Extra cardiac ventricular assist device

• US 5,713,954 A
• Filed: 06/13/1995
• Issued: 02/03/1998
• Est. Priority Date: 06/13/1995
• Status: Expired due to Term

• Current Assignee: Abiomed, Inc. (Johnson & Johnson)
• Original Assignee: Abiomed R&D, Inc. (Johnson & Johnson)
• Inventors: Rosenberg, Meir, Kung, Robert T. V.
• Primary Examiner(s): Willse, David H.
• Application Number:
  US08/490,080
• Time in Patent Office: 966 Days
• Field of Search: 600/16, 600/17, 600/31, 600/37, 601/153, 601/151, 601/152, 623/3
• US Class Current: 600/17
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61F 2002/0068 having a special mesh pattern
• CPC Class Codes: A61M 2205/8243 by induction
• CPC Class Codes: A61M 60/191 mechanically acting upon the outside of the patient's native heart, e.g. compressive structures placed around the heart
• CPC Class Codes: A61M 60/289 Devices for mechanical circulatory actuation assisting the residual heart function by means mechanically acting upon the patient's native heart or blood vessel structure, e.g. direct cardiac compression [DCC] devices
• CPC Class Codes: A61M 60/468 the force acting on the actuation means being hydraulic or pneumatic
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/839 of devices for mechanical circulatory actuation
• CPC Class Codes: A61M 60/873 specially adapted for wireless or transcutaneous energy transfer [TET], e.g. inductive charging

Abstract

An artificial implantable heart assist system with an artificial myocardium employs a number of flexible, non-distensible tubes with the walls along their long axes connected in series to form a cuff. The tubes are sealed for purposes of inflation and deflation with either hydraulic fluid or pneumatic fluid. The cuff is placed around the natural heart. The inflation of the tubular segments provides that they have a circular cross-section, while in the deflated, or collapsed position without being fluid filled, they are essentially flat sheets. The difference in the perimeter length of the cuff in the plane of the tube short axis, arising from the fact that, inflated, each tube has a length along its perimeter equal to the diameter of the inflated tube, while deflated it has a length equal to the perimeter of the tube divided by two, provides for a contractile force. An energy converter is provided in the system for shuttling fluid between a compliant reservoir and the cuff in phase with the systolic and diastolic phase of the natural heart. This system is powered by an internal implanted battery, which can be recharged transcutaneously from an external power source.

Claims

1. An artificial myocardium for use in a patient as ventricular assist device aiding the operation of a natural heart comprising,

an inflatable cuff shaped to conform generally to the shape of a natural heart, implantable within a patient'"'"'s body, and having open ends, said cuff being formed of an interconnected series of closed tubes formed of a flexible, nondistensable, fluidically sealed material, said tubes being oriented with their long axes parallel to an axis connecting one open end with the other,

means implantable within said patient for controllably and periodically filling said tubes with a fluid, such that when filled, each of said tubes assumes a tubular cylindrical shape with a circular cross section, and when emptied of said fluid, each of said tubes assumes a collapsed shape, and

control means for providing said periodic sequence of filling and emptying said tubes with said fluid, said control means being adapted to operate in conjunction with the diastolic and systolic pulsing of said natural heart such that said fluid fills said tubes in conjunction with the systolic phase of said natural heart and empties said tubes in conjunction with the diastolic phase of said natural heart.

2. An artificial myocardium in accordance with claim 1 wherein said fluid filling of said tubes is initiated in response to P or R waves produced by said natural heart.

3. An artificial myocardium in accordance with claim 1 wherein the dimension of each of said tubes is selected to contract the volume enclosed by said cuff, when said tubes are filled by fluid, by a length which is substantially 36% of said cuff circumference when said tubes are substantially not filled by said fluid.

4. An artificial myocardium in accordance with claim 1 wherein each of said tubes is formed such that the cylindrical ends of said tubes have a substantially hemispheric shape when said tubes are inflated and wherein said tubes are interconnected along the long axes of said cylinders.

5. An artificial myocardium in accordance with claim 4 wherein the ratio between the inflated length of said cylinders and the diameter of each of said tubes is equal to or greater than about 4.0.

6. Apparatus in accordance with claim 1 and further including,

a subdermal access port, implantable beneath the skin of said patient in the chest area,

a needle manifold adapted for positioning external to the patient'"'"'s skin, said needle manifold carrying a plurality of syringe needles for puncturing the skin above said subdermal port, said subdermal port being fluidically coupled to said inflatable cuff to provide for external deflation and inflation of said cuff through said needle manifold in case of failure of said implantable means for controllably filling said closed tubes.

7. An artificial myocardium assist system in accordance with claim 1 wherein said tubes are tapered from one end to the other along their long axes to aid in conforming the cuff shape to that of a natural heart.

8. An artificial myocardium assist system for implanting within a human body for use as a ventricular assist with a natural heart, comprising,

an inflatable cuff shaded to conform generally to the shape Of a natural heart and having open ends, said cuff being formed of a interconnected series of closed tubes formed of a flexible, nondistensable, fluidically sealed material, said tubes being oriented with their long axes parallel to an axis connecting the open ends of said cuff,

means for controllably filling said tubes periodically with a fluid, such that when filled, each of said tubes assumes a tubular cylindrical shape with a circular cross section, and when emptied of said fluid, each of said tubes assumes a collapsed tubular shape,

a fluid reservoir, fluidically connected to said tubes,

an electrically energized fluid pump, for pumping fluid within said system between said fluid reservoir and said tubes,

a switching means for selectively directing fluid pressure to either said fluid reservoir or to said tubes,

a fluid pressure controller responsive to selected electrical impulses from said natural heart to control said switching means to periodically and repetitively fill and empty said tubes,

an electrical power source coupled to said electrically energized pump, each of said system elements being formed of a material and structure to be implantable within a human body.

9. An artificial myocardium assist system in accordance with claim 8 and further including a transcutaneous electrical terminal for implantation beneath the skin of a human body and connection to said electric power source.

10. An artificial myocardium assist system in accordance with claim 8 wherein said switching means is arranged to direct said fluid away from said cuff in the event of electrical failure within said system.

11. An artificial myocardium assist system for implanting within a human body for use as a ventricular assist with a natural heart in vivo, comprising,

an inflatable cuff formed with open ends, said cuff being formed of a interconnected series of closed tubes formed of a flexible, nondistensable, fluidically sealed material, said tubes being oriented with their long axes parallel to an axis connecting the open ends of said cuff said cuff being constructed for wrapping around at least a portion of said heart,

means for controllably, periodically, and repetitively filling said tubes with a fluid, such that when filled, each of said tubes assumes a tubular cylindrical shape with a circular cross section, and when emptied of said fluid, each of said tubes has a collapsed tube shape,

a fluid reservoir,

an electrically energized fluid pump, for pumping fluid within said system between said fluid reservoir and said inflatable cuff,

a switching means for selectively directing fluid pressure to either said fluid reservoir or to said cuff,

a fluid pressure controller responsive to selected electrical impulses from said natural heart to control said switching means,

an electrical power source coupled to said electrically energized pump, each of said system elements being formed of a material and structure to be implantable within a human body,

said cuff when said tubes are inflated with a first volume of hydraulic fluid providing a contraction of the volume enclosed by said cuff substantially in excess of said first volume.

12. An artificial myocardium in accordance with claim 11 wherein each of said tubes is formed such that the cylindrical ends of said tubes have a substantially hemispheric shape when said tubes are inflated and wherein said tubes are interconnected along the long axes of said cylinders.

13. An artificial myocardium assist system in accordance with claim 11 wherein said contraction of said cuff is sufficient when said cuff is wrapped around a natural heart to cause it to eject a blood volume larger than said first volume.