IP Library Granted Patent US 11,235,144
Granted Patent B2
US 11,235,144 · App. 16/876,759 · Granted Feb 1, 2022

Systems and methods for musculoskeletal tissue treatment

Inventors: James T. Ryaby (Lewisville, TX); Erik Waldorff (Lewisville, TX); Ronald Midura (Shaker Heights, OH); Maciej Zborowski (Bay Village, OH)
Assignee: ORTHOFIX US LLC
A61N1/0464A61N1/36014A61N1/36034A61N2/02A61N7/02A61B2018/00005A61B2018/0044A61B2018/00565A61B2018/00791A61N1/0452
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Quick Facts
Patent No.
US 11,235,144
App. No.
16/876,759
Granted
Feb 1, 2022
Kind
B2
Abstract

A system and method for pulsed electromagnetic fields (PEMF) tissue engineering enhances musculoskeletal tissue stimulation. A tissue engineering device may include both low and high pulse frequency signal generation components that may alternatively drive one or more coils to generate PEMFs. These PEMFs may be applied to bone tissue, tendons, ligaments, and/or cartilage. A prescribed treatment regimen using the tissue engineering device may include a first period of time where a first pulse frequency is used in treatment that supports tissue proliferation followed by a second period of time where a second pulse frequency (less than the first pulse frequency) is used in treatment that supports tissue differentiation. A treatment regimen may also include, with the frequency characteristic, applying a slew rate to the pulse characteristics that is on the order of around 30 to 100 Tesla per second to drive tissue differentiation in a targeted manner.

Claims (48)

1. An apparatus, comprising:

an electromagnetic field transmitter configured to generate a pulsed electromagnetic field, the pulsed electromagnetic field having a slew rate comprising a ratio of change in amplitude of a magnetic field to a time to make the change in amplitude; and

a controller coupled to the electromagnetic field transmitter and configured to:

direct the slew rate of the pulsed electromagnetic field, wherein the slew rate comprises a value between 30 Tesla/second and 100 Tesla/second;

direct an amplitude of the pulsed electromagnetic field, wherein the amplitude comprises a value between 5 milliTesla and 15 milliTesla; and

maintain a pulse frequency of the pulsed electromagnetic field according to a treatment regimen.

2. The apparatus of claim 1 , wherein the pulse frequency comprises a value between 35 kilohertz and 50 kilohertz.

3. The apparatus of claim 1 , wherein the controller is further configured to:

maintain the slew rate as a first slew rate according to a first portion of the treatment regimen; and

transition from the first slew rate to a second slew rate according to a second portion of the treatment regimen.

4. The apparatus of claim 3 , wherein the first slew rate is lower than the second slew rate.

5. The apparatus of claim 3 , wherein the first slew rate is greater than the second slew rate.

6. The apparatus of claim 3 , wherein the controller is further configured to:

trigger the transition in response to expiration of a timer set according to the treatment regimen.

7. The apparatus of claim 3 , wherein:

the pulse frequency comprises a first pulse frequency, and the pulsed electromagnetic field comprises a first pulsed electromagnetic field at the first pulse frequency with the first slew rate according to the treatment regimen; and

the electromagnetic field transmitter is further configured to generate a second pulsed electromagnetic field at a second pulse frequency with the second slew rate according to the treatment regimen.

8. The apparatus of claim 7 , wherein:

the first slew rate is equal to the second slew rate; and

the first pulse frequency is greater than the second pulse frequency.

9. The apparatus of claim 7 , wherein:

the first slew rate is less than the second slew rate; and

the first pulse frequency is greater than the second pulse frequency.

10. An apparatus for tendon tissue repair, comprising:

a controller configured to maintain a slew rate of a pulsed electromagnetic field, the slew rate comprising a value between 30 Tesla/second and 100 Tesla/second, and the pulsed electromagnetic field comprising an amplitude having a value between 5 milliTesla and 15 milliTesla;

an electromagnetic field transmitter coupled to the controller and configured to generate the pulsed electromagnetic field with the slew rate and the amplitude for a treatment of musculoskeletal tissue; and

a sensor configured to monitor a progress of healing of the musculoskeletal tissue during operation of the electromagnetic field transmitter.

11. The apparatus of claim 10 , wherein the controller is further configured to:

maintain the pulsed electromagnetic field at a pulse frequency between 35 kilohertz and 50 kilohertz.

12. The apparatus of claim 11 , wherein the controller is further configured to select the pulse frequency in response to the progress of healing identified from the sensor.

13. The apparatus of claim 10 , wherein the controller is further configured to:

maintain the slew rate as a first slew rate according to a first portion of a treatment regimen; and

transition from the first slew rate to a second slew rate according to a second portion of the treatment regimen.

14. The apparatus of claim 13 , wherein the first slew rate is lower than the second slew rate.

15. The apparatus of claim 10 , wherein the controller is further configured to:

compare a number of times that the electromagnetic field transmitter is energized to a threshold number; and

deactivate the electromagnetic field transmitter in response to the number of times exceeding the threshold number.

16. A method for tendon tissue repair, comprising:

receiving, by a controller, an input identifying a treatment mode for application of a pulsed electromagnetic (EM) field (PEMF) to a tendon by an EM field generator;

sending, by the controller, a command to the EM field generator to generate a pulsed EM field in response to the input, the pulsed EM field having a slew rate comprising a value between 30 Tesla/second and 100 Tesla/second and an amplitude having a value between 5 milliTesla and 15 milliTesla; and

directing, by the controller, the EM field generator to maintain the pulsed EM field with the slew rate and amplitude according to a treatment regimen.

17. The method of claim 16 , wherein the slew rate comprises a first slew rate, the method further comprising:

determining, by the controller, to transition from the first slew rate to a second slew rate in response to a triggering event according to the treatment regimen.

18. The method of claim 17 , wherein the first slew rate is lower than the second slew rate.

19. The method of claim 16 , further comprising:

comparing, by the controller, a number of times that the EM field generator is energized to a threshold number; and

deactivating, by the controller, the EM field generator in response to the number of times exceeding the threshold number.

20. The method of claim 16 , wherein the tendon comprises a rotator cuff.

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 →
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 →
CHANGE OF NAME Recorded Jan 15, 2021
From: ORTHOFIX INC.
To: ORTHOFIX US LLC
Reel/Frame 055012/0501 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 15, 2021
From: CLEVELAND CLINIC FOUNDATION
To: ORTHOFIX INC.
Reel/Frame 054937/0001 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 15, 2021
From: MIDURA, RONALD; ZBOROWSKI, MACIEJ
To: CLEVELAND CLINIC FOUNDATION
Reel/Frame 054936/0602 →
Cited By (1)
US 12,636,487