IP Library Granted Patent US 10,653,881
Granted Patent B2
US 10,653,881 · App. 15/870,352 · Granted May 19, 2020

Systems and methods for musculoskeletal tissue treatment

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Quick Facts
Patent No.
US 10,653,881
App. No.
15/870,352
Granted
May 19, 2020
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 (42)

1. An apparatus, comprising:

an electromagnetic field transmitter configured to generate a first pulsed electromagnetic field at a first pulse frequency and a second pulsed electromagnetic field at a second pulse frequency; and

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

maintain the first pulse frequency of the first pulsed electromagnetic field when applied to a musculoskeletal tissue of a patient according to a first portion of a treatment regimen to enhance growth of the musculoskeletal tissue;

maintain the second pulse frequency of the second pulsed electromagnetic field when applied to the musculoskeletal tissue according to a second portion of the treatment regimen to stimulate musculoskeletal tissue differentiation, the first pulse frequency being greater than the second pulse frequency; and

transition the electromagnetic field transmitter from the first portion of the treatment regimen to the second portion of the treatment regimen.

2. The apparatus of claim 1 , wherein the first pulse frequency comprises a value between 35 kilohertz and 50 kilohertz, and the second pulse frequency comprises a value between 2 and 6 kilohertz.

3. The apparatus of claim 1 , wherein a total amount of energy when generating the pulsed electromagnetic field according to the first portion of the treatment regimen does not heat tissue near the bone tissue beyond a threshold temperature.

4. The apparatus of claim 1 , wherein:

the pulsed electromagnetic field comprises a first quasi-rectangular pulse as a first ratio of change in amplitude of a magnetic field to a time to make the change in amplitude and a second quasi-rectangular pulse as a second ratio of change in amplitude of the magnetic field to the time to make the change in amplitude,

the first quasi-rectangular pulse comprises a first amplitude that, in combination with the first pulse frequency, comprises a first slew rate,

the second quasi-rectangular pulse comprises a second amplitude that, in combination with the second pulse frequency, comprises a second slew rate, and

the first amplitude is less than the second amplitude and the first slew rate is less than the second slew rate.

5. The apparatus of claim 1 , further comprising:

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

6. The apparatus of claim 5 , wherein the controller is configured to transition from the first portion of the treatment regimen to the second portion of the treatment regimen in response to a result of the sensor monitoring the progress of healing.

7. The apparatus of claim 1 , further comprising:

a timer configured to track use of the electromagnetic field transmitter to the musculoskeletal tissue of the patient.

8. The apparatus of claim 7 , wherein the timer is configured to track a duration of time that the controller maintains the first pulse frequency over a number of different applications.

9. The apparatus of claim 7 , wherein:

the timer is configured to track a number of times that the electromagnetic field transmitter is energized and report the number of times to the controller, and

the controller is configured to compare the number of times to a threshold number and transition from the first portion to the second portion in response the number of times exceeding the threshold number.

10. An apparatus for tendon tissue repair, comprising:

a controller configured to maintain a pulse frequency of a pulsed electromagnetic field of between 35 kilohertz and 50 kilohertz when applied to a musculoskeletal tissue of a patient according to a treatment regimen to stimulate tendon tissue repair of the musculoskeletal tissue for a treatment time comprising between 45 minutes and an hour and a half per day according to a treatment regimen;

an electromagnetic field transmitter configured to generate the pulsed electromagnetic field at the pulse frequency for the treatment time based on a command from the controller; and

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

11. The apparatus of claim 10 , wherein the treatment regimen comprises daily application for the tissue treatment time over between 8 and 25 weeks.

12. The apparatus of claim 10 , wherein the pulse frequency comprises a value between 35 kilohertz and 50 kilohertz.

13. The apparatus of claim 10 , wherein a total amount of energy when generating the pulsed electromagnetic field does not heat tissue in a region reached by the pulsed electromagnetic field beyond a threshold temperature.

14. The apparatus of claim 10 , wherein the pulsed electromagnetic field comprises a quasi-rectangular pulse as a ratio of change in amplitude of a magnetic field to a time to make the change in amplitude.

15. The apparatus of claim 10 ,

wherein the controller is further configured to select the pulse frequency in response to the progress of healing identified from the sensor.

16. A method for tendon tissue repair, comprising:

controlling, by a controller, an electromagnetic (EM) field generator for application of a pulsed EM field (PEMF) to a tendon according to a first treatment mode;

receiving, by the controller, an input identifying a second treatment mode from among a plurality of treatment modes stored by the controller; and

executing, by the controller, a command to the EM field generator to generate a pulsed EM field according to the second treatment mode in response to the input, a first pulse frequency of the first treatment mode being greater than a second pulse frequency of the second treatment mode.

17. The method of claim 16 , wherein the receiving further comprises:

receiving, by the controller from a timer, a timing expiration identifying a transition from the first treatment mode to the second treatment mode.

18. The method of claim 16 , wherein the receiving further comprises:

receiving, by the controller from a sensor, sensor data from one or more tendons as the input.

19. The method of claim 18 , wherein the tendon comprises a rotator cuff.

20. The method of claim 18 , wherein the tendon comprises an Achilles tendon.

Assignments (12)
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 →
ENTITY CONVERSION Recorded Aug 19, 2021
From: ORTHOFIX INC.
To: ORTHOFIX US LLC
Reel/Frame 057247/0265 →
SECURITY INTEREST Recorded Apr 22, 2021
From: ORTHOFIX US LLC
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE ASSISTANT
Reel/Frame 056000/0153 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 15, 2021
From: MIDURA, RONALD; ZBOROWSKI, MACIEJ
To: CLEVELAND CLINIC FOUNDATION
Reel/Frame 054936/0602 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 15, 2021
From: CLEVELAND CLINIC FOUNDATION
To: ORTHOFIX INC.
Reel/Frame 054937/0001 →
CHANGE OF NAME Recorded Jan 15, 2021
From: ORTHOFIX INC.
To: ORTHOFIX US LLC
Reel/Frame 055012/0501 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 10, 2020
From: RYABY, JAMES T.; WALDORFF, ERIK
To: ORTHOFIX, INC.
Reel/Frame 052368/0202 →
SECURITY INTEREST Recorded Oct 28, 2019
From: ORTHOFIX INC.
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 050839/0155 →
SECURITY INTEREST Recorded Aug 29, 2018
From: ORTHOFIX INC.
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 046747/0936 →