Cardiac disease treatment and device

• US 6,682,476 B2
• Filed: 10/23/2002
• Issued: 01/27/2004
• Est. Priority Date: 06/13/2000
• Status: Expired due to Fees

• Current Assignee: Mardil, Inc.
• Original Assignee: Acorn Cardiovascular, Inc.
• Inventors: Alferness, Clifton A., Cox, James E., Girard, Michael J., Shapland, J. Edward, Rohrbaugh, Donald G., Palme, Donald F. II
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): Veniaminov, Nikita R
• Application Number:
  US10/279,176
• Publication Number:
  US 20030045776A1
• Time in Patent Office: 461 Days
• Field of Search: 600/37, 600/16, 600/18, 600/17, 623/3, 623/11, 623/2.11, 623/904, 606/151, 601/153, 604/20, 607/5, 128/898
• US Class Current: 600/37
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: Y10S 623/904 Heart

Abstract

A jacket of biological compatible material has an internal volume dimensioned for an apex of the heart to be inserted into the volume and for the jacket to be slipped over the heart. The jacket has a longitudinal dimension between upper and lower ends sufficient for the jacket to surround a lower portion of the heart with the jacket surrounding a valvular annulus of the heart and further surrounding the lower portion to cover at least the ventricular lower extremities of the heart. The jacket is adapted to be secured to the heart with the jacket surrounding at least the valvular annulus and the ventricular lower extremities. The jacket is adjustable on the heart to snugly conform to an external geometry of the heart and assume a maximum adjusted volume for the jacket to constrain circumferential expansion of the heart beyond the maximum adjusted volume during diastole and to permit unimpeded contraction of the heart during systole.

Claims

1. A device for treating cardiac disease of a heart having a longitudinal axis from an apex to a base and having an upper portion and a lower portion divided by an A-V groove, said heart including a valvular annulus adjacent said A-V groove and ventricular lower extremities adjacent said apex, the device comprising:

a jacket of flexible material defining a volume between an open upper end and a lower end, wherein an expansion of said flexible material is less than about 30% when said material is exposed to a load up to about 5 pounds per inch (9 N/cm);

said jacket dimensioned for said apex of said heart to be inserted into said volume through said open upper end and for said jacket to be slipped over said heart, said jacket further dimensioned for said jacket to have a longitudinal dimension between said upper and lower ends sufficient for said jacket to constrain said lower portion with said jacket constraining said valvular annulus;

said jacket adapted to be secured to said heart with said jacket having portions disposed on opposite sides of the heart between said valvular annulus and said ventricular lower extremities; and

said jacket adapted to be expandibly adjusted on said heart to snugly conform to an external geometry of said heart to constrain circumferential expansion of said heart and permit substantially unimpeded contraction of said heart during systole.

2. A device according to claim 1 wherein:

an expansion of said material along a first axis of said material is between about 30% and 40% when exposed to a uniaxial load between about 0.1 pounds per inch (0.2 N/cm) to about 0.5 pounds per inch (0.9 N/cm) with no lateral constraint;

an expansion of said material along a second axis of said material is between about 20% and 30% when exposed to a uniaxial load between about 0.1 pounds per inch (0.2 N/cm) to about 0.5 pounds per inch (0.9 N/cm) with no lateral constraint; and

said material oriented for said second axis to extend circumferentially around said heart and wherein said first axis is perpendicular to second axis.

3. A device according to claim 1 wherein said jacket is open at said lower end.

4. A device according to claim 1 wherein said jacket is closed at said lower end.

5. A device according to claim 1 wherein said material comprises intertwined fibers.

6. A device according to claim 5 wherein said material is a knit material.

7. A device according to claim 6 wherein said material is a warp knit.

8. A device according to claim 6 wherein said material is an Atlas knit.

9. A device according to claim 5 wherein said material is a weave.

10. A device according to claim 5 wherein said intertwined fibers comprise a plurality of longitudinally extending filaments.

11. A device according to claim 1 wherein said material is selected from a the group consisting of polytetrafluoroethylene, expanded polytetrafluoroethylene, polypropylene, poly(ethylene terephthalate), titanium and stainless steel.

12. A device according to claim 1 wherein said material is formed of elongated fibers selected from a the group consisting of polytetrafluoroethylene, expanded polytetrafluoroethylene, polypropylene, poly(ethylene terephthalate), titanium and stainless steel.

13. A method for treating cardiac disease of a heart having a longitudinal axis from an apex to a base and having an upper portion and a lower portion divided by an A-V groove, the heart including a valvular annulus adjacent the A-V groove and ventricular lower extremities adjacent the apex;

the method comprising;

(a) providing a jacket of flexible material defining a volume between an open upper end and a lower end, wherein an expansion of the flexible material is less than about 30% when the material is exposed to a load up to about 5 pounds per inch (9 N/cm);

(b) slipping the jacket over the head;

(c) constraining the valvular annulus with the jacket;

(d) securing the jacket to the heart with portions of the jacket disposed on opposite sides of the heart between the valvular annulus and the ventricular lower extremities; and

(e) expandibly adjusting the jacket on the heart to conform the jacket to an external geometry of the heart to constrain circumferential expansion of the heart and permit substantially unimpeded contraction of the head during systole.

14. A method according to claim 13 herein:

(a) said step of providing a jacket includes providing a jacket having a multiaxial expansion of the flexible material being less than about 30% when the material is exposed to a load up to about 5 pounds per inch (9 N/cm).

15. A method according to claim 13 wherein:

(a) said step of securing the jacket includes covering a lower end of the heart.

16. A method according to claim 13 wherein:

(a) said step of securing the jacket includes leaving a lower end of the heart exposed.

17. A method according to claim 13 wherein:

(a) said step of providing a jacket includes providing a jacket having;

(i) an expansion of material along a first axis between about 30% and 40% when exposed to a uniaxial load between about 0.1 pounds per inch (0.2 N/cm) to about 0.5 pounds per inch (0.9 N/cm) with no lateral constraint;

(ii) an expansion of material along a second axis between about 20% and 30% when exposed to a uniaxial load between about 0.1 pounds per inch (0.2 N/cm) to about 0.5 pounds per inch (0.9 N/cm) with no lateral constraint.

18. A method according to claim 17 wherein:

(a) said step of securing the jacket includes orienting the material for such that the second axis extends circumferentially around the heart;

the first axis being perpendicular to the second axis.