Organ manipulator having suction member supported with freedom to move relative to its support

• US 6,899,670 B2
• Filed: 07/10/2002
• Issued: 05/31/2005
• Est. Priority Date: 09/07/1999
• Status: Expired due to Term

• Current Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Original Assignee: Origin Medsystems Inc. (Boston Scientific Corporation)
• Inventors: Peng, Steven, Voss, Larry, Vargas, Jaime S., Chin, Albert K., Davis, John, Hancock, David E., Carlson, Grace A.
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US10/193,575
• Publication Number:
  US 20030009080A1
• Time in Patent Office: 1,056 Days
• Field of Search: 600/37, 600/201, 600/206, 600/208, 600/227, 600/228, 600/230, 600/231, 601/132, 602/4, 602/6, 602 60- 61, 602 75- 76, 602/903, 606/151
• US Class Current: 600/37
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 17/085 with adhesive layer
• 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 2017/2929 with a head rotatable about the longitudinal axis of the shaft
• CPC Class Codes: A61B 2017/293 with means preventing relative rotation between the shaft and the actuating rod
• CPC Class Codes: A61B 2017/308 with suction cups

Abstract

An organ manipulator including at least one suction member or adhesive disc mounted to a compliant joint, a flexible locking arm for mounting such suction member or compliant joint, and a method for retracting and suspending an organ in a retracted position using suction (or adhesive force) so that the organ is free to move normally (e.g., to beat or undergo other limited-amplitude motion) in at least the vertical direction during both steps. In preferred embodiments, a suction member exerts suction to retract a beating heart and suspend it in a retracted position during surgery. As the retracted heart beats, the compliant joint allows it to expand and contract freely (and otherwise move naturally) at least in the vertical direction so that hemodynamic function is not compromised. The suction member conforms or can be conformed to the organ anatomy, and its inner surface is preferably smooth and lined with absorbent material to improve traction without causing trauma to the organ. The compliant joint can connect the member to an arm which is adjustably mounted to a sternal retractor or operating table. The compliant joint can be a sliding ball joint, a hinged joint, a pin sliding in a slot, a universal joint, a spring assembly, or another compliant element. In preferred embodiments, the method includes the steps of affixing a suction member to a beating heart at a position concentric with the heart'"'"'s apex, and applying suction to the heart while moving the member to retract the heart such that the heart has freedom to undergo normal beating motion at least in the vertical direction during retraction.

Claims

1. A method for compliant retraction of an organ, including the steps of:

(a) retracting the organ by exerting suction thereon using a suction member coupled to a mounting element, in such a manner that the suction member has freedom to move at least along an axis of said suction member relative to the mounting element in response to normal movement of the organ; and

(b) maintaining the organ in a retracted position by exerting suction thereon using the suction member while said suction member is coupled to the mounting element, in such a manner that said suction member has freedom to move at least along the axis of said suction member relative to the mounting element.

2. The method of claim 1, wherein the suction member is a single suction cup, the organ is a beating heart, and step (b) includes the step of suspending the heart from the suction cup in the retracted position using suction in such a manner that the suction member has freedom to move at least vertically relative to the mounting element in response to normal beating movement of the heart.

3. The method of claim 2, wherein the beating heart has an apex, the suction cup is configured to conform to and exert suction on the apex of the beating heart, and step (a) includes the steps of:

affixing the suction cup to the heart at a position of the heart concentric with said apex of the heart;

applying suction to the heart by coupling the suction member to a vacuum source; and

moving the suction member to retract the heart.

4. The method of claim 1, wherein the suction member comprises multiple suction cups, the organ is a beating heart, and step (b) includes the step of suspending the heart from the multiple suction members in the retracted position using suction in such a manner that each of the suction members has freedom to move at least vertically relative to the mounting element in response to normal beating movement of the heart.

5. An organ manipulation apparatus, including:

at least one suction member defining a vacuum space therein, enabling attachment of said apparatus to an organ to facilitate a surgical procedure;

a support structure; and

a joint coupling said at least one suction member and the support structure, wherein the support structure is configured to support said at least one suction member, with the organ supported in a retracted position by said at least one suction member, such that said at least one suction member has freedom to rotate, with respect to said support structure.

6. The organ manipulation apparatus of claim 5, wherein said at least one suction member has freedom to rotate about a longitudinal axis of said at least one suction member, in response to normal movement of the organ.

7. The organ manipulation apparatus of claim 5, wherein said at least one suction member has freedom to rotate about an axis perpendicular to a longitudinal axis of said at least one suction member.

8. The organ manipulation apparatus of claim 5, wherein said joint allows said at least one suction member a limited amount of translation, relative to said support structure, in directions along a longitudinal axis of said at least one suction member.

9. The organ manipulation apparatus of claim 5, wherein the organ is a beating heart.

10. An organ manipulation apparatus, including:

a contact member including at least one suction element defining a vacuum space therein and enabling attachment of contact member to an organ;

a support structure; and

a joint mechanism coupling said contact member and the support structure, wherein the support structure is configured to support said contact member while attached to the organ to support the organ in a retracted position, wherein said joint mechanism permits limited movement of said contact member with respect to said support structure along a longitudinal axis of said contact member, and rotation of said contact member with respect to said support structure about an axis perpendicular to said longitudinal axis.

11. The organ manipulation apparatus of claim 10, wherein at least one of said limited movement along said longitudinal axis and said rotation are in response to normal movement of the organ.

12. The organ manipulation apparatus of claim 10, wherein said contact member has freedom to rotate about said longitudinal axis in response to normal movement of the organ.

13. The organ manipulation apparatus of claim 10, wherein said contact member has freedom to rotate about a longitudinal axis of said support structure.

14. The organ manipulation apparatus of claim 10, wherein said support structure comprises an arm configured to assume a flexible state and a rigid state.

15. The organ manipulation apparatus of claim 14, wherein said arm comprises multiple joints with a tensioning member passing therethrough, wherein, upon application of tension by said tension member, said arm assumes said rigid state.

16. The organ manipulation apparatus of claim 10, further comprising a vacuum line operatively connected to said contact member.

17. The organ manipulation apparatus of claim 16, wherein said vacuum line extends from said contact member in an orientation aligned with said longitudinal axis of said contact member.

18. An organ manipulation apparatus, including:

at least one suction member defining a vacuum space therein, enabling attachment of said apparatus of an organ;

a support structure; and

an unbiased joint coupling the suction member and the support structure, wherein the support structure is configured to support said at least one suction member, with the organ supported in a retracted position by said at least one suction member, such that said at least one suction member has freedom to move relative to said support structure in response to normal movement of the organ.

19. The organ manipulation apparatus of claim 18, wherein said support structure and said unbiased joint are configured to support said at least one suction member with the organ suspended from said at least one suction member in the retracted position, and with said at least one suction member having freedom to move at least vertically relative to said support structure in response to normal movement of the organ.

20. The organ manipulation apparatus of claim 18, wherein the organ is a beating heart.

21. The organ manipulation apparatus of claim 20, wherein the beating heart has an apex, and said at least one suction member is configured to conform to, and exert suction on, the apex of the beating heart.

22. The organ manipulation apparatus of claim 20, wherein said at least one suction member is a suction cup including:

a shell member attached to said unbiased joint, said shell member defining a vacuum space therein and adapted to seal against the surface of the beating heart around the periphery of said shell member.

23. The organ manipulation apparatus of claim 22, wherein said shell member includes a seal positioned around the periphery, said seal being made of biocompatible foam.

24. The organ manipulation apparatus of claim 22, wherein said shell member is a rigid shell.

25. The organ manipulation apparatus of claim 18, wherein said suction member also includes absorbent material which lines at least a portion of the vacuum space.

26. The organ manipulation apparatus of claim 22, wherein at least a portion of said shell member is deformable in response to external force into an organ-conforming shape which conforms to a surface of the beating heart and remains in the organ-conforming shape following exertion of the external force.

27. The organ manipulation apparatus of claim 26, wherein said shell member comprises a deformable metal mesh including an impermeable elastomeric material.

28. The organ manipulation apparatus of claim 22, wherein an inner surface of said shell member is lined with smooth and soft material.

29. The organ manipulation apparatus of claim 22, wherein said shell member is made of smooth and soft material.

30. The organ manipulation apparatus of claim 29, said suction cup also includes absorbent material which lines at least a portion of an inner surface of said shell member.

31. The organ manipulation apparatus of claim 18, wherein said suction member is shaped and configured to assert sufficient suction to a beating heart to retract the beating heart from a first position to the retracted position.

32. The organ manipulation apparatus of claim 18, wherein said support structure and said unbiased joint are configured to support said at least one suction member, with the organ suspended therefrom and with said at least one suction member having freedom to rotate, with at least a portion of the organ, about a vertical axis relative to said support structure.

33. The organ manipulation apparatus of claim 18, wherein said support structure and said unbiased joint are configured to support said at least one suction member, with the organ suspended therefrom and with said at least one suction member having freedom to rotate, with at least a portion of the organ, about an axis perpendicular to a longitudinal axis of said at least one suction member, relative to said support structure.

35. The organ manipulation apparatus of claim 18, wherein said support structure includes a fixed structure and an arm adjustably mounted to said fixed structure.

36. The organ manipulation apparatus of claim 35, wherein said unbiased joint includes:

a ball joint attached to said arm; and

a member support element mounted to said at least one suction member, said support element being movable relative to said ball joint.

37. The organ manipulation apparatus of claim 35, wherein said fixed structure is a sternal retractor.

38. The organ manipulation apparatus of claim 18, wherein said support structure includes a fixed structure and an arm adjustably mounted to said fixed structure, and wherein said unbiased joint includes:

a support element mounted to said support member, wherein said support element defines two parallel slots; and

a pair of pins mounted to said arm in such a position that each of the pins slides in a different one of the slots.

39. The organ manipulation apparatus of claim 18, also including:

a suction line coupled to said at least one suction member; and

a low-pressure reservoir coupled to said suction line and configured to be coupled to a vacuum source, said reservoir having sufficient volume to continue to maintain assertion of said sufficient suction force for a significant time in the event of interruption of suction flow from the vacuum source to said suction line.

40. The apparatus of claim 39, further including:

a vacuum regulator coupled to said suction line between said at least one suction member and the reservoir, and configured to control the pressure differential.

41. The organ manipulation apparatus of claim 18, including:

multiple suction members defining at least one vacuum space, wherein said suction members are configured to exert sufficient suction force on the organ to move the organ when said suction members are placed against the organ, a negative pressure is applied within said at least one vacuum space to engage at least one of said multiple suction members with the organ, and at least one of said multiple suction members are moved,

wherein said unbiased joint couples said support structure and said multiple suction members.

42. The organ manipulation apparatus of claim 41, wherein said unbiased joint includes:

a set of hinged fingers, each of said fingers having a distal end to which a different one of said suction members is mounted.

43. The organ manipulation apparatus of claim 18, wherein said at least one suction member includes:

a flexible enclosure having a first portion configured to be coupled to a vacuum source, and a second portion which is permeable to gas; and

pellets in the enclosure, whereby evacuation of the enclosure when said second portion of said enclosure is pressed against the organ causes said pellets in the evacuated enclosure to form a rigid structure which conforms to the organ.

44. The organ manipulation apparatus of claim 18, wherein said at least one suction member is a suction cup including:

a rigid core; and

a flexible shell supported by said rigid core, wherein said shell has a generally concave distal surface, and said rigid core is coupled to said unbiased joint so as to have freedom to move relative to said support structure.

45. The organ manipulation apparatus of claim 44, wherein a distal surface of said shell has a periphery, and said shell has a flexible flange portion which extends around said periphery, the apparatus also including:

a seal mounted to said flexible flange portion of said shell.

47. The organ manipulation apparatus of claim 18, wherein said support structure includes a fixed structure and an arm adjustably mounted to said fixed structure, said arm having a plurality of links rendering said arm flexible and wherein said links are lockable to lock said arm in a rigid state.

48. The organ manipulation apparatus of claim 47, wherein said arm further comprises a cable, and wherein said plurality of links comprise a plurality of ball joints threaded along said cable, each of said ball joints having a convex surface, a concave socket surface, a length, and a diameter, wherein said socket surface is shaped for receiving said convex surface of an adjacent one of said ball joints, and said diameter is greater than said length.

49. The organ manipulation apparatus of claim 48, wherein a ratio of said length to said diameter is at least about to 0.345/0.460.

50. The organ manipulation apparatus of claim 18, wherein said support structure includes a fixed structure and an arm adjustably mounted to said fixed structure, said arm has a flexible state and a rigid state, and said arm comprises:

a cable; and

ball joints threaded along said cable, each of said ball joints having a convex surface and a concave socket surface, wherein each of said ball joints is molded from plastic and at least a first portion of said concave socket surface is molded with a texture which provides sufficiently high friction to lock said arm in the rigid state when said convex ball surface of an adjacent one of said ball joints is tightened against said first portion of said concave socket surface.

51. The organ manipulation apparatus of claim 18, wherein said support structure includes a fixed structure and an arm adjustably mounted to said fixed structure, said arm has a flexible state and a rigid state, and said arm comprises:

a cable; and

ball joints threaded along said cable, each of said ball joints having a main portion defining a convex surface and part of a concave socket surface, and an insert portion defining a remaining part of the concave socket surface, wherein said main portion is molded from hard plastic and said insert portion is molded from a material having greater friction than friction provided by the hard plastic.

52. The organ manipulation apparatus of claim 51, wherein said insert portion is molded from a thermoplastic or silicone elastomer.

53. The organ manipulation apparatus of claim 52, wherein said insert portion has an annular shape and comprises thermoplastic or silicone elastomer material having a Shore A durometer hardness in the range of about 50 to about 90.

54. The organ manipulation apparatus of claim 18, wherein said support structure includes a fixed structure and an arm adjustably mounted to said fixed structure, said arm has a flexible state and a rigid state, and said arm comprises:

a cable; and

ball joints threaded along said cable, each of said ball joints having a first portion defining a convex surface and part of a concave socket surface, and a second portion defining a remaining part of said concave socket surface, wherein said first portion of each of said ball joints is molded hard plastic and said second portion is molded thermoplastic or silicone elastomer.

55. The organ manipulation apparatus of claim 18, wherein said support structure includes a fixed structure and an arm adjustably mounted to said fixed structure, said arm has a flexible state and a rigid state, and said arm comprises:

a cable; and

ball joints and sleeves threaded alternately along said cable, each of said ball joints defining a convex surface at each end, and each of said sleeves defining a concave socket surface at each end, wherein each of said ball joints is molded from plastic having a first hardness and each of said sleeves is molded from plastic having a second hardness different from said first hardness.

56. The apparatus of claim 55, wherein each of said ball joints is molded from polycarbonate plastic and each of said sleeves is molded from ULTEM plastic.

57. The organ manipulation apparatus of claim 55, wherein each of said sleeves is molded from polycarbonate plastic and each of said ball joints is molded from ULTEM plastic.

58. The organ manipulation apparatus of claim 18, wherein said support structure includes a fixed structure and an arm adjustably mounted to said fixed structure, said arm has a flexible state and a rigid state, and said arm comprises:

a cable; and

a first set of ball joints and a second set of ball joints threaded alternately along said cable, wherein each of said ball joints in the first set and the second set defines a convex surface and a concave socket surface, each of said ball joints in the first set is molded from plastic having a first hardness and each of said ball joints in the second set is molded from plastic having a second hardness different from said first hardness.

59. The organ manipulation apparatus of claim 58, wherein each of said ball joints in the first set is molded from polycarbonate plastic and each of said ball joints in the second set is molded from ULTEM plastic.

34. The organ manipulation apparatus of 18, wherein said support structure and said unbiased joint are configured to support said at least one suction member, with the organ suspended therefrom and with said at least one suction member having freedom to swing, with at least a portion of the organ, in a vertical plane relative to said support structure.

46. The organ manipulation apparatus of clalim 44, wherein said rigid core is made of plastic and said shell is made of silicone.

60. A surgical apparatus configured to facilitate a surgical procedure, said apparatus comprising:

a flexible rigidifying bag including;

a chamber defined within said bag;

a port through which said chamber is evacuatable; and

rigidifying structure disposed within said chamber and configured to be substantially rigid when said chamber is evacuated; and

a suction member, effective between the flexible rigidifying bag and tissue to which the apparatus is attached, the suction member creating negative pressure between the tissue and the apparatus enabling attachment of said rigidifying bag to tissue.

61. The surgical apparatus of claim 60, wherein said rigidifying structure includes a plurality of beads.

62. A method for compliant retraction of an organ, including the steps of:

(a) retracting the organ by exerting suction thereon using a suction member coupled to a mounting element, in such a manner that the suction member has freedom to move relative to the mounting element in response to normal movement of the organ; and

(b) maintaining the organ in a retracted position by exerting suction thereon using the suction member while said suction member is coupled to the mounting element, in such a manner that said suction member has freedom to rotate about a longitudinal axis thereof, relative to the mounting element.

63. The method of claim 62, wherein the organ is a beating heart, and step (b) includes the step of suspending the heart from the suction member in the retracted position using suction in such a manner that the suction member has freedom to also move vertically relative to the mounting element in response to normal beating movement of the heart.

64. The method of claim 63, wherein the beating heart has an apex, the suction member is configured to conform to and exert suction on the apex of the beating heart, and step (a) includes the steps of:

affixing the suction member to the heart at a position of the heart substantially concentric with said apex of the heart;

applying suction to the heart by coupling the suction member to a vacuum source; and

moving the suction member to retract the heart.

65. The method of claim 62, wherein the suction member comprises multiple suction components, the organ is a beating heart, and step (b) includes the step of suspending the heart from the multiple suction components in the retracted position using suction in such a manner that each of the suction components has freedom to move at least vertically relative to the mounting element in response to normal beating movement of the heart.

66. A method for compliant retraction of an organ, including the steps of:

(a) retracting the organ by exerting suction thereon using a suction member coupled to a mounting element, in such a manner that the suction member has freedom to move relative to the mounting element in response to normal movement of the organ; and

(b) maintaining the organ in a retracted position by exerting suction thereon using the suction member while said suction member is coupled to the mounting element, in such a manner that said suction member has freedom of limited translation, relative to the mounting element, in directions along a longitudinal axis of the suction member, and freedom of rotation, relative to the mounting element, about an axis perpendicular to the longitudinal axis of the suction member.

67. The method of claim 66, wherein said suction member has freedom to rotate about the longitudinal axis thereof, relative to the mounting element.

68. An organ manipulation apparatus, including:

at least one suction member defining a vacuum space therein, for attachment of said apparatus to an organ;

a support member; and

a coupling member including a rotational joint, said coupling member coupling the suction member and the support member, wherein the support member and the coupling member are configured to support the suction member, with the organ supported in a retracted position by the suction member.

69. The organ manipulation apparatus of claim 68, wherein said rotational joint allows said at least one suction member at least a limited amount of rotation about a longitudinal axis of said at least one suction member, relative to said support structure.

70. The organ manipulation apparatus of claim 68, wherein said coupling member further allows said at least one suction member at least a limited amount of translation, relative to said support structure, in directions defined by a longitudinal axis of said at least one suction member.

71. The organ manipulation apparatus of claim 68, wherein said coupling member further allows said at least one suction member at least a limited amount of rotation, relative to said support structure, about an axis perpendicular to a longitudinal axis of said at least one suction member.

72. The organ manipulation apparatus of claim 68, wherein said support member comprises an arm adapted to be adjustably mounted to a fixed structure, and wherein said coupling member includes a spring assembly coupled between said arm and said suction member.

73. The organ manipulation apparatus of claim 72, wherein said assembly biases said rotational joint for suspension of said suction member.

74. The organ manipulation apparatus of claim 68, wherein said coupling member is configured to maintain a constant retraction force on said suction member.

75. An organ manipulation apparatus, including:

at least one suction member defining a vacuum space therein for attachment of said apparatus to an organ;

a support structure; and

a compliant joint coupling said suction member and said support structure, wherein said support structure and said compliant joint are configured to support said at least one suction member, with the organ supported in a refracted position by said at least one suction member, such that said at least one suction member has freedom to move relative to said support structure in response to normal movement of the organ, wherein said compliant joint includes;

a chamber defining a volume maintained at low pressure during exertion of suction force on the organ;

a piston mounted in said chamber at one end of said volume with freedom to translate relative to said chamber, said piston having a first side facing said volume and a second side facing away from said volume; and

an element having fixed maximum length which couples said piston to said at least one suction member, wherein said piston is biased in an equilibrium position in said chamber by a first force coupled through said element to said piston from the organ, and a piston suction force exerted on said piston in a direction opposite to the first force as a result of maintenance of lower pressure on said first side of said piston than on said second side of said piston.

76. An organ manipulation apparatus, including:

at least one suction member defining a vacuum space therein for attachment to an organ;

a support member; and

a joint coupling said at least one suction member with said support member, wherein said joint allows said at least one suction member at least a limited range of freedom to rotate, with respect to said support member, in response to normal movement of the organ.

77. The organ manipulation apparatus of claim 76, wherein said joint comprises a ball joint.

78. The organ manipulation apparatus of claim 77, wherein said ball joint comprises a sliding ball joint.

79. The organ manipulation apparatus of claim 78, wherein said support member comprises an arm adapted to adjustably mount to a fixed structure, and wherein said sliding ball joint is attached to said arm, said sliding ball joint further comprising a member support element mounted to said at least one suction member and extending through said ball, said ball joint being slidable on said member support element.

80. The organ manipulation apparatus of claim 79, further comprising a spring biasing said ball joint toward said at least one suction member.

81. The organ manipulation apparatus of claim 79, further comprising a rotational joint coupling said arm with said sliding ball joint.

82. The organ manipulation apparatus of claim 76, wherein said joint is configured to maintain a constant retraction force on said at least one suction member.

83. The organ manipulation apparatus of claim 76, wherein said joint has a nonlocking state in which said at least one suction member has freedom to move relative to said support member, and a locking state in which said at least one suction member is not free to move relative to said support structure.

84. The organ manipulation apparatus of claim 83, wherein said joint includes a latch which is movable between a first position and a second position, said joint being locked when said latch is in said first position, and said joint being unlocked when said latch is in said second position.

85. The organ manipulation apparatus of claim 77, wherein said support member comprises an arm having a plurality of links rendering said arm flexible and wherein said links are lockable to lock said arm in a rigid state.

86. The organ manipulation apparatus of claim 77, wherein said support member comprises an arm having a flexible state and a rigid state, said arm comprising a cable and ball joints threaded along the cable, each of said ball joints having a main portion defining a convex surface and part of a concave socket surface, and an insert portion defining a remaining part of the concave socket surface, wherein the main portion is molded from hard plastic and the insert portion is molded from a material having greater friction than does the hard plastic.

87. An organ manipulation apparatus, including:

at least one suction member defining a vacuum space therein adapted to attach said apparatus to an organ;

a support arm; and

a sliding ball joint coupling said at least one suction member with said support arm.

88. The organ manipulation apparatus of claim 87, wherein a ball of said sliding ball joint is attached to said arm;

said apparatus further comprising a member support element mounted to said at least one suction member, said support element defining two parallel grooves along which said ball is free to translate.

89. The organ manipulation apparatus of claim 88, further comprising a spring coupled between said ball and said member support element.

90. The organ manipulation apparatus of claim 89, wherein said ball and said member support element are marked in such a manner as to implement a force gauge which provides a visual indication of spring force being exerted by said spring on said member support element.