Circulatory support system

• US 6,716,189 B1
• Filed: 06/08/1999
• Issued: 04/06/2004
• Est. Priority Date: 10/04/1996
• Status: Expired due to Fees

• Current Assignee: United States Surgical Corporation (Medtronic Plc)
• Original Assignee: United States Surgical Corporation (Medtronic Plc)
• Inventors: Jarvik, Robert, Stern, Steven J., Alesi, Daniel E., Cashin, Deborah M., Howansky, Mark, Klinger, John F., Day, Steven R., Kaczynski, Francis X., Hammerquist, Kenneth G., Payea, Keith, Geiste, Robert J.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Deak, Leslie R.
• Application Number:
  US09/328,248
• Time in Patent Office: 1,764 Days
• Field of Search: 604/65-67, 604/799, 604/4.01, 604/6.11, 604/6.14, 604/6.16, 604/28, 604/30, 604/31, 604/43, 604/506-509, 604/96.01, 422/44
• US Class Current: 604/6.16
• CPC Class Codes: A61M 1/3626 Gas bubble detectors
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 1/3666 Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
• CPC Class Codes: A61M 1/3667 with assisted venous return
• CPC Class Codes: A61M 39/281 Automatic tube cut-off devices, e.g. squeezing tube on detection of air
• CPC Class Codes: A61M 60/117 for assisting the heart, e.g. transcutaneous or external ventricular assist devices
• CPC Class Codes: A61M 60/237 the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
• CPC Class Codes: A61M 60/806 Vanes or blades

Abstract

A method for providing at least partial bypass of the heart to supplement the pumping function of the heart to thereby enable the surgeon to perform various surgical procedures thereon includes providing a circulatory assist system having a portable extracorporeal axial flow pump with a pump housing, a rotating pumping member disposed in the pump housing and inlet and outlet cannulated tubes respectively connected to inlet and outlet ports of the pump housing, accessing the patient'"'"'s left atrium of the heart with the inlet cannulated tube, accessing the aorta with the outlet cannulated tube, actuating the rotating pumping member to draw oxygenated blood from the left atrium of the heart through the lumen of the inlet cannulated tube and into the inlet port of the pump housing whereby the pumping member imparts mechanical energy to the oxygenated blood passing through the pump housing and directs the oxygenated blood through the outlet port and through the lumen of the outlet cannulated tube to be transferred by the aorta to the systemic arteries and permitting the right side of the heart to function whereby oxygen-depleted blood returning through the systemic veins to the right atrium is directed through the right ventricle to the patient'"'"'s lungs for oxygenation and subsequent pulmonary circulation.

Claims

1. A circulatory support system to supplement or temporarily replace the pumping function of a patient'"'"'s heart to hereby enable a surgeon to perform surgical procedures thereon, comprising:

an extracorporeal portable blood flow pump including a pump housing having inlet and outlet ports, a pump member mounted in the pump housing to impart mechanical energy to blood entering the inlet port and to direct the blood through the outlet port, the pump member having a variable output;

an inlet cannula connected to the inlet port of the pump housing and having an inlet open end portion defining an ingress path such that when it is inserted within the patient'"'"'s heart or blood vessel associated with the heart, blood is drawn from the patient through the inlet open end portion of the inlet cannula and directed into the pump housing;

an outlet cannula connected to the outlet port of the pump housing and having a lumen and an outlet end portion for insertion within the patient so that blood exiting the outlet port of the pump housing is conveyed through the lumen of the outlet cannula into the patient for transfer by the arterial system of the patient;

a control unit having a processor, operatively coupled to the flow pump, for controlling operation thereof; and

a pressure transducer mounted to a distal end of the inlet cannula for insertion into and sensing pressure within the patient'"'"'s heart or blood vessel associated with the heart and providing a pressure sense signal indicative of the pressure sensed to the control unit, the control unit being operable to command a reduction in the output of the pump member when the pressure is determined to be below a predetermined threshold.

2. The system of claim 1 wherein said pressure transducer is disposed in proximity to the inlet open end portion of the inlet cannula, and the system further including a wire running within an outer sheathing of the inlet cannula from the control unit to the pressure transducer, the pressure sense signal being transmitted to the control unit on the wire.

3. The system of claim 1 wherein the reduction in motor speed to a lower speed is repeated such that the motor speed is ramped down, until the pressure is determined to have risen to a value above a predefined threshold, and the control unit being operative to ramp up the motor speed if the pressure has risen above the predefined threshold.

4. The system of claim 1, further including an air bubble sensor mounted to one of the cannulas for detecting air bubbles in the respective cannula and providing a bubble detect signal indicative of the presence of an air bubble;

wherein the control unit is operative, responsive to receiving a bubble detect signal, to generate an air bubble alarm and to cause the pump member to cease operation thereof.

5. The system of claim 1 wherein said blood flow pump comprises an axial blood flow pump.

6. The system of claim 1, wherein the pressure transducer is mounted to the inlet open end portion of the inlet cannula.

7. A circulatory support system to supplement or temporarily replace the pumping function of a heart, which comprises:

a blood flow pump having blood inflow and outflow openings and being adapted to impart pump energy to blood directed thereto, the blood pump having a varying output;

an inlet cannula in fluid communication with the blood inflow opening of the pump, the inlet cannula having an inlet open end portion defining an ingress path such that when the inlet open end portion is inserted within a patient'"'"'s body it percutaneously accesses at least one of a vessel and heart of a patient, draws blood from within the at least one of the vessel and heart and directs the blood to the blood pump;

an outlet cannula in fluid communication with the blood outflow opening of the pump, the outlet cannula being dimensioned and configured for percutaneously accessing a vessel of the patient to return blood from the pump to the vessel accessed thereby;

a pressure transducer mounted to the inlet cannula proximal of the inlet open end portion for insertion into and sensing pressure within the one of the vessel and heart of the patient for monitoring pressure therein;

a control unit including a processor operatively coupled to the blood pump for controlling operation of the blood pump, the control unit including;

circuitry for supplying power to the blood pump to activate the pump; and

circuitry associated with the pressure transducer, and being responsive to a signal from the pressure transducer to command a reduction in the output of the blood pump when the pressure is determined to be below a predetermined minimum value.

8. The circulatory support system of claim 7 wherein the circuitry associated with the pressure transducer is adapted to reduce the output of the blood pump at a predetermined rate of reduction when the pressure is determined to be below the predetermined minimum value whereby, when the pressure is determined to have risen to at least the predetermined minimum value, the output of the pump is increased to a desired value thereof.

9. The circulatory support system of claim 8 wherein the output of the pump is increased to the desired value thereof subsequent to maintaining the predetermined minimum value of the pressure for a predetermined period of time.

10. The circulatory support system of claim 9 including an air bubble sensor mounted to one of the cannulas for detecting air bubbles and providing a bubble detect signal indicative of the presence of an air bubble.

11. The circulatory support system of claim 10 including a clamping device mounted to one of the cannulas and operative to clamp the respective cannula in response to the bubble detect signal to prevent air from entering the patient'"'"'s bloodstream.