Seal assembly

• US 6,569,120 B1
• Filed: 03/07/1997
• Issued: 05/27/2003
• 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: Castro, Salvatore, Bolanos, Henry, DeFonzo, Stephan A., Young, Wayne P., Green, David T., Sienkiewicz, Henry, Cuny, Douglas J.
• Primary Examiner(s): Ruhl, Dennis
• Assistant Examiner(s): REICHLE, KARIN M
• Application Number:
  US08/814,757
• Time in Patent Office: 2,272 Days
• Field of Search: 604/93, 604/164, 604/167, 604/244, 604/246-247, 604/256, 604/905, 604/167.04, 604/167.06, 137/849, 137/855, 251/149.1
• 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
• CPC Class Codes: F16K 15/1471 slits arranged along multiple axes
• CPC Class Codes: F16K 15/16 with tongue-shaped laminae
• CPC Class Codes: Y10T 137/7885 Multiple slit
• CPC Class Codes: Y10T 137/7891 Flap or reed

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 seal assembly which comprises:

(a) a frame;

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

(i) a first sealing element defining a first semi-circular opening and having a first wall, and

(ii) a second sealing element defining a second semi-circular opening and having a second wall; and

(c) at least one retainer element defining a substantially central aperture, said retainer element including a body portion and a plurality of adjacent movable portions joined to said body portion by hinge regions said adjacent movable portions being 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, 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;

wherein mounting of the at least one sealing gasket assembly onto the frame tensions the first and second walls so that they overlap to define overlapping walls and form a substantial gas and fluid tight seal in the absence of the instrument inserted through the semi-circular openings; and

further wherein the overlapping walls are separable so, as to allow passage of the instrument through the semi-circular openings.

2. A seal assembly according to claim 1 wherein said frame includes at least two attachment members to engage and tension said first and second walls.

3. A seal assembly according to claim 1 wherein the frame tensions the first and second walls by resiliently stretching the overlapping walls.

4. A seal assembly according to claim 1 wherein said at least one sealing gasket assembly is constructed from a flexible material having a durometer value between 25 and 35.

5. A seal assembly according to claim 1 further comprising a housing structure which surrounds and encloses said frame.

6. A seal assembly according to claim 1 wherein at least one of said plurality of movable portions pivots distally from a substantially central longitudinal axis of said seal assembly.

7. A seal assembly according to claim 1, wherein a force is required to insert the instrument having a diameter of no more than about 15 mm through said semi-circular openings of said at least one sealing gasket assembly and said force is no more than about 7 pounds.

8. A seal assembly according to claim 1, wherein the plurality of movable portions are disposed along a plane in the absence of the instrument being inserted therethrough.

9. A seal assembly according to claim 1, which further comprises 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.

10. A seal assembly according claim 9, wherein the plurality of retainer elements comprises two retainer elements which are juxtapositioned relative each other.

11. A seal assembly according to claim 10, wherein said two retainer elements are positioned relative each other such that said II 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.

12. A seal assembly according to claim 1, wherein said plurality of movable portions are formed of plastic.

13. A seal assembly according to claim 1 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.

14. A seal assembly according to claim 13 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 triangular-shaped movable portion of another of said second retainer element.