Digital minimally invasive surgery system

• US 7,383,073 B1
• Filed: 10/16/2001
• Issued: 06/03/2008
• Est. Priority Date: 10/16/2001
• Status: Expired due to Fees

• Current Assignee: MAKO Surgical Corporation (Stryker Corporation)
• Original Assignee: Z-KAT, Inc.
• Inventors: Frechette, Robert F., Tapia, William F., Abovitz, Rony A.
• Primary Examiner(s): Sykes; Angela D.
• Assistant Examiner(s): Cheng; Jacqueline
• Application Number:
  US09/978,599
• Time in Patent Office: 2,422 Days
• Field of Search: 600/407, 600/410, 600/411, 600/414, 600/417, 600/431, 600420-427, 600/437, 600/439
• US Class Current: 600/407
• CPC Class Codes: G06F 8/656 while running
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• 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 software-integrated disposable kit contains a series of sterile packages which hold instrumented surgical tools, surgical accessories, user input computer controlling peripherals (e.g. mouse, keyboard), markers, and a one time use digital medium. When image guided surgery is to be performed, the digital medium is inserted into the computer and the user interface is displayed. The digital medium stores a portion of the software which, in combination with software on the computer, provides all of the software necessary for full user functionality (e.g. display diagnostic image information, tracking surgical instruments, superimposition of surgical tools). At the end of a surgical procedure, the digital medium is deactivated or encrypted and the used surgical tools are then disposed of without reuse. The system allows the user to save relevant information obtained from the surgery (e.g. images, notes) on the digital medium which is encrypted against reuse and archived.

Claims

1. An image guided surgery system comprising:

a computer pre-programmed with a portion of image guided surgery software that provides minimal user functionality, full user functionality being enabled by adding application specific software, the computer being disposed at a surgical site;

a software-integrated disposable kit including;

an openable, transportable case;

instrumented surgical tools for a preselected surgical procedure, the tools being removably disposed in the case;

a digital medium with the application specific software specific to the preselected surgical procedure for upgrading the image guided surgery software to facilitate performance of the preselected surgical procedure, the digital medium being removably disposed in the case;

the case being openable at the surgical site such that the surgical tools are removable from the case at the surgical site for use in the preselected surgical procedure and the digital medium is removable from the case and insertable in the computer to enable full functionality of the image guided surgery software for the preselected surgical procedure;

a tracking system which locates the surgical tools while in use, the tracking system being disposed at the surgical site; and

a display at the surgical site used in conjunction with the computer.

2. The image guided surgery system as set forth in claim 1 further including:

a low cost mobile cart that holds at least the computer, the display, and standard peripherals.

3. The image guided surgery system as set forth in claim 1 wherein when the computer receives and reads the digital medium, the image guided surgery software is fully functional for the preselected surgical procedure and when the digital medium is removed, the image guided surgery software provides the minimal user functionality.

4. An image guided surgery system including:

software-integrated disposable kits including;

a digital medium with application specific software; and

,

instrumented disposable surgical tools;

a computer which receives the digital medium and processes the application specific software;

a tracking system which tracks the surgical tools during a surgical procedure;

a display used in conjunction with the computer; and

a means for deactivating or encrypting the digital medium against reuse at the end of the surgical procedure.

5. The image guided surgery system as set forth in claim 4 wherein the computer includes:

an input/output interface for capturing still-images and/or live video from an imaging device;

a graphic input/output interface for connecting to the display;

an interface for interconnection with at least one of a wired user input device and a wireless user input; and

,

an interface for interconnection with tracking sensors for monitoring position and movement of the instrumented surgical tools.

6. The image guided surgery system as set forth in claim 4, wherein the digital medium includes:

preprogrammed software for superimposing instrumented tools, accessories, implants, and associated hardware on images on the display in a wire frame or a user selected custom format.

7. The image guided surgery system as set forth in claim 4 wherein the digital medium includes:

an area which stores the application specific software;

an area which stores specifications and characteristics of the instrumented surgical tools;

an area which stores 3D virtual representations, images, or information of the instrumented tools and accessories contained in the kit; and

an area which stores additional information relevant to a particular surgical procedure.

8. The image guided surgery system as set forth in claim 4 wherein the tracking system includes:

one of acoustic sensors, infrared sensors, and video cameras, that are utilized to determine a location of the instrumented surgical tools.

9. The image guided surgery system as set forth in claim 4 wherein the tracking system includes:

a mobile cart for positioning a tracking camera in a surgical suite.

10. An image guided surgery system comprising:

an integrated computer;

a software-integrated, single-use, preselected surgical procedure specific kit including;

a portable, openable housing;

a label affixed to the housing to identify the preselected surgical procedure to be performed using the kit;

sterile packaging in which surgical tools for the preselected surgical procedure are contained in sterile condition, the sterile packaging and tools being removably disposed in the housing;

other accessories for the preselected surgical procedure in sterile condition in sterile packaging, the other accessories and their sterile packaging being removably disposed in the housing;

user input devices removably disposed in the housing; and

a disposable, one-time use digital medium readable by the computer and containing a portion of image guided surgery software specific to the preselected surgical procedure, the digital medium being removably disposed in the housing;

a tracking system which locates the surgical tools while in use; and

,

a display used in conjunction with the computer.

11. The image guided surgery system as set forth in claim 10 wherein the user input devices include:

a disposable, sterilizable, wireless peripheral for use by a surgeon at a surgical site for remote communication with the computer.

12. An image guided surgery system comprising:

a software-integrated disposable kit including;

instrumented disposable surgical tools;

a digital medium with application specific software, the digital medium including;

a preprogrammed one-time-use application specific software module to be used in surgery; and

a preprogrammed software module describing the surgical tools, implants, and other accessories;

the instrumented disposable surgical tools and the digital medium being packaged in a common shipping unit from which the tools and digital medium are removable at a surgical site;

a tracking system which tracks the surgical tools during surgery;

a computer which receives the software from the digital medium before a surgical procedure and disables it after the procedure; and

,

a display used in conjunction with the computer.

13. An image guided surgery system comprising:

a computer;

a software-integrated, one-time-use kit including;

a shipping case;

surgical tools removably received in the shipping case; and

,

a digital medium which includes;

preprogrammed software describing dimensional specifications of each of the tools, probes, guides, and any other instrumented accessories contained in the kit, the digital medium being removably received in the shipping case; and

a tracking system which tracks the surgical tools while in use; and

,

a display connected with the computer.

14. A surgery system comprising:

an integrated computer;

a display used in conjunction with the computer;

software-integrated kits, each kit designed for a preselected surgical procedure and including;

a common case;

surgical tools for performing the preselected surgical procedure;

a digital medium preprogrammed with software of 3D virtual representations, images, or information regarding the surgical tools, and any accessories, implants, and associated hardware contained in the kit used to create 3D virtual representations of the surgical tools in images on the display;

the surgical tools and the digital medium both being removably disposed in the common case.

15. A method of image guided surgery using a computer, a one-time-use surgical application specific kit that contains a digital medium with application specific software and surgical tools and accessories, a tracking system that locates the surgical tools while in use, and a display, the method comprising:

at a surgical site in preparation for a surgical procedure, removing the digital medium from the kit and inserting the digital medium into the computer;

augmenting software on the computer with the software from the digital medium to process diagnostic images, register the diagnostic images to a patient'"'"'s anatomy, register different sets of imaging modalities to each other, and track locations of at least one surgical tool;

during the surgical procedure, displaying a virtual representation of the at least one surgical tool on an image on the display, correlating movement of the virtual representation on the image on the display with movement of the at least one surgical tool in physical space;

deactivating or encrypting the digital medium against reuse after the surgical procedure.

16. The method as set forth in claim 15 further including:

using the computer as a planning station before the surgical procedure to define surgical entry points and trajectories.

17. The method as set forth in claim 15 further including:

archiving on the digital medium a record or history of the performed surgical procedure, including downloaded diagnostic images, selected instruments, implants, length of surgical time, notes, or other relevant information obtained during the surgical procedure.

18. The method as set forth in claim 15 further including:

replaying archived data for review and diagnostic follow-up.

19. The method as set forth in claim 15 further including:

preventing reuse of the surgical tools.

20. The method as set forth in claim 15 further including:

disposing of the surgical instruments and the digital medium without reuse after the surgical procedure.

21. A method of image guided surgery comprising:

providing a kit which includes (1) instrumented surgical tools and accessories and (2) a digital medium which is preprogrammed with software including (i) at least a portion of a graphics processing program and (ii) information concerning the surgical tools and accessories;

at a surgical site, removing the digital medium from the kit and inserting it into a processor which, between software with which the processor is preprogrammed and the software from the digital medium, processes electronic medical diagnostic images, correlates a coordinate system of a patient with a coordinate system of the diagnostic images, tracks a location of the instrumented surgical tools in the coordinate system of the patient, and translates the instrument position of the surgical tools into the coordinate system of the diagnostic image;

at the surgical site, removing the surgical tools and accessories from the kit.

22. The method as set forth in claim 21 wherein the kit further includes:

medical appliances, and

a user control for interconnection with the processor to control image displays; and

the method further includes;

at the surgical site, removing the medical appliances and the user control from the kit.

23. The method as set forth in claim 22 further including:

prior to placing the surgical tools, the surgical appliances, and the user control in the surgical kit, packaging the surgical tools, the surgical appliances, and user control in sterile condition in sterile packaging.

24. The method as set forth in claim 22 further including:

prior to placing the digital medium in the kit, programming the medium, with information about the surgical tools and the medical appliances in the kit.

25. The method as set forth in claim 21 further including:

prior to placing the digital medium in the kit, programming the digital medium with dimensional information about and depictions of the surgical tools.

26. The method as set forth in claim 21 further including:

after a surgical procedure, deactivating the digital medium against reuse.

27. The method as set forth in claim 26 further including:

after the surgical procedure, disposing the surgical instruments and the digital medium without reuse.

28. A surgical kit comprising:

a housing;

an identification of a surgical procedure to be performed using the kit, the identification being attached to an exterior of the housing;

surgical tools in sterile condition in sterile packaging which are used in the identified surgical procedure, the tools being removably received in the housing;

medical appliances in sterile condition in sterile packaging which are used in the identified surgical procedure, the medical appliances in sterile packaging being removably disposed in the housing;

an operator control in sterile condition in sterile packaging for electrical interconnection with a graphics processor which is preprogrammed with image guided surgery software that provides limited user functionality outside a sterile field, the operator control in sterile packaging being removably disposed in the housing; and

,

a digital media preprogrammed with a portion of an image guided surgery processing program and descriptive information concerning the surgical tools and the appliances in the kit which is readable by the processor to upgrade the preprogrammed image guided surgery software to full user functionality for the identified surgical procedure, the digital media being removably disposed in the housing.

29. An image guided surgery system comprising:

a set of surgical tools which are instrumented to be tracked during image guided surgery;

a processor which is preprogrammed with less than all software which is used for manipulating diagnostic images during the image guided surgery and for tracking the movement of the instrumented surgical tools during the image guided surgery;

a digital media which is preprogrammed with a remaining portion of the software for processing the diagnostic image data and tracking the movement of the instrumented surgical tools and with descriptive information concerning the instrumented surgical tools; and

a deactivator which deactivates the digital media against reuse at the end of an image guided surgical procedure.

30. The system as set forth in claim 29 wherein the processor includes:

a reader which receives and reads the digital media.

31. The system as set forth in claim 29 further including a surgical kit which includes:

an indication of a surgical procedure with which the kit is to be utilized;

the instrumented surgical tools for use in the indicated surgical procedure; and

,

the digital media.

32. The system as set forth in claim 31 wherein the surgical kit further includes:

surgical appliances used in the indicated procedure; and

a user input control for controlling the processor, the user input control, the surgical appliances, and the surgical tools all being in sterile condition in the kit.

33. The system as set forth in claim 29 wherein the processor includes:

an interface for interconnection with a source of three-dimensional electronic diagnostic images;

an interface for interconnection with a human-readable display for displaying diagnostic images and superimposed representations of the surgical tools;

an interface for interconnection with a user input control; and

,

an interface for interconnection with optical sensors for monitoring position and movement of the instrumented surgical tools.

34. The system as set forth in claim 29 wherein the digital media includes:

a first memory portion which stores the remaining software portion;

a second memory portion which stores descriptive characteristics of the instrumented surgical tools;

a third memory section which stores shape displays corresponding to the surgical tools for display superimposed on a display of the diagnostic image; and

,

a fourth memory portion which carries additional information.

35. An image guided surgery system having a tracking system for tracking movement of surgical tools, a human-viewable display, and a computer with limited user functionality for retrieving surgical information, displaying and manipulating diagnostic images on the display, surgical planning, and superimposing representations of the surgical tools on the diagnostic images on the display, further including:

a single use digital medium containing software to upgrade the computer temporarily to full user functionality for a preselected surgical procedure; and

,

a means for disabling the software from being reused to upgrade the computer after the preselected surgical procedure.

36. A method of implementing a computer-implemented procedure, the method comprising:

providing an integrated computer which receives a digital medium and which renders the digital medium inoperative;

opening a software-integrated disposable kit and removing a digital medium with application specific software and any associated elements;

inserting the digital medium into the integrated computer;

performing the procedure;

deactivating or encrypting the digital medium against reuse in the integrated computer;

removing the digital medium from the integrated computer.