IP Library › Granted Patent US 11,583,659
Granted Patent B2
US 11,583,659 · App. 16/730,605 · Granted Feb 21, 2023

Catheter device

Inventors: Joachim-Georg Pfeffer (Aachen, DE); Thomas Schmitz-Rode (Aachen, DE); Rolf W. Günther (Aachen, DE)
Assignee: AIS GMBH AACHEN INNOVATIVE SOLUTIONS
A61M25/0074A61M60/13A61M60/253A61M60/422A61M25/0068A61M25/0069A61M25/0082A61M60/148A61M60/414F04D3/005F04D3/02F04D29/181F04D29/242F04D29/247F04D29/42Y10S415/90
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Quick Facts
Patent No.
US 11,583,659
App. No.
16/730,605
Granted
Feb 21, 2023
Kind
B2
Abstract

The catheter device comprises a drive shaft connected to a motor, and a rotor mounted on the drive shaft at the distal end section. The rotor has a frame structure which is formed by a screw-like boundary frame and rotor struts extending radially inwards from the boundary frame. The rotor struts are fastened to the drive shaft by their ends opposite the boundary frame. Between the boundary frame and the drive shaft extends an elastic covering. The frame structure is made of an elastic material such that, after forced compression, the rotor unfolds automatically.

Claims (36)

1. A method of providing left side support for a patient's heart with a percutaneous intravascular pump system, the pump system comprising a pump head and a hose, the pump head comprising a rotor inside a pump housing, the method comprising:

inserting the percutaneous intravascular pump system within the patient's vasculature;

positioning the hose across the patient's aortic valve such that a distal end of the hose is positioned within the patient's left ventricle and a proximal end of the hose is positioned in the patient's aorta; and

operating the pump at a given output pressure during first and second time periods so that during the first time period the given output pressure relative to a first ambient pressure in the patient's aorta generates a blood flow from the patient's left ventricle to the patient's aorta that opens the hose, and during the second time period the given output pressure relative to a second ambient pressure in the patient's aorta allows the hose to at least partially close when the patient's aortic valve closes around the hose such that backflow of blood through the hose from the patient's aorta into the patient's left ventricle is restricted or prevented during the second time period.

2. The method of claim 1 , wherein operating the pump during the first time period further comprises running the pump to achieve a positive pressure differential between the given output pressure and the first ambient pressure in the patient's aorta that partially deploys the hose to a diameter less than a maximum diameter of the hose.

3. The method of claim 2 , wherein operating the pump during the first time period further comprises running the pump to achieve a positive pressure differential between the given output pressure and the first ambient pressure in the patient's aorta that deploys the hose to a fixed maximum diameter.

4. The method of claim 1 , wherein operating the pump further comprises, for a given second time period of the first and second time periods and a given first time period of the first and second time periods that immediately follows the given second time period, running the pump to achieve a neutral or negative pressure differential between the given output pressure and the second ambient pressure in the patient's aorta such that the rotor stops when the patient's aortic valve closes during the given second time period, and running the pump to achieve a positive pressure differential between the given output pressure and the first ambient pressure in the patient's aorta such that the rotor restarts when the patient's aortic valve opens during the given first time period.

5. The method of claim 1 , wherein inserting the percutaneous intravascular pump into the patient's vasculature comprises inserting the pump in the patient's femoral artery or axillary artery, advancing the pump in a direction toward the patient's heart, and stopping the insertion at a position inside the patient's vasculature.

6. The method of claim 5 , further comprising inserting the pump head into the patient's vasculature and positioning the hose as an outlet hose.

7. The method of claim 5 , wherein inserting comprises compressing the pump head, moving the compressed pump head and hose to the position inside the patient's vasculature and expanding the pump head and hose.

8. The method of claim 5 , further comprising advancing the pump distally until the pump rotor is in the patient's left ventricle.

9. The method of claim 1 , wherein operating the pump during the second time period further comprises running the pump to achieve a pressure differential between the given output pressure and the second ambient pressure in the patient's aorta such that the hose fully closes when the patient's aortic valve closes around the hose.

10. The method of claim 1 , wherein operating the pump during the first time period further comprises running the pump to achieve a positive pressure differential between the given output pressure and the first ambient pressure in the patient's aorta that causes an exterior surface of the hose to seals against the patient's aortic valve.

11. The method of claim 1 , the intravascular pump system comprising a catheter shaft extending through a lumen of the hose, and

wherein operating the pump during the second time period further comprises running the pump to achieve a pressure differential between the given output pressure and the second ambient pressure in the patient's aorta such that the hose closes around the catheter shaft when the patient's aortic valve closes around the hose.

12. The method of claim 1 , wherein operating the pump further comprises, for a given first time period of the first and second time periods and a given second time period of the first and second time periods that immediately follows the given first time period, running the pump to achieve a positive pressure differential between the given output pressure and the first ambient pressure in the patient's aorta such that the rotor rotates within the pump housing at a first rotation speed during the given first time period, and running the pump to achieve a pressure differential between the given output pressure and the second ambient pressure in the patient's aorta such that rotation of the rotor is reduced relative to the first rotation speed during the given second time period.

13. The method of claim 12 , wherein during the given second time period the rotor does not rotate.

14. The method of claim 1 , wherein blood exits from the hose through one or more agitation outlets located in a proximal region of the hose.

15. The method of claim 1 , wherein operating the pump during the first time period ejects turbulent blood flow toward a coronary artery of the patient.

16. The method of claim 1 , wherein the first time period corresponds to systole, and the second time period corresponds to diastole.

17. A method of providing circulatory support for a patient's heart by a percutaneous intravascular pump system, comprising:

inserting the intravascular pump system percutaneously into the patient's vasculature, the intravascular pump system comprising a pump having a rotor, and a cannula;

advancing the pump and cannula through the patient's vasculature toward the patient's heart until the cannula is positioned across the patient's aortic valve;

operating the pump at a given output pressure during a first time period to achieve a first pressure differential between the given output pressure and a first ambient pressure in the patient's aorta such that the rotor rotates and generates blood flow from the patient's left ventricle into the patient's aorta; and

operating the pump at the given output pressure during a second time period to achieve a second pressure differential between the given output pressure and a second ambient pressure in the patient's aorta such that the rotor stops or rotates at a speed slower than a speed at which it rotates during the first time period, and such that blood backflow through the cannula from the patient's aorta into the patient's left ventricle is restricted or prevented during the second time period,

wherein the first pressure differential is greater than the second pressure differential.

18. The method of claim 17 , wherein operating the pump during the first time period further comprises selecting a pump speed to generate a first flow rate of blood from the patient's left ventricle to the patient's aorta during the first time period.

19. The method of claim 18 , wherein the cannula is configured to attain a maximum diameter when inflated, and wherein operating the pump during the first time period to achieve the first pressure differential causes the cannula to open to the maximum diameter.

20. The method of claim 18 , wherein the cannula is configured to attain a maximum diameter when inflated, and wherein operating the pump during the first time period to achieve the first pressure differential causes the cannula to open to a diameter less than the maximum diameter.

21. The method of claim 17 , wherein the cannula is a collapsible cannula comprising a tubular wall forming an internal lumen.

22. The method of claim 21 , further comprising:

positioning the cannula of the pump across the patient's aortic valve, the collapsible cannula configured to prevent backflow by closing during closure of the patient's aortic valve.

23. The method of claim 17 , further comprising inserting the cannula into the patient's vasculature until one or more cannula exit ports are adjacent to one or more of the patient's coronary arteries.

24. The method of claim 17 , further comprising operating the pump so non-laminar blood flow exits the cannula adjacent one or more of the patient's coronary artery openings.

25. The method of claim 21 , wherein operating the pump during the second time period further comprises selecting a pump speed to generate a second flow rate of blood from the patient's left ventricle to the patient's aorta during the second time period.

26. The method of claim 25 , wherein at the second flow rate the collapsible cannula is closed by closure of the patient's aortic valve.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 31, 2020
From: PFEFFER, JOACHIM GEORG; SCHMITZ-RODE, THOMAS; GÜNTHER, ROLF W.
To: AIS GMBH AACHEN INNOVATIVE SOLUTIONS
Reel/Frame 052270/0171 →
Continuity (6)
Continuation 15891495 · Feb 8, 2018
Continuation 14725281 · May 29, 2015
Continuation 13862752 · Apr 15, 2013
Division 12210435 · Sep 15, 2008
Provisional Application 60978249 · Oct 8, 2007
Related Publication 20200129684A1 · Apr 30, 2020
Cited By (39)
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