially parallel relation to said axis of said aortic graft means, and attached to said aortic graft means, post means, attached to said base member and extending substantially radially away from said aortic graft means, and hook means oriented in substantially parallel relation to said axis, attached to the distal end of said post means for penetrating the aorta and securing said graft means to the aorta.
  • the aortic graft of the invention is employed in a process for excluding from the circulation and, thus, rendering safe, an aortic aneurysm through the use of a balloon catheter and aortic graft comprising the steps of, inserting a contrast filled balloon catheter into the aneurysm to a proximal point just above the aneurysm abutting unaffected arterial tissue; measuring the diameter of the aorta at the proximal point just above the aneurysm; removing the contrast filled balloon catheter from the proximal point and placing it in the affected artery at a distal point just below the aneurysm abutting unaffected arterial tissue; measuring the diameter of the vessel at said distal point, just below the aneurysm; removing the contrast filled balloon catheter; measuring the distance between said proximal and distal points through radiographic techniques; inserting along with a double balloon catheter a graft having first and second ends substantially 1-4 mm larger than
  • Fig. 1 is an enlarged coronal view of the aortic graft of the present invention shown with a double balloon catheter system that is used to implant it.
  • Fig. 2 is an enlarged view of an attachment means of a preferred embodiment of the present invention.
  • Fig. 3 is a coronal view of a balloon catheter being inserted into the cephalic end of the affected artery above the aneurysm in order to measure the diameter of the vessel.
  • Fig. 4 is a coronal view of a contrast filled balloon catheter being inserted into the caudal end of the abdominal artery below the aneurysm to measure the diameter of the vessel.
  • Fig. 5 is a coronal view of the aortic graft and double balloon catheter system of the present invention inserted into the abdominal artery so that the cephalic and caudal ends of the aortic graft are aligned with the cephalic and caudal portions of the aorta above and below the aneurysm, respectively.
  • Fig. 6 is a coronal view of the cephalic abdominal aorta above the aneurysm with the aortic graft and double balloon catheter system inserted, showing the penetration of the aorta wall of the attachment means as the cephalic balloon is inflated.
  • Fig. 7 is a coronal view of the aortic graft and cephalic balloon of Fig. 6 shown at a subsequent stage during inflation of the cephalic balloon as attachment means have penetrated the aorta wall.
  • SUBSTITUTE SHEET Fig. 8 is a coronal view of the caudal abdominal aorta below the aneurysm with the aortic graft and double balloon catheter system inserted, showing the penetration o the aorta wall of the attachment means as the caudal balloon is inflated.
  • Fig. 9 is a coronal view of the aortic graft and cephalic balloon of Fig. 8 show at a subsequent stage during inflation of the caudal balloon as attachment means hav penetrated the aorta wall.
  • Fig. 10 is a coronal view of the aortic graft of the present invention afte attachment means of cephalic and caudal ends have been implanted in the aorta wall an the double balloon catheter system has been withdrawn, excluding the aneurysm.
  • Fig. 11 is a top view of a retainer ring of the present invention.
  • Fig. 12 is an oblique view of an alternative form of the retainer ring of th present invention.
  • Fig. 13 is a coronal view of the cephalic end of aortic graft of the presen invention showing installation of retainer ring in cephalic end with a balloon catheter.
  • Fig. 14 is a coronal view of the caudal end of aortic graft of the presen invention showing installation of retainer ring in caudal end with a balloon catheter.
  • Fig 15 is a coronal view of the aortic graft of the present invention showing th graft implanted in the aorta excluding the aortic aneurysm.
  • Fig. 1 illustrates aortic graft means 10 for repairing an abdominal aortic aneurysm 12. As illustrated in Fig. 3, the aortic aneurysm 12 is located in the abdominal aorta 11 between the renal arteries 15 and the iliac arteries 16.
  • aortic graft 10 of the present invention can also be used in other locations without departing from the scope or spirit of the appended claims.
  • the graft could be used on any type of fluid conducting vessel such as sections of arteries located in other parts of the body or other types of vessels.
  • aortic graft means 10 of the present invention comprises an aortic graft 18 having cephalic 19 and caudal 20 ends and a body 21.
  • the aortic graft 18 of the present invention is preferably fabricated from a flexible, yet resilient, material such as polytetrafluoroethylene (Teflon) or other material having similar flexible and resilient properties.
  • Teflon polytetrafluoroethylene
  • Other substance such as natural or synthetic polymeric substances (such as polyester fabric, Dacron, Mylar, Rayon, cellulose acetate, cellulose butynate) may also be used.
  • a critical consideration is that the substance of which the aortic graft 18 is made be biologically inert and be compatible with the tissues into which the aortic graft is to be implanted. Many materials of this type are well known in the art.
  • aortic graft 18 has a plurality of attachment means 22 and a double balloon catheter system 35.
  • the graft can be prepared and packaged under sterile conditions and assembled in a kit comprising first catheter system for measuring the diameter of the aorta, aortic graft 18, with attachment means 22, a second catherer system which is a double balloon catheter system 35, and a third balloon catheter system 48 with retainer rings 45. It is contemplated that the aortic graft 18, double balloon catheter system 35, and third catheter system 48 of the present invention be manufactured in various sizes so that the system of the present
  • SUBSTITUTE SHEET invention is adaptable to the size and configuration of the aortic aneurysm of the individual patient.
  • attachment means 22 of the present invention comprises base means 23, post means 24, and hook means 25.
  • aortic graft 18 is provided with a plurality of attachment means 22, mounted in the cephalic 19 and caudal 20 ends of aortic graft 18.
  • base means 23 is constructed of a biologically compatible material such as metal or plastic.
  • Base 23 can be a small flat strip of metal that is oriented in substantially parallel relation to the axis of aortic graft 18.
  • Base 23 is attached to the cephalic 19 and caudal 20 ends of aortic graft 18. This attachment can be accomplished by a variety of means including, but not limited to, gluing, welding, riveting, or simply positioning base 23 so that the distal surface of base 23 abuts the proximal surface of the lumen of aortic graft 18 and is held in place by force exerted on post 24.
  • Post means 24 is a post that is preferably oriented in substantially perpendicular relation to base 23.
  • post 24 is mounted on the distal surface of base 23 so that post 24 extends radially outward from the axis of aortic graft 18 when base 23 is in mounted relation to aortic graft 18.
  • Base 23 may be secured to aortic graft 18 through a variety of means including gluing, riveting, welding, or other means that are biologically compatible and will provide a secure attachment of post 24 to base 23.
  • Base 23 can also be secured to aortic graft 18 by mounting base 23 in the lumen of aortic graft 18 so that the distal surface of base 23 abuts the proximal surface of the lumen of aortic graft 18 so that post 24 penetrates and
  • SUBSTITUTE SHEET extends through aortic graft 18. Force exerted on the distal end of post 24 then holds base 23 and post 24 in place.
  • hook means 25 is a hook that is mounted on the distal end of post 24.
  • Hook 25 is oriented substantially parallel relation to base 23 and, thus, the axis of aortic graft 18 when it is implanted in aorta 11.
  • the limb of hook 25 on which tip 26 is located is longer as measured from post 23 than the end of hook 25 distal from tip 26.
  • hook 25 may have one or more barbs 27 for holding attachment means 22 and aortic graft 18 firmly in place relative to aorta 14 at the cephalic 12 and caudal 13 portions of the abdominal aorta above and below aneurysm 11 respectively.
  • Aortic graft means 10 is implanted in abdominal aorta 11 through the use of a double balloon catheter system 35.
  • the double balloon catheter system 35 of the present invention is oriented so that when the balloons are inflated, tip 26 of hook 25 engages the wall of aorta 11 in substantially non-parallel relation in order to facilitate hook 25 penetrates abdominal aorta 11 to secure aortic graft 18 of the present invention to aorta 11.
  • attachment means 22 of the present invention without departing from the scope or spirit of the claimed invention.
  • Post 24 in turn could assume various configurations, provided the distal end of post 24 extends radially from aortic graft 18 to penetrate through aorta 11.
  • Hook 25 could also assume various configurations and orientations, provided it is oriented in a manner so that it does not pose a hazard to nearby organs or systems when aortic graft 18 as implanted in aorta 11.
  • attachment means 22 could be oriented so that it does not rotate in order to penetrate aorta 11 but, rather, simply erodes through aorta 11.
  • aortic graft means 10 can perhaps best be illustrated by the operation of the double balloon catheter system 35.
  • Implantation of the aortic graft means of the present invention involves several steps. First, an incision is made in the femoral artery 17 or iliac artery 16 to provide a means of access to aneurysm 12.
  • a first balloon catheter assembly 28 is employed to measure certain critical features of aorta 11.
  • First balloon catheter 28, as embodied herein, comprises a guide wire 29, a balloon 30, a supply tube 31, a first balloon catheter sheath 32, and contrast material 33.
  • Guide wire 29 is inserted through the incision in femoral artery 17 or iliac artery 16 with first catheter assembly 28.
  • Balloon 30 is filled with a radioopaque contrast material 33 to allow visualization of balloon 30 by radiographic means.
  • Catheter assembly 28 is threaded through the opening of femoral artery 17 or iliac artery 16 until balloon 30 of first catheter 28 has been inserted into aneurysm 12 in the abdominal aorta 11.
  • balloon 30 is aligned with the cephalic portion 13 of the abdominal aorta 11 above aneurysm 12.
  • Balloon 30 is then inflated until it engages the interior surface of the cephalic portion 13 of abdominal aorta 11 immediately above aneurysm 12.
  • Radiographic system 34 is then employed to measure the diameter of the abdominal aorta 11 at its cephalic portion 13, above the aneurysm. This measurement is then recorded.
  • first catheter assembly 28 is then withdrawn until balloon 30 is aligned with the caudal portion 14 of abdominal aorta 11 below aneurysm 12.
  • Balloon 30 is reinflated until it abuts the interior wall of abdominal aorta 11 at the caudal portion 14 of the abdominal aorta 11 below aneurysm 12.
  • Radiographic system 34 is again employed to measure the diameter of abdominal aorta 11 at the caudal portion of abdominal aorta below aneurysm 12. This measurement is also recorded.
  • aortic graft 18 is preferably 2 to 10 mm longer than the distance between the cephalic 13 and caudal 14 portions of abdominal aorta 11 as determined by the radiographic system 34.
  • Aortic graft means 10 of the present invention comprises aortic graft 18, attachment means 22, and double balloon catheter system 35.
  • Double balloon catheter system 35 also comprises radioopaque markers 42. Radioopaque markers 42 are provided on the proximal 37 and distal 38 ends of cephalic balloon 36 as well as on the proximal 40 and distal 41 ends of caudal balloon 39, of double balloon catheter 35. As shown in Fig.
  • aortic graft 10 is inserted through the opening in femoral artery 17 or iliac artery 16 until cephalic balloon 36 is aligned with cephalic portion 13 of abdominal aorta 11 and caudal balloon 39 is aligned with caudal portion 14 of abdominal aorta 11.
  • Cephalic balloon 36 is then inflated. As shown in Fig. 6, inflation of cephalic balloon 36 begins at the distal end 38 of cephalic balloon 36. As distal end 38 of cephalic balloon 36 is inflated, abutting attachment means 22 rotate so that the distal ends of base 23 are moved radially outward from the axis of aortic graft 18 while the proximal ends of base 23 remain proximate to axis of aortic graft 18. This rotation orient tips 26 of hooks 25 in substantially non-parallel relation to abdominal aorta 11. As cephalic balloon 36 is inflated further, tip 26 engages abdominal aorta 11. Inflation of cephalic balloon 36 forces tip 26 to penetrate abdominal aorta wall 11 so that hook 25 extends through abdominal aorta wall 11. Barb 27 passes through the penetration so
  • cephalic balloon 36 As shown in Fig. 7, inflation of cephalic balloon 36 continues in this manner, forcing attachment means 22 through abdominal aorta wall 11 until cephalic balloon 36 is fully inflated.
  • attachment means 22 on cephalic portion 19 of aortic graft 18 will penetrate abdominal aorta wall 11 at cephalic region 13, firmly and permanently anchoring aortic graft 18 to abdominal aorta 11.
  • Cephalic balloon 36 is fully inflated and attachment means 22 and cephalic portion 19 of aortic graft 18 are anchored in proximal portion 13 of vessel wall 11, cephalic balloon is left fully distended.
  • cephalic balloon 36 effectively closes off the flow of blood through abdominal aorta 11 during the remainder of the procedure. Inflation of cephalic balloon 36 firmly holds the cephalic portion 19 of aortic graft 18 in place while the caudal portion 20 of aortic graft 18 is being implanted in the caudal portion 14 of abdominal aorta 11.
  • caudal portion 20 of aortic graft 18 is implanted in caudal portion 14 of abdominal aorta 11 by inflating caudal balloon 39 of double balloon system 35 beginning at the proximal end 40 of caudal balloon 39.
  • proximal end 40 of caudal balloon 39 is inflated, attachment means 22 in caudal portion 20 of aortic graft 18 rotate as described above with respect to cephalic end 19 so that attachment means 22 of caudal portion of aortic graft 18 are firmly and permanently mounted in caudal portion 14 of abdominal aorta 11, as shown in Fig. 9.
  • aortic graft 18 is seated both proximally and distally in abdominal aorta 11. At that point, cephalic 19 and caudal 20 portions of aortic graft 18 effectively exclude further blood from the proximal or distal aorta from reaching aneurysm 11.
  • Body 21 of aortic graft 18 functions as abdominal aorta wall 11 of aneurysm 12. As shown in Fig. 10, once aortic graft 18 is fully seated in cephalic 13 and caudal 14 portions of abdominal
  • aortic graft means 10 further comprises retainer means 45.
  • Retainer means 45 can be a resilient ring of material which functions to hold aortic graft 18 firmly in place in abdominal aorta 11.
  • retainer 45 comprises body 46, locking means 47.
  • retainer 45 can be a split ring which is configured so that the two ends of the split ring cooperate to form a smooth ring.
  • retiner 45 can be a resilient mesh web as shown in Fig. 12.
  • Body 46 of the web preferably comprises legs which are mounted in relation to each other so that the web can collapse to allow for for insertion and to lock in place once it has been implanted and expanded.
  • retainer 45 is inserted into abdominal aorta 11 through the use of third catheter system 48.
  • Retainer 45 has radioopaque markers 42 on its proximal and distal surfaces.
  • radiographic system 34 tracks the location of retainer 45 relative to cephalic portion 13 and 19 of the abdominal aorta 14 and aortic graft 18, respectively.
  • SUBSTITUTE SHEET cephalic balloon 49 is inflated. As cephalic balloon 49 is distended, locking means 47 engage, fixing retainer 45 in the aorta 11 the open position. Once balloon 30 has been fully inflated so that retainer 45 is fully expanded, retainer 45 distends aortic graft 18 and aorta 11, forcing aortic graft 18 and attachment means 22 against cephalic portion 13 of abdominal aorta 11.
  • caudal balloon 50 is then inflated, locking retainer 45 in the caudal portion of aortic graft 20 and aorta 14.
  • Third catheter system 48 is then removed, along with guide wire 29.
  • the incision in femoral artery 17 or iliac artery 16, through which the procedure was performed, is then closed and sutured. Circulation to the lower limbs is restored with aortic graft 18 excluding aneurysm 12 from circulation.
  • aortic graft means 10 can be used with or without retainer 45.
  • Retainer 45 could assume a variety of configurations, shapes and sizes while performing the function of securing aortic graft means 10 and abdominal aorta 14.
  • Attachment means 22 could also assume a variety of configurations in accordance with the scope and spirit of the appended claims.
  • the direction in which each of the balloons of the double balloon catheter system 35 is inflated is not critical, provided attachment means 22 is oriented relative, to the direction of inflation of cephalic 36 and caudal 39 balloons to facilitate penetration of aorta 11.
  • the present invention cover the modifications and variations of the invention, provided they come within the scope of the appended claims or their equivalents.

Abstract

Greffe d'aorte, système (10) et procédé d'implantation de la greffe d'aorte. La greffe d'aorte (18) comprend un matériau essentiellement cylindrique avec un organe de fixation (22) formé d'une pluralité d'ensembles de montants (24) et de crochets (25) implantés au moyen d'un système (35) à deux cathéters de façon à pénétrer dans la paroi (11) de l'aorte en amont et en aval d'un anévrisme (12), assurant ainsi une fixation solide de la greffe (18) d'aorte et l'exclusion de l'anévrisme (12) du système circulatoire.
EP19900909889 1989-06-19 1990-06-15 Aortic graft and method for repairing aneurysm Withdrawn EP0429629A4 (en)

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US36771689A 1989-06-19 1989-06-19
US367716 1989-06-19

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EP0429629A1 EP0429629A1 (fr) 1991-06-05
EP0429629A4 true EP0429629A4 (en) 1991-11-13

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EP (1) EP0429629A4 (fr)
JP (1) JPH07106213B2 (fr)
KR (1) KR950012177B1 (fr)
AU (1) AU632592B2 (fr)
CA (1) CA2033195C (fr)
WO (1) WO1990015582A1 (fr)

Families Citing this family (63)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5104399A (en) 1986-12-10 1992-04-14 Endovascular Technologies, Inc. Artificial graft and implantation method
US7166125B1 (en) 1988-03-09 2007-01-23 Endovascular Technologies, Inc. Intraluminal grafting system
US5669936A (en) * 1983-12-09 1997-09-23 Endovascular Technologies, Inc. Endovascular grafting system and method for use therewith
US5749920A (en) * 1983-12-09 1998-05-12 Endovascular Technologies, Inc. Multicapsule intraluminal grafting system and method
US5275622A (en) * 1983-12-09 1994-01-04 Harrison Medical Technologies, Inc. Endovascular grafting apparatus, system and method and devices for use therewith
US5578071A (en) * 1990-06-11 1996-11-26 Parodi; Juan C. Aortic graft
US5360443A (en) * 1990-06-11 1994-11-01 Barone Hector D Aortic graft for repairing an abdominal aortic aneurysm
AR246020A1 (es) * 1990-10-03 1994-03-30 Hector Daniel Barone Juan Carl Un dispositivo de balon para implantar una protesis intraluminal aortica para reparar aneurismas.
US6682557B1 (en) 1991-04-11 2004-01-27 Endovascular Technologies, Inc. Bifurcated multicapsule intraluminal grafting system and method
CA2202800A1 (fr) 1991-04-11 1992-10-12 Alec A. Piplani Greffe endovasculaire comportant une bifurcation et appareil et methode permettant de mettre la greffe en place
AU658915B2 (en) * 1991-07-04 1995-05-04 Earl Ronald Owen Tubular surgical implant
EP0593600B1 (fr) * 1991-07-04 1999-01-13 OWEN, Earl Ronald Implant chirurgical tubulaire
US5316023A (en) 1992-01-08 1994-05-31 Expandable Grafts Partnership Method for bilateral intra-aortic bypass
US5562725A (en) * 1992-09-14 1996-10-08 Meadox Medicals Inc. Radially self-expanding implantable intraluminal device
CA2125258C (fr) * 1993-08-05 1998-12-22 Dinah B Quiachon Systeme de greffe intraluminale multicapsulaire et methode
US5609627A (en) 1994-02-09 1997-03-11 Boston Scientific Technology, Inc. Method for delivering a bifurcated endoluminal prosthesis
US6051020A (en) 1994-02-09 2000-04-18 Boston Scientific Technology, Inc. Bifurcated endoluminal prosthesis
AU3783195A (en) * 1994-11-15 1996-05-23 Advanced Cardiovascular Systems Inc. Intraluminal stent for attaching a graft
CA2171896C (fr) * 1995-03-17 2007-05-15 Scott C. Anderson Extenseur a ancrage multiple
WO1996036297A1 (fr) * 1995-05-19 1996-11-21 Kanji Inoue Instrument de transplantation, procede pour le courber et procede pour le transplanter
US6814748B1 (en) 1995-06-07 2004-11-09 Endovascular Technologies, Inc. Intraluminal grafting system
FR2743293B1 (fr) * 1996-01-08 1998-03-27 Denis Jean Marc Endoprothese aorto-iliaque
US5824042A (en) 1996-04-05 1998-10-20 Medtronic, Inc. Endoluminal prostheses having position indicating markers
US6133547A (en) 1996-09-05 2000-10-17 Medtronic, Inc. Distributed activator for a two-dimensional shape memory alloy
US5941249A (en) * 1996-09-05 1999-08-24 Maynard; Ronald S. Distributed activator for a two-dimensional shape memory alloy
US5976178A (en) * 1996-11-07 1999-11-02 Vascular Science Inc. Medical grafting methods
WO1998019635A1 (fr) * 1996-11-07 1998-05-14 Vascular Science Inc. Procedes et dispositifs pour manipuler des tubes utilises dans des actes medicaux
US6136007A (en) * 1997-04-17 2000-10-24 St. Jude Medical Cardiovascular Group, Inc, Apparatus for handling tubing used in medical procedures
DE19731834A1 (de) 1997-07-24 1999-06-17 Ernst Peter Prof Dr M Strecker Implantationsvorrichtung
FR2768921B1 (fr) * 1997-10-01 1999-12-10 Braun Celsa Sa Ensemble comprenant une prothese intraluminale et un moyen d'etancheite de cette prothese
US6511506B2 (en) 1997-10-01 2003-01-28 B. Braun Celsa Medical set for intervention on an anatomical duct, sealing ring pertaining to said set and use of said ring
ES2222609T3 (es) * 1997-10-01 2005-02-01 B. Braun Celsa Conjunto medico de intervencion sobre un conducto anatomico y collar de estanqueidad que pertenece a dicho conjunto.
US6248116B1 (en) 1997-12-16 2001-06-19 B. Braun Celsa Medical treatment of a diseased anatomical duct
WO1999030637A1 (fr) * 1997-12-16 1999-06-24 B. Braun Celsa Traitement medical d'une affection de conduit anatomique
US6626919B1 (en) 1997-12-29 2003-09-30 Lee L. Swanstrom Method and apparatus for attaching or locking an implant to an anatomic vessel or hollow organ wall
US6808498B2 (en) 1998-02-13 2004-10-26 Ventrica, Inc. Placing a guide member into a heart chamber through a coronary vessel and delivering devices for placing the coronary vessel in communication with the heart chamber
FR2777450B1 (fr) * 1998-04-16 2000-10-13 Braun Celsa Sa Dispositif medical pour traiter un anevrisme
US6669707B1 (en) 1998-07-21 2003-12-30 Lee L. Swanstrom Method and apparatus for attaching or locking an implant to an anatomic vessel or hollow organ wall
FR2773058B1 (fr) * 1998-11-24 2001-11-02 Braun Celsa Sa Moyen de fixation d'un implant a un conduit anatomique et ensemble medical pour traiter une affection de ce conduit
US6162246A (en) * 1999-02-16 2000-12-19 Barone; Hector Daniel Aortic graft and method of treating abdominal aortic aneurysms
US6613078B1 (en) 2000-08-02 2003-09-02 Hector Daniel Barone Multi-component endoluminal graft assembly, use thereof and method of implanting
US6602286B1 (en) 2000-10-26 2003-08-05 Ernst Peter Strecker Implantable valve system
US7513867B2 (en) 2003-07-16 2009-04-07 Kardium, Inc. Methods and devices for altering blood flow through the left ventricle
US7854761B2 (en) 2003-12-19 2010-12-21 Boston Scientific Scimed, Inc. Methods for venous valve replacement with a catheter
US7566343B2 (en) 2004-09-02 2009-07-28 Boston Scientific Scimed, Inc. Cardiac valve, system, and method
US20060173490A1 (en) 2005-02-01 2006-08-03 Boston Scientific Scimed, Inc. Filter system and method
US7867274B2 (en) 2005-02-23 2011-01-11 Boston Scientific Scimed, Inc. Valve apparatus, system and method
US7722666B2 (en) 2005-04-15 2010-05-25 Boston Scientific Scimed, Inc. Valve apparatus, system and method
US8012198B2 (en) 2005-06-10 2011-09-06 Boston Scientific Scimed, Inc. Venous valve, system, and method
US7569071B2 (en) 2005-09-21 2009-08-04 Boston Scientific Scimed, Inc. Venous valve, system, and method with sinus pocket
US7749249B2 (en) 2006-02-21 2010-07-06 Kardium Inc. Method and device for closing holes in tissue
US8449605B2 (en) 2006-06-28 2013-05-28 Kardium Inc. Method for anchoring a mitral valve
US7837610B2 (en) 2006-08-02 2010-11-23 Kardium Inc. System for improving diastolic dysfunction
US7967853B2 (en) 2007-02-05 2011-06-28 Boston Scientific Scimed, Inc. Percutaneous valve, system and method
US20090287304A1 (en) 2008-05-13 2009-11-19 Kardium Inc. Medical Device for Constricting Tissue or a Bodily Orifice, for example a mitral valve
US20110082538A1 (en) 2009-10-01 2011-04-07 Jonathan Dahlgren Medical device, kit and method for constricting tissue or a bodily orifice, for example, a mitral valve
DE102009047925A1 (de) * 2009-10-01 2011-06-16 Qualimed Innovative Medizinprodukte Gmbh Endoluminales schlauchförmiges Stentgraft
US9050066B2 (en) 2010-06-07 2015-06-09 Kardium Inc. Closing openings in anatomical tissue
US8940002B2 (en) 2010-09-30 2015-01-27 Kardium Inc. Tissue anchor system
US9072511B2 (en) 2011-03-25 2015-07-07 Kardium Inc. Medical kit for constricting tissue or a bodily orifice, for example, a mitral valve
US9668859B2 (en) 2011-08-05 2017-06-06 California Institute Of Technology Percutaneous heart valve delivery systems
WO2014144247A1 (fr) 2013-03-15 2014-09-18 Arash Kheradvar Mécanisme de poignée et fonctionnalité permettant de repositionner et d'extraire des valvules cardiaques transcathéter
AR104494A1 (es) 2016-04-27 2017-07-26 Daniel Barone Hector Prótesis aórtica para el tratamiento de aneurismas aórticos abdominales

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2805749A1 (de) * 1977-02-18 1978-08-24 Mahmood Hasan Choudhury Vorrichtung zum reparieren eines blutgefaesses
WO1989008433A1 (fr) * 1988-03-09 1989-09-21 Lazarus Harrison M Greffe artificielle et procede d'implantation

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3815578A (en) * 1973-05-11 1974-06-11 Investors In Ventures Inc Method of inserting an implant into a portion of a tubular organ whose mucous lining has been partially removed
US4562596A (en) * 1984-04-25 1986-01-07 Elliot Kornberg Aortic graft, device and method for performing an intraluminal abdominal aortic aneurysm repair
EP0183372A1 (fr) * 1984-10-19 1986-06-04 RAYCHEM CORPORATION (a Delaware corporation) Corps extensible de prothèse
JPS6395050A (ja) * 1986-10-08 1988-04-26 鐘淵化学工業株式会社 人工血管
US4872874A (en) * 1987-05-29 1989-10-10 Taheri Syde A Method and apparatus for transarterial aortic graft insertion and implantation

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2805749A1 (de) * 1977-02-18 1978-08-24 Mahmood Hasan Choudhury Vorrichtung zum reparieren eines blutgefaesses
WO1989008433A1 (fr) * 1988-03-09 1989-09-21 Lazarus Harrison M Greffe artificielle et procede d'implantation

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO9015582A1 *

Also Published As

Publication number Publication date
JPH04500328A (ja) 1992-01-23
KR950012177B1 (ko) 1995-10-14
JPH07106213B2 (ja) 1995-11-15
KR920700594A (ko) 1992-08-10
CA2033195A1 (fr) 1990-12-20
EP0429629A1 (fr) 1991-06-05
WO1990015582A1 (fr) 1990-12-27
AU632592B2 (en) 1993-01-07
AU5858990A (en) 1991-01-08
CA2033195C (fr) 1994-11-15

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