Reusable cannula with disposable seal

• US 6,159,182 A
• Filed: 05/22/1998
• Issued: 12/12/2000
• Est. Priority Date: 06/11/1996
• Status: Expired due to Term

• Current Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Original Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Inventors: To, John, Kramer, Thomas, Loomas, Bryan, Davis, John, Kovac, Tim J.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US09/083,772
• Time in Patent Office: 935 Days
• Field of Search: 604/164, 604/167, 604/169, 604/246, 604/249, 604/256, 604/264, 604/164.01, 604/167.01-167.04, 604/167.06
• US Class Current: 604/167.06
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 17/3474 Insufflating needles, e.g. Veress needles
• 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 2017/0023 disposable
• CPC Class Codes: A61B 2017/349 Trocar with thread on outside

Abstract

A disposable seal assembly for use with a reusable cannula, where the seal assembly is designed for use with the cannula during a single medical procedure and the cannula is designed for multiple uses (each time with a different seal assembly) during a number of medical procedures. The seal assembly includes both a flapper valve fluid seal (for sealing the cannula when no medical instrument is inserted through the seal assembly) and at least one instrument seal (for sealing the cannula when a medical instrument is inserted through the seal assembly). Preferably, the seal assembly has a body with a flange which can be snapped onto the cannula before use, and readily removed after use. Also preferably, the flapper valve has an over-centered hinge. In other embodiments, the invention is a seal assembly which includes at least one double instrument seal including a sacrificial flange and a sealing flange, and optionally also a flapper valve. The sealing flange seals the cannula when a medical instrument is inserted through the seal assembly even when the sacrificial flange has been cut during insertion of the instrument. In other embodiments, the invention is a system including a reusable cannula, and a disposable seal assembly of any of the described types which can be snapped onto the cannula before use and readily removed after use.

Claims

1. A disposable seal assembly, including:

a body through which a channel extends to a distal end of the body;

a sacrificial flange having a first diameter and being positioned along the channel at a first location; and

a sealing flange having a second diameter less than the first diameter and being positioned along the channel at a second location distal of the first location of the sacrificial flange, wherein at least one of the sacrificial flange and the sealing flange provides a seal around an instrument when the instrument is positioned in the channel;

the sacrificial flange being shaped so that in response to displacement of a portion of the sacrificial flange by the instrument while the instrument is inserted through the channel, the displaced portion of the sacrificial flange folds toward the sealing flange, thereby displacing a portion of the sealing flange to prevent the sealing flange from being cut by the instrument as the instrument continues translating through the channel the displaced portion of the sacrificial flange being thicker than the portion of the sealing flange;

the sealing flange protruding from the body at an angle relative to the sacrificial flange, so that the sealing flange extends in a direction away from the sacrificial flange; and

the sacrificial flange being disposed generally in a plane extending radially of the channel.

2. The assembly of claim 1, also including:

a mounting flange protruding from the body, wherein the mounting flange is shaped for removably snapping the body onto a cannula.

3. A disposable seal assembly, including:

a body through which a channel extends to a distal end of the body;

a sacrificial flange having in a relaxed state an opening with a first diameter and being positioned along the channel at a first location;

a sealing flange having in a relaxed state a second diameter less than the first diameter of the sacrificial flange and being positioned along the channel at a second location distal of the first location, the sealing flange providing a seal around an instrument when the instrument is positioned in the channel; and

the sacrificial flange being shaped so that in response to displacement of a portion of the sacrificial flange by the instrument as the instrument is inserted through the channel, the displaced portion of the sacrificial flange moves distally thereby displacing a portion of the sealing flange to prevent the sealing flange from being cut by the instrument as the instrument continues translating through the channel.

4. The disposable seal assembly recited in claim 3 wherein the sacrificial flange in its relaxed state is disposed generally in the plane extending transverse to the channel of the body.

5. The disposable seal assembly recited in claim 4 wherein the plane of the sacrificial flange extends generally radially of the channel of the body.

6. The disposable seal assembly recited in claim 5 further comprising:

a zero seal disposed distally of the sacrificial flange and the sealing flange and having properties for sealing the channel in the absence of an instrument positioned within the channel.

7. The disposable seal assembly recited in claim 6 wherein the zero seal includes a valve seat and a valve element forming a seal in the absence of an instrument in the channel;

a trap door providing the valve element and being pivotally mounted relative to the body to form a seal with a valve seat; and

portions of the sealing flange providing the valve seat for the valve element.

8. A disposable seal assembly, including:

a body having a channel which extends between a proximal end and a distal end, the body including a flange for removably snapping the body onto a cannula;

a flexible extension protruding from the body;

a trap door having a generally rigid configuration and being mounted to the flexible extension, such that the flexible extension biases the rigid door into a closed position which seals the channel against a door seat and the flexible extension can move in response to displacement of the rigid door from the closed position by an instrument translating through the channel; and

at least one instrument seal which provides the door seat for the trap door when the instrument is absent from the channel, and which seals the channel against the instrument when the instrument is positioned in the channel.

9. The assembly of claim 8, wherein the body, the flange, the flexible extension, and each said instrument seal are portions of a single piece of molded elastomeric material.

10. The assembly of claim 9, wherein the elastomeric material is a medical grade elastomer.

11. The assembly of claim 8, wherein the door is mounted to the flexible extension such that in response to displacement of the door into an improper position, the flexible extension exerts a restoring force on the door tending to reposition the door into said closed position.

12. The assembly of claim 11, wherein the body has an instrument seal portion against which the door rests when the door is in said closed position, and wherein the door is mounted to the flexible extension such that, in response to displacement of the door proximally through said instrument seal portion, the flexible extension does not tear, and direct manual force exerted by a user distally on the door, together with the restoring force exerted by the flexible extension on the door, is sufficient to reposition the door into said closed position.

13. The disposable seal assembly recited in claim 8, further comprising:

a sacrificial flange disposed proximally of the instrument seal for protecting the instrument seal.

14. The disposable seal assembly recited in claim 13 wherein the sacrificial flange is disposed generally in a plane transverse to the channel of the body.

15. The disposable seal assembly recited in claim 14 wherein the plane of the sacrificial flange extends radially of the channel of the body.

16. A disposable seal assembly, including:

a body through which a channel extends, wherein the body includes a flange shaped for removably snapping the body onto a cannula, and the body has a mounting portion, including;

a trap door mounted to the mounting portion of the body and movable between a first position wherein the door seals the channel against a door seat and a second position wherein the door opens the channel to facilitate instrument translation through the channel, the mounting portion having properties facilitating movement of the door over-center between the first position and the second position; and

at least one instrument seal which provides the door seat for the trap door when the instrument is absent from the channel, and which seals the channel against the instrument when the instrument is positioned in the channel, wherein the body including the mounting portion, the flange, and each said instrument seal are portions of a single piece of molded elastomeric material.

17. The disposable seal assembly recited in claim 16, further comprising:

a sacrificial flange disposed proximally of the instrument seal to protect the instrument seal.

18. The disposable seal assembly recited in claim 17 wherein the sacrificial flange is disposed in a plane extending transverse to the channel of the body.

19. The disposable seal assembly recited in claim 18 wherein the plane of the sacrificial flange extends radially of the channel of the body.

20. A cannula system, comprising:

a reusable cannula having a first end; and

a disposable seal assembly, comprising;

a body through which a channel extends, said body including a flange removably snapped onto the first end of the cannula;

a flexible extension which protrudes from the body;

a trap door having a rigid configuration and being mechanically joined to the flexible extension, so that the flexible extension biases the door against a door seat and into a closed position which seals the channel, and facilitates over-center displacement of the door from the closed position by an instrument translating through the channel; and

at least one instrument seal which provides the door seat for the trap door when the instrument is absent from the channel, and forms the door seat for the trap door and seals the channel when the instrument is positioned in the channel.

21. The system of claim 20, wherein the body, the flange, the flexible extension, and each said instrument seal are portions of a single piece of molded elastomeric material.

22. The system of claim 21, wherein the cannula is made of metal.

26. The seal assembly recited in claim 21 wherein the sacrificial flange extends generally radially of the channel and is thicker in configuration than the instrument seal.

23. A disposable seal assembly, including:

a body having a channel extending between a proximal end and a distal end, the body including a flange shaped for removably snapping the body onto a cannula;

at least one instrument seal disposed to seal the channel when an instrument is positioned within the channel;

a circumferential lip included in the instrument seal, the lip being radially expandable to accommodate instruments of different diameters;

a zero-closure valve disposed in the channel and having properties for blocking the channel when an instrument is not present within the channel, the zero-closure valve having a valve seat and a movable valve element;

a trap door comprising the movable valve element of the zero-closure valve, the trap door being movable between a first position wherein the trap door forms a seal with the valve seat to block the channel, and a second position wherein the trap door is spaced from the valve seat to permit translation of the instrument through the channel; and

the lip of the instrument seal forming the valve seat of the zero-closure valve.

24. The seal assembly recited in claim 23, wherein the trap door moves over-center between the first position and the second position of the trap door.

25. The seal assembly recited in claim 23 wherein the trap door has a rigid configuration.

27. The seal assembly recited in claim 23 further comprising:

a sacrificial flange disposed proximal of the at least one instrument seal and having properties for responding to a sharp tip of the instrument to temporarily move the at least one instrument seal from the path of the instrument in order to prevent damage to the instrument seal.