SYSTEM AND METHOD FOR AN ORTHOPEDIC DYNAMIC DATA REPOSITORY AND REGISTRY FOR RECALL

• US 20100249535A1
• Filed: 03/26/2010
• Published: 09/30/2010
• Est. Priority Date: 03/26/2009
• Status: Abandoned Application

• Current Assignee: OrthoSensor, Inc (Stryker Corporation)
• Original Assignee: OrthoSensor, Inc (Stryker Corporation)
• Inventors: Roche, Martin, Pierce, Jay
• Application Number:
  US12/748,287
• Publication Number:
  US 20100249535A1
• Time in Patent Office: Days
• US Class Current: 600/300
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 2017/00221 with wireless transmission of data, e.g. by infrared radiation or radiowaves
• CPC Class Codes: A61B 2017/0268 for the knee
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/4509 Bone density determination
• CPC Class Codes: A61B 5/4528 Joints A61B5/4533, A61B5/4538 take precedence
• CPC Class Codes: A61F 2/4657 Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2002/4658 for measuring dimensions, e.g. length
• CPC Class Codes: A61F 2002/4666 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61F 2002/4668 for measuring angles
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 70/60 relating to pathologies

Abstract

At least one embodiment is directed to a system (1100) to generate an orthopedic dynamic data repository and registry (2214). The system (1100) can measure a parameter of the muscular-skeletal system and align at least one of the surfaces to a mechanical axis intra-operatively. The system (1100) comprises disposable sensors (1106), disposable targets (1110), lasers (1114), a processing unit (1122), a display (1124), a reader (1120), a receiver (1118), spacer blocks (1102), and a distractor 1104. The sensors (1106) are in communication with the processing unit (1122) to display, process, store, and send data to dynamic data repository and registry (2214). Parameters can be measured pre-operatively, intra-operatively, post-operatively, and long term using sensor (1106). The measurement data is used to identify and provide clinical evidence of a health risk. A notification of the health risk is generated in electronic digital form and sent to at least one entity.

Claims

1. A computer implemented method of notification of patient risk for an orthopedic device, procedure, or medicine comprising:

performing an analysis of a statistically significant sample of measured parameters from a data repository and registry where the analysis indicates a patient risk;

initiating an action if a patient risk is identified;

generating a notification of patient risk; and

sending at least one notification in electronic digital form to at least one entity.

2. The method of claim 1 further including the steps of:

receiving measured parameters of the muscular-skeletal system in an electronic digital form from more than one entity; and

storing the measured parameters in the data repository and registry.

3. The method of claim 2 further including the steps of:

collecting at least one of patient information, equipment information, procedure information, or component information in an operating room;

converting the at least one of patient information, equipment information, procedure information, component information to an electronic digital format;

generating at least one intra-operatively sensed parameter measurement in the operating room;

sending the at least one of patient information, equipment information, procedure information, or component information, and the at least one intra-operatively sensed parameter measurement to the data repository and registry.

4. The method of claim 3 further including the steps of:

measuring parameters of the muscular-skeletal system of the patient post-operatively to generate post-operative measurements and long term measurements;

converting measured parameters of the muscular-skeletal system of the patient to an electronic digital form; and

sending measured parameters of the muscular-skeletal system of the patient to the data repository and registry.

5. The method of claim 1 further including the steps of:

accessing pre-operative measurements related to the orthopedic device, procedure, or medicine from the data repository and registry; and

using pre-operative measurements as clinical evidence in the analysis of patient risk due to the orthopedic device, procedure, or medicine.

6. The method of claim 1 further including the steps of:

accessing intra-operative measurements related to the orthopedic device, procedure, or medicine from the data repository and registry; and

using intra-operative measurements as clinical evidence in the analysis of patient risk due to the orthopedic device, procedure, or medicine.

7. The method of claim 4 further including the steps of:

accessing post-operative measurements related to the orthopedic device, procedure, or medicine from the data repository and registry; and

using intra-operatively sensed parameter measurements as clinical evidence in the analysis of patient risk due to the orthopedic device, procedure, or medicine.

8. The method of claim 4 further including the steps of:

accessing long term measurements related to the orthopedic device, procedure, or medicine from the data repository and registry; and

using intra-operatively sensed parameter measurements as clinical evidence in the analysis of patient risk due to the orthopedic device, procedure, or medicine.

9. The method of claim 1 further including a step of sending the notification to one or more manufacturers.

10. The method of claim 1 further including a step of sending the notification to one or more patients.

11. A computer implemented method of notification of patient risk for an orthopedic device, procedure, or medicine comprising the steps of:

storing measured parameters of the muscular-skeletal system converted to an electronic digital form in a data repository and registry where the data repository and registry includes at least one of patient information, equipment information, procedure information, or component information;

identifying an orthopedic negative outcome where the negative outcome is supported by clinical evidence related to the measured parameters in the data repository and registry;

generating a notification in the electronic digital form; and

sending the notification to at least one at least one entity.

12. The method of claim 11 further including a step of identifying the orthopedic device, procedure, or medicine related to the negative outcome from information in the data repository and registry.

13. The method of claim 11 further including a step of performing an analysis of a statistically significant sample of measured parameters from the data repository and registry where the analysis indicates a patient risk.

14. The method of claim 13 further including a step of using one or more of pre-operative measurements, intra-operative measurements, post-operative measurements, and long term measurements in the analysis from data repository and registry.

15. The method of claim 11 further including the steps of:

identifying patients related to the negative outcome from information in the data repository and registry; and

sending notification related to the analysis to the patients.

16. A computer implemented method of notification of patient risk for an orthopedic implant or procedure comprising the steps of:

performing an analysis of a statistically significant sample of measured parameters from a data repository and registry where the analysis indicates a patient risk from the procedure or orthopedic implant;

initiating an action if a patient risk is identified;

generating a notification in electronic digital form of patient risk; and

sending at least one notification in electronic digital form to at least one patient.

17. The method of claim 16 further including the steps of:

identifying the orthopedic device or procedure from information in the data repository and registry; and

incorporating information related to the orthopedic device or procedure in the notification.

18. The method of claim 16 further including the steps of:

identifying the patients at risk from information in the data repository and registry; and

incorporating information related to the patient in the notification.

19. The method of claim 16 further including a step of using one or more of pre-operative measurements, intra-operative measurements, post-operative measurements, and long term measurements in the analysis from data repository and registry.

20. The method of claim 16 further including the steps of:

receiving measured parameters of the muscular-skeletal system in an electronic digital form from more than one entity; and

storing the measured parameters in the data repository and registry.