Access and cannulation device and method for rapidly placing same and for rapidly closing same in minimally invasive surgery

• US 6,488,692 B1
• Filed: 03/07/2000
• Issued: 12/03/2002
• Est. Priority Date: 09/16/1996
• Status: Expired due to Fees

• Current Assignee: Anastomotix Corp., Confluence Development Corp., Maquet Cardiovascular LLC (Getinge AB), Westshaw Company Limited
• Original Assignee: Origin Medsystems Inc. (Boston Scientific Corporation)
• Inventors: Williamson, Warren P. IV, Spence, Paul A., Christakis, George
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/520,468
• Time in Patent Office: 1,001 Days
• Field of Search: 606/153, 606/139, 606/154, 606/155
• US Class Current: 606/153
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/1152 applying the staples on the outside of the lumen
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2017/3466 for simultaneous sealing of multiple instruments

Abstract

An access and cannulation device includes a mounting element such as the anastomosis mounting element disclosed in U.S. application Ser. No. 08/714,615 (now U.S. Pat. No. 5,868,763) and U.S. application Ser. No. 09/200,796. The device is used to provide access therethrough and via an incision to the interior of a hollow anatomical structure such as a vessel, an organ or the like during surgery, especially minimally invasive surgery. It includes a flexible sleeve with a suture therein for closing the sleeve and locating edges of the structure adjacent to the incision in position for proper healing after completion of a surgical procedure. A tool is also disclosed for manipulating the device to configure it for the surgery and to close it after completion of the surgery whereby the edges of the wall of the structure adjacent to an incision are approximated to promote proper healing.

Claims

1. Apparatus for establishing access to the interior of a hollow anatomical structure, such as a heart or a blood vessel comprising:

a malleable frame;

a flexible sleeve having a distal end and being fixed to said frame;

a plurality of fasteners on said frame, each fastener having a prong located and shaped to extend through a wall of the anatomical structure for fixing said sleeve to the structure adjacent to an incision therein for communication with the interior of the structure through the incision; and

closure means for closing said sleeve and approximating the wall of the anatomical structure adjacent to the incision to promote healing of the vessel after an operation has been completed.

2. The apparatus defined in claim 1 wherein said closure means comprises a suture in said sleeve.

3. The apparatus defined in claim 1 wherein said frame is annular and has an inner edge and an outer edge and each fastener has a proximal end fixed to said frame and being shaped so the frame inner edge is positioned between the fastener distal and proximal ends.

4. The apparatus defined in claim 1 further comprising means on said sleeve for releasably attaching said sleeve to a placement tool.

5. The apparatus defined in claim 1 further comprising a reinforcing element on said sleeve adjacent to the distal end of said sleeve.

6. The apparatus defined in claim 1 further comprising a hemostatic medium on said sleeve.

7. The apparatus defined in claim 1 further comprising a one-way valve mounted on said sleeve.

8. The apparatus defined in claim 7 wherein said valve includes an access port.

9. The apparatus defined in claim 8 further comprising a plurality of access ports included in the valve.

10. Apparatus for establishing restricted access to a hollow anatomical structure during surgery comprising:

a sleeve;

a docking element on said sleeve for attaching an element such as a cannula to said sleeve;

means for mounting said sleeve on the hollow anatomical structure; and

a one-way valve on said sleeve.

11. The apparatus defined in claim 10 further comprising means for closing said sleeve after completion of a surgical procedure.

12. The apparatus defined in claim 11 further comprising means on said sleeve for holding one portion of the anatomical structure in approximation with another portion of the anatomical structure.

15. The apparatus defined in claim 10 wherein said sealable passage is normally closed.

13. Apparatus for establishing restricted access to a hollow anatomical structure during surgery comprising:

a malleable frame for mounting on an anatomical structure adjacent to an incision through a wall of the structure;

means on said frame for creating a sealable passage between the interior of the structure and the exterior of the structure through said frame; and

means for sealably closing said passage.

14. The apparatus defined in claim 13 wherein said sealable passage includes a flexible sleeve.

16. Apparatus for establishing a resealable access into the interior of an anatomical structure through a wall of the structure during a surgical procedure comprising:

a malleable frame mounted on a wall of the structure adjacent to an incision through the wall, said frame being movable from a first configuration holding the incision open to a second configuration closing the incision;

a sleeve secured to the wall around the incision; and

means on said sleeve for closing the incision.

17. The apparatus defined in claim 16 wherein said sleeve includes a docking port for connecting an instrument such as a cannula or the like to said sleeve.

18. The apparatus defined in claim 17 wherein said docking port further includes a one-way valve.

19. The apparatus defined in claim 18 wherein said one-way valve includes projections which engage a tip of the instrument.

20. The apparatus defined in claim 18 wherein said sleeve further includes a plurality of docking ports.

21. The apparatus defined in claim 17 wherein said docking port further includes a seal.

22. The apparatus defined in claim 16 wherein said means for closing said sleeve comprises a suture on said sleeve.

23. The apparatus defined in claim 22 wherein said suture is located inside said malleable frame.

24. The apparatus defined in claim 22 wherein said suture is located outside said malleable frame.

25. The apparatus defined in claim 24 further comprising fasteners and tines on said malleable frame.

26. The apparatus defined in claim 25 further comprising means for attaching a plurality of instruments to said sleeve.

27. A method of cannulating a hollow anatomical structure during surgery comprising:

establishing access to the interior of an internal anatomical structure;

creating a sealable passage between the interior of the structure and the exterior of the structure;

performing a surgical procedure in the interior of the structure through the passage; and

after completing the surgical procedure sealing the passage with a tissue manipulating malleable frame.

28. The method defined in claim 27 further including holding one portion of the structure in approximation with another portion of the structure after sealing the passage using a tissue manipulating malleable frame.

29. The method defined in claim 27 wherein the step of establishing access includes defining an incision in the structure.

30. The method defined in claim 29 wherein the sealable passage includes a one-way valve and the step of creating a sealable valve.

31. The method defined in claim 29 further including attaching a malleable ring to the structure adjacent to the incision.

32. The method defined in claim 31 further including a step of spreading the malleable ring to provide access to the structure through the incision.

33. The method defined in claim 32 wherein the surgical procedure includes cannulating the structure.

34. The method defined in claim 33 wherein the step of sealing the passage includes closing the structure.

35. The method defined in claim 34 wherein the sealable passage includes a sleeve and the step of sealing the passage includes cutting the sleeve.

36. Apparatus for establishing access to the interior of a hollow anatomical structure, such as a heart or a blood vessel comprising:

a malleable frame;

a flexible sleeve having a distal end and being fixed to said frame;

a plurality of fasteners on said frame, each fastener having a prong located and shaped to extend through a wall of the anatomical structure for fixing said sleeve to the structure adjacent to an incision therein for communication with the interior of the structure through the incision; and

closure structure engaged with said sleeve, said structure being selectively operable to compress the sleeve into a closed condition adjacent to the incision to promote healing of the vessel after an operation has been completed.

37. The apparatus defined in claim 36 wherein the closure structure comprises a suture extending around the sleeve.

38. The apparatus defined in claim 36 wherein said frame is annular and has an inner edge and an outer edge and each fastener has a proximal end fixed to said frame and being shaped so the frame inner edge is positioned between the fastener distal and proximal ends.

39. The apparatus defined in claim 36 further comprising a reinforcing element on said sleeve adjacent to the distal end of said sleeve.

40. The apparatus defined in claim 36 further comprising a hemostatic medium on said sleeve.

41. The apparatus defined in claim 36 further comprising a one-way valve mounted on said sleeve.

42. The apparatus defined in claim 41 wherein said valve includes an access port.

43. The apparatus defined in claim 42 further comprising a plurality of access ports.

44. Apparatus for establishing restricted access to a hollow anatomical structure during surgery comprising:

a sleeve;

a docking element on said sleeve for attaching an element such as a cannula to said sleeve;

fasteners on the sleeve securely engageable with the hollow anatomical structure for mounting said sleeve around an incision in the anatomical structure; and

a one-way valve on said sleeve.

45. The apparatus defined in claim 44 further comprising closure structure engaged with said sleeve, said closure structure being selectively operable to compress the sleeve into closed condition after completion of a surgical procedure.

46. The apparatus defined in claim 45 further comprising elements on said sleeve engageable with the anatomical structure for holding one portion of the anatomical structure in approximation with another portion of the anatomical structure.

47. Apparatus for establishing restricted access to a hollow anatomical structure during surgery comprising:

a malleable frame for mounting on an anatomical structure adjacent to an incision through a wall of the structure;

a passage element having an end peripherally secured to the frame for creating a sealable passage between the interior of the structure and the exterior of the structure through said frame; and

closure structure engaged with the passage element, said closure structure being selectively operable to close the passage element.

48. The apparatus defined in claim 47 wherein the passage element includes a flexible sleeve.

49. The apparatus defined in claim 47 wherein said sealable passage is normally closed.

50. Apparatus for establishing a resealable access into the interior of an anatomical structure through a wall of the structure during a surgical procedure comprising:

a malleable frame mounted on a wall of a structure adjacent to an incision through the wall, said frame being movable from a first configuration holding the incision open to a second configuration closing the incision;

a sleeve secured to the wall around the incision; and

structure engaged with said sleeve for selectively closing the incision.

51. The apparatus defined in claim 50 wherein the sleeve includes a docking port for connecting an instrument such as a cannula or the like to the sleeve.

52. The apparatus defined in claim 51 wherein said docking port further includes a one-way valve.

53. The apparatus defined in claim 52 wherein said one-way valve includes projections which engage a tip of the instrument.

54. The apparatus defined in claim 52 wherein the sleeve further includes a plurality of docking ports.

55. The apparatus defined in claim 51 wherein said docking port further includes a seal.

56. The apparatus defined in claim 50 wherein the closure structure comprises a suture extending around the sleeve.

57. The apparatus defined in claim 56 wherein the suture is located inside said malleabe frame.

58. The apparatus defined in claim 56 wherein the suture is located outside said malleable frame.

59. The apparatus defined in claim 58 further comprising fasteners and tines on said malleable frame.

60. The apparatus defined in claim 59 further comprising means for attaching a plurality of instruments to said sleeve.