Balloon dissection apparatus

• US 20030187472A1
• Filed: 04/24/2003
• Published: 10/02/2003
• Est. Priority Date: 10/08/1999
• Status: Active Grant

• Current Assignee: General Surgical Innovations Incorporated (Johnson Controls International plc)
• Original Assignee: General Surgical Innovations Incorporated (Johnson Controls International plc)
• Inventors: Palermo, Thomas J., Tanaka, Shigeru, Powell, Ferolyn T., Peartree, Kenneth A.
• Granted Patent: US 7,695,487 B2
• Time in Patent Office: Days
• US Class Current: 606/190
• 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 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2017/320048 Balloon dissectors
• CPC Class Codes: A61B 2017/3419 Sealing means between cannula and body
• CPC Class Codes: A61B 2017/3486 Balloon
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor

Abstract

Apparatus for creating an anatomic space in tissue in a body including an introducer device having a tubular member with a bore extending therethrough. A tunneling shaft assembly is slidably mounted in the bore of the introducer device. The tunneling shaft assembly includes a tunneling shaft having proximal and distal extremities. A blunt tip is secured to the distal extremity of the tunneling shaft. A balloon assembly is provided. The balloon assembly is removably secured to the tunneling shaft. The balloon assembly includes a deflated collapsed balloon. A sheath encloses the balloon and is carried by the tunneling shaft. The sheath has a weakened region extending longitudinally thereof permitting the sheath to be removed to release the balloon.

Claims

1. A tunneling device comprising:

a tubular member having a proximal end and a distal end, an inner surface and an outer surface, and a lumen extending therethrough,

a substantially rigid tunneling shaft slidably mounted in said lumen of said tubular member, said tunneling shaft having a blunt distal end for tunneling bluntly through tissue;

a guide slidably disposed along said tunneling shaft and configured to generally center said tunneling shaft within said lumen of said tubular member, said guide having a proximal end that engages an opening at said distal end of said tubular member and said guide being operable to enter the opening when a proximal force is applied to said guide.

2. The tunneling device of claim 1 wherein said guide comprises:

a tubular sleeve having a distal end and a proximal end;

an end collar connected to said distal end of said tubular sleeve;

an inner collar connected to said tubular sleeve; and

a guide collar slidably connected between said end collar and said inner collar, wherein said guide collar assumes a first position wherein the outer diameter of said guide collar is greater than the inner diameter of said lumen extending through said tubular member, and a second position wherein the outer diameter of said guide collar is less than the inner diameter of said lumen extending through said tubular member.

3. The device of claim 1, further including a deflated balloon disposed alongside said tunneling shaft.

4. The device of claim 3, further including means for securing said balloon to said tunneling shaft.

5. The device of claim 4, further including a sheath enclosing said balloon, said sheath having a weakened region extending longitudinally thereof permitting said sheath to be removed from said balloon.

6. The device of claim 2 wherein said guide collar includes fingers that move from an expanded position to a retracted position.

7. The device of claim 6 wherein said fingers in an expanded position cause said guide collar to have an outer diameter that is greater than an inner diameter of said tubular member.

8. The device of claim 7 wherein said inner collar has a first shoulder and a second shoulder, said fingers contacting said first shoulder when in a first position and said fingers contacting said second shoulder when in a second position.

9. The device of claim 1 further including a skin seal on said distal end of said tubular member.

10. The device of claim 9 wherein said skin seal comprises a fluid port and a skin seal balloon, said skin seal port in fluid communication with said skin seal balloon.

11. An apparatus for creating an anatomic space comprising:

a cannula having a distal end and a proximal end, said proximal end having at least one port, said cannula having a lumen therethrough;

a skin seal balloon located on an exterior surface of a distal end of said cannula, said skin seal balloon being in fluid communication with one of said at least one port;

a tunneling shaft having a distal end and a proximal end, said tunneling shaft having an enlarged blunt tip on said distal end, said enlarged blunt tip adapted to fit within said lumen of said cannula;

a handle on said proximal end of said tunneling shaft, said handle configured to releasably connect to said proximal end of said cannula;

a balloon associated with a portion of the length of said tunneling shaft; and

a balloon cover generally surrounding said balloon and said tunneling shaft.

12. The apparatus of claim 11 wherein a portion of said tunneling shaft is within said cannula and a portion of said distal end of said tunneling shaft protrudes from said cannula.

13. The apparatus of claim 11 wherein said balloon is generally contained around said tunneling shaft that protrudes from said cannula.

14. The apparatus of claim 11 further including a port cover releasably connected to said cannula, said port cover configured deny access to said at least one air port when connected to said cannula.

15. The apparatus of claim 11 further including a tunneling shaft guide configured to guide said tunneling shaft with said lumen of said cannula.

16. The apparatus of claim 15 wherein said tunneling shaft guide comprises a collar slidably connected to said tunneling shaft.

17. The apparatus of claim 15 wherein said tunneling shaft guide comprises:

a sleeve having a end collar and a stepped collar;

a guide intermediate said stepped collar and said end collar, said guide having at least two fingers that cantilever outward to conform to an outer diameter of the stepped collar.

18. The apparatus of claim 17 whereby in a first position said guide and said stepped collar interact to cause said outer diameter of said guide to exceed said inner diameter of said lumen and in a second position said guide and said stepped collar interact to reduce said outer diameter of said guide to fit within said lumen.

19. An apparatus for creating an anatomic space comprising:

a tubular member having a lumen extending therethrough, said tubular member having a distal end and a proximal end and an inner surface and an outer surface;

a skin seal balloon on said outer surface of said distal end;

a substantially rigid tunneling shaft slidably mounted in said lumen of said tubular member, said tunneling shaft having a blunt distal end for tunneling bluntly through tissue;

a deflated balloon disposed alongside said tunneling shaft;

means for securing said balloon to said tunneling shaft;

a sheath enclosing said balloon, said sheath having a weakened region extending longitudinally thereof permitting said sheath to be removed from said balloon.

20. The apparatus of claim 19 further including a clamp on said tubular member intermediate said skin seal balloon and said proximal end, said clamp configured to temporarily secure said tubular member to a patient.

21. The apparatus of claim 20 wherein said clamp further includes a resilient skin contact portion to engage skin on said patient thereby compressing said skin intermediate said resilient skin contact portion and said skin seal balloon.

22. The apparatus of claim 19 further including means for inflating said balloon after said sheath has been removed to create the anatomic space.

23. The apparatus of claim 19 wherein said deflated balloon further includes a stop-cock valve configured to control fluid flow into said deflated balloon.

24. The apparatus of claim 19 further including a skin seal balloon port in fluid communication with said skin seal balloon.

25. The apparatus of claim 19 further including a handle connected to said sheath, said handle configured to cover said skin seal balloon port until said sheath is removed from said balloon.

26. The apparatus of claim 24 further including a stop-cock valve connected to said skin seal balloon port.

27. The apparatus of claim 19 further including a tunneling shaft guide configured to generally center said tunneling tunneling shaft within said lumen.

28. An apparatus for creating an anatomic space comprising:

a tubular member having a lumen extending therethrough and at least one fluid port on said tubular member such that said at least one fluid port is in fluid communication with said lumen;

a substantially rigid tunneling shaft slidably mounted in said lumen of said tubular member, said tunneling shaft having a blunt distal end for tunneling bluntly through tissue;

a sheath extending distally, said sheath having a weakened region extending longitudinally thereof permitting said sheath to be removed from said tunneling shaft;

a handle connected to a proximal end of said sheath, said handle configured to cover said at least one fluid port when said sheath is enclosing said balloon.

29. The apparatus of claim 28 further including a deflated balloon disposed alongside said tunneling shaft.

30. The apparatus of claim 29 further including means for inflating said balloon after said sheath has been removed to create the anatomic space.

31. The apparatus of claim 29 further including means for securing said balloon to said tunneling shaft.

32. The apparatus of claim 28 wherein said handle includes jaws to secure said handle to said tubular member.

33. The apparatus of claim 32 wherein said handle has a generally concave recessed portion into which said at least one fluid port projects.

34. The apparatus of claim 32 wherein said handle portion includes a hook to facilitate removal of said handle.

35. The apparatus of claim 28 further including a skin seal on an end of said tubular member, said skin seal including at least one balloon in fluid communication with one of said at least one fluid port.

36. The apparatus of claim 28 wherein said sheath is formed of a rigid plastic material.

37. The apparatus of claim 28 further including means for releasably securing said handle and said sheath to said tubular member.

38. The apparatus of claim 28 wherein said lumen includes at least one seal to inhibit escape of gas through said lumen.

39. A method for hernia repair in a patient using a tissue dissection device having a cover, dissection balloon, a tunneling shaft, a cannula and a skin seal, said method comprising

creating an incision in said patient near said location of said hernia;

inserting a tissue dissection device into said patient;

removing a cover from said dissection insufflation device to expose a balloon and at least one fluid port;

inflating said dissection balloon to create dissected tissue layers;

removing said balloon from said patient

inserting a distal end of a cannula having a distal end and a proximal end into said patient;

removing said tunneling shaft from said patient;

inflating a skin seal balloon through said at least one fluid port located on said distal end of said cannula;

insufflating the space between said dissected tissue layers to create a cavity inside said patient.

40. The method of claim 39, further including engaging a clamp to secure said patient skin between said skin seal balloon and clamp.

41. The method of claim 39, wherein said insufflating between said dissected tissue layers occurs through a port on said cannula.

42. The method of claim 39, wherein said insufflating said dissected tissue layers comprises providing gas into said area between said dissected tissue layers.

43. A method for guiding a tunneling shaft within a cannula, said method comprising

placing a tunneling shaft guide around said tunneling shaft;

placing said tunneling shaft guide is in contact with an end of said cannula and said outer diameter of said guide collar is greater than an inner diameter of said cannula;

applying a force to an end of said tunneling shaft guide, wherein said applying a force causes said outer diameter of said tunneling shaft guide to become less than the inner diameter of said cannula.

44. The method of claim 43, wherein applying a force to an end of said tunneling shaft guide comprises pulling said tunneling shaft from within a patient thereby causing a blunt end of said tunneling shaft to apply a force to said end of said tunneling shaft guide.

45. The method of claim 43, wherein said outer diameter of said guide collar being greater than an inner diameter of said cannula prevents said guide collar from moving into said cannula.

46. The method of claim 43, wherein the cannula includes a lumen and said tunneling shaft guide comprises

a tubular sleeve having a distal end and a proximal end;

an end collar connected to said distal end of said tubular sleeve;

an inner collar connected to said tubular sleeve; and

a expandable collar slidably connected between said end collar and said inner collar, wherein said expandable collar assumes a first position wherein the outer diameter of said expandable collar is greater than the inner diameter of said lumen extending through said cannula, and a second position wherein the outer diameter of said expandable collar is less than the inner diameter of said lumen extending through said cannula.

47. An method for creating an anatomic space comprising:

positioning a tubular member inside a patient, said tubular member having a lumen extending therethrough and at least one fluid port on said tubular member such that said at least one fluid port is in fluid communication with said lumen, said tubular member having a substantially rigid tunneling shaft slidably mounted in said lumen of said tubular member, said tunneling shaft having a blunt distal end for tunneling bluntly through tissue;

grasping a handle to remove a sheath that extends distally to cover a balloon, said sheath having a weakened region extending longitudinally thereof permitting said sheath to be removed from said tunneling shaft, wherein said handle also covers said at least one fluid port

inflating said balloon to create said anatomic space.

48. The method of claim 47, wherein said grasping a handle to remove a sheath also includes removing jaws on said handle from said tubular member.

49. The method of claim 47, wherein said anatomic space is created within a patient.

50. The method of claim 49, further including clamping said tubular member said patient.

51. The method of claim 50 further including creating a skin seal to assist in retaining gas inside said anatomic space.

52. The method of claim 51 wherein said skin seal comprises a toroidal shaped balloon on an end of said tubular member.