Backup kit for a patient-specific arthroplasty kit assembly

• US 10,492,798 B2
• Filed: 08/31/2018
• Issued: 12/03/2019
• Est. Priority Date: 07/01/2011
• Status: Active Grant

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Metzger, Robert
• Primary Examiner(s): Tomaszewski, Michael
• Application Number:
  US16/119,517
• Publication Number:
  US 20180368858A1
• Time in Patent Office: 459 Days
• Field of Search: None
• CPC Class Codes: A61B 17/155 Cutting femur
• CPC Class Codes: A61B 17/157 Cutting tibia
• CPC Class Codes: A61B 17/1764 for the knee
• CPC Class Codes: A61B 2017/568 produced with shape and dimensions specific for an individual patient
• CPC Class Codes: A61B 2034/108 Computer aided selection or customisation of medical implants or cutting guides
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/30 Joints
• CPC Class Codes: A61F 2/30942 for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques

Abstract

A method for preparing a backup kit for a plurality of patient-specific arthroplasty procedures scheduled at the same medical facility includes providing a database with data from completed arthroplasty procedures using patient-specific arthroplasty kits. The database includes comparisons between preoperatively planned implant size and intraoperatively implanted implant size. The method includes determining a statistically expected implant size deviation from a planned implant size for each implant included in a plurality of patient-specific arthroplasty kits prepared for a shipment to the medical facility using the database. A backup kit of backup implants is assembled for the shipment. The number and size of the backup implants is determined from the statistically expected implant size deviations.

Claims

1. A backup system for a plurality of patient-specific arthroplasty procedures scheduled at the same medical facility for a plurality of different patients comprising:

a plurality of implants selected and assembled for a shipment of a plurality of patient-specific arthroplasty systems for the medical facility, the plurality of patient-specific arthroplasty systems configured for corresponding arthroplasty procedures at the same medical facility for a planned period of time, at least one of the plurality of patient-specific arthroplasty systems having one or more of the plurality of implants with a size that differs from a planned size of another of the plurality of backup implants that are part of the plurality of patient-specific arthroplasty systems, a number and sizes of at least one of the plurality of implants determined from a statistically expected implant size deviation from a planned implant size in the plurality of patient-specific arthroplasty systems using a database having data from completed arthroplasty procedures with other patient-specific arthroplasty systems, the database including comparisons between preoperatively planned implant sizes and intraoperatively implanted implant sizes.

2. They system of claim 1, wherein the one or more of the plurality of implants comprise one or more backup implants designed to be used instead of the another of the plurality of backup implants should the another of the plurality of backup implants not fit one of the plurality of different patients properly.

3. The system of claim 1, wherein the size of the one or more of the plurality of backup implants differs from the planned size of another of the plurality of backup implants by an interval of 2.5 mm.

4. The system of claim 1, wherein the plurality of patient-specific arthroplasty systems each include a patient-specific alignment guide.

5. The system of claim 4, wherein the patient-specific alignment guide comprises a patient-specific knee alignment guide.

6. The system of claim 5, wherein the plurality of patient-specific arthroplasty systems each include a non-custom femoral implant, a non-custom tibial bearing component and a non-custom tibial implant.

7. The system of claim 1, wherein the planned period of time comprises one of a single day or a single week.

8. A backup system for a plurality of patient-specific arthroplasty procedures scheduled at the same medical facility for a plurality of different patients comprising:

a database of data from completed arthroplasty procedures using prior used patient-specific arthroplasty systems, information collected and provided by the database including comparisons between a plurality of preoperatively planned implant sizes and a plurality of intraoperatively implanted implant sizes, the database being updated after the patient-specific arthroplasty procedures are performed and depending upon the characteristics of implants and instruments used in the plurality of patient-specific arthroplasty procedures;

an omnibus backup system of backup implants assembled for the shipment by accessing and referencing the database, wherein the omnibus backup system includes a plurality of patient-specific arthroplasty systems; and

a computer configured to determine a statistically expected implant size deviation from a planned implant size for each implant included in the plurality of patient-specific arthroplasty systems for the plurality of different patients that form the omnibus backup system during a planned time period prepared for a shipment to the medical facility using the database, the computer determining of the statistically expected implant size deviation being performed utilizing algorithms for statistical analysis;

wherein a number and size of the backup implants are determined from the statistically expected implant size deviations and a number of implants corresponding to the planned implant size based on the totality of procedures for the plurality of different patients during the planned time period.

9. The system of claim 8, wherein the database is updated with intraoperatively implanted implant size for each patient-specific arthroplasty system after a corresponding arthroplasty procedure is completed.

10. The system of claim 8, wherein each of the plurality of patient-specific arthroplasty systems includes a patient-specific alignment guide.

11. The system of claim 8, wherein each of the plurality of patient-specific arthroplasty systems includes a non-custom implant.

12. The system of claim 8, wherein the size of at least one backup implant differs by a size interval of 2.5 mm from the planned implant size.

13. The system of claim 8, wherein the computer is configured to determine a quotient of the rate of mismatch divided by the number of implants corresponding to the preoperatively planned implant sizes.

14. The system of claim 8, wherein the computer is configured to determine a proportion of the backup implants having larger and smaller sizes than the preoperatively planned implant sizes based on the rate of mismatch and the number of implants corresponding to the plurality of the preoperatively planned implant sizes.

15. The system of claim 14, wherein the rate of mismatch includes a rate of oversized mismatch and a rate of undersized mismatch.

16. The system of claim 14, wherein the statistically expected size deviation includes an oversized deviation and an undersized deviation.

17. The system of claim 8, wherein the number and size of the backup implants are determined based on a percentage of mismatch cases to be accounted for.