Apparatus and method for detachably securing a device to a natural heart

• US 6,846,296 B1
• Filed: 09/14/2000
• Issued: 01/25/2005
• Est. Priority Date: 09/14/2000
• Status: Expired due to Term

• Current Assignee: Abiomed, Inc. (Johnson & Johnson)
• Original Assignee: Abiomed, Inc. (Johnson & Johnson)
• Inventors: Buck, Robert L., Milbocker, Michael T., Stewart, Robert B.
• Primary Examiner(s): Yu, Justine R.
• Assistant Examiner(s): HWANG, VICTOR KENNY
• Application Number:
  US09/661,885
• Time in Patent Office: 1,594 Days
• Field of Search: 601/153, 600/16, 600/37, 600/375, 607/119, 607126-131, 623/3.21, 623/3.16
• US Class Current: 601/153
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/6882 Anchoring means

Abstract

Methods and apparatus are disclosed for attaching cardiac devices onto a natural heart by employing arrays of gripping elements, such as hooks or barbs. The gripping elements are designed to penetrate and lodge themselves in the epicardial tissue in order to secure the device to at least a portion of the surface of the heart muscle. The gripping elements, although designed to penetrate the surface of the heart, have limited depth penetration so as to avoid puncture of blood vessels. The attachment mechanisms disclosed herein can also permit both attachment and detachment of device.

Claims

1. In a heart wrap medical device adapted to surround at least a portion of a natural heart and having an inner heart contacting surface, the improvement comprising:

an attachment array for attaching the heart wrap medical device to a natural heart comprising;

at least one substrate that forms part of a heart-contacting surface of the heart wrap medical device; and

a plurality of gripping elements disposed upon the substrate, wherein each of the gripping elements include an elongate element having a curved distal end constructed and arranged to penetrate, and lodge in, cardiac tissue.

2. The device of claim 1 wherein each of the elongate elements has a proximal end that is joined to the substrate.

3. The device of claim 1 wherein each of the elongate elements further comprises a barbed distal end.

5. The device of claim 3 wherein the hooks are sized to penetrate less than 300 micrometers into cardiac tissue, whereby damage to cardiac tissue is lessened.

4. In a heart wrap medical device adapted to surround at least a portion of a natural heart and having an inner heart contacting surface, the improvement comprising:

an attachment array for attaching the heart wrap medical device to a natural heart comprising;

at least one substrate that forms part of a heart-contacting surface of the heart wrap medical device; and

a plurality of hooks disposed upon the substrate wherein the hooks are sized to penetrate no more than 500 micrometers into cardiac tissue, whereby damage to cardiac tissue is lessened.

6. In a heart wrap medical device adapted to surround at least a portion of a natural heart and having an inner heart contacting surface, the improvement comprising:

an attachment array for attaching the heart wrap medical device to a natural heart comprising;

at least one substrate that forms part of a heart-contacting surface of the heart wrap medical device; and

a plurality of gripping elements each of which includes an elongate element having a curved distal end wherein the elongate elements has an uncurled height ranging from about 0.2 millimeters to about 3.0 millimeters, whereby damage to cardiac tissue is lessened.

7. The device of claim 6 wherein the elongate element has an uncurled height ranging from about 0.5 millimeters to about 1.5 millimeters, whereby damage to cardiac tissue is lessened.

8. In a heart wrap medical device adapted to surround at least a portion of a natural heart and having an inner heart contacting surface, the improvement comprising:

an attachment array for attaching the heart wrap medical device to a natural heart comprising;

at least one substrate that forms part of a heart-contacting surface of the heart wrap medical device; and

a plurality gripping elements each of which includes an elongate element disposed upon the substrate wherein the elongate elements further comprises a curved distal end.

9. The device of claim 8 wherein the curved distal end has a radius ranging from about 100 micrometers to about 500 micrometers.

10. In a heart wrap medical device adapted to surround at least a portion of a natural heart and having an inner heart contacting surface, the improvement comprising:

an attachment array for attaching the heart wrap medical device to a natural heart comprising;

at least one substrate that forms part of a heart-contacting surface of the heart wrap medical device; and

a plurality of gripping elements disposed upon the substrate wherein the gripping elements are hooks that are oriented in a pattern that restricts movement of the device in at least one direction to prevent detachment and permits movement in another direction to permit detachment.

11. The device of claim 10 wherein the gripping elements are hooks that are oriented in a pattern that restricts translatory motion in at least one direction.

12. The device of claim 10 wherein the gripping elements are hooks that are oriented in a pattern that restricts rotational motion in at least one direction.

13. A heart wrap medical device for placement on at least a portion of a natural heart comprising:

a device body adapted to contact at least a portion of a heart;

at least one substrate on the device body that contacts the natural heart; and

at least one array of gripping elements disposed on a cardiac-contacting surface of the device to engage the heart during use, wherein the gripping elements each include an elongate element extending from the cardiac-contacting surface, each elongate element having a curved distal end constructed and arranged to penetrate, and lodge in, cardiac tissue.

14. The device of claim 13 wherein each of the elongate elements has a proximal end that is joined to the cardiac-contacting surface.

15. The device of claim 14 wherein the elongate elements further comprise a barbed distal end.

16. The device of claim 13 wherein a plurality of arrays are disposed in spaced apart relationship along the cardiac-contacting surface of the device.

17. The device of claim 13 wherein the device includes a sensor.

18. The device of claim 13 wherein the device is an extra-cardiac assist device.

19. The device of claim 13 wherein the device is an active, extra-cardiac, assist device.

20. The device of claim 13 wherein the device is a passive, extra-cardiac, assist device.

21. A heart wrap medical device for placement on at least a portion of a natural heart comprising,

a device body adapted to contact at least a portion of a heart,

at least one substrate on the device body that contacts the natural heart;

and

at least one array of gripping elements disposed on a cardiac-contacting surface of the device to engage the heart during use, each of which includes a hook wherein the hook is sized to penetrate no more than 500 micrometers into cardiac tissue, whereby damage to cardiac tissue is lessened.

22. The device of claim 21 wherein the hook is sized to penetrate less than 300 micrometers into cardiac tissue, whereby damage to cardiac tissue is lessened.

23. A heart wrap medical device for placement on at least a portion of a natural heart comprising,

a device bode adapted to contact at least a portion of a heart,

at least one substrate on the device body that contacts the natural heart, and

at least one array of gripping elements disposed on a cardiac-contacting surface of the device to engage the heart during use, each of which includes a curved hook wherein the hook has an uncurled height ranging from about 0.2 millimeters to about 3.0 millimeters, whereby damage to cardiac tissue is lessened.

24. The device of claim 23 wherein the hook has an uncurled height ranging from about 0.5 millimeters to abut 1.5 millimeters, whereby damage to cardiac tissue is lessened.

25. A heart wrap medical device for placement on at least a portion of a natural heart comprising,

device body adapted to contact at least a portion of a heart,

at least fine substrate on the device body that contacts the natural heart;

and

at least one array of gripping elements disposed on a cardiac-contacting surface of the device to engage the heart during use, each of which includes an elongate element wherein the elongate element further comprises a curved distal end.

26. The device of claim 25 wherein the curved distal end has a radius ranging from about 100 micrometers to about 200 micrometers.

27. A heart wrap medical device for placement on at least a portion of a natural heart comprising:

a device body adapted to contact at least a portion of a heart;

at least one substrate on the device body that contacts the natural heart; and

at least one array of gripping elements disposed on a cardiac-contacting surface of the device to engage the heart during use, wherein the gripping elements are hooks that are oriented in a pattern that restricts movement of the device in at least one direction to prevent detachment and permits movement in another direction to permit detachment.

28. The device of claim 27 wherein the gripping elements are hooks that are oriented in a pattern that restricts translatory motion in at least one direction.

29. The device of claim 27 wherein the gripping elements are hooks that are oriented in a pattern that restricts rotational motion in at least one direction.

30. An active extra-cardiac assist device comprising:

a wrap element adapted to surround at least a portion of a heart, the wrap element forming a toroidal enclosure with an inner region;

at least one inflatable chamber, which upon inflation decreases the size of the inner region of the wrap element to provide cardiac pumping assistance; and

at least one array of gripping elements disposed on an inner surface of the wrap element to engage a heart during use, wherein the gripping elements include elongate an elongate element extending from an inner surface of the wrap element, each elongate element having a curved distal end constructed and arranged to penetrate, and lodge in, cardiac tissue.

31. The device of claim 30 wherein each of the elongate elements has a proximal end that is joined to the inner surface of the wrap element.

32. The device of claim 30 wherein the elongate elements further comprise a barbed distal end.

33. An active extra-cardiac assist device comprising:

a wrap element adapted to surround at least a portion of a heart, the wrap element forming a toroidal enclosure with an inner region;

at least one inflatable chamber, which upon inflation decreases the size of the inner region of the wrap element to provide cardiac pumping assistance; and

at least one array of gripping elements each of which includes a hook wherein the hook is sized to penetrate no more than 500 micrometers into cardiac tissue, whereby damage to cardiac tissue is lessened.

34. The device of claim 33 wherein the hook is sized to penetrate less than 300 micrometers into cardiac tissue, whereby damage to cardiac tissue is lessened.

35. An active extra-cardiac assist device comprising:

a wrap element adapted to surround at least a portion of a heart, the wrap element forming a toroidal enclosure with an inner region;

at least one inflatable chamber, which upon inflation decreases the size of the inner region of the wrap element to provide cardiac pumping assistance; and

at least one array of gripping elements each of which includes a curved hook wherein the hook has an uncurled height ranging from about 0.2 millimeters to about 3.0 millimeters, whereby damage to cardiac tissue is lessened.

36. The device of claim 35 wherein the hooks have an uncurled height ranging from about 0.5 millimeters to about 1.5 millimeters, whereby damage to cardiac tissue is lessened.

37. An active extra-cardiac assist device comprising:

a wrap element adapted to surround at least a portion of a heart, the wrap element forming a toroidal enclosure with an inner region;

at least one inflatable chamber, which upon inflation decreases the size of the inner region of the wrap element to provide cardiac pumping assistance; and

at least one array of gripping elements each of which contains an elongate element wherein the elongate elements further comprises a curved distal end.

38. The device of claim 37 wherein the curved distal end has a radius ranging from about 100 micrometers to about 200 micrometers.

39. An active extra-cardiac assist device comprising:

a wrap element adapted to surround at least a portion of a heart, the wrap element forming a toroidal enclosure with an inner region;

at least one inflatable chamber, which upon inflation decreases the size of the inner region of the wrap element to provide cardiac pumping assistance; and

at least one array of gripping elements, wherein the gripping elements are hooks that are oriented in a pattern that restricts movement of the device in at least one direction to prevent detachment and permits movement in another direction to permit detachment.

40. The device of claim 39 wherein the gripping elements are hooks that are oriented in a pattern that restricts translatory motion in at least one direction.

41. The device of claim 39 wherein the gripping elements are hooks that are oriented in a pattern that restricts rotational motion in at least one direction.