IP Library Granted Patent US 11,045,647
Granted Patent B2
US 11,045,647 · App. 16/362,022 · Granted Jun 29, 2021

Pulsed electromagnetic field tissue stimulation treatment and compliance monitoring

Inventors: James T. Ryaby (Lewisville, TX); Mamak Monica Keramat (Lewisville, TX); Lesley Allen Bowling (Lewisville, TX); Bobby Don Harris (Lewisville, TX); James Sterling Denton (Lewisville, TX); Philip Hartley Garman (Lewisville, TX); Jeffrey James Culhane (Lewisville, TX); Jonelle Matilda Juricek (Lewisville, TX)
Assignee: ORTHOFIX INC.
A61N1/326A61N1/08A61N1/36003A61N1/36025A61N1/40A61N1/025A61N1/0476A61N1/37211A61N2/02
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Quick Facts
Patent No.
US 11,045,647
App. No.
16/362,022
Granted
Jun 29, 2021
Kind
B2
Abstract

A system and method for PEMF tissue engineering enhances musculoskeletal tissue stimulation by monitoring treatment for compliance with treatment regimens. A PEMF device includes sensors that detect attributes indicating whether the PEMF device is in use. The PEMF device also includes communication devices that connect it with other devices. The data obtained from the sensors may be used to determine a level of compliance in use of the tissue engineering device with a prescribed treatment regimen for the patient. The data is transferred via a paired UE to a remote server. The remote server stores the data in a database and periodically generates compliance reports. The compliance reports are shared with subscribing access devices including the prescribing physician. The UE pairing with the PEMF device maintains a treatment calendar and dynamically modifies reminders based on current treatment status. The treatment regimen may be updated and sent to the PEMF device.

Claims (58)

1. A musculoskeletal tissue engineering and compliance monitoring system, comprising:

a tissue engineering apparatus comprising:

a coil device configured to supply a pulsed electromagnetic field (PEMF) to musculoskeletal tissue of a first patient according to a treatment regimen defining a periodic application of the PEMF;

a sensor configured to detect use of the tissue engineering apparatus on the musculoskeletal tissue; and

a first transceiver configured to transmit use data corresponding to the detected use of the tissue engineering apparatus from the sensor; and

a remote server comprising:

a second transceiver configured to receive the use data; and

a server processor configured to compare the use data to other patient recorded outcomes and cause the second transceiver to transmit an update to the treatment regimen to the tissue engineering apparatus in response to a result of the comparison.

2. The musculoskeletal tissue engineering and compliance monitoring system of claim 1 , wherein the remote server is further configured to:

compile the use data and pain information into a compliance report identifying use of the tissue engineering apparatus.

3. The musculoskeletal tissue engineering and compliance monitoring system of claim 1 , further comprising:

a user equipment (UE) device comprising a third transceiver configured to associate with the tissue engineering apparatus and receive the use data from the tissue engineering apparatus and forward the use data to the second transceiver of the remote server.

4. The musculoskeletal tissue engineering and compliance monitoring system of claim 3 , wherein the UE further comprises a UE processor configured to:

aggregate the use data from the tissue engineering apparatus over a period of time.

5. The musculoskeletal tissue engineering and compliance monitoring system of claim 1 , wherein:

the second transceiver of the remote server is configured to transmit the result of the comparison to a subscribing device and receive the update to the treatment regimen from the subscribing device prior to the transmission of the update to the tissue engineering apparatus.

6. The musculoskeletal tissue engineering and compliance monitoring system of claim 1 , wherein the use data from the tissue engineering apparatus comprises an identifier of the tissue engineering apparatus.

7. The musculoskeletal tissue engineering and compliance monitoring system of claim 6 , wherein the server processor is further configured to associate the use data with the first patient based on the identifier received with the use data.

8. A server configured to monitor compliance in using a musculoskeletal tissue engineering device, comprising:

a non-transitory memory configured to store a database;

a transceiver configured to receive use data corresponding to a detected use of the musculoskeletal tissue engineering device according to a treatment regimen defining a periodic application of a pulsed electromagnetic field (PEMF) to musculoskeletal tissue of a patient; and

a processor configured to:

store the use data in the database to a record corresponding to the patient; and

perform an update to the treatment regimen in response to a comparison of the use data to other patient recorded outcomes.

9. The server of claim 8 , wherein the transceiver is configured to receive the use data originating from the musculoskeletal tissue engineering device via an intermediary user equipment device.

10. The server of claim 8 , wherein the processor is further configured to:

compile the use data and pain information into a compliance report identifying use of the musculoskeletal tissue engineering device.

11. The server of claim 10 , wherein the transceiver is further configured to:

transmit the compliance report to a subscribing device;

receive the update to the treatment regimen from the subscribing device in response to transmitting the compliance report to the subscribing device; and

transmit a treatment change based on the update to the treatment regimen to the musculoskeletal tissue engineering device.

12. The server of claim 10 , wherein the compliance report comprises:

a number of days that the patient has been in possession of the musculoskeletal tissue engineering device; and

an image of a treatment site of the patient with the musculoskeletal tissue.

13. The server of claim 8 , wherein the processor is further configured to:

associate the use data to the record in the database based on an identifier of the musculoskeletal tissue engineering device received with the use data.

14. The server of claim 8 , wherein the processor is further configured to:

aggregate treatment data from the musculoskeletal tissue engineering device, including the use data corresponding to the detected use, over a period of time; and

generate, at an end of the period of time, a compliance report that includes the aggregated treatment data during the period of time.

15. A musculoskeletal tissue engineering and compliance monitoring system, comprising:

a tissue engineering apparatus comprising:

a coil device configured to supply a pulsed electromagnetic field (PEMF) to musculoskeletal tissue of a patient according to a treatment regimen;

a sensor configured to detect use of the tissue engineering apparatus on the musculoskeletal tissue;

a processor configured to collect an activity level of the patient during use of the tissue engineering apparatus according to the treatment regimen; and

a first transceiver configured to transmit the activity level; and

a remote server comprising:

a second transceiver configured to receive the activity level and transmit a flag to a subscribing device in response to the activity level exceeding a threshold level.

16. The musculoskeletal tissue engineering and compliance monitoring system of claim 15 , wherein the remote server is further configured to:

provide a field of activity level options for presentation to the patient, wherein the field of activity level options comprises a selection with a corresponding numeric value.

17. The musculoskeletal tissue engineering and compliance monitoring system of claim 15 , further comprising:

a user equipment (UE) device comprising a third transceiver configured to associate with the tissue engineering apparatus and receive the activity level from an input of the UE device by the patient using the tissue engineering apparatus, and forward the activity level to the second transceiver of the remote server.

18. The musculoskeletal tissue engineering and compliance monitoring system of claim 17 , wherein the remote server is further configured to:

receive an identification of the activity level exceeding the threshold level from the UE device.

19. The musculoskeletal tissue engineering and compliance monitoring system of claim 15 , wherein:

the first transceiver is further configured to transmit use data corresponding to the detected use of the tissue engineering apparatus from the sensor to the remote server.

20. The musculoskeletal tissue engineering and compliance monitoring system of claim 19 , wherein the remote server further comprises:

a server processor configured to compare the use data to other patient recorded outcomes, and generate a compliance report identifying use of the tissue engineering apparatus based on the use data and the activity level,

wherein the second transceiver is further configured to transmit the compliance report to the subscribing device, the compliance report including the flag.

Assignments (8)
RELEASE OF SECURITY INTEREST Recorded Nov 12, 2024
From: BLUE TORCH FINANCE LLC
To: ISOTIS ORTHOBIOLOGICS, INC.; ORTHOFIX US, LLC; SEASPINE, INC.; SEASPINE ORTHOPEDICS CORPORATION; SPINAL KINETICS LLC; THEKEN SPINE, LLC
Reel/Frame 069358/0110 →
SECURITY INTEREST Recorded Nov 8, 2024
From: ORTHOFIX MEDICAL INC.; ORTHOFIX US LLC; SPINAL KINETICS LLC; SEASPINE ORTHOPEDICS CORPORATION; SEASPINE, INC.; ISOTIS ORTHOBIOLOGICS, INC.; THEKEN SPINE, LLC
To: OXFORD FINANCE LLC, AS AGENT
Reel/Frame 069332/0761 →
SECURITY INTEREST Recorded Jan 10, 2024
From: ORTHOFIX US LLC
To: BLUE TORCH FINANCE LLC, AS COLLATERAL AGENT
Reel/Frame 066256/0423 →
ENTITY CONVERSION Recorded Dec 4, 2023
From: ORTHOFIX INC.
To: ORTHOFIX US LLC
Reel/Frame 065763/0716 →
RELEASE OF SECURITY INTEREST Recorded Nov 16, 2023
From: JPMORGAN CHASE BANK, N.A.
To: ORTHOFIX US LLC
Reel/Frame 065609/0223 →
SECURITY INTEREST Recorded Apr 22, 2021
From: ORTHOFIX US LLC
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE ASSISTANT
Reel/Frame 056000/0153 →
SECURITY INTEREST Recorded Oct 28, 2019
From: ORTHOFIX INC.
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 050839/0155 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 22, 2019
From: RYABY, JAMES T.; KERAMAT, MAMAK MONICA; BOWLING, LESLEY ALLEN; HARRIS, BOBBY DON; DENTON, JAMES STERLING; GARMAN, PHILIP HARTLEY; CULHANE, JEFFREY JAMES; JURICEK, JONELLE MATILDA
To: ORTHOFIX INC.
Reel/Frame 048676/0530 →