EP3331589A1 - Pontage coronarien droite - Google Patents

Pontage coronarien droite

Info

Publication number
EP3331589A1
EP3331589A1 EP16835718.4A EP16835718A EP3331589A1 EP 3331589 A1 EP3331589 A1 EP 3331589A1 EP 16835718 A EP16835718 A EP 16835718A EP 3331589 A1 EP3331589 A1 EP 3331589A1
Authority
EP
European Patent Office
Prior art keywords
cannula
inflow
pump
outflow
outflow cannula
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Withdrawn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
EP16835718.4A
Other languages
German (de)
English (en)
Other versions
EP3331589A4 (fr
Inventor
Daniel Burkhoff
Robert C. Farnan
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.)
Heartware Inc
Original Assignee
Heartware Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Heartware Inc filed Critical Heartware Inc
Publication of EP3331589A1 publication Critical patent/EP3331589A1/fr
Publication of EP3331589A4 publication Critical patent/EP3331589A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/857—Implantable blood tubes
    • A61M60/859—Connections therefor
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3659—Cannulae pertaining to extracorporeal circulation
    • 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
    • A61M25/0029—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/135—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/148—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/30—Medical purposes thereof other than the enhancement of the cardiac output
    • A61M60/35—Medical purposes thereof other than the enhancement of the cardiac output for specific surgeries, e.g. for Fontan procedure
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/861—Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/865—Devices for guiding or inserting pumps or pumping devices into the patient's body
    • 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
    • A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
    • A61M2025/0031—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
    • 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
    • A61M2025/0034—Multi-lumen catheters with stationary elements characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
    • 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
    • A61M2025/0037—Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side
    • 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
    • A61M2025/0039—Multi-lumen catheters with stationary elements characterized by lumina being arranged coaxially
    • 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

Definitions

  • the present disclosure relates to an apparatuses, kits and methods for improving venous blood flow into the pulmonary arteries.
  • Fontan procedure An operation known as the Fontan procedure is performed to treat several complex congenital heart abnormalities including tricuspid atresia, pulmonary atresia with intact ventricular septum, hypoplastic left heart syndrome, hypoplastic right heart syndrome, double-inlet ventricle and other abnormalities regarding the pumping ability of the heart. Completion of the operation results in the flow of systemic venous blood to the lungs without passing through a right ventricle.
  • Fontan procedures are completed in two stages.
  • the first stage involves redirecting blood flow from the upper body through the superior vena cava so that the superior vena cava carries blood to the pulmonary arteries instead of the right atrium of the heart.
  • venous blood from the inferior vena cava continues to carry blood from the lower body to the heart.
  • blood from the inferior vena cava is redirected to the lungs through the pulmonary arteries.
  • blood flow through the lungs depends on the pressure in the veins, as blood is no longer pumped by the right ventricle. Creation of a Fontan circulation is palliative in nature, with good results in patients with ideal hemodynamics and substantial morbidity and mortality in those with poor hemodynamics. "Fontan patients" entering adulthood face an uncertain future.
  • Fontan circulation Due to the burden placed on the venous system through completion of a Fontan procedure, a common problem subsequent to the operation is an excessive rise of central venous pressure. Namely, excessive blood pressure in the superior vena cava and the inferior vena cava.
  • Other complications of Fontan circulation include exercise intolerance, ventricular failure, right atrium dilatation and arrhythmia, systemic and hepatic venous hypertension, portal hypertension, coagulopathy, pulmonary arteriovenous malformation, venovenous shunts, and lymphatic dysfunction (e.g., ascites, edema, effusion, protein-losing enteropathy, and plastic bronchitis).
  • Fontan procedures can be found in, for example, Fredenburg, et al., The Fontan Procedure: Anatomy, Complications, and Manifestations of Failure, 31 RADIOGRAPHICS 453, (2011).
  • Fontan patients who have undergone Fontan Procedures that fail typically have two principal options: undergo a heart transplant or a total artificial heart implantation.
  • Fontan patients are not ideal candidates for either of the aforementioned procedures, as such patients are at greater risk of injury as a result of major surgery, particularly open surgery.
  • a heart transplant is not ideal as a solution when the Fontan procedure has already been performed due to the altered anatomy of the superior and inferior vena cavae.
  • Another approach involves implanting a left ventricular assist device (LVAD).
  • LVAD left ventricular assist device
  • such a device does not fully address the problem of a failed Fontan procedure. Therefore, new solutions to problems arising from Fontan procedures are desired.
  • a first aspect of the present invention provides a method of medical treatment.
  • a first step of the method desirably involves connecting a pump having an inflow port and an outflow port to a body of a subject so that the inflow port is in fluid communication with at least one of the venae
  • cavae and the outflow port is in fluid communication with at least one of the left or right pulmonary arteries.
  • a second step of the method desirably involves operating the pump to carry at least some blood flow from at least one of the venae cavae into at least one of the left or right pulmonary artery.
  • the patient has been subject to a Fontan procedure prior to connecting the pump so that the venae cava are in communication with the pulmonary arteries.
  • the method also includes steps of measuring a property related to blood on or in the inflow and/or outflow cannula; communicating a signal related to the property related to blood to a controller connected to the pump; and controlling the pump responsive to the signal.
  • the pump is operated to carry at least some blood flow.
  • the operation of the pump may include carrying blood through an inflow cannula from the at least one of the venae cavae into the pump and carrying blood through an outflow cannula from the pump into the at least one of the left or right pulmonary arteries.
  • the outflow cannula is adapted to create at least a partial seal or obstruction so that when the outflow cannula is disposed in a vessel during operation of the pump, at least some blood outflow from the outflow cannula is prevented from being regurgitated back into a vein.
  • the vessel is sealed by actuating a balloon attached to the outflow cannula prior to operating the pump so that the balloon at least partially seals a space between an outer surface of the outflow cannula and the surrounding vessel to prevent backflow of blood into either of the vena cavae.
  • Another aspect of the present invention provides a method of implanting a medical treatment apparatus.
  • the method of implantation desirably includes the following steps: making at least one percutaneous incision in a patient; simultaneously or sequentially inserting an inflow cannula through one of the at least one percutaneous incision and an outflow cannula through one of the at least one percutaneous incision such that both the inflow and outflow cannula enter a vein; advancing the inflow cannula into the superior vena cava; and advancing the outflow cannula into at least one of the right or left pulmonary artery.
  • the inflow and outflow cannula are both connected to a pump so that during operation of the pump, at least one of the superior vena cava and inferior vena cava is in fluid communication with at least one of the right or left pulmonary artery through the pump.
  • the patient has been subject to a Fontan procedure prior to making the at least one percutaneous incision so that the vena cava is in communication with the pulmonary arteries.
  • the method may involve inserting a guidewire through the outflow cannula and actuating the guidewire, wherein actuation of the guidewire repositions at least one of the inflow and outflow cannula.
  • a second guidewire is inserted through the inflow cannula so that actuation of the first guidewire positions the outflow cannula and actuation of the second guidewire repositions the inflow cannula.
  • the inflow and outflow cannula may be inserted simultaneously through the same percutaneous incision.
  • an inserter sheath is placed through the percutaneous incision prior to disposing the inflow and outflow cannula simultaneously through the inserter sheath.
  • advancing the outflow cannula into at least one of the right or left pulmonary artery creates at least a partial seal between at least one of the left or right pulmonary artery and the outflow cannula disposed therein.
  • a balloon connected to the outflow cannula may be actuated after advancing the outflow cannula into at least one of the right or left pulmonary artery. In this case, actuation of the balloon may cause the balloon to at least partially seal the at least one of the right or left pulmonary artery surrounding the outflow cannula.
  • the present invention relates to a kit for improving blood flow in a patient.
  • the kit desirably includes a pump and an inflow and outflow cannula adapted to be connected to the pump.
  • the inflow cannula may be adapted for placement into at least one of the superior vena cava or the inferior vena cava and the outflow cannula may be adapted for placement into at least one of the right pulmonary artery or the left pulmonary artery.
  • the inflow cannula includes a length that is longer than a length of the outflow cannula.
  • one of the inflow and outflow cannula is entirely disposed within the other of the inflow and outflow cannula over at least a portion of the length of the inflow cannula.
  • the outflow cannula further comprises a first outflow cannula and a second outflow cannula. The first outflow cannula is adapted to be disposed within one of the right or left pulmonary artery and the second outflow cannula is adapted to be disposed in the other of the right or left pulmonary artery.
  • the pump is adapted for placement inside a body of the patient so that placement is either subcutaneous, sub-muscular or within the abdominal, thoracic or other body cavity.
  • FIG. 1 is a side view of a bypass apparatus in accordance with one embodiment of the invention.
  • FIG. 2 is a side view of the bypass apparatus shown in FIG. 1 during one stage of a procedure according to an embodiment of the invention.
  • FIG. 3 is a fragmentary sectional view of the bypass apparatus shown in FIG. 1.
  • FIG. 4 is a diagrammatic perspective view illustrating a first step of a method of implanting the bypass apparatus according to one embodiment of the invention, employing the apparatus shown in FIG. 1.
  • FIG. 5 is a side view illustrating another step of the method.
  • FIG. 6 is a view similar to FIG. 5 but illustrates another step in the method.
  • FIG. 7A is a similar view as that shown in FIG. 5 but depicting an apparatus and method according to another embodiment
  • FIG. 7B is a fragmented sectional view of the inserter with cannulas disposed therein shown in FIG. 7A.
  • FIG. 8 is a side view of a bypass apparatus in accordance with another embodiment of the invention.
  • FIG. 9 is a fragmented sectional view of an inflow and outflow cannula of the bypass apparatus shown in FIG. 8.
  • FIG. 10 is a side view of a bypass apparatus in accordance with another embodiment of the invention.
  • FIG. 11 is a fragmented sectional view of an inflow and outflow cannula of the bypass apparatus shown in FIG. 10.
  • FIG. 12 is a side view of a bypass apparatus in accordance with another embodiment of the invention.
  • FIG. 13 is a side view of an inflow and outflow cannula in accordance with another embodiment of the invention.
  • FIG. 14 is a side view of a bypass apparatus in accordance with another embodiment of the invention.
  • FIG. 15 is a side view of a bypass apparatus in accordance with one embodiment of the invention.
  • FIG. 16 is a fragmentary sectional view of the bypass apparatus shown in FIG. 15.
  • the various apparatuses, kits and methods of the present invention are intended for improvement of blood flow and/or to reduce venous pressure in a patient.
  • One particularly beneficial application of the embodiments described herein is in post-operative Fontan patients to direct and accelerate blood from the veins to the lungs through the pulmonary arteries.
  • patient as used throughout is interchangeable with the term “subject” as used throughout and is intended to refer to the person who is the recipient of the apparatus of the invention.
  • a bypass apparatus 10 according to a first embodiment of the invention is shown in
  • the apparatus includes a blood pump 1.
  • the pump can be of any type known in the art.
  • the blood pump 1 includes an inflow port 3 and outflow port 5.
  • the pump may simply include an inlet and an outlet.
  • a suitable blood pump for the methods described herein is an implantable rotary blood pump, for example, certain rotary blood pumps are disclosed in U.S. Patent Nos. 6,234,772, 7,699,586, 8,157,720, 8,545,380, 8,512,012 and 8,882,477 which are expressly incorporated by reference herein.
  • the use of other types of implantable pumps may also be advantageous in the present invention.
  • the pump 1 is configured so that it can be disposed internal to the patient in a cavity within the body.
  • placement is extrathoracic, or outside the rib cage. Placement can be either subcutaneous or sub-muscular. Other examples of pump placement include within a body cavity such as the abdominal cavity or the thoracic cavity. Placement in other body cavities is also contemplated.
  • the pump 1 can be placed extracorporeally.
  • the pump 1 can also include features so that monitoring devices and other equipment may be affixed to the pump 1.
  • the position of the inflow port 3 and outflow port 5 on the pump 1 is as shown in FIG. 1.
  • ports 3, 5 can be located at any suitable position on the pump 1 to suit the anatomy of the patient.
  • the apparatus 10 also includes an inflow cannula 9 and an outflow cannula 11, as shown in FIGS. 1, 2 and 3.
  • the combined inflow and outflow cannulas 9, 11 are suited for insertion into a blood vessel and also for advancement through the vessel.
  • the inflow cannula 9 and the outflow cannula 11 are arranged in a side -by-side configuration and are attached to one another along part of the length of each cannula. In this configuration portions at the extreme distal end 21, 22 are separated so that each cannula can extend into a separate vessel.
  • the inflow cannula 9 and the outflow cannula 11 are secured to each other through a temporary attachment.
  • the temporary attachment is configured and manufactured in such a way to facilitate the peeling of the inflow cannula 9 from the outflow cannula 11.
  • Some examples of this configuration include scoring of the interface between the two cannulas, or manufacturing the cannulas with a thinner layer of material at the border between the cannulas so that it is easy to peel them apart.
  • the inflow cannula 9 as shown in FIGS. 2-3 is configured to be placed in the inferior vena cava and the outflow cannula 11 is configured to be placed in one or both of the pulmonary arteries.
  • the cannulas can be made of a biocompatible material such as a biocompatible polymer with or without reinforcement or a biocompatible metal such as nitinol.
  • Cannula 9 has an inner lumen 32A for transporting blood from the patient whereas cannula 11 has an inner lumen 32B.
  • the inflow and outflow cannula are of equal diameter and thickness, as shown in FIG. 3, where both the inflow and outflow cannula 9, 11 have inner diameters of about 5 mm.
  • the outer diameter of each cannula is identified as 6 mm, thus making the thickness of each cannula wall 13 approximately 0.5 mm.
  • the cannulas can be of a larger or smaller diameter, or of varying diameter and thickness, depending on the patient and specific requirements dictated by the patient's anatomy. Nonetheless, the cannulas should be of a diameter small enough so that natural flow through the vasculature is not completely blocked.
  • the inflow cannula 9 is longer than the outflow cannula 11.
  • the outflow cannula 11 can have the same or greater length than the inflow cannula 9.
  • the inflow cannula 9 includes openings 39 that are distributed at roughly equal intervals from the distal end 22 up to approximately 10 cm from the distal end 22. Openings 39 extend from the exterior surface of the inflow cannula 9 to the lumen 32A (FIG. 3).
  • the outflow cannula 11 as shown includes a balloon 15 disposed adjacent the distal end 21 of the outflow cannula 11 and an inflation lumen 17. As best seen in FIGS.
  • the inflation lumen 17 extends from a proximal end 19 of the outflow cannula 11 to the balloon 15 and communicates with balloon 15.
  • FIG. 3 in particular shows that the inflation lumen 17 is located within the wall 13 of the outflow cannula.
  • the inflation lumen can be placed outside of the wall or inside the wall 13.
  • the balloon 15 is configured to be actuated between a collapsed and inflated or expanded condition.
  • FIG. 2 the balloon 15 is in a collapsed condition as the outflow cannula 11 is advanced through the subclavian vein 50 and the superior vena cava 52.
  • FIG. 6 shows the balloon 15 in an inflated condition where the outflow cannula 11 is in a desired position in the right pulmonary artery 56.
  • the proximal ends 19, 20 of the inflow and outflow cannulas are configured with placement adapters, 23 and 25, respectively (FIG. 2), to facilitate placement of the cannulas in the patient.
  • the placement adapter 25 at the proximal end 19 of the outflow cannula 11 has a " Y" configuration.
  • the proximal end of the y-shaped placement adapter 25 has two openings.
  • An opening in the first fitting 27 communicates with the inner lumen 32B of the outflow cannula 11 and is configured to receive a guidewire 12B, or the like.
  • the opening in the second fitting 29 communicates with inflation lumen 17 and is configured to receive a syringe (not shown) to inflate the balloon 15 via the inflation lumen 17.
  • the placement adapter 23 at the proximal end 20 of the inflow cannula 9 has a fitting 24 with an opening and is configured to receive a guidewire 12A.
  • Each placement adapter 23, 25 as shown is coupled to the proximal end of the respective cannulas 19, 20 so that the adapters are in communication with the lumens 32A, 32B of the cannulas.
  • the placement adapters 23, 25 are configured to receive a guidewire 12A, 12B, or the like, to aid in advancement and placement of the inflow and outflow cannulas 9, 11 in the patient.
  • the placement adapters 23, 25 include fittings 24, 27 as shown in FIG. 2 configured to connect and create seals with the inlet port 3 and outlet port 5.
  • the adapters are also configured to be connectable to the type of pump being deployed in the procedure.
  • the apparatus according to this embodiment includes two guidewires 12A, 12B, as shown in FIGS. 2-5.
  • the guidewires 12A, 12B are configured so that a cannula configured for placement into the vasculature can be placed over a guidewire or otherwise around it.
  • the guidewires 12A, 12B are coated with or otherwise made of biocompatible materials and are otherwise safe for use inside the body.
  • Each guidewire 12A, 12B also includes flexible properties to the extent necessary to bend within the vasculature as it is advanced.
  • the guidewires 12 A, 12B may be steerable per se and may incorporate conventional features normally used in guidewires.
  • kits in one embodiment of the present invention can include a pump, an inflow cannula and an outflow cannula.
  • the kit can also include additional devices, accessories and/or tools.
  • the kit can include guidewires, introducer needles, vascular dilators, introducer sheaths, syringes, stopcocks, scalpels and/or other devices, accessories and tools used during surgical procedures.
  • a method according to a further embodiment of the invention can be practiced using the bypass apparatus 10 on a patient who has previously had a complete Fontan procedure.
  • the superior 52 and inferior vena cava 54 have each been anastamosed to a pulmonary artery 56, 58. Without further mechanical assistance, this anatomical configuration allows for blood to flow from the superior and inferior vena cava, directly to the right pulmonary artery, left pulmonary artery, or both.
  • the completion of a Fontan procedure bypasses the right side of a patient' s heart through a redirection of blood from the venae cavae directly into at least one of the pulmonary arteries.
  • the venae cavae may still remain connected to the right ventricle and some blood flow may continue to be carried from the venae cavae into the right side of the heart after the procedure.
  • the method according to this embodiment commences with the formation of the percutaneous incision 51 in a patient as shown in FIG. 4.
  • Two guidewires 12 A, 12B are then inserted through the percutaneous incision 51 and into the superior vena cava 52.
  • one guidewire 12B is advanced so that it is directed into the right pulmonary artery 56.
  • another guidewire 12A is advanced so that it is directed into the superior vena cava 52 toward the inferior vena cava 54.
  • the inflow and outflow cannulas 9, 11 are prepared for insertion into the patient. As depicted in FIGS. 4-6, a clinician determines how much of the distal end 21, 22 of each cannula should be separated prior to placement of the inflow 9 and outflow cannula 11. This determination is made, in part, based on the radiography and locations of the branches of the relevant blood vessels.
  • the inflow cannula 9 and outflow cannula 11 may be separated such that each cannula is long enough to reside in its respective destination vessels such as the inferior vena cava and the right pulmonary artery. In FIGS. 5 and 6, separation on a portion of the distal ends of the inflow and outflow cannula is visible.
  • the separation determination is made prior to insertion of a combined inflow and outflow cannula. Then, as shown in FIG. 4, the clinician inserts the distal ends 21, 22 of the cannulas over the guidewires 12A, 12B and through the percutaneous incision 51, which provides surgical access to the subclavian vein 50. With the separation of each cannula established, the inflow and outflow cannula 9, 11 are simultaneously placed over respective guidewires 12A, 12B, and into the superior vena cava 52 via the subclavian vein 50 and/or brachiocephalic vein, as shown in FIGS. 4 and 5.
  • the clinician uses the guidewire 12B from the outflow cannula 11 to guide the outflow cannula 11 away from the inflow cannula 9, into the pulmonary artery, as shown in FIGS. 5 and 6.
  • the clinician actuates the guidewires.
  • the clinician may be assisted by the placement adapters 23, 25 and the respective fittings 24, 27 through which the guidewires 12A, 12B pass at the proximal ends 19, 20 of the cannulas.
  • the inflow cannula 9 will be advanced to and ultimately reside in the inferior vena cava 54, while the outflow cannula 11 will reside in the right pulmonary artery 56, as shown in FIG. 6, and/or the left pulmonary artery 58.
  • the balloon 15 can be inflated through actuation of an end of an inflation lumen 17 at the second fitting 29 adjacent to the proximal end 19 of the outflow cannula 11.
  • actuation can be accomplished with a syringe (not shown) filled with saline or another acceptable liquid or gas.
  • the syringe is inserted into an opening in the second fitting 29 of placement adapter 25 by a clinician (see FIG. 2) and actuated to inflate the balloon 15.
  • the inflated balloon 15 secures the outflow cannula 11 in place and prevents backflow of fluid.
  • the clinician secures the fitting 24 adjacent to the inflow cannula 9 to the inflow port 3 on the pump 1 and the first fitting 27 adjacent to the outflow cannula 11 to the outflow port 5 on the pump 1.
  • the connected pump 1 is placed in a subcutaneous pocket 53 under the skin
  • the venae cavae are in fluid communication with the right pulmonary artery via the inflow 3 and outflow 5 ports of the pump.
  • the pump 1 is activated. Blood is pumped through the blood flow lumen 32A in the inflow cannula 9 from the inferior vena cava 54 and/or the superior vena cava 52 into the pump 1 entering the inflow cannula 9 through openings 39, as shown in
  • FIG. 6 A longer distribution of openings 39 ensures that the inflow is distributed along the length of the vena cava so that no single location has too much inflow. This helps to prevent the vena cava from collapsing inward occluding blood flow entirely. Put another way, the distribution of openings on the inflow cannula optimizes suction inflow without causing suction of a magnitude that would cause the walls of the venae cavae to be drawn towards the inflow cannula. This maintains natural blood flow through the venae cavae. Blood in the pump 1 is then returned, via the blood flow lumen 32B in the outflow cannula 11, into the one or both of the pulmonary arteries 56, 58. As shown in FIG.
  • the outflow cannula 11 prevents outflow blood from doubling back along the exterior of the outflow cannula 11 and into the inferior 54 and/or superior vena cava 52.
  • the outflow cannula can include two or more balloons.
  • the blood flow rate through the bypass apparatus 10 should be sufficient so that it provides a desired pressure in the venae cavae and the right and/or left pulmonary arteries. For example, in some patients, a flow rate of about 2-3 liters per minute when pumping blood into a single pulmonary artery is sufficient. Of course, the exact flow rate necessary for successful operation of the pump will vary based on factors such as the patient's physical characteristics.
  • the flow rate may vary substantially from that indicated in the example above.
  • the flow rate desirably is controlled so as to prevent the development of a pulmonary edema or pulmonary hypertension.
  • the pump is desirably controlled so that mean pressure in the vena cava is maintained within a desired range to prevent development of conditions associated with excessively high or excessively low pressure in the vena cava as discussed above.
  • the desired pressures may be based on pressures that a patient normally experiences over an extended duration, such as a period of several weeks. Of course, the pressure normally experienced by a patient will vary by patient. .
  • Insertion and operation of the bypass apparatus 10 can be in response to, for example, a failed Fontan procedure, as a supplemental procedure in conjunction with a Fontan procedure or as a temporary measure following a Fontan procedure.
  • the methods herein are particularly applicable to patients suffering from a failed or a failing Fontan procedure.
  • the methods provide an additional bypass that relieves the excessive central venous pressure in the venae cavae.
  • the inflow cannula 9 serves to divert blood from the venous system by way of the pump 1, while the outflow cannula 11 serves to deliver blood back to the pulmonary arterial system of the patient, while bypassing the right atrium and/or ventricle.
  • both the inflow cannula 9 and outflow cannula 11 can be placed through the same entry point, i.e. , the percutaneous incision 51.
  • risk of injury to a patient that has previously undergone a Fontan procedure is reduced.
  • Fontan patients are likely to fare better when a minimally invasive procedure is used, as such patients are susceptible to injury as a result of open surgery to replace the heart or revision surgery to repair an existing Fontan procedure.
  • the bypass apparatus 10 can include an inserter sheath 14, as shown in FIGS. 7A and 7B.
  • the inserter sheath 14 is configured for placement internally within the body and in particular, within the vasculature.
  • the inserter sheath is a peel-away sheath that is removable from the body following the implantation procedure.
  • the inserter sheath 14 is a tubular structure with a lumen 34 sized to permit inserter of at least the inflow and outflow cannula 9, 11 therethrough. It is coated with or otherwise made of biocompatible materials.
  • the inserter sheath 14 is used to assist in the inserter of the inflow and outflow cannulas.
  • the inserter sheath 14 can be inserted through the incision 51 and advanced to the location joining the venae cavae 52, 54 with the pulmonary arteries 56, 58.
  • the inflow and outflow cannulas 9, 11 are then disposed in the lumen 34 of the inserter sheath (FIG. 7B) and advanced into the vasculature, directed by the alignment of inserter sheath 14.
  • the structure of the cannulas and elements connecting the cannulas to the pump can be varied. For example, structures distinguishable from a cannula but having a lumen may also serve the function of the cannula 9, 11 and could also be included as part of the bypass apparatus.
  • first and second cannula may be slidably connected to one another, promoting ease of use.
  • Other mechanisms for temporary attachment between cannulas include a soluble polymer that would eventually cause the cannulas to separate. More broadly, any materials, cannula surface shape or other treatment that allows the cannulas to be separated, split or detached can be used.
  • a portion of the side -by-side arrangement can be fully and permanently secured provided that free ends 21, 22 of the cannulas are free to move with respect to each other so that each is capable of entering separate vessels.
  • the placement adapters are removably connected to the cannulas.
  • the placement adapters enclose pump adapters on the cannulas configured to engage with an inlet and outlet of the pump.
  • the placement adapters are decoupled from the cannulas, and the pump adapters are secured to the inlet and outlet of the pump.
  • the pump adapter is configured to close a proximal end of the inflation lumen upon decoupling of the placement adapter.
  • the pump adapters may be configured to be connectable with any type of pump being deployed in the procedure. The pump adapters allow for quick attachment between the cannulas 9, 11 and the pump 1.
  • Placement adapters varying from those shown in FIG. 2 are also contemplated. Namely, it is contemplated that other connector devices that are configured for releasable or permanent connection to the cannula at the proximal end 19, 20 of each cannula may be included as part of the bypass apparatus used in the method. Such connector devices can be configured for placement of guidewire and/or devices (e.g., syringe) to apply fluid pressure or other forms of actuation into a lumen of the cannula.
  • guidewire and/or devices e.g., syringe
  • the steps for inserting the bypass apparatus can vary from the above embodiments.
  • the insertion procedure may be conducted with a single guidewire or in other cases, with three or more guidewires.
  • the method may be supplemented with the placement of valves and/or occluders in one or more vessels, or the balloon on the outflow cannula may be replaced with another device to seal a surrounding vessel.
  • the outflow cannula of the bypass apparatus may have a diameter so that when it is disposed in a vessel, such as a right pulmonary artery, it creates a partial or full seal of the vessel. The outflow cannula can also create an obstruction in the vessel.
  • the approach to insertion of the cannulas can be varied.
  • the cannulas can be placed sequentially and/or into separate percutaneous incisions in the event that the cannulas are separated from one another prior to insertion into the patient.
  • One or both cannulas can be inserted into one of the right internal jugular vein, right external jugular vein, right subclavian vein, right axillary vein or the right brachiocephalic vein. From any of these veins, the cannula can be advanced into the superior vena cava.
  • one or both of the cannulas can be inserted into one of the left internal jugular vein, left external jugular vein, left subclavian vein, left axillary vein or left brachiocephalic vein.
  • the cannula can be advanced in the superior vena cava.
  • both cannulas can be inserted into any one of the above referenced veins at different locations along the length of the vein.
  • the distal end 22 of the inflow cannula 9 is only advanced into the superior vena cava 52 and does not extend into the inferior vena cava.
  • the bypass apparatus is inserted into a percutaneous incision and advanced into the inferior vena cava from the incision without initially advancing through the superior vena cava.
  • the bypass apparatus When the bypass apparatus is advanced into the inferior vena cava from the lower half of the venous system, it can initially be inserted into the right or left femoral vein and from there, advanced into the inferior vena cava.
  • the methods of insertion described herein can be used and or modified for application in the vasculature of a patient that has not undergone a Fontan procedure. In such cases, a vessel pathway to the pulmonary arteries must remain relatively unobstructed and accessible for optimal application of the methods described herein.
  • the cannulas 9, 11 are inserted so that proximal ends of the cannulas extend through and out of the skin of the patient. From the exposed cannulas, the pump is secured and positioned extracorporeally. Extracorporeal placement is particularly well suited when the intended use of the bypass apparatus is temporary. It also has the advantage of being more easily adapted to connect with monitoring equipment.
  • operation of the bypass apparatus 10 can be supplemented with devices (FIGS. 15-16) and analysis equipment connected to or integrated with the pump 1 configured to measure properties relating to blood such as pressure or flow rate in one or more of the cannula, in the vasculature such as in the pulmonary artery or vena cava, or the like.
  • Devices for measurement of properties of blood can be sensors and analysis equipment can be a controller connected to the pump. Where sensors and a controller are included, the sensors are configured to communicate with the controller connected to the pump. The sensors can be configured to monitor pressure and flow rate in vessels such as the venae cavae and pulmonary arteries, among other measurable properties.
  • Measurement can be at one or more locations on the length of the inflow and outflow cannula.
  • the sensors are further configured to transmit signals to the controller based on measurements such as those described above. Transmission of signals can be via a lumen within a wall of the cannula or optical cable and/or electrical conductor inside or outside the wall of the cannula.
  • Specific examples of sensors and transmission mechanisms include a micro-manometer pressure sensor, fluid inside a lumen and a fiber optic pressure sensor. Also, fluid in a separate lumen may transmit pressure from a tip of the cannula to a sensor outside the body.
  • the controller is configured to monitor and analyze the received signals. The controller can monitor various forms of energy received as a signal. Through analysis of the signals, the controller can regulate the activity of the bypass apparatus.
  • pressure in the venae cavae can be monitored (i.e., estimated in real time) and regulated by the controller.
  • measurement sensors 672A, 672B are connected to a controller 670 via pump 601.
  • the sensors 672A, 672B communicate with the controller 670 via optical or electrical conductors 671A, 671B disposed in walls 613 of respective inflow and outflow cannulas 609, 611, as shown in FIG. 16.
  • the devices and analysis equipment described are also contemplated as being compatible with either an extracorporeal pump or an internally disposed pump.
  • sensors can communicate with the controller via wireless communication.
  • FIGS. 8-14 Additional embodiments are shown in FIGS. 8-14.
  • the bypass apparatus is in the inserted position.
  • the bypass apparatus of the embodiments depicted in FIGS. 8-14 generally operates in a similar manner to the bypass apparatus described above.
  • a bypass apparatus 110 can include an inflow 109 and outflow cannula 111 entirely separate from one another, as shown in FIGS. 8 and 9. The structure may otherwise be the same as described in the above embodiments.
  • a sectional view of the inflow and outflow cannula 9, 11 through the subclavian vein 150 is depicted in FIG. 9.
  • both the inflow cannula 109 and the outflow cannula 111 can be inserted into a single percutaneous incision simultaneously or one cannula can be inserted before the other.
  • the inflow cannula 109 can be inserted into a first percutaneous incision while the outflow cannula 111 can be inserted into a second percutaneous incision. Where two percutaneous incisions are made, the cannulas 109, 111 can be inserted simultaneously or sequentially.
  • the method of insertion may be otherwise as described above.
  • FIG. 11 shows a sectional view of the cannulas through the subclavian vein 250. In the same figure, delineation of the inflow lumen 232A and outflow lumen 232B is visible.
  • the inflow cannula 209 can be entirely disposed within the outflow cannula 211 over at least a portion of the length of the outflow cannula 211.
  • Each cannula is sealed so that there is no fluid communication between inflow and outflow.
  • the bypass apparatus 210 is inserted through a single percutaneous incision such that each cannula is inserted simultaneously, though other approaches are contemplated as within the scope of the invention.
  • the bypass apparatus 310 includes three cannulas attached to the pump 301.
  • One cannula is an inflow cannula 309, as described in other embodiments.
  • the other two are outflow cannulas 311A, 31 IB.
  • each outlet cannula is sourced from a separate outlet port 305A, 305B.
  • the configuration shown is not limiting and other forms of connection are also contemplated.
  • the outlet for the two outlet cannulas may be shared. In the implanted position of the bypass apparatus shown in FIG.
  • the outflow cannula 311 A is disposed in the right pulmonary artery 356 and the outflow cannula 311A is disposed in the left pulmonary artery 358.
  • the outflow cannulas 311A, 31 IB are shown positioned on opposite sides of the inflow cannula 309 where all three cannulas are secured to each other.
  • the two outflow cannulas 311A, 31 IB may be adjacent to each other and attached to the inflow cannula 309 on one side.
  • only two of the three cannulas are attached. In others, all three are separate and unattached.
  • each outflow cannula includes a balloon 315A, 315B proximal to its distal end 321A, 321B, as shown in FIG. 12.
  • each outflow cannula 311A, 31 IB may have a placement adapter 325 A, 325B including a first opening for a guidewire and a second opening for a syringe, as described above.
  • a clinician may use the guidewires to aid in directing the cannulas into a desired position.
  • a bypass apparatus 410 includes an outflow cannula 411 A that extends from the pump 401 with a single lumen up to a divergence location 414 where the cannula 411A splits into two outflow cannulas 41 IB, 411C.
  • the divergence location 414 can include a ring, fitting or other adapter to split the cannula 411 A.
  • the outflow cannula 41 IB extends into the right pulmonary artery 456 and the outflow cannula 411C extends into the left pulmonary artery 458.
  • each outflow cannula 41 IB, 411C also includes a balloon 415B, 415C or valve towards a distal end of each cannula, as shown in FIG. 13.
  • the bypass apparatus 410 operates similarly to the three cannula bypass apparatus 310 described above.
  • a pump 501 of the bypass apparatus 510 is disposed in the vasculature.
  • an inflow cannula 509 is disposed in the superior vena cava 552 and extends to the pump 501 disposed in the right pulmonary artery 556.
  • the inflow cannula 509 includes openings 539 and may further include a powered lead 561 attached to the inflow cannula 509, as shown.
  • the powered lead 561 extends to a source of electrical power such as a percutaneous connection or a transcutaneous energy transfer system.
  • Pump 501 is secured between the inflow and outflow cannulas 509, 511.
  • a pump that may be placed within the vasculature is found in US Pat. No. 8,852,072, hereby incorporated by reference in its entirety.
  • the outflow cannula 511 extends from the pump 501 in the direction of blood flow to a free end in the right pulmonary artery 556 and includes a balloon 515 to prevent backflow, as described in the embodiments above.
  • bypass apparatus 510 include an arrangement where the inflow cannula 509 extends toward the inferior vena cava 554 and/or one where the pump 501 and the outflow cannula 511 are disposed in the left pulmonary artery 558 in their implanted position.
  • the pump 501 may be disposed in one or both of the venae cavae.
  • the bypass apparatus 510 may also include two outlet cannulas, one extending into each of the right and left pulmonary arteries.
  • Bypass apparatus 510 may be implanted in a manner similar to that described for the embodiments above. For example, a percutaneous incision is made in a patient, and an inserter sheath is placed therethrough. The inserter sheath is placed far enough into the vasculature so that any object placed therethrough can be directed to at least one of the pulmonary arteries. In part because the diameter of the pump is very compact, the bypass apparatus 510 can be inserted through the inserter sheath into the venous system and then into the superior venae cava 552.
  • the balloon 515 or valve prevents backflow into the venae cavae.
  • additional valves or occluders may be attached to the cannulas or otherwise placed into the vasculature to control blood flow according to the placement of the apparatus elements.

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Abstract

La présente invention concerne un appareil et des procédés pour pomper le sang depuis les veines caves vers les artères pulmonaires et permettant de contourner le ventricule droit du cœur. L'appareil comporte une pompe et une canule d'entrée et de sortie. Selon un mode de réalisation, les canules d'entrée et de sortie sont insérées à travers une seule ouverture percutanée dans une veine sous-clavière et avancées dans les veines caves. Lorsque la canule de sortie est avancée dans une artère pulmonaire, elle est réorientée dans celle-ci. La pompe au niveau d'une extrémité proximale de l'appareil de pontage est disposée dans une cavité du corps, par exemple, à proximité de la cage thoracique d'un patient. Lors du fonctionnement, le sang est transporté à travers la canule d'entrée depuis les veines caves dans la pompe et ensuite pompé à travers la canule de sortie dans au moins l'une parmi l'artère pulmonaire droite ou gauche.
EP16835718.4A 2015-08-07 2016-08-05 Pontage coronarien droite Withdrawn EP3331589A4 (fr)

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CN108653840B (zh) * 2017-03-31 2019-08-20 广东省心血管病研究所 囊状腔肺辅助循环装置
CA3066361A1 (fr) 2017-06-07 2018-12-13 Shifamed Holdings, Llc Dispositifs de deplacement de fluide intravasculaire, systemes et procedes d'utilisation
CN111556763B (zh) 2017-11-13 2023-09-01 施菲姆德控股有限责任公司 血管内流体运动装置、系统
EP3746149A4 (fr) 2018-02-01 2021-10-27 Shifamed Holdings, LLC Pompes à sang intravasculaires et méthodes d'utilisation et procédés de fabrication
CN108144176B (zh) * 2018-02-09 2024-04-05 南华大学附属第二医院 床旁门体分流装置
WO2021011473A1 (fr) 2019-07-12 2021-01-21 Shifamed Holdings, Llc Pompes à sang intravasculaires et méthode d'utilisation et procédé de fabrication
WO2021016372A1 (fr) 2019-07-22 2021-01-28 Shifamed Holdings, Llc Pompes à sang intravasculaires à entretoises et procédés d'utilisation et de fabrication
US11724089B2 (en) 2019-09-25 2023-08-15 Shifamed Holdings, Llc Intravascular blood pump systems and methods of use and control thereof
US20210178142A1 (en) * 2019-12-13 2021-06-17 Lsi Solutions, Inc. Adjustable cannulation assembly and methods thereof

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US6123725A (en) * 1997-07-11 2000-09-26 A-Med Systems, Inc. Single port cardiac support apparatus
US6241699B1 (en) * 1998-07-22 2001-06-05 Chase Medical, Inc. Catheter system and method for posterior epicardial revascularization and intracardiac surgery on a beating heart
WO2012061274A1 (fr) 2010-11-05 2012-05-10 Tufts Medical Center, Inc. Canule ayant une pointe bifurquée pour un dispositif d'assistance cardiaque
US20140275724A1 (en) * 2013-03-15 2014-09-18 W-Z Biotech, Llc Percutaneous dual-lumen cannula for cavopulmonary assist device

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