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US20080262467A1 - Blood Flow Bypass Catheters and Methods for the Delivery of Medium to the Vasculature and Body Ducts - Google Patents

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

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US20080262467A1
US20080262467A1 US11/884,421 US88442106A US2008262467A1 US 20080262467 A1 US20080262467 A1 US 20080262467A1 US 88442106 A US88442106 A US 88442106A US 2008262467 A1 US2008262467 A1 US 2008262467A1
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Prior art keywords
medium
blood
lesion
expandable component
catheter
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Joseph A.C. Humphrey
George T. Gillies
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UVA Licensing and Ventures Group
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    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • 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
    • A61M25/1011—Multiple balloon catheters
    • 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
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/007—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests for contrast media
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes

Definitions

  • the invention relates to the field of catheterization devices and methods for delivering a medication or the like to a lesion in a vascular structure or duct of a patient, as well as a method of for generating configuration catheterization device designs for optimizing performance.
  • PVD peripheral vascular disease
  • CAD coronary artery disease
  • PVD typically affects multiple segments of a given artery. Short segments of severe narrowing are typically treated with catheter-based techniques such as angioplasty and the placement of one or more stents. When there is severe narrowing over a long segment or involving multiple arteries within a limb, surgical revascularization is the treatment of choice. When this is insufficient, particularly in the diabetic population, limb amputation is indicated, and an estimated 60,000 are performed annually in the United States. Severe narrowing within the vessel or related causes of poor blood flow commonly result in the formation of intra-arterial thrombus (clot) formation, which, if not immediately corrected, will lead to the death of tissue and the need for amputation of the host limb. Endovascular catheter placement for the delivery of a thrombolytic agent to dissolve the clot is efficacious, but commonly requires days of drug infusion, intensive care monitoring, and frequent trips to a radiology suite to reposition the catheter.
  • therapeutic agents allows for wide-spread distribution of these agents throughout the body.
  • the function of the therapeutic agent depends upon the uptake of the medication by the targeted organ and upon the agent's pharmacokinetics which determine its concentration as a function of time.
  • non-targeted organs may be adversely affected by the medication, and this can cause potentially serious side-effects. Consequently, the efficacy of the therapeutic agents at the target site can be limited by both its concentration at the site of interest and by its toxicity in other non-targeted organs.
  • the clinical benefits of site-specific catheter-based delivery systems for the administration of therapeutics can include increased safety, increased efficacy, reduced toxicities, more reliable therapeutic drug levels, and decreased and simplified dosing requirements.
  • Safety, efficacy and toxicity are all independent but related parameters in the pharmacokinetics of each therapeutic agent.
  • Site-specific drug delivery into the target tissue ensures that the majority of the drug goes to the site it is intended to act upon with minimal or at least small and tolerable effect upon non-targeted tissue, thereby decreasing the effects of toxicity. This allows for higher concentrations of the therapeutic agent to be administered to the targeted site, thereby increasing the efficacy of the agent.
  • An additional benefit of site-specific delivery of therapeutic agents is that the patient receives a smaller cumulative dose, thereby further reducing the overall risk to the patient.
  • Site-specific catheter-based drug delivery allows local administration of therapeutic agents and reliable therapeutic drug levels to be achieved and maintained because systemic clearance is reduced. By obtaining reliable therapeutic drug levels in this manner, dosing requirements are decreased and simplified. As mentioned above, local drug levels can be maintained at higher levels than could be achieved with systemic administration because systemic toxicity is reduced with local delivery.
  • a site-specific drug-delivery catheter is also required when active biologic agents are being administered to a focal site of injury.
  • site-specific delivery of thrombolytic therapy to the site of a clot in the vascular tree of an ischemic limb is preferred to systemic delivery.
  • site-specific delivery a high local concentration of the thrombolytic agent can be delivered to achieve lysis of the clot material at the site of infusion, whereas, systemic delivery of a thrombolytic therapy could lead to generalized bleeding at multiple remote sites.
  • One alternative that can obviate the problem of washout of the thrombolytic agent downstream from the lesion is to occlude the artery with a blockage means such as a balloon placed distally from the lesion being treated. While effective over brief periods intra-operatively, this approach does limit the time over which the agent can act, because downstream arterial occlusion cannot be maintained indefinitely without ischemic injury to dependent tissues and organs. These problems arise not only with the catheter-based delivery of thrombolytics, but also when delivering new and emerging classes of agents such as stem cell suspensions and angiogenesis factors.
  • Zadno-Azizi et al. Zadno-Azizi G R, Patel M R, Muni K P, Bagaosian C J, Ha H V: Method for Containing and Removing Occlusions in the Carotid Arteries. U.S. Pat. No. 6,90,204, 2004, of which is hereby incorporated by reference herein in its entirety).
  • catheter designs are provided for which the blood flow through the region of the lesion can continue uninterrupted while the medication is being simultaneously applied to the lesion such that the treatment concentration levels and time are optimized.
  • methods for positioning and utilizing the catheter are provided for optimizing the concentration and dwell time of the medication being applied to the lesion.
  • An aspect of various embodiments of the present invention provides a catheter device for insertion into a vascular structure or body duct, wherein the catheter device is designed by employment of a global optimization algorithm based computational fluid dynamics approach.
  • the catheter device having a distal end and a proximal end for delivery of a medium to a lesion.
  • the device comprising: a blood lumen for allowing blood to pass there through; a medium lumen for the delivery of a medium to the lesion, the medium lumen comprising at least one medium egress port for communication with the lesion; an expandable component disposed on the catheter device to block or impede the vascular flow of blood in the vascular structure or body duct; and the blood lumen comprising at least one blood entrance port proximally before the expandable component to allow blood to enter and at least one blood egress port distally beyond the expandable component to allow blood to pass distally beyond the expandable component.
  • the global optimization algorithm may comprise a genetic algorithm/method.
  • the global optimization algorithm may comprise 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. Furthermore, any other suitable and available approach/algorithm may be implemented as well.
  • An aspect of various embodiments of the present invention provides for 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.
  • the catheter device having a distal end and a proximal end, lumens there through, medium port holes, and blood port holes.
  • the 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 the lumens to the lesion through at least one of the medium port holes; and allowing blood of the vasculature of the subject to proximally enter through at least one of the blood port holes and flow through one of the lumens and to exit on a side of the lesion toward the distal end of the catheter device through at least one of the blood port holes.
  • the global optimization algorithm may comprise a genetic algorithm/method.
  • the global optimization algorithm may comprise 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. Furthermore, any other suitable and available approach/algorithm may be implemented as well.
  • An aspect of various embodiments of the present invention provides for 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 the catheter device into the subject.
  • the catheter device comprising passages for blood flow and medium flow and inlet and exit ports for blood flow and medium flow.
  • the method comprising: selecting variables including at least one of: a) geometrical shapes and dimensions of at least some of the blood passages and the medium passages, and b) relative locations and orientations of flow planes of at least some of the inlet ports and exit ports; and applying a global optimization algorithm to the variables to generate a catheter with optimized flow conditions.
  • the global optimization algorithm may comprise a genetic algorithm/method.
  • the global optimization algorithm may comprise 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. Furthermore, any other suitable and available approach/algorithm may be implemented as well.
  • An aspect of various embodiments of the present invention provides for 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.
  • the catheter device intended may be intended for use inside a vasculature or body duct of a subject that includes inserting the catheter device into the subject.
  • the catheter device comprising passages for blood flow and medium flow and inlet and exit ports for blood flow and medium flow.
  • the computer program logic comprising: selecting variables including at least one of: a) geometrical shapes and dimensions of at least some of the blood passages and the medium passages, and b) relative locations and orientations of flow planes of at least some of the inlet ports and exit ports; and applying a global optimization algorithm to the variables to generate a catheter with optimized flow conditions.
  • the global optimization algorithm may comprise a genetic algorithm/method.
  • the global optimization algorithm may comprise 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.
  • any other suitable and available approach/algorithm may be implemented as well.
  • An aspect of various embodiments of the present invention provides for a catheter device for insertion into a vascular structure or body duct, wherein the catheter device includes a distal end and a proximal end for delivery of a medium to a lesion.
  • the device comprising: a blood lumen for allowing blood to pass there through; a medium lumen for the delivery of a medium to the lesion, the medium lumen comprising at least one medium egress port for communication with the lesion; an expandable component disposed on the catheter device to block or impede the vascular flow of blood in the vascular structure or body duct; and the blood lumen comprising at least one blood entrance port proximally before the expandable component to allow blood to enter and at least one blood egress port distally beyond the expandable component to allow blood to pass distally beyond the expandable component.
  • the medium may include, for example and not limited thereto, at least one of the following: agent, substance, material, fluid, gas/air, 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.
  • agent substance, material, fluid, gas/air, 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.
  • An aspect of various embodiments of the present invention provides 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.
  • the catheter device may have a distal end and a proximal end, lumens there through, medium port holes, and blood port holes.
  • the 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 the lumens to the lesion through at least one of the medium port holes; and allowing blood of the vasculature of the subject to proximally enter through at least one of the blood port holes and flow through one of the lumens and to exit on a side of the lesion toward the distal end of the catheter device through at least one of the blood port holes.
  • the medium may include, for example and not limited thereto, at least one of the following: agent, substance, material, fluid, gas/air, 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.
  • agent substance, material, fluid, gas/air, 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.
  • An aspect of various embodiments of the present invention provides 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, continuous branch and bound methods, evolutionary algorithms, and tabu search and scatter search methods, as well as other available algorithms/methods that is able to, for example, 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.
  • FIGS. 1 and 2 are cross-sectional side views of the catheter design of the present invention located within the lumen of a blood vessel where blood flow is occluded distal (or partially distal) to the lesion, and showing blood flow and delivery of an agent through the catheter.
  • FIGS. 3 and 4 are cross-sectional side views of the catheter design of the present invention located within the lumen of a blood vessel where blood flow is occluded proximal (or partially proximal) to the lesion, and showing blood flow and delivery of an agent through the catheter.
  • FIG. 5 is a cross-sectional side view of the catheter design of the present invention located within the lumen of a blood vessel where blood flow is occluded around the lesion (or partially around the lesion), and showing blood flow and delivery of an agent through the catheter.
  • FIG. 6 schematically illustrates a sectional view VI-VI of an embodiment of the blood flow by-pass catheter provided in FIG. 1 .
  • FIG. 7 schematically illustrates a perspective partial view taken at cross-sectional view VII-VII of the blood flow by-pass catheter provided in FIG. 2 .
  • FIG. 8 is a schematic diagram showing a subject undergoing an examination and/or intervention inside or in communication with the bore, component or module of an imaging system (or guidance, navigation or tracking system) whereby a catheter device is disposed within the subject.
  • FIG. 9 is a functional block diagram for a computer system for implementation of an exemplary embodiment or portion of an embodiment of present invention.
  • FIG. 1 shows one possible embodiment of a blood flow by-pass catheter 20 for irrigating thrombi or lesions in a blood vessel 10 with medium, such as medication or other diagnostic or therapeutic agent 16 , or other applicable agent, substance, material medium or fluid as desired or required.
  • medium such as medication or other diagnostic or therapeutic agent 16 , or other applicable agent, substance, material medium or fluid as desired or required.
  • Some examples of medium that may be transferred from the catheter 20 to the subject may include, but not limited thereto, the following: agent, substance, material, therapeutic and diagnostic agents, for example, 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 and/or diagnostic agents, and other such substances.
  • agent substance, material, therapeutic and diagnostic agents
  • therapeutic and diagnostic agents for example, 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 and/or diagnostic agents, and other such substances.
  • agent substance, material, therapeutic and diagnostic agents
  • the presence of the blockage forces the medium or medication to re-circulate in the vicinity of the thrombus or lesion 12 , thus permeating it completely.
  • the rate of irrigation is controlled by the pressure imposed on the medium or medicated flow and is essentially independent of the blood flow rate.
  • the performance of the catheter as determined by the flow and species transport through it shall depend on, among other things, its geometrical and dynamical characteristics.
  • the flow of medium, medication or other diagnostic or therapeutic agent 16 merges with the flow of blood 14 where it travels through the portholes 34 m and enters the inner lumen 31 , acting as the blood lumen, and is discharged with the blood downstream of the blockage.
  • a microcoil device 51 may be located at the tip of outer catheter 20 (or specified/desired location) to help enable a high contrast magnetic resonance imaging of the catheter and its environs or a magnetic resonance spectroscopy measurement (or any other available imaging/tracking/guiding methods, procedures, techniques or treatments available) of species proximal to the tip of catheter 20 in a blood vessel, body duct, brain or other locations of a patient or subject.
  • a magnetic resonance spectroscopy measurement or any other available imaging/tracking/guiding methods, procedures, techniques or treatments available
  • a plurality of the microcoil devices may be used on any combination of overall catheter systems (for example, see teaching described in commonly assigned International Patent Application Serial No.: PCT/US2005/026738, to Gillies et al. filed Jul. 28, 2005, entitled “Coaxial Catheter Systems for Transference of Medium” and corresponding U.S. application Ser. No. 11/191,676, filed Jul. 28, 2005, of which are hereby incorporated by reference herein in their entirety) to best accomplish the magnetic resonance imaging or spectroscopy.
  • a subject may be a human or any animal. It should be appreciated that an animal may be a variety of any applicable type, including, but not limited thereto, mammal, veterinarian animal, livestock animal or pet type animal, etc. As an example, the animal may be a laboratory animal specifically selected to have certain characteristics similar to human (e.g. rat, dog or pig), etc. It should be appreciated that the subject may be any applicable patient, for example.
  • the various components of the catheter device 20 as discussed herein may be a variety of commercially available materials used for all types of catheter systems.
  • materials used for the inner and outer catheters may include, but not limited thereto, the following: polymers, rubber, plastic, composites, metals, ceramics, hydrogels, dialysis membranes and other membranous materials, MR-compatible alloys and materials, and other organic and inorganic compounds and substances and the like.
  • the various components of the catheter device 20 including but not limited thereto, the inner and outer lumens and components thereof, may be flexible or rigid and combination thereof as required or desired for intended use.
  • the catheter device 20 may provide volume contoured delivery/withdrawal (i.e., transfer) of a medium or blood by adjusting its geometry and flexibility/rigidity according to the target location or anatomy (or region, including structure and morphology of any lesion) being treated.
  • FIG. 2 shows another possible embodiment of a blood flow by-pass catheter 20 for irrigating thrombi or lesions in a blood vessel 10 with a medium, such as a medication or other diagnostic or therapeutic agent 16 , or other applicable medium or fluid as desired or required.
  • the flow of blood 14 is blocked by a temporarily enlarged portion or expandable component 41 that may be in direct or indirect communication of the outer lumen (or passage) 26 of the catheter 20 downstream (or at least partially downstream) of the thrombus or lesion 12 .
  • the presence of the blockage forces the medication or other diagnostic or therapeutic agent 16 to re-circulate in the vicinity of the thrombus or lesion 12 , thus permeating it completely.
  • the rate of irrigation is controlled by the pressure imposed on the medicated flow and is essentially independent of the blood flow rate.
  • the performance of the catheter as determined by the flow and species transport through it shall depend on, among other things, its geometrical and dynamical characteristics.
  • the flow of medication or other diagnostic or therapeutic agent 16 merges with the flow of blood 14 where the blood enters through the portholes 24 into the outer lumen 26 , acting as the blood lumen, and is discharged with the blood downstream of the blockage.
  • FIG. 3 shows a third possible embodiment of a blood flow by-pass catheter 20 for irrigating thrombi or lesions in a blood vessel 10 with medication or other diagnostic or therapeutic agent 16 , or other applicable medium or fluid as desired or required.
  • the flow of blood 14 is blocked by a temporarily enlarged portion or expandable component 41 that may be in direct or indirect communication of the outer lumen 26 (or passage) of the catheter 20 upstream (or at least partially upstream) of the thrombus or lesion 12 .
  • the presence of the blockage forces the medication or other diagnostic or therapeutic agent 16 to re-circulate in the vicinity of the thrombus or lesion 12 , thus permeating it completely.
  • the rate of irrigation is controlled by the pressure imposed on the medicated flow and is essentially independent of the blood flow rate.
  • the performance of the catheter as determined by the flow and species transport through it shall depend on, among other things, its geometrical and dynamical characteristics.
  • the flow of medication or other diagnostic or therapeutic agent 16 exits from the port holes 35 b and merges with the flow of blood 14 downstream of the blockage and thrombus or lesion 12 .
  • FIG. 4 shows a fourth possible embodiment of a blood flow by-pass catheter 20 for irrigating thrombi or lesion in a blood vessel 10 with a medium, such as medication or other diagnostic or therapeutic agent 16 , or other applicable medium or fluid as desired or required.
  • the flow of blood 14 is blocked by a temporarily enlarged portion or expandable component 41 of the outer lumen of the catheter 20 upstream (or at least partially upstream) of the thrombus or lesion 12 .
  • the presence of the blockage forces the medication or other diagnostic or therapeutic agent 16 to re-circulate in the vicinity of the thrombus or lesion 12 , thus permeating it completely.
  • the rate of irrigation is controlled by the pressure imposed on the medicated flow and is essentially independent of the blood flow rate.
  • the performance of the catheter as determined by the flow and species transport through it shall depend on, among other things, its geometrical and dynamical characteristics.
  • the flow of medication or other diagnostic or therapeutic agent 16 merges with the flow of blood 14 downstream of the blockage and thrombus or lesion 12 .
  • FIG. 5 schematically illustrates a fifth possible embodiment of a blood flow by-pass catheter 20 for irrigating thrombi or lesions in a blood vessel 10 with a medium, such as medication or other diagnostic or therapeutic agent 16 , or other applicable medium or fluid as desired or required.
  • the flow of blood 14 is blocked by a temporarily enlarged portion or expandable component 41 of the outer lumen 26 (or passage) of the catheter 20 surrounding (or at least partially surrounding) the thrombus or lesion 12 .
  • the medication or other diagnostic or therapeutic agent 16 flows through an annular passage, acting as the agent lumen, in the outer lumen 26 (or passage) of the catheter 20 and, because the end of this passage is sealed at the blockage location, it emerges through port holes 25 m , of the outer lumen 26 for agent egress, in, through or transverse to the temporarily enlarged lining or expandable component 22 of the outer lumen 26 that surrounds or at least partially surrounds the thrombus or lesion 12 .
  • the medication or other diagnostic or therapeutic agent 16 seeps through openings 45 m in this porous lining (or other functional port holes) to bathe the thrombus or lesion 12 and permeates it completely.
  • the rate of irrigation is controlled by the pressure imposed on the medicated flow and is essentially independent of the blood flow rate.
  • the performance of the catheter as determined by the flow and species transport through it shall depend on, among other things, its geometrical and dynamical characteristics.
  • the flow of medication or other diagnostic or therapeutic agent 16 merges with the flow of blood 14 on either side of the thrombus or lesion 12 and is eventually carried downstream in the blood vessel 10 .
  • FIG. 6 schematically illustrates a sectional view VI-VI of an embodiment of the blood flow by-pass catheter 20 provided in FIG. 1 .
  • the catheter 20 contains an outer lumen (passage or annulus) 26 and an inner lumen (passage) 31 .
  • Either lumen can be used for the flow of blood or medium (e.g., medication), or inflating the means for blocking the flow of blood and/or medium.
  • FIG. 7 schematically illustrates a perspective partial view taken at cross-section VII-VII of the blood flow by-pass catheter 20 provided in FIG. 2 .
  • the catheter 20 contains an outer lumen (passage or annulus) 26 and an inner lumen (passage) 31 .
  • Either lumen can be used for the flow of blood or medium (e.g., medication), or inflating the means for blocking the flow of blood and/or medium.
  • a medium such as a medication or other diagnostic or therapeutic agent 16 , or other applicable medium or fluid as desired or required.
  • the flow of blood 14 is blocked by a temporarily enlarged portion or expandable component 41 (not shown) that may be in direct or indirect communication of the outer lumen (or passage) 26 of the catheter 20 downstream (or at least partially downstream) of the thrombus or lesion 12 .
  • the medication or other diagnostic or therapeutic agent 16 flows through the inner lumen (or passage) 31 , acting as the agent lumen, of the catheter 20 and, because the end of this passage is sealed at the blockage location (not shown), it emerges through port holes 35 m , for agent egress, near the thrombus or lesion 12 .
  • the presence of the blockage forces the medication or other diagnostic or therapeutic agent 16 to re-circulate in the vicinity of the thrombus or lesion 12 , thus permeating it completely.
  • angular off set (as designated by the angle referenced as AO) of the inlet passage, via port holes 24 b for blood entrance, and inlet let passage, via port holes 24 m for medium entrance, is along the circumference of the outer lumen or passage 26 .
  • these portholes may be arranged in a variety of ways or locations along the circumferential and axial (e.g., longitudinal) directions of the lumens.
  • FIGS. 1-7 may have been illustrated having various port holes 24 b , 24 m , 34 b , 34 m aligned circumferentially or axially (e.g., longitudinally) with one another.
  • the various port holes 24 b , 24 m , 34 b , 34 m may be arranged in a variety of locations and ways circumferentially and axially (e.g., longitudinally) along the inner lumen 31 (inner passage) and outer lumen 26 (outer passage) in support of the present invention discussed throughout.
  • the dimensions, shapes, contours and angular alignment of the port holes may be varied and designed according to the principals and aspects of the present invention.
  • the openings or portholes allowing the flow of blood to bypass the thrombus (or lesion) by entering the outer lumen, and the openings allowing the medication stream to exit the inner lumen are periodically or selectively distributed around (i.e., circumferentially) the catheter in each case.
  • catheter devices, systems and related methods we emphasize in what follows that these inlet and exit openings can be selectively shaped, staggered and positioned in the circumferential and/or axial (e.g., longitudinal) directions in order to generate non-intuitive patterns of placement that will result in highly three-dimensional, well-mixed flow patterns in the vicinity of the thrombus or lesion, thus benefiting its irrigation and maximizing the medication dwell time, such as concentration and dwell time optimization.
  • FIG. 8 is a schematic diagram showing a patient 110 , or any subject or object, undergoing an examination and/or intervention inside or in communication with the bore, component or module of an imaging system 112 whereby a catheter device 20 is disposed within the patient.
  • the imaging system 112 may be operative relative to any part, parts, vasculature, duct, cavity or anatomy of the patient, subject or object as desired or required for the applicable practice, method, treatment, therapy or procedure.
  • Various embodiments of the catheter device 20 , method of using the catheter device, and method of manufacturing the catheter device are capable of being adapted for various purposes and are not limited to use with the following imaging systems 112 including, but not limited thereto, the following: magnetic resonance imaging (MRI) systems, CT systems, radiotherapy systems, fluoroscopy systems, X-ray imaging systems, ultrasound systems, vascular imaging systems, nuclear imaging systems, positron emission tomography, magnetic resonance angiography, and magnetic resonance spectroscopy systems, and the like.
  • a manifold 114 couples several therapeutic or diagnostic devices typified by device 116 (or device for any applicable agent, substance, or material) to the delivery catheter 118 .
  • a syringe, flow-driver or pumping device 124 is also in communication with the manifold 114 .
  • the cell delivery catheter 118 in turn may be delivered through a guide sheath 120 that may be positioned in a navigation guide 122 .
  • the physician or user inserts the catheter device 118 into the blood vessel (or other anatomy part or duct or subject region) under image system guidance (e.g., MRI guidance or other applicable examination or intervention or imaging system discussed herein).
  • image system guidance e.g., MRI guidance or other applicable examination or intervention or imaging system discussed herein.
  • the same or similar imaging visualization or MRI visualization may be used to follow the progress of the implant both acutely and chronically.
  • This specific version of the catheter 20 within the concepts disclosed herein may have any of the attributes or related methods of use and manufacture as described herein.
  • the catheter device 20 may have various interior and peripheral ports, lumens and related elements within the context of the disclosure provided. Such interior and peripheral ports, lumens and related elements may be used to deliver other devices and perform various diagnostic functions. For example, each lumen, port and related catheter element may communicate with a separate port of the manifold 114 .
  • a lumen, chamber or channel may contain a sensor or transducer 128 , such as a pressure transducer, species concentration sensor, fluid motion stress sensor, or heat sensor, as well as other desired or required transducers or sensors.
  • Other lumens and channels may be devoted to an optical cell counter device, for example.
  • Such a device may operate with a plurality of fibers located in one or more separate lumens and/or ports to measure the number of and viability of cells or medium delivered by the catheter.
  • fiber optics related application/technology is discussed in U.S. patent application Ser. No. 10/444,884, filed May 23, 2003 (U.S. 2003/0204171, published Oct. 30, 2003), of which is hereby incorporated by reference herein in its entirety.
  • the blood and medication streams flowing through the catheter designs of interest may be unsteady, three-dimensional and laminar, and to correspond to incompressible constant property fluids.
  • the fluid stream passing through the core of the catheter is pulsating blood and that passing through the lumen and containing the medication is essentially water (saline).
  • saline essentially water
  • computational fluid dynamics is employed within the framework of an adaptive problem-solving methodology based on the use of Global Optimization methods, such as Genetic Algorithms (GAs), thus allowing optimal catheter design(s).
  • Gs Genetic Algorithms
  • aspects of various embodiments of the present invention provide, but not limited thereto, a strategy to dynamically accumulate information and use it to improve problem-solving performance.
  • GAs Genetic Algorithms
  • Genetic Algorithms belong to the class of Global Optimization methods that include, for example but not limited thereto, simulated annealing, multistart and interval methods, continuous branch and bound methods, evolutionary algorithms, and tabu search and scatter search methods, as well as other Global Optimization methods not specifically enumerated herein.
  • a goal of a Global Optimization method is to determine the absolutely best answer for problems, systems or procedures that offer a number of possible solutions.
  • a feature of the GA methodology is its robustness. Whereas Calculus-based optimization and search (hill-climbing) methods lack robustness. Calculus-based optimization and search (hill-climbing) methods are local in scope and, once a minimum or maximum is found, require random restarts to initiate searches for other minima/maxima.
  • the present solution methodology will work in a way similar to a classical control theory standard feedback loop, wherein a complex process (here the performance of a catheter as determined by the flow and species transport through it, which depend on its geometrical and dynamical characteristics) is connected to an adaptive solution strategy (the GA) via a feedback loop.
  • a complex process here the performance of a catheter as determined by the flow and species transport through it, which depend on its geometrical and dynamical characteristics
  • the GA adaptive solution strategy
  • Subject to input data such as catheter dimensions and flow and medication species boundary conditions, the conservation equations yield field solutions for the primary variables of interest like velocity, pressure and species concentration, and for secondary quantities derived from the primary like shear stresses and mass fluxes.
  • the primary and secondary quantities allow the evaluation of a preformulated performance measure and part of this numerical output is the input to the adaptive strategy used to optimize the catheter design.
  • the adaptive strategy is responsible for the dynamical accumulation of decision-making information through the feedback portion of the loop.
  • a GA is an adaptive search procedure loosely based on the Darwinian notion of evolution by natural selection (see, for instance, Davis L (Editor): Handbook of Genetic Algorithms . Van Nostrand Reinhold, New York, 1991, of which is hereby incorporated by reference herein in its entirety). It uses rules of natural selection to investigate highly complex, multidimensional, multivariable problems. GAs have been employed in a variety of search, optimization and machine learning applications in science and engineering where other more traditional methods either fail or are subject to significant limitations.
  • the objects to be optimized geometrically and dynamically here are the double lumen bypass catheters depicted in, for example, FIGS. 1-8 .
  • the variables could be, but not limited thereto, the following: a) the geometrical shapes and dimensions of the catheter passages; b) the relative locations and orientations of the various inlet and exit flow planes; c) the velocity components, pressure, and concentration at specific locations of blood and/or medium inside and outside the catheter; d) the shear stresses of the flows inside and outside the catheter; and/or e) the concentration and residence time of medication species in the vicinity of the thrombus.
  • Related parameters could be, but not limited thereto, the Reynolds, Schmidt and/or Pulsating Flow parameters.
  • Constraints could be, but not limited thereto, the following: a) the maximum or minimum allowed sizes of the catheter and of its passage dimensions; b) the maximum allowed flow speeds and/or shear stresses; c) the maximum allowed pressure drop and skin friction; e) the maximum allowed medication concentration; and/or f) the overall expected elapsed time needed for treatment.
  • the performance measure to be maximized is usually a complicated multidimensional function of quantities like the above and, often, it is multimodal, possessing several local maxima or minima.
  • an aspect of the various embodiments of the present invention is to provide, among other things, a geometrically and dynamically optimized physical catheter for fabrication and practical use based on a numerical optimization process. Further, an aspect of the various embodiments of the present invention is to provide, among other things, the capability to design and test a catheter, and which may be assisted by experimentation.
  • Various embodiments of the present invention catheter may use solutions of the conservation equations for different geometrical and dynamical renditions of the catheter as the data base from which to determine one or more optimal catheter designs. For this, the GA requires initial input values associated with an initial set of possible flow and concentration field solutions to commence the search for an optimal solution corresponding to one (or more) optimal catheter designs.
  • the GA improves upon these solutions.
  • the set of candidate solutions at time t, P(t), operated upon by the GA is called the population and each member of this set or generation, when encoded as a string of symbols, is called a chromosome.
  • Holland Holland J H: Adaptation in Natural and Artificial Systems . MIT Press, Cambridge, Mass., 1975, of which is hereby incorporated by reference herein in its entirety
  • a GA may be abstractly represented by the following sequence of operations:
  • each iteration in the ‘while’ loop produces a new generation of candidate solutions, also encoded as chromosomes.
  • candidate solutions also encoded as chromosomes.
  • each generation of parent solutions will produce a generation of children solutions (the new set of candidate solutions) which, in general, will have an average performance better than the parent generation.
  • the schema reveals the subset of chromosomes possessing similarities at certain chromosome positions and the schemata derived from good chromosome solutions within a generation provide the building blocks from which to synthesize improved solutions in the offspring generation.
  • ⁇ P M the time-averaged pressure drop between the inlet and exit locations of the medication stream and call [ ⁇ M ] T the time-averaged concentration of the medication species in the vicinity of the thrombus.
  • CF cost function or performance measure CF that rewards increases in [ ⁇ M ] T and penalizes increases in ⁇ P M .
  • the three most critical geometrical parameters bearing on the maximization of CF are the inner diameter D b of the passage through which the blood flows, the annulus gap size D m of the passage through which the medication stream (or applicable medium) flows, and the distance L i-e between the inlet and exit planes for the medication stream.
  • the distance L i-e would be due to the angular off set that the inlet passage and out let passage is along the circumference of the lumen(s). If we encode these quantities in microns using a 13 unit binary numbering scheme, then any of them can, in principle, range between 0000000000000 and 1111111111111 or, equivalently, between 0 and 8191 ⁇ m.
  • the initial set of candidate solutions or encoded chromosomes (in the present case, the geometrical and dynamical characteristics of a catheter) is usually selected randomly.
  • preliminary calculations can help narrow down the range of values.
  • the candidate solutions are encoded as fixed-length chromosomes for which different encoding schemes, such as binary (as illustrated above) and integer, have been used.
  • the ‘Evaluate’ procedure calculates the fitness of each chromosome; this is the measure of performance associated with each candidate solution. It is an important quantity since the probability that a chromosome in the parent population will contribute its schema to the offspring generation is proportional to the chromosome's relative fitness.
  • the function of the ‘Select’ procedure is to specify the actual number of offspring that each parent chromosome contributes to the next generation based on the relative performance of that chromosome. Different selection mechanisms are discussed in Baker J E: Reducing bias and efficiency in the selection algorithm. Proceedings of the Second International Conference on Genetic Algorithms, pp. 14-21.
  • the ‘Recombine’ procedure contains the GA operators that are expected to construct and propagate the schema responsible for good performance.
  • the most prominent GA ‘Recombine’ operators are crossover and mutation.
  • the crossover operator acts on two chromosomes at a time, on average generating fitter offspring by combining the schema in each parent.
  • the mutation operator usually involves the infrequent random alteration of the value of one or more bits in a chromosome.
  • the Select, Recombine and Evaluate procedures are repeated from generation to generation until some pre-established convergence or termination criterion is satisfied.
  • FIG. 9 is a functional block diagram for a computer system 900 for implementation of an exemplary embodiment or portion of an embodiment of present invention.
  • a method of an embodiment of the present invention may be implemented using hardware, software or a combination thereof and may be implemented in one or more computer systems or other processing systems, such as personal digit assistants (PDAs), operated to achieve the best-case or optimized configurations of the catheter devices shown in FIGS. 1-8 and discussed throughout.
  • PDAs personal digit assistants
  • the processing of computational fluid dynamics may be employed within the framework of an adaptive problem-solving methodology that is based on the use of present invention Global Optimization methods and techniques, such as Genetic Algorithms (GAs) that allow for optimal or best-case catheter device design(s).
  • GAs Genetic Algorithms
  • Computer system 900 includes one or more processors, such as processor 904 Processor 904 is connected to a communication infrastructure 906 (e.g., a communications bus, cross-over bar, or network).
  • Computer system 900 may include a display interface 902 that forwards graphics, text, and other data from the communication infrastructure 906 (or from a frame buffer not shown) for display on the display unit 930 .
  • Computer system 900 also includes a main memory 908 , preferably random access memory (RAM), and may also include a secondary memory 910 .
  • the secondary memory 910 may include, for example, a hard disk drive 912 and/or a removable storage drive 914 , representing a floppy disk drive, a magnetic tape drive, an optical disk drive, a flash memory, etc.
  • the removable storage drive 914 reads from and/or writes to a removable storage unit 918 in a well known manner.
  • Removable storage unit 918 represents a floppy disk, magnetic tape, optical disk, etc. which is read by and written to by removable storage drive 914 .
  • the removable storage unit 918 includes a computer usable storage medium having stored therein computer software and/or data.
  • secondary memory 910 may include other means for allowing computer programs or other instructions to be loaded into computer system 900 .
  • Such means may include, for example, a removable storage unit 922 and an interface 920 .
  • removable storage units/interfaces include a program cartridge and cartridge interface (such as that found in video game devices), a removable memory chip (such as a ROM, PROM, EPROM or EEPROM) and associated socket, and other removable storage units 922 and interfaces 920 which allow software and data to be transferred from the removable storage unit 922 to computer system 900 .
  • Computer system 900 may also include a communications interface 924 .
  • Communications interface 924 allows software and data to be transferred between computer system 900 and external devices.
  • Examples of communications interface 924 may include a modem, a network interface (such as an Ethernet card), a communications port (e.g., serial or parallel, etc.), a PCMCIA slot and card, a modem, etc.
  • Software and data transferred via communications interface 924 are in the form of signals 928 which may be electronic, electromagnetic, optical or other signals capable of being received by communications interface 924 .
  • Signals 928 are provided to communications interface 924 via a communications path (i.e., channel) 926 .
  • Channel 926 carries signals 928 and may be implemented using wire or cable, fiber optics, a phone line, a cellular phone link, an RF link, an infrared link, wireless link or connection and other communications channels.
  • computer program medium and “computer usable medium” are used to generally refer to media such as removable storage drive 914 , a hard disk installed in hard disk drive 912 , and signals 928 .
  • These computer program products are means for providing software to computer system 900 .
  • the invention includes such computer program products.
  • Computer programs are stored in main memory 908 and/or secondary memory 910 . Computer programs may also be received via communications interface 924 . Such computer programs, when executed, enable computer system 900 to perform the features of the present invention as discussed herein. In particular, the computer programs, when executed, enable processor 904 to perform the functions of the present invention. Accordingly, such computer programs represent controllers of computer system 900 .
  • the software may be stored in a computer program product and loaded into computer system 900 using removable storage drive 914 , hard drive 912 or communications interface 924 .
  • the control logic when executed by the processor 904 , causes the processor 904 to perform the functions of the invention as described herein.
  • the invention is implemented primarily in hardware using, for example, hardware components such as application specific integrated circuits (ASICs).
  • ASICs application specific integrated circuits
  • the invention is implemented using a combination of both hardware and software.
  • any activity can be repeated, any activity can be performed by multiple entities, and/or any element can be duplicated. Further, any activity or element can be excluded, the sequence of activities can vary, and/or the interrelationship of elements can vary. Unless clearly specified to the contrary, there is no requirement for any particular described or illustrated activity or element, any particular sequence or such activities, any particular size, speed, material, dimension or frequency, or any particularly interrelationship of such elements. Accordingly, the descriptions and drawings are to be regarded as illustrative in nature, and not as restrictive. Moreover, when any number or range is described herein, unless clearly stated otherwise, that number or range is approximate. When any range is described herein, unless clearly stated otherwise, that range includes all values therein and all sub ranges therein.

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US20100160896A1 (en) 2010-06-24
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US8655798B2 (en) 2014-02-18
WO2006089243A3 (fr) 2006-10-12

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