Apparatus for left heart assist

• US 4,522,195 A
• Filed: 06/13/1983
• Issued: 06/11/1985
• Est. Priority Date: 05/25/1981
• Status: Expired due to Term

• Current Assignee: Arrow Interventional, Inc. (Teleflex Incorporated)
• Original Assignee: IABP Corporation
• Inventors: Schiff, Peter
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US06/503,527
• Time in Patent Office: 729 Days
• Field of Search: 128/1 D, 128/1 R, 604/96, 604/95, 604/104, 604/105
• US Class Current: 600/18
• 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 60/139 inside the aorta, e.g. intra-aortic balloon pumps
• 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 60/295 Balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/414 transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
• CPC Class Codes: A61M 60/497 for balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/508 Electronic control means, e.g. for feedback regulation
• CPC Class Codes: A61M 60/833 Occluders for preventing backflow
• CPC Class Codes: A61M 60/843 Balloon aspects, e.g. shapes or materials

Abstract

Apparatus for assisting the heart in the pumping of blood comprising a resilient umbrella-like member positioned within the aorta and adapted to permit the flow of blood in a normal direction and being moved to an open or expanded position to perform a pumping action and to prevent retrograde flow. The umbrella-like member may be combined for use with an intra-aortic balloon or may comprise a stand-alone pumping assembly. The umbrella-like member is preferably mounted upon a catheter for insertion in the desired location. The umbrella-like member is designed to be non-occlusive or occlusive, depending on design, when open. When used alone, operating means are provided, which means are coupled to the umbrella-like member normally maintains the umbrella in its operative, expanded position. Electromechanical control means coupled to the umbrella-like member through a control member is designed to urge the umbrella assembly to its open or closed position, depending on the direction of the control force. The umbrella assembly may also be provided with stiffener members to normally maintain the umbrella in the open position. Umbrella members of a "parachute" design and of a double conical design are disclosed. An alternative assistive assembly employs a spherical member filled with either a non-toxic gas such as, for example, air, or a saline liquid. When filled with a gas, the assembly may be inserted in a patient sitting generally in the upright position. The pumping assembly is pulled downwardly during systole and is capable of at least partially rising by itself during diastole in order to help perfuse coronaries. A drive system comprising a linear stepping motor is used to impart reciprocating movement to the control wire utilized to open and close the umbrella assembly, as well as linearly moving the umbrella assembly in a reciprocating fashion. An electronic controller operates the linear stepping motor under control of an electrocardiogram signal coupled to the controller by a three-wire circuit.

Claims

1. Mechanical blood pumping apparatus for assisting in the pumping function of the heart comprising:

a blood pumping element within a femoral artery of the patient to be treated;

slender coupling means having a first end coupled to said pumping element and having a second end extending outside of the body of the patient being treated; and

drive means connected to the second end of said coupling means for reciprocally moving said pumping element in said femoral artery between a start position and a position displaced from the start position to assist the pumping function of the heart;

first coupling means for resiliently coupling said coupling means to said pumping element; and

second coupling means for resiliently coupling said coupling means to said drive means.

2. The apparatus of claim 1 further comprising means for detecting the failure of said first coupling means to return to a start position upon deenergization of said drive means.

3. Apparatus for assisting the pumping function of the heart, comprising:

elongated, flexible means having a distal end adapted to be positioned within the interior of a fluid carrying vessel within the body, and a proximate end adapted to be positioned to extend outside the body in which the distal end is inserted;

elongated balloon means mounted along, encircling, and airtightly secured to said flexible means and having a first end thereof arranged a spaced distance inward from said distal end;

said flexible means having means communicating with the interior of said elongated balloon means for selectively inflating and deflating said elongated balloon means;

at least one unilateral flow control means arranged on said tubular member a spaced distance from said elongated balloon means so as to be positioned within said vessel;

said flow control means being responsive to fluid flow in a first direction in said fluid carrying vessel to block said fluid flow and responsive to fluid flow in a direction opposite said first direction to permit fluid flow around said flow control means.

4. The apparatus of claim 3 wherein said balloon means is positioned between said distal end and said unilateral flow control means.

5. The apparatus of claim 3 wherein said unilateral flow control means is positioned between said distal end and said balloon means.

6. The apparatus of claim 3 wherein said flow control means is provided with a plurality of small openings to permit fluid flow through said unilateral flow control means when said fluid is flowing in said first direction.

7. Apparatus for assisting the pumping function of the heart, comprising:

an elongated flexible tubular member having a distal end adapted to be positioned within the interior of a fluid carrying vessel within the human body, and a proximal end adapted to be positioned to extend outside of the body into which the distal end is inserted;

elongated balloon means mounted along and encircling and airtightly secured to said tubular member, with a first end thereof being a spaced distance inward from said distal end;

said tubular member having means communicating with the interior of said elongated balloon means for selectively inflating and deflating said elongated balloon means;

first and second unilateral flow control means respectively arranged on said tubular member between said distal end and the first end of said balloon means and a predetermined distance from the end of said balloon means opposite said first end;

said flow control means being responsive to fluid flow in a first direction in said blood carrying vessel to block said fluid flow and responsive to fluid flow in a direction opposite said first direction to permit fluid flow around said flow control means.

8. The apparatus of claim 7 wherein both of said first and second unilateral flow control means are arranged on said tubular member simultaneously to permit fluid flow in said vessel in one direction and to prevent fluid flow in said vessel in the opposite direction.

9. The apparatus of claim 7 wherein each said unilateral flow control means comprises a substantially hollow conical shaped member having its narrow end secured to said tubular member and having its free end, which defines a substantially annular periphery, adapted to move to an open position and cooperating with the interior wall of said vessel to prevent fluid flow when fluid moving in a first direction fills the interior of said conical shaped member and adapted to collapse inwardly when fluid flows in the opposite direction to allow unimpeded flow of the fluid in said vessel in said opposite direction.

10. The apparatus of claim 9 wherein said unilateral flow control means further comprises means for normally biasing said hollow conical shaped member toward said open position.

11. The apparatus of claim 7 wherein said tubular member is positioned in an arterial vessel with the distal end located in the aortic arch.

12. The apparatus of claim 7 wherein said first and second unilateral flow controls means are each comprised of a hollow flexible member surrounding said tubular member and having first and second ends secured to said tubular member;

said flexible member having first and second conical shaped portions flaring outwardly from both said first and second ends toward one another and being joined along an annular portion intermediate portion having a diameter substantially greater than said first and second ends;

at least one of said conical shaped portions having openings to permit fluid to enter and/or exit from the hollow interior of said hollow flexible member.

13. The apparatus of claim 12 wherein means are provided for normally biasing the hollow flexible member to the open position.