Flow-balanced cardiac wrap

• US 6,626,821 B1
• Filed: 05/22/2001
• Issued: 09/30/2003
• Est. Priority Date: 05/22/2001
• Status: Expired due to Term

• Current Assignee: Abiomed, Inc. (Johnson & Johnson)
• Original Assignee: Abiomed, Inc. (Johnson & Johnson)
• Inventors: Milbocker, Michael T., Kung, Robert T. V.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US09/863,887
• Time in Patent Office: 861 Days
• Field of Search: 600/16, 600/17, 600/18, 600/37, 601/153
• US Class Current: 600/16
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• 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 60/468 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

Abstract

A flow-balanced cardiac wrap that assists the right and left ventricles of an affected heart to differing, and adjustable degrees is provided. The wrap generally applies an assist to the left ventricle that is greater than that applied to the right, or that reduces blood output from the right relative to the left. In one embodiment, the wrap comprises a material covering that is applied around the right and left ventricles of the heart, so that the left ventricle is assisted over a larger surface area than the right. The positioning of the right ventricular portion or the wrap is chosen so that desired pumping characteristics for the right ventricle are achieved.

Claims

1. A flow-balanced cardiac wrap that encloses a ventricular region of a heart comprising:

a first section that applies a first variable assist force to the left ventricular region; and

a second section that applies a second variable assist force to the right ventricular region;

wherein the first section applies the first variable assist force over a first area on the left ventricular region and the second section applies the second variable assist force over a second area on the right ventricular region and wherein the second area is smaller than the first area.

2. The flow-balanced cardiac wrap as set forth in claim 1 wherein the second area is located closer to an apex of the heart than the first area.

3. A flow-balanced cardiac wrap that encloses a ventricular region of a heart comprising:

a first section that applies a first variable assist force to the left ventricular region; and

a second section that applies a second variable assist force to the right ventricular region;

wherein the first section applies the first variable assist force over a first area on the left ventricular region and the second section applies the second variable assist force over a second area on the right ventricular region and wherein the second area is located closer to an apex of the heart than the first area.

4. A flow-balanced cardiac wrap that encloses a ventricular region of a heart comprising:

a first section that applies a first variable assist force to the left ventricular region;

a second section that applies a second variable assist force to the right ventricular region; and

a pump for directing inflation pressure to each of the first section and the second section, the pump including a controller that causes the first section to apply the first assist force at a first time and the second section to apply the second assist force at a second time, the first time being different from the second time.

5. The flow-balanced cardiac wrap as set forth in claim 4 wherein the second time begins at a predetermined time after the first time begins.

6. A flow-balanced cardiac wrap that encloses a ventricular region of a heart comprising:

a first section that applies a first variable assist force to the left ventricular region; and

a second section that applies a second variable assist force to the right ventricular region;

wherein each of the first section and the second section include inflation elements, the inflation elements of the first section each being larger in volume at a predetermined inflation pressure than the inflation elements of the second section at the predetermined inflation pressure.

7. A flow-balanced cardiac wrap that encloses a ventricular region of a heart comprising:

a first section that applies a first variable assist force to the left ventricular region; and

a second section that applies a second variable assist force to the right ventricular region;

wherein each of the first section and the second section include inflation elements, a number of inflation elements in the first section each being greater than a number of inflation elements in the second section.

8. A flow-balanced cardiac wrap that encloses a ventricular region of a heart comprising:

a first section that applies a first variable assist force to the left ventricular region; and

a second section that applies a second variable assist force to the right ventricular region;

wherein each of the first section and the second section include inflation elements, the inflation elements in the second section having dead spaces therebetween that are non-distensible.

9. A flow-balanced cardiac wrap that encloses a ventricular region of a heart comprising:

a first section that applies a first variable assist force to the left ventricular region; and

a second section that applies a second variable assist force to the right ventricular region;

wherein each of the first section and the second section include inflation elements, the inflation elements of the first section extending from a top wrap edge to a first bottom edge in a direction toward an apex of the heart for a first distance, the inflation elements of the second section extending from the top wrap edge to a second bottom edge in a direction toward the apex for a second distance, the first distance being greater than the second distance and a first non-distensible member being attached to the second bottom edge to cover a portion of the right ventricle adjacent to the apex.

10. The flow-balanced cardiac wrap as set forth in claim 9 further comprising a second non-distensible member attached to the first non-distensible member and the first bottom edge, the second non-distensible member covering the apex.

11. A flow-balanced cardiac wrap that encloses a ventricular region of a heart comprising:

a first section that applies a first variable assist force to the left ventricular region; and

a second section that applies a second variable assist force to the right ventricular region;

wherein the second section and the first section are joined at attachment locations, the attachment locations including interconnection elements for variably positioning the second section with respect to the first section.

12. The flow-balanced cardiac wrap as set forth in claim 11 wherein the interconnecting elements are adapted to allow the first section to be attached at a variable angle with respect to the first section, whereby a cone angle of the wrap on the heart is adjustable.

13. The flow-balanced cardiac wrap as set forth in claim 12 wherein the interconnecting elements include one of either interengaging hooks and loops, interengaging ties and interengaging rods and loops located on opposing free ends of the first section and the second section, respectively.

14. A flow-balanced cardiac wrap that encloses a ventricular region of a heart comprising:

a first section that applies a first variable assist force to the left ventricular region; and

a second section that applies a second variable assist force to the right ventricular region;

wherein the first section and the second section include a plurality of inflation elements for applying pressure and at least one pair of inflation elements being connected to opposing sides non-distensible dead space, the dead space being adapted to be clinched together to vary a spacing distance and angle between each of the pair of inflation elements.

15. The flow-balanced cardiac wrap as set forth in claim 14 wherein the dead space includes locations for a plurality of ties, adapted to enable the dead space to be clinched into a plurality of shapes.

16. The flow-balanced cardiac wrap as set forth in claim 14 wherein the dead space defines one of either a wedge shape and a rectangular shape in an non-clinched orientation.

17. A flow-balanced cardiac wrap that encloses a ventricular region of a heart comprising:

a first section that applies a first variable assist force to the left ventricular region; and

a second section that applies a second variable assist force to the right ventricular region;

wherein the left section and the right section each include inflation elements to apply the first variable assist force to the left ventricular region and the second variable assist force to the right ventricular region, respectively, and wherein the inflation elements in the right section are sized and arranged to apply a displacement force that displaces a middle portion of the right ventricular region so as to divide blood in a left ventricle of the heart into an ejected portion directed out of the ventricle and a retained portion that remains in the ventricle after application of the second variable assist force.

18. A method for providing cardiac assistance with a cardiac wrap that engages an affected heart comprising:

engaging a ventricular region of the heart with a wrap having a first section and a second section;

applying a first variable assist force to the left ventricular region with the first section; and

applying a second variable assist force to the right ventricular region with the second section;

wherein the step of applying the second variable assist force includes applying the second variable assist force to an area of the right ventricular region that is less than an area of the left ventricular region to which the first variable assist force is applied.

19. The method as set forth in claim 18 wherein the step of applying the second variable assist force includes positioning the second section a predetermined location along the right ventricular region so as to compress a right ventricle of the heart into a portion that ejects a stored portion of blood therein and a portion that retains a stored portion of the blood therein upon application of the second variable assist force.

20. A method for providing cardiac assistance with a cardiac wrap that engages an affected heart comprising:

engaging a ventricular region of the heart with a wrap having a first section and a second section;

applying a first variable assist force to the left ventricular region with the first section; and

applying a second variable assist force to the right ventricular region with the second section;

wherein the first variable assist force applies a different magnitude of pressure than a magnitude of pressure applied by the second variable assist force.

21. A method for providing cardiac assistance with a cardiac wrap that engages an affected heart comprising:

engaging a ventricular region of the heart with a wrap having a first section and a second section;

applying a first variable assist force to the left ventricular region with the first section; and

applying a second variable assist force to the right ventricular region with the second section;

wherein the first variable assist force is applied at a time different than an application of the second variable assist force.

22. A method for providing cardiac assistance with a cardiac wrap that engages an affected heart comprising:

engaging a ventricular region of the heart with a wrap having a first section and a second section;

applying a first variable assist force to the left ventricular region with the first section; and

applying a second variable assist force to the right ventricular region with the second section;

wherein the step of engaging includes adjusting a cone angle of the wrap so as to fit the ventricular region in a predetermined orientation.

23. The method as set forth in claim 22 wherein the step of adjusting includes cinching predetermined dead spaces between inflation elements that apply at least one of the first variable assist force and the second variable assist force.

24. A method for providing cardiac assistance with a cardiac wrap that engages an affected heart comprising:

engaging a ventricular region of the heart with a wrap having a first section and a second section;

applying a first variable assist force to the left ventricular region with the first section and

applying a second variable assist force to the right ventricular region with the second section;

wherein the step of engaging includes providing inflation elements in each of the first section and the second section that respectively apply the first variable assist force and the second variable assist force, and the step of providing includes sizing the inflation elements in the first section larger than the inflation elements in the second section.

25. The method as set forth in claim 24 wherein the wrap includes a bottom edge that is closer to an apex of the heart on the first section than on the second section and further comprising restraining a portion of the right ventricular region between the apex and the bottom edge adjacent to the second section with a non-distensible member.

26. A method for providing cardiac assistance with a cardiac wrap that engages an affected heart comprising:

engaging a ventricular region of the heart with a wrap having a first section and a second section;

applying a first variable assist force to the left ventricular region with the first section; and

applying a second variable assist force to the right ventricular region with the second section;

wherein the step of engaging includes providing inflation elements in each of the first section and the second section that respectively apply the first variable assist force and the second variable assist force;

the method further comprising inflating the inflation elements in the first section at a first time and inflating the inflation elements in the second section at a second time, wherein the first time is different from the second time.

27. The method as set froth in claim 26 wherein the first time is relative to each heart blood-pumping cycle and the second time is relative to each other heart blood-pumping cycle, whereby the second time occurs every two first times.

28. The method as set forth in claim 27 wherein the first time initiates before the second time.

29. A flow-balanced cardiac wrap for assisting a ventricular region of an affected heart comprising:

a first section having a first set of inflation elements that variably displace a left ventricular region of the heart over a first area;

a second section having a second set of inflation elements that variably displace a right ventricular region of the heart over a second area; and

wherein the first area is greater than the second area.

30. A flow-balanced cardiac wrap as set forth in claim 29 wherein the second area is located so that displacement of the right ventricular region by the second set of inflation elements causes a right ventricle of the heart to eject a portion of blood in the ventricle above the second area and retain a portion of blood in the ventricle below the second area.

31. A flow-balanced cardiac wrap for assisting a ventricular region of an affected heart comprising:

a first section having a first set of inflation elements that variably displace a left ventricular region of the heart over a first area;

a second section having a second set of inflation elements that variably displace a right ventricular region of the heart over a second area; and

at least one dead space located between predetermined of the inflation elements on the second section so as to reduce displacement of the right ventricular region.

32. A flow-balanced cardiac wrap for assisting a ventricular region of an affected heart comprising:

a first section having a first set of inflation elements that variably displace a left ventricular region of the heart over a first area, each of the inflation elements of the first set defining a first internal cross-sectional area;

a second section having a second set of inflation elements that variably displace a right ventricular region of the heart over a second area, each of the inflation elements of the second set defining a second internal cross-sectional area; and

the first internal cross-sectional area is greater than the second internal cross-sectional area.

33. A flow-balanced cardiac wrap for assisting a ventricular region of an affected heart comprising:

a wrap body having a plurality of parallel inflation elements for displacing the ventricular region to assist the ventricular region; and

a plurality of non-distensible dead spaces between predetermined of the plurality of inflation elements, the dead spaces being adapted to be clinched together to define a plurality of shapes for the respective of the dead spaces and spacings between inflation elements adjacent the respective of the dead spaces, whereby fit of the wrap body to the ventricular region can be adjusted by cinching the dead spaces.

34. A flow-balanced cardiac wrap for assisting a ventricular region of an affected heart comprising:

a first section having a first set of inflation elements that variably displace a left ventricular region of the heart over a first area;

a second section having a second set of inflation elements that variably displace a right ventricular region of the heart over a second area; and

a first connector set on each of a pair of free ends of the first section and second connector set on each of a pair of free ends of the second section, the first connector set being adapted to interconnect with the second connector set at each of the free ends at a plurality of positions therebetween so as to enable a plurality of discrete configurations for the second section with respect to the first section.

35. The flow-balanced cardiac wrap as set forth in claim 34 wherein the first connector set comprises a first number of connectors at a predetermined spacing therebetween and the second connector set comprises a second number of connectors at the predetermined spacing therebetween and wherein the second number is less than the first number.

36. The flow-balanced cardiac wrap as set forth in claim 35 wherein the first connector set comprises one of hooks and loops and the second connector set comprises one of interengaging loops and hooks, respectively.

37. The flow-balanced cardiac wrap as set forth in claim 35 wherein the first connector set and the second connector set each comprise ties.