Ultrasonic methods for diagnosis and treatment 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.

Claims

.[.1. Using non-ultrasonic detection of symptoms of stroke to dynamically couple an ultrasonic transducer/receiver to a skull, 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, comprising: a) dynamically coupling at least one ultrasonic transmitter/receiver to at least one man-made opening in the skull of the patient; b) imaging a region within the skull of the patient; 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 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 region is classified in terms of normal blood flow..].

.[.5. The process of claim 2, in which a region is classified in terms of inadequate blood flow..].

.[.6. The process of claim 2, in which a region is classified in terms of relatively diffuse blood flow..].

.[.7. The process of claim 2, in which locations of hemorrhagic stroke are determined 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..].

.Iadd.12. A stroke diagnosis/treatment method comprising: mounting a unit having two transmitter/receivers on the head of a subject with each transmitter/receiver acoustically coupled to an acoustic window of the skull, wherein each transmitter/receiver includes a plurality of ultrasonic transducing elements; activating at least some of the transducing elements to direct ultrasonic signals into the brain; receiving echo signals from brain tissue and microbubbles in a blood vessel of the brain with one of the transmitter receivers; processing the echo signals to form two-dimensional or three-dimensional dynamic images of the brain tissue and microbubbles in the blood vessel of the brain; and diagnosing stroke from an image of the brain tissue and the microbubbles..Iaddend.

.Iadd.13. The method of claim 12, wherein diagnosing further comprises diagnosing whether a stroke has occurred and, if so, what type of stroke has occurred..Iaddend.

.Iadd.14. The method of claim 13, wherein diagnosing whether a stroke has occurred further comprises identifying a blood vessel which may be blocked..Iaddend.

.Iadd.15. The method of claim 13, wherein identifying a blood vessel which may be blocked further comprises determining the type of stroke as ischemic..Iaddend.

.Iadd.16. The method of claim 12, wherein diagnosing whether a stroke has occurred further comprises identifying a region of relatively diffuse blood flow..Iaddend.

.Iadd.17. The method of claim 16, wherein identifying a region of relatively diffuse blood flow further comprises determining the type of stroke as hemorrhagic..Iaddend.

.Iadd.18. The method of claim 12, further comprising: following the diagnosis of a stroke, performing stroke therapy; and delivering additional ultrasonic energy during the stroke therapy..Iaddend.

.Iadd.19. The method of claim 18, wherein delivering additional ultrasonic energy during the stroke therapy further comprises delivering additional ultrasonic energy to the brain from which the image of microbubbles in a blood vessel was formed to improve the effectiveness of therapy..Iaddend.

.Iadd.20. The method of claim 19, wherein the image of microbubbles in a blood vessel further comprises a Doppler ultrasonic image of microbubbles in a blood vessel..Iaddend.

.Iadd.21. A method for performing non-ultrasonic detection of symptoms of stroke, the method comprising: dynamically coupling an ultrasonic transducer/receiver to a patient; performing ultrasound imaging with the ultrasonic transducer/receiver, the ultrasound imaging comprising imaging microbubbles in the patient; performing non-ultrasonic detection of symptoms of stroke 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, and detection of change in blood flow in the arteries serving the eye; and determining a diagnosis of stroke based at least in-part on the ultrasound imaging and a detection of symptoms of stroke when performing the non-ultrasonic detection of systems of stroke..Iaddend.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIGS. 1-5 are schematic diagrams of various embodiments of the invention.

(2) FIG. 6 is a schematic cross sectional diagram taken along line 6-6 of FIG. 5.

(3) FIG. 7 is a schematic cross sectional diagram taken along line 7-7 of FIG. 6.

(4) FIGS. 8-10 are schematic diagrams of other various embodiments of the invention.

(5) FIG. 11 is a schematic cross sectional diagram taken along line 11-11 of FIG. 10.

(6) FIGS. 12-14 are schematic diagrams of variations on the embodiment of FIG. 11.

(7) The drawings are schematic representations only. They are not intended to show all specific details discussed below, or those that might be included in a commercial version of any such embodiment. Features shown in one or more Figures could be combined, even if they are not illustrated together in a single FIGURE.

DETAILED DESCRIPTION

(8) The following description is not intended to limit the technological or legal scope of the invention. For example, examples of various embodiments of the invention are only aids to understanding the features, functions, and benefits of the invention in its broadest sense.

(9) FIG. 1 is a schematic diagram of an embodiment of the invention in use, a situation generally indicated as 1. Boxes 2 and 3 illustrate portions of this embodiment that optionally may be physically separated from each other, but act cooperatively, using standard remote communications techniques, whether wired or wireless. The invention is used to diagnose stroke in a patient 4. Ultrasonic energy is generated in generator 5, then sent to and received from the patient 4 by transducer 6. The imager 9 interprets the reflected signal, which is affected (in part) by the nature and quality of the dynamic coupling 8 of the transducer 6 to the patient 4. The scope of the invention is not limited to the manner in which the nature and quality of dynamic coupling 8 is determined. For example, one of many potential techniques is the use of one or more contact sensor(s), pressure sensors, position sensors, etc. (all not shown), according to known principles. Another very important way is analysis of the quality and nature of the reflected ultrasonic signal itself, such as by comparison to baseline data or other parameters.

(10) In any event, actuator 7 may improve the diagnosis in a closed feedback and control loop. In this regard, it should be emphasized that FIG. 1 is schematic only and that the invention is not limited to a separate and/or mechanical actuator 7 operating directly on transducer 6, although that is one possible embodiment. The invention includes electronic “actuation” in the sense of electronic and/or mathematical adjustment to any or all of generator 5, transducer 6, imager 9, or (as described below) dynamic coupling 8 itself.

(11) In general, imager 9 performs any process for identifying data relevant to the diagnosis of stroke. This includes techniques for automatically detecting symptoms based on any relevant criteria. The imaging may be qualitative or quantitative in nature and/or the manner in which it is reported. For example, imager 9 may execute an algorithm for scanning the brain to identify potentially likely symptoms of stroke, then analyze such regions in greater detail using one or more techniques. In doing so, it may perform digital calculations related to the diagnosis of stroke and transmit relevant data to a remote location for full diagnosis and/or confirmation using telemedicine techniques. Yet, in the vicinity of the patient, the result of the calculation may be reported in only a simpler “stroke/no stroke” manner, such as a display which is colored red for adequate perfusion and blue for inadequate perfusion, however quantitative the basis for determining adequacy of perfusion may be.

(12) An optional, non-ultrasonic, detection of symptoms of stroke, illustrated schematically as 10, may also be used confirm, modify, or reject a diagnosis of stroke; as an input to the dyqamic coupling of transducer 6 to the patient 4; or as input to the imaging process.

(13) An optional wired or wireless communication link 11 may be used to transmit any form or content of data to another location, for any purpose. This would include any manner of reporting the results of the diagnosis as described above, or any other relevant information about the status of the system, the patient, etc.

(14) FIG. 2 is a schematic representation of another embodiment of the invention. Transducer 6 is dynamically coupled to the patient 4 between transducer 6 and the patient's skull 11 in the vicinity of an opening 12. In the embodiment shown in the Figure, an optional by acoustic material 20 is used to improve the acoustic coupling of transducer 6 to the patient. The relative sizes of the transducer 6, amount of acoustic material 20 (if used), and opening 12 are shown in schematic form only.

(15) Within the patient's brain 19 are several portions of cerebral vasculature that are imaged by the invention to diagnose stroke in the patient 4. Artery 13 is blocked by blockage 14 and thus the flow of blood downstream is inadequate. This is an example of ischemic stroke. Artery 15 is partially blocked by partial blockage 16 and thus the flow of blood downstream is diffused by the partial blockage and may be detected accordingly. (Typical whole or partial blockages are plaque, emboli, and the like.) By contrast, artery 17 is not blocked at all, but it has burst and thus diffuse blood flow 18 is present outside the vasculature and may be detected accordingly. This is an example of hemorrhagic stroke. Of course, these descriptions are for ease of illustration and should not be taken as limitations on the usual and well-understood medical description of the various types of stroke and the mechanisms that cause them. In any event, transducer 6 is used to diagnose any or all of these conditions in the patient in accordance with the principles of the invention.

(16) FIG. 3 is a schematic illustration of an alternative (or additional) dynamic coupling technique. Vacuum source 21 is used to generate and (if desired) control the dynamic coupling of transducer 6 to the patient 4, by use of a vacuum in chamber 22.

(17) FIG. 4 is a schematic illustration of an alternative (or additional) actuation technique. Transducer 6 is mounted so as to move in one, two, or (as illustrated) three directions according to the motion of ball 23 in socket 24. There are many specific techniques and devices for such actuation, and the invention is not limited to any of them, thus they are not shown for clarity.

(18) FIGS. 5-7 are schematic illustrations of an alternative (or additional) acoustic material application technique. Acoustic material is contained within a separate (reusable or disposable) cartridge 25 that has a removable release liner (not shown for clarity) or an acoustically transparent window or fabric 26 designed to contact patient 4. Cartridge 25 connects to transducer 6 by some appropriate interlock technique. For example, FIG. 6 shows an interlock in which the angles α and β are different from each other to ensure that the cartridge is oriented properly. FIG. 7 shows the use of marks to indicate proper rotation of cartridge 25 onto transducer 6. In any or all of these embodiments, cartridge 25 could be connected to an adapter or other intermediate feature instead of directly to transducer 6.

(19) FIG. 8 schematically illustrates an embodiment in which a system for dispensing acoustic coupling material across in a controlled manner is used. A source 27 of acoustic coupling material replenishes a chamber 28 that couples the transducer 6 to the patient 4 through some type of interface 29 (for example, the acoustically transparent window or fabric 26 of FIG. 7). As before, the source 27 can act in the role of the actuator 7 and thus be part of the closed loop control of the dynamic coupling of transducer 6. Chamber 28 may be part of a removable or disposable cartridge 25 as shown in FIGS. 5-7.

(20) FIG. 9 schematically illustrates the combination of the invention as previously described into an otherwise conventional portable automatic external defibrillator (AED) 30. There are many advantages to this combination, including (without limitation) the ability to share a common power supply (batteries, recharging circuits for rechargeable batteries, etc.) and associated switches (e.g., a main power on-off circuit controlled by a switch connected to a lid that opens and closes); common data storage and removal (either by way of telecommunications link 11, conventional removable data storage media, PC cards, etc.); common ambient condition and battery condition temperature sensors; coordinated detection of whether the defibrillator electrode gel and the ultrasonic transducer acoustic coupling material are still suitable for use, based on temperature, age, or other factors; common audio/visual techniques and equipment for prompting users to follow proper procedures for “one-touch” or other proper use of the equipment, depending on the symptoms observed in the patient and/or instructions received from remote medical personnel (e.g., pre-hospital procedures such as the Los Angeles Prehospital Stroke Screen); common self-test and diagnostic routines (whether performed according to a schedule, periodically, at random times, as dictated by equipment usage, etc.); coordinated remote transmission of the status of such routines over the telecommunications link 11, or a shared communications port; and so on. Even greater advantages lie in the use of the electrocardiogram (ECG or EKG) data gathered by conventional AEDs as input into the dynamic coupling and/or imaging components of the stroke diagnosis. Such data may be used to confirm, modify, or reject a diagnosis, in a manner similar to that described for the non-ultrasonic detection of symptoms of stroke described above. Of course, any of the features just mentioned that do not specifically require presence of an AED could be implemented in a “stand-alone” embodiment of the invention.

(21) FIGS. 10-14 schematically illustrate an embodiment of the invention suitable for the acoustic bone window represented by the eye sockets. In each of these Figures, transducer 6 is shown as a matter of convenience as having a circular cross section, but this is not a limitation on the scope of the invention. The actual shape of transducer 6 would be dictated by normal considerations of anatomy, engineering design, and the like.

(22) FIG. 10 shows an annular transducer 6 arranged to surround the iris 31 (and thus also the pupil 32) of eye 33. For clarity only, these Figures do not show the eyelids, which are transparent at ultrasonic frequencies, but this embodiment would typically be used with the eyelids closed and transducer 6 in contact with them instead of directly with eye 33. As indicated by the dashed arrows, transducer 6 would transmit and receive ultrasonic energy through the eye to the brain of the patient; the annular design reduces the amount of acoustic energy passing through the lens 34 (shown in dashed lines) within the eye 33 so as to minimize adverse effects such as cataracts. Other reductions in energy follow from designing transducer 6 to minimize the amount of acoustic energy that spreads in so-called “side lobes” from the main path of travel indicated in FIG. 10.

(23) FIGS. 12-14 schematically illustrate possible patterns for individual transducing elements within annular transducer 6. FIG. 12 shows a collection of vertically striped individual elements denoted X.sub.1 to X.sub.n. FIG. 13 shows a collection of radially arranged sections. FIG. 14 shows a grid of sections denoted X.sub.m,n that could be activated individually or in groups according to any desired pattern (such as rows, columns, spokes, etc.). In each of these embodiments, individual transducing elements can be activated by ultrasonic generator 5 according to a time-based “rotation” or other pattern that enables three dimensional imaging techniques to be used by imager 9. Such “mini-tomographic” data may be gathered from two locations (two eyesockets) of the patent 4 and electronically combined by imager 9 to provide greater detail and thus accuracy of the diagnosis of stroke that would otherwise be available.

(24) Of course, the use of multiple locations in the manner just described is not limited to only the transducer designs illustrated in FIGS. 10-14, but is an embodiment of the invention that can be practiced with any suitable transducer 6. For example, multiple transducers known as “EchoEye” by EchoCath, Inc. may be used to assemble a composite image by using the data generated by slight changes in the position, frequency and/or phase of the transducer, according to the principles taught in U.S. Pat. No. 5,373,845 (Gardineer et al.).

(25) While the above description is in terms of diagnosis of stroke, it should be noted that any embodiment of the invention could be used in a two-step regimen in which the patient is first diagnosed with stroke, and then additional ultrasonic energy is delivered (perhaps at different frequency, power level and the like) during administration of a therapy such as tPA.

(26) Some embodiments of the invention employ modified or unmodified aspects of otherwise known ultrasonic diagnostic systems. Such systems include those commercially available from, or under development by: Sonosite, Pie Medical, Esaote, the Bracco Group, Philips Medical Systems, ATL, Hewlett-Packard, Agilent Technologies, Toshiba, Toshiba Medical Systems, Toshiba America Medical Systems, General Electric, General Electric Medical Systems, EchoCath, Acuson, Endosonics, Aloka, Hitachi Siemens Medical Systems, Inc., 3D Echotech, Ecton, SPECS USA, Daum, and Multigon Industries.

(27) Some embodiments of the invention employ modified or unmodified aspects of otherwise known non-ultrasonic diagnostic systems. Such systems include those commercially available from, or under development by: Non-Invasive Technology, Baylor College of Medicine; the Center for Innovative Minimally Invasive Therapy (CIMIT) of Massachusetts (including its member organizations such as Massachusetts General Hospital, Brigham and Women's Hospital, Draper Laboratory, and Massachusetts Institute of Technology); Harvard Medical School; Such systems also include those disclosed in any of the documents listed below as incorporated by reference into this document.

Equipment

(28) The invention may be implemented using standard or custom ultrasonic transducers, transmitters/receivers, image generation equipment, etc., by adapting such devices as appropriate to accomplish the objectives described above.

(29) Suitable stabilization devices can be made by modifying existing cardiac tissue stabilizers, such as any of the inventions described and claimed in: International Patent Application number PCT/NL94/00156 (International Publication Number WO 95/01757) U.S. Pat. No. 5,865,730 (Fox et al.) U.S. Pat. No. 5,984,864 (Fox et al.) U.S. Pat. No. 5,894,843 (Benetti et al.)

(30) Suitable vacuum-based stabilization devices can be made by modifying existing commercially available vacuum-based cardiac tissue stabilizers. Examples include the Medtronic Octopus®, Octopus2®, and Octopus®2+Tissue Stabilization Systems, or any similar product.

(31) Suitable vacuum-based stabilization devices can be made by modifying known vacuum-based cardiac tissue stabilizers such as any of the inventions described or claimed in: U.S. Pat. No. 5,836,311 (Borst et al.) U.S. Pat. No. 5,927,284 (Borst et al.) U.S. Pat. No. 6,015,378 (Borst et al.) U.S. Pat. No. 5,727,569 (Benetti et al.) U.S. Pat. No. 6,032,672 (Taylor) U.S. Pat. No. 5,906,607 (Taylor et al.) U.S. Pat. No. 5,782,746 (Wright) U.S. Pat. No. 5,865,730 (Fox et al.) U.S. Pat. No. 6,071,295 (Takahashi) U.S. Pat. No. 6,007,523 (Mangosong) U.S. Pat. No. 6,007,486 (Hunt et al.) U.S. Pat. No. 5,891,017 (Swindle et al.) U.S. Pat. No. 5,885,271 (Hamilton et al.) U.S. Pat. No. 6,019,722 (Spence et al.) International Patent Application Number PCT/US96/15091 (International Publication Number WO 97/10753)

(32) Other suitable stabilization devices can be made by modifying existing vacuum-based eye tissue stabilizers such as

(33) Suction rings employed in Lasik™ brand laser surgery

(34) Devices disclosed in U.S. Pat. No. 5,171,245 (Sher)

(35) Any known algorithms for detecting emboli or other aspects of blood flow can be used, including those described in the documents in the Appendix, and also: U.S. Pat. No. 4,109,642 Reid et al.) U.S. Pat. No. 5,042,490 (Federov et al.) U.S. Pat. No. 5,348,015 (Moehring et al.) International Patent Application Number PCT/US99/26740 (International Publication Number WO 00/27288)

(36) The systems and methods employed in any known ultrasonic system may be adapted for use in embodiments of the invention. Such systems include those disclosed and claimed in the references in the Appendix, and especially the following: U.S. Pat. No. 5,123,415 (Daigle) U.S. Pat. No. 5,295,485 (Shinomura et al.) U.S. Pat. No. 5,360,005 (Wilk) U.S. Pat. No. 5,369,624 (Fukukita et al.) U.S. Pat. No. 5,590,658 (Chiang et al.) U.S. Pat. No. 5,690,114 (Chiang et al.) U.S. Pat. No. 5,839,442 (Chiang et al.) U.S. Pat. No. 5,904,652 (Gilbert et al.) U.S. Pat. No. 5,957,846 (Chiang et al.) U.S. Pat. No. 5,964,709 (Chiang et al.) U.S. Pat. No. 6,106,472 (Chiang et al.) U.S. Pat. No. 6,111,816 (Chiang et al.) U.S. Pat. No. 5,709,209 (Friemel, et al.) U.S. Pat. No. 5,722,412 (Pflugrath et al.) U.S. Pat. No. 5,782,769 (Hwang et al.) U.S. Pat. No. 5,817,024 (Ogle et al.) U.S. Pat. No. 5,893,363 (Little, et al.) U.S. Pat. No. 5,976,088 (Urbano et al.) U.S. Pat. No. 6,004,270 (Urbano et al.) U.S. Pat. No. 6,056,691 (Urbano et al.) U.S. Pat. No. 6,086,537 (Urbano et al.) U.S. Pat. No. 6,135,961 (Pflugrath et al.) U.S. Pat. No. 6,126,608 (Kemme et al.) U.S. Pat. No. 6,102,863 (Pflugrath et al.) U.S. Pat. No. 6,106,468 (Dowdell)

Improvements

(37) Based on this disclosure, there are several improvements to the invention that are clearly desirable and already understood by the inventors to be within the legal scope of the invention. In general, this includes any improvement, currently known or later discovered, in areas such as portable electronics, ultrasonic imaging systems, computer graphics, signal processing, stroke diagnosis and treatment, and the like, that is suitable for use with the invention.

(38) Such improvements specially include those that do not depend for their function, operation, or success on the specific medical condition and diagnostic techniques this invention relies upon. In other words, improvements to any similar device that is not the invention could and should be applied to the invention, as appropriate.

(39) Examples of improvements within the currently understood scope of the invention include:

(40) Reduction in cost, weight, and power consumption.

(41) Reduction in the time required to form an image.

(42) Improvements in imaging quality

(43) Reduction in time required to form an image.

(44) Changes in shape, size, and format of the image.

(45) Changes in shape, size, and format of the equipment.

(46) Improved ergonomic design, such as improvement in the fit to the patient, ease of use by the operator, or any type of adaptation to a harsh or otherwise specialized operating environment.

(47) Substitution of materials for any reason.

(48) Improved reliability or quality.

(49) Improved graphics, resolution, larger screen size.

(50) Faster transfer and processing of data.

(51) Remote transmission and/or processing of data.

(52) Provided they lie within the scope of the claims below, or are considered equivalent under the law, the legal scope of the invention includes any improvements or changes of the types described above, even if they are developed after the date of this document.

DOCUMENTS INCORPORATED BY REFERENCE

(53) The full disclosure of each of the following documents is incorporated into this document.

(54) All books, articles, documents, publications, U.S. Patents, U.S. Patent Applications, and International Patent Applications cited elsewhere in this document.

(55) The following medical textbooks: Aaslid (ed.), Transcranial Doppler Sonography (1986), ISBN 3211819355 Babikian et al (eds.), Transcranial Doppler Ultrasound (2.sup.nd edition 1999) ISBN 0750699698 Barnett (ed.), Stroke (3.sup.rd edition, 1998), ISBN 0443075514 Bogdahn et al. (eds.), Echoenhancers and Transcranial Color Duplex Sonography (1998), ISBN 0632048565 Bogousslavsky (ed.), Stroke Syndromes (1995), ISBN 0521453976 Ebrahim and Harwood, Stroke (2.sup.nd edition, 1999), ISBN 0192628763 Greenberg (ed.), Neuroimaging: A Companion to Adams and Victor's Principles of Neurology (2.sup.nd edition, 1999), ISBN 0071346155 Hademos et al., The Physics of Cerebrovascular Diseases: Biophysical Mechanisms of Development, Diagnosis and Therapy (1998), ISBN 1563965585 Jensen and Jensen, Estimation of Blood Velocities Using Ultrasound: A Signal Processing Approach (1996), ISBN 0521464846 McGahan and Goldberg (eds.), Diagnostic Ultrasound (1998), ISBN 0397516142 Meyer, Diagnosis and Management of Stroke and TIAs (1982), ISBN 0201041847′ Semple et al., An Atlas of Stroke (2nd edition 1999), ISBN 1850700826. Millikan et al. (eds.), Stroke (1987), ISBN 0812110161 Newell and Aaslid, Transcranial Doppler (1991), ISBN 0881678368 Poeck, et al. (eds.), New Trends in Diagnosis and Management of Stroke (1987), ISBN 0387183698 Sandler et al., Correlative Imaging (1989), ISBN 0683075020 Tegeler et al., Neurosonology (1995), ISBN 0815187920 Tempkin, Ultrasound Scanning (2.sup.nd edition, 1998), ISBN 0721668798 Weinberger (ed.), Non-Invasive Imaging of Cerebrovascular Disease (1988) ISBN 08451-45045 Whisnant, Stroke (1993), ISBN 07506057X Wiebers et al., Handbook of Stroke (1997), ISBN 0316947601.

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(57) The following U.S. Pat. Nos. 6,135,961; 6,111,816; 6,106,472; 6,086,537; 6,056,691; 6,004,270; 5,976,088; 5,975,081; 5,970,025; 5,967,991; 5,967,991; 5,964,709; 5,961,462; 5,957,846; 5,954,675; 5,954,053; 5,940,123; 5,938,607; 5,935,071; 5,924,988; 5,922,945; 5,921,928; 5,919,138; 5,919,137; 5,917,190; 5,916,168; 5,904,652; 5,903,516; 5,899,865; 5,897,851; 5,897,498; 5,893,363; 5,893,363; 5,891,035; 5,879,303; 5,879,303; 5,873,821; 5,860,924; 5,855,556; 5,853,370; 5,851,186; 5,839,442; 5,837,900; 5,833,613; 5,827,969; 5,820,558; 5,817,024; 5,817,024; 5,807,263; 5,800,356; 5,795,297; 5,792,051; 5,782,769; 5,782,769; 5,782,755; 5,779,631; 5,770,823; 5,770,801; 5,769,079; 5,768,939; 5,762,067; 5,752,517; 5,729,508; 5,722,412; 5,722,412; 5,720,710; 5,720,708; 5,720,291; 5,718,229; 5,715,823; 5,713,362; 5,713,362; 5,707,607; 5,707,606; 5,690,114; 5,673,701; 5,669,388; 5,669,388; 5,669,385; 5,664,574; 5,660,909; 5,655,539; 5,648,942; 5,647,364; 5,645,066; 5,640,960; 5,636,631; 5,635,619; 5,634,466; 5,634,465; 5,630,418; 5,617,863; 5,606,972; 5,603,323; 5,596,987; 5,595,723; 5,590,658; 5,582,176; 5,573,751; 5,568,384; 5,562,098; 5,558,855; 5,558,853; 5,558,094; 5,555,887; 5,553,614; 5,546,946; 5,540,230; 5,540,230; 5,529,070; 5,517,994; 5,494,038; 5,492,134; 5,492,121; 5,488,953; 5,485,842; 5,482,047; 5,482,045; 5,479,930; 5,476,097; 5,474,073; 5,471,990; 5,471,989; 5,456,257; 5,450,851; 5,438,994; 5,425,370; 5,425,370; 5,421,336; 5,409,688; 5,409,005; 5,402,793; 5,402,778; ,390,675; 5,390,674; 5,386,827; 5,381,795; 5,373,845; 5,373,845; 5,373,845; 5,365,929; 5,353,799; 5,348,015; 5,343,865; 5,343,865; 5,343,865; 5,329,927; 5,329,927; 5,329,927; 5,305,756; 5,295,485; 5,295,307; 5,287,753; 5,255,682; 5,233,994; 5,226,422; 5,226,420; 5,215,094; 5,207,225; 5,197,477; 5,187,672; 5,167,230; 5,161,536; 5,158,088; 5,123,415; 5,122,974; 5,119,815; 5,103,827; 5,099,847; 5,095,910; 5,081,995; 5,076,278; 5,076,278; 5,062,428; 5,050,610; 5,016,641; 4,975,892; 4,975,723; 4,972,331; 4,926,871; 4,887,306; 4,883,059; 4,829,430; 4,817,618; 4,800,317; 4,691,418; 4,670,339; 4,658,827; 4,657,895; 4,644,795; 4,607,642; 4,603,702; 4,581,636; 4,567,895; 4,543,960; 4,542,653; 4,508,122; 4,508,122; 4,431,006; 4,430,898; 4,417,582; 4,411,360; 4,407,294; 4,399,704; 4,392,486; 4,354,502; 4,341,222; 4,298,009; 4,298,009; 4,282,880; 4,282,755; 4,282,577; 4,277,979; 4,258,576; 4,249,539; 4,237,902; 4,233,989; 4,222,274; 4,197,751; 4,197,749; 4,168,628; 4,165,182; 4,153,894; 4,131,024; 4,035,822; 4,019,818; 3,997,717; 3,978,508; 3,969,578; 3,953,822.

Alternative Embodiments

(58) The following numbered aspects of the invention are part of the original disclosure of this invention. They are written as if they were individual inventions, so that they may be specifically considered as such in subsequent applications. Thus, some of the following may duplicate the claims at the end of this application. Some of them may contain additional limitations than those claims. 1. Diagnosing stroke using dynamic coupling of at least one ultrasonic transducer/receiver to a skull. 2. Using non-ultrasonic detection of symptoms of stroke to dynamically couple an ultrasonic transducer/receiver to a skull. 3. The method of invention 2 in which the non-ultrasonic detection comprises computed tomography scanning. 4. The method of invention 2 in which the non-ultrasonic detection comprises magnetic resonance scanning. 5. The method of invention 2 in which the non-ultrasonic detection comprises differential spectrophotometric methods or near-infrared detection of tissue characteristics. 6. The method of invention 2 in which the non-ultrasonic detection comprises detection or measurement of a biological material. 7. The method of invention 2 in which the non-ultrasonic detection comprises detection or measurement of a chemical. 8. The method of invention 2 in which the non-ultrasonic detection comprises detection or measurement of A100β. 9. The method of invention 2 in which the non-ultrasonic detection comprises use of biological assay techniques. 10. The method of invention 2 in which the non-ultrasonic detection comprises detection of change in blood pressure. 11. The method of invention 2 in which the non-ultrasonic detection comprises detection of change in pressure within the eye. 12. The method of invention 2 in which the non-ultrasonic detection comprises detection of change in blood flow in arteries serving organs other than the brain. 13. The method of invention 2 in which the non-ultrasonic detection comprises detection of change in blood flow in the arteries serving the eye. 14. For a patient having a skull containing brain tissue and blood vessels, and in a process for diagnosing stroke in the patient, a subprocess of dynamic coupling at least one ultrasonic transducer/receiver to at least one opening in the skull. 15. For a patient having a skull containing brain tissue and blood vessels, and in a process for diagnosing stroke in the patient, a subprocess of stabilizing at least one ultrasonic transducer/receiver to at least one opening in the skull. 16. For a patient having a skull containing brain tissue and blood vessels, and in a process for diagnosing stroke in the patient, a subprocess of compensating at least one ultrasonic transducer/receiver coupled to at least one opening in the skull. 17. For a patient having a skull containing brain tissue and blood vessels, and in a process for diagnosing stroke in the patient, a subprocess of compensating an image produced from at least one ultrasonic transducer/receiver coupled to at least one opening in the skull. 18. For a patient having a skull containing brain tissue and blood vessels, and in a process for diagnosing stroke in the patient, a subprocess comprising: a) dynamically coupling at least one of the ultrasonic transmitter/receivers to at least one opening in the skull of the patient; and b) imaging the brain tissue or blood vessels. 19. The subprocess of any of inventions 14 to 18, further comprising generating and receiving ultrasonic signals suitable for processing into information about the brain tissue or blood vessels. 20. The subprocess of any of inventions 14 to 18, further comprising applying a vacuum to the skull. 21. The subprocess of any of inventions 14 to 18, further comprising applying an acoustic coupling material to the skull. 22. The subprocess of any of inventions 14 to 18, in which the ultrasonic transducer/receiver is coupled to at least one man-made opening in the skull. 23. The subprocess of any of inventions 14 to 18, in which the ultrasonic transducer/receiver is coupled to at least ocular opening in the skull. 24. The subprocess of any of inventions 14 to 18, in which the ultrasonic transducer/receiver is coupled to at least one nasal opening in the skull. 25. The subprocess of any of inventions 14 to 18, in which the ultrasonic transducer/receiver is coupled to at least one aural opening in the skull. 26. The subprocess of any of inventions 14 to 18, in which the ultrasonic transducer/receiver is coupled to at least one acoustic bone window in the skull. 27. For a patient having a skull containing brain tissue and blood vessels, a process for diagnosing hemorrhagic stroke in the patient, comprising: a) dynamically coupling at least one ultrasonic transmitter/receiver to at least one opening in the skull of the patient; b) imaging a region within the skull of the patient; and c) determining presence of hemorrhagic stroke by identifying relatively diffuse blood flow within the skull of the patient. 28. The process of invention 27, in which the imaging comprises generating and receiving ultrasonic signals suitable for processing into information about the region within the skull of the patient. 29. The process of invention 27, in which a region is classified in terms of normal blood flow. 30. The process of invention 27, in which a region is classified in terms of inadequate blood flow. 31. The process of invention 27, in which a region is classified in terms of relatively diffuse blood flow. 32. The process of invention 27, in which locations of hemorrhagic stroke are determined by identifying relatively diffuse blood flow outside the blood vessels of the brain. 33. For a patient having a skull containing blood vessels, a process for diagnosing ischemic stroke in the patient, comprising: a) dynamically coupling at least one ultrasonic transmitter/receiver to at least one opening in the skull of the patient; b) imaging a region within the skull of the patient; and c) determining presence of ischemic stroke by identifying at least one location of inadequate blood flow within the skull of the patient. 34. The process of invention 33 in which the imaging comprises generating and receiving ultrasonic signals suitable for processing into information about the region within the skull of the patient. 35. The process of invention 33 in which a region is classified in terms of normal blood flow. 36. The process of invention 33 in which a region is classified in terms of inadequate blood flow. 37. The process of invention 33 in which a region is classified in terms of relatively diffuse blood flow. 38. The process of invention 33 in which locations of ischemic stroke are determined by identifying relatively inadequate blood flow within the blood vessels of the brain. 39. The process of invention 33 in which presence of ischemic stroke is determined by identifying at least one location where there is at least partial blockage of blood flow. 40. For a patient having a skull containing brain tissue and blood vessels, a process for diagnosing between hemorrhagic and ischemic stroke, comprising: a) dynamically coupling at least one ultrasonic transmitter/receiver to at least one opening in the skull of the patient; b) imaging a region within the skull of the patient; and c) classifying a region within the skull of the patient in terms of adequacy of blood flow. 41. The process of invention 40 in which the imaging comprises generating and receiving ultrasonic signals suitable for processing into information about the region within the skull of the patient. 42. The process of invention 40 in which a region is classified in terms of normal blood flow. 43. The process of invention 40 in which a region is classified in terms of inadequate blood flow. 44. The process of invention 40 in which a region is classified in terms of relatively diffuse blood flow. 45. The process of invention 40 in which locations of hemorrhagic stroke are determined by identifying relatively diffuse blood flow outside the blood vessels of the brain. 46. The process of invention 40 in which locations of ischemic stroke are determined by identifying relatively inadequate blood flow within the blood vessels of the brain. 47. The process of invention 40 in which presence of ischemic stroke is determined by identifying at least one location where there is at least partial blockage of blood flow. 48. The process of any of inventions 27, 33, or 40, further comprising applying a vacuum to the skull. 49. The process of any of inventions 27, 33, or 40, further comprising applying an acoustic coupling material to the skull. 50. The process of any of inventions 27, 33, or 40, in which the ultrasonic transducer/receiver is coupled to at least one man-made opening in the skull. 51. The process of any of inventions 27, 33, or 40, in which the ultrasonic transducer/receiver is coupled to at least ocular opening in the skull. 52. The process of any of inventions 27, 33, or 40, in which the ultrasonic transducer/receiver is coupled to at least one nasal opening in the skull. 53. The process of any of inventions 27, 33, or 40, in which the ultrasonic transducer/receiver is coupled to at least one aural opening in the skull. 54. The process of any of inventions 27, 33, or 40, in which the ultrasonic transducer/receiver is coupled to at least one acoustic bone window in the skull. 55. For a patient having a skull containing blood vessels serving a brain, a system for diagnosing hemorrhagic stroke in the patient, comprising: a) at least one ultrasonic transmitter/receiver receiver which generates and receives ultrasonic signals suitable for imaging the blood vessels of the brain, b) at least one apparatus to dynamically couple any of the ultrasonic transmitter/receivers to at least one opening in the skull of the patient; and c) a processor for imaging the blood vessels of the brain from at least one signal received from at least one ultrasonic transmitter/receiver. 56. For a patient having a skull containing blood vessels serving a brain, a system for diagnosing ischemic stroke in the patient, comprising. a) at least one ultrasonic transmitter/receiver receiver which generates and receives ultrasonic signals suitable for imaging the blood vessels of the brain, b) at least one apparatus to dynamically couple any of the ultrasonic transmitter/receivers to at least one opening in the skull of the patient; and c) a processor for imaging the blood vessels of the brain from at least one signal received from at least one ultrasonic transmitter/receiver. 57. For a patient having a skull containing blood vessels serving a brain, a system for discriminating between hemorrhagic stroke and ischemic stroke in the patient, comprising: a) at least one ultrasonic transmitter/receiver receiver which generates and receives ultrasonic signals suitable for imaging the blood of the brain, b) at least one apparatus to dynamically couple any of the ultrasonic transmitter/receivers to at least one opening in the skull of the patient; and c) a processor for imaging the blood vessels of the brain from at least one signal received from at least one ultrasonic transmitter/receiver. 58. The system of any of inventions 55, 56, or 57, further comprising acoustic coupling material positioned between the ultrasonic transmitter/receiver and the skull. 59. The system of any of inventions 55, 56, or 57, in which the ultrasonic transducer/receiver is coupled to at least one man-made opening in the skull. 60. The system of any of inventions 55, 56, or 57, in which the ultrasonic transducer/receiver is coupled to at least ocular opening in the skull. 61. The system of any of inventions 55, 56, or 57, in which the ultrasonic transducer/receiver is coupled to at least one nasal opening in the skull. 62. The system of any of inventions 55, 56, or 57, in which the ultrasonic transducer/receiver is coupled to at least one aural opening in the skull. 63. The system of any of inventions 55, 56, or 57, in which the ultrasonic transducer/receiver is coupled to at least one acoustic bone window in the skull. 64. The system of any of inventions 55, 56, or 57, in which more than one transducer/receiver is dynamically coupled to a like number of openings, but only a single image is produced. 65. An apparatus for diagnosing hemorrhagic stroke in a patient having a skull containing brain tissue and blood vessels, comprising: a) at least one ultrasonic transmitter/receiver; and b) a subassembly that dynamically couples at least one ultrasonic transmitter/receiver to the skull of the patient. 66. An apparatus for diagnosing ischemic stroke in a patient having a skull containing brain tissue and blood vessels, comprising: a) at least one ultrasonic transmitter/receiver; and b) at least one subassembly that dynamically couples at least one ultrasonic transmitter/receiver to the skull of the patient. 67. An apparatus for diagnosing between hemorrhagic and ischemic stroke in a patient having a skull containing brain tissue and blood vessels, comprising: a) at least one ultrasonic transmitter/receiver; and b) at least one subassembly that dynamically couples at least one ultrasonic transmitter/receiver to the skull of the patient. 68. The apparatus of any of inventions 65, 66, or 67, in which the subassembly stabilizes the transducer/receiver to the skull. 69. The apparatus of any of inventions 65, 66, or 67, further comprising acoustic coupling material between the ultrasonic transmitter/receiver and the skull. 70. The apparatus of any of inventions 65, 66, or 67, in which acoustic coupling material may be inserted into or removed from a location between the ultrasonic transmitter/receiver and the skull. 71. The apparatus of any of inventions 65, 66, or 67, in which acoustic coupling material is supported by a disposable member that may be inserted into or removed from a location between the ultrasonic transmitter/receiver and the skull. 72. The apparatus of any of inventions 65, 66, or 67, in which normal operation of the apparatus is prevented in the absence of an acoustic coupling material. 73. The apparatus of any of inventions 65, 66, or 67, in which normal operation of the apparatus occurs only in the presence of a sufficient amount of an acoustic coupling material. 74. The apparatus any of inventions 65, 66, or 67, in which the apparatus further comprises: a) a subapparatus that determines a quantity of an acoustic coupling material positioned between the ultrasonic transmitter/receiver and the skull, and b) a subapparatus that modifies normal operation of the apparatus based on the determined quantity of acoustic coupling material. 75. The apparatus of any of inventions 65, 66, or 67, in which the apparatus further comprises a subapparatus that inserts acoustic coupling material between the ultrasonic transmitter/receiver and the skull. 76. The apparatus of any of inventions 65, 66, or 67, in which the apparatus further comprises a subapparatus that receives acoustic coupling material between the ultrasonic transmitter/receiver and the skull. 77. The apparatus of any of inventions 65, 66, or 67, in which the apparatus inhibits diagnosis in the absence of sufficient acoustic coupling material. 78. The apparatus of any of inventions 65, 66, or 67, in which the apparatus permits diagnosis only in the presence of sufficient acoustic coupling material. 79. The apparatus any of inventions 65, 66, or 67, in which the apparatus further comprises: a) a subapparatus that determines a quantity of acoustic coupling material present and b) a subapparatus that modifies diagnosis based on the quantity of acoustic coupling material present. 80. The apparatus of invention 65, in which the apparatus further comprises: a) a subapparatus that determines a quantity of acoustic coupling material present and b) a subapparatus that bases the determination of hemorrhagic stroke, in part, on the quantity of acoustic coupling material present. 81. The apparatus of invention 66, in which the apparatus further comprises: a) a subapparatus that determines a quantity of acoustic coupling material present and b) a subapparatus that bases the determination of ischemic stroke, in part, on the quantity of acoustic coupling material present. 82. The apparatus of invention 67, in which the apparatus further comprises: a) a subapparatus that determines a quantity of acoustic coupling material present and b) a subapparatus that bases the discrimination between hemorrhagic stroke and ischemic stroke, in part, on the quantity of acoustic coupling material present. 83. A process, subprocess, apparatus, or system that detects or measures or assesses the amount or quality of dynamic coupling between a transducer/receiver and a skull, and then inhibits or permits or modifies diagnosis of stroke accordingly. 84. A process, subprocess, apparatus, or system that detects or measures or assesses the amount or quality of dynamic coupling between a transducer/receiver and a skull, and then inhibits or permits or modifies diagnosis of stroke accordingly using closed loop control of the amount or quality of dynamic coupling. 85. Each of the embodiments of invention 84 in which the closed loop control is performed using an algorithm selected from the group consisting essentially of all possible combinations of proportional control, integral control, and derivative control. 86. Each of the embodiments of invention 84 in which the amount or quality of dynamic coupling is adjusted by adjusting the extent of a vacuum applied to the skull. 87. Each of the embodiments of invention 84 in which the amount or quality of dynamic coupling is adjusted by adjusting the amount or location of an acoustic coupling material between the transducer/receiver and the skull. 88. Each of the embodiments of inventions 86 or 87 in which the amount or quality of dynamic coupling is adjusted in a single location. 89. Each of the embodiments of inventions 86 or 87 in which the amount or quality of dynamic coupling is adjusted in multiple locations by respective amounts that may or may not be the same in each location. 90. Each of the embodiments of invention 84 in which the amount or quality of dynamic coupling is adjusted by modifying an imaging process. 91. A process, subprocess, apparatus, or system for identifying type of stroke in a patient having a skull containing brain tissue and blood vessels, comprising: a) at least one ultrasonic transmitter/receiver; and b) at least one apparatus to dynamically couple at least one ultrasonic transmitter/receiver to the skull of the patient;
in which the process, subprocess, apparatus, or system: c) creates a non-Doppler ultrasonic image of a blood vessel serving the brain; d) creates a Doppler ultrasonic image of microparticulates flowing in the blood vessel; and e) identifies type of stroke based on flow rate of the microparticulates. 92. A process, subprocess, apparatus, or system for identifying type of stroke in a patient having a skull containing brain tissue and blood vessels, comprising. a) at least one ultrasonic transmitter/receiver; and b) at least one apparatus to dynamically couple at least one ultrasonic transmitter/receiver to the skull of the patient;
in which the process, subprocess, apparatus, or system: c) creates a harmonic ultrasonic image of the blood vessels serving the brain, d) creates a Doppler ultrasonic image of microparticulates flowing in the blood vessels serving the brain, and e) identifies type of stroke based on identification and comparison of at least one zone of diffuse blood flow and at least one zone of normal tissue. 93. A process, subprocess, apparatus, or system for dynamically coupling an ultrasonic transmitter/receiver to a skull of a patient such that the process, subprocess, apparatus, or system creates an ultrasonic image of brain tissue or blood vessels, comprising: a) positioning, adjacent the skull, a platform which comprises at least one suction port; b) coupling the platform to the patient by the application of suction to at least one suction port; and c) coupling the ultrasonic transmitter/receiver to the platform. 94. Each of embodiments of invention 93 in which the platform is shaped in at least a portion of a circular arc. 95. Each of embodiments of invention 93 in which the platform comprises at least two portions, each of which is shaped in at least a portion of a circular arc, the two portions being arranged generally opposite each other. 96. Each of embodiments of invention 93, further comprising adjusting the amount and/or location of acoustic coupling material between the ultrasonic transducer/receiver and the skull. 97. Any of the previous embodiments of inventions 1-96, embodied in a portable form suitable for mounting on the patient's head. 98. Any of the previous embodiments of inventions 1-97, in which the ultrasonic system is a portable system as disclosed (and especially as claimed) in any of the patents cited above that are assigned to Sonosite or ATL. 99. Any of the previous embodiments of inventions 1-97, in which the ultrasonic system uses techniques disclosed (and especially as claimed) in any of the patents cited above that are assigned to EchoCath, especially EchoFlow. 100. Any of the previous embodiments of inventions 1-99, in which the image processor includes an expert system. 101. Any of the previous embodiments of inventions 1-100, in which the image processor includes a neural network.