Guidable intravascular blood pump and related methods

• US 10,279,095 B2
• Filed: 09/26/2018
• Issued: 05/07/2019
• 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
• Application Number:
  US16/143,289
• Publication Number:
  US 20190022291A1
• Time in Patent Office: 223 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. A method for perfusing a patient with an intravascular blood pump system, the intravascular blood pump system comprising:

an intravascular blood pump comprising a rotor having a rotor hub tapering in a distal direction, at least one blade extending 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 and a shroud within which the rotor is rotatably disposed;

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

a guide mechanism comprising a lumen having a proximal end and a distal end, the guide mechanism adapted to guide a distal portion of said intravascular blood pump system to a predetermined location within a circulatory system of the patient, wherein an axis coaxial with and extending through a portion of said guide mechanism extends through a region delimited by the outer cannula surface, and wherein the guide mechanism is configured to allow for a guide wire to slideably advance therealong, the method comprising the steps of;

progressing the guide wire to a predetermined location in the circulatory system of the patient; and

advancing the intravascular blood pump system along the guide wire to the predetermined location.

2. The method of claim 1, wherein the guide mechanism is configured such that the guide wire passes through the region delimited by the outer cannula surface at a location proximal to where the guide wire establishes slidable contact with the guide mechanism.

3. The method of claim 1, wherein the intravascular blood pump system further comprises:

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

a blood pressure detection mechanism comprising a fluid column disposed within the elongate catheter and configured to detect a pressure of blood proximate the intravascular blood pump.

4. The method of claim 3, wherein the blood pressure detection mechanism comprises at least one of a piezo-electric pressure sensing element and a strain gauge.

5. The method of claim 1, wherein the intravascular blood pump system further comprising:

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, the cannula is configured such that when the intravascular 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, 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, and

wherein a portion of the 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 shroud.

6. The method of claim 1, wherein the intravascular blood pump system has a pigtail shaped distal tip or a J-shaped distal tip, wherein at least a portion of the lumen is located proximal to the pigtail shaped distal tip or the J-shaped distal tip.

7. The method of claim 6, wherein when the intravascular blood pump is positioned in the patient to provide left-heart support, the pigtail shaped distal tip or the J-shaped distal tip is wholly within a left ventricle of the patient.

8. 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 a 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 a distal direction, at least one blade extending 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 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 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, both the elongate lumen and the cannula lumen not extending through the rotor hub or the catheter;

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 a left ventricle of the patient'"'"'s heart;

placing the guide wire through both the cannula and the elongate lumen, 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 the 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 an aorta; 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.

9. The method of claim 8, 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.

10. The method of claim 8, wherein the intravascular blood pump system further comprises:

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.

11. The method of claim 8, wherein the intravascular blood pump system further comprises a rotor shroud, a portion of the rotor shroud having an outer diameter matching an inner diameter of a proximal portion of the cannula, wherein the proximal portion of the cannula disposed about a distal end of the rotor shroud.

12. The method of claim 8, wherein the elongate lumen is an integral extension of a wall of the cannula.

13. The method of claim 8, wherein the elongate lumen is adapted to guide the guide wire through a distal end of the intravascular blood pump system.

14. The method of claim 8, wherein the elongate lumen is shorter in length than the cannula lumen.

15. The method of claim 8, wherein the elongate lumen is at least partially disposed within an outer surface of the cannula and wherein the intravascular blood pump system is configured for the guide wire to exit the intravascular blood pump system through an end of the elongate lumen.

16. The method of claim 8, wherein the intravascular blood pump system has a pigtail shaped distal tip or a J-shaped distal tip, wherein at least a portion of the elongate lumen is located proximal to the pigtail shaped distal tip or the J-shaped distal tip.

17. A method for providing left-heart support using an intravascular blood pump system, the intravascular blood pump system comprising:

an intravascular 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 intravascular blood pump comprising a rotor having a rotor hub tapering in a distal direction and a rotor shroud at least partially disposed about the rotor hub, at least one blade extending 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 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 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, the cannula is configured such that when the intravascular 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 lumen 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 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

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, both the elongate lumen and the cannula lumen not extending through the rotor hub, the elongate lumen adapted to guide the guide wire through a distal end of the intravascular blood pump system, the elongate lumen shorter in length than the cannula lumen;

the method comprising 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 a left ventricle of the patient'"'"'s heart;

placing the guide wire through both the cannula and 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 the 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 an aorta, and the elongate lumen is wholly within the left ventricle during left-heart support; 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.

18. The method of claim 17, wherein the intravascular blood pump further comprises 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.

19. The method of claim 17, wherein the intravascular blood pump system further comprises:

a motor assembly and a drive cable, the drive cable at least partially disposed within the catheter,

wherein the motor assembly and the 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.

20. The method of claim 17, wherein the elongate lumen is an integral extension of a wall of the cannula.

21. The method of claim 17, wherein the elongate lumen is adapted to guide the guide wire through a distal end of the intravascular blood pump system.

22. The method of claim 17, wherein the elongate lumen is at least partially disposed within an outer surface of the cannula and wherein the intravascular blood pump system is configured for the guide wire to exit the intravascular blood pump system through an end of the elongate lumen.

23. The method of claim 17, wherein the intravascular blood pump system has a pigtail shaped distal tip or a J-shaped distal tip, wherein at least a portion of the elongate lumen is located proximal to the pigtail shaped distal tip or the J-shaped distal tip.

24. A method for providing left-heart support using an intravascular blood pump system, the intravascular blood pump system comprising:

an intravascular 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 intravascular blood pump comprising a rotor having a rotor hub tapering in a distal direction and a rotor shroud at least partially disposed about the rotor hub, at least one blade extending outward from the rotor hub, a distal end of the rotor 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 cannula coupled to a distal end of the intravascular blood pump, a first 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 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, the cannula is configured such that when the intravascular 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 lumen 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 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, 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;

the method comprising the steps;

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

passing the guide wire through the cannula, 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 the 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 an aorta, and the pigtail shaped distal tip or the J-shaped distal tip is wholly within the left ventricle during left-heart support; 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.

25. The method of claim 24, wherein the intravascular blood pump further comprises 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, and wherein at least a second portion of the rotor shroud has the same outer diameter as the proximal portion of the cannula.

26. The method of claim 24, wherein the intravascular blood pump system 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, both the elongate lumen and the cannula lumen not extending through the rotor hub or the catheter.

27. The method of claim 26, wherein the elongate lumen is an integral extension of a wall of the cannula.

28. The method of claim 26, wherein the intravascular blood pump system is configured for the guide wire to exit the intravascular blood pump system through an end of the elongate lumen.

29. The method of claim 26, wherein at least a portion of the elongate lumen is located proximal to the pigtail shaped distal tip or the J-shaped distal tip.

30. The method of claim 26, 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 the 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.