Guidable intravascular blood pump and related methods

• US 10,322,218 B2
• Filed: 10/05/2018
• Issued: 06/18/2019
• 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): Marcetich, Adam
• Application Number:
  US16/153,619
• Publication Number:
  US 20190046708A1
• Time in Patent Office: 256 Days
• 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:

a blood pump adapted to be guided to a predetermined location within a circulatory system of a patient by a guide wire and configured to provide left-heart support, the blood pump comprising a rotor having a rotor hub and at least one blade extending outward from the rotor hub;

a rotor shroud at least partially disposed about the rotor hub;

an elongate catheter extending proximally with respect to the blood pump;

a cannula extending from the rotor shroud and comprising an outer cannula surface, the outer cannula surface having a substantially circular cross-section along a portion of its length;

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 of the one or more first ports is located in proximity to the rotor and at least one second port of the one or more second ports is spaced apart from and located distal to the at least one first port, wherein the cannula is configured such that when the blood pump is positioned in the patient to provide left-heart support a distal end of the cannula and the at least one second port are positioned inside the patient'"'"'s heart and a proximal end of the cannula and the at least one first port are positioned in the patient'"'"'s aorta, and the 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; and

a pigtail shaped distal tip or a J-shaped distal tip distal to each of the one or more second ports.

2. The intravascular blood pump system of claim 1, wherein a proximal linear portion of the pigtail shaped distal tip or the J-shaped distal tip is adjacent to the one or more second ports.

3. The intravascular blood pump system of claim 1, wherein the pigtail shaped distal tip or the J-shaped distal tip serves as a guidability feature.

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

5. The intravascular blood pump system of claim 4, wherein the pressure sensing element is adjacent to the one or more first ports and a proximal end of the pigtail shaped distal tip or the J-shaped distal tip is fixed or attached to a distal end of the intravascular blood pump system.

6. The intravascular blood pump system of claim 1, further comprising an elongate lumen sized to slidably receive the guide wire and dimensioned such that the guide wire passes slidably through the elongate lumen, the elongate lumen is sized smaller cross sectionally than the cannula lumen and is shorter in length than the cannula, and wherein the elongate lumen is at least one of an extension of a wall of the cannula and at least partially disposed within an outer surface of the cannula;

and

wherein a distal portion of the rotor shroud has an outer diameter matching an inner diameter of a proximal portion of the cannula, the proximal portion of the cannula disposed about a distal portion of the rotor shroud, and wherein at least a proximal portion of the rotor shroud has the same outer diameter as the proximal portion of the cannula.

7. The intravascular blood pump system of claim 6, further comprising:

a motor assembly and a drive cable, 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.

8. An intravascular blood pump system, comprising:

a blood pump adapted to be guided to a predetermined location within a circulatory system of a patient by a guide wire and configured to provide left-heart support, the blood pump comprising a rotor having a rotor hub and at least one blade extending outward from the rotor hub;

a rotor shroud at least partially disposed about the rotor hub;

an elongate catheter extending proximally with respect to the blood pump;

a cannula extending from the rotor shroud and comprising an outer cannula surface, the outer cannula surface having a substantially circular cross-section along a portion of its length, wherein a distal 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 portion 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 of the one or more first ports is located in proximity to the rotor and at least one second port of the one or more second ports is spaced apart from and located distal to the at least one first port, wherein the cannula is configured such that when the blood pump is positioned in the patient to provide left-heart support a distal end of the cannula and the at least one second port are positioned inside the patient'"'"'s heart and a proximal end of the cannula and the at least one first port are positioned in the patient'"'"'s aorta, and the 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;

a pigtail shaped distal tip or a J-shaped distal tip, wherein a proximal end of the pigtail shaped distal tip or the J-shaped distal tip is fixed or attached to a distal end of the cannula and the pigtail shaped distal tip or the J-shaped distal tip is distal to each of the one or more second ports; and

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

9. The intravascular blood pump system of claim 8, wherein a proximal linear portion of the pigtail shaped distal tip or the J-shaped distal tip is adjacent to the one or more second ports.

10. The intravascular blood pump system of claim 8, wherein the pigtail shaped distal tip or the J-shaped distal tip serves as a guidability feature.

11. The intravascular blood pump system of claim 8, wherein at least a proximal portion of the rotor shroud has the same outer diameter as the proximal portion of the cannula.

12. The intravascular blood pump system of claim 8, wherein the pressure sensing element comprises at least one of a piezo-electric pressure sensing element and a strain gauge and wherein the pressure sensing element is adjacent to the one or more first ports.

13. The intravascular blood pump system of claim 8, further comprising an elongate lumen sized to slidably receive the guide wire and dimensioned such that the guide wire passes slidably through the elongate lumen, the elongate lumen is sized smaller cross sectionally than the cannula lumen and is shorter in length than the cannula, and wherein the elongate lumen is at least one of an extension of a wall of the cannula and at least partially disposed within an outer surface of the cannula.

14. The intravascular blood pump system of claim 13, 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.

15. An intravascular blood pump system, comprising:

a blood pump adapted to be guided to a predetermined location within a circulatory system of a patient by a guide wire and configured to provide left-heart support, the blood pump comprising a rotor having a rotor hub and at least one blade extending outward from the rotor hub;

a rotor shroud at least partially disposed about the rotor hub;

an elongate catheter extending proximally with respect to the blood pump;

a cannula extending from the rotor shroud and comprising an outer cannula surface, the outer cannula surface having a substantially circular cross-section along a portion of its length, wherein a distal portion of the rotor shroud has an outer diameter matching an inner diameter of a proximal portion of the cannula, the proximal portion of the cannula disposed about a distal portion of the rotor shroud, and wherein at least a proximal portion of the rotor shroud has the same outer diameter as the proximal portion of the cannula;

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 of the one or more first ports is located in proximity to the rotor and at least one second port of the one or more second ports is spaced apart from and located distal to the at least one first port, wherein the cannula is configured such that when the blood pump is positioned in the patient to provide left-heart support a distal end of the cannula and the at least one second port are positioned inside the patient'"'"'s heart and a proximal end of the cannula and the at least one first port are positioned in the patient'"'"'s aorta, and the 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; and

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

16. The intravascular blood pump system of claim 15, further comprising a pigtail shaped distal tip or a J-shaped distal tip, wherein a proximal end of the pigtail shaped distal tip or the J-shaped distal tip is fixed or attached to a distal end of the intravascular blood pump system, and the pigtail shaped distal tip or the J-shaped distal tip is distal to each of the one or more second ports.

17. The intravascular blood pump system of claim 16, wherein a proximal linear portion of the pigtail shaped distal tip or the J-shaped distal tip is adjacent to the one or more second ports.

18. The intravascular blood pump system of claim 16, wherein the pigtail shaped distal tip or the J-shaped distal tip serves as a guidability feature.

19. The intravascular blood pump system of claim 15, wherein the pressure sensing element comprises at least one of a piezo-electric pressure sensing element and a strain gauge.

20. The intravascular blood pump system of claim 19, wherein the pressure sensing element is adjacent to the one or more first ports.

21. The intravascular blood pump system of claim 15, further comprising an elongate lumen sized to slidably receive the guide wire and dimensioned such that the guide wire passes slidably through the elongate lumen, the elongate lumen is sized smaller cross sectionally than the cannula lumen and is shorter in length than the cannula, and wherein the elongate lumen is at least one of an extension of a wall of the cannula and at least partially disposed within an outer surface of the cannula.

22. The intravascular blood pump system of claim 21, 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.

23. An intravascular blood pump system, comprising:

a blood pump adapted to be guided to a predetermined location within a circulatory system of a patient by a guide wire and configured to provide left-heart support, the blood pump comprising a rotor having a rotor hub and at least one blade extending outward from the rotor hub;

a rotor shroud at least partially disposed about the rotor hub;

an elongate catheter extending proximally with respect to the blood pump;

a cannula extending from the rotor shroud and comprising an outer cannula surface, the outer cannula surface having a substantially circular cross-section along a portion of its length;

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 of the one or more first ports is located in proximity to the rotor and at least one second port of the one or more second ports is spaced apart from and located distal to the at least one first port, wherein the cannula is configured such that when the blood pump is positioned in the patient to provide left-heart support a distal end of the cannula and the at least one second port are positioned inside the patient'"'"'s heart and a proximal end of the cannula and the at least one first port are positioned in the patient'"'"'s aorta, and the 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;

a pigtail shaped distal tip or a J-shaped distal tip distal to each of the one or more second ports; and

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

24. The intravascular blood pump system of claim 23, wherein a proximal linear portion of the pigtail shaped distal tip or the J-shaped distal tip is adjacent to the one or more second ports.

25. The intravascular blood pump system of claim 23, wherein the pigtail shaped distal tip or the J-shaped distal tip serves as a guidability feature.

26. The intravascular blood pump system of claim 23, wherein at least a proximal portion of the rotor shroud has the same outer diameter as a proximal portion of the cannula, and the proximal portion of the cannula is disposed about a distal portion of the rotor shroud, and a proximal end of the pigtail shaped distal tip or the J-shaped distal tip is fixed or attached to a distal end of the intravascular blood pump system.

27. The intravascular blood pump system of claim 23, wherein the pressure sensing element comprises at least one of a piezo-electric pressure sensing element and a strain gauge.

28. The intravascular blood pump system of claim 27, wherein the pressure sensing element is adjacent to the one or more first ports.

29. The intravascular blood pump system of claim 23, further comprising an elongate lumen sized to slidably receive the guide wire and dimensioned such that the guide wire passes slidably through the elongate lumen, the elongate lumen is sized smaller cross sectionally than the cannula lumen and is shorter in length than the cannula, and wherein the elongate lumen is at least one of an extension of a wall of the cannula and at least partially disposed within an outer surface of the cannula.

30. The intravascular blood pump system of claim 29, further comprising:

a motor assembly and a drive cable, the drive cable at least partially disposed within the catheter extending proximally with respect to the blood pump,

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.