IMPLANTABLE DEVICE AND METHOD FOR DETECTING INTRAMURAL PRESSURE WITHIN AN ORGAN OF A SUBJECT - Patent application

Abstract

Disclosed is an implantable device comprising a tube having a first lumen housing one or more microparticles surrounded by a first liquid, a liquid reservoir in fluid communication with a first end of the first lumen and having a flexible cover for supplying a second liquid to the first lumen, and a gas reservoir in fluid communication with a second end of the first lumen, wherein the microparticles comprise a material configured to be detected by an external device. In some embodiments, the first liquid and the second liquid are the same liquid. In some embodiments, the first liquid and the second liquid are immiscible. In some embodiments, each microparticle has a diameter of 0.5-0.9 times the hydraulic diameter of the first lumen and comprises a material that allows for detection of the individual movement of each microparticle by an external device.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to Israeli Patent Application No. 291216, entitled "IMPLANTABLE DEVICE AND METHOD FOR DETECTING IN VIVO PRESSURE IN AN ORGAN OF A SUBJECT," filed March 8, 2022, which is incorporated by reference in its entirety.

[0002] The present invention relates generally to an implantable device and method for detecting in vivo pressure within an organ of a subject, and more particularly to an implantable device and method for detecting in vivo pressure within an organ of a subject using microparticles. [Background technology]

[0003] Measuring the intravital pressure within the organs of a subject, for example, measuring the intraocular pressure in the eye, may enable early detection of diseases such as glaucoma and high blood pressure.

[0004] Glaucoma is an eye disease associated with damage to the optic nerve that leads to progressive, irreversible vision loss. Glaucoma is characterized by irreversible loss of retinal ganglion cells, ultimately resulting in blindness. Intraocular pressure (IOP) is the primary cause of glaucoma, and lowering IOP is the only way to avoid irreversible vision loss. Treatment of glaucoma relies heavily on accurately measuring and monitoring IOP levels.

[0005] Currently known methods for detecting glaucoma include static intraocular pressure measurement and frequent timed measurements. The main drawback of these methods is that both methods must be performed by experienced and skilled operators and must be performed during the day (in a clinic) when intraocular pressure is at its lowest. Furthermore, due to the above, these methods are limited to a single snapshot of the eye and are therefore inefficient in checking changes in IOP over the course of a day or night, or, for example, daily.

[0006] High blood pressure (hypertension) is a long-term medical condition in which blood pressure in the arteries is persistently high. Long-term high blood pressure is a major risk factor for stroke, coronary artery disease, heart failure, atrial fibrillation, peripheral artery disease, vision loss, chronic kidney disease, and dementia.

[0007] Blood pressure measurements are taken at specific times using dedicated automated equipment or by a professional. To ensure accuracy, multiple (at least two) blood pressure readings should be taken at 1-2 minute intervals. Ambulatory blood pressure measurements over a 12-24 hour period are the most accurate method to confirm the diagnosis. However, all methods require the subject to expose their upper arm and wear a blood pressure cuff to take discrete measurements each time. This equipment is very uncomfortable and cannot be worn continuously for the subject's lifetime. Summary of the Invention [Problem to be solved by the invention]

[0008] Therefore, there is a need for an implantable device and method for sensing in vivo pressure within a subject's organ that is comfortable and capable of providing pressure measurements over extended periods of time (e.g., hours, days, weeks or more). [Means for solving the problem]

[0009] Some aspects of the invention are directed to an implantable device comprising a tube having a first lumen housing one or more microparticles surrounded by a first liquid, a liquid reservoir in fluid communication with a first end of the first lumen and comprising a flexible cover for supplying a second liquid to the first lumen, and a gas reservoir in fluid communication with a second end of the first lumen, the microparticles comprising a material configured to be detected by an external device. In some embodiments, the first liquid and the second liquid are the same liquid. In some embodiments, the first liquid and the second liquid are immiscible. In some embodiments, each microparticle has a diameter of 0.5 to 0.9 times the hydraulic diameter of the first lumen and comprises a material that allows for detection of the individual movement of each microparticle by an external device.

[0010] In some embodiments, the density of the microparticles is at least 5% lower than the density of the first liquid. In some embodiments, the tube is curved or straight. In some embodiments, the tube is made of a flexible material.

[0011] In some embodiments, the microparticles comprise a material that is visible in an image taken by an optical camera. In some embodiments, the microparticles are colored with a color that can be detected in the image. In some embodiments, the microparticles are fluorescently colored.

[0012] In some embodiments, the microparticles comprise a magnetic material and / or a conductive material. In some embodiments, the diameter of each microparticle is between 0.5 and 0.9 times the hydraulic diameter of the first lumen.

[0013] In some embodiments, the liquid reservoir is a balloon and the flexible cover is included in the outer shell of the balloon. In some embodiments, the implantable device further comprises a second lumen that is a gas reservoir. In some embodiments, the liquid reservoir has a flat shape with an open surface covered by a flexible membrane. In some embodiments, the gas reservoir also has a flat shape.

[0014] In some embodiments, the organ is an eye of the subject and the hydraulic diameter of the first lumen is between 40 and 150 microns. In some embodiments, the organ is a blood vessel of the subject and the hydraulic diameter of the first lumen is between 150 and 3500 microns. In some embodiments, the organ is a lung section of the subject and the hydraulic diameter of the first lumen is between 120 and 1500 microns.

[0015] In some embodiments, the material of the flexible covering is selected such that pressure on the flexible covering after implantation causes fluid to flow from the fluid reservoir into the first lumen, hi some embodiments, the microparticles are microcapsules.

[0016] Some further aspects of the present invention are directed to a method of determining in vivo pressure within an organ of a subject, the method including receiving a signal from an external detector indicative of a position of one or more microparticles contained in an implantable device implanted within the organ, determining the position of the one or more microparticles based on the signal, receiving at least one previously recorded position of the one or more microparticles, detecting a change in position of the microparticles between the received position and the at least one previously recorded position, and determining the in vivo pressure based on the change in position.

[0017] In some embodiments, determining the location of the one or more microparticles includes receiving at least two known locations in the implantable device, identifying the at least two known locations in the received signals, and determining the location of the one or more microparticles based on the signal indicating the location of the one or more microparticles and the at least two signals.

[0018] In some embodiments, receiving at least one previously recorded location of the one or more microparticles includes receiving a plurality of previously recorded locations associated with different dates. In some embodiments, the organ is an eye and the intravital pressure is intraocular pressure. In some embodiments, the external detector is an optical camera and the method includes receiving an image of the eye from the optical camera including an image of one or more microparticles, determining a location of the one or more microparticles within the lumen from the image, receiving at least one previously recorded location of the microparticle within the lumen, and detecting intraocular pressure when the change in location is greater than a threshold value.

[0019] In some embodiments, the organ is a blood vessel and the intravital pressure is blood pressure. In some embodiments, the external detector is thermal imaging, X-ray imaging, magnetic imaging (MRI), and computed tomography (CT). BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The subject matter which is regarded as the invention is particularly pointed out and distinctly claimed in the concluding portion of this specification, however the invention, both as to its organization and method of operation, together with its objects, features, and advantages, may best be understood by reference to the following detailed description taken in conjunction with the accompanying drawings. [Brief description of the drawings]

[0021] [Figure 1A] 1 is a diagram of an implantable device for detecting in vivo pressure within an organ of a subject, according to some embodiments of the present invention. [Figure 1B] FIG. 2 is a diagram of another implantable device for detecting in vivo pressure within an organ of a subject, according to some embodiments of the present invention. [Figure 1C] FIG. 2 is a diagram of another implantable device for detecting in vivo pressure within an organ of a subject, according to some embodiments of the present invention. [Diagram 2] 1 is a diagram of a device implanted in a subject's eye, according to some embodiments of the present invention. [Diagram 3] FIG. 2 is a diagram of another implantable device for detecting in vivo pressure within an organ of a subject, according to some embodiments of the present invention. [Figure 4] 1 is a flow chart of a method for detecting in vivo pressure in an organ of a subject, according to some embodiments of the present invention. [Diagram 5] FIG. 1 is a block diagram illustrating a computing device that may be included in a system for detecting in vivo pressure in an organ of a subject, according to some embodiments of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] It will be understood that for simplicity and clarity of illustration, elements illustrated in the figures have not necessarily been drawn to scale. For example, the dimensions of some elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements.

[0023] Those skilled in the art will appreciate that the present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The foregoing embodiments are therefore to be considered in all respects as illustrative rather than limiting the invention described herein. The scope of the present invention is therefore indicated by the appended claims rather than the foregoing description, and all changes that come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

[0024] In the following detailed description, many specific details are described to provide a thorough understanding of the present invention. However, it will be understood by those skilled in the art that the present invention may be practiced without these specific details. In some cases, well-known methods, procedures, and components have not been described in detail so as not to obscure the present invention. Some features or elements described with respect to one embodiment may be combined with features or elements described with respect to other embodiments. For clarity, the description of the same or similar features or elements may not be repeated.

[0025] Although embodiments of the invention are not limited in this respect, for example, descriptions using terms such as "processing," "computing," "calculating," "determining," "establishing," "analyzing," "checking," and the like may refer to operations and / or processes of a computer, computing platform, computing system, or other electronic computing device that manipulates and / or transforms data represented as physical (e.g., electronic) quantities in the computer's registers and / or memory into other data that is similarly represented as physical quantities in the computer's registers and / or memory or other information non-transitory storage medium capable of storing instructions for performing operations and / or processes.

[0026] Although embodiments of the invention are not limited in this respect, the term "plurality" as used herein can include, for example, "multiple," or "two or more." The term "plurality" may be used throughout this specification to describe two or more components, devices, elements, units, parameters, etc. The term "set" as used herein can include one or more items.

[0027] Some aspects of the present invention are directed to devices implanted in a subject's organ to measure the internal pressure of the organ, e.g., eye, blood vessel, lung section, etc. When such a device is implanted in the eye, it may be possible to detect early stages of glaucoma in a simple and reliable manner. In some embodiments, when such a device is implanted in an artery, it may be possible to monitor blood pressure in patients at high risk of developing hypertension.

[0028] A device according to embodiments of the present invention may include at least one tube having a lumen housing one or more microparticles. In some embodiments, the one or more microparticles may include a material configured to be detected by an external device. For example, each microparticle may have a color (e.g., fluorescent color) that can be detected in an image taken by a camera. In another example, the one or more microparticles may include a conductive or magnetic material configured to be detected by a thermal camera, a magnetic sensor, or the like. In some embodiments, the material may allow for detection of the movement of the at least one microparticle (each microparticle individually) by an external device.

[0029] In some embodiments, the lumen may contain a liquid surrounding the microparticles, the liquid having a density higher than that of the microparticles. The liquid may be supplied from a liquid reservoir connected to one end of the lumen, the liquid reservoir comprising a flexible cover. Thus, when pressure is applied to the flexible cover, the liquid from the reservoir may push the microparticles to move within the lumen. In some embodiments, a gas reservoir may be connected to the other end of the lumen opposite the liquid reservoir to allow the volume occupied by the liquid to change. In some embodiments, the movement of the microparticles due to the application of internal pressure (e.g., intraocular pressure of the eye, blood pressure of the artery, etc.) to the liquid reservoir may be indicative / proportional to the level of internal pressure.

[0030] Devices according to some embodiments of the present invention do not include or require a power source, and do not need to be powered, and therefore such devices can remain in the organ for several years, e.g., 5-10 years, without intervention.

[0031] Reference is now made to FIG. 1A, which is a non-limiting example of an implantable device, according to some embodiments of the present invention. The implantable device 100 may include a tube 10 having a first lumen 12 containing a microparticle 14 surrounded by a liquid 24 (e.g., a first liquid 211 shown in FIG. 1C). In some embodiments, the device 100 (and thus the tube 10) may be sized to be implanted within an organ of a subject. In the non-limiting example shown in FIG. 1A, the organ is the subject's eye, and thus the hydraulic diameter of the first lumen 12 may be between 40 and 150 microns.

[0032] In some embodiments, one or more of the microparticles 14 may include a material configured to enable detection of the one or more microparticles by an external device. In some embodiments, when the organ is an eye, the external device may be, for example, a camera of a user device 80 that takes an image of the eye, as described and illustrated with respect to FIG. 2. In such a case, the one or more microparticles 14 may include a material that is visible in an image taken by the optical camera, for example, the one or more microparticles 14 may be colored with a color that is detectable in the image, or the microparticles 14 may be colored with a fluorescent color.

[0033] In some embodiments, the diameter of each microcapsule 14 is 0.5 to 0.9 times the hydraulic diameter of the first lumen 12. In some embodiments, the diameter of each microcapsule 14 is 0.6 to 0.9 times the hydraulic diameter of the first lumen 12. In some embodiments, the diameter of each microcapsule 14 is 0.5 to 0.8 times the hydraulic diameter of the first lumen 12. In some embodiments, the diameter of each microcapsule 14 is 0.6 to 0.8 times the hydraulic diameter of the first lumen 12. In some embodiments, the cross-section of the first lumen 12 can be circular, elliptical, rectangular, hexagonal, etc. For example, when the hydraulic diameter of the first lumen 12 is 40 to 150 microns, the diameter of each microcapsule 14 is 20 microns to 135 microns or any value therebetween. In some embodiments, the diameter of each microcapsule 14 is greater than 15 microns.

[0034] In some embodiments, the device 100 may further include a liquid reservoir 20 with a flexible cover 22 for supplying a liquid 24 (e.g., the second liquid 213 shown in FIG. 1C or the first liquid) in fluid communication with the first end 13 of the first lumen 12. In some embodiments, the density of the microparticles 14 is at least 5%, e.g., at least 7%, at least 10%, at least 15%, at least 20%, at least 30%, at least 40%, at least 50% or more lower than the density of the liquid 24. In a non-limiting example, the microparticles 14 are microcapsules filled with air or any other gas or solution that is lighter than the liquid, and the liquid 24 can be water, hypodermic fluid, any intravenous fluid, silicone-based gel, or other viscous biocompatible fluid, etc.

[0035] In some embodiments, the material of the flexible covering 22 is selected such that pressure (e.g., intraocular pressure) applied to the flexible covering 22 after implantation will result in the flow of liquid 24 from the liquid reservoir 20 to the first lumen 12. In the non-limiting example of Figure 1A, the liquid reservoir 20 has a flat shape with an open face covered by the flexible covering 22, which is a membrane made of any thin biocompatible polymeric material that covers the liquid 24 in the liquid reservoir 20. Some non-limiting examples of biocompatible polymeric materials include liquid crystal polymer (LCP), poly(methyl methacrylate) (PMMA), polysulfone (PSU), polyphenylsulfone (PPSU), and any silicone-based film including, but not limited to, polydimethylsiloxane (PDMS), butyl rubber, and the like.

[0036] In some embodiments, the device 100 may further include a gas reservoir 30 fluidly connected to the second end 15 of the first lumen 12. In the non-limiting example of Figure 1A, the gas reservoir 30 has a flattened shape.

[0037] In some embodiments, the device 100 may further include a fixation element 40 for fixing the device 100 to an organ, for example, an eye.

[0038] Reference is now made to FIG. 1B, which is an illustration of another non-limiting example of an implantable device, according to some embodiments of the present invention. The implantable device 200 may include a tube 110 having a first lumen 112 containing one or more microparticles 114 surrounded by a liquid 124. In some embodiments, the diameter of each microcapsule 114 is 0.5-0.9 times the hydraulic diameter of the first lumen. In some embodiments, the device 200 may be sized to be implanted within an organ of a subject. In the non-limiting example shown in FIG. 1B, the organ is the subject's eye, and thus the hydraulic diameter of the first lumen 112 may be 40-150 microns. In some embodiments, the diameter of each microcapsule 114 is 15 microns or greater.

[0039] In some embodiments, the microparticles 114 can be substantially the same as the microparticles 14 of the device 100 .

[0040] In some embodiments, the device 200 may further include a liquid reservoir 120 with a flexible cover 122 in fluid communication with the first end 113 of the first lumen 112 for providing a liquid 124 surrounding the microparticles 114. In some embodiments, the density of the microparticles 114 is at least 5%, e.g., at least 7%, at least 10%, at least 15%, at least 20%, at least 30%, at least 40%, at least 50% or more less than the density of the liquid 124. In a non-limiting example, the microparticles 114 are microcapsules filled with air or any other gas or solution that is lighter than the liquid, and the liquid 124 may be water, hypodermic fluid, any intravenous fluid, silicone-based gel, or other viscous biocompatible fluid, etc.

[0041] In some embodiments, the material of the flexible covering 122 is selected such that pressure (e.g., intraocular pressure) on the flexible covering 122 after implantation causes flow of the liquid 124 from the liquid reservoir 120 into the first lumen 112. In the non-limiting example of Figure 1B, the liquid reservoir 120 is a balloon and the flexible covering 122 is contained within the outer shell of the balloon.

[0042] In some embodiments, the device 200 may further include a gas reservoir 130 fluidly connected to the second end 115 of the first lumen 112. In the non-limiting example of FIG. 1B, the tube 110 may include a second lumen 130 that acts as a gas reservoir.

[0043] In some embodiments, tube 10 (FIG. 1A) or 110 (FIG. 1B) is curved. According to other embodiments, tube 310 is substantially straight, as shown and described with respect to FIG. 3. In some embodiments, tube 10 or 110 is made from a flexible biocompatible polymer, such as, but not limited to, liquid crystal polymer (LCP), poly(methyl methacrylate) (PMMA), polysulfone (PSU), polyphenylsulfone (PPSU).

[0044] Reference is now made to FIG. 1C, which is an illustration of another non-limiting example of an implantable device, according to some embodiments of the present invention. The implantable device 250 may include a tube 210 having a first lumen 212 containing one or more microparticles 214 surrounded by a first liquid 211. In some embodiments, the diameter of each microcapsule 214 is 0.5-0.9 times the hydraulic diameter of the first lumen. In some embodiments, the device 250 may be sized to be implanted within an organ of a subject. In a non-limiting example shown in FIG. 1C, the organ is the subject's eye, and thus the hydraulic diameter of the first lumen 112 may be 40-150 microns. In some embodiments, the diameter of the one or more microparticles 214 is greater than 15 microns, for example, 20-134 microns.

[0045] In some embodiments, the microparticles 214 can be substantially the same as the microparticles 14 and 114 of the devices 100 and 200. In some embodiments, the density of the microparticles 214 is at least 5%, e.g., at least 7%, at least 10%, at least 15%, at least 20%, at least 30%, at least 40%, at least 50% or more less than the density of the first liquid 211. In a non-limiting example, the microparticles 214 are microcapsules filled with air or any other gas or solution that is lighter than liquid, and the liquid 211 can be water, hypodermic fluid, any intravenous fluid, silicone-based gel, or other viscous biocompatible fluid, etc.

[0046] In some embodiments, the device 250 may further include a liquid reservoir 220 comprising a flexible cover 222 in fluid communication with the first end 223 of the first lumen 212. The liquid reservoir 220 is configured to supply a second liquid 213 to the lumen 212. In some embodiments, the first lumen 212 includes another portion filled with the second liquid 213, the second portion being defined between the first liquid 211 and the gas 235 present at the end 225 of the lumen 212.

[0047] In some embodiments, the first liquid 211 and the second liquid 213 do not mix. For example, the first liquid 211 can be water or any other aqueous solution and the second liquid 213 can be oil or an oil-based solution, or vice versa. The structure of the device 250 may allow for easier detection of the movement of one or more particulates 214 (e.g., each particulate 214 individually) along the inner tube 212. In some embodiments, pressure applied to the second liquid 213 in the liquid reservoir 220 causes the one or more particulates 214 and the first liquid 211 to move together. The first liquid 211 is confined between two regions of the second liquid 213, and thus the one or more particulates 214 may be restricted to move only with the first liquid 211.

[0048] In some embodiments, the device 250 may further include a gas reservoir 230 fluidly connected to the second end 225 of the first lumen 212. In the non-limiting example of FIG. 1C, the tube 210 may include a second lumen 230 that acts as a gas reservoir.

[0049] In some embodiments, devices 100, 200, and 250 may further include one or more fixation arms 40 extending from tube 110. Fixation arms 40 are configured to support tube 110 within an organ, for example, within an eye, as shown in FIG.

[0050] In some embodiments, the external device may detect the movement of a single particle 14, 114, 214 or multiple particles 14, 114, 214. The external device (e.g., a camera) may detect the movement of each particle in a multiple particle, or the movement of several individual particles 14, 114, 214 from a multiple particle.

[0051] Reference is now made to FIG. 2, which is an image diagram of an implantable device, such as device 100, implanted in a user's eye 5. In the non-limiting example of FIG. 2, device 100, and possibly devices 200 or 250, are implanted in the anterior chamber of eye 5. In some embodiments, this implantation can be combined with cataract surgery. As will be appreciated by those skilled in the art, device 100 and / or 200 do not include or require a power source, nor do they need to be powered. Thus, device 100 and / or 200 can remain in the eye for several years, for example 5-10 years, without intervention.

[0052] Reference is now made to Figure 3, which is an illustration of another non-limiting example of an implantable device for detecting in vivo pressure within an organ of a subject, according to some embodiments of the present invention. The device 300 may be implanted within an organ, such as a blood vessel (e.g., an artery) or a lung region.

[0053] The implantable device 300 may include a tube 310 having a first lumen 312 containing microparticles 314. In some embodiments, the diameter of each microcapsule 314 is 0.5-0.9 times the hydraulic diameter of the first lumen. In some embodiments, the device 300 (and thus the tube 310) may be sized to be implanted within an organ of a subject. In a non-limiting example shown in FIG. 3, the organ is a blood vessel (e.g., an artery) of the subject, and the hydraulic diameter of the first lumen 312 may be 150-3500 microns. In another non-limiting example, the organ is a lung section of the subject, and the hydraulic diameter of the first lumen 312 may be 120-1500 microns. In some embodiments, the tube 310 may be made of a flexible material configured to conform to the shape of the blood vessel or lung section.

[0054] In some embodiments, the diameter of each microcapsule 314 is between 60 microns and 3150 microns, or any value therebetween.

[0055] In some embodiments, the particulate 314 may include a magnetic or conductive material configured to be detected by a sensor capable of detecting such materials. For example, the particulate 314 may include a metal powder, a carbon powder, a ceramic material, etc.

[0056] In some embodiments, the device 300 may further include a liquid reservoir 320 comprising a flexible cover 322 in fluid communication with the first end 313 of the first lumen 312 for providing a liquid 324 surrounding the microparticles 314. In some embodiments, the density of the microparticles 314 is at least 5%, e.g., at least 7%, at least 10%, at least 15%, at least 20%, at least 30%, at least 40%, at least 50% or more less than the density of the liquid 324. In a non-limiting example, the microparticles 314 are microcapsules filled with air or any other gas or solution that is lighter than liquid, and the liquid 324 can be water, hypodermic fluid, any intravenous fluid, silicone-based gel, or other viscous biocompatible fluid, etc.

[0057] In some embodiments, the material of the flexible covering 322 is selected such that pressure (e.g., blood pressure) on the flexible covering 322 after implantation causes the flow of liquid 324 from the liquid reservoir 320 into the first lumen 312. In the non-limiting example of Figure 3, the liquid reservoir 320 is a balloon and the flexible covering 322 is contained within the outer shell of the balloon.

[0058] In some embodiments, the device 300 may further include a gas reservoir 330 fluidly connected to the second end 315 of the first lumen 312. In the non-limiting example of Figure 3, the tube 310 may include a second lumen 330 that is a gas reservoir.

[0059] Reference is now made to Figure 4, which is a flow chart of a method for determining in vivo pressure in an organ of a subject, according to some embodiments of the present invention. The method of Figure 4 may be performed by the computing device 10 shown and described with respect to Figure 5, or by any other computing device. In some embodiments, the method may be performed after implantation of a device, such as device 100, 200, 250, or 300, in the organ of the subject.

[0060] At step 410, a signal is received from an external detector, the signal indicating the location of one or more particles contained in an implantable device implanted within an organ. For example, the signal may be an image of an eye showing a particle 14, 114, or 214. In another example, the signal may be a thermal image of an arm showing a metal particle 340 in a blood vessel. In yet another example, the image may be an X-ray image of a chest showing a metal / magnetic particle 340 in a lung area. In some embodiments, at least one particle, e.g., a single particle or multiple individual particles, may be detectable in the image, each of which may be individually detectable in the image.

[0061] In step 420, the location of one or more particles may be determined based on the signal. In a non-limiting example, determining the location may include receiving at least two known locations (e.g., three known locations) in the implantable device, such as the location of the first end 13 / 113 / 223 / 313 and the second end 15 / 115 / 225 / 315 (and optimally further locations therebetween). The method may include identifying at least two known locations in the signal, such as in an image, a thermal image, or an X-ray image, identifying the particle in the signal, and calculating the relative location of the particle to the two known locations. For example, any image analysis program may be used to identify the first end 13 / 113 / 313 and the second end 15 / 115 / 315 and the particle 14 / 114 / 314 in any type of image. In a non-limiting example of an optical image, the first end 13 / 113 and the second end 15 / 115 may be marked with a fluorescent material or a particular color. In a non-limiting example of thermal and / or x-ray imaging, the first end 313 and the second end 315 may be marked with a conductive or magnetic marker. Thus, the location of the particle may be determined based on the signal indicative of the location of the particle and at least two known locations.

[0062] In step 430, at least one previously recorded location of the microparticle may be received, for example, from the storage system 6 of the computing device 9. The previously recorded location may be determined in a manner similar to that described in step 420, using signals received from the same external detector detecting the same implantable device implanted in the same organ.

[0063] In step 440, a change in the position of the microparticles (for each microparticle individually) between the received position and at least one previously recorded position is detected. This change indicates a change in the in vivo pressure in the organ on the flexible cover 22 / 122 / 322 and thus a movement of the microparticles, as the liquid 24 / 124 / 324 flows from the liquid reservoir 20 / 120 / 320 to the tube 10 / 110 / 310 while the microparticles 14 / 114 / 314 are pushed and move along the first lumen 12 / 112 / 312 or vice versa. The higher the in vivo pressure, the greater the change detected. Thus, in step 450, the in vivo pressure can be determined based on the change in position. In some embodiments, a look-up table is stored in the storage system 6, which can relate the change in position to the level of in vivo pressure.

[0064] In a non-limiting example, the external detector is an optical camera and the method includes receiving an image of the eye 5 including an image of the particulate 14 or 114 from an optical camera, such as an optical camera included in the user device 80, and determining a position of the particulate within the lumen 12 or 112 from the image. The method may further include receiving at least one previously recorded position of the particulate within the lumen and detecting intraocular pressure when the change in position is greater than a threshold value.

[0065] In another non-limiting example, the external detector can be a thermal camera, which can be included in the user device 80 or can be a dedicated device, and the in vivo pressure can be the subject's blood pressure.

[0066] In another non-limiting example, the external detector can be an x-ray camera, an MRI device, or a CT device, and the in vivo pressure can be the pressure within a lung segment.

[0067] Reference is now made to FIG. 5, which is a block diagram illustrating a computing device that may be included in one embodiment of a system for detecting in vivo pressure in an organ of a subject, according to some embodiments.

[0068] The computing device 9 may include a processor or controller 2, which may be, for example, a central processing unit (CPU) processor, chip, or any suitable computing or computational device, an operating system 3, memory 4, executable code 5, a storage system 6, input devices 7, and output devices 8. The processor 2 (or one or more controllers or processors, possibly across multiple units or devices) may be configured to perform methods described herein and / or to perform or function as various modules, units, etc. More than one computing device 9 may be included in a system according to embodiments of the present invention, and one or more computing devices 9 may function as components of a system according to embodiments of the present invention.

[0069] Operating system 3 may be or may include any code segment (e.g., similar to executable code 5 described herein) designed and / or configured to perform tasks including coordinating, scheduling, arbitrating, monitoring, controlling, or otherwise managing the operation of computing device 10, such as scheduling the execution of software programs or tasks, or enabling communication of software programs or other modules or units. Operating system 3 may be a commercially available operating system. It should be noted that operating system 3 may be an optional component, e.g., in some embodiments, a system may include a computing device that does not require or includes an operating system 3.

[0070] The memory 4 may be or include, for example, a random-access memory (RAM), a read only memory (ROM), a dynamic RAM (DRAM), a synchronous DRAM (SD-RAM), a double data rate (DDR) memory chip, a flash memory, a volatile memory, a non-volatile memory, a cache memory, a buffer, a short-term memory unit, a long-term memory unit, or other suitable memory or storage unit. The memory 4 may be or include multiple, possibly different, memory units. The memory 4 may be a non-transitory readable medium of a computer or a processor, or a non-transitory storage medium of a computer, for example, a RAM. In one embodiment, the non-transitory storage medium, such as the memory 4, a hard disk drive, or another storage device, may store instructions or code that, when executed by the processor, cause the processor to perform the methods described herein.

[0071] Executable code 5 may be any executable code, such as an application, a program, a process, a task, or a script. Executable code 5 may be executed by processor or controller 2, possibly under control of operating system 3. For example, executable code 5 may be an application, which may include a method for detecting intravital pressure in an organ of a subject, as previously described herein. For clarity, a single item of executable code 5 is shown in FIG. 5, but systems according to some embodiments of the present invention may include multiple executable code segments similar to executable code 5 that may be loaded into memory 4 and cause processor 2 to execute methods described herein.

[0072] Storage system 6 may be or include, for example, a flash memory known in the art, a memory internal or embedded in a microcontroller or chip known in the art, a hard disk drive, a CD-Recordable (CD-R) drive, a Blu-ray disk (BD), a universal serial bus (USB) device, or other suitable removable and / or fixed storage unit. Previously recorded locations of particles of devices 100, 200, and 300 may be stored in storage system 6 and loaded from storage system 6 into memory 4 where they may be processed by processor or controller 2. In some embodiments, some of the components shown in FIG. 5 may be omitted. For example, memory 4 may be a non-volatile memory having the storage capacity of storage system 6. Thus, although shown as a separate component, storage system 6 may be embedded or included in memory 4.

[0073] The input devices 7 may be or include any suitable input devices, components, or systems, such as a detachable keyboard or keypad, a mouse, etc. The output devices 8 may include one or more (possibly detachable) displays or monitors, speakers, and / or any other suitable output devices. Any applicable input / output (I / O) devices may be connected to the computing device 1 as indicated by blocks 7 and 8. For example, a wired or wireless network interface card (NIC), a universal serial bus (USB) device, or an external hard drive may be included in the input devices 7 and / or output devices 8. It will be appreciated that any suitable number of input devices 7 and output devices 8 may be operatively connected to the computing device 9 as indicated by blocks 7 and 8.

[0074] Systems according to some embodiments of the present invention may include components such as, but not limited to, multiple central processing units (CPUs) or any other suitable general-purpose or specific processors or controllers (e.g., similar to element 2), multiple input units, multiple output units, multiple memory units, and multiple storage units.

[0075] Unless explicitly stated, the method embodiments described herein are not constrained to a particular order or sequence. Furthermore, all formulas described herein are intended as examples only, and other or different formulas may be used. In addition, some of the method embodiments described or elements thereof may occur or be performed at the same time.

[0076] While certain features of the invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents will occur to those skilled in the art, and it is therefore to be understood that the appended claims are intended to cover all such modifications and changes that fall within the true spirit of the invention.

[0077] Various embodiments are presented, each of which may include features from the other embodiments presented, and embodiments not specifically described may include various features described herein.

Claims

1. It is an implantable device, A tube having a first lumen containing one or more particles surrounded by a first liquid, A liquid reservoir having a flexible cover that is fluidly connected to the first end of the first lumen and supplies a second liquid to the first lumen, A gas reservoir that is fluidly connected to the second end of the first lumen, The device comprises a material that allows for the detection of the individual movement of each particle, wherein each particle has a diameter of 0.5 to 0.9 times the hydraulic diameter of the first lumen, and the material allows for the detection of the individual movement of each particle by an external device. An implantable device.

2. The implantable device according to claim 1, wherein the first liquid and the second liquid are the same liquid.

3. The implantable device according to claim 1, wherein the first liquid and the second liquid do not mix.

4. The implantable device according to any one of claims 1 to 3, wherein the density of the fine particles is at least 5% lower than the density of the first liquid.

5. The implantable device according to claim 1, wherein the tube is curved or straight.

6. The implantable device according to claim 1, wherein the tube is made of a flexible material.

7. The implantable device according to claim 1, wherein the fine particles include a material visible in an image taken with an optical camera.

8. The implantable device according to claim 7, wherein the fine particles are colored with a color detectable by image.

9. The implantable device according to claim 7, wherein the fine particles are colored with a fluorescent color.

10. The implantable device according to claim 1, wherein the fine particles include a magnetic material and / or a conductive material.

11. The implantable device according to claim 1, wherein the diameter of each of the aforementioned fine particles is greater than 15 microns.

12. The implantable device according to claim 1, wherein the liquid reservoir is a balloon, and the flexible cover is included in the outer shell of the balloon.

13. The implantable device according to claim 12, further comprising a second lumen which is a gas reservoir.

14. The implantable device according to claim 1, wherein the liquid reservoir has a flat shape with an opening surface covered by a flexible membrane.

15. The implantable device according to claim 14, wherein the gas reservoir has a flattened shape.

16. The implantable device according to claim 1, wherein the organ is the eye of the subject, and the hydraulic diameter of the first lumen is 40 to 150 microns.

17. The implantable device according to claim 1, wherein the organ is a blood vessel of the subject, and the hydraulic diameter of the first lumen is 150 to 3500 microns.

18. The implantable device according to claim 1, wherein the organ is a lung segment of the subject, and the hydraulic diameter of the first lumen is 120 to 1500 microns.

19. The implantable device according to claim 1, wherein the material of the flexible cover is selected such that pressure applied to the flexible cover after implantation causes a flow of liquid from the liquid reservoir to the first lumen.

20. The implantable device according to claim 1, wherein the fine particles are microcapsules.

21. A method for determining the intracellular pressure within a subject's organs, Receiving signals from an external detector indicating the location of one or more microparticles contained in an implantable device implanted within an organ, Determining the position of one or more particles based on the aforementioned signal, Receiving at least one previously recorded position of the one or more fine particles, To detect a change in the position of one or more particles between the received position and the at least one previously recorded position, Determining intracellular pressure based on the aforementioned change in position, A method that includes this.

22. Determining the position of one or more of the aforementioned particles is: Receiving at least two known locations in an implantable device, Identifying at least two known locations in the received signal, The position of the one or more particles is determined based on the signal indicating the position of the one or more particles and the at least two signals, The method according to claim 21, including the method described in claim 21.

23. The method according to claim 21 or 22, wherein receiving at least one previously recorded location of one or more particles includes receiving a plurality of previously recorded locations associated with different dates.

24. The method according to claim 21, wherein the organ is an eye and the intracellular pressure is intraocular pressure.

25. The external detector is an optical camera, Receiving an image of an eye containing images of one or more microparticles from the optical camera, The position of one or more microparticles within the lumen is determined from the aforementioned image, Receiving the previously recorded position of at least one of one or more microparticles within the lumen, The intraocular pressure is detected when the change in the aforementioned position is greater than a threshold, The method according to claim 24, including the method described in claim 24.

26. The method according to claim 21, wherein the organ is a blood vessel and the intracellular pressure is blood pressure.

27. The method according to claim 21, wherein the external detector is thermal imaging, X-ray imaging, magnetic imaging (MRI), and computed tomography (CT).

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