WO2022094690A1 - Dispositif influençant un écoulement de fluide pouvant être implanté dans un corps de mammifère - Google Patents

Dispositif influençant un écoulement de fluide pouvant être implanté dans un corps de mammifère Download PDF

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Publication number
WO2022094690A1
WO2022094690A1 PCT/CA2021/050469 CA2021050469W WO2022094690A1 WO 2022094690 A1 WO2022094690 A1 WO 2022094690A1 CA 2021050469 W CA2021050469 W CA 2021050469W WO 2022094690 A1 WO2022094690 A1 WO 2022094690A1
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WIPO (PCT)
Prior art keywords
impeller
module
impeller vane
modules
hub module
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Application number
PCT/CA2021/050469
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English (en)
Inventor
Gabriel GEORGES
François TRUDEAU
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Puzzle Medical Devices Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from PCT/CA2020/051677 external-priority patent/WO2021062566A1/fr
Application filed by Puzzle Medical Devices Inc. filed Critical Puzzle Medical Devices Inc.
Priority to US17/712,789 priority Critical patent/US20230056440A1/en
Publication of WO2022094690A1 publication Critical patent/WO2022094690A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/861—Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/135—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/205—Non-positive displacement blood pumps
    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A61M60/237—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/804—Impellers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/804—Impellers
    • A61M60/806—Vanes or blades
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/804—Impellers
    • A61M60/806—Vanes or blades
    • A61M60/808—Vanes or blades specially adapted for deformable impellers, e.g. expandable impellers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/865—Devices for guiding or inserting pumps or pumping devices into the patient's body

Definitions

  • the present technology relates to mammalian body implantable fluid flow influencing devices.
  • Fluid carrying conduits in patients may require fluid flow influencing (e.g, an increase in fluid flow rate, a decrease in fluid flow rate, a stoppage of fluid flow, a diversion of fluid flow, etc.) in various medical situations.
  • fluid flow influencing e.g, an increase in fluid flow rate, a decrease in fluid flow rate, a stoppage of fluid flow, a diversion of fluid flow, etc.
  • Heart failure is an example of a common such situation.
  • patients with heart failure their heart becomes unable to pump enough blood to meet their body’s needs for blood and oxygen.
  • Heart failure is a disease affecting upwards of 6 million Americans and 26 million people worldwide at any given time. There is no cure. For those suffering from heart failure, their ability to function in everyday life and their overall quality of life steadily and inevitably decline. There may be times of rapid deterioration. Even with the best of medical care, heart failure sufferers’ symptoms will slowly, inevitably progress. They will rapidly become limited in their activities. At some point in time, they will experience increasing symptoms of the disease even at rest and under optimal medical therapy. People with end-stage heart failure disease currently have a 2-year estimated chance of survival of only 20%.
  • Examples of minimally invasive surgical techniques are percutaneous transcatheter techniques, in which a catheter (e.g, a relatively long flexible tube) is inserted into the patient’s body and the intervention is performed through the lumen (i.e., the hollow cavity) of the catheter at a site distal to (e.g., away from) the catheter insertion site.
  • transcatheter techniques generally are lower risk to the patient, shorter in time for the surgeon to perform, and have shorter patient recuperation times. They are usually preferred by patients.
  • Heart transplantation involves the removal of a patient’s diseased heart and its replacement with a healthier heart from a heart donor.
  • donor hearts There are, however, an extremely limited number of donor hearts available. In North America for example, only about 3,000 donor hearts are available each year. So, heart transplantation is not an option which is generally available to patients, as the number of donor hearts is far less than the number of sufferers of the disease.
  • heart transplantation obviously requires very invasive open surgery. It carries additional significant risks, including (but in no way limited to) transplant coronary artery disease and life-long suppression of the recipient’s immune system. For all of these reasons, heart transplantation is in most cases limited to younger patients, and therefore younger patients are prioritized on heart transplant lists.
  • total artificial heart Another current treatment possibility for heart disease is through the removal of a patient’s diseased heart and its replacement with an artificial heart device (typically known as a “total artificial heart”). While the number of total artificial hearts is not limited (as is the case with donor human hearts) as they are manufactured devices, at the moment their use is limited to being only temporary. No total artificial heart is available for permanent implantation. Thus, total artificial hearts are used in patients who are in the end-stages of heart disease, but for whom no donor heart is yet available. Their use is quite limited, as the number of donor hearts is limited. In addition, implantation of a total artificial heart still requires very invasive open surgery, and carries risks as noted above. There are very few total artificial heart products currently available for use in patients. One product is the SynCardiaTM Temporary Artificial Heart. Another potential product, which is still in development, is the CarmatTM artificial heart. Ventricular Assist Devices (Open Surgical Implantation)
  • a third current treatment possibility for heart disease is through the implantation and use of what is known as a “Ventricular Assist Device” (commonly abbreviated to and referred to as a ‘VAD’).
  • a VAD is a mechanical pump that is surgically implanted within a patient to help a weakened heart pump blood. Unlike a total artificial heart, a VAD does not replace a patient’s own heart, instead it helps the patient’s native heart pump blood.
  • VADs may be used to help the left side of a patient’s heart, in which case they are known as LVADs. Or, they may be used to help the right side of a patient’s heart, in which case they are known as RVADs.
  • VADs are far more commonly used.
  • VADs may either be used as a bridge until a heart transplant can be performed (as is the case with total artificial hearts) or they may be used long term in patients whose condition makes it impossible to receive a heart transplant or who require immediate long-term support.
  • VADs There are different types and configurations of VADs, some of which will be discussed below.
  • VADs are both significant.
  • patients are at risk of embolic stroke (e.g., a stroke caused by the blockage of a blood vessel due to a blood clot having formed), for amongst other reasons, the positioning of a VAD at the apex of the heart.
  • Patents are also at risk of a cerebral (i.e., brain) or gastro-intestinal hemorrhage as most VADs pump blood continuously (as opposed to a normal heart, which pumps blood in pulses).
  • VADs all of these generations of VADs described above that are currently in use (or previously had been used) require (or required) invasive classic open surgery (e.g., a median sternotomy or a less invasive mini -thoracotomy).
  • invasive classic open surgery e.g., a median sternotomy or a less invasive mini -thoracotomy.
  • a VAD is surgically atached (e.g., sutured) to the heart while the main VAD body remains external to the patient’s vasculature (e.g, heart and blood vessels).
  • the pump inlet of the VAD is sutured to the left or right ventricle of the heart (depending on whether the VAD is an LVAD or an RVAD) and the outflow tubing from the VAD is sutured to the aorta (in the case of an LVAD) or the pulmonary artery (in the case of an RVAD).
  • ImpellaTM the only commercial product that can be implanted percutaneously transcatheter is the ImpellaTM family of micro-pump devices from AbiomedTM.
  • An Impella device has a single micro axial pump (e.g., having an impeller) with a cannula (e.g, a small tube-like structure).
  • the device is implanted within the left ventricle (in the case of an LVAD) or right ventricle (in the case of an RVAD) of the heart so as to cross the aortic valve (in the case of an LVAD) or tricuspid and pulmonary valve (in the case of an RVAD).
  • the inlet of the pump is within the ventricle or within the vessels that discharge fluid into the ventricle and the outlet of the pump is outside of the heart, in the aorta (in the case of an LVAD) and in the pulmonary artery (in the case of an RVAD).
  • aorta in the case of an LVAD
  • RVAD pulmonary artery
  • the VAD provides pumping assistance to the ventricle of the heart.
  • Impella device is implanted via a percutaneous procedure.
  • access to the patient’s internal organs is made via needle-puncture of the skin (e.g., via the well-known conventional Seidinger technique).
  • the needle-puncture site is relatively remote from the actual internal organs that the surgeon will be operating on.
  • the initial needle puncture of the skin takes place in the patient’s groin area so that the surgeon can access the patient’s vasculature through the femoral vessels. Once access is obtained, the surgeon can advance the necessary tools to conduct the surgical procedure through the patient’s vasculature to their heart.
  • the surgeon then conducts the procedure on the heart, usually via wires extending from the tools, travelling through the patient’s vasculature and outside of the patient’s body via the access opening that the surgeon had previously made. Once the procedure has been completed, the surgeon removes the tools from the patient’s vasculature in the same manner. In such procedures, access via the femoral artery (in the patient’s groin area) or the axillary artery (about the patient’s clavicle) are more common.
  • Impella device One difficulty that arises with respect to such percutaneous procedures and devices, such an Impella device, is that the size of the device is significantly limited because of the remote peripheral insertion location of the device (through femoral or axillary artery, as the case may be). I.e., the size of the structures that will travel through the patient’s blood vessels is limited to being only slightly larger than those vessels themselves, as those vessels can only stretch a limited amount before they will become damaged. Additionally, peripheral vascular disease, which is very common in older patients, further reduces the size and compliance of vessels due to atheromatous plaque build-up and calcification. In the context of an Impella device, what this means is that the actual physical size of the pump (including the motor and the impeller) is limited since the pump must travel through the patient’s blood vessels to the patient’s heart.
  • Impella device pump limits the actual physical size of the cannula of the pump through which the pumped blood will flow.
  • the impeller of the pump will have to rotate at a very high speed.
  • This high impeller rotation speed can be problematic, however.
  • High impeller rotation speed generates substantial shear stress forces on the blood elements being pumped, leading to known detrimental phenomena such as platelet activation, von Willebrand factor multimer destruction, destruction of red blood cells (hemolysis) and thrombus formation. All of which can lead to embolic strokes or pump thrombosis, as described above. Expandable Impellers
  • McBride et al. As background on expandable impeller pumps, United States Patent No. 7,393,181 (McBride et al.), issued July 1, 2008, entitled “Expandable Impeller Pump” (hereinafter “McBride et al.”) describes ""An impeller ... comprises a hub, and at least one blade supported by the hub. The impeller has a deployed configuration in which the blade extends away from the hub, and a stored configuration in which the impeller is radially compressed, for example by folding the blade... ” (Abstract, McBride et al.). For ease of understanding this concept, figures 1A, IB, 2, 3A and 3B of McBride et al. are reproduced herein as Figs.
  • FIG. 1A shows an impeller in a deployed configuration, the impeller comprising a hub 10 and blades such as blade 12.
  • the impeller has a radius Rl, as measured from the central long axis of the hub to the outermost blade tip...
  • FIG. IB shows the impeller in a stored configuration, with blade 12 folded or otherwise deformed towards the hub 10.
  • the radius R2 is less than the radius Rl shown in FIG. 1A.
  • An impeller according to an embodiment of the present invention has flexible blades that can be folded such that the maximum diameter of the impeller in the folded state is approximately half, or less than half, the diameter of the impeller in the operating state.
  • FIG. 2 is a schematic illustrating deployment of the impeller.
  • the impeller has hub 20 and blades such as 22, and is retained in the stored configuration by storage sleeve 24.
  • a rotating shaft 30 is used to drive the impeller.
  • the figure also shows a guide wire 28 within the rotating shaft, which can be used to position the impeller, and also to help push the impeller out of the storage sleeve...
  • An impeller in the stored configuration can be stored in a cylindrical cavity formed by storage sleeve 24 of diameter approximately equal to or less than half the diameter of the fluid pipe 26...
  • FIG. 3A further illustrates an impeller in a stored configuration, showing blades such as blade 34, and hub 30.
  • FIG. 3B shows the impeller pushed out of the storage sleeve and self-deployed. ” (McBride et al. ; col. 5, line 57 to col. 6, line 53)
  • Impella devices improved percutaneously transcatheterly-implantable VAD solutions have been conceived of.
  • Such devices include devices developed by Magenta MedicalTM, by Second Heart AssistTM, the HeartmateTM PHP by AbbottTM and others. These devices all have a common goal of overcoming the limitations of the Impella devices by using impellers that have the capability of being expanded in vivo as was generally discussed above.
  • a device can be implanted percutaneously transcatheterly with the pump impeller having vanes in a delivery (compact) configuration (the diameter of which being sufficiently small enough to be able to travel through a catheter extending within the patient’s blood vessels, without causing damage).
  • the impeller vanes then can be deployed (expanded) to yield an impeller having a larger diameter than the one it had with the delivery configuration.
  • the impeller of one of these devices can be operated at relatively lower speeds (as compared with the one of an Impella device - a non-expandible impeller), as the expandable impeller in its operating configuration has a relatively larger diameter than that of the Impella device impeller.
  • Reitan teaches a device with impeller vanes rotatably or pivotably connected to a central hub. Thus, the vanes rotate or pivot from a compact (delivery, storage, etc.) configuration to an expanded (deployed, operational, etc.) configuration.
  • the design of the Reitan device enables a relatively large change in impeller diameter between the compact and expanded configurations. Such a design thereby enables the implantation and operation of an impeller with a relatively large diameter and a lower rotational speed, thus enabling sufficient volumetric blood flow with reduced risk of negative impact on blood components.
  • Impellers of a such a design therefore have a reduced hydraulic efficiency as compared with impellers that do not require such changes in configuration.
  • Another drawback is that the mechanical joints on such devices (which enable the vanes to rotate or pivot) frequently represent a geometric discontinuity where blood stagnation can occur. Unfortunately, this elevates the risk of thromboembolism formation and negatively affects the clinical viability of devices of such a design. (This list of drawbacks is only exemplary.)
  • a fluid flow influencing device e.g, a VAD
  • the result of such efforts is an impeller designed to have reduced diameter for delivery (and in some instances for storage, transport, and/or removal, etc.) and to have an increased diameter for operation, without requiring a conventional expandable impeller.
  • the present technology achieves this result, in summary, by providing an impeller having an in vivo assemblable modular design.
  • the modules making up the impeller are sequentially deliverable when unassembled to a delivery site within the mammalian body via a catheter having been percutaneously inserted into a conduit system (e.g. , the vasculature) of the body.
  • the modules are then assemblable at (or near) the delivery site to form the impeller.
  • the assembled impeller is then operable at the delivery site (in which case the delivery site would be the implantation site) or is movable to an implantation site distinct from the delivery site and then operable at that location, as the case might be. (Typically, the latter would be the case when there would not be enough space at the implantation site to assemble the impeller (but there would be enough space to operate it), and there would be enough space at (or near) the delivery site to assemble the impeller.).
  • an impeller having a particular operating diameter may be implantable within a body, notwithstanding the fact that that operating diameter exceeds the diameter of the conduits in the conduit system through which that impeller is to be delivered.
  • inventions of the present technology provide a mammalian body implantable fluid flow influencing device.
  • the device comprises a modular impeller.
  • the modular impeller has an impeller hub module and at least one impeller vane module.
  • the impeller hub module is dimensioned and shaped to be deliverable to a delivery site within a conduit of a conduit system of the mammalian body via a catheter.
  • Each impeller vane module has at least a portion of an impeller vane.
  • Each impeller vane module has, with respect to the impeller hub module, an assembled configuration in which the impeller vane module mates with the impeller hub module, and an unassembled configuration in which the impeller vane module is unmated with the impeller hub module.
  • Each impeller vane module is dimensioned and shaped to be deliverable to the delivery site within the conduit of the conduit system of the mammalian body via the catheter when in the unassembled configuration.
  • the modular impeller is formed when the impeller vane module is retained in its assembled configuration.
  • the impeller is dimensioned and shaped to be operable within a conduit of the conduit system of the mammalian body, which, as was noted above, may in some cases be at the delivery site and in other cases may be at an implantation site distinct from the delivery site.
  • the impeller is operable within at least one of the conduits of the conduit system of the mammalian body (to which it was delivered) and another conduit of the conduit system of the mammalian body (to which it may have been moved in vivo).
  • the modular impeller is dimensioned and shaped to be operable at/within the location of the body at which it is implanted and operated without causing material harm to the patient.
  • the device is termed a “fluid flow influencing” device and not simply a “pump”, as it is foreseen that it would be possible to operate the impeller of the device so as to increase the native volumetric flow rate (which, may, in some instances be zero), as in the case of a pump. It is also foreseen that it would be possible in some instances to operate the impeller of the device so as to decrease or divert the native volumetric flow rate within the conduit.
  • the modules of the modular impeller are dimensioned and shaped to be deliverable through the conduit system of the mammalian body via a catheter.
  • the size of the catheter required may vary. For example, were the device to be implanted within a patient suffering from coronary artery disease with heart failure, their peripheral vasculature through which the catheter must pass may be partially blocked by peripheral artery disease and thus have reduced cross- sectional area as compared with that of a person not suffering from that disease.
  • the surgeon would thus have to select the appropriately sized catheter and impeller modules (device) such that the catheter can pass through the minimum available cross-section of the blood vessels, to the delivery site, and the modules can be delivered (e.g, can themselves pass through) via the catheter to the delivery site.
  • the size of catheters for use in human beings is measured according to the French scale (Fr).
  • Such catheters commonly vary in outer diameter between 3 Fr (1 mm) and 36 Fr (12 mm).
  • the Fr scale may be converted to millimetres by dividing the Fr by 3.). So, for example, if it were determined that a 6 Fr catheter was to be used in a particular procedure, any components to be delivered through that catheter must be selected such that their dimensions and shapes will permit them to be delivered through a catheter of 6 Fr.
  • the impeller hub module and each of the impeller vane modules meet such a limitation.
  • each one of the units to be implanted has a minimum-bounding right circular cylinder.
  • a minimum bounding right circular cylinder is right circular cylinder whose axis is generally parallel to (including colinear with) a longitudinal axis of the object in question (e.g, an impeller vane module, an impeller hub module, etc.
  • Each minimum-bounding right circular cylinder has a diameter, and each diameter is between 1 mm (3 Fr) and 12 mm (36 Fr) inclusive.
  • a difference between a largest one of the diameters and a smallest one of the diameters is at most 2 mm (6 Fr).
  • the minimum diameter of the catheter necessary will be defined by the largest diameter, as far as the design will allow, having the diameters of each of the units to be implanted close to one another is likely to be optimal in most embodiments.
  • the impeller hub module is the module that has or forms most (if not all) of the impeller hub.
  • the hub is the central rotating part of the impeller to which torque is imparted and to which the vanes are attached.
  • An impeller vane module is a module that has or forms most (if not all) of an impeller vane.
  • the vanes are the broad structures attached to the hub that impart motion to the fluid when the impeller rotates.).
  • a portion of the impeller hub may be part of the impeller vane module, and/or a portion of a vane (or vanes) may be present on an impeller hub module.
  • Modules of the present technology do not lose their characterization as an impeller “hub” module merely because they do not form the entirety of the impeller hub. (E.g, the impeller vane modules may form a portion of the impeller hub, in some embodiments.)
  • modules of the present technology do not lose their characterization as an impeller “vane” module merely because they do not have the entirety of a vane.
  • the impeller hub module may have a portion of an impeller vane or vanes, in some embodiments.).
  • the impeller hub module has an outer surface that is shaped as a portion (or portions) of a curved side surface of a right circular cylinder.
  • the bases of the of the impeller vane modules have a surface shaped to align flush with the outer surface of the impeller hub module, and to complete the curved side surface of the right circular cylinder.
  • at least part of the bases of the impeller vane modules will form part of the impeller hub when the impeller is fully assembled and operable.
  • each of the impeller vane modules has a center of mass.
  • the centers of mass of the impeller vane modules are all equally angularly spaced around an axis of rotation of the impeller hub module in a plane perpendicular to the axis of rotation, (ii) The centers of mass of the impeller vane modules are equally radially distant from the axis of rotation of the impeller hub module in the plane. The purpose of such a design may be to assist in mass balancing of the assembled impeller.
  • each impeller vane module has an assembled configuration and an unassembled configuration with respect to the impeller hub module.
  • the impeller vane module mates with the impeller hub module.
  • the term “mates” includes being correctly positioned one with respect to the other such that a portion of an operative impeller is formed. It is thus foreseen that in most (but not all) embodiments, there will be only one position of an impeller vane module with respect to the impeller hub module when the former is in the assembled configuration.
  • the impeller module vane module is unmated with the impeller hub module.
  • the term “unmated” includes being positioned one with respect to the other such that no portion of an operative impeller is formed. It is thus foreseen that in most (but not all) embodiments, there will be a large number of positions which an impeller vane module may be in with respect to an impeller hub module when the former is in the unassembled configuration.
  • the modular impeller is formed when each of the impeller vane modules is retained in its assembled configuration. No particular means of retention is required. Any means of retention not incompatible with the delivery, assembly, operation, and removal of the modular impeller, nor incompatible with its use inside a living body, is within the scope of the present technology. Specific examples of such retention means are provided hereinbelow.
  • modular impellers of the present technology will have only one single impeller vane module, far more often than not impellers having multiple impeller vane modules will be the case. In some such embodiments, there will be an even number (e.g, two) of impeller vane modules, in other such embodiments there will be an odd number (e.g, three) of impeller vane modules.
  • each one of the impeller vane modules has a control wire attached thereto and that control wire is manipulable to move that impeller vane module from its unassembled configuration into its assembled configuration.
  • control wire is manipulable to move that impeller vane module from its unassembled configuration into its assembled configuration.
  • control wires of the impeller vane modules extend through a channel in the impeller hub module.
  • the purpose of the channel is to assist in ensuring the correct positioning of the control wires and/or in preventing the control wires from interfering with or being interfered with by other structures, elements or components (as the case may be). This, however, is not required to be the purpose of such channel in any particular embodiment.
  • each control wire of each of the impeller vane modules extends through a discrete channel in the impeller hub module.
  • Such discrete channels may be in place of or in addition to the channel referred to in the previous paragraph.
  • the purpose of such discrete channels may be to assist in ensuring the correct positioning of the control wires and/or in preventing the control wires from interfering with or being interfered with by other structures, elements or components (as the case may be). This, however, is not required to be the purpose of such channels in any particular embodiment.
  • each control wire may extend from its impeller vane module through a discrete channel in the impeller hub module and then to a common channel in the impeller hub module.
  • the wires may be joined to a single wire (e.g, within the common channel) which then extends proximally through the conduit system (e.g, vasculature) for manipulation by the surgeon (e.g, outside of the body of the patient).
  • the surgeon need only manipulate that single wire, which causes simultaneous movement of the control wires of each of the impeller vane modules.
  • the impeller vane modules are retained in their assembled configuration via different means.
  • each one of the impeller vane modules is retained in its assembled configuration solely via tension in its control wire.
  • the impeller hub module has a plurality of impeller hub connectors (e.g. , connectors associated with the impeller hub module).
  • Each one of the impeller vane modules further has a base (e.g, a structure to which the elements of the impeller vane module are attached (e.g, the portion of the impeller vane)).
  • the base has an impeller vane module connector (e.g, a connector associated with the impeller vane module).
  • the impeller vane module connector and at least one of the impeller hub module connectors are structured to releasably connect to each other.
  • each one of the impeller vane modules is retained in its assembled configuration via, at least in part, releasable connection of its impeller vane module connector to at least one of the impeller hub module connectors
  • releasable connection of an impeller vane module connector to at least one of the impeller hub module connectors may be achieved in a number of ways.
  • such releasable connection may be achieved by means of a mechanical interlock between the connectors, which, in various embodiments, could be at least by one or more of a sliding interconnection, a screwing interconnection, an expanding interconnection, and/or a frictional interconnection.
  • such releasable connection may be achieved by a magnetic interlock, the magnetic interlock being in place of or in addition to a mechanical interlock (or other type of connector).
  • the control wires of the various impeller vane modules are tensioned as well to assist in retaining the impeller vane modules in their assembled configuration.
  • each impeller vane module has a proximal end and an impeller vane module secondary connector on the proximal end.
  • the impeller vane module secondary connector is structured and arranged to releasably connect to a corresponding impeller hub module secondary connector on the impeller hub module when the impeller vane module is in its assembled configuration.
  • the releasable connection of these secondary connectors may be achieved by any appropriate means, including those described in the previous paragraph in relation to the “primary” connectors.
  • the control wire of each one of the impeller vane modules is detachable from that one of the impeller vane modules when that one of the impeller vane modules is in its assembled configuration.
  • detached control wires of impeller vane modules are re-attachable to at least one of the impeller vane modules when that one of the impeller vane modules is in its assembled configuration.
  • a detached control wire may be re-attached only to the impeller vane module from which it was detached, and in other embodiments, a detached control wire may be reattached to any impeller vane module (irrespective of whether that wire had previously been attached to that impeller vane module or not).
  • no particular means of attachment, detachment, and/or re-attachment is required. Any such means not incompatible with the delivery, assembly, operation, and removal of the modular impeller, nor incompatible with its use inside a body, is within the scope of the present technology.
  • the device further comprises a motor.
  • the motor is operatively connectable to the impeller hub module for rotating the impeller.
  • the motor generates torque, which is transmitted via the operative connection to the impeller hub, to cause the rotation of the impeller hub.
  • the device further comprises a flexible drive shaft operatively connected to the motor and to the impeller hub module, for transmitting torque from the motor to the impeller hub module to rotate the impeller.
  • a flexible drive shaft permits, in some embodiments, the motor to remain outside of the body of the patient even during operation of the device. In such embodiments the flexible drive shaft extends through the vasculature of the patient to the device.
  • the device further comprises a hollow control cable having a lumen therein.
  • the control cable may, as a non-limiting example, be used to manipulate the device or a component or components thereof, similarly to the manner in which the control wires (where present) may be used to manipulate the impeller vane modules.
  • control wires where present
  • the device further comprises a hollow control cable having a lumen therein.
  • the control cable may, as a non-limiting example, be used to manipulate the device or a component or components thereof, similarly to the manner in which the control wires (where present) may be used to manipulate the impeller vane modules.
  • the flexible drive shaft is rotatably disposed within the lumen of the control cable.
  • the control cable may protect the conduit system of the body from damage caused by the rotation of the flexible drive shaft.
  • the flexible drive shaft is itself hollow, having a lumen therein.
  • multiple discrete lumens are present.
  • the control wires of the impeller vane modules may extend through one of the lumens.
  • each of the control wires may extend through a separate one of the discrete lumens; in others, multiple control wires may extend through a single lumen.
  • each of the control wires extends to a proximal end of the flexible drive shaft and is secured in place at the proximal end of the flexible drive shaft by a releasable fastener.
  • at least one lumen of the flexible drive shaft contains a heat transfer fluid.
  • a heat transfer fluid One potential use of such a fluid could be to transfer heat generated by the rotation of the flexible driveshaft (e.g., when the device is in operation) outside of the body of the patient.
  • the device further comprises a housing in which the motor is disposed.
  • the motor is operatively connectable to the impeller hub module via a drive shaft.
  • the housing, the motor, the drive shaft, and the impeller hub module form a single implantable unit.
  • the single implantable unit is dimensioned and shaped to be deliverable to the delivery site within the conduit of the conduit system of the mammalian body via the catheter. The use of such a structure permits, in some embodiments, the motor to be implanted within the patient at the implantation site.
  • the device further comprises a hollow control cable having a lumen therein and having a distal end at least indirectly (i.e., directly or indirectly) attached to the housing.
  • the device further comprises electrical wiring in electrical communication with the motor for providing electrical power to the motor, the electrical wiring extending within the lumen of the control cable.
  • the control wires of the impeller vane modules extend through the lumen of the control cable (irrespective of whether the electrical wiring extends the lumen of the control cable).
  • a purge system with purge fluid going through a lumen in the control cable around the motor wires into the motor housing and exiting at the interface between the motor and the impeller hub module may also be present.
  • the device further comprises a wire network.
  • the wire network has a proximal end and a distal end.
  • the wire network is connected at its proximal end to a component of the device independent from rotational movement of the impeller hub module (e.g, a component that does not rotate when the impeller hub module (and thus the impeller) rotates).
  • the wire network has a collapsed configuration and an expanded configuration and is overcomably biased towards the expanded configuration. When the wire network is in its collapsed configuration it is dimensioned and shaped to be deliverable to the delivery site within the conduit of the conduit system of the mammalian body via the catheter.
  • the wire network when the wire network is in the collapsed configuration it surrounds at least part of the impeller hub module. And, when the wire network is in the expanded configuration, it surrounds at least the vanes of the impeller without interfering with operation of the impeller.
  • the wire network when in the expanded configuration, is dimensioned and shaped to exert a force on a wall of the conduit into which it is implanted at the implantation site (e.g, of at least one of the conduit and another conduit of the conduit system of the mammalian body). And the force is sufficient to anchor the device in place at the implantation site.
  • the distal end of the wire network forms a variable-size distal opening.
  • That opening is of an insufficient size to permit impeller vane modules to pass through that opening
  • Each one of the impeller vane modules is in its unassembled configuration distal to the impeller hub module
  • the control wires of the impeller vane modules extend through that opening.
  • that opening is of a sufficient size to permit impeller vane modules to pass through that opening, and each of the impeller vane modules is moveable through that opening towards its assembled configuration.
  • the impeller hub module has a distal spindle.
  • the device further includes a distal bearing hub distal to the impeller hub module.
  • the distal bearing hub has a bearing supporting the distal spindle of the impeller hub module.
  • the work network has distal wires extending distally beyond a distal end of the impeller hub module.
  • the distal wires are connected to the distal bearing hub.
  • the wire network When the wire network is in its expanded configuration: (i)
  • the wire network has a plurality of distal gaps bounded at least in part by at least one of the distal wires.
  • the control wire of each one of the impeller vane modules passes through a one of the gaps. That one of the gaps is of a sufficient size to permit that one of the impeller vane modules to pass through that one of the gaps. That one of the impeller modules is movable through that one of the gaps towards its assembled configuration.
  • each of the impeller vane modules has at least two separate impeller vane module components, and that each impeller vane module is formed in vivo when all of the impeller vane module components of which it is made are assembled together. This may be achieved, for example, by using control wires and connectors as described hereinabove.
  • the impeller is an axial impeller.
  • a diameter of the impeller is between 4 mm and 35 mm inclusive.
  • An operating speed of the impeller is between 1000 RPM and 60,000 RPM inclusive.
  • An output of the impeller is between 0.5 liters/min. and 10 liters/min. inclusive.
  • the mammalian body is a human body.
  • the conduit system of the human body is a vascular system of the human body.
  • the conduit of the vascular system is one of an aorta, a left ventricle, a vena cava, a pulmonary artery, and a right ventricle.
  • the catheter is a delivery sheath.
  • the device further comprises a loader connectable at least indirectly (i.e., directly or indirectly) to the delivery sheath for loading the device into the delivery sheath.
  • a loader connectable at least indirectly (i.e., directly or indirectly) to the delivery sheath for loading the device into the delivery sheath.
  • At least the impeller hub module and the impeller vane modules in their unassembled configuration are within the loader in series one distal to another, with the impeller hub module being proximal to the impeller vane modules.
  • implementations of the present technology provide a method of implanting a mammalian body implantable fluid flow influencing device as described hereinabove into conduit of a conduit system of a mammalian body, the method comprising: a) obtaining access to the conduit system of the mammalian body; b) guiding a delivery sheath to the delivery site; c) inserting the impeller vane modules in their unassembled configuration distal end first into the delivery sheath in series one after another; d) inserting the impeller hub module into the delivery sheath; e) guiding the impeller vane modules and the impeller hub module within the delivery sheath to the delivery site; f) promoting exit of the impeller vane modules from the delivery sheath at the delivery site; g) promoting exit of the impeller hub module from the delivery sheath at the delivery site; h) withdrawing the delivery sheath from the body; and i) manipulating the control wires of the impeller vane modules to move the
  • first”, “second”, “third”, etc. have been used as adjectives only for the purpose of allowing for distinction between the nouns that they modify from one another, and not for the purpose of describing any particular relationship between those nouns.
  • first unit and “third unit” is not intended to imply any particular type, hierarchy or ranking (for example) of/between the units.
  • any “second unit” must necessarily exist in any given situation.
  • the word “embodiment(s)” is generally used when referring to physical realizations of the present technology and the word “implementations” is generally used when referring to methods that are encompassed within the present technology (which generally involve also physical realizations of the present technology).
  • the use of these different terms is not intended to be limiting of or definitive of the scope of the present technology. These different terms have simply been used to allow the reader to better situate themselves when reading the present lengthy specification.
  • Embodiments and implementations of the present technology each have at least one of the above-mentioned objects and/or aspects, but do not necessarily have all of them. It should be understood that some aspects of the present technology that have resulted from attempting to attain the above-mentioned object may not satisfy this object and/or may satisfy other objects not specifically recited herein.
  • FIG. 1A is a prior art expandable impeller as shown in Fig. 1A of McBride et al. and described therein.
  • FIG. IB is a prior art expandable impeller as shown in Fig. IB of McBride et al. and described therein.
  • FIG. 2 is a prior art expandable impeller as shown in Fig. 2 of McBride et al. and described therein.
  • FIG. 3A is a prior art expandable impeller as shown in Fig. 3A of McBride et al. and described therein.
  • FIG. 3B is prior art expandable impeller as shown in Fig. 3B of McBride et al. and described therein.
  • FIG. 4 is an isometric view of a percutaneously transcatheterly implantable intravascular blood pump being a first embodiment of the present invention, taken from the distal end thereof.
  • FIG. 5 is another isometric of the blood pump of Fig. 4.
  • FIG. 6 is an isometric view of the impeller hub module of the blood pump of Fig. 4, taken from the distal end thereof.
  • FIG. 7 is an isometric view of a first impeller vane module of the blood pump of Fig. 4, taken from the distal end thereof.
  • FIG. 8 is an isometric view of the first impeller vane module of Fig. 7, taken from the proximal end thereof.
  • FIG. 9 is view of a single implantable unit (motor housing, impeller hub, anchor) and two impeller vane units in an unassembled configuration of the blood pump of Fig. 4, within a delivery sheath (with the anchor being in the compact configuration), with part of the delivery sheath having been cut away to show the components inside.
  • FIG. 10 is an isometric view of the blood pump of Fig. 4, taken from the distal end thereof, with both of the impeller pump modules in an unassembled configuration.
  • FIG. 11 is an isometric view of the anchor of the blood pump of Fig. 4, in its expanded configuration, taken from the distal end thereof.
  • FIG. 12 is an isometric view of the anchor of the blood pump of Fig. 4, in its compact configuration, taken from towards the proximal end thereof.
  • FIG. 13 is a side elevation view of the impeller hub module and a first impeller vane module of the blood pump of Fig. 4, in an unassembled configuration.
  • FIG. 14 is an isometric view of blood pump of Fig. 4, with the first impeller vane being pulled towards its assembled configuration.
  • FIG. 15 is an isometric close-up view of the proximal end of the first impeller vane module and the proximal end of the impeller hub module as the first impeller vane module is approaching its assembled configuration.
  • FIG. 16 is a side elevation view of the impeller hub module and the first impeller vane module of the blood pump of Fig. 4, in the assembled configuration, with second impeller vane (not shown) being in an unassembled configuration.
  • FIG. 17 is an isometric view of the blood pump of Fig. 4, taken from the distal end thereof, with both the first impeller vane module and the second impeller vane module being their assembled configurations such that the impeller is fully assembled.
  • FIG. 18 is another isometric view of the blood pump of Fig. 4, taken from the distal end thereof, with both the first impeller vane module and the second impeller vane module being their assembled configurations such that the impeller is fully assembled.
  • FIG. 19 is still another isometric view of the blood pump of Fig. 4, taken from the distal end thereof, with both the first impeller vane module and the second impeller vane module being their assembled configurations such that the impeller is fully assembled.
  • FIG. 20 is a plan view of the distal end of the fully assembled impeller shown in Figs. 18 & 19.
  • FIG. 21 is a side elevation view of the blood pump of Fig. 4 with the fully assembled impeller shown in Figs. 18 & 19.
  • FIG. 22 is a side elevation view of the blood pump of Fig. 4, similar to Fig. 21, but with the housing of the drive unit and the control cable being shown as transparent.
  • FIG. 23 is a schematic view of the distal end of the first control wire and the interior of the first impeller vane unit.
  • a mammalian body implantable fluid flow influencing device 100 which is one embodiment of the present technology. It is to be expressly understood that the device 100 is merely one embodiment, amongst many, of the present technology. Other embodiments are also described hereinbelow. Thus, the description thereof that follows is intended to be only a description of illustrative examples of the present technology. This description is not intended to define the scope or set forth the bounds of the present technology. In some cases, what are believed to be helpful examples of modifications to the device 100 and/or other embodiments may also be set forth hereinbelow. This is done merely as an aid to understanding, and, again, not to define the scope or set forth the bounds of the present technology.
  • Device 100 is a percutaneously transcatheterly implantable intravascular blood pump, which may be used as a ventricular assist device (a “VAD”).
  • VAD ventricular assist device
  • percutaneously transcatheterly implantable intravascular blood pumps are well known in the art.
  • device 100 has the following major components: an axial impeller 104, a drive unit 120, and an anchor 126.
  • Device 100 also has a control cable 134 extending proximally from the proximal end of the drive unit 120, and a proximal end unit 136 at the proximal end of the control cable 134.
  • a control cable 134 extending proximally from the proximal end of the drive unit 120, and a proximal end unit 136 at the proximal end of the control cable 134.
  • the device 100 being a percutaneously trans catheterly implantable intravascular blood pump, in use, when appropriately implanted within the vasculature of a patient, is operable to increase the patient’s native blood flow rate.
  • the device is employed as a VAD or a cardiac assist device in cases where the patient’s heart is unable to pump a sufficient amount of blood on its own to provide enough blood flow to their peripheral organs (in the case of the left heart) or to their lungs (in the case of the right heart).
  • the impeller 104 of the device 100 has a central hub 105 and two vanes 114a, 114b projecting outward from the hub 105.
  • the impeller 104 is considered axial impeller, in view of its overall dimensions and as the fluid being pumped by the impeller is pushed by the vanes generally in a direction parallel to the longitudinal axis of the impeller 104 (e.g., an axis colinear with the longitudinal axis 138 of the device 100 - hereinafter, for ease of understanding, the longitudinal axes of the impeller 104, the device 100, the impeller hub module 106, and the impeller hub 105 are all colinear in this embodiments and are all thus labeled as 138).
  • the entirety of the flow fluid generated by axial impellers is not axial, there is some radial component.
  • the presence of such radial component is generally tolerable and does not mean that the impeller in question is not an axial impeller.
  • Impeller 104 is a modular impeller. Thus, impeller 104 is made of different modules that are separate structures from one another, but that are combinable together (e.g, assemblable) in vivo to make a complete, fully operational impeller 104. In Figs. 18 and 19, the assembled fully-operational impeller 104 is shown. In this embodiment, the impeller 104 has three separate modules, one impeller hub module 106 and two impeller vane modules (i.e., a first impeller vane module 110a and a second impeller vane module 110b).
  • the impeller hub module 106 is shown by itself in Fig. 6. As can be seen in Fig. 6, the impeller hub module 106 is elongate body generally having the form of a right circular cylinder. Thus, a cross-section of the impeller hub module 106 taken in a plane perpendicular to the longitudinal axis 138 would be a circle were it not for the present of the impeller hub module connectors 150a, 150b (described hereinbelow); and, this is the case for cross-sections taken anywhere along the longitudinal axis 138 (in this embodiment).
  • the impeller hub module has a distal end 148 and a proximal end 166.
  • distal and proximal are defined with respect to the location at which the surgeon is accessing the vasculature of the of the patient into which the device is being implanted. Thus, “distal” is further from the surgeon, and “proximal” is closer to the surgeon.
  • the distal end of a component enters the body of the patient before the proximal end in this embodiment.
  • the impeller hub module 106 has two impeller hub module connectors, a first impeller hub module connector 150a associated with the first impeller vane module 110a and a second impeller hub connector 150b associated with the second impeller vane module 110b.
  • first impeller hub module connector 150a and the second impeller hub module connector 150b are identical. (This is not the case in all embodiments, as in some embodiments each of the impeller hub module connectors are not identical.)
  • each impeller hub module connector 150a, 150b is accessible and viewable from the exterior of the impeller hub module 106.
  • Each impeller hub module connector 150a, 150b has a channel 152a, 152b that extends parallel to the longitudinal axis 138 of the device 100 (and the longitudinal axis 138 of the impeller hub module 106 itself).
  • each channel 152, 152b is generally circular in cross section (albeit with a small arc missing), as can be seen in Fig. 6.
  • the ends 155a, 157a of the missing arc the plane perpendicular to the longitudinal axis 138, when joined together by a line 159a, form a segment of the circle in that plane that has a length that is less than the diameter of that circle.
  • Each channel 152a, 152b has a proximal end (not labelled) at the proximal end 166 of the impeller hub module 106 and a distal end (not labelled) at the distal end 148 of the impeller hub module 106.
  • Each proximal end is a “wall” (e.g., a generally planar surface) 160a, 160b that is perpendicular to the longitudinal axis 138.
  • a passage 164a, 164b through a control wire 116a, 116b (respectively) will pass - as is described in further detail below) and the cavity 162a, 162b of a secondary connector 189a, 189b which will also be described hereinbelow.
  • each channel 152a, 152b is an opening 154a, 154b.
  • the distal opening 154a, 154b of each channel 152a, 152b are sloped as they extend through the tapered portion 146.
  • Each channel 152a, 152b thus forms a socket of a dovetail joint, as is further described hereinbelow.
  • a longitudinally extending shelf 156a, 158a is extending on each side of each channel 152a, 152b, a longitudinally extending shelf 156a, 158a (on the sides of channel 152a), 156b, 158b (on the sides of channel 152b).
  • the impeller hub module 106 is made of titanium. In other embodiments, the impeller hub module 106 is made of any other suitable medical grade material (or combination of materials) including composites, metals, alloys or plastics (e.g., PEEK). The impeller hub module 106 is manufactured using conventional techniques appropriate to the material(s) of which it is made.
  • the first impeller vane module 110a is shown.
  • the second impeller vane module 110b is identical to the first impeller vane module 110a and thus, will not be specifically described herein. (In other embodiments this is not the case.)
  • the first impeller vane module 110a is an elongate structure having a proximal end 182a and a distal end 184a.
  • the first impeller vane module 110a has a base 112a, an impeller vane 114a projecting from the base 112a and a first impeller vane module connector 118a extending from the side of the base 112a opposite to that one from which the impeller vane 114a projects.
  • Each of the base 112a, the impeller vane 114a, and the first impeller vane module connector 118a extends the entire length of the impeller vane module 110a from the proximal end 182a to the distal end 184a in this embodiment.
  • the first impeller vane module connector 118a is generally a right circular cylinder portion 193a of which is connected to the base 112a of the first impeller vane module 110a.
  • a segment 195a of a cross-section of the circle 191a formed by the proximal end 182a wall 186a in a plane perpendicular the longitudinal axis 138 is formed by the line jointing the intersections (194a, 196a) of the circle 191a with the connecting portion 193a.
  • a passage 190a leading inside the connector 118a As will be discussed further below, the passage 190a is for the control wire 116a.
  • proximal end 182a wall 186a projecting proximally from the proximal end 182a wall 186a are detents 188a that form the part of a secondary connector 189a that is disposed on the first impeller vane module 110a.
  • distal end 184a has a sloped face 180a (with respect to the longitudinal axis 138)
  • the base 112a and the first impeller vane module connector 118a are dimensioned and shaped to complete the part of the hub 105 of the impeller hub module 106 that is “missing” because of the presence of the impeller hub module connector 150a.
  • the length of the first impeller vane module 110a is the same as the length of the first impeller hub module connector 150a.
  • the first impeller vane module connector 118a has a diameter just slightly smaller than the diameter of the channel 152a, and the length of the segment 159a is just slightly smaller than the length of the segment 195a.
  • the base 112a has a shape that conforms to both the shelves 156a, 158a and to the outer surface 140 of the impeller hub module 106.
  • the impeller vane modules 110a, 110b are each made of titanium. In other embodiments, the impeller vane modules 110a, 110b are made of any other suitable medical grade material (or combination of materials) including composites, metals, alloys or plastics (e.g, PEEK). The impeller vane modules 110a, 110b are manufactured using conventional techniques appropriate to the material(s) of which they are made.
  • Units of the device 100 to be implanted within the patient’s body are dimensioned and shaped to be deliverable through the vasculature of the patient’s body via a catheter (e.g., a delivery sheath 198).
  • a catheter e.g., a delivery sheath 198.
  • the maximum size of the catheter that may be used in a particular transcatheter procedure varies.
  • the surgeon has to select a catheter sized such that the catheter will pass through the minimum available cross-section of the blood vessels of the patient along the path to the delivery site.
  • the diameter of the minimum-bounding right circular cylinder of each one of those units can be no greater than 4 mm (its radius no greater than 2 mm).
  • the diameter of the minimum-bounding right circular cylinder of each one of the impeller vane modules 110a, 110b, the impeller hub module 106, and the motor housing 120 is slightly less than 4 mm, so they would be able to be used in the above exemplary procedure.
  • the diameter of the impeller 104, once assembled, will be larger than 4 mm, without being expendable.
  • the proximal end 182a of the first impeller vane module connector 118a of the first impeller vane module 110a is slidden into the channel 152a of the first impeller hub module connector 150a via the distal opening 154a at the distal end 148 of the impeller hub module 106.
  • the proximal end wall 186a at the proximal end of the first impeller vane module 110a registers completely with the proximal end wall 160a of the proximal end of the channel 152a.
  • the first impeller vane module connector 118a acts as the tail in the sliding dovetail connection (with, as was described above, the channel 152a of the first impeller hub connector module 106 acting as the socket). This arrangement results because the outer diameter of the right circular cylinder of the first impeller vane module connector 118a is greater than the length of the segment 159a. Thus, during normal operation of the device, when the impeller 104 is rotating, the first impeller vane module 110a can neither be pulled nor pushed away from its assembled configuration in a direction perpendicular to (or having a component that is perpendicular to) the longitudinal axial 134 of the impeller hub module 106.
  • the detents 188a of the secondary connector 189a on the first impeller vane module 118a are inserted into and releasably secured within the cavity 162a of the second connector 189a on the end wall 162a of the first impeller hub module connector 150a.
  • the first impeller vane module 110a cannot be slidden out of its assembled configuration either.
  • a portion 192a of the outer surface of the base 112a of the first impeller vane module is shaped to align with and complete the outer surface 140 of the impeller hub module 106, such that the impeller hub 105 (but for the vanes) has the shape of a right circular cylinder.
  • the sloped face 180a of the distal end 184a of the first impeller vane module 110a aligns with and completes the tapered portion 146 of the distal end 148 of the impeller hub module 106.
  • Each of the impeller vane modules 110a, 110b has a center of mass (not shown).
  • the impeller hub module 106 also has a center of mass (not shown), which is located along the longitudinal axis 138 of the impeller hub module 106.
  • the impeller vane modules 110a, 110b are designed (e.g, size, shape, materials of construction, vane design, etc.) such that when the first impeller vane module connector 118a is fully slidden into the channel 152a into its assembled configuration and when the second impeller vane module 118b is fully slidden into the channel 152b into its assembled configuration (e.g, in Figs.
  • the center of mass (not shown) of the assembled impeller 104 is located same location as (i.e., is coincident with) the center of mass of the impeller hub module 106.
  • the centers of mass of the impeller vane modules 110a, 110b are all equally angularly spaced (i.e., at 180° degrees from one another) around the axis of rotation (i.e., the longitudinal axis 138) of the impeller 104 in a plane perpendicular to the axis 138 containing the center of mass of the impeller hub module 106.
  • the centers of mass of the impeller vane modules 110a, 110b are equally radially distant from the axis 138 of the impeller hub module 106 in that plane. In this manner the impeller 104 will be mass balanced, which is optimal for its rotation.
  • the drive unit 120 has a housing 122 containing an electric motor 176 and a drive shaft 174.
  • the electric motor 176 drives the drive shaft 174
  • the drive shaft 174 drives the impeller 104.
  • the housing 122 an elongate generally right circular cylindrical in shape, having a diameter which is generally the same as the diameter of the impeller hub module 106 (and thus the hub 105 of the impeller 104).
  • the impeller hub module 106 and the drive unit 120 are connected together to form single implantable unit 102 (as they are implanted and explanted as a single unit in this embodiment).
  • control cable 134 At the proximal end 121 of the drive unit 120, extending proximally, is a control cable 134.
  • the control cable 134 is hollow, having a lumen 172 therein.
  • the lumen 172 communicates with the interior of the housing 122 containing the motor 176.
  • Electrical wiring 178 for providing electricity to power the motor 176 extends from the motor 176 through the cavity of the housing 122 and then through the lumen 172 of the control cable 134 to the proximal end unit 136 of the device 100, where the wiring can be put into electric communication with an appropriate power source.
  • the control cable 134 is of a conventional design.
  • anchor 126 is a wire network having a compact configuration and an expanded configuration.
  • the anchor 126 exerts a force on the walls of the conduit into which the device 100 has been implanted. That force is sufficient to anchor the device 100 in place within the conduit when the device is being assembled, disassembled, and operating normally.
  • the wire network is sized and dimensioned such that the impeller 104 is able to rotate during normal operation of the device 100 without contacting the wire network (or any other part of the anchor 126) nor the conduit itself.
  • the wire network 126 has three different groups of wires. It is the second group of wires 128 that abut up against the walls of the conduit into which the device has been implanted in order to secure the device 100 in place. As can be seen in the Figs., in this embodiment when the anchor 126 is in the expanded configuration the wires of the second group 128 generally surround the impeller 104.
  • wires of the first group 129 Proximal to the wires of the second group 128 are wires of the first group 129. At their distal end (unlabeled), wires of the first group 129 connect to and extend proximally from the wires of the second group 128. At their proximal end (unlabeled) wires of the first group 129 are connected to a metal band 124 that is non-moveably affixed to the housing 122 of the drive unit 102. The housing 122 of the drive unit 120 does not rotate when the device 100 is in operation and the impeller 104 is rotating.
  • wires of the third group 130 Distal to the wires of the second group 128 are wires of the third group 130. At their proximal end (unlabeled), wires of the third group 130 connect to and extend distally from the wires of the second group 128. At the distal end (unlabeled) wires of the third group 130 are connected to a metal band 132 that is non-moveably affixed to the distal tip body 108. The distal tip body 108, rotatably holds the distal spindle 168 of the impeller hub module 106, allowing the impeller 104 to rotate without rotating the distal tip body 108. Referring to Figs.
  • gaps 170a, 170b in the wires of the third group 130 that allow for the passage of the impeller vane modules 110a, 110b (respectively) from outside of the wire network of the anchor 126 to inside of the wire network of the anchor 126 as will be explained in further detail hereinbelow.
  • the anchor 126 is made of nitinol, which is a shape memory alloy. It is the “shape memory” of the nitinol which causes the bias of the wire network 126 of the anchor to its expanded configuration.
  • a first control wire 116a is attached to the first impeller vane module 110a and a second control wire 116b is attached to the second impeller vane module 110b.
  • the distal end 117a of the first control wire 116a enters the interior of the first impeller vane module 110a through the hole 190a in the proximal end wall 186a of the proximal end 182a of first impeller vane module 110a.
  • a magnet 200a which is in magnetic connection with magnet 202a within the interior of the first impeller vane module 110a.
  • the magnetic connection between magnet 200a and 202a releasably secures the distal end 117a of the first control wire 116a in place within the interior of the first impeller vane module 110a.
  • the first control wire 116a then extends proximally through the distal opening 154a into the channel 152a of the first impeller hub module connector 150a.
  • the first control wire 116a then enters the opening 164a in the wall 160a at the proximal end of the first impeller hub module connector 150a.
  • the first control wire 116a passes through a passage (not shown) which starts at the opening 164a in the wall 160a, passes through the body of the impeller hub module 106 and ends up at the very end of the proximal end 166 of the impeller hub module 106.
  • the first control wire 116a then passes through the housing 122 of the drive unit 120 (from its distal end 123 to its proximal end 121) and passes into the lumen 172 of the control cable 134.
  • the first control wire 116a finally passes through the control cable 134 and is accessible by the surgeon at the proximal end unit 136.
  • the distal end 117b of the second control wire 116b enters the interior of the second impeller vane module 110b through the hole 190b in the proximal end wall 186b of the proximal end 182b of second impeller vane module 110b.
  • a magnet 200b which is in magnetic connection with magnet 202b within the interior of the second impeller vane module 110b.
  • the magnetic connection between magnet 200b and 202b releasably secures the distal end 117b of the second control wire 116b in place within the interior of the second impeller vane module 110b.
  • the second control wire 116b then extends proximally through the distal opening 154b into the channel 152b of the second impeller hub module connector 150b.
  • the second control wire 116b then enters the opening 164b in the wall 160b at the proximal end of the second impeller hub module connector 150b.
  • the second control wire 116b passes through a passage (not shown) which starts at the opening 164b in the wall 160b, passes through the body of the impeller hub module 106 and ends up at the very end of the proximal end 166 of the impeller hub module 106.
  • the first control wire 116b then passes through the housing 122 of the drive unit 120 (from its distal end 123 to its proximal end 121) and passes into the lumen 172 of the control cable 134.
  • the second control wire 116b finally passes through the control cable 134 and is accessible by the surgeon at the proximal end unit 136.
  • Device 100 can be transcatheterly implanted and explanted using standard conventional techniques. (The WO ‘765 Publication provides a very detailed description of such techniques, and they are not repeated herein for the sake of brevity.).
  • the implantation of device 100 typically starts with device 100 being inside a loader.
  • Fig. 9 shows device 100 inside a delivery sheath 198 (being particular type of catheter), the device 100 when inside a loader would look essentially the same.
  • the distal end of the loader (198) is on the right of the figure and the proximal end of the loader (198) is on the left of the figure.
  • the second impeller vane module 110b closest to the distal end of the loader (198) is the second impeller vane module 110b.
  • the second impeller vane module 110b has the same orientation in the loader (198) as the device 100 itself.
  • the distal end 184b of the second impeller vane module 110b is closest to the distal end of the loader (198).
  • the second impeller vane module 110b is in an unassembled configuration with respect to the impeller hub module 106.
  • first impeller vane module 110a Immediately proximal to the second impeller vane module 110b in the loader (198) is the first impeller vane module 110a.
  • the first impeller vane module 110a has the same orientation in the loader (198) as the device 100 itself.
  • the distal end 184a of the first impeller vane module 110a is adjacent the proximal end 182b of the second impeller vane module 110b.
  • the second impeller vane module 110a is in an unassembled configuration with respect to the impeller hub module 106.
  • the single implantable unit 102 which combines the impeller hub module 106 and the drive unit 120.
  • the single implantable unit 102 has the same orientation in the loader (198) as the device 100 itself.
  • the distal end 148 of the impeller hub module 106 is adjacent the proximal end 182a of the first impeller vane module 110a.
  • the proximal end 121 of the drive unit 120 is closest to the proximal end of the loader (198).
  • the control cable 134 extends proximally from the proximal end 121 of the drive unit 120 to the proximal end unit 136.
  • the wire network anchor 126 is in its collapsed configuration within the loader (198).
  • the second control wire 116b extends from the proximal end 182b of the second impeller vane module 110b, passes by the first impeller vane module 110a, passes into the channel 152b of the second impeller hub connector 150b of the impeller hub module 106, extends through the housing 122 of the drive unit 120, enters the lumen 172 of the control cable 134 and extends to the proximal end unit 136 of the device 100.
  • the first control wire 116a extends from the proximal end 182a of the first impeller vane module 110a, passes into the channel 152a of the first impeller hub connector 150a of the impeller hub module 106, extends through the housing 122 of the drive unit 120, enters the lumen 172 of the control cable 134 and extends to the proximal end unit 136 of the device 100.
  • the delivery site of the device 100 may be within thoracic descending aorta.
  • the device 100 can be implanted by the surgeon in the following manner by: (1) Obtaining access to the femoral artery of the patient (e.g, via the well-known Seidinger technique). (2) Guiding a delivery sheath 198 to the delivery site (e.g, using a conventional guidewire and railing the delivery sheath 198 along the guidewire).
  • Promoting exit of the impeller vane modules 110b, 110a from the delivery sheath 198 at the delivery site e.g, by partially withdrawing the delivery sheath 198 while keeping the impeller vane modules 110b, 110a in place (e.g, via their control wires 116b, 116a).
  • Promoting exit of the single implantable unit 102 from the delivery sheath 198 at the delivery site In the embodiment of the device 100 described above, this causes the wire network anchor 126 to adopt its expanded configuration, anchoring the single implantable unit 102 (of which the impeller hub module 106 is a part) in place.
  • Withdrawing the delivery sheath 198 from the body e.g, by partially withdrawing the delivery sheath 198 while keeping the impeller vane modules 110b, 110a in place (e.g, via their control wires 116b, 116a).
  • the impeller 104 of the device 100 is assembled in vivo at the delivery site.
  • Fig. 10 illustrates the configuration of the device 100 just after delivery as described hereinabove. The surgeon then manipulates the first control wire 116a of the first impeller vane module 110a to bring the first impeller vane module 110a into its assembled configuration with respect to the impeller hub module 106. As can be well seen in Figs.
  • gaps 170a, 170b are formed in the wires of the third group 130 that allow for the passage of the impeller vane modules 110a, 110b (respectively) from outside of the wire network of the anchor 126 to inside of the wire network of the anchor 126.
  • the surgeon pulls the first control wire 116a of the first impeller vane module 110a to move the first impeller vane module 110a from a position outside of and distal to the wire network of the anchor 126 to a position where the first impeller vane module 110a starts to move through the gap 170a and starts to slide into its assembled configuration.
  • the right circular cylinder portion 193a of the first impeller vane module connector 118a enters the opening 154a of the channel 152a of the first impeller hub module connector 150a.
  • the first impeller vane module 110a continues to slide closer to the proximal end wall of 160a of the first impeller hub module connector 150a.
  • the right circular cylinder portion 193a of the first impeller vane module connector 118a continues to travel within the channel 152a of the first impeller hub module connector 150a.
  • first impeller vane module 110a is in its assembled configuration with respect to the impeller hub module 106.
  • the first impeller vane module 110a is retained in its assembled configuration as a result of the dovetail joint formed by the right circular cylinder portion 193a of the first impeller vane module connector 118a and the channel 152a of the first impeller hub module connector 150a, and as a result of the detent 188a of the secondary connector 189a being retained in the cavity 162a.
  • the surgeon manipulates the second control wire 116b of the second impeller vane module 110b to bring the second impeller vane module 110b into its assembled configuration with respect to the impeller hub module 106.
  • gaps 170a, 170b are formed in the wires of the third group 130 that allow for the passage of the impeller vane modules 110a, 110b (respectively) from outside of the wire network of the anchor 126 to inside of the wire network of the anchor 126.
  • the surgeon pulls the second control wire 116b of the second impeller vane module 110b to move the second impeller vane module 110b from a position outside of and distal to the wire network of the anchor 126 to a position where the second impeller vane module 110b starts to move through the gap 170b and starts to slide into its assembled configuration.
  • the right circular cylinder portion 193b of the second impeller vane module connector 118b enters the opening 154b of the channel 152b of the second impeller hub module connector 150b.
  • the surgeon continues to pull the second control wire 116b, the second impeller vane module 110b continues to slide closer to the proximal end wall of 160b of the second impeller hub module connector 150b.
  • the right circular cylinder portion 193b of the second impeller vane module connector 118b continues to travel within the channel 152b of the second impeller hub module connector 150b.
  • the detent 188b of the secondary connector 189b projecting from the proximal end wall 186b enters the cavity 162b of the secondary connector 189b and is releasably retained therein.
  • the proximal end wall 186b of the proximal end 182b of the second impeller vane module 110b completely abuts the proximal end wall 160b of the second impeller hub connector 150b.
  • second impeller vane module 110b is in its assembled configuration with respect to the impeller hub module 106.
  • the second impeller vane module 110b is retained in its assembled configuration as a result of the dovetail joint formed by the right circular cylinder portion 193b of the second impeller vane module connector 118b and the channel 152b of the second impeller hub module connector 150b, and as a result of the detent 188b of the secondary connector 189b being retained in the cavity 162b.
  • magnet 200a becomes disconnected from magnet 202a.
  • the distal end 117a of the first control wire 116a including magnet 200a are now within the housing 122 of the drive unit 120 at the distal end 123 of the drive unit 120.
  • the distal end 117a of the first control wire 116a including magnet 200a remain in that position, completely clear of the impeller 104, during operation of the impeller 104.
  • the impeller 104 is thus free to rotate without interference from the first control wire 116a and magnet 200a.
  • the surgeon pulls on the second control wire 116b with sufficient force to overcome the magnetic connection holding the second control wire 116a in place within the interior of the second impeller vane module 110b.
  • magnet 200b becomes disconnected from magnet 202b.
  • the surgeon continues to pull the second control wire 116b until the distal end 117b of the second control wire 116b including magnet 200b have exited the passage at the proximal end 166 of the impeller hub module 106.
  • the distal end 117b of the second control wire 116b including magnet 200b are now within the housing 122 of the drive unit 120 at the distal end 123 of the drive unit 120.
  • the distal end 117b of second the control wire 116b including magnet 200b remain in that position, completely clear of the impeller 104, during operation of the impeller 104.
  • the impeller 104 is thus free to rotate without interference from the second control wire 116b and magnet 200b.
  • the device 100 In explantation of the device 100, the device 100 is first disassembled, by reversing the assembly process described above. Once the device has been disassembled it is conventionally retrieved using snare and a retrieval sheath as described in the WO ‘765 Publication.
  • the term “and/or” is to be taken as specific disclosure of each of the two 10 specified features or components with or without the other.
  • a and/or B is to be taken as specific disclosure of each of (i) A, (ii) B and (iii) A and B, just as if each is set out individually herein.

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

Abstract

Dispositif influençant un écoulement de fluide pouvant être implanté dans un corps de mammifère, comprenant une pale modulaire ayant : un module moyeu de pale dimensionné et mis en forme pour pouvoir être administré au niveau d'un site d'administration à l'intérieur d'une conduite d'un système de conduite du corps de mammifère par l'intermédiaire d'un cathéter. Un module vanne de pale ayant au moins une portion d'une vanne de pale ; ayant, par rapport au module moyeu de pale, une configuration assemblée dans laquelle le module vanne de pale s'accouple au module moyeu de pale, et une configuration non assemblée, dans laquelle le module vanne de pale n'est pas accouplé au module moyeu de pale et étant dimensionné et mis en forme pour pouvoir être administré au site d'administration par l'intermédiaire des cathéters lorsqu'il se trouve dans la configuration non assemblée. La pale modulaire est formée lorsque le module vanne de pale est retenu dans sa configuration assemblée, et dimensionnée et mise en forme pour pouvoir fonctionner à l'intérieur d'au moins une conduite du système de conduite. Est divulgué un procédé d'implantation.
PCT/CA2021/050469 2019-10-05 2021-04-08 Dispositif influençant un écoulement de fluide pouvant être implanté dans un corps de mammifère WO2022094690A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US17/712,789 US20230056440A1 (en) 2019-10-05 2022-04-04 Mammalian body implantable fluid flow influencing device

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US202063109846P 2020-11-04 2020-11-04
US63/109,846 2020-11-04
CAPCT/CA2020/051677 2020-12-05
PCT/CA2020/051677 WO2021062566A1 (fr) 2019-10-05 2020-12-05 Système de turbine modulaire pour circulation de fluide
IBPCT/IB2021/052465 2021-03-25
IBPCT/IB2021/052465 2021-03-25

Related Parent Applications (1)

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IBPCT/IB2021/052465 Continuation 2019-10-05 2021-03-25

Related Child Applications (1)

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US17/712,789 Continuation US20230056440A1 (en) 2019-10-05 2022-04-04 Mammalian body implantable fluid flow influencing device

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WO2022094690A1 true WO2022094690A1 (fr) 2022-05-12

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130204362A1 (en) * 2010-07-15 2013-08-08 Ecp Entwicklungsgesellschaft Mbh Blood pump for the invasive application within a body of a patient
US20140275726A1 (en) * 2013-03-15 2014-09-18 Thoratec Corporation Catheter pump assembly including a stator
US20150306291A1 (en) * 2014-04-25 2015-10-29 Yale University Percutaneous Device and Method for Promoting Movement of a Bodily Fluid

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130204362A1 (en) * 2010-07-15 2013-08-08 Ecp Entwicklungsgesellschaft Mbh Blood pump for the invasive application within a body of a patient
US20140275726A1 (en) * 2013-03-15 2014-09-18 Thoratec Corporation Catheter pump assembly including a stator
US20150306291A1 (en) * 2014-04-25 2015-10-29 Yale University Percutaneous Device and Method for Promoting Movement of a Bodily Fluid

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