Percutaneous intravascular centrifugal heart pump and method Inventor: David Esteban Paniagua Gonzalez

Abstract

A percutaneous heart pump having a centrifugal flow and a valve conduit that enables one-way flow. The present invention is a small percutaneous intravascular centrifugal pump incorporating an expandable uniflow valve conduit having a valve, a centrifugal impeller, a shaft, a guide wire, a deliverable sheath, and an external coupling to an infusion pump and a motor.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 345,374, filed May 24, 2022, and entitled Percutaneous Endovascular Centrifugal Heart Pump, which is incorporated by reference in its entirety and made a part of this application. [Technical field]

[0002] The present invention relates to a percutaneous intravascular centrifugal heart pump for supporting a failing heart as a bridge to recovery or during high-risk cardiac intervention. [Background technology]

[0003] Pumps have been popular for centuries. The first rotary pump dates back to Archimedes' screw pump (250 BC), used to displace fluid from a lower plane 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 and mathematical interpretation of pump flows were described by Daniel Bernoulli and Leonhard Euler in the 1700s, who derived the velocity triangle, which is still used today to calculate pump flows.

[0004] Pumps are classified as displacement pumps and rotary pumps. Displacement pumps produce intermittent flow by periodic energy transfer. Rotary pumps generate continuous flow by energy transfer through impeller speed. There are three classical rotary pumps: centrifugal, axial, and mixed flow. Axial flow pumps use a propeller to advance a mass of fluid on the same axis as the initial flow. Centrifugal pumps generate flow by applying angular momentum principles to a mass of fluid through an impeller passage to advance the mass of fluid radially. Mixed flow pumps use a combination of centrifugal and axial flow.

[0005] In medicine, displacement pumps have applications in hemodialysis and heart and lung machines. The Jarvik and HeartMate II Left Ventricular Assist Devices (LVAD) use axial pumps. The HeartMate III and HeartWare (LVAD) use centrifugal pumps. Dr. Richard Wampler developed the HemoPump (1985), the first percutaneous axial pump to assist the human heart, inspired by the Archimedes screw pump. This work proceeded through individuals such as Dr. Helmut Reul and Dr. OHFrazier, and led to the development of the Impella device by Thorsten Sieb.

[0006] It has taken almost 60 years of research in the medical field to learn and accept that the human body can function without pulses. Despite all these efforts, there is still much more progress and innovation to be made in this field.

[0007] 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 problem with prior art PMCS is the sheath size and impeller rotation speed required to generate adequate flow. The AbioMed Impella® has an outer diameter of 18F (6mm), 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, laceration, dissection, total occlusion, transection, spasm or embolic events.

[0008] The sheath sizes required to introduce PMCS are limiting factors for vascular access and pump performance. The smallest currently available devices have a sheath size of 6 mm (O.D.) for the 2.5 Impella® (2.5 L / min) and CP Impella® (3 L / min) devices, and a 10 mm HemoShield is recommended for vascular access for the 5.0 Impella® device (5 L / min). This sheath size is problematic because the average common femoral artery diameter is 6.6 mm (3.9 - 8.9 mm). The Impella® devices have sheaths of approximately the same diameter size as the access vessel. Additionally, the 5.0 Impella® is rarely inserted percutaneously due to its profile. The introduction of these large cannulas exposes the bloodstream to risk and can cause lactic acidosis, limb ischemia, and amputation.

[0009] Furthermore, large sheaths have difficulty bending to conform to human anatomy, especially in tortuous arteries, increasing the stress applied to the arterial wall of the blood vessel and thus resulting in complications. For example, the friction generated by large sheaths can dislodge calcium within the arteries and aorta, which can embolize the heart, limbs, kidneys, or brain, causing a heart attack, limb ischemia, renal infarction, or stroke in the patient, respectively. Therefore, due to the anatomical reasons described above, not all patients are candidates for the smallest available devices. Another concern that is a limiting factor is vascular tortuosity (Figure 1). This tortuosity is a risk factor for vascular injury when advancing a large sheath. The presence of highly calcified blood vessels can cause calcium embolism when advancing a large device. A further concern is the curvature of the aortic arch and the difficulty of advancing a large sheath catheter without interacting with the aortic wall (Figure 3).

[0010] The present invention meets these needs by providing the first miniaturized intravascular percutaneous centrifugal pump in the medical field.

Summary of the Invention

Means for Solving the Problem

[0011] The present invention includes a small insertion profile that houses a valve conduit, a shaft, an impeller, a stator, and a guide wire all inside an 8F to 12F (French) sheath. The present invention expands to 10 - 20 mm during operation, thereby enabling a lower impeller speed of 4,000 - 25,000 RPM, i.e., a rotational speed 3 - 6 times lower than that of current ventricular assist devices (33,000 - 57,000 RPM). Further, the present invention provides a low blood flow velocity (0.54 m / s), i.e., 12 times lower than the current technology (6.25 m / s), while still generating up to 5 L / min across the unidirectional valve conduit. This helps to minimize blood cell trauma.

[0012] The present invention is the first percutaneous endovascular centrifugal heart pump on the market, providing cardiologists with a thin device that facilitates insertion into the human body and operability while minimizing vascular damage and complications. Patients who were previously not considered candidates due to blood vessel size will now be able to receive this treatment.

[0013] The present invention meets an as yet unfulfilled need by providing access to patients with small tortuous blood vessels who are not eligible for heart support with available technologies, by providing a truly thin profile device. The present invention is 36% smaller in diameter and pumps up to 5 L / min at a lower rotational speed.

[0014] The reduction in impeller speed and the increase in valve conduit diameter result in reduced blood cell damage and easier insertion and advancement of the present invention in patients with tortuous small blood vessels who are not eligible for heart support with available technologies. The present invention assists the heart in recovering its cardiac function and gives the patient's heart time to recover. Thus, it delays the progression to end-stage heart disease while having a direct medical and economic impact.

Brief Description of the Drawings

[0015] [Figure 1] It is a general view of the present invention showing an enlarged view, a partial view with the sheath removed, the sheath, a valve conduit, and a partial view with the frame removed.

[0016] [Figure 2a] It is a front view of a closed impeller having a plurality of stages cut from a single piece of material. [Figure 2b] It is a top view of a closed impeller having a plurality of stages cut from a single piece of material.

[0017] [Figure 2c] It is a front view of an open impeller having a plurality of stages cut from a single piece of material. [Figure 2d] It is a top view of an open impeller having a plurality of stages cut from a single piece of material.

[0018] [Figure 2e] It is a top view of the impeller and the vane angle distribution α.

[0019] [Figure 2f] It is a perspective view of the impeller. [Figure 2g] It is another perspective view of the impeller.

[0020] [Figure 3a] It is a side view of the frame of the valve conduit in the closed state. [Figure 3b] It is a side view of the frame of the valve conduit in the open state.

[0021] [Figure 3c] It is a side view of the frame of the valve conduit in the closed state having slits at both ends. [Figure 3d] It is a side view of the frame of the valve conduit in the expanded state having slits at both ends.

[0022] [Figure 4a]A side view of the arterial version of the present invention showing the shaft, frame, impeller, shaft stabilizer, and insertion tip.

[0023] [Figure 4b] Similar to Figure 4a, but a view without the impeller.

[0024] [Figure 5a] A view showing the interaction of the shaft, impeller, shaft stabilizer, and insertion tip.

[0025] [Figure 5b] Similar to Figure 5a, but a view showing the shaft, impeller, shaft stabilizer, and insertion tip as partially separated components.

[0026] [Figure 6] An isometric view of the interaction of the shaft, impeller, shaft stabilizer, and insertion tip.

[0027] [Figure 7a] A side view of the present invention showing the stator, shaft, impeller, valve conduit, frame, and insertion tip.

[0028] [Figure 7b] A cross-sectional view of the present invention taken along A-A of Figure 7a.

[0029] [Figure 8a] A cross-sectional side view of the present invention.

[0030] [Figure 8b] An enlarged view of the end of the present invention shown in Figure 8a, showing the shaft, impeller, valve conduit, frame, and insertion tip.

[0031] [Figure 9a] A left side view of the present invention showing the valve conduit, valve conduit valve, frame, stator, shaft stabilizer, and insertion tip.

[0032] [Figure 9b] Front view of the present invention showing a valve conduit, a valve conduit valve, a frame, a stator, a shaft stabilizer, and an insertion tip.

[0033] [Figure 9c] Right side view of the present invention showing a valve conduit, a valve conduit valve, a frame, a stator, a shaft stabilizer, and an insertion tip.

[0034] [Figure 10a] Left side view of the present invention showing a valve conduit, a valve conduit valve having a larger opening angle in the open position, a frame, a stator, a shaft stabilizer, a sheath, a guide wire, and an insertion tip.

[0035] [Figure 10b] Front view of the present invention as seen in FIG. 10a, showing a valve conduit, a valve conduit valve having a larger opening angle in the open position, a frame, a stator, a shaft stabilizer, a sheath, a guide wire, and an insertion tip.

[0036] [Figure 11a] Front view of the arterial version of the present invention showing a valve conduit, a valve conduit valve in the closed position, a frame, a stator, a shaft stabilizer, a sheath, a guide wire, and an insertion tip.

[0037] [Figure 11b] Side view of the arterial version of the present invention as seen in FIG. 11a, with the valve conduit valve in the open position.

[0038] [Figure 12a] Isometric view of the arterial version of the present invention showing the valve in the open position.

[0039] [Figure 12b] Isometric view of the arterial version of the present invention showing the valve in the closed position.

[0040] [Figure 12c] An isometric view of the arterial version of the present invention showing the positions of inflow and outflow.

[0041] [Figure 13] A bottom view of the arterial version of the present invention showing the impeller, valve conduit, and valve conduit valve in the open position.

[0042] [Figure 14] A top view of the arterial version of the present invention showing the valve conduit, valve conduit valve in the open position with valve conduit circulation jets.

[0043] [Figure 15] A side view of the venous version of the present invention.

[0044] [Figure 16] A cross-sectional side view of the venous version of the present invention.

[0045] [Figure 17] An enlarged cross-sectional side view of the venous version of the insertion tip and venous shaft stabilizer of the present invention.

[0046] [Figure 18] A top view of the venous version of the present invention as seen in FIG. 15 showing the valve conduit, open valve conduit valve, and valve conduit circulation flow jets.

[0047] [Figure 19a] A side view of the venous version of the present invention showing the stator, shaft, frame, venous shaft stabilizer, impeller, and insertion tip.

[0048] [Figure 19b] Similar to FIG. 19a but without the impeller.

[0049] [Figure 20a] A side view of the venous version of the present invention showing the shaft, impeller, venous stabilizer, and insertion tip.

[0050] [Figure 20b] Similar to FIG. 20a, it is a partial view of the components.

[0051] [Figure 21] An isometric view of the venous version of the present invention showing the shaft, impeller, venous stabilizer, and insertion tip.

[0052] [Figure 22] An isometric divided view of the venous version of the present invention showing the shaft, impeller, venous stabilizer, and insertion tip.

[0053] [Diagram 23] An isometric view of the venous version of the present invention showing the stator, shaft, frame, venous shaft stabilizing device, and insertion tip, but without the valve conduit.

[0054] [Figure 24] A diagram comparing the arterial version and the venous version of the present invention.

[0055] [Figure 25a] A side view showing the connection between the motor and the device of the present invention.

[0056] [Figure 25b] A cross-sectional view of the side view shown in FIG. 25a.

[0057] [Figure 26a] Another cross-sectional side view showing the connection between the motor and the device of the present invention.

[0058] [Figure 26b] A detailed enlarged view of the area enclosed by the circle in FIG. 26a.

[0059] [Figure 27a]Side view of the connection between the motor and the device of the present invention showing the separated components.

[0060] [Figure 27b] Cross-sectional view of the side view shown in FIG. 27a.

[0061] [Figure 28] Isometric view of the connection between the motor and the device shown in FIG. 27a.

[0062] [Figure 29a] Diagram showing the components for connecting the heart pump to the motor of the present invention. [Figure 29b] Another diagram showing the components for connecting the heart pump to the motor of the present invention. [Figure 29c] Another diagram showing the components for connecting the heart pump to the motor of the present invention. [Figure 29d] Another diagram showing the components for connecting the heart pump to the motor of the present invention. [Figure 29e] Another diagram showing the components for connecting the heart pump to the motor of the present invention. [Fig. 29f] Another diagram showing the components for connecting the heart pump to the motor of the present invention. [Figure 29g] Another diagram showing the components for connecting the heart pump to the motor of the present invention. [Figure 29h] Another diagram showing the components for connecting the heart pump to the motor of the present invention.

[0063] [Figure 30a] Diagram showing the sheath removal process of the present invention using a tension mechanism. [Figure 30b] Another diagram showing the sheath removal process of the present invention using a tension mechanism.

[0064] [Figure 31a] Diagram showing the sheath removal process of the present invention using a pressing mechanism. [Figure 31b]Another view showing the sheath removal process of the present invention using a pressing mechanism.

[0065] [Diagram 32] A side view of the present invention and its motor.

[0066] [Diagram 33] A diagram showing steps 1 and 2 for inserting the arterial version of the present invention into the body.

[0067] [Diagram 34] A diagram showing steps 3 and 4 for inserting the arterial version of the present invention into the body.

[0068] [Diagram 35] A diagram showing step 5 for inserting the arterial version of the present invention into the body.

[0069] [Diagram 36] A cross-sectional view of the heart from step 1 above, showing the placement of the arterial version of the present invention inside the body on the left side of the heart, with the wire located in the left ventricle.

[0070] [Figure 37] A cross-sectional view of the heart from step 2 above, showing the placement of the arterial version of the present invention on the left side of the heart and advancing through the aortic valve into the left ventricle.

[0071] [Figure 38] A cross-sectional view of the heart from step 3 above, showing the placement of the arterial version of the present invention on the left side of the heart and the sheath removal of the present invention passing through the aortic valve.

[0072] [Figure 39] A cross-sectional view of the heart from step 4 above, showing the placement of the arterial version of the present invention on the left side of the heart when the present invention has been completely sheath-removed and the valve conduit valve is closed.

[0073] [Diagram 40] A cross-sectional view of the heart from step 5 showing the placement of the arterial version of the present invention on the left side of the heart when the valve of the guiding catheter is fully open.

[0074] [Figure 41a] A diagram showing the access points by the guide wire 500 for the venous version of the present invention through the femoral vein and the jugular vein. [Figure 41b] Another diagram showing the access points by the guide wire 500 for the venous version of the present invention through the femoral vein and the jugular vein.

[0075] [Figure 42a] A diagram showing the access points by the guide wire 500 for the venous version of the present invention through the subclavian vein and the antecubital veins such as the ulnar cutaneous vein and the radial cutaneous vein. [Figure 42b] Another diagram showing the access points by the guide wire 500 for the venous version of the present invention through the subclavian vein and the antecubital veins such as the ulnar cutaneous vein and the radial cutaneous vein.

[0076] [Diagram 43] A diagram showing the insertion of the venous version of the present invention into the venous system using the femoral vein.

[0077] [Diagram 44] A cross-sectional view of the heart showing Method 1 for placing the venous version of the present invention at the lung position on the right side of the heart.

[0078] [Diagram 45] A cross-sectional view of the heart showing Method 2 for placing the venous version of the present invention at the lung position on the right side of the heart.

[0079] [Diagram 46] A cross-sectional view of the heart showing Method 1 for placing the venous version of the present invention at the tricuspid position on the right side of the heart, introduced via the jugular vein.

[0080] [Figure 47] A cross-sectional view of the heart showing Method 2 of placing the venous version of the present invention at the tricuspid position on the right side of the heart, introduced via the femoral vein.

[0081] [Figure 48] A cross-sectional view of the heart showing the placement of guidewire 500 entering the left ventricle beyond the mitral valve for subsequent placement of the venous version of the present invention. Guidewire 500 enters the right atrium of the heart from the inferior vena cava, crosses the atrial septum into the left atrium, and is positioned within the left ventricle across the mitral valve.

[0082] [Figure 49] A cross-sectional view of the heart showing the placement of the venous version of the present invention at the mitral valve. The venous version of the present invention enters the right atrium of the heart from the inferior vena cava, crosses the atrial septum into the left atrium, and is positioned within the left ventricle across the mitral valve.

[0083] [Figure 50] A cross-sectional view of the heart showing the placement of guidewire 500 within the left ventricle beyond the mitral valve for placement of the venous version of the present invention. Guidewire 500 enters the right atrium of the heart from the superior vena cava, crosses the atrial septum into the left atrium, and is positioned within the left ventricle across the mitral valve.

[0084] [Figure 51] A cross-sectional view of the heart showing the placement of the venous version of the present invention at the mitral valve. The venous version of the present invention enters the right atrium of the heart from the superior vena cava, crosses the atrial septum into the left atrium, and is positioned within the left ventricle across the mitral valve.

[0085] [Figure 52a] A diagram showing the flow profile of the present invention with a restricted opening of the valved conduit valve. [Fig. 52b] Another diagram showing the flow profile of the present invention with a restricted opening of the valved conduit valve.

[0086] [Figure 53a] It is a diagram showing the flow profile of the present invention in a state where the valve conduit valve is fully open. [Figure 53b] It is another diagram showing the flow profile of the present invention in a state where the valve conduit valve is fully open.

[0087] [Figure 54a] It is a diagram comparing the axial flow impeller of the prior art with the impeller of the present invention. [Fig. 54b] It is another diagram comparing the axial flow impeller of the prior art with the impeller of the present invention.

[0088] [Fig. 54c] It is a diagram comparing the axial flow of the axial flow impeller of the prior art with the centrifugal flow of the impeller of the present invention. [Fig. 54d] It is another diagram comparing the axial flow of the axial flow impeller of the prior art with the centrifugal flow of the impeller of the present invention.

[0089] [Figure 55a] It is a side view of the arterial version of the present invention showing the arrangement of the microelectromechanical system (MEMS) pressure sensors 338a / 338b. [Figure 55b] It is another side view of the arterial version of the present invention showing the arrangement of the microelectromechanical system (MEMS) pressure sensors 338a / 338b.

[0090] [Figure 56] It is a side view of the venous version of the present invention showing the arrangement of the microelectromechanical system (MEMS) pressure sensors 338c / 338d.

[0091] [Figure 57] It is a front view of the arterial version of the present invention showing the electrical connection and communication between the arterial version of the present invention and its power supply and monitor.

[0092] [Figure 58]Another front view of the arterial version of the present invention, further showing the electrical connection and communication between the arterial version of the present invention and its power supply and monitor.

DETAILED DESCRIPTION OF THE INVENTION

[0093] The features and advantages of the present disclosure, as well as additional features and advantages, will become readily apparent to those skilled in the art by considering the following detailed description of the exemplary embodiments of the present disclosure and by referring to the accompanying drawings. It should be understood that the present specification and the accompanying drawings, which are exemplary embodiments, are not intended to limit the scope of the claims of this patent or any patent or patent application claiming the priority of this patent. On the contrary, the intention is to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of the claims. Without departing from such spirit and scope, changes may be made to the specific embodiments and details disclosed herein.

[0094] When showing and describing the preferred embodiments in the accompanying drawings, common or similar elements are referred to by the same or identical reference numerals, or are apparent from the drawings and / or description of this specification. The drawings are not necessarily to scale, and certain features and specific views of the drawings may be shown exaggerated or schematically for clarity and brevity.

[0095] When used throughout various parts (and headings) of this specification and this patent application, the terms "disclosure", "the present disclosure" and their variations are not intended to mean all possible embodiments encompassed by the present disclosure or any particular claim. Therefore, the subject matter of each such reference should not be considered necessary or a part thereof for all embodiments of this specification or any particular claim solely for such reference.

[0096] As used in this specification and the appended claims, terms such as "coupled" and variations thereof are intended to mean either an indirect or direct connection or engagement. Thus, when a first device is coupled to a second device, that connection may be a direct connection or an indirect connection through other devices and connections.

[0097] The use of the terms "a", "an", "the" and similar referents in the context of describing the invention (particularly in the context of the following claims) are to be construed to include both the singular and the plural unless specifically indicated otherwise herein or clearly contradicted by the context. Further, note that the terms "first", "second", etc. as used herein do not denote any order, quantity, or importance, but are used to distinguish one element from another.

[0098] Certain terms are used in this specification and the appended claims to refer to particular components. As those skilled in the art will appreciate, different people may refer to components by different names. This document is not intended to distinguish between components that have different names but perform the same function.

[0099] Also, the terms "comprising" and "including" are used non - limitatively in this specification and the appended claims and thus must be construed to mean "including but not limited to". Further, references to singular components and aspects in this specification and the appended claims do not necessarily limit the disclosure or the appended claims to only one of such components or aspects, but should generally be construed to mean one or more as appropriate and desirable in each particular instance.

[0100] Accordingly, the preferred embodiments of the present disclosure provide advantages over the prior art and are well adapted to perform one or more of the objectives of the present disclosure. However, the present disclosure does not require each of the components and operations described above and is in no way limited to the embodiments or methods of operation described above. Any one or more of the above components, features, and processes may be used in any suitable configuration without including other such components, features, and processes. Further, the present disclosure includes additional features, capabilities, functions, methods, uses, and applications that are not specifically addressed herein but will become apparent or will be apparent from the description herein, the accompanying drawings, and the claims.

[0101] As used herein, the suffix “(s)” is intended to include both the singular and plural of the term it modifies, thereby including at least one of that term (e.g., colorant includes at least one colorant). “Optional” or “optionally” means that the subsequent described event or circumstance may or may not occur, and that the description includes instances where the event occurs and instances where it does not. As used herein, “combination” includes blends, mixtures, alloys, reaction products, and the like.

[0102] Next, the present invention will be described more fully hereinafter with reference to the accompanying drawings, in which some preferred embodiments of the present invention are shown. However, the present invention may be embodied in many different forms and should not be construed as limited to the embodiments described herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. Like numbers refer to like elements throughout.

[0103] Referring to FIG. 1, a percutaneous intravascular centrifugal heart pump 300 is used to assist a heart including both the left and right sides of the heart. As used herein, the term "percutaneous intravascular centrifugal heart pump 300" may be simply referred to herein as "heart pump 300" or "pump 300". Its application is directed through the movement of fluid from one location to another to assist the human heart and provide blood supply to the body when the native human heart is weak. The pump 300 may be introduced into the human body via an arterial-arterial percutaneous intravascular centrifugal heart pump 300a or via a venous-venous percutaneous intravascular centrifugal heart pump 300b. As used herein, the term "arterial percutaneous intravascular centrifugal heart pump 300a" may be simply referred to herein as "arterial heart pump 300a" or "heart pump 300a" or "arterial pump 300a". As used herein, the term "venous percutaneous intravascular centrifugal heart pump 300b" may be simply referred to herein as "venous heart pump 300b" or "heart pump 300b" or "venous pump 300b".

[0104] Percutaneous heart pumps have a two-sided nature. Smaller-profile percutaneous heart pumps are easier to insert and can target a larger population, but they result in higher impeller speeds and flow rates and may cause blood cell damage. On the other hand, larger percutaneous heart pumps are difficult to insert and limit the population, but these pumps have lower impeller speeds, lower blood velocities, and can minimize blood cell damage.

[0105] Therefore, its two-sided nature is as follows. JPEG2025519141000002.jpg72170Table 1 below is a comparison between the Impella CP (AbioMed, manufactured in 2016 by AbioMed of Danvers, Massachusetts (www.abiomed.com), "Impella® 2.5, 5.0, LD and Impella CP® INSTRUCTIONS FOR USE & CLINICAL REFERENCE MANUAL for Use During Cardiogenic Shock Impella Ventricular Support Systems") and the present invention.

Table 1

[0106] Accordingly, the present invention (the percutaneous intravascular centrifugal heart pump 300) solves this dichotomy by having a small insertion profile with the ability to operate with a larger profile. This targets a larger population by facilitating insertion access to the human body, and at the same time provides a lower impeller speed to minimize blood cell damage to the patient.

[0107] Preliminary results of the percutaneous intravascular centrifugal heart pump 300 show an output flow rate of 13 L / min at zero head pressure and a flow rate of 9.5 L / min at a head pressure of 80 mmHg. JPEG2025519141000004.jpg82170

[0108] Impeller

[0109] Next, referring to FIGS. 2a - 2g, one of the components that make up the percutaneous intravascular centrifugal heart pump 300 is the impeller 204. The impeller 204 is cut from a single sheet and / or tube of a smart material such as nitinol (FIGS. 2a and 2b). The diameter of the tube can range between about 1.5 mm and about 5 mm, preferably about 2.5 mm.

[0110] The impeller 204 includes an inner wall 203, an impeller outflow end 205, and an impeller inflow end 209. The impeller 204 includes a plurality of stages such as the uppermost stage vanes 200, the middle stage vanes 201, and the lowermost stage vanes 202. Referring to FIG. 2c, the vanes are set in a shape so as to be formed. The finish temperature Af of the austenite transformation of nitinol can be in the range of about 10°C to about 40°C, preferably in the range of about 5°C to about 20°C.

[0111] Each stage has two vanes spaced 180 degrees apart. Referring to FIG. 2d, the uppermost stage vanes 200 include two vanes 200a / 200b, the middle stage 201 includes two vanes 201a / 201b, and the lowermost stage 202 includes two vanes 202a / 202b. The inclination angle of each vane from the horizontal plane may be in the range of 15 degrees to 65 degrees, preferably 35 degrees. Thereby, the diameter of the impeller 204 can be made between about 8 mm and about 20 mm, preferably about 14 mm.

[0112] Furthermore, it includes vanes of each stage shifted in proportion to the number of stages of the impeller 204. Therefore, it follows the following configuration equation.

[0113] α = 180 / L

[0114] In the formula, α is the insertion displacement degree or offset degree that each stage has from the previous vane insertion degree, and L is the number of stages included in the impeller 204. For example, referring to FIGS. 2c and 2e, the impeller 204 having three stages results in an angular displacement of 60 degrees (180 divided by 3) when viewed from the top view (FIG. 2e). Therefore, the angle between the uppermost stage 200a and the middle stage 201a is 60 degrees, and the angle between the middle stage 201a and the lowermost stage 202a is also 60 degrees. The expanded state of the impeller 204 can be in the range of about 9 mm to about 22 mm, preferably about 15 mm.

[0115] As shown in FIG. 2a, the impeller 204 can return the vanes to the closed position when the device is sheathed again. That is, the uppermost vane 200 of the impeller 204 is coupled to the uppermost surface 206, the middle vane 201 is coupled to the middle surface 207, and the lowermost vane 202 is coupled to the lowermost surface 208.

[0116] The design of the impeller 204 is one of the features that enables the percutaneous intravascular centrifugal heart pump 300 to function between about 4,000 RPM and about 25,000 RPM, preferably about 10,000 RPM, which enables it to pump at rates exceeding about 5 L / min.

[0117] Referring to FIGS. 2f and 2g, the impeller 204 may include arterial slots 210a / 210b for entry through the arterial system and venous slots 211a 211b for entry through the venous system.

[0118] The impeller 204 may also include a coating that can be hydrophobic or hydrophilic to minimize thrombus formation.

[0119] The impeller 204 may also include drug elution capabilities for incorporating agents such as heparin to minimize thrombus formation.

[0120] Frame Next, referring to FIGS. 3a - 3d, the percutaneous intravascular centrifugal heart pump 300 includes a frame 303. The frame 303 is manufactured from a single tube of a smart material such as nitinol having a diameter between about 1 mm and about 5 mm, preferably between about 2 mm and about 3 mm. The frame 303 includes an outflow section 313 and an inflow section 314. The frame 303 may include one or two slits 337 (FIGS. 3c - 3d) to facilitate the insertion of a mandrel for shaping and assembling the frame 303. The frame 303 can be shaped (FIG. 3b) at an Af temperature that can range between about 10°C and about 35°C, preferably between about 15°C and about 20°C.

[0121] In its expanded state, the frame 303 may have multiple diameters. Referring to FIG. 3b, the frame 303 may include three different diameters: an upper section 316, a central section 317, and a lower section 318. The upper section 316 may have an expanded diameter between about 10 mm and about 26 mm, with a preferred diameter of about 20 mm. The central section 317 may have an expanded diameter between about 9 mm and about 20 mm, with a preferred diameter of about 15 mm. The lower section 318 may have an expanded diameter between about 10 mm and about 26 mm, with a preferred diameter of about 18 mm. These diameter variations form the valve anchors 311 / 312. The upper valve anchor 311 is designed to be attached to the upper section of the native valve tip, and the lower valve anchor 312 is designed to be attached to the lower section of the native heart valve tip. This design allows the frame 303 to self - fix. The anchors 311 / 312 help to stabilize the percutaneous intravascular centrifugal heart pump 300 during positioning and operation. These diameters are larger than those of prior art devices and, as a result, help to more securely fix the frame to the native valve tip and prevent early release or dislodgment.

[0122] Considering the designs and materials used as discussed herein, the present invention provides a small - diameter percutaneous intravascular centrifugal heart pump (between about 3 and about 4 mm, see Table 1 above) during implantation, but the frame 303 can expand to preferably three different ranges of diameters depending on its upper section 316, central section 317, and lower section 318 as noted above. This expansion provides a significant improvement over the prior art by providing enhanced anchor points to the native valve tip as noted herein.

[0123] Thus, by selecting a 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 have a small diameter, but once the sheath is removed, it expands to an enhanced diameter of the three sections of the frame, providing a firm fixation to the native valve cusp and an enhanced impeller size to improve the flow within the valve conduit 301 as discussed herein.

[0124] Nitinol is known as a smart material or SMM or SMT. Nitinol is an alloy of nickel and titanium and is used in the manufacture of vascular stents. The material is first shaped into a predetermined shape and then compressed and held in place, for example, by a sheath. After this is placed at the desired location within the human body, the sheath or other compression means such as a winding wire is removed. Then, the heat of the body returns the material to its original shape.

[0125] Thus, in the present invention, the frame 303 is first shaped into a predetermined shape, for example, as shown in FIG. 3b or FIG. 3d, to include the anchor points 311 / 312. Then, as described herein, it is contracted or compressed and held in place as described herein and shown in FIGS. 3a and 3c. When the heart pump 300a or 300b is positioned at the desired location within the heart, the sheath is removed and the frame 303 is expanded to its predetermined shape having the previously formed anchor points 311 / 312. The frame 303 may also include a drug elution ability for incorporating a drug such as heparin to minimize thrombus formation.

[0126] Overview of Arterial Percutaneous Intravascular Centrifugal Heart Pump

[0127] Next, referring to FIGS. 4a and 4b, the heart pump 300a includes a stator 310, an inner shaft 308, an impeller 204, a frame 303, a shaft stabilizing device 304, and an insertion tip 305. During operation of the present invention, the impeller 204 and the shaft 308 rotate, while the remaining components (stator 310, frame 303, shaft stabilizing device 304, insertion tip 305) do not rotate. The stator 310 is attached to the frame 303, and the frame is attached to the insertion tip 305 by an adhesive and / or mechanical attachment. The adhesive is a medical grade epoxy.

[0128] Next, referring to FIGS. 5a and 5b, the impeller joint 306 is attached to the impeller 204 and the shaft 308 at each of its ends. The impeller joint 306 includes two channels 328a / 328b that are inserted along the impeller slots 210a / 210b of the impeller 204. Thus, the impeller joint channels 328a / 328b can guide the insertion of the impeller 204 and assist in the transmission of rotational force to the impeller 204. Further, if the connection of the impeller 204 to the shaft 308 is impaired, the impeller joint channels may act as a fixing mechanism for the impeller 204.

[0129] Next, referring to FIGS. 5a, 5b, and 6, the insertion of the impeller 204 onto the shaft 308 is performed by sliding the impeller outflow end 205 completely to the shaft distal end 325 until it reaches the impeller joint 306 and the impeller joint channels 328a, 328b are aligned with and inserted into the impeller slots 210a, 210b.

[0130] Next, referring to FIGS. 3a - 3d, 4a, 4b, 5a, 5b and 6, the frame 303 may have one or two slits 337 at both ends, i.e., the inlet section 314 and the outlet section 313, to allow insertion of the shaft 308 having the impeller 204 for assembly. The frame 303 is attached to the stator 310 by adhering the outlet section 313 to the distal end of the stator 310. Further, the shaft stabilizer 304 is disposed by inserting the distal end 325 into the shaft stabilizer inlet 333. The shaft stabilizer 304 is then attached to the frame 303 by adhering the inlet section 314 of the frame to the shaft stabilizer frame fixture 335.

[0131] Referring to FIGS. 5a - 5b and 6, the shaft stabilizer 304 has heat and fluid dissipation ports within the proximal 331a / 331b and distal 332a / 332b. These ports can promote heat transfer and minimize flow stagnation between the shaft 308 and the shaft stabilizer 304. The shaft stabilizer heat dissipation proximal ports 331a / 331b may be 180 degrees apart. Further, the distal ports 332a / 332b may also be 180 degrees apart for heat dissipation of the shaft stabilizer. The longitudinal spacing between the ports 331a / 331b and the ports 332a / 332b may range between about 5 mm and about 50 mm, preferably about 18 mm. The diameters of the ports 331a / 331b and 332a / 332b may range between about 0.10 mm and about 3 mm, preferably about 1 mm.

[0132] FIG. 7a shows a side view of the arterial heart pump 300a having the stator 310, the valve conduit 301, the valve conduit valve 302, the frame 303, and the insertion tip 305.

[0133] FIG. 7b shows a cross - sectional view of the arterial heart pump 300a having the impeller 204 and the shaft 308.

[0134] Next, referring to FIGS. 8a and 8b, an arterial heart pump 300a is shown, depicting the interaction of the stator 310, shaft 308, impeller 204, frame 303, insertion tip 305, shaft stabilization device 304, valve conduit 301, and valve conduit valve 302a. The frame 303 is attached to a shaft stabilization device frame fixture 335. The shaft 308 is inside the inner wall 336 of the shaft stabilization device. The shaft 308 is not fixed to the shaft stabilization device 304 and the insertion tip 305. The outer wall 321 and the inner wall 336 of the shaft stabilization device form an annular gap 334. The shaft stabilization device 304 has a clearance between the inner wall 336 of the shaft stabilization device and the outer wall 321 of the shaft of about 0.10 mm to about 1 mm. The shaft 308 includes a lumen 315 that allows a guide wire to pass through. The guide wire can exit the lumen 315 in the insertion tip lumen 309.

[0135] FIGS. 9a - 9c show side, front, and right side views of the arterial percutaneous intravascular centrifugal heart pump 300a. As shown, 300a has a stator 310, which is attached to the frame 303 and includes a valve conduit 301, valves 302a / 302b / 302c, a frame 303, an insertion tip 305, and a shaft stabilization device 304. The valve conduit 301 may be made of biological and synthetic materials. Biological materials such as sheep, bovine, or porcine pericardium are shown in FIGS. 9 - 11. Synthetic materials may be polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), silicone, polyethylene, polyurethane, and nylon.

[0136] Further referring to FIGS. 9 - 11, the valve conduit 301 may have a thickness in the range of about 0.01 mm to 0.30 mm, preferably about 0.05 mm. The valve conduit 301 may be disposed outside the frame 303, inside the frame 303, or both outside and inside the frame 303. The valve conduit 301 may conform to the geometry of the frame 303 and maintain the upper section 316 and the frame central section 317 in a fixed state at 311 and 312.

[0137] During insertion, the sheath 504 keeps the valve conduit 301, the valve conduit valves 302a / 302b 302c, the frame 303, and the impeller 204 in a contracted state. When the sheath 504 retracts, the valve conduit 301, the valve conduit valves 302a / 302b / 302c, the frame 303, and the impeller 204 expand as shown in FIGS. 10a and 10b. The sheath 504 requires sufficient tensile strength to accommodate the folded components. The sheath 504 may be made of a polymer such as PTFE, FTP, ETFT, polypropylene or polyethylene, or a combination of a metal and a polymer such as nitinol, stainless steel, cobalt chrome. The sheath 504 may have a diameter in the range of about 1 mm to about 6 mm, preferably about 3 mm. The sheath 504 may have a wall thickness in the range of about 0.01 mm to about 0.6 mm, preferably about 0.25 mm.

[0138] Referring now to FIGS. 9a-9c as well as FIGS. 10a and 10b, the conduit valve 302a / 302b / 302c may have a thickness that can range from about 0.01 mm to about 0.35 mm, preferably about 0.05 mm. The valve 302 may comprise a plurality of valves such as 302a / 302b / 302c, although two or three valves are preferred. The valve 302a / 302b / 302c may have a restricted opening as shown in FIGS. 9a-9c, or a fuller opening as shown in FIGS. 10a and 10b. Referring to FIG. 14, the valve conduit 301 may also include a circulation jet 327 that allows fluid to move and minimizes stagnant flow.

[0139] The valve conduit valves 302a / 302b / 302c are actuated in response to differential pressure. When the pressure inside the valve conduit 301 is greater than the pressure outside the valve conduit 301, the conduit valves 302a / 302b / 302c open as shown in FIGS. 10a-10b and 11b. However, when the pressure outside the valve conduit 301 is greater than the pressure inside the valve conduit 301, the valves 302a / 302b / 302c close as shown in FIG. 12b to prevent backflow.

[0140] The arterial percutaneous intravascular centrifugal heart pump 300a sucks fluid from the inflow section of the frame 303 and transfers the fluid across the valve conduit 301 towards the outflow outer valves 302a / 302b / 302c as shown in Fig. 12c.

[0141] Fig. 13 is a bottom view of the arterial percutaneous intravascular centrifugal heart pump 300a. This shows the impeller 204 and the valve conduit valves 302a / 302b / 302c. Further, the top view of the arterial heart pump 300a (Fig. 14) shows the valve conduit 301, the valve conduit valves 302a / 302b / 302c, and the conduit circulation jets 327a / 327b / 327c.

[0142] Overview of the venous percutaneous intravascular centrifugal heart pump

[0143] Referring to Fig. 15, the venous percutaneous intravascular centrifugal heart pump 300b can be inserted into the patient's body via the venous system. The venous percutaneous intravascular centrifugal heart pump 300b has a sheath 504, a frame 303, a shaft 308, a valve conduit 301, valve conduit valves 302a / 302b / 302c, a venous shaft stabilizer 319, and an insertion tip 305.

[0144] Fig. 16 shows a cross-section of the venous heart pump 300b, further showing the sheath 504, the stator 310, the frame 303, the valve conduit 301, the impeller 204, the conduit valves 302a / 302b, the venous shaft stabilizer 319, and the insertion tip 305.

[0145] FIG. 17 is a detailed view A of FIG. 16 showing the interaction between the impeller 204, the frame 303, the venous shaft stabilization device 319, and the insertion tip 305. The frame 303 is attached to the venous shaft stabilization device frame slot 324. The outflow section 313 of the frame 303 is inserted into the venous shaft stabilization device frame slot 324 and is typically adhered using a medical grade epoxy or equivalent binder. The shaft 308 (FIG. 16) is not attached to either the frame 303 or the venous shaft stabilization device 319. When the frame 303 is folded, the shaft 308 does not move. However, the frame 303 and the venous shaft stabilization device 319 are longitudinally displaced relative to each other such that the frame 303 is able to reduce its diameter. When the frame 303 is folded, the venous shaft stabilization device inner wall 320 advances over the shaft outer wall 321, and thus the outer wall 321 remains within the inner wall 320 of the venous shaft stabilization device 319. When the frame 303 expands, the venous shaft stabilization device inner wall 320 moves longitudinally rearward over the shaft outer wall 321. Thus, one of the purposes of the venous shaft stabilization device 319 is to minimize and stabilize the movement of the shaft 308 while the shaft 308 is rotating.

[0146] Referring now to FIG. 18, a top view of the venous heart pump 300b is shown, depicting the valve conduit 301, the valves 302a / 302b / 302c, and the recirculation flow jets 327a / 327b / 327c. The recirculation flow jets 327a / 327b / 327c serve to minimize flow stagnation. The recirculation flow jets 327a / 327b / 327c are preferably openings that allow the fluid to move in response to pressure. The diameter of each opening 327a / 327b / 327c may vary between about 0.1 mm and about 3 mm, and may preferably be about 0.5 mm. Each valve conduit 301 includes one or more recirculation flow jets 327a / 327b / 327c.

[0147] Next, referring to FIGS. 19a-19b, FIGS. 20a-20b, FIG. 21, FIG. 22, and FIG. 23, impeller 204 is attached to shaft 308 at its proximal end and to shaft distal end 325 at its distal end. Impeller slides 210a / 210b are aligned with shaft impeller channels 328a / 328b. Impeller inlet end 209 is aligned with impeller junction 306. Impeller 204 is adhered to shaft 308 using a medical grade epoxy or equivalent adhesive. Shaft 308 is inside venous shaft stabilizer 319, and impeller outlet end 205 faces venous shaft stabilizer inlet 326. During operation of venous pump 300b, impeller 204 and shaft 308 rotate, while the remaining components (stator 310, frame 303, venous shaft stabilizer 319, insertion tip 305) do not rotate. Venous shaft stabilizer 319 has heat and fluid dissipation ports proximally 329a / 329b and distally 330a / 330b. These ports can facilitate heat transfer and minimize flow stagnation between shaft 308 and venous shaft stabilizer 319. The heat dissipation proximal ports 329a / 329b of the venous shaft stabilizer may be 180 degrees apart. Further, the distal ports 330a / 330b may also be 180 degrees apart for heat dissipation of the shaft stabilizer. The longitudinal spacing between ports 329a / 329b and ports 330a / 330b may range between about 5 mm and about 50 mm, preferably about 18 mm. The diameters of ports 329a / 329b and 330a / 330b may range between about 0.10 mm and about 3 mm, preferably about 1 mm.

[0148] Overview of arterial pump 300a vs. venous pump 300b

[0149] Referring to FIG. 24, a comparison between an arterial percutaneous intravascular centrifugal heart pump 300a and a venous percutaneous intravascular centrifugal heart pump 300b is shown. Inflow and outflow are reversed in the venous percutaneous intravascular centrifugal heart pump 300b as compared to the arterial percutaneous intravascular centrifugal heart pump 300a and the valve conduit 301, the frame 303, and the valve conduit valves 302a / 302b / 302c. Further, the venous shaft stabilizer 319 extends onto the venous heart pump 300b as compared to the shaft stabilizer 304 of the arterial device 300a.

[0150] Motor connection

[0151] Next, referring to FIGS. 25a and 25b, a motor 501 drives the heart pump 300. A stator motor connector 502 attaches the stator 310 and the shafts 308 and 308 to the motor 501. The connector 502 may include flushing ports 503a / 503b. The ports 503a / 503b are used to add or remove fluid from inside the stator 310 and the shafts 308. To achieve this connection, Luer locks 512a / 512b may be used. The ports 503a / 503b may be connected to a continuous fluid injection pump to lubricate the system and reduce frictional and vibrational forces.

[0152] Referring further to FIGS. 25a-25b, and also to FIGS. 26a-26b, 27a-27b, and 28, motor 501 may include a motor shaft 517 that drives shaft 308. Preferably, motor shaft 517 is attached to motor joint 522 by a fastener or adhesive, thereby fixing motor joint 522 to motor shaft 517. Motor joint 522 may include one or more magnets 509a / 509b / 509c / 509d. Motor joint 522 may have magnet slots 523a / 523b / 523c / 523d, where magnets 509a / 509b / 509c / 509d may be inserted. Rotational joint 513 is attached to shaft 308 by chemical adhesion or electromagnetic force. Rotational joint 513 may include magnets 510a / 510b / 510c / 510d within magnet slots 524a / 524b / 524c / 524d. Magnet slots 523d and 524d are not shown in the figure because they are located on the opposite side of the figure.

[0153] Further referring to FIGS. 25a - 25b, FIGS. 26a - 26b, FIGS. 27a - 27b, and FIG. 28, the shaft 308 is attached to the bearing 519 (FIG. 26b) by attaching the shaft outer wall 321 to the inner ring 528 of the bearing 519. Again, the attachment can be achieved by adhering using a medical - grade epoxy or equivalent agent. The bearing 519 allows the shaft 308 to rotate while the stator motor connector 502 remains stationary. The bearing 519 includes ball bearings 515a / 515b that rotate the shaft 308 while maintaining the stator motor connector 502 in a stationary state. A seal 529 that prevents fluid from escaping or leaking past the bearing. The bearing 519 includes an outer ring 527 that is attached to the stator motor connector 502 and does not rotate. The bearing 519 may have ball bearings 515a / 515b / 515c / 515d that are rotatable to allow the inner ring 528 to rotate while the outer ring 527 remains stationary. This allows the shaft 308 to be rotated while the stator motor connector 502 and the stator 310 remain stationary.

[0154] Referring to FIGS. 25a-25b and FIGS. 26a-26b, the stator motor connector 502 is attached to the stator 310. The shaft 308 includes a guide wire port 521 to allow fluid to enter the shaft lumen 322, minimize flow stagnation, and provide lubrication to the guide wire. Fluid can be inserted or removed through the flushing ports 503a / 503b. The fluid enters and exits through the flushing port lumens 514a / 514b and enters the lubrication region 516. The fluid can enter the guide wire lubrication port 521 and the shaft-stator gap 526. The gap 526 is the space between the shaft outer wall 321 and the stator lumen 307. The rotary joint 513 is connected to the shaft lumen 322 and has a lumen 525 that allows the guide wire to enter and exit. This is done by the guide wire 500 entering the rotary joint lumen 525 and then entering the shaft lumen 322. The rotary joint lumen 525 is sealed by a guide wire seal device 511 when the motor joint 522 is inserted. The guide wire seal 511 may be made of a polymer such as silicone, nylon, PTFE, or a metal such as stainless steel, cobalt-chromium, or a combination of polymer and metal. The guide wire seal 511 is attached to the motor joint 522. Thus, when the motor joint 522 is connected to the rotary joint 513, the rotary joint lumen 525 is sealed.

[0155] Referring to FIGS. 27a-27b, 28, and 29a-29h, the motor joint 522 is attached to the motor 5501. The rotary joint 513 is attached to the stator motor connector 502. The rotary joint 513 includes connection guides 536a / 536b / 536c / 536d that minimize the area and thus facilitate insertion into the upper surface 533 of the motor joint (FIGS. 29a-29h). This is further guided by the motor joint gradients 532a / 532b / 532c / 532d. The connection is further facilitated by the motor joint magnets 509a / 509b / 509c / 509d and the rotary joint magnets 510a / 510b / 510c / 510d. The magnets are arranged such that the motor joint 522 and the rotary joint 513 are attracted to each other by arranging opposite poles of the magnets at each joint. For example, the motor joint magnet 509a may have an N pole and the rotary joint magnet 510 may have an S pole, thus generating an attractive force. This setting may be repeated for the remaining motor joint magnets 509b / 509c / 509d and the remaining rotary joint magnets 510b / 510c / 510d. This magnetic attractive force locks the motor joint to the rotary joint and thus mates the upper surface 533 of the motor joint with the inner portion 537 of the rotary joint.

[0156] Sheath removal, repositioning, recapture, and control release process

[0157] Next, referring to FIGS. 30a, 30b, 31a, and 31b, to remove the sheath, the sheath valve adapter 505 and the sheath 504 are pulled along the stator 310 toward the stator motor connector 502, and thus, as shown in FIG. 30b, the sheath valve adapter 505 can be drawn toward the stator motor connector 502. Such a pressing force may be achieved by pushing the stator motor connector 502 along the stator 310 toward the sheath valve adapter 505 and the sheath 504. Thereby, the stator motor connector 502 is drawn toward the sheath valve adapter 505 (FIGS. 31a - 31b). All of these operations use fluoroscopy and ultrasound guidance to remove the valve conduit 301 and the impeller 204 from the sheath in a controlled release manner. If the deployment is not satisfactory, the device may be recaptured and repositioned.

[0158] Referring to FIG. 32, when sheath removal is complete, the guide wire 500 may be removed. At this point, the motor 501 is connected to the stator motor connector 502 at the motor junction 522. The motor 501 is joined to the stator motor connector 502 using the rotating junction magnets 510a - 510d and the motor junction magnets 509a - 509d.

[0159] To re - sheath or recapture the percutaneous intravascular centrifugal heart pump 300, the sheath valve adapter 505 and the sheath 504 are pulled away from the stator motor connector 502 along the stator 310. This can be done by either pushing or pulling on the different components described.

[0160] Insertion of the Arterial Percutaneous Intravascular Centrifugal Heart Pump

[0161] The insertion of the arterial percutaneous intravascular centrifugal heart pump 300a into the human body 602 can be summarized in five steps as shown in FIGS. 33 - 35.

[0162] Step 1 shown in FIG. 33 is to evaluate the human body 602 by identifying access to the patient. The access is first made through the femoral artery 603. Alternative accesses can be the brachial artery or axillary artery or direct aortic puncture if the present invention may be required when performing open heart surgery.

[0163] Step 2 is to insert the guide wire 500 into the femoral artery 603, advance it across the abdominal aorta 604 towards the descending aorta 605, cross the aortic arch 606, and pass through the ascending aorta 404 to enter the left ventricle 400 (see also FIG. 36).

[0164] Step 3 (FIG. 34) - When the guide wire 500 is in place, the arterial percutaneous intravascular centrifugal heart pump 300a is advanced by inserting the guide wire 500 into the insertion tip lumen 309. The insertion tip 305 is advanced within the human body 602 by penetrating the skin and entering the femoral artery 603. The arterial percutaneous intravascular centrifugal heart pump 300a is further advanced to the abdominal aorta 604, descending aorta 605, aortic arch 606, and ascending aorta 404 while crossing the aortic valve tip 403.

[0165] Step 4 (FIG. 34) - When the arterial percutaneous intravascular centrifugal heart pump 300a is pulled or pushed together with the sheath 504 and the stator motor connector 502 to remove the sheath, the guide wire 500 can be removed by placing the pump across the aortic valve tip 403. When the guide wire 500 is removed, the motor 501 may be connected to the arterial percutaneous intravascular centrifugal heart pump 300a by the stator motor connector 502.

[0166] Step 5 (FIG. 35) - When the motor 501 is connected to the stator motor connector 502, the motor may be turned on, thereby rotating the motor shaft 517, as well as the shaft 308 and the impeller 204. Thereby, blood is driven from the left ventricle 400 towards the ascending aorta 404 across the valve conduit 301, unloading the left ventricle 400.

[0167] Vascular access is obtained using anatomical landmarks, radiological landmarks, and ultrasound-guided vascular access. The aim is to access the artery within the anterior wall of the vessel. For femoral access, the goal is to access the femoral artery 603 above the bifurcation and below the tangent traced at the upper edge of the femoral head. In the case of the axillary artery, the plan is to access the vessel in the upper third of the humerus using anatomical landmarks, radiological landmarks, and ultrasound-guided access, with special care taken not to interfere with the brachial plexus.

[0168] The artery is accessed using the Seldinger technique in which the needle is advanced from the skin towards the vessel. When the needle is within the vessel, the wire is advanced into the artery. The needle is withdrawn and the introducer sheath is advanced over the wire into the artery. Once vascular access is achieved, the introducer sheath is aspirated and flushed. A pigtail catheter is advanced over the wire into the left ventricle 400. The wire is removed and the catheter is aspirated and cleaned. Anticoagulation is initiated to achieve an ACT level between 250 and 300. The left ventricular pressure is recorded.

[0169] Next, a guide wire 500 (preferably about 0.035 inches in diameter) is advanced inside the pigtail catheter and preferentially enters the left ventricle 400. When the guide wire 500 is positioned within the left ventricle 400 and first the pigtail and then the insertion sheath are removed from the body 602, the arterial percutaneous intravascular centrifugal heart pump 300a is advanced within the left ventricle 400 over the guide wire 500. As the folded valve conduit 301 segment of the sheath 504 passes the aortic valve cusp 403, the sheath 504 is retracted onto the stator 310 or the stator 310 is advanced over the guide wire 500 to sheath extract the valve conduit 301 having the impeller 204 inside. When the valve conduit 301 has passed the aortic valve cusp 403 and is fully expanded, the guide wire 500 is withdrawn from the body 602 and the stator motor junction 502 of the arterial percutaneous intravascular centrifugal heart pump 300a is coupled to the motor junction 522 and the motor 501. Hemodynamic support is initiated while performing a continuous wash with a special solution to maintain anticoagulation.

[0170] Deployment of an Arterial Percutaneous Intravascular Centrifugal Heart Pump into the Aorta

[0171] Refer to FIGS. 36 - 38

[0172] Left ventricular wall 401

[0173] Mitral valve 402

[0174] Right atrium 405.

[0175] Tricuspid valve 406

[0176] Right ventricle 407

[0177] Right ventricular wall 408

[0178] Left atrium 409

[0179] Pulmonary valve cusp tip 410

[0180] Pulmonary valve cusp base 411

[0181] Pulmonary artery 412

[0182] The guide wire 500 is advanced across the ascending aorta 404, across the aortic valve leaflet 403, and into the left ventricle 400. When the guide wire 500 is properly positioned, the arterial percutaneous intravascular centrifugal heart pump 300a is advanced along the guide wire 500 through the insertion tip lumen 309. When the insertion tip 305 crosses the aortic valve leaflet 403, the sheath removal process may be initiated.

[0183] Next, referring to FIGS. 38 - 40, when the arterial percutaneous intravascular centrifugal heart pump 300a is sheath - removed, the sheath 504 is retracted from the insertion tip 305, and the sheath is being retracted. The frame 303 begins to expand and may interact with the aortic valve leaflet 403. When the arterial percutaneous intravascular centrifugal heart pump 300a is completely sheath - removed, the valve conduit 301 may fully interact with the aortic valve leaflet 403. At this point, most of the valve conduit is within the ascending aorta 404. The frame central section 317 may rest on the aortic valve leaflet 403, the bottom section of the fixed valve 312 may rest on the lower portion of the aortic valve leaflet 403, and the upper section of the fixed valve 311 may also rest on the aortic valve leaflet 403 (FIG. 39).

[0184] When the arterial percutaneous intravascular centrifugal heart pump 300a is sheath - removed, the guide wire 500 is removed. The valve conduit valve 302 prevents blood flow from entering the left ventricle 400. When the left ventricle 400 contracts to generate a positive pressure, the valve conduit valve 302 opens when the ventricular pressure is greater than the aortic pressure. Further, when the aortic pressure is greater than the ventricular pressure, the valve conduit valve 302 closes, thereby minimizing backflow. The valve conduit valve 302 allows time for the placement of the motor 501. When the motor 501 is connected and turned on, the impeller 204 opens the valve conduit valve 302 and generates a pressure to unload the left ventricle 400 (see FIG. 40).

[0185] Insertion of the venous percutaneous intravascular centrifugal heart pump

[0186] Refer to FIGS. 41a - 41b, FIGS. 42a - 42b, and FIG. 43

[0187] Great saphenous vein 609

[0188] Kidney 610

[0189] Radial vein 611

[0190] Brachial vein 612

[0191] Right heart 613

[0192] Cephalic vein 614

[0193] Internal jugular vein 615

[0194] Ulnar vein 616

[0195] Medial cubital vein 617

[0196] Jugular vein 618

[0197] Ulnar cutaneous vein 619

[0198] The insertion of the venous percutaneous intravascular centrifugal heart pump 300b has a plurality of entry points within the human body 602.

[0199] The first entry point passes through the great saphenous vein 609. The guide wire 500 enters from the great saphenous vein 609 and is inserted into the body 602, and is advanced through the kidney 610 and the inferior vena cava 414 (Figure 41a). Then, the guide wire 500 enters the right side of the heart 613.

[0200] The second entry point passes through the jugular vein 615. The guide wire 500 enters from the jugular vein 615 and is inserted into the body 602, and is advanced through the cephalic vein and the superior vena cava 413 (Figure 41b). Then, the guide wire 500 enters the right side of the heart 613.

[0201] The third entry point passes through the subclavian vein 620. The guide wire 500 enters from the subclavian vein 620 and is inserted into the body 602 and advanced through the brachiocephalic vein and the superior vena cava 413 (FIG. 42a). Then, the guide wire 500 enters the right side of the heart 613.

[0202] The fourth entry point passes through the ulnar cutaneous vein 619, the medial cubital vein 617 or the radial cutaneous vein 618. The guide wire 500 enters the body from the medial cubital vein 617, the ulnar cutaneous vein 619, or the radial vein 618. The guide wire is advanced while passing through the subclavian vein 620, the brachiocephalic vein 614, and the superior vena cava 413 (FIG. 42b). Then, the guide wire 500 enters the right side of the heart 613.

[0203] The guide wire 500 provides guidance for the venous percutaneous intravascular centrifugal heart pump 300b at each of these four entry points (FIG. 43). The venous pump 300b has a hollow space throughout to allow the insertion of the guide wire 500. When the guide wire 500 is inserted into the venous heart pump 300b, the venous heart pump 300b is advanced into the body 602 over the guide wire 500 along the path established by the guide wire 500. Throughout the insertion of the venous heart pump 300b, the guide wire 500 remains stationary. Thus, the venous heart pump 300b can enter the body through the four entry points mentioned, namely the femoral vein 609, the jugular vein 615, the subclavian vein 620, and the medial cubital vein 617 or the radial cutaneous vein 618.

[0204] When the venous percutaneous intravascular centrifugal heart pump 300b reaches its final position, it is sheath - removed, then the guide wire 500 is removed, and the motor 501 is connected (see FIG. 32). The motor connection of the venous percutaneous intravascular centrifugal heart pump 300b is the same as that of the arterial percutaneous intravascular centrifugal heart pump 300a.

[0205] Vascular access is obtained using anatomical landmarks, radiographic landmarks, and ultrasound-guided vascular access. The aim is to access the femoral vein 609, jugular vein 615, or subclavian vein 620 on the anterior wall of the blood vessel, and the veins of the upper limb.

[0206] The vein is accessed using the Seldinger technique where the needle is advanced from the skin towards the blood vessel. When the needle is within the blood vessel, the wire is advanced into the vein. The needle is withdrawn and the insertion sheath is advanced over the wire into the selected vein. Once vascular access is achieved, the insertion sheath is aspirated and flushed. Next, anticoagulation is initiated to achieve an ACT level between 250 and 300.

[0207] The pigtail catheter or Swan Ganz catheter is advanced into the right atrium 405, right ventricle 407, and pulmonary artery 412. All pressures are recorded. Next, the guide wire 500 (also preferably about 0.035 inches in diameter here) is advanced into the pulmonary artery 412 or its branches using the pigtail catheter or Swan Ganz catheter. When the guide wire 500 is positioned in the pulmonary artery 412 or one of its branches, the pigtail or Swan Ganz catheter is removed, and subsequently the insertion sheath is removed from the body 602. Then, the venous percutaneous intravascular centrifugal heart pump 300b is introduced and advanced into the pulmonary artery 412. When the folded valve conduit 301 segment of the sheath 504 crosses the aortic valve, the sheath is retracted on the stator or the stator is advanced on the wire to sheath-remove the valve conduit 301 with an impeller inside. When the valve conduit 301 is fully expanded crossing the pulmonary valve tip base 410 and pulmonary valve tip apex 411, the guide wire 500 is withdrawn from the body 602, and the stator motor junction 502 of the venous percutaneous intravascular centrifugal heart pump 300b is coupled to the motor junction 522 and the motor 501. Hemodynamic support is initiated while continuously flushing with a special solution to maintain anticoagulation.

[0208] Pulmonary Placement of Venous Percutaneous Intravascular Centrifugal Heart Pump

[0209] Refer to FIGS. 44 to 45

[0210] Pulmonary valve tip 410

[0211] Pulmonary valve base 411

[0212] Pulmonary artery 412

[0213] Superior vena cava 413

[0214] Inferior vena cava 414

[0215] There are two insertion methods for the pulmonary placement of the venous percutaneous intravascular centrifugal heart pump 300b.

[0216] Referring to FIG. 44, one method is to advance the guide wire 500 across the superior vena cava 413, cross the tricuspid valve 406, enter the right ventricle 407, and cross to enter the pulmonary artery 412. Further, the venous percutaneous intravascular centrifugal heart pump 300b is advanced on the guide wire 500 between the right ventricle 407 and the pulmonary artery 412. When this is achieved, the venous percutaneous intravascular centrifugal heart pump 300b is sheath-removed by retracting the sheath 504 from the insertion tip 305 (FIG. 44). During the sheath removal process, the valve conduit 301 contacts the pulmonary valve tip 411. Thus, the frame central section 317 is firmly fixed to the pulmonary valve tip 411 because the diameter of the central section 317 is enhanced compared to the prior art. The frame lower section 318 remains within the right ventricle 407, and the frame upper section 316 remains within the pulmonary artery 412. When deployment and delivery are complete, the guide wire 500 may be removed, followed by connection of the motor. The advantage of the valve conduit valves 302a to 302c is that they replace the function of the native pulmonary valve and minimize the occurrence of backflow during the removal process of the guide wire 500 and the connection of the motor 501. If the present invention is not fully deployed, this can be recaptured by repositioning.

[0217] Referring to FIG. 45, the second method is to advance the guide wire 500 across the inferior vena cava 414, across the tricuspid valve 406, into the right ventricle 407, and across into the pulmonary artery 412. As described above, during the sheath removal process, the valve conduit 301 contacts the tip 411 of the pulmonary valve cusp, while the frame central section 317 also firmly fixes itself to the tip 411 of the pulmonary valve cusp here. The frame lower section 318 remains within the right ventricle 407, and the frame upper section 316 remains within the pulmonary artery 412. When deployment and delivery are complete, the guide wire 500 is removed and subsequently the motor is connected. The advantage of the valve conduit valves 302a - 302c is that they replace the function of the native pulmonary valve and minimize the occurrence of backflow during the removal process of the guide wire 500 and the connection of the motor 501.

[0218] Tricuspid Valve Placement of a Venous Percutaneous Intravascular Centrifugal Heart Pump

[0219] There are two insertion methods for the tricuspid placement of the venous percutaneous intravascular centrifugal heart pump 300b.

[0220] Referring to FIG. 46, one method is to advance the guide wire 500 across the superior vena cava 413, across the tricuspid valve 406, and into the right ventricle 407. The venous percutaneous intravascular centrifugal heart pump 300b is advanced over the guide wire 500 between the right atrium 405 and the right ventricle 407. Once this is achieved, the venous percutaneous intravascular centrifugal heart pump 300b is sheath-removed by retracting the sheath 504 from the insertion tip 305. During the sheath removal process, the valve conduit 301 contacts the tricuspid valve 406, and the frame central section 317 is fixed to the tricuspid valve 406 because the diameter of the central section 317 is increased compared to prior art devices. The frame lower section 318 remains within the right atrium 405, and the frame upper section 316 remains within the right ventricle 407. When deployment and delivery are complete, the guide wire 500 is removed and subsequently the motor is connected. The advantage of the valve conduit valves 302a - 302c is that they replace the function of the native tricuspid valve 406 and minimize the occurrence of backflow during the removal process of the guide wire 500 and the connection of the motor 501.

[0221] Referring to FIG. 47, a second method is to advance the guide wire 500 across the inferior vena cava 414, across the tricuspid valve 406, and into the right ventricle 407. The venous percutaneous intravascular centrifugal heart pump 300b is advanced over the guide wire 500 between the right atrium 405 and the right ventricle 407. Once this is achieved, the venous percutaneous intravascular centrifugal heart pump 300b is sheath-removed by retracting the sheath 504 from the insertion tip 305. During the sheath removal process, the valve conduit 301 contacts the tricuspid valve 406, and the frame central section 317 firmly fixes itself to the tricuspid valve 406, while the frame lower section 318 remains within the right atrium 405 and the frame upper section 316 remains within the right ventricle 407. When deployment and delivery are complete, the guide wire 500 is removed and subsequently the motor is connected. The advantage of the valve conduit valves 302a - 302c is that they replace the function of the native tricuspid valve 406 and minimize the occurrence of backflow during the removal process of the guide wire 500 and the connection of the motor 501.

[0222] Mitral Valve Placement of a Venous Percutaneous Intravascular Centrifugal Heart Pump

[0223] There are two insertion methods for the mitral valve placement of the venous percutaneous intravascular centrifugal heart pump 300b.

[0224] Referring to FIG. 48, one method is to advance the guide wire 500 across the inferior vena cava 414, across the right atrium 405, across the atrial septum into the left atrium 409, and across the mitral valve 402 into the left ventricle 400. To achieve access to the left side of the heart, this is done by a transseptal puncture in which a small puncture is made in the atrial septum located between the right atrium 405 and the left atrium 409. Thus, the puncture of the right atrium 405 provides access to the left side of the heart. Further, the guide wire 500 enters the left atrium 409 and enables it to cross the mitral valve 402 and enter the left ventricle 400.

[0225] Referring to FIG. 49, when the guide wire 500 is within the left ventricle 400, the venous percutaneous intravascular centrifugal heart pump 300b is advanced over the guide wire 500 and crosses the right atrium 405 to enter the left atrium 409 and the left ventricle 400. The venous percutaneous intravascular centrifugal heart pump 300b is sheath removed when it is between the left atrium 409 and the left ventricle 400. When this is achieved, the venous percutaneous intravascular centrifugal heart pump 300b is sheath removed by retracting the sheath 504 from the insertion tip 305. The valve conduit 301 contacts the mitral valve 402, and the frame central section 317 can also firmly fix itself to the mitral valve 402 here, while the frame lower section 318 remains within the left atrium 409 and the frame upper section 316 remains within the left ventricle 400. When deployment and delivery are complete, the guide wire 500 is removed and subsequently the motor is connected. The advantage of the valve conduit valves 302a - 302c is that they replace the function of the native mitral valve 402 and minimize the occurrence of backflow during the removal process of the guide wire 500 and the connection of the motor 501.

[0226] Referring to FIG. 50, the second method involves advancing the guide wire 500 across the superior vena cava 413, crossing the right atrium 405 and entering the left atrium 409, and crossing the mitral valve 402 and entering the left ventricle 400. To achieve access to the left side of the heart, this is done by a transseptal puncture in which a small puncture is made within the right atrium 405 connected to the left atrium 409. Thus, the puncture of the right atrium 405 provides access to the left side of the heart and enables the guide wire 500 to cross and enter the left atrium 409 and then enter the left ventricle 400.

[0227] Next, referring to FIG. 51, when the guide wire 500 is within the left ventricle 400, the venous percutaneous intravascular centrifugal heart pump 300b is advanced over the guide wire 500, crosses the right atrium 405 and enters the left atrium 409, and reaches the left ventricle 400. The venous percutaneous intravascular centrifugal heart pump 300b is sheath-removed when it is between the left atrium 409 and the left ventricle 400. The venous percutaneous intravascular centrifugal heart pump 300b is sheath-removed by retracting the sheath 504 from the insertion tip 305. The valve conduit 301 contacts the mitral valve 402, the frame central section 317 is firmly fixed to the mitral valve 402, while the frame lower section 318 remains within the left atrium 409 and the frame upper section 316 remains within the left ventricle 400. When deployment and delivery are completed, the guide wire 500 may be removed, and subsequently a motor may be connected. The advantage of the valve conduit valves 302a - 302c is that they replace the function of the native mitral valve 402 and minimize the occurrence of backflow during the removal process of the guide wire 500 and the connection of the motor 501.

[0228] Flow profile

[0229] The percutaneous intravascular centrifugal heart pump 300 converts the mechanical energy of the fluid into hydraulic energy using centrifugal force. The impeller 204 uses centrifugal force to forcibly discharge the fluid while converting the axial flow into a radial flow perpendicular to it. The impeller 204 sucks in the fluid on the same axis as the valve conduit 301 and discharges the fluid perpendicular to the axis of the valve conduit 301.

[0230] Referring to FIGS. 52a - 52b, the percutaneous intravascular centrifugal heart pump 300 may direct flow according to the angle of the opening using the valve conduit valve 302. As seen in FIG. 52b, when the opening of the valve conduit valve 402 is restricted, the outflow is directed downward 601 and laterally. This downward flow 601 is caused by the restricted opening of the valve conduit valve 402 and guides the blood flow toward the coronary apex 415. The downward-directed flow may create a recirculation flow 600 across the aortic sinus and improve blood flow to the heart.

[0231] Next, referring to FIGS. 53a - 53b, when the opening of the valve conduit valve 402 is increased, the outflow is discharged outward 608. This centrifugal flow is generated by the design of the impeller 204 that uses centrifugal force to discharge the fluid radially outward. FIG. 53b shows the flow direction created by the percutaneous intravascular centrifugal heart pump 300. The inflow 607 has an axial vector that is converted to a perpendicular vector at the outflow segment 608. This is achieved by the impeller 204 that generates centrifugal force.

[0232] Referring to FIGS. 54a - 54b, it shows the difference in impeller design between the axial flow impeller and the percutaneous intravascular centrifugal heart pump impeller 204. In FIG. 54a, due to the vane design, there is no space in the axial flow impeller, which obstructs the axial view from the top view. However, referring to FIG. 54b, the percutaneous intravascular centrifugal heart pump impeller has a space between the upper vanes 200, middle vanes 201, and lower vanes 202. The percutaneous intravascular centrifugal heart pump impeller does not obstruct the axial view from the top view in FIG. 54b.

[0233] FIGS. 54c and 54d further show the difference between the axial impeller compared to the percutaneous intravascular centrifugal heart pump impeller 204. The axial impeller combines the fluid and moves its flow axially (FIG. 54c) in the same direction as the inflow. That is, the axial flow pump uses a propeller to advance the fluid mass on the same axis as the initial flow.

[0234] However, referring to FIG. 54d, the percutaneous intravascular centrifugal heart pump impeller 204 uses centrifugal force to move fluid perpendicular to the inflow, and thus ejects the fluid radially outward (perpendicular to the inflow). The centrifugal pump applies the principle of angular momentum to a mass of fluid passing through the impeller passageway to generate flow by advancing the mass of fluid radially.

[0235] Electronic device

[0236] Next, referring to FIGS. 55a - 55b and FIG. 56, the percutaneous intravascular centrifugal heart pump 300 may have sensors for the arterial percutaneous intravascular centrifugal heart pump 300a and the venous percutaneous intravascular centrifugal heart pump 300b.

[0237] Referring to FIGS. 55a - 55b, the arterial percutaneous intravascular centrifugal heart pump 300a may include one or more microelectromechanical systems (MEMS) sensors at proximal location 338a and distal location 338b. Such sensors may measure pressure, temperature, position, flow, location, pH, lactate, etc. The proximal sensor 338a may be located on the stator 310, and the distal sensor 338b may be located on the shaft stabilizer 304. The location of these sensors above and below the impeller enables measurement of the differential pressure on the device.

[0238] Referring to FIG. 56, the venous percutaneous intravascular centrifugal heart pump 300b may include one or more microelectromechanical systems (MEMS) sensors at proximal location 338c and distal location 338d. Again, such sensors may measure pressure, temperature, position, flow rate, location, pH, lactate, etc. The proximal sensor 338c may be located on the stator 310, and the distal sensor 338d may be located on the venous shaft stabilizer 319. Again, the location of these sensors above and below the impeller enables measurement of the differential pressure on the device.

[0239] Preferably, the sensors 338a to 338d are powered by high frequency and are commercially available as, for example, the model 1.2 BAR SCB10H-B012FB pressure sensor element from Murata Manufacturing Co., Ltd. in Nagaokakyo, Kyoto, Japan.

[0240] Energy transfer:

[0241] Next, referring to FIGS. 57 and 58, the percutaneous intravascular centrifugal heart pump 300 may be connected to a power source and a processor 700 via a motor cable 707. FIGS. 57 to 58 show the hookup of the arterial version of the present invention, but the hookup of the venous version of the present invention is the same.

[0242] The power source and the processor 700 may operate with a battery as shown in FIG. 57, or may be connected to an electrical outlet 709 by a power connector 708 as shown in FIG. 58. In either case, the power source and the processor 700 may communicate with a computer 702 by Bluetooth, radio frequency, and / or Wi-Fi 701. The power source and the processor 700 may also communicate with the sensors 338a to 338d of the percutaneous intravascular centrifugal heart pump 300 while they are inside the patient's body. Thus, the computer 702 may also communicate with the sensors 338a to 338d of the percutaneous intravascular centrifugal heart pump 300 inside the patient's body.

[0243] Computer 702 may include a power circuit and battery 703, a transmitter and receiver 706, a host processor 704, and a touch controller 705. Computer 702 may be a desktop computer such as a Dell-Inspiron Compact Desktop (Round Rock, Texas, Dell Computer Company), a laptop computer such as an XPS13 Laptop (Round Rock, Texas, Dell Computer Company) or a MacBook Pro (Cupertino, California, Apple, inc.), or a portable smart phone such as an iPad or iPhone (Cupertino, California, Apple, inc.) or a Samsung Galaxy tablet or phone (Suwon, South Korea, Samsung Electronics Co., Ltd,).

[0244] Accordingly, computer 702 may generate a readout of various parameters received from sensors 338a - 338d, including the operating values of the present invention such as output speed, inflow speed, pressure, pH, temperature, impeller function and performance, and motor function and performance.

[0245] Thus, while the preferred selections of embodiments of the present invention have been described in detail, it will be understood and apparent to those skilled in the art that many physical changes may be made to the device without changing the concepts of the present invention and the principles embodied therein. Accordingly, this embodiment is to be considered in all respects as illustrative and not restrictive, and the scope of the present invention is indicated by the appended claims rather than by the foregoing description, and accordingly, all changes that come within the meaning and range of equivalency of the claims are to be embraced therein.

Claims

1. A percutaneous heart pump, comprising: an impeller having a proximal end and a distal end, and an extendable blade rotatable on the outside to create centrifugal force; a rotatable shaft attached in proximity to the proximal end of the impeller; a non-rotatable stator for supporting the shaft; a valve conduit attached to the stator and having a valve; a non-rotatable expandable frame attachable to the valve conduit and circumscribing the impeller; a removable sheath circumscribing the frame before the frame is expanded; and a percutaneous heart pump comprising the same.

2. The percutaneous heart pump according to claim 1, wherein the impeller comprises at least one stage of at least two extendable vanes positioned equidistantly along the circumference of the impeller.

3. The impeller comprises at least two stages of extendable vanes, each stage being positioned along the longitudinal axis of the impeller, and the vanes of each stage being circumferentially offset from the vanes of an adjacent stage according to the following formula: α = 180 / L where α is the angular offset degree between adjacent stages of the vanes, and L is the number of stages. The percutaneous heart pump according to claim 2.

4. The percutaneous heart pump according to claim 1, further comprising a motor rotatably connected to the rotatable shaft for rotating the impeller.

5. The percutaneous heart pump according to claim 1, wherein rotation of the impeller converts an axial flow along the longitudinal axis of the valve conduit into a transverse radially outward centrifugal flow through the valve.

6. The percutaneous heart pump according to claim 5, wherein the impeller rotates between about 4000 revolutions per minute and about 25,000 revolutions per minute.

7. The percutaneous heart pump according to claim 1, wherein before removing the sheath, the percutaneous heart pump has an outer diameter between about 1.5 mm and about 5 mm.

8. The percutaneous heart pump according to claim 7, wherein the outer diameter of the percutaneous heart pump is preferably 3 mm.

9. The percutaneous heart pump according to claim 1, wherein the frame made of a formable material includes at least one anchor region adapted to contact the native valve leaflets of the heart.

10. The percutaneous heart pump according to claim 9, wherein the frame comprises at least two anchor regions.

11. The percutaneous heart pump according to claim 10, wherein the frame expands to a diameter between about 9 mm and about 20 mm.

12. The percutaneous heart pump according to claim 11, wherein the frame expands to a diameter of about 15 mm.

13. The percutaneous heart pump according to claim 1, wherein the valve conduit includes at least three regions with different diameters.

14. The percutaneous heart pump according to claim 1, wherein the valve opens and closes in response to a pressure difference.

15. The percutaneous heart pump according to claim 1, wherein the valve has a thickness between about 0.01 mm and about 0.30 mm.

16. The percutaneous heart pump according to claim 15, wherein the valve has a thickness of about 0.05 mm.

17. The percutaneous heart pump for arterial application starts an axial flow proximate to the distal end of the impeller along the longitudinal axis of the valve conduit, discharges radially outward through the valve, and the proximal end of the valve conduit that is substantially sealed assists in discharging the flow radially outward through the valve. The percutaneous heart pump according to claim 1.

18. The percutaneous heart pump according to claim 17, wherein the sealed end includes at least one opening.

19. The percutaneous heart pump according to claim 18, wherein the opening is between about 0.1 mm and about 3 mm, preferably about 0.5 mm.

20. The percutaneous heart pump for venous application starts an axial flow proximate to the proximal end of the impeller along the longitudinal axis of the valve conduit, discharges radially outward through the valve, and the distal end of the valve conduit that is substantially sealed assists in discharging the flow radially outward through the valve. The percutaneous heart pump according to claim 1.

21. The percutaneous heart pump according to claim 20, wherein the sealed end includes at least one opening.

22. The percutaneous heart pump according to claim 21, wherein the opening is between about 0.1 mm and about 3 mm, preferably about 0.5 mm.

23. The percutaneous heart pump according to claim 1, further comprising a shaft stabilizing device attached to the distal end of the impeller.

24. The percutaneous heart pump according to claim 23, further comprising at least one sensor fixed to the stator in proximity to the impeller.

25. The percutaneous heart pump according to claim 24, further comprising at least two sensors, wherein the second sensor is fixed to the shaft stabilizing device.

26. The percutaneous heart pump according to claim 24, wherein the sensor measures a pressure difference.

27. The percutaneous heart pump according to claim 24, wherein at least one of the sensors measures temperature.

28. The percutaneous heart pump according to claim 24, wherein at least one of the sensors measures the direction and velocity of fluid flow.

29. The percutaneous heart pump according to claim 24, wherein at least one of the sensors measures pH.

30. The percutaneous heart pump according to claim 24, wherein at least one of the sensors measures lactate.

31. The percutaneous heart pump according to claim 1, wherein the impeller contains an elutable drug.

32. The percutaneous heart pump according to claim 1, wherein the frame contains an elutable drug.

33. A percutaneous heart pump, an impeller having a proximal end and a distal end and an extendable blade rotatable outwardly to create centrifugal force, a rotatable shaft attached adjacent to the proximal end of the impeller, the impeller comprising at least one stage of at least two extendable vanes positioned equidistantly along the circumference of the impeller, a rotatable shaft, a non-rotatable stator supporting the shaft, a valve conduit attached to the stator and having a valve displaceable radially in response to a pressure difference created by rotation of the impeller, a non-rotatable expandable frame composed of a moldable material including at least one anchor region adapted to contact the native valve leaflets of the heart, a sheath circumscribing the frame before the frame is expanded, comprising a percutaneous heart pump.

34. The percutaneous heart pump according to claim 33, further comprising a motor rotatably connected to the rotatable shaft for rotating the impeller.

35. The percutaneous heart pump according to claim 33, wherein the impeller rotates between about 4000 revolutions per minute and about 25,000 revolutions per minute.

36. The percutaneous heart pump according to claim 33, wherein the rotation of the impeller converts an axial flow along the longitudinal axis of the valve conduit into a lateral radially outward flow through the valve.

37. The percutaneous heart pump according to claim 33, wherein the frame made of a shapeable material includes at least one anchor region adapted to contact the native valve leaflets of the heart.

38. The percutaneous heart pump according to claim 33, wherein the frame comprises at least two anchor regions.

39. The percutaneous heart pump for arterial application starts an axial flow proximate to the distal end of the impeller along the longitudinal axis of the valve conduit, discharges radially outward through the valve, and the proximal end of the valve conduit that is substantially sealed assists in discharging the flow radially outward through the valve. The percutaneous heart pump according to claim 33.

40. The percutaneous heart pump according to claim 39, wherein the sealed end includes at least one opening.

41. The percutaneous heart pump according to claim 40, wherein the opening is between about 0.1 mm and about 3 mm, preferably about 0.5 mm.

42. The percutaneous heart pump for venous application starts an axial flow proximate to the proximal end of the impeller along the longitudinal axis of the valve conduit, discharges radially outward through the valve, and the distal end of the valve conduit that is substantially sealed assists in discharging the flow radially outward through the valve. The percutaneous heart pump according to claim 33.

43. The percutaneous heart pump according to claim 42, wherein the sealed end includes at least one opening.

44. The percutaneous heart pump according to claim 43, wherein the opening is between about 0.1 mm and about 3 mm, preferably about 0.5 mm.

45. The percutaneous heart pump according to claim 33, further comprising a shaft stabilization device attached to the distal end of the impeller.

46. The percutaneous heart pump according to claim 33, further comprising at least one sensor fixed to the stator in proximity to the impeller.

47. The percutaneous heart pump according to claim 46, further comprising at least two sensors, wherein the second sensor is fixed to the shaft stabilization device.

48. The percutaneous heart pump according to claim 47, wherein the sensor measures differential pressure.

49. The percutaneous heart pump according to claim 47, wherein at least one of the sensors measures temperature.

50. The percutaneous heart pump according to claim 47, wherein at least one of the sensors measures the direction and velocity of the fluid flow.

51. The percutaneous heart pump according to claim 47, wherein at least one of the sensors measures pH.

52. The percutaneous heart pump according to claim 47, wherein at least one of the sensors measures lactate.

53. The percutaneous heart pump according to claim 33, wherein the impeller contains an elutable drug.

54. The percutaneous heart pump according to claim 33, wherein the frame contains an elutable drug.

55. A percutaneous heart pump, an impeller having a proximal end and a distal end and an extendable blade rotatable outwardly by centrifugal force, a rotatable shaft attached adjacent to the proximal end of the impeller, a non-rotatable stator supporting the shaft, a valve conduit attached to the stator and having a valve, a non-rotatable expandable frame attached to the valve conduit and circumscribing the impeller, a sheath circumscribing the frame before the frame is expanded and comprising, the impeller comprising at least two stages of extendable vanes, each stage being positioned along the longitudinal axis of the impeller, and the vanes in each stage being circumferentially offset from the vanes of an adjacent stage according to the following formula, α = 180 / L where α is the angular offset degree of adjacent stages of the vanes and L is the number of stages, a percutaneous heart pump.

56. The percutaneous heart pump for arterial application starts an axial flow adjacent to the distal end of the impeller along the longitudinal axis of the valve conduit, discharges radially outward through the valve, and the proximal end of the valve conduit, which is substantially sealed, assists in discharging the flow radially outward through the valve. The percutaneous heart pump according to claim 55.

57. The percutaneous heart pump according to claim 56, wherein the sealed end includes at least one opening.

58. The percutaneous heart pump according to claim 57, wherein the opening is between about 0.1 mm and about 3 mm, preferably about 0.5 mm.

59. The percutaneous heart pump, which is for venous application, starts an axial flow along the longitudinal axis of the valve conduit close to the proximal end of the impeller, discharges it radially outward through the valve, and the distal end of the valve conduit, which is substantially sealed, assists in discharging the flow radially outward through the valve. The percutaneous heart pump according to claim 55.

60. The rotation of the impeller converts an axial flow along the longitudinal axis of the valve conduit into a lateral radially outward flow through the valve. The percutaneous heart pump according to claim 55.

61. The frame composed of a formable material includes at least an anchor region adapted to contact the natural valve leaflets of the heart. The percutaneous heart pump according to claim 55.

62. The frame expands to a diameter between about 9 mm and about 20 mm. The percutaneous heart pump according to claim 60.

63. The frame expands to a diameter of about 15 mm. The percutaneous heart pump according to claim 62.

64. The valve conduit includes at least three regions with different diameters. The percutaneous heart pump according to claim 55.

65. The impeller rotates between about 4000 revolutions per minute and about 25,000 revolutions per minute. The percutaneous heart pump according to claim 60.

66. Before removing the sheath, the percutaneous heart pump includes an outer diameter between about 1.5 mm and about 5 mm. The percutaneous heart pump according to claim 55.

67. The outer diameter of the percutaneous heart pump is preferably 2.5 mm. The percutaneous heart pump according to claim 66.

68. The percutaneous heart pump according to claim 55 further comprises a shaft stabilizing device attached to the distal end of the impeller.

69. The percutaneous heart pump according to claim 55 further comprises at least one sensor fixed to the stator in proximity to the impeller.

70. The percutaneous heart pump according to claim 69 further comprises at least two sensors, and the second sensor is fixed to the shaft stabilizing device.

71. The sensor measures differential pressure. The percutaneous heart pump according to claim 70.

72. At least one of the sensors measures temperature. The percutaneous heart pump according to claim 70.

73. The transcutaneous heart pump according to claim 70, wherein at least one of the sensors measures the direction and velocity of the fluid flow.

74. The transcutaneous heart pump according to claim 70, wherein at least one of the sensors measures pH.

75. The transcutaneous heart pump according to claim 70, wherein at least one of the sensors measures lactate.

76. A method for implanting a transcutaneous heart pump into a human body, comprising: providing a heart pump, the heart pump comprising: an impeller having a proximal end and a distal end, and an extendable blade rotatable outwardly by centrifugal force; a rotatable shaft attached proximate to the proximal end of the impeller; a non-rotatable stator supporting the shaft; a valve conduit attached to the stator and having a valve; a non-rotatable expandable frame made of a moldable material, attachable to the valve conduit and circumscribing the impeller; a removable sheath circumscribing the frame before the frame is expanded; and routing the heart pump into the human heart through a predetermined artery or vein; positioning the valve conduit proximate to a predetermined native valve of the human heart; removing the sheath to allow the frame to expand into a predetermined shape; fixing the frame to contact the native valve tip of the predetermined valve; rotating the impeller to create an axial fluid flow transmitted to a radially outward fluid flow through the valve; and

77. The method according to claim 76, wherein the impeller is rotated at between about 4000 revolutions per minute and about 25,000 revolutions per minute.

78. The method according to claim 76, wherein the heart pump further comprises at least two sensors supported proximate to each end of the impeller.

79. The method according to claim 78, further comprising measuring a differential pressure.

80. The method according to claim 78, further comprising measuring a temperature.

81. The method according to claim 78, further comprising measuring the direction and velocity of the fluid.

82. The method according to claim 78, further comprising measuring the pH of the fluid.

83. The method according to claim 78, further comprising measuring lactate.

84. The method according to claim 76, further comprising the step of stopping the rotation of the impeller and reinstalling a sheath on the frame before removing the heart pump from the patient.

85. The method according to claim 76, wherein the valve conduit is disposed proximate to the pulmonary valve.

86. The method according to claim 76, wherein the valve conduit is disposed proximate to the tricuspid valve.

87. The method according to claim 76, wherein the valve conduit is disposed proximate to the mitral valve.

88. A method for implanting a percutaneous heart pump into a human body, comprising: providing a heart pump, the heart pump comprising: an impeller having a proximal end and a distal end and an extendable blade rotatable outwardly by centrifugal force; a rotatable shaft attached proximate to the proximal end of the impeller; a non-rotatable stator supporting the shaft; a valve conduit attached to the stator and having a valve; a non-rotatable expandable frame made of a moldable material attachable to the valve conduit and circumscribing the impeller; a removable sheath circumscribing the frame before the frame is expanded; and routing the heart pump into the human heart through a predetermined artery or vein; disposing the valve conduit proximate to a predetermined native valve of the human heart; removing the sheath to allow the frame to expand into a predetermined shape; fixing the frame to contact the native leaflets of the predetermined native valve; repositioning the heart pump to a preferred position; re-fixing the frame to contact the native leaflets of the predetermined native valve; rotating the impeller to create an axial fluid flow transmitted to a radially outward fluid flow through the valve; reinstalling the sheath; removing the heart pump and including.

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