Percutaneous right ventricular assist apparatus and method

• US 8,992,408 B2
• Filed: 09/05/2013
• Issued: 03/31/2015
• Est. Priority Date: 01/09/2006
• Status: Active Grant

• Current Assignee: Cardiacassist Inc. (LivaNova Plc)
• Original Assignee: Cardiacassist Inc. (LivaNova Plc)
• Inventors: Magovern, James A., Allison, Scott B., Barraclough, Royce G., Revenaugh, James R., Smith, Douglas E., Wang, David H. J.
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): LEVICKY, WILLIAM J
• Application Number:
  US14/019,230
• Publication Number:
  US 20140081074A1
• Time in Patent Office: 572 Days
• Field of Search: 600 16- 18
• US Class Current: 600/16
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 60/117 for assisting the heart, e.g. transcutaneous or external ventricular assist devices
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/232 Centrifugal pumps
• CPC Class Codes: A61M 60/585 User interfaces

Abstract

A system for assisting the right heart of a patient includes a PA cannula adapted for insertion into a PA of a patient through the right internal jugular vein of the patient. The system includes a percutaneous RA cannula adapted for insertion into an RA of the patient. The system includes a blood pump disposed outside of the patient to which the RA cannula and the PA cannula are connected to provide right ventricular circulatory support to the patient without any left ventricular assist. A method for assisting the right heart of a patient includes the steps of inserting a PA cannula into a PA of a patient. There is the step of inserting an RA cannula into an RA of the patient. There is the step of connecting the RA cannula and the PA cannula to a blood pump disposed outside of the patient. There is the step of activating the blood pump to provide right ventricular circulatory support to assist the heart of the patient.

Claims

1. A closed chest system for assisting the right heart of a patient comprising:

a pulmonary artery (PA) cannula adapted for insertion into the right internal jugular vein of the patient and to extend into the PA of the patient via an anatomical pathway through the right heart;

a percutaneous right atrium (RA) cannula adapted for insertion into a peripheral vein of the patient and to extend into the RA of the patient, so that the right ventricle of the patient is bypassed;

a blood pump comprising an inlet connected to the RA cannula and an outlet connected to the PA cannula for providing only right ventricular circulatory support to the patient without open heart surgery or left ventricle support; and

a controller controlling the blood pump.

2. The closed chest system as described in claim 1, wherein the controller is in communication with the blood pump and detects and manages faults and produces an alert signal in response to a detected fault.

3. The closed chest system as described in claim 1, wherein the controller operates the blood pump to provide right ventricular assist of the patient at a level which is ½

to ⅔

of normal cardiac blood flow of the patient.

4. The closed chest system as described in claim 1, wherein the blood pump is a ventricular assist pump.

5. The closed chest system as described in claim 1, wherein the PA cannula has an end hole and two side holes for blood flow to the right and left lungs.

6. The closed chest system as described in claim 5, wherein the end hole and side holes enable blood flow to the left and right lungs of the patient without allowing backflow into the right ventricle of the patient.

7. The closed chest system as described in claim 1, wherein the blood pump pumps unoxygenated blood from the RA through the RA cannula and returns the blood to the PA through the PA cannula.

8. The closed chest system as described in claim 1, wherein the peripheral vein comprises one of a femoral vein or a vein in the patient'"'"'s neck or upper body.

9. A method for assisting the heart of a patient comprising the steps of:

inserting a pulmonary artery (PA) cannula into the right internal jugular vein of the patient;

moving the PA cannula in the vasculature and into the PA of the patient via an anatomical pathway through the right heart;

inserting a right atrium (RA) cannula into a peripheral vein of the patient;

moving the RA cannula in the vasculature and into the RA of the patient, so that the right ventricle of the patient is bypassed;

connecting the RA cannula and the PA cannula to a blood pump, with the RA cannula connected to an inlet of the blood pump and the PA cannula connected to an outlet of the blood pump;

activating the blood pump to provide only right ventricular assist to the heart of the patient and without open heart surgery or left ventricle support; and

controlling the blood pump with a controller in communication with the blood pump.

10. The method as described in claim 9, further comprising positioning the PA cannula in the PA using a balloon.

11. The method as described in claim 9, wherein the inserting the PA cannula step includes passing a pulmonary wedge pressure catheter through the PA cannula, floating the catheter into the PA, and advancing a super stiff wire through a pulmonary artery port of a Swan-Ganz catheter.

12. The method as described in claim 11, further comprising removing the pulmonary wedge pressure catheter and the wire from the patient once the PA cannula is in the patient.

13. The method as described in claim 9, wherein the PA cannula has an end hole and at least two side holes which allow blood flow to the left and right lungs of the patient without allowing backflow into the right ventricle of the patient.

14. The method as described in claim 9, further comprising pumping unoxygenated blood from the RA with the blood pump through the RA cannula and returning the blood to the PA through the PA cannula.

15. The method as described in claim 9, wherein the peripheral vein comprises one of a femoral vein or a vein in the patient'"'"'s neck or upper body.

16. The method as described in claim 9, wherein the inserting the RA cannula step includes inserting the RA cannula into the peripheral vein of the patient over a wire.

17. The method as described in claim 9, wherein the activating step includes starting 2 L/min blood flow for at least two minutes and then adjusting the blood flow based on the patient'"'"'s requirements.

18. The method as described in claim 9, further comprising using imaging guidance when the RA cannula and the PA cannula are in the RA and PA, respectively.

19. The method as described in claim 9, wherein the activating step includes the step of providing blood flow to the right and left lungs through the PA cannula.

20. The method as described in claim 9, further comprising providing blood flow from the blood pump for right ventricular assist of the patient at a level which is ½

to ⅔

of normal cardiac blood flow of the patient.