Laparoscopic sealed access device

• US 6,578,577 B2
• Filed: 03/13/2001
• Issued: 06/17/2003
• Est. Priority Date: 12/01/1998
• Status: Expired due to Term

• Current Assignee: JNC Corporation (Chisso Corporation)
• Original Assignee: Atropos Limited
• Inventors: Bonadio, Frank, Reid, Alan, Young, Derek William, McManus, Ronan Bernard, Cushieri, Alfred
• Primary Examiner(s): Dvorak, Linda C.
• Assistant Examiner(s): RAM, JOCELYN DEBRA
• Application Number:
  US09/804,552
• Publication Number:
  US 20020072762A1
• Time in Patent Office: 826 Days
• Field of Search: 602/3, 602/13, 602/22, 602/63, 606/202, 606/1, 606/108, 128/849, 128/850, 128/851, 128/852, 128/853, 128/854, 128/855, 128/856, 600/204, 600/206, 600/207, 600/208, 604/513, 604/264, 604/539
• US Class Current: 128/850
• CPC Class Codes: A61B 17/0293 with ring member to support retractor elements
• 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 17/3431 being collapsible, e.g. made of thin flexible material A61B17/3423 takes precedence
• 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
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/3435 using everted sleeves
• CPC Class Codes: A61B 2017/3482 inside
• CPC Class Codes: A61M 2025/0062 having features to improve the sliding of one part within another by using lubricants or surfaces with low friction
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/0119 Eversible catheters
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A hand access device for use in hand assisted laparoscopic surgery comprises a substantially tubular inflatable sleeve of pliable gas tight material having a twisted inner sleeve section and an outer sleeve section. The device has an inner O-ring for insertion through a wound opening in the abdominal wall and an outer O-ring for location outside of the wound opening. On insertion of a surgeon'"'"'s arm the sleeve everts while monitoring a reduced lumen seal to the arm and a seal to the wound openings.

Claims

1. A medical sealing device for engaging an incision in a patient, comprising:

a sleeve comprising,

a sleeve wall having an incision engagable wall section and a central lumen wall section, and

an inflation space surrounding the central lumen wall section, the central lumen wall section including a twisted wall portion for assisting sealed access through the central lumen wall section when the inflation space is inflated, and the twisted wall portion being twisted in a direction about a longitudinal axis of the sleeve.

2. A medical sealing device according to claim 1, further comprising at least one ring positioned adjacent an end portion of the incision engagable wall section for assisting in a positioning of the sleeve about the incision, the ring being orientated to lie in a plane generally perpendicular to the longitudinal axis of the sleeve.

3. A medical sealing device according to claim 2, wherein the at least one ring is axially movable in relation to the sleeve.

4. A medical sealing device according to claim 3, wherein the at least one ring is located within the inflation space.

5. A medical sealing device according to claim 2, wherein the at least one ring comprises two rings, one ring being axially movable in relation to the sleeve and the other ring being fixedly coupled to the sleeve.

6. A medical sealing device according to claim 2, wherein the at least one ring is a flexible O-ring.

7. A medical sealing device according to claim 2, wherein the at least one ring comprises two rings fixedly coupled to the sleeve, one ring coupled adjacent each end portion of the incision engagable wall section for assisting in maintaining the sleeve about the incision, each said ring being orientated to lie in a plane that is generally perpendicular to the longitudinal axis of the sleeve.

8. A medical sealing device according to claim 7, wherein the two rings are coupled to the sleeve outside of the inflation space.

9. A medical sealing device according to claim 7, wherein the two rings are coupled to the sleeve within the inflation space.

10. A medical sealing device according to claim 1, further comprising two rings located within the inflation space, said rings being axially spaced from each other and each lying in a plane generally perpendicular to the longitudinal axis of the sleeve.

11. A medical sealing device according to claim 10, wherein the two rings are each independently axially movable in relation to the sleeve.

12. A medical sealing device according to claim 10, wherein the two rings are coupled to each other and are together axially moveable in relation to the sleeve.

13. A medical sealing device according to claim 1, wherein the sleeve is formed of a pliable material.

14. A medical sealing device according to claim 1, wherein the incision engagable wall section is formed of a material different than the material of a remaining portion of the sleeve wall.

15. A medical sealing device according to claim 14, wherein the incision engagable wall section is formed of a material more flexible than the material of the remaining portion of the sleeve wall.

16. A medical sealing device according to claim 1, wherein the incision engagable wall section has approximately the same diameter as the twisted wall portion if measured when the inflation space is uninflated and the twisted wall portion were in an untwisted state.

17. A medical sealing device according to claim 1, wherein the twisted wall portion of the sleeve comprises a diameter smaller than a minimum diameter of an object to be received or passed through the lumen, the diameter of the twisted wall portion being measured when the inflation space is fully inflated.

18. A medical sealing device according to claim 17, wherein said object is one of a hand and a medical device.

19. A medical sealing device according to claim 1, further comprising an access port to the inflation space for assisting in an inflation of the inflation space.

20. A medical sealing device for engaging an incision in a patient, comprising:

a sleeve comprising an incision engagable wall section, a movable wall section, and an inflation space,

the movable wall section movable relative to the engagable wall section and forming at least a central lumen, the central lumen comprising a twisted wall portion for assisting sealed access through the lumen when the inflation space is inflated, and the twisted wall portion being twisted in a direction about a longitudinal axis of the sleeve.

21. A medical sealing device according to claim 20, further comprising at least one ring positioned at one end portion of the movable wall section for assisting in a positioning of the sleeve about the incision, the ring being orientated to lie in a plane generally perpendicular to the longitudinal axis of the sleeve.

22. A medical sealing device according to claim 21, wherein the at least one ring is axially movable in relation to the sleeve.

23. A medical sealing device according to claim 22, wherein the at least one ring is located within the inflation space.

24. A medical sealing device according to claim 21, wherein the at least one ring comprises two rings, one ring being axially movable in relation to the sleeve and the other ring being fixedly coupled to the sleeve.

25. A medical sealing device according to claim 21, wherein the at least one ring is a flexible O-ring.

26. A medical sealing device according to claim 21, wherein the at least one ring comprises two rings fixedly coupled to the sleeve, one ring coupled at each end portion of the movable wall section for assisting in maintaining the sleeve about the incision, each said ring being orientated to lie in a plane that is generally perpendicular to the longitudinal axis of the sleeve.

27. A medical sealing device according to claim 26, wherein the two rings are coupled to the sleeve outside of the inflation space.

28. A medical sealing device according to claim 26, wherein the two rings are coupled to the sleeve within the inflation space.

29. A medical sealing device according to claim 20, further comprising two rings located within the inflation space, said rings being axially spaced from each other and each lying in a plane generally perpendicular to the longitudinal axis of the sleeve.

30. A medical sealing device according to claim 29, wherein the two rings are each independently axially movable in relation to the sleeve.

31. A medical sealing device according to claim 29, wherein the two rings are coupled to each other and are together axially moveable in relation to the sleeve.

32. A medical sealing device according to claim 20, wherein the sleeve is formed of a pliable material.

33. A medical sealing device according to claim 20, wherein the incision engagable wall section is formed of a material different than the material forming the movable wall section.

34. A medical sealing device according to claim 33, wherein the incision engagable wall section is formed of a material more flexible than the material forming the movable wall section.

35. A medical sealing device according to claim 20, wherein the incision engagable wall section has approximately the same diameter as the twisted wall portion if measured when the inflation space is uninflated and the twisted wall portion were in an untwisted state.

36. A medical sealing device according to claim 20, wherein the twisted wall portion of the sleeve comprises a diameter smaller than a minimum diameter of an object to be received or passed through the lumen, the diameter of the twisted wall portion being measured when the inflation space is fully inflated.

37. A medical sealing device according to claim 36, wherein said object is one of a hand and a medical device.

38. A medical sealing device according to claim 20, further comprising an access port to the inflation space for assisting in an inflation of the inflation space.

39. A medical sealing device for engaging an incision in a patient, comprising:

a sleeve comprising an incision engagable wall section, a movable wall section, and an inflation space;

a proximal ring member located at a proximal end portion of the movable wall section and axially movable in relation to the sleeve member; and

a distal ring member located at a distal end portion of the movable wall section,

the proximal and distal ring members assisting in a positioning of the sleeve about the incision and being orientated to lie in a plane generally perpendicular to a longitudinal axis of the sleeve,

the movable wall section movable relative to the engagable wall section and forming at least a central lumen, the central lumen comprising a twisted wall portion that is twisted in a direction about the longitudinal axis of the sleeve, and

the movable wall section assisting in the sealing of an object extending through the central lumen and movable upon engagement and axial movement of the object with the central lumen by eversion so that a part of an inner portion of the sleeve moves to become a part of an outer portion of the sleeve and a section of the outer portion of the sleeve moves to become a section of the inner portion of the sleeve.

40. A medical sealing device according to claim 39, wherein the distal ring member is fixedly coupled to the sleeve.

41. A medical sealing device according to claim 39, wherein the proximal and distal ring members each comprise a flexible O-ring.

42. A medical sealing device according to claim 39, wherein the sleeve is formed of a pliable material.

43. A medical sealing device according to claim 39, wherein the incision engagable wall section is formed of a material different than the material forming the movable wall section.

44. A medical sealing device according to claim 39, wherein the incision engagable wall section has approximately the same diameter as the twisted wall portion if measured when the inflation space is uninflated and the twisted wall portion were in an untwisted state.

45. A medical sealing device according to claim 39, wherein the twisted wall portion of the sleeve comprises a diameter smaller than a minimum diameter of an object to be received or passed through the lumen, the diameter of the twisted wall portion being measured when the inflation space is fully inflated.

46. A medical sealing device according to claim 45, wherein said object is one of a hand and a medical device.

47. A medical sealing device according to claim 39, further comprising an access port to the inflation space for assisting in an inflation of the inflation space.

48. A medical sealing device for engaging an incision in a patient, comprising:

a sleeve comprising an incision engagable wall section, a movable wall section, and an inflation space; and

a ring member located at an end portion of the movable wall section for assisting in a positioning of the sleeve about the incision,

the movable wall section movable relative to the engagable wall section and forming at least a central lumen, the central lumen comprising a twisted wall portion that is twisted in a direction about the longitudinal axis of the sleeve,

the movable wall section assisting in the sealing of an object extending through the central lumen and movable upon engagement and axial movement of the object with the central lumen by eversion so that a part of an inner portion of the sleeve moves to become a part of an outer portion of the sleeve and a section of the outer portion of the sleeve moves to become a section of the inner portion of the sleeve, and

the incision engagable wall section having approximately the same diameter as the twisted wall portion if measured when the inflation space is uninflated and the twisted wall portion were in an untwisted state.

49. A medical sealing device for engaging an incision in a patient, comprising:

a sleeve having at least a central lumen section capable of receiving an object extending therethrough, the central lumen section having a twisted wall portion twisted in a direction about a longitudinal axis of the sleeve, and the sleeve further including an axially non-extended configuration when the object is received within the central lumen, and an axially extended configuration when the object is sealingly engaged within the central lumen, the central lumen section including a smaller diameter in the axially extended configuration than in the axially non-extended configuration, and the sleeve further including an inflation space surrounding the central lumen, and inflation of the inflation space urges the sleeve into contact with the object and into the extended configuration.

51. A medical sealing device according to claim 49, further comprising at least one ring positioned adjacent an end portion of an incision engagable wall section of the sleeve, the at least one ring assisting in a positioning of the sleeve about the incision, the ring being orientated to lie in a plane generally perpendicular to the longitudinal axis of the sleeve.

52. A medical sealing device according to claim 51, wherein the at least one ring comprises two rings, one ring located adjacent opposing end portions of the incision engagable wall section.

53. A medical sealing device according to claim 49, wherein the sleeve further includes an incision engagable wall section formed of a material more flexible than the material of the remaining portion of the sleeve.

54. A medical sealing device according to claim 49, wherein said object is one of a hand and a medical device.

50. A medical sealing device for engaging an incision in a patient, comprising:

a sleeve having at least a central lumen section capable of receiving an object extending therethrough, the central lumen section having a twisted wall portion twisted in a direction about a longitudinal axis of the sleeve, and the sleeve further including an axially non-extended configuration when the object is received within the central lumen, and an axially extended configuration when the object is sealingly engaged within the central lumen, the central lumen section including a smaller diameter in the axially extended configuration than in the axially non-extended configuration, the medical sealing device further including a tension spring member coupled to the sleeve, and compression of the spring member urges the sleeve out of contact with the object and into the non-extended configuration.

55. A medical sealing device for engaging an incision in a patient, comprising:

a housing comprising a distal portion having an incision engaging section, a proximal portion, and an axial opening extending through the housing, the proximal portion being movable relative to the distal portion;

a spring member located within the housing;

a twisted sleeve member located within the housing, coupled to the spring member, and comprising an adjustable opening for assisting in sealed access through the axial opening and into the patient, the adjustable opening being aligned with the axial opening of the housing and adjusted by urging the spring in a compression direction.

56. A medical sealing device according to claim 55, wherein the spring member is coupled to a proximal end portion of the twisted sleeve member and to a distal end portion of the twisted sleeve member.

57. A medical sealing device according to claim 55, wherein the distal portion of the housing comprises a reduced diameter portion and a receiving portion for accepting the spring member and twisted sleeve member;

and the proximal portion comprises a cap member engagable and axially movable relative to the distal portion, wherein movement of the cap member toward the distal portion of the housing assists in compressing both the spring member and the twisted sleeve member to enlarge the adjustable opening of the twisted sleeve member.

58. A medical sealing device according to claim 57, wherein the receiving portion of the housing comprises a flexible tube.

59. A method for providing sealed access through an incision in a patient, comprising the steps of:

placing a hand access device into communication with the incision, the access device comprising a sleeve member having a first end, a second end and a central lumen having a twisted wall portion twisted about a longitudinal axis of the sleeve member;

introducing an object within at least a portion of the central lumen of the sleeve member;

applying a force to the sleeve member so that the central lumen sealingly engages the object, the force causing an increase in the axial distance between the first and second end and a decrease in a diameter of the central lumen, as compared to the axial distance between the first and second end and diameter of the central lumen when the object extends through the lumen without application of the force, and the sleeve member includes an inflation space and the force is applied by inflating the inflation space.

60. A method for providing sealed access through an incision in a patient, comprising the steps of:

placing a hand access device into communication with the incision, the access device comprising a sleeve member having a first end, a second end and a central lumen having a twisted wall portion twisted about a longitudinal axis of the sleeve member;

introducing an object within at least a portion of the central lumen of the sleeve member;

applying a force to the sleeve member so that the central lumen sealingly engages the object, the force causing an increase in the axial distance between the first and second end and a decrease in a diameter of the central lumen, as compared to the axial distance between the first and second end and diameter of the central lumen when the object extends through the lumen without application of the force, and the force is applied by a tension spring member coupled to the sleeve member.

61. A medical sealing device formed by a process comprising:

twisting a flexible sleeve member about its longitudinal axis so that a proximal end portion is rotated relative to a distal end portion;

folding the proximal end portion and distal end portion radially outward;

sealingly attaching the proximal and distal end portions together so as to form an inflatable chamber.

62. A medical sealing device formed by a process according to claim 61, further comprising coupling ring members to the flexible sleeve member to assist in positioning the sealing device during use.

63. A medical sealing device formed by a process according to claim 62, wherein the ring members are flexible ring members.

64. A medical sealing device formed by a process according to claim 61, further comprising coupling a valve member to the inflatable chamber to assist in inflating the inflatable chamber.