Split hoop wound retractor with gel pad

• US 7,909,760 B2
• Filed: 10/12/2006
• Issued: 03/22/2011
• Est. Priority Date: 10/14/2005
• Status: Active Grant

• Current Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Original Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Inventors: Brustad, John R, Albrecht, Jeremy J., Gadberry, Donald L., Ko, Jennifer T., Johnson, Gary M.
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): NEGRELLIRODRIGUEZ, CHRISTINA
• Application Number:
  US11/548,758
• Publication Number:
  US 20070185387A1
• Time in Patent Office: 1,622 Days
• Field of Search: 600/203, 600205-208, 600 21- 22, 600/201, 600/215, 600/225, 600/231, 600/233
• US Class Current: 600/208
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• 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 17/0293 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 17/3439 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 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 17/3496 Protecting sleeves or inner probes; Retractable tips for protecting body piercing guide needles A61M25/0612
• 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 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/0225 flexible, e.g. fabrics, meshes, or membranes
• CPC Class Codes: A61B 2017/0287 with elastic retracting members connectable to a frame, e.g. hooked elastic wires
• CPC Class Codes: A61B 2017/3419 Sealing means between cannula and body
• CPC Class Codes: A61B 2017/347 Locking means, e.g. for locking instrument in cannula
• CPC Class Codes: A61B 2050/005 with a lid or cover
• CPC Class Codes: A61B 2050/0051 closable by rotation
• CPC Class Codes: A61B 90/40 Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment

Abstract

An incrementally adjustable wound retractor, which provides access to a body cavity, includes an inner ring having a diameter greater than the desired diameter of the wound incision, an outer ring having an annular axis and a diameter greater than the desired diameter of the wound incision, and a flexible sleeve disposed in a generally cylindrical form between the inner and outer rings. The outer ring includes first and second circular tubes spaced apart axially with each including a lumen having a rigid, noncompliant split hoop placed therein. The outer ring may be rolled over itself and around the annular axis to retract the sleeve with sufficient force to stretch the incision to the desired diameter. A gel cap seal may be coupled to the outer ring outside of the biological body to seal the opening produced by the wound retractor between the body cavity and outside the body cavity.

Claims

1. A surgical access device, comprising:

a wound retractor for retracting an opening in a biological body wall, the wound retractor having,

an outer ring having an annular axis and adapted for juxtaposition with an outer surface of the biological body wall,

an inner ring adapted for juxtaposition with an inner surface of the biological body wall, and

a sleeve coupling the outer ring to the inner ring, the sleeve being adapted to traverse the opening in the body wall,

wherein the outer ring has a neutral state, in which the outer ring is substantially noncompliant, and a transitional state, in which the outer ring is rolled over itself around the annular axis, thereby rolling the sleeve around the outer ring to retract and seal the opening in the body wall; and

a gel cap adapted for direct attachment to the outer ring of the wound retractor in the neutral state, the gel cap having,

a cap ring adapted to be coupled to the outer ring of the wound retractor,

a lip disposed at a distal end of the cap ring, the lip curving radially inward from a wall of the cap ring and extending around a portion of a circumference thereof,

a lever spaced from the lip of the cap ring and pivotably coupled to the cap ring, the lever pivoting on a plane that is perpendicular to a longitudinal axis of the cap ring, the lever comprising a flat, distal lip positioned at a distal end of the lever and lying in a plane that is positioned perpendicular to the longitudinal axis of the cap ring, and

a gel pad coupled to the cap ring, the gel pad being made of a gel material, the gel pad including an access portion for providing a passage from external the body to a body cavity, the passage forming an instrument seal in the presence of an instrument inserted therethrough and a zero seal in the absence of an instrument inserted therethrough, wherein

in an open state, the lever is pivoted outwardly, away from a body of the cap ring, and

in a closed state, with the outer ring of the wound retractor positioned within the cap ring, the lever is pivoted toward the cap ring such that the distal lip of the lever protrudes radially inwardly from the body of the cap ring, and the lip of the cap ring and the distal lip of the lever abut the distal surface of the outer ring of the wound retractor, thereby securing the gel cap to the wound retractor.

2. The surgical access device of claim 1, the outer ring of the wound retractor having a lumen, and further comprising:

a substantially noncompliant hoop positioned in the lumen of the outer ring of the wound retractor.

3. The surgical access device of claim 2, the outer ring of the wound retractor having two lumens, and further comprising:

a substantially noncompliant hoop positioned in each of the two lumens of the outer ring of the wound retractor.

4. The surgical access device of claim 1, the sleeve including a material that is flexible and impermeable to fluids and bacteria.

5. The surgical access device of claim 1, the inner ring being made of materials having sufficient hardness to retain the shape of the inner ring after insertion of the inner ring into a body cavity.

6. The surgical access device of claim 1, the outer ring being made of materials that allow the outer ring to be turned around its annular axis.

7. The surgical access device of claim 1, wherein the lip of the cap ring and the lip of the lever being configured to receive the outer ring of the wound retractor such that the outer ring of the wound retractor is positioned between the lip of the cap ring and the lip of the lever at a distal end and the gel pad at a proximal end.

8. The surgical access device of claim 1, wherein a distal portion of the cap ring is adapted to receive the outer ring of the wound retractor such that the outer ring of the wound retractor embeds into the gel pad and displaces the gel, thereby forming a seal between the gel pad and the outer ring and sleeve of the wound retractor.

9. The surgical access device of claim 1, the access portion of the gel pad including a plurality of intersecting dead-end slits.

10. The surgical access device of claim 1, wherein the gel pad covers and seals the entire opening in the cap ring.

11. The surgical access device of claim 1, wherein the gel pad is adapted to cover the entire surgical opening.

12. The surgical access device of claim 1, the outer surface of the cap ring including a lug, the lever being coupled to the lug.

13. The surgical access device of claim 1, the lever including locking means for facilitating prevention of unintended opening of the lever from the second state to the first state.

14. The surgical access device of claim 1, the gel cap including more than one lever with the levers being equally spaced between each other and the lip on the cap ring.

15. The surgical access device of claim 1, wherein the lever is substantially opposite the lip on the cap ring.

16. A surgical access device, comprising:

a wound retractor for retracting an opening in a biological body wall, the wound retractor having

an outer ring having an annular axis and adapted to be positioned near a proximal surface of the biological body wall,

an inner ring adapted to be positioned near a distal surface of the biological body wall, and

a sleeve coupling the outer ring to the inner ring,

wherein the outer ring has a neutral state, in which the outer ring is substantially noncompliant, and a transitional state, in which the outer ring is rolling over itself around the annular axis, thereby rolling the sleeve around the outer ring to retract and seal the opening in the body wall; and

a gel cap adapted for being attached to the outer ring of the wound retractor in the neutral state, the gel cap having

a cap ring adapted to be coupled to the outer ring of the wound retractor,

a lever pivotably coupled to the cap ring, and

a gel pad coupled to the cap ring and including an access portion for providing a passage from external the body to a body cavity, the passage forming an instrument seal in the presence of an instrument inserted therethrough and a zero seal in the absence of an instrument inserted therethrough,

wherein the outer ring of the wound retractor is configured to be positioned within the cap ring such that pivoting the lever relative to the cap ring secures the gel cap to the wound retractor.

17. A surgical access device, comprising:

a wound retractor for retracting an opening in a biological body wall, the wound retractor comprising;

an outer ring having an annular axis and adapted to be positioned proximally of a proximal surface of the biological body wall,

an inner ring adapted to be positioned distally of a distal surface of the biological body wall, and

a sleeve coupling the outer ring to the inner ring,

wherein the outer ring has a neutral state, in which the outer ring is substantially noncompliant, and a transitional state, in which the outer ring is rolling over itself around the annular axis, thereby rolling the sleeve around the outer ring to retract and seal the opening in the body wall; and

a sealing cap adapted for being coupled to the outer ring of the wound retractor in the neutral state.

18. The surgical access device of claim 17, wherein the sealing cap comprises a gel seal including an access portion for providing a passage from external the body to a body cavity, the passage forming an instrument seal in the presence of an instrument inserted therethrough and a zero seal in the absence of an instrument inserted therethrough.

19. The surgical access device of claim 17, wherein the sealing cap comprises a lever.

20. The surgical access device of claim 17, further comprising a wound retractor having an outer ring, an inner ring, and a sleeve, wherein the outer ring has a neutral state in which the outer ring is substantially noncompliant and a transitional state in which the outer ring is rolling over itself around the annular axis thereby rolling a sleeve around the outer ring to retract and seal an opening in a body wall.

21. A surgical access device, comprising:

a wound retractor for retracting an opening in a biological body wall, the wound retractor comprising;

an outer ring having an annular axis and adapted to be positioned proximally of a proximal surface of the biological body wall,

an inner ring adapted to be positioned distally of a distal surface of the biological body wall, and

a sleeve coupling the outer ring to the inner ring,

wherein the outer ring has a neutral state, in which the outer ring is substantially noncompliant, and a transitional state, in which the outer ring is rolling over itself around the annular axis, thereby rolling the sleeve around the outer ring to retract and seal the opening in the body wall.

22. The surgical access device of claim 21, the outer ring of the wound retractor having a lumen, and further comprising:

a substantially noncompliant hoop positioned in the lumen of the outer ring of the wound retractor.

23. The surgical access device of claim 22, the outer ring of the wound retractor having two lumens, and further comprising:

a substantially noncompliant hoop positioned in each of the two lumens of the outer ring of the wound retractor.

24. The surgical access device of claim 23, further comprising a sealing cap adapted for being coupled to the outer ring of the wound retractor in the neutral state.

25. The surgical access device of claim 24, wherein the sealing cap comprises a gel seal.

26. A surgical access device, comprising:

a gel cap adapted for being attached to an outer ring of a wound retractor having a neutral state in which the outer ring is substantially noncompliant and a transitional state in which the outer ring is rolling over itself around an annular axis thereby rolling a sleeve around the outer ring to retract and seal an opening in a body wall, the gel cap comprising

a cap ring adapted to be coupled to the outer ring of the wound retractor, and

a gel pad coupled to the cap ring and including an access portion for providing a passage from external the body to a body cavity, the passage forming an instrument seal in the presence of an instrument inserted therethrough and a zero seal in the absence of an instrument inserted therethrough,

wherein the gel cap further comprises a lever pivotably coupled to the cap ring, and wherein the cap ring is configured to be positioned around the outer ring of the wound retractor such that pivoting the lever relative to the cap ring secures the gel cap to the wound retractor.