Method and apparatus for providing a container to a sterile environment

• US 9,168,102 B2
• Filed: 01/18/2006
• Issued: 10/27/2015
• Est. Priority Date: 01/18/2006
• Status: Active Grant

• Current Assignee: Medtronic Navigation Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Navigation Incorporated (Medtronic Plc)
• Inventors: Ryterski, Eric, Kendrick, Lance
• Primary Examiner(s): Thomson, William
• Assistant Examiner(s): LIPITZ, JEFFREY BRIAN
• Application Number:
  US11/334,798
• Publication Number:
  US 20070166188A1
• Time in Patent Office: 3,569 Days
• Field of Search: 606/1, 128/849, 422/1
• US Class Current: 1/1
• CPC Class Codes: A61B 2050/3015 transparent
• CPC Class Codes: A61B 2050/314 Flexible bags or pouches
• CPC Class Codes: A61B 46/10 specially adapted for instruments, e.g. microscopes
• CPC Class Codes: B65B 7/02 Closing containers or receptacles deformed by, or taking-up shape, of, contents, e.g. bags, sacks
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A method and apparatus for providing an unsterilized item to a sterile field is disclosed. The item can include a human input device. The sterile field can be in an operating room.

Claims

1. A system for delivering an item to a sterile field by a user, comprising:

a container having an open end and a closed end, wherein the container is configured to contain the item;

a closure system configured to close the open end of the container to an ambient environment, wherein the closure system includes a deformable member, at least a portion of the open end of the container can be wrapped about the deformable member, and the deformable member is configured to be crimped to a selected position to maintain the position of at least a portion of the open end of the container;

the container including an exterior wall to define an internal portion where the item is operable to be positioned within the internal portion;

wherein the container is configured to receive the item through the open end during an operative procedure to move the item into a sterile field without sterilizing the item;

a passage system comprising a sleeve including a first open end, a second open end, and a wall extending between the first open end and the second open end, the sleeve provided within the container and configured to be pulled partially out of the container at a first time;

wherein the sleeve having the first open end, the second open end, and the wall extending between the first open end and the second open end is removable from the container at a second time that is later than the first time when then sleeve is pulled partially out of the container; and

a handle in addition to the closure system, wherein the handle has a flap that is connected near the closure system and extends away from the closure system towards the closed end of the container to define a volume between the exterior wall of the container and the flap and configured to be grasped by the user and protect the user from contacting the item when the item is positioned within the container, the handle comprising a part of the container.

2. The system of claim 1, wherein the container further includes an edge wall so that the container defines a first dimension near a first portion and a second greater dimension near a second portion.

3. The system of claim 2, wherein the first dimension is at an open portion of the container and the second dimension is at a closed end of the container.

4. The system of claim 2, wherein the portion of the container defining the first dimension can be operated to close the container by moving a portion of the container closer to the second portion of the container.

5. The system of claim 2, wherein the first dimension and the second dimension are operable to make the container define a trapezoidal shape.

6. The system of claim 1, wherein the closure system substantially seals an interior of the container from an exterior environment.

7. The system of claim 1, wherein said container is at least one of transparent, opaque, semi-transparent, or combinations thereof.

8. The system of claim 1, wherein the closure system includes at least one of a twist tie, a four-ended twist tie, a groove and rail interlock system, a color change system, an adhesive, or combinations thereof.

9. The system of claim 1, wherein the item includes a human input device.

10. The system of claim 9, wherein the human input device includes at least one of a mouse, a track ball, a keyboard, a stylus, a laser input member, a foot pedal, or combinations thereof.

11. The system of claim 9, wherein the human input device is operable to be positioned through the closure system and substantially surrounded by the container.

12. The system of claim 1, wherein the item comprises a portion of a surgical navigation system.

13. The system of claim 12, wherein the surgical navigation system includes at least one of a tracking system, a tracking sensor, a processor, a human readable output system, an imaging system, a surgical instrument, a dynamic reference frame, a localizer, or combinations thereof.

14. The system of claim 13, wherein the surgical navigation system includes the processor and the item is operable to provide instructions to the processor.

15. The system of claim 1, wherein the handle is coupled to the container separate and in addition to the closure system.

16. The system of claim 1, wherein the flap comprises a skirt configured about the closure system.

17. The system of claim 16, wherein the flap is connected to the container and extends in a direction away from the closure system and towards a closed end of the container, defining a covered section between the flap and the container, the covered section configured to cover a portion of the user when the handle is grasped.

18. A system for delivering an item to a sterile field by a user, comprising:

a container configured to contain the item, the container having an open end defined by a wall and a closed end defined by the wall, wherein the wall defines an internal portion where the item is operable to be positioned within the internal portion;

a closure system configured to close the container to an ambient environment, wherein the closure includes a deformable member;

a handle configured to be grasped by the user and protect the user from contacting the item when the item is positioned within the container, the handle comprising a part of the container; and

a passage system defined by a sleeve having a first open terminal end, a second open terminal end, and a wall extending between the first open terminal end and the second open terminal end, the sleeve provided within the container and configured to be pulled partially out of the container at a first time and completely removed from the container at a second time later than the first time such that the second open terminal end is removed from the container;

wherein the item is operable to pass through the sleeve at the first time from an exterior environment to the internal portion of the container and be positioned within the container during an operative procedure to move the item into a sterile field without sterilizing the item.

19. The system of claim 18, wherein the handle is coupled to the container proximate to the closure system at the open end of the container and comprises a skirt configured about the closure system, the skirt extending in a direction away from the closure system and the open end, wherein the skirt defines a covered section encompassing a volume between the flap and the container, the covered section configured to cover a portion of the user when the handle is grasped.

20. The system of claim 18, wherein the sleeve-having the first open terminal end, the second open terminal end, and the wall extending between the first open terminal end and the second open terminal end is separate and removable from the container so that the first terminal end and the second terminal end are separated from the container and comprises a shape substantially similar to the container but with smaller dimensions.

21. The system of claim 20, wherein the sleeve defines a funnel shape wherein the first open terminal end is larger than the second open terminal end and the wall extends between the first open terminal end and the second open terminal end.

22. The system of claim 18, wherein at least a portion of the open end of the container is configured to be wrapped about the deformable member, and the deformable member is configured to be crimped to a selected position to maintain the position of at least a portion of the open end of the container.

23. The system of claim 18, wherein the handle is adjacent the closure system.

24. A system for delivering an item to a sterile field by a user, comprising:

a container configured to contain the item within an internal volume defined by an exterior wall, wherein the container includes one opening at a first end of the exterior wall into the internal volume of the container;

a closure system having a deformable member configured to be placed at the first end near the one opening and to close the one opening of the container to an ambient environment;

a handle adjacent to the closure system and extending away from the first end towards a second end of the container, wherein the second end is closed; and

a passage system comprising a sleeve having a first open terminal end, a second open terminal end, and a wall extending between the first open terminal end and the second open terminal end, the sleeve provided within the internal volume of the container and configured to be moved partially out of the container at a first time and entirely removed from the container at a second time that is later than the first time;

wherein the item is operable to pass through the sleeve from an exterior environment to the internal volume of the container at the first time;

wherein the container is configured to contain the item in the internal volume after the sleeve is entirely removed at the second time.

25. The system of claim 24, wherein the sleeve defines a funnel shape wherein the first open end is larger than the second open end and the wall extends between the first open terminal end and the second open terminal end and at least the second open terminal end is moveable within the container.

26. The system of claim 24, wherein the closure system is configured to crimp to close the container.

27. The system of claim 24, wherein the closure system is integral with the container and the sleeve is configured to be removed through the closure system and the closure system is configured to close the container after the sleeve is removed.