Cardiac bypass catheter system and method of use

• US 6,582,388 B1
• Filed: 07/21/1999
• Issued: 06/24/2003
• Est. Priority Date: 11/21/1997
• Status: Expired due to Fees

• Current Assignee: Innovative Interventional Technologies BV
• Original Assignee: Innovative Interventional Technologies BV
• Inventors: Peacock, James C. III, Coleman, Ronald, Kadan, Jeffrey S., Gotha, Frederick
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Deak, Leslie R
• Application Number:
  US09/358,247
• Time in Patent Office: 1,434 Days
• Field of Search: 604/4, 604/6.1, 604/6.11, 604/6.16, 604/8-10, 604/34, 604/39-43, 604/96-104, 604/194, 604/619, 128/898
• US Class Current: 604/8
• 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 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/12127 Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61M 2025/0079 Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• 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

Abstract

A medical device assembly is adapted to isolate the heart from systemic circulation while perfusing oxygenated blood to the systemic arterial circulation during a minimally invasive bypasss procedure. An arterial catheter with an external shunt valve forms a funnel which shunts antegrade aortic blood flow from the aortic root, into a distal flow port and through an internal flow lumen in the catheter, out an intermediate flow port along the catheter proximally of the anchor, and into the systemic arterial circulation. A distal internal valve selectively occludes the shunted antegrade aortic blood flow between the distal flow port and the intermediate flow port and isolates the left heart chambers from the systemic arterial circulation. Oxygenated blood may then flow from a cardiopulmonary bypass pump, distally through the internal flow lumen, out the intermediate port. The assembly also includes a venous catheter which aspirates venous blood from the vena cavae and into the cardiopulmonary bypass pump while substantially isolating the right heart chambers from the vena cavae and without circumferentially engaging the internal walls of the vena cavae. Distal and intermediate external valves are positioned along the venous catheter within the superior and inferior vena cava, respectively, and between the sinus venarum into the right atrium and either a distal or intermediate flow port, also respectively. The flow ports communicate with a cardiopulmonary bypass pump through at least one flow lumen through the catheter. Each external valve is adjustable to have an outer diameter which is slightly less than the inner diameter of the respective vena cava so that venous blood is substantially occluded from flowing into the sinus venarum and is instead aspirated into the adjacent flow port.

Claims

1. A medical device assembly for aspirating a volume of venous blood from at least one of a superior or inferior vena cava adjacent to a heart while substantially isolating a right ventricle of the heart from the vena cavae, the heart including the right ventricle, a right atrium, and a sinus venarum through which the vena cavae communicate with the right atrium, the assembly comprising:

an elongate body with a proximal end portion, a distal end portion, and a flow lumen that extends between a distal flow port located along the distal end portion and a proximal flow port located along the proximal end portion, the distal end portion being adapted for retrograde percutaneous transluminal delivery into a region of the vena cavae adjacent to the sinus venarum such that the distal flow port is positioned within the superior vena cava, and the proximal flow port being adapted to couple to an inlet port of a cardiopulmonary bypass pump;

an external valve which is located along the distal end portion proximally of the distal flow port and which is adjustable from a closed position, which is adapted to allow a volume of venous blood to flow from the superior vena cavae, through the sinus venarum into the right atrium, and into the right ventricle, to an open position, which is adapted to substantially isolate the right ventricle from the superior and inferior vena cavae without circumferentially engaging an interior surface of either of the superior or inferior vena cavae; and

an external valve actuator with a proximal end portion and a distal end portion that is coupled to the external valve, and which is adapted to selectively adjust the external valve between said open and closed positions.

2. The medical device assembly of claim 1, wherein said external valve further comprises a valve member which is located at a discrete location along a circumference of the elongate body and which is adjustable from a first radial position to a radially displaced position which is located adjacent to the elongate body,

whereby the closed position for the external valve is at least in part characterized by aligning the discrete location of the valve member with the sinus venarum such that the valve member in the radially displaced position is located at least in part within the right atrium.

3. The medical device assembly of claim 2, wherein the valve member further comprises two separate members which are adjustable from a first relative position, wherein the two separate members are separated by a space, to a second relative position, wherein the space is substantially narrowed.

4. The medical device assembly of claim 3, wherein at least one separate member is expandable from a radially collapsed condition, which at least in part characterizes the first relative position, to a radially expanded condition, which at least in part characterizes the second relative position;

and further comprising an expansion actuator having a proximal end portion and a distal end portion which is coupled to the at least one separate member and is adapted to adjust the at least one separate member from the radially collapsed condition to the radially expanded condition.

5. The medical device assembly of claim 4, wherein the at least one separate member further comprises an expandable balloon, and wherein the expansion actuator further comprises an expansion actuating lumen extending between the distal and proximal end portions of the expansion actuator, the expansion actuating lumen in the distal end portion of the expansion actuator being fluidly coupled to the expandable balloon, and the expansion actuating lumen in the proximal end portion of the expansion actuator being adapted to fluidly couple to a pressurizeable fluid source.

6. The medical device assembly of claim 3, wherein at least one of the two separate members is moveable with respect to the other separate member;

and further comprising an actuator with a proximal end portion and a distal end portion which is adapted to move the at least one separate member relative to the other;

whereby moving the at least one separate member relative to the other adjusts the two separate members from the first relative position to the second relative position.

7. The medical device assembly of claim 1, said external valve further comprising:

an expandable member which is adjustable by said external valve actuator from a radially collapsed condition, which characterizes at least in part the open position, to a radially expanded condition wherein the expandable member has an outer diameter which substantially occludes the superior vena cava but is less than an inner diameter of the superior vena cava.

8. The medical device assembly of claim 7, wherein said elongate body further comprises an intermediate flow port which is located proximally of the external valve and is adapted to be positioned within the inferior vena cava when the distal flow port is positioned within the superior vena cava, said intermediate flow port being in fluid communication with either the flow lumen or an intermediate flow lumen which extends between the intermediate flow port and a second proximal flow port which is located along the proximal end portion of the elongate body and which is adapted to couple to an inlet port of a cardiopulmonary bypass pump.

9. The medical device assembly of claim 8, wherein the external valve is a distal external valve, and further comprising:

an intermediate external valve which is located along the distal end portion of the elongate body distally of the intermediate flow port and also proximally of the distal external valve such that the distal and intermediate external valves are adapted to be positioned within the superior and inferior vena cavae, respectively, said intermediate external valve also being adjustable from an open position, which is adapted to allow for a volume of blood to flow from the inferior vena cava and through the sinus venarum into the right atrium and ventricle, to a closed position, which is adapted to substantially isolate the right atrium from the inferior vena cava, and

an intermediate external valve actuator with a proximal end portion and a distal end portion which is coupled to the intermediate external valve and which is adapted to adjust the intermediate external valve from the open position to the closed position.

10. The medical device assembly of claim 9, wherein the intermediate external valve further comprises an expandable member which is adjustable by said intermediate external valve actuator from a radially collapsed condition, which characterizes the open position for the intermediate external valve, to a radially expanded condition, which characterizes the closed position for the intermediate external valve.

11. The medical device assembly of claim 10, wherein the expandable member of the intermediate external valve further comprises an expandable balloon, and wherein the intermediate external valve actuator further comprises an intermediate valve actuating lumen which is adapted to fluidly couple the expandable balloon of the intermediate external valve'"'"'s expandable member to a pressurizeable fluid source.

12. The medical device assembly of claim 9, wherein said elongate body further comprises a leakage port which is located along the elongate body between the intermediate external valve and the distal external valve and being in fluid communication with either the flow lumen or the intermediate flow lumen or a leakage flow lumen which extends along the elongate body between the leakage flow port and a third proximal flow port which is located along the proximal end portion of the elongate body and which is adapted to couple to an inlet port of a cardiopulmonary bypass pump.

13. The medical device assembly of claim 9, wherein said intermediate external valve actuator further comprises in-part said intermediate external valve actuator and also further comprises a distal external valve actuator which is coupled to the distal external valve.

14. The medical device assembly of claim 7, wherein said expandable member further comprises an expandable balloon, and wherein said external valve actuator further comprises an external valve actuating lumen which is adapted to fluidly couple the expandable balloon with a pressurizeable fluid source.

15. A method for performing a cardiac bypass procedure on a heart in a mammal, the heart comprising a right ventricle, a right atrium, and a sinus venarum through a superior vena cava and an inferior vena cava communicate with the right atrium, comprising:

positioning an external valve, which is located on a distal end portion of a venous catheter, within a region of the superior and inferior vena cavae which is adjacent to the sinus venarum; and

adjusting said external valve located on the distal end portion from an open position to a closed position which isolates the right ventricle from the vena cavae without circumferentially engaging an interior wall of the vena cavae.

16. The method of claim 15, further comprising:

adjusting the external valve from a radially collapsed condition to a radially expanded condition which has an outer diameter that is smaller than an inner diameter of the interior wall of the vena cavae.

17. The method of claim 16, wherein the venous catheter further includes an internal flow lumen extending between a distal flow port located along the distal end portion distally of the external valve and a proximal flow port located along the venous catheter along a proximal end portion of the venous catheter, further comprising:

coupling the proximal flow port to an inlet port of a cardiopulmonary bypass pump; and

aspirating a volume of venous blood from the superior vena cavae, into the internal flow lumen through the distal flow port, proximally along the internal flow lumen, and out from the internal flow lumen through the proximal flow port, and into the inlet port of the cardiopulmonary bypass pump.

18. The method of claim 17, wherein the external valve further includes a valve member which is positioned at a discrete location along the circumference of the venous catheter, further comprising:

positioning the discrete location of the valve member so that it is aligned with and adjacent to the sinus venarum; and

adjusting the valve member from a first radial position to a radially displaced position which is at least in part within the right atrium and which at least in part characterizes the closed position for the external valve.

19. The method of claim 18, further comprising

when the valve member is adjusted to the radially displaced position, farther adjusting the valve member from a radially collapsed condition to a radially expanded condition.

20. The method of claim 19, wherein the valve member further comprises two expandable members which are separated by a space, further comprising:

positioning the two expandable members within the right ventricle and atrium, respectively, such that the tricuspid valve is located within the space; and

expanding at least one of the two expandable members such that the space is narrowed and such that the tricuspid valve is engaged between the two expandable members to thereby isolate the right ventricle from the right atrium and also from the vena cavae.

21. A medical device assembly for selectively shunting antegrade blood flow from an aortic root in an aorta of an animal and into a proximal region of the aorta which is located proximally of the aortic root, the aorta further including an aortic wall, comprising:

an elongate body with a proximal end portion, a distal end portion, and a flow lumen which extends between a distal flow port located along the distal end portion of the elongate body and an intermediate flow port located along the distal end portion of the elongate body proximally of the distal flow port such that the intermediate flow port is adapted to be positioned within the proximal region of the aorta when the distal flow port is positioned within the aortic root;

an external shunt valve which is located along the elongate body between the proximal and distal flow ports, which includes an anchor and a funnel, and which is adjustable between an open position and a shunting position;

an actuator with a proximal end portion and a distal end portion that is coupled to the external shunt valve, and which is adapted to selectively adjust the external shunt valve between the open and shunting positions such that in the open position the anchor and funnel are adapted to allow passage of the antegrade blood flow through an exterior space between the distal end portion of the elongate body and the aortic wall, and wherein in the shunting position the anchor is adapted to radially engage the aortic wall such that the distal end portion of the elongate body is secured at a predetermined location along the aorta, and the funnel is adapted to substantially shunt the antegrade blood flow from the aortic root, into the flow lumen through the distal flow port, out of the flow lumen through the intermediate flow port, and into the proximal region of the aorta while substantially isolating the antegrade blood flow from the exterior space;

said elongate body further comprising a proximal flow port located along the proximal end portion of said elongate body where said flow lumen communicates exteriorly of said elongate body;

a cannula member having a distal end, a proximate end, and an axis of elongation slidably carried at least in part within said flow lumen where said distal end is selectively positionable within said flow lumen;

an expandable valve member carried by said cannula member adjacent said distal end of said cannula member and so adapted to permit selective adjustment between respective open and closed positions whereby adjusting said expandable valve to the closed position when said expandable valve is positioned within said flow lumen between the distal end of said elongate member and said intermediate flow port, said intermediate flow port and said proximate flow port are in fluid communication and isolated from said distal flow port; and

whereby adjusting said expandable valve to the closed position where said expandable valve is positioned within said flow lumen between said proximate flow port and said intermediate port, said intermediate port and said distal flow port are in fluid communication and isolated from said proximal flow port.

22. The medical device assembly of claim 21 further comprising:

a cardioplegia delivery member with a proximal end portion, a distal end portion, and a cardioplegia delivery lumen that extends between a distal cardioplegia port located along the distal end portion of the cardioplegia delivery member and a proximal cardioplegia port located along the proximal end portion of the cardioplegia delivery member, the proximal cardioplegia port being adapted to couple to a pressurizeable source of cardioplegia agent, and the distal cardioplegia port being adapted to deliver a cardioplegia agent, distally of the external shunt valve to thereby temporarily arrest the beating of the heart; and

a ventricular venting member with a distal end portion that extends distally from the distal end portion of the elongate body and also with a proximal end portion which terminates proximally along the proximal end portion of the elongate body, the ventricular venting member also forming a vent lumen that extends between a distal vent port located along the distal end portion of the ventricular venting member and a proximal vent port located along the proximal end portion of the ventricular venting member,

such that the distal vent port is adapted to be positioned within the left ventricle when the distal flow port is positioned within the aortic root, and wherein the proximal vent port is adapted to couple to a decompression pump such that fluid may be aspirated from the left ventricle through the vent lumen.

23. The medical device assembly of claim 22 further comprising:

a cardiopulmonary bypass machine having an outlet port for the delivery of oxygen-rich blood into the arterial circulation and an inlet port for receiving blood from venous circulation;

the outlet port of the cardiopulmonary bypass machine being coupled to the proximal flow port of the elongate body.

24. The medical device assembly of claim 23, further comprising:

a venous catheter with a venous cannula member having a proximal end portion, a distal end portion, and further forming a venous flow lumen extending between a distal venous flow port located along the distal end portion of the venous cannula member and a proximal venous flow port located along the proximal end portion of the venous cannula member;

the proximal venous flow port being coupled to the inlet port of the cardiopulmonary bypass machine, and

wherein the distal end portion of the venous cannula member is adapted for percutaneous transluminal delivery into a superior vena cava at a region adjacent to a sinus venarum in a right atrium, and is also adapted to substantially aspirate a volume of blood from the superior vena cava and also from an inferior vena cava and into the venous flow lumen through the distal venous flow port.

25. The medical device assembly of claim 21 where said cannula member further comprises:

a cardioplegia delivery lumen that extends between a distal cardioplegia port located along the distal end portion of said cannula member and a proximal cardioplegia port located along said proximal end portion of said cannula member, the proximal cardioplegia being adapted to couple to a pressurizeable source of cardioplegia agent, and the distal cardioplegia port being adapted to deliver a cardioplegia agent, distally of the external shunt valve to thereby temporarily arrest the beating of the heart; and

a vent lumen that extends between a distal vent port located along the distal end portion of said cannula member and a proximal vent port located along the proximal end portion of said cannula member, such that the distal vent port is adapted to be positioned within the left ventricle when the distal flow port is positioned within the aortic root, and wherein the proximal vent port is adapted to couple to a decompression pump such that fluid may be aspirated from the left ventricle through the vent lumen.

26. The medical device assembly of claim 25 further comprising:

a cardiopulmonary bypass machine having an outlet port for the delivery of oxygen-rich blood into the arterial circulation and an inlet port for receiving blood from venous circulation;

the outlet port of the cardiopulmonary bypass machine being coupled to the proximal flow port of the elongate body.

27. The medical device assembly of claim 26 further comprising:

a venous catheter with a venous cannula member having a proximal end portion, a distal end portion, and further forming a venous, flow lumen extending between a distal venous flow port located along the distal end portion of the venous cannula member and a proximal venous flow port located along the proximal end portion of the venous cannula member;

the proximal venous flow port being coupled to the inlet port of the cardiopulmonary bypass machine, and

wherein the distal end portion of the venous cannula member is adapted for percutaneous transluminal delivery into a superior vena cava at a region adjacent to a sinus venarum in a right atrium, and is also adapted to substantially aspirate a volume of blood from the superior vena cava and also from an inferior vena cava and into the venous flow lumen through the distal venous flow port.

28. A medical device assembly for selectively shunting a volume of blood from an aortic root of an aorta in an animal and into the proximal region of the aorta, the aorta further including an aortic wall, comprising:

an elongate body with a proximal end portion, a distal end portion, and a flow lumen which extends between a distal flow port located along the distal end portion and an intermediate flow port located along the distal end portion proximally of said distal flow port;

a cannula member having a distal end and an axis of elongation slidably carried at least in part within said flow lumen where said distal end of said cannula member is selectively positionable within said flow lumen;

an expandable valve member carried by said cannula member selectively positionable within said flow lumen and so adapted to permit selective adjustment between respective open and closed positions,

an expandable valve actuator coupled to said expandable valve member so constructed and adapted to selectively permit adjustment of said expandable valve member between the open and closed positions;

such that when said expandable valve member is positioned within said flow lumen between said intermediate flow port and said proximal port and said expandable valve member is adjusted to the closed position;

said distal flow port is in fluid communication with said intermediate port isolating said proximal port from fluid flow through said flow lumen, and where said expandable valve member is positioned between said intermediate port and said distal port, said intermediate and proximate port are in fluid communication when said expandable valve is adjusted to the closed position and said distal port is isolated from fluid flow within said flow lumen.

29. The medical device assembly of claim 28, further comprising:

a cardioplegia delivery member with a proximal end portion, a distal end portion, and a cardioplegia delivery lumen which extends between a distal cardioplegia port located along the cardioplegia delivery member'"'"'s distal end portion and a proximal cardioplegia port located along the cardioplegia delivery member'"'"'s proximal end portion, the proximal cardioplegia port being adapted to couple to a pressurizeable cardioplegia agent source such that a cardioplegia agent may be delivered through the cardioplegia delivery lumen, out the distal cardioplegia port, and into the aortic root to thereby temporarily arrest the beating of the heart; and

a ventricular venting member which includes a distal end portion that extends from the elongate body distally from the distal flow port, a proximal end portion, and a vent lumen that extends between a distal vent port located along the ventricular venting member'"'"'s distal end portion and a proximal vent port located along the ventricular venting member'"'"'s proximal end portion,

wherein the distal end portion of the ventricular venting member is adapted such that the distal vent port is positioned within the left ventricle when the distal flow port is positioned within the aortic root, and wherein the proximal vent port is adapted to couple to a decompression pump such that a volume of blood may be aspirated from the left ventricle, into the distal vent port, through the vent lumen, out the proximal vent port, and into the decompression pump.

30. The medical device assembly of claim 29 further comprising:

a cardiopulmonary bypass machine having an outlet port for the delivery of oxygen-rich blood into the arterial circulation and an inlet port for receiving blood from venous circulation;

the outlet port of the cardiopulmonary bypass machine being coupled to the proximal flow port of the elongate body.

31. The medical device assembly of claim 30, further comprising:

a venous catheter with a venous cannula member having a proximal end portion, a distal end portion, and further forming a venous flow lumen extending between a distal venous flow port located along the distal end portion of the venous cannula member and a proximal venous flow port located along the proximal end portion of the venous cannula member;

the proximal venous flow port being coupled to the inlet port of the cardiopulmonary bypass machine, and

wherein the distal end portion of the venous cannula member is adapted for percutaneous transluminal delivery into a superior vena cava at a region adjacent to a sinus venarum in a right atrium, and is also adapted to substantially aspirate a volume of blood from the superior vena cava and also from an inferior vena cava and into the venous flow lumen through the distal venous flow port.

32. The medical device assembly of claim 28 where said cannula member further comprises:

a cardioplegia delivery lumen that extends between a distal cardioplegia port located along the distal end portion of said cannula member and a proximal cardioplegia port located along the proximal end portion of said cannula member, the proximal cardioplegia port being adapted to couple to a pressurizeable source of cardioplegia agent, and the distal cardioplegia port being adapted to deliver a cardioplegia agent, distally of the external shunt valve to thereby temporarily arrest the beating of the heart; and

a vent lumen that extends between a distal vent port located alone the distal end portion of said cannula member and a proximal vent port located along the proximal end portion of said cannula member,

such that the distal vent port is adapted to be positioned within the left ventricle when the distal flow port is positioned within the aortic root, and wherein the proximal vent port is adapted to couple to a decompression pump such that fluid may be aspirated from the left ventricle through the vent lumen.

33. The medical device assembly of claim 32, further comprising:

a venous catheter with a venous cannula member having a proximal end portion, a distal end portion, and further forming a venous flow lumen extending between a distal venous flow port located along the distal end portion of the venous cannula member and a proximal venous flow port located along the proximal end portion of the venous cannula member;

the proximal venous flow port being coupled to the inlet port of the cardiopulmonary bypass machine, and wherein the distal end portion of the venous cannula member is adapted for percutaneous transluminal delivery into a superior vena cava at a region adjacent to a sinus venarum in a right atrium, and is also adapted to substantially aspirate a volume of blood from the superior vena cava and also from an inferior vena cava and into the venous flow lumen through the distal venous flow port.