Apparatus and method for guiding placement of a minimally invasive surgical instrument

• US 6,432,121 B1
• Filed: 08/27/1999
• Issued: 08/13/2002
• Est. Priority Date: 06/02/1992
• Status: Expired due to Fees

• Current Assignee: General Surgical Innovations Incorporated (Johnson Controls International plc)
• Original Assignee: General Surgical Innovations Incorporated (Johnson Controls International plc)
• Inventors: Jervis, James E.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US09/384,806
• Time in Patent Office: 1,082 Days
• Field of Search: 606/190, 606/192, 606/194, 606/108, 606/191, 600/201, 600/206, 600/207, 600/204
• 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 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/3421 Cannulas
• 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 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/0225 flexible, e.g. fabrics, meshes, or membranes
• CPC Class Codes: A61B 2017/320044 Blunt dissectors
• CPC Class Codes: A61B 2017/320048 Balloon dissectors
• CPC Class Codes: A61B 2090/0813 Accessories designed for easy sterilising, i.e. re-usable
• CPC Class Codes: A61B 90/361 Image-producing devices, e.g. surgical cameras
• 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 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 25/0194 Tunnelling catheters
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1038 Wrapping or folding devices for use with balloon catheters
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

An expansible tunneling apparatus and associated methods for creating an anatomic working space for a surgical procedure. Various embodiments of one and two piece apparatus that permit laparoscopic observation both during tunneling and during subsequent balloon dissection are disclosed. In a disclosed one piece embodiment, a tubular member has a bore extending therethrough and an open distal end. A lip is formed in the distal end of the tubular member to capture the distal tip of a laparoscope that is inserted into the tubular member to permit observation of the procedure both during tunneling to a desired location and during subsequent balloon inflation. An elongated neck of the balloon is secured to the tunneling member. The elongated neck permits the tubular member to be withdrawn slightly from the balloon after inflation to facilitate observation. After the balloon has been advanced to the desired location in the body it is inflated through a balloon inflation lumen to cause the balloon to dissect tissue and create an operating space. Various balloon constructions and a reusable design are also disclosed.

Claims

1. A surgical device for p reserving a path to a dissected region of tissue in a body comprising:

a flexible, elongate rod having distal and proximal ends, the rod having a longitudinal axis extending along said rod from the proximal end to the distal end; and

a cup attached to the distal end of said rod, the cup having a circumference defining an opening substantially facing the proximal end of the rod, the circumference defining a plane substantially perpendicular to the longitudinal axis of the rod, the opening of the cup being adapted to accommodate a distal tip of a tunneling device, wherein the distal end of the rod is attached off-center to the cup at a location along the circumference of the cup.

2. The surgical device of claim 1 wherein said cup is made of a substantially transparent material.

3. The apparatus of claim 1, wherein said cup is configured for releasably receiving said distal tip of said tunneling device.

4. A surgical apparatus for creating an anatomic working space, comprising:

a tunneling device comprising

a substantially rigid tunneling shaft having a distal end;

a balloon being deflated and coupled to said tunneling shaft; and

a guide device comprising

a semi-flexible, elongate rod having a distal end; and

a cup disposed on the distal end of said rod off-center from said rod, said cup releasably receiving the distal end of said tunneling shaft of the tunneling device, and said rod extending proximally from said cup along the balloon and tunneling shaft.

5. The apparatus of claim 4 wherein said tunneling shaft comprises a tubular member having an internal bore adapted to receive a laparoscope.

6. The apparatus of claim 5 wherein said tubular member is formed of a substantially transparent material.

7. The apparatus of claim 4, wherein said balloon is formed in a generally cylindrical roll about said tunneling shaft.

8. A method of creating a dissected region of tissue in a body, comprising:

inserting a surgical apparatus into an incision in the body, said surgical apparatus comprising a substantially rigid tunneling shaft having a distal end, a balloon being deflated and coupled to said tunneling shaft, and a guide comprising a semi-flexible, elongate rod having a distal end, and a cup disposed on the distal end of said rod, said cup releasably receiving the distal end of said tunneling shaft, and said rod extending proximally from said cup along the balloon and tunneling shaft;

advancing the surgical apparatus until a desired location is reached;

inflating said balloon thereby creating the dissected region of tissue;

deflating said balloon; and

removing said tunneling shaft and balloon while leaving in place said guide to preserve a path to the dissected region.

9. The method of claim 8 further comprising:

after removing said tunneling shaft and balloon, advancing a cannula over said rod into the dissected region.

10. The method of claim 8 further comprising:

after removing said tunneling shaft and balloon, inserting a cannula having a guide lumen into the dissected region by inserting said rod of said guide into said guide lumen and advancing said cannula distally along said rod into the dissected region.

11. The method of claim 8 further comprising:

after removing said tunnneling shaft and balloon, advancing an obturator over said rod into the dissected region.

12. The method of claim 8 further comprising:

after removing said tunneling shaft and balloon, inserting an obturator having a guide lumen into the dissected region by inserting said rod of said guide into said guide lumen and advancing said obturator distally along said rod into the dissected region.

13. The method of claim 8, wherein said surgical apparatus is a laparoscopic apparatus.

14. The method of claim 8, wherein said balloon is formed in a generally cylindrical roll about said tunneling shaft.

15. A surgical device comprising:

a flexible, elongate rod having proximal and distal ends, the rod having a longitudinal axis; and

a cup having a circumference defining an opening, the cup bang attached at a location along the circumference of the cup to the distal end of and off-set from said rod, the opening of the cup facing the proximal end of the rod and adapted to accommodate a distal tip of a laparoscopic tunneling apparatus.

16. The surgical device of claim 15 wherein said cup is made of a substantially transparent material.

17. A laparoscopic apparatus for preserving a path to a dissected space within body tissue, said apparatus for use with a laparoscopic tunneling device comprising an elongate tubular tunneling member and a balloon disposed on said tunneling device, said tunneling device having a distal tip, the apparatus comprising:

a flexible, elongate rod having proximal and distal ends; and

a cup attached to the distal end of and off-set from said rod, said cup adapted to releasably receive the distal tip of the laparoscopic tunneling apparatus.

18. The surgical device of claim 17 wherein said cup is made of a substantially transparent material.

19. A laparoscopic surgical apparatus for creating an anatomic working space, comprising:

a laparoscopic tunneling device including a substantially rigid tunneling shaft having a proximal end and a distal end and a balloon being deflated and coupled to said tunneling shaft, said balloon formed in a generally cylindrical roll about said tunneling shaft; and

a guide device including a semi-flexible, elongate rod having proximal and distal ends, and a cup disposed on the distal end of and off-set from said rod, wherein said cup releasably receives the distal end of said tunneling shaft, and said rod extends proximally from said cup along the balloon and tunneling shaft.

20. The apparatus of claim 19 wherein said tunneling shaft comprises a tubular member having an internal bore adapted to receive a laparoscope.

21. The apparatus of claim 20 wherein said tubular member is formed of a substantially transparent material.

22. A method of creating and preserving a path to a dissected region of tissue in a body, comprising:

inserting a laparoscopic apparatus into an incision in the body, said laparoscopic apparatus comprising a substantially rigid tunneling shaft having a proximal end and a distal end, a balloon being deflated and coupled to said tunneling shaft, said balloon formed in a generally cylindrical roll about said tunneling shaft, and a guide comprising a semi-flexible, elongate rod having proximal and distal ends, and a cup disposed on the distal end of said rod, said cup releasably receiving the distal end of said tunneling shaft, and said rod extending proximally from said cup along the balloon and tunneling shaft;

advancing the laparoscopic apparatus until a desired location is reached;

inflating said balloon thereby creating the dissected region of tissue;

deflating said balloon;

removing said tunneling shaft and balloon; and

leaving in place said guide to preserve a path to the dissected region of the tissue.

23. The method of claim 22 further comprising:

after removing said tunneling shaft and balloon and leaving in place said guide, advancing a cannula over said rod into the dissected region.

24. The method of claim 22 further comprising:

after removing said tunneling shaft and balloon and leaving in place said guide, inserting a cannula having a guide lumen into the dissected region by inserting said rod of said guide into said guide lumen and advancing said cannula distally along said rod into the dissected region.

25. The method of claim 22 further comprising:

after removing said tunneling shaft and balloon and leaving in place said guide, advancing an obturator over said rod into the dissected region.

26. The method of claim 22 further comprising:

after removing said tunneling shaft and balloon and leaving in place said guide, inserting an obturator having a guide lumen into the dissected region by inserting said rod of said guide into said guide lumen and advancing said obturator distally along said rod into the dissected region.

27. A surgical apparatus for creating an anatomic workspace, comprising:

a tunneling device comprising

a substantially rigid tunneling shaft having a distal end, and

a balloon being deflated and coupled to the tunneling shaft; and

a guide device oriented external to the tunneling device comprising

a semi-flexible, elongate rod having a distal end and a central axis, and

a cup disposed on the distal end of the rod, wherein the cup releasably receives the distal end of the tunneling shaft of the tunneling device, and wherein the rod extends proximally from the cup along the balloon and tunneling shaft.

28. The surgical apparatus of claim 27 wherein the cup of the guide device is disposed off-center from the central axis of the rod of the guide device.