US2024033509A1PendingUtilityA1

Method and device for stimulating bone growth

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Assignee: BONGENIX LLCPriority: Aug 1, 2022Filed: Aug 1, 2022Published: Feb 1, 2024
Est. expiryAug 1, 2042(~16 yrs left)· nominal 20-yr term from priority
Inventors:Carl T. Brighton
A61N 1/326A61N 1/3787A61N 1/205A61N 1/3603A61N 1/40A61N 1/36014A61N 1/36034A61N 1/0464A61N 1/0468
64
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Claims

Abstract

A bone stimulating method and device for treating injured or diseased bone tissue, includes exposing the injured or diseased bone tissue to a first electric field over a predetermined treatment period, the first electric field ranging from 10 mV/cm to 40 mV/cm and having a first predetermined time period within the predetermined treatment period and exposing the injured or diseased bone tissue to a second electric field over the predetermined treatment period, the second electric field ranging from 10 mV/cm to 60 mV/cm and having a second predetermined time period within the predetermined treatment period that is greater than the first predetermined time period. The first electric field is specific and selective for up-regulating expression of specific bone cell genes in the injured or diseased bone tissue when the injured or diseased bone tissue containing the specific bone cell genes is exposed to the first electric field and the second electric field is specific and selective for up-regulating expression of specific bone stem cell genes in the injured or diseased bone tissue when the injured or diseased bone tissue containing the specific bone stem cell genes is exposed to the second electric field.

Claims

exact text as granted — not AI-modified
1 - 22 . (canceled) 
     
     
         23 . A device for treating injured or diseased bone tissue, the comprising:
 an electrical signal generator;   at least one memory storing instructions;
 a central processing unit for executing the instructions stored in the at least one memory, which causes the electrical signal generator to generate:
 a first electric field over a predetermined treatment period, the first electric field ranging from 10 mV/cm to 40 mV/cm and having a first predetermined time period within the predetermined treatment period; and 
 a second electric field over the predetermined treatment period, the second electric field ranging from 10 mV/cm to 60 mV/cm and having a second predetermined time period within the predetermined treatment period that is greater than the first predetermined time period; and 
 
   field generating devices electrically connected to the electrical signal generator, the field generating devices operative for exposing the injured or diseased bone tissue to the first and second electric fields;   wherein the first electric field is specific and selective for up-regulating expression of specific bone cell genes in the injured or diseased bone tissue when the injured or diseased bone tissue containing the specific bone cell genes is exposed to the first electric field; and   wherein the second electric field is specific and selective for up-regulating expression of specific bone stem cell genes in the injured or diseased bone tissue when the injured or diseased bone tissue containing the specific bone stem cell genes is exposed to the second electric field.   
     
     
         24 . The device according to  claim 23 , wherein the first electric field is generated from a first capacitively coupled specific and selective signal having a frequency of 30 kHz to 80 kHz and a duty cycle ranging from 12.5% to 100%. 
     
     
         25 . The device according to  claim 24 , wherein the second electric field is generated from a second capacitively coupled specific and selective signal having a frequency of 30 kHz to 80 kHz and a duty cycle ranging from 50% to 100%. 
     
     
         26 . The device according to  claim 23 , wherein the second electric field is generated from a second capacitively coupled specific and selective signal having a frequency of 30 kHz to 80 kHz and a duty cycle ranging from 50% to 100%. 
     
     
         27 . The device according to  claim 23 , wherein the specific bone cell genes and the specific bone stem cell genes whose expression is up-regulated by the first and second electric fields comprise BMP 2 and 4, TGF-beta 1, 2, and 3, FGF-2, BGP and ALP. 
     
     
         28 . The device according to  claim 27 , wherein the up-regulated expression of the specific bone cell and bone stem cell genes increases proteins levels of BMP 2 and 4, TGF-beta 1, 2, and 3, FGF-2, BGP and ALP in the injured or diseased bone tissue. 
     
     
         29 . The device according to  claim 23 , wherein the specific bone cell genes and the specific bone stem cell genes whose expression is up-regulated by the first and second electric fields increases protein levels of BMP 2 and 4, TGF-beta 1, 2, and 3, FGF-2, BGP and ALP in the injured or diseased bone tissue. 
     
     
         30 . The device according to  claim 23 , wherein the injured or diseased bone tissue is exposed to the first and second electric fields in a sequential manner. 
     
     
         31 . The device according to  claim 23 , wherein the first electric field is 20 mV/cm. 
     
     
         32 . The device according to  claim 23 , wherein the frequency of the first capacitively coupled specific and selective signal is 60 kHz. 
     
     
         33 . The device according to  claim 23 , wherein the duty cycle of the first capacitively coupled specific and selective signal is 50%. 
     
     
         34 . The device according to  claim 23 , wherein the first predetermined time period is 1 to 12 hours. 
     
     
         35 . The device according to  claim 23 , wherein the first predetermined time period is  2  hours. 
     
     
         36 . The device according to  claim 23 , wherein the second electric field is 20 mV/cm. 
     
     
         37 . The device according to  claim 23 , wherein the frequency of the second capacitively coupled specific and selective signal is 60 kHz. 
     
     
         38 . The device according to  claim 23 , wherein the duty cycle of the second capacitively coupled specific and selective signal is 50%. 
     
     
         39 . The device according to  claim 23 , wherein the second predetermined time period is 8 to 24 hours. 
     
     
         40 . The device according to  claim 23 , wherein the second predetermined time period is 12 hours. 
     
     
         41 . The device according to  claim 23 , wherein the predetermined treatment period is 12 to 48 hours. 
     
     
         42 . The device according to  claim 23 , wherein the predetermined treatment period is 48 hours. 
     
     
         43 . The device according to  claim 23 , wherein the injured or diseased bone tissue containing the specific bone stem cell genes is exposed to the second electric field 5 hours after the exposure of the injured or diseased bone tissue containing the specific bone cell genes to the first electric field has ended. 
     
     
         44 . The device according to  claim 23 , wherein the injured or diseased bone tissue containing the specific bone cell genes is exposed to the first electric field 5 hours after the exposure of the injured or diseased bone tissue containing the specific bone stem cell genes to the second electric field has ended. 
     
     
         45 . The device according to  claim 23 , wherein the field generating devices comprise a pair of conductive electrodes. 
     
     
         46 . The device according to  claim 23 , wherein the field generating devices comprise first and second pairs of conductive electrodes.

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