Valve assembly for introducing instruments into body cavities

• US 20030195472A1
• Filed: 05/23/2003
• Published: 10/16/2003
• Est. Priority Date: 10/18/1991
• Status: Active Grant

• Current Assignee: David T. Green, Douglas J. Cuny, Henry Bolanos, Henry Sienkiewicz, Salvatore Castro, Stephan A. DeFonzo, Wayne P. Young
• Original Assignee: David T. Green, Douglas J. Cuny, Henry Bolanos, Henry Sienkiewicz, Salvatore Castro, Stephan A. DeFonzo, Wayne P. Young
• Inventors: Castro, Salvatore, Bolanos, Henry, Cuny, Douglas J., DeFonzo, Stephan A., Young, Wayne P., Green, David T., Sienkiewicz, Henry
• Granted Patent: US 6,981,966 B2
• Time in Patent Office: Days
• US Class Current: 604/167.04
• CPC Class Codes: A61B 17/34 Trocars; Puncturing needles pointed biopsy instruments A61B10/0233; devices for piercing the ear-lobes A44C7/001; seals or hemostasis valves A61M39/06
• CPC Class Codes: A61B 2017/3464 with means acting on inner surface of valve or seal for expanding or protecting, e.g. inner pivoting fingers
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61M 2039/0626 used with other surgical instruments, e.g. endoscope, trocar
• CPC Class Codes: A61M 2039/0633 the seal being a passive seal made of a resilient material with or without an opening
• CPC Class Codes: A61M 2039/064 Slit-valve
• CPC Class Codes: A61M 2039/0653 Perforated disc
• CPC Class Codes: A61M 2039/0686 comprising more than one seal
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof

Abstract

A valve assembly is provided for permitting the introduction of a surgical instrument into a patient'"'"'s body while providing a substantial seal about the instrument. The valve assembly includes a sealing gasket assembly providing a fluid tight seal before instrument insertion, and is configured and dimensioned for accommodating an instrument and providing a substantial fluid tight seal after insertion of an instrument. The valve assembly may further include a deformable sealing member having a substantially central aperture for accommodating the instrument. The sealing member provides a substantial seal about the instrument when the instrument is passed therethrough impeding the egress of fluids and gasses through the valve assembly.

Claims

1. A valve assembly for maintaining a substantial fluid tight seal between an internal portion of a patient'"'"'s body and an outside atmosphere during introduction of a surgical instrument into the patient'"'"'s body, which comprises:

at least one sealing gasket assembly including at least a pair of overlapping elements defining a passageway therethrough, said elements forming a substantial gas tight seal prior to inserting an instrument therethrough, said elements being constructed of a flexible material to allow passage of said instrument through said passageway; and

at least one deformable sealing element fabricated at least in part from a flexibly resilient material and defining a substantially central aperture for accommodating said instrument such that said flexibly resilient material defining said aperture engages the surface of the instrument to provide a substantially fluid tight seal for preventing passage of fluids past said deformable sealing element.

2. A valve assembly for maintaining a substantial fluid tight seal between an internal portion of a patient'"'"'s body and an outside atmosphere during introduction of a surgical instrument into the patient'"'"'s body which comprises:

sealing structure including at least one sealing gasket assembly having first and second overlapping elements defining a passageway therethrough, said elements forming a substantial gas and fluid tight seal prior to inserting an instrument therethrough, said elements further being constructed of a flexible material to allow passage of said instrument through said passageway and provide substantial sealing about said instrument; and

means for tensioning said first and second overlapping elements of said sealing gasket such that said overlapping elements are biased in a closed position providing a gas and fluid tight seal prior to instrument insertion therethrough.

3. A valve assembly according to claim 2, wherein said tensioning means includes a frame for receiving and tensioning said first and second elements of said sealing gasket assembly.

4. A valve assembly according to claim 2 further comprising housing structure for housing said tensioning means such that said sealing gasket is positionable substantially within said housing.

5. A valve assembly according to claim 2 further comprising means for inhibiting contact of said instrument adjacent said sealing structure.

6. A valve assembly according to claim 5 wherein said means for inhibiting defines a passageway for receiving said instrument and includes at least one movable portion such that said movable portion inhibits contact between said instrument and said adjacent sealing structure.

7. A valve assembly according to claim 2 wherein said sealing structure further comprises a third sealing element having an at least partially tapered body portion being at least partially of a flexible material and defining a substantially central aperture for accommodating said instrument.

8. A valve assembly according to claim 7 wherein said tapered body of said third sealing element is generally conical in configuration.

9. A valve assembly according to claim 2 further comprising means for stabilizing said instrument when said instrument is positioned at least partially in said valve assembly.

10. A valve assembly according to claim 9 wherein said stabilizing means is positioned adjacent an entrance of said valve assembly such that said instrument is substantially guided by said stabilizing means.

11. A valve assembly according to claim 2 further comprising wiper means for substantially removing fluids from an outer surface of said instrument, said wiper means including a body portion constructed at least partially of a deformable material and defining a substantially central aperture for accommodating said instrument.

12. A valve assembly for maintaining a substantial fluid tight seal between an internal portion of a patient'"'"'s body and an outside atmosphere during introduction of a surgical instrument into the patient'"'"'s body which comprises:

sealing structure including at least one sealing gasket assembly having first and second overlapping elements defining an openable passageway therethrough, said first and second overlapping elements forming a substantial gas and fluid tight seal prior to inserting an instrument therethrough, said overlapping elements being constructed of a flexible material to accommodate passage of said instrument through said passageway while substantially sealing about said instrument; and

said sealing gasket being couplable to a frame such that said first and second overlapping elements are tensioned.

13. A valve assembly according to claim 12 wherein said frame includes at least two attachment members to engage and tension said first and second overlapping elements.

14. A valve assembly according to claim 13 wherein said first and second overlapping elements are resiliently stretched when positioned on said attachment members.

15. A valve assembly according to claim 12 wherein said sealing gasket is coupled to said frame using an adhesive.

16. A valve assembly according to claim 13 wherein said sealing gasket assembly includes a generally cylindrical body portion having radially tensioned first and second overlapping elements.

17. A valve assembly according to claim 12 wherein said sealing gasket assembly includes a durometer value between about 25 and about 45.

18. A valve assembly according to claim 12 further comprising a housing structure having said frame positioned substantially therein, said housing further having a peripheral body portion enclosing said frame.

19. A valve assembly according to claim 18 wherein said housing is generally cylindrical in shape for accommodating a substantially circular sealing gasket.

20. A valve assembly according to claim 12 wherein said frame includes at least two pins, said sealing gasket being positionable on said pins to provide tensioning of said first and second overlapping elements.

21. A valve assembly according to claim 19 wherein said housing comprises a first section and a second section, said sealing gasket being positionable therebetween.

22. A valve assembly according to claim 12 wherein said sealing structure further comprises a deformable third sealing element fabricated at least in part from a flexibly resilient material, said deformable third sealing element defining a substantially central aperture for accommodating said instrument therethrough, and said third sealing element contacting a periphery of said instrument passed therethrough, at least a portion of said deformable third sealing element being tapered to provide resilient flexing of said sealing member material about said instrument passed therethrough.

23. A valve assembly according to claim 22 wherein said tapered portion is substantially conical in shape.

24. A valve assembly according to claim 12 wherein said third sealing element has a durometer valve between about 20 and about 50.

25. The valve assembly according to claim 12 further comprising at least one retainer element defining a substantially central aperture for receiving an instrument, said retainer element including at least one movable portion for engaging said instrument during insertion to inhibit contact between said instrument and said sealing structure.

26. The valve assembly according to claim 25 wherein said at least one movable portion pivots distally from a substantially central longitudinal axis of said valve assembly when said instrument passes through said retainer element.

27. The valve assembly according to claim 12 further comprising a plurality of retainer elements, said retainers being positioned such that a plurality of movable portions of one said retainer elements are in overlapping relation with a plurality of movable portions of at least one other said retainer element.

28. A valve assembly according to claim 27 wherein said plurality of movable portions of said plurality of retainer elements are juxtapositioned such that slits defined by said movable portions of one retainer element transect the movable portions of at least one other retainer member.

29. A valve assembly according to claim 12 further comprising a stabilizer plate positioned near an entrance to said valve assembly such that said instrument is substantially guided along a predetermined path by said stabilizer plate when said instrument is passed therethrough.

30. A valve assembly according to claim 22 wherein said aperture of said third sealing element is less than about 12 mm.

31. A valve assembly according to claim 12 wherein said third sealing element is positioned adjacent a proximal end of said valve assembly.

32. A valve assembly according to claim 12 wherein said sealing structure further comprises a fourth sealing element at least partially constructed of a deformable material, said fourth sealing element having a substantially central aperture for accommodating said instrument therethrough, said deformable material of said fourth sealing element defining a periphery of said central aperture such that said periphery engages an outer surface of said instrument passed therethrough.

33. A valve assembly according to claim 12, wherein said valve assembly is adapted to admit an endoscopic portion of said surgical instrument having a diameter of no more than about 9 mm under an applied insertion force of no more than about 5 pounds.

34. A valve assembly according to claim 12, wherein said valve assembly accepts an endoscopic portion of said surgical instrument having a diameter between about 5 mm and 8 mm under an applied insertion force of no more than about 4 pounds.

35. A valve assembly according to claim 12, wherein said valve assembly is adapted to admit an endoscopic portion of said surgical instrument having a diameter of no more than about 15 mm under an applied insertion force of no more than about 7 pounds.

36. A cannula assembly for a trocar assembly, said cannula assembly adapted to maintain a substantial seal between a cavity inside of a patient'"'"'s body and an outside atmosphere, said cannula assembly comprising:

a tubular body portion;

a cannula valve housing positioned at a proximal end of said tubular body portion of said cannula;

sealing structure comprising at least one sealing gasket assembly having first and second overlapping elements defining a passageway therethrough, said elements forming a substantial fluid and gas tight seal prior to inserting an instrument therethrough, said elements being constructed of a flexible material to allow passage of said instrument through said passageway; and

said sealing gasket assembly being couplable to a frame such that said first and second overlapping elements are tensioned for biasing said overlapping elements in a closed position prior to an instrument passing therethrough.

37. A cannula assembly according to claim 36 wherein said sealing structure further comprises at least one deformable third sealing element fabricated from a flexibly resilient material and defining a substantially central aperture for accommodating said instrument.

38. A cannula assembly according to claim 36 further comprising at least one retainer element having at least one movable portion, said retainer element having a passageway to receive said instrument, such that said movable portion inhibits contact between said instrument and said sealing structure.

39. A cannula assembly according to claim 36 further comprising at least one retainer element defining a substantially central aperture, said retainer element including at least one movable portion extending from a perimeter of said retainer element towards a longitudinal axis of said retainer element, said at least one movable portion defining at least one slits said retainer element receiving said instrument while said movable portion inhibits contact between said instrument and said sealing structure.

40. A cannula assembly according to claim 36 further comprising:

an outer sleeve slidably positioned about said tubular body portion of said cannula;

a plurality of articulated arm members positioned at a distal end of said outer sleeve, at least one hinge positioned proximal of a midpoint of each of said arms, said articulated arms being manipulable between an extended position and a non-extended position such that a portion of each arm proximal each of said hinges is positioned substantially perpendicular relative to said tubular body portion when said arms are in said extended position; and

cannula member including a substantially circular member longitudinally positionable about said tubular body portion, said substantially circular member including a flange at a distal end thereof, said flange being positionable against a patient'"'"'s body such that said flange forms a substantially continuous seal against the skin of said body wall and said substantially circular member being substantially rigid for providing enhanced stabilization of said cannula positioned within said body cavity.

41. A cannula according to claim 40 wherein said articulated arms are integral with said outer sleeve.

42. A trocar assembly comprising:

an obturator;

a cannula assembly removably receiving said obturator, said cannula assembly including a tubular body portion and a cannula valve housing positioned at a proximal end of said tubular body portion;

sealing structure within said cannula valve housing including at least one sealing gasket assembly having first and second overlapping elements defining a passageway therethrough, said elements forming a substantial gas and fluid tight seal prior to inserting an instrument therethrough, said elements being constructed of a resilient material allowing passage of said instrument through said passageway; and

said sealing gasket assembly being couplable to a frame such that said first and second overlapping elements are tensioned for biasing said overlapping elements in a closed position.

43. A trocar assembly according to claim 42 wherein said first and second overlapping elements each have an aperture being offset from each other such that said overlapping elements form a substantial gas tight seal prior to inserting an instrument therethrough.

44. A trocar assembly according to claim 42 wherein said sealing structure further includes a third sealing element of flexible resilient deformable material defining a substantially central aperture for accommodating said instrument, said material of said third sealing element defining said aperture engages said instrument passed therethrough to provide a substantially fluid tight seal for inhibiting egress of fluids past said deformable third sealing element.

45. A trocar assembly according to claim 44 further comprising at least one retainer element having at least one movable portion, said retainer element having a passageway for receiving an instrument, such that said movable portion inhibits contact between said instrument and said sealing structure.

46. A cannula assembly according to claim 42 further comprising:

an outer sleeve slidably positioned about said tubular body portion of said cannula;

a plurality of articulated arm members positioned at a distal end of said outer sleeve, at least one hinge positioned proximal of a midpoint of each of said arms, said articulated arms being manipulable between an extended position and a non-extended position such that a portion of each arm proximal each of said hinges is positioned substantially perpendicular relative to said tubular body portion when said arms are in said extended position; and

cannula member including a substantially circular member longitudinally positionable about said tubular body portion, said substantially circular member including a flange at a distal end thereof, said flange being positionable against a patient'"'"'s body such that said flange forms a substantially continuous seal against the skin of said body wall and said substantially circular member being substantially rigid for providing enhanced stabilization of said cannula positioned within said body cavity.

47. A cannula according to claim 46 wherein said articulated arms are integral with said outer sleeve.