Device, surgical access port, and method of retracting an incision into an opening and providing a channel through the incision

• US 5,906,577 A
• Filed: 04/30/1997
• Issued: 05/25/1999
• Est. Priority Date: 04/30/1997
• Status: Expired due to Term

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson), University Of Massachusetts
• Original Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC), University Of Massachusetts
• Inventors: Verdura, Javier, Carroll, Maureen E., Beane, Richard, Ek, Steve, Niemann, Allison C., Stamm, Edward I. Jr., Hasslinger, Randall J.
• Primary Examiner(s): Smith, Jeffrey A.
• Application Number:
  US08/847,155
• Time in Patent Office: 755 Days
• Field of Search: 600/201, 600/207, 600/208, 600/235, 600/245, 128/850, 128/852, 128/856, 128/887, 606/213
• US Class Current: 600/207
• 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 17/0293 with ring member to support retractor elements
• 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 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/3419 Sealing means between cannula and body
• CPC Class Codes: A61B 2017/3466 for simultaneous sealing of multiple instruments
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2090/306 using optical fibres
• CPC Class Codes: A61B 42/00 Surgical gloves; Finger-stalls specially adapted for surgery; Devices for handling or treatment thereof
• CPC Class Codes: A61B 42/10 Surgical gloves
• CPC Class Codes: A61B 90/40 Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment

Abstract

A device for retracting edges of an incision in a surface to form an opening including: a flexible, tubular skirt having an upper end, a lower end, and a channel therebetween; a ring connected to the lower end of the skirt for maintaining the lower end in an open configuration and defining an exit opening to the channel; and an inflatable collar connected to the skirt and surrounding the upper end. The ring is designed to fit through the incision and remain under the surface when it is oriented parallel to surface. The collar, when inflated, maintains the upper end in an open configuration and defines an entry opening to the channel. During use, the ring is inserted through the incision and the collar is inflated while remaining outside of the incision, thereby drawing the skirt against the edges of the incision and retracting the edges of the incision to form the opening. The retracting device can be included in a surgical access port, which further includes a flexible sleeve connected to at least one of the inflatable collar and the skirt, extending the channel from the exit opening of the skirt to an open end of the flexible sleeve distal to the skirt. The device can include a light source in the vicinity of the exit opening.

Claims

1. A device for retracting edges of an incision in a surface to form an opening, the device comprising:

a flexible, tubular skirt having an upper end, a lower end, and a channel therebetween;

a non-inflatable ring connected to the lower end of the skirt for maintaining the lower end in an open configuration and defining an exit opening to the channel, wherein the ring is designed to fit through the incision and remain under the surface when it is oriented parallel to surface and is configured to contact an underside of the surface; and

an inflatable collar connected to the skirt and surrounding the upper end, wherein the collar, when fully inflated, maintains the upper end in an open configuration and defines an entry opening to the channel.

2. The device of claim 1, wherein the collar when fully inflated has an inner aperture having a diameter greater than the length of the incision.

3. The device of claim 1, further comprising a light source connected to the lower end of the skirt.

4. The device of claim 3, wherein the light source is a fiber optic cable.

5. The device of claim 1, wherein the skirt includes a hem-shaped pocket that encloses the ring.

6. The device of claim 1, wherein the ring has a substantially elliptical shape.

7. The device of claim 1, further comprising a second ring adjacent to an outer perimeter of the inflatable collar for reinforcing the entry opening.

8. The device of claim 7, further comprising a detachable cap for sealing the entry opening, wherein the detachable cap is adapted to be received by the second ring.

9. The device of claim 1, further comprising an inflatable cuff connected to an inner wall of the skirt and surrounding the entry opening for sealing around a surgeon'"'"'s arm inserted into the channel.

10. The device of claim 9, further comprising a detachable plug covering the entry opening, wherein the detachable plug is adapted to be received by the inflatable cuff.

11. A surgical access port comprising:

the device of claim 1; and

a flexible sleeve connected to at least one of the inflatable collar and the skirt, extending the channel from the exit opening of the skirt to an open end of the flexible sleeve distal to the skirt.

12. The access port of claim 11, wherein the flexible sleeve can be removed and reattached to the device of claim 1.

13. The access port of claim 11, wherein the flexible sleeve includes an inner sleeve and an outer sleeve forming a chamber therebetween, and an inlet port for inflating the chamber, whereby inflating the chamber compresses together a central portion of the inner sleeve, thereby sealing the channel.

14. The access port of claim 13, further comprising a pair of drawstrings attached to opposite sides of the central portion of the inner sleeve and pulling the sides in opposite directions toward the outer sleeve, thereby collapsing the central portion of the inner sleeve into two flattened portions contacting each other to form a seal.

15. The access port of claim 13, wherein the central portion of the inner sleeve includes two sealed regions opposite one another in which immediately adjacent portions of the inner sleeve are welded together, thereby dividing the central portion into two substantially flattened portions extending along the length of the channel adjacent to one another.

16. The access port of claim 11, further comprising a flap valve that connects to the open end of the flexible sleeve and extends into the channel, wherein the flap valve seals the channel when there is a positive pressure differential between the channel and the surroundings.

17. The access port of claim 16, further comprising a pair of drawstrings attached to opposite ends of the flap valve and pulling the ends in opposite directions to enhance the sealing ability of the flap valve.

18. The access port of claim 11, further comprising a light source connected to the skirt in the vicinity of the exit opening.

19. The access port of claim 11, wherein the flexible sleeve comprises an iris valve.

20. The access port of claim 11, further comprising an inflatable cuff attached to an inner surface of the sleeve for sealing around a surgeon'"'"'s arm.

21. The access port of claim 20, wherein the inflatable cuff is surrounded by a backing of a substantially non-expandable material.

22. The access port of claim 21, further comprising a second ring connected to the sleeve and surrounding the open end of the sleeve.

23. The access port of claim 22, further comprising a detachable cap for sealing the open end of the sleeve, wherein the detachable cap is adapted to be received by the second ring.

24. The access port of claim 11, further comprising:

a sealing collar attached to the sleeve and surrounding the open end, said sealing collar having a groove along its inner perimeter; and

a glove comprising a flange at the open end of the glove that mates with the groove and seals the channel when inserted into the groove.

25. The access port of claim 11, further comprising:

a sealing collar attached to the sleeve and surrounding the open end, said sealing collar including an inwardly expanding inflatable bladder; and

a glove having an enlarged cuff, wherein when the glove is inserted into the sleeve, the enlarged cuff mates with the inflated bladder and seals the opening.

26. The access port of claim 11, further comprising:

a sealing collar attached to the sleeve and surrounding the open end, said sealing collar having a groove along its inner perimeter;

a bracelet having a fixed diameter that mates with the groove; and

a glove, wherein during use the bracelet is worn by a surgeon underneath the glove and is mated to the sealing collar, a portion of the glove being held within the groove by the bracelet, thereby sealing the channel.

27. A surgical access port, for use with a surgical glove, comprising:

a device for retracting the edges of a surgical incision to form an opening into a patient'"'"'s body cavity;

a sealing sleeve attached to the device external to the body cavity, wherein the sealing sleeve comprises,

a flexible sleeve providing a channel from its open end distal to the retracting device through to the opening, and

a sealing collar attached to the sleeve and surrounding the open end; and

a semi-rigid bracelet separable from the glove and having a fixed diameter that releasably mates with the sealing collar, the bracelet being configured to fasten a portion of the glove to the sealing collar when worn beneath the glove and mated to the sealing collar.

28. The access port of claim 27, further comprising the glove.

29. A method of using the surgical access port of claim 27, comprising the steps of:

placing the bracelet around an arm of the surgeon;

placing the glove over a hand of the surgeon so that the glove extends over the bracelet;

inserting the gloved hand into the access port; and

attaching the portion of the inserted glove to the access port by mating the bracelet with the sealing collar of the access port.

30. A surgical access port comprising:

a device for retracting the edges of a surgical incision to form an opening into a patient'"'"'s body cavity, the retracting device comprising an upper portion for overlying tissue surrounding the incision, a lower portion for underlying the tissue surrounding the incision, and a flexible skirt connecting the upper and lower portion, all of which permit the retracting device to form a gas-tight seal with the edges of the incision; and

a sealing sleeve attached to the device external to the body cavity, wherein the sealing sleeve comprises;

a flexible sleeve providing a channel from its open end distal to the retracting device through to the opening; and

drawstrings connected to the flexible sleeve for sealing the channel.

31. A surgical access port comprising:

a device for retracting the edges of a surgical incision to form an opening into a patient'"'"'s body cavity; and

a sealing sleeve attached to the device external to the body cavity, wherein the sealing sleeve comprises;

a flexible sleeve providing a channel from its open end distal to the retracting device through to the opening;

drawstrings connected to the flexible sleeve for sealing the channel; and

an outer sleeve surrounding the flexible sleeve and forming a chamber therebetween, and an inlet port for inflating the chamber, whereby inflating the chamber compresses together a central portion of the flexible sleeve, thereby sealing the channel, and wherein the drawstrings attach to opposite sides of the central portion of the flexible sleeve.

32. A surgical access port comprising:

a device for retracting the edges of a surgical incision to form an opening into a patient'"'"'s body cavity; and

a sealing sleeve attached to the device external to the body cavity, wherein the sealing sleeve comprises;

a flexible sleeve providing a channel from its open end distal to the retracting device through to the opening;

drawstrings connected to the flexible sleeve for sealing the channel; and

a flap valve that connects to the open end of the flexible sleeve and extends into the channel, wherein the flap valve seals the channel when there is a positive pressure differential between the channel and the surroundings, and wherein the drawstrings attach to opposite ends of the flap valve to enhance the sealing ability of the flap valve.

33. A device for retracting edges of an incision in a surface to form an open channel, the device comprising:

an upper toroidal portion for positioning above the surface around the incision, the upper toroidal portion defining and enclosing an inflatable, sealed interior;

a lower portion insertable through the incision and orientable to underlie the surface beneath the incision; and

a flexible, gas-tight tubular skirt having an upper end connected to the upper toroidal portion and a lower end connected to the lower portion, wherein during use the lower portion maintains the lower end in an open configuration, the upper toroidal portion, lower portion, and skirt defining an open channel extending through the incision, the channel having side-walls that are gas impermeable.

34. The device of claim 33, wherein the upper toroidal portion includes an inflation port for inflating the sealed interior.

35. The device of claim 33, wherein the lower portion is non-inflatable.

36. The device of claim 33, wherein the upper toroidal portion comprises two superimposed, inflatable collars.

37. A surgical access port comprising:

the device of claim 33; and

a flexible, gas-tight sleeve connected to the device and extending the channel away from the incision.

38. The access port of claim 37, wherein the sleeve is releasably connected to the device.

39. A surgical access port comprising:

the device of claim 36; and

a flexible, gas-tight sleeve connected to the device and extending the channel away from the incision, wherein the sleeve comprises a resilient ring configured to releasably attached to a groove formed between the two superimposed collars.

40. A method of retracting an incision into an opening and providing a channel through the incision, the channel having gas-impermeable sides and the method comprising:

inserting a ring at one end of a gas-tight tubular skirt through the incision and orienting the ring to underlie and contact tissue surrounding the incision;

orientating a toroidal upper portion at an opposite end of the gas-tight tubular skirt to overlie and contact tissue surrounding the incision; and

expanding the toroidal upper portion, while maintaining the contact between the toroidal upper portion and the tissue surrounding the incision, to thereby draw the skirt outward from the incision, retract the incision into an opening, and provide the channel through the incision.

41. The method of claim 40, wherein the ring is non-inflatable.

42. A method of performing minimally invasive surgery, the method comprising:

retracting an incision and providing a channel into the incision using the method of claim 40;

releasably attaching a sleeve to the upper portion to extend the channel away from the incision, wherein the extended channel has gas-impermeable sides; and

accessing an interior of a patient through the channel.

43. The method of claim 42, further comprising insufflating the interior of the patient.