Blood Flow Bypass Catheters and Methods for the Delivery of Medium to the Vasculature and Body Ducts

Abstract

A catheterization device that may be designed by use of an adaptive genetic algorithm computational fluid dynamics approach, as well as other Global Optimization methods that may include simulated annealing, multistart and interval methods, con-tinuous branch and bound methods, evolutionary algorithms, and tabu search and scatter search methods, as well as other available Global Optimization methods that is able to maximize/optimize the dwell time of an infused agent in the vicinity of a vascular lesion. The device may have an internal by-pass channel that allows the blood upstream of the lesion to continue its pulsatile flow through the vessel in the part of it occluded by the lesion, while simultaneously allowing the disbursement and maximal dwell time of an antithrombolytic or other diagnostic or therapeutic agent needed to treat the lesion. Different embodiments of the catheterization device are disclosed and indications for the use of these devices in the treatment of vascular diseases are discussed.

1 . A catheter device for insertion into a vascular structure or body duct, wherein said catheter device designed by employment of a global optimization algorithm based computational fluid dynamics approach, wherein said catheter device having a distal end and a proximal end for delivery of a medium to a lesion, said device comprising:
 a blood lumen for allowing blood to pass there through;   a medium lumen for the delivery of a medium to the lesion, said medium lumen comprising at least one medium egress port for communication with the lesion;   an expandable component disposed on said catheter device to block or impede the vascular flow of blood in the vascular structure or body duct; and   said blood lumen comprising at least one blood entrance port proximally before said expandable component to allow blood to enter and at least one blood egress port distally beyond said expandable component to allow blood to pass distally beyond said expandable component.   
   
   
       2 . The device of  claim 1 , wherein the medium comprises at least one of agent, substance, material, thrombolytic agents, clot lysis agents, chemotherapies, cell slurries, gene therapy vectors, growth factors, contrast agents, angiogenesis factors, radionuclide slurries, anti-infection agents, anti-tumor compounds, receptor-bound agents and/or other types of drugs, therapeutic agent and/or diagnostic agent. 
   
   
       3 . The device of  claim 1 , wherein:
 said expandable component comprises at least one port, said at least one port of said expandable component being in communication with said at least one medium egress port for communication of the medium with the lesion.   
   
   
       4 . The device of  claim 3 , wherein a plurality of said at least one port of said expandable component comprises a porous surface of said expandable component. 
   
   
       5 . The device of  claim 1 , wherein said expandable component is at least one of inflatable balloon, angioplasty balloon means, an occlusive stent, a mechanically or otherwise expandable sleeve, a chemically or otherwise activated foam-based occluder, an electrically or magnetically activated occlusion means, or any combination of said such occlusive devices, means and methods. 
   
   
       6 . The device of  claim 5 , wherein said angioplasty balloon is inflated by fluid provided through a delivery lumen of said catheter. 
   
   
       7 . The device of  claim 1 , wherein said expandable component being actuated by at least one of the following processes: hydraulically, pneumatically, electrically, magnetically, chemically or by some other physical process. 
   
   
       8 . The device of  claim 1 , wherein said expandable component is a temporarily enlargeable lining of outer wall of said catheter device. 
   
   
       9 . The device of  claim 8 , wherein said enlargement being actuated by at least one of the following processes: hydraulically, pneumatically, electrically, magnetically, chemically or by some other physical process. 
   
   
       10 . The device of  claim 1 , further comprising a means for pumping said medium through said medium lumen. 
   
   
       11 . The device of  claim 10 , wherein said pumping means comprises at least one of syringe, flow-driver, or pumping device. 
   
   
       12 . The device of  claim 1 , further comprising a plurality of micro-coils disposed near or at the distal tip of said catheter, said micro-coils for improved magnetic resonance imaging and/or magnetic resonance spectroscopy. 
   
   
       13 . The device of  claim 1 , wherein said global optimization algorithm comprises a genetic algorithm. 
   
   
       14 . The device of  claim 1 , wherein said global optimization algorithm comprises at least one of simulated annealing, multistart and interval methods, continuous branch and bound methods, evolutionary algorithms, and tabu search and scatter search methods, as well as other available Global Optimization methods. 
   
   
       15 . A method for delivering a medium to a lesion inside of a vascular structure or body duct by inserting a catheter device designed by a global optimization algorithm based computational fluid dynamics approach into a subject, said catheter device having a distal end and a proximal end, lumens there through, medium port holes, and blood port holes, wherein said method comprises:
 inflating an expandable component to block or impede the vascular flow of blood or other body fluid through the vasculature structure or the body duct;   delivering the medium through one of said lumens to said lesion through at least one of said medium port holes; and   allowing blood of the vasculature of the subject to proximally enter through at least one of said blood port holes and flow through one of said lumens and to exit on a side of said lesion toward said distal end of said catheter device through at least one of said blood port holes.   
   
   
       16 . The method of  claim 15 , wherein the medium comprises at least one of agent, substance, material, thrombolytic agents, clot lysis agents, chemotherapies, cell slurries, gene therapy vectors, growth factors, contrast agents, angiogenesis factors, radionuclide slurries, anti-infection agents, anti-tumor compounds, receptor-bound agents and/or other types of drugs, therapeutic agent and/or diagnostic agent. 
   
   
       17 . The method of  claim 15 , wherein said inflating comprises placing said expandable component on a side of said lesion that is toward said distal end of said catheter device or placing a portion of said expandable component on a side of said lesion that is toward said distal end of said catheter device. 
   
   
       18 . The method of  claim 15 , wherein said inflating comprises placing said expandable component on a side of said lesion that is toward said proximal end of said catheter device or placing a portion of said expandable component on a side of said lesion that is toward said proximal end of said catheter device. 
   
   
       19 . The method of  claim 15 , wherein said inflating comprises placing said expandable component to surround said lesion or at least partially surround said lesion. 
   
   
       20 . The method of  claim 15 , wherein said inflating comprises placing said expandable component adjacent to said lesion or at least partially adjacent to said lesion. 
   
   
       21 . The method of  claim 15 , wherein said delivering the medium comprises sending the medium through said medium port holes that are:
 located on a side of said expandable component that is toward said distal end of said catheter device, or   partially located on a side of said expandable component that is toward said distal end of said catheter device.   
   
   
       22 . The method of  claim 15 , wherein said delivering comprises:
 sending said medium through said medium port holes that are
 located on a side of said expandable component that is toward said proximal end of said catheter device, or 
 partially located on a side of said expandable component that is toward said proximal end of said catheter device; and 
   re-entering said medium through said medium port holes.   
   
   
       23 . The method of  claim 15 , wherein:
 said expandable component comprises a at least one port hole disposed thereto or in communication therewith; and   said delivering comprises sending said medium through said expandable component.   
   
   
       24 . The method of  claim 15 , further comprising performing an angioplasty procedure on said lesion using said expandable component. 
   
   
       25 . The method of  claim 15 , further comprising controlling the rate of irrigation of said medium with said lesion. 
   
   
       26 . The method of  claim 15 , wherein said global optimization algorithm comprises a genetic algorithm. 
   
   
       27 . The method of  claim 15 , wherein said global optimization algorithm comprises at least one of simulated annealing, multistart and interval methods, continuous branch and bound methods, evolutionary algorithms, and tabu search and scatter search methods, as well as other available Global Optimization methods. 
   
   
       28 . A method for generating a configuration of elements of a catheter device for use inside a vasculature or body duct of a subject that includes inserting said catheter device into the subject, said catheter device comprising passages for blood flow and medium flow and inlet and exit ports for blood flow and medium flow, said method comprising:
 selecting variables including at least one of:
 a) geometrical shapes and dimensions of at least some of said blood passages and said medium passages, and 
 b) relative locations and orientations of flow planes of at least some of said inlet ports and exit ports; and 
   applying a global optimization algorithm to the variables to generate a catheter with optimized flow conditions.   
   
   
       29 . The method of  claim 28 , wherein said variables further comprise:
 velocity components, vorticity components, pressure, and/or concentration of blood and/or medium at specific locations of blood and/or medium inside and outside of the catheter device.   
   
   
       30 . The method of  claim 28 , wherein said variables further comprise at least one of:
 a) shear stresses and/or vorticity components of the flow of the blood and/or medium inside and outside said catheter device; and   b) concentration and residence time of medium in the vicinity of the specific location outside said catheter device.   
   
   
       31 . The method of  claim 30 , wherein the specific location outside said catheter device being located in the vasculature or tubular body duct. 
   
   
       32 . The method of  claim 30 , wherein said variables further comprise at least one of:
 Reynolds, Schmidt and/or Pulsating Flow parameters for the blood and/or medium.   
   
   
       33 . The method of  claim 30 , wherein said method further comprises applying constraints to said generation comprising at least one of:
 a) maximum or minimum allowed sizes of the catheter and/or dimensions said passages;   b) maximum allowed flow speeds and/or shear stresses;   c) maximum allowed pressure drop and skin friction;   e) maximum allowed medication concentration; and   f) overall expected elapsed time needed for treatment.   
   
   
       34 . The method of any one of  claims 28 ,  29 ,  30 ,  32  and  33 , wherein said global optimization algorithm comprises a genetic algorithm. 
   
   
       35 . The method of any one of  claims 28 ,  29 ,  30 ,  32  and  33 , wherein said global optimization algorithm comprises at least one of simulated annealing, multistart and interval methods, continuous branch and bound methods, evolutionary algorithms, and tabu search and scatter search methods, as well as other available Global Optimization methods. 
   
   
       36 . The method of  claim 28 , wherein the medium comprises at least one of agent, substance, material, thrombolytic agents, clot lysis agents, chemotherapies, cell slurries, gene therapy vectors, growth factors, contrast agents, angiogenesis factors, radionuclide slurries, anti-infection agents, anti-tumor compounds, receptor-bound agents and/or other types of drugs, therapeutic agent and/or diagnostic agent. 
   
   
       37 . A computer program product comprising a computer useable medium having computer program logic for enabling at least one processor in a computer system to generate a configuration of elements on a catheter device, wherein said catheter device intended for use inside a vasculature or body duct of a subject that includes inserting said catheter device into the subject, said catheter device comprising passages for blood flow and medium flow and inlet and exit ports for blood flow and medium flow, said computer program logic comprising:
 selecting variables including at least one of:
 a) geometrical shapes and dimensions of at least some of said blood passages and said medium passages, and 
 b) relative locations and orientations of flow planes of at least some of said inlet ports and exit ports; and 
   applying a global optimization algorithm to the variables to generate a catheter with optimized flow conditions.   
   
   
       38 . The computer program product of  claim 37 , wherein said variables further comprise:
 velocity components, vorticity components, pressure, and/or concentration of blood and/or medium at specific locations of blood and/or medium inside and outside of the catheter device.   
   
   
       39 . The computer program product of  claim 37 , wherein said variables further comprise at least one of:
 a) shear stresses and/or vorticity components of the flow of the blood and/or medium inside and outside said catheter device; and   b) concentration and residence time of medium in the vicinity of the specific location outside said catheter device.   
   
   
       40 . The computer program product of  claim 39 , wherein the specific location outside said catheter device being located in the vasculature or tubular body duct. 
   
   
       41 . The computer program product of  claim 39 , wherein said variables further comprise at least one of:
 Reynolds, Schmidt and/or Pulsating Flow parameters for the blood and/or medium.   
   
   
       42 . The computer program product of  claim 39 , wherein said method further comprises applying constraints to said generation comprising at least one of:
 a) maximum or minimum allowed sizes of the catheter and/or dimensions of said passages;   b) maximum allowed flow speeds and/or shear stresses;   c) maximum allowed pressure drop and skin friction,   e) maximum allowed medication concentration; and   f) overall expected elapsed time needed for treatment.   
   
   
       43 . The computer program product of any one of  claims 37 ,  38 ,  39 ,  41  and  42 , wherein said global optimization algorithm comprises a genetic algorithm. 
   
   
       44 . The computer program product of any one of  claims 37 ,  38 ,  39 ,  41  and  42 , wherein said global optimization algorithm comprises at least one of simulated annealing, multistart and interval methods, continuous branch and bound methods, evolutionary algorithms, and tabu search and scatter search methods, as well as other available Global Optimization methods. 
   
   
       45 . A catheter device for insertion into a vascular structure or body duct, wherein said catheter device having a distal end and a proximal end for delivery of a medium to a lesion, said device comprising:
 a blood lumen for allowing blood to pass there through;   a medium lumen for the delivery of a medium to the lesion, said medium lumen comprising at least one medium egress port for communication with the lesion;   an expandable component disposed on said catheter device to block or impede the vascular flow of blood in the vascular structure or body duct; and   said blood lumen comprising at least one blood entrance port proximally before said expandable component to allow blood to enter and at least one blood egress port distally beyond said expandable component to allow blood to pass distally beyond said expandable component.   
   
   
       46 . The device of  claim 45 , wherein the medium comprises at least one of agent, substance, material, thrombolytic agents, clot lysis agents, chemotherapies, cell slurries, gene therapy vectors, growth factors, contrast agents, angiogenesis factors, radionuclide slurries, anti-infection agents, anti-tumor compounds, receptor-bound agents and/or other types of drugs, therapeutic agent and/or diagnostic agent. 
   
   
       47 . The device of  claim 45 , wherein:
 said expandable component comprises at least one port, said at least one port of said expandable component being in communication with said at least one medium egress port for communication of the medium with the lesion.   
   
   
       48 . The device of  claim 47 , wherein a plurality of said at least one port of said expandable component comprises a porous surface of said expandable component. 
   
   
       49 . The device of  claim 45 , wherein said expandable component is at least one of inflatable balloon, angioplasty balloon means, an occlusive stent, a mechanically or otherwise expandable sleeve, a chemically or otherwise activated foam-based occluder, an electrically or magnetically activated occlusion means, or any combination of said such occlusive devices, means and methods. 
   
   
       50 . The device of  claim 49 , wherein said angioplasty balloon is inflated by fluid provided through a delivery lumen of said catheter. 
   
   
       51 . The device of  claim 45 , wherein said expandable component being actuated by at least one of the following processes: hydraulically, pneumatically, electrically, magnetically, chemically or by some other physical process. 
   
   
       52 . The device of  claim 45 , wherein said expandable component is a temporarily enlargeable lining of outer wall of said catheter device. 
   
   
       53 . The device of  claim 52 , wherein said enlargement being actuated by at least one of the following processes: hydraulically, pneumatically, electrically, magnetically, chemically or by some other physical process. 
   
   
       54 . The device of  claim 45 , further comprising a means for pumping said medium through said medium lumen. 
   
   
       55 . The device of  claim 54 , wherein said pumping means comprises at least one of syringe, flow-driver, or pumping device. 
   
   
       56 . The device of  claim 45 , further comprising a plurality of micro-coils disposed near or at the distal tip of said catheter, said micro-coils for improved magnetic resonance imaging and/or magnetic resonance spectroscopy. 
   
   
       57 . A method for delivering a medium to a lesion inside of a vascular structure or body duct by inserting a catheter device into a subject, said catheter device having a distal end and a proximal end, lumens there through, medium port holes, and blood port holes, wherein said method comprises:
 inflating an expandable component to block or impede the vascular flow of blood or other body fluid through the vasculature structure or the body duct;   delivering the medium through one of said lumens to said lesion through at least one of said medium port holes; and   allowing blood of the vasculature of the subject to proximally enter through at least one of said blood port holes and flow through one of said lumens and to exit on a side of said lesion toward said distal end of said catheter device through at least one of said blood port holes.   
   
   
       58 . The method of  claim 57 , wherein the medium comprises at least one of agent, substance, material, thrombolytic agents, clot lysis agents, chemotherapies, cell slurries, gene therapy vectors, growth factors, contrast agents, angiogenesis factors, radionuclide slurries, anti-infection agents, anti-tumor compounds, receptor-bound agents and/or other types of drugs, therapeutic agent and/or diagnostic agent. 
   
   
       59 . The method of  claim 57 , wherein said inflating comprises placing said expandable component on a side of said lesion that is toward said distal end of said catheter device or placing a portion of said expandable component on a side of said lesion that is toward said distal end of said catheter device. 
   
   
       60 . The method of  claim 57 , wherein said inflating comprises placing said expandable component on a side of said lesion that is toward said proximal end of said catheter device or placing a portion of said expandable component on a side of said lesion that is toward said proximal end of said catheter device. 
   
   
       61 . The method of  claim 57 , wherein said inflating comprises placing said expandable component to surround said lesion or at least partially surround said lesion. 
   
   
       62 . The method of  claim 57 , wherein said inflating comprises placing said expandable component adjacent to said lesion or at least partially adjacent to said lesion. 
   
   
       63 . The method of  claim 57 , wherein said delivering the medium comprises sending the medium through said medium port holes that are:
 located on a side of said expandable component that is toward said distal end of said catheter device, or   partially located on a side of said expandable component that is toward said distal end of said catheter device.   
   
   
       64 . The method of  claim 57 , wherein said delivering comprises:
 sending said medium through said medium port holes that are
 located on a side of said expandable component that is toward said proximal end of said catheter device, or 
 partially located on a side of said expandable component that is toward said proximal end of said catheter device; and 
   re-entering said medium through said medium port holes.   
   
   
       65 . The method of  claim 57 , wherein:
 said. expandable component comprises a at least one port hole disposed thereto or in communication therewith; and   said delivering comprises sending said medium through said expandable component.   
   
   
       66 . The method of  claim 57 , further comprising performing an angioplasty procedure on said lesion using said expandable component. 
   
   
       67 . The method of  claim 57 , further comprising controlling the rate of irrigation of said medium with said lesion.