Systems and methods for surgical and interventional planning, support, post-operative follow-up, and functional recovery tracking

• US 9,700,292 B2
• Filed: 05/20/2015
• Issued: 07/11/2017
• Est. Priority Date: 09/17/2012
• Status: Active Grant

• Current Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Original Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Inventors: Serhan, Hassan A., Martin, Thomas, Nawana, Namal, DiPietro, Jennifer, Nordstrom, Christopher, Horton, William C., Frasier, William J., O'Neil, Michael, Sommerich, Robert E., Parsons, Matthew
• Primary Examiner(s): Gilligan, Luke
• Assistant Examiner(s): TIEDEMAN, JASON S
• Application Number:
  US14/717,563
• Publication Number:
  US 20150261922A1
• Time in Patent Office: 783 Days
• Field of Search: 705 11- 3
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 17/50 Instruments, other than pincettes or toothpicks, for removing foreign bodies from the human body locating otherwise A61B5/06; locating by radiation A61B6/00; removing calculi A61B17/22; from the eyes A61F9/00709
• CPC Class Codes: A61B 2010/009 Various features of diagnostic instruments
• CPC Class Codes: A61B 2010/0093 slide rules
• CPC Class Codes: A61B 2017/00115 with audible or visual output
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/0262 with a provision for protecting nerves
• CPC Class Codes: A61B 2034/101 Computer-aided simulation of surgical operations
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2034/2057 Details of tracking cameras
• CPC Class Codes: A61B 2034/252 indicating steps of a surgical procedure
• CPC Class Codes: A61B 2034/254 being adapted depending on the stage of the surgical procedure
• CPC Class Codes: A61B 2034/256 having a database of accessory information, e.g. including context sensitive help or scientific articles
• CPC Class Codes: A61B 2090/365 augmented reality, i.e. correlating a live optical image with another image
• CPC Class Codes: A61B 2090/502 Headgear, e.g. helmet, spectacles
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 34/25 : User interfaces for surgical systems
• CPC Class Codes: A61B 5/0022 : Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/1118 : Determining activity level
• CPC Class Codes: A61B 5/4509 : Bone density determination
• CPC Class Codes: A61B 5/4566 : Evaluating the spine A61B5/4561 takes precedence
• CPC Class Codes: A61B 5/4571 : Evaluating the hip
• CPC Class Codes: A61B 5/4824 : Touch or pain perception evaluation A61B5/4821 takes precedence
• CPC Class Codes: A61B 5/4833 : Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/4848 : Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/7282 : Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/746 : Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61B 5/7475 : User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: A61B 6/4494 : Means for identifying the diagnostic device
• CPC Class Codes: A61B 6/485 : involving fluorescence X-ray imaging
• CPC Class Codes: A61B 6/506 : for diagnosis of nerves
• CPC Class Codes: A61B 8/08 : Detecting organic movements or changes, e.g. tumours, cysts, swellings A61B8/02 - A61B8/06 take precedence
• CPC Class Codes: A61B 90/98 : using electromagnetic means, e.g. transponders
• CPC Class Codes: G01L 5/00 : Apparatus for, or methods of, measuring force, work, mechanical power, or torque, specially adapted for specific purposes
• CPC Class Codes: G06Q 10/00 : Administration; Management
• CPC Class Codes: G06Q 10/10 : Office automation; Time management
• CPC Class Codes: G09B 23/28 : for medicine
• CPC Class Codes: G16H 10/20 : for electronic clinical trials or questionnaires
• 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 30/20 : for handling medical images, e.g. DICOM, HL7 or PACS
• CPC Class Codes: G16H 40/20 : for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: G16H 40/40 : for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/50 : for simulation or modelling of medical disorders
• CPC Class Codes: G16H 50/70 : for mining of medical data, e.g. analysing previous cases of other patients
• CPC Class Codes: G16H 70/20 : relating to practices or guidelines
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

Abstract

Various systems and methods are provided for surgical and interventional planning, support, post-operative follow-up, and functional recovery tracking. In general, a patient can be tracked throughout medical treatment including through initial onset of symptoms, diagnosis, non-surgical treatment, surgical treatment, and recovery from the surgical treatment. In one embodiment, a patient and one or more medical professionals involved with treating the patient can electronically access a comprehensive treatment planning, support, and review system. The system can provide recommendations regarding diagnosis, non-surgical treatment, surgical treatment, and recovery from the surgical treatment based on data gathered from the patient and the medical professional(s). The system can manage the tracking of multiple patients, thereby allowing for data comparison between similar aspects of medical treatments and for learning over time through continual data gathering, analysis, and assimilation to decision-making algorithms.

Claims

1. A method of treating a patient, comprising:

receiving pre-operative data regarding a patient, the pre-operative data including at least one of pre-operative pain data, pre-operative range-of-motion data, and pre-operative level-of-activity data;

collecting data from a trial device inserted into a joint of the patient, the trial device having a force sensor embedded therein, the force sensor being configured to sense a force acting on the trial device, and the collected data being indicative of force acting on the trial device;

devising a plan based at least in part upon the collected data and the pre-operative data, the plan including a desired implant location in the patient;

receiving post-operative data regarding the patient following performance of a surgical procedure on the patient that implanted an implant into the patient and that was performed at least in part based on the plan, the post-operative data including at least one of post-operative pain data, post-operative range-of-motion data, and post-operative level-of-activity data;

comparing the pre-operative data and the post-operative data and determining, based on the comparison, whether the post-operative data indicates and improvement over the pre-operative data,

wherein the improvement in post-operative pain data is indicated by less patient pain than the pre-operative pain data,

wherein the improvement in the post-operative range-of-motion data is indicated by greater patient range of motion than the pre-operative range-of-motion data, and

wherein the improvement in the post-operative level-of-activity data is indicated by greater patient level of activity than the pre-operative level-of-activity data;

receiving data from the implant within the patient indicative of a post-implant location of the implant in the patient;

determining an implant location deviation by comparing the received post-implant location of the implant in the patient to the desired implant location;

determining an effectiveness of the plan based at least in part upon the collected data, the determined implant location deviation, and the comparison of the pre-operative and post-operative data;

based on the result of the determining, adjusting a physical characteristic of the implant within the patient;

storing the plan, implant adjustment information, and effectiveness information as future plan data to thereby improve future effectiveness of the plan with respect to at least one of pain of the patient, range-of-motion of the patient, and level-of-activity of the patient; and

accessing and utilizing the future plan data as part of a treatment of a subsequent patient.

2. The method of claim 1, wherein the plan is devised using performance data of devices similar to the trial device previously inserted into other patients.

3. The method of claim 2, further comprising updating the performance data in view of the pre-operative data, the post-operative data, and the plan to prepare the performance data for future use in devising a second plan for a second patient.

4. The method of claim 1, wherein the post-operative data includes data includes data measured by the implant implanted in the patient.

5. The method of claim 1, wherein a processor receives the preoperative data, collects the data from the force sensor, devises the plan, receives the post-operative data, compares the pre-operative data and the post-operative data, determines the implant deviation, and determines the effectiveness of the plan, stores the future plan data in a memory, and accesses and utilizes the future plan data.

6. The method of claim 1, wherein the surgical procedure is performed on the joint of the patient.

7. The method of claim 1, wherein the implant has a sensor embedded therein;

the method further comprises collecting data from the sensor embedded in the implant after the implantation of the implant into the patient; and

determining the effectiveness of the plan is also based at least in part on the data collected from the sensor.

8. The method of claim 1, wherein the physical characteristic of the implant is adjusted wirelessly.

9. A surgical system, comprising:

an implant device having an embedded force sensor, the implant device being configured to be inserted into a joint of a patient, the force sensor being configured to sense a force acting on the device, and the implant device being configured to collect data being indicative of force acting on the trial device;

a memory storing pre-operative data regarding a plurality of patients, and post-operative data regarding the plurality of patients; and

a processor configured to

receive pre-operative data regarding a patient that includes at least one of preoperative pain data, pre-operative range-of-motion data, and pre-operative level-of-activity data,

devise a plan based at least in part upon the received pre-operative data, the stored pre-operative data, the stored post-operative data, the plan including a desired implant device location in the patient,

receive data from the sensor embedded in the implant device inserted into the patient during performance of a surgical procedure on the patient being performed at least in part based on the plan,

receive post-operative data regarding the patient following performance of the surgical procedure, the post-operative data regarding the patient including at least one of postoperative pain data, post-operative range-of-motion data, and post-operative level-of-activity data,

compare the pre-operative data regarding the patient and the post-operative data regarding the patient and determine, based on the comparison, whether the post-operative data indicates an improvement over the pre-operative data,

wherein the post-operative pain data indicates an improvement by indicating less patient pain than the pre-operative pain data, the post-operative range-of-motion data indicates an improvement by indicating greater patient range of motion than die pre-operative range-of-motion data, and the post-operative level-of-activity data indicates an improvement by indicating greater patient level of activity than the pre-operative level-of-activity data,

receive data from the implant device implanted within the patient, the data indicative of a post-implant location of the implant device in the patient,

determining an implant location deviation by comparing the received post-implant location of the implant device in the patient to the desired implant device location,

determine an effectiveness of the plan based at least in part upon the sensor data, the determined implant device location deviation, and the comparison of the pre-operative data regarding the patient and the post-operative data regarding the patient, and

based on a result of the determining, adjust a physical characteristic of the implanted implant device within the patient,

store the plan, implant adjustment information, and effectiveness information as future plan data to thereby improve future effectiveness of the plan with respect to at least one of pain of the patient, range-of-motion of the patient, and level-of-activity of the patient, and

access and utilize the future plan data as part of a treatment of a subsequent patient.

10. The system of claim 9, wherein the processor is configured to update the pre-operative data regarding the plurality of patients with the pre-operative data regarding the patient and to update the post-operative data regarding the plurality of patients with the postoperative data regarding the patient, thereby improving an ability to devise future plans for other patients through continual learning.

11. The system of claim 9, wherein performance of the a surgical procedure includes implanting the implant device in the patient, and processor is configured to, after the performance of the surgical procedure, collect additional data from the sensor embedded in the implant device implanted in the patient.

12. The system of claim 11, wherein determining the effectiveness of the plan based at least in part upon the collected additional data.

13. The system of claim 9, further comprising a cloud server that includes the processor.

14. The system of claim 9, wherein determining the effectiveness of the plan includes tracking forces sensed by the force sensor.

15. The system of claim 9, wherein the physical characteristic of the implant device is adjusted wirelessly.

16. A method of treating a patient, comprising:

receiving pre-operative data regarding a patient, the pre-operative data including at least one of pre-operative pain data, pre-operative range-of-motion data, and pre-operative level-of-activity data;

formulating a plan for treating the patient based on the pre-operative data, the plan including a desired implant location in the patient;

collecting data from a sensor embedded in a trial orthopedic device inserted into a joint of the patient in accordance with the plan, the trial device having a force sensor embedded therein, the force sensor being configured to sense a force acting on the trial device, and the collected data being indicative of force acting on the trial device;

receiving post-operative data regarding the patient following performance of a surgical procedure on the patient that implanted an implant into the patient and that was based at least in part upon the collected data, the post-operative data including at least one of post-operative pain data, post-operative range-of-motion data, and post-operative level-of-activity data;

comparing the pre-operative data and the post-operative data and determining, based on the comparison, whether the post-operative data indicates and improvement over the pre-operative data,

wherein the improvement in post-operative pain data is indicated by less patient pain than the pre-operative pain data,

wherein the improvement in the post-operative range-of-motion data is indicated by greater patient range of motion than the pre-operative range-of-motion data, and

wherein the improvement in the post-operative level-of-activity data is indicated by greater patient level of activity than the pre-operative level-of-activity data;

receiving data from the implant within the patient indicative of a post-implant location of the implant in the patient;

determining an implant location deviation by comparing the received post-implant location of the implant in the patient to the desired implant location;

determining an effectiveness of the plan based upon the determined implant location deviation of the implant in the patient and based upon a comparison of the pre-operative data and the post-operative data;

based on a result of the determining, adjusting a physical characteristic of the implant within the patient to thereby improve future effectiveness of the plan with respect to at least one of pain of the patient, range-of-motion of the patient, and level-of-activity of the patient;

storing the plan, implant adjustment information, and effectiveness information as future plan data to thereby improve future effectiveness of the plan with respect to at least one of pain of the patient, range-of-motion of the patient, and level-of-activity of the patient; and

accessing and utilizing the future plan data as part of a treatment of a subsequent patient.

17. The method of claim 16, further comprising retrieving stored processor-based performance data of similar patients, wherein the plan is based upon the retrieved processor-based performance data of similar patients and upon a predictive algorithm thereof.

18. The method of claim 17, further comprising updating the processor-based performance data with the pre-operative data, the post-operative data, and the plan, thereby improving the predictive algorithm through continual learning.

19. The method of claim 16, wherein determining the effectiveness of the plan includes evaluating change between the at least one of the pre-operative pain data, preoperative range-of-motion data, and pre-operative level-of-activity data and the at least one of postoperative pain data, post-operative range-of-motion data, and post-operative level-of-activity data.

20. The method of claim 16, wherein the physical characteristic of the implant is adjusted wirelessly.

21. A method of treating a patient, comprising:

receiving pre-operative data regarding a patient indicative of a pre-operative pain level of the patient;

storing the received pre-operative data;

receiving operative data during performance of a surgical procedure on the patient that includes implanting an orthopedic device in the patient, the device having a sensor embedded therein, and the received operative data including data sensed by the sensor indicative of force acting on the orthopedic device;

storing the received operative data;

devising a plan based at least in part upon the stored operative data and the pre-operative data, the plan including a desired implant location in the patient;

receiving post-operative data regarding the patient

following performance of the surgical procedure on the patient that was performed at least in part based on the plan, the post-operative data including post-operative pain data indicative of a post-operative condition of the patient;

storing the received post-operative data;

evaluating the performance of the surgical procedure with respect to the patient'"'"'s pain level to determine an improvement in the post-operative pain data by comparing the stored pre-operative data that is indicative of the pre-operative pain level of the patient, the stored operative data including the data sensed by the sensor, and the stored postoperative data that is indicative of the post-operative condition of the patient,

wherein the improvement in post-operative pain data is indicated by less patient pain than the pre-operative pain data;

receiving data from the orthopedic device within the patient indicative of a post-implant location of the implant in the patient;

determining an orthopedic device location deviation by comparing the received post-implant location of the orthopedic device in the patient to the desired orthopedic device location;

determining an effectiveness of the plan based at least in part upon the operative data, the determined implant location deviation, and the comparison of the pre-operative and post-operative data;

based on a result of the evaluating, adjusting a physical characteristic of the implanted orthopedic device within the patient in order to reduce the post-operative pain level of the patient;

storing the plan, implant adjustment information, and effectiveness information as future plan data to thereby improve future effectiveness of the plan with respect to at least one of pain of the patient, range-of-motion of the patient, and level-of-activity of the patient; and

accessing and utilizing the future plan data as part of a treatment of a subsequent patient.

22. The method of claim 21, wherein the received post-operative data includes data sensed by the sensor.

23. The method of claim 21, wherein the received post-operative data includes data indicative of a post-operative pain level of the patient.

24. The method of claim 21, wherein the received post-operative data includes data indicative of any one or more of mobility, gait, walking speed, flexibility, muscular strength, posture, range of motion, neurologic tracking, joint movement tracking, and bone density.

25. The method of claim 21, further comprising receiving at least one of pre-operative range-of-motion data and pre-operative level-of-activity data regarding the patient, and receiving at least one of post-operative range-of-motion data and post-operative level-of-activity data regarding the patient;

and

wherein the of evaluating the performance of the surgical procedure uses at least one of the received pre-operative range-of-motion data and the received pre-operative level-of-activity data regarding the patient, and the received at least one of post-operative range-of-motion data and postoperative level-of-activity data regarding the patient.

26. The method of claim 25, wherein the plan is devised using post-operative data regarding a plurality of patients similar to the patient.

27. The method of claim 21, wherein the physical characteristic of the orthopedic device is adjusted wirelessly.