Antegrade hemodynamic support

• US 10,307,575 B2
• Filed: 04/02/2018
• Issued: 06/04/2019
• Est. Priority Date: 04/03/2017
• Status: Active Grant

• Current Assignee: Henry Ford Health System
• Original Assignee: Henry Ford Health System
• Inventors: Alaswad, Khaldoon
• Primary Examiner(s): Manuel, George
• Application Number:
  US15/943,477
• Publication Number:
  US 20180280668A1
• Time in Patent Office: 428 Days
• CPC Class Codes: A61M 1/1698 Blood oxygenators with or without heat-exchangers intracorporal A61M1/1678; manufacturing of membranes therefor B01D67/00; semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi-permeable membranes characterised by their material B01D71/00
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202
• 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 60/165 implantable in, on, or around the heart
• CPC Class Codes: A61M 60/216 including a rotating member acting on the blood, e.g. impeller
• CPC Class Codes: A61M 60/857 Implantable blood tubes

Abstract

The procedure to place antegrade hemodynamic support (AHS) combine currently available procedures and devices in a unique fashion to solve a significant problem for patients who need large bore hemodynamic support. The AHS procedure involves delivering an AHS device or a catheter connected to an AHS device to a patient'"'"'s aorta in an antegrade fashion, alleviating the workload on the patient'"'"'s heart and supporting the patient hemodynamically to maintain normal functions of the body organs.

Claims

1. A method of providing hemodynamic support to a patient'"'"'s heart for alleviating workload therefrom, said method comprising:

providing a hemodynamic support system, wherein the hemodynamic support system comprises a catheter, the catheter comprising at least two lumens and having an inlet port and outlet port, wherein the inlet port is proximal of the outlet port;

introducing the catheter into a vein of the patient;

advancing the catheter in an antegrade direction into a vena cava;

advancing the catheter in the antegrade direction into a right atrium;

passing the catheter transseptally from the right atrium into a left atrium;

advancing the catheter across a mitral valve;

advancing the catheter in the antegrade direction through a left ventricular outflow tract into an ascending aorta;

removing blood from the patient via the inlet port and through a first of the at least two lumens and delivering the blood to another portion of the hemodynamic support system;

returning the blood to the patient by delivering the blood through a second of the at least two lumens, wherein the blood is returned from the outlet port to the ascending aorta, the outlet port adjacent a distal portion of the catheter; and

alleviating the workload on the patient'"'"'s heart and supporting the patient'"'"'s normal body functions.

2. The method of claim 1, wherein introducing the catheter into the vein of the patient comprises introducing the catheter into an internal jugular vein or a subclavian vein, thereby permitting increased patient mobility.

3. The method of claim 1, wherein passing the catheter transseptally from the right atrium into the left atrium comprises using a peel away sheath to access the left atrium.

4. A method of delivering hemodynamic support to a patient'"'"'s heart for alleviating workload therefrom, said method comprising:

providing a hemodynamic support system, wherein the hemodynamic support system comprises an outer catheter and an inner catheter, wherein the outer catheter comprises a first port, a second port, and a third port, wherein the inner catheter comprises an outlet port disposed on a distal portion thereof;

introducing the outer catheter into a vein of the patient and advancing the outer catheter towards the heart;

introducing the inner catheter into the first port;

advancing the inner catheter through the outer catheter in an antegrade direction and out the third port, wherein the third port is disposed on a distal portion of the outer catheter;

disposing the outlet port in an ascending aorta;

removing blood from the patient via the third port or a plurality of apertures disposed on the distal portion of the outer catheter, wherein the third port or the plurality of apertures is proximal of the outlet port;

moving the blood through the second port and delivering the blood to another portion of the hemodynamic support system;

returning the blood to the patient by delivering the blood through the outlet port; and

alleviating the workload on the patient'"'"'s heart and supporting the patient'"'"'s normal body functions.

5. The method of claim 4, wherein introducing the outer catheter into the vein of the patient comprises introducing the outer catheter into an internal jugular vein or a subclavian vein.

6. The method of claim 4, wherein introducing the inner catheter into the vein of the patient comprises introducing the inner catheter into an internal jugular vein or a subclavian vein.

7. The method of claim 4, wherein advancing the inner catheter in an antegrade direction further comprises:

advancing the inner catheter in an antegrade direction into a vena cava;

advancing the inner catheter in the antegrade direction into a right atrium;

passing the inner catheter transseptally from the right atrium into a left atrium;

advancing the inner catheter across a mitral valve; and

advancing the catheter in the antegrade direction through a left ventricular outflow tract into the ascending aorta.

8. The method of claim 7, wherein passing the inner catheter transseptally from the right atrium into the left atrium comprises using a peel away sheath to access the left atrium.

9. The method of claim 4, wherein the outer catheter comprises a plurality of axially oriented elongate elements disposed along the distal portion of the outer catheter, the method further comprising radially expanding the plurality of elongate elements thereby forming a barrier around the third port or the plurality of apertures, the barrier preventing tissue from obstructing the third port or the plurality of apertures, and further forming an anchor for the outer catheter.

10. The method of claim 4, wherein the third port or the plurality of apertures is disposed in the left atrium or the left ventricle.

11. A method of providing hemodynamic support to a patient'"'"'s heart for alleviating workload therefrom, said method comprising:

providing a hemodynamic support system, wherein the hemodynamic support system comprises two separate catheters, an inlet catheter and an outlet catheter, the inlet catheter comprises an inlet port disposed on a distal portion thereof, the outlet catheter comprises an outlet port disposed on a distal portion thereof;

introducing the outlet catheter into a vein of the patient;

advancing the outlet catheter in an antegrade direction into an ascending aorta, wherein the outlet port is disposed in the ascending aorta;

introducing the inlet catheter into a vein of the patient;

advancing the inlet catheter proximal to the outlet port;

removing blood from the patient through the inlet catheter via the inlet port and delivering the blood to another portion of the hemodynamic support system;

returning the blood to the patient by delivering the blood to the ascending aorta through the outlet catheter via the outlet port; and

alleviating the workload on the patient'"'"'s heart and supporting the patient'"'"'s normal body functions.

12. The method of claim 11, wherein introducing the outlet catheter into the vein of the patient comprises introducing the catheter into an internal jugular vein or a subclavian vein, thereby permitting increased patient mobility.

13. The method of claim 11, wherein advancing the outlet catheter in an antegrade direction into an ascending aorta comprises:

advancing the outlet catheter in an antegrade direction into a vena cava

advancing the outlet catheter in the antegrade direction into a right atrium;

passing the outlet catheter transseptally from the right atrium into a left atrium;

advancing the outlet catheter across a mitral valve; and

advancing the outlet catheter in the antegrade direction through a left ventricular outflow tract into the ascending aorta.

14. The method of claim 13, wherein passing the outlet catheter transseptally from the right atrium into the left atrium comprises using a peel away sheath to access the left atrium.

15. The method of claim 11, wherein introducing the inlet catheter into the vein of the patient comprises introducing the catheter into an internal jugular vein or a subclavian vein, thereby permitting increased patient mobility.

16. The method of claim 11, wherein the inlet port is disposed in the left atrium, left ventricle, pulmonary artery, anywhere in a venous system of the patient, or anywhere in a right side of the heart.

17. The method of claim 11, wherein the inlet catheter comprises a plurality of axially oriented elongate elements disposed along the distal portion of the inlet catheter, the method further comprising radially expanding the plurality of elongate elements thereby forming a barrier around the inlet port or the plurality of apertures, the barrier preventing tissue from obstructing the inlet port or the plurality of apertures, and further forming an anchor for the inlet catheter.

18. A method of providing hemodynamic support to a patient'"'"'s heart for alleviating workload therefrom, said method comprising:

providing a hemodynamic support system, wherein the hemodynamic support system comprises a catheter system, a second catheter, a snare, and a guide wire;

introducing the snare into an internal jugular vein or a subclavian vein of the patient;

advancing the snare into an inferior vena cava;

introducing the second catheter into a common femoral vein of the patient;

advancing the second catheter through the snare;

advancing the second catheter in an antegrade direction into a right atrium;

passing the second catheter transseptally from the right atrium into the left atrium;

advancing the second catheter across a mitral valve;

advancing the second catheter in the antegrade direction through a left ventricular outflow tract into an ascending aorta;

introducing the guide wire into the second catheter from the common femoral vein;

advancing the guide wire through the second catheter to the ascending aorta;

removing the second catheter from the patient while the guide wire remains in the patient;

snaring the guide wire with the snare;

externalizing the proximal portion of the guide wire from the internal jugular vein or the subclavian vein;

introducing the catheter system into the internal jugular vein or the subclavian vein; and

advancing the catheter system into the heart, wherein a distal portion of the catheter system is positioned in the ascending aorta.

19. The method of claim 18, wherein the hemodynamic support system further comprises a second snare, wherein the second snare is introduced into an artery of the patient, wherein the second snare snares one portion of the guide wire.

20. The method of claim 19, wherein the one portion of the guide wire is externalized from a peripheral artery.