Method for closing a blood passage of a blood vessel

Abstract

A method for closing a blood passage of a blood vessel in an operation region of a patient, wherein said operation region is located just before said blood passage, said method comprising a step of releasing a pure undiluted cyanoacrilate-based surgical glue in the operation region, in order to cause a sudden interaction of said surgical glue with blood and other biological material present in the operation region and to cause the formation of an acrylic polymer matrix, which incorporates the blood and biological material forming a plug that stops said blood passage (FIG. 27 ).

1 . A method for closing a blood passage of a blood vessel in an operation region of a patient, wherein said operation region is located just before said blood passage, said method comprising:
 releasing a pure undiluted cyanoacrilate-based surgical glue in the operation region, in order to cause a sudden interaction of said surgical glue with blood and other biological material present in the operation region and to cause the formation of an acrylic polymer matrix, which incorporates the blood and biological material forming a plug that stops said blood passage.   
     
     
         2 . A method according to  claim 1 , wherein said blood passage is selected among a percutaneous entry site of an artery or of a vascular prosthesis, or a blood passage of a pseudoaneurysm. 
     
     
         3 . A method according to  claim 1 , wherein said cyanoacrilate-based surgical glue is selected from the group comprised of N-butyl-2-cianoacrylate. 2-octyl-2-cianoacrylate. 
     
     
         4 . A method according to  claim 1 , wherein said operation region is selected as a region facing an entry site and rich of fat, lymph, periadventitial tissues. 
     
     
         5 . A method according to  claim 1 , wherein said releasing of said surgical glue comprises the steps of:
 prearranging a duct that has an inlet port and an outlet mouth for said surgical glue;   inserting said duct through an opening made on a skin plane of said patient;   advancing said duct through a biological medium of the patient's body until said operation region is reached, in such a way that, once reached said operation region, said outlet mouth is in said operation region and said inlet port remains outside of said opening in said skin plane;   hydraulically connecting said inlet port with a source of said surgical glue and with a pressurizing means that can be operated by an operator for applying an injection pressure on said surgical glue;   operating said pressurizing means causing an outflow of said surgical glue through said duct and then said releasing of surgical glue at said operation region through said outlet mouth;   
       wherein a step is also provided of:
 prearranging a liquid contact preventing means that is associated to said duct, said liquid contact preventing means adapted to impede in said duct a contact of said surgical glue with said biological medium prior to said outflow, in particular a contact of said surgical glue with blood of said patient. 
 
     
     
         6 . A method for closing an entry site of an artery or of a vascular prosthesis according to  claim 2 , said vascular entry site engaged by an introducer sheath, wherein said surgical glue is released in a channel that has been created by the introducer sheath and that is left free by extracting the introducer sheath from the entry site. 
     
     
         7 . A method according to  claim 6 , wherein a step is provided of compression by an operator's finger of said skin plane near the percutaneous entry site and, while maintaining this compression, said introducer sheath is extracted through said skin plane, such that said compression assists disengaging said surgical glue from a surface of said introducer sheath and releasing said surgical glue into said channel, engages mainly with such biological materials as fat, lymph, periadventitial tissues, sticking together the walls of the channel and sealing the channel. 
     
     
         8 . A method according to  claim 6 , wherein said step of advancing through a biological medium of the patient's body is carried out by causing a translation of said duct on said introducer sheath, said duct slidingly coupled on said elongated introducer sheath, a coupling means being provided which is adapted to couple said duct with said elongated introducer sheath. 
     
     
         9 . A method according to  claim 8 , wherein said coupling means comprises a short tube that is coaxially coupled with said elongated introducer sheath. 
     
     
         10 . A method according to  claim 9 , wherein said surgical glue is released in an annular narrow space that is defined between said short tube and said introducer sheath, such that said surgical glue reaches said operation region through said annular narrow space. 
     
     
         11 . A method according to  claim 5 , wherein a step is provided of prearranging a block means integral to said duct, said block means adapted to engage with said skin plane during said step of advancing, said step of advancing stopped when said block means abuts against said skin plane. 
     
     
         12 . A method according to  claim 5 , wherein steps are provided of:
 prearranging a liquid-retaining means for retaining a barrier liquid in said duct;   selecting a barrier liquid;   introducing said barrier liquid into said duct;   prearranging a liquid outflow means for causing an outflow of said barrier liquid through said duct;   operating said liquid outflow means,   
       such that said barrier liquid interposes between said surgical glue and said outlet mouth, and such that, by operating said liquid outflow means and said pressurizing means, from said outlet mouth firstly a releasing of said barrier liquid occurs and then said releasing of surgical glue occurs, 
       such that said surgical glue is substantially undiluted when it is released at said operation region. 
     
     
         13 . A method according to  claim 12 , wherein said barrier liquid is elected from the group comprised of:
 a saline solution;   a glucose solution;   distilled water.   
     
     
         14 . A method according to  claim 12  for treating a pseudoaneurysm that is directly connected to an artery, or one that is connected to an artery through a small duct, i.e. formations that are defined by a tissue around a blood vessel, and that pulsate due to said blood that enters and exits through a direct passage, or a duct, the method providing steps of:
 compression upon a skin plane above the blood vessel upstream with respect to said pseudoaneurysm, and then a 
 compression upon a skin plane above said pseudoaneurysm until said pseudoaneurysm is completely deflated and shrunk on the wall of said blood vessel, after a needle has been inserted which allows blood to flow out of the pseudoaneurysm to prevent the walls from being broken due to the compression, said needle stably filled with a saline solution; 
 preferably under echographic control, guiding a device that comprises said needle as a duct for the haemostasis of the pseudoaneurysms, through said tissues; 
 releasing surgical glue in a pure state into said shrunk pseudoaneurysm, where said surgical glue reacts completely and creates a matrix with the tissues which is suitable for blocking said passage, such that no dissolution of surgical glue occurs into said blood vessel or through said tissues; 
 interruption of said compression upon said skin plane 
 
     
     
         15 . A method according to  claim 14 , wherein said pseudoaneurysm is connected to an artery through a small duct, said method comprising a step of:
 releasing a dose of said surgical glue in said duct for definitively clogging said duct; and of   percutaneous aspiration of said pseudoaneurysm.   
     
     
         16 . A method for carrying out a percutaneous endovascular intervention according to  claim 1 , wherein said operation region is a remote operation region located far from an entry site, said method comprising the steps of
 prearranging a duct, i.e. a catheter, adapted to move along an endovascular path in a patient, said duct having an inlet port and an outlet mouth for a surgical glue;   prearranging a liquid-retaining means for retaining a barrier liquid in said duct;   selecting a barrier liquid;   introducing said barrier liquid into said duct;   prearranging a liquid outflow means for causing an outflow of said barrier liquid through said duct;   inserting said duct through an opening on a skin plane of said patient;   moving said catheter through the blood vessels, under echographic or radiographic control, until achieving with said outlet mouth said endovascular remote operation region, in such a way that, once reached said operation region, said outlet mouth is in said operation region and said inlet port remains outside of said opening in said skin plane;   hydraulically connecting said inlet port with a source of said surgical glue and with a pressurizing means that can be operated by an operator for applying an injection pressure on said surgical glue;   operating said liquid outflow means,   
       such that said barrier liquid interposes between said surgical glue and said outlet mouth, and such that, by operating said liquid outflow means and said pressurizing means, from said outlet mouth firstly a releasing of said barrier liquid occurs and then said releasing of surgical glue occurs, 
       such that said surgical glue is substantially undiluted when it is released at said operation region. 
     
     
         17 . A method according to  claim 16 , wherein said percutaneous endovascular intervention is selected from the group comprised of:
 an embolization of a blood vessel,   a treatments of a arteriovenous malformation or of small aneurysmatic disease, such as a small cerebral aneurysm,   an arterial dissection.   
     
     
         18 . A method according to  claim 16 , wherein said barrier liquid comprises a radiographic liquid contrast agent, and said step of moving said catheter through said blood vessels, i.e. along an endovascular path of the patient's body, is carried out under radiographic control, such that a radiographic means can be used for displaying the point that has been selected for releasing the surgical glue. 
     
     
         19 . A method according to  claim 1 , wherein said blood passage provides a supply of blood by arteries to a type II endoleak of an aneurysm, an endoprosthesis being previously tightly arranged about the aneurysm, such that a continuity is created between the sections of the blood vessels that are interested by the aneurysm, said method comprising:
 percutaneously pricking said aneurysm;   bringing said surgical glue, to the terminals of the lumbar arteries.