Meniscus prosthetic device selection and implantation methods

• US 9,326,863 B2
• Filed: 07/29/2011
• Issued: 05/03/2016
• Est. Priority Date: 04/09/2008
• Status: Active Grant

• Current Assignee: Active Implants Corporation
• Original Assignee: Active Implants Corporation
• Inventors: Linder-Ganz, Eran, Shterling, Avraham, Weissberg, Noam
• Primary Examiner(s): Stewart, Jason-Dennis
• Application Number:
  US13/194,787
• Publication Number:
  US 20110288643A1
• Time in Patent Office: 1,740 Days
• Field of Search: 623/16.11, 623/14.12, 623/20.14, 623 2032- 2034
• US Class Current: 1/1
• CPC Class Codes: A61B 2034/108 Computer aided selection or customisation of medical implants or cutting guides
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/3872 Meniscus for implantation between the natural bone surfaces
• CPC Class Codes: A61F 2/461 of knees
• CPC Class Codes: A61F 2/4684 Trial or dummy prostheses
• CPC Class Codes: A61F 2002/30014 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2002/30064 Coating or prosthesis-covering structure made of biodegradable material
• CPC Class Codes: A61F 2002/30065 thermoplastic, i.e. softening or fusing when heated, and hardening and becoming rigid again when cooled
• CPC Class Codes: A61F 2002/30069 elastomeric
• CPC Class Codes: A61F 2002/30329 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2002/30563 having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
• CPC Class Codes: A61F 2002/30565 having spring elements
• CPC Class Codes: A61F 2002/30616 Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/30673 Lubricating means, e.g. synovial pocket
• CPC Class Codes: A61F 2002/30841 Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/30884 Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
• CPC Class Codes: A61F 2002/30906 shot- sand- or grit-blasted
• CPC Class Codes: A61F 2002/3093 for promoting ingrowth of bone tissue
• CPC Class Codes: A61F 2002/30943 : using mathematical models
• CPC Class Codes: A61F 2002/30948 : using computerized tomography, i.e. CT scans
• CPC Class Codes: A61F 2002/30955 : using finite-element analysis
• CPC Class Codes: A61F 2002/30957 : using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/3895 : unicompartimental
• CPC Class Codes: A61F 2210/0071 : thermoplastic
• CPC Class Codes: A61F 2220/0008 : Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2240/008 : Means for testing implantable prostheses
• CPC Class Codes: A61F 2250/0018 : differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0064 : Sets comprising a plurality of prosthetic parts of different sizes
• CPC Class Codes: B33Y 50/00 : Data acquisition or data processing for additive manufacturing
• CPC Class Codes: B33Y 80/00 : Products made by additive manufacturing

Abstract

Methods of selecting and implanting prosthetic devices for use as a replacement meniscus are disclosed. The selection methods include a pre-implantation selection method and a during-implantation selection method. The pre-implantation selection method includes a direct geometrical matching process, a correlation parameters-based matching process, and a finite element-based matching process. The implant identified by the pre-implantation selection method is then confirmed to be a suitable implant in the during-implantation selection method. Methods of implanting meniscus prosthetic devices are also disclosed.

Claims

1. A method of treating a damaged meniscus, comprising:

utilizing a pre-implantation matching process to identify a best suitable meniscus prosthetic device for replacing the damaged meniscus, the pre-implantation matching process comprising a correlation parameters-based matching process that considers at least one of an area correlation, a width correlation, a length correlation, and a perimeter correlation, the area correlation defined by a meniscus contact area divided by a medial tibia area, the width correlation defined by an average meniscus width divided by a medial tibia width, the length correlation defined by a medial meniscus length divided by a medial tibia length, and the perimeter correlation defined by a meniscus perimeter divided by a medial tibia perimeter;

positioning a trial meniscus prosthetic device into a knee joint, the trial meniscus prosthetic device selected based on utilizing the pre-implantation matching process, wherein the trial meniscus prosthetic device includes radiopaque features distinguishing the trial meniscus prosthetic device from a permanent meniscus prosthetic device; and

evaluating a fit of the trial meniscus prosthetic device within the knee joint.

2. The method of claim 1, wherein the pre-implantation matching process further comprises a direct geometrical matching process and a finite element-based matching process.

3. The method of claim 1, wherein evaluating the fit of the trial comprises moving the knee joint through a variety of motions simulating natural motions of the knee.

4. The method of claim 1, further comprising:

implanting an alternative trial of an alternative meniscus prosthetic device into the knee joint and evaluating a fit of the alternative trial.

5. The method of claim 1, further comprising:

implanting the best suitable meniscus prosthetic device into the knee joint.

6. The method of claim 5, wherein the best suitable meniscus prosthetic device comprises a medial meniscus prosthetic device and wherein implanting the best suitable meniscus prosthetic device comprises:

fully flexing the knee joint;

positioning the prosthetic device on a medial condyle of the knee joint;

positioning a portion of the prosthetic device in a gap between the femur and the tibia adjacent a posterior portion of the femur;

extending the knee joint; and

applying a valgus force on the knee joint.

7. The method of claim 6, wherein implanting the best suitable meniscus prosthetic further comprises:

inserting a traction suture; and

applying tension with the traction suture to urge the prosthetic device into position.

8. A method of treating a damaged meniscus, comprising:

utilizing a pre-implantation matching process to identify a best suitable meniscus prosthetic device for replacing the damaged meniscus, the pre-implantation matching process comprising a correlation parameters-based matching process that considers a correlation parameter including at least one of an area correlation, a width correlation, a length correlation, and a perimeter correlation, the area correlation defined by a meniscus contact area divided by a medial tibia area, the width correlation defined by a tibia width, the length correlation defined by a medial tibia length, and the perimeter correlation defined by a meniscus perimeter divided by a medial tibia perimeter;

comparing a patient knee image to one or more of the correlation parameters; and

determining a trial prosthetic meniscus replacement device based on the comparing;

positioning the trial meniscus prosthetic device into a knee joint, wherein the trial meniscus prosthetic device includes at least one of a marking or a coloring to visually distinguish the trial meniscus prosthetic implant from a permanent meniscus prosthetic implant; and

evaluating a fit of the trial meniscus prosthetic device within the knee joint.

9. A method of treating a damaged meniscus, comprising:

utilizing a pre-implantation matching process to identify a meniscus prosthetic implant for replacing at least a portion of the damaged meniscus, the pre-implantation matching process comprising a correlation parameters-based matching process that considers a correlation parameter including at least one of an area correlation, a width correlation, a length correlation, and a perimeter correlation, the area correlation defined by a meniscus contact area divided by a medial tibia area, the width correlation defined by a tibia width, the length correlation defined by a medial tibia length, and the perimeter correlation defined by a meniscus perimeter divided by a medial tibia perimeter;

comparing an image of a patient knee joint to one or more of the correlation parameters; and

determining a trial meniscus prosthetic implant based on the comparing;

positioning the trial meniscus prosthetic implant in the patient knee joint;

removing the trial meniscus prosthetic implant; and

implanting a permanent meniscus prosthetic implant having a similar size and shape as the trial meniscus prosthetic implant,

wherein the permanent meniscus prosthetic implant includes reinforcing fibers positioned around a circumference thereof, the permanent meniscus prosthetic implant including a greater number of the reinforcing fibers compared to the trial meniscus prosthetic implant.

10. The method of claim 9, wherein the trial meniscus prosthetic implant includes radiopaque features.

11. The method of claim 9, wherein the permanent meniscus prosthetic implant does not include radiopaque features.

12. The method of claim 9, wherein the trial meniscus prosthetic implant is formed to be more easily removed from the knee joint than the permanent meniscus prosthetic implant.

13. The method of claim 9, wherein a wall of the permanent meniscus prosthetic implant is less flexible than a wall of the trial meniscus prosthetic implant.

14. The method of claim 9, wherein the trial meniscus prosthetic implant includes a visual indicator to visually distinguish the trial meniscus prosthetic implant from the permanent meniscus prosthetic implant.

15. The method of claim 14, wherein the visual indicator includes at least one of a marking or a coloring.