Backup surgical instrument system and method

• US 9,918,740 B2
• Filed: 06/20/2012
• Issued: 03/20/2018
• Est. Priority Date: 02/27/2006
• Status: Expired due to Fees

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Uthgenannt, Brian A., Friend, Christopher W., Durcholz, Bradley T., Catanzarite, Joshua B., Metzger, Robert, Worrell, Kai Robert
• Primary Examiner(s): Yang, Andrew
• Application Number:
  US13/527,981
• Publication Number:
  US 20120303004A1
• Time in Patent Office: 2,099 Days
• CPC Class Codes: A61B 17/154 for preparing bone for knee prosthesis
• CPC Class Codes: A61B 17/56 Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
• CPC Class Codes: A61B 2017/564 Methods for bone or joint treatment
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/108 Computer aided selection or customisation of medical implants or cutting guides
• CPC Class Codes: A61B 2034/252 indicating steps of a surgical procedure
• CPC Class Codes: A61B 2034/258 providing specific settings for specific users
• CPC Class Codes: A61B 2050/105 Cabinets
• CPC Class Codes: A61B 2050/185 Drawers
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 50/10 Furniture specially adapted for surgical or diagnostic appliances or instruments
• CPC Class Codes: A61B 50/13 Trolleys, e.g. carts
• CPC Class Codes: A61B 50/15 Mayo stands; Tables
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 50/33 Trays

Abstract

A method for preparing surgical kits for use during a surgery includes preparing a pre-operative surgical plan for a patient and selecting a set of surgical instruments based on the pre-operative surgical plan. The set of surgical instruments includes at least a general instrument, a first size-specific instrument, a patient-specific instrument, and a surgeon-specific instrument. The general instrument is selected from a predetermined group of off-the-shelf instruments. The first size-specific instrument has a first size selected from predetermined sizes. The patient-specific instrument includes a three-dimensional contoured engagement surface configured to nest into a portion of a native anatomy in a single location. The surgeon-specific instrument is selected based on a surgeon preference and is a different instrument than the selected general instrument, first size-specific instrument, and patient-specific instrument. The method further includes preparing a surgeon instrument kit containing the set of surgical instruments in sterilized form.

Claims

1. A method for assembling surgical kits for use during a surgery, comprising:

obtaining image information for anatomy of a patient;

generating a pre-operative surgical plan for performing a procedure on the patient using the image information;

creating a three-dimensional model of a bone from the patient using the image information;

manufacturing a patient-specific instrument including a three-dimensional contoured engagement surface configured to nest into a portion of a native anatomy in a single location, the three-dimensional contoured engagement surface generated using the image information;

obtaining a set of surgical instruments based on the pre-operative surgical plan, the set of surgical instruments including at least;

a general instrument selected from a predetermined group of off-the-shelf instruments, the general instrument being a non-disposable type;

a first size-specific instrument having a first size selected from predetermined sizes;

the patient-specific instrument; and

a surgeon-specific instrument selected based on a surgeon preference for performing the procedure, the surgeon-specific instrument being different than the selected general instrument, first size-specific instrument, and patient-specific instrument, the surgeon-specific instrument comprising one of a plurality of accepted instruments for performing a surgical task, the plurality of accepted instruments being alternatives to each other for achieving the same result;

packaging a surgeon instrument kit containing the set of surgical instruments in sterilized form in a container;

delivering the surgeon instrument kit to a surgeon for use during the surgery;

staging the surgeon instrument kit relative to an operating room used for the surgery; and

individually packaging a backup instrument into a backup instrument package based on and separate from the surgeon instrument kit, the backup instrument package containing only one sterilized replacement instrument for one of the surgical instruments, the sterilized replacement instrument being a duplicate of the one of the surgical instruments.

2. The method of claim 1, further comprising stocking the backup instrument to a mobile storage cart, wherein staging the backup instrument relative to the operating room includes staging the mobile storage cart relative to the operating room.

3. The method of claim 1, wherein the patient-specific instrument is an alignment guide for positioning a cutting instrument with respect to the native anatomy.

4. The method of claim 1, wherein the first size-specific instrument is a cutting guide for guiding a cutting instrument.

5. The method of claim 1, wherein the first size-specific instrument is a trial implant component.

6. The method of claim 1, further comprising packaging a backup kit based on the surgeon instrument kit, the backup kit including a second size-specific instrument selected from the predetermined sizes and having a second size different than the first size.

7. The method of claim 1, further comprising packaging a backup kit based on the surgeon instrument kit, wherein the surgeon-specific instrument is an instrument used to perform a preferred procedure selected from among predetermined procedures for performing a surgical task, and wherein the backup kit includes a replacement instrument used to perform an alternate procedure selected from among the predetermined procedures.

8. The method of claim 1, wherein the surgeon instrument kit includes a first plurality of instruments and the method further includes preparing a plurality of backup packages containing sterilized replacement instruments for the first plurality of instruments, each of the backup packages containing only one of the replacement instruments.

9. The method of claim 1, further comprising:

generating image information with an imaging system in order to obtain the image information for the anatomy of the patient;

storing the image information on a non-transitory tangible computer readable medium;

creating the three-dimensional model from the stored image information;

generating the pre-operative surgical plan using the three-dimensional model, the pre-operative surgical plan including digital images of resection planes of the anatomy; and

manufacturing the patient-specific instrument using the three-dimensional model.

10. The method of claim 1, wherein the general instrument is not specifically designed to match unique features of anatomy of any particular patient.

11. A method for assembling surgical kits for use during a surgery, comprising:

creating a three-dimensional model of a bone from a patient using image information;

manufacturing a patient-specific instrument using the three-dimensional model to include a three-dimensional contoured engagement surface configured to nest into a portion of a native anatomy in a single location;

packaging a surgeon instrument kit containing a plurality of surgical instruments, including the patient-specific instrument;

delivering the surgeon instrument kit to an operating room for use by a surgeon during the surgery;

individually packaging a backup instrument separate from the surgeon instrument kit, the backup instrument kit comprising one replacement instrument for a corresponding one of the surgical instruments, the one replacement instrument performing a duplicate function of the corresponding one of the surgical instruments, wherein the only one replacement instrument comprises a replacement for the patient-specific instrument;

stocking the backup instrument to a mobile storage cart;

staging the mobile storage cart at a location near the operating room to be accessible during the surgery using the surgeon instrument kit prior to the surgery; and

selectively replacing the one of the surgical instruments with the replacement instrument.

12. The method of claim 11, wherein the method includes individually packaging a plurality of backup instruments separate from the surgeon instrument kit, each package including a sterilized replacement instrument for the surgical instruments, each package containing only one of the replacement instruments.

13. The method of claim 12, wherein, collectively, the backup instruments include replacement instruments for each of the surgical instruments of the surgeon instrument kit.

14. The method of claim 11, wherein the staging the mobile storage cart relative to the operating room includes moving the mobile storage cart from a predetermined first designated location within a medical facility to a predetermined second designated location within the medical facility different than the first designated location.

15. The method of claim 11, wherein the replacement instrument has a first size and the one of the surgical instruments has a second size different than the first size.

16. The method of claim 11, wherein the one of the surgical instruments is a first instrument used to perform a preferred procedure selected from among predetermined procedures for performing a surgical task, and wherein the replacement instrument is a second instrument used to perform an alternate procedure selected from among the predetermined procedures to perform the surgical task.

17. The method of claim 11, further comprising delivering the surgeon instrument kit and the backup instrument to a medical facility together in a single delivery container.

18. The method of claim 11, wherein the only one replacement instrument comprises a duplicate instrument of the corresponding one of the surgical instruments.

19. The method of claim 11, wherein the mobile storage cart is staged during the surgery using the surgeon instrument kit.

20. The method of claim 19, wherein the mobile storage cart is staged at a medical facility where the surgery is being performed.

21. The method of claim 11, wherein the mobile storage car includes separate shelves or drawers for the surgeon instrument kit and each backup instrument kit.

22. A method for assembling surgical kits for use during a surgery, comprising:

obtaining image information for anatomy of a patient;

generating a pre-operative surgical plan for performing a procedure on the patient using the image information;

creating a three-dimensional model of a bone from the patient using the image information;

manufacturing a patient-specific instrument including a three-dimensional contoured engagement surface configured to nest into a portion of a native anatomy in a single location, the three-dimensional contoured engagement surface generated using the image information;

obtaining a set of surgical instruments based on the pre-operative surgical plan, the set of surgical instruments including at least;

a general instrument selected from a predetermined group of off-the-shelf instruments, the general instrument being a non-disposable type;

a first size-specific instrument having a first size selected from predetermined sizes;

the patient-specific instrument; and

a surgeon-specific instrument selected based on a surgeon preference for performing the procedure, the surgeon-specific instrument being different than the selected general instrument, first size-specific instrument, and patient-specific instrument, the surgeon-specific instrument comprising one of a plurality of accepted instruments for performing a surgical task, the plurality of accepted instruments being alternatives to each other for achieving the same result;

packaging a surgeon instrument kit containing the set of surgical instruments in sterilized form in a container, wherein the surgeon instrument kit includes a first plurality of instruments;

delivering the surgeon instrument kit to a surgeon for use during the surgery;

staging the surgeon instrument kit relative to an operating room used for the surgery; and

preparing a plurality of backup packages containing sterilized replacement instruments for the first plurality of instruments, each of the backup packages containing only one of the replacement instruments.