Skin seal with inflatable membrane

• US 5,964,781 A
• Filed: 06/02/1997
• Issued: 10/12/1999
• Est. Priority Date: 05/19/1995
• 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.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): SHAI, DAPHNA
• Application Number:
  US08/867,285
• Time in Patent Office: 862 Days
• Field of Search: 606/213, 606/192, 604/116, 604/117, 604/237, 604/115, 620/32
• US Class Current: 606/213
• 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 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 17/3431 being collapsible, e.g. made of thin flexible material A61B17/3423 takes precedence
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/3419 Sealing means between cannula and body
• CPC Class Codes: A61B 2017/3486 Balloon
• CPC Class Codes: A61B 90/40 Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment

Abstract

A skin seal or trocar stabilizer with an inflatable balloon in the shape of a dumbbell, where the balloon may be stored within a cannula for easy placement in an incision and inflated to deploy the balloon inside the body, and a portion of the balloon expands inside the cannula, whereby medical instruments may be passed through the skin seal into a laparoscopic work space while the balloon is inflated, thereby allowing the use of normal short surgical instruments during laparoscopic procedures and during insufflation.

Claims

1. A device for sealing an incision through one or more layers of body tissue, said layer of body tissue having a known thickness, said device comprising;

a tube having a distal end, a proximal end, and a lumen extending therethrough;

a balloon surrounding the tube, said balloon having a distal portion, a proximal portion and a middle section, said balloon having a lumen extending therethrough, said lumen being coaxial with and inside the lumen of the tube, said middle section of said balloon having an outer diameter closely matching the outer diameter of the tube and wherein an inside wall of said balloon is disposed within said lumen of the tube.

2. A device for sealing an incision through one or more layers of body tissue, said layer of body tissue having a known thickness, said device comprising;

a tube having a distal end, a proximal end and a lumen extending therethrough;

a balloon surrounding the tube, said balloon having a distal portion, a proximal portion and a middle section, said balloon having a lumen extending therethrough, said lumen being coaxial with and inside the lumen of the tube, said middle section of said balloon having an outer diameter closely matching the outer diameter of the tube, said distal portion of the balloon having an enlarged cross section compared to the middle section and wherein an inside wall of said balloon is disposed within said lumen of the tube.

4. The device of claim 2 wherein the distal portion of the balloon has a large diameter compared to the middle section of the balloon, said large diameter being sufficient to ensure that the distal portion of the balloon, when inflated, is large enough to cover the incision.

5. The device of claim 2 further comprising:

a flange on the proximal end of the tube, said flange sized and dimensioned to cover the incision.

3. A device for sealing an incision through one or more layers of body tissue, said layer of body tissue having a known thickness, said device comprising;

a tube having a distal end, a proximal end and a lumen extending therethrough;

a balloon surrounding the tube, said balloon having a distal portion, a proximal portion and a middle section, said balloon having a lumen extending therethrough, said lumen being coaxial with and inside the lumen of the tube, said middle section of said balloon having an outer diameter closely matching the outer diameter of the tube, said distal portion of the balloon having an enlarged cross section compared to the middle section, said large diameter being sufficient to ensure that the distal portion of the balloon, when inflated, is large enough to cover the incision and wherein an inside wall of said balloon is disposed within said lumen of the tube.

6. A device for sealing an incision through one or more layers of body tissue, said layer of body tissue having a known thickness, said device comprising;

a tube having a distal end, a proximal end and a lumen extending therethrough;

a balloon surrounding the tube, said balloon having a distal portion, a proximal portion and a middle section, said balloon having a lumen extending therethrough, said lumen being coaxial with and inside the lumen of the tube, said middle section of said balloon having an outer diameter closely matching the outer diameter of the tube, said distal portion of the balloon having an enlarged cross section compared to the middle section, said distal portion being stored within the lumen of the tube when the balloon is uninflated and capable of unfolding and expanding outside the lumen upon inflation and wherein an inside wall of said balloon is disposed within said lumen of the tube.

7. A method of inserting instruments into the body through an incision through one or more layers of tissue, said one or more layers having a known thickness, said method comprising:

providing a seal comprising;

a tube having a distal end, a proximal end, and a lumen extending therethrough; and

a balloon surrounding the tube, said balloon having a distal portion, a proximal portion and a middle section, said balloon having a lumen extending therethrough, said lumen being coaxial with and inside the lumen of the tube, said middle section of said balloon having an outer diameter closely matching the outer diameter of the tube, said distal portion of the balloon having an enlarged cross section compared to the middle section, said distal portion being stored within the lumen of the tube when the balloon is uninflated and capable of unfolding and expanding outside the lumen upon inflation;

inserting the seal through the incision while the distal portion of the balloon is stored within the lumen of the tube; and

inflating the balloon so that the distal portion of the balloon expands and exits the lumen of the tube, said distal portion of the balloon inflating to a larger cross section than the tube.

8. The method of claim 7 wherein the tube further comprises a flange on the proximal end of said tube, said flange being sized and dimensioned to cover the incision.

9. The method of claim 7 wherein the proximal portion of the balloon has an enlarged cross section compared to the middle section.

10. A method of sealing an incision through one or more layers of tissue, said one or more layers having a known thickness, said method comprising:

providing a seal comprising;

a tube having a distal end, a proximal end, and a lumen extending therethrough; and

a balloon surrounding the tube, said balloon having a distal portion, a proximal portion and a middle section, said balloon having a lumen extending therethrough, said lumen being coaxial with and inside the lumen of the tube, said middle section of said balloon having an outer diameter closely matching the outer diameter of the tube, said distal portion of the balloon having an enlarged cross section compared to the middle section, said distal portion being stored within the lumen of the tube when the balloon is uninflated and capable of unfolding and expanding outside the lumen upon inflation;

inserting the seal through the incision while the balloon is uninflated and the distal portion is stored within the lumen of the tube; and

inflating the balloon so that the distal portion of the balloon expands and exits the lumen of the tube, said distal portion of the balloon inflating to a larger cross section than the tube, the lumen of the balloon closing by expansion of the balloon.

11. The method of claim 10 wherein the tube further comprises a flange on the proximal end of said tube, said flange being sized and dimensioned to cover the incision.

12. The method of claim 10 wherein the proximal portion of the balloon has an enlarged cross section compared to the middle section.

13. A method of inserting instruments into the body through an incision through one or more layers of tissue, said one or more layers having a known thickness, said method comprising:

providing a seal comprising;

a tube having a distal end, a proximal end, and a lumen extending therethrough; and

a balloon surrounding the tube, said balloon having a distal portion, a proximal portion and a middle section, said balloon having a lumen extending therethrough, said lumen being coaxial with and inside the lumen of the tube, said middle section of said balloon having an outer diameter closely matching the outer diameter of the tube;

inserting the seal through the incision; and

inflating the balloon so that a substantially airtight seal is formed in the lumen of the balloon.

14. The method of claim 13 wherein the tube further comprises a flange on the proximal end of said tube, said flange being sized and dimensioned to cover the incision.