Artificial ventricle

• US 4,863,461 A
• Filed: 03/21/1988
• Issued: 09/05/1989
• Est. Priority Date: 03/21/1988
• Status: Expired due to Fees

• Current Assignee: Cardiowest Technologies Incorporated
• Original Assignee: Symbion Incorporated (Broadcom, Inc.)
• Inventors: Jarvik, Robert
• Primary Examiner(s): Apley, Richard J.
• Assistant Examiner(s): Cheng, Joe H.
• Application Number:
  US07/170,982
• Time in Patent Office: 533 Days
• Field of Search: 623/3, 623/900, 128/1 D, 600/16, 600/17, 600/18, 600/36, 600/37
• US Class Current: 623/3.21
• 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 60/165 implantable in, on, or around the heart
• CPC Class Codes: A61M 60/427 the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/837 Aspects of flexible displacement members, e.g. shapes or materials
• CPC Class Codes: A61M 60/894 Passive valves, i.e. valves actuated by the blood
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

An artificial ventricle for replacing the human heart and comprising a shell formed from an upper housing and a lower base. A plurality of thin-walled, flexible pumping diaphragm layers are suspended from the base in a specific manner, and divide the shell into complementary upper and lower fluid receiving chambers. The diaphragm layers are shaped so as to travel through a specifically defined geometry of space. A seamless, thin-walled, Flexible blood bladder lines and occupies the upper chamber. The bladder has an upper portion attached to an inner surface of the housing, and an unadhered lower portion in contact with the pumping diaphragms.

Claims

1. An artificial ventricle, comprising:

a semi-rigid outer shell having a generally oval shape and comprised of an upper housing part, a lower base part, and means joining said parts together to form a sealed seam between said parts;

blood pumping means including a thin walled, flexible diaphragm attached to said shell adjacent said seam and dividing said shell into sealed, complementary, upper and lower fluid receiving chambers, said diaphragm being movable between an end diastolic position wherein said diaphragm conforms to and is supported by said base part, and an end systolic position wherein said diaphragm conforms to and is spaced apart from said housing part by a predetermined head space, where said diaphragm is configured so that the end diastolic and end systolic positions of said diaphragm enclose a volume having the form of a right, oblate ovaloid which is symmetrical with respect to a median plane perpendicular to the direction of movement of said diaphragm between the end diastolic and end systolic positions, said ovaloid having, on each side of said median plane, two end sections each defined by a portion of a sphere and a midsection located between said end sections and defined by a portion of a cylinder, and wherein said end sections intersect said median plane such that, in a plane perpendicular to said median plane, the tangents to end sections which face one another on opposite sides of said median plane form an angle not greater than about 150°

;

means for directing blood into and out of said upper chamber; and

means for connecting said lower chamber to a source of a pumping fluid, said pumping fluid selectively causing said diaphragm to move within said shell.

2. An artificial ventricle as defined in claim 1 wherein said outer shell has a generally oval outline in a plane parallel to said median plane.

3. An artificial ventricle as defined in claim 1 wherein said angle is about 140°

.

4. An artificial ventricle as defined in claim 1 wherein said shell has a generally oblate ovaloid shape.

5. An artificial ventricle as defined in claim 1 wherein each spherical end portion has a radius r, and the length of the mid-section is from about 1/2 r to r.

6. An artificial ventricle as defined in claim 1 wherein the angle is from about 70°

to 140°

.

7. An artificial ventricle as defined in claim 1 wherein said blood pumping means further comprise:

a flexible bladder lining a portion of said upper chamber, said bladder including an upper portion which is adhered to said housing part and a lower portion which is integral with said upper portion, said lower portion defining a blood diaphragm.

8. An artificial ventricle as defined in claim 7, wherein said blood diaphragm has a pair of unadhered, contiguous, radiused pleats joined to said upper portion.

9. An artificial ventricle as defined in claim 8, wherein said means joining said housing parts comprise:

an outer gasket sealingly interconnecting said housing part to said base part, said gasket having an inner periphery defining an internal vertical groove between said gasket and said base part and containing an inwardly radiused cove, said cove seating and supporting one of said blood diaphragm pleats.

10. An artificial ventricle as defined in claim 1, further comprising:

an insert disposed between said base part and said diaphragm for seating and supporting said diaphragm when said diaphragm is in said end-diastolic position, said insert having a plurality of apertures therethrough communicating with said lower chamber.

11. An artificial ventricle, comprising:

a semi-rigid outer shell, including an upper housing part, a lower base part, and a sealing gasket sealingly interconnecting said housing part to said base part, said housing part and said base part being configured to define a sealed internal volume within said shell, said sealing gasket being formed to have a surface portion which is adjacent said housing part and faces toward said internal volume, said surface portion constituting a cove having a concave curvature, and said sealing gasket being formed to define, with said base part, an internal groove which comunicates with said internal volume;

a pumping diaphragm assembly having a plurality of thin walled, flexible, pumping diaphragm layers attached to said shell adjacent said groove and dividing said volume into sealed, upper and lower fluid-receiving chambers, said pumping diaphragm layers being collapsibly distensible between an end diastolic position where said pumping diaphragm layers conform to and are supported by said base part, and an end systolic position where said pumping diaphragm layers conform to and are spaced apart from said housing part by a predetermined head clearance;

a thin walled, flexible, blood bladder lining said upper chamber, said bladder having an upper portion with an upper surface adhered to said housing part adjacent said cove, and a lower portion which is integral with said upper portion, said lower portion defining a blood diaphragm which is distensible relative to said upper portion and which is movable with said pumping diaphragm layers in sliding contact with one of said pumping diaphragm layers, said blood diaphragm including a pair of unadhered, contiguous, radiused pleats adjacent said upper portion, one of said pleats lining said cove, and a second pleat having a curvature reversing in direction with movement of said blood diaphragm together with said pumping diaphragm layers between said end diastolic and end systolic positions;

means for directing blood into and out of said blood bladder; and

means for connecting said lower chamber to a source of a pumping fluid which selectively causes said pumping diaphragm assembly to move within said shell.

12. An artificial ventricle as defined in claim 11, wherein said gasket is tapered outwardly between said groove and said cove.

13. An artificial ventricle as defined in claim 11, further including a registration gasket located on one of said pumping diaphragm layers, and wherein said base part has a first slot located adjacent said groove, and said registration gasket is disposed in said first slot and registers said pumping diaphragm assembly with respect to said base part.

14. An artificial ventricle as defined in claim 13 wherein said housing part has a second slot and said sealing gasket extends into said second slot and thereby registers said housing part with respect to said base part.

15. A fluid pump adapted for use as an artificial ventricle, comprising:

a semi-rigid outer shell including an upper housing part, a lower base part, and means joining said parts together to form a sealed seam between said parts;

blood pumping means including a thin walled, flexible pumping diaphragm attached to said shell adjacent said seam and dividing said shell into sealed, complementary, upper and lower fluid receiving chambers, said diaphragm being movable between an end diastolic position wherein said diaphragm conforms to and is supported by said base part, and an end systolic position wherein said diaphragm conforms to and is spaced apart from said housing part by a predetermined head space, and wherein said diaphragm travels through upper and lower continuous volumes of space defined by;

taking a cylindrical midsection having a long axis perpendicular to the direction of movement of said diaphragm between said end diastolic and end systolic positions and being capped at each end with hemispherical end portions, cutting said capped cylindrical section into two substantially equal volumes of space by a pair of parallel planes parallel to said long axis, and then joining the two substantially equal volumes together;

means for directing blood into and out of said upper chamber; and

means for connecting said lower chamber to a source of a pumping fluid which selectively causes said diaphragm to move within said shell between said end diastolic and systolic positions.

16. A fluid pump as defined in claim 15 wherein said hemispherical end portions intersect said long axis and form, at the location of intersection with said axis, an angle no greater than about 150°

.

17. A fluid pump as defined in claim 16 wherein said angle is about 140°

, and further wherein said hemispherical end portions have a radius r, and the length of said midsection is from about 1/2 r to r.

18. A fluid pump as defined in claim 15, wherein said blood pumping means further comprise:

a flexible bladder lining a portion of said upper chamber, said bladder including an upper portion adhered to said housing part and a lower portion which is integral with said upper portion and which defines a blood diaphragm that is distensible relative to said upper portion.

19. A fluid pump as defined in claim 18, wherein said blood diaphragm has a pair of unadhered, contiguous, radiused pleats joined to said upper portion.

20. A fluid pump as defined in claim 19, wherein said means joining said parts together comprise:

an outer gasket sealingly interconnecting said housing part to said base part, said gasket having an inner periphery defining an internal groove between said gasket and said base part, said outer gasket being formed to have a surface portion which faces toward the interior of said shell and which constitutes a cove having a concave curvature, said cove seating and supporting one of said blood diaphragm pleats.

21. A fluid pump as defined in claim 15, further including a registration gasket disposed on said diaphragm, and wherein said base part defines a first slot located adjacent said seam, said registration gasket being disposed in said first slot thereby registering said diaphragm with respct to said base part.

22. A fluid pump as defined in claim 20, wherein said housing part defines a second slot and said outer gasket extends into said second slot thereby registering said housing part with respect to said base part.

23. A fluid pump adapted for use as an artificial ventricle, comprising:

a semi-rigid outer shell having a generally oval configuration and comprised of an upper housing part and a lower base part, said lower base part having first and second registration slots, and housing part being joined and registered with respect to said base part by means of said first registrations slot;

a thin walled, flexible pumping diaphragm attached to said shell and dividing said shell into sealed, complementary, upper and lower fluid receiving chambers, said diaphragm being movable between an end diastolic position wherein said diaphragm conforms to and is supported by said base part, and an end systolic position wherein said diaphragm conforms to and is spaced apart from said housing part by a predetermined head space;

means for directing blood into and out of said upper chamber;

means for connecting said lower chamber to a source of a pumping fluid which selectively causes said diaphragm to move within said shell;

a registration gasket joined to said diaphragm and disposed in said second registration slot, thereby registering said diaphragm with respect to said base part; and

a flexible bladder lining a portion of said upper chamber, said bladder including an upper portion which is adhered to said housing part and a lower portion which is integral with said upper portion and which defines a distensible blood diaphragm movable with said pumping diaphragm.

24. A fluid pump as defined in claim 23, wherein said blood diaphragm has a pair of unadhered, contiguous, radiused pleats joined to said upper portion.

25. A fluid pump as defined in claim 24, further comprising:

an outer gasket sealingly interconnecting said housing part to said base part, said outer gasket having an inner periphery defining an internal groove between said outer gasket and said base part, said outer gasket being formed to have a surface portion which faces toward the interior of said shell and which constitutes a cove having a concave curvature, said cove seating and supporting one of said blood diaphragm pleats.

26. A fluid pump adapted for use as an artificial ventricle, comprising:

a semi-rigid outer shell having a generally oval configuration and comprised of an upper housing part and a lower base part, said lower base part having first and second registration slots, and housing part being joined and registered with respect to said base part by means of said first registrations slot;

a thin walled, flexible pumping diaphragm attached to said shell and dividing said shell into sealed, complementary, upper and lower fluid receiving chambers, said diaphragm being movable between an end diastolic position wherein said diaphragm conforms to and is supported by said base part, and an end systolic position wherein said diaphragm conforms to and is spaced apart from said housing part by a predetermined head space;

means for directing blood into and out of said upper chamber;

means for connecting said lower chamber to a source of a pumping fluid which selectively causes said diaphragm to move within said shell;

a registration gasket joined to said diaphragm and disposed in said second registration slot, thereby registering said diaphragm with respect to said base part; and

an insert disposed between said base part and said pumping diaphragm for seating and supporting said pumping diaphragm in said end diastolic position, said insert having a plurality of apertures therethrough communicating with said lower chamber.