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

• US 6,506,149 B2
• Filed: 09/07/1999
• Issued: 01/14/2003
• Est. Priority Date: 09/07/1999
• Status: Expired due to Term

• Current Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Original Assignee: Origin Medsystems Inc. (Eli Lilly and Company)
• Inventors: Voss, Larry, Vargas, Jaime S., Chin, Albert K., Davis, John W., Peng, Steven, Hancock, David E., Carlson, Grace A.
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US09/390,792
• Publication Number:
  US 20020091300A1
• Time in Patent Office: 1,225 Days
• Field of Search: 600/37, 600/201, 600/206, 600/208, 600/227, 600/228, 600/230, 600/231, 623/3, 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
• 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. An organ manipulation apparatus, including:

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

a support structure; and

a joint coupling the suction member and the support structure, wherein the support structure and the compliant joint are configured to support the suction member, with the organ supported in a retracted position by the suction member, such that the suction member has freedom to rotate, with respect to said support structure, about a longitudinal axis of said at least one suction member in response to normal movement of the organ.

2. The organ manipulation apparatus of claim 1, wherein said joint allows said at least one suction member a limited amount of translation, relative to said support structure, in directions defined by said longitudinal axis.

3. An organ manipulation apparatus, including:

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

a support structure; and

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

4. The apparatus of claim 3, wherein the support structure and the unbiased joint are configured to support the suction member with the organ suspended from the suction member in the retracted position, and with the suction member having freedom to move at least vertically relative to the support structure in response to normal movement of the organ.

5. The apparatus of claim 3, wherein the organ is a beating heart.

6. The apparatus of claim 5, wherein the beating heart has an apex, and the suction member is configured to conform to, and exert suction on, the apex of the beating heart.

7. The apparatus of claim 5 wherein the suction member is a suction cup including:

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

8. The apparatus of claim 7, wherein said shell member includes a seal positioned around the periphery, said seal being made of biocompatible foam.

9. The apparatus of claim 7, wherein the shell member is a rigid shell.

10. The apparatus of claim 3, wherein the suction member also includes absorbent material which lines at least a portion of the vacuum space.

11. The apparatus of claim 7, wherein at least a portion of the 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.

12. The apparatus of claim 11, wherein the shell member comprises a deformable metal mesh including an impermeable elastomeric material.

13. The apparatus of claim 7, wherein the inner surface of the shell member is lined with smooth and soft material.

14. The apparatus of claim 7, wherein the shell member is made of smooth and soft material.

15. The apparatus of claim 14, wherein the suction cup also includes absorbent material which lines at least a portion of the inner surface of the shell member.

16. The apparatus of claim 3, wherein the 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.

17. The apparatus of claim 3, wherein the support structure and the unbiased joint are configured to support the suction member, with the organ suspended therefrom and with the suction member having freedom to rotate, with at least a portion of the organ, about a vertical axis relative to the support structure.

18. The apparatus of claim 3, wherein the support structure and the unbiased joint are configured to support the suction member, with the organ suspended therefrom and with the suction member having freedom to swing, with at least a portion of the organ, in a vertical plane relative to the support structure.

19. The apparatus of claim 3, wherein the support structure includes a fixed structure and an arm adjustably mounted to the fixed structure.

20. The apparatus of claim 19, wherein the unbiased joint includes:

a ball joint attached to the arm; and

a member support element mounted to the suction member, said support element being movable relative to said ball joint.

21. The apparatus of claim 19, wherein the fixed structure is a sternal retractor.

22. The apparatus of claim 3, wherein the support structure includes a fixed structure and an arm adjustably mounted to the fixed structure, and wherein the unbiased joint includes:

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

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

23. The apparatus of claim 3, also including:

a suction line coupled to the suction member; and

a low-pressure reservoir coupled to the 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 the suction line.

24. The apparatus of claim 23, further including:

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

25. The apparatus of claim 3, further including:

multiple suction members defining at least one vacuum space, wherein the suction members are configured to exert sufficient suction force on the organ to move the organ when the 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 the unbiased joint couples the support structure and the multiple suction members.

26. The apparatus of claim 25, wherein the unbiased joint includes:

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

27. The apparatus of claim 3, wherein the 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 the second portion of the bag is pressed against the organ causes the pellets in the evacuated enclosure to form a rigid structure which conforms to the organ.

28. The apparatus of claim 3, wherein the suction member is a suction cup including:

a rigid core; and

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

29. The apparatus of claim 25, wherein the distal surface of the shell has a periphery, and the shell has a flexible flange portion which extends around the periphery, the apparatus also including:

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

30. The apparatus of claim 25, wherein the rigid core is made of plastic and the shell is made of silicone.

31. The apparatus of claim 3 wherein the support structure includes a fixed structure and an arm adjustably mounted to the fixed structure, the arm having a plurality of links rendering said arm flexible and wherein said links are lockable to:

lock said arm in a rigid state.

32. The apparatus of claim 31, 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 the socket surface is shaped for receiving the convex surface of an adjacent one of the ball joints, and the diameter is greater than the length.

33. The apparatus of claim 32, wherein a ratio of the length to the diameter is at least substantially equal to 0.345/0.460.

34. The apparatus of claim 3, wherein the support structure includes a fixed structure and an arm adjustably mounted to the fixed structure, the arm has a flexible state and a rigid state, and the arm comprises:

a cable; and

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

35. The apparatus of claim 3, wherein the support structure includes a fixed structure and an arm adjustably mounted to the fixed structure, the arm has a flexible state and a rigid state, and the arm comprises:

a cable; and

ball joints threaded along the cable, each of the 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.

36. The apparatus of claim 35, wherein the insert portion is molded from a thermoplastic or silicone elastomer.

37. The apparatus of claim 36, wherein the insert portion has an annular shape and comprises thermoplastic or silicone elastomer material having a Shore A durometer hardness in the range 50 to 90.

38. The apparatus of claim 3, wherein the support structure includes a fixed structure and an arm adjustably mounted to the fixed structure, the arm has a flexible state and a rigid state, and the arm comprises:

a cable; and

ball joints threaded along the cable, each of the 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 the concave socket surface, wherein the first portion of each of the ball joints is molded hard plastic and the second portion is molded thermoplastic or silicone elastomer.

39. The apparatus of claim 3, wherein the support structure includes a fixed structure and an arm adjustably mounted to the fixed structure, the arm has a flexible state and a rigid state, and the arm comprises:

a cable; and

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

40. The apparatus of claim 39, wherein each of the ball joints is molded from polycarbonate plastic and each of the sleeves is molded from ULTEM plastic.

41. The apparatus of claim 39, wherein each of the sleeves is molded from polycarbonate plastic and each of the ball joints is molded from ULTEM plastic.

42. The apparatus of claim 3, wherein the support structure includes a fixed structure and an arm adjustably mounted to the fixed structure, the arm has a flexible state and a rigid state, and the arm comprises:

a cable; and

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

43. The apparatus of claim 42, wherein each of the ball joints in the first set is molded from polycarbonate plastic and each of the ball joints in the second set is molded from ULTEM plastic.

44. A method for compliant retraction of the 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.

45. The method of claim 44, 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.

46. The method of claim 45, 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.

47. The method of claim 44, 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.

49. The apparatus of claim 45, wherein the organ is a beating heart, and the support structure, the compliant joint, and the disc are configured to suspend the organ below the disc in the retracted position, with the disc having freedom to move at least vertically relative to the support structure in response to beating movement of the organ.

48. An organ manipulation apparatus, including:

at least one bio-absorbable disc with an adhesive surface configured to be adhered to an organ, wherein the disc is configured to exert sufficient traction force on the organ to move the organ when the adhesive surface is pressed against the organ and said disc is moved;

a support structure; and

a compliant joint coupled between the disc and the support structure, wherein the support structure and the compliant joint are configured to support the disc with the organ suspended from the disc in a retracted position, and with the disc having freedom to move, at least vertically, relative to the support structure.

50. An organ manipulation apparatus, including:

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

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.

51. The organ manipulation apparatus of claim 50, 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.

52. The organ manipulation apparatus of claim 50, 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.

53. The organ manipulation apparatus of claim 50, wherein the support member comprises an arm adapted to be adjustably mounted to a fixed structure, and wherein the coupling member includes a spring assembly coupled between the arm and the suction member.

54. The organ manipulation apparatus of claim 53, wherein said assembly biases said rotational joint for suspension of said suction member.

55. The organ manipulation apparatus of claim 50, wherein the coupling member is configured to maintain a constant retraction force on the suction member.

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

(a) retracting the organ by exerting traction thereon using a bio-absorbable disc having an adhesive surface affixed to the organ, wherein the disc is coupled to a mounting element in such a manner that the disc has freedom to move at least along an axis of said disc relative to the mounting element; and

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

57. The method of claim 56, wherein the organ is a beating heart, and step (b) includes the step of suspending the heart from the disc in the retracted position in such a manner that the disc has freedom to move at least vertically relative to the mounting element in response to normal beating movement of the heart.

58. An organ manipulation apparatus, including:

multiple suction members defining at least one vacuum space, wherein the suction member is configured to exert sufficient suction force on an organ to move the organ when the suction member is 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 said at least one of the multiple suction members is moved;

a support structure; and

a compliant joint coupling said multiple suction members and said support structure, wherein the support structure and the compliant joint are configured to support the multiples suction members, with the organ supported in a retracted position by said at least one of said multiple suction members, such that said at least one of said multiple suction members has freedom to move relative to the support structure in response to normal movement of the organ.

59. An organ manipulation apparatus, including:

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

a support structure; and

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

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

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

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

60. An organ manipulation apparatus, including:

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

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.

61. The organ manipulation apparatus of claim 60, wherein said joint comprises a ball joint.

62. The organ manipulation apparatus of claim 61, wherein said ball joint comprises a sliding ball joint.

63. The organ manipulation apparatus of claim 62, 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 the suction member and extending through said ball, said ball joint being slidable on said member support element.

64. The organ manipulation apparatus of claim 63, further comprising a spring biasing said ball joint toward said at least one suction member.

65. The organ manipulation apparatus of claim 63, further comprising a rotational joint coupling said arm with said sliding ball joint.

66. The organ manipulation apparatus of claim 60, wherein said joint is configured to maintain a constant retraction force on the suction member.

67. The organ manipulation apparatus of claim 60, wherein said joint has a nonlocking state in which the suction member has freedom to move relative to the support member, and a locking state in which the suction member is not free to move relative to the support structure.

68. The organ manipulation apparatus of claim 67, 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.

69. The organ manipulation apparatus of claim 61, 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.

70. The apparatus of claim 69, 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.

71. An organ manipulation apparatus, including:

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

a support arm; and

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

72. The organ manipulation apparatus of claim 71, 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.

73. The organ manipulation apparatus of claim 72, further comprising a spring coupled between said ball and said member support element.

74. The organ manipulation apparatus of claim 73, 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.