Guidable intravascular blood pump and related methods

• US 9,561,314 B2
• Filed: 08/17/2016
• Issued: 02/07/2017
• Est. Priority Date: 09/03/1999
• Status: Expired due to Term

• 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): MARCETICH, ADAM M
• Application Number:
  US15/239,574
• Publication Number:
  US 20160367740A1
• Time in Patent Office: 174 Days
• 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. An intravascular blood pump system, comprising:

an intravascular blood pump adapted to be guided to a predetermined location within the circulatory system of a patient by a guide wire and the intravascular blood pump 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;

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 lumen of the cannula 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 wherein the intravascular blood pump is configured to draw 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 while the cannula is positioned across an aortic valve of the patient, the cannula is configured such that when the intravascular blood pump is positioned in the patient to provide left-heart support the distal end of the cannula and the at least one second port are positioned inside the patient'"'"'s heart and the proximal end of the cannula and the at least one first port are positioned in the patient'"'"'s aorta;

a catheter connected to a proximal end of the intravascular blood pump, a purge lumen extending through the catheter and operatively arranged to deliver purge fluid towards the intravascular blood pump;

an elongate lumen arranged coaxially with at least a portion of the cannula and in series longitudinally with the cannula, and an end of the elongate lumen is adjacent an end of the cannula, the elongate lumen sized to slidably receive the guide wire and having a diameter sized smaller than a diameter of the cannula lumen;

a pressure sensing element configured to sense pressure proximate the intravascular blood pump;

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.

2. The intravascular blood pump system of claim 1 wherein the rotor comprises a second blade extending radially from the rotor hub and wherein the hub has a distal end extending distally beyond a most distal portion of the blades.

3. The intravascular blood pump system of claim 1 wherein the housing is configured to have the purge fluid pass through it.

4. The intravascular blood pump system of claim 1 wherein the cannula is reinforced with a spiral wire.

5. The intravascular blood pump system of claim 1 wherein the pressure sensing element comprises at least one of a piezo-electric pressure sensing element and a strain gauge.

6. The intravascular blood pump system of claim 5 wherein the pressure sensing element further comprises a fluid column extending through the catheter.

7. The intravascular blood pump system of claim 1 wherein the pressure sensing element is used to determine a differential pressure.

8. The intravascular blood pump system of claim 1 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.

9. The intravascular blood pump system of claim 1 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 comprises a dual construction arrangement whereby the rotor is configured to be docked within the rotor shroud.

10. The intravascular blood pump system of claim 1 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.

11. The intravascular blood pump system of claim 10 wherein the elongate lumen is located proximal to the distal tip member.

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

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

14. The intravascular blood pump system of claim 1 further comprising a fluid delivery pump configured to deliver purge fluid through the purge lumen towards the intravascular blood pump.

15. The intravascular blood pump system of claim 14 wherein the fluid delivery pump is configured to deliver the purge fluid at a pressure than 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.

16. The intravascular blood pump system of claim 1 further comprising a rotor shroud disposed about the rotor and wherein a proximal end of the cannula is disposed about a distal end of the rotor shroud.

17. The intravascular blood pump system of claim 1 further comprising a rotor shroud having a distal portion with a first outer diameter and a more proximal portion with a second outer diameter larger than the first outer diameter.

18. The intravascular blood pump system of claim 1 further comprising an elongate tubular element defining the elongate lumen.

19. The intravascular blood pump system of claim 1 wherein the purge lumen is a side lumen extending longitudinally through the catheter but offset radially from a central axis of the catheter.

20. An intravascular blood pump system, comprising:

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 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 lumen of the cannula 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 wherein the intravascular blood pump is configured to draw 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 while the cannula is positioned across an aortic valve of the patient, the cannula is configured such that when the intravascular blood pump is positioned in the patient to provide left-heart support the distal end of the cannula and the at least one second port are positioned inside the patient'"'"'s heart and the proximal end of the cannula and the at least one first port are positioned in the patient'"'"'s aorta;

a catheter connected to a proximal end of the intravascular blood pump, a purge lumen extending through the catheter and operatively arranged to deliver purge fluid towards the intravascular blood pump;

an elongate lumen arranged coaxially with at least a portion of the cannula and in series longitudinally with the cannula, and an end of the elongate lumen is adjacent an end of the cannula, the elongate lumen sized to slidably receive the guide wire and having a diameter sized smaller than a diameter of the cannula lumen;

a pressure sensing element configured to sense pressure proximate the intravascular blood pump and comprising a fluid column extending through the catheter;

a housing connected to a proximal end of the catheter, the housing configured to have the purge fluid passing through it;

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; and

a fluid delivery pump configured to deliver purge fluid through at least one of the first and second conduits, and through the housing and the purge lumen towards the intravascular blood pump.

21. The intravascular blood pump system of claim 20 further comprising a distal tip member at one end of the cannula, 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.

22. The intravascular blood pump system of claim 21 wherein the distal tip member is pigtail shaped.

23. The intravascular blood pump system of claim 21 wherein the distal tip member is J-shaped.

24. The intravascular blood pump system of claim 20 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 comprises a dual construction arrangement whereby the rotor is configured to be docked within the rotor shroud.

25. The intravascular blood pump system of claim 20 wherein the pressure sensing element further comprising at least one of a piezo-electric pressure sensing element and a strain gauge.

26. The intravascular blood pump system of claim 20 wherein the purge lumen is a side lumen extending longitudinally through the catheter but offset radially from a central axis of the catheter.

27. An intravascular blood pump system, comprising:

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 and operatively arranged to deliver purge fluid towards the intravascular blood pump;

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 lumen of the cannula 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, the cannula is configured such that when the intravascular blood pump is positioned in the patient to provide left-heart support the distal end of the cannula and the at least one second port are positioned inside the patient'"'"'s heart and the proximal end of the cannula and the at least one first port are positioned in the patient'"'"'s aorta, the intravascular blood pump is configured to draw 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 while the cannula is positioned across an aortic valve of the patient;

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 and is shorter in length than the cannula lumen, both the elongate lumen and the cannula lumen not extending through the rotor hub, the intravascular blood pump system configured for the guide wire to extend proximally away from the intravascular blood pump, the guide wire not passing through the rotor hub or the catheter, and the guide wire extending out of the intravascular blood pump system in a distal direction through the elongate lumen, wherein when the intravascular blood pump is positioned in the patient to provide left-heart support the elongate lumen lies wholly within the left ventricle;

a pressure sensing element configured to sense pressure proximate the intravascular blood pump comprising a fluid column extending through the catheter;

a housing connected to a proximal end of the catheter, the housing configured to have the purge fluid pass through it;

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; and

a fluid delivery pump configured to deliver purge fluid through at least one of the first and second conduits, and through the housing and the purge lumen towards the intravascular blood pump.

28. The intravascular blood pump system of claim 27 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 comprises a dual construction arrangement whereby the rotor is configured to be docked within the rotor shroud.

29. The intravascular blood pump system of claim 27 further comprising a pigtail shaped distal tip member or a J-shaped distal tip member at one end.

30. The intravascular blood pump system of claim 29 wherein the elongate lumen is located proximal to the distal tip member.