Medical imaging feedback for an implantable medical device

• US 7,974,697 B2
• Filed: 01/26/2006
• Issued: 07/05/2011
• Est. Priority Date: 01/26/2006
• Status: Expired due to Fees

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Maschino, Steven E., Buras, William R.
• Primary Examiner(s): Bertram; Eric D.
• Application Number:
  US11/340,337
• Publication Number:
  US 20070173902A1
• Time in Patent Office: 1,986 Days
• Field of Search: 607/45
• US Class Current: 607/45
• CPC Class Codes: A61N 1/36071 Pain

Abstract

A method, system, and apparatus are provided for performing an adaptive stimulation process using medical imaging feedback data for affecting an operation of an implantable medical device. The first stimulation signal is applied to a neural structure for modulation of a target portion of the patient'"'"'s brain associated with a disorder. Medical imaging data is acquired that is indicative of whether the target portion of the brain is modulated as a result of the first stimulation signal. The first signal characteristic is modified to generate a second stimulation signal in response to a determination that said target portion of the brain is not modulated as a result of said first stimulation signal. The first and second stimulation signals may be used to navigate an effect of the first and second stimulation signals until a targeted portion of the human body is stimulated according to a predetermined threshold.

Claims

1. A method for providing an adaptive stimulation using an implantable medical device, comprising:

providing a first stimulation signal comprising a first signal characteristic;

applying said first stimulation signal to an extracranial portion of a cranial nerve for modulation of a target portion of a patient'"'"'s brain associated with a disorder;

before applying said first stimulation signal, generating a first brain map comprising data relating to states of multiple different portions of the brain, including said target portion of the brain, during a time period prior to application of said first stimulation signal to said cranial nerve, wherein the operation of generating said first brain map comprises acquiring medical imaging data using a medical imaging device selected from the group consisting of a computed axial tomography (CAT) device, a phototron emission tomography (PET) device, a single photon emission computed tomography (SPECT) device, a magneto encephalography (MEG) device, a diffuse optical tomography device (DOT), a functional transcranial doppler device, and a magnetic resonance spectroscopy (MRS) device;

after beginning application of said first stimulation signal, generating a second brain map comprising data relating to states of multiple different portions of the brain, including said target portion of the brain, during a time period after application of said first stimulation signal has begun;

comparing said first brain map to said second brain map to compute a brain-map difference;

generating a third brain map comprising data relating to said brain-map difference, said third brain map indicating whether said target portion of the brain was modulated as a result of said first stimulation signal and whether a non-target portion of the brain was modulated as a result of said first stimulation signal;

determining whether said first stimulation signal sufficiently modulated said target portion of the brain, based at least in part on said third brain map;

modifying said first signal characteristic to generate a second stimulation signal in response to a determination that said target portion of the brain was not sufficiently modulated as a result of said first stimulation signal;

in response to a determination that said target portion of the brain was not sufficiently modulated as a result of said first stimulation signal, determining which region of the brain was affected by said first stimulation signal, based at least in part on said third brain map; and

iteratively modifying stimulation signals and computing brain map differences to guide stimulation effects through multiple portions of the brain, until sufficient modulation of said target portion of the brain is detected, to determine stimulation signal characteristics suitable to modulate said target portion of the brain;

wherein said first, second, and third brain maps provide substantially three-dimensional representations.

2. The method of claim 1, wherein applying said first stimulation signal to said portion of said cranial nerve comprises applying said first and said second stimulation signals to a cranial nerve selected from a group consisting of a vagus nerve, a trigeminal nerve, a vestibulocochlear nerve, an olfactory nerve and a glossopharyngeal nerve.

3. The method of claim 1, further comprising synchronizing the timing of the delivery of said first stimulation signal and the timing of acquisition of said medical imaging data.

4. The method of claim 1, wherein acquiring said medical imaging data comprises acquiring at least one of a chemical characteristic, a biological characteristic, and an electrical characteristic associated with a portion of a patient'"'"'s brain.

5. The method of claim 1, wherein modifying said first signal characteristic comprises modifying at least one of a pulse width, a frequency, a polarity, and an amplitude of said first signal.

6. The method of claim 1, further comprising:

comparing said medical imaging data with an equivalent predetermined reference data to generate a compared value;

correlating said compared value to said first stimulation signal; and

modifying said first characteristic based upon said correlating of said compared value to said first stimulation signal.

7. The method of claim 1, wherein determining whether a target portion of the brain has been sufficiently modulated by said first stimulation signal comprises determining whether said target portion of the brain experienced a change in at least one characteristic from the group consisting of a blood flow, a chemical characteristic, an electrical characteristic, and a physical characteristic as a result of said first stimulation signal.

8. The method of claim 1, wherein said target portion of the patient'"'"'s brain comprises an area from the group consisting of an ascending noradrenergic pathway from the locus coeruleus, an ascending serotonergic pathway from the dorsal raphe, a basal forebrain cholinergic pathway, a brain stem cholinergic pathway, a pathway of the basal limbic system, a pathway of the corticofugal glutamate system, a nigrostriatal pathway, pathway of the circuit of Papez, a mesolimbic pathway, a mesocortical pathway, a corticospinal tract pathway, an internal capsule pathway, a corticobulbar tract pathway, a tuberoinfundibular pathway, a corpus callosum pathway, a pathway of the formix, a cerebellorubrothalamocortical pathway, and a cerebral peduncular loop, a brain stem, a thalamus, an insula, amygdale, hypothalamus, a caudate, a putamen, a cingulate, a subgenual cingulate, a substantia innominata, an anterior cingulate cortex, a substantia nigra, a cingulate gyrus, a prefrontal cerebral cortex, dorsolateral cortex, ventrolateral cortex, a motor cortex, anterior inferior temporal lobes, a subcallosal area, an insular cortical region, a ventral tegmental area, posterior cingulate cortex, dorsal anterior cingulate gyrus, a basal ganglia, a substantia nigra pars compacta, ventral anterior cingulum, dorsal anterior cingulum, a centromedian fascicular complex, an area tempestas, and a bed nucleus of the stria terminalis.

9. The method of claim 1, wherein said medical imaging device is selected from the group consisting of a CAT device, a PET device, and a SPECT device.

10. The method of claim 1, wherein:

said medical imaging device is selected from the group consisting of a CAT device, a PET device, and a SPECT device; and

said target portion of the patient'"'"'s brain comprises an area from the group consisting of an ascending noradrenergic pathway from the locus coeruleus, an ascending serotonergic pathway from the dorsal raphe, a basal forebrain cholinergic pathway, a brain stem cholinergic pathway, a pathway of the basal limbic system, a pathway of the corticofugal glutamate system, a nigrostriatal pathway, pathway of the circuit of Papez, a mesolimbic pathway, a mesocortical pathway, a corticospinal tract pathway, an internal capsule pathway, a corticobulbar tract pathway, a tuberoinfundibular pathway, a corpus callosum pathway, a pathway of the formix, a cerebellorubrothalamocortical pathway, and a cerebral peduncular loop, a brain stem, a thalamus, an insula, amygdale, hypothalamus, a caudate, a putamen, a cingulate, a subgenual cingulate, a substantia innominata, an anterior cingulate cortex, a substantia nigra, a cingulate gyrus, a prefrontal cerebral cortex, dorsolateral cortex, ventrolateral cortex, a motor cortex, anterior inferior temporal lobes, a subcallosal area, an insular cortical region, a ventral tegmental area, posterior cingulate cortex, dorsal anterior cingulate gyrus, a basal ganglia, a substantia nigra pars compacta, ventral anterior cingulum, dorsal anterior cingulum, a centromedian fascicular complex, an area tempestas, and a bed nucleus of the stria terminalis.