Percutaneous Endovascular Centrifugal Heart Pump and Method

Percutaneous heart pump that has centrifugal flow and valve conduit allowing flow in one direction. The present invention is a miniaturized percutaneous endovascular centrifugal pump that incorporates an expandable uniflow valve conduit with valves, a centrifugal impeller, a shaft, a guidewire, a deliverable sheath and extracorporeal couplings to an infusion pump and motor.

FIELD OF THE INVENTION

The present invention relates to a percutaneous endovascular centrifugal heart pump to support the failing heart as a bridge to recovery or during high-risk cardiac interventions.

BACKGROUND OF THE INVENTION

Pumps have been around for centuries. The first rotary pump dates back to Archimedes' screw pump (250 B.C.), used to displace fluid from a lower to a higher plane. The first centrifugal pump was introduced for mud lifting in 1475 in a treatise by Francesco di Giorgio Martini. The physics of pump flow and mathematical interpretation were explained by Daniel Bernoulli and Leonhard Euler in the 1700s who derived the velocity triangles used still today to calculate pump flow.

Pumps are classified as displacement and rotary pumps. Displacement pumps produce intermittent flow with periodic energy transfer; rotary pumps generate continuous flow with energy transfer due to impeller velocity. There are three classical rotary pumps: centrifugal, axial, and mixed flow. Axial pumps use a propeller to advance the fluid's mass on the same axis as the initial flow. Centrifugal pumps generate flow by applying the angular momentum principle to the fluid's mass through the impeller passages advancing the mass of fluid radially. A mixed flow pump uses a combination of centrifugal and axial.

In medicine, displacement pumps have applications for hemodialysis and heart and lung machines. The Jarvik and HeartMate II left ventricular assist devices (LVAD) use axial pumps; the HeartMate III and HeartWare (LVADs) use centrifugal pumps. Dr. Richard Wampler developed the HemoPump (1985), the first percutaneous axial flow pump for supporting the human heart inspired by the Archimedes screw pump. This work was advanced through individuals such as Dr. Helmut Reul and Dr. O. H. Frazier, which led to the development of the Impella device by Thorsten Sieb.

It took almost 60 years of work in the medical field to learn and accept that the human body can function without a pulse. Despite all these efforts, there is still a lot more progress to be made and innovate in this field.

There is a societal need for a low-profile or miniature percutaneous mechanical circulatory support (mPMCS) to treat patients with small or diseased femoral arteries. The main problems with prior art PMCS are sheath size and the impeller rotational speed necessary to generate adequate flow. The AbioMed Impella™ has an outer diameter of 18F (6 mm), increasing the difficulty of accessing the femoral artery. This large catheter is problematic in patients with small access points, tortuous or calcified vessels increasing the risk of complications such as bleeding, tears, dissection, total occlusion, transections, spasms, or embolic events.

The sheath size required to introduce the PMCS is a limiting factor for vessel access and pump performance. The current smallest available device has a sheath size of 6 mm (O.D.) diameter for 2.5 Impella™ (2.5 L/min) and the CP Impella™ (3 L/min) device and for 5.0 Impella™ device (5 L/min), it is recommended the 10 mm diameter HemoShield for vascular access. This sheath size creates a problem because the average common femoral artery diameter is 6.6 mm (3.9 to 8.9 mm). The Impella™ device has a sheath with approximately the same diameter size as the access vessel. Additionally, the 5.0 Impella™, due to its profile, percutaneous insertion is rarely done. The introduction of these large cannulas may jeopardize blood flow, causing lactic acidosis, limb ischemia, and amputations.

Furthermore, large sheaths have flexion difficulties conforming to the human anatomy, especially in tortuous arteries, increasing the stress applied at the vessel's arterial walls, thus leading to complications. For example, the friction produced by the large sheath can dislodge calcium in the artery and the aorta, which can embolize to the heart, limb, kidney, or the brain causing a heart attack, limb ischemia, renal infarct, or stroke in the patient, respectively. Thus, not all patients are candidates for the smallest available device due to the anatomical reasons explained above. Another concern that is a limiting factor is the vessel tortuosity (FIG.1). This tortuosity is a risk factor for vessel damage when advancing a large sheath. The presence of heavily calcified vessels may cause calcium embolization when advancing the large device. An additional concern is the curvature of the aortic arch and the difficulty of advancing a large sheath catheter without interacting with the aortic wall (FIG.3).

The present invention satisfies these needs by providing the first miniaturized endovascular percutaneous centrifugal pump in the medical field.

SUMMARY OF THE INVENTION

The present invention comprises a small insertion profile, housing the valve conduit, shaft, impeller, stator, and guidewire, all inside an 8F-12F (French) sheath. The present invention expands to 10-20 mm during operation, which allows lower impeller speeds of 4,000 to 25,000 RPMs-3 to 6 times lower rotational speeds than current ventricular assist devices (33,000-57,000 RPM). Furthermore, the present invention provides low blood velocities (0.54 m/s) while still generating up to 5 L/min across the uniflow valve conduit; 12 times lower velocities than current technologies (6.25 m/s). This helps minimize blood cell trauma.

The present invention will be the first percutaneous endovascular centrifugal heart pump in the market, providing cardiologists a low-profile device that would facilitate insertion, maneuverability in the human-body minimizing damage to the vessels and complications. Patients who previously were not considered candidates due to vessel size would have access to this therapy.

The present invention fills the unmet need offering a true-low profile device by providing access to patients who currently do not have an option due to their small arteries. The present invention will be 36% smaller in diameter, and it will pump up to 5 L/min at lower rotational velocities.

The reduction in impeller speed and increased valve conduit diameter will lower blood cell damage and facilitate the insertion and advancement of the present invention in patients with tortuous and small vessels who do not qualify for heart support with available technology. The present invention will support the heart to restore cardiac function, giving the patient's heart time to recover. Thus, decreasing the progression to an end-stage heart disease with a medical and economical direct impact.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Characteristics and advantages of the present disclosure and additional features and benefits will be readily apparent to those skilled in the art upon consideration of the following detailed description of exemplary embodiments of the present disclosure and referring to the accompanying figures. It should be understood that the description herein and appended drawings, being of example embodiments, are not intended to limit the claims of this patent or any patent or patent application claiming priority hereto. On the contrary, the intention is to cover all modifications, equivalents and alternatives falling within the spirit and scope of the claims. Changes may be made to the particular embodiments and details disclosed herein without departing from such spirit and scope.

In showing and describing preferred embodiments in the appended figures, common or similar elements are referenced with like or identical reference numerals or are apparent from the figures and/or the description herein. The figures are not necessarily to scale and certain features and certain views of the figures may be shown exaggerated in scale or in schematic in the interest of clarity and conciseness.

As used herein and throughout various portions (and headings) of this patent application, the terms “disclosure”, “present disclosure” and variations thereof are not intended to mean every possible embodiment encompassed by this disclosure or any particular claim(s). Thus, the subject matter of each such reference should not be considered as necessary for, or part of, every embodiment hereof or of any particular claim(s) merely because of such reference.

The term “coupled” and the like, and variations thereof, as used herein and in the appended claims are intended to mean either an indirect or direct connection or engagement. Thus, if a first device couples to a second device, that connection may be through a direct connection, or through an indirect connection via other devices and connections.

The use of the terms “a” and “an” and “the” and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Further, it should be noted that the terms “first,” “second,” and the like herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another.

Certain terms are used herein and in the appended claims to refer to particular components. As one skilled in the art will appreciate, different persons may refer to a component by different names. This document does not intend to distinguish between components that differ in name but not function.

Also, the terms “including” and “comprising” are used herein and in the appended claims in an open-ended fashion, and thus should be interpreted to mean “including, but not limited to . . . ” Further, reference herein and in the appended claims to components and aspects in a singular tense does not necessarily limit the present disclosure or appended claims to only one such component or aspect, but should be interpreted generally to mean one or more, as may be suitable and desirable in each particular instance.

Preferred embodiments of the present disclosure thus offer advantages over the prior art and are well adapted to carry out one or more of the objects of this disclosure. However, the present disclosure does not require each of the components and acts described above and are in no way limited to the above-described embodiments or methods of operation. Any one or more of the above components, features and processes may be employed in any suitable configuration without inclusion of other such components, features and processes. Moreover, the present disclosure includes additional features, capabilities, functions, methods, uses and applications that have not been specifically addressed herein but are, or will become, apparent from the description herein, the appended drawings and claims.

The suffix “(s)” as used herein is intended to include both the singular and the plural of the term that it modifies, thereby including at least one of that term (e.g., the colorant(s) includes at least one colorants). “Optional” or “optionally” means that the subsequently described event or circumstance can or cannot occur, and that the description includes instances where the event occurs and instances where it does not. As used herein, “combination” is inclusive of blends, mixtures, alloys, reaction products, and the like.

Referring toFIG.1, the percutaneous endovascular centrifugal heart pump300is used to support the heart, including both the left side and the right side of the heart. As used herein, the term “percutaneous endovascular centrifugal heart pump300” may be referred to herein simply as “heart pump300” or “pump300.” The application is directed through the motion of fluid from one location to another to support the human heart, providing blood supply to the body at a time when the native human heart is weak. Pump300may be introduced to the human body through the arterial system-arterial percutaneous endovascular centrifugal heart pump300a, or through the venous system-venous percutaneous endovascular centrifugal heart pump300b. As used herein, the term “arterial percutaneous endovascular centrifugal heart pump300a” may be referred to herein simply as “arterial heart pump300a” or “heart pump300a” or “arterial pump300a.” Similarly, as used herein the term “venous percutaneous endovascular centrifugal heart pump300b” may be referred to herein simply as “venous heart pump300b” or “heart pump300bor venous pump300b.”

Percutaneous heart pumps have a dichotomy—a smaller profile percutaneous heart pump may facilitate insertion and target a larger population; however, this leads to higher impeller speeds and flow velocity which may cause blood cell damage. On the other hand, larger percutaneous heart pumps have a difficulty in insertion and limits the population; however, these pumps may have lower impeller speeds, lower blood velocity, and minimize blood cell damage.

Table 1 below is a comparison between Impella CP [AbioMed, “Impella® 2.5, 5.0, LD and Impella CP® INSTRUCTIONS FOR USE & CLINICAL REFERENCE MANUAL for Use During Cardiogenic Shock Impella Ventricular Support Systems,” 2016 manufactured by AbioMed Company of Danvers, MA. www.abiomed.com.] and the present invention.

Thus, the present invention—the percutaneous endovascular centrifugal heart pump300—solves this dichotomy by having a small insertion profile with the ability to operate at a larger profile. This targets a larger population by facilitating insertion access to the human body, and at the same time offers lower impeller speeds minimizing blood cell damage to the patient.

Preliminary results of the percutaneous endovascular centrifugal heart pump300, show an output flow rate of 13 L/minute with zero head pressure and a flow rate of 9.5 L/minute with a head pressure of 80 mmHg.

Referring now toFIGS.2a-2g, one of the components that make up the percutaneous endovascular centrifugal heart pump300is the impeller204. Impeller204is cut from a single sheet and or tube of smart material such as Nitinol (FIG.2aandFIG.2b). The diameter tube can range between about 1.5 mm to about 5 mm, preferably about 2.5 mm.

Impeller204includes an inner wall203, impeller outflow end205, and impeller inflow end209. Impeller204includes a plurality of levels, such as a top-level vane200, mid-level vanes201, and lower-level vanes202. Referring toFIG.2c, the vanes are shape set to form. The Nitinol's austenite transformation finish temperature, Af, can range between about 10 C to about 40 C, preferably between about 5 C and about 20 C.

At each level there are two vanes spaced 180 degrees apart. Referring toFIG.2d, top-level vane200includes two vanes200a/200b, the mid-level201includes two vanes201a/201b, and lower-level202includes two vanes202a/202b. The tilted angulation of each vane from the horizontal plane may be in the range of 15 degrees to 65 degrees, preferably 35 degrees. This allows the diameter of impeller204to be between about 8 mm and about 20 mm, preferably about 14 mm.

Furthermore, each level of vanes shifted in proportion to the number of levels of impeller204includes. Thus, following the constitutive equation:

Where α is the insertion displacement or offset in degrees that each level will have from the previous vane insertion in degrees and L is the number of levels impeller204includes. For example, referring toFIGS.2cand2e, impeller204with three (3) levels results in 60 degrees angular displacement when viewed from the top view (180divided by 3) (FIG.2e). Thus, the angle between top-level200aand mid-level201ais 60 degrees, and the angle between mid-level201aand lower-level202ais also 60 degrees. The expanded state of impeller204can range between about 9 mm and about 22 mm, preferably about 15 mm.

The impeller204can return the vanes to the closed position when the device is resheathed as shown inFIG.2a. That is, impeller204top-level vanes200will close to couple with top-level surface206, mid-level vanes201will close to couple with mid-level surface207, and lower-level vanes202will close to couple with lower-level surface208.

Impeller204design is one of the features that permits percutaneous endovascular centrifugal heart pump300to function between about 4,000 RPMs and about 25,000 RPMs, preferably about 10,000 RPMs permitting it to pump more than about 5 L/min.

Referring toFIGS.2fand2g, Impeller204may include arterial slots210a/210bfor entry through the arterial system and venous slot211a211bfor entry through the venous system.

The impeller204may also include a coating that can be hydrophobic or hydrophilic to minimize blood clot formation.

The impeller204may also include drug eluting capabilities to incorporate medication such as heparin to minimize blood clot formation.

Frame

Referring now toFIGS.3a-3d, percutaneous endovascular centrifugal heart pump300includes frame303. Frame303is manufactured from a single tube of smart material, such as Nitinol, having a diameter between about 1 mm to about 5 mm, preferably between about 2 mm and about 3 mm. Frame303includes outflow section313and inflow section314. Frame303may include one or two slits337to facilitate the insertion of a mandrel for shape setting frame303and for assembly (FIGS.3c-d). Frame303can be shape-set (FIG.3b), with an Af temperature that can range between about 10 C to about 35 C, preferably between about 15 C and about 20 C.

In its expanded state frame303may have a plurality of diameters. Referring toFIG.3b, frame303may comprise three different diameters: top-section316, mid-section317, and lower-section318. Top-section316may have an expanded diameter between about 10 mm and about 26 mm, with a preferred diameter of about 20 mm. Mid-section317may have an expanded diameter between about 9 mm and about 20 mm, with a preferred diameter of about 15 mm. Lower-section318may have an expanded diameter between about 10 mm and about 26 mm, with a preferred diameter of about 18 mm. These variations in diameters form valve anchors311/312. Top valve anchor311is designed to attach to the upper section of the native leaflet and the lower valve anchor312is designed to attach to the lower section of the native heart valve leaflet. This design permits frame303to self-anchor. Anchors311/312aid in stabilizing the percutaneous endovascular centrifugal heart pump300during positioning and operation. These diameters are larger than prior art devices, and as a result, serve to more securely anchor the frame to the native valves leaflets prohibiting premature release or dislodgement.

In view of the design and the material used as discussed herein, the present invention provides for a small diameter percutaneous endovascular centrifugal heart pump during installation (between about 3 and about 4 mm-see Table 1 above) yet provides that the frame303can expand to preferably three different ranges of diameters depending on its top-section316, mid-section317, and lower-section318as noted above. This expansion is a significant improvement over the prior art by providing enhanced anchor points to the native valve leaflets as noted herein.

Thus, by selecting smart material, such as Nitinol, instead of a polymer as commonly used by the prior art, the present invention can be designed and shaped as discussed herein to be a small diameter yet once unsheathed, it can expand to the enhanced diameters for the three sections of the frame providing a firm anchor to the native leaflets and enhanced impeller size for improved flow within the within the valve conduit301as discussed herein.

Nitinol is known as a smart material or SMM or SMT. Nitinol is a nickel and titanium alloy and is used in the manufacture of vascular stents. The material is originally shaped into a predetermined form and then compressed and held in place by a sheath, for example. After it is placed in the desired location within the human body the sheath or other compressing means such as a wound wire is removed. The heat of the body then returns the material to its original shape.

Thus, in the present invention, frame303is initially shaped into a predetermined shape as shown for example inFIG.3bor3dto include anchoring points311/312. It is then constricted or compressed and held in place as described herein and shown inFIGS.3aand3c. as described herein. Once heart pump300aor300bis positioned at the desired location within the heart, it is unsheathed and frame303is permitted to expanded to its predetermined shape having previously shaped anchor points311/312. Frame303may include also include drug eluting capabilities to incorporate medication such as herapin to minimize blood clot formation.

Arterial Percutaneous Endovascular Centrifugal Heart Pump Overview

Referring now toFIGS.4aand4b, heart pump300aincludes stator310, internal shaft308, impeller204, frame303, shaft stabilizer304, and insertion tip305. During the operation of the present invention, impeller204and shaft308rotate, while the remaining components (stator310, frame303, shaft stabilizer304, insertion tip305) do not rotate. Stator310is attached to frame303and frame is attached to insertion tip305by bonding agent and or mechanical attachment. The bonding agent such be medical grade epoxy.

Referring now toFIGS.5aand5b, an impeller junction306is attached at each of its ends to impeller204and shaft308. Impeller junction306includes two channels328a/328bthat insert along the impeller slots210a/210bof the impeller204. As such, impeller junction channels328a/328bcan provide guidance in the insertion of impeller204and aid in the transmission of rotational force to impeller204. Furthermore, in the event the bonding of impeller204to shaft308fails, the impeller junction channels may act as a fixing mechanism to impeller204.

Referring now toFIGS.5a,5band6, the insertion of impeller204to shaft308is done by sliding the impeller outflow end205to the shaft distal end325all the way until it reaches the impeller junction306and the impeller junction channels328a328bare aligned and inserted with the impeller slots210a210b.

Referring now toFIGS.3a-3d,4a,4b,5a,5b. and6, frame303may have one or two slits337on either end, inflow section314, and outflow section313allowing insertion of shaft308with impeller204for assembly. Frame303is attached to the stator310by bonding outflow section313to the distal end of stator310. Furthermore, shaft stabilizer304is placed by inserting the distal end325in the shaft stabilizer entrance333. The shaft stabilizer304is then attached to the frame303by bonding the frame's inflow section314to the shaft stabilizer frame attachment335.

Referring toFIGS.5a-5band6, shaft stabilizer304has heat and fluid dissipation ports in the proximal331a/331band in the distal332a/332b. These ports may facilitate heat transfer and minimize stagnant flow between shaft308and shaft stabilizer304. The shaft stabilizer heat dissipation proximal ports331a/331bmay be spaced 180 degrees apart. Furthermore, distal ports332a/332bmay also be spaced 180 degrees for the shaft stabilizer heat dissipation. The longitudinal spacing between ports331a/331band ports332a/332bmay range between about 5 mm and about 50 mm, preferably about 18 mm. The diameter of ports331a/331band332a/332bmay range between about 0.10 mm and about 3 mm, preferably about 1 mm.

FIG.7aillustrates a side view of arterial heart pump300ahaving stator310, valve conduit301, valve conduit valves302, frame303, and insertion tip305.

Referring now toFIGS.8aand8b, arterial heart pump300ais illustrated showing the interactions of stator310, shaft308, impeller204, frame303, insertion tip305, shaft stabilizer304, valve conduit301, valve conduit valves302a. Frame303is attached to shaft stabilizer frame attachment335. Shaft308is inside the shaft stabilizer inner wall336. Shaft308is not fixed to the shaft stabilizer304and or the insertion tip305. Shaft outer wall321and inner wall336of the shaft stabilizer forming an annular gap334. Shaft stabilizer304has a clearance of between about 0.10 mm and about 1 mm between shaft stabilizer inner wall336and shaft outer wall321. Shaft308includes an inner lumen315, which allows a guidewire to pass through. The guidewire may exit inner lumen315at the insertion tip inner lumen309.

FIGS.9a-9cillustrate the side view, front side view, right side view of the arterial percutaneous endovascular centrifugal heart pump300a. As shown,300ahas stator310that is attached to frame303and contains valve conduit301, valves302a/302b/302c, frame303, insertion tip305, and shaft stabilizer304. Valve conduit301may be made from biological material and synthetic material. Biological material such as ovine, bovine, or porcine pericardium is illustrated inFIGS.9-11. Synthetic material may be Polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), silicone, Polyethylene, polyurethane, and Nylon.

Referring still toFIGS.9-11, valve conduit301may have a thickness that can range from about between 0.01 mm and 0.30 mm, preferably about 0.05 mm. Valve conduit301may be placed on the outside of frame303, on the inside of frame303, or on the outside and inside of frame303. Valve conduit301may adapt to the geometry of frame303, maintaining top section316and frame midsection317anchored at311and312.

During insertion sheath504keeps valve conduit301, valve conduit valves302a/302b302c, frame303, and impeller204in a collapsed state. When sheath504is retracted, valve conduit301, valve conduit valves302a/302b/302c, frame303, and impeller204expand as shown inFIGS.10aand10b. Sheath504requires enough tensile strength to contain said components collapsed. Sheath504may be manufactured of a polymer such as PTFE, FTP, ETFT, polypropylene or polyethylene, or combination of metal and polymer such metals as nitinol, stainless steel, cobalt chromium. Sheath504may have a diameter ranging from between about 1 mm to about 6 mm, preferably about 3 mm. Sheath504may have a wall thickness that ranges from between about 0.01 mm to about 0.6 mm, preferably about 0.25 mm.

Referring still toFIGS.9a-9cand10aand10b, conduit valves302a/302b/302cmay have a thickness that can range from between about 0.01 mm to about 0.35 mm, preferably about 0.05 mm. Valve302may comprise a plurality of valves such as302a/302b/302c, though preferably two or three valves. Valves302a/302b/302cmay have limited openings as shown inFIG.9a-9cor a fuller opening as shown inFIGS.10aand10b. Referring toFIG.14, valve conduit301may also include circulation jets327that allow fluid to mobilize, minimizing stagnant flow.

Valve conduit valves302a/302b/302care activated as a function of differential pressure, When the pressure within valve conduit301is greater than the pressure outside valve conduit301, conduit valves302a/302b/302copen as shown inFIGS.10a-10band11b. However, when the pressure outside valve conduit301is greater than the pressure inside valve conduit301, then valves302a/302b/302cclose preventing backflow as shown inFIG.12b.

Arterial percutaneous endovascular centrifugal heart pump300asuctions fluid from the inflow section of frame303and transitions the fluid across valve conduit301towards the outflow outside valves302a/302b/302cas shown inFIG.12c.

FIG.13is a bottom view of arterial percutaneous endovascular centrifugal heart pump300a. It shows impeller204and valve conduit valves302a/302b/302c. Furthermore, top view (FIG.14) of arterial heart pump300aillustrates valve conduit301, valve conduit valves302a/302b/302c, and conduit circulation jets327a/327b/327c.

Venous Percutaneous Endovascular Centrifugal Heart Pump Overview

Referring toFIG.15, venous percutaneous endovascular centrifugal heart pump300bmay be inserted in the patient's body through the venous system. Venous percutaneous endovascular centrifugal heart pump300bhas sheath504, frame303, shaft308, valve conduit301, valve conduit valves302a/302b/302c, venous shaft stabilizer319, and insertion tip305.

FIG.17is the detailed view A ofFIG.16illustrating the interactions between the impeller204, frame303, venous shaft stabilizer319, and insertion tip305. Frame303is attached to venous shaft stabilizer frame slot324. Outflow section313of frame303is inserted into the venous shaft stabilizer frame slot324and typically bonding using a medical grade epoxy or equivalent bonding agent. Shaft308(FIG.16) is not attached to either frame303and or venous shaft stabilizer319. When frame303is collapsed, shaft308does not move; however, frame303and venous shaft stabilizer319are displaced longitudinally relative to one another to allow frame303to reduce in diameter. When frame303is collapsed, venous shaft stabilizer inner wall320will advance across shaft outer wall321and outer wall321will thus remain within the inner wall320of the venous shaft stabilizer319. When frame303expands, venous shaft stabilizer inner wall320moves longitudinally back across shaft outer wall321. Thus, one purpose of venous shaft stabilizer319is to minimize and stabilize movement of shaft308as shaft308is rotating.

Referring now toFIG.18, a top view of venous heart pump300bis shown illustrating valve conduit301, valves302a/302b/302c, and valve conduit recirculating flow jets327a/327b/327c. Recirculating flow jets327a/327b/327cserve to minimize stagnant flow. Recirculating flow jets327a/327b/327care preferably apertures that allow fluid to move as function of pressure. The diameter of each aperture327a/327b/327cmay vary between about 0.1 mm and about 3 mm, preferably about 0.5 mm. Each valve conduit301includes one or more recirculating flow jets327a/327b/327c.

Referring now toFIGS.19a-19b,20a-20b,21,22, and23, impeller204is attached at its proximal end to shaft308and at its distal end to shaft distal end325. Impeller slides210a/210bare aligned with shaft impeller channel328a/328b. Impeller inflow end209aligns with impeller junction306. Impeller204is bonded to the shaft308, using a medical grade epoxy or equivalent bonding agent. The shaft308rests inside the venous shaft stabilizer319, and the impeller outflow end205faces venous shaft stabilizer entrance326. During the operation of the venous pump300b, impeller204and shaft308rotate, while the remaining components (stator310, frame303, venous shaft stabilizer319, insertion tip305) do not rotate. The venous shaft stabilizer319has heat and fluid dissipation ports in the proximal329a/329band in the distal330a/330b. These ports may facilitate heat transfer and minimize stagnant flow between shaft308and venous shaft stabilizer319. The venous shaft stabilizer heat dissipation proximal ports329a/329bmay be spaced 180 degrees apart. Furthermore, distal ports330a/330bmay also be spaced 180 degrees for the shaft stabilizer heat dissipation. The longitudinal spacing between ports329a/329band ports330a/330bmay range between about 5 mm and about 50 mm, preferably about 18 mm. The diameter of ports329a/329band330a/330bmay range between about 0.10 mm and about 3 mm, preferably about 1 mm.

Overview of Arterial Pump300aVersus Venous Pump300b

Referring toFIG.24, a comparison between the arterial percutaneous endovascular centrifugal heart pump300aand the venous percutaneous endovascular centrifugal heart pump300bis shown. The inflow and outflows are reversed for the venous percutaneous endovascular centrifugal heart pump300bcompared to the arterial percutaneous endovascular centrifugal heart pump300aas well as valve conduit301, frame303, valve conduit valves302a/302b/302c. Furthermore, venous shaft stabilizer319is extended on the venous heart pump300bcompared to the shaft stabilizer304of the arterial device300a.

Motor Connection

Referring now toFIGS.25aand25b, motor501drives heart pump300. Stator motor connector502attaches stator310and shaft308and shaft308to motor501. Connector502may include flushing ports503a/503b. Ports503a/503bare used to add or remove fluid from inside stator310and shaft308. Luer lock512a/512bmay be used to achieve this connection. Ports503a/503bmay be connected to a continuous fluid infusion pump to lubricate the system mitigating frictional and vibrational forces.

Referring still toFIGS.25a-bbut now also toFIGS.26a-b,27a-b, and28, motor501may include motor shaft517which will drive shaft308. Preferably, motor shaft517is attached to motor junction522by either fasteners or a by bonding, thereby fixing motor junction522to motor shaft517. Motor junction522may include one or more magnets509a/509b/509c/509d. Motor junction522may have magnet slots523a/523b/523c/523dwherein magnets509a/509b/509c/509dmay be inserted. Rotating junction513is attached to shaft308by means of chemical bonding or electromagnetic forces. Rotating junction513may include magnets510a/510b/510c/510dwithin magnet slots524a/524b/524c/524d. Magnet slots523dand524dare not shown in the figures due to their location on the opposite side of the figure.

Referring still toFIGS.25a-b,26a-b,27a-b, and28, shaft308is attached to bearing519(FIG.26b) by attaching shaft outer wall321to the inner race528of bearing519. Again, the attachment may be accomplished by bonding using medical-grade epoxy or an equivalent agent. Bearing519allows shaft308to rotate while stator motor connector502remains stationary. Bearing519includes ball bearings515a/515bthat allows the shaft308to rotate while maintaining stator motor connector502stationary. A seal529that prevents fluid from escaping or leaking past the bearing. Bearing519includes an outer race527that does not rotate and is attached to stator motor connector502. The bearing519has ball bearings515a/515b/515c/515dthat may rotate to allow inner race528to rotate while outer race527remains stationary. This allows shaft308to rotate while stator motor connector502and stator310remain stationary.

Referring toFIGS.25a-band26a-b, stator motor connector502is attached to stator310. Shaft308includes a guidewire port521to allow fluid to enter shaft inner lumen322, minimize stagnant flow, as well as provide lubrication to the guidewire. Fluid can be inserted or removed through flushing ports503a/503b. Fluid enters or exits through flushing port lumen514a/514band enters the lubricating region516. Fluid can enter guidewire lubrication port521and shaft-stator gap526. Gap526is the space between shaft outer wall321and stator inner lumen307. Rotating junction513has an inner lumen525that connects to shaft inner lumen322and allows the guidewire to enter or exit. This is done by the guidewire500entering the rotating junction inner lumen525followed by shaft inner lumen322. Rotating junction inner lumen525is sealed by guidewire seal device511when motor junction522is inserted. Guidewire seal511may be made of a polymer such as silicone, nylon, PTFE; or metal such as stainless steel, cobalt-chromium; or a combination of a polymer and metal. Guidewire seal511is attached to motor junction522. Thus, when motor junction522is connected to rotating junction513, the rotating junction inner lumen525is sealed.

Referring toFIGS.27a-b,28, and29a-h, motor junction522is attached to motor5501. Rotating junction513is attached to the stator motor connector502. Rotating junction513includes connecting guides536a/536b/536c/536dthat minimize the area, thus facilitating insertion to motor junction top surface533(FIGS.29a-h). This is further guided by motor junction slope532a/532b/532c/532d. The connection is further facilitated by motor junction magnets509a/509b/509c/509dand rotating junction magnets510a/510b/510c/510d. The magnets are placed so that motor junction522and rotating junction513are attracted to one another by placing opposite poles of the magnets at each junction. For instance, motor junction magnet509amay have a north pole, while the rotating junction magnet510may have a south pole, thus creating an attraction force. This setup may be repeated for the remaining motor junction magnets509b/509c/509dand the remaining rotating junction magnets510b/510c/510d. This magnetic attraction locks the motor junction to the rotating junction, thus mating motor junctions' top surface533and the rotating junction's inner section537.

Unsheathing, Repositioning, Recapture, and Control Release Process

Referring now toFIGS.30a,30b,31a,31b, for the unsheathing, sheath valve adapter505and sheath504may be pulled toward stator motor connector502along stator310, thus bringing sheath valve adapter505towards stator motor connector502as illustrated inFIG.30b. Such a pushing force may be accomplished by pushing stator motor connector502towards sheath valve adapter505and sheath504along stator310. This brings stator motor connector502towards sheath valve adapter505(FIG.31a-b). Both these actions unsheath valve conduit301and impeller204in a controlled release manner using radiological angiographic and ultrasonic guidance. In the event the deployment is not satisfactory, the device may be recaptured and repositioned.

Referring toFIG.32, when unsheathing is complete, guidewire500may be removed. At this point motor501is connected to stator motor connector502at motor junction522. Motor501is joined with stator motor connector502using the rotating junction magnets510a-dand motor junction magnets509a-d.

To resheath or recapture the percutaneous endovascular centrifugal heart pump300, sheath valve adapter505and sheath504are pulled away from stator motor connector502along stator310. This can be done by either pushing or pulling relative to the different components described.

Insertion of Arterial Percutaneous Endovascular Centrifugal Heart Pump

The insertion of the arterial percutaneous endovascular centrifugal heart pump300ainto the human body602may be summed up in five steps as shown inFIGS.33-35.

Step1as shown inFIG.33is assessing the human body602by identifying access to the patient. Access is initially done through the femoral artery603. Alternative access will be brachial or axillary artery or direct aortic puncture in cases that may need the present invention while performing open heart surgery.

Step2is to insert a guidewire500into the femoral artery603and advance across the abdominal aorta604towards the descending aorta605, crossing the aortic arch606and passing through the ascending aorta404into the left ventricle400(See alsoFIG.36).

Step3(FIG.34)—once the guidewire500is in place, the arterial percutaneous endovascular centrifugal heart pump300ais advanced by inserting the guidewire500in the insertion tip inner lumen309. The insertion tip305is advanced in the human body602by penetrating the skin into the femoral artery603. The arterial percutaneous endovascular centrifugal heart pump300ais further advanced to the abdominal aorta604, desscending aorta605, aortic arch606ascending aorta404, crossing the aortic valve leaflets403.

Step4(FIG.34)—once the arterial percutaneous endovascular centrifugal heart pump300ais unsheathed, by either pulling or pushing the sheath504and stator motor connector502together, and placing it across the aortic valve leaflets403, the guidewire500may be removed. Once the guidewire500is removed, the motor501may be connected to the arterial percutaneous endovascular centrifugal heart pump300aby means of the stator motor connector502.

Step5(FIG.35)—once the motor501is connected to the stator motor connector502, the motor may be turned on which will turn the motor shaft517, as well the shaft308and impeller204. This will drive the blood from the left ventricle400across the valve conduit301towards the ascending aorta404unloading the left ventricle400.

Vascular access is obtained using anatomical landmarks, radiological landmarks and ultrasound guided vascular access. The objective is to access the artery in the anterior wall of the vessel. For femoral access the goal is to access the femoral artery603above the bifurcation and below a tangential line traced at the superior border of the femoral head. For axillary artery, the plan is to access the vessel in the superior third of the humeral bone using anatomical landmarks, radiological landmarks and ultrasound guided access, taking special care not to interfere with the brachial plexus.

The artery will be accessed using the Seldinger technique, where a needle is advanced from the skin toward the vessel. When the needle is inside the vessel, a wire is advanced into the artery. The needle is withdrawn and a insertion sheath is advanced over the wire into the artery. Once vascular access is achieved, the insertion sheath is suctioned and flushed. A pigtail catheter is advanced over the wire into the left ventricle400. The wire is removed, and the catheter is suctioned and flushed. Anticoagulation is started to achieved ACT levels between 250 to 300. Left ventricular pressure is recorded.

Guidewire500(preferably about 0.035 inches in diameter) is then advanced inside the pigtail catheter into the left ventricle400preferential. Once the guidewire500is placed in the left ventricle400the pigtail first and then the insertion sheath is removed from the body602the arterial percutaneous endovascular centrifugal heart pump300ais advance into the left ventricle400over the guidewire500. When the collapsed valve conduit301segment of the sheath504is across the aortic valve leaflets403, the sheath504is retracted over the stator310or the stator310is advanced over the guidewire500unsheathing the valve conduit301with the impeller204inside. Once the valve conduit301is fully expanded across the aortic valve leaflets403, the guidewire500is withdrawn from the body602and the stator motor connection502of arterial percutaneous endovascular centrifugal heart pump300ais coupled with the motor junction522and motor501. Hemodynamic support is started continuous flushing with special solution to maintain anticoagulation.

Arterial Percutaneous Endovascular Centrifugal Heart Pump Deployment into the Aortic

The guidewire500is advanced across the ascending aorta404crossing the aortic valve leaflets403into the left ventricle400. Once the guidewire500is in place, the arterial percutaneous endovascular centrifugal heart pump300ais advanced along the guidewire500through the insertion tip inner lumen309. When the Insertion tip305crosses the aortic valve leaflets403, the unsheathing process may begin.

Referring now toFIGS.38-40, when the arterial percutaneous endovascular centrifugal heart pump300ais unsheathed—retracting the sheath504from the insertion to305—the sheath is retracted. The frame303may begin to expand and interact with the aortic valve leaflets403. When the arterial percutaneous endovascular centrifugal heart pump300ais fully unsheathed the valve conduit301may fully interact with aortic valve leaflets403. At this point, most of the valve conduit is in the ascending aorta404. The frame midsection317may rest on the aortic valve leaflets403, the bottom section of the valve anchored312may rest on the lower portion of the aortic valve leaflets403, and the top section of the valve anchored311may also rest on the aortic valve leaflets403(FIG.39).

Once the arterial percutaneous endovascular centrifugal heart pump300ais unsheathed, guidewire500is removed. The valve conduit valves302prevent blood flow from entering the left ventricle400. As the left ventricle400contracts and generates positive pressure the valve conduit valves302open when the ventricular pressure is greater than the aortic pressure. Furthermore, if the aortic pressure is greater than the ventricular pressure then the valve conduit valves302close, thereby minimizing regurgitation flow. The valve conduit valves302allow time for the placement of the motor501. Once the motor501is connected and turned on, the impeller204would generate pressure opening the valve conduit valves302and unloading the left ventricle400(SeeFIG.40).

Insertion of Venous Percutaneous Endovascular Centrifugal Heart Pump

The insertion of the venous percutaneous endovascular centrifugal heart pump300bhas multiple points of entry in the human body602.

The first point of entry is through the femoral vein609. The guidewire500is inserted in the body602entering the femoral vein609, it is advanced passing the kidneys610and inferior vena cava414(FIG.41a). The guidewire500then enters the right side of the heart613.

The second point of entry is through the jugular vein615. The guide wire500is inserted into the body602entering the jugular vein615, it is advanced passing the brachiocephalic vein and the superior vena cava413(FIG.41b). The guidewire500then enters the right side of the heart613.

The third point of entry is through the subclavian vein620. The guide wire500is inserted into the body602entering the subclavian vein620, it is advanced passing the brachiocephalic vein and the superior vena cava413(FIG.42a). The guidewire500then enters the right side of the heart613.

The fourth point of entry is through the basilic vein619, the medial cubital vein617or the cephalic vein618. The guidewire500is inserted in the body entering the medial cubital vein617, the basilic vein619, or the cephalic vein618. It is advanced passing the subclavian vein620, the brachiocephalic vein614, and the superior vena cava413(FIG.42b). The guidewire500then enters the right side of the heart613.

Guidewire500provides guidance for the venous percutaneous endovascular centrifugal heart pump300bfor each of these four points of entry (FIG.43). The venous pump300bhas a hollow spacing throughout to allow the guidewire500to be inserted. As the guidewire500is inserted in the venous heart pump300b, the venous heart pump300bis advanced across the guidewire500into the body602following the path that the guidewire500has established. Throughout the insertion of the venous heart pump300b, the guidewire500remain stationary. Thus, the venous heart pump300bmay enter the body through the four entry points noted: femoral vein609, jugular vein615, subclavian vein620, and medial cubital vein617or cephalic vein618.

Once the venous percutaneous endovascular centrifugal heart pump300bhas reached its final placement, it is unsheathed, followed by removal of the guidewire500and connection of the motor501(SeeFIG.32). The motor connection for the venous percutaneous endovascular centrifugal heart pump300bis the same as the arterial percutaneous endovascular centrifugal heart pump300a.

Vascular access is obtained using anatomical landmarks, radiological landmarks and ultrasound guided vascular access. The objective is to access the femoral vein609, jugular vein615or subclavian vein620in the anterior wall of the vessel, and veins of the upper extremeties.

The vein is accessed using the Seldinger technique, where a needle is advanced from the skin toward the vessel. When the needle is inside the vessel, a wire is advanced into the vein. The needle is withdrawn, and an insertion sheath is advanced over the wire into the selected vein. Once vascular access has been achieved the insertion sheath is suction and flushed. Anticoagulation is then started to achieved ACT levels between 250 to 300.

A pigtail catheter or a Swan Ganz catheter is advanced into the right atrium405, right ventricle407and pulmonary artery412. All pressures are recorded. The guidewire500(again preferably about 0.035 inches in diameter) is then advanced using the pigtail catheter or Swan Ganz catheter into the pulmonary artery412or its branches. Once the guidewire500is placed in the pulmonary artery412or one of its branches, the pigtail or the Swan Ganz catheter is removed, followed by the removal of the insertion sheath from the body602. The venous percutaneous endovascular centrifugal heart pump300bis then introduced and advanced into the pulmonary artery412. When the collapsed valve conduit301segment of the sheath504is across the pulmonary valve, the sheath is retracted over the stator or the stator is advanced over the wire unsheathing the valve conduit301with the impeller inside. Once the valve conduit301is fully expanded across the pulmonary valve leaflet base410and pulmonary valve leaflet tip411, the guidewire500is withdrawn from the body602and the stator motor connection502of venous percutaneous endovascular centrifugal heart pump300bis coupled with the motor junction522and motor501. Hemodynamic support is started continuously flushing with special solution to maintain anticoagulation.

Pulmonary Placement of Venous Percutaneous Endovascular Centrifugal Heart Pump

For pulmonary placement of the venous percutaneous endovascular centrifugal heart pump300b, there are two methods of insertion.

Referring toFIG.44, one method is advancing the guidewire500across the superior vena cava413, crossing the tricuspid valve406, entering the right ventricle407, and crossing into the pulmonary artery412. Furthermore, the venous percutaneous endovascular centrifugal heart pump300bis advanced on the guidewire500in between the right ventricle407and pulmonary artery412. Once this is achieved, the venous percutaneous endovascular centrifugal heart pump300bis unsheathed by retracting the sheath504away from the insertion tip305(FIG.44). During the unsheathing process, the valve conduit301contacts the pulmonary valve leaflet tip411. Thus, the frame midsection317firmly anchors to the pulmonary valve leaflet tip411due to the enhanced diameter of the midsection317compared to the prior art. The frame lower section318remains in the right ventricle407and the frame top-section316remains in the pulmonary artery412. Once deployed and delivery is satisfied, the guidewire500may be removed, followed by the connection of the motor. The advantage of the valve conduit valves302a-cis that they replace the function of the native pulmonary valve minimizing regurgitant flow from occurring during the removal process of the guidewire500and connection of the motor501. If the present invention is not placed satisfactory it may be recapture by repositioning.

Referring toFIG.45, the second method is advancing the guidewire500across the inferior vena cava414, crossing the tricuspid valve406, entering the right ventricle407, and crossing into the pulmonary artery412. As mentioned previously, during the unsheathing process, valve conduit301contacts the pulmonary valve leaflet tip411while frame midsection317again firmly anchors itself to pulmonary valve leaflet tip411. Frame lower section318remains in the right ventricle407, and frame top-section316remains in the pulmonary artery412. Once deployed and delivery is satisfied, the guidewire500is removed, followed by the connection of the motor. The advantage of the valve conduit valves302a-cis that they replace the function of the native pulmonary valve minimizing regurgitant flow from occurring during the removal process of the guidewire500and connection of the motor501.

Tricuspid Placement of the Venous Percutaneous Endovascular Centrifugal Heart Pump

For tricuspid placement of the venous percutaneous endovascular centrifugal heart pump300b, there are two methods of insertion.

Referring toFIG.46, one method is advancing guidewire500across the superior vena cava413, crossing the tricuspid valve406, and entering the right ventricle407. The venous percutaneous endovascular centrifugal heart pump300bis advanced over guidewire500between the right atrium405and right ventricle407. Once this is achieved, the venous percutaneous endovascular centrifugal heart pump300bis unsheathed by retracting the sheath504away from the insertion tip305. During the unsheathing process, the valve conduit301contacts the tricuspid valve406and the frame midsection317anchors to tricuspid valve406due to the enhanced diameter of the midsection317compared to prior art devices. Frame lower section318remains in the right atrium405and frame top-section316remains in the right ventricle407. Once deployed and delivery is satisfied, the guidewire500is removed, followed by connection of the motor. The advantage of the valve conduit valves302a-cis that they replace the function of the native tricuspid valve406minimizing regurgitant flow from occurring during the removal process of the guidewire500and connection of the motor501.

Referring toFIG.47, the second method is advancing guidewire500across the inferior vena cava414, crossing the tricuspid valve406, and entering the right ventricle407. The venous percutaneous endovascular centrifugal heart pump300bis advanced over guidewire500between the right atrium405and right ventricle407. Once this is achieved, the venous percutaneous endovascular centrifugal heart pump300bis unsheathed by retracting sheath504away from the insertion tip305. During the unsheathing process, the valve conduit301contacts the tricuspid valve406and the frame midsection317firmly anchors itself to the tricuspid valve406while frame lower section318remains in the right atrium405and frame top-section316remains in the right ventricle407. Once deployed and delivery is satisfied, guidewire500is removed, followed by the connection of the motor. The advantage of the valve conduit valves302a-cis that they replace the function of the native tricuspid valve406minimizing regurgitant flow from occurring during the removal process of the guidewire500and connection of the motor501.

Mitral Placement of the Venous Percutaneous Endovascular Centrifugal Heart Pump

For mitral placement of the venous percutaneous endovascular centrifugal heart pump300b, there are two methods of insertion.

Referring toFIG.48, one method is advancing guidewire500across the inferior vena cava414, crossing the right atrium405, crossing the atrial septum into the left atrium409, and crossing the mitral valve402into the left ventricle400. To achieve access to the left side of the heart, it is done by transseptal puncture, where a small puncture is made in the atrial septum located between the right atrium405and the left atrium409. Thus, puncturing the right atrial405provides access to the left side of the heart. Furthermore, allowing the guidewire500to enter the left atrium409and crossing the mitral valve402into the left ventricle400.

Referring toFIG.49, once guidewire500is in the left ventricle400, the venous percutaneous endovascular centrifugal heart pump300bis advanced on the guidewire500crossing the right atrium405into the left atrium409and into the left ventricle400. The venous percutaneous endovascular centrifugal heart pump300bis unsheathed when it is in between the left atrium409and the left ventricle400. Once this is achieved, the venous percutaneous endovascular centrifugal heart pump300bis unsheathed by retracting the sheath504away from the insertion tip305. The valve conduit301contacts mitral valve402and frame midsection317once again can firmly anchor itself to the mitral valve402while frame lower section318remains in the left atrium409and frame top-section316remains in the left ventricle400. Once deployed and delivery is satisfied, the guidewire500is removed, followed by the connection of the motor. The advantage of the valve conduit valves302a-cis that they replace the function of the native mitral valve402minimizing regurgitant flow from occurring during the removal process of the guidewire500and connection of the motor501.

Referring toFIG.50, the second method is by advancing guidewire500across the superior vena cava413, crossing the right atrium405into the left atrium409, and crossing the mitral valve402into the left ventricle400. To achieve access to the left side of the heart, it is done by transseptal puncture, where a small puncture is made in the right atrium405that is connected to the left atrium409. Thus, puncturing the right atrial405provides access to the left side of the heart allowing guidewire500to enter the left atrium409and crossing into the left ventricle400.

Referring now toFIG.51, once guidewire500is in the left ventricle400, the venous percutaneous endovascular centrifugal heart pump300bis advanced on the guidewire500crossing the right atrium405into the left atrium409to the left ventricle400. The venous percutaneous endovascular centrifugal heart pump300bis unsheathed when it is in between the left atrium409and the left ventricle400. The venous percutaneous endovascular centrifugal heart pump300bis unsheathed by retracting the sheath504away from the insertion tip305. The valve conduit301contacts the mitral valve402and the frame midsection317firmly anchors to the mitral valve402while frame lower section318remains in the left atrium409and frame top-section316remains in the left ventricle400. Once deployed and delivery is satisfied, the guidewire500may be removed, followed by the connection of the motor. The advantage of the valve conduit valves302a-cis that they replace the function of the native mitral valve402minimizing regurgitant flow from occurring during the removal process of the guidewire500and connection of the motor501.

Flow Profile

The percutaneous endovascular centrifugal heart pump300converts the mechanical energy of the fluids into hydraulic energy using centrifugal force. Impeller204uses centrifugal forces to expel the fluid radially converting axial flow to perpendicular flow. Impeller204suctions fluid in the same axis as valve conduit301and expels fluid perpendicular to the axis of valve conduit301.

Referring toFIG.52a-b, the percutaneous endovascular centrifugal heart pump300may use the valve conduit valves302to direct the flow depending on the angle of opening. As seen inFIG.52b, when valve conduit valves402opening is limited, the outflow is directed downward601and lateral. This downward flow601is caused by valve conduit valves402limited opening directing the blood flow towards the coronary cusp415. The flow directed downward may create recirculation flow600across the sinus of the aortic improving blood flow to the heart.

Referring now toFIGS.53a-b, when the opening of the valve conduit valves402is increased, the outflow is expelled outwardly608. This centrifugal flow is generated by impeller204design, which uses centrifugal forces to expel the fluid outwardly radially.FIG.53billustrates the flow direction created by the percutaneous endovascular centrifugal heart pump300. The inflow607has an axial vector that is converted to a perpendicular vector at the outflow segment608. This is achieved by means of impeller204, which generates centrifugal forces.

Referring toFIGS.54a-billustrate the differences in impeller design between an axial flow impeller and the percutaneous endovascular centrifugal heart pump impeller204. InFIG.54a, an axial flow impeller does not have any spacings and obstructs an axial view from the top view due to the vane design. However, referring toFIG.54b, percutaneous endovascular centrifugal heart pump impeller has spacings between the top-level vane200, mid-level vane201, and lower-level vane202; and the percutaneous endovascular centrifugal heart pump impeller does not obstruct an axial view from the top view ofFIG.54b.

FIGS.54cand54dfurther illustrates the differences in an axial impeller compared to percutaneous endovascular centrifugal heart pump impeller204. An axial impeller couples the fluid to move the flow axially (FIG.54c) in the same direction as the inflow. That is, axial pumps use a propeller to advance the fluid's mass on the same axis as the initial flow.

However, referring toFIG.54d, the percutaneous endovascular centrifugal heart pump impeller204uses centrifugal forces to move the fluid perpendicular to the inflow, thus ejecting the fluid radially outwardly (perpendicular to the inflow). Centrifugal pumps generate flow by applying the angular momentum principle to the fluid's mass through the impeller passages advancing the mass of fluid radially.

Electronics

Referring now toFIGS.55a-band56, the percutaneous endovascular centrifugal heart pump300may have sensors for the arterial percutaneous endovascular centrifugal heart pump300aand venous percutaneous endovascular centrifugal heart pump300b.

With reference toFIGS.55a-b, the arterial percutaneous endovascular centrifugal heart pump300amay include one or more microelectromechanical systems (MEMS) sensors in a proximal location338aand a distal location338b. Such sensors may measure pressure, temperature, position, flow, location, pH, lactate, etc. Proximal sensor338amay be located on stator310, and distal sensor338bmay be located on shaft stabilizer304. The location of these sensors above and below the impeller permits the measurement of differential pressure across the device.

With reference toFIG.56, the venous percutaneous endovascular centrifugal heart pump300bmay include one or more microelectromechanical systems (MEMS) sensors in a proximal location338cand distal location338d. Again, such sensors may measure pressure, temperature, position, flow, location, pH, lactate, etc. Proximal sensor338cmay be located on the stator310, and distal sensor338dmay be located on the venous shaft stabilizer319. Again, the location of these sensors above and below the impeller permits the measurement of differential pressure across the device.

Preferably, sensors338a-dare powered by radiofrequency, and are commercially available such as model 1.2 BAR SCB10H-B012FB pressure sensor element from Murata Manufacturing Co., Ltd. of Nagaokakyo, Kyoto, Japan.

Referring now toFIGS.57and58, the percutaneous endovascular centrifugal heart pump300may be connected to a power supply and processor700through motor cable707. WhileFIGS.57-58shown the hookup for an arterial version of the present invention, the hookup for a venous version of the present invention would be the same.

The power supply and processor700may operate off a battery as shown inFIG.57or connected to an electrical outlet709by means of a power connector708as shown inFIG.58. In either case, the power supply and processor700may communicate with a computer702by means of Bluetooth, radiofrequency, and/or Wi-Fi701. The power supply and processor700may also communicate with sensors338a-dof the percutaneous endovascular centrifugal heart pump300while in the patient's body. Thus, computer702may communicate as well with sensors338a-dof the percutaneous endovascular centrifugal heart pump300in the patient's body.

Computer702may have a power supply circuit and battery703, transmitter and receiver706, host processor704, and touch controller705. The computer702may be a desktop computer such as Dell—Inspiron Compact Desktop (Dell Computer Company, Round Rock, TX), a laptop computer such as XPS 13 Laptop (Dell Computer Company, Round Rock, TX) or MacBook Pro (Apple, inc., Cupertino, CA), or a handheld smart phone such as an iPad or iPhone (Apple, inc., Cupertino, CA) or Samsung Galaxy Tablet or phone (Samsung Electronics Co., Ltd, Suwon-si, South Korea).

The computer702may thus generate a readout of the various parameters being received from sensors338a-d, including operational values of the present invention such output rates, inflow rates, pressures, pH, temperature, impeller function and performance, and motor function and performance.

Having thus described in detail a preferred selection of embodiments of the present invention, it is to be appreciated and will be apparent to those skilled in the art that many physical changes could be made in the apparatus without altering the inventive concepts and principles embodied therein. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore to be embraced therein.