Method and device for organ positioning

• US 20020095067A1
• Filed: 06/12/2001
• Published: 07/18/2002
• Est. Priority Date: 01/13/2001
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Guenst, Gary W., Jahns, Scott E., Gubbin, Douglas H., Daigle, Thomas, Pignato, Paul A., Olig, Christopher, Jolly, Katherine, Montpetit, Karen
• Granted Patent: US 6,676,597 B2
• Time in Patent Office: Days
• US Class Current: 600/37
• CPC Class Codes: A61B 17/0206 with antagonistic arms as supports for retractor elements
• CPC Class Codes: A61B 17/22004 using mechanical vibrations, e.g. ultrasonic shock waves A61B17/225 takes precedence
• CPC Class Codes: A61B 2017/0243 for immobilizing local areas of the heart, e.g. while it beats trocars attached to inner organs or inner body tissue A61B2017/3488
• CPC Class Codes: A61B 2017/2905 flexible
• CPC Class Codes: A61B 2017/308 with suction cups
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

This invention provides an organ positioning device and method that employs suction to hold organ tissue to the device. The device allows the organ, for example, heart to be positioned in a desired orientation but otherwise allowing movement of the heart as the heart beats. The device is designed to be relatively atraumatic to heart tissue. Generally, the device comprises a resiliently flexible suction head having a plurality of legs that flex to conform to the surface of the heart. The suction head has vacuum passageways in fluid communication with the legs to apply suction between the legs and the surface of the heart.

Claims

1. A heart positioning device comprising:

a resiliently-flexible suction pad having a plurality of legs that flex to conform to the surface of the heart, the suction pad having vacuum passageways in fluid communication with the legs to apply suction between the legs and the surface of the heart;

a vacuum line connected to the vacuum passageway; and

a support arm connected to the suction pad to position the suction pad to thereby position or hold the heart.

2. The heart positioning device according to claim 1 wherein the suction pad has a generally starfish-shaped configuration.

3. The heart positioning device according to claim 1 wherein the vacuum passageway is configured to maintain suction in the other legs when one leg is released from the heart.

4. The heart positioning device according to claim 1 wherein the legs are configured and sufficiently flexible that they can be drawn against one another to a collapsed position for entering into thoracic cavity through a small incision, cannula or port.

5. The heart positioning device according to claim 1 wherein the plurality of legs consist essentially of 2-4 legs.

6. The heart positioning device according to claim 5 wherein the plurality of legs consist essentially of 3 legs.

7. The heart positioning device according to claim 1 wherein the suction pad is formed of a polymeric material.

8. The heart positioning device according to claim 1 wherein the suction pad is integrally molded with a resiliently-flexible suspension element connecting the suction pad to the support arm, the suction pad and suspension element being molded of the same material.

9. The heart positioning device according to claim 8 wherein the suspension element comprises a bellows-type structure that flexes to allow the suction pad to move in response to beating of the heart.

10. The heart positioning device according to claim 9 wherein the suspension element flexes to allow the suction pad to rotate about an axis defined by the suspension element.

11. The heart positioning device according to claim 10 wherein the suspension element and suction pad resiliently flex in response to beating of the heart.

12. The heart positioning device according to claim 1 wherein the suction pad has:

a surface with channels formed in the surface in fluid communication with the vacuum passageway for drawing vacuum between the suction pad and tissue to grasp the tissue; and

at least one tissue-engaging structure within each channel to prevent the channels from being closed off as the tissue and suction pad are drawn together to allow continued fluid communication along the channels.

13. The heart positioning device according to claim 12 wherein the vacuum passageway has an orifice in fluid communication with the channels, the suction pad further including a plurality of tissue engaging structures adjacent the orifice to prevent the orifice and tissue being drawn together to close the orifice, thereby maintaining fluid communication between the vacuum passageway and the channels.

14. The heart positioning device according to claim 13 wherein each legs includes at least one of the channels.

15. The heart positioning device according to claim 14 wherein the suction pad is sufficiently resiliently flexible that the suction pad draws down toward the surface of the heart more than the surface of the heart is pulled into the channels.

16. The heart positioning device according to claim 1 wherein the support arm can be changed between a flexible condition for moving the suction pad, and a rigid position for maintaining the end of the support arm connected to the suction pad in a stationary position, the suction pad including suspension means for accommodating motion of the heart.

17. The heart positioning device according to claim 16 wherein suction pad is permitted to rotate relative to the support arm along a first axis.

18. The heart positioning device according to claim 17 wherein the support arm includes a pivotable element connected to the suction pad that is free to pivot along a second axis generally perpendicular to the first axis.

19. The heart positioning device according to claim 1 wherein the suction pad has a tissue-engaging porous mesh in fluid communication with the vacuum passageway for drawing vacuum between the suction pad and tissue to grasp the tissue and for preventing the vacuum passageway from being closed off as the tissue and suction pad are drawn together.

20. The heart positioning device according to claim 19 wherein the mesh is formed of a metallic, ceramic or polymeric material.

21. A suction pad for use in a heart positioning device, the suction pad being formed of resiliently flexible material and having a plurality of legs that flex to conform to the surface of the heart, the suction pad having vacuum passageways in fluid communication with the legs to apply suction between the legs and the surface of the heart.

22. The suction pad according to claim 21 wherein the suction pad is integrally molded of substantially elastomeric material, the suction pad including a flange extending along the legs to seal between the legs and the surface of the heart, the flange being deformable as suction is applied between the legs and the surface of the heart.

23. The suction pad according to claim 21 wherein the suction pad has a generally starfish-shaped configuration.

24. The suction pad according to claim 21 wherein the vacuum passageway is configured to maintain suction in the other legs when one leg is released from the heart.

25. The suction pad according to claim 21 wherein the legs are configured and sufficiently flexible that they can be drawn against one another to a collapsed position for entering into thoracic cavity through a small incision, cannula or port.

26. The suction pad according to claim 21 wherein the plurality of legs consist essentially of 2-4 legs.

27. The suction pad according to claim 26 wherein the plurality of legs consist essentially of 3 legs.

28. The suction pad according to claim 21 wherein the suction pad is formed of a polymeric material.

29. The suction pad according to claim 21 wherein the suction pad is integrally molded with a resiliently-flexible suspension element connecting the suction pad to the support arm, the suction pad and suspension element being molded of the same material.

30. The suction pad according to claim 29 wherein the suspension element comprises a bellows-type structure that flexes to allow the suction pad to move in response to beating of the heart.

31. The suction pad according to claim 30 wherein the suspension element flexes to allow the suction pad to rotate about an axis defined by the suspension element.

32. The suction pad according to claim 31 wherein the suspension element and suction pad resiliently flex in response to beating of the heart.

33. The suction pad according to claim 21 having:

a surface with channels formed in the surface in fluid communication with the vacuum passageway for drawing vacuum between the suction pad and tissue to grasp the tissue; and

at least one tissue-engaging structure within each channel to prevent the channels from being closed off as the tissue and suction pad are drawn together to allow continued fluid communication along the channels.

34. The suction pad according to claim 33 wherein the vacuum passageway has an orifice in fluid communication with the channels, the suction pad further including a plurality of tissue engaging structures adjacent the orifice to prevent the orifice and tissue being drawn together to close the orifice, thereby maintaining fluid communication between the vacuum passageway and the channels.

35. The suction pad according to claim 34 wherein the suction pad has a tissue-engaging porous mesh positioned on the tissue-engaging structures and in fluid communication with the vacuum passageway.

36. The suction pad according to claim 35 wherein the mesh is formed of a metallic, ceramic or polymeric material.

37. The suction pad according to claim 36 wherein each legs includes at least one of the channels.

38. The suction pad according to claim 37 wherein the suction pad is sufficiently resiliently flexible that the suction pad draws down toward the surface of the heart more than the surface of the heart is pulled into the channels.

39. The suction pad according to claim 38 wherein the suction pad includes a resiliently flexible peripheral flange.

40. The suction pad according to claim 39 wherein the resiliently flexible peripheral flange includes an inner surface having a texture that tends to grip the surface of the heart when suction is drawn through the vacuum passageway.

41. The suction pad according to claim 40 wherein the texture comprises a plurality of bumps formed along the inner surface of the peripheral flange.

42. A method of using the suction pad of claim 40 comprising the following steps:

placing the suction pad against the surface of the heart; and

drawing suction through the vacuum passageway to draw the suction pad down towards the surface of the heart and flex the peripheral flange until the bumps engage the surface of the heart.

43. A method of using the suction pad of claim 41 comprising the following steps:

placing the suction pad against the surface of the heart; and

drawing suction through the vacuum passageway to draw the suction pad down towards the surface of the heart and flex the peripheral flange against the surface of the heart until the texture of the inner wall of the peripheral flange engages the surface of the heart.

44. A method of using the suction pad of claim 39 comprising the following steps:

placing the suction pad against the surface of the heart; and

drawing suction through the vacuum passageway to draw the suction pad down towards the surface of the heart and flex the peripheral flange against the surface of the heart.

45. A method of using the suction pad of claim 38 comprising the following steps:

placing the suction pad against the surface of the heart; and

drawing suction through the vacuum passageway to draw the suction pad down towards the surface of the heart.

47. The device of claim 46 wherein the bellows-type suspension element and suction head are integrally molded of elastomeric material.

48. The device of claim 47 wherein the vacuum passageway further extends through the bellows.

50. The suction head of claim 49 further having:

a surface with channels in fluid communication with the vacuum passageway for drawing vacuum between the suction head and the surface of the heart to grasp the heart; and

at least one tissue-engaging structure within each channel to prevent the channels from being closed off as the surface of the heart and suction head are drawn together to allow continued fluid communication along the channels.

51. The suction head of claim 50 wherein the suction head has a tissue-engaging porous mesh positioned on the at least one tissue-engaging structure and in fluid communication with the vacuum passageway.

52. The suction head of claim 51 wherein the mesh is formed of a metallic, ceramic or polymeric material.

46. A heart positioning device comprising:

a suction head having a vacuum passageway for applying suction between the suction head and the surface of the heart;

a vacuum line connected to the vacuum passageway;

a support arm connected to the suction head to position the suction head to thereby position or hold the heart; and

a bellows-type suspension element connecting the suction head and support arm, the bellows-type suspension element flexing to allow the suction head to move in response to beating of the heart.

49. A suction head for use in a heart positioning device, the suction head being formed of resiliently flexible material, the suction head having vacuum passageways for applying suction to the surface of the heart and a resiliently flexible peripheral flange, the suction head or flange being sufficiently resiliently flexible that the suction head draws down toward the surface of the heart more than the surface of the heart is pulled into the suction head.

53. A suction device for positioning and holding a beating heart, the suction device comprising:

a suction head having a vacuum passageway for applying suction between the suction head and the surface of the heart; and

a bellows-type suspension element extending from the suction head for connecting the suction head to a support arm, the bellows-type suspension element flexing to allow the suction head to move in response to beating of the heart.

54. The device of claim 53 wherein the bellows-type suspension element and suction head are integrally molded of elastomeric material.

55. The device of claim 54 wherein the vacuum passageway further extends through the bellows.

56. The device of claim 55 wherein the suction head has a tissue-engaging porous mesh in fluid communication with the vacuum passageway.

57. The device of claim 56 wherein the mesh is formed of a metallic, ceramic or polymeric material.

59. A method according to claim 58 wherein device is positioned after the heart is exposed to permit access to all surfaces of the heart.

60. A method according to claim 59 wherein the heart is exposed by a sternotomy.

61. A method according to claim 59 wherein the heart is exposed by a thoracotomy.

62. A method according to claim 58 wherein the suction head is positioned on the heart through an opening provided in a closed chest surgery procedure.

63. A method according to claim 58 wherein the heart is beating as it is held by the suction head.

64. A method according to claim 63 wherein the heart is held by the suction head such that the heart is permitted to pivot as it beats.

65. A method according to claim 63 wherein the surgical repair comprises stabilizing the heart near the site of the surgical repair.

66. A method according to claim 65 wherein stabilizing the heart comprises vacuum stabilization of the heart.

67. A method according to claim 58 wherein the suction head is positioned onto the apex of the heart.

68. A method according to claim 58 wherein the suction head is positioned immediately adjacent to the apex of the heart.

69. A method according to claim 68 wherein the suction head is positioned onto the left ventricle immediately lateral to the apex of the heart.

70. A method according to claim 58 wherein the step of holding the heart in a second position comprises removably clamping the suction head in position on a fixture which is stationary with respect to the patient.

71. A method according to claim 70 wherein the suction head is removably clamped onto a retractor.

58. A method for surgical treatment of a heart comprising:

positioning a resiliently-flexible suction head having a plurality of outwardly extending legs against a surface of the heart near the apex of the heart with the heart in a first position;

applying suction to the suction head on the surface of the heart such that the plurality of legs conform to the surface of the heart and adhere the suction head to the surface of the heart;

holding at least a portion of the heart in a second position by the suction head;

performing a surgical repair on the heart in the second position;

removing the suction head from the surface of the heart.

72. A medical device for contacting a surface of a heart comprising:

a resiliently-flexible suction pad having at least one vacuum passageway to apply suction between a portion of the suction pad and the surface of the heart;

a porous material disposed on the suction pad between the vacuum passageway and the surface of the heart;

a vacuum line connected to the vacuum passageway; and

a support arm connected to the suction pad to position the suction pad relative to the heart.

73. The medical device according to claim 72 wherein the suction pad has a plurality of legs arranged in a generally starfish-shaped configuration.

74. The medical device according to claim 73 wherein the vacuum passageway is configured to maintain suction in the other legs when one leg is released from the heart.

75. The medical device according to claim 73 wherein the legs are configured and sufficiently flexible that they can be drawn against one another to a collapsed position for entering into thoracic cavity through a small incision, cannula or port.

76. The medical device according to claim 72 wherein the vacuum passageway has an orifice in fluid communication with a plurality of channels, the porous material located adjacent the orifice to prevent the orifice and tissue being drawn together to close the orifice, thereby maintaining fluid communication between the vacuum passageway and the channels.

77. The medical device according to claim 72 wherein the porous material is recessed within the suction pad and wherein the suction pad is sufficiently resiliently flexible that the suction pad draws down toward the surface of the heart as vacuum is applied.

78. The medical device according to claim 72 wherein the support arm can be changed between a flexible condition for moving the suction pad, and a rigid position for maintaining the end of the support arm connected to the suction pad in a stationary position, the suction pad including suspension means for accommodating motion of the heart.

79. The medical device according to claim 72 wherein suction pad is permitted to rotate relative to the support arm along a first axis.

80. The medical device according to claim 72 wherein the support arm includes a pivotable element connected to the suction pad that is free to pivot along a second axis generally perpendicular to the first axis.

81. The medical device according to claim 72 wherein the porous material is a mesh.

82. The medical device according to claim 72 wherein the porous material is an open cell foam.

83. The medical device according to claim 72 wherein the porous material has about 10 to about 50 openings per inch.

84. The medical device according to claim 72 wherein the porous material engages heart tissue upon application of a vacuum.

85. The medical device according to claim 84 wherein the porous material has a textured surface to promote frictional contact with the heart tissue.

86. The medical device according to claim 72 wherein the porous material is separated from portions of the suction pad by standoffs.