Implantable device and method for detecting in vivo pressure in organ of subject

By implanting an implantable device containing particles in the organ and monitoring the changes in the particle position using an external detector, the problems of discontinuous and uncomfortable pressure monitoring in the prior art are solved, and long-term and comfortable pressure monitoring is achieved.

CN119136724APending Publication Date: 2024-12-13IOP MEDICAL LTD
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Patent Information

Application Number
CN202380037687.3
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2022-03-08
Filing Date
2023-03-08
Publication Date
2024-12-13

AI Technical Summary

Technical Problem

Existing methods for detecting stress in organs require experienced operators and are unable to continuously monitor pressure changes during the day and at night, and the equipment is uncomfortable and cannot be worn for a long time.

Method used

An implantable device is designed, including a tube with an inner cavity, where the liquid surrounding the particles is monitored by means of an external detector through image or other imaging techniques through the coordination of the liquid reservoir and the gas reservoir. to determine the pressure in the body.

Benefits of technology

It enables continuous and comfortable monitoring of internal pressure for a long time (hours, days, or weeks) without the need for power, and can be retained in the organ for many years and provide continuous pressure data.

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Abstract

An implantable device is disclosed, the device comprising: a tube having a first lumen, the first lumen comprising one or more particulates surrounded by a first liquid; a reservoir comprising a flexible cap in fluid communication with the first end of the first lumen for providing a second liquid to the first lumen; the gas storage device is in fluid communication with the second end of the first inner cavity; wherein the particulate comprises 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 particle has a diameter between 0.5 and 0.9 of the hydraulic diameter of the first lumen, and includes a material that allows movement of each particle to be detected by an external device, respectively.
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Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to Israeli patent application serial number 291216, filed on March 8, 2022, entitled “IMPLANTABLE DEVICE AND METHOD FOR DETECTING IN VIVO PRESSURE IN AN ORGAN OF A SUBJECT,” the contents of which are incorporated by reference in their entirety. Technical Field

[0003] The present invention generally relates to implantable devices and methods for detecting in vivo pressure in an organ of a subject. More specifically, the present invention relates to implantable devices and methods for detecting in vivo pressure in an organ of a subject using microparticles. Background Art

[0004] Measuring in vivo pressure in a subject's organ, such as measuring the intraocular pressure in the eye, may allow for early detection of diseases such as glaucoma, hypertension, and the like.

[0005] Glaucoma is an ophthalmic disease associated with optic nerve damage, which leads to progressive and irreversible vision loss. Glaucoma is characterized by the irreversible loss of retinal ganglion cells, which ultimately leads to blindness. Intraocular pressure (IOP) is the main cause of glaucoma, and lowering IOP is the only way to avoid irreversible vision loss. The treatment of glaucoma relies heavily on accurately measuring and monitoring IOP levels.

[0006] Currently known methods for detecting glaucoma include static intraocular pressure measurement and frequent instantaneous measurement. The main disadvantages of these methods are that both methods must be performed by experienced and skilled operators and are performed during the day (in the clinic) when the intraocular pressure is lowest. In addition, for the reasons mentioned above, these methods are limited to a single snapshot of the eye and therefore cannot effectively examine how the IOP changes during the day and night or, for example, every day.

[0007] Hypertension is a long-term condition characterized by persistently high blood pressure in the arteries. Chronic high blood pressure is a major risk factor for stroke, coronary artery disease, heart failure, atrial fibrillation, peripheral arterial disease, vision loss, chronic kidney disease and dementia.

[0008] Blood pressure measurements are taken by dedicated automatic instruments or professionals at specific times. Multiple blood pressure readings (at least two) should be obtained at intervals of 1-2 minutes to ensure accuracy. Ambulatory blood pressure monitoring for 12 to 24 hours is the most accurate method for diagnosis. However, all methods require the subject to wear a blood pressure cuff on the bare upper arm, and the data for each measurement is discontinuous. This device is very uncomfortable and cannot be worn continuously throughout the subject's life cycle.

[0009] Therefore, there is a need for implantable devices and methods for detecting in vivo pressure in an organ of a subject that are both comfortable and capable of providing pressure measurements over extended periods of time (eg, hours, days, weeks, or longer). Summary of the invention

[0010] Some aspects of the present invention relate to an implantable device comprising: a tube having a first lumen, the first lumen The cavity includes one or more microparticles surrounded by a first liquid; a liquid reservoir including a flexible cover, which is in fluid communication with a first end of the first inner cavity for providing a second liquid to the first inner cavity; a gas reservoir in fluid communication with a second end of the first inner cavity; wherein the microparticles include 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, wherein the first liquid and the second liquid are immiscible. In some embodiments, the diameter of each microparticle is between 0.5 and 0.9 of the hydraulic diameter of the first inner cavity, and includes a material that allows the movement of each microparticle to be detected separately by an external device.

[0011] 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.

[0012] In some embodiments, the microparticles include a material that is visible in an image captured by an optical camera. In some embodiments, the microparticles are colored with a color that is detectable in the image. In some embodiments, the microparticles are colored with a fluorescent color.

[0013] In some embodiments, the microparticles include magnetic material and / or conductive material. In some embodiments, the diameter of each microparticle is between 0.5 and 0.9 of the hydraulic diameter of the first lumen.

[0014] In some embodiments, wherein the reservoir is a balloon, and wherein the flexible cover is included in the outer shell of the balloon. In some embodiments, the implantable device further comprises a second inner cavity as a gas reservoir. In some embodiments, the reservoir has a flat shape, and its open face is covered by a flexible membrane. In some embodiments, the gas reservoir also has a flat shape.

[0015] In some embodiments, the organ is an eye of the subject, and wherein 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 wherein the hydraulic diameter of the first lumen is between 150 and 3500 microns. In some embodiments, the organ is a lung segment of the subject, and wherein the hydraulic diameter of the first lumen is between 120 and 1500 microns.

[0016] In some embodiments, the material of the flexible cover is selected such that pressure applied to the flexible cover after implantation causes fluid to flow from the reservoir into the first lumen. In some embodiments, the microparticles are microcapsules.

[0017] Some additional aspects of the present invention relate to a method for determining in vivo pressure in an organ of a subject, comprising: receiving a signal from an external detector indicating the position of one or more microparticles included in an implantable device implanted in 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 at least one previously recorded position; and determining the in vivo pressure based on the change in position.

[0018] In some embodiments, determining the location of one or more particles 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 particles based on the signal indicating the location of the one or more particles and the at least two signals.

[0019] In some embodiments, receiving at least one previously recorded position of the one or more particles comprises receiving a plurality of previously recorded positions associated with different dates. In some embodiments, the organ is an eye, and wherein the in vivo pressure is intraocular pressure. In some embodiments, the external detector is an optical camera, and the method comprises: receiving an image of the eye from the optical camera, the image comprising an image of the one or more particles; determining from the image the position of the one or more particles in the lumen; receiving at least one previously recorded position of the particles in the lumen; and detecting the intraocular pressure if the change in position is greater than a threshold.

[0020] In some embodiments, the organ is a blood vessel, and wherein the in vivo 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

[0021] The subject matter which is regarded as the invention is particularly pointed out and clearly claimed in the concluding portion of the specification. However, the invention as to its organization and method of operation, together with objects, features, and advantages thereof, is best understood by reference to the following detailed description and the accompanying drawings, in which:

[0022] Figure 1A is an illustration of an implantable device for detecting in vivo pressure in an organ of a subject according to some embodiments of the present invention;

[0023] Figure 1B is an illustration of another implantable device for detecting in vivo pressure in an organ of a subject according to some embodiments of the present invention;

[0024] Figure 1C is an illustration of another implantable device for detecting in vivo pressure in an organ of a subject according to some embodiments of the present invention;

[0025] Figure 2 is an illustration of a device implanted in an eye of a subject according to some embodiments of the present invention;

[0026] Figure 3 is an illustration of another implantable device for detecting in vivo pressure in an organ of a subject according to some embodiments of the present invention;

[0027] Figure 4 is a flow chart of a method of detecting in vivo pressure in an organ of a subject according to some embodiments of the present invention; and

[0028] Figure 5 is a block diagram depicting 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.

[0029] It is understood that, for the sake of simplicity and clarity of illustration, the elements shown in the figures are not necessarily drawn to scale. For example, for the sake of clarity, the size of some elements may be exaggerated relative to other elements. In addition, where appropriate, reference numerals may be repeated in the various figures to indicate corresponding or similar elements. DETAILED DESCRIPTION

[0030] Those skilled in the art will appreciate that the present invention may be implemented in other specific forms without departing from its spirit or essential features. Therefore, the foregoing embodiments should be considered in all respects as illustrative rather than restrictive of the invention described herein. Therefore, the scope of the present invention is indicated by the appended claims rather than the above description, and all changes within the meaning and equivalent range of the claims should be included in the claims.

[0031] In the detailed description below, many specific details are listed to provide a thorough understanding of the present invention. However, it will be appreciated by those of ordinary skill in the art that the present invention can be implemented without these specific details. In other cases, well-known methods, procedures, and components are not described in detail to avoid obscuring the present invention. Some features or elements described in connection with one embodiment may be combined with features or elements described in connection with other embodiments. For clarity, the discussion of the same or similar features or elements may not be repeated.

[0032] Although embodiments of the invention are not limited in this regard, terms used in the discussion, such as "processing," "computing," "calculating," "determining," "establishing," "analyzing," "checking," or similar terms, may refer to operations and / or processes of a computer, a computing platform, a computing system, or another electronic computing device that manipulates and / or converts data represented as physical quantities (e.g., electronic quantities) in registers and / or memories of a computer into other data also represented as physical quantities in computer registers and / or memories or other information non-transitory storage media that can store instructions for performing the operations and / or processes.

[0033] Although embodiments of the present invention are not limited in this regard, the terms "plurality" and "a plurality" as used herein may include, for example, "multiple" or "two or more". The terms "plurality" or "a plurality" may be used throughout the specification to describe two or more components, devices, elements, units, parameters, etc. The term "set" as used herein may include one or more items.

[0034] Some aspects of the present invention relate to devices to be implanted in a subject's organ (e.g., eye, blood vessel, lung segment, etc.) in order to measure the internal pressure in the organ. Such a device, when implanted in the eye, may allow for the detection of early stages of glaucoma in a simple and reliable manner. In some embodiments, such a device, when implanted in an artery, may allow for the monitoring of blood pressure in patients at high risk for hypertension.

[0035] Devices according to embodiments of the present invention may include at least one tube having an inner cavity that includes one or more microparticles. In some embodiments, one or more microparticles may include a material configured to be detected by an external device. For example, each microparticle may include a color (e.g., a fluorescent color) that can be detected in an image captured by a camera. In another example, one or more microparticles may include a conductive or magnetic material that is configured to be detected by a thermal imager, a magnetic sensor, and the like. In some embodiments, the material may allow the movement of at least one microparticle (each microparticle individually) to be detected by an external device.

[0036] In some embodiments, the inner cavity may include a liquid having a density higher than that of the microparticles, surrounding the microparticles. The liquid may be provided by a reservoir, which includes a flexible cover connected to one end of the inner cavity. Thus, when pressure is applied to the flexible cover, the liquid from the reservoir may push the microparticles to move within the inner cavity. In some embodiments, in order to allow the volume occupied by the liquid to change, a gas reservoir may be connected at the other end of the inner cavity, opposite the liquid reservoir. In some embodiments, the movement of the microparticles due to the application of internal pressure (e.g., intraocular pressure in the eye, blood pressure in an artery, etc.) to the reservoir may be indicative / related to the level of the internal pressure.

[0037] The device according to some embodiments of the present invention does not include or require any power source, nor does it need to be powered. Therefore, such a device can remain in the organ for several years, such as 5 to 10 years, without any intervention.

[0038] Reference now Figure 1A , which is an illustration of a non-limiting example of an implantable device according to some embodiments of the present invention. Implantable device 100 may include a tube 10 having a first lumen 12, the first lumen 12 including a fluid 24 (e.g., Figure 1C 1 ) surrounded by the first liquid 211. In some embodiments, the device 100 (and therefore the tube 10) is sized to be implanted in an organ of a subject. Figure 1A In the non-limiting example shown, the organ may be an eye of a subject, and thus the hydraulic diameter of the first lumen 12 is between 40 and 150 microns.

[0039] In some embodiments, one or more particles 14 may include a material configured to allow detection of the one or more particles 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 captures an image of the eye, as described with respect to Figure 2 In this case, one or more particles 14 include a material that is visible in an image captured by the optical camera, for example, one or more particles 14 may be colored with a color that is detectable in the image, or the particles 14 may be colored with a fluorescent color.

[0040] In some embodiments, the diameter of each microcapsule 14 is between 0.5 and 0.9 of the hydraulic diameter of the first lumen 12. In some embodiments, the diameter of each microcapsule 14 is between 0.6 and 0.9 of the hydraulic diameter of the first lumen 12. In some embodiments, the diameter of each microcapsule 14 is between 0.5 and 0.8 of the hydraulic diameter of the first lumen 12. In some embodiments, the diameter of each microcapsule 14 is between 0.6 and 0.8 of 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, and the like. For example, when the hydraulic diameter of the first lumen 12 is between 40 and 150 microns, the diameter of each microcapsule 14 is between 20 microns and 135 microns, or any value therebetween. In some embodiments, the diameter of each microcapsule 14 is greater than 15 microns.

[0041] In some embodiments, the device 100 may further include a reservoir 20 including a flexible cover 22 in fluid communication with the first end 13 of the first lumen 12 for providing a liquid 24 (e.g., Figure 1C In some embodiments, the density of the microparticles 14 is at least 5%, such as 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 may be microcapsules filled with air or any other gas or solution lighter than the liquid, and the liquid 24 may be water, subcutaneous fluid, any intravenous fluid, silicone-based gel or other viscous biocompatible fluid, etc.

[0042] In some embodiments, the material of the flexible cover 22 is selected so that after implantation, pressure (eg, intraocular pressure) exerted on the flexible cover 22 causes the fluid 24 to flow from the reservoir 20 into the first lumen 12. Figure 1A In a non-limiting example, the reservoir 20 has a flat shape, and its open face is covered by a flexible cover 22, which is a membrane made of any thin biocompatible polymer material, covering the liquid 24 inside the reservoir 20. Some non-limiting examples of biocompatible polymer materials may include liquid crystal polymer (LCP), polymethyl methacrylate (PMMA), polysulfone (PSU), polyphenylsulfone (PPSU), and any silicon-based film, including but not limited to polydimethylsiloxane (PDMS), butyl rubber, etc.

[0043] In some embodiments, the device 100 may further include a gas reservoir 30 in fluid communication with the second end 15 of the first lumen 12. Figure 1A In the non-limiting example of FIG. , the gas reservoir 30 has a flat shape.

[0044] In some embodiments, the device 100 may further include a tactile element 40 for securing the device 100 in an organ, such as an eye.

[0045] Reference now Figure 1B , which is an illustration of another non-limiting example of an implantable device according to some embodiments of the present invention. Implantable device 200 may include tube 110 having a first lumen 112, first lumen 112 including one or more microcapsules 114 surrounded by a liquid 124. In some embodiments, the diameter of each microcapsule 114 is between 0.5 and 0.9 of the hydraulic diameter of the first lumen. In some embodiments, device 200 is sized to be implanted in an organ of a subject. Figure 1B In the non-limiting example shown, the organ may be an eye of a subject, and thus the hydraulic diameter of the first lumen 112 is between 40 and 150 microns. In some embodiments, the diameter of each microcapsule 114 is equal to or greater than 15 microns.

[0046] In some embodiments, particles 114 may be substantially identical to particles 14 of device 100 .

[0047] In some embodiments, the device 200 may further include a reservoir 120, the reservoir 120 including 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% lower than the density of the liquid 124, such as at least 7%, at least 10%, at least 15%, at least 20%, at least 30%, at least 40%, at least 50% or more. In a non-limiting example, the microparticles 114 may be microcapsules filled with air or any other gas or solution that is lighter than the liquid, and the liquid 124 may be water, subcutaneous injection fluid, any intravenous injection fluid, silicone-based gel or other viscous biocompatible fluid, etc.

[0048] In some embodiments, the material of the flexible cover 122 is selected such that pressure (eg, intraocular pressure) exerted on the flexible cover 122 after implantation causes the fluid 124 to flow from the reservoir 120 into the first lumen 112. Figure 1B In the non-limiting example of , the reservoir 120 is a balloon, and the flexible cover 122 is included in the outer shell of the balloon.

[0049] In some embodiments, the device 200 may further include a gas reservoir 130 in fluid communication with the second end 115 of the first lumen 112. Figure 1B In a non-limiting example, the tube 110 may include a second inner cavity 130 that serves as a gas reservoir.

[0050] In some embodiments, the tube 10 ( Figure 1A Middle) or pipe 110( Figure 1B According to other embodiments, the tube 310 is substantially straight, such as Figure 3 In some embodiments, the tube 10 or 110 is made of a flexible biocompatible polymer, such as, but not limited to, liquid crystal polymer (LCP), polymethylmethacrylate (PMMA), polysulfone (PSU), polyphenylsulfone (PPSU), and the like.

[0051] Reference now Figure 1C , which is an illustration of another non-limiting example of an implantable device according to some embodiments of the present invention. Implantable device 250 may include a tube 210 having a first lumen 212, the first lumen including one or more microcapsules 214 surrounded by a first liquid 211. In some embodiments, the diameter of each microcapsule 214 is between 0.5 and 0.9 of the hydraulic diameter of the first lumen. In some embodiments, device 250 is sized to be implanted in an organ of a subject. Figure 1C In the non-limiting example shown, the organ may be an eye of a subject, and thus the hydraulic diameter of the first lumen 112 is between 40 and 150 microns. In some embodiments, the diameter of one or more microparticles 214 is greater than 15 microns, such as 20 to 134 microns.

[0052] 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%, such as 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 first liquid 211. In a non-limiting example, the microparticles 214 can be microcapsules filled with air or any other gas or solution that is lighter than the liquid, and the liquid 211 can be water, subcutaneous injection fluid, any intravenous injection fluid, silicone-based gel or other viscous biocompatible fluid, etc.

[0053] In some embodiments, the device 250 may further include a reservoir 220, the reservoir 220 including a flexible cover 222, in fluid communication with a first end 223 of the first lumen 212. The reservoir 220 is configured to provide a second liquid 213 to the lumen 212. In some embodiments, the first lumen 212 may include another portion filled with the second liquid 213, the second portion being defined between the first liquid 211 and a gas 235 located at an end 225 of the lumen 212.

[0054] In some embodiments, the first liquid 211 and the second liquid 213 are immiscible. For example, the first liquid 211 can be water or any other aqueous solution, and the second liquid 213 can be oil or an oily solution, or vice versa. The structure of the device 250 can more easily detect the movement of one or more particles 214 (e.g., each particle 214 individually) along the inner tube 212. In some embodiments, the one or more particles 214 move with the first liquid 211 as a result of the pressure exerted on the second liquid 213 in the reservoir 220. The first liquid 211 can be enclosed between two regions of the second liquid 213, and therefore, the one or more particles 214 are restricted to move only with the first liquid 211.

[0055] In some embodiments, the device 250 may further include a gas reservoir 230 in fluid communication with the second end 225 of the first lumen 212. Figure 1C In a non-limiting example, the tube 210 may include a second inner cavity 230 that serves as a gas reservoir.

[0056] In some embodiments, the devices 100, 200, and 250 may further include one or more haptic arms 40 extending from the tube 110. The haptic arms 40 are configured to support the tube 110 within an organ, e.g., Figure 2 Shown in the eye.

[0057] In some embodiments, an external device can detect the movement of a single particle 14, 114, 214 or a plurality of particles 14, 114, 214. An external device (e.g., a camera) can detect the movement of each particle in the plurality of particles or the movement of some single particles 14, 114, 214 in the plurality of particles.

[0058] Reference now Figure 2 , which is an illustration of an image of an implantable device (e.g., device 100) implanted in an eye 5 of a user. Figure 2 In a non-limiting example, device 100 and possibly device 200 or 250 are implanted in the anterior chamber of eye 5. In some embodiments, the implantation can be performed in conjunction with cataract surgery. It should be understood by those of ordinary skill in the art that device 100 and / or 200 does not include or require any power source, nor does it require power. Therefore, device 100 and / or 200 can remain in the eye for several years, such as 5 to 10 years, without any intervention.

[0059] Reference now Figure 3 , which is an illustration of another non-limiting example of an implantable device for detecting in vivo pressure in an organ of a subject according to some embodiments of the present invention. Device 300 can be implanted in an organ such as a blood vessel (e.g., an artery) or a lung segment.

[0060] Implantable device 300 may include tube 310 having a first lumen 312 containing microparticles 314. In some embodiments, the diameter of each microcapsule 314 is between 0.5 and 0.9 of the hydraulic diameter of the first lumen. In some embodiments, device 300 (and therefore tube 310) is sized to be implanted in an organ of a subject. Figure 3 In the non-limiting example shown, the organ can be a blood vessel (e.g., an artery) of a subject, and the hydraulic diameter of the first lumen 312 can be between 150 and 3500 microns. In another non-limiting example, the organ can be a lung segment of a subject, and the hydraulic diameter of the first lumen 312 can be between 120 and 1500 microns. In some embodiments, the tube 310 can be made of a flexible material that is configured to adjust to the shape of the blood vessel or lung segment.

[0061] In some embodiments, each microcapsule 314 has a diameter between 60 microns and 3150 microns, or any value therebetween.

[0062] In some embodiments, the particles 314 may include magnetic materials or conductive materials that are configured to be detected by sensors capable of detecting such materials. For example, the particles 314 may include metal powders, carbon powders, ceramic materials, and the like.

[0063] In some embodiments, the device 300 may further include a reservoir 320, the reservoir 320 including 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% lower than the density of the liquid 324, such as at least 7%, at least 10%, at least 15%, at least 20%, at least 30%, at least 40%, at least 50%, or more. In a non-limiting example, the microparticles 314 may be microcapsules filled with air or any other gas or solution lighter than the liquid, and the liquid 324 may be water, subcutaneous injection fluid, any intravenous injection fluid, silicone-based gel or other viscous biocompatible fluid, etc.

[0064] In some embodiments, the material of the flexible cover 322 is selected such that pressure (eg, blood pressure) exerted on the flexible cover 322 after implantation causes the fluid 324 to flow from the reservoir 320 into the first lumen 312. Figure 3 In a non-limiting example, the reservoir 320 is a balloon and the flexible cover 322 is included in the shell of the balloon.

[0065] In some embodiments, the device 300 may further include a gas reservoir 330 in fluid communication with the second end 315 of the first lumen 312. Figure 3 In a non-limiting example, the tube 310 may include a second lumen 330 that serves as a gas reservoir.

[0066] Reference now Figure 4 , which is a flow chart of a method of determining in vivo pressure in an organ of a subject according to some embodiments of the present invention. Figure 4 The method can be obtained by Figure 5 The method may be performed by the computing device 10 or any other computing device as described and discussed. In some embodiments, the method may be performed after a device such as device 100, 200, 250, or 300 is implanted in an organ of a subject.

[0067] In step 410, a signal may be received from an external detector that indicates the location of one or more particles included in an implantable device implanted in an organ. For example, the signal may be an image of an eye showing particles 14, 114, or 214. In another example, the signal may be a thermal image of an arm showing metal particles 340 within a blood vessel. In yet another example, the image may be a chest X-ray image showing metal / magnetic particles 340 in a lung segment. In some embodiments, at least one particle may be detected in the image, for example, a single particle, or a plurality of different particles, each of which may be separately detected in the image.

[0068] In step 420, the location of one or more particles can be determined based on the signal. In a non-limiting example, determining the location can 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 location of the second end 15 / 115 / 225 / 315 (and preferably another location between the two). The method can 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 relative to the two known locations. For example, any image analysis program can 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 the non-limiting example of an optical image, the first end 13 / 113 and the second end 15 / 115 can be marked with a fluorescent material or a specific color. In the non-limiting example of thermal and / or X-ray images, the first end 313 and the second end 315 may be labeled with conductive or magnetic markers. Thus, the location of the particle may be determined based on the signal indicative of the location of the particle and the at least two known locations.

[0069] In step 430, at least one previously recorded position of the microparticle may be received, for example, from a storage system 6 of a computing device 9. The previously recorded position may be determined in a manner similar to the determination discussed in step 420, using a signal received from the same external detector, detecting the same implantable device implanted in the same organ.

[0070] In step 440, a change in position of the particles (each particle individually) between the received position and at least one previously recorded position is detected. The change may represent movement of the particles due to a change in in vivo pressure in the organ, which presses the flexible cover 22 / 122 / 322, thereby causing the liquid 24 / 124 / 32 to flow from the reservoir 20 / 120 / 320 to the tube 10 / 110 / 310, while pushing the particles 14 / 114 / 314 to move along the first lumen 12 / 112 / 312 or vice versa. The higher the in vivo pressure, the greater the detected change. Therefore, in step 450, the in vivo pressure may be determined based on the change in position. In some embodiments, a lookup table may be stored in the storage system 6, which may relate the change in position to the level of in vivo pressure.

[0071] In one non-limiting example, the external detector is an optical camera, and the method includes: receiving an image of the eye 5 from an optical camera, such as an optical camera included in the user device 80, the image including an image of the particle 14 or 114; determining from the image the position of the particle in the lumen 12 or 112. The method may further include receiving at least one previously recorded position of the particle in the lumen; and detecting the intraocular pressure if the change in position is greater than a threshold.

[0072] In another non-limiting example, the external detector is a thermal imager, which may be included in the user device 80 or may be a dedicated device, and the in vivo pressure may be the blood pressure of the subject.

[0073] In another non-limiting example, the external detector is an X-ray camera, MRI or CT device, and the in vivo pressure can be the pressure of a lung segment.

[0074] Reference now Figure 5 , which is a block diagram depicting a computing device, which may be included in embodiments of a system for detecting in vivo pressure in an organ of a subject, according to some embodiments.

[0075] The computing device 9 may include a processor or controller 2, which may be, for example, a central processing unit (CPU) processor, a chip or any suitable computing device or computing device, an operating system 3, a memory 4, an executable code 5, a storage system 6, an input device 7, and an output device 8. The processor 2 (or one or more controllers or processors, possibly across multiple units or devices) may be configured to perform the methods described herein, and / or to perform or act as various modules, units, etc. According to embodiments of the present invention, more than one computing device 9 may be included in the system, and one or more computing devices 9 may act as components of the system.

[0076] The operating system 3 may be or may include any code segment (e.g., similar to the executable code 5 described herein) that is designed and / or configured to perform tasks involving coordination, scheduling, arbitration, supervision, control, or otherwise managing the operation of the computing device 10, such as scheduling the execution of software programs or tasks or enabling software programs or other modules or units to communicate. The operating system 3 may be a commercial operating system. It should be noted that the operating system 3 may be an optional component, for example, in some embodiments, the system may include a computing device that does not require or include an operating system 3.

[0077] The memory 4 may be or may 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 storage unit, a long-term storage unit, or other suitable storage unit or storage units. The memory 4 may be or may include a plurality of possibly different memory units. The memory 4 may be a computer or processor non-temporary readable medium, or a computer non-temporary storage medium, such as RAM. In one embodiment, a non-temporary storage medium such as the memory 4, a hard drive, another storage device, etc. may store instructions or codes, which, when executed by the processor, may cause the processor to implement the methods described herein.

[0078] The executable code 5 may be any executable code, such as an application, program, process, task or script. The executable code 5 may be executed by the processor or controller 2 under the control of the operating system 3. For example, the executable code 5 may be an application that may include the method for detecting in vivo pressure in an organ of a subject as described above. Although for clarity, in Figure 5 A single item of executable code 5 is shown in FIG, but a system according to some embodiments of the present invention may include multiple executable code segments similar to the executable code 5, which can be loaded into the memory 4 and cause the processor 2 to execute the method described herein.

[0079] Storage system 6 may be or may include, for example, flash memory as known in the art, memory internal to or embedded in a microcontroller or chip as known in the art, a hard drive, a recordable compact disk (CD-R) drive, a Blu-ray Disc (BD), a universal serial bus (USB) device, or other suitable removable and / or fixed storage device. Previously recorded particle locations of devices 100, 200, and 300 may be stored in storage system 6 and may be loaded from storage system 6 into memory 4 where they may be processed by processor or controller 2. In some embodiments, Figure 5Some of the components shown in the figure may be omitted. For example, the memory 4 may be a non-volatile memory having the storage capacity of the storage system 6. Therefore, although shown as a separate component, the storage system 6 may be embedded or included in the memory 4.

[0080] The input device 7 may be or may include any suitable input device, component or system, such as a detachable keyboard or keypad, a mouse, etc. The output device 8 may include one or more (possibly detachable) displays or monitors, speakers and / or any other suitable output device. As shown in boxes 7 and 8, any applicable input / output (I / O) device may be connected to the computing device 1. For example, the input device 7 and / or the output device 8 may include a wired or wireless network interface card (NIC), a universal serial bus (USB) device, or an external hard disk. It should be appreciated that any appropriate number of input devices 7 and output devices 8 may be operatively connected to the computing device 9 as shown in boxes 7 and 8.

[0081] 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.

[0082] Unless explicitly stated, the method embodiments described herein are not limited to a particular order or sequence. In addition, all formulas described herein are examples only, and other or different formulas may also be used. In addition, some of the method embodiments described or their elements may occur or be implemented at the same time point.

[0083] Although certain features of the present invention have been illustrated and described herein, many modifications, substitutions, changes and equivalents will occur to those skilled in the art. It is therefore intended that the appended claims cover all such modifications and changes that fall within the true spirit of the invention.

[0084] Various embodiments have been proposed. Of course, each of these embodiments may include features of other embodiments proposed, and embodiments not specifically described may include various features described herein.

Claims

1. An implantable device comprising: a tube having a first lumen including one or more particles surrounded by a first liquid; a reservoir including a flexible cover in fluid communication with the first end of the first inner cavity for providing a second liquid to the first inner cavity; a gas reservoir in fluid communication with the second end of the first inner cavity; Each particle has a diameter between 0.5 and 0.9 of the hydraulic diameter of the first lumen and comprises a material that allows movement of each particle to be individually detected by an external device.

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

3. The implantable device of claim 1, wherein the first liquid and the second liquid are immiscible.

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

5. The implantable device according to any one of claims 1-4, wherein the tube is curved or straight.

6. The implantable device according to any one of claims 1 to 5, wherein the tube is made of a flexible material.

7. The implantable device of any one of claims 1-6, wherein the microparticles comprise a material visible in an image captured with an optical camera.

8. The implantable device of claim 7, wherein the microparticles are colored with a color detectable in the image.

9. The implantable device of claim 7, wherein the microparticles are colored with a fluorescent color.

10. The implantable device according to any one of claims 1 to 6, wherein the microparticles comprise magnetic material and / or conductive material.

11. The implantable device of any one of claims 1-10, wherein the diameter of each microparticle is greater than 15 microns.

12. The implantable device of any one of claims 1-10, wherein the reservoir is a balloon, and wherein the flexible cover is included in a housing of the balloon.

13. The implantable device of claim 12, further comprising a second inner cavity serving as the gas reservoir.

14. The implantable device according to any one of claims 1 to 12, wherein the reservoir has a flat shape, an open face of which is covered by a flexible membrane.

15. The implantable device of claim 14, wherein the gas reservoir has a flat shape.

16. The implantable device of any one of claims 1-15, wherein the organ is an eye of a subject, and wherein the hydraulic diameter of the first lumen is between 40 and 150 microns.

17. The implantable device of any one of claims 1-15, wherein the organ is a blood vessel of a subject, and wherein the hydraulic diameter of the first lumen is between 150 and 3500 microns.

18. The implantable device of any one of claims 1-15, wherein the organ is a lung segment of a subject, and wherein the hydraulic diameter of the first lumen is between 120 and 1500 microns.

19. The implantable device of any one of claims 1-18, wherein the material of the flexible cover is selected such that pressure applied to the flexible cover after implantation causes fluid to flow from the reservoir into the first lumen.

20. The implantable device of any one of claims 1-19, wherein the microparticles are microcapsules.

21. A method for determining in vivo pressure in an organ of a subject, the method comprising: receiving a signal from an external detector indicative of a location of one or more microparticles included in an implantable device implanted in the organ; determining a position of the one or more particles based on the signal; receiving at least one previously recorded position of the one or more particles; detecting a change in position of the one or more particles between the received position and the at least one previously recorded position; and The in vivo pressure is determined based on the change in position.

22. The method of claim 21 , wherein determining the position of the one or more particles comprises: receiving at least two known locations in the implantable device; identifying the at least two known locations in the received signal; and The position of the one or more particles is determined based on the signal indicative of the position of the one or more particles and the at least two signals.

23. The method of claim 21 or claim 22, wherein receiving at least one previously recorded position of the one or more particles comprises receiving a plurality of previously recorded positions associated with different dates.

24. The method of any one of claims 21-23, wherein the organ is an eye, and wherein the in vivo pressure is intraocular pressure.

25. The method of claim 24, wherein the external detector is an optical camera and the method comprises: receiving an image of the eye from the optical camera, the image including an image of the one or more particles; determining a location of the one or more particles in the lumen from the image; receiving at least one previously recorded position of the one or more particles in the lumen; and If the position change is greater than a threshold, the intraocular pressure is detected.

26. The method of any one of claims 21-25, wherein the organ is a blood vessel, and wherein the in vivo pressure is blood pressure.

27. The method according to any one of claims 21-25, wherein the external detector is thermal imaging, X-ray imaging, magnetic imaging (MRI) and computed tomography (CT).