Device and method for stabilizing cardiac tissue

• US 6,338,738 B1
• Filed: 08/31/1999
• Issued: 01/15/2002
• Est. Priority Date: 08/31/1999
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Yardimci, Atif M., Smith, Donald A., Weyrauch, Charles R., Herriott, Lise J., Stadler, Cristina J., Heslington, Donald R., Steele, Kenneth J., Ariagno, Scott R., Bellotti, Marc, Marttila, Alan W.
• Primary Examiner(s): Mancene, Gene
• Assistant Examiner(s): Priddy, Michael B.
• Application Number:
  US09/386,666
• Time in Patent Office: 868 Days
• Field of Search: 600/201, 600/217, 600/226-227, 600/231, 600/232, 600/234, 600/235, 600/37, 600/210, 606/232
• US Class Current: 606/232
• CPC Class Codes: A61B 17/0206 with antagonistic arms as supports for retractor elements
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0243 for immobilizing local areas of the heart, e.g. while it beats
• CPC Class Codes: A61B 2017/2926 Details of heads or jaws
• CPC Class Codes: F16M 11/045 adapted to left-right translation movement
• CPC Class Codes: F16M 11/18 with mechanism for moving the apparatus relatively to the stand
• CPC Class Codes: F16M 11/40 by means of coilable or bendable legs or spiral shaped legs
• CPC Class Codes: F16M 2200/022 by friction
• CPC Class Codes: F16M 2200/024 by positive interaction, e.g. male-female connections
• CPC Class Codes: F16M 2200/066 being part of the head
• CPC Class Codes: F16M 2200/08 Foot or support base

Abstract

The present invention is directed to a new and useful device and method for stabilizing cardiac tissue at a surgical site during heart surgery, and specifically useful during beating heart surgery. The device includes a foot for contacting a heart tissue and two arms movably connected together for selective movement to vary and adjust the position of the foot on the heart. The foot and the arm assembly are designed to optimize stability of the foot in contact with heart tissue, and therefore, to optimize stability of the heart during surgical procedure. The device is capable of being mounted on a chest spreader. The foot has a bottom surface which is angled for better stabilization and engagement with the heart.

Claims

1. A surgical device for stabilizing cardiac tissue during surgery, said device comprising:

a support structure having a distal end and a proximal end; and

a stabilizing foot attached to said support structure at a distal end, the foot comprising two laterally spaced apart fingers connected by a bridge at one end of the fingers, said fingers each having an inner edge with said edges being located generally in a first plane and defining a surgical site therebetween, said fingers having bottom surfaces, each said bottom surface having a beveled surface portion extending upwardly and away from the inner edge at an angle in the range of between about 10° and

about 35°

from the first plane.

2. The surgical device of claim 1 wherein said inner edges are generally parallel.

3. The surgical device of claim 1 wherein said bottom surfaces each include a second surface portion extending at an angle from the beveled surface to an outer edge of each finger.

4. The surgical device of claim 3 wherein each second surface portion of the bottom surfaces is generally parallel to the first plane.

5. The surgical device as set forth in claim 1 wherein said bottom surfaces are textured.

6. The surgical device as set forth in claim 5 wherein the texture is a plurality of generally concentric ribs.

7. The surgical device of claim 1 further comprising a mounting post for connecting the foot to the support structure.

8. The surgical device of claim 7 wherein the mounting post is secured to the bridge and projects therefrom.

9. The surgical device of claim 7 wherein the mounting post is secured to the finger and projects therefrom.

10. The surgical device as set forth in claim 7 wherein said mounting post is generally normal to said first plane.

11. The surgical device of claim 7 wherein said post is generally parallel to said first plane and generally parallel to a longitudinal axis of each said finger.

12. The surgical device of claim 7 wherein said post is generally parallel to said first plane and generally perpendicular to a longitudinal axis of each said finger.

13. The surgical device of claim 1 wherein said bridge has a bottom surface that has a substantial portion thereof spaced above said first plane.

14. The surgical device of claim 1 wherein said each finger has a top surface that meets the beveled surface portion of the bottom surface of each finger at the corresponding inner edge.

15. The surgical device of claim 14 wherein the top surface of each finger gradually converges with the beveled surface portion of the bottom surface of each finger in the area of the inner edge.

16. The surgical device of claim 1 wherein said beveled surface portion are at least 6 mm wide.

17. The surgical device as set forth in claim 1 wherein said inner edges are spaced apart a distance in the range of between about 6 mm and about 13 mm.

18. The surgical device of claim 7 wherein the mounting post is removably connected to the support structure.

19. The surgical device of claim 18 wherein the connection of the mounting post to the support structure is a snap-fit connection.

20. The surgical device of claim 1 wherein the support structure comprises a first elongate arm and wherein the stabilizing foot is connected to said first elongate arm.

21. The surgical device of claim 20 wherein the stabilizing foot is movably connected to the first elongate arm.

22. The surgical device of claim 21 further comprising a first joint and a first lock means cooperating with the first joint and having a locked position for selective locking of the first arm relative to the stabilizing foot and an unlocked position wherein said first joint is operable to be maintained substantially in position until moved by an operator.

23. The surgical device of claim 20 wherein the support structure further comprises a second elongate arm movably connected to the first elongate arm for selective multi-axis movement of the first and second arms relative to one another.

24. The surgical device of claim 23 further comprising a second joint and a second lock means with a locked position for selective locking of the first and second arms in a selected position relative to one another, and an unlocked position wherein said second joint is operable to maintain said first and second arms substantially in position until moved by an operator.

25. The surgical device of claim 1 wherein the proximal end of the support structure is movably mounted to a surgical spreader.

26. The surgical device of claim 24 further comprising a third joint and a third lock means cooperating with said third joint to removably mount the surgical device to a chest spreader.

27. The surgical device of claim 24 wherein said second joint includes a pair of C-clamps pivotally secured to one another with each said C-clamp having an arm receiving bore therethrough frictionally engaging the respective first or second arm mounted in the respective bore.

28. The surgical device of claim 27 wherein said C-clamps each have a toothed surface in engagement with one another to selectively pivotally lock the C-clamps in a plurality of pivoted positions and the first pivot joint including a fastening member securing the C-clamps together.

29. The surgical device of claim 27 wherein each respective first and second arm can move axially, rotationally and pivotally relative to one another within the C-clamps.

30. The surgical device of claim 26 wherein said first and third lock means include a preload pad.

31. The surgical device as set forth in claim 30 wherein said first and third lock means includes a rod member mounted in the respective arm for selective axial movement therein, one end of the rod is selectively in force applying engagement with the respective preload pad whereby axial movement in a direction toward the respective preload pad will increase the friction and movement in a direction away from the respective preload pad will reduce the friction to as low as the preload friction.

32. A foot for use with a heart stabilizing device for engaging a portion of a heart during a heart surgery procedure, said foot comprising:

two laterally spaced apart fingers, said fingers each having an inner edge with said edges defining a surgical site therebetween, each finger having a bottom surface, each said bottom surface having an angled surface portion extending upwardly and away from the inner edge.

33. The foot of claim 32 wherein an included angle between the angled surface portions is in the range of between about 110°

and about 160°

.

34. The foot of claim 32 wherein an included angle between the angled surface portions is in the range of between about 120°

and about 140°

.

35. The foot of claim 32 further comprising a bridge secured to and extending between the fingers adjacent one end of each finger.

36. The foot of claim 33 further comprising a mounting post secured to the bridge or one of the fingers and extending therefrom.

37. The foot of claim 32 wherein said inner edges are generally parallel.

38. The foot of claim 32 wherein said bottom surfaces each include a second surface portion extending at an angle from the angled surface portion to an outer edge of each finger.

39. The foot of claim 38 wherein said second surface portion extends at an angle relative to the respective angled surface portion which is in the range of between about 145°

and about 170°

.

40. The foot of claim 32 wherein said bottom surface is textured.

41. The foot of claim 40 wherein said texture is a plurality of generally concentric ribs running generally lengthwise of the respective finger.

42. The foot of claim 36 wherein the inner edges of the fingers lie in a first plane and said mounting post is generally normal to said first plane.

43. The foot of claim 36 wherein the inner edges of the fingers lie in a first plane and said mounting post is located at an angle to said first plane.

44. The foot of claim 36 wherein the inner edges of the fingers lie in a first plane and said mounting post is generally parallel to said first plane and generally parallel to a longitudinal axis of each said finger.

45. The foot of claim 36 wherein the inner edges of the fingers lie in a first plane and said mounting post is generally parallel to said first plane and generally perpendicular to a longitudinal axis of each said finger.

46. The foot of claim 35 wherein said bridge has a lower surface that has a substantial portion thereof spaced above a plane defined by the inner edges.

47. The surgical device of claim 32 wherein said each finger has a top surface that meets the angled surface portion of the bottom surface at the corresponding inner edge at an acute angle.

48. The surgical device of claim 32 further comprising a pad removably secured to the bottom surface of the foot.

49. The foot of claim 32 wherein said inner edges are spaced apart a distance in the range of between about 6 m and about 13 mm.

50. The foot of claim 32 wherein the angled surface portion of the bottom surface of each finger has a width of at least about 6 mm.

51. The foot of claim 36 wherein the mounting post is adapted for removable connection of the foot to the heart stabilizing device.

52. The method for selectively isolating and stabilizing cardiac tissue at a surgical site comprising the steps of:

obtaining a device for isolating and stabilizing cardiac tissue comprising a stabilizing foot having at least two heart engaging bottom surfaces, such bottom surfaces being inwardly angled relative to each other;

placing said angled heart engaging bottom surfaces on opposite sides of the surgical site;

applying force to the heart through said angled heart engaging bottom surfaces to thereby stretch and stabilize cardiac tissue at the surgical site;

performing a medical procedure on the cardiac tissue.

53. The method of claim 52 wherein the heart is beating during the medical procedure.

54. The method of claim 52 wherein the force applied through the stabilizing device is a mechanical force.

55. The method of claim 52 wherein the force applied through the stabilizing device is a vacuum force.

56. The method of claim 52 further comprising a step of adjusting the orientation of a stabilizing foot relative to the surgical site.

57. The method of claim 56 wherein the adjusting step further comprises locking the position and orientation of the stabilizing foot relative to the surgical site.