Access port device for use in surgery

• US 5,803,921 A
• Filed: 05/08/1995
• Issued: 09/08/1998
• Est. Priority Date: 02/18/1994
• Status: Expired due to Fees

• Current Assignee: Gaya Limited
• Original Assignee: Gaya Limited
• Inventors: Bonadio, Frank
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Shai, Daphna
• Application Number:
  US08/433,498
• Time in Patent Office: 1,219 Days
• Field of Search: 626/1, 626/108, 626/185, 626/213, 604/167, 604/169, 604/174, 604/180, 18/850, 18/853, 18/584, 18/856
• US Class Current: 606/1
• 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 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 17/3498 Valves therefor, e.g. flapper valves, slide valves haemostasis valves A61M39/06; check valves A61M39/24
• CPC Class Codes: A61B 2017/2931 with releasable head
• CPC Class Codes: A61B 2017/3419 Sealing means between cannula and body
• CPC Class Codes: A61B 2017/348 Means for supporting the trocar against the body or retaining the trocar inside the body
• CPC Class Codes: A61B 2046/205 Adhesive drapes
• CPC Class Codes: A61B 46/13 the drapes entering the patient's body
• CPC Class Codes: A61B 46/23 with means to retain or hold surgical implements
• CPC Class Codes: A61B 90/40 Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment

Abstract

An access port device (40) for use in surgery is provided which comprises a sleeve (41,42) having an exit opening located at a distal end thereof for insertion into an incision made in a patient'"'"'s body, the exit opening allowing access to the patient'"'"'s body cavity. The device (40) also includes exit opening sealing means for insertion into the incision. There is an entry opening located at a proximal end of the sleeve (41,42) and entry sealing means for sealing the device in the region of the entry opening, so that when the patient'"'"'s body cavity is inflated by gas, the exit sealing means and the entry sealing means prevent substantial leakage of gas from the patient'"'"'s body cavity while the entry sealing means also provides access for a surgeon'"'"'s hand or surgical instrument and sealing about the arm remaining outside the access port device. The invention also relates to surgical instruments for use with such an access port and to a surgical drape for use in surgery using the access port and instruments of the invention.

Claims

1. An access port for use in surgery comprising:

an elongate sleeve of flexible material having an entry opening located at a proximal end of the sleeve and an exit opening located at a distal end of said sleeve,

an inflatable chamber surrounding said sleeve and extending substantially coaxially therewith from the proximal end of the sleeve for a distance along the length of said sleeve, said inflatable chamber when inflated operating to collapse said sleeve to close said entry opening, said sleeve being attached to and surrounded by said inflatable chamber with said sleeve extending through said inflatable chamber and outwardly therefrom to provide a projecting flexible sleeve portion extending outwardly from the inflatable chamber to the exit opening at the distal end of said sleeve whereby said projecting sleeve portion can be inserted through an incision and into a patient'"'"'s body cavity to provide a flexible sleeve portion adjacent to said exit opening within said body cavity free of a surrounding inflatable chamber.

2. An access port according to claim 1, wherein the inflatable chamber is of generally "hour-glass" profile defining an upper chamber and a lower chamber, the lower chamber being insertable into the incision made in the patient'"'"'s body cavity.

3. The access port of claim 2 wherein a laterally extending flange is secured to said upper chamber in spaced relationship to said lower chamber to affix the access port externally to a patient.

4. An access port as claimed in claim 1 wherein said sleeve is formed with two opposed, substantially flat sleeve sidewalls which collapse together into contact in response to pressure in said inflatable chamber.

5. An access port as claimed in claim 4 wherein said entry opening and access opening are elongate openings defined by the sleeve sidewalls of said sleeve.

6. The access port of claim 5 wherein the sleeve sidewalls of said sleeve are formed to provide a flap valve at said exit opening.

7. The access port of claim 6 wherein a flange is secured to said inflatable chamber in spaced relationship to the proximal end of said sleeve, for affixing the access port externally to a patient, said flange extending laterally relative to said projecting sleeve portion.

8. The access port of claim 4 wherein said sleeve forms an inner wall for said inflatable chamber, said inflatable chamber having a chamber outer wall including two flat chamber sidewalls coextensive with said sleeve sidewalls.

9. The access port of claim 8 wherein said sleeve sidewalls and chamber sidewalls are sheets of gas impermeable flexible material bonded at their common side edges and proximal ends.

10. The access port of claim 8 wherein the sleeve sidewalls of said sleeve are formed to provide a flap valve at said exit opening.

11. The access port of claim 10 wherein at least a first flap valve is formed within said sleeve to close said sleeve, said first flap valve being positioned in spaced relationship to the proximal and distal ends of said sleeve.

12. The access port of claim 11 wherein opposite sides of said sleeve are connected to the chamber outer wall at a location spaced from said sleeve proximal end so as to divide the inflatable chamber into upper and lower subchambers in fluid communication.

13. The access port of claim 12 wherein a flange is secured to said inflatable chamber in spaced relationship to the proximal end of said sleeve, for affixing the access port externally to a patient, said flange extending laterally relative to said projecting sleeve portion.

14. An access port as claimed in claim 13 wherein the sleeve sidewalls of said sleeve are formed to be wider adjacent to said exit opening to provide a wider section of said sleeve on said projecting flexible sleeve portion.

15. The access port of claim 14 wherein resilient tensioning units are secured to the projecting sleeve portion of said sleeve to force said sleeve sidewalls into contact at said exit opening.

16. An access port as claimed in claim 12 in which a separate tensioning device is provided in the distal region of the sleeve spaced from the distal edge to place the sleeve sidewalls under a generally transverse tension thereby creating a taut region across the sleeve operable as a further seal as part of an exit sealing means.

17. An access port as claimed in claim 16 in which the tensioning device comprises a pair of opposed arcuate bands operable to prevent retraction of the sleeve from the abdominal cavity.

18. An access port as claimed in claim 17 in which laterally projecting wings are provided at the side edges of the sleeve to provide anchoring points for the opposed arcuate bands.

19. An access port as claimed in claim 4 wherein the sleeve sidewalls of said sleeve are formed to be wider adjacent to said exit opening to provide a wider section of said sleeve on said projecting flexible sleeve portion.

20. The access port of claim 4 wherein the sleeve sidewalls of said sleeve are formed to provide a flap valve at said exit opening.

21. The access port of claim 20 wherein resilient tensioning units are secured to the projecting sleeve portion of said sleeve to force said sleeve sidewalls into contact at said exit opening.

22. The access port of claim 1 wherein a flange is secured to said inflatable chamber in spaced relationship to the proximal end of said sleeve, for affixing the access port externally to a patient, said flange extending laterally relative to said projecting sleeve portion.

23. The access port of claim 22 wherein said flange extends around but is spaced from said sleeve, said flange being oval in configuration.

24. The access port of claim 1 wherein said inflatable chamber includes chamber walls forming an enclosed inflatable chamber that in use is not in fluid communication with a patient'"'"'s body cavity whereby the pressure in the inflatable chamber may be different from the pressure in the patient'"'"'s body cavity, a pressure inlet being mounted on a chamber wall of said inflatable chamber.

25. The access port of claim 1 wherein said inflatable chamber extends to a lowermost chamber end which surrounds and is spaced from said sleeve, the projecting flexible sleeve portion extending outwardly from said lowermost chamber end, and a laterally extending flange is secured to said lowermost chamber end for affixing the access port externally to a patient, said flange being spaced from said sleeve.

26. The access port of claim 1 wherein at least a first flap valve is formed within said sleeve to close said sleeve, said first flap valve being positioned in spaced relationship to the proximal and distal ends of said sleeve.

27. The access port of claim 26 wherein said sleeve is formed with two opposed substantially flat sidewalls, the sidewalls of said sleeve being formed to provide a second flap valve at said exit opening.

28. The access port of claim 27 wherein said first flap valve is positioned in spaced relationship between said entry opening and said projecting flexible sleeve portion.

29. The access port of claim 28 wherein said first flap valve is formed of first and second sheets of flexible material each having a tethered end and a free end, the tethered end of said first sheet being connected to one of said sleeve sidewalls and the tethered end of said second sheet being connected to the remaining sleeve sidewall, the free ends of said sheets engaging to close said sleeve at a point spaced from said tethered ends in the direction of the distal end of said sleeve.

30. The access port of claim 1 wherein said inflatable chamber includes chamber walls forming an enclosed inflatable chamber that in use is not in fluid communication with a patient'"'"'s body cavity whereby the pressure in the inflatable chamber may be different from the pressure in the patient'"'"'s body cavity, a pressure inlet being mounted on a chamber wall of said enclosed inflatable chamber.

31. The access port of claim 30 wherein at least a first flap valve is formed within said sleeve to close said sleeve, said first flap valve being positioned in spaced relationship to the proximal and distal ends of said sleeve.

32. The access port of claim 1 wherein said sleeve forms an inner wall for said inflatable chamber, said inflatable chamber having a chamber outer wall spaced from said sleeve and connected to said sleeve at the proximal end of said sleeve.

33. The access port of claim 32 wherein opposite sides of said sleeve are connected to the chamber outer wall at a location spaced from said sleeve proximal end so as to divide the inflatable chamber into upper and lower subchambers in fluid communication.

34. The access port of claim 33 wherein the opposite sides of the sleeve are connected to the chamber outer wall at a plurality of opposite spaced locations.

35. An access port for use in surgery comprising:

an inflatable chamber having two, flexible, opposed substantially flat chamber inner sidewalls which collapse together into contact in response to pressure in said inflatable chamber, said inner chamber sidewalls defining a passage through said inflatable chamber between a chamber entry opening and a chamber exit opening at a chamber exit end;

and a flexible non-inflatable extension section secured to the chamber exit end of said inflatable chamber in communication with the passage therethrough, said extension section being adapted to be inserted through an incision into a patient'"'"'s body cavity to provide a flexible sleeve portion extending outwardly from the inflatable chamber, said extension section having a sleeve entry opening and a sleeve exit opening and two substantially flat, flexible sidewalls which form a flap valve at said sleeve exit opening.

36. An access port as claimed by claim 35 wherein the inner chamber sidewalls form a second flap valve at said chamber exit.

37. An access port as claimed by claim 36 wherein a laterally projecting chamber flange is connected to said inflatable chamber to surround said chamber exit opening and a laterally projecting extension section flange is secured to said extension section to surround said sleeve entry opening, said chamber and extension flanges being secured together.

38. An access port device for use in surgery comprising a sleeve having an entry opening located at a proximal end of the sleeve and having an exit opening located at a distal end thereof for insertion into an incision made in a patient'"'"'s body, the exit opening allowing access to the patient'"'"'s body cavity, characterized in that the device includes exit opening sealing means provided by the sleeve being collapsible on itself by gas pressure within the abdominal cavity of the patient at or adjacent the distal edges of the sleeve, the sleeve being formed by sheets of flexible, gas impermeable, sterilisable, biocompatible material having joined side edges which are collapsible together by gas pressure within the abdominal cavity of the patient at or adjacent, the distal end of the sleeve so as to provide a seal, whereby when the patient'"'"'s body cavity is inflated by gas, the exit sealing means prevents substantial leakage of gas from the patient'"'"'s body cavity through the sleeve while providing access for a surgeon'"'"'s hand or surgical instrument.

39. An access port as claimed in claim 38 having entry sealing means for sealing the sleeve in a region adjacent to the entry opening, whereby when the patient'"'"'s body cavity is inflated by gas, the entry sealing means assists in preventing substantial leakage of gas from the patient'"'"'s body cavity while providing access for a surgeon'"'"'s hand while sealing about a surgeon'"'"'s arm which extends outside the access port device.

40. An access port as claimed in claim 39, wherein the entry sealing means comprises an inflatable chamber arranged in surrounding relation to the sleeve and capable of exerting a pressure on the sleeve causing at least a portion of it to contract thereby sealing the entry opening.

41. An access port as claimed in claim 40 in which a separate tensioning device is provided adjacent to the distal end of the sleeve spaced from the exit opening to place the sheets forming the sleeve under a generally transverse tension thereby creating a taut region across the sleeve operable as a further seal as part of the exit sealing means.

42. An access port as claimed in claim 41 in which the tensioning device comprises a pair of opposed arcuate bands operable to prevent retraction of the sleeve from the abdominal cavity.

43. An access port as claimed in claim 42 in which laterally extending wings are provided at the side edges of the sleeve to provide anchoring points for the opposed arcuate bands.