Medical imaging feedback for an implantable medical device

• US 20070173902A1
• Filed: 01/26/2006
• Published: 07/26/2007
• Est. Priority Date: 01/26/2006
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Maschino, Steven, Buras, William
• Granted Patent: US 7,974,697 B2
• Time in Patent Office: Days
• 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 (IMD), comprising:

providing a first stimulation signal comprising a first signal characteristic;

applying said first stimulation signal to a neural structure for modulation of a target portion of the patient'"'"'s brain associated with a disorder;

acquiring medical imaging data using a medical imaging system 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, an electroencephalography (EEG) device, a magneto encephalography (MEG) device, a diffuse optical tomography device (DOT), a functional transcranial doppler device, an ultrasound device, an X-ray device, and a magnetic resonance spectroscopy (MRS) device, said medical imaging data being indicative of whether said target portion of the brain is modulated as a result of said first stimulation signal; and

modifying said first signal characteristic 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.

2. The method of claim 1, wherein applying said first stimulation signal to a neural structure 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, a current amplitude, a voltage amplitude, an on-time and an off-time of said first signal.

6. The method of claim 1, further comprising:

comparing said medical imaging data with an equivalent 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, further comprising:

generating a first brain map comprising data relating to the state of said target portion of the brain during a time period prior to applying said first stimulation signal to said neural structure;

generating a second brain map comprising data relating to the state of said target portion of the brain during at least one of a time period at least partially during said step of applying said first stimulation signal and a time period after applying said first stimulation signal;

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; and

modifying at least one characteristic of said first stimulation signal based upon said third brain map.

8. The method of claim 1, further comprising:

determining whether said target portion of the brain has been sufficiently modulated by said first stimulation signal based upon said medical imaging; and

modifying a characteristic of said first stimulation signal to generate a second stimulation signal based upon a determination that said target portion of the brain is not sufficiently affected by said first stimulation signal, and navigating an effect of the second stimulation signal to said target portion of the brain.

9. The method of claim 8, wherein generating said second stimulation signal to navigate an effect of said second stimulation signal comprises iteratively navigating a plurality of neural connections associated with the brain to modulate said target portion of the brain.

10. The method of claim 8, 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 of a blood flow, a chemical characteristic, a radiographic characteristic, an electrical characteristic, a magnetic characteristic, and a physical characteristic as a result of said first stimulation signal.

11. The method of claim 1, further comprising synchronizing the timing between a delivery of said first stimulation signal and acquiring said medical imaging data.

12. A method for providing an adaptive stimulation using an implantable medical device (IMD), comprising:

providing a first stimulation signal comprising a first signal characteristic to treat a disorder;

applying said first stimulation signal to a neural structure to provide an effect on a predetermined region of the brain associated with said disorder;

acquiring medical imaging data responsive to said first stimulation using a medical imaging device;

determining whether said predetermined region of the brain has been sufficiently affected by said first stimulation signal based upon said medical imaging data;

modifying said first characteristic of said first stimulation signal to generate a second stimulation signal based upon a determination that said predetermined region of the brain has not been sufficiently affected by said first stimulation signal; and

navigating an effect of said second stimulation signal to said predetermined region of the brain, wherein navigating said effect comprises iteratively guiding stimulation effects relating to said first and second stimulation signals throughout a plurality of regions of the brain to modulate a targeted region of the brain.

13. The method of claim 12, wherein navigating an effect of said second stimulation signal to said predetermined region of the brain comprises modulating at least one of a pathway of the circuit of Papez, a mesolimbic pathway, a mesocortical pathway, a nigrostriatal pathway, a pathway of the fomix, a corticospinal tract pathway, an internal capsule pathway, a corticobulbar tract pathway, a tuberoinfundibular pathway, a corpus callosum pathway, a cerebellorubrothalamocortical pathway, a cerebral peduncular loop, 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 neurotransmitter pathway from a group consisting of a noradrenergic pathway, a serotoninergic pathway, a dopaminergic pathway, a catecholaminergic pathway, a GABAergic pathway, an opioidergic pathway and a cholinergic pathway.

14. A method for providing an adaptive stimulation using an implantable medical device (IMD), comprising:

correlating a target portion of the brain to a disorder;

generating a first brain map comprising data relating to the state of the brain during a time period prior to applying a first stimulation signal to a neural structure of the patient;

providing a first stimulation signal using said implantable medical device to treat said disorder, said first stimulation signal comprising a first signal characteristic;

applying said first stimulation signal to said neural structure of the patient;

generating a second brain map comprising data relating to the state of the brain during at least one of a time period at least partially during said step of applying said first stimulation signal and a time period after applying said first stimulation signal;

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 comprising data indicative of whether said target portion of the brain has been modulated by said first stimulation signal; and

modifying said first signal characteristic to generate a second stimulation signal based upon a determination that said target portion of the brain was not modulated by said first stimulation signal.

15. The method of claim 14, wherein said neural structure is a cranial nerve.

16. The method of claim 15, further comprising performing at least one of:

continuing to apply said first stimulation signal to said cranial nerve based upon said determination that said target portion of the brain has been modulated by said first stimulation signal; and

applying said second stimulation signal to a said cranial nerve in response to a determination that said target portion of the brain was not modulated by said first stimulation signal.

17. The method of claim 14, wherein correlating said target portion of the brain to said disorder comprises correlating said target portion of the brain to at least one of a mood disorder, an epilepsy disorder, an eating disorder, a chronic pain disorder, a hormonal disorder, a metabolic disorder associated with the hypothalamus, and a heart rhythm disorder.

18. An implantable medical system for treating a physiological disorder, comprising:

an implantable medical device (IMD) for providing a first stimulation signal comprising a first signal characteristic to a portion of a cranial nerve to treat a disorder;

an electrode operatively coupled to said IMD, said electrode to apply said first stimulation signal from said IMD to said portion of said patient'"'"'s body;

a medical imaging system operatively coupled to said IMD, said medical imaging system to acquire medical imaging data responsive to said first stimulation signal and being indicative of whether a target portion of the brain corresponding to said disorder is substantially modulated as a result of said first stimulation signal, said medical imaging system comprising a system 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, an electroencephalography (EEG) device, a magneto encephalography (MEG) device, a diffuse optical tomography device (DOT), a functional transcranial doppler device, an ultrasound device, an X-ray device, and a magnetic resonance spectroscopy (MRS) device; and

said IMD further comprising a stimulation feedback unit for modifying said first signal characteristic based upon a determination that said target portion of the brain is not substantially modulated as a result of said first stimulation signal to generate a second stimulation signal.

19. The implantable medical system of claim 18, wherein said first signal characteristic comprises at least one of a pulse width, a frequency, a polarity, and an amplitude.

20. The implantable medical system of claim 18, wherein said medical imaging system is capable of acquiring data indicative of at least one of a chemical effect, a biological effect, and an electrical effect occurring upon said target portion of the brain in response to said first stimulation.

21. The implantable medical system of claim 18, further comprising an external unit, said external unit to provide communication with said IMD, said communication comprising at least one of providing a control parameter setting to said IMD to control an operation of said IMD, and downloading data from said IMD.

22. The implantable medical system of claim 18, wherein said IMD comprises:

a controller to control an operation of said IMD;

a stimulation unit operatively coupled to said controller, to provide said first and said second stimulation signals;

an imaging/stimulation correlation unit to correlate medical image data to said first stimulation signal;

a stimulation timing circuit to provide data relating to synchronizing the operation of the IMD and the medical imaging system; and

a communication unit to provide communication with said external unit; and

wherein said stimulation feedback unit is operatively coupled to said imaging/stimulation correlation unit.

23. The implantable medical system of claim 18, further comprising a medical imaging/IMD controller communicatively coupled to said medical imaging system and said IMD, said imaging/IMD controller to:

correlate said target portion of the brain to said disorder;

generate a first brain map comprising data relating to the state of the target portion of the brain during a time period prior to delivering said first stimulation signal;

generate a second brain map comprising data relating to the target portion of the brain during at least one of a time period at least partially during said delivery of said first stimulation signal and a time period after delivering said first stimulation signal;

generate a third brain map based upon a comparison of said first brain map to said second brain map;

determine whether said target portion of the brain has been sufficiently modulated by said first stimulation signal based upon said third brain map; and

modify said first characteristic of said first stimulation signal to generate said second stimulation signal based upon a determination that said predetermined region of the brain was not sufficiently modulated by said first stimulation, wherein generating said second stimulation signal comprises directing an effect of said second stimulation to said target portion of the brain for modulating said target portion of the brain.

24. The implantable medical system of claim 18, wherein said target region of the brain comprises at least one of an insula, a subcallosal area, a cingulate, a thalamus, a prefrontal cerebral cortex, dorsolateral cortex, ventrolateral cortex, dorsal anterior cingulate gyrus, posterior cingulate cortex, anterior inferior temporal lobes, a brain stem, a cerebellum, a set of white matter tracts, a centromedian fascicular complex, a ventral medial thalamic nucleus, a ventral posterior medical nucleus, a parafascicular nucleus, a subthalamic nucleus, a caudate, a putamen, a subgenual cingulate, a cingulate gyrus, ventral anterior cingulum, dorsal anterior cingulum, ventral tegmental area, periaqueductal gray matter, a bed nucleus of the stria terminalis, a supraoptic nucleus, a forebrain circumventricular organ, a ventral tegmentum, a substantia nigra pars compacta, a ventral medial nucleus of the thalamus, a basal ganglia, a subthalamic nucleus, a substantia nigra, a pallidal, a cerebellum, a motor cortex, a substantia innominata, a nucleus accumbens, an anterior cingulate cortex, an insular cortical region, a caudate nucleus, and an area tempestas.