Method and apparatus employing conformable sleeve for providing percutaneous access

• US 5,814,058 A
• Filed: 08/14/1996
• Issued: 09/29/1998
• Est. Priority Date: 03/05/1993
• Status: Expired due to Term

• Current Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Original Assignee: InnerDyne, Inc. (Medtronic Plc)
• Inventors: Carlson, John, Tsuji, Craig K., Orth, Michael J., Masterson, Steven P.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US08/696,755
• Time in Patent Office: 776 Days
• Field of Search: 604/104, 604/109, 604/164, 604/166, 604/171, 604/172, 604/264, 604/280, 604/281, 604/52, 604/53, 606/191, 606/198, 606/108, 600/201
• US Class Current: 606/185
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/3431 being collapsible, e.g. made of thin flexible material A61B17/3423 takes precedence
• 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 17/3474 Insufflating needles, e.g. Veress needles
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2090/0815 Implantable devices for insertion in between organs or other soft tissues
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor
• CPC Class Codes: A61M 2025/0025 having a collapsible lumen
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

Methods and systems for introducing articles and surgical instruments to target body cavities utilize conformable sleeves which are percutaneously positioned within the cavity. Articles may then be passed directly through the conformable sleeve, without use of a rigid cannula, either by pushing the articles inwardly through the sleeve using an introducer or pulling the articles inwardly through the sleeve using a tapered carrier. Surgical instruments are also passed directly inwardly through the sleeve. Such systems and methods may be used in a variety of minimally invasive surgical procedures.

Claims

1. A method for percutaneously introducing an article, said method comprising:

percutaneously inserting a conformable sleeve to a target site in a body cavity;

passing an article from outside the body and through a lumen of the conformable sleeve, wherein passage of the article radially expands the lumen as the article advances; and

grasping the article with graspers and pulling the article away from the sleeve with the graspers into the body cavity.

2. A method as in claim 1, wherein the passing step comprises:

mounting the article on a shaft; and

introducing the shaft and article through the conformable sleeve so that said article extends from the sleeve into the body cavity.

3. A method as in claim 2, further comprising withdrawing the shaft from the conformable sleeve after the article has been removed, wherein the sleeve radially collapses.

4. A method as in claim 2, wherein the mounting step comprises storing the article in a recess on the shaft.

5. A method as in claim 4, wherein the recess is disposed proximal to a tapered distal end of the shaft.

6. A method as in claim 5, wherein the recess is covered by a cover and the article is removed through an aperture in the cover.

7. A method as in claim 5, wherein the recess is covered by a cover and the removing step comprises retracting the cover to expose the article in the body cavity.

8. A method as in claim 1, wherein the grasting step comprises:

percutaneously inserting a grasping element into the body cavity;

grasping the article with a distal end of the grasping element; and

pulling the grasping element away from the conformable sleeve to draw the article into the body cavity.

9. A method as in claim 8, wherein the article is disposed in a tapered carrier and wherein a tapered end of the carrier is grasped by the grasping element and pulled through the conformable sleeve and the carrier is drawn into the body cavity.

10. A method as in claim 9, further comprising removing the article from the tapered carrier after the tapered carrier has been drawn into the body cavity.

11. A method as in claim 1, wherein the article has a non-circular cross-sectioned periphery so that the conformable sleeve is radially expanded to a non-circular cross-section as the article passes.

12. A method for performing a procedure at a target site in a body cavity, said method comprising:

percutaneously inserting a conformable sleeve to the target site;

positioning an elongate instrument through a central lumen of the conformable sleeve so that an end effector at a distal end of the instrument is positioned at the target site and a handle at a proximal end of the instrument remains outside the body; and

manipulating the handle to deploy the end effector to perform the procedure.

13. A method as in claim 12, wherein the manipulating step comprises actuating an actuator on the handle to deploy the end effector.

14. A method as in claim 13, whereas the end effector comprises a component selected from the group consisting of graspers, scissors, forceps, needle drivers, electrosurgical probes, staplers, viewing scopes, irrigation devices, and suction devices.

15. A method as in claim 14, wherein the end effector comprises graspers and the method further comprises manipulating a proximal handle on the graspers to grasp and remove a surgical mesh from a second instrument and to place said mesh over tissue.

16. A method as in claim 12, wherein the manipulating step comprises translating the handle to engage the end effector against tissue in the body.

17. A system for percutaneously introducing an article, said system comprising:

an elongate introducer having a proximal end, a distal end, and a storage location near the distal end for removably carrying the article; and

an elongate conformable sleeve having a proximal end, a distal end, and a lumen which slidably receives the introducer shaft, said sleeve having a compliant or elastic structure so that its cross-section will collapse when positioned in a constrictive percutaneous penetration but will expand as the introducer is passed through the lumen.

18. A system as in claim 17, wherein the introducer shaft has a tapered distal end to facilitate passage through the lumen of the elongate sleeve.

19. A system as in claim 18, wherein the storage location on the introducer shaft is recessed behind the tapered distal end.

20. A system as in claim 19, which introducer shaft includes a tubular cover over the storage location.

21. A system as in claim 20, wherein the tubular cover has an aperture for accessing the storage location.

22. A system as in claim 20, wherein the tubular cover retracts relative to the shaft.

23. A system as in claim 17, wherein the elongate sleeve has a length in the range from 5 cm to 20 cm and a maximum internal diameter when radially expanded in the range from 1 mm to 18 mm.

24. A system as in claim 23, wherein the introducer shaft has a length which is at least 5 cm longer than the elongate sleeve.

25. A system as in claim 17, further comprising the article carried within the storage location on the introducer shaft.

26. A system as in claim 25, wherein the article is a surgical mesh.

27. Apparatus for use in combination with an elongate conformable sleeve, said introducer shaft comprising:

a shaft having a proximal end and a distal end;

a tapered tip at the distal end of the shaft, said taper defining a recessed region on the shaft for receiving an article to be delivered by the shaft through the conformable sleeve; and

a handle at the proximal end of the shaft.

28. Apparatus as in claim 27, wherein the shaft comprises a tubular cover which extends proximally from the tapered distal tip, wherein the recessed region is disposed within the cover.

29. Apparatus as in claim 28, wherein the tubular cover has an aperture for accessing the article.

30. Apparatus as in claim 28, wherein the tubular cover is retractable relative to the distal tip to expose the article.

31. Apparatus as in claim 27, shaft has a length in the range from 5 cm to 20 cm and a maximum width in the range from 5 mm to 18 mm.

32. A system for percutaneously introducing an article, said system comprising:

a tapered carrier having a hollow body, tapered distal end, and an opening at the proximal end to permit loading and unloading of the article; and

an elongate conformable sleeve having a proximal end, a distal end and a lumen which slidably receives the tapered carrier, said sleeve having an elastic or compliant structure so that its cross-section will collapse when positioned in a constrictive percutaneous penetration but will expand as the tapered carrier is passed through the lumen.

33. A system as in claim 32, wherein the elongate sleeve has a length in the range from 5 cm to 20 cm and a maximum internal diameter when radially expanded in the range from 5 mm to 18 mm.

34. A system as in claim 33, wherein the tapered carrier is non-collapsible.

35. A system as in claim 34, wherein the tapered carrier has a length in the range from 5 cm to 20 cm and a maximum width at its proximal end of from 5 mm to 18 mm.

36. A system for percutaneously introducing an article, said system comprising:

an elongate introducer having a proximal end, a distal end, a storage location near the distal end for removably carrying the article, and a tubular cover over the storage location; and

an elongate conformable sleeve having a proximal end, a distal end, and a lumen which slidably receives the introducer shaft, said sleeve having a compliant or elastic structure so that its cross-section will collapse when positioned in a constrictive percutaneous penetration but will expand as the introducer is passed through the lumen.

37. A system as in claim 36, wherein the introducer shaft has a tapered distal end to facilitate passage through the lumen of the elongate sleeve.

38. A system as in claim 37, wherein the storage location on the introducer shaft is recessed behind the tapered distal end.

39. A system as in claim 36, wherein the tubular cover has an aperture for accessing the storage location.

40. A system as in claim 36, wherein the tubular cover retracts relative to the shaft.

41. A system as in claim 36, wherein the elongate sleeve has a length in the range from 5 cm to 20 cm and a maximum internal diameter when radially expanded in the range from 1 mm to 18 mm.

42. A system as in claim 41, wherein the introducer shaft has a length which is at least 5 cm longer than the elongate sleeve.

43. A system as in claim 36, further comprising the article carried within the storage location on the introducer shaft.

44. A system as in claim 43, wherein the article is a surgical mesh.

45. A system for percutaneously introducing an article, said system comprising:

an elongate introducer having a proximal end, a distal end, and a storage location near the distal end for removably carrying the article;

an article removably carried within the storage location on the introducer shaft; and

an elongate conformable sleeve having a proximal end, a distal end, and a lumen which slidably receives the introducer shaft, said sleeve having a compliant or elastic structure so that its cross-section will collapse when positioned in a constrictive percutaneous penetration but will expand as the introducer is passed through the lumen.

46. A system as in claim 45, wherein the introducer shaft has a tapered distal end to facilitate passage through the lumen of the elongate sleeve.

47. A system as in claim 46, wherein the storage location on the introducer shaft is recessed behind the tapered distal end.

48. A system as in claim 47, which introducer shaft includes a tubular cover over the storage location.

49. A system as in claim 48, wherein the tubular cover has an aperture for accessing the storage location.

50. A system as in claim 48, wherein the tubular cover retracts relative to the shaft.

51. A system as in claim 45, wherein the elongate sleeve has a length in the range from 5 cm to 20 cm and a maximum internal diameter when radially expanded in the range from 1 mm to 18 mm.

52. A system as in claim 51, wherein the introducer shaft has a length which is at least 5 cm longer than the elongate sleeve.

53. A system as in claim 45, wherein the article is a surgical mesh.

54. A system for percutaneously introducing an article, said system comprising:

an elongate introducer having a proximal end, a distal end, and a recessed receptacle near the distal end for removably carrying the article; and

an elongate conformable sleeve having a proximal end, a distal end, and a lumen which slidably receives the introducer shaft, said sleeve having a compliant or elastic structure so that its cross-section will collapse when positioned in a constrictive percutaneous penetration but will expand as the introducer is passed through the lumen.

55. A system as in claim 54, wherein the introducer shaft has a tapered distal end to facilitate passage through the lumen of the elongate sleeve.

56. A system as in claim 55, wherein the storage location on the introducer shaft is recessed behind the tapered distal end.

57. A system as in claim 56, which introducer shaft includes a tubular cover over the storage location.

58. A system as in claim 57, wherein the tubular cover has an aperture for accessing the storage location.

59. A system as in claim 57, wherein the tubular cover retracts relative to the shaft.

60. A system as in claim 54, wherein the elongate sleeve has a length in the range from 5 cm to 20 cm and a maximum internal diameter when radially expanded in the range from 1 mm to 18 mm.

61. A system as in claim 60, wherein the introducer shaft has a length which is at least 5 cm longer than the elongate sleeve.

62. A system as in claim 54, further comprising the article carried within the storage location on the introducer shaft.

63. A system as in claim 62, wherein the article is a surgical mesh.