EP0986409A1 - Appareil d'assistance ventriculaire avec pompe a sang axiale a rotor ferme - Google Patents

Appareil d'assistance ventriculaire avec pompe a sang axiale a rotor ferme

Info

Publication number
EP0986409A1
EP0986409A1 EP98923962A EP98923962A EP0986409A1 EP 0986409 A1 EP0986409 A1 EP 0986409A1 EP 98923962 A EP98923962 A EP 98923962A EP 98923962 A EP98923962 A EP 98923962A EP 0986409 A1 EP0986409 A1 EP 0986409A1
Authority
EP
European Patent Office
Prior art keywords
axial flow
blood pump
pump
flow blood
impeller
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Withdrawn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
EP98923962A
Other languages
German (de)
English (en)
Inventor
Michel Carrier
Stéphane TRUDELLE
Rosaire Mongrain
André GARON
Alain Girard
Ricardo Camar Ro
Conrad L. Pelletier
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.)
Cardianove Inc
Original Assignee
Cardinove 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 Cardinove Inc filed Critical Cardinove Inc
Publication of EP0986409A1 publication Critical patent/EP0986409A1/fr
Withdrawn legal-status Critical Current

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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
    • A61M60/40—Details relating to driving
    • A61M60/403—Details relating to driving for non-positive displacement blood pumps
    • A61M60/419—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being permanent magnetic, e.g. from a rotating magnetic coupling between driving and driven magnets
    • 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
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/17—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
    • A61M60/174—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial system
    • 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
    • A61M60/20—Type thereof
    • A61M60/205—Non-positive displacement blood pumps
    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A61M60/237—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
    • 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
    • A61M60/40—Details relating to driving
    • A61M60/403—Details relating to driving for non-positive displacement blood pumps
    • A61M60/408—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable
    • A61M60/411—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor
    • A61M60/416—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor transmitted directly by the motor rotor drive shaft
    • 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
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/804—Impellers
    • A61M60/806—Vanes or blades
    • 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
    • A61M60/871—Energy supply devices; Converters therefor
    • A61M60/873—Energy supply devices; Converters therefor specially adapted for wireless or transcutaneous energy transfer [TET], e.g. inductive charging
    • 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
    • A61M60/871—Energy supply devices; Converters therefor
    • A61M60/876—Implantable batteries
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3507—Communication with implanted devices, e.g. external control
    • A61M2205/3523—Communication with implanted devices, e.g. external control using telemetric means
    • 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
    • A61M60/40—Details relating to driving
    • A61M60/403—Details relating to driving for non-positive displacement blood pumps
    • A61M60/422—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being electromagnetic, e.g. using canned motor pumps

Definitions

  • the present invention relates to a ventricular assist device and more particularly to an enclosed-impeller axial flow blood pump.
  • the type of treatments for heart failure depends on the extent and severity of the illness. Many patients can be cured with rest and drug therapy but there is still severe cases that require heart surgery including heart transplantation. Actually, the mortality rate for patients with cardiomyopathy who received drug therapy is about 25 % within 2 years and there still is some form of theses diseases that cannot be treated medically. One of the last options that remain for these patients is heart transplantation. Unfortunately, according to the procurement agency UNOS (United Network for Organ Sharing in United States) the waiting list for heart transplantation grows more than 2 times faster than the number of heart donors.
  • UNOS United Network for Organ Sharing in United States
  • VAD Ventricular Assist Devices
  • VAD Implantable Ventricular Assist Systems
  • characteristics include medical requirements that are to restore hemodynamic function (pressure and cardiac index) avoid hemolysis, prevent clot formation infection and bleeding, and minimize anti- coagulation requirement. More technical characteristics include: small size, control mode, long durability ( > 2 years), low heating, noise and vibration.
  • VADs can be used in several circumstances where a patient has poor hemodynamic functions (low cardiac output, low ejection fraction, low systolic pressure). Whatever the origin of the cardiac failure, the goal of the VAD is to help the heart in his pumping action. The VAD unloads the heart by producing an enhanced circulation and thus restoring the hemodynamic functions which will provide good end organ perfusion. Many devices can achieve these goals; however they are not optimal, and hemolysis and thrombus formation are still important problems to investigate. In the 1970's, the first approach to solve the problem of mechanical support was to imitate as much as possible the heart physiology. This resulted in the development of several pulsatile devices, some of these initial designs are still used.
  • a non-pulsatile VAD In a non-pulsatile VAD, an impeller is enclosed in a housing and continuously rotates to produce a pumping action. The faster the rotation, the higher the blood flow. These devices are called non-pulsatile or continuous because they operate at constant speed. Most axial flow blood pumps operate around 10 000 rpm (Rotations Per Minute). However, in in-vivo conditions, there is a dynamic range (about 1000 rpm around the operating point) over which the output flow is pulsatile. Since the native heart is still contracting, a pressure difference between the ventricle (inlet) and the aorta (outlet) is created. This pressure variation will produce a variation in the pump flow.
  • Non-pulsatile VADs present a much smaller volume than pulsatile ones, around 25 cc for an axial blood flow pump, and 100 cc for a centrifugal pump compared to 150 cc and more for pulsatile devices.
  • a complete axial-flow VAD is usually smaller than the graft used for pulsatile pump.
  • the clinical impact is the possibility to use this type of VADs in small adults as well as in children.
  • the small dimensions enable to place the pump in a more orthotopic position; that is, in the thorax near the heart instead of the upper abdomen. This eliminates the use of long cannula passing through the diaphragm.
  • the shape and size can be made to place the VAD in an intra-ventricular position.
  • the electrical power required to drive a non-pulsatile VAD is lower than for pulsatile VADs.
  • Non-pulsatile VAD are mechanically simpler than pulsatile VADs; they do not require complex structures such as valves, diaphragms, blood sacs, vents or compliance chambers.
  • Non-pulsatile continuous VADs are made of a simple motor to which is coupled an impeller contained in an housing.
  • One important advantage of a simple mechanical design is that it enables better durability. Durability as long as 5 to 10 years (Nose, Y., 1995a, "Can We Develop a Totally
  • Hemolysis or tearing of the red blood cells can be estimated with a parameter called the Normalized Index of Hemolysis (NIH).
  • NIH Normalized Index of Hemolysis
  • the NIH of most pulsatile VADs is around 0.04 mg/dL (Nose, Y., 1995a, "Can We Develop a Totally Implantable Rotary Blood Pump? ", Artificial Organs, Vol. 19, pp. 561-562) whereas for continuous VADs the NIH drops to a range between 0.002 to 0.004 mg/dL, that is about 10 to 20 times smaller. As a consequence, these non-pulsatile VADs are less traumatic for blood.
  • Non-pulsatile VADs require less maintenance allowing the patient a greater autonomy. Also, as it is now known, most patients with a VAD are discharged from the hospital and returned to a normal life after about a month. Presently, because of the vent in pulsatile VADs, patients cannot take a bath or swim since water could enter the motor compartment.
  • Continuous VADs are less restrictive and allow the patient to practice more activities.
  • Centrifugal blood pumps were first used in cardio- pulmonary bypass for heart surgery. Based on results obtained with the Bio-Medicus pump (Medtronic Bio-Medicus Inc., Eden Prarie, MN), several groups decided to develop much smaller centrifugal pumps so that they could be totally implantable.
  • the rotation of the impeller produces a centrifugal force that drags blood from the inlet port on top to the outlet port at the bottom side.
  • the impeller is coupled to an electric motor. This coupling is made either ( a) magnetically by means of permanent magnets located under the impeller and on the rotor of the motor or ( b) mechanically by means of a shaft interposed between the impeller and the motor's rotor. Magnetically coupled devices generally show better functionality because no seal is required between the motor and the impeller shaft.
  • centrifugal pumps A problem related to centrifugal pumps is that although they are much smaller than pulsatile pumps, they are still too large to be totally implanted in a human thorax thus eliminating any intra-ventricular implantation.
  • axial flow ventricular assist blood pumps were developed. These axial flow blood pumps can decrease the hemolysis rate by decreasing the time of exposure of the blood to friction forces and by reducing the intensity of these forces. Another interesting advantage is that axial flow blood pumps are generally much smaller than centrifugal pumps.
  • the first commercially available axial flow blood pump was the Hemopump (Medtronic Inc. Minneapolis, MN) used as short term circulatory support. Based on the good results obtained with this pump, several groups have initiated the development of totally implantable axial flow VADs for long term uses.
  • This axial flow blood pump comprises two stators, one at the inflow and one at the outflow. These stator have two functions: they support the bearing shaft around which the impeller will rotate (middle part) and they modify the blood flow path.
  • the inflow stator initiates the rotation of the flow so that the blade tip of the rotor does not create too much shear stress on the blood cells.
  • the outflow stator straightens the flow so that blood from the pump enters the blood stream with a generally axial profile.
  • Permanent magnets are enclosed in the center of the impeller and two motor windings are located in the casing on each side of the rotor.
  • This configuration constitutes a DC brushless motor; this is a simple and durable motor which minimizes the number of mechanical parts.
  • the power cable is connected directly to the DC brushless motor controller to change motor speed.
  • the chest is opened by means of a left thoracotomy and no cardiopulmonary bypass is used.
  • the pump axial outflow is anastomosed to the aorta with a Dacron graft.
  • a ventriculotomy is made to insert the pump into the ventricle through a sewing ring attached to the apex.
  • the DeBakey/NASA VAD is very similar to the Jarvik-
  • This axial flow pump is a sealed-bearing type pump whose motor is separated from the impeller.
  • This axial flow pump has a so called dry motor configuration compared to the Jarvik 2000 and DeBakey/NASA pumps presenting a so called wet motor configuration.
  • the impeller is coupled to the motor by a driving shaft. Blood enters the pump through four holes provided at its base, passes through the impeller and the flow straightener to finally exits the pump through a tapered end thereof.
  • the pump is designed to produce a gradient of pressure along its geometrical axis.
  • the surgical placement of the pump is quite different from the other VADs.
  • An incision is made at the apex and the pump is inserted in the left ventricle until the base of the motor is in contact with the apex.
  • the motor stays outside the heart and is sutured to the heart.
  • the outlet port of the pump is passed through the aortic valve and since blood ejects directly in the aorta, no outflow cannula is required.
  • VAD The main problem with this VAD is the presence of the seal of the driving shaft that requires continuous infusion of sterile solution in the sealed area to prevent blood from entering. This requires an external refillable bag to contain the sterile solution and a transcutaneous cannula connected to the pump purge port.
  • This pump is similar to the DeBakey/NASA and the Jarvik 2000 pumps. It is placed next to the heart and is connected between the apex of the heart and the aorta. It is also a sealed-bearing type pump and, accordingly, requires a purge system. This system has a second pump which injects 15 ml/day of sterile solution in the sealed area. A pump without purge system is now under development. Three animals have been supported for 1 month with the AxiPump (Konishi, H., Antaki, J.F. et al., 1996b, "Long-term Animal Survival with an Implantable Axial Flow Pump as a Left Ventricular Assist Device", Artificial Organs, vol. 20, pp. 124-127).
  • a first object of the present invention is to provide an axial flow blood pump and a VAD including this axial flow blood pump which eliminate the drawbacks of the prior art.
  • Another object of the present invention is to provide a VAD of simple design, small size, and including a control mode and a potential for long term durability (> 2 years), low heating and minimized vibrations.
  • a third object of the invention is to provide ( a) a VAD comprising an enclosed impeller axial flow blood pump optimizing pumping efficiency while which restoring hemodynamic functions, minimizing hemolysis, minimizing anti-coagulant requirements and preventing clot formation, infection, and bleeding, and ( b) such a VAD provided with a heart implantable design.
  • an axial flow blood pump comprising: a stationary housing structure; and an impeller rotatably mounted in the stationary housing structure about an axis of rotation to produce a flow of blood along this axis of rotation.
  • the impeller includes a generally cylindrical shroud centered on the axis of rotation and defining an inner surface, a plurality of impeller blades extending inwardly from the inner surface of the shroud to intersect with each other at the axis of rotation, and a central hub centered on the axis of rotation and formed by the intersection of the impeller blades.
  • the enclosed-impeller geometry of the axial flow blood pump, as well as the small diameter of the central hub substantially increase the volume of blood the pump is capable of containing and therefore of pumping.
  • the axial flow blood pump further comprises an electric motor drive incorporated in both the generally cylindrical shroud and the stationary housing structure.
  • the electric motor drive comprises a set of windings enclosed in the stationary housing structure, and a set of elongated axial permanent magnets embedded in the shroud.
  • the permanent magnets are parallel to each other and each pair of laterally adjacent permanent magnets are spaced apart from each other by the same distance.
  • the generally cylindrical shroud has first and second opposite ends
  • the stationary housing structure comprises a first annular stator coaxial with the generally cylindrical shroud, having an inner surface and located adjacent to the first end of the generally cylindrical shroud;
  • the stationary housing structure comprises a second annular stator coaxial with the generally cylindrical shroud, having an inner surface and located adjacent to the second end of the generally cylindrical shroud;
  • the inner surfaces of the generally cylindrical shroud, the first annular stator and the second annular stator define a generally continuous, smooth inner surface of the pump
  • the inner surface of the shroud is generally cylindrical and has a constant first diameter
  • the inner surface of the first annular stator has a proximate end located adjacent to the first end of the generally cylindrical shroud and having a second diameter equal to the first diameter; and - the inner surface of the second annular stator has a proximate end located adjacent to the second end of the generally cylindrical shroud and having a third diameter equal to said first and second diameter.
  • the central hub comprises two axial end pivots
  • the stationary housing structure comprises a pair of support members for rotatably supporting the two end pivots of the central hub in view of rotatably mounting the impeller in the stationary housing structure.
  • the stationary housing structure comprises a blood inlet and a cage extending over the blood inlet to prevent an inner wall of the ventricle to close the blood inlet;
  • the stationary housing structure comprises a fixation mechanism for preventing the axial flow blood pump to displace into the ventricle, this fixation mechanism preferably including an elongated needle member passing through the wall of the heart from the inside of the ventricle to the outside of the heart, and a fixation member mounted on the free end of the needle member on the outside of the heart.
  • the present invention further relates to a ventricular assist system comprising an axial flow blood pump according to the invention implanted in one ventricle of a living heart.
  • An electric energy source supplies the electric motor drive with electric energy
  • a controller unit controls supply of electric energy to the electric motor drive in order to control at least the speed of rotation of the impeller of the axial flow blood pump.
  • Figure 1 is a cross sectional view of a human heart in which an axial flow blood pump according to the present invention is installed;
  • Figure 2 is a side elevational view of the axial flow blood pump of Figure 1 ;
  • Figure 3 is a side elevational, cross sectional view of the axial flow blood pump of Figure 1 ;
  • Figure 4 is a cross sectional view of the axial flow blood pump of Figure 1 , taken along line 4-4 of Figure 2;
  • Figure 5 is a side elevational, cross sectional partial view of the axial flow blood pump of Figure 1 ;
  • Figure 6 is a schematic view of a VAD system implanted in a human being and comprising the axial flow blood pump of Figure 1.
  • the originality of the present invention is at least in part related to the axial flow blood pump itself, although the pump is only one element of the complete VAD system.
  • important aspects of the pump design are addressed.
  • the pump design takes into account anatomical and physiological considerations combined to mechanical, electrical and material requirements. Then, following this discussion, the global characteristics of the VAD system are presented.
  • the axial flow blood pump of the present invention is not restricted to an application to an implantable VAD system. Other possible applications are liver perfusion, active perfusion PTCA-catheter, bladder draining, etc. Since the axial flow blood pump according to the invention overcomes a number of drawbacks of the blood pumps of the prior art, those of ordinary skill in the art will understand that such an axial flow blood pump can be used as part of an intra-corporal system such as an intra-ventricular VAD, or an extra-ventricular VAD (i.e. a VAD located in the abdomen), or alternatively as a para-corporal or extra-corporal VAD, often used in bridge to heart transplantation. It shall also be understood that the axial flow blood pump of the present invention can be used in temporary VADs (ie. bridge to heart transplant) or permanent VADs. A non limitative example of permanent VAD is the intra-ventricular VAD in accordance with the present invention.
  • intra-ventricular VAD In the following description, an example of permanent or temporary intra-ventricular VAD is disclosed. For certainty, it shall be understood that the concept of the axial flow blood pump described herein is adaptable to other types of VADs. Furthermore, it should be understood that the intra-ventricular VAD disclosed in the following description is a preferred embodiment and hence could be modified at will within the scope of the appended claims.
  • FIG. 1 illustrates the proposed position of the axial flow blood pump 10 in the left ventricle 11.
  • the axial flow blood pump 10 has also been designed to fit in small adults and in teens.
  • the size of the axial flow blood pump 10 is limited in regard to the ventricular dimension of humans to a BSA (Body Surface Area) of 1.5 m 2 .
  • BSA Body Surface Area
  • a ventricular dimension for humans corresponding to a BSA of 1.5 m 2 was used.
  • the physical size and shape of the axial flow blood pump 10 could also be adapted to meet the anatomical dimensions of individuals falling outside this 95% of the population. Similarly, the size and shape could be adapted to specific and particular individuals and heart conditions.
  • the internal diameter of the left ventricle 11 ranges from 37 to 46 mm in diastole and between 22 to 31 mm in systole. This diameter is determined at the center of the ventricular length (segment AB in Figure 1).
  • the diameter near the apex at the first third of the ventricular length is about 1.5 cm (segment CD of Figure 1).
  • the internal length of the ventricle from the apex to mitral valve ranges from 55 to 70 mm.
  • the other important parameter is the surface of the aortic valve opening which ranges from 2.5 to 4 cm 2 .
  • the favored insertion procedure is to use the same approach as with valve replacement.
  • an incision is made at the root of the aorta 12 ( Figure 1) and the axial flow blood pump 10 is inserted though the aortic valve and then into the left ventricle 11.
  • the axial flow blood pump is then pushed until its base reaches the myocardium at the apex 13.
  • the axial flow blood pump 10 should be fixed.
  • an outflow cannula should pass through the aortic valves to further reduce bleeding.
  • One of the main roles of the axial flow blood pump 10 is to restore a hemodynamic function in patients with cardiac failure.
  • the pump 10 is susceptible to work at flow rates between 1 to 10 l/min against a pressure as high as 200 mmHg and, more commonly, at a flow rate between 3 to 5 l/min against a pressure of 100 mmHg.
  • Another important consideration for blood pump design is the hemolysis rate. Hemolysis is the tearing of red blood cells which empties the content of the cells in the blood stream resulting in free hemoglobin; the normal level of plasma free hemoglobin is around 10 mg/dl.
  • a blood pump with a normalized index of hemolysis (NIH) of 0.005 g/100 I and lower is considered to be almost athromatic for red blood cells.
  • a NIH of about 0.05 g/100 I could be tolerated.
  • a NIH situated between 0.005 g/100 I to 0.05 g/100 I is envisaged for a VAD according to the present invention.
  • the NIH will be as close to 0.005 g/100 I as possible.
  • the platelets are other important blood elements; their activation by high hydromechanical forces should be avoided in order to prevent clot formation.
  • Part A describes the external shape and size of a preferred embodiment of the axial flow blood pump according to the invention and part B describes the internal conception of this axial flow blood pump.
  • Figure 1 shows that the preferred embodiment of the axial flow blood pump 10 sit at the bottom of the left ventricle 11 , in the region of the apex 13 of the heart 14.
  • an inflow cage 15 ( Figures 1 and 2) is mounted on the intake end of the axial flow blood pump 10.
  • the inflow cage 15 presents the general configuration of an hemisphere.
  • the diameter of the inflow cage 15 is set to 15 mm, which is smaller than the segment CD ( Figure 1) and suitable to limit the level of pressure on the walls of the left ventricle 11 near the apex 13.
  • the outflow diameter 16 ( Figure 2) is reduced so as to reduce as much as possible the obstruction caused by an outflow cannula 17 to the operation of the aortic valves (not shown); since the function of the axial flow blood pump 10 is to assist blood circulation, blood flow contribution from the natural contraction of the heart 14 should be maintained.
  • the diameter of the outflow cannula 17 is of 1.3 cm 2 .
  • a blood diffuser 18 is formed at the distal end of the cannula.
  • the function of diffuser 18 is to reduce the shear stress on blood cells. Without diffuser 18, the velocity of blood ejected from the pump 10 is higher than the velocity of blood ejected from the heart 14. The difference in velocity between these two blood flows will result in shear stress proportional to this difference. Since the velocity is inversely proportional to the cross-section area, a solution for reducing the relative velocity of the blood flows from the pump 10 and from the heart 14 is (a) to increase the area of the orifice 19 of the cannula 17 to reduce the velocity of the flow of blood from the pump 10, and ( b) to decrease the area occupied by the blood flow from the heart to increase the velocity of the latter blood flow. This is exactly the role of diffuser 18. Of course, parameters such as the angle of opening and the length of the diffuser 18 can be adjusted at will to fit the mechanical characteristics of the pump 10 in view of minimizing the shear stress on the blood cells.
  • the diameter of the axial flow blood pump 10 is a compromise between pumping requirements and minimal interference with heart contraction.
  • the maximum allowable diameter 20 is about 22 mm which is the diameter of the left ventricle 11 in systole. This dimension is reasonable since people with heart failure have dilated ventricles.
  • the maximum length 21 of the axial flow pump 10, as illustrated in Figure 2, is set in regard of the average distance between the apex 13 and the mitral valve 22 of the heart 14. In a preferred embodiment, the length 21 of the axial flow blood pump 10 is about 55 mm. As shown in Figure , a reduction of the pump diameter (see 23) toward the outflow increases the mitral valve clearance in order to minimize interference with the mitral valve function. Since in this preferred embodiment the axial flow blood pump 10 will be completely located inside the left ventricle 11 , blood will circulate around the casing 24 of this pump 10. As a consequence, the external surface of the casing 24 should be as smooth as possible and avoid as much as possible abrupt deviations to thereby minimize vortices, turbulence and recirculation zones which may be at the origin of clot formation.
  • fixation mechanism 25 At the pump inflow, a fixation mechanism 25 is provided.
  • fixation mechanism 25 comprises:
  • an elongated needle member 26 which is, from the inside of the left ventricle 11 , through the myocardium and the epicardium at the apex 13 of the heart 14; and - a fixation disk 27 fastened to the free end of the needle member 26 on the outside of the heart 14 to firmly fix the axial flow blood pump 10 in place.
  • a fixation disk 27 fastened to the free end of the needle member 26 on the outside of the heart 14 to firmly fix the axial flow blood pump 10 in place.
  • any other fixation mechanism it is within the scope of the present invention to employ any other fixation mechanism.
  • the required electrical supply for the operation of the motor (to be described in the following description) is made through a wire that could, for example, extend from the pump 10 along the needle member 26 to reach the controller and the energy source.
  • the axial flow blood pump 10 comprises a stationary housing structure comprising a first stationary inflow stator 28, a second stationary stator 31 and a cylindrical pump stator 40.
  • the first stationary stator 28 induces a rotation (see arrow 29) to the blood flow about the longitudinal axis 32 of the axial flow blood pump 10. This initial rotation 29 minimizes abrupt changes in the blood flow path when it reaches the impeller 30 (rotor).
  • the second stationary stator 31 is used to transform the rotational motion (see arrow 31) of the flow about the longitudinal axis 32 into a translational motion (see arrow 33); in other words, the second stator 31 acts as a flow straightener 34.
  • the pump design should minimize shearing stress in order to minimize hemolysis.
  • reduction of the rotational speed would obviously contribute to reduce hemolysis.
  • reduction of the rotational speed while pumping the same volume of blood requires an increase of the volume of blood contained in the rotor zone of the pump 10.
  • the volume of blood contained in the rotor zone can be increased by minimizing the volume of the central hub of the pump rotor.
  • the axial flow blood pump 10 presents an enclosed-impeller axial flow configuration.
  • the impeller 30 comprises a set of four blades such as 35 enclosed in a shroud 36 whereby these blades are locked with one another. This enables a reduction of the strength, and therefore of the dimensions of the central hub 37 to obtain an optimal pumping volume while providing the required structural support for the blades 35.
  • elongated permanent magnets such as 38 can be inserted axially in the shroud 36, thereby providing optimal electromagnetic coupling between the permanent magnets 38 and motor windings such as 39, inserted into the cylindrical pump casing 40 extending between the stators 28 and 31 and surrounding the shroud 36.
  • the four blades 35 intersect at the central hub 37 protruding at both ends from the impeller 30 to form end pivots 41 and 42 ( Figure 3).
  • the function of the end pivots 41 and 42 ( Figure 3) is to support the impeller 30 at each extremity.
  • the end pivots 41 and 42 are respectively inserted into respective bushings 43 and 44.
  • Bushing 43 is mounted on the inflow stator 28 through a number of radial arms 45 schematically illustrated in Figure 3.
  • bushing 44 is mounted on the stator 31 through a number of radial arms 46 schematically illustrated in Figure 3.
  • the bearings formed by the bushing and pivot assemblies 41 ,43 and 42,44 are the only mechanical parts subject to wear. Therefore, these parts are expected to be mostly responsible for the life of the axial flow blood pump 10.
  • the number of blades 35 and their shape should be optimally determined in relation to pumping performance and other hydrodynamic considerations.
  • the influence of the blade angulation on the level of shearing stresses, turbulence and cavitation responsible for red blood cell damage and increase of hemolysis rate should be carefully investigated.
  • FIG. 5 shows that the internal diameter of the shroud 36 is the same as the internal diameter of the stators 28 and 31. Therefore, the inner surfaces of the shroud 36 and the stators 28 and 31 defines an inner continuous and smooth surface of the axial flow blood pump 10, to prevent as much as possible abrupt irregularities responsible for flow perturbations. Still referring to Figure 5, the cylindrical shroud 36 of the impeller 30 is inserted in the cylindrical pump casing 40; this could be viewed as a double casing configuration.
  • the gap 47 separating the outer cylindrical surface of the shroud 36 from the inner cylindrical surface of the pump casing 40 should be sufficiently large to prevent mechanical shocks and produce sufficient blood flow in order to increase washout and prevent clot formation. On the other hand, too large a gap will reduce the pump efficiency and may result in higher hemolysis.
  • blood flow through the gap 47 between the outer cylindrical surface of the shroud 36 and the inner cylindrical surface of the pump casing 40 can be reduced by bevelling outwardly the annular edge surface 48 of stator 28 and bevelling inwardly the annular edge surface 49 of the stator 31.
  • the axial flow blood pump 10 will be actuated by means of a brushless DC (direct current) motor.
  • This brushless configuration presents the advantage of minimal wear.
  • Two other interesting characteristics of brushless DC motors are high rotational speed and high torque.
  • the brushless DC motor is composed of the elongated axial permanent magnets 38 inserted in the shroud 36 and the windings 39 inserted in the cylindrical pump casing 40.
  • the configuration in which the blades 35 are embedded in the shroud 36 to increase the pumping volume has also an advantage related to the electromagnetic coupling between the permanent magnets 38 and the motor windings 39.
  • the permanent magnets 38 are embedded in the shroud 36 and the windings 39 are embedded in the cylindrical pump casing 40.
  • the insertion of the permanent magnets 38 in the shroud 36 very close to the windings 38 provides for an optimal electromagnetic coupling and obviously minimizes electrical losses.
  • the configuration according to the present invention does not restrict the number of magnets to the number of blades.
  • the choice of materials for an implantable device is crucial and several properties of the available materials should be considered: strength, durability, hardness, elasticity, wear resistance, surface finish and biocompatibility. Biocompatibility is very important to minimize irritation, rejection and thrombogenesis. The interaction between the surface of the material and the biological tissues is very complex. In several cases, treatments of the surface with human proteins, certain drugs like heparin or other biocompatible material may considerably increase the biocompatibility and minimize thrombus formation.
  • VAD SYSTEM Figure 6 schematically illustrates an embodiment of implantable VAD system including an axial flow blood pump 10.
  • the VAD system is composed of four main parts:
  • TEIT Transcutaneous Energy and Information Transmission
  • the TEIT system 54 works as a transformer.
  • System 54 is composed of two electrical coils, namely an external transmission coil 55 and an internal reception coil 56.
  • a RF (Radio Frequency) signal is applied to the external transmission coil 55 by a transmission circuit 57 supplied by the external battery 52, and the RF signal is transmitted to the internal reception coil 56.
  • the transmitted energy will be used to supply all the internal components of the VAD system.
  • the same TEIT system could eventually be used for transferring to the controller 50 operational data as well as programmable parameters.
  • the VAD system includes three external components advantageously incorporated to a belt 58 or suspenders (not shown).
  • the first external component is a source of energy in the form of a rechargeable battery 52 of good mobility (the external source of energy can also be fixed when the patient is stationary for example during sleeping time).
  • the second external component is a transmission circuit which converts the DC voltage from the external energy source into a RF signal.
  • the third external component is the transmission coil 55 which transmits the RF signal to the reception coil 56.
  • the VAD system also requires the implantation of four internal components.
  • the first internal component is the axial flow blood pump 10 itself.
  • the second internal component is the sub-cutaneous reception coil 56.
  • the third internal component is the rechargeable battery 51.
  • the fourth internal element is the controller 50. Controller 50 is a very important part of the system and achieves several functions. The main function of the controller 50 is to determine the blood flow rate to be delivered by the pump 10 considering the BSA and the level of activity of the patient (estimated by the heart rate). The controller 50 will adjust the speed of rotation of the axial flow blood pump 10 in relation to heart rate measurements.
  • the controller 50 converts the RF signal from the internal coil 56 into DC power. This DC power is used by the controller 50 to supply power to the pump 10 and to recharge the internal battery 51 when required.
  • the controller 50 also monitors the pump energy consumption. Interestingly, perturbation in energy consumption of the axial flow blood pump may serve to diagnose mechanical problems. For example, a slow but constant increase in energy consumption may reveal bearing wear or thrombus formation interfering with the pump operation. Another possibility is a sudden increase in energy consumption which may reveal a significant obstruction of the pump 10.
  • the last function of the controller 50 is to communicate information. In that context it is used to receive external programmable parameters and to monitor and transfer data to a computer for processing thereof.
  • the controller 50 is the central component of the VAD system, its reliability is imperative. To minimize risks of hazards and malfunctions, several strategies must be combined. First, the redundancy of critical electronic components of the controller 50 is recommended, and a watch dog circuit to detect erratic behaviours of the controller 50 is proposed. Finally, the watch dog circuit can be coupled to a backup circuit whose function it to fix a blood flow in case of major problems with the controller 50.
  • VADs ventricular assist devices
  • VAD is becoming a cost effective solution considering the fact that patients are discharged from the hospitals more rapidly and may return to normal life occupations.
  • several insurance companies are now reimbursing the implantation of VADs.
  • the axial flow blood pump 10 provides an excellent bridge to heart transplant and aims at long term implant.
  • the new proposed axial flow blood pump 10 should answer most of the remaining problems and limitations of the prior art axial flow blood pumps, especially those related to hemolysis and bleeding.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Mechanical Engineering (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Computer Networks & Wireless Communication (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne une pompe à sang axiale constituée d'une structure corps fixe et d'un rotor monté rotatif dans ladite structure autour d'un axe de rotation, de façon à produire un flux de sang suivant ledit axe. Le rotor comprend une chemise généralement cylindrique, centrée sur l'axe de rotation; une pluralité d'aubes de rotor, allongées vers l'intérieur depuis la surface interne de la chemise de façon à s'entrecouper au niveau de l'axe de rotation; et un moyeu central, centré sur l'axe de rotation et formé par l'intersection des aubes. La pompe comporte également un moteur électrique disposé à la fois dans la chemise et dans la structure corps. Plus spécifiquement, le moteur électrique comprend une série de bobinages, enfermés dans la structure corps fixe, et une série d'aimants permanents allongés axialement, incorporés à la chemise. La pompe peut être utilisée dans un appareil d'assistance ventriculaire implantable. La géométrie axiale à rotor fermé de la pompe, associée au petit diamètre du moyeu central, accroît le volume de sang que la pompe est capable de contenir et donc de pomper.
EP98923962A 1997-05-30 1998-05-29 Appareil d'assistance ventriculaire avec pompe a sang axiale a rotor ferme Withdrawn EP0986409A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CA2206644 1997-05-30
CA002206644A CA2206644A1 (fr) 1997-05-30 1997-05-30 Dispositif d'assistance ventriculaire comprenant une pompe a sang axiale a roue fermee
PCT/CA1998/000534 WO1998053864A1 (fr) 1997-05-30 1998-05-29 Appareil d'assistance ventriculaire avec pompe a sang axiale a rotor ferme

Publications (1)

Publication Number Publication Date
EP0986409A1 true EP0986409A1 (fr) 2000-03-22

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Country Link
EP (1) EP0986409A1 (fr)
AU (1) AU7634398A (fr)
CA (1) CA2206644A1 (fr)
WO (1) WO1998053864A1 (fr)

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US11511103B2 (en) 2017-11-13 2022-11-29 Shifamed Holdings, Llc Intravascular fluid movement devices, systems, and methods of use
US11654275B2 (en) 2019-07-22 2023-05-23 Shifamed Holdings, Llc Intravascular blood pumps with struts and methods of use and manufacture
US11724089B2 (en) 2019-09-25 2023-08-15 Shifamed Holdings, Llc Intravascular blood pump systems and methods of use and control thereof
US11964145B2 (en) 2019-07-12 2024-04-23 Shifamed Holdings, Llc Intravascular blood pumps and methods of manufacture and use
US12102815B2 (en) 2019-09-25 2024-10-01 Shifamed Holdings, Llc Catheter blood pumps and collapsible pump housings
US12121713B2 (en) 2019-09-25 2024-10-22 Shifamed Holdings, Llc Catheter blood pumps and collapsible blood conduits
US12161857B2 (en) 2018-07-31 2024-12-10 Shifamed Holdings, Llc Intravascular blood pumps and methods of use
US12220570B2 (en) 2018-10-05 2025-02-11 Shifamed Holdings, Llc Intravascular blood pumps and methods of use
US12409310B2 (en) 2019-12-11 2025-09-09 Shifamed Holdings, Llc Descending aorta and vena cava blood pumps
US12465748B2 (en) 2019-08-07 2025-11-11 Supira Medical, Inc. Catheter blood pumps and collapsible pump housings
US12599758B2 (en) 2019-12-19 2026-04-14 Shifamed Holdings, Llc Intravascular blood pumps, motors, and fluid control

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US11717670B2 (en) 2017-06-07 2023-08-08 Shifamed Holdings, LLP Intravascular fluid movement devices, systems, and methods of use
US11511103B2 (en) 2017-11-13 2022-11-29 Shifamed Holdings, Llc Intravascular fluid movement devices, systems, and methods of use
US12076545B2 (en) 2018-02-01 2024-09-03 Shifamed Holdings, Llc Intravascular blood pumps and methods of use and manufacture
US11229784B2 (en) 2018-02-01 2022-01-25 Shifamed Holdings, Llc Intravascular blood pumps and methods of use and manufacture
US10722631B2 (en) 2018-02-01 2020-07-28 Shifamed Holdings, Llc Intravascular blood pumps and methods of use and manufacture
US12161857B2 (en) 2018-07-31 2024-12-10 Shifamed Holdings, Llc Intravascular blood pumps and methods of use
US12220570B2 (en) 2018-10-05 2025-02-11 Shifamed Holdings, Llc Intravascular blood pumps and methods of use
US11964145B2 (en) 2019-07-12 2024-04-23 Shifamed Holdings, Llc Intravascular blood pumps and methods of manufacture and use
US11654275B2 (en) 2019-07-22 2023-05-23 Shifamed Holdings, Llc Intravascular blood pumps with struts and methods of use and manufacture
US12465748B2 (en) 2019-08-07 2025-11-11 Supira Medical, Inc. Catheter blood pumps and collapsible pump housings
US12102815B2 (en) 2019-09-25 2024-10-01 Shifamed Holdings, Llc Catheter blood pumps and collapsible pump housings
US12121713B2 (en) 2019-09-25 2024-10-22 Shifamed Holdings, Llc Catheter blood pumps and collapsible blood conduits
US11724089B2 (en) 2019-09-25 2023-08-15 Shifamed Holdings, Llc Intravascular blood pump systems and methods of use and control thereof
US12409310B2 (en) 2019-12-11 2025-09-09 Shifamed Holdings, Llc Descending aorta and vena cava blood pumps
US12599758B2 (en) 2019-12-19 2026-04-14 Shifamed Holdings, Llc Intravascular blood pumps, motors, and fluid control

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Publication number Publication date
CA2206644A1 (fr) 1998-11-30
AU7634398A (en) 1998-12-30
WO1998053864A1 (fr) 1998-12-03

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