Expansible tunneling apparatus for creating an anatomic working space

• US 5,496,345 A
• Filed: 10/17/1994
• Issued: 03/05/1996
• Est. Priority Date: 06/02/1992
• Status: Expired due to Term

• Current Assignee: General Surgical Innovations Incorporated (Johnson Controls International plc)
• Original Assignee: General Surgical Innovations Incorporated (Johnson Controls International plc)
• Inventors: Mollenauer, Kenneth H., Monfort, Michelle Y., Kieturakis, Maciej J.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): Dawson, Glenn
• Application Number:
  US08/324,519
• Time in Patent Office: 505 Days
• Field of Search: 600/201, 600/204, 600/207, 606/1, 606/108, 606/151, 606/119-122, 606/191-199, 606/213, 604/95, 604/104, 604/164, 604/264, 604/160, 604/161, 604/170, 604/171, 128/836
• US Class Current: 606/192
• 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 2017/320044 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 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 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

An expansible tunneling apparatus for tunneling bluntly to a desired location within the human body and for creating an anatomic working space for the performance of a surgical procedure by utilizing an inflatable balloon to dissect tissue along natural separation planes once the desired space has been reached. In a disclosed embodiment, a tubular member has a bore extending therethrough to provide an open distal end. A rigid tunneling shaft is insertable into the bore of the tubular member to provide a blunt tipped obturator. A balloon associated with the apparatus is disposed such that it surrounds the tunneling shaft when the balloon is deflated, as it would be when tunneling bluntly through tissue. A sheath surrounds the balloon and has a weakened region that permits the sheath to be released thereby permitting the balloon to expand to dissect tissue layers and create the anatomic working space. A balloon inflation lumen may be utilized to supply an appropriate balloon inflation medium to inflate the balloon.

Claims

1. An expansible tunneling apparatus for creating an anatomic working space in a body comprising:

a substantially rigid tubular member having a bore therein and an open distal end;

a rigid tunneling shaft having a blunt distal end for tunneling bluntly through tissue in the body, said rigid shaft slidably receivable in said bore of said tubular member wherein said blunt distal end of said tunneling shaft extends through and beyond said open distal end to form, together with said tubular member, a blunt tipped obturator for tunneling through tissue in the body;

a balloon, said balloon being deflated and formed into a roll surrounding said tunneling shaft during tunneling through tissue;

a sheath surrounding at least a portion of said deflated balloon and said tunneling shaft, said sheath being provided with a weakened region to permit said sheath to separate from said deflated balloon thereby releasing said balloon; and

means for inflating said deflated balloon after tunneling to a desired location to create the anatomic working space.

2. The apparatus of claim 1 wherein said balloon is a non-elastomeric balloon formed from two sheets of non-elastomeric material having outer margins, said balloon formed by sealing said sheets together at said outer margins.

3. The apparatus of claim 1 wherein said balloon is formed or a non-elastomeric material and assumes a manta-ray shape when inflated.

4. The apparatus of claim 1 wherein said weakened region comprises a series of spaced apart perforations running longitudinally of said sheath.

5. The apparatus of claim 1 wherein said shaft, in cooperation with said sheath provides said obturator with a blunt enclosed end.

6. The apparatus of claim 1 further comprising means for introducing an insufflation gas into the working space.

7. The apparatus of claim 1 wherein said inflation means comprises a balloon inflation lumen extending from said balloon and a fitting attached to said lumen for connecting to an inflation source.

8. The apparatus of claim 1 further comprising an introducer for insertion into the body, said introducer comprising a housing having a bore extending therethrough and a hollow cylindrical member extending from said housing, sand housing bore in communication with a bore extending through said cylindrical member to provide a continuous bore through said introducer, said tubular member and sad tunneling shaft removably insertable through said continuous bore in said introducer.

9. The apparatus of claim 8 wherein said introducer further comprises:

a valve member mounted in said introducer housing, said valve member movable between a first position in which said housing bore is closed and a second position in which said housing bore is open;

a seal mounted in said introducer housing proximal of said valve member and having a central opening in communication with said bore in said housing, said seal for engaging said tubular member to provide a substantially fluid tight seal therewith; and

an insufflation port in communication with said continuous bore in said introducer for infusing insufflation gas into the working space.

10. A tunneling apparatus for creating an anatomic working space comprising:

an introducer comprising a housing having an internal bore formed therein and a cylindrical member extending distally from said housing, said cylindrical member having a bore in communication with said bore in said housing, said housing further comprising;

a valve member mounted in said housing, said valve movable between a first position in which said bore in said housing is closed and a second position in which said bore is open; and

a seal mounted in said housing proximally of said valve;

a rigid shaft for tunneling through tissue in a body, said shaft removably insertable through said seal and said valve in said housing and into said bore in said cylindrical member, said shaft having a blunt distal end having a shape selected from the group consisting of substantially hemispherical and substantially ellipsoidal;

a balloon, said balloon being deflated and surrounding said shaft wherein said deflated balloon and said shaft form an obturator for tunneling through tissue; and

means for inflating said deflated balloon after tunneling to a desired location to create the anatomic working space.

11. The apparatus of claim 10 wherein said cylindrical member has an open distal end and said blunt distal end of said shaft extends through and beyond said open distal end during tunneling through tissue in a body.

12. The apparatus of claim 10 wherein said valve member is a flapper valve.

13. The apparatus of claim 10 wherein said balloon is formed from an elastomeric material.

14. The apparatus of claim 10 wherein said balloon is a shaped balloon formed from a non-elastomeric material.

15. The apparatus of claim 14 wherein said non-elastomeric shaped balloon is formed from two sheets of non-elastomeric material having outer margins, said balloon formed by sealing said sheets together at said outer margins.

16. The apparatus of claim 15 wherein said balloon assumes a substantially manta-ray shape when inflated.

17. The apparatus of claim 10 further comprising a tubular member having a bore extending therethrough, said tubular member insertable through said bores in said housing and said cylindrical member and extending beyond a distal end of said cylindrical member when fully inserted, said tunneling shaft slidably receivable in said bore of said tubular member.

18. The apparatus of either claim 10 or claim 11 wherein said deflated balloon is formed into a generally cylindrical roll and wherein the apparatus further comprises a sheath surrounding at least a portion of said rolled deflated balloon and said shaft, said sheath having a weakened region extending longitudinally thereof to permit said sheath to separate from said rolled deflated balloon so that said balloon can unroll and progressively expand to create the anatomic working space.

19. The apparatus of claim 10 wherein said blunt distal end is substantially hemispherical.

20. The apparatus of claim 10 wherein said blunt distal end is substantially ellipsoidal.