EP0028218A1

EP0028218A1 - Method and apparatus for pumping blood within a vessel

Info

Publication number: EP0028218A1
Application number: EP79901456A
Authority: EP
Inventors: Horst E. Krause; Edwin L. Stanley
Original assignee: Individual
Current assignee: Individual
Priority date: 1979-05-07
Filing date: 1980-11-17
Publication date: 1981-05-13
Also published as: WO1980002366A1; EP0028218A4

Abstract

Un systeme de pompage a augmentation dynamique (10) comprend un catheter ferme, rempli de liquide (18) qui est introduit dans un conteneur telle qu'une artere, et le systeme de pompage fonctionne en synchronisation avec le coeur pour aider le coeur pendant les moments de defaillance de la fonction cardiaque en produisant des ondes de pression ou de pulsation de frequence plus elevee pendant la diastole et pendant la periode de contraction isometrique du coeur. Cette sequence d'impulsion est ajustee sur les caracteristiques de transmission dynamique d'un systeme circulatoire choisi, tel que le systeme vasculaire coronaire pour assurer la transmission d'energie de pulsation maximum dans le sous-systeme. Le catheter (18) possede un ballon (12) qui pompe de maniere a maintenir un debit sanguin adequat au travers du miocarde et possede un passage (17) d'injection de quantite successive de produits pharmaceutiques dans les arteres coronaires. Le systeme de pompage (10) fonctionne egalement pour penetrer dans les tissus du miocarde ischemiques avec du sang arteriel et des produits pharmaceutiques. Le systeme de pompage (10) peut egalement etre utilise pour ameliorer la perfusion d'autres parties du systeme circulatoire systemique par exemple pour eviter des effets prejudiciables tels que la defaillance renale. Une pompe de seringue a piston (36) est utilisee pour injecter des produits pharmaceutiques au travers du passage (17) du catheter. L'une quelconque de ces fonctions ou une combinaison de ces fonctions peuvent etre utilisees en fonction des conditions particulieres du patient.A dynamically augmented pumping system (10) includes a closed, liquid-filled catheter (18) which is introduced into a container such as an artery, and the pumping system operates in synchronization with the heart to assist the heart during moments of heart function failure by producing higher frequency pressure or pulsation waves during diastole and during the period of isometric contraction of the heart. This pulse sequence is adjusted to the dynamic transmission characteristics of a selected circulatory system, such as the coronary vascular system, to ensure the transmission of maximum pulsating energy in the subsystem. The catheter (18) has a balloon (12) which pumps to maintain adequate blood flow through the miocardium and has a passage (17) for injecting successive amounts of pharmaceuticals into the coronary arteries. The pumping system (10) also functions to penetrate ischemic miocardial tissue with arterial blood and pharmaceuticals. The pumping system (10) can also be used to improve the perfusion of other parts of the systemic circulatory system for example to avoid detrimental effects such as renal failure. A plunger syringe pump (36) is used to inject pharmaceuticals through the catheter passage (17). Any one of these functions or a combination of these functions can be used depending on the particular conditions of the patient.

Description

METHOD AND APPARATUS FOR PUMPIN G BLOOD WITHIN A VESSEL

Summary of the Invention In one embodiment, a s ealed liquid-filled catheter has a hydraulically inflatable bulbous tip and is ins erted into a proper artery of a patient so that the tip is advanced clos e to the aortic valve. The catheter also has a small open ended pas s age which facilitates the injec¬ tion of medication or radiopaque solutions for angiographic purposes , and als o transmits aortic pressure to an extra-corporeal transducer for pressure recording. The primary liquid -filled catheter pass age functions as a conduit to inject and withdraw the liquid from the inflat- able tip so that the tip expands and collaps es at a controlled higher fre¬ quency and in timed relation with the heart puls e.

The inflation of the catheter tip generates pressure waves in the aorta, and an oscilloscope dis plays the aortic pressure and a superimposed train of pressur e waves . These waves travel in the proximal and distal directions thus transmitting energy in both direc¬ tions. The energy transmitted towards the coronary arteries is greater than that tr ansmitted distally. The res ulting pres sure amplitudes in the coronary arteries can be a multiple s even to ten times the natural pressure wave amplitude in the aorta if the frequency of tip inflation and deflation is properly adjusted to the transmission characteristics of the aorta and coronary arteries .

Other features and advantages of the invention will be appar ¬ ent from the following des cription, the accompanying drawings and the appended claims . Brief Des cription of the Drawings FIG. 1 illustrates an augmenting pump and medication pump system constructed^" in accordance with the invention and showing the catheter in enlarged axi'al^" s ect ion with the tip portion inflated; FIG. 2 is an enlarged axial s ection of the catheter tip portio when deflated;

FIG. 3 illustrates the inflated and deflated catheter tip por ¬ tion in the aorta adj acent the heart valves ;

FIG. 4 is a typical display on a multi-channel oscilloscope connected to monitor the aortic pressure, the ECG R -wave, and the volume of injected medication;

FIG. 5 is a schematic block diagram of an electronic control system for operating the augmenting pump shown in FIG, 1; and

FIG. 6 is another schematic block diagram of an electronic control system for operating both the augmenting pump and medication pump shown in FIG. 1.

Description of the Preferred Embodiment Referring to FIG. 1, a flexible catheter 10 is constructed of a non-resilient flexible material and includes a tip portion 12 which is inflatable between a collapsed condition (FIG. 2 ) and a generally spheri¬ cal inflated condition with a center indentation (FIG. 1) when the tip por ¬ tion has a volume of approximately three cubic centimeters . The tip portion 12 is inflated and deflated at a selected frequency by means of pumping and withdrawing a hydraulic fluid or liquid s uch as a s aline solution through a primary pass age 14 defined by a tubular portion 16. The catheter 10 also defines a smaller pass age 17 which is defined by an integrally molded tubular portion 18 having a tip or end portion 19 which projects axially or forwardly from the inflatable tip portion 12 of the catheter. As illustrated in FIG. 3, the catheter 10 is inserted into a patient's artery so that the inflatable tip portion 12 is located within the aorta 25 close to the aortic valve 26. The pressure waves produced by inflating and deflating the tip portion 12 are effective to transmit the primary energy towards the coronary arteries 27 and 28.

The changes in position of the inflatable catheter tip portion 12 and/or the changes of the frequency of tip inflation and deflation provide control over the relative amounts of energy transmitted both forwardly and rearwardly. This permits vascular sections, either proximal or distal to the tip location, to be selected as the major recipients of pulsatile energy. The pulsatile energy substitutes for all or a part of the cardiac work reduction which occurs in cases of cardiac insufficiency. The beneficial effect of this energy in most cases of application is the intermittent elevation of blood pressure and flow momentum to normal levels in order to maintain some minimum pene¬ tration of high resistant vascular beds and tissue, thus minimizing the possibility of permanent organ or tissue damage.

The tissue of primary interest iε the myocardium. Benefi¬ cial effects are provided for the intact part of the myocardium and the ischemic hypoxic part. The intact part of the myocardium will receive an adequate amount of blood through either alternating or stepwise increasing pressure and flow pulses during the diastolic period. The frequency of the pulses is adjusted according to the location of the tip portion 12 in relation to the coronary ostiae and the known transmission characteristics of the intermediate section of aorta and the coronary arteries in order to facilitate an optimum transmission of energy into the myocardium. A 20 Hz component is desirable, for example, if the tip portion 12 is placed close to the coronary ostiae.

Critical closing pressures at several levels are known in the myocardium. The highest levels of these critical closing pressures are exceeded by the pump system of the invention to produce a complete penetration of the healthy part of the myocardium. This is of particular importance for the subendocardial layers which offer the greatest resis¬ tance to flow and are most prone to damage in ischemia.

The subepicardial vasculature is completely closed during the systolic period through the squeezing effect of the contracted myo- cardial muscle. The epicardial vessels are patent because they are located in the epicardial surface rather than embedded in the myocar¬ dium. These vessels can receive blood during the systolic period but they cannot pass it on. Pressure and flow pulses inside the surface vessels are therefore reflected back and the superposition of incident and reflected waves produces high pressure values. Collaps ed collateral ves sels exist normally between the major coronary arteries of the human heart, and are most numerous around the apex. The vessels are also known to be patent in s ome healty humans , approximately 100 ho.urs after an infarction, and occa- sionally after treatment with certain pharmaca prior to an infarct. The effect of generated elevated pres sure puls es in accordance with the in¬ vention is the accelerated recruitment of collateral connections and the subsequent s alvation of a greater mass of infarcted tissue than during the natural development of collateral connections. The above treatment is aided by the injection of drugs throu the medication catheter tube 18 and its projecting tip or end portion 19. The effects of these drugs are twofold. The amount of fluid passing through the initially opened collateral vessels is very small in compari¬ son to the normal influx of blood into that area and may not be s ufficient to avoid myocardial damage. The initially entering fluid, therefore, carries pharmaca which arrest the biochemical breakdown in the isch- emic area before it becomes irreversible. Additional pharmacological agents may be applied to accelerate collateral development, in particu¬ lar lumen increase, and assure an adequate supply of blood for the infarcted area at the earliest possible time.

The treatment of the ischemic myocardium requires the tip portion 12 to be inflated during the systolic period. However, the infla¬ tion must be limited to the isometr.ic contraction period of the myocar¬ dium. The subepicardial vessels are already clos ed but the ventricle does not eject blood into the aorta 25. When this ejection occurs , the tip portion 12 is collapsed in order to decrease the ventricular after - load. This requirement and the necess ary speed of operation due to the tip location and optimal tuning to cardiovascular dynamics requires a dynamically acting relatively small tip portion 12. The extracorporeal equipment for the control and timing of the tip portion performance is tuned to the dimensions and dynamics of the catheter 10 including the tip portion.

The augmentation pump system of the invention includes two major parts which are the electro -mechanical ass embly shown in FIG. 1 and its electronic control system shown in FIG. 5. The three catheter portions 12 , 16 and 18 are combined to form one integral part, but the portions may have different durometers or stiffnes ses . The two catheter portions 16 and 18 extend par allel to each other and ar e fus ed along a major portion of the catheter 10 and define the two pas s ages 14 and 17, res pectively. The distal end of the medication catheter 18 is open, and the end portion 19 extends through and past the inflatable catheter tip portion 12 s o that the catheter tip portion 12 s urrounds the medication catheter end portion 19. The outer or proximal end of the catheter tube 16 is attached to an augmentation pump 35, and the outer or proximal end of the catheter tube 18 is attached to a medication injector pump 36. The augmentation pump 35 is designed to deliver and with¬ draw liquid fluid from the tip portion 12 and includes a pump body or housing 38 having a tubular tip portion 39 which is coupled to the outer end of the catheter tube 16. The housing 38 has a bottom flange 42 and receives a cylindrical rod or piston 44. A bellows -type rolling dia¬ phr agm 46 extends over the piston 44 and has an outwardly proj ecting peripheral flange portion which is clamped and s ealed to the housing flange 42 by concentric s leeve 48. The catheter 10, pump housing 38 and attached diaphragm 46 form a s ealed dis pos able unit which is prefilled with a pr edetermined volume of hydraulic fluid s uch as the s aline solu¬ tion mentioned above.

The pump housing flange 42 is s ecured to a tubular coupling housing 52 which has a bas e flange" -53 s ecured to a pump driver or excit¬ er 55 having a reciprocating or puls ating piston 56 coupled to the pump piston 44. The pump driver or exciter 55 is adj ustable or controllable for s electing the amplitude and fr equency of puls ation or reciprocation of the piston 56 and the pump piston 44. This control provides for pre¬ cis ely s electing the frequency of inflation and deflation of the catheter tip portion 12 by movement of the hydraulic fluid captured within the tip portion 12 and catheter pas s age 14 and within the pump housing 38 above the diaphragm 46. The driver 55 has s ufficient power to overcome the vis cous friction of the liquid within the catheter passage 14 and also to overcome the arterial or aortic press ure which opposes inflation of the catheter tip portion 12. As mentioned above, permanent connections ar e us ed to make the catheter 10 and pump 35 assembly as an integral self-contained unit. The augmenting tip 12, augmentation catheter pass age 14, and the cham ber of the augmentation pump housing 38 are prefilled with the pumping liquid and are supplied in s ealed -sterilized packages . The unit is quick ly attached to the driver or exciter 55 immediately before its use and is disposed of after treatment.

Different types of drivers or exciters 55 may be used de¬ pending upon the special requirements of application of the system. Cti type of pump driver is an electromagnetic exciter 55 of sufficient power output, frequency range, and range of displacement amplitude for the piston 56. Another type of driver is an electrical stepping motor which provides for precise control of the piston 44 of the augmentation pump 35. The electromagnetic exciter 55 connects with the coupler housing 52 which confines linear bearing for guiding the piston 56 to assure accurate reciprocating movement of the piston 56. The outer end of the piston 56 is attached by a quick coupling device (not shown) to the augmentation pump piston 44. Either the exciter 55 or coupling housin 52 is preferably provided with a mechanical stop to limit inflation of the catheter tip 12 to a maximum safe level. The operation of the pump 35 and catheter 10 produces a high speed alternating or pulsating action of the tip portion 12 at a fre¬ quency substantially above the normal pulse frequency of the heart. For example, as shown in FIG. 4, 'the tip portion 12 is puls ed at a frequency of about 20 Hz. so that nine or ten puls es are produced during the diastolic and part of the systolic or contraction period of each heart pulse. The dynamic characteristics of all parts involved, such as the tip portion 12, the catheter tube 16, the augmentation pump 35 and the driver 55 are selected to assure a high speed operation over a sufficient range of frequencies . This requirement determines the type of material and wall thickness used for the tube portion 16 and tip portion 12. The elastic and inertial properties of the pump 35 and driver 55 are adapted by s electing the moving parts with the correct mass and by adding elastic elements .

The injection pump 36 delivers medication through the ed- ication catheter tube 18. The delivery is controlled as to the amount

ITU injected and as to the time of inj ection. For example, the injection may be made at one time or in any number of installments at any intervals of time and in any synchronization wit.h 'respect to the cardiac cycle of the patient or in relation to the inflation and deflation of the tip portion 12. The medication injection system illustrated, includes a conventional syringe 62 which is coupled to the catheter tube 18 and has a plunger or piston 63 attached to an actuating plate 64. The plate 64 is supported for linear movement by a plurality of guide rods 67 which extend between a s et of end plates 68 and 71. The actuating plate 64 also has a threaded hole which r eceives a lead s crew 73 driven by a reversible electrical stepping motor 74 mounted on the end support plate 71.

Thus rotation of the lead screw 73 by actuation of the stepping motor 74 controls the displacement of the piston 63 of the syringe 62 and thereby controls the injection of the medication from the syringe 62 through the catheter tube 18 and its tip or end portion 19. Small incre¬ mental rotation of the lead screw 73 provides for accurate injection of a very small volume of medication in timed relation with the actuation of the augmentation pump 35. A three way valve (not shown) could be installed in the catheter tube 18 in order that the passage 17 may also be used for sensing and monitoring aortic blood pressure.

Referring to FIG. 5, an electronic control system controls the augmentation pump driver or electromagnetic exciter 55 for select¬ ing the volume of liquid displaced into the inflatable tip portion 12 and the frequency of inflation. The system also activates the augmenting tip inflation in relation to events occurring during the cardiac cycle by receiving an input signal from an electrocardiogram (ECG) 80 which is monitoring the patient's heart pulse. The R -wave from an R-wave detector 82 is us ed as a signal which triggers the activation of the exciter 55 after a variable delay period s elected by adjusting a variable delay unit 84. The operator s ets the delay period, the frequency and amplitude of pump action, the duration of pump action, and the infla¬ tion rate-time relation (for instance sinusoidal, triangular, rectangular , ramp, single step, s ucces sion of steps , etc).

The oper ation of the augmentation pump exciter 55 is controlled by a function generator 86. The function generator is set to produce an alternating output signal of a s elected frequency, amplitude and wave shape, and the output signal forms an input to a power ampli¬ fier 88 which feeds an amplified signal to the exciter 55. Since the electromagnetic exciter 55 is not a "stiff" driver, a feed back loop 89 is us ed when a particular piston position must be hel momentarily. The feed back loop 89 consists of a position transducer 9 attached to the piston 56 of the driver 55. The transducer 92 generates a signal in proportion to the piston displacement, and this signal is fed into a summing amplifier 94.

The summing amplifier 94 is inserted between the function generator 86 and the power amplifier 88 and determines the difference between the signal coming from the function generator 86 and the signal coming from the displacement transducer 92 and feeds this difference into the power amplifier 88. The output of the summing amplifier 94 and consequently the input to the power amplifier 88 is zero if the piston 56 is in the position as demanded by the function generator 86. Any discrepancy results in a signal from the summing amplifier 94 to the • power amplifier 88 which, in turn, corrects the position of the piston 56.

The above description applies to the basic electronic instru¬ mentation that is required to control the electromagnetic exciter 55 on a continuous basis if no triggering ihrough an external signal is required In some applications the driver or exciter 55 must be started and stoppe in timed relation with the cardiac cycle. For example, the augmenting tip 12 must be evacuated and stopped at the end of the isometric contrac¬ tion period as shown in FIG. 4.

The R-wave from the electrocardiogram 80 is used as the point of reference for starting and stopping the exciter 55. Thus the patient's ECG is monitored and recorded on a multi-channel triggered oscilloscope 100 (FIG. 5) for obs ervation. The ECG signal is also an input into a R -wave detector 82 which detects either the slope at the ons et of the R-wave or the instance at which the R-wave exceeds a certain voltage level. The R-wave detector 82 then transmits a puls e to the variable delay unit 84.

( OM If the pulse from the R -wave detector 82 was transmitted directly to the function generator 86, this would immediately trigger the function generator 86 and inflate the augmenting tip portion 12 during the systolic period. The tip portion 12 cannot be inflated during this period becaus e of the related intolerable increas e of ventricular pressure. The activation of the function generator 86 is therefore delayed in relation to the R -wave. The puls e from the R -wave detector 82 is transmitted to a circuit which delays the transmis sion to the function generator. The period of delay is adjustable and triggers the opera- tion of the pump system in relation to the R -wave.

The ECG and aortic blood pressure are displayed on a multi¬ channel triggered oscilloscope 100 so that the user may observe the effect of the augmenting pump operation on the aortic pressure pulses and their placement and duration within the cardiac cycle. This infor - mation enables the user to correct or adjust the placement of the series of pressure pulses within a cardiac cycle by adjusting the delay time. The display of the ECG and aortic pressure on the s cope 100 is triggered by using the impuls e from the R -wave detector 82. An almost standing picture of ECG and aortic pressure may be produced on the dis play screen of the oscillos cope 100, thereby greatly aiding the interpretation, of both recordings.

The actuation of the tip portion 12 as to wave shape, fre¬ quency, amplitude, and period of operation in relation to cardiac events is s elected according to each medical cas e. The aortic pressure, the ECG R -wave, the dis play of thes e signals on the trigger oscilloscope

100, the variable delay 84 and the function generator 86 may also be used for controlling a stepping motor and lead screwdriver 106 (FIG. 6 ) which may be used in place of the electromagnetic exciter 55. A stepping motor is an inherently stiff driver , and current is maintained on the motor windings when the motor is not being stepped for producing a high holding torque. The feed back loop consisting of the position trans ¬ ducer 92 and summing amplifier 94 is not es s ential for a stepping motor, but may be retained to s erve as a precision control and s afety control for the stepping motor. The power amplifier shown in FIG. 5 is replaced by a translator module 105 (FIG. 6 ) to control the operation

f OMPI of the stepping motor 106 which replaces the electromagnetic exciter 55. As also shown in FIG. 6 , the medication pump 36 is actuated by an electronic control which permits inj ection of medication in various ways such as in one-shot or in successive steps . This requires a contr over the frequency of injection and the advance of the piston 63 in timed relation to either a cardiac event or to the inflation and deflation of the augmenting tip portion 12. The additional controls shown in FIG. 6 are the same controls as required for the control of the augmenting tip portion 12 and includes a variable delay 114, a function generator 116 and a translator module 125 for controlling the operation of the stepping motor 74 of the medication pump. The position of the injection pump 36 is s ensed by a transducer 128 and dis played on the s cope 100 so that the user may adjust the injection time in relation to aortic pressure or to other cardiac events by using the variable delay 114. It is thus apparent from the above description that the metho and apparatus of the invention may be us ed for treating pre -infarction angina, a patho physio logical state of regional tissue ischemia and de¬ crease in normal muscle function. This state is usually caused by blockage of a coronary artery by an atherosclerotic intra-luminal mass. The augmentation in accordance with the invention may be used to open up collateral vess els immediately after the coronary arteriography which identifies the cause. The catheter pulsating close to the coronary ostia to deliver short burst of energy is _ effective to open up the collater ¬ al vessels. In a coronary care unit, the puls ation may be monitored by existing equipment and its effectiveness measured by the return to normal function of the heart muscle and the improvement of the pre- infar cation angina.

The invention may also be used in connection with bypass open heart surgery when there exists a pathophysiological state of global heart hypoxia related to a low total body blood pressure and flow. The coronary blood flow may be completely stopped for periods of 5 to 10 minutes then reperfusion accomplished by unclamping of the thoracic aorta. This cycle may be repeated s everal times for a total bypass time of two hours, more or les s . R eturn of normal cardiac muscle function may be delayed for one to three days , and regional ischemia/myocardial infarction occurs in 10 to 20% of the cases . The augmentation system may be used prior to bypass surgery and during each period of unclamping the aorta for reperfusion and for the one to three days following surgery. With the inflatable tip portion 12 close to the coronary arteries , the generation of pressure levels greater than the critical opening pres sures of the numerous small coronary arteries would increas e total blood flow to the cardiac tiss ues. The reversal of progressive hypoxia during bypass surgery and more rapid return toward normal function may be evaluated both at the surgical table and in the post-surgical intensive care unit. This technique should lessen the morbidity and mortality of open heart surgery.

The method and apparatus of the invention may also be used for a shocked kidney which is a pathophysiological state in which a temporary decreas e in systemic blood press ure is associated with a prolonged loss of normal kidney function, i spite of return to normal systemic blood press ure, regional blood flow to the kidney remains low. The decreas ed kidney function may not be detected for hours after the insult. Management presently consists of control of blood volume, electrolyte balance and stimulation of kidney function by tubular diuretics and osmolar solutions. During the prolonged ten to twenty days of kidney malfunction, renal dialysis may be necessary to sustain life. During and after an episode of hypo.tension, the augmenting tip portion 12 may be situated close to the renal artery take off from the abdominal aorta in order to reopen the small renal arteriols by the dynamic pressure wave form. The reestablishment of th e renal vascular press ¬ ure gradient and tubular perfusion by the technique would prevent the shock kidney state and resultant morbidity.

Another use of the augmentation pump device of the invention is in connection with organ transplant when there normally occurs a pathophysiological state of whole organ anoxia resulting from abrupt loss of blood flow and pressure during removal of the organ (kidney, heart, liver, etc. ) from the donor 's body. Implantation of the organ into the recipient's body and restoration of the blood flow by surgical anas ¬ tomosis of the arteries and veins do not result in immediate return of tissue viability in the tr ansplanted organ. The augmentation pump of the invention may be used in the donor 's body prior to removal of the organ to maintain blood pressure above the critical closing press ure and in the receptor 's body following the vess el anastomosis to exceed the critical opening pressure of the transplanted organ. "Viability of tissues should be enhanced by this procedure during the critical period of removal and also to improve the organ function in the recipient's body.

While the method and form of pump apparatus herein descri¬ bed constitute a preferred embodiment of the invention, it is to be under - stood that the invention is not limited to the precis e method and form of apparatus described, and that changes may be made therein without departing from the s cope and spirit of the invention as defined in the appended claims .

The invention having thus been described, the following is claimed:

Claims

ϊ. A method for augmenting the pumping action of the heart, comprising the steps of forming an elongated tubular catheter having an inflatable portion, confining a fluid within the catheter , ins erting the catheter into a ves s el witli -the inflatable portion in a predetermined loca-

5 tion, connecting the catheter to a pump having means for puls ating the fluid within the catheter at a frequency substantially greater than the normal puls ation fr equency of the heart, and operating the pump to effect inflation and deflation of the inflatable portion within a time period substantially shorter than the time period of the cardiac cycle to

10 produce a dynamic pres s ure wave form in the blood.

2. A method as defined in claim 1 and including the steps of monitoring the puls ation of the heart, operating the pump in timed rela¬ tion with the heart puls ation, and producing repetitive inflation and deflation of the inflatable portion of the catheter with a hydraulic fluid

5 during the diastolic period and/or isometric contraction period of the heart.

3. A method as defined in claim 2 and including the step of selecting the amplitude and frequency of inflation and deflation of the inflatable catheter portion in accordance with the heart puls ation.

4. A method as defined in laim- 1 and including the step of form¬ ing the inflatable catheter portion so that it inflates primarily in one predetermined direction for controlling the direction of pulsatile energy transmitted to the blood in respons e to inflation and deflation of the

5 inflatable catheter portion.

5. A method as defined in claim 1 and including the steps of locating the inflatable catheter portion within the aorta, and operating the pump to produce repetitive inflation and deflation of the inflatable catheter portion in timed relation with heart puls es for generating and

5 transmitting pressure waves into the myocardium during the is ometric contraction periods .

6. A method as defined in claim 5 and including the step of producing the pressure waves with sufficient amplitude to open previous collaps ed collateral vessels within the myocardium.

7. A method as defined in claim 1 including the steps of moni¬ toring the aortic blood pressure and the heart puls e of a patient, produc ing a visual display of the blood pressure and heart pulse, and producin repetitive inflation and deflation of the inflatable portion of the catheter with a hydraulic fluid during the diastolic and/or isometric contraction period of the heart.

8. A method as defined in claim 1 and including the step of injecting a predetermined volume of medication through the catheter in timed relation with the inflation and deflation of the inflatable portion of the catheter.

9. Apparatus for augmenting the pumping action of the heart, comprising an elongated tubular catheter having an inflatable portion, said catheter confining a fluid and adapted to be inserted into an artery with the inflatable portion in a predetermined location, a pump connecte to the catheter and having means for puls ating the fluid within the cathe¬ ter at a frequency substantially greater than the normal pulsation fre¬ quency of the heart, and power όper.ated. means for driving the pump for inflating and deflating the inflatable portion within a time period sub¬ stantially shorter than the time period of the cardiac cycle to produce a dynamic pressure wave form in the blood.

10. Apparatus as defined in claim 9 and including means for ope ating the pump in timed relation with the heart puls ation, said catheter being filled with a hydraulic fluid, and means for repetitively inflating and deflating the inflatable portion of the catheter during one cardiac cycle.

11. Apparatus as defined in claim 9 wherein s aid power operated means is adjustable for s electing the amplitude and frequency of inflation and deflation of the inflatable catheter portion.

12. Apparatus as defined in claim 9 wherein the inflatable cathe¬ ter portion includes means for inflating primarily in one predetermined direction for controlling the direction of puls atile energy transmitted to the blood.

13. Apparatus as defined in claim 9 wherein s aid inflatable por ¬ tion of the catheter defines a non -symmetrical annular chamber surround¬ ing a tubular catheter portion defining a passage.

14. Apparatus as defined in claim 13 including pump means connected to s aid tub ular catheter portion for injecting a medication fluid into the blood being pulsed by the inflatable portion of the catheter.

15. Apparatus as defined in claim 9 wherein said pump compris es a pump housing connected to s aid catheter, a flexible diaphragm connect¬ ed to s aid pump housing, and a reciprocating piston connected to move the diaphragm.

16. Apparatus as defined in claim 15 wherein s aid pump housing and s aid diaphragm cooperate with said catheter to confine hydraulic fluid within a sealed catheter unit.

17. Apparatus as defined in claim 9 including means for s ensing the puls ation of the heart, and time delay means for actuating s aid means for driving the pump in response to operation of s aid s ensing means to effect inflating and deflating of the inflatable portion of the catheter during the isometric contraction period of the heart.

18. Apparatus as defined in claim 10 wherein s aid catheter de¬ fines a primary pass age for receiving the hydraulic fluid and a s econd¬ ary passage adapted for inj ecting medication into the blood.