Apparatus and methods for treating congestive heart disease

• US 20040064091A1
• Filed: 05/13/2003
• Published: 04/01/2004
• Est. Priority Date: 01/11/1999
• Status: Active Grant

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: FlowMedica, Inc. (AngioDynamics, Inc.)
• Inventors: Schmulewitz, Ascher, Rosenthal, Michael H., Arad, Michael, Spenser, Benjamin, Kramer, Andrew W., Keren, Gad, Payne, Sam G., Pesotchinsky, Sophia, Kesten, Randy J.
• Granted Patent: US 7,335,192 B2
• Time in Patent Office: Days
• US Class Current: 604/96.01
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61B 2017/061 hollow or tubular
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3623 Means for actively controlling temperature of blood
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2210/1082 Kidney
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• 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 60/113 : in other functional devices, e.g. dialysers or heart-lung machines
• 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 60/232 : Centrifugal pumps
• CPC Class Codes: A61M 60/258 : Piston pumps
• CPC Class Codes: A61M 60/279 : Peristaltic pumps, e.g. roller pumps
• CPC Class Codes: A61M 60/33 : of kidneys
• CPC Class Codes: A61M 60/38 : Blood oxygenation
• CPC Class Codes: A61M 60/414 : transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
• CPC Class Codes: A61M 60/833 : Occluders for preventing backflow
• CPC Class Codes: A61M 60/867 : using position detection during deployment, e.g. for blood pumps mounted on and driven through a catheter

Abstract

Methods and apparatus are provided for treating congestive heart by actively or passively enhancing perfusion to the renal arteries. A first embodiment comprises a specially configured balloon catheter and extracorporeal pump, wherein the pump operates in a “once-through” fashion or alternating volume displacement mode. In another embodiment the catheter includes a pair of balloons to isolate a region of the aorta, and a third balloon that directs flow into the renal arteries. In still further embodiments, a stent or cuff having a constricted region is deployed in or around the aorta, respectively, to create a backpressure upstream of the stent or cuff. Methods of enhancing renal perfusion also are provided.

Claims

1. Apparatus for perfusing a kidney in vivo, the apparatus comprising:

a catheter having an inlet port, the inlet port configured for placement in a source of autologous blood, an outlet port, and a lumen in fluid communication with inlet port and the outlet port;

a first inflatable member disposed on the catheter adjacent to the outlet port; and

a pump that causes blood to flow from the inlet port to the outlet port, so that blood exiting the outlet port is directed to a renal artery.

2. The apparatus of claim 1 wherein the outlet port is adapted to be disposed within the renal artery and the first inflatable member retains the outlet port in the renal artery.

3. The apparatus of claim 1 further comprising a second inflatable member, wherein the outlet port is disposed between the first and second inflatable members, and the first and second inflatable members are adapted to isolate a region of the aorta when inflated.

4. The apparatus of claim 1 wherein the lumen includes an inlet lumen coupled to the inlet port and an outlet lumen coupled to the outlet port, wherein the inlet lumen is coupled to an inlet of the pump and the outlet lumen is coupled to an outlet of the pump.

5. The apparatus of claim 1 further comprising an oxygenation element coupled between the inlet port and the outlet port of the catheter.

6. The apparatus of claim 1 wherein the pump includes a piston and shaft that reciprocate, reciprocation of the piston and shaft alternately causing blood to be drawn into the lumen through the inlet port and expelled from the lumen through the outlet port.

7. The apparatus of claim 4 further comprising one or more one-way valves that permit blood to flow only from the inlet port to the outlet port.

8. The apparatus of claim 1 wherein a first portion of the catheter is adapted to be disposed through either a patient'"'"'s femoral artery or upper aortic artery and a second portion of the catheter is adapted to be disposed in the patient'"'"'s aorta through the contralateral femoral artery.

9. The apparatus of claim 1 further comprising radiopaque markers disposed on any of the first and second occlusion balloons and the center balloon.

10. The apparatus of claim 1 wherein pump further comprises control circuitry that adjusts operation of the pump responsive to a preselected measured parameter.

11. Apparatus for perfusing one or more kidneys in vivo comprising:

a catheter having first and second inflation lumens; and

first and second occlusion balloons coupled in fluid communication to the first inflation lumen;

a center balloon coupled in fluid communication to the second inflation lumen; and

a valve for selectively coupling the first and second occlusion balloons to the first inflation lumen or coupling the center balloon to the second inflation lumen;

and a pump coupled to the valve.

12. The apparatus of claim 11 further comprising a controller that first causes the pump to inflate the first and second balloons to trap an amount of blood, and then causes the pump to inflate the center balloon.

13. Apparatus for enhancing perfusion of a patient'"'"'s kidneys, the apparatus comprising:

a stent having a constricted region, the stent adapted to be placed in the aorta at a location below the patient'"'"'s junction to the renal arteries.

14. Apparatus for enhancing perfusion of a patient'"'"'s kidneys, the apparatus comprising:

a cuff having a constricted region, the cuff adapted to be placed around the aorta at a location below the patient'"'"'s junction to the renal arteries.

15. A method of enhancing perfusion of a patient'"'"'s kidney in vivo, the method comprising:

providing a catheter having an inlet port, an outlet port, a lumen there between, a first inflatable member and a pump;

inserting the catheter through the patient'"'"'s aorta so that the outlet port is disposed in a renal artery;

inflating the inflatable member to retain the outlet port in the renal artery;

disposing the inlet port in a source of autologous blood;

coupling the pump to the catheter; and

activating the pump to cause blood to flow from the inlet port to the outlet port.

16. The method of claim 15 wherein coupling the pump to the catheter comprises coupling the pump between the inlet port and the outlet port.

17. The method of claim 15 wherein the pump includes a piston and shaft that reciprocate and activating the pump comprises reciprocating the piston and shaft alternately to cause blood to be drawn into the lumen through the inlet port and expelled from the lumen through the outlet port.

18. The method of claim 17 wherein catheter further comprises one or more one-way valves and activating the pump further comprises activating the pump further comprises permitting blood to flow only from the inlet port to the outlet port through the one or more one-way valves.

19. The method of claim 15 further comprising:

measuring a flow-related parameter; and

adjusting operation of the pump responsive to the measured flow-related parameter.

20. The method of claim 15 further comprising oxygenating blood flowing between the inlet port and the outlet port.

21. A method of enhancing perfusion to a patient'"'"'s kidney in vivo, the method comprising:

providing a catheter having an inlet port, an outlet port, a lumen there between, first and second inflatable members and a pump;

inserting the catheter through the patient'"'"'s aorta so that the outlet port is disposed in the patient'"'"'s aorta;

inflating the first and second inflatable members to isolate a region of the aorta including the patient'"'"'s junction to the renal arteries;

disposing the inlet port in a source of autologous blood;

coupling the pump to the catheter; and

activating the pump to cause blood to flow from the inlet port to the outlet port.

22. The method of claim 21 wherein coupling the pump to the catheter comprises coupling the pump between the inlet port and the outlet port.

23. The method of claim 21 wherein the pump includes a piston and shaft that reciprocate and activating the pump comprises reciprocating the piston and shaft alternately to cause blood to be drawn into the lumen through the inlet port and expelled from the lumen through the outlet port.

24. The method of claim 21 further comprising oxygenating blood flowing between the inlet port and the outlet port.

26. The method of claim 21 further comprising deflating the first, second and third balloons to re-establish blood flow through the aorta.

25. A method of enhancing perfusion to a patient'"'"'s kidneys in vivo, the method comprising:

providing a catheter having first, second and third balloons, the third balloon disposed between the first and second balloons;

placing the catheter in the patient'"'"'s aorta so that the first and second balloons straddle a region of the aorta including the patient'"'"'s junction to the renal arteries;

inflating the first and second balloons to trap an amount of blood within the region and isolate the region;

inflating the third balloon to direct the trapped blood into the renal arteries.

27. A method for enhancing perfusion of a patient'"'"'s kidneys, the method comprising:

providing a stent having a constricted region; and

deploying the stent in a patient'"'"'s aorta at a location below the junction to the renal arteries to create a backpressure in the aorta.

28. A method for enhancing perfusion of a patient'"'"'s kidneys, the method comprising:

providing an inflatable cuff;

surgically placing the inflatable cuff around

a patient'"'"'s aorta at a location below the junction to the renal arteries constricted region; and

inflating the inflatable cuff to create a backpressure in the aorta.

29. An apparatus for perfusing a patient'"'"'s kidneys with blood, comprising:

an elongated catheter shaft having a first end, a second end, a blood inlet port, a blood outlet port, and at least one lumen extending between the blood inlet port and the blood outlet port;

an in-line blood pump; and

at least one expandable member proximate to the second end which has an expanded configuration which secures the expanded expandable member within the abdominal aorta.

30. The apparatus of claim 29 wherein the in-line pump is an archimedean screw pump.

31. The apparatus of claim 29 comprising at least two expandable members longitudinally displaced from one another along the catheter shaft.

32. The apparatus of claim 31 wherein the blood outlet port is located between the two expandable members.

33. The apparatus of claim 31 wherein the in-line blood pump is an archimedean screw pump and the archimedean screw pump is located at a transverse location between the two expandable members.

34. An apparatus for locally delivering a drug to a patient'"'"'s kidney comprising:

an elongated catheter shaft having a first end, a second end including at least one discharge port, and at least one lumen in fluid communication with the discharge ports;

a drug source; and

at least one expandable member proximate to the second end which has an expanded configuration which secures the expanded expandable member within the abdominal aorta.