SURGICAL INSTRUMENT ACCESS DEVICE

• US 20070151566A1
• Filed: 11/29/2006
• Published: 07/05/2007
• Est. Priority Date: 09/17/2003
• Status: Active Grant

• Current Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Original Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Inventors: Kahle, Henry, Johnson, Gary, Adlparvar, Payam
• Granted Patent: US 8,187,177 B2
• Time in Patent Office: Days
• US Class Current: 128/856
• 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 17/3498 Valves therefor, e.g. flapper valves, slide valves haemostasis valves A61M39/06; check valves A61M39/24
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/0507 using microwaves or terahertz waves
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/6889 Rooms
• CPC Class Codes: A61B 5/6898 Portable consumer electronic devices, e.g. music players, telephones, tablet computers

Abstract

A surgical access device includes a single valve that forms a seal with a body wall and provides an access channel 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 for an instrument having a diameter up to about 37 mm. The valve can include a gel material and the access channel can include a protective sleeve to provide for wound protection during insertion and withdrawal of a sharp surgical instrument. The valve further comprises a cap ring which may be inserted or molded with the gel material. The protective sleeve may be bonded or molded around an inner diameter of the cap ring The protective sleeve may be a single tubular member, or may comprise a plurality of axially extending sleeve members having a plurality of axial slits The protective sleeve and the cap ring may comprise of the same or different materials The surgical access device further comprises at least one support ring disposed circumferentially of the valve forming a hollow space, and a wound retractor operatively placed in the hollow space. The wound retractor includes an inner ring, an outer ring, and a flexible sleeve connecting the inner ring and the outer ring.

Claims

1. A surgical access device adapted for disposition relative to an incision in a patient, the access device facilitating insertion of a surgical instrument having a diameter up to about 37 mm through the access device and maintenance of a sealing relationship with said surgical instrument, comprising:

a valve structure including a gel material and an access channel, the access channel being adapted to receive the surgical instrument and the qel material being adapted to form a seal with the surgical instrument disposed in the access channel;

a wound retractor adapted to dilate the incision;

the access channel including a protective sleeve extending into communication with the incision in the patient; and

the gel material including an elastomer.

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

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

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

5. The surgical access device of claim 1, wherein the gel material includes at least one of a urethane, polyvinylchloride, Isoprene, Styrene-Ethylene/Butylene-Styrene block copolymer, an oil, and a foaming agent.

6. The surgical access device of claim 1, wherein the elastomer includes a base and an oil forming with the base an elastomeric oil mixture.

7. The surgical access device of claim 6, wherein the oil includes at least one of a vegetable oil, a petroleum oil, and a silicone oil.

8. The surgical access device of claim 1, wherein the valve structure further comprises a cap ring which may be inserted or molded into the gel material.

9. The surgical access device of claim 8, wherein the protective sleeve is bonded or molded around an inner diameter of the cap ring.

10. The surgical access device of claim 9, wherein the protective sleeve provides for wound protection during insertion and withdrawal of an instrument.

11. The surgical access device of claim 1, further comprising:

at least one support ring disposed circumferentially of the valve structure forming a hollow space,

wherein the wound retractor is operatively placed in the hollow space.

12. The surgical access device of claim 11, wherein the wound retractor includes an inner ring, an outer ring, and a flexible sleeve coupling the inner ring and the outer ring.

13. The surgical access device of claim 9, wherein the protective sleeve is a single tubular member.

14. The surgical access device of claim 9, wherein the protective sleeve comprises a plurality of axially extending sleeve members having a plurality of axial slits.

15. The surgical access device of claim 9, wherein the protective sleeve and the cap ring comprise of the same materials.

16. The surgical access device of claim 9, wherein the protective sleeve and the cap ring comprise of different materials.

36. The surgical access device of claim 1, wherein the valve structure further comprises a cap ring coupled to the gel material.

37. The surgical access device of claim 36, wherein the protective sleeve is coupled around the diameter of the cap ring.

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

a valve structure disposed relative to the incision in a sealing relationship with the body wall around the incision and extending into communication with the incision in the patient;

a wound retractor adapted to dilate the incision;

a protective sleeve adapted to extend into the incision;

a valve included in the valve structure and disposed relative to the incision in the body wall, the valve having a single seal;

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

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

18. The surgical access device of claim 17, the valve structure further comprising a cap ring, the cap ring being coupled to the valve.

19. The surgical access device of claim 18, wherein the protective sleeve is coupled around the diameter of the cap ring.

20. The surgical access device of claim 19, wherein the protective sleeve provides for wound protection during insertion and withdrawal of the instrument.

21. The surgical access device of claim 18, further comprising:

at least one support ring disposed circumferentially of the valve structure forming a hollow space,

wherein the wound retractor is operatively placed in the hollow space.

22. The surgical access device of claim 21, wherein the wound retractor includes an inner ring, an outer ring, and a flexible sleeve coupling the inner ring and the outer ring.

23. The surgical access device of claim 19, wherein the protective sleeve is a single tubular member.

24. The surgical access device of claim 19, wherein the protective sleeve comprises a plurality of axially extending sleeve members having a plurality of axial slits.

25. A medical access device, including:

a valve structure having an elongate configuration;

at least one wall defining with the valve structure a working channel sized and configured to receive a surgical instrument; and

a gel disposed in the working channel and being adapted to form a seal with any instrument having a diameter up to about 37 mm disposed in the working channel;

the valve structure comprising,

a gel cap, and

an abdominal base, and

the gel cap comprising,

a gel pad,

a circumferential cap ring coupled to the gel pad, and

a protective sleeve coupled around the diameter of the cap ring.

28. The medical access device of claim 25, wherein the protective sleeve is a single tubular member.

29. The medical access device of claim 25, wherein the protective sleeve comprises a plurality of axially extending sleeve members having a plurality of axial slits.

30. The medical access device of claim 25, wherein the cap ring has an annular void on an inner circumference to form a sealing relationship with the abdominal base.

31. The medical access device of claim 30, wherein the abdominal base comprises a rounded end surface along its inner diameter to secure an outer ring of a wound retractor.

32. The medical access device of claim 30, wherein the abdominal base comprises a plurality of toggles along its inner diameter to create a seal with the cap or to release the base from the cap.

33. The medical access device of claim 30, wherein the abdominal base comprises a plurality of latches along its inner diameter to create a seal with the cap or to release the base from the cap.

34. The medical access device of claim 30, wherein the abdominal base comprises a mating means along its inner diameter to create a seal with the cap or to release the base from the cap.

35. The medical access device of claim 30, wherein the abdominal base comprises a raised wall along its inner diameter to fit a corresponding cap ring.

26. (canceled)

27. (canceled)

38. A low-profile surgical valve structure adapted for disposition relative to an incision in a body wall and proximate an outer surface of the body wall, the incision being retracted by a wound retractor having an outer ring that expands around an outer edge of the incision at an outer surface of the body wall, the valve structure facilitating insertion of an instrument through the valve structure and maintenance of a sealing relationship with the instrument, comprising:

a gel pad adapted to be disposed over the incision and forming a seal with the wound retractor, the gel pad including a gel material comprising a thermoplastic base and an oil;

a slit formed in the pad to provide an access opening through the pad, the slit being adapted to extend into communication with the incision; and

a circumferential cap ring coupled to the gel pad, the cap ring being adapted to removably couple the valve structure to the outer ring of the wound retractor,

wherein the access opening forms a zero seal in the absence of an instrument extending therethrough and an instrument seal in the presence of an instrument extending therethrough.

39. The valve structure of claim 38, the cap ring forming a hollow space adapted to receive the wound retractor.

40. The valve structure of claim 38, wherein the gel pad includes a single access opening.

41. The valve structure of claim 38, further comprising at least one additional access opening in the gel pad, the at least one additional access opening being formed by inserting an instrument through the gel pad away from the slit.

42. The valve structure of claim 38, the thermoplastic base of the gel pad including at least one of a silicone, urethane, polyvinylchloride, isoprene, and styrene-ethylene/butylene-styrene.

43. The valve structure of claim 42, the thermoplastic base of the gel further including a foaming agent.

44. The valve structure of claim 38, the oil of the gel pad including at least one of a mineral oil, a vegetable oil, a petroleum oil, and a silicone oil.

45. A surgical access device adapted for disposition relative to an incision in a body wall and for facilitating a sealing relationship with an instrument extending through the device, the access device comprising:

a valve structure disposed relative to the incision in a sealing relationship with the body wall around the incision and extending into communication with the incision in the patient;

a wound retractor adapted to dilate the incision;

a protective sleeve adapted to extend into the incision, the protective sleeve being coupled around the diameter of the cap ring;

a valve included in the valve structure and disposed relative to the incision in the body wall, the valve having a single seal;

a cap ring included in the valve structure, the cap ring being coupled to the valve;

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

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

46. The surgical access device of claim 45, wherein the protective sleeve provides for wound protection during insertion and withdrawal of the instrument.

47. The surgical access device of claim 45, wherein the protective sleeve is a single tubular member.

48. The surgical access device of claim 45, wherein the protective sleeve comprises a plurality of axially extending sleeve members having a plurality of axial slits.

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

a valve structure disposed relative to the incision in a sealing relationship with the body wall around the incision and extending into communication with the incision in the patient;

a valve included in the valve structure and disposed relative to the incision in the body wall, the valve having a single seal;

a cap ring included in the valve structure, the cap ring being coupled to the valve;

at least one support ring disposed circumferentially of the valve structure forming a hollow space;

a wound retractor adapted to dilate the incision, the wound retractor being operatively placed in the hollow space;

a protective sleeve extending into communication with the incision, the protective sleeve being coupled around the diameter of the cap ring;

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

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

50. The surgical access device of claim 49, wherein the wound retractor includes an inner ring, an outer ring, and a flexible sleeve coupling the inner ring and the outer ring.