System and method for identifying a landmark

• US 9,763,598 B2
• Filed: 11/10/2015
• Issued: 09/19/2017
• Est. Priority Date: 04/27/2009
• Status: Active Grant

• Current Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Original Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Inventors: Ritchey, Nicholas S., Wilhelm, Hoa La, Grusin, Nathaniel Kelley
• Primary Examiner(s): SEVILLA, CHRISTIAN ANTHONY
• Application Number:
  US14/937,454
• Publication Number:
  US 20160058321A1
• Time in Patent Office: 679 Days
• CPC Class Codes: A61B 17/1703 using imaging means, e.g. by X-rays
• CPC Class Codes: A61B 17/1707 using electromagnetic effects, e.g. with magnet and external sensors
• CPC Class Codes: A61B 17/1725 for applying transverse screws or pins through intramedullary nails or pins
• CPC Class Codes: A61B 17/7233 with special means of locking the nail to the bone
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2072 Reference field transducer attached to an instrument or patient
• CPC Class Codes: A61B 2034/256 having a database of accessory information, e.g. including context sensitive help or scientific articles
• CPC Class Codes: A61B 2090/0813 Accessories designed for easy sterilising, i.e. re-usable
• CPC Class Codes: A61B 2090/363 Use of fiducial points
• CPC Class Codes: A61B 2090/3958 emitting a signal
• CPC Class Codes: A61B 2090/397 electromagnetic other than visible, e.g. microwave
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• CPC Class Codes: A61B 5/1127 using markers
• CPC Class Codes: A61B 5/4504 Bones A61B5/4547 takes precedence
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61L 2/07 Steam
• CPC Class Codes: A61L 2/081 Gamma radiation
• CPC Class Codes: H01F 41/00 : Apparatus or processes specially adapted for manufacturing or assembling magnets, inductances or transformers; Apparatus or processes specially adapted for manufacturing materials characterised by their magnetic properties
• CPC Class Codes: Y10T 29/4902 : Electromagnet, transformer or inductor

Abstract

A field generator for use in a surgical targeting system is disclosed. The field generator includes a mounting structure including elements that are configured to receive components of an electromagnetic field generator. The elements are disposed on the mounting structure at locations and orientations relative to each other. The field generator includes at least one covering formed over the mounting structure, wherein, in use, the locations and orientations of the elements relative to each other remain substantially unaltered after exposure to one or more sterilization processes.

Claims

1. A method comprising:

sterilizing a landmark identifier with autoclave sterilization, the landmark identifier comprising a plurality of magnetic field generating elements mounted to an internal mounting structure;

after sterilizing the landmark identifier, using the landmark identifier to identify one or more landmarks of an orthopaedic implant; and

after using the landmark identifier to identify the one or more landmarks of the orthopaedic implant, sterilizing the landmark identifier with autoclave sterilization.

2. The method of claim 1, wherein sterilizing the landmark identifier with autoclave sterilization comprises placing the landmark identifier in an environment having a temperature of at least 120 degrees Celsius.

3. The method of claim 1, wherein sterilizing the landmark identifier with autoclave sterilization comprises sterilizing a landmark identifier comprising a plurality of receiving elements defined in the internal mounting structure, the magnetic field generating elements being mounted to the mounting structure at the respective receiving elements, the internal mounting structure being configured to maintain a predetermined position and orientation of the magnetic field generating elements relative to each other during the autoclave sterilization.

4. The method of claim 1, wherein using the landmark identifier to identify one or more landmarks of an orthopaedic implant comprises:

placing the landmark identifier near a sensor such that the sensor produces sensor data based on a magnetic field produced by the landmark identifier; and

using a display of a targeting system to position the landmark identifier in a predetermined position relative to the one or more landmarks, the display indicating a position of an instrument determined based on the sensor data.

5. The method of claim 1, wherein using the landmark identifier to identify one or more landmarks of an orthopaedic implant comprises:

placing the landmark identifier near a sensor coupled to an intramedullary nail, such that the sensor produces sensor data in response to a sequence of magnetic field distributions generated by the magnetic field generating elements of the landmark identifier; and

aligning a drill guide with an axis of a distal hole of the intramedullary nail based on a display of a targeting system that receives the sensor data and that displays a position of the landmark identifier relative to the distal hole of the intramedullary nail based on the sensor data.

6. A method comprising:

obtaining a landmark identifier comprising a housing and a plurality of magnetic field generating elements that are mounted to an internal mounting structure within the housing;

sterilizing the landmark identifier with an autoclave sterilization process that provides pressure, humidity, and a temperature of at least 120 degrees Celsius; and

after sterilizing the landmark identifier, providing the sterilized landmark identifier for use in a surgical procedure.

7. The method of claim 6, wherein obtaining the landmark identifier comprises obtaining a landmark identifier comprising a mounting structure comprising a plurality of receiving elements having the magnetic field generating elements mounted on or in the receiving elements, the plurality of receiving elements being disposed on the mounting structure at particular locations and orientations relative to each other;

and

wherein providing the sterilized landmark identifier comprises providing the sterilized landmark identifier with the receiving elements in the particular locations and orientations relative to each other after sterilizing the landmark identifier.

8. The method of claim 6, wherein obtaining the landmark identifier comprises obtaining a landmark identifier wherein the mounting structure that has a flexural strength of at least 10,000 psi.

9. The method of claim 6, wherein obtaining the landmark identifier comprises obtaining a landmark identifier having the magnetic field generating components mounted on the mounting structure such that the autoclave sterilization process does not change the orientations of the magnetic field generating components by more than 2 degrees.

10. The method of claim 6, wherein obtaining the landmark identifier comprises obtaining a landmark identifier having the magnetic field generating components mounted on the mounting structure such that the autoclave sterilization process does not change the locations of the electromagnetic field generating components by more than 0.005 inches.

11. The method of claim 6, wherein obtaining the landmark identifier comprises obtaining a landmark identifier having a silicone outer covering.

12. The method of claim 6, wherein sterilizing the landmark identifier with the autoclave sterilization process comprises directly exposing the landmark identifier to the pressure, humidity, and temperature of the autoclave process.

13. The method of claim 6, further comprising placing:

placing the landmark identifier near a sensor such that the sensor produces sensor data based on a magnetic field produced by the landmark identifier; and

using a display of a targeting system to position the landmark identifier in a predetermined position relative to the one or more landmarks, the display indicating a position of an instrument determined based on the sensor data.

14. A field generator for use in a surgical targeting system, the field generator comprising:

a mounting structure comprising receiving elements disposed on the mounting structure at locations and orientations relative to each other;

magnetic field generating components received in the receiving elements, the electromagnetic field generating components being configured to produce a sequence of multiple different magnetic field distributions; and

a housing that extends around the mounting structure and the magnetic field generating elements,

wherein the mounting structure is configured to maintain the positions of the receiving elements within a predetermined tolerance relative to each other after the field generator is subjected to one or more autoclave sterilization processes.

15. The field generator of claim 14, wherein the mounting structure has one or more recessed portions.

16. The field generator of claim 14, wherein the magnetic field generating components are inductive coils.

17. The field generator of claim 14, wherein the housing comprises a covering that includes a silicone material.

18. The field generator of claim 14, wherein the mounting structure that has a flexural strength of at least 10,000 psi.

19. The field generator of claim 14, wherein the mounting structure is configured to maintain positions of the magnetic field generating elements such that autoclave sterilization does not change the orientations of the magnetic field generating components by more than 2 degrees.

20. The field generator of claim 14, wherein the mounting structure is configured to maintain positions of the magnetic field generating elements such that autoclave sterilization does not change the locations of the electromagnetic field generating components by more than 0.005 inches.