Guidable intravascular blood pump and related methods

• US 9,597,437 B2
• Filed: 08/17/2016
• Issued: 03/21/2017
• Est. Priority Date: 09/03/1999
• Status: Expired due to Fees

• Current Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Original Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Inventors: Aboul-Hosn, Walid N., Kanz, William R., Baker, Bruce A.
• Primary Examiner(s): Alter, Alyssa M
• Application Number:
  US15/239,772
• Publication Number:
  US 20160367741A1
• Time in Patent Office: 216 Days
• Field of Search: 600/16
• US Class Current: 1/1
• CPC Class Codes: A61M 2025/0177 having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2205/3348 Pressure measurement using a water column
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 60/13 by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
• 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 60/221 the blood flow through the rotating member having both radial and axial components, e.g. mixed flow pumps
• 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 60/414 transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
• CPC Class Codes: A61M 60/422 the force acting on the blood contacting member being electromagnetic, e.g. using canned motor pumps
• CPC Class Codes: A61M 60/523 using blood flow data, e.g. from blood flow transducers
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61M 60/825 Contact bearings, e.g. ball-and-cup or pivot bearings
• CPC Class Codes: A61M 60/827 Sealings between moving parts
• CPC Class Codes: A61M 60/829 having a purge fluid supply
• CPC Class Codes: A61M 60/857 Implantable blood tubes
• CPC Class Codes: A61M 60/865 Devices for guiding or inserting pumps or pumping devices into the patient's body
• CPC Class Codes: A61M 60/894 Passive valves, i.e. valves actuated by the blood
• CPC Class Codes: Y10S 415/90 Rotary blood pump

Abstract

An improved intravascular blood pump and related methods involving the broad inventive concept of equipping the intravascular blood pump with guiding features such that the intravascular blood pump can be selectively positioned at a predetermined location within the circulatory system of a patient.

Claims

1. A method for providing left-heart support using an intravascular blood pump system, wherein the intravascular blood pump system comprises:

an intravascular blood pump adapted to be guided to a predetermined location within the circulatory system of a patient by a guide wire and configured to provide left-heart support, the intravascular blood pump comprising a rotor having a rotor hub tapering in the distal direction, at least one blade extending radially outward from the rotor hub, the rotor hub having a distal end extending distally beyond a most distal portion of the at least one blade;

a catheter coupled to a proximal end of the intravascular blood pump, a purge lumen extending through the catheter;

a cannula coupled to a distal end of the intravascular blood pump, one or more first ports and one or more second ports establishing fluid communication between a cannula lumen and an exterior region of the cannula, wherein at least one first port is located in proximity to the rotor and at least one second port is spaced apart from and located distal to the at least one first port; and

an elongate lumen associated with the cannula and sized to slidably receive the guide wire and dimensioned such that the guide wire passes slidably and coaxially through the elongate lumen, the elongate lumen is sized smaller cross sectionally than the cannula lumen, both the elongate lumen and the cannula lumen not extending through the rotor hub;

wherein the method for providing left-heart support comprises the steps of

passing the guide wire into the patient such that a distal end of the guide wire is positioned in the left ventricle of the patient'"'"'s heart;

placing the guide wire through both the cannula and the elongate lumen such that the guide wire extends proximally away from the intravascular blood pump, the guide wire not passing through the rotor hub or the catheter, and the guide wire extends out of the intravascular blood pump system in a distal direction through the elongate lumen;

advancing the cannula into the patient using the guide wire and positioning the cannula across an aortic valve of the patient such that a distal end of the cannula and the at least one second port are positioned in the left ventricle and a proximal end of the cannula and the at least one first port are positioned in the aorta;

passing purge fluid through the purge lumen to the intravascular blood pump;

measuring pressure adjacent the intravascular blood pump; and

spinning the rotor so as to pump blood from the patient'"'"'s heart into the at least one second port through the cannula lumen and out the at least one first port to provide left-heart support.

2. The method of claim 1 wherein the guide wire enters the intravascular blood pump system through one end of the elongate lumen and exits the intravascular blood pump system through an opposite end of the elongate lumen.

3. The method of claim 1 wherein the cannula is positioned such that the elongate lumen lies wholly within the left ventricle during left-heart support and the elongate lumen is distal to the intravascular blood pump.

4. The method of claim 1 wherein the guide wire and intravascular blood pump system are inserted into and advanced along the femoral artery towards the patient'"'"'s heart.

5. The method of claim 1 further comprising the step of pressurizing the purge fluid to a pressure sufficient to avoid clotting of the patient'"'"'s blood and sufficient to assure that the pressure is higher than the patient'"'"'s blood pressure adjacent the intravascular blood pump.

6. The method of claim 1 further comprising the step of increasing blood volume in the left ventricle to facilitate pumping of blood out of the left ventricle.

7. The method of claim 1 further comprising the step of inserting a guide catheter into the patient, wherein the guide wire is placed in the patient through the guide catheter.

8. The method of claim 1 further comprising the step of calculating blood pressure adjacent the intravascular blood pump.

9. The method of claim 1 further comprising the step of removing the guide wire from the patient after the cannula is advanced into the patient.

10. The method of claim 1 wherein the intravascular blood pump system further comprising a housing connected to a proximal end of the catheter and first and second conduits each connected to the housing, at least one of the first conduit and second conduit in fluid communication with the purge lumen, the housing remains outside the patient while providing left-heart support;

and

wherein the method further comprising the step of pumping the purge fluid through one of the first and second conduits, through the housing and purge lumen to the intravascular blood pump.

11. The method of claim 1 wherein the cannula is reinforced with a spiral wire and wherein the purge lumen is a side lumen extending longitudinally through the catheter but offset radially from a central axis of the catheter.

12. The method of claim 1 wherein the intravascular blood pump further comprising a pressure sensing element configured to sense pressure proximate the intravascular blood pump, the pressure sensing element comprising at least one of a piezo-electric pressure sensing element and a strain gauge.

13. The method of claim 12 wherein the pressure sensing element further comprising a fluid column extending through the catheter.

14. The method of claim 12 wherein the pressure sensing element is used to determine a differential pressure.

15. The method of claim 1 wherein the intravascular blood pump system further comprising a rotor shroud, a portion of the rotor shroud having an outer diameter matching an inner diameter of a proximal portion of the cannula.

16. The method of claim 1 wherein the intravascular blood pump system further comprising a rotor shroud disposed about the rotor and wherein a proximal portion of the cannula is disposed about a distal portion of the rotor shroud, the distal portion of the rotor shroud having an outer diameter smaller than a diameter of a more proximal portion of the rotor shroud, at least a portion of the rotor shroud having the same outer diameter as the cannula.

17. The method of claim 1 wherein the intravascular blood pump system further comprising a rotor shroud, motor assembly and a drive cable, the drive cable at least partially disposed within the catheter,

wherein the motor assembly and drive cable are configured to drive the rotor, wherein the elongate lumen is proximal to the cannula and the motor assembly is configured to remain external to the patient, and

wherein the intravascular blood pump system comprising a dual construction arrangement whereby the rotor is configured to be docked within the rotor shroud.

18. The method of claim 1 wherein the elongate lumen runs longitudinally through and is an integral extension of a wall of the cannula.

19. The method of claim 1 wherein the elongate lumen is a side lumen extending longitudinally but offset radially from a central axis of the cannula along at least a portion of the cannula.

20. The method of claim 1 wherein the elongate lumen is adapted to guide the guide wire through a distal end of the intravascular blood pump system.

21. The method of claim 1 wherein the elongate lumen is shorter in length than the cannula lumen.

22. The method of claim 1 wherein the intravascular blood pump system further comprising a distal tip member at one end, the distal tip member comprising a stem portion, extending distally away from a distal end of the cannula lumen, and a curved tail portion located distal to the stem portion.

23. The method of claim 1 wherein the intravascular blood pump system further comprising a pigtail shaped distal tip member at one end.

24. The method of claim 1 wherein the intravascular blood pump system further comprising a J-shaped shaped distal tip member at one end.

25. The method of claim 1 wherein the intravascular blood pump system further comprising a fluid delivery pump configured to deliver purge fluid through the purge lumen towards the intravascular blood pump at a pressure that is both sufficient to avoid clotting of the patient'"'"'s blood and that is higher than a blood pressure of the patient adjacent the intravascular blood pump.

26. The method of claim 1 wherein the elongate lumen is at least partially disposed within an outer surface of the cannula.

27. The method of claim 22 wherein the elongate lumen is located proximal to the distal tip member.

28. A method for providing left-heart support using an intravascular blood pump system, wherein the intravascular blood pump system comprises:

an intravascular blood pump adapted to be guided to a predetermined location within the circulatory system of a patient by a guide wire and configured to provide left-heart support, the intravascular blood pump comprising a rotor having a rotor hub tapering in the distal direction and a rotor shroud at least partially disposed about the rotor hub, at least one blade extending radially outward from the rotor hub, a distal end of the hub extending distally beyond a most distal portion of the at least one blade;

a catheter coupled to a proximal end of the intravascular blood pump, a purge lumen extending through the catheter;

a cannula coupled to a distal end of the intravascular blood pump, a portion of the rotor shroud having an outer diameter matching an inner diameter of a proximal portion of the cannula, the proximal portion of the cannula disposed about a distal end of the rotor shroud, one or more first ports and one or more second ports establishing fluid communication between a cannula lumen and an exterior region of the cannula, wherein at least one first port is located in proximity to the rotor and at least one second port is spaced apart from and located distal to the at least one first port;

an elongate lumen associated with the cannula and sized to slidably receive the guide wire and dimensioned such that the guide wire passes slidably and coaxially through the elongate lumen, the elongate lumen is sized smaller cross sectionally than the cannula lumen, both the elongate lumen and the cannula lumen not extending through the rotor huh, the elongate lumen adapted to guide the guide wire through a distal end of the intravascular blood pump system, the elongate lumen is at least partially disposed within an outer surface of the cannula;

a housing connected to a proximal end of the catheter; and

first and second conduits each connected to the housing, at least one of the first conduit and second conduit in fluid communication with the purge lumen, the housing remains outside the patient while providing left-heart support;

wherein the method for providing left-heart support comprises the steps of

passing the guide wire through the patient'"'"'s femoral artery such that a distal end of the guide wire is positioned in the left ventricle of the patient'"'"'s heart;

placing the guide wire through both the cannula and the elongate lumen, wherein the guide wire enters the intravascular blood pump system through one end of the elongate lumen and exits the intravascular blood pump system through an opposite end of the elongate lumen, the guide wire not passing through the rotor hub or the catheter;

advancing the cannula into the patient using the guide wire and positioning the cannula across an aortic valve of the patient such that a distal end of the cannula and the at least one second port are positioned in the left ventricle and a proximal end of the cannula and the at least one first port are positioned in the aorta;

passing purge fluid through one of the first and second conduits, through the housing and purge lumen to the intravascular blood pump;

measuring pressure adjacent the intravascular blood pump; and

spinning the rotor so as to pump blood from the patient'"'"'s heart into the at least one second port through the cannula lumen and out the at least one first port to provide left-heart support.

29. The method of claim 28 wherein the intravascular blood pump system further comprising a fluid delivery pump configured to deliver purge fluid through the purge lumen towards the intravascular blood pump at a pressure that is both sufficient to avoid clotting of the patient'"'"'s blood and that is higher than a blood pressure of the patient adjacent the intravascular blood pump.

30. The method of claim 28 wherein the intravascular blood pump system further comprising a motor assembly and a drive cable, the drive cable at least partially disposed within the catheter,

wherein the motor assembly and drive cable are configured to drive the rotor,

wherein the elongate lumen is proximal to the cannula and the motor assembly is configured to remain external to the patient, and

wherein the intravascular blood pump system comprising a dual construction arrangement whereby the rotor is configured to be docked within the rotor shroud.