US2019321641A1PendingUtilityA1

Therapeutic modulation to treat blood glucose abnormalities, including type 2 diabetes, and/or reduce hba1c levels, and associated systems and methods

Assignee: NEVRO CORPPriority: Mar 29, 2018Filed: Mar 29, 2019Published: Oct 24, 2019
Est. expiryMar 29, 2038(~11.7 yrs left)· nominal 20-yr term from priority
A61N 1/36171A61N 1/0551A61N 1/36062A61N 1/36175A61N 1/36189A61N 1/36007A61N 1/36135A61N 1/0558A61N 1/0553
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Claims

Abstract

Systems and methods for treating a patient having a blood glucose abnormality, such as type 2 diabetes (T2D), using an electrical signal are disclosed. A representative method for treating a patient includes, based at least in part on a patient indication of a blood glucose abnormality, positioning at least one implantable signal delivery device proximate to a target location at the patient's spinal cord within a vertebral range of from about C8 to about T12. The method further includes directing an electrical signal to the target location via the implantable signal delivery device, wherein the electrical signal has a frequency in a frequency range of from 1.2 kHz to 100 kHz.

Claims

exact text as granted — not AI-modified
1 . A method for treating a patient having a blood glucose abnormality, comprising:
 based at least in part on a patient indication of a blood glucose abnormality, positioning at least one implantable signal delivery device proximate to a target location at the patient's spinal cord within a vertebral range of from about C8 to about T12; and   directing an electrical signal to the target location via the implantable signal delivery device, wherein the electrical signal has a frequency in a frequency range of from 1.2 kHz to 100 kHz.   
     
     
         2 . The method of  claim 1  wherein the blood glucose abnormality includes type  2  diabetes (T2D) and/or metabolic syndrome. 
     
     
         3 . The method of  claim 1  wherein the target location is along a longitudinal midline of the patient's spinal cord. 
     
     
         4 . The method of  claim 1  wherein the at least one implantable signal delivery device is a paddle lead. 
     
     
         5 . The method of  claim 1  wherein the electrical signal has a frequency of about 10 kHz. 
     
     
         6 . The method of  claim 5  wherein the electrical signal has a pulse width of about 30 microseconds. 
     
     
         7 . The method of  claim 6  wherein the electrical signal has an amplitude from about 20% of the patient's sensory threshold to about 90% of the patient's sensory threshold. 
     
     
         8 . The method of  claim 7  wherein the target location is from T4 to T6. 
     
     
         9 . The method of  claim 8  wherein the electrical signal inhibits one or more of the patient's sympathetic nerves associated with an organ selected from the group consisting of the patient's stomach, liver, pancreas, and one or more adrenal glands. 
     
     
         10 . The method of  claim 9  wherein the one or more sympathetic nerves are supplied by the patient's celiac ganglion. 
     
     
         11 . The method of  claim 7  wherein the target location is from T7 to T12. 
     
     
         12 . The method of  claim 11  wherein the electrical signal inhibits one or more of the patient's sympathetic nerves associated with an organ selected from the group consisting of the patient's stomach, duodenum, jejunum, ileum, and large intestine. 
     
     
         13 . The method of  claim 12  wherein the one or more sympathetic nerves are supplied by the patient's celiac ganglion and/or superior mesenteric ganglia. 
     
     
         14 . The method of  claim 12  wherein the electrical signal further comprises a duty cycling period having an on cycle and an off cycle. 
     
     
         15 . The method of  claim 14  wherein the organ is the patient's stomach, and wherein the on cycle is about 20 seconds, and the off cycle is about 20 seconds. 
     
     
         16 . The method of  claim 14  wherein the organ is the patient's duodenum, and wherein the on cycle is about 5 seconds, and the off cycle is about 5 seconds. 
     
     
         17 . The method of  claim 14  wherein the organ is the patient's jejunum, and wherein the on cycle is about 5.5 seconds, and the off cycle is about 5.5 seconds. 
     
     
         18 . The method of  claim 14  wherein the organ is the patient's ileum, and wherein the on cycle is about 7.5 seconds, and the off cycle is about 7.5 seconds. 
     
     
         19 . The method of  claim 14  wherein the organ is the patient's large intestine, and wherein the on cycle is about 10 seconds, the off cycle is about 10 seconds. 
     
     
         20 . The method of  claim 1  wherein the electrical signal is delivered to the target location while the patient is prandial. 
     
     
         21 . The method of  claim 20  wherein the electrical signal is delivered for a time within a time period of from about 30 minutes and about 120 minutes. 
     
     
         22 . The method of  claim 1  wherein the patient's blood glucose level is reduced by at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, or at least about 50% following delivery of the electrical signal. 
     
     
         23 . The method of  claim 1  wherein directing the electrical signal reduces a level of HbA1c in the patient. 
     
     
         24 . The method of  claim 23  wherein the patient's HbA1c level is reduced by at least about 1%, at least about 1.5%, at least about 2%, at least about 2.5%, at least about 3%, at least about 3.5%, at least about 4%, at least about 4.5%, at least about 5%, at least about 6%, at least about 7%, at least about 8%, at least about 9%, or at least about 10% following delivery of the electrical signal. 
     
     
         25 . The method of  claim 1  wherein directing the electrical signal includes directing the electrical signal to lamina X of the patient's spinal cord. 
     
     
         26 . The method of  claim 25  wherein the electrical signal is directed to lamina X of the patient's spinal cord via conduction of the patient's cerebral spinal fluid at the patient's dorsal median sulcus or via one or more of laminae I-IX. 
     
     
         27 . The method of  claim 1  wherein the electrical signal inhibits one or more of the patient's sympathetic nerves to promote glucose uptake in the patient's liver and/or lower the patient's post-prandial blood glucose levels. 
     
     
         28 . The method of  claim 1 , further comprising:
 monitoring the patient's blood glucose abnormality by measuring the patient's blood glucose level; and   in response to results obtained from monitoring the patient's blood glucose abnormality, performing at least one of the following processes:
 (a) adjusting at least one signal delivery parameter in accordance with which the electrical signal is directed to the target location, wherein the signal delivery parameter is at least one of frequency, amplitude, pulse width, or duty cycle, 
 (b) continuing to deliver the electrical signal without adjusting at least one signal delivery parameter, 
 (c) terminating delivery of the electrical signal. 
   
     
     
         29 . A method for treating a patient, comprising:
 based at least in part on a patient indication of T2D, positioning an implantable signal delivery device proximate to a target location at the patient's spinal cord in a vertebral range of from about C8 to about T12; and   directing an electrical signal to the target location via an implantable signal delivery device having a plurality of contacts, wherein the electrical signal has a frequency of 10 kHz, a pulse width of 30 microseconds, and an amplitude from about 20% of the patient's sensory threshold to about 90% of the patient's sensory threshold.   
     
     
         30 . (canceled) 
     
     
         31 . The method of  claim 29  wherein the implantable signal delivery device is positioned to span a first portion of the patient's tissue on a first side of the patient's spinal cord midline and a second portion of the patient's tissue on a second side of the patient's spinal cord midline. 
     
     
         32 . The method of  claim 31  wherein at least one contact of the implanted signal delivery device is positioned proximate to the first portion and at least one contact is positioned proximate to the second portion. 
     
     
         33 . The method of  claim 29  wherein the target location is from T4 to T6. 
     
     
         34 . The method of  claim 33  wherein the electrical signal inhibits one or more sympathetic nerves associated with an organ selected from the group consisting of the patient's stomach, liver, pancreas, and one or more adrenal glands. 
     
     
         35 . (canceled) 
     
     
         36 . The method of  claim 29  wherein the target location is from T7 to T12. 
     
     
         37 . The method of  claim 36  wherein the electrical signal inhibits one or more of the patient's sympathetic nerves associated with an organ selected from the group consisting of the patient's stomach, duodenum, jejunum, ileum, and large intestine. 
     
     
         38 . The method of  claim 37  wherein the one or more sympathetic nerves are supplied by the patient's celiac ganglion and/or superior mesenteric ganglia. 
     
     
         39 - 47 . (canceled) 
     
     
         48 . The method of  claim 29  wherein the patient's blood glucose level is reduced by at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, or at least about 50% following delivery of the electrical signal. 
     
     
         49 . The method of  claim 29  wherein directing the electrical signal reduces a level of HbA1c in the patient. 
     
     
         50 . The method of  claim 49  wherein the patient's HbA1c level is reduced by at least about 1%, at least about 1.5%, at least about 2%, at least about 2.5%, at least about 3%, at least about 3.5%, at least about 4%, at least about 4.5%, at least about 5%, at least about 6%, at least about 7%, at least about 8%, at least about 9%, or at least about 10% following delivery of the electrical signal. 
     
     
         51 . (canceled) 
     
     
         52 . The method of claim wherein the electrical signal is directed to lamina X of the patient's spinal cord via conduction of the patient's cerebral spinal fluid at the patient's dorsal median sulcus or via one or more of laminae I-IX. 
     
     
         53 . (canceled) 
     
     
         54 . The method of  claim 29 , further comprising:
 monitoring the patient's T2D by measuring the patient's blood glucose levels; and   in response to results obtained from monitoring the patient's T2D, adjusting at least one signal delivery parameter in accordance with which the electrical signal is applied to the target location, wherein the signal delivery parameter is selected from the group consisting of frequency, amplitude, pulse width, and duty cycle.   
     
     
         55 . A method for treating a, comprising:
 based at least in part on a patient indication of T2D, positioning at least one implantable signal delivery device proximate to a target location at the patient's spinal cord within a vertebral range of from about C8 to about T12;   directing an electrical signal to the target location via the at least one implantable signal delivery device to modify the patient's (a) blood glucose level or (b) insulin level, or (c) both (a) and (b), wherein the electrical signal has a frequency in a frequency range of from 1.2 kHz to 100 kHz.   
     
     
         56 - 59 . (canceled) 
     
     
         60 . A method for treating a patient, comprising:
 based at least in part on a patient indication of T2D, positioning at least one first contact proximate to a first target location at the patient's spinal cord within a vertebral range of about T2 to about T12, and placing at least one second contact proximate to a second target location at the patient's spinal cord within the vertebral range of about T2 to about T12; and   directing a first electrical signal to the first target location via the at least one first contact and directing a second electrical signal to the second target location via the at least one second, wherein the first and second electrical signals each have a frequency in a frequency range of from 1.2 kHz to 100 kHz.   
     
     
         61 - 97 . (canceled)

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