Valve system for introducing objects into anatomical body portions

• US 5,180,373 A
• Filed: 06/07/1991
• Issued: 01/19/1993
• Est. Priority Date: 06/07/1991
• Status: Expired due to Term

• Current Assignee: Tyco Healthcare Group LP (Medtronic Plc), United States Surgical Corporation (Medtronic Plc)
• Original Assignee: United States Surgical Corporation (Medtronic Plc)
• Inventors: Bolanos, Henry, Green, David T., Sienkiewicz, Henry
• Primary Examiner(s): Hirsch, Paul J.
• Application Number:
  US07/711,756
• Time in Patent Office: 592 Days
• Field of Search: 604/167, 604/264, 604/256, 251/149.1
• US Class Current: 604/167.03
• 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 2017/3464 with means acting on inner surface of valve or seal for expanding or protecting, e.g. inner pivoting fingers
• CPC Class Codes: A61M 2039/062 used with a catheter
• 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 2039/0646 Duckbill-valve
• CPC Class Codes: A61M 2039/0686 comprising more than one seal
• 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 adapted for introduction of an elongated object into a patient'"'"'s body having a first valve formed of a resilient material and defining an aperture for reception of the object, the aperture being configured and dimensioned such that insertion of the object into the aperture will cause the resilient material defining the aperture to resiliently engage the outer surface of the object in a fluid tight manner. A second valve is positioned adjacent and distal of the first valve in general alignment therewith, whereby the second valve defines an aperture in general alignment with the aperture of the first valve, and is formed of a flexible material at least in the region defining the apeture. A pair of manually operable clamps are provided to selectively permit the aperture of the second valve to be opened or closed so as to permit entry of the object such that the object first passes through the first valve and then the second valve prior to entry into the patient'"'"'s body.

Claims

1. A valve assembly adapted for introduction of an elongated object into a patient'"'"'s body which comprises:

(a) first valve means formed of a resilient material and defining an aperture for reception of the object, said aperture being configured and dimensioned such that insertion of the object into said aperture will cause the resilient material defining said aperture to resiliently engage the outer surface of the object in a substantially fluid tight manner;

(b) second valve means positioned adjacent said first valve means in general alignment therewith, said second valve means defining an aperture in general alignment with said aperture of said first valve means, and being formed of a flexible material at least in the region defining said aperture; and

(c) manually operable means to selectively permit said aperture of said second valve means to be opened or closed so as to permit entry of the object.

2. A valve assembly for introduction of a surgical instrument into a patient'"'"'s body while selectively maintaining a fluid tight seal between the inner portion of the patient'"'"'s body and the outside atmosphere, which comprises:

(a) valve body means defining proximal inlet and distal outlet means;

(b) first valve means formed of a resilient material and extending across said proximal inlet means of said valve body means, said first valve means defining an aperture configured and dimensioned for reception of the object in a manner such that resilient material surrounding aperture engages the surface of the object to provide a substantially fluid tight seal which prevents passage of fluids past the interface;

(c) second valve means positioned adjacent and distally of said first valve means and extending across said proximal inlet means of said valve body means, said second valve means including an aperture defined at least in part by flexible material and in general alignment with said aperture of said first valve means and of dimension sufficient to permit passage of the object after the object is passed through said first valve means;

(d) means to bias said flexible material defining said aperture of said second valve means to a configuration whereby said aperture is closed to form a fluid tight seal prior to inserting the object therethrough; and

(e) means to open said aperture of said second valve means to permit passage of the object therethrough when the object is passed through said first valve means.

3. The valve assembly according to claim 2 wherein said means to open said aperture of said second valve means is manually operable.

4. A valve assembly for introduction of elongated objects into a patient'"'"'s body while maintaining the atmospheric integrity therein, which comprises:

(a) valve body means defining a proximal inlet opening and a distal outlet opening;

(b) first valve means formed of a flexible elastomeric resilient material and defining an aperture for reception of the object, said aperture being configured and dimensioned such that insertion of the object into said aperture will cause the flexible resilient material defining said aperture to resiliently engage and conform to the outer surface of the object in a substantially fluid tight manner;

(c) second valve means positioned adjacent said first valve means in general alignment therewith, said second valve means defining an aperture in general alignment with said aperture of said first valve means, and being formed of a flexible resilient material at least in the region adjacent to and defining said aperture; and

(d) manually operable means to selectively open said aperture of said second valve means whereby the object may pass therethrough.

5. The valve assembly according to claim 4 wherein the object comprises a surgical instrument.

6. The valve assembly according to claim 5 wherein said first valve means is positioned across said proximal opening of said valve body means and said second valve means is positioned adjacent said first valve means and distally thereof.

7. The valve assembly according to claim 6 wherein said first and second valve means are formed integrally of a flexible elastomeric resilient material, said first valve means connected to said second valve means at the proximal end thereof, said first valve means being positioned at least partially within said second valve means.

8. The valve assembly according to claim 7 wherein said first and second valve means are joined at the proximal end and are attached to said valve body means across the proximal opening thereof.

9. The valve assembly according to claim 8 wherein said valve body means comprises a neck extending distally of the distal end thereof, said neck defining an opening communicating with the interior of said valve body means.

10. The valve assembly according to claim 9 wherein said distally extending neck of said valve body means is adapted to receive a tubular member such that said tubular member extends distally of said valve body means.

11. The valve assembly according to claim 10 wherein said second valve means comprises an elastomeric generally cylindrically shaped member connected integrally at the proximal end thereof to said proximal end of said first valve means and being open at the distal end, said distal opening being capable of being closed by collapsing said distal end of said second valve means until the half portions thereof resiliently contact each other to a duckbill shape to form a substantial fluid tight seal.

12. The valve assembly according to claim 11 wherein said open distal end of said second valve means is biased toward the closed fluid tight position.

13. The valve assembly according to claim 12 wherein clamp means is positioned and adapted to bias said open end of said second valve means toward the collapsed configuration.

14. The valve assembly according to claim 13 wherein said clamp means comprises a pair of clamp blades, each blade connected to a portion of said distal open end of said second valve means, said clamp blades being biased toward each other to close the distal opening of said second valve means.

15. The valve assembly according to claim 14 wherein said clamp blades are each biased toward the other by a respective torsion spring mounted within said valve body.

16. The valve assembly according to claim 15 wherein each said clamp blade is connected to a pivotal arm and each pivotal arm is biased toward the position corresponding to the closed position of said second valve means.

17. The valve assembly according to claim 16 wherein each said pivotal arms is mounted for pivotal movement toward the valve-open position by engagement with at least one slidable pin.

18. The valve assembly according to claim 17 wherein each said pin is positioned for slidable movement within said valve body means and is movable manually by engagement by the user'"'"'s fingers, each said pin defining an opening for reception of the free end portion of the respective pivot arm.

19. The valve assembly according to claim 18 wherein said proximal end of said first and second valve means is attached to and supported by an annular ring.

20. The valve assembly according to claim 19 wherein said annular ring includes a plurality of elongated fingers which extend distally therefrom and are positioned within said first valve means in supporting contact with the inner surface thereof, said fingers providing an interface between said first valve means and objects inserted therein.

21. The valve assembly according to claim 20 wherein each said slidable pin has a frusto-conical shaped tip adjacent each pivot arm for engagement with said respective pivot arm when said pins are moved toward each other by manual action of the user.

22. The valve assembly according to claim 21 wherein said valve body means is a two piece valve housing assembled at a medial interface.

23. The valve assembly according to claim 22 wherein said valve housing is constructed of a relatively rigid plastic material such as polycarbonate, polyethylene or the like.

24. A valve assembly for introduction of an elongated object such as a surgical instrument or the like into the body of a patient while maintaining substantial fluid tight seal between internal body portions and the outside atmosphere at all times prior to and after insertion of the object, which comprises:

(a) a valve housing having an inlet opening at the proximal end and an outlet opening at the distal end;

(b) first valve means formed of a resilient material and extending across said inlet opening of said valve housing, said first valve means defining an aperture dimensioned for reception of the object in a manner such that resilient material surrounding said aperture engages the surface of the object in conforming relation therewith to provide a substantial fluid tight seal which prevents passage of fluids past the interface;

(c) second valve means formed of a resilient material and positioned adjacent said first valve means and extending across the inlet opening of said valve housing, said second valve means defining an aperture in general alignment with said aperture of said valve means and distally thereof, said distal aperture being of dimension sufficient to permit passage of the object after the object is passed through said aperture of said first valve means;

(d) a pair of plate members positioned to engage the portion of said second valve means defining said distal aperture, said plate members being biased toward each other by resilient spring means to bias the resilient material surrounding said distal aperture of said second valve means to a configuration whereby said aperture is closed to form a fluid tight seal prior to positioning the object therein; and

(e) manually operable means adapted to separate said plate members in a manner to open said aperture of said second valve means to permit passage of the object therethrough when the object is passed through said first valve means.

25. The valve assembly according to claim 24 wherein said first and second valve means are integrally formed of an elastomeric material.

26. The valve assembly according to claim 25 wherein said first valve means is positioned within said second valve means and said first and second valve means are connected to each other at the proximal ends thereof, said first and second valve means each defining an opening at the distal ends thereof

27. The valve assembly according to claim 26 wherein said first valve means has a generally conical configuration.

28. The valve assembly according to claim 26 wherein said first and second valve means are supported on valve support means which comprises a support ring defining mounting flange means, said support ring having a plurality of distally extending resilient flexible fingers positioned within said first valve means to provide support to said first valve means such that when objects are inserted into said distal opening of said first valve means, said fingers provide an interface between said first valve means and the object to prevent damage to said first valve means prior to insertion of the object into said distal aperture of said first valve means.

29. The valve assembly according to claim 28 wherein said first and second valve means are integrally molded of synthetic or natural rubber.

30. A cannula and trocar assembly for puncturing a patient'"'"'s body wall for the introduction of elongated objects such as surgical instruments or the like into the body of a patient while maintaining a substantial fluid tight seal between internal body portions and the outside atmosphere at all times prior to and after insertion of the object, which comprises:

(a) a valve housing having an inlet opening at the proximal end and an outlet opening at the distal end, said distal end opening having a tubular cannula extending distally therefrom;

(b) a trocar positioned within said valve housing and said cannula;

(c) first valve means formed of a resilient material and extending across the inlet opening of said valve housing, said first valve means defining an aperture dimensioned for reception of said trocar or the object in a manner such that resilient material surrounding said aperture engages the surface of the trocar or the object to provide a substantial fluid tight seal which prevents passage of fluids past the interface;

(d) second valve means of resilient material positioned distal and adjacent said first valve means and extending across the inlet opening of said valve housing, said second valve means defining an outlet aperture in general alignment with said distal aperture of said valve means and of dimension sufficient to permit passage of the trocar or object after the trocar or object is passed through said first valve means;

(e) a pair of plate members positioned within said valve housing to engage the portion of said second valve means defining said aperture, said plate members biased toward each other by resilient spring means to bias the resilient material surrounding said aperture of said second valve means to a configuration whereby said aperture is closed to form a fluid tight seal prior to positioning the object therein; and

(f) manually operable means adapted to separate said plate members in a manner to open said aperture of said second valve means to permit passage of the object therethrough when the object is passed through said first valve means.

31. The valve assembly according to claim 30 wherein said first and second valve means are integrally molded of synthetic or natural rubber, said first and second valve means being connected at the proximal end and defining a proximal opening, said first valve means having a generally conical shape and being positioned within said second valve means, said second valve means having a generally cylindrical shape when said distal outlet aperture is opened and being collapsible at the outlet end in a manner to provide contact between the two half portions to provide a substantial fluid tight seal.

32. A method of selectively sealing a valve assembly for communication with inner portions of a patient'"'"'s body while permitting introduction of an elongated instrument therethrough, said valve assembly having a proximal inlet opening and a distal outlet opening, comprising:

(a) providing first valve means comprised of resilient material defining an opening which permits entry therethrough by the instrument while resiliently contacting the outer surface;

(b) providing second valve means distal of said first valve means; and

(c) selectively controlling the open and closed condition of said second valve means to permit passage of said instrument after entry through said first valve means.