US2014277267A1PendingUtilityA1

Neuromodulation system and method for transitioning between programming modes

Assignee: BOSTON SCIENT NEUROMODULATIONPriority: Mar 15, 2013Filed: Mar 15, 2014Published: Sep 18, 2014
Est. expiryMar 15, 2033(~6.6 yrs left)· nominal 20-yr term from priority
A61N 1/36185A61N 1/36164A61N 1/37247A61N 1/36071
49
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Claims

Abstract

An external control device and method for programming an implantable neuromodulator coupled to an electrode array implanted adjacent tissue of a patient having a medical condition. Electrical modulation energy is conveyed to tissue of the patient in accordance with a series of modulation parameter sets. The patient perceives paresthesia in response to the conveyance of the electrical modulation energy to the tissue in accordance with at least one of the modulation parameter sets. One of the modulation parameter set(s) is identified based on the perceived paresthesia. Another modulation parameter set is derived from the identified modulation parameter set. Electrical modulation energy is conveyed to the tissue of the patient in accordance with the other modulation parameter set without causing the patient to perceive paresthesia.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . An external control device for programming an implantable neuromodulator coupled to an electrode array, comprising:
 a user interface including a programming selection control element configured for allowing a user to select one of a first programming mode having a first limit on a modulation parameter and a second programming mode having a second limit on the modulation parameter different from the first limit; and   controller/processor circuitry configured for allowing a user to program the neuromodulator in the first programming mode, and allowing the user to program the neuromodulator in the second programming mode in response to actuation of the programming selection control element.   
     
     
         2 . The external control device of  claim 1 , wherein controller/processor circuitry is configured for defining a series of modulation parameter sets during the programming of the neuromodulator in the first programming mode, and instructing the neuromodulator to convey electrical energy to the electrode array in accordance with the series of modulation parameter sets in a manner that displaces a locus of a resulting electrical field relative to the electrode array. 
     
     
         3 . The external control device of  claim 2 , wherein the controller/processor circuitry, in response to the actuation of the programming selection control element, is configured for deriving another modulation parameter set from the last modulation parameter set of the series of modulation parameter sets, and instructing the neuromodulator to convey electrical energy to the electrode array in accordance with the other modulation parameter set during the programming of the neuromodulation to device in the second programming mode. 
     
     
         4 . The external control device of  claim 3 , wherein the controller/processor circuitry is configured for deriving the other modulation parameter set in a manner that causes an electrical field resulting from the conveyance of the electrical energy to the electrode array in accordance with the other modulation parameter set to have a locus that is the same as the locus of the electrical field resulting from the conveyance of the electrical energy to the electrode array in accordance with the last modulation parameter set. 
     
     
         5 . The external control device of  claim 1 , wherein the modulation parameter is a pulse rate. 
     
     
         6 . The external control device of  claim 5 , wherein the first limit is an upper limit value less than 1500 Hz, and the second limit is a lower limit value greater than 1500 Hz. 
     
     
         7 . The external control device of  claim 1 , wherein the modulation parameter is a pulse width. 
     
     
         8 . The external control device of  claim 7 , wherein the first limit is a lower limit value greater than 100 μs, and the second limit is an upper limit value less than 100 μs. 
     
     
         9 . The external control device of  claim 1 , wherein the modulation parameter is an electrode combination. 
     
     
         10 . The external control device of  claim 9 , wherein the first limit is a range of electrode combinations having only anodic electrodes as primary modulating electrodes, and the second limit is a range of electrode combinations having only cathodic electrodes as primary modulating electrodes. 
     
     
         11 . The external control device of  claim 9 , wherein the first limit is a range of monopolar electrode combinations, and the second limit is a range of multipolar electrode combinations. 
     
     
         12 . The external control device of  claim 9 , wherein the modulation parameter is a fractionalized electrode combination. 
     
     
         13 . The external control device of  claim 1 , wherein each of the first and second programming modes is a semi-automated programming mode. 
     
     
         14 . The external control device of  claim 1 , wherein the controller/processor circuitry is configured for defining a virtual multipole relative to the electrode array when programming the neuromodulator in the first programming mode, and computing amplitude values for the electrode array that emulate the virtual multipole, wherein the first modulation parameter set includes the computed amplitude values. 
     
     
         15 . The external control device of  claim 14 , wherein each of the first and second programming modes is a semi-automated programming mode configured for panning the virtual multipole across the electrode array. 
     
     
         16 . The external control device of  claim 1 , further comprising telemetry circuitry, wherein the controller/processor circuitry is configured for programming the neuromodulator via the telemetry circuitry. 
     
     
         17 . The external control device of  claim 1 , further comprising a housing containing the user interface and the controller/processor circuitry. 
     
     
         18 . A method of operating an implantable neuromodulator coupled to an electrode array implanted adjacent tissue of a patient having a medical condition, comprising:
 conveying electrical modulation energy to tissue of the patient in accordance with a series of modulation parameter sets, thereby gradually displacing the locus of the resulting electrical field relative to the tissue, such that a plurality of different loci of the resulting electrical field can be respectively associated with the series of modulation parameter sets;   causing the patient to perceive paresthesia in response to the conveyance of the electrical modulation energy to the tissue in accordance with at least one of the modulation parameter sets;   identifying one of the at least one modulation parameter sets based on the perceived paresthesia;   deriving another modulation parameter set from the identified modulation parameter set; and   conveying electrical modulation energy to the tissue of the patient in accordance with the other modulation parameter set, thereby creating an electrical field having a locus relative to the tissue that is the same as the locus of the electrical field associated with the identified modulation parameter set, and without causing the patient to perceive paresthesia.   
     
     
         19 . The method of  claim 18 , wherein the medical condition affects a body region of the patient, the electrical modulation energy conveyed to the tissue in accordance with the identified modulation parameter set causes the patient to perceive the paresthesia in the body region. 
     
     
         20 . The method of  claim 18 , wherein the medical condition is chronic pain. 
     
     
         21 . The method of  claim 18 , wherein the identified modulation parameter set and the other modulation parameter set define different pulse rates. 
     
     
         22 . The method of  claim 21 , wherein the identified modulation parameter set defines a pulse rate less than 1500 Hz, and the other modulation parameter set defines a pulse rate greater than 1500 Hz. 
     
     
         23 . The method of  claim 18 , wherein the identified modulation parameter set and the other modulation parameter set define different pulse widths. 
     
     
         24 . The method of  claim 23 , wherein the identified modulation parameter set defines a pulse width greater than 100 μs, and the other modulation parameter set defines a pulse width less than 100 μs. 
     
     
         25 . The method of  claim 18 , wherein the identified modulation parameter set and the other modulation parameter set define different electrode combinations. 
     
     
         26 . The method of  claim 25 , wherein the identified modulation parameter set is a monopolar electrode combination, and the other modulation parameter set is a multipolar electrode combination. 
     
     
         27 . The method of  claim 25 , wherein the different electrode combinations are different fractionalized electrode combinations. 
     
     
         28 . The method of  claim 18 , further comprising:
 defining a series of virtual poles relative to the electrode array;   computing amplitude values for electrode combinations that respectively emulate the series of virtual poles, wherein the series of modulation parameter sets respectively define the electrode combinations;   defining another virtual pole relative to the electrode array; and   computing amplitude values for another electrode combination that emulates the other virtual pole, wherein the other modulation parameter set defines the other electrode combination.   
     
     
         29 . The method of  claim 28 , wherein the series of virtual poles is defined by panning a virtual pole across the electrode array. 
     
     
         30 . The method of  claim 18 , further comprising programming the neuromodulator with the other modulation parameter set. 
     
     
         31 . The method of  claim 18 , wherein the neuromodulator is implanted within the patient. 
     
     
         32 . The method of  claim 18 , wherein the tissue is spinal cord tissue. 
     
     
         33 .- 250 . (canceled)

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