Direct mechanical bi-ventricular cardiac assist device

• US 5,749,839 A
• Filed: 05/21/1996
• Issued: 05/12/1998
• Est. Priority Date: 08/18/1994
• Status: Expired due to Term

• Current Assignee: Duke University
• Original Assignee: Duke University
• Inventors: Kovacs, Stephen G.
• Primary Examiner(s): DeMille, Danton D.
• Application Number:
  US08/655,310
• Time in Patent Office: 721 Days
• Field of Search: 601/151-3, 623/3, 600/16, 600/17
• US Class Current: 601/153
• 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 60/191 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 60/427 the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61M 60/839 of devices for mechanical circulatory actuation
• CPC Class Codes: A61M 60/859 Connections therefor
• CPC Class Codes: A61M 60/861 Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
• CPC Class Codes: A61M 60/892 Active valves, i.e. actuated by an external force

Abstract

A direct mechanical bi-ventricular cardiac assist device comprises a ventricular actuation cup having two independently operated diaphragms for independently actuating the right and left ventricle of the patient'"'"'s heart. The pressure and timing of each diaphragm can be independently varied to maximize forward cardiac output. The ventricular actuation cup is constructed in two components including a main body section and an end piece. The diaphragm wraps around the ends of the main body section and the edges of the diaphragm are bonded to the outer surface of the main body section. Bonding of the diaphragm to the outer surface of the ventricular actuation cup eliminates lifting and tearing vectors which could result in diaphragm failure.

Claims

1. A ventricular assist device, comprising:

(a) a cup having an open top and defining a heart cavity sized to receive a human heart, said cup being formed of a material with sufficient rigidity to form a self-supporting shell;

(b) an annular diaphragm disposed along an inner surface of the cup and thereby defining a fluid chamber therebetween;

(c) a pressure inlet in said cup communicating with said fluid chamber for alternately applying positive and negative pressures to said fluid chamber to actuate said diaphragm, wherein the diaphragm distends to compress the heart when a positive pressure is applied to said fluid chamber, and contracts when negative pressure is applied to said fluid chamber allowing said heart to relax; and

(d) a size-adjustment assembly to allow for size adjustment of the open top of said cup relative to the human heart inserted into said heart cavity of said cup, said assembly including (i) an inflatable compensation ring adjacent said open top of said cup and positioned between said inner surface of said cup and said diaphragm, (ii) an opening formed in said cup adjacent to said compensation ring, and (iii) a fill valve positioned in said opening and fluid-connectable to said compensation ring to allow fluid to be injected into said compensation ring and thereby inflate the same, whereby the size of said open top of said cup is adjusted.

2. The ventricular assist device of claim 1 further including a constant pressure vacuum port communicating with the interior of said cup.

3. The ventricular assist device of claim 2 further including a flexible seal surrounding said cup opening, said flexible seal extending inwardly from the upper end of said main body section.

4. The ventricular assist device of claim 2 including a plurality of pressure inlets communicating with said fluid chamber, said pressure inlets being circumferentially spaced a fixed distance from the upper end of said main body section.

5. The ventricular assist device of claim 4 further including a drive connector fixed to the end piece of said cup, said drive connector including a center tube communicating with said constant pressure vacuum port, and at least one distribution chamber surrounding said center tube, wherein each said pressure inlets in said main body section is connected by a separate fluid supply line to said distribution chamber in said drive connector.

6. The ventricular actuation device of claim 2, wherein said diaphragm includes a pair of semi-annular diaphragm sections each disposed along a respective portion of said inner surface of said cup, and wherein said fluid chamber includes a pair of semi-annular fluid chamber sections established each established between a respective one of said diaphragm sections and said portion of said inner surface of said cup, said fluid chamber sections being fluid-isolated from one another to allow for independent application of said positive and negative fluid pressures thereto.

7. The ventricular assist device of claim 6 further including a drive connector fixed to said cup, said drive connector including a center tube communicating with said constant pressure vacuum port, and at least one distribution chamber surrounding said center tube, wherein each said pressure inlets in said main body section is connected by a separate fluid supply line to said distribution chamber in said drive connector.

8. The ventricular assist device of claim 7 including two semi-annular distribution chambers surrounding said center tube, each said distribution chamber being connected by said fluid supply lines to respective sets of inlet ports.

9. The ventricular assist device of claim 6 wherein said diaphragms are fixed to the outer surface of said main body section of said cup.

10. A bi-ventricular cardiac assist device comprising:

(a) a self-supporting cup-shaped outer shell having opposed upper and lower ends and an inner surface which establishes an interior cavity for receiving a heart therein;

(b) a diametrically opposed pair of slots oriented generally longitudinally between said upper and lower ends of said outer shell;

(c) a pair of flexible semi-annular diaphragms disposed adjacent to respective semi-annular sections of said inner surface of said outer shell so as to establish a respective pair of fluid chambers between said pair of diaphragms and said semi-annular sections of said inner surface of said outer shell;

(d) said pair of diaphragms including upper and lower edges wrapped around a respective semi-annular section of said upper and lower ends of said outer shell, and a pair of side edges each inserted through a respective one of said slots, wherein said upper, lower and side edges of said pair of diaphragms are bonded to an exterior surface of said outer shell; and

(e) a pressure drive system fluid-connected to each one of said pair of fluid chambers for separately and independently pressurizing said pair of fluid chambers to cause separate and independent distention and contraction of said pair of diaphragms.

11. The device of claim 10, wherein said upper, lower and side edges of said pair of diaphragms are bonded to said exterior surface of said outer shell by an isotropic bonding agent which forms a unitary structure between said pair of diaphragms and said outer shell.

12. The device of claim 11, wherein said pair of diaphragms, said outer shell and said isotropic bonding agent are formed of substantially the same urea-linked polyurethane copolymer.

13. The device of claim 11, further comprising a constant pressure vacuum port communicating with the interior cavity of said outer shell.

14. The device of claim 11, further comprising an inflatable compensation ring disposed between said inner surface of said outer shell and said pair of diaphragms.

15. The device of claim 14, further comprising an opening in said outer shell, and a fill valve positioned in said opening and fluid-connectable to said compensation ring to allow fluid to be injected into said compensation ring and thereby inflate the same, whereby the size of said upper end of said shell is adjusted.

16. The device of claim 11, further comprising at least one pair of pressure inlets each communicating with a respective one of said pair of fluid chambers.

17. The device of claim 16, further comprising a plurality of said pressure inlets circumferentially spaced a fixed distance from the upper end of said outer shell.

18. The device of claim 17, further comprising;

a constant pressure vacuum port communicating with the interior cavity of said outer shell,

an end piece fixed to said lower end of said outer shell, and

a drive connector fixed to said end piece, said drive connector including a center tube communicating with said constant pressure vacuum port, and at least one distribution chamber surrounding said center tube, wherein each of said pressure inlets in said outer shell is connected by a separate fluid supply line to said distribution chamber in said drive connector.