BLOOD CENTRIFUGAL PUMP SYSTEM

专利摘要:
centrifugal blood pump system the present invention relates to a blood pump system (10) for persistently increasing the total diameter and lumen diameter of peripheral veins and arteries by persistently increasing the blood velocity and shear stress of wall in a peripheral vein or artery for a period of time sufficient to result in a persistent increase in the total diameter and the lumen diameter of the vessel. the blood pump system includes a blood pump (25), blood duct (s) (20, 30), a control system with optional sensors, and a power source. the pump system is configured to connect to a patient's vascular system and pump blood at a desired rate and pulsation. blood pumping is monitored and adjusted, as needed, to maintain the desired blood speed, wall shear stress and desired pulsability in the target vessel to optimize the rate and extent of persistent increase in the total diameter and lumen diameter of the target vessel.
公开号:BR112014003425B1
申请号:R112014003425-7
申请日:2012-08-15
公开日:2020-12-15
发明作者:M.D.F. Nicholas Franano
申请人:Flow Forward Medical, Inc；
IPC主号:

专利说明:

CROSS REFERENCE TO RELATED REQUESTS
[001] This application claims priority from US Patent Application Number 61 / 564,671 entitled "Blood Pump Systems and Methods", filed on November 29, 2011, and claims priority from US Patent Application Number 61 / 524,761, entitled " Blood Pump Systems and Methods ", filed on August 17, 2011, which is part of a continuation of US Patent Application Number 13 / 030,054, entitled" System and Method for Increasing the Total Diameter of Veins "filed in 17 February 2011, which claims priority of US Patent Application Number 61 / 305,508 entitled "System and Method for Increasing the Total Diameter of Veins" filed on February 17, 2010, and is related to PCT International Patent Application Number PCT / US12 / 50978 copending, co-deposited, entitled "System and Method for Increasing the Total Diameter of Veins and Arteries", filed on August 15, 2012, and is related to US Patent Application Number 61 / 524,759 copen tooth, entitled "System and Method for Increasing the Total Diameter of Veins and Arteries", filed on August 17, 2011, and US Patent Application Number 61 / 561,859, entitled "System and Method for Increasing the Total Diameter of Veins and Arteries ", filed on November 19, 2011, all of which are incorporated by reference in their entirety. FIELD OF THE INVENTION
[002] The present invention relates to a blood pump system that includes a pump, conduits, a control unit, and an energy source, whereby the system can be used to persistently increase blood flow arteries and veins of patients. Specifically, this invention may be useful to persistently increase the total diameter and lumen diameter of veins and arteries in patients who need a vascular access site for hemodialysis, a bypass graft, or other type of surgery or procedure where a larger diameter vein or artery is desired. This invention may also be useful to provide increased local blood flow to organs and tissues in need, such as the lower extremities of patients with peripheral arterial disease (PAD). HISTORICAL INFORMATION
[003] There are more than half a million patients with chronic kidney disease (CKD) in the United States, with more than 100,000 new CKD patients each year. There is a four percent annual increase in the projected prevalence population due to such driving factors as, for example, high blood pressure, diabetes, and an elderly population.
[004] Hemodialysis is the treatment of choice for 92% of CKD patients, because without hemodialysis or some other form of treatment these CKD patients would die. A typical CKD patient undergoing hemodialysis treatment must have his vascular system connected to a hemodialysis machine two or three times a week. For hemodialysis, there are three common vascular access site options. The preferred location option is an arteriovenous fistula (AVF), which is a direct, surgically created connection between an artery and a vein, preferably on the wrist, or alternatively, on the forearm, arm, leg, or groin. Another option of access site is an arteriovenous graft (AVG), which is a surgically created connection between an artery and a vein using an interposed synthetic conduit. The main option for the final access site is a catheter inserted into a large vein in the neck, chest, leg, or other anatomical location.
[005] Patients with an AVF have less morbidity, less mortality, and a lower cost of care compared to patients with an AVG or a catheter; therefore, an AVF on the wrist is the preferred form of vascular access for hemodialysis. Patients with an AVG or catheter have substantially higher rates of infection and death than patients who have an AVF, with catheter patients having the worst results. In addition, patients who have an AVG or catheter have a higher average care cost, with catheter patients having the highest costs. If a patient is eligible for an AVF, the wrist or forearm is generally preferred over an AVF in the arm due to higher rates of hand ischemia and the generally shorter and deeper vein segments of the arm.
[006] Unfortunately, approximately 85 percent of patients are ineligible for an AVF on the wrist, mainly due to very small vein and artery diameters. Furthermore, approximately 60 percent of all AVFs created are not usable without additional surgical and interventional procedures due to an occurrence commonly referred to as "maturation failure", which is correlated with the small diameter of veins and arteries. The availability of veins and arteries with larger diameters is correlated with higher AVF eligibility and lower rates of maturation failure.
[007] Currently, there are few options to permanently and persistently increase the diameter of a vein or artery. All current methods use mechanical dilation methods, such as balloon angioplasty, which can lead to injury to veins or arteries. Since a patient needs to have peripheral veins and arteries of a certain size for a doctor to create an AVF, it is desirable to have a method and system for persistently and permanently increasing the size or diameter of peripheral veins or arteries.
[008] Currently, small "heart pumps" exist. However, such pumps are expensive and not designed and sized for use at one end. As such, there is a need in the art for systems, components, and methods to increase the diameter of peripheral veins and arteries at a reasonable cost. In addition, there is a need for a pump device that can increase the diameter of peripheral veins and arteries . SUMMARY OF THE INVENTION
[009] The present application relates to a blood pump system for use in increasing the diameter of veins and arteries, preferably peripheral veins and arteries. The system will work to move the blood in such a way as to cause an increase in diameters of veins or arteries. This can be done by discharging ("pushing") blood into a vein or artery or removing ("pulling") blood from a vein or artery. By either method, the system increases blood flow within a vessel, which ultimately leads to a persistent increase in vessel diameter. As such, the system and, more specifically, the pump use a mechanical means to activate the biological response pathways that result in the enlargement or "reshaping" of veins or arteries. The system has a blood pump, ducts to carry blood to and from the blood pump, a control system to monitor the blood pump and modify the operation of the blood pump, and a power source. As such, the system comprises a group of limbs that can, for example, be inserted into an artery at one end and a vein at the other, whereby, when activated, blood is pumped at a rate such that a tension of wall shear (WSS) over the endothelium of the vein, artery, or both is elevated for a period of time sufficient to cause a persistent increase in the vein or artery. Any of a variety of pumps can be used as long as the pump can be controlled to produce the desired blood vessel diameter increase.
[0010] Various types of blood pumps can be employed, including positive displacement and rotary pumps, with rotary type pumps being preferred. In one embodiment, a rotary blood pump system includes a housing that defines an inlet to receive blood and an outlet to discharge blood. The pump housing is designed and dimensioned to accommodate a rotating impeller suspended on supports. The pump housing may have a first support at the inlet portion of the housing and a second support at the outlet portion of the housing. The blood enters and exits the rotating impeller, whereby the impeller increases the speed at which the blood leaves. This increased speed is recovered or translated as an increased pressure as the blood slows down inside the pump diffuser, which ends at the pump outlet.
[0011] In other modalities, several types of blood pump can be used. For example, an axial flow pump, a mixed flow pump, or preferably a centrifugal blood pump can be used. In addition, a variety of pump impeller mounts can be used, including, but not limited to, magnetic mounts, hydrodynamic mounts, and preferably pivot (contact) types. Similarly, various types of pump diffusers can be used, including but not limited to a manifold diffuser, or preferably a volute diffuser.
[0012] In one embodiment, a centrifugal blood pump with pivot supports includes a pump housing that defines a pump inlet that has a flow inlet diffuser for receiving blood and directing blood over an impeller, the pump having an upper chamfer and an upper pivot support that extends from a top of the housing into the entrance, and a lower chamfer and a lower pivot support that extends from a bottom of the housing into the internal space of the housing. The pump also includes the impeller suspended within the housing, the impeller still having a support lumen for receiving an impeller pivot. The impeller pivot has a first end to couple the input portion (upper) pivot support and a second end to couple the exit portion (lower) pivot support. In one embodiment, the ends of the impeller pivot are convex and at least one end of each pivot support is concave. In another embodiment, the ends of the impeller pivot are concave and the pivot supports are convex. The impeller may include a variety of fin or blade constructions designed to contact and accelerate blood within the volute. For example, the impeller defines a plurality of blades on the upper surface of the impeller and extending radially from a center of the impeller to an outer edge of the impeller. The blades accelerate the blood from the central impeller inlet to its peripheral outlet. In another option, the impeller does not include blades or fins, but does include a means for moving or propelling blood. The impeller optionally includes at least one wash lumen, cutout, or hole that extends parallel to a central impeller geometry from a lower surface through the impeller to an upper surface. The lumen is designed to prevent blood stagnation under the impeller and around the lower pivot support.
[0013] The blood pump is a motor, preferably electric, designed to actuate the impeller. In one embodiment, the blood pump includes a drive motor that has at least one magnet mechanically attached to the impeller and at least one armature mechanically attached to the housing. The armature induces an electromotive force on at least one magnet attached to the impeller. The pump motor can be a brushless direct current (DC) motor with axial clearance brushes with a sensorless rear electromotive force switching. The motor employs a sintered iron boron neodymium (NdFeB) alloy for the magnets on the rotor and a three-phase flat "race track" coil configuration in the stator. The motor has a pancake aspect ratio, with a very small axial length compared to its diameter.
[0014] The blood pump system has one or more ducts that includes a first duct (flow inlet) that has two ends, a first end that is fluidly connected at a location in the vascular system and receives blood from that location, and a second end that is fluidly connected to the pump. The flow inlet conduit supplies blood to the pump. The blood pump system has a second conduit (flow outlet) that has two ends, a first end that is fluidly connected to the pump and receives blood from the pump, and a second end that is fluidly connected to a location in the vascular system. The flow outlet supplies blood to a location in the vascular system.
[0015] In various modalities, the ducts of the blood pump system have an individual length between 2 cm and 110 cm and a combined length between 4 cm and 220 cm, and can be cut to a desired length by a surgeon or other doctor , including during the implantation of the pump system. The ducts each have an internal diameter between 2 mm and 10 mm, and preferably between 4 mm and 6 mm. Conduits can be formed at least in part from polyurethane (such as Pellethane® or Carbothane®), polyvinyl chloride, polyethylene, silicone elastomer, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyethylene terephthalate (PET, for example, Dacron), and their combinations. The conduits may also include an elastic reservoir.
[0016] All or portions of the ducts can be reinforced with a memory material in a twisted or spiral form, such as nitinol, or other self-expanding or radially expanding material. The conduits may have chamfered ends that fluidly connect to the vascular system. The ends can be chamfered at an angle between 10 degrees and 80 degrees. One or more conduits may have a number of holes or fenestrations in the walls of the distal ends, when configured for placement within the lumen of a blood vessel or other intravascular location. Ducts can be attached to the pump using radially compressive connectors.
[0017] In one embodiment, a blood pump system includes a blood pump and a control system to monitor the blood pump system and modify the operation of the blood pump to maintain an increased mean wall shear stress inside an artery or vein fluidly connected to the blood pump. The control system is also configured to maintain a medium wall shear stress within a vein in the range of 0.76 to 23 Pa, or preferably in the range of 2.5 to 10 Pa. In another embodiment, the Control monitors and maintains an increased average blood velocity within an artery or vein fluidly connected to the blood pump. In this modality, the control system is configured to maintain an average blood speed within an artery or vein in the range of 10 cm / s and 120 cm / s, or preferably in the range of 25 cm / s and 100 cm / s. In either mode, the blood pump system is configured to maintain an increased average wall shear stress or an increased average blood speed for at least 1 day, 7 days, 14 days, 28 days, 42 days, 56 days, 84 days, or 112 days.
[0018] The blood pump system has a control system to achieve and maintain the desired flow rate, which can optionally include a control device for receiving information and controlling the operation of the pump of the blood pumping system. At a minimum, the control system can be manually actuated to adjust the engine speed. Alternatively, an automatic (ie, "intelligent") control system can be used. Optionally, the control system includes sensors that can be located inside the pump, the ducts, or in the patient's vascular system. The control device can measure the rotational speed of the motor based on the zero crossings of the back-emf waveform. These zero crossings indicate the rotor's magnetic pole inversions. The motor speed is controlled by pulse width modulation (PWM) of the input voltage, and the torque is controlled by the PWM of the input current. The control device also monitors other pump motor status variables, such as current and voltage, from which both the flow rate through the blood pumping system and the wall shear stress in the peripheral blood vessel can be estimated and controlled. The control device preferably includes a memory, a processor to control the speed of the pump motor, analyze the information that comes from the motor drive electronics and optional sensors, and execute coded instructions in a computer-readable medium. The blood pump system includes a cable to electrically connect the control device to the pump and optional sensors. The blood pump system also includes an energy source that, in various ways, can be integrated into the control device. In several embodiments, the power source of the blood pump system can be mobile (for example, a rechargeable battery or fuel cell) or stationary (for example, a power base unit connected to the AC network).
[0019] The control system can acquire information from several sources. The motor drive electronics within the control device can measure at least one of the motor speed, input power or current required to operate the pump. In other embodiments, the control system includes sensors within the blood pump or conduits that measure at least one blood rate, a blood flow rate, a resistance to blood flow in a peripheral blood vessel, a blood pressure, a pulsatility index, and their combinations. In other embodiments, the control system includes sensors in the patient's vascular system that measure at least one blood rate, blood flow rate, blood pressure, pulsatility index, vessel diameter, and combinations thereof.
[0020] In several modalities, the control system can estimate and maintain a desired and high level of wall shear stress in a target vessel or a donor artery or vein, using the information from the control device and / or sensors, such as such as a motor speed, a motor input power, a pump flow rate, a pump pressure height, pressure near the junction of the flow outlet duct, and the target vessel, pressure drop across a vessel blood, and their combinations. For the purpose of this application "target vessel", "target blood vessel", "target vein", or "target artery" refers to a specific segment of an artery or vein that is intended to achieve a total diameter and diameter of lumens persistently increased when a pump - duct assembly is implanted, configured, and operated in such a way as to result in the persistent increase in total diameter and lumen diameter.
[0021] Various control system methods can be used to automatically control the operation of the blood pump system. In one embodiment, a method for determining and controlling a wall shear stress in a blood vessel includes the steps of measuring a blood viscosity, measuring a blood flow rate in a blood pump system or in the blood vessel, and measuring a blood vessel ray. The steps also include determining the blood vessel wall shear stress of a measured blood viscosity, the measured flow rate and blood vessel radius, comparing the determined wall shear stress to a predetermined reference value, and adjusting a blood pump speed when the determined wall shear stress does not approach the predetermined reference value. The steps are repeated until the determined wall shear stress approaches the predetermined reference value.
[0022] In another embodiment, a method for computing and controlling a wall shear stress in a blood vessel includes the steps of estimating blood viscosity, measuring a blood flow rate in a blood pump system or in the blood vessel , and measure a blood vessel radius. The steps also include determining the wall shear stress of the estimated blood viscosity, the measured blood flow rate, and the blood vessel radius, comparing the determined wall shear stress with a predetermined reference value, and adjusting a speed of blood pump when the determined wall shear stress does not approach the predetermined reference value. The steps are repeated until the determined wall shear stress approaches the predetermined reference value.
[0023] In one embodiment, a method for estimating and controlling a wall shear stress in a blood vessel includes the steps of estimating blood viscosity, measuring at least one motor state variable for a selected blood pump system of a voltage, current, or pump speed, and estimate a rate of blood flow in the blood pump system. The steps also include measuring a blood vessel pressure, determining a blood vessel vascular resistance of the estimated blood flow rate and the pressure measured in the blood vessel, estimating a blood vessel radius. The steps further include determining the wall shear stress of the estimated blood viscosity, the estimated blood flow rate, and the blood vessel radius, comparing the determined wall shear stress with a predetermined reference value, and adjusting the speed when the determined wall shear stress does not approach the predetermined reference value. The steps are repeated until the determined wall shear stress approaches the predetermined reference value.
[0024] In another embodiment, a method for estimating and controlling a wall shear stress in a blood vessel using a blood pump system includes the steps of estimating blood viscosity, measuring at least one motor state variable, blood pump system selected from a voltage, current, or pump speed, and estimate a blood flow rate and pressure height in the blood pump system. The steps also include calculating a vascular, blood vessel resistance of the estimated blood flow rate and estimated pressure height, estimating a blood vessel radius, and determining the estimated blood viscosity wall shear stress, flow rate estimated blood flow and blood vessel radius. The steps further include comparing the determined wall shear stress with a predetermined setpoint and adjusting the pump speed when the determined wall shear stress does not approach the predetermined setpoint. The steps are repeated until the determined wall shear stress approaches the predetermined reference value.
[0025] In one embodiment, a method for estimating and controlling a wall shear stress in a blood vessel using a blood pump system includes the steps of estimating at least one member selected from a group consisting of blood viscosity , a blood flow rate, a pressure height in the blood pump system, and a blood vessel radius, measure at least one motor state variable of the blood pump system selected from a group consisting of a voltage, a current, and a pump speed, and determine the wall shear stress in the blood vessel. The steps also include comparing the determined wall shear stress with a predetermined setpoint and adjusting the pump speed when the determined wall shear stress does not approach the predetermined setpoint. The steps are repeated until the determined wall shear stress approaches the predetermined reference value.
[0026] In yet another embodiment, a sensorless method for preventing a collapse of a blood vessel fluidly connected to a blood pump system when detecting imminent collapse at an inlet of the blood pump system includes the steps of measuring a blood pump motor current and continuously determine a spectral analysis representation of the blood pump motor current in a form of a Fourier series. The steps also include providing a detection indication when the amplitude of the second harmonic term of the Fou-rier series exceeds a reference value and decreasing a pump speed when the amplitude of the second harmonic term of the Fourier series exceeds the reference value. The steps are repeated until the amplitude of the second harmonic term falls below the reference value.
[0027] In several other modalities, the systems and methods described here can be encoded in a computer-readable medium that can be executed by any reference values or predetermined standards used by the systems and methods can be stored in a database or other suitable storage medium. BRIEF DESCRIPTION OF THE FIGURES
[0028] Figure 1 is an isometric view of the pump.
[0029] Figure 2 is an exploded isometric view of the pump showing its components contained within the body identified in Figure 1.
[0030] Figures 3A and 3B are, respectively, elevations in partial and total cross section of the pump as done along section line 3-3 in Figure 1.
[0031] Figures 4A and 4B are, respectively, elevations in partial and total cross section of the pump as done along section line 4-4 in Figure 1.
[0032] Figures 5A-B are enlarged views of the pivot geometry axis area of Figures 3B and 4B.
[0033] Figures 6A-B, respectively, are upper and lower isometric views of the impeller pivot.
[0034] Figures 7A-B, respectively, are upper and lower isometric views of the impeller pivot.
[0035] Figures 8A-B are seen in lateral elevation of impeller pivot modalities.
[0036] Figures 9A-B are, respectively, opposite end views of a representative support pin used on each end of the impeller pivot to support and allow the rotation of the impeller pivot.
[0037] Figure 10 is a view of an embodiment of the upper support pin.
[0038] Figures 11A-B are seen in lateral elevation of modalities of the representative support pin.
[0039] Figure 12 is a longitudinal cross section of a representative support pin assembly.
[0040] Figure 13 is a plan view of the inlet cover and impeller housing.
[0041] Figures 14-16 are, respectively, elevations in cross section made along section lines 14-14, 15-15, and 16-16 in Figure 13.
[0042] Figure 17 is an isometric partial cross section of the impeller chamber inlet.
[0043] Figures 18A and 18B are, respectively, a plan view of the entrance cover portion that defines the entrance channel and an end elevation view thereof.
[0044] Figures 19A and 19B are the same respective views as in Figures 18A and 18B, except that in another modality.
[0045] Figures 20A and 20B are the same respective views as in Figures 18A and 18B, except that in another modality.
[0046] Figures 21-23 are the same views as Figure 18A except for three other modalities.
[0047] Figures 24A and 24B are, respectively, plan and side elevation views of another modality of the entrance cover and the entrance channel similar to that described in Figure 21, except also including an arcuate wedge portion.
[0048] Figure 25 is an isometric view of the pump with the upper impeller housing removed to reveal the impeller that occupies the impeller chamber.
[0049] Figure 26 is a perspective view of a blood pump system according to an embodiment.
[0050] Figures 27A-27D are seen in perspective of the connection between the pump and the ducts according to a modality.
[0051] Figures 28A and 28B are seen in perspective of the connection between the pump and the ducts according to a modality.
[0052] Figures 29A and 29B are seen in perspective of the connection between the pump and the ducts that include a side door according to a modality.
[0053] Figures 30A and 30B are seen in perspective of the connection between the pump and the ducts that include a septum according to a modality.
[0054] Figure 31 is a view of the distal portion of the flow outlet duct according to an embodiment.
[0055] Figures 33A and 32B are seen from the intravascular portion of a flow inlet conduit according to an embodiment.
[0056] Figure 33 is a schematic view of the pump system according to an embodiment.
[0057] Figure 34 is a schematic view of the pump system according to another modality.
[0058] Figure 35 is a schematic view of a control system according to a modality.
[0059] Figures 36A-36D are flow charts of control system methods according to various modalities.
[0060] Figure 36E is a graph of anastomosis pressures and blood flow rates for an in vitro model of the pump system according to a modality.
[0061] Figures 36F-36H are flowcharts of control system methods according to various modalities.
[0062] Figure 37 is a schematic view of the pump system as applied to a patient's circulatory system according to a modality.
[0063] Figure 38 is a schematic view of the pump system as applied to a patient's circulatory system according to a second embodiment.
[0064] Figure 39 is a schematic view of the system without a pump as applied to a patient's circulatory system according to a third modality.
[0065] Figure 40 is a schematic view of the pump system as applied to a patient's circulatory system according to a fourth modality.
[0066] Figure 41 is a longitudinal cross section of the junction between the nearest segment and the distal segment.
[0067] Figure 42 is a plan view of a medical kit.
[0068] Figure 43 is a schematic diagram of a pump controller system according to the flow outlet pressure. DETAILED DESCRIPTION OF THE INVENTION
[0069] The systems and components of the present application refer to a blood pump system. More specifically, in various embodiments, the present application relates to a blood pump designed and sized to discharge blood into a target vessel or draw blood from a target vessel in such a way and for such a period of time that the diameter of the target vessel (vein or artery) is persistently increased. Even more specifically, the present application relates to a rotary blood pump system configured to persistently increase the mean and / or peak blood velocity and the mean and / or peak wall shear stress in selected segments of veins or arteries for a period of time sufficient to persistently increase the total diameter and lumen diameter of selected segments of veins or arteries. The term "persistent increase" or "persistent dilation" when used to describe dilation or an increase in the total diameter and lumen diameter of an artery or vein, is used here to mean that even if the pump is turned off, an increase in the total diameter or the lumen diameter of a vessel can still be demonstrated when compared to the total diameter or the lumen diameter of the vessel before the blood pumping period. That is, the total diameter the lumen diameter of the vessel has become larger regardless of the pressure generated by the pump. The blood pump system may therefore be useful in certain patients, including CKD patients in need of a vascular access site for hemodialysis. The blood pump system can include a rotating blood pump, one or more blood transport lines, a control system and a power source. The blood pump system draws blood from one location in the vascular system and discharges blood to another location in the vascular system. During operation, such a blood pump system can persistently increase the mean and / or peak blood velocity and the mean and / or peak WSS within a target blood vessel to a level and for a period of time sufficient to increase persistently the total diameter and the lumen diameter of the target blood vessel. The system works in settings where blood is drawn from the target blood vessel or in settings where blood is discharged into the target blood vessel. In addition, the system can be used simultaneously to increase the size of the donor and recipient vessels.
[0070] Optional blood-carrying conduits may include a flow inlet conduit to carry blood from a location in the vascular system (such as a donor vein, donor artery, or right atrium) to the blood pump and an flow outlet conduit for loading blood from the blood pump to a location in the vascular system (such as a peripheral acceptance vein or artery or an acceptance location such as the right atrium). The blood pump system also includes a control system. A preferred control system is designed to collect information about the operating parameters and performance of the blood pump system, and changes in the vascular system such as changes in the diameter of a donor artery, a donor vein, an acceptance artery, or a patient's acceptance vein. The blood pump system is primarily configured to pump a sufficient amount of blood so that a desired average or peak wall shear stress (WSS) is achieved within a segment of the blood vessel (the "target blood vessel" or "target vessel") and for a sufficient period of time so that the total diameter and diameter of the permanent or persistent lumen of the blood vessel segment are increased. The average WSS can be calculated using the measured, estimated, or assumed vessel diameter and the average measured, estimated, or assumed blood flow rate through the blood pump system.
[0071] The diameter of blood vessels can be determined by measuring the diameter of the void within the center of the blood vessel. For the purpose of this application, this measurement is referred to as "lumen diameter". The diameter of blood vessels can be determined by measuring the diameter in a way that includes the void within the center of the blood vessel and the wall of the blood vessel. For the purpose of this application, this measurement is referred to as "total diameter". The invention relates to simultaneously and persistently increasing the total diameter and lumen diameter of a peripheral vein by moving blood (preferably with low pulsatility) into the peripheral acceptance vein, thereby increasing the blood velocity within the peripheral acceptance vein and increasing the WSS over the endothelium of the peripheral acceptance vein. Systems and methods are described in which the blood velocity in a peripheral acceptance vein and the WSS over the peripheral acceptance vein endothelium are increased using a pump. Systems and methods are also described that draw or "pull" blood so that blood velocity and WSS are increased in the donor vessel, either an artery or a vein. Preferably, the pump actively discharges blood into the peripheral acceptance vein, where the pumped blood has reduced pulsatility, such as when the pulse pressure is lower than the blood in a peripheral artery.
[0072] To start a detailed discussion of the blood pump 25 of system 10, reference is made to Figure 1, which is an isometric view of the blood pump 25. In one embodiment, the blood pump 25 is a pump miniaturized centrifuge that has a magnetic drive in which the pump impeller is rotationally driven by rotating magnetic fields. For example, rotating magnetic fields can be generated by energizing a number of electromagnets in a specific sequence. In another example, rotating magnetic fields can be generated by rotating a number of permanent magnets or energized electromagnets. The pump can have a diameter approximately equal to that of a coin in the order of, for example, a quarter of a US dollar, half a US dollar, or a larger currency. As shown in Figure 1, blood pump 25 includes a body 105, an inlet 110, an outlet 115, and a power cord 120. Power cord 120 connects blood pump 25 to control device 21 of a system control unit 14 and power source. The power source can be part of the control device 21 or be separate. The power cable allows communication between the control device 21 and the blood pump motor 25. The cable can also be used to transfer energy from a power source to the motor or pump. More specifically, the power cable 120 connects the electrical components of the magnetic drive within the body 105 to an electrical power source (e.g., a battery).
[0073] Inlet 110 is capable of being fluidly coupled to flow inlet conduit 20 through a coupling arrangement (e.g., a barbed end, a flange, and a locking collar). Inlet 110 provides a fluid path into the inlet region (i.e., center) of the pump impeller. The impeller inlet region can be of a variety of constructions as long as blood is received from the outlet at a higher rate than at the inlet. Outlet 115 is capable of being fluidly coupled to the flow outlet duct 30 through a coupling arrangement similar to the inlet (for example, a barbed end, a flange, and a locking collar) Outlet 115 provides a fluid path the outlet region (ie periphery) of the pump impeller.
[0074] As illustrated in Figure 2, which is an exploded isometric view of the blood pump 25 showing its components contained within the body 105 identified in Figure 1, the blood pump 25 includes an inlet cap 125, a pin upper support 130, an upper impeller housing 135, an impeller 140, an impeller pivot 145, a magnet assembly 150, a magnet housing 155, a lower support pin 160, a lower impeller housing 165, a set electric coil 170, and a coil assembly compartment cover 175. Inlet cover 125 and upper impeller housing 135 each include approximately half of inlet 110.
[0075] As shown in Figures 3A and 3B, which are, respectively, elevations in partial and total cross section of the blood pump 25 as taken along section line 3-3 in Figure 1, the components mentioned with respect to to Figure 2 generally sandwich together to form the bomb. For example, as can be understood from Figures 2-3A, the inlet cover 125 and the upper impeller housing 135 respectively include an upper inlet portion 110A that extends horizontally and a lower inlet portion 110B that extends horizontally. Typically, the entrance and the exit are opposite and located on different planes. When the inlet cap 125 and the upper impeller housing 135 are sandwiched together, they define an inlet fluid channel 180 that leads through inlet 110 to impeller inlet hole 185. Inlet cover 125 and the upper impeller 135 respectively define approximately an upper half and a lower half of channel 180. A sealing groove 190 is defined in the upper impeller housing 135 adjacent to the edge of channel 180 and is adapted to receive a resilient fluid sealing member to create a fluid-tight seal between the inlet cap 125 and the upper impeller housing 135,
[0076] Figures 4A and 4B are, respectively, elevations in partial and total cross section of the blood pump 25 taken along section line 4-4 in Figure 1. As can be understood from Figures 2, 4A, and 4B, the upper impeller housing 135 and the lower impeller housing 165 respectively include a horizontally extending upper outlet portion 115A and a horizontally extending lower outlet portion 115B. When the upper impeller housing 135 and lower impeller housing 165 are sandwiched together, they define an outlet fluid channel 200 (i.e., volute) that leads from the impeller chamber 205 to outlet 115. The upper impeller 135 and lower impeller housing 165 respectively define approximately an upper half and a lower half of channel 200. A sealing groove 211 is defined in the lower impeller housing 165 adjacent to the edge of channel 200 and the impeller chamber 205 and it is adapted to receive a resilient fluid sealing member to create a fluid-tight seal between the upper impeller housing 135 and the lower impeller housing 165.
[0077] As indicated in Figures 2-4B, magnets 150 are a plurality of magnets in the form of a ring or disc. The magnets 150 are located within the volume of the magnet compartment 155 and the volume of the impeller 140. The magnet compartment is received within the impeller. The magnet compartment 155 and the impeller 140 respectively form the lower and upper portions of the volume within which the magnets 150 are located. The magnet compartment, the magnets, and the impeller are coupled together in a fixed integral assembly that rotates as a unit within the 205 impeller chamber. Alternative constructions can be used that cause the impeller to rotate.
[0078] As shown in Figures 2-4B, the electrical coil assembly 170 is a plurality of electrical coils 210 arranged in a circular arrangement on the lower impeller housing and optionally covered by a support disk 215. The coil assembly electric 170 is fixed inside the coil chamber 220 defined in the lower impeller housing 165 and capped by the coil compartment cover 175. An internal bottom structure 225 separates the impeller chamber 205 from the coil chamber 220. The electric cable 120 ( see Figure 1) extends through the passage 230 in the lower impeller housing 165 to the coil chamber 220 and the coils 210. The electrical energy supplied to the coils 210 through the electric cable 120 generates rotating magnetic fields, which act on the magnets 150 to cause the magnets, and the impeller 140 coupled to the magnets to rotate. Impeller rotation causes impeller blades 235 to act on the fluid (e.g., blood) present within the impeller chamber, resulting in a moment being transferred to the fluid that is recovered as a pressure increase in the fluid channel outlet 200. The fluid is thus sucked into the inlet 110 at low pressure and discharged from the outlet 115 at a higher pressure.
[0079] As shown in Figures 3A-4B, the pivot geometry axis for impeller 140, magnets 150, and housing 155 is impeller pivot 145. As shown in Figures 5A-B, impeller pivot 145 is articulated supported (ie restricted in all degrees of freedom except rotation around a single geometry axis) through an upper support pin 130 and a lower support pin 160. The upper support pin 130 is received and fixed inside a cylindrical recess 240 in the inlet cover 125, while the lower support pin 160 is received and fixed inside a cylindrical recess 245 in the lower impeller housing 165. The impeller pivot 145 extends through and is fixed in an opening central cylindrical 250 on impeller 140.
[0080] In a 250 impeller assembly embodiment, the impeller pivot 145, the upper support pin 130, and the lower support pin 160 are formed from high purity alumina, such as CoorsTek® AD-998. In another impeller assembly mode, impeller pivot 145, upper support pin 130, and lower support pin 160 are formed of silicon carbide-hardened alumina, such as Greenleaf® WG-300. In both embodiments, the dimensions of the impeller pivot 145, the upper support pin 130, and the lower support pin 160 are designed to limit contact stresses to levels permissible for high-purity alumina or hardened alumina. with silicon carbide, respectively, in view of peak thrust loads generated by hydrostatic forces and shock loads. In another embodiment of the impeller assembly, the impeller pivot 145 is formed of alumina hardened with silicon carbide, such as Greenleaf® WG-300 or of high purity alumina, such as Co-orsTek® AD-998, while the upper support pin 130, lower support pin 160, or both are formed of ultra high molecular weight polyethylene. In addition, the geometry of each component of the impeller assembly has been selected to limit fatigue and wear in order to meet the safety and durability requirements of the system 10.
[0081] As illustrated in Figures 6A-7B, the impeller pivot includes an upper hemispherical convex support surface 255 and a lower hemispherical convex support surface 260. Coimo indicated in Figures 6A, 6B, and 8A, a modality of the pivot of impeller has a total length L1 of approximately 10.15 mm, more or less 0.05 mm, and a pivot diameter D1 of approximately 2 mm, more or less approximately 0.01 mm. The upper support surface 255 has a radius R1 of approximately 0.61 mm, plus or minus 0.02 mm and extends a length L2 beyond an adjacent lip 265 by approximately 0.55 mm, plus or minus 0.02 mm. The lower support surface 260 has a R2 radius of approximately 0.31 mm, plus or minus 0.02 mm and extends a length L21 beyond an adjacent lip 265 by approximately 0.55 mm, plus or minus 0.02 mm. Similarly, an alternative embodiment of impeller pivot 45, as shown in Figures 7A, 7B, and 8B, has a total length L1 of approximately 10.15 mm, plus or minus 0.05 mm, and a diameter of pivot D1 of approximately 2 mm, more or less approximately 0.01 mm. The upper support surface 255 has a radius of approximately 0.31 mm, plus or minus 0.02 mm and extends a length L2 beyond an adjacent lip 265 by approximately 0.55 mm, plus or minus 0.02 mm. The lower bearing surface 260 has a radius R2 of approximately 0.31 mm, plus or minus 0.02 mm and extends a length L21 beyond an adjacent lip 265 by approximately 0.55 mm, plus or minus 0.02 mm. Other sizes and dimensions can be used depending on the size and performance requirements of the pump. The sizes are such that the resulting pump can be used on a patient to increase the diameter of a vessel.
[0082] As can be understood from Figures 5A and 5B, the upper support pin 130 and the lower support pin 160 generally have the same configuration, but are opposite to each other. As shown in Figures 9A-B, the upper support pin 130 and the lower support pin 160, have a concave teacup or hemispherical support surface 270 on one end and a generally flat surface 275 on the opposite end. Similarly, Figure 10 shows a specific embodiment of the upper support pin 130, which has a concave teacup or hemispherical support surface 270 on one end and a generally flat surface 275 on the opposite end. In this embodiment, the hemispherical concave support surface 270 of the upper support pin 130 has a greater radius than the concave support surface on the lower support pin 160.
[0083] As illustrated in Figure 11A, a support pin modality 130, 160 has a total length L3 of approximately 7.5 mm, plus or minus 0.1 mm, a minimum pivot diameter D2 of approximately 2 mm, plus 0.01 mm or less, and a radius of approximately 0.6 mm at the edge near the support surface 270. Near the non-supporting end 275 of the support pin 130, 160, a groove 280 extends circumferentially around the pin for provide a mechanical interlock to hold the support pin in place within the blood pump 25. Similarly, an alternative embodiment of the support pins 130, 160 as shown in Figure 11B, has a total length L3 of approximately 7.5 mm, plus or less 0.1 mm, a minimum pivot diameter D2 of approximately 3 mm, plus or minus 0.01 mm, and a radius of approximately 0.2 mm at the edge near the flat end 275. Near the non-pin end of the pin support 130, 160, there is a groove 280 that extends circumferentially and around the pivot used to provide a mechanical interlock to hold the support pin in place. Other sizes and dimensions can be used depending on the size of the pump, the materials of the support pin, and the forces acting on the support pin.
[0084] As can be understood from Figures 3B, 4B, and 5A-11B, the convex upper support surface 255 of impeller pivot 145 is rotationally received against the concave support surface 270 of the upper support pin 130, and the surface convex bottom support 260 of impeller pivot 145 is rotationally received against the concave support surface 270 of bottom support pin 160. Thus, the convex support ends 255, 260 of impeller pivot 145 are supported hinged by the concave support surfaces 270 of the upper and lower support pins 130 and 160, respectively. Consequently, the impeller assembly can rotate freely within impeller chamber 205 over impeller pivot 145, which is supported end-to-end with support pins 130 and 160, in a configuration commonly known as a "double pin support" ".
[0085] In yet another embodiment of the impeller assembly, the impeller assembly is a composite of the impeller shaft 145, the upper support pin 130, and the lower support pin 160. The composite design is beneficial with respect to simplicity, tolerances, and cost of machined support components. All of these constructions are designed to allow the engine to run in a continuous state for approximately one day at 1-12 weeks or more, without breaks.
[0086] As shown in Figure 12, the impeller shaft 145 with comprises an impeller pivot body 146 and two impeller pivot inserts 147. Impeller pivot body 146 comprises a machinable metal, such as stainless steel, and impeller pivot inserts 147 comprise high purity alumina, such as CoorsTek AD-998, or silicon carbide hardened alumina, such as Greenleaf WG-300. Impeller pivot inserts 147 are affixed to the impeller pivot body 146 by an adhesive and / or an interference fit. Optionally, chamber 146A can be filled with an adhesive or other potting material that is resistant to compression. The composite configuration and materials mentioned above can be applied to modalities of both the upper support pin 130 and the lower support pin 160, where the pin inserts 148 couple the impeller pivot inserts 147. Optionally, the chambers 148A for each support pin 130 and 160, can be filled with an adhesive or other potting material that is resistant to compression.
[0087] Inlet cap 125 and its inlet channel 150 may have a variety of configurations depending on the blood pump mode 25. For example, inlet cap 125 shown in Figure 2 is shown to be generally coextensive with the housing upper impeller 135. In other embodiments, the inlet cover 125 may be substantially smaller than, and not coextensive with, the upper impeller housing 135, as shown in Figures 13-15, which are seen from the inlet cover and the impeller housing.
[0088] As shown in Figures 14-16, which are, respectively, elevations in cross section made along lines 14-14, 15-15, and 16-16 in Figure 13, the entrance 110 is a construction of two parts which have portions 110A and 110B that each form approximately half of the inlet 110 and are each part of the inlet cover 125 and upper impeller housing 135 respectively. Each portion 110A and 110B has defined in it approximately half of the inlet channel. inlet 180. As illustrated in Figure 14, inlet channel 180 initially has a circular diameter D5 of approximately 4 mm. As indicated in Figure 15, the inlet channel 180 transitions from a circular cross section to a generally rectangular cross section that has a width W5 of approximately 8.4 mm and an H5 height of approximately 1.5 mm. Again, as the dimensions change, so do the listed measurements.
[0089] As shown in Figure 16, inlet channel 180 surrounds impeller chamber inlet hole 185, which extends around upper support 145 received inside, and affixed to, inlet cover 125. As shown in 17, which is an isometric partial cross section of impeller chamber inlet 185, impeller chamber inlet 185 leads to impeller chamber 205 near inlet region 300 of impeller 140. The end of upper support of impeller pivot 145 extends upwardly through orifice 185 to interface pivotally with upper support pin 130 supported within inlet cover 125. impeller blades 235 extend radially outwardly from input region 300 of impeller 140.
[0090] As shown in Figures 18A and 18B, which are, respectively, a plan view of the entrance cover portion 110A that defines the entrance channel 180 at the end elevation thereof, in one embodiment, the entrance channel 180 it can be said to have an elliptical configuration. Specifically, a cylindrical channel portion 180A transitions from portion 180C to a cylindrical channel portion 180B. A cylindrical island or chamfer portion 305 that supports the upper support pin 130 is generally centered on the elliptical channel portion 180B and includes a cylindrical hole 240 that receives the upper support pin 130 similar to that shown in Figure 17. In one embodiment , the cylindrical channel portion 180A has a D6 diameter of approximately 4 mm. The elliptical channel portion 180B has a width W6 of approximately 12.4 mm. The distal distance W7 between the chamfer wall 305 and the distal end of the wall defining the elliptical channel portion 180B is approximately 1.5 mm. In other embodiments, the cylindrical channel portion 180A has a D6 diameter of approximately 5 mm or 6 mm.
[0091] As shown in Figures 19A and 19B, which are the same respective views as Figures 18A and 18B, except in another embodiment, the input channel 180 can be said to have a circular configuration. Specifically, a cylindrical channel portion 180A transitions in the portion 180C into a circular channel portion 180B. A cylindrical island or chamfer portion 305 that supports the upper support pin 130 is generally centered on the circular channel portion 180B and includes a cylindrical hole 240 that receives the upper support pin 130 similar to that shown in Figure 17. In one embodiment , the cylindrical channel portion 180A has a D9 diameter of approximately 3.5 mm to 4.5 mm, preferably 4 mm. The circular channel portion 180B has a width W9 of approximately 11.5 mm to 13 mm, preferably 12.4 mm. The distal distance W10 between the chamfer wall 305 and the distal end of the wall that defines the circular channel portion 180B is approximately 3.5 mm to 4.5 mm, preferably 4.2 mm. In other embodiments, the cylindrical channel portion 180A has a D6 diameter of approximately 5 mm or 6 mm.
[0092] As shown in Figures 20A and 20B, which are the same respective views as Figures 18A and 18B, except for another embodiment, the input channel 180 can be said to have a complex arcuate configuration. Specifically, a cylindrical channel portion 180A transitions in the portion 180C into a complex arcuate channel portion 180B. A cylindrical island or chamfer portion 305 that supports the upper support pin 130 is generally centered on the complex arcuate portion 180B and includes a cylindrical hole 240 that receives the upper support pin 130 similar to that shown in Figure 17. In one embodiment , the cylindrical channel portion 180A has a diameter D12 of approximately 4 mm. The complex arcuate channel portion 180B has a width W13 of approximately 8.4 mm. The distal distance W14 between the chamfer wall 305 and the distal end dome 307 of the wall defining the complex arcuate channel portion 180B is approximately 1.75 mm. The distal distance W15 between the chamfer wall 305 and the distal end crack 310 of the wall defining the complex arcuate channel portion 180B is approximately 0.5 mm to 1.5 mm, preferably 1 mm. In other embodiments, the cylindrical channel portion 180A has a D6 diameter of approximately 5 mm or 6 mm.
[0093] As shown in Figures 21-23, which are the same views as Figure 18A, except for three other embodiments, the input channel 180 can be said to have a teardrop configuration. Specifically, a cylindrical channel portion 180A transitions to a tear channel portion 180B. A cylindrical island or chamfer portion 305 that supports the upper support pin 130 is generally centered on the tear channel portion 180B and includes a cylindrical hole 240 that receives the upper support pin 130 similar to that shown in Figure 17. In this embodiment, the cylindrical channel portion 180A has a D15 diameter of approximately 4 mm. The tear channel portion 180B has a W20 width of approximately 8 mm. The chamfer 305 has a D16 diameter of 4 mm. A transition region 180C of channel 180 between tear portion 180B and cylindrical channel portion 180A has walls that diverge from each other at an angle AN1 of approximately 8 degrees. In other embodiments, the cylindrical channel portion 180A has a D6 diameter of approximately 5 mm or 6 mm.
[0094] For the embodiment of Figure 21, the distal distance W21 between the chamfer wall 305 and the distal end of the wall that defines the tear channel portion 180B is approximately 2 mm. For the embodiment of Figure 22, the distal distance W21 between the chamfer wall 305 and the distal end of the wall defining the tear channel portion 180B is approximately 1 mm. For the modality of Figure 23, the distal distance W21 between the chamfer wall 305 and the distal end of the wall that defines the tear channel portion 180B is approximately 0 mm because the chamfer intersects the distal end of the wall defines the teardrop channel portion.
[0095] As shown in Figures 24A and 24B, which are, respectively, seen in plane and side elevation of another modality of the inlet cap 110 and inlet channel 180 similar to that described in Figure 21, and a wedge portion arcuate 320 may extend between the distal wall of the tear channel portion 180B to the distal side of chamfer 305. In such an embodiment, the cylindrical island or chamfer portion 305 is generally centered on the tear channel portion 180B and includes a cylindrical hole 240 that receives the upper support pin 130 similarly to that illustrated in Figure 17. In one embodiment, the dimensional configuration of the embodiment shown in Figures 24A and 24B is substantially the same as discussed with respect to Figure 21, the significant difference being the presence of the arched wedge portion 320. As can be understood from Figures 24A and 24B, the wedge portion 320 has walls that are arched to gently curve from the ceiling and the adjacent wall of the portion teardrop channel 180B for the vertical extension of chamfer 305. Such a wedge portion 320 can be seen to exist in the modality shown in Figures 3A, 3B and 17 and can reduce the areas of stagnation of incoming channel flow and facilitate the entry of tangential fluid flow through impeller chamber inlet 185.
[0096] As shown in Figure 25, which is an isometric view of the blood pump 25 with the upper impeller housing removed to reveal the impeller 140 occupying the impeller chamber 205, the outlet fluid channel 200 exits the chamber impeller substantially tangential to the outer circumferential edge of the impeller. As indicated in Figures 3B, 4B, 17, and 25, a plurality of holes 350 (i.e., wash holes) are circumferentially distributed around the impeller pivot center hole 250, and holes 350 are generally parallel to the hole central 250 and extend through the total thickness of the impeller to sprout over both the upper and lower limits of the impeller. The lower openings of the holes 350 are located near the lower support interface between the lower support 165 and the lower support surface of impeller pivot 260 (see Figure 8). As a result, the fluid can be flowed through holes 350 to clean the lower support interface. For example, a fluid can be flowed through the impeller chamber inlet hole 185, radially out along the impeller blades 235, through the clearance under the impeller, and then back into the region of the chamber inlet hole. impeller 185. This blood flow is used to clean the lower side of the impeller, the lower support interface, the upper support interface, and the region behind the chamfer 305.
[0097] As can be understood from Figures 3B, 5, 17, and 25, in one embodiment, the impeller 140 is supported rotatable within the impeller chamber 205 on an axis 145 that extends through a center of the impeller. The shaft has an upper support end and a lower support end, each end rotatably operatively coupled to the pump housing. The impeller has an upper face, a lower face, and multiple holes 350 that extend through the impeller from the upper face to the lower face. The multiple holes are generally evenly distributed radially around the center of the impeller. In addition, the multiple holes extend through the impeller generally parallel to each other and to the shaft. Inlet channel 180 leads to an inlet hole 185 of the impeller chamber. The inlet channel opens into the impeller chamber generally perpendicular to the inlet channel. The entry orifice extends over at least a portion of an outer circumferential surface of the axis near the upper support end. The entry orifice and holes drilled in directions that are generally parallel to each other. During the operation of the pump, at least a portion of the blood pumped through the circular impeller chamber along the upper and lower faces of the impeller through the holes. Thus, impeller holes eliminate flow dead spots around the impeller, generally keeping blood flowing along all impeller blood contact surfaces. Consequently, the holes help to prevent the accumulation of blood in the vicinity of the shaft / impeller intersection and along the sides and underside of the impeller.
[0098] The body and impeller of the blood pump 25, including the blood contact surfaces, are made of a variety of rigid biocompatible materials. One option includes plastics, more preferably injection moldable plastics such as PEEK. In various embodiments, the blood contact surfaces of the blood pump 25 may comprise Ti6Al4V, Ti6Al7Nb, or other commercially pure titanium alloys. In one embodiment, the surfaces of the pump components to be exposed to the patient's blood may have antithrombotic coatings. For example, luminous surfaces can be coated with Astute®, a heparin-based anti-thrombotic coating by BioInteractions Ltd., or Applause ™, a heparin coating by SurModics, Inc.
[0099] In other embodiments, the surfaces of the blood pump system components in contact with the patient's tissue may have antimicrobial coatings. For example, the external surfaces of synthetic ducts 16 and 18 or the external surfaces of the pump or power cable 120 (which is also known as a "conductor") can be coated with Avert®, an active antimicrobial coating of surface by BioInteractions Ltd.
[00100] In several modalities, the blood pump 25 can be implanted inside a patient. In contrast, in other embodiments, the blood pump 25 can remain external to the patient. For example, when located outside the patient, the blood pump 25 can be attached to the patient using tape, sutures, or other suitable means to affix the pump to the patient. System 10 can be powered by usable electronics that have rechargeable batteries 28, as shown in Figure 34.
The pump for the pump system 10 described herein can be a rotary pump, including, for example, a centrifugal flow pump, a radial flow pump, or a mixed flow pump. As shown in Figures 1-15, in one embodiment, the pump is a centrifugal pump. Without recognizing specific limitations, the blood pump 25 can be configured to routinely pump approximately 0.05 to 1.0 L / min, 0.2 to 1.5 L, or 0.5 to 3.0 L / min, for example.
[00102] Although the pump configuration discussed above with respect to Figures 1-25 is advantageous, other pump configurations can be employed with the pump systems and methods described herein. Consequently, the systems and methods described herein should not be limited to the pump configuration discussed above with respect to Figures 1-25, but should include all types of pumps applicable to the systems and methods described herein.
[00103] A preferred embodiment of the pump system 10 described herein with reference to Figures 1-25 satisfies several unique needs that cannot be satisfied by any blood pump system known in the art. Specifically, the Arteriovenous Fistula Eligibility ("AFE") pump system ("AFE System") can be configured for up to 12 weeks of intended use. In addition, the AFE pump system can be configured as a centrifugal rotary blood pump system for low flow rate (for example, 50 to 1500 mL / min) and medium pressure range (for example, 25 to 350 mmHg). A control scheme used with the AFE pump system can be optimized to maintain a stable and high mean WSS of 0.76 - 23 Pa in target veins that are directly fluidly connected to the blood pump or a blood pump system conduit. , or target veins that are fluidly connected to a vein that is directly fluidly connected to the blood pump or a conduit in the blood pump system. The AFE pump system is configured to operate for a period of time so that the total diameter and lumen diameter of the target vein will persistently increase by 25%, 50%, or 100% or more, using the detection of operating parameters and periodic speed adjustment.
[00104] For certain modalities, the flow inlet conduit can be placed by percutaneous approach, with a portion of the flow inlet conduit residing in an intravascular location, and the flow outflow conduit can be placed by surgical approach adaptable to initial vein diameters between 16 mm. In this configuration, a high average WSS within the target blood vessel results from the discharge of blood into the target blood vessel.
[00105] For other modalities, the outflow conduit can be placed by percutaneous approach, with a portion of the outflow conduit residing in an intravascular location, and the inlet flow can be placed by surgical approach adaptable to initial vein or artery diameters between 1-6 mm. In this configuration, a high mean WSS within the target blood vessel results from the removal of blood from the target blood vessel. In certain configurations, WSS can be elevated both in a blood vessel where blood is removed and in a blood vessel where blood is discharged, making both blood vessels target blood vessels. Pump system 10 achieves both ease of insertion / removal and resistance to infection. The pump system 10 is a mobile system with a pump that is adaptable for placement or implanted or extracorporeal. In various embodiments, the pump system 10 is powered by a usable electronics with rechargeable batteries.
[00106] The pump system 10 includes a flow inlet conduit 20 and a flow outflow conduit 30, as shown in Figure 26. Flow inlet conduit 20 is placed in fluid communication with a location in the vascular system , draws blood from this location, and charges it to the blood pump 25. In certain embodiments, the flow inlet conduit 20 is configured to place at least a portion of the flow inlet conduit within the lumen of the vascular system. In other embodiments, the flow inlet 20 is joined to the blood vessel by a surgical anastomosis. The outlet flow conduit 30 is configured to communicate fluid with another location in the vascular system and direct blood from the blood pump 25 to the other location in the vascular system. In certain embodiments, the flow outlet conduit 20 is configured to place at least a portion of the flow outlet conduit within the lumen of the vascular system. In other embodiments, the outflow conduit 30 is joined to a blood vessel by a surgical anastomosis.
[00107] The ducts 20 and 30 can each have a length ranging between 2 cm and 110 cm and a total combined length of 4 cm to 220 cm. The length of each conduit 20 and 30 can be cut to a desired length as determined by the location of the blood pump 25 and the location of the connections between the conduits and the vascular system. The ducts 20 and 30 also have thin walls but are resistant to compression and resistant to bending which are between 0.5 mm and 4 mm thick and internal diameters between 2 mm and 10 mm. Preferably, the internal diameters for the ducts are 4 to 6 mm.
[00108] The flow inlet and flow outlet 20 and 30 can be connected to the blood pump 25 using any suitable connector that is durable, resistant to leakage, and is not susceptible to unintentional decoupling. Typically, the front edge of the connector is thin in order to minimize the staggered change in fluid path diameter between the inner diameter of conduits 20 and 30 and the inner diameter of the connector. Preferably, the staggered change in fluid path diameter should be less than 0.5 mm. In one embodiment, as shown in Figures 27A-27D, conduits 20 and 30 are connected to blood pump 25 using barbed connections 400A and 400B and radially compressed retainers (i.e. locking collars) 402A and 402B. As an example, and not a limitation, the radially compressive seals 402A and 402B can be BarbLock® seals manufactured by Saint-Gobain Performance Plastics, a division of Saint-Gobain S.A. based in Courbevoie, France. In another embodiment, conduits 20 and 30 are connected to the blood pump 25 using sterile Pure-Fit® connectors, also manufactured by Saint-Gobain Performance Plastics.
[00109] The radial compressive retainers 402A and 402B are placed over the proximal ends 404 and 406 of the flow inlet and flow outlet 20 and 30, respectively. The conduits 20 and 30 are then placed over the barbed connection 400A and 400B to form a fluid connection between the conduits and the blood pump 25. Collars 408A and 408B of the radial compressive retainers 402A and 402B are placed along the conduits 20 and 30 to surround the flues and barbed connections 400A and 400B. External sleeves 410A and 410B of the radial compressive retainers 402A and 402B are then moved along a longitudinal geometric axis of the retainers to compressively couple the respective collars 408A and 408B, conduits 20 and 30, and the barbed connections 400A and 400B. In one embodiment, the outer sleeves 410A and 410B are moved by a compressive tool configured to couple the outer sleeves and a support shoulder 412A and 412B of the barbed connections 400A and 400B, respectively. The compression tool can also be configured to remove the radial compressive retainers 402A and 402B.
[00110] In other modalities, alternative connectors can be used. Preferably, the alternative connectors are durable, leak resistant and resistant to unintentional displacement. For example, as shown in Figures 28A-B, ducts 20 and 30 couple barbed connections, similar to barbed connections 400A and 400B, to form a fluid connection between the ducts and the blood pump 25. Ducts 20 and 30 are attached to the barbed connections using circular clamps 414A and 414B that apply a radial compressive force to the ducts portion over the barbed connections by means of a 416A-416B ratchet mechanism of the clamps. Circular clamps 414A and 414B provide a leak-resistant and durable connection that can be removed with a removal tool (not shown) which releases the 416A-416B ratchet mechanisms from the clamps.
[00111] In another embodiment the flow inlet 20 and flow outflow 30 contain side doors that provide controlled access to the fluid path. The side ports can be used periodically to introduce a contrast in the fluid path to allow fluoroscopic visualization, to obtain blood samples, to infuse drugs, or for other clinically useful purposes. Any side door design that allows periodic access to the flow path and does not leak or alter the fluid flow path when not accessed is suitable. As an example, and not a limitation, the side port may be a "T" port connection that includes a check valve that opens when a syringe is inserted and closes when the syringe is removed. As shown in Figures 29A-B, A "T" port assembly 418 with auxiliary piping 420 is in fluid communication with the pump outlet 115 and the flow outlet duct 30.
[00112] In another embodiment, a side port for the flow inlet 20, flow outflow 30, or both use a septum access port 422 that has a septum 424, as shown in Figures 30A-B , through which a suitable hypodermic needle can be inserted for access and then removed, after which the septum closes, preventing loss of fluid from the conduit. Suitable materials for septum 424 include, but are not limited to, silicone, polyurethane, and other elastomeric polymers. The 20 or 30 inlet and / or outlet conduit segment, respectively, which includes septum 424, is of a suitable thickness to close a hypodermic perforation hole when the needle is removed. As shown in Figures 30A-B, the septum access port 422 is shown in which the septum 424 makes up a portion of the flow outlet duct 30. As an example, and not limitation, the septum access port 422 can extend approximately one centimeter over the length of the flow outlet duct 30. The septum 424 may be attached to the flow outlet duct 30 by any suitable means including, but not limited to, adhesive attachment, thermal bonding, and thermal bonding between layers internal and external conduit piping.
[00113] In various embodiments, conduits 20 and 30 can be comprised of materials commonly used to make hemodialysis catheters such as polyurethane, polyvinyl chloride, polyethylene, silicone and polytetrafluoroethylene (PTFE), and including Pellethane® or Carbothane®. In other embodiments, conduits can be comprised of materials commonly used to make hemodialysis grafts or synthetic peripheral bypass grafts such as expanded polytetrafluoroethylene (ePTFE) or Dacron. In additional embodiments, conduits can be comprised of combinations of polyurethane, polyvinyl chloride, polyethylene, silicone, PTFE, Pellethane®, Carbothane®, Carbothane® PC-3575, ePTFE, or Dacron.
[00114] For example, the entire length of the flow inlet conduit 20 may be composed of polyurethane. In another embodiment, shown in Figure 31, a segment 500 of the flow outlet duct 30 configured to make a fluid communication with the blood pump 25 is composed of polyurethane while a segment 502 of the flow outlet duct configured to make a fluid communication with the vascular system is composed of ePTFE.
[00115] As an example and not a limitation, and as shown in Figure 41, which is a longitudinal cross section of the junction between the nearest segment 500 and the distal segment 502, the nearest segment 500 of the flow outlet duct 30 is joined at the distal segment 502 of the flow outlet duct during the manufacturing process by placing one or more layers 502A of ePTFE from the distal segment between layers 500A of polyurethane from the nearest segment. The overlapping layers of polyurethane and ePTFE are then laminated with heat to connect the nearest segment 500 and distal segments 502 together.
[00116] In another example, one or more holes are drilled inside the overlapping sections of the ePTFE of segment 502 before laminating the conduit with heat. When the flow outlet 30 is heated to a temperature that is sufficient to melt the polyurethane without melting the ePTFE (for example, 93.3 ° C to 260.0 ° C (200 ° F to 500 ° F)), the fused polyurethane fills and then cools inside the holes created in the ePTFE 502 segment. The inner and outer polyurethane layers of the 500 segment are joined within the holes to mechanically join the two segments 500 and 502 together as well as mechanically join the inner layers and outer polyurethane in the overlapping segment.
[00117] The flow outflow 30 embodiment manufactured to have the ePTFE 502A layer sandwiched between the 500A polyurethane layers is advantageous in that the ePTFE 502A layer can be readily sutured to blood vessels using standard techniques. This is also the case for the flow inlet conduit 20 manufactured as discussed above with reference to Figure 41.
[00118] As illustrated in Figure 42, which is a plan view of a medical kit 1000, the blood pump 25, flow inlet conduit 20, flow outflow conduit 30, the control device 21, and the cable of energy 120 can be provided in a sterile package 1005 with instructions 1010 on how to assemble and implant the pump system in a patient. The medical kit 1000 can also include barbed connections 400A and 400B and radially compressive retainers 402A and 402B. In one embodiment, one or both of the conduits 20, 30 are manufactured as described above with respect to Figure 41 and contained in the sterile package 1005 together with the blood pump 25. The medical kit 1000, at least, includes a system for unloading or remove blood and instructions for implementation and use.
[00119] In one embodiment, the blood pump 25 is controlled via the control unit 21 of a pump control system 14 by reading the flow outlet pressure and adjusting the pump speed accordingly. For example, as shown in Figure 43, which is a schematic diagram of a pump system 10 controlled according to the fluid outlet pressure, a flow outlet pressure sensor 1050 can be operatively coupled to the pump outlet 115 of blood 25 or more downstream, such as, for example, somewhere along the length of the flow outlet duct 30. Processor 24 can compare the pressure reading of the flow outlet pressure sensor 1050 with a range of target flow output pressures stored in memory 27. The processor will then adjust the pump drive speed 170 accordingly to make the pressure reading of the 1050 flow output pressure sensor within the output pressure range of target stream stored in memory.
[00120] In one embodiment, control system 14 also includes a 1060 flow inlet pressure sensor that can be operatively coupled to inlet 110 of blood pump 25 or more upstream, such as, for example, somewhere along the length of the flow inlet 20. Processor 24 can read both the pressure reading from the 1050 flow-out pressure sensor and the pressure reading from the 1060 flow-in pressure sensor and calculate a difference in pressure. This pressure difference can then be compared with a range of target pressure differences stored in memory 1055. The processor will then adjust the speed of the pump drive 170 to bring the calculated pressure difference within the target pressure difference range. stored in memory.
[00121] In other embodiments, the flow inlet and flow outlet 20 and 30 can be of any material or combination of materials as long as the conduits 20 and 30 exhibit desirable characteristics, such as flexibility, sterility, resistance to bending and compression , and can be connected to a blood vessel through an anastomosis or inserted into the lumen of a blood vessel, as needed. In addition, conduits 20 and 30 preferably exhibit the characteristics necessary for subcutaneous tunneling as desired, such as comprising lubricating outer surface coatings such as Harmony ™ advanced lubricity coatings.
[00122] As another example, the flow inlet and flow outlet ducts 20 and 30 may have an outer layer composed of a different material than the inner layer. All or a portion of the outer layers of the inlet and outflow ducts 20 and 30 can also be coated with a lubricating agent, such as silicone or a hydrophilic coating to assist in subcutaneous tunneling and removal from the body, and to mitigate possible allergic reactions to latex. In certain embodiments, at least a portion of the surface of the outer layer of the inlet and outflow ducts 20 and 30 may have an antimicrobial coating. In other embodiments, at least a portion of the surface of the blood pump 25 or the supply cable 120 may have an antimicrobial coating. For example, AvertTM, an active surface antimicrobial coating can be used. In certain embodiments, a portion of the surface of the outer layer of a flow inlet and flow outlet duct may include a material to resist infection and encourage fabric incorporation, such as a Dacron velvety fabric, a velvety polyester fabric , or silicone. One such material is the VitaCuff® antimicrobial sheath by Vitaphore Corp. The VitaCuff sheath is comprised of two concentric layers of material. The inner layer is constructed of medical grade silicone. The outer, tissue-interfacing layer comprises a collagen matrix with an antimicrobial activity that is attributable to silver ions bound to collagen. In certain embodiments, this material absorbs physiological fluids, expands rapidly, and helps to provide a physical barrier at the exit site. Tissue growth occurs, additionally holding the conduit in place, and reducing the movement of the conduit to reduce the incidence of exit site infection.
[00123] In certain embodiments, at least a portion of the luminous blood contact surfaces of the flow inlet and flow outlets 20 and 30 can be coated with an antithrombotic agent or material. Similarly, at least a portion of the blood contact surfaces of the blood pump 25 can be coated with an antithrombotic agent or material. For example, surfaces can be coated with the Applause® coating from SurModics, Inc., or the Astute® coating from BioInteractions Ltd., which are both hydrophilic copolymer coatings that contain heparin.
[00124] In certain embodiments, at least a portion of the flow inlet conduit 20 and flow outflow conduit 30 is preferably reinforced to resist bending and compression. For example, conduits 20 and 30 can be reinforced with nitinol or another memory alloy of self-expanding or radially expanding material or form. Preferably, a layer of braided nitinol is wound around at least a portion of each of the ducts 20 and 30 or incorporated into the duct walls. In one embodiment, the flow inlet conduit 20 is reinforced by braided nitinol embedded in the conduit walls. In another embodiment, the flow inlet duct can be reinforced by braided stainless steel that is incorporated into the wall of ducts 20 and 30. Alternatively, a loop of nitinol or PTFE can be wrapped around portions of ducts 20 and 30 or incorporated in these. For example, as shown in Figure 31, the distal segment 502 of the flow outlet duct 30 t and a PTFE loop 504 incorporated around the ePTFE duct forming the duct wall 514. In other embodiments, a nitinol loop can be wrapped around portions of conduits 20 and 30 or incorporated into them.
[00125] The density of the braided nitinol incorporated in both the flow inlet and flow outlet 20 and 30, commonly measured in pixels per inch ("PPI"), is typically between approximately 10 and 200, and preferably between approximately 20 and approximately 60. In various embodiments, the braid density may vary over the lengths of the inlet and outflow ducts 20 and 30. For example, the braid density may be greater in portions of the 20 ducts and 30 adjacent to the blood pump 25, in order to maintain greater duct rigidity and minimize the risk of external duct compression or duct collapse during suction, while allowing more flexibility in different duct segments.
[00126] In one embodiment, as shown in Figures 32A-32B, the intravascular portion 506 of the flow inlet 20 is fenestrated through multiple side holes 508. These side holes improve the flow of blood and reduce the risk suction of the vein or right atrium wall through the end hole in case of partial obstruction of the conduit tip. Preferably, the side holes 508 are circular and vary in diameter from 0.5 mm to 1.5 mm. In other embodiments, however, side holes 508 can be elliptical or any other shape and size suitable for aspirating intravascular blood.
[00127] As shown in Figures 31 and 32A-32B, the distal end 506 of the flow inlet conduit 20 and the distal end 510 of the flow outflow conduit 30 can be cut and chamfered at an angle between 10 ° and 80 ° . In certain embodiments, the chamfer reduces the risk of suction of the vein or right atrium wall through the end hole in the event of partial obstruction of the conduit tip during blood aspiration. In other modalities, the chamfer increases the area of the conduit as it joins the vascular system in an anastomotic connection. Preferably, but without limitation, the distal ends 506 and 510 are chamfered at 45 °. The flow inlet and flow outlets 20 and 30 are adapted for ease of insertion, subcutaneous tunneling, and removal, while also providing resistance to infection and thrombosis.
[00128] In one embodiment, a portion of the flow inlet 20 can be inserted into the lumen of a blood vessel and advanced to the desired position using a percutaneous approach or an open surgical approach. To assist in positioning the flow inlet and flow outlet 20 and 30, the ducts may have bands of radiopaque marker or other radiopaque materials embedded in the walls 512 and 514 of the flow inlet and flow outlet ducts, respectively, which are visible under fluoroscopy. For example, portions of the flow inlet and flow outlet 20 and 30 can be composed of polyurethane Carbothane®PC-3575 incorporated with barium sulfate salts. In other embodiments, the portions of the flow inlet and flow outlet 20 and 30 that are configured to be inserted into the lumen of the vascular system can be self-expanding or radially expanding walls (as can be achieved by incorporating nitinol) so that the diameter the intravascular portion of the flow inlet and flow outlet 20 and 30 will coincide with the diameter of the vascular system at that location, as seen with the self-expanding segment of GORE® Hybrid Vascular Graft.
[00129] In several modalities, including the modality shown in Figure 37, the flow inlet and flow outlets 20 and 30 can be attached to blood vessels using a surgical anastomosis, using suture in a running or divided way, hereinafter hereinafter described as an "anastomotic connection". An anastomotic connection can also be made with surgical clamps and other standard ways to phase an anastomosis. For example, an anastomotic connection can be made between the distal ePTFE 502 segment of the flow outlet 30 and a blood vessel.
[00130] In certain modalities where an anastomotic connection is made, the flow outlet conduit 30 is attached to blood vessels that have an initial diameter between 1 mm and 20 mm, and preferably vessels that have an initial diameter between 1 mm and 6 mm.
[00131] In contrast, in other embodiments, shown in Figures 32A-B and 37-40, portions of the inlet and outflow ducts 20 and 30 are placed inside a blood vessel or the right atrium. For example, the distal end 506 of the flow inlet 20 can be positioned within the right atrium or the superior vena cava. As shown in Figures 32A-32B, or lateral holes 508 aid in the aspiration or discharge of blood when the distal end 506 has been placed intravascularly.
[00132] In several other modalities, at least one of the flow inlet and flow outlet 20 and 30 can be compatible for use with a hemodialysis machine. For example, a patient using the blood pump system 10 may also need to receive hemodialysis treatment. In this example, blood can be drawn from the blood pump system, passed through a hemodialysis machine, and then discharged back into the blood pump system for delivery back to the vascular system, thereby eliminating the need for to create an additional vascular access site in the patient.
[00133] As shown in Figure 35, a control system modality 14 includes a control device 21 that has at least one processor 24 and a memory 27 for supplying energy to the pump and receiving information from the blood pump 25, via that the information is used to adjust and control the pump speed and estimate the rate of fluid flow through the pump system. Processor 24 is configured to read, process, and execute systems, methods, and instructions encoded in a computer-readable medium. The control system 14 then estimates the wall shear stress in the target vessel using the measured or estimated vessel diameter and the measured or estimated average flow rate of the pump system. The control device also includes a power source 26. Optionally having a battery 28.
[00134] In one embodiment, control system 14 receives a sensor feedback from one or more sensors 122. Any of a variety of suitable sensors can be used to detect any of a variety of changes in a physical amount of blood , the blood pump 25 of the blood pump system 10, and / or the target vessel. The sensors 122 generate a signal indicative of the change to be analyzed and / or processed. Essentially, sensors 122 monitor a variety of properties of the blood pump system 10, the blood flowing through the system, and the target blood vessel for changes that can be processed and compared with desired reference values or predetermined standards. The desired reference values or predetermined standards can be stored in a database or other suitable medium.
[00135] In various embodiments, one or more sensors 122 may be in communication with the blood pump 25, and the inlet conduit 20, and the outflow conduit 30, or donor vessel or location, or the vessel or location acceptance. In various embodiments, the control system 14 or its portions can be located internally within the blood pump 25 housing or housing. For example, one or more sensors 122 can be located at the inlet 110 or the outlet 115 of the blood pump 25 In other embodiments, the control system 14 can be external to the pump.
[00136] The wall shear stress can be used as a variable to configure the operation of the pump system 10 to result in an increase in the total diameter and lumen diameter of the target vessel or an increase in the length of the target vessel.
[00137] Assuming a Hagen-Poiseuille blood flow (ie, a laminar flow with a fully developed parabolic velocity profile) within the lumen of a vessel that has a circular cross section, then the WSS can be determined using the equation: WSS (Pa) = 4Qμ / πR3 [Equation 1] where: Q = flow rate (m3 / s) μ = blood viscosity (Pa / s) R = vessel radius (m) WALL SHEAR STRENGTH CONTROL METHOD # 1: MANUAL
[00138] The average or peak WSS in the target blood vessel can be controlled by adjusting the pump speed, which affects the rate of blood flow through the pump-conduit system and therefore blood flow through the target vessel. As shown in Figure 36A, a manual control method 600 may involve directly measuring blood viscosity in block 602 (sampling the patient's blood and analyzing it on a viscometer), the blood flow rate in the blood pump system or the rate of blood flow in the target vessel in block 604 (by placing an ultrasonic flow sensor or in the flow inlet or flow outflow by ultrasound or thermal dilution methods, respectively) and the vessel radius in the block 606 (by various imaging methods including angiography, ultrasound, computed tomography, or magnetic resonance imaging). The WSS acting on the vessel wall is determined in block 608, compared with the desired level in blocks 610 or 612, and then the pump flow rate (Q) is adjusted through changes in the rotational speed of the pump impeller in blocks 614 or 616. Changes in pump speed are affected by varying the active cycle of the pulse width modulation of the motor input voltage. WALL SHEAR TENSION CONTROL METHOD # 2: AUTOMATIC WITH INDIRECT BLOOD VISCOSITY MEASUREMENTS, DIRECT BLOOD FLOW, AND TARGET BLOOD VESSEL DIAMETER
[00139] An automatic WSS control system may involve a direct measurement of the blood flow rate in the pump system or the target vessel, and the direct measurement of the diameter of the target blood vessel. As shown in Figure 36B, this automatic WSS control method 620 may involve indirect measurements of blood viscosity in block 622 (estimated based on its known relationship to the measured hematocrit and approximate average WSS). A periodic calibration of the viscosity estimator in block 624 can be performed using direct viscosity measurements as previously described. In clinical practice, blood viscosity varies slowly. METHOD # 3 FOR WALL SHEAR TENSION CONTROL: AUTOMATIC WITH INDIRECT BLOOD VISCOSITY MEASUREMENTS, BLOOD FLOW, TARGET BLOOD VESSEL DIAMETER, AND DIRECT VEIN MEASUREMENT MEASUREMENTS
[00140] As shown in Figure 36C, an automatic WSS 630 control method may involve indirect measurements of blood viscosity (estimated based on its known relationship with the measured hematocrit and approximate average WSS) in block 622, rate of blood flow through the blood pump system (estimated based on its relationship to the motor state variables) in block 632, target blood vessel pressure measurements in block 634, and vessel radius measurements (estimated based on vascular resistance) in block 638. Vascular resistance is calculated in block 636 based on the estimated pump flow rate and blood pressure measured in the vessel. A periodic calibration of blood viscosity, pump flow, and blood vessel radius estimators, respectively, can be performed using direct measurements in blocks 624, 640, and 642, respectively, as previously described. WALL SHEAR TENSION CONTROL METHOD # 4: AUTOMATIC WITH INDIRECT BLOOD VISCOSITY MEASUREMENTS, BLOOD FLOW, PUMP PRESSURE HEIGHT, AND TARGET BLOOD VESSEL DIAMETER
[00141] As shown in Figure 36D, an automatic WSS 650 control method may involve indirect measurements of blood viscosity (estimated based on its known relationship with the measured hematocrit and approximate average WSS) in block 622, rate of blood flow through the blood pump system (estimated based on its relationship to the motor state variables) in block 632, and the vessel radius (estimated based on vascular resistance) in block 638. Vascular resistance is calculated in block 636 based on the pump flow rate estimated in block 632 and the pump pressure height, where the pump pressure height is also estimated in block 652 based on its relationship with the motor state variables . A periodic calibration of blood viscosity, pump flow, and target vessel radius estimators can be performed using direct measurements in blocks 624, 640, and 642, respectively, as previously described. Periodic calibration of the pump pressure height estimator can be performed by measuring the pump inlet and pump outlet pressures with separate pressure transducers and calculating their difference in block 654, or directly measuring the pressure height using the pump with a differential pressure sensor. DETERMINATION WITHOUT BLOOD PUMP SYSTEM FLOW RATE SENSOR AND PRESSURE HEIGHT:
[00142] Referring to Figure 35, the processor 24 is adapted to detect and monitor an electric current that appears in one or more of the electric coils of the pump coil set 170 through the power cable 120 which, together with the monitoring from the voltage provided in the coil assembly allows the processor 24 to derive the input power (Pin) consumed by the blood pump 25 and an actual rotational speed of the impeller 140 (w). Processor 24 can estimate the pump flow rate (Q) or changes in the flow rate (ΔQ) as a function of Pin and w. For example, Q = f [Pin, w]. More specifically, the following equation is used: Q = a + b • ln (Pin) + c • w0.5 [Equation 2]
[00143] where:
[00144] Q = flow rate (L / min)
[00145] Pin = Motor input power (W)
[00146] w = Pump speed (rpm)
[00147] The motor input power is derived from the measured motor voltage and current. Values for a, b, and c are derived from a curve fit of the pump flow rate graph as a function of motor speed and input power.
[00148] Processor 24 can also estimate pump pressure height (Hp) or changes in pump pressure height (ΔHp) as a function of Pin and w. For example, Hp = f [Pin, w]. More specifically, the following equation is used: Hp = d + e • ln (Pin) + f • w2.5 [Equation 3]
[00149] The values for d, e, and f are derived from a curve adjustment of the pump pressure height graph as a function of pump speed and motor input power, where Hp is measured through the flow inlet duct 20, of the pump 25, and the flow outlet duct 30. DETERMINATION OF VASCULAR RESISTANCE AND VESSEL RADIUS ESTIMATION:
[00150] Vascular resistance (Rv) is resistance to flow that must be overcome to push blood through the circulatory system. The resistance is equal to the actuation pressure (Hv) divided by the flow rate. When the blood pump system is connected to a target vessel that is a vein, vascular resistance is calculated using the following equation: Rv = (Pv - CVP) / Q [Equation 4]
[00151] where:
[00152] Hv = height of pressure lost through the peripheral vessel in the blood return path to the heart (mmHg)
[00153] Pv = pressure of the vein at the anastomosis (mmHg)
[00154] CVP = central venous pressure (mmHg)
[00155] Rv = vascular resistance ((mmHg • min) / L)
[00156] Normally, CVP varies between 2-8 mmHg and can be ignored in the above equation because the operating ranges of Pv and Q are proportionally much larger. As illustrated in Figure 36E, vascular resistance can be plotted as the slope of several Pv vs. V curves. Q 660. Since curves 660 are not linear, the slope is a function of Q. As illustrated by the following equation, vascular resistance can be derived by temporarily increasing the speed by several hundred rpm (Δw), measuring the resulting change in pressure flow (ΔPv), and estimating the resulting change in pump flow (ΔQ): Rv (Q) = ΔPv / ΔQ [Equation 5]
[00157] It is noted that vascular resistance is a strong function of vessel diameter or radius, with the smallest veins having a high vascular resistance. Vascular resistance can be quantified in several units, for example. Wood units ((mmHg • min) / L) can be multiplied by eight to convert to SI units ((Pa ^ s) / m3).
[00158] Alternatively, the pump pressure height (Hp) can be used as a basis for calculating vascular resistance. When the pump conduit system is configured to draw blood from a location in the vascular system to discharge it into a peripheral artery or vein, it is a reasonable assumption that the pressure height gained through the system (Hp) is exactly equal to the height of pressure lost through the peripheral vessel in the path of the blood return to the heart (Hv): Hv = Hp [Equation 6]
[00159] The radius of the peripheral vessel is inversely proportional to its vascular resistance (Rv), the ratio of Hv to Q. Assuming a Hagen-Poiseuille blood flow in the circular cross section, vascular resistance can be represented using the equation: Rv ( Pa ^ s / m3) = Pv / Q = 8-μ-L / π-R4 [Equation 7]
[00160] where:
[00161] Pv is expressed in units of Pa
[00162] Q is expressed in units of (m3 / s)
[00163] μ = blood viscosity (Pa / s)
[00164] R = vessel radius (m)
[00165] L = vessel length (m)
[00166] In practice, Equation 7 would be refined based on in vivo measurement of pressure drop through specific veins of known diameter. This provides an empirical form of the equation: Rv (Pa ^ s / m3) = K ^ μ / R4 [Equation 8]
[00167] where:
[00168] K is an empirical constant for the target vein (m) DETERMINATION OF WALL SHEAR STRESS
[00169] The wall shear stress in the target vessel can be determined based on the above equations. using Equation 4, the pump flow rate can be expressed according to the following equation: Q = Pv / Rv [Equation 9]
[00170] Using equation 8, the vessel radius can be expressed according to the following equation: R = (K-μ / Rv) 0.25 [Equation 10]
[00171] Using equations 1, 9, and 10, the wall shear stress can be expressed according to the following equation: WSS (Pa) = ((4-Pv) / (π-K075)) • (μ / Rv) 075 [Equation 11]
[00172] In several modalities, the estimated variables used by the control system are periodically calibrated. For example, flow rate and pressure height estimates are periodically calibrated using actual measured values at intervals ranging from 1 minute to up to 30 days. Similarly, the artery or vein radius estimate is periodically calibrated using actual measured values at an interval ranging from 1 minute and up to 30 days. SECURITY ASPECTS AND ALARMS:
[00173] The automatic control system may also include safety aspects to avoid the dangers associated with changes in the patient's cardiovascular system or defects in the pump system or pump control system. As shown in Figure 36F, a speed control method 670 can detect characteristic changes in the motor current waveform associated with decreased preload or increased afterload (for example, due to thrombosis), suction, limitation of flow, and imminent collapse of the vessel around the flow inlet duct tip in block 672. A spectral analysis of the motor current waveform is performed using a Fourier transform in block 674. When the amplitude of the second harmonic term of the Fourier series exceeds a predetermined value in block 676, a suction has occurred and a collapse is considered imminent. The pump speed is immediately decreased at block 616 and an alarm is triggered at block 678A within control device 21. When normal operation is restored, the alarm is canceled at block 678B.
[00174] As shown in Figure 36G, a 680 speed control method can detect low flow conditions. When the pump flow rate falls below the safe limit level to prevent thrombosis of the pump system - line 10 in block 682, the pump speed is immediately increased in block 614 and an alarm is triggered in block 678A inside the control device 21. When normal operation is restored, the alarm is canceled in block 678B.
[00175] As shown in Figure 36H, a speed control method 690 can detect high shear stress conditions. When the WSS rises above the safe limit level to prevent damage to the vessel endothelium in block 692, the silly speed is immediately decreased in block 616 and an alarm is triggered in block 678A within the control device 21. when normal operation is restored, the alarm is canceled in block 678B.
[00176] In yet another modality in which the flow inlet 20 is connected to an artery and the flow outflow 30 is connected to a vein, the control system 14 monitors and modifies the pulsatility of blood flow that is discharged into the acceptance vein. For example, the control system 14 can monitor the electrocardiogram or monitor the cyclical changes in the pulse wave of blood that comes into the blood pump system. During ventricular contraction and pulse wave propagation, the control system can slow the rotational speed of the pump. During systole and after the pulse wave has passed, the control system can increase the rotational speed of the pump. In this way, the pulsatility in the blood entering the acceptance vein can be reduced. Alternatively, the pulsatility of the blood in the acceptance vein can be periodically checked manually, as can be performed with ultrasound, and the pump can be manually adjusted, for example, by tuning the flow column characteristics of the pump, adding an adaptation reservoir or elastic reservoir (a segmental or diffuse change) for flow inlet or pump flow outlet, or modulating pump speed. Other adjustments can also be made. Alternatively, an adaptation reservoir or elastic reservoir can be added to the flow inlet or flow outlets at the time of implantation of the blood pump system.
[00177] In several other modalities, the control system 14 is monitored and adjusted manually or with a program or software application encoded in a computer-readable medium and executable by the processor 24, or other automated systems. Computer-readable media may include volatile media, non-volatile media, removable media, non-removable media and / or other available media that can be accessed by the control system 14. As an example and not a limitation, the media readable by computer can include computer storage media and communication media. Computer storage media may include memory, volatile media, non-volatile media, removable media and / or non-removable media implemented in a method or technology for storing information, such as computer-readable instructions, data structures, data, program modules, or other data.
[00178] The software program can include executable instructions to automatically adjust the pump speed and maintain the desired amount of blood flow, average blood speed, and average WSS in the vessel segment to be treated (the "target vessel" or the "target blood vessel") in which a persistent increase in total diameter and lumen diameter, or length, is desired, be it a donor artery, a donor vein, an acceptance artery, or an acceptance vein. Alternatively, the total diameter, lumen diameter, length, and blood flow in the target vessel can be periodically checked manually, as can be done with ultrasound, and the pump can be manually adjusted, for example, by tuning the column characteristics flow rate or modulating the pump speed. Other adjustments can also be made.
[00179] In one embodiment, the average blood rate is determined by calculating an average of multiple discrete blood rate measurements and adding the discrete measurements and dividing the total by the number of measurements. The average blood velocity can be calculated by taking measurements over a period of milliseconds, seconds, 1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, or multiple hours.
[00180] In another modality, the average WSS is determined by making a series of discrete measurements, making multiple discrete WSS determinations (using these measurements), adding the discrete WSS determinations, and dividing the total by the number of determinations. The average WSS can be calculated by taking measurements and making discrete WSS determinations over a period of seconds, 1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, or multiple hours.
[00181] In one embodiment, the control system 14 receives information from the sensor 22 in communication with the blood pump 25. In other embodiments, the control system 14 receives information from a sensor 22 in communication with a flow inlet conduit 20 or a flow outlet duct 30 or in a vessel in fluid communication with the flow inlet or flow outlet duct. In various embodiments, all or portions of the control system 14 may be located within the pump housing 25, while in other embodiments, all or a portion of the control system may be located within the conduits, or within the control device 21.
[00182] The systems and methods described here increase the average WSS level in peripheral veins and arteries. The average normal WSS for veins varies between 0.076 Pa and 0.76 Pa. The systems described here are configured to increase the level of average WSS in the peripheral acceptance vein to a range between 0.76 Pa and 23 Pa, preferably for a range between 2.5 Pa and 10 Pa. The average mean WSS for arteries varies between 0.3 Pa and 1.5 Pa. For artery dilation, the systems and methods described here increase the average WSS level to a range between 1 , 5 Pa and 23 Pa, preferably for a range between 2.5 Pa and 10 Pa. In certain instances, a sustained average WSS of less than 0.76 Pa in veins or less than 1.5 Pa in arteries may increase the total diameter and the lumen diameter of these vessels but the extent and rate of this increase is not likely to be clinically significant or compatible with routine clinical practice. A sustained average WSS greater than 23 Pa in arteries or veins is likely to cause a denudation (loss) of the blood vessel endothelium, or damage to the endothelium, which is known to delay the dilation of blood vessels in response to increases in blood velocity. average blood and average WSS. Pumping blood in a way that increases the average WSS to the desired range for preferably 1 day to 84 days, and more preferably between approximately 7 and 42 days, for example, produces a persistent increase in the total diameter and diameter of lumen in an acceptance vein, a donor vein, or a donor artery so that veins and arteries that are initially ineligible or suboptimal for use as hemodialysis access sites or bypass grafts due to the small diameter of the vein or artery whether usable or more optimal. The blood pumping process can be monitored and adjusted periodically. For example, the pump can be adjusted over a period of minutes, hours, 1 day, 3 days, 1 week, or multiple weeks due to changes in the peripheral vein or artery (such as a persistent increase in the total diameter and diameter of lumen) before achieving the desired persistent dilation.
[00183] Referring to Figures 37-40, a system 10 for increasing the diameter and lumen diameter of veins and arteries is illustrated as used for a patient 1. In Figure 37, system 10 draws deoxygenated venous blood from the venous system of the patient and discharges this blood into the peripheral acceptance vessel 700. System 10 also increases the average blood velocity in the peripheral acceptance vessel 700 and increases the average WSS exerted on the endothelium of the peripheral acceptance vessel 700 to increase the total diameter and the lumen diameter of the peripheral acceptance vessel 700 located, for example, on an arm or leg. The diameter of blood vessels such as peripheral veins can be determined by measuring the diameter of the lumen, which is an open space in the center of the blood vessel where the blood is flowing, or by measuring the diameter of the total vessel, which includes the open space and blood vessel walls.
[00184] The invention also refers to simultaneously and persistently increasing the total diameter and the lumen diameter of a peripheral vein or artery by directing blood into or out of the peripheral vein or artery, thereby increasing the speed average blood within the peripheral vein or artery and increasing the mean WSS over the endothelium of the peripheral vein or artery. Systems are described in which the average blood speed in a peripheral vein or artery and the average WSS over the vein or peripheral artery endothelium is increased using a blood pump system. Preferably, the pump directs blood into the peripheral vein, where the pumped blood has reduced pulsatility, such as when pulse pressure is lower than blood in a peripheral artery.
[00185] System 10 is suitable for maintaining a flow rate preferably between 50 mL / min and 2500 mL / min and optionally between 50 mL / min and 1000 mL / min while also maintaining a pressure range between 25 mmHg and 350 mmHg. As previously described, the control system 14 can be optimized to maintain a uniform average wall shear stress between 0.76 Pa and 23 Pa in peripheral veins so that the total diameter and the lumen diameter of the peripheral veins are persistently increased as much as 5% to more than 200%.
[00186] The systems described here also increase the average blood speed in peripheral veins. At rest, the average blood velocity in the cephalic vein in humans is generally between 5 and 9 cm / s (0.05 and 0.09 m / s). For the systems described here, the average blood velocity in the peripheral vein is increased to a range between 10 cm / s and 120 cm / s (0.1 and 1.2 m / s), preferably a range between 25 cm / s 100 cm / s (0.25 m / s and 1.0 m / s), depending on the total diameter or initial lumen diameter of the peripheral acceptance vein and the total diameter or final lumen that is desired. The systems described here also increase the average blood rate in peripheral arteries. At rest, the average blood velocity in the brachial artery is usually between 10 and 15 cm / s (0.1 and 0.15 m / s). For the systems and methods described here, the average blood velocity in the peripheral artery is increased to a range between 10 cm / s and 120 cm / s (0.1 and 1.2 m / s), preferably to a range between 25 cm / s if 100 cm / s (0.25 and 1.0 m / s), depending on the total diameter or initial lumen diameter of the artery, the final diameter or lumen diameter that is desired.
[00187] Preferably, the average blood velocity is increased between 1 day and 84 days, or preferably between 7 and 42 days, to induce a persistent increase in the total diameter and in the lumen diameter in the peripheral acceptance vein , peripheral acceptance artery, peripheral donor vein, or peripheral donor artery so that veins and arteries that were initially ineligible or suboptimal for use as a hemodialysis access site or bypass graft due to a small vein or artery diameter make become usable. This can also be achieved by intermittently increasing the average blood rate during the treatment period, with intervening periods of normal average blood rate.
[00188] Studies have shown that baseline hemodynamic forces and changes in hemodynamic forces within veins and arteries play a vital role in determining the total diameter and lumen diameter, and the length of these veins and arteries. For example, persistent increases in mean blood speed and mean WSS can lead to a persistent increase in lumen diameter or total diameter, and length, of veins and arteries. High mean blood speed and mean WSS are detected by endothelial cells, which trigger signaling mechanisms that result in stimulation of vascular smooth muscle cells, attraction of monocytes and macrophages, and synthesis and release of proteases capable of degrading the components extracellular matrix such as collagen and elastin. As such, the present invention is concerned with increasing the mean blood velocity and mean WSS for a sufficient period of time to result in remodeling of veins and arteries and an increase in the total diameter and lumen diameter, and length, of the veins and arteries.
[00189] The systems described here increase the average WSS level in a peripheral vein or artery. The average normal WSS for veins varies between 0.076 Pa and 0.76 Pa. The systems described here increase the level of average WSS in veins for a range between 0.76 Pa and 23 Pa, preferably for a range between 2.5 Pa and 10 Pa. The average normal WSS for arteries varies between 0.3 Pa and 1.5 Pa. To persistently increase the total diameter and lumen diameter of arteries, the systems and methods described here increase the average WSS level to a range between 1.5 Pa and 23 Pa, preferably between 2.5 Pa and 10 Pa. Preferably, the average WSS is increased between 1 day and 84 days, or preferably between 7 days and 42 days, to induce a persistent increase in the total diameter and lumen diameter in the peripheral acceptance vein, in the peripheral acceptance artery, in the peripheral donor vein, or in the peripheral donor artery so that the veins and arteries that were initially ineligible or suboptimal for use as a hemodialysis access site or bypass graft due to a small and the diameter of the vein and artery becomes usable. This can also be done by intermittently increasing the average WSS during the treatment period, with intervening periods of normal average WSS.
[00190] In some circumstances, sustained periods of average WSS levels in the peripheral veins less than 0.076 Pa or in peripheral arteries less than 1.5 Pa may result in increased total diameter and lumen diameter of these veins and arteries, but the extent and rate of this increase is not likely to be clinically significant or compatible with routine clinical practice. Average WSS levels sustained in peripheral veins and arteries higher than approximately 23 Pa are likely to cause denudation (loss) of the vein endothelium, or damage to the vein endothelium. Endothelial denudation or damage to blood vessel endothelium is known to reduce the increase in total diameter and lumen diameter of blood vessels when adjusting the mean blood velocity and increased mean WSS. The increased mean WSS induces a sufficiently persistent increase in the total diameter and lumen diameter, or length, in the veins and arteries so that those that were initially ineligible or suboptimal for use as a hemodialysis access site or bypass graft due to a small vein or artery diameter became usable or more optimal. The diameter of the peripheral acceptance vein, the peripheral acceptance artery, the peripheral donor vein, or the peripheral donor artery can be determined intermittently, such as every 1 day, 3 days, 1 week, or multiple weeks, for example, for allow a pump speed adjustment to optimize the rate and extent of persistent increase in the total diameter and lumen diameter of the vein and artery during the treatment period.
[00191] The systems described here also increase the average blood speed in peripheral veins. At rest, the average blood velocity in the cephalic vein in humans is generally between 5 and 9 cm / s (0.05 and 0.09 m / s). For the systems described here, the average blood velocity in the peripheral vein is increased to a range between 10 cm / s and 120 cm / s (0.1 and 1.2 m / s), preferably to a range between 25 cm / s 100 cm / s (0.25 m / s and 1.0 m / s), depending on the total diameter or initial lumen diameter of the peripheral acceptance vein and the total diameter or final lumen diameter of the acceptance vein. The systems described here also increase the average blood rate in peripheral arteries. At rest, the average blood velocity in the brachial artery is usually between 10 and 15 cm / s (0.1 and 0.15 m / s). For the systems and methods described here, the average blood velocity in the peripheral artery is increased to a range between 10 cm / s and 120 cm / s (0.1 and 1.2 m / s), preferably to a range between 25 cm / s and 100 cm / s (0.25 and 1.0 m / s), depending on the total diameter or initial lumen diameter of the peripheral artery and the total diameter or final lumen diameter of the peripheral artery. Preferably, the mean blood velocity is increased between 1 day and 84 days, or preferably, between 7 and 42 days, to induce a persistent increase in the total diameter and in the lumen diameter, or length, in the acceptance vein. peripheral, peripheral acceptance artery, peripheral donor vein, or peripheral donor artery so that the veins and arteries that were initially ineligible or suboptimal for use as a hemodialysis access site or bypass graft due to a small vein or artery diameter or inadequate length becomes usable. Average blood speed levels in the peripheral acceptance vein, peripheral acceptance artery, peripheral donor vein, or peripheral donor artery less than 10 cm / s (0.1 m / s) can result in a total diameter and diameter of increased lumen of these veins and arteries, but the extent and rate of this increase is not likely to be clinically significant or compatible with routine clinical practice. Average blood velocity levels in peripheral acceptance veins, peripheral acceptance arteries, peripheral donor veins, or peripheral donor arteries higher than approximately 120 cm / s (1.2 m / s) are likely to cause denudation (loss ) of the endothelium of the veins, or damage to the endothelium of the veins. Denudation or damage to blood vessel endothelium is known to reduce the increase in total diameter and lumen diameter of blood vessels seen in the adjustment of increased mean blood velocity. The average blood velocity increased in the desired range and for a sufficient period of time induces a sufficiently persistent increase in the total diameter and lumen diameter, or length, in the veins and arteries, so that those that were initially ineligible or suboptimal for use as a hemodialysis access site or bypass graft due to a small diameter of vein or artery or inadequate length becomes usable. The total diameter or lumen diameter of the peripheral acceptance vein, the peripheral acceptance artery, the peripheral donor vein, and the peripheral donor artery can be determined intermittently, such as every minute, hour, 1 day, 3 days, 1 week, or multiple weeks, for example, to allow a pump speed adjustment to optimize the rate and extent of persistent increase in the total diameter and lumen diameter of the vein and artery during the treatment period.
[00192] In an embodiment shown in Figure 34, system 10 includes blood pump 25, conduit pair 12, and control device 21 for moving deoxygenated venous blood from a donor vein or location in a patient's venous system to a peripheral acceptance vein. In various modalities, the peripheral acceptance vein can be a cephalic vein, a radial vein, a median vein, an ulnary vein, an antecubital vein, a median cephalic vein, a median basilic vein, a basilic vein, a brachial vein, a smaller saphenous vein, a larger saphenous vein, a femoral vein, or other veins. Other veins that could be useful in creating a hemodialysis access site or bypass graft or other veins useful for other vascular surgery procedures that require the use of veins can be used. Ducts 12 move deoxygenated blood into the peripheral acceptance vein. The persistently high mean blood velocity and the high mean WSS in the peripheral vessel cause a persistent and progressive increase in the total diameter and lumen diameter of the peripherally accepted vein. Thus, the system 10 of the present invention advantageously increases the diameter or length of the peripheral vein 4 so that it can be used, for example, to construct a hemodialysis access site (such as an AVF or AVG), a graft from bypass, or used in another clinical setting where a vein of a certain diameter or length is required, as determined by someone skilled in the art.
[00193] As used here, deoxygenated blood is blood that passed through the capillary system and had oxygen removed by the surrounding tissues and then passed on to the venous system. A peripheral vein, as used herein, means any vein with a portion that resides outside the chest, abdomen, or pelvis. In the modality shown in Figure 37, the peripheral acceptance vein 712 is the cephalic vein. However, in other modalities, the peripheral acceptance vein can be a radial vein, a median vein, an ulnary vein, an anti-tubular vein, a median cephalic vein, a median basilic vein, a basilic vein, a brachial vein, a smaller saphenous vein, a larger saferen vein, a femoral vein, or other veins. In addition to a peripheral vein, other veins that could be useful in creating a hemodialysis access site or bypass graft or other veins useful for other vascular surgery procedures that require the use of veins can also be used as veins of acceptance, such as those residing in the chest, abdomen, and pelvis.
[00194] Figure 37 illustrates another embodiment for using system 10 to increase the total diameter and lumen diameter of a blood vessel. In this embodiment, system 10 is configured to remove deoxygenated blood from a donor vein 700 and move blood to the superior vena cava or right atrium 702 of the heart 704. As shown, a flow inlet conduit 706 is connected in communication fluid with the donor vein 700, in this case the cephalic vein. In one embodiment, the connection can be made using a short ePTFE segment of the flow inlet conduit 706 which is used to secure the flow inlet conduit 706 in the donor vein 700 while the remaining segment of the flow inlet conduit is made using polyurethane. In other embodiments, at least a portion of the flow inlet or flow outlet comprises nitinol, for resistance to bending and compression. As shown, one end of the outflow conduit 710 is connected to the blood pump 25 while the other end of the outflow conduit is fluidly connected in the superior vena cava and in the right atrium 702 by an intravascular portion. For the embodiment of Figure 37, a blood pump is used to increase the rate at which blood moves from the donor vein 700 to the superior vena cava and the right atrium 702 of the heart 704 in order to achieve a desired high level of heart rate. medium blood and a high level of mean WSS in the donor vein 700. The pump is operated at a rate and for a time sufficient to result in a persistent increase in the total diameter and lumen diameter of the donor vein, such as a 10% increase, an increase of 25%, an increase of 50%, or an increase of 100% or more of the starting diameter. In an additional embodiment, one or more venous valves between the junction of the flow inlet conduit 706 and the donor vein 700, and the right atrium 702 can be rendered incompetent or less competent (using any of the methods available to someone skilled in the art) ) to allow blood to flow in a retrograde way into the donor vein 700 and then into the flow inlet conduit 706.
[00195] Figure 38 illustrates another embodiment for using system 10 to increase the total diameter and lumen diameter of a blood vessel. In this embodiment, system 10 is configured to remove oxygenated blood from a donor artery 712 (in this case the brachial artery) and move the blood to the superior vena cava and the right atrium 702 of the heart 704. As shown, an inlet conduit flow 706, is connected in fluid communication with the donor artery 712. In one embodiment, the connection can be made using a short segment of ePTFE from the flow inlet conduit 706 which is used to secure the flow inlet conduit to the donor artery 712 while the remaining segment of the flow inlet conduit is made using polyurethane. In other embodiments, one or both segments of the flow inlet duct 706 still comprise nitinol, such as for resistance to bending and compression. As shown, one end of the outflow conduit 710 is connected to the blood pump 25 while the other end of the outflow conduit is fluidly connected in the superior vena cava and in the right atrium 702 by an intravascular portion. For the embodiment of Figure 38, a blood pump is used to increase the rate at which blood moves from the donor artery 712 to the right atrium 702 of the heart 704 in order to achieve a desired high level of average blood velocity and a level high mean WSS in the donor vein 712. The pump is operated at a rate and long enough to result in a desired persistent increase in the total diameter and lumen diameter of the donor artery, such as a 10% increase, an increase of 25 %, an increase of 50%, or an increase of 100% or more of the starting diameter.
[00196] In other modalities, the oxygenated arterial blood can be moved from a donor artery to an acceptance location. Donor arteries may include, but are not limited to, a radial artery, an ulnary artery, an interosseous artery, a brachial artery, an anterior tibial artery, a posterior tibial artery, a peroneal artery, a popliteal artery, a deep artery, a superficial femoral artery, or a femoral artery.
[00197] Figure 39 illustrates another embodiment for using system 10 to increase the total diameter and lumen diameter of a blood vessel. In this embodiment, system 10 is configured to remove oxygenated blood from a donor artery 712 (in this case the brachial artery) and move the blood to the superior vena cava and the right atrium 702 of the heart 704. As shown, a conduit 716 is connected in fluid communication with donor artery 712. In one embodiment, the connection can be made using a short ePTFE segment from conduit 716 which is used to secure the flow inlet conduit in donor artery 712 while the remaining segment of Inlet flow duct is made using polyurethane. In other embodiments, one or both segments of conduit 716 still comprise nitinol, such as for resistance to folding and compression. For the modality of Figure 39, there is no pump and the blood moves passively from the donor artery 712 of higher pressure to the superior vena cava and the right atrium 702 of lower pressure, and the conduit 716 is configured in length and lumen diameter. to achieve a desired high level of mean blood velocity and mean WSS in donor artery 712. Conduit 717 remains in place long enough to result in a desired persistent increase in the total diameter and lumen diameter of donor artery 712, such as a 10% increase, a 25% increase, a 50% increase, or a 100% or more increase in the starting diameter.
[00198] Figure 40 illustrates another modality for using system 10 to increase the total diameter and the lumen diameter of a peripheral artery. In this embodiment, system 10 is configured to remove oxygenated blood from a target artery 718, such as the radiating artery, and move the blood to an acceptance artery 720, such as the brachial artery. As shown, a flow inlet conduit 706 is connected in fluid communication with target artery 718. In one embodiment, the connection between flow inlet conduit 706 and an artery or flow outflow conduit 710 and a artery is made using a short ePTFE segment of the respective conduit which is used to fluidly connect the flow inlet conduit in the target artery 718 or the flow outflow conduit 710 which is fluidly connected in the acceptance artery 720, while the remaining segments the flow inlet and flow outlet ducts can be made using polyurethane. In other embodiments, one or both segments of the flow inlet conduit 706 or flow outflow conduit 710 still comprise nitinol, such as for resistance to bending and compression.
[00199] As shown, one end of the flow outlet duct 710 is connected to the blood pump 25 while the other end of the flow outlet duct is fluidly connected to the acceptance artery 720. For the embodiment of Figure 40, a pump of blood 25 is used to increase the rate at which blood is drawn from target artery 718 in order to achieve a desired high level of average blood velocity and a medium high level of WSS in the target artery. The pump is operated at a rate and long enough to result in a desired persistent increase in the total diameter and lumen diameter of the target artery 718, such as a 10% increase, a 25% increase, a 50% increase, or an increase of 100% or more in the starting diameter. Although the invention has been explained in relation to exemplary aspects and modalities, it should be understood that several of its modifications will be apparent to those skilled in the art when reading the description. Therefore, it should be understood that the invention described herein is intended to cover such modifications as they fall within the scope of the appended claims.

权利要求:
Claims (28)
[0001]
1. Centrifugal blood pump system (10) to persistently increase the overall diameter of veins in which the blood pump (25) is configured to pump blood into a peripheral vein and in which the system (10) is configured to increase the speed of blood in the peripheral vein, the centrifugal blood pump system (10) characterized by the fact that it comprises: a) a centrifugal blood pump (25) comprising: i) a pump housing comprising : - an inlet (110) comprising an inlet diffuser for receiving blood and directing blood to an impeller (140), the inlet diffuser further comprising an upper pivot support and a lower pivot support, in which a projection extends from the pump housing for the inlet and wherein the projection comprises a recess that accepts and supports at least a portion of a stationary portion of the upper pivot support; - an impeller housing comprising a recess that accepts and supports at least a portion of the stationary portion of the lower pivot support; and - an exit; - in which entrance transitions from a circular cross section to a generally rectangular cross section; ii) an impeller (140) suspended within the pump housing and disposed between the stationary parts of the upper and lower pivot supports, the impeller (140) having: - a pivot axis of the upper impeller comprising a rotating portion of the pivot support upper that is configured to engage the stationary portion of the upper pivot support; - a lower impeller pivot axis comprising a rotating portion of the lower pivot support which is configured to engage the stationary portion of the lower pivot support; - a plurality of blades on the upper surface of the impeller (140) and extending radially away from a center of the impeller (140), the blades to direct the blood received at the inlet to the outlet when the pump is in operation; - a plurality of holes extending parallel to a central impeller axis from a lower surface through the impeller to an upper surface; and - at least one magnet mechanically coupled to the impeller (140); iii) an electric motor for magnetically coupling the at least one magnet, in which the electric motor rotates the at least one magnet and the impeller (140) when the pump is in operation; b) an inlet conduit (20) having a first end and a second end, where the first end is configured to make a fluid connection to the inlet and the second end is configured for insertion into the lumen of a donor vein; c) an outlet conduit (30) having a first end and a second end, wherein the first end is configured to make a fluid connection to the outlet and the second end is configured for insertion into the lumen of a receiving vein; and d) a control device (21) for controlling the speed of the impeller (140), the control device (21) including a processor, a memory, a battery, and a cable to electrically connect the control device (21) to the centrifugal pump in which the processor is configured to control the speed of the impeller (140) to maintain a blood pumping rate between 50 mL / min and 1500 mL / min for at least 7 days.
[0002]
Blood centrifugal pump system (10) according to claim 1, characterized in that the inlet diffuser transitions from a generally round lumen to a generally rectangular or oval lumen.
[0003]
3. Blood centrifugal pump system (10) according to claim 2, characterized in that the inlet diffuser has an arcuate shape.
[0004]
4. Blood centrifugal pump system (10) according to claim 1, characterized in that the inlet diffuser has an arcuate shape.
[0005]
Blood centrifugal pump system (10) according to claim 1, characterized in that at least one of the plurality of impeller blades (140) is arched.
[0006]
6. Blood centrifugal pump system (10) according to claim 1, characterized in that the one or more magnets of the impeller (140) form a ring or disk.
[0007]
7. Blood centrifugal pump system (10) according to claim 1, characterized in that the ends of the rotating portion of the pivot supports are convex and the ends of the stationary portion of the pivot supports are concave, or where the ends of the rotating portion of the pivot supports are concave and the ends of the stationary portion of the pivot supports are convex, or where the end of one of the rotating parts of the pivot supports is convex and the end of its stationary portion associated with the pivot supports is concave and the end of the rotation portion of the other pivot support is concave and the end of its associated stationary portion of the other pivot support is convex.
[0008]
Blood centrifugal pump system (10) according to claim 7, characterized in that the convex support surfaces are hemispherical.
[0009]
9. Blood centrifugal pump system (10) according to claim 7, characterized in that the concave support surfaces have a minimum diameter between 1 mm and 3 mm with a radius between 0.2 mm and 0.6 mm.
[0010]
10. Blood centrifugal pump system (10) according to claim 6, characterized in that the rotating portion of the pivot supports has a length between 6 mm and 8 mm.
[0011]
11. Blood centrifugal pump system (10) according to claim 1, characterized in that the pivot axis of the upper impeller comprises a rotating portion of the upper pivot support and configured to engage the stationary portion of the the upper pivot and the lower impeller pivot axis comprising a rotating portion of the lower pivot support and configured to engage the stationary portion of the lower pivot support are two parts of a single impeller pivot axis (140).
[0012]
Blood centrifugal pump system (10) according to claim 1, characterized in that at least one of the stationary parts of a pivot support comprises a circumferential groove to provide a mechanical interlock with the upper recess or the lower recess.
[0013]
13. Blood centrifugal pump system (10) according to claim 1, characterized in that the one or more of the rotating or stationary parts of the pivot supports comprises alumina or alumina and silicon carbide.
[0014]
Blood centrifugal pump system (10) (25) according to claim 1, characterized in that the pump housing comprises an inlet cover and an upper impeller housing (140) and in which the inlet engaged in the upper impeller housing (140) defines at least a portion of the inlet.
[0015]
Blood centrifugal pump system (10) according to claim 1, characterized in that the inlet cover comprises a recess to receive at least a portion of the stationary portion of the upper pivot support.
[0016]
16. Blood centrifugal pump system (10) according to claim 1, characterized in that the pump housing comprises an upper impeller housing and a lower impeller housing and where the upper impeller housing is engaged in the lower impeller housing defines at least a portion of the outlet.
[0017]
17. Blood centrifugal pump system (10) according to claim 16, characterized in that the lower impeller housing comprises a recess for receiving the stationary portion of the lower pivot support.
[0018]
The blood centrifugal pump system (10) (25) of claim 1, characterized in that at least one of the inlet lines further comprises at least one inlet port configured to provide fluid communication to the inlet line (20) or the outlet conduit (30) further comprises at least one outlet port configured to provide fluid communication to the outlet conduit.
[0019]
19. Blood centrifugal pump system (10) according to claim 18, characterized in that the inlet or outlet port is configured to provide access to the fluid path within the corresponding conduit.
[0020]
20. Centrifugal blood pump system (10) according to claim 18, characterized by the fact that at least one of the inlet or outlet ports is configured to allow a fluid connection with a hemodialysis machine and the blood centrifugal pump system (10) (25) is configured to provide vascular access during hemodialysis.
[0021]
21. Centrifugal blood pump system (10) according to claim 1, characterized in that at least one of the inlet duct (20) and the outlet duct (30) comprises polyurethane.
[0022]
22. Centrifugal blood pump system (10) according to claim 1, characterized in that at least a portion of one of the inlet duct (20) and the outlet duct (30) comprises a material with shape memory or self-expanding.
[0023]
23. Centrifugal blood pump system (10) according to claim 22, characterized in that at least a portion of the material with shape memory, self-expanding material, nitinol or stainless steel is formed in one braid or bobbin.
[0024]
24. Centrifugal blood pump system (10) according to claim 1, characterized in that at least one of the inlet duct (20) and the outlet duct (30) is connected to the blood pump or to a conduit segment comprising a port using a radially compressive connector.
[0025]
25. Centrifugal blood pump system (10) according to claim 1, characterized by the fact that a sheath is connected to the outer surface of the inlet (20) or outlet duct.
[0026]
26. Centrifugal blood pump system (10) according to claim 1, characterized by the fact that at least one blood contact surface is covered with an antithrombotic coating.
[0027]
27. Centrifugal blood pump system (10) according to claim 1, characterized by the fact that the control device (21) is configured to maintain the average wall shear stress in a range of 2, 5 to 10.0 Pa within a vein fluidly connected to the outlet duct (30) for at least 7 days, 14 days, 28 days, 56 days or 112 days when the system (10) is in operation.
[0028]
28. Centrifugal blood pump system (10) according to claim 1, characterized by the fact that the control device (21) is configured to maintain the average blood speed in the range of 10 cm / s and 120 cm / s, or 25 cm / s and 100 cm / s within a vein fluidly connected to the outlet duct (30) for at least 7 days, 14 days, 28 days, 56 days or 112 days when the system (10) is in operation.

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法律状态:
2018-03-06| B25A| Requested transfer of rights approved|Owner name: FLOW FORWARD MEDICAL, INC. (US) |

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2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-10-15| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-09-29| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2020-12-15| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 15/08/2012, OBSERVADAS AS CONDICOES LEGAIS. |

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2021-07-20| B25A| Requested transfer of rights approved|Owner name: ARTIO MEDICAL, INC. (US) |

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2021-08-10| B25G| Requested change of headquarter approved|Owner name: ARTIO MEDICAL, INC. (US) |

优先权:

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申请号 | 申请日 | 专利标题

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US201161524761P| true| 2011-08-17|2011-08-17|

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US61/524,761|2011-08-17|

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US201161564671P| true| 2011-11-29|2011-11-29|

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US61/564,671|2011-11-29|

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PCT/US2012/050983|WO2013025826A1|2011-08-17|2012-08-15|Blood pump systems and methods|

---