Meniscus prosthetic device selection and implantation methods

• US 7,991,599 B2
• Filed: 04/09/2008
• Issued: 08/02/2011
• Est. Priority Date: 04/09/2008
• Status: Active Grant

• Current Assignee: Active Implants Corporation
• Original Assignee: Active Implants Corporation
• Inventors: Shterling, Avraham, Linder-Ganz, Eran, Weissberg, Noam
• Primary Examiner(s): Craig; Dwin M
• Application Number:
  US12/100,115
• Publication Number:
  US 20090259314A1
• Time in Patent Office: 1,210 Days
• Field of Search: 623/14.12, 623/18.11, 623/17.16, 703/7, 703/11, 600/594, 600/300, 600/587, 606/1, 606/102, 606/53, 606/71
• US Class Current: 703/7
• 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 selecting a meniscus prosthetic device for a patient from a library of available prosthetic devices, the method comprising:

a pre-implantation matching process comprising;

a direct geometrical matching process comprising;

obtaining an image of the patient'"'"'s healthy knee,

segmenting the knee into components, including a healthy meniscus, and

comparing the healthy meniscus to the available prosthetic devices to identify any geometrically suitable prosthetic devices;

a correlation parameters-based matching process comprising;

obtaining an image of the patient'"'"'s injured knee,

determining one or more correlation parameters for the available prosthetic devices based on anatomical measurements of the injured knee, and

comparing the one or more correlation parameters for the available prosthetic devices to an accepted normative data range to identify any correlation-parameter suitable prosthetic devices; and

a finite element-based matching process comprising;

creating a finite element model of the patient'"'"'s injured knee based on the image of the patient'"'"'s injured knee,

simulating a loading of the patient'"'"'s injured knee with an available prosthetic device positioned therein for one or more of the available prosthetic devices, and

evaluating a load distribution for the one or more of the available prosthetic devices to identify any finite-element suitable prosthetic devices.

2. The method of claim 1, wherein the pre-implantation matching process further comprises:

identifying one or more best suitable prosthetic devices from the geometrically suitable prosthetic devices, the correlation-parameter suitable prosthetic devices, and the finite-element suitable prosthetic devices.

3. The method of claim 2, wherein identifying the one or more best suitable prosthetic devices comprises:

weighting the direct geometrical matching process, the correlation parameters-based matching process, and the finite element-based matching process.

4. The method of claim 3, wherein the direct geometrical matching process, the correlation parameters-based matching process, and the finite element-based matching process are given equal weight.

5. The method of claim 3, wherein at least one of the direct geometrical matching process, the correlation parameters-based matching process, and the finite element-based matching process is given less weight than another of the direct geometrical matching process, the correlation parameters-based matching process, and the finite element-based matching process.

6. The method of claim 2, further comprising:

a during-implantation matching process comprising;

introducing a first trial prosthetic device into the damaged knee, the first trial prosthetic device corresponding to one of the best suitable prosthetic devices; and

evaluating the fit of the first trial prosthetic device.

7. The method of claim 6, wherein the during-implantation matching process further comprises:

introducing a second trial prosthetic device into the damaged knee, the second trial prosthetic device corresponding to another of the best suitable prosthetic devices; and

evaluating the fit of the second trial prosthetic device.

8. The method of claim 1, wherein the pre-implantation matching process is configured to identify suitable medial meniscus prosthetic devices.

9. The method of claim 8, wherein the one or more correlation parameters of the correlation parameters-based matching process are selected from the group consisting of an area correlation, a width correlation, a length correlation, and a perimeter correlation.

10. The method of claim 9, wherein the area correlation is defined by a meniscus contact area divided by a medial tibia area.

11. The method of claim 9, wherein the width correlation is defined by an average meniscus width divided by a medial tibia width.

12. The method of claim 11, wherein the average meniscus width is defined by an average of an anterior meniscus width and a posterior meniscus width.

13. The method of claim 9, wherein the length correlation is defined by a medial meniscus length divided by a medial tibia length.

14. The method of claim 9, wherein the perimeter correlation is defined by a meniscus perimeter divided by a medial tibia perimeter.

15. The method of claim 1, wherein the direct geometrical matching process further comprises:

creating a virtual solid model of the healthy meniscus;

wherein comparing the healthy meniscus to the available prosthetic devices comprises comparing dimensions of the virtual solid model of the healthy meniscus to dimensions of the available prosthetic devices.