Temporary hemostatic plug apparatus and method of use

• US 20050033361A1
• Filed: 06/16/2004
• Published: 02/10/2005
• Est. Priority Date: 06/16/2003
• Status: Active Grant

• Current Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories Incorporated)
• Inventors: Boldenow, Gregory Alan, Galdonik, Jason A.
• Granted Patent: US 8,114,102 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0493 Protective devices for suturing, i.e. for protecting the patient's organs or the operator
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/2833 Locking means
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065

Abstract

A temporary hemostatic plug apparatus for use in a patient includes a plug structure configured to be placed within a patient'"'"'s tubular body structure. The plug structure may be configured to be placed in an incision to create a bloodless operating field for a surgeon to operate, for example to perform an anastomosis. This may be done by deploying the plug structure out from within the lumen to create a hemostatic seal around the incision. Once the surgeon has completed the operation, the plug apparatus may be removed from the lumen through the incision, or through any other point of access in the lumen.

Claims

1. Apparatus for temporarily and hemostatically sealing a first opening in a lumen, comprising:

a plug; and

a primary shaft connected to the plug;

wherein the plug and the shaft are adapted to be inserted into the lumen through a second opening and the plug is positioned against the first opening to create a hemostatic seal.

2. The apparatus of claim 1 wherein the plug comprises an outer surface and is reconfigurable in use from a first configuration to a second configuration, the first configuration having a collapsed outer surface and the second configuration having a stiff outer surface.

3. The apparatus of claim 2 wherein the plug comprises a thin-walled portion.

4. The apparatus of claim 3 wherein the thin-walled portion is made from stainless steel.

5. The apparatus of claim 3 wherein the thin-walled portion is made from nitinol.

6. The apparatus of claim 2 wherein the plug comprises a coil.

7. The apparatus of claim 1 further comprising at least one side shaft.

8. The apparatus of claim 7 wherein the side shaft further comprises an arm configured to enhance the seal between the plug and the lumen.

9. The apparatus of claim 8 wherein the arm is configured to press against the lumen wall to increase the pressure between the plug and the opening.

10. The apparatus of claim 7 wherein the side shaft is movably coupled to the primary shaft.

11. The apparatus of claim 10 wherein the primary shaft and the side shaft comprise locking portions configured to maintain the position of the primary shaft relative to the side shaft.

12. The apparatus of claim 11 wherein the locking portions comprise magnetic material.

13. The apparatus of claim 11 wherein the locking portions comprise teeth.

14. The apparatus of claim 1 wherein the plug comprises at least one rib.

15. The apparatus of claim 14 wherein the lumen wall is configured to rest against the rib such that the lumen wall is visibly accessible.

16. The apparatus of claim 15 wherein the entire lumen wall is visibly accessible.

17. The apparatus of claim 14 wherein the portion of the plug that is in contact with the lumen wall is configured to be larger than the opening.

18. Apparatus for temporarily and hemostatically sealing an opening in a lumen to form a bloodless region for a surgical operation, comprising:

a plug; and

a primary shaft connected to the plug;

wherein the plug is adapted to be inserted in the lumen and positioned against the opening to create a hemostatic seal; and

a surgical operation site is created outside the periphery of the plug.

19. The apparatus of claim 18 wherein the plug is reconfigurable in use from a first configuration to a second configuration, the first configuration having a collapsed outer surface and the second configuration having a stiff outer surface.

20. The apparatus of claim 19 wherein the plug comprises a thin-walled portion.

21. The apparatus of claim 19 wherein the thin-walled portion is made from stainless steel.

22. The apparatus of claim 19 wherein the thin-walled portion is made from nitinol.

23. The apparatus of claim 19 wherein the plug comprises a coil.

24. The apparatus of claim 19 wherein the apparatus comprises an inflatable balloon.

25. The apparatus of claim 19 further comprising at least one side shaft.

26. The apparatus of claim 25 wherein the side shaft further comprises an arm configured to enhance the seal between the plug and the lumen.

27. The apparatus of claim 26 wherein the arm is configured to press against the lumen wall to increase the pressure between the plug and the opening.

28. The apparatus of claim 25 wherein the side shaft is movably coupled to the primary shaft.

29. The apparatus of claim 28 wherein the primary shaft and the side shaft comprise locking portions configured to maintain the position of the primary shaft relative the side shaft.

30. The apparatus of claim 29 wherein the locking portions comprise magnetic material.

31. The apparatus of claim 29 wherein the locking portions comprise teeth.

32. The apparatus of claim 19 wherein the apparatus is placed in the lumen through the opening.

33. The apparatus of claim 19 wherein the apparatus is placed in the lumen through a second opening.

34. The apparatus of claim 19 wherein the plug comprises at least one rib.

35. The apparatus of claim 34 wherein the lumen wall is configured to rest against the rib such that the lumen wall is visibly accessible.

36. The apparatus of claim 35 wherein the entire lumen wall is visibly accessible.

37. The apparatus of claim 34 wherein the portion of the plug that is in contact with the lumen wall is configured to be larger than the opening.

38. Apparatus for temporarily and hemostatically sealing an opening in a lumen, comprising:

a plug comprising a balloon;

a shaft configured to be attached to the plug; and

a tube configured to be concentrically slid over the shaft to modify the shape of the balloon.

39. The apparatus of claim 38 wherein the plug is reconfigurable in use from a first configuration to a second configuration, the first configuration having a collapsed outer surface and the second configuration having a stiff outer surface.

40. The apparatus of claim 38 wherein the plug further comprises a frame.

41. The apparatus of claim 40 wherein the frame is made from nitinol.

42. The apparatus of claim 39 wherein the plug, in the second configuration, further comprises a contour configured to match the lumen wall.

43. A method for temporarily and hemostatically sealing a first opening in a lumen, comprising:

inserting a plug in the lumen through a second opening;

positioning the plug against the first opening using a primary shaft connected to the plug; and

creating a seal between the plug and the lumen.

44. The method of claim 43 wherein the step of positioning the plug further comprises pressing an arm of a side shaft against the lumen wall.

45. The method of claim 44 wherein the step of positioning the plug further comprises maintaining the position of the primary shaft relative the side shaft.

46. The method of claim 45 wherein the maintaining further comprises using locking portions fixed to the primary shaft and the side shaft.

47. A method for temporarily and hemostatically sealing an opening in a lumen to form a bloodless region for a surgical operation, comprising:

inserting a plug in the lumen through the opening;

positioning the plug against the opening using a shaft connected to the plug; and

creating a seal between the plug and the lumen wherein the lumen is operated on outside the periphery of the plug.

48. The method of claim 47 further comprising attaching a graft lumen to the lumen outside the periphery of the plug.

49. A method for temporarily and hemostatically sealing an opening in a lumen, comprising:

inserting a plug comprising a balloon in the lumen;

positioning the plug against the opening using a shaft connected to the plug;

sliding a tube concentrically over the shaft to modify the shape of the balloon; and

creating a seal between the plug and the lumen.

50. The method of claim 49 wherein the sliding step further comprises shaping the balloon into the plug.

51. The method of claim 49 further comprising inserting a frame into the plug.

52. Apparatus for temporarily and hemostatically sealing a first opening in a lumen, comprising:

a plug comprising a coil;

a shaft connected to the distal end of the coil; and

a wire connected to the proximal end of the coil;

wherein;

the plug is placed in the lumen and positioned against the opening to create a seal between the plug and the lumen; and

the plug is removed from the lumen by pulling on the wire to unwind the coil.