System and method for balloon-assisted retraction tube

• US 5,967,970 A
• Filed: 09/17/1998
• Issued: 10/19/1999
• Est. Priority Date: 09/26/1997
• Status: Expired due to Fees

• Current Assignee: Cowan, Michael A., Mark R. Lee
• Original Assignee: Cowan, Michael A., Mark R. Lee
• Inventors: Cowan, Michael A., Lee, Mark R.
• Primary Examiner(s): Smith, Jeffrey A.
• Application Number:
  US09/154,570
• Time in Patent Office: 397 Days
• Field of Search: 600/201, 600/203, 600/204, 600/205, 600/207, 600/208, 600/206, 600/235, 600/114, 600/115, 600/116, 606/191, 606/192
• US Class Current: 600/207
• 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 17/3421 Cannulas
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• 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 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/320048 Balloon dissectors

Abstract

A system and method for balloon-assisted retraction technique for the purposes of retraction of tissues and insertion of instruments in connection with advanced surgeries such as microscopic or endoscopic surgeries. A balloon assembly comprising an introducer, a balloon, and a sheath is inserted either manually or with the aid of stereotactic techniques. An endoscope may be used to ensure the proper docking of the introducer assembly. The balloon is then inflated slowly to retract the tissues, in order to create a corridor with minimal invasion. The corridor is expanded and retained using a series of dilators and retractor. The retractor comprises ports through which endoscope and other surgical instruments may pass. Surgical operation is performed through the corridor. The present invention overcomes the disadvantages of conventional retraction systems by providing better visualization and enhanced manual dexterity, as well as providing minimal invasion to allow a shorter recovery period.

Claims

1. A system for retraction of tissues and insertion of instruments comprising:

a balloon, the balloon having a tubular shape, the balloon having an inner tubular surface and an outer tubular surface, the balloon having a proximal end and a distal end, the balloon having a first opening near the proximal end and through the first opening the balloon is inflated and deflated, and the balloon having a deflated state and an inflated state;

a retractor, the retractor having a tubular shape, the retractor having an inner tubular surface and an outer tubular surface, the retractor having a proximal end and a distal end, the retractor having a first opening at the proximal end and a second opening at the distal end; and

sequential cannulated dilators, the dilators having a tubular shape, the dilators having an inner tubular surface and an outer tubular surface, the dilators having a proximal end and a distal end, the dilators having a first opening at the proximal end and a second opening at the distal end, the dilators having increasing circumferences,

whereby

the balloon is inserted between tissues to create a corridor, the balloon is inflated through the balloon'"'"'s first opening to expand the corridor;

the retractor is inserted into the corridor to retain the corridor; and

the dilators are inserted in series, from the dilator having the smallest circumference to the dilator having the largest circumference, such that the dilator having the smallest circumference is inserted first, then a dilator having the next larger circumference is inserted over the dilator having the smallest circumference, such that this process is repeated until the retractor is inserted over the dilator having the largest circumference, in order to expand and retain the corridor.

2. A system according to claim 1 further comprising:

an introducer, the introducer having a tubular shape, the introducer having an inner tubular surface and an outer tubular surface, the introducer having a proximal end and a distal end, the introducer having a first opening at the proximal end and a second opening at the distal end,

whereby the introducer provides structural rigidity to the balloon, while the balloon is being inserted between tissues, so that the balloon may be properly placed at a desired site.

3. A system according to claim 2 further comprising:

a flexible endoscope, wherein the flexible endoscope is passed through the introducer via the introducer'"'"'s first opening and second opening,

whereby the flexible endoscope ensures that the balloon is inserted at a desired site.

4. A system according to claim 1 further comprising:

a sheath, the sheath having a tubular shape, the sheath having an inner tubular surface and an outer tubular surface, the sheath having a proximal end and a distal end, the sheath being made of deformable material, the material having properties for expanding and stretching, the sheath being attached to the balloon in at least one location,

whereby the sheath provides structural rigidity to the balloon, while the balloon is being inserted between tissues, so that the balloon may be properly placed at a desired site.

5. A system according to claim 1 further comprising:

a sheath, the sheath being a part of the balloon, the sheath forming at least a part of the outer tubular surface of the balloon, the sheath being made of deformable material, the material having properties for expanding and stretching,

whereby the sheath provides structural rigidity to the balloon, while the balloon is being inserted between tissues, so that the balloon may be properly placed at the desired site.

6. A system according to claim 1 further comprising:

a flexible arm assembly, the flexible arm assembly having attaching means,

whereby the flexible arm assembly secures the retractor in a fixed position so that the retractor need not be hand-held.

7. A system according to claim 1, wherein

the balloon'"'"'s outer circumference is about 10 millimeters when the balloon is in a deflated state, and the balloon'"'"'s outer circumference is about 20 millimeters when the balloon is in an inflated state.

8. A system for retraction of tissues and insertion of instruments comprising:

a balloon, the balloon having a tubular shape, the balloon having an inner tubular surface and an outer tubular surface, the balloon having a proximal end and a distal end, the balloon having a first opening near the proximal end and through the first opening the balloon is inflated and deflated, and the balloon having a deflated state and an inflated state; and

a retractor, the retractor having a tubular shape, the retractor having an inner tubular surface and an outer tubular surface, the retractor having a proximal end and a distal end, the retractor having a first opening at the proximal end and a second opening at the distal end, wherein the retractor having at least one port, the port being attached to the inner tubular surface of the retractor, the port having an inner circumferential surface and an outer circumferential surface, the inner circumferential surface defines a small space,

whereby

the balloon is inserted between tissues to create a corridor, the balloon is inflated through the balloon'"'"'s first opening to expand the corridor;

the retractor is inserted into the corridor to retain the corridor; and

after surgical instruments have been passed through the port, by limiting the freedom of their movement within the small space, the port secures the surgical instruments and the port minimizes the cross-controlling of instruments.

9. A system according to claim 8 further comprising:

an introducer, the introducer having a tubular shape, the introducer having an inner tubular surface and an outer tubular surface, the introducer having a proximal end and a distal end, the introducer having a first opening at the proximal end and a second opening at the distal end,

whereby the introducer provides structural rigidity to the balloon, while the balloon is being inserted between tissues, so that the balloon may be properly placed at a desired site.

10. A system according to claim 9 further comprising:

a flexible endoscope, wherein the flexible endoscope is passed through the introducer via the introducer'"'"'s first opening and second opening,

whereby the flexible endoscope ensures that the balloon is inserted at a desired site.

11. A system according to claim 8 further comprising:

a sheath, the sheath having a tubular shape, the sheath having an inner tubular surface and an outer tubular surface, the sheath having a proximal end and a distal end, the sheath being made of deformable material, the material having properties for expanding and stretching, the sheath being attached to the balloon in at least one location,

whereby the sheath provides structural rigidity to the balloon, while the balloon is being inserted between tissues, so that the balloon may be properly placed at a desired site.

12. A system according to claim 8 further comprising:

a sheath, the sheath being a part of the balloon, the sheath forming at least a part of the outer tubular surface of the balloon, the sheath being made of deformable material, the material having properties for expanding and stretching,

whereby the sheath provides structural rigidity to the balloon, while the balloon is being inserted between tissues, so that the balloon may be properly placed at the desired site.

13. A system according to claim 8 further comprising:

a flexible arm assembly, the flexible arm assembly having attaching means,

whereby the flexible arm assembly secures the retractor in a fixed position so that the retractor need not be hand-held.

14. A system according to claim 8, wherein

the balloon'"'"'s outer circumference is about 10 millimeters when the balloon is in a deflated state, and the balloon'"'"'s outer circumference is about 20 millimeters when the balloon is in an inflated state.

15. A system according to claim 8, wherein

the surgical instruments comprising an endoscope and instruments for irrigation or suction or both.

16. A method for retraction of tissues and insertion of instruments comprising:

inserting a balloon through tissues, the balloon having a tubular shape, the balloon having an inner tubular surface and an outer tubular surface, the balloon having a proximal end and a distal end, the balloon having a first opening at the proximal end and through the first opening the balloon is inflated and deflated, and the balloon having a deflated state and an inflated state;

inserting a retractor, the retractor having a tubular shape, the retractor having an inner tubular surface and an outer tubular surface, the retractor having a proximal end and a distal end, the retractor having a first opening at the proximal end and a second opening at the distal end; and

inserting sequential cannulated dilators in series, the dilators having a tubular shape, the dilators having an inner tubular surface and an outer tubular surface, the dilators having a proximal end and a distal end, the dilators have increasing circumferences, from the dilator having the smallest circumference to the dilator having the largest circumference, the inserting is performed such that the dilator having the smallest circumference is inserted first, then a dilator having the next larger circumference is inserted over the dilator having the smallest circumference, such that this process is repeated until the retractor is inserted over the dilator having the largest circumference, in order to expand and retain the corridor,

whereby the balloon is inserted between the tissues to create a corridor, the balloon is inflated to expand the corridor, and the retractor is inserted into the corridor to retain the corridor.

17. A method according to claim 16, further comprising:

inserting an introducer through tissues, the introducer having a tubular shape, the introducer having an inner tubular surface and an outer tubular surface, the introducer having a proximal end and a distal end, the introducer having an opening at the proximal end and a second opening at the distal end,

whereby the introducer provides structural rigidity to the balloon, while the balloon is being inserted between tissues, so that the balloon may be properly placed at a desired site.

18. A method according to claim 17, further comprising:

inserting a flexible endoscope, whereby the flexible endoscope is passed through the introducer'"'"'s first opening and second opening to ensure that the balloon is inserted at a desired site.

19. A method according to claim 16, wherein

inserting the balloon also inserts a sheath, the sheath having a tubular shape, the sheath having an inner tubular surface and an outer tubular surface, the sheath having a proximal end and a distal end, the sheath is made of deformable material, the material having properties for expanding and stretching, the sheath being attached to the balloon in at least one location,

whereby the sheath provides structural rigidity to the balloon, while the balloon is being inserted between tissues, so that the balloon may be properly placed at a desired site.

20. A method according to claim 16, wherein

inserting the balloon also inserts a sheath, the sheath being a part of the balloon, the sheath forming at least a part of the outer tubular surface of the balloon, the sheath being made of deformable material, the material having properties for expanding and stretching,

whereby the sheath provides structural rigidity to the balloon, while the balloon is being inserted between tissues, so that the balloon may be properly placed at the desired site.

21. A method according to claim 16, further comprising:

securing a flexible arm assembly to the retractor, the flexible arm assembly having attaching means, whereby the flexible arm assembly secures the retractor in a fixed position so that the retractor need not be hand-held.

22. A method according to claim 16, further comprising:

inflating the balloon which changes the balloon from a deflated state to an inflated state, whereby the outer circumference of the balloon is about 10 millimeters when the balloon is in a deflated state, and the outer circumference of the balloon is about 20 millimeters when the balloon is in an inflated state.

23. A method for retraction of tissues and insertion of instruments comprising:

inserting a balloon through tissues, the balloon having a tubular shape, the balloon having an inner tubular surface and an outer tubular surface, the balloon having a proximal end and a distal end, the balloon having a first opening at the proximal end and through the first opening the balloon is inflated and deflated, and the balloon having a deflated state and an inflated state;

inserting a retractor, the retractor having a tubular shape, the retractor having an inner tubular surface and an outer tubular surface, the retractor having a proximal end and a distal end, the retractor having a first opening at the proximal end and a second opening at the distal end; and

inserting instruments through at least one port, the port being attached to the inner tubular surface of the retractor, the port having an inner circumferential surface and an outer circumferential surface, the inner circumferential surface defines a small space,

whereby

the balloon is inserted between the tissues to create a corridor, the balloon is inflated to expand the corridor;

the retractor is inserted into the corridor to retain the corridor; and

after surgical instruments have been passed through the port, by limiting the freedom of their movement within the small space, the port secures the surgical instruments and the port minimizes the cross-controlling of instruments.

24. A method according to claim 23, further comprising:

inserting an introducer through tissues, the introducer having a tubular shape, the introducer having an inner tubular surface and an outer tubular surface, the introducer having a proximal end and a distal end, the introducer having an opening at the proximal end and a second opening at the distal end,

whereby the introducer provides structural rigidity to the balloon, while the balloon is being inserted between tissues, so that the balloon may be properly placed at a desired site.

25. A method according to claim 24, further comprising:

inserting a flexible endoscope, whereby the flexible endoscope,is passed through the introducer'"'"'s first opening and second opening to ensure that the balloon is inserted at a desired site.

26. A method according to claim 23, wherein

inserting the balloon also inserts a sheath, the sheath having a tubular shape, the sheath having an inner tubular surface and an outer tubular surface, the sheath having a proximal end and a distal end, the sheath is made of deformable material, the material having properties for expanding and stretching, the sheath being attached to the balloon in at least one location,

whereby the sheath provides structural rigidity to the balloon, while the balloon is being inserted between tissues, so that the balloon may be properly placed at a desired site.

27. A method according to claim 23, wherein

inserting the balloon also inserts a sheath, the sheath being a part of the balloon, the sheath forming at least a part of the outer tubular surface of the balloon, the sheath being made of deformable material, the material having properties for expanding and stretching,

whereby the sheath provides structural rigidity to the balloon, while the balloon is being inserted between tissues, so that the balloon may be properly placed at the desired site.

28. A method according to claim 23, further comprising:

securing a flexible arm assembly to the retractor, the flexible arm assembly having attaching means, whereby the flexible arm assembly secures the retractor in a fixed position so that the retractor need not be hand-held.

29. A method according to claim 23, further comprising:

inflating the balloon which changes the balloon from a deflated state to an inflated state, whereby the outer circumference of the balloon is about 10 millimeters when the balloon is in a deflated state, and the outer circumference of the balloon is about 20 millimeters when the balloon is in an inflated state.

30. A method according to claim 23, wherein the inserting of surgical instruments comprising inserting an endoscope and instruments for irrigation or suction or both.