Ultrasonic method, system, and device for diagnosis of stroke

Abstract

A medical diagnostic method, system and related equipment particularly adapted to diagnose disorders of the blood circulation serving the head and neck, and especially the brain. A preferred use of the system is early, rapid, accurate, diagnosis of stroke, especially whether the stroke is due to blockage of a blood vessel or leakage from the blood vessel.

1. Using A method for the non-ultrasonic detection of symptoms of stroke to dynamically couple an ultrasonic transducer/receiver to a skull, comprising:
 transmitting and receiving ultrasonic waves from within the skull with an ultrasonic transducer/receiver; 
 processing received ultrasonic waves to form an image of a brain within the skull; and 
 modifying a diagnosis of ischemic or hemorrhagic stroke based on the image with data from a non-ultrasonic detection technique, in which the non-ultrasonic detection comprises at least one of the group consisting of computed tomography scanning, magnetic resonance scanning, differential spectrophotometric methods, near-infrared detection of tissue characteristics, detection of a biological material, measurement of a biological material, detection of a chemical, measurement of a chemical, detection of S100β, measurement of S100β, use of biological assay techniques, detection of change in blood pressure, detection of change in pressure within the eye, detection of change in blood flow in arteries serving organs other than the brain, or detection of change in blood flow in the arteries serving the eye. 
 
     
     
       2. For a patient having a skull containing brain tissue and blood vessels, a process for diagnosing stroke in the patient with a diagnostic imaging system, comprising:
 a) dynamically coupling at least one ultrasonic transmitter/receiver to at least one man-made opening in the skull of the patient; 
 b) two dimensionally or three dimensionally imaging a brain tissue region within the skull of the patient with the ultrasonic transmitter/receiver; and 
 c) at least one of: determining presence of hemorrhagic stroke by identifying relatively diffuse blood flow within the skull of the patient; determining presence of ischemic stroke by identifying at least one location of inadequate blood flow within the skull of the patient; and diagnosing between hemorrhagic and ischemic stroke by classifying a the region within the skull of the patient in terms of adequacy of blood flow. 
 
     
     
       3. The process of  claim 2 , in which the imaging comprises generating and receiving ultrasonic signals suitable for processing into information about the region within the skull of the patient. 
     
     
       4. The process of  claim 2 , in which a the region is classified in terms of normal blood flow. 
     
     
       5. The process of  claim 2 , in which a the region is classified in terms of inadequate blood flow. 
     
     
       6. The process of  claim 2 , in which a the region is classified in terms of relatively diffuse blood flow. 
     
     
       7. The process of  claim 2 , in which locations of hemorrhagic stroke are determined detected by identifying relatively diffuse blood flow outside the blood vessels of the brain. 
     
     
       8. The process of  claim 2  in which locations of ischemic stroke are determined by identifying relatively inadequate blood flow within the blood vessels of the brain. 
     
     
       9. The process of  claim 2  in which presence of ischemic stroke is determined by identifying at least one location where there is at least partial blockage of blood flow. 
     
     
       10. The process of  claim 2 , further comprising applying a vacuum to the skull. 
     
     
       11. The process of  claim 2 , further comprising applying an acoustic coupling material to the skull. 
     
     
       12. An ultrasonic stroke diagnosis/therapy apparatus comprising:
 a mounting unit suitable for mounting on the head of a patient;   a plurality of ultrasonic transmitter/receivers each including a plurality of transducing elements, located on the mounting unit for transmitting ultrasonic waves and receiving reflected echo signals through acoustic windows of the skull, the ultrasonic waves of each transmitter/receiver accessing a brain tissue image area inside the skull; and   a separate imager, in communication with the transmitter/receivers for receiving reflected echo signals, the imager configured to produce a dynamic two-dimensional or three-dimensional ultrasonic image of the brain tissue for stroke diagnosis or therapy, the imager configured to at least one of: determine presence of hemorrhagic stroke by identifying relatively diffuse blood flow within the skull of the patient; determine presence of ischemic stroke by identifying at least one location of inadequate blood flow within the skull of the patient; and diagnose between hemorrhagic and ischemic stroke by classifying the region within the skull of the patient in terms of adequacy of blood flow.   
     
     
       13. The ultrasonic stroke diagnosis/therapy apparatus of claim 12, wherein the imager further comprises a computer readable medium comprising instructions configured to be responsive to digital echo signal data which produces two-dimensional or three-dimensional images for the diagnosis of the presence and type of stroke. 
     
     
       14. The ultrasonic stroke diagnosis/therapy apparatus of claim 13, wherein the computer readable medium is further operable to identify a region of relatively diffuse blood flow within the brain. 
     
     
       15. The ultrasonic stroke diagnosis/therapy apparatus of claim 14, wherein the computer readable medium is further configured to find a region in which blood flow is outside of arteries. 
     
     
       16. The ultrasonic stroke diagnosis/therapy apparatus of claim 13, wherein the computer readable medium is further configured to identify a location of inadequate blood flow within the brain. 
     
     
       17. The ultrasonic stroke diagnosis/therapy apparatus of claim 16, wherein the computer readable medium is further operable to identify a location of a blood vessel within the brain which is blocked. 
     
     
       18. The ultrasonic stroke diagnosis/therapy apparatus of claim 12, wherein the apparatus is further operable to administer stroke therapy; and
 wherein at least one of the transmitter/receivers is further operable to deliver ultrasonic energy during the administration of stroke therapy.   
     
     
       19. The ultrasonic stroke diagnosis/therapy apparatus of claim 12, wherein the imager is further operable to form a two-dimensional or three-dimensional image of a flow of microbubbles. 
     
     
       20. The ultrasonic stroke diagnosis/therapy apparatus of claim 12, wherein one of the transmitter/receivers is operable to detect a stroke in an area outside the view of another one of the transmitter/receivers. 
     
     
       21. The ultrasonic stroke diagnosis/therapy apparatus of claim 12, wherein the acoustic windows further comprise temporal windows of the skull. 
     
     
       22. The ultrasonic stroke diagnosis/therapy apparatus of claim 12, wherein the mounting unit is suitable for holding the ultrasonic transmitter/receivers in acoustically coupled relation to the acoustic windows. 
     
     
       23. The ultrasonic stroke diagnosis/therapy apparatus of claim 12, further comprising a plurality of image processors located on the mounting unit. 
     
     
       24. The ultrasonic stroke diagnosis/therapy apparatus of claim 12, wherein the transducing elements are arranged in a grid of elements. 
     
     
       25. The ultrasonic stroke diagnosis/therapy apparatus of claim 24, wherein the elements are activated in groups. 
     
     
       26. A portable stroke diagnosis/treatment system suitable for use by first responders and other field medical personnel comprising:
 a head-mounted device including at least two transmitter/receivers, each transmitter/receiver including a plurality of ultrasonic transducing elements which are adapted to be coupled to an acoustic window of the skull when the device is mounted on the head of a subject;   a portable power supply; and   an imager, physically separate from but in communication with the transmitter/receivers, and configured to be responsive to reflected signals received by the transducing elements and configured to produce a two dimensional or three dimensional ultrasonic image of brain tissue for stroke diagnosis or therapy, the imager configured to at least one of: determine presence of hemorrhagic stroke by identifying relatively diffuse blood flow within the skull of the patient; determine presence of ischemic stroke by identifying at least one location of inadequate blood flow within the skull of the patient; and diagnose between hemorrhagic and ischemic stroke by classifying the region within the skull of the patient in terms of adequacy of blood flow.   
     
     
       27. The portable stroke diagnosis/treatment system of claim 26, wherein the portable power supply includes a battery. 
     
     
       28. The portable stroke diagnosis/treatment system of claim 26, further including on-board data storage. 
     
     
       29. The portable stroke diagnosis/treatment system of claim 26, wherein the imager is further responsive to reflected signals received by the transducing elements for producing an ultrasonic image of microbubbles in a blood vessel serving the brain. 
     
     
       30. The portable stroke diagnosis/treatment system of claim 29, wherein the ultrasonic image of microbubbles in a blood vessel further comprises a Doppler ultrasonic image. 
     
     
       31. The portable stroke diagnosis/treatment system of claim 26, wherein the transmitter/receivers are further operable following the diagnosis of a stroke to deliver additional ultrasound during therapy. 
     
     
       32. A stroke treatment system comprising:
 a transducer unit comprising a two-dimensional grid of transducing elements;   a head mount to which the transducer unit is mounted, the head mount being adapted to retain the transducer unit acoustically coupled to the head of a subject; and   an imager, in communication with the transducer unit, the imager configured to be responsive to reflected signals received by the transducer unit for the formation of a two-dimensional or three-dimensional image of an image area of brain tissue and configured to at least one of: determine presence of hemorrhagic stroke by identifying relatively diffuse blood flow within the skull of the patient; determine presence of ischemic stroke by identifying at least one location of inadequate blood flow within the skull of the patient; and diagnose between hemorrhagic and ischemic stroke by classifying the region within the skull of the patient in terms of adequacy of blood flow.   
     
     
       33. The stroke treatment system of claim 32, wherein the transducing elements are activated in groups. 
     
     
       34. The stroke treatment system of claim 33, further comprising an image processor unit, connected to the transducer unit,
 wherein the image processor unit is mounted to the head mount.   
     
     
       35. The stroke treatment system of claim 32, wherein the three-dimensional image further comprises an ultrasonic image of microbubbles in a blood vessel of the brain tissue. 
     
     
       36. The stroke treatment system of claim 35, wherein the transducer unit is further operable to deliver ultrasonic energy during therapy to an image area of the brain tissue corresponding to an ultrasonic image of microbubbles in a blood vessel. 
     
     
       37. The stroke treatment system of claim 35, wherein the ultrasonic image of microbubbles in a blood vessel further comprises a Doppler ultrasonic image. 
     
     
       38. The stroke treatment system of claim 32, further comprising a second transducer unit comprising a two-dimensional grid of transducing elements, the second transducer unit being mounted to the head mount,
 wherein the head mount is adaptable to retain the transducer units acoustically coupled to acoustic windows of the skull.   
     
     
       39. The stroke treatment system of claim 38, wherein the imager is in communication with the second transducer unit and is responsive to reflected signals received by the second transducer unit for the formation of a three-dimensional image of a second image area of the brain tissue. 
     
     
       40. The stroke treatment system of claim 39, wherein the second image area overlaps the first image area. 
     
     
       41. The stroke treatment system of claim 32, wherein the imager produces a dynamic three-dimensional image. 
     
     
       42. The stroke treatment system of claim 32, wherein the three-dimensional image identifies a location of inadequate blood flow within the brain. 
     
     
       43. The stroke treatment system of claim 32, wherein the transducer unit is further operable to deliver ultrasonic energy during therapy. 
     
     
       44. The stroke treatment system of claim 43, wherein the transducer unit is operable to deliver ultrasonic energy during therapy after the imager has produced a three-dimensional image which identifies a location of inadequate blood flow within the brain. 
     
     
       45. The stroke treatment system of claim 43, wherein the transducer is further operable to deliver ultrasonic energy to the image area. 
     
     
       46. A stroke treatment system comprising:
 a transducer unit having a plurality of transducing elements;   a head mount to which the transducer unit is mounted, the head mount being adaptable to retain the transducer unit acoustically coupled to the head of a subject;   an imager, in communication with the transducer unit, the imager being adapted to be responsive to reflected signals received by the transducer unit for the creation of a two-dimensional or three dimensional harmonic ultrasonic image of brain tissue in the interior of the skull and configured to at least one of: determine presence of hemorrhagic stroke by identifying relatively diffuse blood flow within the skull of the patient; determine presence of ischemic stroke by identifying at least one location of inadequate blood flow within the skull of the patient; and diagnose between hemorrhagic and ischemic stroke by classifying the region within the skull of the patient in terms of adequacy of blood flow.   
     
     
       47. The stroke treatment system of claim 46, wherein the ultrasonic image further comprises an ultrasonic image of microbubbles in a blood vessel. 
     
     
       48. The stroke treatment system of claim 47, further comprising a second transducer unit having a plurality of transducing elements, the second transducer unit being mounted to the head mount,
 wherein the head mount is adaptable to retain the transducer units acoustically coupled to acoustic windows of the skull.   
     
     
       49. The stroke treatment system of claim 48, wherein the first transducer unit images a first image area inside the skull and the second transducer unit images a second image area inside the skull. 
     
     
       50. The stroke treatment system of claim 49, wherein at least one of the image areas identifies a location of ischemic stroke.