Impeller for a rotary ventricular assist device

Abstract

Claims

2. The impeller of claim 1 in which from essentially 70-80 weight percent of platinum is present in the alloy.

3. The impeller of claim 1 in which from essentially 20-30 weight percent of cobalt is present in the alloy.

4. The impeller of claim 1 which is carried in a rotary pump.

5. The impeller of claim 1 in which the alloy of the impeller is in a heat-treated state for improved magnetic properties.

6. The impeller of claim 1 which comprises a single, integral piece.

7. A magnetically driven, rotary ventricular assist device for pumping blood of a patient, said device carrying the impeller of claim 1.

8. The device of claim 7 which is implantable in the patient.

9. The device of claim 7 which supplements the blood pumping action of the patient's heart.

10. The device of claim 7 which serves as a full substitute for the blood pumping action of the patient's heart.

11. The device of claim 7 which provides an axial, pumped blood flow.

12. The device of claim 7 which provides a centrifugal, pumped blood flow.

13. An impeller for a magnetically driven, rotary ventricular assist device which is implantable in the patient, said impeller being substantially entirely made of a magnetic alloy which consists essentially of about 70-80 weight percent of platinum and about 20-30 weight percent of cobalt.

14. The impeller of claim 13 which is carried in a rotary pump.

15. The impeller of claim 14 in which the alloy of the impeller is in a heat-treated and quenched state for improved magnetic properties.

16. The impeller of claim 14 in which from essentially 76-79 weight percent of platinum is present in the alloy.

17. A magnetically driven, rotary ventricular assist device for pumping blood of a patient, said device carrying an impeller which is substantially entirely made of a magnetic alloy which consists essentially of platinum and cobalt, the alloy of the impeller being in a heat-treated state for improved magnetic properties, and comprising a single, integral piece.

18. The device of claim 17 which provides a centrifugal, pumped blood flow.

19. The device of claim 17 which provides an axial, pumped blood flow.

20. The device of claim 17 in which from essentially 70 to 80 wt. percent of platinum and 20 to 30 weight percent of cobalt is present in the alloy.

21. The device of claim 20 in which 76-79 wt. percent of platinum is present.

Description

[0001] Various designs of blood pumps are known for pumping the blood of a patient to assist a failing heart in the pumping. Particularly, implantable, magnetically driven, rotary ventricular assist devices (VADs) are blood pumps which may, if desired, be implanted in the patient to provide assistance in the pumping for hearts that are afflicted with congestive heart failure or the like. Examples of such pumps are rotary type blood pumps as disclosed in U.S. Pat. Nos. 6,688,861, 6,120,537, 6,234,998, 6,234,772 and 6,234,635.

[0002] By this invention, a blood pump impeller is provided, which impeller is magnetizable to a high degree, and which may be manufactured as a single piece, thereby eliminating assembly procedures and hermeticity concerns, which concerns are associated with a traditional approach of placing magnetic materials within an impeller casing, and laser welding closure caps to the casing, as in certain prior art techniques.

DESCRIPTION OF THE INVENTION

[0003] By this invention, an impeller for a blood pump is provided, the impeller being substantially entirely made of a magnetic alloy which typically consists essentially of about 70-80 weight percent of platinum and about 20-30 weight percent of cobalt. In some embodiments, from essentially 76-79 weight percent of platinum is present in the alloy. An "impeller" is defined as the movable, fluid driving portion of a pump.

[0004] It is also desirable for the impeller to comprise a single, integral piece, which is more easily accomplished when using an impeller of the above described alloy because, unlike certain other "high strength", permanent, magnetic alloys, this particular alloy can be easily fabricated into complex shapes, using conventional metal working and casting methods. Also, the alloy used in this invention is magnetically isotropic, so that parts can be easily magnetized with a plurality of magnetic poles in any geometric orientation. These characteristics allow the impeller to be fabricated from a solid piece of the alloy used in this invention, thus eliminating the need to build assemblies of magnets and support structures, as in the case of prior art ventricular assistance devices, with a resulting reduction of manufacturing costs. Additionally, the alloy used in this invention is biocompatible, and has high resistance to corrosion, also having a Rockwell hardness on the order of 31 Rc, which eliminates the need for a hard, outer coating.

[0005] The impeller, typically as a single piece of raw material prior to fabrication, is preferably heat treated so that the alloy of the impeller can achieve enhanced magnetic and mechanical properties. Such a heat treatment process may be a known process as described in British Patent No. 1,067,054. The impeller is then magnetized by a known technique, and exhibits excellent magnetic properties. Such heat treated alloys are commercially available.

[0006] In some embodiments, the alloy may contain essentially from 21-24 weight percent of cobalt in the alloy.

[0007] The impeller of this invention may be used in a magnetically driven, rotary ventricular assist device (VAD) for pumping blood of a patient, with the device carrying the impeller of this invention. However, by this invention, other, nonrotary impellers may be provided for blood pumps, for example a positive displacement, ventricular assist device, where a magnetic piston is used made of the alloy in accordance with this invention.

[0008] Preferably, the ventricular assist device (VAD) of this invention may be implantable in the patient, and may be of any known design, for example as disclosed in the above U.S. Patents. The rotary, ventricular assist device for pumping blood of the patient may supplement the blood pumping action of the patient's heart, or it may serve as a full substitute for the blood pumping action of the patient's heart, comprising a full artificial heart. The VAD device may provide an axial, pumped blood flow as shown below, or it may provide a centrifugal, pumped blood flow as in U.S. Pat. No. 6,688,861, the disclosures of which are incorporated by reference.

[0009] While it is known to use magnets made of platinum-cobalt alloys in blood pumps, as in Dorman et al. U.S. Pat. No. 3,608,088, by this invention, essentially the entire impeller of the pump is made of the alloy specified, rather than stainless steel or the like. Thus, implantable blood pumps such as VAD pumps with the impeller of this invention exhibit significant advantages, as described above.

DESCRIPTION OF THE DRAWINGS

[0010] In the drawings, FIG. 1 is an enlarged, longitudinal sectional view of an implantable, sealed rotary blood pump of this invention.

[0011] FIG. 2 is a further, enlarged perspective view of the rotary impeller of the pump of FIG. 1.

[0012] FIGS. 3 and 4 are additional side views of the impeller of FIG. 2 in differing positions.

[0013] FIG. 5 is a sectional view taken along line 5-5 of FIG. 2.

[0014] FIG. 6 is a perspective view of a single piece impeller for a centrifugal flow ventricular assist device.

DESCRIPTION OF SPECIFIC EMBODIMENTS

[0015] Referring to FIGS. 1-5, a single piece impeller or rotor 14, positioned in an axial flow, ventricular assist device (VAD) 10, is disclosed. The integral, one-piece impeller 14 disclosed comprises a homogeneous alloy of essentially 77.6 weight percent platinum, the balance being substantially cobalt.

[0016] Impeller 14 is conventionally heat treated to achieve good magnetic properties, and magnetized, with the North (N) and South (S) magnetic poles being as indicated on bladelike projections 20 (FIG. 4).

[0017] The heat treated, homogeneous alloy used was purchased from Engelhard Corporation of Iselin, N.J. The single-piece impeller 14 may be formed by machining from a single piece of the purchased alloy, which was then magnetized in a conventional manner in the pole pattern indicated, for example as performed by Magnet Applications of Horsham, Pa. The impeller is used in VAD 10 as described below.

[0018] Rotor 14 is positioned within the lumen of pump housing 12, and acts as an impeller, having a hydrodynamic surface (specifically a series of hydrodynamic surfaces 16 that tend to propel blood in an axial direction as indicated by arrow 18) as rotor 14 is rotated clockwise. This blood pump 10 may be connected to the patient's vascular system to serve as a rotary ventricular assist device (VAD).

[0019] Rotor/impeller 14 comprises radially outwardly extending, blade-like projections 20 having side walls 16 that define generally longitudinally extending spaces 22 between the projections 20. The projections 20 and their side walls 16 are shaped to form curves in the longitudinally extending spaces 22 which are of a shape tending to drive blood in axial direction 18 as rotor/impeller 14 is rotated (clockwise in the embodiment of FIG. 1).

[0020] It will be noted, particularly from FIG. 5, that the longitudinally extending spaces 22 collectively have, adjacent to radially outer periphery 23 at the outer circumference of rotor 14, a collective, total circumferential width that is substantially less than the collective, total circumferential width of the projections 20 at the same radially outer periphery 23. This is illustrated by peripheral width 26, illustrated on one of the longitudinally extending spaces 22 in FIG. 5, when compared with peripheral width 28 of adjacent, blade-like projections 20. Collectively, the four widths 26 of each of the spaces 22 comprise a collective, total width of all four longitudinally extending spaces 22. Four times the distance of arc 28 represents the collective, total width of the four blade-like projections 20. It can be readily seen that the collective total width of the longitudinally extending spaces 22 is substantially less at periphery 23 than the collective, total width of the respective blade-like projections 20, in the embodiment of FIGS. 1-5.

[0021] It is preferred for transverse sections (FIG. 5) of longitudinally extending spaces 22 to have generally parallel side walls 16, although it can also be seen from FIG. 1 and other drawings that the overall width of longitudinally extending spaces 22 may vary along their lengths, being particularly somewhat narrower at upstream areas 30, and wider at downstream areas 32, as shown in FIG. 1. Thus, it can be seen from particularly FIG. 1 that clockwise rotation of rotor 14 will result in a flow of blood within the lumen of housing 12 from left to right in direction 18.

[0022] Blood pump 10 further comprises a motor, which includes magnetized, thick, wing-like projections 20, having the respective poles, N. S. The motor also comprises a motor stator 36 (FIG. 1), including an electrically conductive coil 38, within an enclosure 40, which surrounds housing 12 and rotor 14, and serves to rotate rotor 14 by the conventional application of electric power to coil 38, which is converted via magnetic force to torque, causing rotor 14 to rotate clockwise. The specific technology for accomplishing this may be similar to that which is well known in the prior art.

[0023] FIGS. 1-4 show radially outer faces 42 of blade-like projections 20, also showing a pair of hydrodynamic bearings 44, 46, which may be defined on projections 20 in the embodiment of FIGS. 1-5, and which use fluid pressure to cause rotor 14 to be centered in the lumen of tubular housing 12 as rotor 14 rotates, in a manner generally shown in FIG. 1, without the need for physical bearings utilizing rubbing, solid surfaces.

[0024] Thus, rotor 14 rotates, being held away from the inner wall of housing 12 by hydrodynamic bearings 44, 46 on each of the wing-like projections 20. At the rear of rotor 14, an inner, annular ring 52 of housing 12 (FIG. 1) is seen to project a bit inwardly from the inner wall cylinder housing 12, to limit the leftward motion of rotor 14. Ring 52 may, if desired, comprise an annular series of spaced projections, or it may comprise a solid ring, with hydrodynamic bearings 44 serving to prevent contact between rotor 14 and ring 52 as the pump is operating with clockwise rotation of rotor 14. A similar, annular ring 53 may be defined near the other end of housing 12 for similar purpose.

[0025] Of course, it is within the scope of this invention to design a rotor which can rotate in the counterclockwise direction, making use of the principles and advantages as described above.

[0026] If desired, the stator 36 may comprise a separate, hermetically sealed, coil motor that slides over tubular housing 12 in position, and is secured thereto. Otherwise, stator and coil 38 may be integrally attached to housing 12.

[0027] Each of thrust bearings 44, 46 define a recessed, curved outer surface which forms a recessed end portion relative to the outer face 42 of each projection 20, located at the forward end of each bearing 44, 46 from the viewpoint of the (clockwise) spin of the rotor 14a, so that recessed end forms a leading edge of rotation. The recessed surface then tapers in a gradual, curved manner outwardly to the rear end of each thrust bearing 44, 46, at which point, the bearing surface is not recessed, or only very slightly recessed, in a manner similar to that described in Wampler et al. U.S. Pat. No. 6,234,772.

[0028] Thus, as the rotor rotates, the respective thrust bearings, 44, 46 on each projection 20 scoop blood into a cross-sectional, recessed area of each bearing that decreases going from end to end, the effect of this being to pressurize the blood, and to thus repel each projection 20 from the inner wall of housing 12 as the rotor rotates. Since the rotor is spaced from the walls of housing 12, the pressurized blood is released out of each bearing by passing across the end and out the sides of the recess.

[0029] A pressure relief zone is provided at the trailing rotary end of each rotating projection 20.

[0030] Basically, the VAD of FIGS. 1-5 is similar, but for the improvements disclosed herein, to that disclosed in LaRose et al. U.S. patent application Ser. No. 11/003,810, filed Dec. 3, 2004, the disclosures of which are incorporated by reference.

[0031] Referring to FIG. 6, a one-piece impeller 74a for a centrifugal flow ventricular assist device is shown, a particular VAD device in which the impeller operates being as described in U.S. Pat. No. 6,688,861, particularly FIG. 12. This one-piece, centrifugal flow impeller 74a may also be made of the above described, homogeneous alloy of 77.6 weight percent platinum, with the balance being essentially cobalt, being conventionally heat treated and quenched by the manufacturer to achieve its good magnetic properties. The respective magnetic poles N, S are as shown in FIG. 6, and may be formed by a conventional magnetization process. The impeller is then used in a VAD of an appropriate type.

[0032] This invention is also applicable to mixed flow ventricular assist device impellers as well.

[0033] Thus, by this invention, one piece impellers for blood pumps, and particularly VADs which may be implanted into the patient, are provided. Because of the use of the impellers of this invention, the impellers may have very strong magnetic properties, for strong electromagnetic coupling, thus permitting a compact VAD design with high efficiency. They may also, unlike certain other permanent magnet alloys which are hard and brittle, be easily fabricated into complex shapes using conventional metal working and casting methods. They are also magnetically isotropic, so that parts can be easily magnetized with a plurality of magnetic poles positioned in any geometric orientation. These characteristics allow components to be fabricated from a single, solid piece of platinum-cobalt alloy, thus eliminating the need to build assemblies of magnets and support structures, for a reduction of manufacturing costs. The alloy used in this invention is biocompatible, has a high resistance to corrosion, and is very hard, on the order of a Rockwell hardness of 31 Rc, thus eliminating the need for an outer, hardened coating.

[0034] The above has been offered for illustrative purposes only, and is not intended to limit the scope of the invention of this application, which is as defined in the claims below.