Surgical access apparatus and method

• US 20040015185A1
• Filed: 03/20/2003
• Published: 01/22/2004
• Est. Priority Date: 10/19/2000
• Status: Active Grant

• Current Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Original Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Inventors: Bowes, Robert R., Pingleton, Edward D., Brustad, John R., Hilal, Nabil, Dulak, Gary R., Adlparvar, Payam, Ewers, Richard C.
• Granted Patent: US 7,473,221 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• 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 17/3474 Insufflating needles, e.g. Veress needles
• 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 2017/00265 Hand assisted surgery, i.e. minimally invasive surgery with at least part of an assisting hand inside the body
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/3419 Sealing means between cannula and body
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments catheters A61B2017/22072
• CPC Class Codes: A61B 2017/3492 against the outside of the body
• CPC Class Codes: A61M 13/003 Blowing gases other than for carrying powders, e.g. for inflating, dilating or rinsing

Abstract

A surgical access device includes a single valve that forms a seal with the body wall and provides an access charnel into a body cavity. The valve has properties for creating a zero seal in the absence of an instrument as well as an instrument seal with instruments having a full range of instrument diameter. The valve can include a gel and preferably an ultragel comprised of an elastomer and an oil providing elongation greater than 1000 percent and durometer less than 5 Shore A. The shore valve can be used as a hand port where the instrument comprises the arm of a surgeon, thereby providing hand access into the cavity.

A method for making the surgical access device includes the combining or a gelling agent with an oil, preferably in a molding process. A method for using the device includes steps for creating an opening with the instrument. In a particular process, an organ can be removed from the body cavity through the single valve to create an organ seal while the organ is addressed externally of the body cavity. The valve and method are particularly adapted for laparoscopic surgery wherein the abdominal cavity is insufflated with a gas thereby requiring the zero seal, the instrument seal, and the organ seal in various procedures.

Claims

1. A surgical access device adapted for disposition relative to an incision in a patient, the access device facilitating insertion of a hand of the surgeon through the access device and maintenance of a sealing relationship with an arm of the surgeon, comprising:

a valve including a gel material having portions defining an access channel;

the access channel having a length not less than about one-quarter inch and extending into communication with the incision in the patient; and

the gel material including an elastomer.

2. The surgical access device recited in claim 1, wherein the elastomer includes a silicone.

3. The surgical access device recited in claim 1, wherein the elastomer includes a urethane.

4. The surgical access device recited in claim 3, further comprising a foaming agent forming with the urethane a foam gel.

5. The surgical access device recited in claim 1, wherein the gel includes at least one of a urethane, polyvinylchloride, Isoprene, Kraton an oil, and a foaming agent.

6. The surgical access device recited in claim 1, wherein the elastomer includes:

a base; and

an oil forming with the base an elastomeric oil mixture.

7. The surgical access device recited in claim 6, wherein the oil includes at least one of:

a vegetable oil, a petroleum oil, and a silicone oil.

8. A surgical access device facilitating insertion of a surgeon'"'"'s hand through the hand port in a sealing relationship with the surgeon'"'"'s arm during laparoscopic surgery through an incision in an abdominal wall of a patient, the access device comprising:

a valve structure forming a pad adapted to be disposed over the incision and to form a seal around the incision;

the pad including a gel material having portions defining an access channel through the pad and extending into communication with the incision in the patient, the gel material providing the pad with properties including lubricity, appearance wound treatment, anti-cancer protection, and antimicrobial protection; and

an additive disposed relative to the gel material and having properties for modifying at least one of the properties of lubricity, appearance, wound treatment, anti-cancer protection, and antimicrobial protection, of the pad.

9. The surgical access device recited in claim 8, wherein the additive includes at least one of a powder, cornstarch and a fine particulate.

10. The surgical access device recited in claim 9, wherein the additive is disposed on the elastomer as a surface treatment.

11. The surgical access device recited in claim 8, wherein the additive is a mechanical device disposed in the elastomer.

51. The surgical access device recited in claim 9, wherein the elastomeric oil mixture has a durometer less than about 5 Shore A.

12. A surgical access device facilitating a sealing relationship Edith an instrument extending through the device and into an incision into a body wall of the patient, the access device comprising:

a valve structure disposed relative to the incision in a sealing relationship with the body wall around the incision;

a valve included in the valve structure and disposed relative to the incision in the body wall;

the valve having a first state in the absence of an instrument extending through the valve structure, and a second state in the presence of an instrument extending through the valve structure;

the single valve in the first state forming a zero seal in the absence of the instrument extending through the valve structure; and

the valve in the second state forming a seal with the instrument in the presence of the instrument extending through the access device

13. The surgical access device recited in claim 12, further comprising:

an external flange extending radially outwardly of the valve structure and adapted for disposition exteriorly of the body wall.

14. The surgical access device recited in claim 13, further comprising:

an interior flange extending radially outwardly of the valve structure and adaptive for operative disposition interiorly of the body wall.

15. The surgical access device recited in claim 14, wherein the access device in radial cross section has the general configuration of the letter “

H”

.

16. The surgical access device recited in claim 12, wherein:

the valve is a first valve including portions defining a slit; and

the valve structure further comprises a second valve having a duckbill configuration and being disposed distally at the first valve.

17. The surgical access device recited in claim 14, further comprising:

at least one support ring disposed in at last one of the interior flange and the exterior flange.

18. The surgical hand port recited in claim 14, wherein:

the interior flange has a first thickness;

the exterior flange has a second thickness greater than the first thickness of the interior flange

19. The surgical access device recited in claim 12, wherein the instrument comprises an arm of a surgeon.

20. A medical access device, including:

a tubular member having an elongate configuration;

at least one wall defining with the tubular member a working channel sized and configured to receive an instrument; and

an ultragel disposed in the working channel and being adapted to form a seal with any instrument disposed in the working channel

21. The medical access device recited in claim 20, wherein:

the ultragel has properties including any elongation of not less than about 1200 percent a durometer measurable on the Shore A scale.

22. The medical access device recited in claim 21, wherein:

the ultragel has properties including an elongation not less than about 1500 percent, a durometer of not greater than 200 Bloom.

23. A surgical hand port facilitating a sealing relationship with a surgeon'"'"'s arm extending through the hand port and into an incision in an abdominal wall of a patient, the hand port comprising:

a valve structure comprising only a single valve disposed relative to the incision in the abdominal wall, the single valve having a first state in the absence of the arm of the surgeon extending through the valve structure, and a second state in the presence of the arm of the surgeon extending through the valve structure;

means for coupling the valve structure to the abdominal wall in a sealing relationship with the abdominal wall around the incision;

the single valve in the first state forming a zero seal in the absence of the arm of the surgeon extending through the valve structure; and

the single valve structure in the second state forming an arm seal with the arm of the surgeon in the presence of the arm of the surgeon extending through the hand port.

24. The surgical hand port recited in claim 23, wherein the valve structure further comprises:

a gel;

portions of the gel, at least partially defining an opening through the valve structure; and

the opening defining portions of the gel having properties in the first state for sealing the opening in the absence of the arm of the surgeon extending through the opening.

25. The surgical hand port recited in claim 24, wherein the opening defining portions of the gel define the opening in the shape of at least one slit.

26. The surgical hand port recited in claim 25, wherein:

the valve structure is disposed generally in a first plane; and

the slit is defined in a second plane generally non-perpendicular to the first plane.

27. The surgical hand port recited in claim 25, wherein:

the valve structure is disposed generally in a first plane; and

the slit is defined in a second plane generally perpendicular to the first plan

28. The surgical hand port recited in claim 24, wherein the opening defining portions define the opening with a spiral configuration.

29. The surgical hand port recited in claim 24, wherein the opening defining portions define the opening with at least one pair of mating flappers

30. The surgical hand port recited in claim 24, wherein:

the valve structure has an axis;

the opening defining, portions define the openings generally as a line in radial cross section; and

the length of the line increases with progressive positions distally along the axis of the valve structure.

31. The surgical hand port recited in claim 23, wherein the zero seal and the arm seal have properties for inhibiting the escape of liquids and eases through the single seal.

32. The surgical hand port recited in claim 24, wherein the gel includes:

an elastomer; and

a foaming agent

33. The surgical hand port recited in claim 24, wherein the gel includes silicone

34. The surgical hand port recited in claim 24, wherein the gel includes an oil.

35. The surgical hand port recited in claim 23, wherein the coupling means includes an adhesive having properties for attaching the valve structure to the abdominal wall.

36. The surgical hand port recited in claim 24, further comprising:

at least one support ring disposed circumferentially of the valve structure to reinforce the single valve of the valve structure.

37. The surgical hand port recited in claim 24, wherein the gel is a thermoplastic elastomer

38. The surgical hand port recited in claim 28, further comprising a septum seal disposed across the spiral opening.

39. The surgical hand port recited in claim 24, wherein the gel is a thermoset elastomer

40. A surgical hand port facilitating insertion of a surgeon'"'"'s hand through the hand port in a sealing relationship with the surgeon'"'"'s arm during laparoscopic surgery through an incision in an abdominal wall of a patient, the hand port comprising:

a valve structure coupled to the abdominal wall in a sealing relationship with the abdominal wall around the incision;

the valve structure being disposed relative to the incision and forming with the incision an access channel, the valve structure having a first state in the absence of the arm of the surgeon extending through the valve structure and a second state in the presence of the arm of the surgeon extending through the valve structure;

the valve structure in the first state having properties for forming a gas seal with itself along the access channel;

the valve structure in the second state forming a gas seal with the arm of the surgeon extending through the hand port; and

first portions of the valve structure including a gel defining an opening through the valve structure to receive the arm of the surgeon;

41. The surgical hand port recited in claim 40, further comprising,

second portions of the valve structure defining a proximal cavity communicating with the opening defined by the first portions of the valve structure.

42. The surgical hand port recited in claim 41, wherein the cavity in radial cross section has the shape of a rectangle.

43. The surgical hand port recited in claim 41, wherein the cavity in radial cross section has the shape of a trapezoid.

44. The surgical hand port recited in claim 41, wherein:

the valve structure has an axis; and

the first portions of the gel define the opening along the axis.

45. The surgical hand port recited in claim 44, wherein the second portions of the gel include side wails which converge with progressive distal positions along the axis

46. The surgical hand port recited in claim 42, wherein the cavity has the shape of a cylinder.

47. The surgical hand port recited in claim 41, wherein the gel is a first gel and the valve structure further comprises:

a second gel disposed radially outwardly of the first portions of the first gel defining a the opening; and

the second gel being more rigid than the first gel in order to reinforce the first gel defining the opening.

48. The surgical hand port recited in claim 40, wherein the gel includes an elastomer and an oil.

49. A surgical hand port facilitating insertion of a hand of a surgeon through the hand port in a sealing relationship with an arm of the surgeon during laparoscopic surgery through an incision in an abdominal wall of a patient the hand port comprising:

a valve structure disposed over the incision and forming a seal around the incision.

a valve included in the valve structure, the valve being formed of a gel material including portions defining a sealable opening providing access to the incision;

the gel material having properties for sealing the opening in the absence of any object extending through the opening, and for sealing the opening around the arm of the surgeon extending through the opening; and

the gel material including an elastomeric oil mixture.

50. The surgical access device recited in claim 49, wherein the elastomeric oil mixture has properties including an elongation greater than about 1000 percent.

52. A method for making a surgical access device adapted for use in providing sealable access for an instrument extending through the access device and an incision in the body wall of a patient, comprising the steps of:

providing a gelling agent;

mixing the gelling agent with an oil to form an oil gel;

molding the oil gel into the configuration of a pad sized and shaped for disposition relative to the incision in the body wall; and

creating an opening through the pad to provide sealable access for the instrument to extend through the pad and the incision in the body wall.

53. The method recited in claim 52, farther comprising the steps of:

providing an additive having at least one of the properties for radiation absorption, detoxification, detackification and anti-oxidation; and

during the mixing step, combining the additive with the oil gel.

54. The method recited in claim 53, wherein the combining step includes the step of applying the additive to the oil gel as a surface treatment.

55. The method recited in claim 52, where the molding step includes the step of embedding hardware in the oil gel.

56. The method recited in claim 52, wherein the creating step includes the step of:

placing an insert into the oil gel prior to the molding step; and

removing the insert from the oil gel to create the opening

57. A method for using a eel seal in a surgical procedure for operating on an organ contained in a body cavity defined by a body wall, comprising the steps of:

providing the gel seal in the form of a pad having a slit extending through the pad;

creating an incision in the body wall;

placing the pad relative to the incision to create a firs, seal around the incision the slit communicating pith the incision and forming a second seal relative to the incision;

removing at least a portion of the organ from the body cavity through the incision in the body wall and the slit in the pad;

during the removing step forming the second seal with the organ;

operating on the organ exteriorly of the body cavity; and

returning the organ to the body cavity through the slit in the pad and the incision in the body wall.

58. The method recited in claim 57, wherein the removing step includes the steps of:

inserting a hand through the slit in the pad and the incision in the body wall;

grasping the organ interiorly of the body cavity; and

withdrawing the hand and the organ through the incision in the body wall and the slit in the pad.

59. The method recited in claim 57, wherein the first seal and the second seal are gas seals inhibiting the escape of as from the body cavity through the pad.

60. The method recited in claim 57, wherein the providing step includes the step of forming the gel seal of an oil gel material.

61. A method for using an access device to provide instruments access through an opening in a body wall and into a body cavity comprising:

providing a pad of gel material with portions free of any opening through the pad;

sealing the pad to the body wall around the incision inserting the instrument, at least partially, through the portions of the pad to form an opening through the gel material;

forming an instrument seal between the gel and the instrument when the instrument is positioned through the pad; and

forming a zero seal at the opening when the instrument is not positioned through the pad.