Surgical sealing device

• US 20050155611A1
• Filed: 11/05/2004
• Published: 07/21/2005
• Est. Priority Date: 11/05/2003
• Status: Abandoned Application

• Current Assignee: Atropos Limited
• Original Assignee: Atropos Limited
• Inventors: Vaugh, Trevor, Bonadio, Frank, Butler, John
• Application Number:
  US10/981,730
• Publication Number:
  US 20050155611A1
• Time in Patent Office: Days
• US Class Current: 128/887
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 17/3498 Valves therefor, e.g. flapper valves, slide valves haemostasis valves A61M39/06; check valves A61M39/24

Abstract

A surgical sealing device comprises sealing device of a gelatinous elastomeric material, a distal ring element and a proximal ring element. The ring elements are twisted relative to one another to twist the valve body into a twisted configuration to seal across a wound opening. The ring elements are snap-fitted together to maintain the valve in the twisted configuration. By passing an object, such as surgeon'"'"'s hand through the valve, the opposing sidewalls of a lumen through the valve may be forced radially apart to partially open the lumen, and thereby enable the surgeon'"'"'s hand to access the interior of the abdomen. The valve remains twisted during insertion of the surgeon'"'"'s hand through the valve to minimise the loss of insufflation gases from the abdomen.

Claims

1. A surgical sealing device comprising a sealing valve for sealing across an opening to an internal cavity, the sealing valve having a material which is twisted to form a seal, the seal being maintained upon passage of an object therethrough.

2. A device as claimed in claim 1 wherein the material defines a lumen extending therethrough, the lumen being closed when the material is twisted to form the seal.

3. A device as claimed in claim 2 wherein the material is configured to enable the lumen to be at least partially opened for passage of an object through the lumen to access the internal cavity, while the lumen remains twisted.

7. A device as claimed in claim 1 wherein a first part of the material is twistable relative to a second part of the material between an untwisted configuration and a twisted configuration.

8. A device as claimed in claim 7 wherein in the untwisted configuration, the lumen is open.

9. A device as claimed in claim 7 wherein in the twisted configuration, the lumen is closed.

10. A device as claimed in claim 1 wherein the valve is at least partially of a gelatinous elastomeric material.

11. A device as claimed in claim 7 wherein the first part of the valve comprises a distal end part of the valve.

12. A device as claimed in claim 7 wherein the second part of the valve comprises a proximal end part of the valve.

13. A device as claimed in claim 7 wherein, in the twisted configuration, a third part of the valve is movable relative to a fourth part of the valve to at least partially open the lumen.

14. A device as claimed in claim 13 wherein the third part of the valve is movable substantially radially relative to the fourth part of the valve.

15. A device as claimed in claim 13 wherein the third part of the valve comprises a part of a sidewall of the lumen.

16. A device as claimed in claim 15 wherein the fourth part of the valve comprises an opposing part of the sidewall of the lumen.

17. A device as claimed in claim 7 wherein, in the twisted configuration, the valve is constrained longitudinally.

18. A device as claimed in claim 17 wherein, in the twisted configuration, the location of the first part of the valve is longitudinally fixed relative to the location of the second part of the valve.

19. A device as claimed in claim 18 wherein, in the twisted configuration, the first part of the valve engages the second part of the valve.

20. A device as claimed in claim 7 wherein, in the twisted configuration, the lumen is at least partially openable upon engagement of an object with the closed lumen and passage of the object through the lumen.

21. A device as claimed in claim 7 wherein, in the twisted configuration, the valve is configured to effect a seal between a sidewall of the lumen and an object inserted through the lumen.

22. A device as claimed in claim 7 wherein, in the twisted configuration, the lumen is biased towards being closed.

23. A device as claimed in claim 22 wherein the valve is of a resilient material to bias the lumen towards being closed.

24. A device as claimed in claim 7 wherein the valve comprises a generally cylindrical sealing body which is twistable into the twisted configuration.

25. A device as claimed in claim 24 wherein the generally cylindrical sealing body is formed by moulding or extrusion.

26. A device as claimed in claim 24 wherein the generally cylindrical sealing body is formed from a generally flat sheet of material.

27. A device as claimed in claim 7 wherein the first part of the material and/or the second part of the material is turned radially outwardly.

28. A device as claimed in claim 27 wherein the first part of the material and/or the second part of the material is provided in the form of a flange.

29. A device as claimed in claim 7 wherein the device comprises a lock for maintaining the valve in the twisted configuration.

30. A device as claimed in claim 29 wherein the lock comprises a first lock part attached to the first part of the valve and a second lock part attached to the second part of the valve, the first lock part being coupleable to the second lock part to maintain the first part of the valve twisted relative to the second part of the valve.

31. A device as claimed in claim 30 wherein the first lock part and the second lock part are configured to be snap-fitted together.

32. A device as claimed in claim 30 wherein the lock part is attached to the part of the valve by overmoulding a part of the valve over at least part of the lock part.

33. A device as claimed in claim 32 wherein the lock part comprises one or more overmould openings therein.

34. A device as claimed in claim 30 wherein the lock part is attached to the part of the valve by a mechanical attachment arrangement.

35. A device as claimed in claim 34 wherein the mechanical attachment arrangement comprises one or more protruding male elements for co-operative reception in one or more female recesses.

36. A device as claimed in claim 35 wherein the lock part comprises the one or more male elements and the part of the valve comprises the one or more female recesses.

37. A device as claimed in claim 30 wherein the lock part is rigid relative to the valve.

38. A device as claimed in claim 30 wherein the lock part comprises a ring element.

39. A device as claimed in claim 1 wherein the device comprises a grip element for gripping of the valve.

40. A device as claimed in claim 39 wherein the device comprises a first grip element attached to the first part of the valve and a second grip element attached to the second part of the valve.

41. A device as claimed in claim 40 wherein the grip element is attached to the part of the valve by overmoulding a part of the valve over at least part of the grip element.

42. A device as claimed in claim 41 wherein the grip element comprises one or more overmould openings therein.

43. A device as claimed in claim 40 wherein the grip element is attached to the part of the valve by a mechanical attachment arrangement.

44. A device as claimed in claim 43 wherein the mechanical attachment arrangement comprises one or more protruding male elements for co-operative reception in one or more female recesses.

45. A device as claimed in claim 44 wherein the grip element comprises the one or more male elements and the part of the valve comprises the one or more female recesses.

46. A device as claimed in claim 39 wherein the grip element is rigid relative to the valve.

47. A device as claimed in claim 39 wherein the grip element comprises a ring element.

48. A device as claimed in claim 1 wherein the device is mountable to a retractor device.

49. A device as claimed in claim 48 wherein the device comprises a mounting element for mounting the device to a retractor device.

50. A device as claimed in claim 49 wherein the mounting element is fixedly attached to the valve.

51. A device as claimed in claim 50 wherein a part of the valve is overmoulded over at least part of the mounting element.

52. A device as claimed in claim 51 wherein the mounting element comprises one or more overmould openings therein.

53. A device as claimed in claim 50 wherein the mounting element is attached to the valve by a mechanical attachment arrangement.

54. A device as claimed in claim 53 wherein the mechanical attachment arrangement comprises one or more protruding male elements for co-operative reception in one or more female recesses.

55. A device as claimed in claim 54 wherein the mounting element comprises the one or more male elements and the valve comprises the one or more female recesses.

56. A device as claimed in claim 49 wherein the mounting element comprises an engagement formation for snap-fit mounting of the device to retractor device.

57. A device as claimed in claim 49 wherein the mounting element comprises a screw-thread formation for screw-thread mounting of the device to a retractor device.

58. A device as claimed in claim 49 wherein the mounting element is rigid relative to the valve.

59. A device as claimed in claim 49 wherein the mounting element comprises a ring element.

60. A device as claimed in claim 49 wherein the device is configured to effect a seal between the device and a retractor device upon mounting of the device to the retractor device.

61. A device as claimed in claim 60 wherein at least part of the valve is configured to engage a retractor device upon mounting.

62. A device as claimed in claim 49 wherein the mounting. element comprises a sleeve for extending between the valve and a retractor device.

63. A device as claimed in claim 62 wherein the sleeve is hookable around a part of a retractor device to mount the device to the retractor device.

64. A device as claimed in claim 63 wherein the sleeve comprises a mounting ring for hooking around a part of a retractor device.

65. A device as claimed in claim 64 wherein the mounting ring is an O-ring.

66. A device as claimed in claim 62 wherein a distal end of the sleeve is coupled to the valve and a proximal and of the sleeve is coupleable to a retractor device.

67. A device as claimed in claim 62 wherein the device comprises a sealing element for sealingly engaging the mounting element to a retractor device.

68. A device as claimed in claim 67 wherein the sealing element comprises a sealing ring.

69. A device as claimed in claim 10 wherein the gelatinous elastomeric material comprises a plasticiser.

70. A device as claimed in claim 69 wherein the plasticiser is selected from the group consisting of naturally derived oils, synthetic oils and liquid oligomers.

71. A device as claimed in claim 10 wherein the gelatinous elastomeric material is a silicone based gel.

72. A device as claimed in claim 1 wherein the valve is configured to be located externally of an internal cavity proximally of an opening to the internal cavity.

78. A surgical assembly comprising:

a retractor device for retracting the sides of an opening to an internal cavity; and

a surgical sealing device as claimed in claim 1.

79. An assembly as claimed in claim 78 wherein the surgical sealing device is mounted to the retractor device.

80. An assembly as claimed in claim 79 wherein the retractor device has a distal end and a proximal end, and the surgical sealing device is located adjacent to the distal end of the retractor device.

81. An assembly as claimed in claim 79 wherein the retractor device has a distal end and a proximal end, and the surgical sealing device is located adjacent to the proximal end of the retractor device.

4. A surgical sealing device comprising a sealing valve for sealing across an opening to an internal cavity;

the sealing valve having a material defining a lumen;

the material being twisted to close the lumen;

the lumen being at least partially opened upon passage of an object through the lumen.

5. A device as claimed in claim 4 wherein the material sealingly engages the object upon passage therethrough.

6. A device as claimed in claim 4 wherein the lumen is at least partially opened while the material remains twisted.

73. A device as claimed in claim I wherein the valve is configured to be located within an internal cavity distally of an opening to the internal cavity.

74. A surgical sealing device comprising a sealing valve for sealing across an opening to an internal cavity:

the sealing valve having a lumen extending therethrough;

the valve being twisted to close the lumen for sealing across the opening;

the valve being movable substantially in a radial direction to enable the lumen to be at least partially opened for passage of an object through the lumen to access the internal cavity, while the valve remains twisted.

75. A surgical sealing device comprising a sealing valve for sealing across an opening to internal cavity;

the sealing valve having a lumen extending therethrough;

the valve being twisted to close the lumen for sealing across the opening;

the lumen being at least partially openable upon engagement of an object with the closed lumen and passage of the object through the lumen to access the internal cavity, while the valve remains twisted.

76. A surgical sealing device comprising a sealing valve for sealing across an opening to an internal cavity;

the sealing valve having a lumen extending therethrough;

the valve being twisted to close the lumen for sealing across the opening;

the valve being configured to enable the lumen to be at least partially opened for passage of an object through the lumen to access the internal cavity, while the valve remains twisted;

the valve being constrained longitudinally.

77. A surgical sealing device comprising a sealing valve for sealing across an opening to an internal cavity;

the sealing valve having a lumen extending therethrough;

a first part of the valve being twistable relative to a second part of the valve between an untwisted configuration, in which the lumen is open, and a twisted configuration to close the lumen for sealing across the opening;

in the twisted configuration, the valve being configured to enable the lumen to be at least partially opened for passage of an object through the lumen to access the internal cavity.

82. A method of accessing an internal cavity through an opening to the internal cavity, the method comprising the steps of:

providing a sealing valve, the valve being twisted to form a seal;

arranging the twisted valve to seal across the opening; and

passing an object through the twisted valve, while maintaining the seal, to access the internal cavity.

83. A method as claimed in claim 82 wherein the valve has a lumen extending therethrough, and the valve is twisted into a twisted configuration to close the lumen and form the seal.

84. A method as claimed in claim 83 wherein the lumen is at least partially opened by passing of the object through the twisted valve.

85. A method as claimed in claim 84 wherein the step of passing an object through the valve in the twisted configuration causes a third part of the valve to move relative to a fourth part of the valve to at least partially open the lumen.

86. A method as claimed in claim 85 wherein the third part of the valve is moved substantially radially relative to the fourth part of the valve.

87. A method as claimed in claim 83 wherein the method comprises the step of longitudinally constraining the valve in the twisted configuration.

88. A method as claimed in claim 83 wherein the method comprises the step of twisting the valve from an untwisted configuration, in which the lumen is open, to the twisted configuration.

89. A method as claimed in claim 88 wherein the valve is pre-twisted into the twisted configuration.

90. A method as claimed in claim 89 wherein the valve is supplied in the twisted configuration.

91. A method as claimed in claim 90 wherein the step of twisting the valve is performed during manufacture of the sealing valve.

92. A method as claimed in claim 88 wherein the step of twisting the valve is performed during a surgical procedure.

93. A method as claimed in claim 83 wherein the method comprises the step of hooking the valve in the twisted configuration.

94. A method as claimed in claim 82 wherein the valve is arranged within the opening.

95. A method as claimed in claim 82 wherein the valve is arranged externally of the internal cavity proximally of the opening.

96. A method as claimed in claim 82 wherein the valve is arranged within the internal cavity distally of the opening.

97. A method as claimed in claim 83 wherein the method comprises the step of effecting a seal between a sidewall of the lumen and the object passing through the lumen.

98. A method as claimed in claim 82 wherein the method comprises the step of retracting the sides of the opening to the internal cavity.

99. A method as claimed in claim 82 wherein the method comprises the step of mounting the valve to a retractor device.

100. A method as claimed in claim 99 wherein the method comprises the step of effecting a seal between the valve and the retractor device.

101. A method as claimed in claim 83 wherein the object passed through the lumen comprises a surgeon'"'"'s hand and/or forearm.

102. A method as claimed in claim 83 wherein the object passed through the opening comprises a surgical instrument.

103. A method of accessing an internal cavity through an opening to the internal cavity, the method comprising the steps of:

providing a sealing valve, having a lumen extending therethrough, the sealing valve being twisted into a twisted configuration to close the lumen closed;

arranging the valve in the twisted configuration to seal across the opening;

passing an object through the valve in the twisted configuration to at least partially open the lumen; and

passing the object through the lumen to access the internal cavity.