Valve assembly for introducing instruments into body cavities

• US 6,981,966 B2
• Filed: 05/23/2003
• Issued: 01/03/2006
• Est. Priority Date: 10/18/1991
• Status: Expired due to Fees

• Current Assignee: United States Surgical Corporation (Medtronic Plc)
• Original Assignee: United States Surgical Corporation (Medtronic Plc)
• Inventors: Bolanos, Henry, Cuny, Douglas J., Young, Wayne P., Green, David T., Sienkiewicz, Henry, Castro, Salvatore, DeFonzo, Stephan A.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US10/444,378
• Publication Number:
  US 20030195472A1
• Time in Patent Office: 956 Days
• Field of Search: 604/264, 604/93.01, 604104-109, 604/164.01, 604/164.02, 604/164.03, 604/164.08, 604/164.1, 604/164.11, 604/167.06, 604/171, 604/174
• US Class Current: 604/167.02
• 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:

sealing structure including at least one sealing gasket assembly having first and second overlapping elements each defining an opening arranged so that, said elements form a substantial gas and fluid tight seal prior to inserting an instrument therethrough, said elements being further constructed of a flexible material to allow passage of said instrument through said openings 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.

2. A valve assembly according to claim 1, wherein said tensioning means includes a frame for receiving and tensioning first and second elements of said sealing gasket assembly.

3. A valve assembly according to claim 1 further comprising a housing structure for housing said tensioning means such that said sealing gasket is positionable substantially within said housing.

4. A valve assembly according to claim 1 further comprising means for inhibiting contact of said instrument sealing structure.

5. A valve assembly according to claim 4, 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.

6. A valve assembly according to claim 1 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.

7. A valve assembly according to claim 6 wherein said tapered body of said third sealing element is generally conical in configuration.

8. A valve assembly according to claim 1 further comprising means for stabilizing said instrument when said instrument is positioned at least partially in said valve assembly.

9. A valve assembly according to claim 8 wherein said stabilizing means is positioned adjacent an entrance of said valve assembly such that said instrument is substantially guided by said stabilizing means.

10. A valve assembly according to claim 1, 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.

11. 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 each defining an opening arranged so that, said elements form 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 openings; 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.

12. A cannula assembly according to claim 11, 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.

13. A cannula assembly according to claim 11, further comprising at least one retainer element having at least one movable portion, said retainer element having passageway to receive said instrument, such that said movable portion inhibits contact between said instrument and said sealing structure.

14. A cannula assembly according to claim 11 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 slit, said retainer element receiving said instrument while said movable portion inhibits contact between said instrument and said sealing structure.

15. A cannula assembly according to claim 11 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 for providing enhanced stabilization of said cannula positioned within said body cavity.

16. A cannula according to claim 15, wherein said articulated arms are integral with said outer sleeve.

17. A seal assembly which comprises:

a frame;

at least one sealing gasket assembly constructed of a flexible material and mounted to said frame, the sealing gasket assembly including;

a first sealing element defining a first semicircular opening and having a first wall; and

a second sealing element defining a second semicircular opening and having a second wall; and

at least one retainer element defining a substantially central aperture, said retainer element having adjacent movable portions configured and dimensioned to inhibit contact between an instrument and said at least one sealing gasket assembly upon insertion of the instrument through the sealing gasket assembly;

the at least one sealing gasket assembly being mounted so that the first and second walls overlap and define a substantial gas and fluid tight seal in the absence of the instrument inserted through the semicircular openings and so that the first and second walls are separable to allow the passage of the instrument through the semicircular openings.

18. A valve assembly according to claim 17 wherein said frame includes at least two attachment members to engage and tension said first and second walls.

19. A seal assembly according to claim 17 wherein the frame tensions the first and second walls by resiliently stretching the first and second walls.

20. A seal assembly according to claim 17 wherein said at least one sealing gasket assembly is constructed from a flexible material having a durometer value between about 25 and 35.

21. A seal assembly according to claim 17 further comprising a housing structure which surrounds and encloses said frame.

22. A seal assembly according to claim 17 wherein at least one of said plurality of movable portions pivots distally from a substantially central longitudinal axis of said seal assembly.

23. A seal assembly according to claim 17 wherein a force is required to insert an instrument having a diameter of no more than about 15 mm through and semi-circular openings of said at least one sealing gasket assembly and said force is not more than about 7 pounds.

24. A seal assembly according to claim 17, wherein the plurality of movable portions are disposed along a plane in the absence of an instrument being inserted therethrough.

25. A seal assembly according to claim 17 which further comprises a plurality of retainer elements, each of said plurality of retainer elements defining a substantially central aperture, and including plurality of adjacent movable portions configured and dimensioned to inhibit contact between the instrument and said at least one sealing gasket assembly upon insertion of the instrument through the sealing gasket assembly, wherein said adjacent movable portions are each defined by a pair of slits extending radially at least partially between said adjacent movable portions from said substantially central aperture.

26. A seal assembly according to claim 25, wherein the plurality of retainer elements comprises two retainer elements which are juxtapositioned relative each other.

27. A seal assembly according to claim 26, wherein said two retainer elements are positioned relative each other such that said plurality of movable portions of one of said two retainer elements are axially offset relative to the plurality of movable portions of the other of said two retainer elements.

28. A seal assembly according to claim 17, wherein said plurality of movable portions are formed of plastic.

29. A seal assembly according to claim 17, further comprising a plurality of retainer elements, each of said plurality of retainer elements defining a substantially central aperture, and including a plurality of adjacent movable portions configured and dimensioned to inhibit contact between the instrument and said at least one sealing gasket assembly upon insertion of the instrument through the sealing gasket assembly, wherein said adjacent movable portions are each defined by a pair of slits extending radially at least partially between said adjacent movable portions from said substantially central aperture, said plurality of retainers being positioned such that said plurality of adjacent movable portions of a first of said plurality of retainer elements are in overlapping juxtaposed relation with said plurality of adjacent movable portions of a second of said plurality of retainer elements.

30. A seal assembly according to claim 29 wherein each of said plurality of adjacent movable portions of said plurality of retainer elements is triangular shaped, and further wherein at least one of said slits which defines a triangular shaped movable portion of said first retainer element transects the triangle shaped movable portion of another of said second retainer element.