Eyewear-based System and Method to Mechanically Increase Intraocular Pressure
20230098038 · 2023-03-30
Inventors
- Abigail Osborne (Morgantown, WV, US)
- Emma Robertson (Lincoln University, PA, US)
- Ross Fontana (Winston-Salem, NC, US)
- Taylor Stump (Morgantown, WV, US)
- Hassan Alkhadrawi (Morgantown, WV, US)
- Jessica Allen (Gainesville, FL, US)
- Joel Palko (Morgantown, WV, US)
Cpc classification
A61B3/16
HUMAN NECESSITIES
A61B3/0075
HUMAN NECESSITIES
A61F9/00781
HUMAN NECESSITIES
A61F9/04
HUMAN NECESSITIES
International classification
A61B3/16
HUMAN NECESSITIES
A61B3/00
HUMAN NECESSITIES
Abstract
In one aspect, the present disclosure relates to an eyewear-based system and method comprised of an ocular compression device positioned around a user's head to compress the globes of a user's eyes using direct mechanical force to artificially elevate the user's intraocular pressure. An application of this system is to increase intraocular pressure in users with glaucoma or users who are at risk for glaucoma to assess novel biomarkers for glaucoma progression. The ocular compression device may be used in conjunction with an ocular imaging device, such as an optical coherence tomography angiography device, to characterize changes in the user's optic nerve head structure as a function of intraocular pressure. This abstract is intended as a scanning tool for purposes of searching in the particular art and is not intended to be limiting of the present disclosure.
Claims
1. An ocular compression device for wearing on the face of a user, comprising: a goggle body frame surrounding the eyes of the user wherein the goggle body frame has a transverse direction and a longitudinal direction; at least one spanner connected to the goggle body frame; at least one pressure probe connected to the at least one spanner; wherein the at least one spanner is adjustable in the transverse direction to align the at least one pressure probe with at least one eye of the user; and wherein the at least one pressure probe is adjustable in the longitudinal direction to contact the face of the user and apply extraocular pressure using mechanical force to elevate the intraocular pressure of at least one eye of the user.
2. The device of claim 1, wherein the goggle body frame is secured to the head of the user with a headband to provide fit for the head of the user.
3. The device of claim 1, wherein the goggle body frame is connected to a goggle body lining made of a soft material in contact with the face of the user to alleviate discomfort.
4. The device of claim 1, wherein the at least one pressure probe is adjacent to at least one lower globe of an eye or one upper globe of an eye.
5. The device of claim 1, wherein the ocular compression device is comprised of two spanners and two pressure probes such that each pressure probe is adjacent to the lower globe of each eye of the user.
6. The device of claim 1, wherein the ocular compression device is comprised of two spanners and two pressure probes such that each pressure probe is adjacent to the upper globe of each eye of the user.
7. The device of claim 1, wherein the ocular compression device is comprised of two spanners and two pressure probes such that each pressure probe is adjacent to the upper and lower globe of a single eye of the user.
8. The device of claim 1, wherein in the ocular compression device is comprised of four spanners and four pressure probes such that each pressure probe is adjacent to the upper and lower globe of each eye of the user.
9. The device of claim 1, wherein the spanner is comprised of a spanner housing and a spanner linear actuation subassembly.
10. The device of claim 1, wherein the pressure probe is comprised of a pressure probe housing, a pressure probe linear actuation subassembly, and an eye rest.
11. The device of claim 10, wherein the the eye rest is in the shape of an asymmetric crescent.
12. The device of claim 9, wherein the spanner linear actuation subassembly is manipulated manually by hand or automatically via an electric motor.
13. The device of claim 10, wherein the pressure probe linear actuation subassembly is manipulated manually by hand or automatically via an electric motor.
14. The device of claim 1, wherein the extraocular pressure is dynamic, static, or a combination thereof.
15. The device of claim 1, wherein the extraocular pressure imparts an intraocular pressure from about 5 mm Hg to about 60 mm Hg.
16. The device of claim 1, wherein the ocular compression device is used to screen the user for ocular hypertension, glaucoma, or a combination thereof.
17. The device of claim 1, wherein the goggle body frame is secured to the head of the user with a headband to provide fit for the head of the user; wherein the goggle body frame is connected to a goggle body lining made of a soft material in contact with the face of the user to alleviate discomfort; wherein the ocular compression device is comprised of two spanners and two pressure probes such that each pressure probe is adjacent to the lower globe of each eye of the user; wherein the spanner is comprised of a spanner housing and a spanner linear actuation subassembly; wherein the pressure probe is comprised of a pressure probe housing, a pressure probe linear actuation subassembly, and an eye rest; wherein the eye rest is in the shape of an axymmetric crescent; wherein the spanner linear actuation subassembly is manipulated manually by hand or automatically via an electric motor; wherein the spanner linear actuation subassembly is manipulated manually by hand or automatically via an electric motor; wherein the extraocular pressure is dynamic, static, or a combination thereof.
18. A method to elevate the intraocular pressure of at least one eye of a user, comprising: fitting an ocular compression device on the face of a user; manipulating at least one spanner connected to the ocular compression device in the transverse direction to align at least one pressure probe with at least one eye of the user; manipulating the at least one pressure probe connected to the at least one spanner in the longitudinal direction to contact the face of the user to apply extraocular pressure using mechanical force to elevate the intraocular pressure of at least one eye of the user.
19. The method of claim 18, wherein the application of extraocular pressure is used to screen the user for ocular hypertension, glaucoma, or a combination thereof.
20. The method of claim 18, wherein the extraocular pressure is dynamic, static, or a combination thereof.
21. A system for acquiring ocular data from a user, comprising: an ocular compression device; an ocular imaging device; a computing device; a controller, wherein the computing device is in electronic communication with the controller which is in electronic communication with the ocular compression device; wherein the computing device commands the controller to manipulate the ocular compression device to apply extraocular pressure by mechanical force to elevate the intraocular pressure of at least one eye of the user; and wherein the computing device commands the controller to manipulate the ocular imaging device to record ocular data for the at least one eye of the user for at least a portion of the time the mechanical force is applied to the at least one eye.
22. The system of claim 21, wherein the ocular imaging device performs optical coherence tomography, optical coherence tomography angiography, or a combination thereof.
23. The system of claim 21, wherein the system is used to screen the user for ocular hypertension, glaucoma, or a combination thereof.
24. The system of claim 21, wherein the extraocular pressure is dynamic, static, or a combination thereof.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present disclosure. Moreover, in the drawings, like reference numerals designate corresponding parts throughout the several views.
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DETAILED DESCRIPTION OF THE INVENTION
[0040] In one embodiment of the invention, an OCD 1 is comprised of a goggle body frame 2, at least one spanner 3, at least one pressure probe 4, a goggle body lining 5, and a headband 6 (see
[0041] In a nonlimiting example, the goggle body frame 2 houses a plurality of spanners 3 connected to a plurality of pressure probes 4, respectively (see
[0042] In a nonlimiting example, the goggle body frame 2 is comprised of a durable, semi-flexible material such as a polymer (see
[0043] In one embodiment of the invention, the OCD 1 is comprised of two spanners 3 connected to two pressure probes 4, respectively, to compress the lower globe 10 of both eyes of the user (see
[0044] In one embodiment of the invention, the OCD 1 is comprised of two spanners 3 connected to two pressure probes 4, respectively, to compress the upper globe 9 of both eyes of the user.
[0045] In one embodiment of the invention, the OCD 1 is comprised of one spanner 3 connected to one pressure probe 4, respectively, to compress the lower globe 10 of a single eye of the user (see
[0046] In one embodiment of the invention, the OCD 1 is comprised of two spanners 3 connected to two pressure probes 4, respectively, to compress the upper globe 9 and lower globe 10 of a single eye of the user.
[0047] In one embodiment of the invention, the OCD 1 is comprised of four spanners 3 connected to four pressure probes 4, respectively, to compress the upper globe 9 and lower globe 10 of both eyes of the user (see
[0048] For spatial reference, the longitudinal direction 7 is defined as the direction approximately normal to a local ocular region of the user. The transverse direction 8 is defined as the direction approximately normal to the longitudinal direction 7 and approximately parallel to a line connecting the center of each of the user's eyes (see
[0049] In a nonlimiting example, a plurality of spanners 3 connect to a plurality of pressure probes 4 wherein the plurality of spanners 3 is connected to a plurality of respective corners of the goggle body frame 2. The plurality of spanners 3 provide independent, continuous, transverse spatial manipulation of the plurality of pressure probes 4 with respect to the plurality of corners of the goggle body frame 2 to accomodate the user's unique facial anatomy (see
[0050] In one embodiment, a spanner 3 is an assembly of two main subcomponents: a spanner housing 12 and a spanner linear actuation subassembly comprised of a linear gear 13 and a circular gear 14. The spanner housing 12 supports the spanner linear actuation subassembly and is connected to a corner of the goggle body frame 2 (see
[0051] In a nonlimiting example, a plurality of pressure probes 4 connect to a plurality of respective spanners 3. The plurality of pressure probes 4 provide independent, continuous, longitudinal spatial manipulation to a plurality of eye rests 20 to apply EOP via compression against an upper globe 9, a lower globe 10, or a combination thereof (see
[0052] In one embodiment, the pressure probes 4 are an assembly of three main subcomponents: a pressure probe housing 16, an eye rest 20, and a pressure probe linear actuation subassembly comprised of a threaded rod 17 and a ball bearing 18. The pressure probe housing 16 supports the eye rest 20 and pressure probe linear actuation subassembly. The threaded rod 17 is supported near its proximal end within the pressure probe housing 16. The pressure probe housing 16 is internally threaded to mesh with the threaded rod 17. The proximal end of the pressure probe housing 16 is connected to the distal end of the spanner linear actuation subassembly. The eye rest 20 is connected to the distal end of the pressure probe linear actuation subassembly. The ball bearing 18 is connected to the eye rest 20 and threaded rod 17 such that the threaded rod 17 rotates to translate the eye rest 20 in the longitudinal direction 7 while keeping the orientation of the eye rest 20 approximately constant to conform to the local ocular region of the user's face when making contact. For manual adjustment of the pressure probe 4 in the longitudinal direction 7, a pressure probe knob 19 may be connected to the distal end of the threaded rod 17 and rotated by hand about the same axis as the threaded rod 17 (see
[0053] In a nonlimiting example, the eye rest 20 is in the shape of an asymmetric crescent to conform around the upper globe 9 or lower globe 10 of the user's eyes (see
[0054] In one embodiment, the spanner linear actuation subassembly, pressure probe linear actuation subassembly, or a combination thereof, may be manipulated by an electric motor or alternate means to provide linear actuation. A person having ordinary skill in the art would appreciate that there are many approaches to provide linear actuation that are applicable beyond the examples disclosed herein but are within the scope of this invention.
[0055] In one embodiment, a controller 22 is in electronic communication with the OCD 1 to manipulate the longitudinal position 7, transverse position 8, or a combination thereof, of at least one eye rest 20 to produce EOP and a resultant imparted IOP increase on the user's eyes.
[0056] In one embodiment, the controller 22 is also in electronic communication with an OID 11 to coordinate OID data acquisition as a function of eye rest 20 spatial manipulation by the controller 22.
[0057] In one embodiment, a system comprises a computing device 23 which is in electronic communication with the OCD 1, the OID 11, and a controller 22 such that, when instructed by an application 24, the computing device 23 commands the controller 22 to manipulate at least one eye rest 20 to impart EOP on at least one upper globe 9 or lower globe 10 of the user's eyes such that the IOP of at least one eye of the user increases. The application 24 further instructs the computing device 23 to command the OID 11 to perform data acquisition for at least a portion of the time while EOP is being applied. The application of EOP commanded by the computing device 23 may be time variant and may be in the form of a step function or ramping function to increase IOP over time, as nonlimiting examples.
[0058] In a nonlimiting example, the application 24 instructs the computing device 23 to command the OID 11 to perform data acquisition for at least a portion of the time while EOP is being applied such that the eye rest 20 is receding and IOP decreases over time. These time varying, dynamic data acquisition aspects can help characterize stress-strain relationships within the eye and provide enhanced analysis of eye perfusion and eye re-perfrusion in a controlled manner.
[0059] This system can be used to characterize changes such as, but not limited to, ocular perfusion as a function of IOP, change in posterior globe strain as a function of IOP, and change in corneal strain as a function of IOP. These metrics can then be used as biomarkers for either diagnosing glaucoma or corneal disease such as Keratoconus/corneal ectasia or helping to understand a patient's risk of progressing with these diseases.
[0060] In one embodiment of the invention, the OCD 1 is designed to operate in conjunction with an OID 11 in an ophthalmologic setting for early glaucoma screenings by simulating an elevated IOP environment indicative of a user with glaucoma to examine the user's ocular vascular response. The OCD 1 is positioned around the user's head while resting the goggle body frame 2 on the user's face. The headband 6 is positioned around the user's head to provide a comfortable fit. Each spanner 3 is manipulated in the transverse direction 8 to align each respective pressure probe 4 such that each eye rest 20 is aligned with either an upper globe 9 or lower globe 10 of each eye. Each pressure probe 4 is then manipulated in the longitudinal direction 7 such that each eye rest 20 contacts the user's face and compresses the upper globe 9 or lower globe 10 of each respective eye using mechanical force. Once each spanner 3 and each pressure probe 4 are properly oriented, the user positions their face in view of an OID 11, such as but not limited to an OCTA device, for OID data acquisition of the user's eyes. Each pressure probe 4 is manipulated again to impart EOP on the user's eyes while OID data acquisition is in progress. As each pressure probe 4 is manipulated in the longitudinal direction 7, each eye rest 20 is pressed against the upper globe 9 or lower globe 10 of each eye to achieve a desired increase in IOP by constricting the flow of the aqueous homor through the veins. The upper The OCD 1 introduces EOP to alter the IOP of the trabecular meshwork and Schlemm's canal and by also compressing the tissue of the lower and upper eyes to block the flow of aqueous humor fluid through the circulating fluidic vessels of the eye. The EOP event may be a static event, a dynamic event, or a combination thereof.
[0061] In a nonlimiting example, an EOP event can be dynamic such that a decrease in IOP over time is recorded via OID data acquisition. This occurs after an elevated IOP has already been established and each eye rest 20 recedes from the upper globe 9 or lower globe 10 of each respective eye resulting in a reduced mechanical force over time, allowing IOP to decrease over time.
[0062] Manipulation of each spanner 3 and pressure probe 4 is respectively performed, as nonlimiting examples, manually by hand via spanner knob 15, pressure probe knob 19, automatically using an electric motor and controller 22, or a combination thereof. Manipulation of each spanner 3 and pressure probe 4 may also be performed independently, simultaneously, or a combination thereof.
[0063] In a nonlimiting example, the spanners 2 can be manually snap adjusted in the transverse direction 8 to align the pressure probes 4 with each eye. The pressure probes 4 then actuate such that each eye rest 20 applies equal compression to the upper globe 9 of the user's eyes, the lower globe 10 of the user's eyes, or a combination thereof, resulting in equal EOP applied to each of the user's eyes during an EOP event.
[0064] Example OCD 1 performance data were acquired from three users using the OCD 1 shown in
TABLE-US-00001 TABLE 1 User OCD Performance Data. Full USER1 USER 2 USER 3 Rota- Comfort Comfort Comfort tion IOP Scale IOP Scale IOP Scale Count (mm Hg) (1-10) (mm Hg) (1-10) (mm Hg) (1-10) 0 21 10 24 9 18 8 1 21 10 22 7 19 8 2 21 10 20 7 20 8 3 22 9 25 7 21 7 4 21 8 35 7 26 7 5 23 8 36 6 27 7 6 29 7 36 6 31 6 7 39 6 38 6 33 5 8 46 4 37 5 — 4 9 — — 48 5 — —
[0065] The example OCD 1 shown in
[0066] OID data was collected to further illustrate the performance of the example OCD 1 shown in
REFERENCES
[0067] 1. Jacobs, D. (2020, Aug. 4) Open-angle Glaucoma: Epidemiology, Clinical Presentation, and Diagnosis. Available from: https://www.uptodate.com/contents/open-angle-glaucoma-epidemiology-clinical-presentation-and-diagnosis [0068] 2. Kent, C. (2011, Jun. 13). IOP: Managing the Fluctuating Factor. Available from: https://wwv.reviewofophthalmology.com/article/iop-managing-the-fluctuation-factor [0069] 3. Sunderland D K, Sapra A. Physiology, Aqueous Humor Circulation. [Updated 2022 Jan. 8]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 January-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK553209/ [0070] 4. Chuangsuwanich T, Tun T A, Braeu F A, Wang X, Chin Z Y, Panda S K, Buist M, Strouthidis N, Perera S, Nongpiur M, Aung T, Girard M J, Differing Associations between Optic Nerve Head Strains and Visual Field Loss in Normal- and High-Tension Glaucoma Subjects, Ophthalmology (2022), doi: https://doi/org/10.1016/j.ophtha.2022.08.007