ADJUSTABLE HEADPIECE WITH ANATOMICAL MARKERS AND METHODS OF USE THEREOF
The invention generally relates to an adjustable headpiece with anatomical markers and methods of use thereof. In certain embodiments, the invention provides an apparatus that includes a headpiece configured to be worn on a head of a user. The headpiece includes at least a first receptacle configured to receive and retain a first energy source, and the headpiece is adjustable in at least one direction. There is at least one anatomical marker coupled to the headpiece. In that manner, a position of the receptacle can be adjustably aligned to a region of neural tissue in the head based on an alignment of the at least one anatomical marker with its designated anatomical structure.
The present application claims the benefit of and priority to U.S. provisional application Ser. No. 62/069,476, filed Oct. 28, 2014, the content of which is incorporated by reference herein in its entirety.
FIELD OF THE INVENTIONThe invention generally relates to an adjustable headpiece with anatomical markers and methods of use thereof.
BACKGROUNDThere has been a rapid increase in the application of stimulation devices to treat a variety of pathologies, particularly neuropathologies. FDA approved therapies already include treatments for disorders such as Parkinson's disease, depression, and epilepsy, and the number of indications being explored is growing exponentially. Effective electromagnetic stimulation techniques alter the firing patterns of cells by applying electromagnetic energy to electrically responsive cells, such as neural cells. The stimulation may be applied invasively, e.g., by performing surgery to remove a portion of the skull and implanting electrodes in a specific location within brain tissue, or non-invasively, e.g., transcranial direct current stimulation or transcranial magnetic stimulation. Other forms of energy can also be used to stimulate tissue, both invasively and noninvasively.
Non-invasive stimulation requires that the stimulation source be precisely positioned on the scalp so that the stimulation can be focused on a particular structure or structures in the brain. Traditionally, trial and error was used until the desired response (finger twitch) was generated. That process involved moving the non-invasive stimulation source along the head until the stimulation source stimulated the structure in the brain that caused the desired response. For example, a finger twitch indicated that the stimulation source was positioned to stimulate the motor cortex. In another approach, a non-invasive stimulation source is positioned over the head using external landmarks and measurements. That process involves a technician using a tape measure to measure from an external landmark on a subject's head to the desired location on the head that corresponds with where the particular structure within the brain is located. The measuring process is repeated from different markers to get a precise location for placement of the stimulation source. The measuring approach is not only cumbersome, it also requires that a subject be re-measured every time they come in for treatment.
More recently, imaging sources have been used to facilitate positioning of the stimulation source. In that approach, the non-invasive stimulation source is navigated and positioned over a specified target location based upon feedback from the imaging source, such as a subject's MRI image. However, it is costly to us imaging data to facilitate placement of the stimulation source, and requires a technician to have access to expensive imaging instruments, such as an MRI machine. Furthermore, reliance on imaging data for positioning of the stimulation source means that a subject must always come to a physician's office for stimulation.
SUMMARYThe invention provides a stimulation apparatus that is custom fit to a user's head and that allows for stimulation to be effectively targeted (localized) to a desired region of neural tissue. Aspects of the invention are accomplished using a headpiece configured to be worn on a head of a user. The headpiece includes at least a first receptacle configured to receive and retain a first energy source, and the headpiece is adjustable in at least one direction. There is at least one anatomical marker coupled to the headpiece. The apparatus is configured such that a position of the receptacle can be adjustably aligned to a region of neural tissue in the head based on an alignment of the at least one anatomical marker with its designated anatomical structure. Once the proper alignment is achieved, the configuration of the headpiece is locked in place. Accordingly, the apparatus is customized to a subject's head and repeatably and reliably positions a non-invasive stimulation source at a proper location on the subject's head for stimulation of a particular brain structure. In that manner, a subject does not need to be re-measured for each stimulation session, because the apparatus has been custom fit to the user's head. That saves the subject time during subsequent stimulation sessions and the reproducibility of the targeting makes it easy to effectively dose the stimulation and characterize safety parameters. Furthermore, once custom fit, imaging data is not required for positioning of the stimulation source in subsequent stimulation sessions, so the subject can receive stimulation outside of a physician's office.
In certain embodiments, the apparatus includes the first energy source that is configured to connect to the receptacle. The connection may be a permanent connection or a releasable connection.
Another aspect of the invention provides an apparatus that includes a headpiece configured to be worn on a head of a user. The headpiece includes a first energy source, and the headpiece is adjustable in at least one direction. At least one anatomical marker is coupled to the headpiece so that a position of the first energy source can be adjustably aligned to a region of neural tissue in the head based on an alignment of the at least one anatomical marker with its designated anatomical structure.
For either of the above aspects, the apparatuses may additionally include a locking mechanism that locks adjustability of the headpiece to prevent further adjustment of the headpiece while the apparatus is being worn on the head of the user. Generally, the headpiece is adjustable in a plurality of different directions. For example, the headpiece is adjustable in at least a vertical direction and/or a horizontal direction.
Positioning of the first energy source may be accomplished using only a single anatomical marker. However, for either of the above aspects, the apparatuses may include a plurality of anatomical markers, each marker being coupled to the headpiece. The markers can be located about the headpiece in any configuration and at any angle to one another. In certain embodiments, at least two of the markers are arranged about the headpiece to be perpendicular to each other. In other embodiments, at least two of the markers are arranged about the headpiece to be 180 degrees with respect to each other. In certain embodiments, the markers are configured such that at least two of the markers are arranged about the headpiece to be perpendicular to each other, and at least two of the markers are arranged about the headpiece to be 180 degrees with respect to each other. More than one marker may be advantageous over a single marker embodiment because it may allow for more accurate positioning of the stimulation sources. In a preferred embodiment, three or more markers are used so that the stimulation sources may be triangulated for precise locating, based on the three markers.
Stimulation can be achieved with only a single energy source. However, for either of the above aspects, more than one energy source may be used to achieve stimulation of the neural tissue. In that manner, apparatuses of the invention may include a second receptacle for a second energy source, or more than two receptacles and/or energy sources.
Any type of energy sources known in the art may be used with apparatuses of the invention. Exemplary types of energy sources include mechanical, optical, electromagnetic, thermal, or a combination thereof. In particular embodiments, the energy source is a mechanical source, such as an ultrasound device. In other embodiments, the energy source is an electrical source. In other embodiments, the energy source is a magnetic source. Other exemplary types of energy sources include Transcranial Direct Current Stimulation (TDCS), Transcranial Ultrasound (TUS), Transcranial Doppler Ultrasound (TDUS), Transcranial Electrical Stimulation (TES), Transcranial Alternating Current Stimulation (TACS), Cranial Electrical Stimulation (CES), or Transcranial Magnetic Stimulation (TMS). In other embodiments, the stimulation is provided by a combination of two energy sources, such as an electric source and a mechanical source. In other embodiments, the stimulation is a combination of Transcranial Ultrasound (TUS) and Transcranial Direct Current Stimulation (TDCS).
Another aspect of the invention provides an apparatus that includes a headpiece configured to be worn on a head of a user. The headpiece includes a first receptacle configured to receive and retain a first energy source and a second receptacle configured to receive and retain a second energy source, and the headpiece is adjustable in a plurality of different directions. At least three anatomical markers are coupled to the headpiece, in which a first anatomical marker is a nasion marker, a second anatomical marker is an inion marker, and a third anatomical marker is a first tragus marker. The apparatus is configured so that a position of at least one of the receptacles can be adjustably aligned relative to a region of neural tissue in the head based on an alignment of the at least three anatomical markers with their designated anatomical structures. In certain embodiments, the apparatus includes the first and second energy sources, and any of the above sources may be used with this aspect of the invention. The first and second energy sources are configured to connect to the receptacle. The connection may be a permanent connection or a releasable connection. In certain embodiments, the first receptacle is adjustably coupled to the headpiece and the second receptacle is non-adjustably coupled to the headpiece.
In certain embodiments, the apparatus further includes a fourth anatomical marker, such as a second tragus marker. In such embodiments, the first tragus marker aligns to one side of the head and the second tragus marker aligns to the other side of the head. In other embodiments, the apparatus further includes a fifth anatomical marker, such as a CZ marker. In certain embodiments, the apparatus additionally includes a locking mechanism that locks adjustability of the headpiece to prevent further adjustment of the headpiece while the apparatus is being worn on the head of the user.
The invention generally relates to an adjustable headpiece with anatomical markers and methods of use thereof. An exemplary embodiment of an apparatus of the invention is shown in
As shown in
As will be discussed in other embodiments below, two stimulation sources is only exemplary, and apparatuses of the invention require only a single stimulation source, but can include more than one stimulation source, such as two, three, four, five, etc. stimulation sources. In the exemplary embodiment shown in
Receptacles 103 and 104 shown in
A tightening knob 103e connects to the hinged cover 103a and locks the micro adjust ball joint 103c in place in the receptacle 103. The micro adjust positioning system can be adjusted and then fixed with any fixing mechanism, such as a screw mechanism, either for use during a single use, multiple uses, or permanently. When not permanently fixed, the system could be adjusted again later through the same process for additional use such as for example at a different location and/or for a different subject. The first stimulation source 114 (e.g., an ultrasound probe) can be fixed to the micro adjust ball through connector mechanism 103f which may or may not be releasable. By having a separate fixing mechanism for the micro adjust ball 103c and the first stimulation source 114 (e.g., an ultrasound probe), one could have the ability to fix the position of the micro adjust ball 103c, and thus the stimulation source, and keep that position fixed while still being able to remove the first stimulation source from the receptacle 103. This for example could allow a care provider to tune the device fitting for a patient by locking the micro adjust positioning system and still being able to remove and exactly replace the first stimulation source 114. In an alternate embodiment, a tightening apparatus could be used to fix both the micro adjust ball and the first stimulation source. In an alternate embodiment, the micro adjust ball 103c is not used, and the ultrasound source is fit to a fixed component of the receptacle. In alternate embodiments, the first stimulation source 114 and the parts of the receptacle that connect to it are not used in receptacle 103, and only the second stimulation source 115 is used.
Additionally, stimulation source 114 (e.g., an ultrasound probe), can include a connector mechanism 114a that interacts with connector mechanism 103f to secure stimulation source 114 to receptacle 103. For example, connector mechanism 103f is an indentation and connector mechanism 114a is a corresponding protrusion. The protrusion couples into the indentation, thereby locking the stimulation source 114 into place. The locking can be permanent or releasable.
Turning back to
As shown in
Bridging mediums can be used in connect with one or both stimulation/energy sources. Any bridging medium known in the art can be used with apparatuses of the invention and the bridging medium chosen will depend on the type of stimulation/energy source used. Bridging mediums and their use are further described for example in Wagner et al. (U.S. Pat. No. 8,718,758), the content of which is incorporated by reference herein in its entirety.
In receptacle 104 there are two different bridging mediums 117-118. In the embodiment shown in
The descriptions above regarding the receptacles and stimulation/energy sources is only exemplary. Any type of stimulation source (i.e., energy source) known in the art may be used with apparatuses of the invention. Exemplary types of energy sources include mechanical, optical, electromagnetic, thermal, or a combination thereof. In particular embodiments, the energy source is a mechanical source, such as an ultrasound device. In other embodiments, the energy source is an electrical source. In other embodiments, the energy source is a magnetic source. Other exemplary types of energy sources include Transcranial Direct Current Stimulation (TDCS), Transcranial Ultrasound (TUS), Transcranial Doppler Ultrasound (TDUS), Transcranial Electrical Stimulation (TES), Transcranial Alternating Current Stimulation (TACS), Cranial Electrical Stimulation (CES), Transcranial Pulsed Stimulation, or Transcranial Magnetic Stimulation (TMS). In other embodiments, the stimulation is provided by a combination of two energy sources, such as an electric source and a mechanical source. In other embodiments, the stimulation is a combination of Transcranial Ultrasound (TUS) and Transcranial Direct Current Stimulation (TDCS).
In the embodiment shown in
Headpiece 101 includes at least three anatomical markers. As discussed below, three anatomical markers is only exemplary, and apparatuses of the invention can have only a single anatomical marker, or can have more than one anatomical marker, such as two, three, four, five, six, seven, eight, nine, ten, etc. The apparatus shown in
The anatomical markers shown in
Additionally, apparatuses of the invention can use less than three or more than three anatomical markers. For example, the fixation of the headpiece based on the 3 anatomical markers, and fixed angles of components of the headpiece, it can be assumed that the tragus on the left side of the head is symmetrical with the tragus on the right side of the head (
In certain embodiments, the placement of the anatomical marker(s), or other connected components of the headpiece, are controlled by mathematical functions which are used to determine relative or fixed positions of other components, such as based on predetermined relative or fixed angles or distances (such as for example moving a component of the device along 20% along a line defined from the tragus to CZ at the midline between inion and nasion). While this information is preferably determined directly based on marker position and patient head characteristics, other information such as imaging and physiological measurements can be used as part of these mathematical functions. Furthermore, in alternative embodiments a separate marker could be placed as a mathematical function based on the characteristics of the anatomical markers.
More than one marker can be advantageous over a single marker embodiment because it may allow for more accurate positioning of the stimulation sources (and important when using a stimulation source that is not mono-polar, or requires information about the position, angle, and relative placement of a source). In a preferred embodiment, three or more markers are used so that the stimulation sources may be triangulated for precise locating, based on the three markers. In an alternative design four markers or more may be used. A system based on three markers or more markers is important to define a unique and reproducible coordinate system on a patients head that is receiving stimulation (although 4 points is better to define a unique 3 dimensional space, an exemplary headpiece described herein uses the fixed angles of the head piece and the fitting procedure to define a reproducible coordinate space on the stimulation subject's head (for example, by using the headpiece described in
As shown ins
In certain embodiments, each point of adjustability may include a locking mechanism. However, if two points of adjustability intersect, a single locking mechanism can function to lock both of those points of adjustability. Once the proper alignment is achieved, the configuration of the headpiece is locked in place. Accordingly, the apparatus is customized to a subject's head and repeatably and reliably positions a non-invasive stimulation source at a proper location on the subject's head for stimulation of a particular brain structure. In that manner, a subject does not need to be re-measured for each stimulation session, because the apparatus has been custom fit to the user's head. That saves the subject time during subsequent stimulation sessions and the reproducibility of the targeting makes it easy to effectively dose the stimulation and characterize safety parameters. Furthermore, once custom fit, imaging data is not required for positioning of the stimulation source in subsequent stimulation sessions, so the subject can receive stimulation outside of a physician's office. Furthermore, in certain embodiments, imaging data is not needed and stimulation to certain brain areas can be determined based on customizing the fits of the device to the patient (such as for example providing anodal tDCS to a patient's primary motor cortex while fixing the cathode above the contralateral orbital).
In other embodiments, there is no locking mechanism because it is an optional component of the apparatuses of the invention. That is, apparatuses of the invention can function without the locking mechanism, but such embodiments require that a technician or user to check the apparatus to ensure that the stimulation sources are properly aligned prior to their use.
In certain embodiments, imaging may be used to guide fine tuning of adjustability of the headpiece prior to it being locked into a fixed configuration, to assess the use of the device after it is locked into place during the time when it is being used, and/or to assess the use of the device after it is locked into place and after it has been used. Imaging to guide placement of stimulation/energy sources on a head is described for example in, Wagner et al., (U.S. patent application publication number 2011/0275927), the content of which is incorporated by reference herein in its entirety.
In other embodiments, the filtering properties of the neural tissue within the head are used to guide fine tuning of adjustability of the headpiece prior it being locked into a fixed configuration, which can be optionally done in conjunction with imaging. Calculating and tuning stimulation based on filtering properties (e.g., mechanical and/or electrical filtering properties) of tissue is described for example, Wagner et al., (U.S. patent application publication number 2012/0226200), the content of which is incorporated by reference herein in its entirety.
In other embodiments, the device can be coupled to a source or sources that provide sensory signals to the wearer, such as devices which provide visual, auditory, tactile, smell, and/or taste stimuli, for example the device might simply be coupled to a light source, which for example could provide a light signal to a patient (such as certain light to sooth the patient during stimulation), or coupled to a sound source which provides a signal to adjust the level of alertness of a patient, or coupled to multiple sensory information such as a virtual reality system.
While as described above, any material which is safe and efficacious can be used for the design of the headpiece, in alternative embodiments the device could be designed entirely out of materials compatible with imaging systems (such MRI compatible materials and/or materials compatible with imaging systems described in Wagner et al. (U.S. patent application publication number 2011/0275927)). This would allow one to wear the device during imaging, whether for stimulation while undergoing imaging or to simply analyze the imaging data with the headpiece in place (even when stimulation is not being given). The headpiece could also be integrated with registration/ marker materials (such as for example vitamin E pellets for MRI, air filled tubes for MRI, metallic pellets for MRI, metallic pellets for CT, Gallium-68 for PET, Co-57 for SPECT, etc.) to be able to localize the relative location of the headpiece and stimulation sources to head and/or brain targets. The headpiece can also be coupled with other physiological measurement methods, such as those described in described in Wagner et al. (U.S. patent application publication number 2011/0275927). When both recording (imaging and/or physiological measurement methods) and stimulation systems are used, the recording and stimulation systems could be coupled, such as through an analysis circuit or computational system, to provide further control of stimulation or to focus the recording system. The coupling circuit and/or analysis circuit could be housed in one of the receptacles or in a component of the headpiece.
The device can be designed using mechanical hand-operated parts and/or developed with automation technology, such as with control circuitry, robotic components, and/or transduction mechanisms. These components can be used to control any part of the device use, from placement to relative measurements between different anatomical markers.
In alternative embodiments the system can be designed so all or part of the stimulation source power components and control electronics are housed in the receptacles or other parts of the headpiece, so there is no need for wire connectivity, and or the device could be worn while moving and/or performing other activities which would be prevented from having external wired connections. A control system could further be connected to the system through a telecommunications device, such as for Bluetooth or wi-fi control (such as through a cell phone or personal computer device), such as described above. In certain embodiments, computational components, power components, storage, read, and/or write circuitry can be integrated into the device.
In certain embodiments, the headpiece can make use of a component(s) which combines a receptacle(s) and anatomical marker(s) such that they are not separate in form and/or function or that they housed together in a similar coupling structure, such as for example stimulation can take place at one of the anatomical marker points as might be the case for an occipital lobe directed stimulation placed from an inion point.
As already mentioned, the above is an exemplary embodiment of the invention.
While the device is preferably designed to be used with human subjects, alternative embodiments entail adapting the technology for other species, e.g., other primates, such as monkeys.
In alternative embodiments, a headpiece could be worn to allow for pre-surgical evaluation prior to deep brain stimulation surgery. For example, by wearing the headpiece and allowing an operator to adjust the positioning of the stimulator until a patient maintains an ideal and/or improved response to stimulation, the headpiece could be used in helping identify the proper brain stimulation targets.
Incorporation by ReferenceReferences and citations to other documents, such as patents, patent applications, patent publications, journals, books, papers, web contents, have been made throughout this disclosure. All such documents are hereby incorporated herein by reference in their entirety for all purposes.
EquivalentsThe invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The foregoing embodiments are therefore to be considered in all respects illustrative rather than limiting on the invention described herein.
Claims
1. An apparatus comprising:
- a headpiece configured to be worn on a head of a user and comprising at least a first receptacle configured to receive and retain a first energy source, the headpiece being adjustable in at least one direction; and
- at least one anatomical marker coupled to the headpiece so that a position of the receptacle can be adjustably aligned to a region of neural tissue in the head based on an alignment of the at least one anatomical marker with its designated anatomical structure.
2. The apparatus according to claim 1, further comprising the first energy source.
3. The apparatus according to claim 1, wherein the headpiece is adjustable in a plurality of different directions.
4. The apparatus according to claim 3, wherein the headpiece is adjustable in a vertical direction and a horizontal direction.
5. The apparatus according to claim 1, the apparatus comprises a plurality of anatomical markers, each marker being coupled to the headpiece.
6. The apparatus according to claim 5, wherein at least two of the markers are arranged about the headpiece to be perpendicular to each other.
7. The apparatus according to claim 6, wherein at least two of the markers are arranged about the headpiece to be 180 degrees with respect to each other.
8. The apparatus according to claim 1, further comprising a second receptacle for a second energy source.
9. The apparatus according to claim 8, the first energy source is a mechanical energy source and the second energy source is an electrical energy source.
10. The apparatus according to claim 1, wherein the first receptacle is configured to receive and releasably retain the first energy source.
11. An apparatus comprising:
- a headpiece configured to be worn on a head of a user and comprising a first receptacle configured to receive and retain a first energy source and a second receptacle configured to receive and retain a second energy source, the headpiece being adjustable in a plurality of different directions; and
- at least three anatomical markers coupled to the headpiece, wherein a first anatomical marker is a nasion marker, a second anatomical marker is an inion marker, and a third anatomical marker is a first tragus marker, and wherein the apparatus is configured so that a position of at least one of the receptacles can be adjustably aligned relative to a region of neural tissue in the head based on an alignment of the at least three anatomical markers with their designated anatomical structures.
12. The apparatus according to claim 11, further comprising the first and second energy sources.
13. The apparatus according to claim 12, wherein the first energy source is an ultrasound source and the second energy source is an electrical energy source.
14. The apparatus according to claim 13, wherein the first receptacle is adjustably coupled to the headpiece and the second receptacle is non-adjustably coupled to the headpiece.
15. The apparatus according to claim 11, wherein the headpiece is adjustable in a vertical direction and a horizontal direction.
16. The apparatus according to claim 11, further comprising a fourth anatomical marker.
17. The apparatus according to claim 16, wherein the fourth marker is a second tragus marker.
18. The apparatus according to claim 17, wherein the first tragus marker aligns to one side of the head and the second tragus marker aligns to the other side of the head.
19. The apparatus according to claim 16, further comprising a fifth anatomical marker, wherein the fifth marker is a CZ marker.
20. The apparatus according to claim 11, further comprising a locking mechanism that locks adjustability of the headpiece to prevent further adjustment of the headpiece while the apparatus is being worn on the head of the user.
21-29. (canceled)
Type: Application
Filed: Sep 30, 2015
Publication Date: Oct 19, 2017
Inventors: Timothy Andrew Wagner (Somerville, MA), William Edelman (Sharon, MA), Laura Dipietro (Cambridge, MA), Paul James Mulhauser (New York, NY), Kyungmin Andy Lee (New York, NY)
Application Number: 15/507,994