# US 8,784,490 B2 · Method of designing orthopedic implants using in vivo data

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- Number: US 8,784,490 B2
- Document ID: US8784490B2
- Status: Granted
- Kind: B2
- Application number: 13/109,548
- Filed: 2011-05-17
- Published: 2011-10-13
- Granted: 2014-07-22
- Earliest claimed: 2008-11-18
- Applicants: Ray C. Wasielewski
- Inventors: Ray C. Wasielewski
- Web page: https://patentgrep.com/patent/US8784490B2

## CPC

- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- A61B 90/06: {Measuring instruments not otherwise provided for}
- A61F 2/28: Bones
- A61F 2/30942: {for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques}
- A61F 2/32: for the hip
- A61F 2/38: for elbows or knees
- A61F 2/3859: {Femoral components}
- A61F 2/389: {Tibial components (A61F2/3868 takes precedence)}
- A61F 2/40: for shoulders
- A61F 2/4657: {Measuring instruments used for implanting artificial joints (for surgical instruments A61B90/06)}
- A61F 2/4684: {Trial or dummy prostheses}
- B29C 64/386: Data acquisition or data processing for additive manufacturing
- G06F 30/00: Computer-aided design [CAD]
- A61B 2034/102: {Modelling of surgical devices, implants or prosthesis}
- A61B 2034/104: {Modelling the effect of the tool, e.g. the effect of an implanted prosthesis or for predicting the effect of ablation or burring}
- A61B 2034/105: {Modelling of the patient, e.g. for ligaments or bones}
- A61B 2034/108: {Computer aided selection or customisation of medical implants or cutting guides}
- A61B 2090/065: {for measuring contact or contact pressure}
- A61B 2090/376: {using X-rays, e.g. fluoroscopy}
- A61F 2/3868: {with sliding tibial bearing}
- A61F 2/3886: {for stabilising knees against anterior or lateral dislocations}
- A61F 2002/30331: {made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit}
- A61F 2002/30518: {with possibility of relative movement between the prosthetic parts}
- A61F 2002/30604: {modular}
- A61F 2002/30616: {Sets comprising a plurality of prosthetic parts of different sizes or orientations}
- A61F 2002/30672: {temporary}
- A61F 2002/3071: {Identification means; Administration of patients}
- A61F 2002/30952: {using CAD-CAM techniques or NC-techniques}
- A61F 2002/30957: {using a positive or a negative model, e.g. moulds}
- A61F 2002/30985: {using three dimensional printing [3DP]}
- A61F 2002/4633: {for selection of endoprosthetic joints or for pre-operative planning}
- A61F 2002/4666: {for measuring force, pressure or mechanical tension}
- A61F 2310/00179: Ceramics or ceramic-like structures
- B33Y 80/00: Products made by additive manufacturing
- Y10T 29/49: Method of mechanical manufacture
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00)
- G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N)
- B33Y: ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

The present disclosure is directed to orthopedic implants and methods of rapid manufacturing orthopedic implants using in vivo data specific to an orthopedic implant or orthopedic trial. Specifically, the instant disclosure utilizes permanent orthopedic implants and orthopedic trials (collectively, “implants”) outfitted with kinematic sensors to provide feedback regarding the kinematics of the trial or implant to discern which implant is preferable, and thereafter rapid manufacturing the implant.

## Claims

### Claim 1

A method of fabricating an orthopedic implant comprising:
generating patient-specific in vivo kinematic data by using an orthopedic trial mounted to a patient; and,
rapid manufacturing an orthopedic component for implantation into the patient using the patient-specific in vivo kinematic data;
wherein:
the orthopedic implant includes a reconfigurable element, where the reconfigurable element includes a sensor operative to generate the patient-specific in vivo kinematic data;
the orthopedic trial comprises a tibial tray and a tibial post of a knee implant;
the tibial post extending away from the tibial tray opposite a bone mounting location for the tibial tray; and,
the reconfigurable element includes the tibial post that is repositionable with respect to the tibial tray.

### Claim 2 (depends on 1)

The method of claim 1, wherein the step of generating patient-specific in vivo kinematic data includes repositioning the orthopedic trial through a range of motion, while mounted to the patient, to generate the patient-specific in vivo kinematic data.

### Claim 3 (depends on 1)

The method of claim 1, further comprising the step of generating patient-specific in vivo kinematic data by using a second orthopedic trial mounted to the patient.

### Claim 4 (depends on 3)

The method of claim 3, wherein the step of generating patient-specific in vivo kinematic data by repositioning the second orthopedic trial includes repositioning the second orthopedic trial through a range of motion, while mounted to the patient, to generate the patient-specific in vivo kinematic data.

### Claim 5 (depends on 3)

The method of claim 3, further comprising the step of comparing the patient-specific in vivo kinematic data generated from the orthopedic trial and the second orthopedic trial to discern which trial provided a superior kinematic fit.

### Claim 6 (depends on 5)

The method of claim 5, wherein the step of comparing the patient-specific in vivo kinematic data generated from the orthopedic trial and the second orthopedic trial to discern which trial provided the superior kinematic fit occurs in substantially real-time.

### Claim 7 (depends on 3)

The method of claim 3, further comprising the step of prioritizing the orthopedic trial and the second orthopedic trial in view of the patient-specific in vivo kinematic data.

### Claim 8 (depends on 1)

The method of claim 1, wherein the step of generating patient-specific in vivo kinematic data by using the orthopedic trial mounted to the patient includes using at least one of an accelerometer, a vibration sensor, an ultrasonic sensor, and a sound sensor.

### Claim 9 (depends on 1)

The method of claim 1, wherein the step of generating patient-specific in vivo kinematic data by using the orthopedic trial mounted to the patient includes using at least one of fluoroscopic data acquisition and X-ray data acquisition.

### Claim 10 (depends on 1)

The method of claim 1, further comprising the step of delivering the rapid manufactured orthopedic component for implantation into the patient.

### Claim 11 (depends on 1)

The method of claim 1, further comprising the step of using a computer interface to suggest a configuration of the orthopedic component using the patient-specific in vivo kinematic data.

### Claim 12 (depends on 1)

The method of claim 1, further comprising the step of scanning the orthopedic trial to generate orthopedic trial scan data, wherein the step of rapid manufacturing the orthopedic component for implantation into the patient includes using the orthopedic trial scan data.

### Claim 13 (depends on 1)

The method of claim 1, further comprising the step of displaying the patient-specific in vivo kinematic data time matched with pictorial data to allow concurrent qualitative and quantitative analysis of the orthopedic trial.

### Claim 14 (depends on 1)

The method of claim 1, further comprising the step of intraoperatively adjusting a geometric configuration of the orthopedic trial.

### Claim 15

A method of fabricating an orthopedic implant comprising:
generating patient-specific in vivo kinematic data by using a first orthopedic trial mounted to a patient;
responsive to the in vivo kinematic data generated by using the first orthopedic trial, processing the in vivo kinematic data using a computer and a database with pre-existing in vivo data to develop a suggested second orthopedic trial;
generating further patient-specific in vivo kinematic data by using a second orthope trial mounted to a patient; and,
rapid manufacturing an orthopedic component for implantation into the patient using the patient-specific in vivo kinematic data.

### Claim 16 (depends on 15)

The method of claim 15, wherein the step of generating patient-specific in vivo kinematic data by using the first orthopedic trial includes repositioning the first orthopedic trial through a range of motion, while mounted to the patient, to generate the patient-specific in vivo kinematic data.

### Claim 17 (depends on 15)

The method of claim 15, wherein the step of generating further patient-specific in vivo kinematic data by repositioning the second orthopedic trial includes repositioning the second orthopedic trial through a range of motion, while mounted to the patient, to generate the further patient-specific in vivo kinematic data.

### Claim 18 (depends on 15)

The method of claim 15, wherein the orthopedic component comprises at least one of a tibial orthopedic implant and a femoral orthopedic implant.

### Claim 19 (depends on 18)

The method of claim 18, wherein the orthopedic component comprises a tibial orthopedic implant and the tibial orthopedic implant comprises a tibial tray bearing insert.

### Claim 20 (depends on 15)

The method of claim 15, wherein the step of generating patient-specific in vivo kinematic data by using an orthopedic trial mounted to a patient includes using at least one of an accelerometer, a vibration sensor, an ultrasonic sensor, and a sound sensor.

### Claim 21 (depends on 15)

The method of claim 15 wherein the step of generating patient-specific in vivo kinematic data by using an orthopedic trial mounted to a patient includes using at least one of fluoroscopic data acquisition and X-ray data acquisition.

### Claim 22 (depends on 15)

The method of claim 15, further comprising the step of comparing the patient-specific in vivo kinematic data generated from the orthopedic trial with the further patient-specific in vivo kinematic data generated from the second orthopedic trial to discern which trial provided a superior kinematic fit.

### Claim 23 (depends on 22)

The method of claim 22, wherein the step of comparing the patient-specific in vivo kinematic data with the further patient-specific in vivo kinematic data occurs in substantially real-time.

### Claim 24 (depends on 15)

The method of claim 15, further comprising the step of prioritizing the orthopedic trial and the second orthopedic trial in view of the patient-specific in vivo kinematic data.

### Claim 25 (depends on 15)

The method of claim 15, further comprising the step of delivering the rapid manufactured orthopedic component for implantation into the patient.

### Claim 26 (depends on 15)

The method of claim 15, further comprising the step of using a computer interface to suggest a configuration of the orthopedic component using the patient-specific in vivo kinematic data.

### Claim 27 (depends on 15)

The method of claim 15, further comprising the step of scanning the orthopedic trial to generate orthopedic trial scan data, wherein the step of rapid manufacturing the orthopedic component for implantation into the patient includes using the orthopedic trial scan data.

### Claim 28 (depends on 15)

The method of claim 15, further comprising the step of displaying the patient-specific in vivo kinematic data time matched with pictorial data to allow concurrent qualitative and quantitative analysis of the orthopedic trial.

### Claim 29 (depends on 15)

The method of claim 15, further comprising the step of intra.operatively adjusting a geometric configuration of the orthopedic trial.

### Claim 30 (depends on 15)

The method of claim 15, wherein he orthopedic component comprises an implant for a shoulder prosthesis.

### Claim 31 (depends on 30)

The method of claim 30, wherein the implant comprises at least one of a ball and a cup.

### Claim 32 (depends on 15)

The method of claim 15, wherein he orthopedic component comprises an implant for a hip prosthesis.

### Claim 33 (depends on 32)

The method of claim 32, wherein the implant comprises at least one of a ball and a cup.

### Claim 34

A method of fabricating an orthopedic implant comprising:
generating patient-specific in vivo kinematic data by using an orthopedic trial mounted to a patient; and,
rapid manufacturing an orthopedic component for implantation into the patient using the patient-specific in vivo kinematic data;
wherein:
the orthopedic implant includes a reconfigurable element, where the reconfigurable element includes a sensor operative to generate the patient-specific in vivo kinematic data;
the orthopedic trial comprises a tibial tray and a tibial condyle receiver of a knee implant;
the reconfigurable element includes the tibial condyle receiver that is repositionable with respect to the tibial tray;
the tibial condyle receiver includes a first tibial condyle receiver and a second tibial condyle receiver; and,
the first tibial condyle receiver is independently repositionable with respect to the second tibial condyle receiver.

### Claim 35 (depends on 34)

The method of claim 34, wherein the step of generating patient-specific in vivo kinematic data includes repositioning the orthopedic trial through a range of motion, while mounted to the patient, to generate the patient-specific in vivo kinematic data.

### Claim 36 (depends on 34)

The method of claim 34, further comprising the step of generating patient-specific in vivo kinematic data by using a second orthopedic trial mounted to the patient.

### Claim 37 (depends on 36)

The method of claim 36, wherein the step of generating patient-specific in vivo kinematic data by repositioning the second orthopedic trial includes repositioning the second orthopedic trial through a range of motion, while mounted to the patient, to generate the patient-specific in vivo kinematic data.

### Claim 38 (depends on 36)

The method of claim 36, further comprising the step of comparing the patient-specific in vivo kinematic data generated from the orthopedic trial and the further patient-specific in vivo kinematic data generated from the second orthopedic trial to discern which trial provided a superior kinematic fit.

### Claim 39 (depends on 38)

The method of claim 38, wherein the step of comparing the patient-specific in vivo kinematic data generated from the orthopedic trial and the further patient-specific in vivo kinematic data generated from the second orthopedic trial to discern which trial provided the superior kinematic fit occurs in substantially real-time.

### Claim 40 (depends on 38)

The method of claim 38, further comprising the step of prioritizing the orthopedic trial and the second orthopedic trial in view of the patient-specific in vivo kinematic data.

### Claim 41 (depends on 34)

The method of claim 34, wherein the step of generating patient-specific in vivo kinematic data by using an orthopedic trial mounted to a patient includes using at least one of an accelerometer, a vibration sensor, an ultrasonic sensor, and a sound sensor.

### Claim 42 (depends on 34)

The method of claim 34, wherein the step of generating patient-specific in vivo kinematic data by using the orthopedic trial mounted to the patient includes using at least one of fluoroscopic data acquisition and X-ray data acquisition.

### Claim 43 (depends on 34)

The method of claim 34, further comprising the step of delivering the rapid manufactured orthopedic component for implantation into the patient.

### Claim 44 (depends on 34)

The method of claim 34, further comprising the step of using a computer interface to suggest a configuration of the orthopedic component using the patient-specific in vivo kinematic data.

### Claim 45 (depends on 34)

The method of claim 34, further comprising the step of scanning the orthopedic trial to generate orthopedic trial scan data, wherein the step of rapid manufacturing the orthopedic component for implantation into the patient includes using the orthopedic trial scan data.

### Claim 46 (depends on 34)

The method of claim 34, further comprising the step of displaying the patient-specific in vivo kinematic data time matched with pictorial data to allow concurrent qualitative and quantitative analysis of the orthopedic trial.

### Claim 47 (depends on 34)

The method of claim 34, further comprising the step of intraoperatively adjusting a geometric configuration of the orthopedic trial.