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US-20260124447-A1 - METHODS FOR PROMOTING POST-SURGICAL HEALING AND DEVICES FOR SAME

US20260124447A1US 20260124447 A1US20260124447 A1US 20260124447A1US-20260124447-A1

Abstract

Systems, devices and methods are provided for transcutaneously delivering energy impulses to bodily tissues for therapeutic purposes, such as for enhancing the body's bone healing process in spinal fusion patients. A therapeutic stimulator system comprises a housing for an energy source and a signal generator. The system further includes one or more electrodes coupled to the signal generator. A processor is coupled to the housing and configured to determine usage levels of the signal generator and/or motion data of the housing. The system may include a mobile device that allows the patient to input user status data, such as pain levels, and compare the user status data with the usage levels and/or the motion data, thereby improving patient compliance with a prescribed therapy regimen.

Inventors

  • Richard H. Pearce
  • Jon Christopher McAuliffe

Assignees

  • THERAGEN, INC.

Dates

Publication Date
20260507
Application Date
20251231

Claims (20)

  1. 1 . A method for promoting post-surgical healing, comprising: applying a therapeutic signal through a skin of a patient to a target stimulation site; detecting a physiological parameter of the patient; prompting the patient to enter patient status information into a software application; and comparing the patient status information with the physiological parameter.
  2. 2 . The method of claim 1 , wherein the patient status information comprises one or more patient reported outcome measures obtained after a surgical intervention has been completed.
  3. 3 . The method of claim 1 , wherein the one or more patient reported outcome measures comprise one or more of: level of post-interventional pain, mood, medication use, activity level and amount of sleep.
  4. 4 . The method of claim 1 , wherein the physiological parameter includes one or more of heart rate, heart rate variability, heart rhythm, blood pressure, blood oxygen, blood flow, body temperature, gaze, and gait.
  5. 5 . The method of claim 1 , further comprising detecting motion of the patient.
  6. 6 . The method of claim 5 , wherein the therapeutic signal is applied from a wearable device, the method further comprising detecting motion of the wearable device.
  7. 7 . The method of claim 1 , further comprising transmitting one or more electrical impulses transcutaneously through an outer skin surface of the patient to a target location within a spine of the patient, wherein the one or more electrical impulses are sufficient to enhance bone healing in the patient.
  8. 8 . A method for promoting post-surgical healing comprising: applying a therapeutic signal through a skin of a patient to a target stimulation site over a period of time; detecting a plurality of motion data associated with motion of the patient during the period of time; and combining the plurality of motion data into a single parameter that represents a relative intensity level of patient activity.
  9. 9 . The method of claim 8 , further comprising selecting the relative intensity level from an interval scale that represents at least three intensity levels of patient activity.
  10. 10 . The method of claim 9 , further comprising determining quantities of patient activity based on the at least three intensity levels of patient activity.
  11. 11 . The method of claim 8 , wherein the therapeutic signal is applied from a wearable device and the plurality of motion data is associated with motion of the wearable device.
  12. 12 . The method of claim 8 , further comprising prompting the patient to enter patient status information into a software application and comparing the patient status information with the relative intensity level of patient activity.
  13. 13 . The method of claim 12 , wherein the patient status information comprises one or more of level of post-interventional pain, mood, medication use, activity level and amount of sleep.
  14. 14 . The method of claim 8 , further comprising transmitting one or more electrical impulses transcutaneously through an outer skin surface of the patient to a target location within a spine of the patient, wherein the one or more electrical impulses are sufficient to enhance bone healing in the patient.
  15. 15 . A method for promoting post-surgical healing comprising: applying a therapeutic signal through a skin of a patient to a target stimulation site over a period of time; and determining a cumulative duration of time that the therapeutic signal is transmitted to the patient over the period of time.
  16. 16 . The method of claim 15 , wherein the therapeutic signal is applied from an energy source within a wearable device, the method further comprising determining a usage level of the energy source over the period of time.
  17. 17 . The method of claim 15 , further comprising prompting the patient to enter patient status information into a software application and comparing the patient status information with the cumulative duration of time.
  18. 18 . The method of claim 17 , wherein the patient status information comprises one or more of level of post-interventional pain, mood, medication use, activity level and amount of sleep.
  19. 19 . The method of claim 15 , further comprising transmitting one or more electrical impulses transcutaneously through an outer skin surface of the patient to a target location within a spine of the patient, wherein the one or more electrical impulses are sufficient to enhance bone healing in the patient.
  20. 20 . The method of claim 17 , further comprising compiling the patient status information and the cumulative duration of time into an aggregate set of data.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 18/397,104, filed Dec. 27, 2023, which is a continuation of U.S. patent application Ser. No. 17/887,661, filed Aug. 15, 2022, which is a continuation of U.S. patent application Ser. No. 17/506,851, filed Oct. 21, 2021, which claims benefit of U.S. Provisional Application No. 63/146,196, filed Feb. 5, 2021, all of which are hereby incorporated by reference in their entireties. FIELD The present systems, methods and devices generally relate to the delivery of energy impulses (and/or fields) to bodily tissues for therapeutic purposes. Specifically, these systems, methods and devices relate to the use of non-invasive devices, particularly transcutaneous electrical stimulation devices, for enhancing the body's bone healing process in, for example, spinal fusion patients. BACKGROUND The use of electrical stimulation for the treatment of medical conditions has been well known in the art for nearly two thousand years. It has been recognized that electrical stimulation of bone, muscle and/or nerve tissue may promote healing. Therapeutic stimulator devices have been designed to promote healing after spinal surgery, such as spinal fusion or spondylodesis. Spinal fusion is a neurosurgical or orthopedic surgical technique that joins two or more vertebrae to decompress and stabilize the spine. Spinal fusion may also relieve the pain and pressure from mechanical pain of the vertebra or on the spinal cord that results from pathological conditions of a spinal disc, such as degenerative disc disease, spinal stenosis, spondylolisthesis, spinal fractures, scoliosis and kypohosis. The procedure can be performed at any level in the spine (cervical, thoracic or lumbar) and generally prevents any movement between the fused vertebrae. After a spinal fusion has been performed, it is necessary for multiple bone fragments to heal together, or “fuse” to create one solid bone. A fusion does not occur immediately at the time of surgery, but rather results from a process called osteogenesis, which is a body's way of growing bony tissue. Over time (e.g., a few months and up to one year), this bone growth process most often unites the bone segments into a solid union of bone. Unfortunately, in many patients who have undergone spinal fusion, the bones will not grow together and fuse within a normal period of time. This is sometimes referred to as a failed fusion or pseudoarthrosis and may occur with patients who have had a previously failed fusion, are having a multi-level spinal fusion (i.e., more than one disc in the vertebrae), patients with a diagnosis of Grade III (or worse) spondylolisthesis, or patients with co-morbidities, such as osteoporosis, vascular disease, diabetes, obesity, renal disease, and the like. Because of these risks, an electrical bone growth stimulator is sometimes used to help enhance the body's bone healing process. Human bone is actually a living tissue and, like skin, has the inherent ability to heal itself when broken or injured. Broken bone helps promote the body's bone healing process by creating its own electrical field. In the same way, application of an electrical stimulator can enhance the body's natural bone healing process. Electrical bone growth stimulators may be implanted at the time of the spinal fusion surgery in a soft pocket of tissue under the skin in the lower back. In other cases, external bone growth stimulation devices may be worn outside the skin and do not require surgical implantation or extraction. Typically, the external device is worn after spinal fusion either as thin skin pads/electrodes that are placed directly over the fusion site to deliver a type of electrical stimulation called capacitive coupling, or one or two treatment coils placed into a brace or directly onto the skin that deliver a type of electromagnetic field called a Pulsed ElectroMagnetic Field (PEMF) or a Combined Magnetic Field (CMF). Unlike an internal (implanted) bone growth stimulator, an external bone growth stimulator may also be prescribed for the patient to use several weeks or months after the fusion surgery if the bone is not fusing as desired. Depending on the device and the patient's situation, an external bone growth stimulator will be prescribed to be worn for a specific number of hours each day (typically within the range of 2 hours to 24 hours per day). Sometimes the patient may be allowed to break up the wear time into several one-or two-hour sessions each day, or to vary the times that the device is worn each day, to better suit the patient's schedule. Typically, the external bone growth stimulator will be worn for a period of 3 to 12 months following the surgery. Current therapeutic stimulator devices provide a demonstrable benefit at improving patient outcomes, provided that patients are compliant in using the device as prescribed or indicated by the treating physician. However, the long tr