FLEXIBLE BRAIN PROBE OVER GUIDEWIRE
20200375461 ยท 2020-12-03
Inventors
Cpc classification
A61B2560/0223
HUMAN NECESSITIES
International classification
A61B5/00
HUMAN NECESSITIES
Abstract
In one embodiment, a brain probe system includes a guidewire configured to be inserted into blood vessels of a brain of a living subject, a flexible tube having a lumen sized to fit around the guidewire, the lumen being configured to slide axially over the guidewire so that a length of the lumen surrounds a length of the guidewire in the blood vessels of the brain, the flexible tube including a distal end, and at least one bipolar electrode pair disposed in the distal end of the flexible tube, and configured to detect signals indicative of respective electrical activity of the brain at respective locations in the blood vessels of the brain.
Claims
1. A brain probe system, comprising: a guidewire configured to be inserted into blood vessels of a brain of a living subject; a flexible tube having a lumen sized to fit around the guidewire, the lumen being configured to slide axially over the guidewire so that a length of the lumen surrounds a length of the guidewire in the blood vessels of the brain, the flexible tube including a distal end; and at least one bipolar electrode pair disposed in the distal end of the flexible tube, and configured to detect signals indicative of respective electrical activity of the brain at respective locations in the blood vessels of the brain.
2. The system according to claim 1, wherein the flexible tube includes at least one groove therein in which the at least one bipolar electrode pair are disposed.
3. The system according to claim 1, further comprising a tracking subsystem including a location tracking sensor comprised in the distal end of the flexible tube, and configured to track the locations of the at least one bipolar electrode pair in the blood vessels.
4. The system according to claim 3, wherein the tracking subsystem includes a location pad having at least one magnetic field radiator configured to transmit alternating magnetic fields into a region where the brain is located, the location tracking sensor including a coil to detect at least part of the transmitted alternating magnetic fields.
5. The system according to claim 3, wherein the flexible tube includes a groove therein in which the location tracking sensor is disposed.
6. The system according to claim 3, wherein the location tracking sensor includes a coil.
7. The system according to claim 3, further comprising processing circuitry configured to generate an electroanatomic map of the brain providing a representation of the respective electrical activity of the brain at the respective tracked locations.
8. The system according to claim 7, wherein the electroanatomic map is a volumetric map of the respective electrical activity of the brain at the respective locations.
9. The system according to claim 1, wherein the electrical activity of the brain at each of the respective locations is detected without using electrodes applied outside of the blood vessels.
10. The system according to claim 1, wherein the flexible tube is magnetic resonance imaging (MRI) compatible.
11. The system according to claim 1, further comprising an optical fiber and lens connected to the flexible tube to capture images in the brain.
12. The system according to claim 1, further comprising an irrigation pump configured to pump irrigation fluid via the lumen of the flexible tube into the brain.
13. The system according to claim 1, wherein the flexible tube includes a distal portion of at least 5 cm in length, wherein at least the distal portion of the flexible tube has a maximum outer diameter of 3 mm.
14. The system according to claim 1, wherein the guidewire includes a distal end, the system further comprising a tracking subsystem including a location tracking sensor comprised in the distal end of the guidewire, and configured to track a position of the distal end of the guidewire.
15. A brain probing method, comprising: inserting a guidewire into blood vessels of a brain of a living subject; axially sliding a lumen of a flexible tube over the guidewire in the blood vessels of the brain so that a length of the lumen surrounds a length of the guidewire in the blood vessels of the brain; and detecting signals indicative of respective electrical activity of the brain at respective locations in the blood vessels of the brain using at least one bipolar electrode pair disposed in the distal end of the flexible tube.
16. The method according to claim 15, further comprising removing the guidewire from the brain while leaving the flexible tube in the blood vessels of the brain.
17. The method according to claim 15, further comprising tracking the locations of the at least one bipolar electrode pair in the blood vessels using a location tracking sensor comprised in the distal end of the flexible tube.
18. The method according to claim 17, further comprising: transmitting alternating magnetic fields into a region where the brain is located; and detecting at least part of the transmitted alternating magnetic fields with a coil of the location tracking sensor.
19. The method according to claim 17, further comprising generating an electroanatomic map of the brain providing a representation of the respective electrical activity of the brain at the respective tracked locations.
20. The method according to claim 19, wherein the electroanatomic map is a volumetric map of the respective electrical activity of the brain at the respective locations.
21. The method according to claim 15, wherein the electrical activity of the brain at each of the respective locations is detected without using electrodes applied outside of the blood vessels.
22. The method according to claim 15, further comprising capturing images of the brain using an optical fiber and lens connected to the flexible tube.
23. The method according to claim 15, further comprising pumping irrigation fluid via the lumen of the flexible tube into the brain.
24. The method according to claim 15, further comprising tracking a position of the distal end of the guidewire.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0038] The present invention will be understood from the following detailed description, taken in conjunction with the drawings in which:
[0039]
[0040]
[0041]
[0042]
[0043]
[0044]
[0045]
DESCRIPTION OF EXAMPLE EMBODIMENTS
Overview
[0046] EEG (electroencephalograph) signals may be measured by applying electrodes to a patient's head. EEG signals may be used to give a first approximation to locations originating brain activity, but deriving these locations is difficult computationally, and is also relatively inexact.
[0047] Additionally, there are many conditions, such as Parkinson's disease, tinnitus, deep depression, sudden seizures, which may be caused by some defect in the functioning of the brain. Present systems use external electrodes attached to the patient's head to acquire EEG signals, but these signals do not provide sufficient detail of brain functioning.
[0048] Embodiments of the present invention provide a system to measure brain activity more accurately, using a flexible tube, which is inserted into blood vessels of the brain over a pre-inserted guidewire such that a length of a lumen of the flexible tube surrounds a length of the guidewire. Once the flexible tube has been inserted into the blood vessels of the brain, the guidewire may optionally be removed. The tube is dimensioned to be inserted into the brain. In some embodiments, at least a distal portion of (at least 5 cm in length of) the flexible tube has a maximum outer diameter of about 3 mm. At least one pair of bipolar electrodes and a location tracking sensor may be disposed in a distal end of the flexible tube. The location tracking sensor may form part of a magnetic and/or electric tracking subsystem. In some embodiments, the flexible tube may be magnetic resonance imaging (MRI) compatible and/or designed to be atraumatic (e.g., no sharp edges or ends). Additionally, or alternatively, a fiber optic and lens arrangement may be connected to the flexible tube to capture images inside the blood vessels allowing analysis of features within the brain, for example, but not limited to, clots.
[0049] The bipolar electrode pair(s) captures electrical activity of the brain without the need to use head surface electrodes. Additionally, as the location of the flexible tube is accurately tracked, the electrical activity of the brain may be accurately mapped according to the respective locations of the respective electrical activity.
[0050] In particular, the flexible tube is inserted into, and moved around in, blood vessels of the brain of a living subject, and the bipolar electrode pair(s) detects signals indicative of respective electrical activity of the brain at respective locations in the blood vessels of the brain. The tracking subsystem tracks the locations of the bipolar electrode pair(s) in the blood vessels and processing circuitry generates an electroanatomic brain map providing a representation of the respective electrical activity of the brain at the respective tracked locations. In some embodiments, the electroanatomic brain map is a volumetric (three-dimensional (3D)) map of the respective electrical activity of the brain at the respective locations.
[0051] While the brain is not a cyclic system like the heart, the generated electroanatomic brain map allows tracing, in time and space, of firing instances of the brain, illustrating for example firing during a seizure. The firing sequences may or may not be repeatable. In generating the electroanatomic brain map, the detected electrical activity may be processed to provide data other than firing instances, for example, but not limited to, conduction paths, bursts, irregularities, and/or underlying background activity. The various features of the electroanatomic brain map may be illustrated using any one or more of the following: colors, shading, arrows, lines, and/or annotations. The electroanatomic brain map may show areas of higher amplitude and/or more frequent electrical activity using a certain presentation scheme (e.g., thicker lines or arrows, darker colors or shading) and areas of lower amplitude and/or less frequent electrical activity using a certain presentation scheme (e.g., thinner lines or arrow, lighter colors or shading).
[0052] The electroanatomic brain map may allow drilling down to different sections of the electroanatomic brain map and/or viewing different slices of the electroanatomic brain map. In some embodiments, the electroanatomic brain map may be represented as a shell (e.g. a type of skeletal structure or translucent map) so that inner features of the map may also be visible from the outside of the brain.
[0053] The electroanatomic brain map may be particularly useful, for example, in investigating patients with recurring problems, such as those with chronic pain, tinnitus, and/or seizures, where extra activity of certain areas of the brain is suspected. Areas of the brain which, on a relative basis, are more active can be further investigated at a higher resolution, and the map of such areas may be helpful in treating the patient.
System Description
[0054]
[0055] In some embodiments, prior to performing the procedure, CT images of a patient 32 are acquired. The CT images are stored in a memory 42 for subsequent retrieval by processing circuitry 40. The processing circuitry 40 uses the images to present, for example, a brain section image 59 on a display 56. During the disclosed procedure, tracking systems 20a and 20b register a position of a distal end of a guidewire (shown in
[0056] The position of the distal end of the flexible tube 28 and/or the guidewire may be tracked using a magnetic tracking subsystem 23, which tracks position and orientation coordinates of a magnetic sensor fitted at the distal ends. The magnetic tracking subsystem 23 may form part of a tracking subsystem 33. In some embodiments, the flexible tube 28 and/or the guidewire may be tracked using any suitable tracking system for example, but not limited to, an electrical based tracking system using multiple head surface electrodes (not shown) to track the position of the flexible tube 28 and/or the guidewire based on a signal emitted by an electrode of the flexible tube 28 and/or the guidewire.
[0057] Using magnetic position tracking subsystem 23, a physician 54 advances the distal end of the guidewire and/or the flexible tube 28 through blood vessels, usually arteries, to perform an invasive therapeutic procedure and/or to map electrical activity of the brain (described in more detail with reference to
[0058] In system 20a, shown in
[0059] Physician 54, operating system 20a, holds a controller handle 29, which is connected to the proximal end of flexible tube 28 and/or the guidewire. Controller handle 29 allows the physician to advance and navigate flexible tube 28 and/or the guidewire in the brain, for example, through an entry point 22 at an artery at a thigh of patient 32. As noted above and described below, physician 54 navigates the distal end of the guidewire and/or flexible tube 28 using position and orientation signals from a magnetic sensor fitted at the distal end of the guidewire and/or flexible tube 28. Console 50 receives the position signals through the cable 19 that connects to flexible tube 28 via handle 29.
[0060] Elements of system 20a, including radiators 26a, are controlled by processing circuitry 40, comprising a processing unit communicating with one or more memories (e.g., the memory 42). Processing circuitry 40 may be mounted in console 50, which comprises operating controls 58 that typically include a keypad and/or a pointing device such as a mouse or trackball. Physician 54 uses operating controls on handle 29 to interact with the processing circuitry 40 while performing the registration of system 20a. During the registration process, the brain section image 59 is presented on display 56. Subsequent to the registration process described above, physician 54 uses the operating controls to advance the distal end of the guidewire and/or the flexible tube 28 to one or more desired locations in the brain.
[0061] Processing circuitry 40 uses software stored in the memory 42 to operate system 20a. In practice, some or all of the functions of the processing circuitry 40 may be combined in a single physical component or, alternatively, implemented using multiple physical components. These physical components may comprise hard-wired or programmable devices, or a combination of the two. In some embodiments, at least some of the functions of the processing circuitry 40 may be carried out by a programmable processor under the control of suitable software. This software may be downloaded to a device in electronic form, over a network, for example. Alternatively, or additionally, the software may be stored in tangible, non-transitory computer-readable storage media, such as optical, magnetic, or electronic memory.
[0062] In some embodiments, the console 50 may also include an irrigation pump 35 for pumping irrigation fluid through a lumen of the flexible tube 28. In some embodiments, the console 50 may include a signal generator 37.
[0063] System 20b, shown in
[0064] Systems 20a and 20b shown in
[0065] Carto magnetic tracking systems, which track a location and orientation of a magnetic position sensor in an organ of a body using techniques similar to those applied by systems 20a and 20b, are produced by Biosense-Webster (Irvine, Calif.). In general, position sensing using current distribution measurements and/or external magnetic fields are described in detail in U.S. Pat. Nos. 5,391,199, 6,690,963, 6,484,118, 6,239,724, 6,618,612, 6,332,089, 7,756,576, 7,869,865, and 7,848,787, in PCT Patent Publication WO 96/05768, and in U.S. Patent Application Publications 2002/0065455 A1, 2003/0120150 A1 and 2004/0068178 A1.
[0066] Reference is now made to
[0067] The guidewire 60 may be formed from any suitable materials or mixture of materials, such as a metal spiral and/or a solid rod core-wire, which may include one or more surface channels cut into the surface of the solid rod core-wire for accepting electrical wires to connect to the location tracking sensor 62. In some embodiments, the surface channel(s) spirals around the core wire away from the distal end towards the proximal end of the guidewire 60. The solid rod core-wire may be formed from any suitable material for example, but not limited to, stainless steel, cobalt chromium or nitinol. The guidewire 60 may have any suitable length. In some embodiments, the guidewire 60 has a length in the range of 1-3 meters, for example about 2 meters. The guidewire 60 may have any suitable outer diameter. In some embodiments the guidewire 60 may have an outer diameter in the range of 200-900 microns, for example, 300 microns. The distal end of the guidewire 60 may be tapered or rounded, for example, by grinding the distal end.
[0068] A shrink-sleeve (not shown) may be disposed over the guidewire 60. The shrink-sleeve helps retain electrical wires in the surface channel. The shrink-sleeve may be formed from any suitable material, for example, a polyethylene terephthalate (PET) or a fluoropolymer. The shrink-sleeve typically covers the guidewire 60 for its entire length. In some embodiments, the shrink-sleeve may only partially cover the guidewire 60.
[0069] The location tracking sensor 62 may comprise a coil, for example, a wound coil. The coil may have any suitable diameter, for example, between 0.5 mm and 1 mm, and in some embodiments, 0.65 mm. The coil may include any suitable insulated wire. In some embodiments, the coil is wound from insulated copper wire around the distal end 61. The distal end 61 may have a slightly smaller outer diameter than the rest of the guidewire 60 in order that the wound coil is about level with the rest of the surface of the guidewire 60. The gauge of the wire may be any suitable gauge. In some embodiments, the wire is 60-gauge insulated copper wire, which has an outer diameter of about 8 microns. The coil is covered with any suitable cover, for example, but not limited to, the shrink sleeve described above, a plastic cover such as a plastic tube, or with a coating such an as enamel or epoxy paint, shrink sleeve, or metal cover. A metal cover may also provide shielding from high frequency electromagnetic interference.
[0070] Reference is now made to
[0071] The flexible tube 28 includes a lumen 63 extending from a proximal end to a distal end 64 of the flexible tube 28. The lumen 63 is sized to fit around the guidewire 60 (as shown in
[0072] The tracking subsystem 33 (
[0073] In some embodiments, the coil is disposed beneath an outer casing of the flexible tube 28 and is generally disposed coaxially with the flexible tube 28. The coil may have any suitable diameter. The coil may include any suitable insulated wire. In some embodiments, the coil is wound from insulated copper wire. The gauge of the wire may be any suitable gauge. In some embodiments, the wire is 60-gauge insulated copper wire, which has an outer diameter of about 8 microns. The coil is covered with any suitable cover, for example, but not limited to, a shrink sleeve, a plastic cover such as a plastic tube, with a coating such an as enamel or epoxy paint, or a metal cover. A metal cover may also provide shielding from high frequency electromagnetic interference.
[0074] The bipolar electrode pair(s) 66 are disposed in the distal end 64 of the flexible tube 28. The bipolar electrode pair(s) 66 are configured to detect signals indicative of respective electrical activity of the brain at respective locations in the blood vessels of the brain. The flexible tube 28 may include at least one groove therein in which the bipolar electrode pair(s) 66 are disposed. Each electrode may be crimped or otherwise attached to the flexible tube 28. The flexible tube 28 may have any suitable number of bipolar electrode pairs 66. The bipolar electrode pairs 66 may detect signals indicative of electrical activity in the brain without having to use body/head surface electrodes for detecting the electrical activity. In some embodiments, body/head surface electrodes may be used as part of the tracking subsystem 33 to track a location of the bipolar electrode pair(s) 66 of the flexible tube 28. The bipolar electrode pair(s) 66 may be composed of any suitable material for example, but not limited to, platinum-iridium alloy. The electrodes may have any suitable width, for example, in a range of 0.2 mm to 0.6 mm, and typically 0.4 mm.
[0075] An optical fiber 67 and a lens 68 may be connected to the flexible tube 28 to capture images in the brain. In other embodiments, the optical fiber 67 and lens 68 are optional. The optical fiber 67 and wires connected to the location tracking sensor 65 and the bipolar electrode pair(s) 66 may be fed down the lumen 63 and attached to the wall of the lumen 63 using any suitable adhesive.
[0076] The irrigation pump 35 (
[0077] Reference is now made to
[0078] Reference is now made to
[0079] The bipolar electrode pairs 66 may then be moved by moving the distal end 64 of the flexible tube 28 around in the blood vessels of the brain. The bipolar electrode pair(s) 66 are configured to detect (block 73) signals indicative of respective electrical activity of the brain at respective locations in the blood vessels of the brain. The electrical activity of the brain at each of the respective locations is generally detected without using electrodes applied outside of the blood vessels (e.g., on the surface of the scalp). The tracking subsystem 33 (
[0080] While the brain is not a cyclic system like the heart, the generated electroanatomic map 77 allows tracing, in time and space, of firing instances of the brain, illustrating for example firing during a seizure. The firing sequences may or may not be repeatable. In generating the electroanatomic map 77, the detected electrical activity may be processed to provide data other than firing instances, for example, but not limited to, conduction paths, bursts, irregularities, and/or underlying background activity. The various features of the electroanatomic map 77 may be illustrated using any one or more of the following: colors, shading, arrows, lines, and/or annotations. The electroanatomic map 77 may show areas of higher amplitude and/or more frequent electrical activity using a certain presentation scheme (e.g., thicker lines or arrows, darker colors or shading) and areas of lower amplitude and/or less frequent electrical activity using a certain presentation scheme (e.g., thinner lines or arrow, lighter colors or shading).
[0081] The electroanatomic map 77 may allow drilling down to different sections of the electroanatomic map 77 and/or viewing different slices of the electroanatomic map 77. In some embodiments, the electroanatomic map 77 may be represented as a shell (e.g. a type of skeletal structure or translucent map) so that inner features of the map 77 may also be visible from the outside of the brain.
[0082] The electroanatomic map 77 may be particularly useful, for example, in investigating patients with recurring problems, such as those with chronic pain, tinnitus, and/or seizures, where extra activity of certain areas of the brain is suspected. Areas of the brain which, on a relative basis, are more active can be further investigated at a higher resolution, and the map of such areas may be helpful in treating the patient. In some embodiments, the mapping is performed during an episode where abnormal brain activity is suspected, for example, during a seizure, during a spell of depression, or in response to a trigger which is suspected to produce some detectable brain activity.
[0083] As used herein, the terms about or approximately for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, about or approximately may refer to the range of values 20% of the recited value, e.g. about 90% may refer to the range of values from 72% to 108%.
[0084] Various features of the invention which are, for clarity, described in the contexts of separate embodiments may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment may also be provided separately or in any suitable sub-combination.
[0085] The embodiments described above are cited by way of example, and the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not disclosed in the prior art.