WO1994009835A1

WO1994009835A1 - Cannula pumps for temporary cardiac support

Info

Publication number: WO1994009835A1
Application number: PCT/US1993/009947
Authority: WO
Inventors: Robert Jarvik
Original assignee: Robert Jarvik
Priority date: 1992-10-30
Filing date: 1993-10-18
Publication date: 1994-05-11
Also published as: JPH08504621A; EP0746344A1; AU678411B2; US5755784A; AU678697B2; AU5363594A; AU1770495A; CA2147616A1; CA2147616C; US5776190A; US5888241A; US5376114A; AU1770395A; AU683994B2; EP0746344A4

Abstract

A cannula pump (10) is provided which incorporates a miniature rotary pump into a cardiac cannula of essentially the same size as currently utilized with routine cardiopulmonary bypass. The pump may be inserted via a single small incision in the heart to obtain both inflow and outflow cannulation simultaneously, and provide sufficient flow to completely unload the ventricle during its use. Because application of the device is extraordinarily simplified, it is suitable for rapid emergency insertion in any setting where the chest can be safely opened, including emergency room and battlefield applications. A small electric motor (16), implanted within the heart, provides power to the impeller (36) via a small shaft (34) supported on blood immersed bearings (42). A disposable cannula pump utilized with a reusable motor provides an inexpensive device for routine surgical use.

Description

CANNUIA POMPS FOR TEMPORARY CARDIAC SUPPORT

DESCRIPTION OF THE INVENTION

This invention relates to circulatory support utilizing miniat rotary blood pumps inserted into the heart for emergency use or dur heart surgery. The invention includes pumps mounted within cannu adapted for extremely simple application at surgery which are capa of providing the entire pumping output required for patient survival

BACKGROUND OF THE INVENTION

Mechanical blood pumps are commonly applied to temporar support the pumping function of the heart during heart surgery during periods of heart failure. The most widely applied devi include roller pumps and centrifugal pumps currently used in more t 400,000 cases of heart surgery annually. Usually, the pumps compr part of a cardiopulmonary bypass circuit in which many components combined including an oxygenator, a heat exchanger, blood reservo and filters, and many feet of tubing to transport the blood from patient on the operating table to the heart-lung machine located nea and back to the patient. Blood is withdrawn from the patient via upt cannulae placed into the vena cavae and atria or ventricles of heart and pumped back into the pulmonary artery and aorta via ret cannulae. The system generally works well but is complicated expensive, exposes the blood to a high surface area of fore materials which cause damage, requires full anticoagulation, requires considerable time to set up and manage by a skil technician. In most cases of coronary artery bypass surgery the he is cooled and stopped and an oxygenator is used although it is necessary to actually open the heart as it is with valve surgery. I few cases, the oxygenator is omitted from the system and the patie own lungs continue to function during the course of the surgi procedure. In such cases, either the pumping function of the l ventricle alone or both the left and right ventricles, is suppor mechanically. Pulsatile pumps and continuous flow pumps have been u experimentally and in human cases. The heart is not cooled and is stopped, although drugs may be given to slow its rate. The proced has a number of important advantages in appropriate cases, howev present blood pumps, cannulae, and tubing sets have not been develo specifically for this application, and setup, cannulation, priming, patient management during the procedure are somewhat makeshift leave room for considerable improvement. The cannula pump of present invention is especially suited to this use, and grea simplifies the procedure, reducing the number of cannulation sit reducing the surface area of foreign materials, reducing the prim volume and setup time, and permitting very simple management of he function during the procedure.

To support the systemic circulation, a single cannula containin miniature rotary pump is inserted into the heart, via a small incisi and both the necessary inflow and outflow connections are accomplis immediately. The blood pump may be inserted via the apex of ventricle, the atrium, or the aorta, but in each case only cannulation is necessary. The pump itself resides within the cann and is connected by a short drive shaft to a small motor outside heart, usually positioned immediately adjacent to the heart in dir connection with the cannula. If support of the pulmonic circulation required, this is also achieved by a single cannulation via the ri ventricle, right atrium, superior vena cava, or pulmonary artery. Th to support the total heart function, two cannula pumps, each requir only one cannulation site, are used. Cannula pumps are advantageous cases requiring emergency circulatory support where the chest can rapidly opened for access to the heart and the simple cannula pump be inserted immediately. Because no cumbersome or large equipment involved, the device can be applied in tight quarters, where use larger more complicated systems is precluded, and in cases of card arrest where there is inadequate time to setup and prime other devic Examples include ambulance, aircraft, emergency room, cardiac cath l and rescue or military use in the field.

SUMMARY OF THE INVENTION

The present invention relates to miniature blood pumps utilized provide all or part of the pumping function of the heart during card surgery, during temporary periods of heart failure, and during medi emergencies involving severe heart failure. The device includes miniature pump, such as an axial-flow or mixed-flow pump mounted wit a generally tubular cannula, similar in size and shape to cannulae u to withdraw blood from the heart or to return blood to the gr vessels during routine heart-lung machine utilization. However, cannulae generally differ functionally because, with the pump moun within the cannula, a single cannula is able to provide both the inf and outflow functions and therefore a single insertion site sufficient, in many cases. In some cases, such as where the patient a prosthetic valve which prevents passage of a cannula across it, cannulation sites may be used. The pumps of the present invention use blood-immersed mechsnical bearings and the principles of high-f washing of the junction of the rotary and stationary parts of the. p to prevent thrombus accumulation. These principles together with method of intraventricular implantation are disclosed in my previ patents #4,994,078 and #5,092,879. Although the present invention much in common with the inventions of these prior patents, ba adaptations of the pump and motor bearing system are new as well as cannula type of device, its function, and its methods of use. present invention utilizes a small-diameter wire as a rotating sh which drives the pump impeller, compared to the stationary wire of previous devices. It is feasible for temporary use since wear minimal in a period of a few hours or even a few weeks, compared to permanent implant applications which require durability of many yea Tension on the wire is not required, and the wire is sufficiently st to impart the necessary rotary torque without warping, breaking, vibrating excessively. The pumps are smooth and quiet during use will not cause significant blood damage if fabricated properly.

The present invention requires major surgery for its insertion differs from previous prior art inventions such as the "HIGH-CAPAC INTRAVASCULAR BLOOD PUMP UTILIZING PERCUTANEOUS ACCESS" by Wampl U.S. Patent #4,625,712, in its structure and function, as well as intended use. The present cannula pump is not suitable for percutane access, and is inserted via mεlor surgery for use during the surgi procedure, or for relatively short term use following surgery. invention of Wampler utilizes a remote motor placed about a meter a from the pump and connected to it via a long flexible shaft. The mo is located outside the body whereas the motor used with the pres invention is implanted within the body and is directly coupled to pump by a short stiff shaft only a few centimeters long. T eliminates the problem of flexible shaft breakage which has caused FDA to withdraw experimental approval to test the Wampler pump in hu patients. Since the present pump is not inserted through a long sm diameter blood vessel via an access site remote from the heart, it able to be large enough to support the entire cardiac output, as rol pumps and centrifugal pumps utilized during cardiac surgery typica must do. The Wampler pump is limited due to the small diameter manda by the remote insertion requirement and can only provide a fraction the blood flow necessary for full support of the patient. Essentia the Wampler pump is a remotely inserted assist pump, and the pres invention is a directly inserted, high flow, total cardiac out bypass pump.

Utilizing cannula pumps of the present invention, approximat 1.2 cm in diameter, blood flow up to 8 liters per minute is obtai with 100 mm-Hg outflow pressure and rotational speed varying f approximately 15,000 to 25,000 rpm, depending upon flow and pressu With flow in the range of 6 liters per minute and pressure in the ra of 80 mm-Hg, which represents a typical operating condition, the po requirement for the system is below 15 watts. This permits batt operation for several hours with a very compact and lightwei battery. The system may include a simple control and display mod which is small enough to be sterilized and utilized in the ster surgical field. It may also incorporate microprocessor-based cont and monitoring algorithms to regulate the flow and pressure, or display the flow and pressure measured by sensors or calculated f comparison of measurements of speed and power consumption to a kn database.

Cannulae may be provided with built-in pressure sensors or fl sensing devices such as a hot-wire anemometer or ultrasonic flow pro and may be configured such that the simple insertion of the cannu accomplishes complete instrumentation including pressure and f measurements at the appropriate locations. Alternatively, the cann pumps may be used with no flow and pressure sensors and pati management can be accomplished by other observations, such as degree of expansion or collapse of the left atrium during surgery the adequacy of perfusion as judged by the arterial blood gases.

The cannulae pumps are capable of being fabricated utiliz primarily injection-molded, polymeric components, permitting low-c and disposability of the cannulae and pumps themselves. The mot which provide rotary power to the shaft may be provided in a reusa configuration or also maybe made very inexpensively to permit them be disposable. A completely disposable unit incorporating both disposable motor and pump together with the cannulae is disclosed one embodiment of the invention.

OBJECTS OF THE INVENTION

It is an object of the present invention to provide miniat rotary blood pumps mounted within cannulae for insertion into the he to support its pumping function.

It is a further object of the invention to provide an extrem simple method of cardiac support capable of rapid application medical emergencies.

It is a still further object of the invention to provide cann pumps which can be manufactured and sold at relatively low co permitting routine disposable use.

It is another object of the invention to improve the art of he surgery and patient care, decrease morbidity and lower hospital cost

It is a further object of the invention to provide cannula pu that may be rapidly and effectively applied in emergency open ch surgical procedures at remote locations away from a fully equip hospital operating room.

It is further object of the invention to provide cannula pu incorporating flow and pressure sensors and automatic control modes.

It is a further object of the invention to provide methods operating the pump motor without rotary shaft seals and without need for a continuous supply of fluid for a flush seal. It is a further object of the invention to provide simple cann pumps which may be coated with anticoagulants, thus avoiding diminishing the need for systemic anticoagulation.

It is a further object of the present invention to provide system of heart support which minimizes exposure of the blood foreign materials.

It is an additional object of the invention to prov inexpensive disposable axial- or mixed-flow blood pumps suitable use with an oxygenator in the system.

These and other objects of the present invention will be m fully understood by referring to the drawings and speci descriptions in the following sections.

THE DRAWINGS

Certain preferred embodiments of the invention are illustrated the following figures:

Figure 1 is a schematic illustration of the heart, partially section with the anterior wall of the right ventricle and part of pulmonary artery removed. Two cannula pumps are shown, one inser through the apex of the left ventricle, with the out-flow across aortic valve into the aorta and the other inserted across the apex the right ventricle with the outflow across the pulmonic valve into pulmonary artery.

Figure 2 shows a longitudinal section of a cannula pump includ the motor module. The pump and motor are assembled for use.

Figure 3 is a longitudinal section of the generally cylindri cannula and blood-pumping components contained therein. Figure 3 is enlarged portion of the cannula pump system illustrated in Figure 2.

Figure 4 is a longitudinal section of a reusable motor and mo housing. The disposable components of the cannula pump are not shown.

Figure 5 is a longitudinal section of the disposable compone the cannula pump illustrated in Figure 2, showing all disposa components except the outflow cannula, and including a remova hypodermic needle for filling a fluid chamber within the device.

Figure 6 is a longitudinal section of a cannula pump having disposable motor disposed in a housing formed integral with cannula.

Figure 7 is a longitudinal section of another embodiment o cannula pump showing a reusable motor and motor housing, an disposable pump with the cannula in position to be coupled to rotating shaft of the motor via a mechanical connector.

Figure 8 is a longitudinal section of an embodiment of invention in which a small diameter motor having an outside diame approximately the same as the largest diameter of the pump incorporated within the cannula.

Figure 9 is a schematic drawing of the heart and great vessels which a cannula pump similar to that shown in Figure 8 has b inserted into the left ventricle with the outflow cannula sect placed across the aortic valve into the aorta.

Figure 10 is a schematic drawing of the heart showing a cann pump placed with the electric motor in the right atrium, and the p placed within the right ventricle, with the outflow cannula sect positioned across the pulmonic valve into the pulmonary artery.

Figure 11 is another schematic illustration showing the l ventricle and aorta, with the right ventricle removed. A cannula p is shown placed with the motor within the left ventricle and the p together with the outflow cannula section placed in the aorta.

GENERAL DESCRIPTION OF THE INVENTION

It is common surgical procedure to insert a tube, generally kn as a cannula, into any of the various chambers of the heart or any the great vessels which bring blood to and carry blood away from heart. Cannulae of many sizes and shapes are used, including flexi polymer tubes, wire-reinforced polymer tubes, and even rigid me tubes. Generally, these tubes must be small enough to permit them to inserted into the heart or great vessels with minimal damage to tissues and must be large enough to permit sufficient blood flow gi that a considerable pressure drop occurs across small diameter tubes higher flow rates, especially when the tubes are long. In any sys where a blood pump is used to replace or assist in the function of of the ventricles, blood must be removed via a cannula from either ventricle itself or the inflow vessels leading to the ventricle must then pass through a pump which ejects it into one of the la arteries.

The present invention provides pumps mounted inside the cannu themselves which has many advantages previously cited, includ greater simplicity of application to the patient, reduction in resistance to blood flow of long tubes, reduced exposure to fore materials, and ease of patient management. Cannula pumps may provided in numerous embodiments, may reside within the heart itse within the great vessels, or only a portion of the cannula may introduced into the vascular system and the pump may be located outs the heart and beside it on the surgical field.

Figure 1 is a generally schematic view of the heart showing cannula pumps inserted for support of both the left heart function the right heart function. The left ventricle, generally indicated at contains a miniature axial flow pump within a cannula, and the ri ventricle, indicated at 4, contains another pump. The outflow porti of the cannulae deliver blood respectively from the left ventricl into the aorta 6, and from the right ventricle 4 into the pulmon artery 8. The cannula pump in the right ventricle is driven by electric motor, generally located and shown at 10. The actual ax flow blood pumping portion is indicated at 12, and the outflow t which channels the blood into the pulmonary artery is shown at Thus, blood enters through side holes as indicated by the arrows at and directly encounters the axial flow pump hydrodynamic elements. passage for the blood between the inflow position 15 and the outf into the pulmonary artery, generally indicated at 14, is very short offers both a relatively low resistance to flow and a small surf area of artificial materials to which the blood is expos Additionally, because the entire volume of blood within the cann pump remains within the vascular system itself, it is appropriate consider that the priming blood volume of this pump is essentia zero. That is, no blood need be withdrawn from the cardiovascu system to fill the pump and tubing circuit with this embodiment.

A second cannula pump, inserted in the left ventricle, is powe by an electric motor 16, and contains an axial flow pump within left ventricle 18 into which blood enters through side holes 22 indicated by the arrows. The blood is pumped out of the outflow port of the cannula 20 which carries the blood across the aortic va leaflets 24 and into the aorta 6. The right and left cannula pu together thus intake blood from both ventricles and pump the blood i the two main arteries leaving the heart. The pump is respectiv inserted through a small incision in the apex of either ventricle held there by a purse-string suture as indicated in Figure 1 at 30, the right-sided cannula pump, and indicated at 28 for the left-si pump. Since the pumps are inserted with the patient's open chest the heart is exposed, the surgeon can readily feel the heart and eas ascertain that the tip of the cannulae has passed across the pro valve and into the aorta or pulmonary artery as desired, rather t across an inflow valve and into the left atrium or right atrium, wh would be improper. The anatomy of the heart makes proper placem relatively simple and it is almost a straight-line direct path from apex to the aorta. With cannula pumps inserted in the fashion shown Figure 1, the outflow valve, that is the aortic valve or pulmon artery valve, is able to close around the outside of the cann permitting a sufficient seal to prevent major leakage back from artery into the respective ventricle. This increases the effectiven and efficiency of the pump because if the valve were absent incompetent, a considerable portion of the blood ejected out of cannula could flow directly back to the inflow side of the p effectively making a short circuit without being pumped through organs of the body as desired. However, even without complete seal of the aortic or pulmonary artery valves, a considerable stream blood is ejected from the cannula pump at high flow to provide momen to the column of blood in the vessel and may provide a sort of jet-p effect. Thus, it is possible to create a cannula pump that functionally effective even without a cannula actually crossing aortic or pulmonary artery valve if a sufficiently high-velocity str of blood is ejected by the tip of a cannula pump within the ventri and directed properly across the valve orifice.

In some patients who have mechanical heart valves implanted either the aorta or pulmonary artery, it is not possible to pas cannula across the mechanical valve. In such cases, cannula pumps be used where the inflow into the pump is via the apex of the ventri or via the atrium and the outflow of the pump returns the blood i the aorta or pulmonary artery via a second incision into that bl vessel. In certain other situations, for example in surgical procedu where the ventricular chambers of the heart must be opened for purposes of the operation, cannula pumps that withdraw blood from atria and return it to aorta or pulmonary artery, are required rat than devices inserted into the ventricular cavity.

Figure 2 shows a longitudinal sectional view of the cannula pu Blood enters the axial flow pump section 18 through side holes 22, is ejected through the outflow cannula 20. The pump contains a rig relatively elongated portion 32 which is passed across.the apex of heart and serves as a support around which the heart muscle is t utilizing the purse-string suture. An electric motor to provide po to the pump impeller is indicated at 16 and contains motor windings laminations 60, and a housing 62 with an electric cable 68. Figur illustrates the housing containing the windings and laminations of motor for use in an embodiment such as shown in Figure 2 where motor and housing are reusable and the other complements of the cann pump are disposable. The motor and housing in Figure 4 combine with disposable pump and bearings illustrated in Figure 5 and an outf cannula portion to yield the complete operational device shown Figure 2.

Referring to Figure 3, the general layout of an axial flow p such as may be used with many embodiments of the invention is sho Several axial flow pump impeller blades 38 are mounted on an impel hub 36 supported for rotation on a set of bearings 40, 42 and 44. impeller is driven by a stiff rotating wire 34 which transmits rot mechanical energy produced by the electric motor to the impeller. St referring to Figure 3, the impeller hub rotating thrust bearing mem 40 and shaft 34 are all bonded together to form a single rotating un Shaft 34 extends into stationary bearing 42 and is rotationa supported by it. Shaft 34 also passes through stationary bear element 44 and is rotationally supported by that bearing memb

Rotating thrust bearing member 40 is composed of a wear-resist material similar to the stationary bearing elements 42 and 44. At e end axially it absorbs the thrust bearing load to maintain the ax position of the impeller while it is rotating and to carry and trans thrust loads produced by the action of the impeller blades against bloodstream. The rotating thrust bearing member 40 translates th loads to the stationary bearing members. Two small gaps 54 and 56 ex at each end of the rotating impeller hub. Blood enters these paper-t gaps and bathes the bearings, including the small cylindrical between shaft 34 and each stationary bearing element 42 and 44. rotating impeller is supported by the bearing elements in suc fashion that there is a smooth, continuous line of flow across junction between the stationary and rotating components of the pump gaps 54 and 56. The blood enters the inflow side holes 22, pas across the inflow stator blades 52, supported on the inflow hub smoothly crosses the gap between the inflow hub and the impeller hub

54, passes across the impeller blades 38 and the impeller hub 36, then smoothly passes across the gap 56 between the rotating impel hub and outflow stator hub 46 and finally passes across the outf stator blades 48 and then out of the pump through the outflow cannul

Figure 5 shows the disposable cannula pump including the ax flow pump bearings, drive shaft, and the motor magnet and motor mag bearings utilized to transmit torque magnetically from the windings the motor to the shaft. The elongated outflow cannula segment omitted in Figure 5. A slot 66 in the disposable portion of the cann pump is configured to receive a pin 64 (Figure 4) as the motor coupled to the cannula. In the embodiment shown, this coupling accomplished by sliding the disposable cannula components shown

Figure 5 into the motor housing shown in Figure 4 which results in assembly shown in Figure 2. The pin and slot prevent the cannula f rotating within the motor housing thereby permitting the rotatio torque to turn only the motor magnet and attached elements and rotate the entire cannula. The disposable components are retained proper connection to the reusable motor and housing components magnetic forces, by an interference fit, or by other mechanical mean

Power to rotate the impeller is transmitted to the shaft 34 by magnet 70 which is bonded to the shaft 34 via an intermediary hol shaft 76. The motor magnet is caused to rotate by the rotat electromagnetic fields produced by the surrounding motor windings in Figure 2) and thus it is seen that in the embodiment shown in Fig 5 the entire end of the disposable portion of the cannula p containing the motor magnet may be sealed and thus eliminate rot mechanical shaft seals through which either air or fluids could le The motor magnet 70 is supported by a pair of bearings 72 and 74 the shaft 76. These bearings may be any of a number of suitable typ including fluid-lubricated sleeve-type journal bearings, ball bearin or hydrodynamic fluid film bearings. Many materials are suitable this application, especially considering that the cannula pump designed for short-term use and the durability of the bearings need be very long. Note that in the embodiment illustrated in Figure 5, motor magnet bearings 72 and 74 are located some distance from the p impeller bearings 42 and 44. The drive shaft 34 transverses elongated channel 58, and any blood which enters this chamber thro the narrow gap between the shaft 34 and the impeller bearing 44 m travel the full length of this channel to reach the motor mag bearings. A elastomeric flexible sealing stopper 82 is inserted int hole in the end of the cannula near the motor magnet bearings. T stopper may be punctured by a small hypodermic needle 84 through wh fluid can be injected into the chamber containing the motor magnet motor magnet bearings which is in continuity with the chamber lead to the impeller bearing 44. Shortly prior to the use of the cann pump in the patient an appropriate fluid such as sterile heparini saline or a low-molecular-weight dextran solution is injected hypodermic needle 84 so as to completely fill the chamber surround the motor magnet, motor magnet bearings, and shaft. Air that is pres in this chamber at the time the fluid is ejected is forced to exit the vicinity of the impeller through the narrow gap between the sh 34 and the bearing sleeve 44. If sleeve-type bearings are used support the motor magnet, such as shown in Figure 5, a small hole may be included to facilitate passage of the fluid through the beari while the chamber is being filled. After the chamber is complet filled, the hypodermic needle is withdrawn and the stopper 82 seals needle hole. Thereafter when the cannula pump is inserted into heart, blood fills the outflow section of the cannula and the sp surrounding the impeller and inflow and outflow stator blades an tiny amount of blood enters the gap between the rotating impeller and stationary stator hubs. A film of blood diffuses into the between the stationary impeller bearings 42 and 44 and the rotat shaft 34. This blood mixes with the anticoagulated fluid in the between bearing sleeve 44 and shaft 34 and thus when the pump is tur on the bearing is immersed in blood partly diluted by anticoagulated fluid. In the embodiment shown in Figure 5 there is mechanical lip seal preventing blood from entering chamber 58 ultimately reaching the area of the motor magnet bearings. Howev since the chamber in which the motor magnet bearings are contained rigid and sealed and pre-filled with fluid prior to use of the pump the patient, blood cannot enter that chamber unless some of the fl already present is removed. Therefore exchange of fluid between bloodstream and the chamber is very limited and only a small amount blood diffuses or seeps into the chamber during the duration of use the cannula pump in the patient. This blood is highly diluted anticoagulated and therefore does not interfere with the function the motor bearings.

Figure 6 shows an embodiment of the invention in which electric motor as well as the remainder of the cannula pump are integrated in one disposable unit. Disposable motor 92 is enclosed i polymeric housing 86 which is attached to the axial flow pump sect

18 at the inflow stator blade supports 88. The embodiment shown

Figure 6 functions very similarly to the embodiment shown in Figur and has the advantage that the air gap 94 between the motor windings and the motor magnet 90 can be very small permitting high efficiency the motor. As seen in Figure 2, the air gap 96 must be larger when motor is separable from the cannula parts of the pump to accommod the cannula wall. In the configuration shown in Figure anticoagulated fluid may be injected via the hypodermic needle i chamber 80 which communicates with the elongated chamber 58 via bore of the motor. Fluid thus can be injected via the hypodermic nee and completely fill the chambers containing the motor, motor bearin and shaft, and reach the blood contacting portion of the pump at impeller bearing 44.

Figure 7 shows an additional embodiment of the invention in wh the motor may be reusable and provided in a sterilizable housing wh may be attached to a disposable portion of the catheter pump contain the stators, impeller, and inflow and outflow openings for the blo Referring to Figure 7, the motor 90 is encased in a motor housing and incorporates ball bearings 104 and 106 supporting a shaft 108 fi to the motor magnet 102. The shaft is sealed with a radial lip s 110. The shaft has a cavity 114 which is not round in cross section another shape such as square or rectangular and is adapted to receiv like-shaped shaft extension 112 which provides a coupling to trans rotary torque from the motor shaft 108 to the cannula pump shaft 34. this configuration the motor bearings and motor magnets are surrounded by fluid but rather are surrounded by air. Blood and ot fluids are kept out of the chamber in which the motor is housed by rotary shaft seal 110. Similarly, chamber 58 in the disposable part the device may remain filled with air rather than fluid because rotary shaft seals 122 and 124 are utilized to exclude fluids. Th prior to operation of the embodiment shown in Fig 7, the cann portion is affixed to the motor portion by inserting the shaft 112 i the hole 114 and pressing the end of the cannula 118 into the hole in the end of the motor housing. The parts may be thus attac together by an interference friction fit or other methods of retent may be provided, such as a screw-on connector. The function of blood pump impeller, stators, and pump impeller bearings is v similar to that described for the embodiment shown in Figure 3, w the bearings immersed in blood which enters the narrow gaps between rotating and stationary parts.

Figure 8 illustrates a cannula pump in which a motor 126 utilized which is of small enough diameter to be inserted throug small incision in the heart, such as in the apex. Such a mot approximately 12mm in diameter by 22 mm long, provides suffici power to pump the entire normal workload of the left ventricle, sufficiently powerful motors can be made even smaller. The mo receives electric power through wires 156 which enter the heart vi cable 158 which passes across the wall of the ventricle and is sea by a purse string suture 28 or may pass across the wall of the heart another location. The rotor of the motor 128 is supported by beari

130 and 132 and is connected to the pump impeller hub 134 wh supports the impeller blades 136 by a small diameter shaft 133. In present embodiment, a rotary shaft seal 142 prevents blood f entering the motor and motor bearing housing 127. Additional bl immersed bearings, 138 and 140 are provided to support the sh within the blood stream. Bearing 138 is supported in the motor hous and bearing 140 is supported by the hub of the outflow stator 136 wh in turn is supported by outflow stator blades 137 within the p housing 148. Thus, when power is applied to rotate the motor rotor rotary mechanical power it provides is transferred to the impeller the rotating shaft 133. the action of the rotor blades against blood draws blood into the pump via inflow openings 150 and 152 pumps the blood through the outflow cannula 153 and out of the outf opening 154.

Figure 9 shows a cannula pump inserted into the left ventricl at the apex and retained in place temporarily by a purse string sut 128. The power cable 158 protrudes from the apex and connects to motor controller and electric power source (not shown) . This embodim is advantageous compared to that shown in Figure 1 in which the mo located outside the heart can interfere with the surgeon's other tas such as suturing coronary artery bypass grafts.

Figure 10 shows another embodiment in which the device inserted across the wall of the right atrium and affixed in place b purse string suture 29. The device utilizes a motor 160 which is wit the right atrium 164, connected to the pump impeller, 168 by a flexi shaft 166 and also a small diameter rigid shaft 135. This shaft supported on blood immersed bearings (not shown) in a fashion simi to the pump of Figure 8. The pump is enclosed in a pump housing which is located in the left ventricle and the blood is pumped acr an outflow cannula through the aortic valve 24 and is discharged i the aorta at 172. This separation of the motor and pump has advantage that there is a long distance for blood to diffuse from pump to the motor for embodiments that do not use a rotary shaft se

Similarly, an embodiment similar to that shown in Figure 10 can applied with the motor in the left atrium and the pump in the l ventricle.

Figure 11 shows another embodiment similar to that shown Figure 8 in which the pump housing 148 is elongated sufficiently permit the pump 136 to be in the aorta while the motor 126 is in ventricle. The rotating shaft 133 transmits power across the aor valve 24 to the pump impeller.

Additional embodiments of the cannula pump invention incl embodiments in which the cannula pump is provided with two separ flexible polymeric tubular extensions to permit insertion of one as inflow and the other as an outflow tube. Thus without departing f the scope of the above defined invention, numerous other use embodiments may be provided.

The information disclosed in the description of the pres invention is intended to be representative of the principles that have described. It will thus be seen that the objects of the invent set forth above and those made apparent from the preceding descript are efficiently obtained and that certain changes may be made in above articles and constructions without departing from the scope the invention. It is intended that all matter contained in the ab description or shown in the accompanying drawings shall be interpre as illustrative but not in a limiting sense.

Claims

CLAIMSIt is also understood that the following claims are intended cover all of the generic and specific features of the invention her described and all statements of the scope of the invention which a matter of language might be said to fall there between.I claim:

1. A blood pump and cannula system adapted to be inserted into one or more chambers of the heart via a single small incision in heart and to provide temporary support of cardiac function comprisin a. minimally hemolytic blood pumping means including a rotat impeller mounted within a generally cylindrical bore of a tubu cannula; b. an inflow opening permitting blood to enter the pumping me directly from the chamber of the heart in which the impeller located; c. outflow means to channel blood beyond the chamber of the he in which the impeller is located without requiring a sutu connection; d. electric motor means located within the heart to rotate impeller and thereby impart pumping energy to the blood.

2. The blood pump of Claim 1 incorporating electric mo components affixed to pump and cannula components by a flexible mem via which power is transmitted from the motor to the pump.

3. The blood pump and cannula system as described in Claim having a generally tapered rigid tip to facilitate introducti adapted to dilate a small incision in the heart as the cannula inserted and thus enlarge the hole to the proper size for the cann and no larger.

4. A miniature rotary hydrodynamic blood pump comprising: a. Minimally hemolytic axial flow pump or mixed flow pump me including an impeller having blades affixed to a rotating supported for rotation within the blood stream by blood immer mechanical bearing means, b. Pump housing means having a generally cylindrical or coni bore, within which a stationary hub supporting said bearing m is mounted adjacent to said impeller, such that only a very s gap exists between said stationary hub and said rotating hub the impeller, c. A small diameter rotating shaft affixed to the rotating hu said impeller, supported by said bearing means, and adapted impart torque to the impeller to rotate it, d. Minimally hemolytic blood immersed bearing means suppor said impeller for rotation in a configuration such that onl thin film of blood occupies the gap between said rota impeller hub and said stationary hub, e. Said housing means, impeller, and bearing means configured that a stream of blood of sufficiently high velocity washes ac the gap between the hub of the rotating impeller and the stat ary hub of the pump adjacent to it to prevent thrombus acc lation at said gap severe enough to cause failure of the pump. f. Means to provide power to rotate the shaft and thereby pump blood.

5. The blood pump of Claim 4, in which said means to provide p includes a reusable motor removably affixed to disposable components the device.

6. The blood pump of Claim 4, in which the blood pumping means mounted within a cannula.

7. The blood pump of Claim 4, including means to loca anticoagulate the blood occupying the bearings.

8. The method of rapid application of cardiac assist blood pump to either the left side (systemic circulation) or right side (pulmo circulation) of a patient whose heart is surgically accessi comprising: a. Making a small incision in the patient's heart, b. Inserting a single cannula within which an electric motor pumping means are mounted into the left or right side of heart through said incision such that said single cannula provi for both uptake of blood from within the heart and outflow blood via the cannula to the aorta or the pulmonary artery and, c. Operating said pumping means in conjunction with said can to impart mechanical energy to the blood-stream.

9. The method of Claim 8, in which the pumping means is an a flow, mixed flow, or centrifugal pump.

10. The method of treating heart disease by surgically opera on the heart while the function of the heart is supported b mechanical blood pump temporarily inserted therewithin.

11. The method of preventing malfunction of a temporary blood having both blood immersed pump impeller bearings and motor bear that are exposed to blood but are not completely blood imme comprising; a. Enclosing the motor bearings in a rigid chamber which completely sealed except at a single orifice of minimal a through which some blood can pass and through which passes a s diameter shaft to convey power from the motor to a pump mechanism located within the blood stream, b. Before blood pumping is begun, filling said chamber with fl in which said motor bearings can operate, c. Providing a sufficient distance between said orifice and motor bearings, such that only blood mixed with said fl reaches the vicinity of the motor bearings during the time device is used, d. and providing a sufficient volume of fluid in said chamber s that the degree to which the blood is diluted by the fl prevents significant impairment of the motor bearing funct during the time for which the pump is used.

12. The method of minimizing friction due to thrombus formation the bearings of a blood pump having blood immersed bearings compri of introducing fluid containing anticoagulants or thrombolytic age into the pump at a position adjacent to the bearings such that s fluid locally mixes with the blood in which the bearings are direc immersed, thereby reducing thrombus formation or causing dissolution of thrombus already present.

13. The method of Claim 12 in which said fluid is supplied f one or more reservoir chambers so as to diffuse gradually into blood which bathes the bearings.

14. The method of Claim 12 in which said fluid is supplied to vicinity of the bearings under pressure and mixes with the bl bathing the bearings due to flow resulting from said pressure rat than by diffusion alone.

15. An integrated cannula and blood pump system adapted to prov left heart or right heart bypass during major surgical procedures temporarily thereafter, comprising: a. A generally tubular cannula adapted to be surgica implanted such that a portion of it is inserted into the heart the cannula forms at least part of a conduit through which bl is pumped into either the aorta or pulmonary artery, b. Blood pumping means mounted within said cannula and adapted pump blood therethrough, c. Generally cylindrical motor means implanted in the pati within the heart, d. Power coupling means adapted to transfer mechanical ene provided by said motor means to said blood pumping means.

16. The integrated cannula and blood pump system of Claim 15, which the pump is located within the aorta or pulmonary artery.

17. The integrated cannula and blood pump system of Claim 15, which the blood pump is an axial flow pump or mixed flow pump.

18. The integrated cannula and blood pump system of Claim 15, which the blood pump and cannula are disposable and flow or press sensing means are affixed thereto.

19. The method of treating heart disease of Claim 10 in which s mechanical blood pump includes an electric motor implanted within heart.