Medical devices for connecting tissue that encode information and / or indicate status of local environment

Abstract

Medical devices for connecting, for example holding together, tissue may include one or more identification elements and / or one or more environmental status elements. Some such medical devices are imageable with at least one imaging modality, such as one using x-rays, radio waves, sound waves, or more than one of these. An identification element may be used to identify medical devices. An environmental status element may be used to indicate one or more characteristics of a local environment for a medical device. An identification element and / or an environmental status element may be a portion of a medical device. For example, an identification element and / or an environmental status element may be embedded in, woven into, integrated with, disposed on or in, and / or coated onto or into a medical device. Methods of using such structures and medical images in which such structures are discernable also disclosed.

Description

Attorney Docket No. : 2019150-0019MEDICAL DEVICES FOR CONNECTING TISSUE THAT ENCODE INFORMATION AND / OR INDICATE STATUS OF LOCAL ENVIRONMENTCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and benefit of U.S. Provisional Patent Application No. 63 / 640,588 filed April 30, 2024, the disclosure of which is incorporated by reference herein in its entirety.BACKGROUND

[0002] Most medical devices include identifying information, such as a manufacturer, model, serial number, or combination thereof, that is physically indicated on or in the device itself. For example, total joint replacements and other implants are almost always inscribed or otherwise marked with a serial number. Such serial numbers allow for the implants to be tracked, both within a hospital and back to a manufacturer. Such tracking may be performed, for example, for utilization analysis or in case a manufacturing defect requires further analysis, respectively. However, medical devices that connect (e.g., hold together) tissue, such as sutures, suture tape, or surgical meshes, do not include identifying information. Such medical devices are used in medical (e.g., surgical) procedures for a variety of purposes. For example, a suture may be used to connect (e g., hold) torn or cut tissue in a wound or to connect (e.g., hold) sides of an incision used in a surgical procedure (e g., as an entry point or as part of a resection). These medical devices cannot be tracked for any reason because they do not include identifying information. There is a need, therefore, for medical devices that connect tissue to be able to be identified.SUMMARY

[0003] Disclosed herein are, inter alia, medical devices for connecting (e.g., holding) tissue that include an identification element that encodes information. Encoded information may include, for example, a serial number, a lot number, a batch number, or a combination thereof. Encoded information may alternatively or additionally include a manufacturer of the medical device and / or a model of the medical device. One or more encoding portions may encode information. For example, radiopaque encoding portion(s) may be used to encode information, such as a serial number. In some embodiments, an encoding portion is a filament or fiber, for example that is part of a thread such as a multifilament thread. In some embodiments, anPage 1 of 9512747491 vlAttorney Docket No. : 2019150-0019 identification element is readable using x-rays, radio waves (e.g., in combination with a magnetic field), sound waves, or more than one of these. In some embodiments, an identification element is readable using a medical imaging modality, such as, for example, x-ray imaging, magnetic resonance imaging (MRI), computed tomography (CT), sonography (e.g., ultrasound), or more than one of these. Information may be encoded based on spatial arrangement, spatial distribution (e.g., spacing), position, orientation, shape, size, construction to produce a responsive signal (e.g., material), or a combination thereof of one or more encoding portions.

[0004] Structures similar (e.g., identical) to identification elements may be used to indicate one or more characteristics of a local environment for a medical device. Disclosed herein are also, inter alia, medical devices for connecting (e.g., holding) tissue that include an environmental status element that is structured to be readable to indicate one or more characteristics of a local environment for the medical device. An environmental status element may be structured to be so readable in that it includes one or more radiopaque portions that are in a configuration (e.g., arrangement and / or made of material) such that the environmental status element is readable to indicate the one or more characteristics. Thus, medical devices for connecting tissue disclosed herein may provide information about a local environment that may otherwise not be readily observable. For example, it is often difficult to tell the state of internal tissue after a surgical procedure on the tissue. A state of internal tissue may be difficult or impossible to discern in medical images, such as x-ray images or MRIs. In some embodiments, a medical device includes an environmental status element that is readable to indicate one or more characteristics of a local environment, for example in x-ray image or MRI. In some embodiments, an environmental status element may be readable based on configuration (e.g., spacing and / or material).

[0005] A medical device for connecting (e.g., holding together) tissue may be a suture, suture tape, or a mesh (e.g., surgical mesh). A medical device may include a suture anchor. A medical device for connecting tissue may include one or more identification elements and / or one or more environmental status elements. For example, a suture may include an identification element and / or an environmental status element, which may be the same element or different elements. In some embodiments, a medical device includes a suture anchor physically associated with an identification element and / or environmental status element. In some embodiments, the suture anchor includes the identification element and / or the environmental status element.Page 2 of 9512747491 vlAttorney Docket No. : 2019150-0019

[0006] Medical devices for connecting tissue are often sold in larger quantities than are needed for a particular use. For example, sutures may be sold in multi-meter lengths that are then cut down to the needed size during a surgical procedure. Therefore, it is generally not known at the outset which portion of a medical device may be used in a given procedure. Thus, in some embodiments a medical device includes a plurality of identification elements that each encode same information (e.g., a plurality of identical identification elements).

[0007] A plurality of identification elements may be spatially separated on a medical device, for example along a long axis of the medical device. Adjacent identification elements may be separated from each other by a distance of no more than 3 cm (e.g., wherein the distance is no more than 2 cm, no more than 1 cm, or no more than 0.5 cm). Identification elements may each be no more than 3 cm in a longest dimension (e.g., no more than 2 cm, no more than 1 cm, or no more than 0.5 cm in the longest dimension). Identification elements may repeat at a linear density of at least 0.2 per cm (e.g., at least 0.33 per cm, at least 0.5 per cm, at least 0.75 per cm, at least 1 per cm, at least 1.5 per cm, at least 2 per cm, or at least 3 per cm). Different identification elements may include different portions of the same material(s) and / or structure(s). For example, a suture may include one or more radiopaque filaments that are arranged in a spiral pattern where one or more repeated spacings and / or phase in the spiral pattern repeatedly encode same information along the spiral pattern thereby defining a plurality of identification elements. Similarly, multiple environmental status elements may be included in a medical device in a manner just described for identification elements.

[0008] By including multiple identification elements, for example at a high density, it can be highly likely or completely assured that at least one whole identification element is included in a portion of a medical device that is used (e.g., in a surgical procedure). Moreover, because encoding schemes disclosed herein can encode information in small areas, physically small identification elements, either alone or in combination with high density, may aid the likelihood that at least one whole identification element is included in a portion of a medical device. By including multiple identification elements that encode same information in a medical device, it is not necessary for a user (e.g., nurse, physician, and / or surgeon) to be able to physically see an identification element and / or to select a specific portion of a medical device for use in order to ensure that a whole identification element is included in a used portion of a medical device.Page 3 of 9512747491 vlAttorney Docket No. : 2019150-0019

[0009] Also disclosed herein are non-transitory medical images of tissue connected (e.g., held together) by a medical device disclosed herein. In some embodiments, information identifying a medical device is discernable in a medical image. In some embodiments, one or more characteristics of a local environment near tissue connected by a medical device in a medical image. A medical image may be a radiological image. A medical image may be an x-ray image (e.g., a dual energy x-ray absorptiometry image), an MRI image, a CT image, or a sonogram (e.g., an ultrasound image). A medical image may be an image of an internal portion (e.g., internal tissue) of a subject (e.g., human or non-human animal, such as cat or dog). A medical image (e.g., of internal tissue) may be acquired from outside of a body, for example as is conventionally done in x-ray, MRI, CT, or ultrasound imaging. Without medical devices disclosed herein, such medical images are not possible for medical devices that connect tissue. Conventional medical devices for connecting tissue, such as sutures, are generally not visible in images of internal tissue, and, in any case, there is no portion of conventional medical devices for connecting tissue that can be used to identify the medical devices (e.g., manufacturer, model, serial number), let alone once the medical device is placed internally (e.g., and therefore only observable from outside imaging).

[0010] The present disclosure includes medical devices for connecting tissue that include one or more passive identification elements and / or one or more passive environmental status elements. Medical devices for connecting tissue that include a passive identification element as disclosed herein provide simple mechanisms to encode information. Such simple mechanisms may (i) be able to be integrated a medical device itself without substantively altering core functionality or structure of the medical device, (ii) avoid the need for power and / or complicated circuitry in order to be read, and / or (iii) not require special and / or additional procedures to be read. For example, a multifilament suture or multifiber suture tape may include one or more identification elements and / or one or more passive environmental simply by using one or more radiopaque filaments or fibers in place of conventional filament(s) or fiber(s), respectively. In some embodiments, a medical device for connecting tissue that includes an identification element and / or environmental status element has same dimensions and / or shape as an otherwise equivalent medical device without the element(s). For example, a suture, suture tape, or mesh as disclosed herein may appear and behave substantially identically to a conventional suture, suture tape, or mesh to a user, such as a nurse, physician, or surgeon. As another example, radio frequency IDPage 4 of 9512747491 vlAttorney Docket No. : 2019150-0019(RFID)-type (active) identification schemes would be unsuitable for medical devices disclosed herein due to issues related to power and circuitry, in-situ readability, and biocompatibility (e.g., safety). As another example, passive identification elements and passive environmental status elements as disclosed herein can be read as part of a routine (e.g., planned) medical imaging procedure, for example without the need to use any special imaging procedure or steps. For example, information can be acquired by reading identification element(s) and / or environmental status element(s) via conventional medical imaging procedures, such as x-ray, CT, MRI, and ultrasound.

[0011] Any two or more of the features described in this specification, including in this summary section, may be combined to form implementations of the disclosure, whether specifically expressly described as a separate combination in this specification or not.BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The present teachings described herein will be more fully understood from the following description of various illustrative embodiments, when read together with the accompanying drawings. It should be understood that the drawing described below is for illustration purposes only and is not intended to limit the scope of the present teachings in any way. The foregoing and other objects, aspects, features, and advantages of the disclosure will become more apparent and may be better understood by referring to the following description taken in conjunction with the accompanying drawings, in which:

[0013] Fig. 1 illustrates an example of a medical device including an identification element, according to illustrative embodiments of the present disclosure;

[0014] Fig. 2A illustrates an example of a medical device including an identification element, according to illustrative embodiments of the present disclosure;

[0015] Fig. 2B illustrates an example of a medical device including an identification element, according to illustrative embodiments of the present disclosure;

[0016] Fig. 2C illustrates an example of a medical device including an identification element, according to illustrative embodiments of the present disclosure;

[0017] Fig. 2D illustrates an example of a medical device including an identification element, according to illustrative embodiments of the present disclosure;Page 5 of 9512747491 vlAttorney Docket No. : 2019150-0019

[0018] Fig. 3A illustrates an example of a medical device including an identification element, according to illustrative embodiments of the present disclosure;

[0019] Fig. 3B illustrates an example of a medical device including an identification element, according to illustrative embodiments of the present disclosure;

[0020] Fig. 3C illustrates an example of a medical device including an identification element, according to illustrative embodiments of the present disclosure;

[0021] Fig. 3D illustrates an example of a medical device including an identification element, according to illustrative embodiments of the present disclosure;

[0022] Fig. 4A illustrates an example of a medical device including an environmental status element, according to illustrative embodiments of the present disclosure;

[0023] Fig. 4B illustrates an example of a medical device including an environmental status element, according to illustrative embodiments of the present disclosure;

[0024] Fig. 5A illustrates an example of a medical device including an environmental status element, according to illustrative embodiments of the present disclosure;

[0025] Fig. 5B illustrates an example of a medical device including an environmental status element, according to illustrative embodiments of the present disclosure;

[0026] Fig. 5C illustrates an example of a medical device including an environmental status element, according to illustrative embodiments of the present disclosure;

[0027] Fig. 5D illustrates an example of a medical device including an environmental status element, according to illustrative embodiments of the present disclosure;

[0028] Fig. 6A is a brightfield image of an example of a medical device including an identification element, according to illustrative embodiments of the present disclosure;

[0029] Fig. 6B is an x-ray image of an identification element, according to illustrative embodiments of the present disclosure;

[0030] Fig. 7 shows an example of an identification system including a medical device, according to illustrative embodiments of the present disclosure;

[0031] Fig. 8A shows an example of an identification system including a medical device, according to illustrative embodiments of the present disclosure;

[0032] Fig. 8B is an x-ray image of an identification system, according to illustrative embodiments of the present disclosure;Page 6 of 9512747491 vlAttorney Docket No. : 2019150-0019

[0033] Fig. 9 shows an example of an identification system including a medical device, according to illustrative embodiments of the present disclosure;

[0034] Fig. 10A is a representation of an x-ray image of an identification system, according to illustrative embodiments of the present disclosure;

[0035] Fig. 10B is a representation of an x-ray image of an identification system, according to illustrative embodiments of the present disclosure;

[0036] Fig. 11 illustrates multiple examples of a medical device including a plurality of configurations of identification elements, according to illustrative embodiments of the present disclosure;

[0037] Fig. 12 shows examples of an identification system including a medical device, according to illustrative embodiments of the present disclosure;

[0038] Fig. 13 illustrates multiple examples of a medical device including identification elements in a mesh configuration, according to illustrative embodiments of the present disclosure;

[0039] Fig. 14 illustrates a longitudinal view of an example of a medical device including identification elements, according to illustrative embodiments of the present disclosure;

[0040] Fig. 15A illustrates an exemplary cross-sectional view of a coreless, braided suture, according to illustrative embodiments of the present disclosure;

[0041] Fig. 15B illustrates an exemplary cross-sectional view of a coreless, braided suture, according to illustrative embodiments of the present disclosure;

[0042] Fig. 16A illustrates an exemplary cross-sectional view of a coreless, braided suture, according to illustrative embodiments of the present disclosure;

[0043] Fig. 16B illustrates an exemplary cross-sectional view of a coreless, braided suture, according to illustrative embodiments of the present disclosure;

[0044] Fig. 17 illustrates an exemplary simulation of a longitudinal X-ray image of a taut braided structure including identification elements, according to illustrative embodiments of the present disclosure;

[0045] Fig. 18 is a flow chart diagram of a method of identifying a medical device, according to illustrative embodiments of the present disclosure;Page 7 of 9512747491 vlAttorney Docket No. : 2019150-0019

[0046] Fig. 19 is a flow chart diagram of a method of determining characteristics of the local environment of a medical device, according to illustrative embodiments of the present disclosure;

[0047] Fig. 20 is a block diagram of an example network environment for use in the methods and systems described herein, according to illustrative embodiments of the present disclosure; and

[0048] Fig. 21 is a block diagram of an example computing device and an example mobile computing device, for use in illustrative embodiments of the present disclosure.DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

[0049] Disclosed herein are medical devices for connecting (e.g., holding together) tissue that include one or more identification elements and / or one or more environmental status elements. Some such medical devices may be used to connect (e.g., hold) tissue of humans and / or non-human animals. Some such medical devices may be used in medical and / or veterinary applications (e.g., surgery). Some such medical devices are imageable with at least one (non-visible-wavelength) imaging modality, such as one using x-rays, radio waves, sound waves, or more than one of these. A passive identification element may be used to identify medical devices. A passive environmental status element may be used to indicate one or more characteristics of a local environment for (e.g., near) a medical device. The one or more characteristics may be a tension state of the medical device and / or a local pH near the medical device. An identification element and / or an environmental status element may be a portion of a medical device (e.g., distinct portions or a common portion). For example, an identification element and / or an environmental status element may be embedded in, woven into, integrated with, disposed on or in, and / or coated onto or into a medical device. Methods of using such structures and medical images in which such structures are discernable also disclosed.Identification Elements

[0050] Identification elements disclosed herein (e.g., that include one or more encoding portions that are radiopaque and / or that attenuate sound waves to encode information) may be included in a medical device. For example, an identification element may be embedded in aPage 8 of 9512747491 vlAttorney Docket No. : 2019150-0019 medical device, disposed internally to a medical device, disposed on or in an interior of a medical device, woven or braided into a medical device, or disposed on or in an internal component of a medical device.

[0051] An identification element may encode information using one or more encoding portions. An encoding portion may be radiopaque. An encoding portion may be readable using x-rays, radio waves (e.g., in combination with a magnetic field), sound waves, or a combination thereof (more than one of these). An encoding portion may produce signal in response to x-rays, radio waves (e.g., in combination with a magnetic field), sound waves, or a combination thereof. For example, an encoding portion may produce signal by selective absorption, absorption and emission (e.g., of a different characteristic particle or signal from an excitation particle or signal), reflection, refraction, or a combination thereof. For example, different produced signal may result in different contrast being visible in an image (e.g., a human-readable image). An encoding portion may be readable using an imaging modality, such as, for example, x-ray (e.g., dual -energy x-ray absorptiometry), computed tomography, magnetic resonance imaging, ultrasound, or a combination thereof (more than one of these). An identification element may be readable using x- rays, radio waves (e.g., in combination with a magnetic field), sound waves, or a combination thereof (more than one of these) such that information can be determined from the identification element (e.g., one or more encoding portions thereof). For example, x-ray imaging (e.g., dualenergy x-ray absorptiometry), magnetic resonance imaging (MRI), computed tomography (CT), and / or sonography (e.g., ultrasound) may be used to read an identification element or one or more encoding portions.

[0052] An encoding portion may be radiopaque (e.g., to x-rays and / or radio waves) and / or attenuate sound waves. For example, an encoding portion may be a radiopaque thread, a radiopaque fiber, or a radiopaque filament. An encoding portion may include one or more radiopaque contrasting agents, one or more metallic elements, one or more radiopaque particles, one or more radiopaque dyes, one or more radiopaque inks (e.g., metallic ink(s)), or a combination thereof. In some embodiments, an encoding portion is optically clear. In some embodiments, an encoding portion includes one or more optically-clear radiopaque dyes, one or more optically-clear radiopaque inks, or both. In some embodiments, an encoding portion includes two (e.g., optically clear) radiopaque species (e.g., inks, dyes, or an ink and a dye) of different radiodensities. ForPage 9 of 9512747491 vlAttorney Docket No. : 2019150-0019 example, gadolinium, iodine, an oxide (e.g., iron oxide or titanium dioxide), barium (e g., as barium sulfate), manganese salt (e.g., manganese chloride), aluminum, bismuth (e.g., elemental bismuth and / or as bismuth oxychloride or bismuth trioxide), titanium, or a combination thereof may be used in an encoding portion.

[0053] A portion of an identification element may be radiopaque (e.g., to x-rays and / or radio waves) and / or attenuate sound waves. Radiopaque does not necessarily mean that all incident x-rays and / or radio waves are blocked (e.g., absorbed). In some embodiments, an identification element includes one or more encoding portions that are radiopaque such that the one or more encoding portions are discernable against background (e.g., an object and / or label) using x-rays and / or radio waves (e.g., in x-ray and / or MRI, respectively). In some embodiments, an identification element includes one or more encoding portions attenuate sound waves such that the one or more encoding portions are discernable against background (e.g., tissue) using sound waves (e.g., in a sonography modality). In some embodiments, an identification element includes one or more encoding portions that enhance visibility in one or more imaging modalities. In some embodiments, an identification element includes a first encoding portion that is radiopaque such that it is discernable from a second radiopaque encoding portion included in the identification element using x-rays and / or radio waves, for example based on wavelength and / or intensity. In some embodiments, an identification element includes a first encoding portion that attenuates sound waves such that, using sound waves, it is discernable from a second encoding portion included in the identification element that attenuates sound waves. An encoding portion may have variable radiodensity or constant radiodensity (or variable attenuation or constant attenuation to sound waves). An encoding portion may have variable attenuation of sound waves or constant attenuation of sound waves. A sound-attenuating encoding portion may be discernable in an imaging modality that uses sound waves based on how the encoding portion attenuates sound waves.

[0054] An identification element may encode information using, for example, one or more contrasting agents, one or more particles, one or more metallic elements, one or more dyes, one or more inks (e.g., metallic ink(s)), one or more threads (e.g., one or more mono-filament threads, one or more multi -filament threads, or a combination thereof), one or more fibers (e.g., one or more mono-filament fibers, one or more multi-filament fibers, or a combination thereof), one orPage 10 of 9512747491 vlAttorney Docket No. : 2019150-0019 more filaments, one or more ribbons, or a combination thereof. An encoding portion of an identification element may be, for example, one or more contrasting agents, one or more particles, one or more metallic elements, one or more dyes, one or more inks (e.g., metallic ink(s)), one or more threads (e.g., one or more mono-filament threads, one or more multi-filament threads, or a combination thereof), one or more fibers (e.g., one or more mono-filament fibers, one or more multi-filament fibers, or a combination thereof), one or more filaments, or one or more ribbons. For example, gadolinium, iodine, an oxide (e.g., iron oxide or titanium dioxide), barium (e.g., as barium sulfate), manganese salt (e.g., manganese chloride), aluminum, bismuth (e.g., elemental bismuth and / or as bismuth oxychloride or bismuth trioxide), titanium, or a combination thereof may be used in an identification element (e.g., one or more encoding portions thereof).

[0055] In some embodiments, an identification element encodes information using one or more optically-clear radiopaque dyes, one or more optically-clear radiopaque inks, or both. In some embodiments, an identification element encodes information using two (e.g., optically clear) radiopaque species (e.g., inks, dyes, or an ink and a dye) of different radiodensities. Such different radiodensity materials may be able to be distinguished during imaging (e.g., x-ray imaging, such as dual-energy x-ray absorptiometry).

[0056] An identification element may encode information using one or more fibers that are braided into a thread (e.g., with or without one or more other fibers). An identification element, such as a thread, filament, or fiber, may include one or more polymer materials, such as, one or more silicones, one or more nylons, one or more polyethylenes (e.g., ultra-high-molecular-weight polyethylene (UHMWPE)), one or more polypropylenes, one or more polyesters, one or more polytetrafluoroethylenes (PTFEs), or a combination thereof. An encoding portion may be a tracer line. An identification element may encode information using a single encoding portion, for example a single filament or single fiber.

[0057] An encoding portion may be braided into an identification element. For example, an identification element may be or include a multifilament fiber where one or more of the filaments in the fiber are encoding portion(s) that encode information. For example, an identification element may be or include a multifiber thread where one or more of the fibers in the thread are encoding portion(s) that encode information. Such a multifilament or multifiber identification element may include a core (e.g., including one or more filaments or one or morePage 11 of 9512747491 vlAttorney Docket No. : 2019150-0019 fibers, respectively) and / or a sheath (e.g., including one or more filaments or one or more fibers, respectively) (e.g., may be coreless). An identification element may encode information using one or more braided elements (e.g., radiopaque braided element(s)). An encoding portion may be a braided element. An encoding portion may be, for example, one or more particles or one or more dyes disposed in or on a thread, fiber, or filament. In some embodiments, an encoding portion is or is included in a core of an identification element (e.g., a core of a fiber or thread). In some embodiments, an encoding portion is or is included in a sheath of an identification element (e.g., a sheath of a fiber or thread) (e.g., whether or not a core is present).

[0058] An encoding portion may have different radiodensity (whether variable or constant) than other material in an identification element (e.g., other fiber(s) and / or filament(s)) and / or an object. In some embodiments, a radiopaque portion of an identification element (e.g., an encoding portion) has a radiodensity that is at least at least l .lx, at least 1.2x, at least 1.3x, at least 1.4x, at least 1.5x, at least 2x, at least 3x, at least 4x, at least 5x, or at least lOx a radiodensity of one or more other portions (e.g., non-encoding portion(s)) of a medical device that includes the identification element. In some embodiments, a radiopaque portion of an identification element (e.g., an encoding portion) has a radiodensity that is at least at least 1. lx, at least 1 ,2x, at least 1 ,3x, at least 1 ,4x, at least 1 ,5x, at least 2x, at least 3x, at least 4x, at least 5x, or at least lOx a radiodensity of tissue, for example human tissue or non-human animal (e.g., cat or dog) tissue.

[0059] In some embodiments, an identification element encodes multiple pieces of information (e.g., corresponding to a model and a manufacturer or a serial number and a manufacturer or a lot number and a model or a batch number and a model). In some embodiments, an identification element encodes information corresponding to multiple identities (e.g., corresponding to a model and a manufacturer or a serial number and a manufacturer or a lot number and a model or a batch number and a model). A medical device may include multiple identification elements that together encode multiple copies of information. In some embodiments, a medical device includes multiple identification elements where the multiple identification elements encode same information. In some embodiments, a medical device includes multiple identification elements where two or more of the identification elements encode different information, for example at least one of the identification elements encodes information identifying a manufacturer and at least one of the identification element encodes information identifying a model. MultiplePage 12 of 9512747491 vlAttorney Docket No. : 2019150-0019 identification elements included in a medical device may be disposed at different portions of the medical device (e.g., may be physically separated). Multiple identification elements may be formed from different portions of one or more common structures. For example, a suture may include one or more radiopaque filaments that form a distinct pattern that repeats over the length of the suture thereby defining multiple identification elements.

[0060] In some embodiments, an identification element includes one or more portions that indicate a start point and / or end point of information encoded in the identification element (e.g., of the information). In some embodiments, an identification element includes one or more portions that encode information indicating a start point and / or end point of the information encoded in the identification element. In some embodiments, an identification element includes one or more portions that encode information indicating a start point and / or end point of a region of an identification element that encodes the information. For example, one or more portions indicating a start point may precede a portion of an identification element that corresponds to (e.g., encodes) a first character of the information. For example, one or more portions indicating an end point may succeed a portion of an identification element that corresponds to (e.g., encodes) a last character of the information.

[0061] In some embodiments, different encoding portions of an identification element are spatially separated from each other such that different portions (e.g., characters) of information are discretely encoded in an identification element. For example there may be blank space in an identification element in which no encoding portion is present between portions of the identification element. The size, shape, and / or spacing (e.g., pattern of spacings) of such blank space (that is, the size, shape, and / or spacing between distinct encoding portions) may itself act to encode information. For example, an encoding may be based not only on characteristics within encoding portions but also how the encoding portions are separated and / or sized relative to each other.

[0062] An identification element may be embedded into a medical device. An identification element may be integrated with (e.g., within) a medical device. An identification element may be a portion of a medical device. An identification element may be woven into a medical device. An identification element may be disposed on an interior of a medical device. AnPage 13 of 9512747491 vlAttorney Docket No. : 2019150-0019 identification element may be disposed on a surface of a medical device. An identification element may be internal to a medical device.

[0063] In some embodiments, an identification element is no more than 3 cm, no more than 2 cm, no more than 1 cm, no more than 5 mm, no more than 4 mm, no more than 3 mm, no more than 2 mm, or no more than 1 mm in at least one dimension (e.g., a length dimension and / or a diameter dimension). In some embodiments, an encoding portion is no more than 3 cm, no more than 2 cm, no more than 1 cm, no more than 5 mm, no more than 4 mm, no more than 3 mm, no more than 2 mm, or no more than 1 mm in at least one dimension (e.g., a length dimension and / or a diameter dimension). In some embodiments, each of one or more identification elements is no more than 3 cm, no more than 2 cm, no more than 1 cm, or no more than 0.5 cm in a longest dimension. In some embodiments, adjacent identification elements included in a medical device are separated by a distance of no more than 3 cm, no more than 2 cm, no more than 1 cm, or no more than 0.5 cm. In some embodiments, identification elements repeat at a linear density of at least 0.2 per cm, at least 0.33 per cm, at least 0.5 per cm, at least 0.75 per cm, at least 1 per cm, at least 1.5 per cm, at least 2 per cm, or at least 3 per cm.

[0064] At least a portion of a medical device for connecting tissue may be optically clear and / or not radiopaque, for example an identification element or non-identification-element portion. Identification elements disclosed herein may be of a size or construction such that they are not visible to an unaided human viewer. For example, they may be too small to be noticeable or may be made of materials that make any encoded information undiscernible without magnification and / or viewed using the appropriate probe waves (e.g., using the appropriate imaging modality or modalities). Moreover, certain manners of encoding information may make an identification element appear uniform unless viewed in the appropriate manner (e.g., magnification and / or imaging modality). For example, color of an identification element in the visible spectrum may appear uniform but radiodensity varies. In some embodiments, information is encoded by an identification element using one or more optically clear encoding portions, for example that include (e.g., are formed by) optically clear but radiodense ink or dye. In general, for medical applications, it is irrelevant whether or not identification elements are noticeable to an unaided human viewer. In some embodiments, it is preferable that one or more identification elements included in a medical device for connecting tissue are observable to an unaided humanPage 14 of 9512747491 vlAttorney Docket No. : 2019150-0019 viewer (e.g., are radiodense and visible). Such identification element(s) may allow a user to identify relevant identifying information, such as manufacturer, model, serial number, lot number, and / or batch number, without needing to use an imaging modality to view the information. Thus, simple observation or confirmation of information can occur before placing a medical device and an imaging modality can be used after placement as needed or desired to (further) confirm the information.

[0065] An element that includes one or more encoding portions may encode information, such as, for example, identifying information. In some embodiments, a medical device for connecting tissue includes an element that encodes information. The information may be identifying information.Information

[0066] Information may be multiple digits. Information may be multiple characters. Information may include one or more letters and / or one or more numbers. Information may be unique to, or uniquely identify, a medical device (e.g., a serial number). Information may be unique to, or uniquely identify, a type of medical device, for example may identify a model, a lot number, or a batch number. Information may be unique to a manufacturer of a medical device. Information may be unique to, or uniquely identify, an organization (e.g., company or hospital) (e g., manufacturer). Information may be or identify a manufacturer and / or model of a medical device. Information may be or identify a lot number, a batch number, or a serial number.

[0067] An encoding portion may encode a single character (e.g., letter or number) of information. Multiple encoding portions may together encode a single character (e.g., letter or number). Information encoded by an identification element may be no more than 50, no more than 25, no more than 20, no more than 15, no more than 10, or no more than 5 characters long, for example to facilitate smaller identification element sizes and / or easy reading of an identification element. An identification element may encode information in a base that is not base 10. For example, an identification element may encode information in binary (base 2). Information may be encoded in binary using, for example, two types of encoding portions having different radiodensities. Information may be encoded as a readable pattern (e.g., a barcode). An identification element may encode information as a barcode.Page 15 of 9512747491 vlAttorney Docket No. : 2019150-0019

[0068] One or more encoding portions of an identification element may be spatially arranged, spatially distributed, phased positioned, oriented, shaped, sized, constructed to produce a responsive signal, or a combination thereof to encode one or more characters (e.g., letter(s) and / or number(s)) of information. For example, a spacing between adjacent encoding portions may correspond to a character (e g., a l or a 0 in binary information or information encoded as a binary code). For example, a spacing between adjacent portions of one or more braided elements (e.g., between adjacent braided elements or portions thereof) may encode information. One or more encoding portions may be phased (e.g., relative to each other) to encode information, for example a phase difference between portions of an encoding portion and / or between different encoding portions. Such phasing may be applied using, for example, spiraled elements (e.g., braided elements). An encoding portion may be constructed to produce a responsive signal in that the signal has a specific wavelength and / or intensity (e.g., by down-conversion of incident energy). An encoding portion may produce a responsive signal by, for example, selective absorption, reflection, refraction, or a combination thereof. Information may be encoded by a spatial distribution, position, and / or size of one or more encoding portions of an identification element. An encoding portion may encode at least a portion of a character of more than one pieces of information. For example, a size of an encoding portion (e.g., particle) may correspond to a first piece of information (e.g., identifying a manufacturer) and shape (or spacing) of the encoding portion may correspond to a second piece of information (e.g., identifying a model).

[0069] Information may be a particular arrangement (e.g., pattern) of one or more encoding portions. Thus, information need not necessarily correspond to a set (e g., string) of characters (e.g., a string of letters and / or numbers). For example, information may be a particular spatial arrangement, spatial distribution, phase, position, orientation, size, construction to produce a responsive signal, or combination thereof of one or more encoding portions. For example, a manufacturer of a medical device may use information that is a particular spiral arrangement (e.g., pattern) (e.g., that produces a particular signal in response to x-rays) and an identification element that includes one or more encoding portions with characteristics that correspond to the spiral arrangement (e.g., when x-rays are applied) therefore encodes the information. Such a spiral arrangement may be based on phase, for example such that one or more encoding portions are phased relative to each other to encode at least a portion of an authentication code. In somePage 16 of 9512747491 vlAttorney Docket No. : 2019150-0019 embodiments, for example where information is a string (e.g., of letter(s) and / or number(s)), a mapping is used to correspond arrangements (e.g., patterns) to a character set used for the string. As another example, a set of ordered spacings of encoding portions or a set of ordered spacings of a single encoding portion may be used as information without the set corresponding to certain characters (e.g., letter(s) or number(s)).

[0070] In some embodiments, different encoding portions with different radiodensities may be used as an arrangement (e.g., pattern) that encodes information. In some embodiments, an arrangement may be formed by a particular (e.g., ordered) sequence of one or more encoding portions different radiodensities. For example, a particular sequence of one or more particles / cluster of particles and / or one or more filaments (e.g., in a spiral) may be used as information (or portion thereof). For example, a certain alternation of two or more (e.g., three or four) encoding portion(s) of different radiodensities may be used, like an AB-type sequence (e.g., AABABBABB) or ABC-type sequence (e.g., ABBCBAAC).

[0071] In some embodiments, a variable radiodensity may be used as an arrangement (e.g., pattern) that is information. For example, a length over the variation occurs and / or a function of intensity over distance may define an arrangement that is information. In some embodiments, identifying information may be encoded based on how high or low radiodensity is at one or more given points along an encoding portion of an identification element that encodes the information. For example, one manufacturer may use a higher radiodensity encoding portion(s) and another manufacturer may use lower radiodensity encoding portion(s), whether constant or variable, as identifying information, either alone or, in many embodiments, in combination with one or more other manners for encoding information. For example, a trained and / or experienced user may be able to distinguish a medical device from one manufacturer and a medical device from another manufacturer based on radiodensity, alone or in combination with other manner(s) of encoding information.Page 17 of 9512747491 vlAttorney Docket No. : 2019150-0019Methods of Determining Identity

[0072] Identification elements disclosed herein may be used in methods of identifying medical devices, for example in-situ. In some embodiments, a method includes receiving information for a medical device that has been acquired, at least in part, by reading a passive identification element included in the medical device that encodes the information. For example, reading an identification element may produce information. In some embodiments, a method includes identifying a medical device using received information.

[0073] In some embodiments, a method includes acquiring information, for example by reading an identification element. In some embodiments, reading an identification element includes applying x-rays, radio waves (e.g., in combination with a magnetic field), or sound waves to the identification element and receiving a signal in response. For example, an image may be formed using applied x-rays, radio waves, or sound waves. In some embodiments, reading an identification element includes forming a human readable image (e.g., an x-ray image, a CT image, an ultrasound image, or an MRI image). A human readable image is interpretable by a human, whether or not the image is ultimately processed or interpreted by a human or a computer. Thus, in some embodiments, signal received in response to applied waves may be translated into information.

[0074] In some embodiments, an identity of a medical device that connects tissue can be determined. An image in which the medical device is discernable may be received. For example, an image may be rendered or displayed by a processor of a computing device. An identity of the medical device may be determined based on how a medical device appears in an image. For example, based on spacing of one or more encoding portions or another manner disclosed herein. A method may include acquiring an image or the image may have been previously acquired. Acquiring an image may include applying x-rays, radio waves (e.g., in combination with a magnetic field), or sound waves to a medical device (e.g., and tissue connected by the medical device), for example through a body and / or from outside of a body (e.g., a human body or a nonhuman animal body). Acquiring an image may include forming an x-ray image, a CT scan, an MRI image, or a sonograph in which the environmental status element is discernable

[0075] A medical device discernable in an image may include an identification element that encodes information that identifies the medical device. An identification element may bePage 18 of 9512747491 vlAttorney Docket No. : 2019150-0019 discernable within an image. A method may include determining information based on an image. Determining an identity may be based on such information. An identity may include a serial number, a lot number, a batch number, or a combination thereof. An identity may include a manufacturer of a medical device and / or a model of a medical device.Environmental Status Elements and Methods of Their Use

[0076] A medical device for connecting (e.g., holding together) tissue may include one or more environmental status elements. An environmental status element may indicate or be structured to be readable to indicate one or more characteristics of a local environment for a medical device. In some embodiments, an environmental status element indicates a tension state of a medical device. In some embodiments, an environmental status element is structured to be readable to indicate a pH of a local environment, a tension of a local environment, a pressure of a local environment, a temperature of a local environment, or a combination thereof [e.g., near (e.g., in contact with) a medical device]. For example, an environmental status element may be coated with a pH sensitive coating, or may be a coating on a medical device, that causes a change in state of the environmental status element upon a change in local pH near the environmental status element. A change in state may be a contraction or expansion (e.g., a radial contraction or expansion). A change in state may be a change in attenuation. An environmental status element may be pH sensitive, tension sensitive, pressure sensitive, temperature sensitive, or a combination thereof.

[0077] In some embodiments, a state of an environmental status element includes a conformational state (e.g., size, shape, and / or spacing) that may change upon change of local environment. In some embodiments, spacing of one or more encoding portions of an environmental status element may change in response to changes in a local environment. For example, spacing of one or more encoding portions may change in response to changes in local pH. As another example, spacing of encoding portions may change when a medical device is under tension. In some embodiments, radial dimension of encoding portions of the environmental status element may change in response to changes of the local environment. For example, a radial dimension of encoding portions may change in response to the changes in local pH.Page 19 of 9512747491 vlAttorney Docket No. : 2019150-0019

[0078] In some embodiments, a medical device may include a plurality of environmental status elements. In some embodiments, environmental status elements may be spatially separated on a medical device. For example, environmental status elements may be spatially separated along a long axis of a medical device (e.g., a long axis of a suture). In some embodiments, different environmental status elements may indicate or be structured to be readable to indicate different characteristics of the local environment from each other. For example, one or more environmental status elements may indicate or be structured to be readable to indicate pH of a local environment and one or more other environmental status elements may indicate or be structured to be readable to indicate tension of a medical device. In some embodiments, one of the environmental status elements may include an identification element that encodes information.

[0079] In some embodiments, a medical device may include one or more identification elements and one or more environmental status elements. In some embodiments, an identification element encodes information in a different manner from a manner in which an environmental status element indicates or is structured to be readable to indicate one or more characteristics of a local environment. For example, an identification element may encode information based on size and / or radiodensity of one or more encoding portions while an environmental status element may indicate or be structured to be readable to indicate one or more characteristics of local environment based on spacing of one or more encoding portions. As another example, an identification element may encode information based on longitudinal spacing of one or more encoding portions (e.g., along a suture) while an environmental status element may indicate or be structured to be readable to indicate one or more characteristics of local environment based on radial spacing of one or more encoding portions. In some embodiments, an environmental status element includes an identification element that encodes information. In some embodiments, an identification element that encodes information includes an environmental status element.

[0080] In some embodiments, a method is for characterizing a local environment near a medical device that is connecting tissue (e.g., connecting two or more tissues) where the medical device includes an environmental status element. A method may include receiving (e.g., by a processor of a computing device) an image of tissue in which an environmental status element is discernable. Receiving may be or include rendering or displaying by a processor of a computing device. A method may include characterizing a local environment near a medical device based onPage 20 of 9512747491 vlAttorney Docket No. : 2019150-0019 how an environmental status element appears in an image, for example based on spacing of one or more encoding portions in the image.

[0081] Characterizing a local environment may include determining a qualitative status of the local environment, for example as healthy or not healthy (e.g., infected). A qualitative status may include a relative acidity of a local environment, a relative temperature of a local environment, a relative pressure of a local environment, or a combination thereof. For example, characterizing a local environment may include determining that the local environment has an elevated acidity relative to baseline. For example, characterizing a local environment may include determining whether a medical device and / or the local environment is under tension. Characterizing a local environment may include determining a quantitative status of the local environment. A quantitative status may include an amount of tension that a medical device is under in a local environment. A method may include determining a health status of tissue, for example based on a qualitative or quantitative status. For example, a method may include determining whether tissue is healthy or not healthy (e.g., infected), for example based on a qualitative or quantitative status. A local environment may be a surgical site and characterizing may include an indication of health of the surgical site. A local environment may be a surgical site and a method may include determining health of the surgical site based on a characterizing.

[0082] In some embodiments, a method is for characterizing pH of tissue near a medical device that is connecting the tissue (e.g., connecting two or more tissues). A method may include receiving (e.g., by a processor of a computing device) an image of tissue in which a medical device (e.g., an environmental status element thereof) is discernable. Receiving may be or include rendering or displaying by a processor of a computing device. A method may include characterizing pH of tissue based on how a medical device appears in an image. Characterizing pH may include determining a relative pH relative to a baseline, for example a baseline that corresponds to healthy corresponding tissue (e.g., same tissue in a healthy state). Determining relative pH may include determining that pH is higher or lower than a previously determined relative pH, for example relative to another image of the same tissue taken at an earlier time. Characterizing may be based on a configuration of a medical device that is discernable in an image, for example based on a configuration of an environmental status element. A configuration may be a configuration of an environmental status element included in a medical device.Page 21 of 9512747491 vlAttorney Docket No. : 2019150-0019

[0083] In some embodiments, a method is for characterizing local pressure near a medical device that is connecting tissue. Pressure is a useful characteristic of a local environment for understanding patient health. For example, compartment syndrome is the increase in interstitial pressure in an anatomical compartment (e.g., edema) that can cause pain and muscle and / or nerve damage and may be indicated by a change in local pressure. While compartment syndrome typically occurs after trauma, it can also be triggered by surgery. In some embodiments, a medical device for connecting tissue includes an environmental status element that is structure to indicate local pressure, for example to identify and / or suggest whether compartment syndrome is occurring. For example, an environmental status element may appear differently (e.g., under x-ray) at one pressure than at another pressure. For example, an environmental status element may include one or more encoding portions that appear to have a first radiodensity at a first pressure and a second radiodensity at a second pressure, for example due to a change in shape, as may be caused due to compression.

[0084] Thus, in some embodiments, a medical device that includes an environmental status element structured to be readable to indicate pressure of a local environment may include one or more compressible materials (e.g., as encoding portion(s)). A compressible material may have a first thickness (e.g., and therefore appear to have a first radiodensity in a two-dimensional radiological image) at a first pressure and a second thickness (e.g., and therefore appear to have a second radiodensity in the two-dimensional radiological image) at a second pressure (e.g., higher than the first pressure) due to compressibility. In some embodiments, a medical device includes an environmental status element that includes a (e.g., thin) pouch that includes radiodense material (e.g., surrounded by a braided sheath). At one pressure (e.g., a baseline pressure) density of radiodense material in such a pouch may be too low to discern in an imaging modality (e.g., x-ray) (e g., against background), whereas at a second, higher pressure, density is higher and therefore the pouch is visible. Such a pouch may be at least partially filled with a liquid or gel (e.g., hydrogel) that includes a radiodense material (e.g., dye). Density may increase due to, for example external (outside of the pouch) venting of solvent for the radiodense material or venting of solvent to a secondary internal portion of the pouch (e.g., thereby compressing one or more walls of the pouch). In some embodiments, for example due to compression of one or more encoding portions, an environmental status element may not be visible using an imaging modality when at a baselinePage 22 of 9512747491 vlAttorney Docket No. : 2019150-0019 pressure (e.g., due to having an apparent radiodensity similar to background) and may be visible using the imaging modality at a second pressure that is above the baseline pressure (e.g., due to compression). In some embodiments, a pattern may appear a first way in an image at a first pressure and appears a different way at a second pressure.

[0085] In some embodiments, there is a range of patterns that can be indicated by an environmental status element, such as a bar which continuously or in steps gets larger as pressure continues to increase (e.g., a variable radiodensity). An environmental status element may indicate relative pressure or absolute pressure (e.g., corresponding to local pressure being within a certain pressure range and / or exceeding a threshold pressure) (e.g., corresponding to a number that is consistent with actual pressure inside an anatomic space). A method may include characterizing local pressure based on how a medical device appears in an image. Characterizing local pressure may include determining a relative pressure relative to a baseline, for example a baseline that corresponds to healthy corresponding tissue. Characterizing may be based on a configuration of a medical device that is discernable in an image, for example based on a configuration of an environmental status element.

[0086] In some embodiments, a method is for characterizing local temperature near a medical device that is connecting the tissue. With an infection, there may be an increase in temperature, especially at the site of infection, for example of a few degrees (e.g., in a range of 100-105 °F). In some embodiments, a medical device for connecting tissue, for example an environmental status element thereof, is structured to be readable to indicate a temperature, for example a relative temperature. In some embodiments, an environmental status element includes radiodense particles and an affinity of the radiodense particles may change in response to temperature, for example when temperature exceeds a threshold. In this way, an environmental status element may appear radiopaque in an as-implanted state, but become radiolucent in the presence of higher temperatures. If more than one particle attachment mechanism was used, an environmental status element may be responsive to more than one temperature threshold. In some embodiments, an environmental status element includes a radiopaque material that swells or shrinks with increasing temperature such that the radiopaque material exhibits a change in size and / or shape between different temperatures. As another example, an environmental status element may include a radiopaque material that is structure to indicate temperature of a localPage 23 of 9512747491 vlAttorney Docket No. : 2019150-0019 environment based on how the environmental status element appears in an imaging modality. For example, computed tomography based (CT-based) thermometry may be used to determine a temperature of local environment based on how an environmental status element appears in an image generated using CT-based thermometry.

[0087] In some embodiments, a method is for characterizing local temperature near a medical device that is connecting the tissue. A method may include characterizing the local temperature based on how a medical device appears in an image. Characterizing the local temperature may include determining a relative temperature relative to a baseline, for example a baseline that corresponds to healthy corresponding tissue. Characterizing may be based on a configuration of a medical device that is discernable in an image, for example based on a configuration of an environmental status element. In some embodiments, an environmental status element includes a temperature sensitive radiopaque material. At a baseline temperature, a radiopaque material may have a radiodensity that is not readable by an imaging modality, for example is not discernable relative to background. At a temperature higher relative to a baseline temperature, a radiopaque material may have a higher radiodensity that is readable by an imaging modality. Accordingly, at a temperature higher relative to baseline temperature, the environmental status element appears in the image. In some embodiments, changes in local temperature may cause changes in radiodensity of a radiopaque material, which in turn changes appearance of an environmental status element in an image.

[0088] In some embodiments, an environmental status element includes two or more temperature sensitive radiopaque materials. The two or more radiopaque materials may have different radiodensities. At a baseline temperature, the radiopaque materials may have radiodensities that are not readable by an imaging modality. Accordingly, at the baseline temperature, the environmental status element does not appear in the image. At temperatures higher relative to the baseline temperature, temperature thresholds, the radiopaque materials may include higher radio-densities that are readable by an imaging modality. The radiopaque materials may include different temperature thresholds, so that each radiopaque material becomes readable by an imaging modality at a different local temperature. Accordingly, at different temperatures higher relative to baseline temperature, different portions of the environmental status element that includes the radiopaque materials with higher radiodensities appear in the image.Page 24 of 9512747491 vlAttorney Docket No. : 2019150-0019

[0089] In some embodiments, a method is for determining health of tissue that is connected by a medical device. A method may include receiving (e.g., by a processor of a computing device) an image of tissue in which a medical device (e.g., an environmental status element thereof) is discernable. A method may include determining whether tissue is infected and / or whether tissue is healed based on how a medical device (e g., an environmental status element thereof) appears in an image. A method may include determining whether tissue is infected and / or whether tissue is healed based on how an environmental status element of a medical device appears in an image. Determining whether tissue is infected and / or whether tissue is healed may be based on a configuration of the medical device discernable in an image. A configuration may be a configuration of an environmental status element included in a medical device. Health of tissue (e.g., whether or not tissue is infected) may be indicated by, for example, local pH, temperature, pressure, tension, or a combination thereof.

[0090] A method of characterizing local environment, characterizing pH, and / or determining health of tissue may include acquiring an image. Acquiring an image may include applying x-rays, radio waves (e.g., in combination with a magnetic field), or sound waves to a medical device and / or tissue connected by the medical device, for example through tissue. Acquiring an image may include forming an x-ray image, a CT scan, an MRI image, or a sonograph in which an environmental status element is discernable. Tissue (e.g., connected by a medical device) may be discernable in an acquired image.

[0091] Environmental status elements disclosed herein (e.g., that include one or more encoding portions that are radiopaque and / or that attenuate sound waves to encode information) may be included in a medical device. For example, an environmental status element may be embedded in a medical device, disposed internally to a medical device, disposed on or in an interior of a medical device, woven or braided into a medical device, or disposed on or in an internal component of a medical device.

[0092] An environmental status element may encode information using one or more encoding portions. An encoding portion may be radiopaque. An encoding portion may be readable using x-rays, radio waves (e.g., in combination with a magnetic field), sound waves, or a combination thereof (more than one of these). An encoding portion may produce signal in response to x-rays, radio waves (e.g., in combination with a magnetic field), sound waves, or aPage 25 of 9512747491 vlAttorney Docket No. : 2019150-0019 combination thereof. For example, an encoding portion may produce signal by selective absorption, absorption and emission (e.g., of a different characteristic particle or signal from an excitation particle or signal), reflection, refraction, or a combination thereof. For example, different produced signal may result in different contrast being visible in an image (e.g., a human- readable image). An encoding portion may be readable using an imaging modality, such as, for example, x-ray (e.g., dual-energy x-ray absorptiometry), computed tomography, magnetic resonance imaging, ultrasound, or a combination thereof (more than one of these). An environmental status element may be readable using x-rays, radio waves (e.g., in combination with a magnetic field), sound waves, or a combination thereof (more than one of these) such that information can be determined from the environmental status element (e.g., one or more encoding portions thereof). For example, x-ray imaging (e.g., dual-energy x-ray absorptiometry), magnetic resonance imaging (MRI), computed tomography (CT), and / or sonography (e.g., ultrasound) may be used to read an environmental status element or one or more encoding portions.

[0093] An encoding portion may be radiopaque (e.g., to x-rays and / or radio waves) and / or attenuate sound waves. For example, an encoding portion may be a radiopaque thread, a radiopaque fiber, or a radiopaque filament. An encoding portion may include one or more radiopaque contrasting agents, one or more metallic elements, one or more radiopaque particles, one or more radiopaque dyes, one or more radiopaque inks (e.g., metallic ink(s)), or a combination thereof. In some embodiments, an encoding portion is optically clear. In some embodiments, an encoding portion includes one or more optically-clear radiopaque dyes, one or more optically-clear radiopaque inks, or both. In some embodiments, an encoding portion includes two (e.g., optically clear) radiopaque species (e.g., inks, dyes, or an ink and a dye) of different radiodensities. For example, gadolinium, iodine, an oxide (e.g., iron oxide or titanium dioxide), barium (e.g., as barium sulfate), manganese salt (e.g., manganese chloride), aluminum, bismuth (e.g., elemental bismuth and / or as bismuth oxychloride or bismuth trioxide), titanium, or a combination thereof may be used in an encoding portion.

[0094] A portion of an environmental status element may be radiopaque (e.g., to x-rays and / or radio waves) and / or attenuate sound waves. Radiopaque does not necessarily mean that all incident x-rays and / or radio waves are blocked (e.g., absorbed). In some embodiments, an environmental status element includes one or more encoding portions that are radiopaque such thatPage 26 of 9512747491 vlAttorney Docket No. : 2019150-0019 the one or more encoding portions are discernable against background (e.g., an object and / or label) using x-rays and / or radio waves (e.g., in x-ray and / or MRI, respectively). In some embodiments, an environmental status element includes one or more encoding portions attenuate sound waves such that the one or more encoding portions are discernable against background (e.g., tissue) using sound waves (e.g., in a sonography modality). In some embodiments, an environmental status element includes one or more encoding portions that enhance visibility in one or more imaging modalities. In some embodiments, an environmental status element includes a first encoding portion that is radiopaque such that it is discernable from a second radiopaque encoding portion included in the environmental status element using x-rays and / or radio waves, for example based on wavelength and / or intensity. In some embodiments, an environmental status element includes a first encoding portion that attenuates sound waves such that, using sound waves, it is discernable from a second encoding portion included in the environmental status element that attenuates sound waves. An encoding portion may have variable radiodensity or constant radiodensity (or variable attenuation or constant attenuation to sound waves). An encoding portion may have variable attenuation to sound waves or constant attenuation of sound waves. A sound-attenuating encoding portion may be discernable in an imaging modality that uses sound waves based on how the encoding portion attenuates sound waves.

[0095] An environmental status element may include, for example, one or more contrasting agents, one or more particles, one or more metallic elements, one or more dyes, one or more inks (e.g., metallic ink(s)), one or more threads (e.g., one or more mono-filament threads, one or more multi-filament threads, or a combination thereof), one or more fibers (e.g., one or more monofilament fibers, one or more multi-filament fibers, or a combination thereof), one or more filaments, one or more ribbons, or a combination thereof. An encoding portion of an environmental status element may be, for example, one or more contrasting agents, one or more particles, one or more metallic elements, one or more dyes, one or more inks (e.g., metallic ink(s)), one or more threads (e.g., one or more mono-filament threads, one or more multi -filament threads, or a combination thereof), one or more fibers (e.g., one or more mono-filament fibers, one or more multi-filament fibers, or a combination thereof), one or more filaments, or one or more ribbons. For example, gadolinium, iodine, an oxide (e.g., iron oxide or titanium dioxide), barium (e.g., as barium sulfate), manganese salt (e.g., manganese chloride), aluminum, bismuth (e.g., elementalPage 27 of 9512747491 vlAttorney Docket No. : 2019150-0019 bismuth and / or as bismuth oxychloride or bismuth trioxide), titanium, or a combination thereof may be used in an environmental status element (e.g., one or more encoding portions thereof).

[0096] In some embodiments, an environmental status element includes one or more optically-clear radiopaque dyes, one or more optically-clear radiopaque inks, or both. In some embodiments, an environmental status element may include two (e.g., optically clear) radiopaque species (e.g., inks, dyes, or an ink and a dye) of different radiodensities. Such different radiodensity materials may be able to be distinguished during imaging (e.g., x-ray imaging, such as dual-energy x-ray absorptiometry).

[0097] An environmental status element may include one or more fibers that are braided into a thread (e.g., with or without one or more other fibers). An environmental status element, such as a thread, filament, or fiber, may include one or more polymer materials, such as, one or more silicones, one or more nylons, one or more polyethylenes (e.g., ultra-high-molecular-weight polyethylene (UHMWPE)), one or more polypropylenes, one or more polyesters, one or more polytetrafluoroethylenes (PTFEs), or a combination thereof. An encoding portion may be a tracer line. An environmental status element include a single encoding portion, for example a single filament or single fiber.

[0098] An encoding portion may be braided into an environmental status element. For example, an environmental status element may be or include a multifilament fiber where one or more of the filaments in the fiber are encoding portion(s). For example, an environmental status element element may be or include a multifiber thread where one or more of the fibers in the thread are encoding portion(s). Such a multifilament or multifiber environmental status element may include a core (e.g., including one or more filaments or one or more fibers, respectively) and a sheath (e.g., including one or more filaments or one or more fibers, respectively). An environmental status element may include one or more braided elements (e.g., radiopaque braided element(s)). An encoding portion may be a braided element. An encoding portion may be, for example, one or more particles or one or more dyes disposed in or on a thread, fiber, or filament. In some embodiments, an encoding portion is or is included in a core of an environmental status element (e.g., a core of a fiber or thread). In some embodiments, an encoding portion is or is included in a sheath of an environmental status element (e.g., a sheath of a fiber or thread).Page 28 of 9512747491 vlAttorney Docket No. : 2019150-0019

[0099] An encoding portion may have different radiodensity (whether variable or constant) than other material in an environmental status element (e.g., other fiber(s) and / or filament(s)) and / or an object. In some embodiments, a radiopaque portion of an environmental status element (e.g., an encoding portion) has a radiodensity that is at least at least 1. lx, at least 1 ,2x, at least 1 ,3x, at least 1 ,4x, at least 1 ,5x, at least 2x, at least 3x, at least 4x, at least 5x, or at least lOx a radiodensity of one or more other portions (e.g., non-encoding portion(s)) of a medical device that includes the environmental status element. In some embodiments, a radiopaque portion of an environmental status element (e.g., an encoding portion) has a radiodensity that is at least at least l. lx, at least 1.2x, at least 1.3x, at least 1.4x, at least 1.5x, at least 2x, at least 3x, at least 4x, at least 5x, or at least lOx a radiodensity of tissue, for example human tissue or non-human animal (e.g., cat or dog) tissue.

[0100] In some embodiments, an environmental status element is structured to be readable to indicate more than one characteristic of a local environment, for example tension and pH (e.g., relative pH). For example, an environmental status element may indicate tension in one manner (e.g., longitudinal spacing) and pH in another manner (e.g., radial size or spacing). In some embodiments, a medical device includes multiple environmental status elements where the multiple environmental status elements are structured to be readable to indicate one or more same characteristics of a local environment. In some embodiments, a medical device includes multiple environmental status elements where two or more of the environmental status elements are structured to be readable to indicate different characteristics, for example at least one of the environmental status elements is structured to be readable to indicate tension and at least one of the environmental status element is structured to be readable to indicate pH. Multiple environmental status elements included in a medical device may be disposed at different portions of the medical device (e.g., may be physically separated). Multiple environmental status elements may be formed from different portions of one or more common structures. For example, a suture may include one or more radiopaque filaments that form a distinct pattern that repeats over the length of the suture thereby defining multiple environmental status elements. In some embodiments, an environmental status element includes one or more portions that indicate a start point and / or end point of an environmental status element.Page 29 of 9512747491 vlAttorney Docket No. : 2019150-0019

[0101] An environmental status element may be embedded into a medical device. An environmental status element may be integrated with (e.g., within) a medical device. An environmental status element may be a portion of a medical device. An environmental status element may be woven into a medical device. An environmental status element may be disposed on an interior of a medical device. An environmental status element may be disposed on a surface of a medical device. An environmental status element may be internal to a medical device.

[0102] In some embodiments, an environmental status element is no more than 3 cm, no more than 2 cm, no more than 1 cm, no more than 5 mm, no more than 4 mm, no more than 3 mm, no more than 2 mm, or no more than 1 mm in at least one dimension (e.g., a length dimension and / or a diameter dimension). In some embodiments, an encoding portion is no more than 3 cm, no more than 2 cm, no more than 1 cm, no more than 5 mm, no more than 4 mm, no more than 3 mm, no more than 2 mm, or no more than 1 mm in at least one dimension (e.g., a length dimension and / or a diameter dimension). In some embodiments, each of one or more environmental status elements is no more than 3 cm, no more than 2 cm, no more than 1 cm, or no more than 0.5 cm in a longest dimension. In some embodiments, adjacent environmental status elements included in a medical device are separated by a distance of no more than 3 cm, no more than 2 cm, no more than 1 cm, or no more than 0.5 cm. In some embodiments, environmental status elements repeat at a linear density of at least 0.2 per cm, at least 0.33 per cm, at least 0.5 per cm, at least 0.75 per cm, at least 1 per cm, at least 1.5 per cm, at least 2 per cm, or at least 3 per cm.

[0103] At least a portion of a medical device for connecting tissue may be optically clear and / or not radiopaque, for example an environmental status element or other portion. Environmental status elements disclosed herein may be of a size or construction such that they are not visible to an unaided human viewer. For example, they may be too small to be noticeable or may be made of materials are undiscernible without magnification and / or being viewed using the appropriate probe waves (e.g., using the appropriate imaging modality or modalities). In some embodiments, an environmental status element includes one or more optically clear encoding portions, for example that include (e.g., are formed by) optically clear but radiodense ink or dye.

[0104] A local environment may be a region of tissue where no portion of the region is more than 5 cm, more than 4 cm, more than 3 cm, more than 2 cm, or more than 1 cm from aPage 30 of 9512747491 vlAttorney Docket No. : 2019150-0019 medical device (e.g., from an environmental status element thereof). A local environment may be or include a region of tissue that contacts a medical device.

[0105] Environmental status elements have been described as being structured to be readable to indicate one or more characteristics of a local environment. Such structuring may be a chemical structuring (e.g., being made of one or more particular materials) and / or a physical structuring.Non-Transitory Medical Images

[0106] A medical device that includes one or more identification elements and / or one or more environmental status elements may be imaged with an imaging modality, such as x-ray, CT, MRI, or ultrasound. One or more non-transitory medical images may be acquired of such a medical device. Such medical images may be acquired in-situ, for example after a surgical procedure. Such medical images may be used to monitor tissue healing, to determine whether tissue is infected, or to otherwise observe tissue and / or a medical device. A medical device may be discernable in a medical image due to one or more identification elements and / or one or more environmental status elements being included in the medical device. One or more identification elements and / or one or more environmental status elements may be discernable in a medical image, for example due to one or more encoding portions thereof.

[0107] In some embodiments, a non-transitory medical image is an image of tissue connected (e g., held together) by a medical device. Information identifying the medical device may be discernable in the image. Information identifying a medical device that is discernable in an image may be a serial number, a lot number, a batch number, or a combination thereof. Information identifying a medical device that is discernable in an image may be a manufacturer and / or a model of the medical device. A medical device may include an identification element that encodes information discernable in a medical image.

[0108] In some embodiments, a non-transitory medical image is an image of tissue connected (e.g., held together) by a medical device. At least a portion of the medical device may be discernable in the image such that one or more characteristics of a local environment near (e.g., in contact with) the medical device are discernable based on the at least a portion of the medical device. In some embodiments, the one or more characteristics include a relative pH (e.g., relativePage 31 of 9512747491 vlAttorney Docket No. : 2019150-0019 to a baseline or standard fortissue connected by a medical device). In some embodiments, one or more characteristics include whether a medical device is under tension (e.g., thereby indicating a state of tissue connected by the medical device, such as a state of healing or state of health).

[0109] A medical image may be a radiological image. A medical image may be a sonogram (e g., an ultrasound image). A medical image may be an MRI image. A medical image may be a CT image. A medical image may be an x-ray image, for example a dual energy x-ray absorptiometry image.

[0110] A medical image may have been acquired from outside of a body (e.g., of a human body or a non-human animal body). Tissue connected (e.g., held together) by a medical device may be discernable in a medical image. A medical image may be of an internal portion of a body (e.g., of a human or non-human animal). A medical image may be of internal tissue (e g., of a human or non-human animal).[0U1] A medical image may be a printed image. A medical image may be a film image. One or more medical images may be stored on one or more non-transitory computer-readable media.

[0112] A method may include acquiring a medical image. For example, a medical image may be acquired from outside of a body that includes (e.g., internal) tissue connected by a medical device. Acquiring an image may include providing (e.g., directing) x-rays, radio waves (e.g., in combination with a magnetic field), or sound waves to tissue and / or a medical device connecting the tissue. For example, acquiring an image may include providing (e g., directing) x-rays, radio waves (e.g., in combination with a magnetic field), or sound waves into a body. A medical image may be acquired using x-rays, radio waves (e.g., in combination with a magnetic field), or sound waves. A method may include rendering, by a processor of a computing device, a medical image. A method may include displaying, by a processor of a computing device, a medical image. A method may include constructing (e.g., by a processor of a computing device) a medical image. A method may include developing a medical image. One or more non-transitory computer-readable media may have instructions (e.g., one or more programs) stored thereon that, when executed by a processor, cause the processor to perform any such method or methods.Medical Devices and Tissues Connected by Medical DevicesPage 32 of 9512747491 vlAttorney Docket No. : 2019150-0019

[0113] A medical device for connecting tissue may hold together tissue. In some embodiments, a medical device for connecting tissue connects two or more tissues (e.g., two or more different tissues). In some embodiments, a medical device for connecting tissue connects tissue of a body, for example a human body or a non-human animal body. In some embodiments, a medical device connects human tissue. In some embodiments, a medical device connects non- human animal tissue, for example of a dog or a cat. In some embodiments, a medical device for connecting tissue connects tissue of an animal. In some embodiments, a medical device for connecting tissue connects tissue of a human. In some embodiments, a medical device for connecting tissue connects tissue of a non-human animal.

[0114] In some embodiments, a medical device connects wounded tissue. For example, a medical device may connect two sides of a wound. In some embodiments, a medical device connects tissue through which an incision has been made, for example during a surgical procedure. In some embodiments, a medical device connects two sides of an incision. In some embodiments, a medical device for connecting tissue closes an incision. In some embodiments, a medical device for connecting tissue closes a wound.

[0115] In some embodiments, a medical device for connecting tissue is used to connect tissue during a surgical procedure. A surgical procedure may be an elective procedure, a trauma procedure, or an emergency procedure. In some embodiments, a medical device for connecting tissue is placed during a surgical procedure. In some embodiments, a medical device for connecting tissue is used to connect tissue during a trauma procedure. In some embodiments, a medical device for connecting tissue is used to connect tissue during an emergency procedure. In some embodiments, a medical device for connecting tissue is used to connect tissue during an elective procedure. In some embodiments, a medical device for connecting tissue is used in an operating room. In some embodiments, a medical device for connecting tissue is used in a hospital. In some embodiments, a medical device for connecting tissue is used in a clinic. For example, a surgeon or non-surgeon physician may use a medical device for connecting tissue.

[0116] A medical device for connecting tissue may have been cut from a larger whole. A medical device for connecting tissue may be a cut portion. A medical device for connecting tissue may include (i) only a portion of one identification element of a set of identical identification elements included in the medical device, (ii) only a portion of one environmental status elementPage 33 of 9512747491 vlAttorney Docket No. : 2019150-0019 of a set of identical environmental status elements included in the medical device, or (iii) both (i) and (ii), for example due to a portion thereof having been cut off. A medical device for connecting tissue may be or include a cut portion. A medical device for connecting tissue may include one or more cut ends. A medical device for connecting tissue may include one or more cut edges and / or one or more cut comers.

[0117] A medical device for connecting tissue may be a thread or fiber. A medical device for connecting tissue may be or include a monofilament or multifilament device. A medical device for connecting tissue may be or include monofilament or multifilament thread. A medical device for connecting tissue may be or include a braided structure (e.g., may be or include a braided thread). A medical device for connecting tissue may be braided. A medical device for connecting tissue may be woven. A medical device for connecting tissue may be tubular (e.g., a woven tube). A medical device for connecting tissue may be or include a mesh (e.g., a surgical mesh). A medical device for connecting tissue may include a suture anchor. A medical device for connecting tissue may be or include suture tape. A medical device for connecting tissue may be or include a suture. A suture may be a monofilament or multifilament suture. A suture may be a thread (e.g., a braided thread). A suture may include one or more fibers. Suture tape may be woven or braided. Suture tape may include one or more threads (e.g., monofilament or multifilament threads). Suture tape may include one or more fibers (e.g., monofilament or multifilament fibers). Suture tape may be tubular. A medical device for connecting tissue may include a suture anchor. A mesh, such as a surgical mesh, may include a one or more monofilaments and / or one or more multifilaments (e g., thread(s) and / or fiber(s)).

[0118] A medical device for connecting tissue may be disposed internally. A medical device for connecting tissue may be disposed inside of a body, for example a human body or a non-human animal body, such as a cat body or dog body. A medical device for connecting tissue may be disposed externally, for example connecting an incision or wound in skin tissue (e.g., epidermis).

[0119] A medical device may be or include a thread, filament, or fiber. A medical device may include one or more polymer materials, such as, one or more silicones, one or more nylons, one or more polyethylenes (e.g., ultra-high-molecular-weight polyethylene (UHMWPE)), one or more polypropylenes, one or more polyesters, one or more polytetrafluoroethylenes (PTFEs), or aPage 34 of 9512747491 vlAttorney Docket No. : 2019150-0019 combination thereof. A medical device, such as, for example, suture tape, may include Dyneema® or Spectra®.

[0120] In some embodiments, a medical device is at least 5 cm, at least 10 cm, at least 20 cm, at least 1 m, at least 2 m, or at least 5 m in at least one dimension (e.g., a length dimension). In some embodiments, a medical device is no more than 5 mm, no more than 4 mm, no more than 3 mm, no more than 2 mm, or no more than 1 mm in at least one dimension (e.g., a diameter).

[0121] A medical device may be disposed internally in a body. A medical device may be disposed inside of a human body (e.g., disposed inside of a body of a patient). A medical device may be disposed inside of a non-human animal (e.g., a dog or cat). A medical device may be closing a wound. A medical device may be closing an incision (e.g., a surgical incision). A medical device may have been placed as part of a surgical procedure (e.g., an elective procedure, a trauma procedure, or an emergency procedure).

[0122] A medical device may be biodegradable (e.g., degrade away in-situ over time) or nondegradable (e.g., remain within a body indefinitely).

[0123] Tissue connected by or connectable with a medical device may be or include, for example, muscle, epithelial tissue, connective tissue (e.g., bone, tendon, ligament, adipose tissue, or areolar tissue), nervous tissue, or a combination thereof. Tissue connected by or connectable with a medical device may be internal tissue.Additional Exemplary Embodiments

[0124] Fig. 1 illustrates an example of a medical device 10 including an identification element 11 that encodes information, according to some embodiments of the present disclosure. The identification element 11 includes a thread 14 and one or more encoding portions 12. The one or more encoding portions 12 encode the information 13. The information 13 may include an alphanumeric code. The alphanumeric code, for example, may only include numbers (e.g., a decimal number, a binary number). In another example, the alphanumeric code may only include letters. In another example, the alphanumeric code may include combinations of letters and numbers. The encoding portions 12 may include several ways to encode the information 13, as further described herein in connection with Figs. 2A-D and Figs. 3A-D.Page 35 of 9512747491 vlAttorney Docket No. : 2019150-0019

[0125] Fig. 2A illustrates an example of a medical device 10 including an identification element 11 that encodes information. In this example, the identification element 11 includes a thread 14 that includes encoding portions 12. The encoding portions are particles and / or clusters of particles. In some embodiments, the encoding portions 12 may be evenly distributed with a spacing dl between two successive encoding portions 12. In this case, the information is a simple code that is set by a combination of encoding portion size, encoding portion shape (e.g., particulate), and spacing dl. In some embodiments, one or two of these may be irrelevant to the information. For example, encoding portion size may be irrelevant and the information is derived from only spacing and shape or shape is irrelevant and the information is derived from only spacing and size or neither shape nor size matters and the information is derived only from spacing. In some embodiments, when fewer characteristics are used to encode an information, more precise tolerances may be used (e g., the information may be encoded by a more precise spacing if size and shape are not considered and a less precise spacing if size and / or shape is considered). Fig. 3A illustrates a related exemplary embodiment where there are one or more encoding portions 12 that is / are filament(s) or fiber(s) woven or braided into the thread 14.

[0126] Fig. 2B illustrates an example of a medical device 10 including an identification element 11. Identification element 11 includes a thread 14 and encoding portions 12 that encode information. The encoding portions are particles and / or clusters of particles. The encoding portions 12 are distributed unevenly, resulting in varying spacing between the encoding portions 12, which contributes to the encoding of information. For example, different spacings may correspond to different characters in the information 13. In another example, the number of similarly spaced encoding portions before a larger gap may correspond to different characters in the information 13. Fig. 3B illustrates a related exemplary embodiment where the encoding portions 12 are filament(s) or fiber(s) woven or braided into the thread 11. Still referring to Fig. 3B, different spacings and / or phases between blocks of spirals may correspond to different characters in the information 13 or the number of spirals of one or more encoding portions before a larger gap may correspond to different characters in the information 13.

[0127] Fig. 2C illustrates an example of a medical device 10 including an identification element 11. The identification element 11 includes a thread 14 and encoding portions 12 that encode information. The encoding portions are particles and / or clusters of particles. The encodingPage 36 of 9512747491 vlAttorney Docket No. : 2019150-0019 portions 12 include different sizes and different spacings (in some embodiments, different sizes are used with constant spacings), contributes to the encoding of information. For example, different sizes of encoding portions 12 may correspond to different characters in the information 13. For example, a Morse code type encoding scheme may be used using different sizes (e.g., regardless of spacings). The encoding portions 12, for example, may represent a bar code that encodes information.

[0128] Fig. 2D illustrates an example of a medical device 10 including an identification element 11. The identification element 11 includes a thread 14 and encoding portions of different radiodensities 12A, 12B and 12C that encode information. The encoding portions are particles and / or clusters of particles. The encoding portions of different radiodensities 12A-C may appear as different contrasts in an image, for example, a two-energy x-ray absorptiometry image. The encoding portions 12A-C may be arranged in a pattern that encodes information. In some embodiments, the pattern corresponds to different characters in the information 13. For example, a base three information may be used if three different radiodensities of encoding portions are use. Figs. 3C-D illustrate related exemplary embodiments where the encoding portions 12A-C are filament(s) or fiber(s) woven or braided into the thread 14. Fig. 3C illustrates encoding portions 12A-C an ABC pattern (but the pattern need not be repetitious as illustrated), in this case where all of the encoding portions 12A-C are spiraled in a same orientation (e.g., direction). Fig. 3D illustrates a similar pattern as Fig. 3C but here encoding portion 12C is spiraled in a different orientation (e.g., direction) from encoding portions 12A-B.

[0129] Fig. 4A illustrates an example of a medical device 10 including an environmental status element 15 that indicates one or more characteristics of a local environment. In this example, the environmental status element 15 includes a thread 14 that includes encoding portions 12. The encoding portions are filaments or fibers woven or braided into the thread 14. In some embodiments, the encoding portions 12 may be evenly distributed with a spacing dl between two successive encoding portions 12. In this case, the environmental status element 15 indicates one or more characteristics of a local environment based on the spacing dl. Fig. 4B illustrates the medical device 10 of Fig. 4A wherein the encoding portions 12 of the environmental status element 15 include a different spacing dl . In this case, the changes in spacing dl corresponds to the changesPage 37 of 9512747491 vlAttorney Docket No. : 2019150-0019 in the local environment of medical device 10. A larger dl spacing may indicate that the medical device 10 is under tension.

[0130] Fig. 5A illustrates an example of a medical device 10 including an environmental status element 15 that indicates one or more characteristics of a local environment. In this example, the environmental status element 15 includes a thread 14 that includes encoding portions 12A. The encoding portions 12 may be evenly distributed with a spacing dl between two successive encoding portions 12 and a uniform radial dimension d3. The environmental status element 15 or the medical device 10 is coated with a pH sensitive radiopaque coating that causes a change in state of the environmental status element 15 in response to changes in local pH near the medical device 10.

[0131] Fig. 5B illustrates the medical device 10 of Fig. 5 A wherein the local pH changes has resulted in a different radiodensity in encoding portions 12B of the environmental status element 15. The encoding portions 12B may appear as a different contrast in an image compared to encoding portions 12A.

[0132] Fig. 5C illustrates the medical device 10 of Fig. 5A wherein the encoding portions 12A of the environmental status element 15 include a different spacing dl in response to the changes in local pH. In this case, the environmental status element 15 indicates one or more characteristics of a local environment based on the changes in spacing dl. For example, a larger dl spacing may indicate that the pH near the medical device 10 has become more acidic.

[0133] Fig. 5D illustrates the medical device 10 of Fig. 5 A wherein the encoding portions 12A of the environmental status element 15 include a radial dimension d3 in response to the changes in local pH. In this case, the environmental status element 15 indicates one or more characteristics of a local environment based on the changes in radial dimension d3. For example, a larger d3 may indicate that the pH near the medical device 10 has become more alkaline.

[0134] Fig. 6A is a brightfield image of an exemplary medical device 10 including an identification element 11 that has been constructed. The identification element 11 is a thread 14 and radiopaque encoding portions 12 are woven into the thread 14. In this example, there are four similar encoding portions 12 that are spiraled in a same orientation with a spacing and phase between each of the spirals. The encoding portions 12 are discernable from the rest of the identification element 11 in the brightfield image, at least in the magnified view shown (they mayPage 38 of 9512747491 vlAttorney Docket No. : 2019150-0019 be undiscemible or less discernable in an unmagnified view). Fig. 6B shows an x-ray image 16 of the identification element 11 of Fig. 6A showing that the different encoding portions are discernable. The parts of the identification element 11 that are not the encoding portions 12 are not radiopaque (and are optically clear as seen in Fig. 6A) and therefore do not show up against background in the x-ray image 16. The spacing dl between two successive encoding portions 12 is about 0.6 mm in this example. The spacing dl, and / or other characteristics of the encoding portions 12, may be used to encode information.

[0135] Fig. 7 illustrates an example of an identification system 20 including a medical device 10, according to some embodiments of the present disclosure. The medical device 10 include at least one identification element 11. The medical device 10 may be used to connect two or more internal tissues 21. In this example, the tissue 21 is part of a shoulder and the medical device 10 is used to tightly hold two or more portions of the tissue 21 together to assist with healing after a surgical repair or injury.

[0136] Fig. 8A illustrates an example of an identification system 20 including a medical device 10, according to some embodiments of the present disclosure. The medical device includes at least on identification element 11 wherein the encoding portions 12 are disposed. In this example, the medical device 10 is used to tightly hold two or more portions of tissue 21 together to assist with healing after a surgical repair or injury. Fig. 8B shows a medical image 30 of the identification system 20 of Fig. 8A. In this example, the medical image 30 is an x-ray image. The X-ray image 30 includes tissue 21 and the encoding portions 12 that are radiopaque. The parts of the medical device 10 and the identification element 11 that are not radiopaque may not show up against background in the x-ray image 30.

[0137] Fig. 9 illustrates an example of an identification system 20 including a medical device 10, according to some embodiments of the present disclosure. The medical device includes at least one identification element 11 wherein the encoding portions 12 are disposed. In this example, the medical device 10 is used to secure tissue 21 during a medical procedure.

[0138] Fig. 10A illustrates an example of a medical image 30 of an identification system 20 including a medical device 10, according to some embodiments of the present disclosure. In this example, the medical image 30 is an x-ray image. The x-ray image 30 shows tissue 21 and encoding portions 12 that are radiopaque. The medical device 10 is a suture tape to tightly holdPage 39 of 9512747491 vlAttorney Docket No. : 2019150-0019 tissue 21 together to facilitate healing. Fig. 1 OB illustrates an example of an x-ray image 30 of the identification system 20 of Fig. 10A where the suture tape has been tightened (e.g., closed). The x-ray image(s) 30 may be acquired during a follow-up appointment shows the tissue 21 and the encoding portions 12 of the suture tape 10.

[0139] Fig. 11 illustrates multiple examples of a medical device 10 including an identification element 11, according to some embodiments of the present disclosure. The top identification element 11 includes a thread 14 and one or more encoding portions 12, where the encoding portion(s) 12 are one or more metallic elements. The next identification element 11 includes a thread 14 and one or more encoding portions 12, where the encoding portion(s) 12 are elongated fibrous material in a structural weaving configuration or a tracer line, wherein at least a portion of the elongated fibrous material is doped with at least one contrasting agent to facilitate its detection or visibility in a medical imaging modality. The next identification element 11C includes a thread 14 and one or more encoding portions 12 where the one or more encoding portion(s) 12 are in the form of a mesh overlay. The mesh overlay may include one or more fibrous materials arranged in a mesh configuration. At least a portion of the fibrous material(s) may be doped with at least one contrasting agent before the mesh overlay is applied or affixed to the medical device 10 to form the identification element 11. The at least one contrasting agent may facilitate the detection and / or visibility of the mesh overlay. The last identification element 11 includes a thread 14 and one or more encoding portions 12 that include a hydrogel integrated with one or more encoding portions 12. A medical device may include a hydrogel (e g., as a coating). In some embodiments, one or more encoding portions (e.g., contrasting agent(s)) may be integrated with a hydrogel. In some embodiments, a hydrogel may expand or swell when exposed to one or more fluids within tissue (e.g., of a body), thereby causing a medical device in which it is included to become stronger and / or form a tighter and / or more secure connection once it is attached to tissue.

[0140] Fig. 12 illustrates an example of an identification system 20 including a medical device 10, according to some embodiments of the present disclosure. The medical device 10 is used to facilitate closure and / or healing 23 of an incision / wound 22 within an internal portion of the body. The medical device 10 includes an identification element 11 wherein the encoding portions 12 are included in a mesh.Page 40 of 9512747491 vlAttorney Docket No. : 2019150-0019

[0141] Fig. 13 illustrates multiple examples of a medical device 10 including identification elements 11 in a mesh configuration, according to some embodiments of the present disclosure. One of the identification elements 11 includes encoding portions 12 configured in a plurality of structural weaving patterns or individual tracer lines. The structural weaving pattern may encode information. One of the identification elements 11 includes encoding portions 12 in the form of particles (e.g., metallic particles).

[0142] Fig. 14 illustrates a longitudinal view of an example of a medical device 10 including an identification element 11, according to some embodiments of the present disclosure. In this example, the medical device 10 is a braided structure form by a braided material 17. In some embodiments, the braided material 17 is braided around a core material. In some embodiments, the braided material 17 is braided without a core material. Cross-sections 31 and 32 are taken across the braided material 17 to show the interior portion of the braided structure 10, as further described in connection with Figs. 15A and 15B, respectively.

[0143] Figs. 15A and 15B illustrate exemplary cross-sectional views 31 and 32 of a coreless, braided medical device 10, according to some embodiments of the present disclosure. Fig. 15A shows a pattern produced by the braided material 17 at the cross section 31 of Fig 14 which includes encoding portions 12 of the identification element 11, and an empty core. The position of encoding portions 12 in relation to other encoding portions 12 change as the braided material 17 is followed along its length. A different pattern produced by the braided material 17 at the cross section 32 of Fig 14 is shown in Fig. 15 B.

[0144] Figs. 16A and 16B, illustrate exemplary cross-sectional views 31 and 32 of a coreless, braided medical device 10 that is under tension, resulting in flattening of the braided structure 10 and a repositioning of the encoding portions 12 of an environmental status element 15. For example, encoding portions 12 may collapse on the previous empty core. This collapsing of the encoding portions 12 may create a region that is readable, or differently readable, on an x- ray image. In some embodiments, due to periodicity of a braided pattern, a readable region can vary along the length of a braided medical device 10. The braided medical device 10 is configured to produce one x-ray signal when lax and a second distinctive x-ray signal when taut. In another example, the environmental status element 11 of the braided medical device 10, includingPage 41 of 9512747491 vlAttorney Docket No. : 2019150-0019 encoding portions 12 is configured such that the x-ray signal changes continuously, and accordingly the amount of axial tension in the braided medical device 10 can be deduced.

[0145] Fig. 17 illustrates an exemplary simulation of a longitudinal X-ray image 30 of a taut braided medical device 10 including identification element 11, according to some embodiments of the present disclosure. In this example, the braided structure demonstrates a pattern of two bands of encoding portion 12 along its length.

[0146] Fig. 18 is a flow chart of a method 100 of identifying a medical device, according to illustrative embodiments. In step 102, an identification element within a medical device is read by applying x-rays, radio waves, and / or sound waves. In step 104, a signal from the identification element in response to the x-rays, radio waves and / or sound waves is received. In step 106, a medical image (e.g., human-readable image) is formed based on the received signal. In step 108, the received signal is translated into information. In step 110, the information is received. In step 112, the information is used to identify the manufacturer and / or the model of the medical device.

[0147] Fig. 19 is a flow chart diagram of a method 120 of determining one or more characteristics of a local environment of a medical device, according to illustrative embodiments. In step 122, an environmental status element within a medical device is read by applying x-rays, radio waves, and / or sound waves. In step 124, a signal from the environmental status element is received in response to x-rays, radio waves and / or sound waves. In step 126, a medical image (e.g., a human-readable image) is formed based on the received signal. In step 128, the received signal is translated into information. In step 130, the information is received. In step 132, the information is used to determine one or more characteristics of a local environment of the medical device.

[0148] Without limitation to the foregoing description, the following is an enumerated list of non-limiting exemplary embodiments included in the present disclosure. Those of ordinary skill in the art will appreciate that one or more features discussed above may be included with or incorporated into any of the following numbered embodiments to form additional embodiments.1. A medical device for connecting (e.g., holding together) tissue (e.g., two or more tissues or two sides of an incision or wound) (e.g., tissue of a human or other animal), the device comprising an identification element that encodes identifying information.Page 42 of 9512747491 vlAttorney Docket No. : 2019150-00192. The medical device of embodiment 1, wherein the identification element encodes a serial number, a lot number, a batch number, or a combination thereof.3. The medical device of embodiment 1 or embodiment 2, wherein the identification element encodes a manufacturer of the medical device and / or a model of the medical device.4. The medical device of any one of the preceding embodiments, wherein the information identifies a serial number, a lot number, a batch number, a manufacturer of the medical device, a model of the medical device, or a combination thereof.5. The medical device of any one of the preceding embodiments, wherein the medical device is a suture.6. The medical device of any one of embodiments 1-4, wherein the medical device is suture tape.7. The medical device of any one of embodiments 1-4, wherein the medical device is a mesh (e.g., a surgical mesh).8. The medical device of any one of embodiments 1-4, wherein the medical device comprises a suture anchor physically associated with the identification element.9. The medical device of embodiment 8, wherein the suture anchor comprises the identification element.10. The medical device of any one of the preceding embodiments, comprising a plurality of identification elements each encoding same information.11. The medical device of embodiment 10, wherein the identification elements are spatially separated on the medical device.Page 43 of 9512747491 vlAttorney Docket No. : 2019150-001912. The medical device of embodiment 11, wherein the identification elements are spatially separated along a long axis of the medical device (e.g., a long axis of a suture).13. The medical device of any one of embodiments 10-12, wherein each of the identification elements is no more than 3 cm in a longest dimension (e.g., no more than 2 cm, no more than 1 cm, or no more than 0.5 cm in the longest dimension).14. The medical device of any one of embodiments 10-13, wherein adjacent ones of the identification elements are separated by a distance of no more than 3 cm (e.g., wherein the distance is no more than 2 cm, no more than 1 cm, or no more than 0.5 cm).15. The medical device of any one of embodiments 10-14, wherein the identification elements repeat at a linear density of at least 0.2 per cm (e.g., at least 0.33 per cm, at least 0.5 per cm, at least 0.75 per cm, at least 1 per cm, at least 1.5 per cm, at least 2 per cm, or at least 3 per cm).16. The medical device of any one of the preceding embodiments, comprising an environmental status element that is structured to be readable to indicate one or more characteristics of a local environment for the medical device.17. The medical device of embodiment 16, wherein the environmental status element is pH sensitive (e.g., is structured to be readable to indicate a pH of the local environment).18. The medical device of embodiment 17, wherein the environmental status element or the medical device is coated with a pH sensitive coating that causes a change in state of the environmental status element upon a change in local pH near the environmental status element.19. The medical device of embodiment 18, wherein the state is a conformational state (e.g., size, shape, and / or spacing).Page 44 of 9512747491 vlAttorney Docket No. : 2019150-001920. The medical device of any one of embodiments 16-19, wherein the environmental status element is tension sensitive (e.g., is structured to be readable to indicate whether the medical device is under tension or not).21. The medical device of any one of embodiments 16-20, wherein the environmental status element is structured to be readable to indicate a tension state of the medical device.22. The medical device of any one of embodiments 16-21, wherein the environmental status element is temperature sensitive (e.g., is structured to be readable to indicate a temperature of the local environment).23. The medical device of any one of embodiments 16-22, wherein the environmental status element is pressure sensitive (e.g., is structured to be readable to indicate a pressure of the local environment).24. The medical device of any one of embodiments 16-23, wherein the environmental status element comprises one or more radiopaque portions (e.g., and the one or more radiopaque portions change a size, spacing, and / or shape upon a change in environmental status).25. The medical device of any one of embodiments 16-24, wherein the environmental status element is readable using x-rays, radio waves (e g., in combination with a magnetic field), sound waves, or more than one of these.26. The medical device of any one of embodiments 16-25, wherein the identification element is the environmental status element.27. The medical device of embodiment 26, wherein the identification element encodes the information in a different manner from a manner in which the environmental status element is structured to be readable to indicate the one or more characteristics (e.g., wherein the identification element encodes the information based on size and / or radiodensity of one or more encodingPage 45 of 9512747491 vlAttorney Docket No. : 2019150-0019 portions and the environmental status element indicates the one or more characteristics based on spacing of the one or more encoding portions).28. The medical device of any one of embodiments 16-25, wherein the identification element and the environmental status element are different elements.29. The medical device of any one of embodiments 1-25, comprising a plurality of environmental status elements that are each structured to be readable to indicate one or more characteristics of a local environment for the medical device.30. The medical device of embodiment 29, wherein the environmental status elements are spatially separated on the medical device.31. The medical device of embodiment 30, wherein the environmental status elements are spatially separated along a long axis of the medical device (e.g., a long axis of a suture).32. The medical device of any one of embodiments 29-31, wherein each of the environmental status elements is no more than 3 cm in a longest dimension (e.g., no more than 2 cm, no more than 1 cm, or no more than 0.5 cm in the longest dimension).33. The medical device of any one of embodiments 29-32, wherein adjacent ones of the environmental status elements are separated by a distance of no more than 3 cm (e.g., wherein the distance is no more than 2 cm, no more than 1 cm, or no more than 0.5 cm).34. The medical device of any one of embodiments 29-33, wherein the environmental status elements repeat at a linear density of at least 0.2 per cm (e.g., at least 0.33 per cm, at least 0.5 per cm, at least 0.75 per cm, at least 1 per cm, at least 1.5 per cm, at least 2 per cm, or at least 3 per cm).Page 46 of 9512747491 vlAttorney Docket No. : 2019150-001935. The medical device of any one of embodiments 29-34, wherein each of the environmental status elements is each structured to be readable to indicate a same one or more characteristics of the local environment.36. The medical device of any one of embodiments 29-34, wherein at least two of the environmental status elements are structured to be readable to indicate at least one different characteristic of the local environment from each other (e.g., one or more of the environmental status elements are structured to be readable to indicate pH of the local environment and one or more others of the environmental status elements are structured to be readable to indicate tension of the medical device).37. The medical device of any one of embodiments 29-36, wherein one of the environmental status elements is the identification element.38. The medical device of embodiment 37, wherein the identification element encodes the information in a different manner from a manner in which the one of the environmental status elements is structured to be readable to indicate the one or more characteristics (e.g., wherein the identification element encodes the information based on size and / or radiodensity of one or more encoding portions and the one of the environmental status elements indicates the one or more characteristics based on spacing of the one or more encoding portions).39. The medical device of any one of embodiments 29-38, wherein each of the environmental status elements is an identification element that encodes information.40. The medical device of any one of embodiments 29-36, wherein the identification element and the environmental status element are different elements.41. The medical device of any one of the preceding embodiments, wherein the identification element comprises one or more radiopaque encoding portions.Page 47 of 9512747491 vlAttorney Docket No. : 2019150-001942. The medical device of any one of the preceding embodiments, wherein the identification element comprises one or more threads, one or more filaments, and / or one or more fibers that encode the information [e.g., one or more fibers that are braided into a thread (e.g., with or without one or more other fibers) such that the one or more fibers encode the information],43. The medical device of any one of the preceding embodiments, wherein the identification element comprises one or more threads, one or more filaments, and / or one or more fibers that are radiopaque.44. The medical device of any one of the preceding embodiments, wherein the information comprises one or more characters and the identification element comprises one or more encoding portions that each encode one of the one or more characters.45. The medical device of embodiment 43 or embodiment 44, wherein the one or more encoding portions are spatially arranged, spatially distributed, phased, positioned, oriented, or a combination thereof such that the one or more encoding portions encode the information.46. The medical device of any one of the preceding embodiments, wherein the information comprises one or more characters and the identification element comprises a plurality of encoding portions, wherein two or more of the plurality of encoding portions together encode one of the one or more characters.47. The medical device of any one of the preceding embodiments, wherein the identification element comprises one or more encoding portions (e.g., one or more threads, one or more filaments, and / or one or more fibers) that are spatially arranged, spatially distributed, phased, positioned, oriented, shaped, sized, constructed to produce a responsive signal, or a combination thereof such that the one or more encoding portions encode the information.Page 48 of 9512747491 vlAttorney Docket No. : 2019150-001948. The medical device of any one of the preceding embodiments, wherein the information is encoded by a spatial distribution, phase, position, and / or size of one or more encoding portions of the identification element.49. The medical device of any one of the preceding embodiments, wherein the identification element comprises one or more encoding portions that form a readable pattern that encodes the information.50. The medical device of any one of the preceding embodiments, wherein the identification element comprises one or more encoding portions that form a readable pattern that is the information.51. The medical device of any one of the preceding embodiments, wherein the identification element comprises one or more braided elements that encode the information based on one or more spacings between adjacent portions of the one or more braided elements (e.g., between adjacent braided elements).52. The medical device of any one of the preceding embodiments, wherein the identification element is readable using x-rays, radio waves, sound waves, or a combination thereof.53. The medical device of any one of the preceding embodiments, wherein the identification element comprises one or more materials of variable radio-density that encode at least a portion of the information.54. The medical device of any one of the preceding embodiments, wherein the identification element comprises a plurality of radiopaque elements that together encode at least a portion of the information.Page 49 of 9512747491 vlAttorney Docket No. : 2019150-001955. The medical device of any one of the preceding embodiments, wherein the identification element comprises a plurality of radiopaque elements that each encode a character in the information.56. The medical device of any one of the preceding embodiments, wherein the information is unique to the medical device.57. The medical device of any one of the preceding embodiments, wherein the identification element is not visible to unaided human eyes.58. The medical device of any one of the preceding embodiments, wherein the information is no more than 50 (e.g., no more than 25, no more than 20, no more than 15, no more than 10, or no more than 5) characters long.59. The medical device of any one of the preceding embodiments, wherein the identification element encodes the information in a base that is not base 10 (e.g., wherein the identification element encodes the information in binary).60. The medical device of any one of the preceding embodiments, wherein one or more first encoding portions (e.g., filament(s), fiber(s), ink(s)) of the identification element encode a first portion of the information (e.g., a manufacturer name) and one or more second portions (e.g., filament(s), fiber(s), ink(s)) of the identification element encode a second portion of the information distinct from the first portion (e.g., a model name or serial number).61. The medical device of any one of the preceding embodiments, wherein the identification element comprises one or more first encoding portions that encode a first portion of the information in a first manner and one or more second encoding portions that encode a second portion of the information in a second manner different from the first manner (e.g., wherein the first manner is based on size and the second manner is based on spatial distribution and / or phase).Page 50 of 9512747491 vlAttorney Docket No. : 2019150-001962. The medical device of any one of the preceding embodiments, wherein the information is encoded by a single portion (e.g., single fdament or single fiber) of the identification element (e.g., using variable radiodensity).63. The medical device of any one of the preceding embodiments, wherein the information is encoded by one or more encoding portions disposed on an outer surface of the medical device.64. The medical device of any one of the preceding embodiments, wherein the information is encoded by one or more encoding portions adhered to an outer surface of the medical device.65. The medical device of any one of the preceding embodiments, wherein the information is encoded by one or more encoding portions that are integrated with the medical device.66. A medical device for connecting (e.g., holding together) tissue (e.g., two or more tissues or two sides of an incision or wound) (e.g., tissue of a human or other animal), the device comprising an environmental status element that is structured to be readable to indicate one or more characteristics of a local environment for the medical device.67. The medical device of embodiment 66, wherein the medical device is a suture.68. The medical device of embodiment 66, wherein the medical device is suture tape.69. The medical device of embodiment 66, wherein the medical device is a mesh (e.g., a surgical mesh).70. The medical device of embodiment 66, wherein the medical device comprises a suture anchor physically associated with the environmental status element.71. The medical device of embodiment 70, wherein the suture anchor comprises the environmental status element.Page 51 of 9512747491 vlAttorney Docket No. : 2019150-001972. The medical device of any one of embodiments 66-71, wherein the environmental status element is pH sensitive (e.g., is structured to be readable to indicate a pH of the local environment).73. The medical device of embodiment 72, wherein the environmental status element or the medical device is coated with a pH sensitive coating that causes a change in state of the environmental status element upon a change in local pH near the environmental status element.74. The medical device of embodiment 73, wherein the state is a conformational state (e.g., size, shape, and / or spacing).75. The medical device of any one of embodiments 66-74, wherein the environmental status element is tension sensitive (e.g., is structured to be readable to indicate whether the medical device is under tension or not).76. The medical device of any one of embodiments 66-75, wherein the environmental status element is structured to be readable to indicate a tension state of the medical device.77. The medical device of any one of embodiments 66-76, wherein the environmental status element is temperature sensitive (e.g., is structured to be readable to indicate a temperature of the local environment).78. The medical device of any one of embodiments 66-77, wherein the environmental status element is pressure sensitive (e.g., is structured to be readable to indicate a pressure of the local environment).79. The medical device of any one of embodiments 66-78, wherein the environmental status element comprises one or more radiopaque portions (e.g., and the one or more radiopaque portions change a size, spacing, and / or shape upon a change in environmental status).Page 52 of 9512747491 vlAttorney Docket No. : 2019150-001980. The medical device of any one of embodiments 66-79, wherein the environmental status element is readable using x-rays, radio waves (e.g., in combination with a magnetic field), sound waves, or more than one of these.81. The medical device of any one of embodiments 66-80, wherein the environmental status element is an identification element that encodes information.82. The medical device of embodiment 81, wherein the identification element encodes the information in a different manner from a manner in which the environmental status element is structured to be readable to indicate the one or more characteristics (e.g., wherein the identification element encodes the information based on size and / or radiodensity of one or more encoding portions and the environmental status element indicates the one or more characteristics based on spacing of the one or more encoding portions).83. The medical device of any one of embodiments 66-82, wherein the environmental status element is not also an identification element that encodes information.84. The medical device of any one of embodiments 66-83, comprising a plurality of environmental status elements that are each structured to be readable to indicate one or more characteristics of a local environment for the medical device.85. The medical device of embodiment 84, wherein the environmental status elements are spatially separated on the medical device.86. The medical device of embodiment 85, wherein the environmental status elements are spatially separated along a long axis of the medical device (e.g., a long axis of a suture).87. The medical device of any one of embodiments 84-86, wherein each of the environmental status elements is no more than 3 cm in a longest dimension (e.g., no more than 2 cm, no more than 1 cm, or no more than 0.5 cm in the longest dimension).Page 53 of 9512747491 vlAttorney Docket No. : 2019150-001988. The medical device of any one of embodiments 84-87, wherein adjacent ones of the environmental status elements are separated by a distance of no more than 3 cm (e.g., wherein the distance is no more than 2 cm, no more than 1 cm, or no more than 0.5 cm).89. The medical device of any one of embodiments 84-88, wherein the environmental status elements repeat at a linear density of at least 0.2 per cm (e.g., at least 0.33 per cm, at least 0.5 per cm, at least 0.75 per cm, at least 1 per cm, at least 1.5 per cm, at least 2 per cm, or at least 3 per cm).90. The medical device of any one of embodiments 84-89, wherein each of the environmental status elements are each structured to be readable to indicate a same one or more characteristics of the local environment.91. The medical device of any one of embodiments 84-89, wherein at least two of the environmental status elements are structured to be readable to indicate at least one different characteristic of the local environment from each other (e.g., one or more of the environmental status elements are structured to be readable to indicate pH of the local environment and one or more others of the environmental status elements are structured to be readable to indicate tension of the medical device).92. The medical device of any one of embodiments 84-91, wherein one of the environmental status elements is an identification element that encodes information.93. The medical device of embodiment 92, wherein the identification element encodes the information in a different manner from a manner in which the one of the environmental status elements is structured to be readable to indicate the one or more characteristics (e.g., wherein the identification element encodes the information based on size and / or radiodensity of one or more encoding portions and the one of the environmental status elements indicates the one or more characteristics based on spacing of the one or more encoding portions).Page 54 of 9512747491 vlAttorney Docket No. : 2019150-001994. The medical device of any one of embodiments 84-93, wherein each of the environmental status elements is an identification element that encodes information.95. The medical device of any one of embodiments 84-91, comprising one or more identification elements that each encode information, wherein none of the environmental status element is an identification element.96. A non-transitory medical image of tissue connected by a medical device, wherein information identifying the medical device is discernable in the image.97. The image of embodiment 96, wherein the information comprises a serial number, a lot number, a batch number, or a combination thereof.98. The image of any one of embodiments 96-97, wherein the information comprises a manufacturer and / or a model of the medical device.99. The image of any one of embodiments 96-98, wherein the image is a radiological image.100. The image of any one of embodiments 96-98, wherein the image is a sonogram (e g., an ultrasound image).101. The image of any one of embodiments 96-99, wherein the image is an MRI image.102. The image of any one of embodiments 96-99, wherein the image is a CT image.103. The image of any one of embodiments 96-99, wherein the image is an x-ray image.104. The image of embodiment 103, wherein the image is a dual energy x-ray absorptiometry image.Page 55 of 9512747491 vlAttorney Docket No. : 2019150-0019105. The image of any one of embodiments 96-104, wherein the medical device is a suture.106. The image of any one of embodiments 96-104, wherein the medical device is suture tape.107. The image of any one of embodiments 96-104, wherein the medical device is a mesh (e.g., a surgical mesh).108. The image of any one of embodiments 96-104, wherein the medical device comprises a suture anchor.109. The image of any one of embodiments 96-108, wherein the medical device comprises an identification element that encodes the information.110. The image of any one of embodiments 96-109, wherein the medical device is a medical device according to any one of embodiments 1-95.111. The image of any one of embodiments 96-110, wherein the tissue is internal tissue.112. The image of any one of embodiments 96-111, wherein the tissue is human tissue.113. The image of any one of embodiments 96-111, wherein the tissue is tissue of a non-human animal.114. The image of any one of embodiments 96-113, wherein the image has been acquired from outside of a body (e.g., of the human body or of the non-human animal body).115. The image of any one of embodiments 96-114, wherein the tissue connected by the medical device is two or more tissues (e.g., two or more internal tissues).Page 56 of 9512747491 vlAttorney Docket No. : 2019150-0019116. A non-transitory medical image of tissue connected by a medical device, wherein at least a portion of the medical device is discernable in the image such that one or more characteristics of a local environment near (e.g., in contact with) the medical device are discernable based on the at least a portion of the medical device.117. The image of embodiment 116, wherein the one or more characteristics comprise a relative pH (e.g., relative to a baseline or standard for the tissue).118. The image of embodiment 116 or embodiment 117, wherein the one or more characteristics comprise whether the medical device is under tension.119. The image of any one of embodiments 116-118, wherein the one or more characteristics comprise a relative temperature (e.g., relative to a baseline or standard for the tissue).120. The image of any one of embodiments 116-119, wherein the one or more characteristics comprise a relative pressure (e.g., relative to a baseline or standard for the tissue).121. The image of any one of embodiments 116-120, wherein the image is a radiological image.122. The image of any one of embodiments 116-120, wherein the image is a sonogram (e.g., an ultrasound image).123. The image of any one of embodiments 116-121, wherein the image is an MRI image.124. The image of any one of embodiments 116-121, wherein the image is a CT image.125. The image of any one of embodiments 96-99, wherein the image is an x-ray image.126. The image of embodiment 125, wherein the image is a dual energy x-ray absorptiometry image.Page 57 of 9512747491 vlAttorney Docket No. : 2019150-0019127. The image of any one of embodiments 116-126, wherein the medical device is a suture.128. The image of any one of embodiments 116-126, wherein the medical device is suture tape.129. The image of any one of embodiments 116-126, wherein the medical device is a mesh (e.g., a surgical mesh).130. The image of any one of embodiments 116-126, wherein the medical device comprises a suture anchor.131. The image of any one of embodiments 116-130, wherein the medical device comprises an identification element that encodes the information.132. The image of any one of embodiments 116-131, wherein the medical device is a medical device according to any one of embodiments 1-65.133. The image of any one of embodiments 116-132, wherein the tissue is internal tissue.134. The image of any one of embodiments 116-133, wherein the tissue is human tissue.135. The image of any one of embodiments 116-133, wherein the tissue is tissue of a non-human animal.136. The image of any one of embodiments 116-135, wherein the image has been acquired from outside of a body (e.g., of the human body or of the non-human animal body).137. The image of any one of embodiments 116-136, wherein the tissue connected by the medical device is two or more tissues (e.g., two or more internal tissues).Page 58 of 9512747491 vlAttorney Docket No. : 2019150-0019138. The medical image of any one of embodiments 96-137, wherein the medical image is a printed image.139. The medical image of any one of embodiments 96-137, wherein the medical image is a film image.140. One or more non-transitory computer-readable media having one or more medical images according to any one of embodiments 96-137 stored thereon.141. A method comprising acquiring the medical image of any one of embodiments 96-137(e.g., from outside of a body that comprises the tissue) [e.g., wherein acquiring comprises providing (e g., directing) x-rays, radio waves (e g., in combination with a magnetic field), or sound waves to the tissue and / or the medical device (e.g., into the body)] (e.g., wherein the image is acquired using x-rays, radio waves (e.g., in combination with a magnetic field), or sound waves).142. A method comprising rendering, by a processor of a computing device, the medical image of any one of embodiments 96-137.143. A method comprising displaying, by a processor of a computing device, the medical image of any one of embodiments 96-137.144. A method comprising constructing (e.g., by a processor of a computing device) the medical image of any one of embodiments 96-137.145. A method comprising developing the medical image of any one of embodiments 96-137.146. One or more non-transitory computer-readable media having instructions (e g., one or more programs) stored thereon that, when executed by a processor, cause the processor to perform the method according to any one of embodiments 142-144.Page 59 of 9512747491 vlAttorney Docket No. : 2019150-0019147. A method of characterizing a local environment near a medical device that is connecting tissue (e.g., connecting two or more tissues), wherein the medical device comprises an environmental status element, the method comprising: receiving (e.g., by rendering or displaying) (e.g., by a processor of a computing device) an image of the tissue in which the environmental status element is discernable; and characterizing the local environment near the medical device based on how the environmental status element appears in the image.148. The method of embodiment 147, comprising acquiring the image.149. The method of embodiment 148, wherein acquiring the image comprises applying x-rays, radio waves (e.g., in combination with a magnetic field), or sound waves to the medical device (e.g., and the tissue) [e.g., through tissue (e.g., through the tissue)].150. The method of embodiment 148 or embodiment 149, wherein acquiring the image comprises forming an x-ray image, a CT scan, an MRI image, or a sonograph in which the environmental status element is discernable.151. The method of any one of embodiments 147-150, wherein the local environment is a region of the tissue, wherein no portion of the region is more than 5 cm (e.g., is more than 4 cm, more than 3 cm, more than 2 cm, or more than 1 cm) from the medical device.152. The method of any one of embodiments 147-150, wherein the local environment is a region of tissue that contacts the medical device.153. The method of any one of embodiments 147-152, wherein the tissue is discernable in the image.Page 60 of 9512747491 vlAttorney Docket No. : 2019150-0019154. The method of any one of embodiments 147-153, wherein characterizing the local environment comprises determining a qualitative status of the local environment [e.g., as healthy or not healthy (e.g., infected)].155. The method of embodiment 154, wherein the qualitative status comprises a relative acidity of the local environment (e.g., wherein characterizing the local environment comprises determining that the local environment has an elevated acidity relative to baseline).156. The method of embodiment 154, wherein the qualitative status comprises a relative temperature of the local environment (e.g., wherein characterizing the local environment comprises determining that the local environment has an elevated temperature relative to baseline).157. The method of embodiment 154, wherein the qualitative status comprises a relative pressure of the local environment (e.g., wherein characterizing the local environment comprises determining that the local environment has an elevated pressure relative to baseline).158. The method of any one of embodiments 147-157, wherein characterizing the local environment comprises determining a quantitative status of the local environment.159. The method of embodiment 158, wherein the quantitative status comprises an amount of tension that the medical device is under in the local environment.160. The method of embodiment 158 or embodiment 159, comprising determining a health status of the tissue based on the quantitative status [e.g., determining whether the tissue is healthy or not healthy (e.g., infected)].161. The method of any one of embodiments 147-160, wherein the image is of an internal portion of a body (e.g., of a human or non-human animal).Page 61 of 9512747491 vlAttorney Docket No. : 2019150-0019162. The method of any one of embodiments 147-161 , wherein the medical device is disposed internally in a body.163. The method of any one of embodiments 147-162, wherein the medical device is disposed inside of a human body (e.g., disposed inside of a body of a patient).164. The method of any one of embodiments 147-162, wherein the medical device is disposed inside of a non-human animal (e.g., a dog or cat).165. The method of any one of embodiments 147-164, wherein the medical device is closing a wound.166. The method of any one of embodiments 147-164, wherein the medical device is closing an incision (e.g., a surgical incision).167. The method of any one of embodiments 147-166, wherein the medical device has been placed as part of a surgical procedure (e.g., an elective procedure, a trauma procedure, or an emergency procedure).168. The method of any one of embodiments 147-167, wherein the local environment is a surgical site and the characterizing comprises an indication of health of the surgical site.169. The method of any one of embodiments 147-168, wherein the local environment is a surgical site and the method comprises determining health of the surgical site based on the characterizing.170. A method of characterizing pH of tissue near a medical device that is connecting the tissue (e.g., connecting two or more tissues), the method comprising: receiving (e.g., by rendering or displaying) (e.g., by a processor of a computing device) an image of the tissue in which the medical device is discernable; andPage 62 of 9512747491 vlAttorney Docket No. : 2019150-0019 characterizing pH of the tissue based on how the medical device appears in the image.171. The method of embodiment 170, wherein characterizing the pH comprises determining a relative pH relative to a baseline.172. The method of embodiment 171, wherein the baseline corresponds to healthy corresponding tissue.173. The method of any one of embodiments 170-172, wherein determining the relative pH comprises determining that the pH is higher or lower than a previously determined relative pH (e.g., relative to another image of the tissue taken at an earlier time).174. The method of any one of embodiments 170-173, wherein the characterizing is based on a configuration of the medical device that is discernable in the image.175. The method of embodiment 174, wherein the configuration is a configuration of an environmental status element comprised in the medical device.176. A method of determining health of tissue that is connected by a medical device, the method comprising: receiving (e g., by rendering or displaying) (e.g., by a processor of a computing device) an image of tissue in which the medical device is discernable; and determining whether the tissue is infected and / or whether the tissue is healed based on how the medical device appears in the image.177. The method of embodiment 176, comprising determining whether the tissue is infected and / or whether the tissue is healed based on how an environmental status element of the medical device appears in the image.Page 63 of 9512747491 vlAttorney Docket No. : 2019150-0019178. The method of embodiment 176 or embodiment 177, wherein determining whether the tissue is infected and / or whether the tissue is healed is based on a configuration of the medical device discernable in the image.179. The method of embodiment 178, wherein the configuration is a configuration of an environmental status element comprised in the medical device.180. A method of determining an identity of a medical device that connects tissue, the method comprising: receiving (e.g., by rendering or displaying) (e.g., by a processor of a computing device) an image in which the medical device is discernable; and determining an identity of the medical device based on how the medical device appears in the image.181. The method of embodiment 180, wherein (i) the medical device comprises an identification element that encodes information that identifies the medical device, (ii) the identification element is discernable within the image, (iii) the method comprises determining the information based on the image and (iv) determining the identity is based on the information.182. The method of embodiment 180 or embodiment 181, wherein the identity comprises a serial number, a lot number, a batch number, or a combination thereof.183. The method of any one of embodiments 180-182, wherein the identity comprises a manufacturer of the medical device and / or a model of the medical device.184. The method of any one of embodiments 180-183, comprising acquiring the image.185. The method of embodiment 184, wherein acquiring the image comprises applying x-rays, radio waves (e.g., in combination with a magnetic field), or sound waves to the medical device (e.g., and the tissue).Page 64 of 9512747491 vlAttorney Docket No. : 2019150-0019186. The method of embodiment 184 or embodiment 185, wherein acquiring the image comprises forming an x-ray image, a CT scan, an MRI image, or a sonograph in which the environmental status element is discernable.187. The method of any one of embodiments 147-186, wherein the medical device is a medical device according to any one of embodiments 1-95.Exemplary Computing Devices

[0149] Illustrative embodiments of systems and methods disclosed herein were described above with reference to computations performed locally by a computing device. However, computations performed over a network are also contemplated. FIG. 20 shows an illustrative network environment 2000 for use in the methods and systems described herein. In brief overview, referring now to FIG. 20, a block diagram of an illustrative cloud computing environment 2000 is shown and described. The cloud computing environment 2000 may include one or more resource providers 2002a, 2002b, 2002c (collectively, 2002). Each resource provider 2002 may include computing resources. In some implementations, computing resources may include any hardware and / or software used to process data. For example, computing resources may include hardware and / or software capable of executing algorithms, computer programs, and / or computer applications. In some implementations, illustrative computing resources may include application servers and / or databases with storage and retrieval capabilities. Each resource provider 2002 may be connected to any other resource provider 2002 in the cloud computing environment 2000. In some implementations, the resource providers 2002 may be connected over a computer network 2008. Each resource provider 2002 may be connected to one or more computing device 2004a, 2004b, 2004c (collectively, 2004), over the computer network 2008.

[0150] The cloud computing environment 2000 may include a resource manager 2006. The resource manager 2006 may be connected to the resource providers 2002 and the computing devices 2004 over the computer network 2008. In some implementations, the resource manager 2006 may facilitate the provision of computing resources by one or more resource providers 2002 to one or more computing devices 2004. The resource manager 2006 may receive a request for aPage 65 of 9512747491 vlAttorney Docket No. : 2019150-0019 computing resource from a particular computing device 2004. The resource manager 2006 may identify one or more resource providers 2002 capable of providing the computing resource requested by the computing device 2004. The resource manager 2006 may select a resource provider 2002 to provide the computing resource. The resource manager 2006 may facilitate a connection between the resource provider 2002 and a particular computing device 2004. In some implementations, the resource manager 2006 may establish a connection between a particular resource provider 2002 and a particular computing device 2004. In some implementations, the resource manager 2006 may redirect a particular computing device 2004 to a particular resource provider 2002 with the requested computing resource.

[0151] FIG. 21 shows an example of a computing device 2100 and a mobile computing device 2150 that can be used in the methods and systems described in this disclosure. The computing device 2100 is intended to represent various forms of digital computers, such as laptops, desktops, workstations, personal digital assistants, servers, blade servers, mainframes, and other appropriate computers. The mobile computing device 2150 is intended to represent various forms of mobile devices, such as personal digital assistants, cellular telephones, smart-phones, and other similar computing devices. The components shown here, their connections and relationships, and their functions, are meant to be examples only, and are not meant to be limiting.

[0152] The computing device 2100 includes a processor 2102, a memory 2104, a storage device 2106, a high-speed interface 2108 connecting to the memory 2104 and multiple high-speed expansion ports 2110, and a low-speed interface 2112 connecting to a low-speed expansion port 2114 and the storage device 2106. Each of the processor 2102, the memory 2104, the storage device 2106, the high-speed interface 2108, the high-speed expansion ports 2110, and the low- speed interface 2112, are interconnected using various busses, and may be mounted on a common motherboard or in other manners as appropriate. The processor 2102 can process instructions for execution within the computing device 2100, including instructions stored in the memory 2104 or on the storage device 2106 to display graphical information for a GUI on an external input / output device, such as a display 2116 coupled to the high-speed interface 2108. In other implementations, multiple processors and / or multiple buses may be used, as appropriate, along with multiple memories and types of memory. Also, multiple computing devices may be connected, with each device providing portions of the necessary operations (e.g., as a server bank, a group of bladePage 66 of 9512747491 vlAttorney Docket No. : 2019150-0019 servers, or a multi -processor system). Also, multiple computing devices may be connected, with each device providing portions of the necessary operations (e.g., as a server bank, a group of blade servers, or a multi -processor system). Thus, as the term is used herein, where a plurality of functions are described as being performed by “a processor”, this encompasses embodiments wherein the plurality of functions are performed by any number of processors (e.g., one or more processors) of any number of computing devices (e.g., one or more computing devices). Furthermore, where a function is described as being performed by “a processor”, this encompasses embodiments wherein the function is performed by any number of processors (e.g., one or more processors) of any number of computing devices (e.g., one or more computing devices) (e.g., in a distributed computing system).

[0153] The memory 2104 stores information within the computing device 2100. In some implementations, the memory 2104 is a volatile memory unit or units. In some implementations, the memory 2104 is a non-volatile memory unit or units. The memory 2104 may also be another form of computer-readable medium, such as a magnetic or optical disk.

[0154] The storage device 2106 is capable of providing mass storage for the computing device 2100. In some implementations, the storage device 2106 may be or contain a computer- readable medium, such as a hard disk device, an optical disk device, a flash memory or other similar solid state memory device, or an array of devices, including devices in a storage area network or other configurations. Instructions can be stored in an information carrier. The instructions, when executed by one or more processing devices (for example, processor 2102), perform one or more methods, such as those described above. The instructions can also be stored by one or more storage devices such as computer- or machine-readable mediums (for example, the memory 2104, the storage device 2106, or memory on the processor 2102).

[0155] The high-speed interface 2108 manages bandwidth-intensive operations for the computing device 2100, while the low-speed interface 2112 manages lower bandwidth-intensive operations. Such allocation of functions is an example only. In some implementations, the highspeed interface 2108 is coupled to the memory 2104, the display 2116 (e.g., through a graphics processor or accelerator), and to the high-speed expansion ports 2110, which may accept various expansion cards (not shown). In the implementation, the low-speed interface 2112 is coupled to the storage device 2106 and the low-speed expansion port 2114. The low-speed expansion portPage 67 of 9512747491 vlAttorney Docket No. : 2019150-00192114, which may include various communication ports (e.g., USB, Bluetooth®, Ethernet, wireless Ethernet) may be coupled to one or more input / output devices, such as a keyboard, a pointing device, a scanner, or a networking device such as a switch or router, e.g., through a network adapter.

[0156] The computing device 2100 may be implemented in a number of different forms, as shown in the figure. For example, it may be implemented as a standard server 2120, or multiple times in a group of such servers. In addition, it may be implemented in a personal computer such as a laptop computer 2122. It may also be implemented as part of a rack server system 2124. Alternatively, components from the computing device 2100 may be combined with other components in a mobile device (not shown), such as a mobile computing device 2150. Each of such devices may contain one or more of the computing device 2100 and the mobile computing device 2150, and an entire system may be made up of multiple computing devices communicating with each other.

[0157] The mobile computing device 2150 includes a processor 2152, a memory 2164, an input / output device such as a display 2154, a communication interface 2166, and a transceiver 2168, among other components. The mobile computing device 2150 may also be provided with a storage device, such as a micro-drive or other device, to provide additional storage. Each of the processor 2152, the memory 2164, the display 2154, the communication interface 2166, and the transceiver 2168, are interconnected using various buses, and several of the components may be mounted on a common motherboard or in other manners as appropriate.

[0158] The processor 2152 can execute instructions within the mobile computing device 2150, including instructions stored in the memory 2164. The processor 2152 may be implemented as a chipset of chips that include separate and multiple analog and digital processors. The processor 2152 may provide, for example, for coordination of the other components of the mobile computing device 2150, such as control of user interfaces, applications run by the mobile computing device 2150, and wireless communication by the mobile computing device 2150.

[0159] The processor 2152 may communicate with a user through a control interface 2158 and a display interface 2156 coupled to the display 2154. The display 2154 may be, for example, a TFT (Thin-Film-Transistor Liquid Crystal Display) display or an OLED (Organic Light Emitting Diode) display, or other appropriate display technology. The display interface 2156 may comprisePage 68 of 9512747491 vlAttorney Docket No. : 2019150-0019 appropriate circuitry for driving the display 2154 to present graphical and other information to a user. The control interface 2158 may receive commands from a user and convert them for submission to the processor 2152. In addition, an external interface 2162 may provide communication with the processor 2152, so as to enable near area communication of the mobile computing device 2150 with other devices. The external interface 2162 may provide, for example, for wired communication in some implementations, or for wireless communication in other implementations, and multiple interfaces may also be used.

[0160] The memory 2164 stores information within the mobile computing device 2150. The memory 2164 can be implemented as one or more of a computer-readable medium or media, a volatile memory unit or units, or a non-volatile memory unit or units. An expansion memory 2174 may also be provided and connected to the mobile computing device 2150 through an expansion interface 2172, which may include, for example, a SIMM (Single In Line Memory Module) card interface. The expansion memory 2174 may provide extra storage space for the mobile computing device 2150, or may also store applications or other information for the mobile computing device 2150. Specifically, the expansion memory 2174 may include instructions to carry out or supplement the processes described above, and may include secure information also. Thus, for example, the expansion memory 2174 may be provided as a security module for the mobile computing device 2150, and may be programmed with instructions that permit secure use of the mobile computing device 2150. In addition, secure applications may be provided via the SIMM cards, along with additional information, such as placing identifying information on the SIMM card in a non-hackable manner.

[0161] The memory may include, for example, flash memory and / or NVRAM memory (non-volatile random access memory), as discussed below. In some implementations, instructions are stored in an information carrier and, when executed by one or more processing devices (for example, processor 2152), perform one or more methods, such as those described above. The instructions can also be stored by one or more storage devices, such as one or more computer- or machine-readable mediums (for example, the memory 2164, the expansion memory 2174, or memory on the processor 2152). In some implementations, the instructions can be received in a propagated signal, for example, over the transceiver 2168 or the external interface 2162.Page 69 of 9512747491 vlAttorney Docket No. : 2019150-0019

[0162] The mobile computing device 2150 may communicate wirelessly through the communication interface 2166, which may include digital signal processing circuitry where necessary. The communication interface 2166 may provide for communications under various modes or protocols, such as GSM voice calls (Global System for Mobile communications), SMS (Short Message Service), EMS (Enhanced Messaging Service), or MMS messaging (Multimedia Messaging Service), CDMA (code division multiple access), TDMA (time division multiple access), PDC (Personal Digital Cellular), WCDMA (Wideband Code Division Multiple Access), CDMA2000, or GPRS (General Packet Radio Service), among others. Such communication may occur, for example, through the transceiver 2168 using a radio-frequency. In addition, short-range communication may occur, such as using a Bluetooth®, Wi-Fi™, or other such transceiver (not shown). In addition, a GPS (Global Positioning System) receiver module 2170 may provide additional navigation- and location-related wireless data to the mobile computing device 2150, which may be used as appropriate by applications running on the mobile computing device 2150.

[0163] The mobile computing device 2150 may also communicate audibly using an audio codec 2160, which may receive spoken information from a user and convert it to usable digital information. The audio codec 2160 may likewise generate audible sound for a user, such as through a speaker, e.g., in a handset of the mobile computing device 2150. Such sound may include sound from voice telephone calls, may include recorded sound (e.g., voice messages, music files, etc.) and may also include sound generated by applications operating on the mobile computing device 2150.

[0164] The mobile computing device 2150 may be implemented in a number of different forms, as shown in the figure. For example, it may be implemented as a cellular telephone 2180. It may also be implemented as part of a smart-phone 2182, personal digital assistant, or other similar mobile device.

[0165] Various implementations of the systems and techniques described here can be realized in digital electronic circuitry, integrated circuitry, specially designed ASICs (application specific integrated circuits), computer hardware, firmware, software, and / or combinations thereof. These various implementations can include implementation in one or more computer programs that are executable and / or interpretable on a programmable system including at least one programmable processor, which may be special or general purpose, coupled to receive data andPage 70 of 9512747491 vlAttorney Docket No. : 2019150-0019 instructions from, and to transmit data and instructions to, a storage system, at least one input device, and at least one output device.

[0166] These computer programs (also known as programs, software, software applications or code) include machine instructions for a programmable processor, and can be implemented in a high-level procedural and / or object-oriented programming language, and / or in assembly / machine language. As used herein, the terms machine-readable medium and computer- readable medium refer to any computer program product, apparatus and / or device (e.g., magnetic discs, optical disks, memory, Programmable Logic Devices (PLDs)) used to provide machine instructions and / or data to a programmable processor, including a machine-readable medium that receives machine instructions as a machine-readable signal. The term machine-readable signal refers to any signal used to provide machine instructions and / or data to a programmable processor.

[0167] To provide for interaction with a user, the systems and techniques described here can be implemented on a computer having a display device (e.g., a CRT (cathode ray tube) or LCD (liquid crystal display) monitor) for displaying information to the user and a keyboard and a pointing device (e.g., a mouse or a trackball) by which the user can provide input to the computer. Other kinds of devices can be used to provide for interaction with a user as well; for example, feedback provided to the user can be any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback); and input from the user can be received in any form, including acoustic, speech, or tactile input.

[0168] The systems and techniques described here can be implemented in a computing system that includes a back end component (e.g., as a data server), or that includes a middleware component (e.g., an application server), or that includes a front end component (e.g., a client computer having a graphical user interface or a Web browser through which a user can interact with an implementation of the systems and techniques described here), or any combination of such back end, middleware, or front end components. The components of the system can be interconnected by any form or medium of digital data communication (e.g., a communication network). Examples of communication networks include a local area network (LAN), a wide area network (WAN), and the Internet.

[0169] The computing system can include clients and servers. A client and server are generally remote from each other and typically interact through a communication network. ThePage 71 of 9512747491 vlAttorney Docket No. : 2019150-0019 relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other.

[0170] The foregoing description included various disclosure regarding identification elements and environmental status elements, including embodiments of their structure and inclusion in medical devices for connecting tissue. It is expressly contemplated that teachings regarding identification elements herein may be applied to environmental status elements and vice versa, as will be apparent to those of ordinary skill in the art.

[0171] Without limitation to the foregoing description, the following is an enumerated list of non-limiting exemplary embodiments included in the present disclosure. Those of ordinary skill in the art will appreciate that one or more features discussed above may be included with or incorporated into any of the following numbered embodiments to form additional embodiments.

[0172] It is contemplated that systems, devices, methods, and processes of the disclosure encompass variations and adaptations developed using information from the embodiments described herein. Adaptation and / or modification of the systems, devices, methods, and processes described herein may be performed by those of ordinary skill in the relevant art.

[0173] Throughout the description, where articles, devices, and systems are described as having, including, or comprising specific components, or where processes and methods are described as having, including, or comprising specific steps, it is contemplated that, additionally, there are articles, devices, and systems according to certain embodiments of the present disclosure that consist essentially of, or consist of, the recited components, and that there are processes and methods according to certain embodiments of the present disclosure that consist essentially of, or consist of, the recited processing steps.

[0174] It should be understood that the order of steps or order for performing certain action is immaterial so long as operability is not lost. Moreover, two or more steps or actions may be conducted simultaneously. As is understood by those skilled in the art, the terms “over”, “under”, “above”, “below”, “beneath”, and “on” are relative terms and can be interchanged in reference to different orientations of the layers, elements, and substrates included in the present disclosure. For example, a first layer on a second layer, in some embodiments means a first layer directly on and in contact with a second layer. In other embodiments, a first layer on a second layer can include another layer there between.Page 72 of 9512747491 vlAttorney Docket No. : 2019150-0019

[0175] In this application, unless otherwise clear from context or otherwise explicitly stated, (i) the term “a” may be understood to mean “at least one”; (ii) the term “or” may be understood to mean “and / or”; (iii) the terms “comprising” and “including” may be understood to encompass itemized components or steps whether presented by themselves or together with one or more additional components or steps; and (iv) where ranges are provided, endpoints are included.

[0176] Headers have been provided for the convenience of the reader and are not intended to be limiting with respect to the disclosed or claimed subject matter.

[0177] Certain embodiments of the present disclosure were described above. It is, however, expressly noted that the present disclosure is not limited to those embodiments, but rather the intention is that additions and modifications to what was expressly described in the present disclosure are also included within the scope of the disclosure. Moreover, it is to be understood that the features of the various embodiments described in the present disclosure were not mutually exclusive and can exist in various combinations and permutations, even if such combinations or permutations were not made express, without departing from the spirit and scope of the disclosure. The disclosure has been described in detail with particular reference to certain embodiments thereof, but it will be understood that variations and modifications can be effected within the spirit and scope of the claimed invention.PARTS LIST dl / d2 distance / spacing d3 radial distance10 medical device11 identification element12 encoding portion13 information14 fiber15 environmental status element16 image of medical device17 braided materialPage 73 of 9512747491 vlAttorney Docket No. : 2019150-001920 identification system21 body part22 incision / wound23 closure and / or healing30 medical image31 / 32 cross section of medical devicePage 74 of 9512747491 vl

Claims

Attorney Docket No. : 2019150-0019What is claimed is:

1. A medical device for connecting tissue, the device comprising an identification element that encodes identifying information.

2. The medical device of claim 1, wherein the identification element encodes a serial number, a lot number, a batch number, or a combination thereof.

3. The medical device of claim 1 or claim 2, wherein the identification element encodes a manufacturer of the medical device and / or a model of the medical device.

4. The medical device of any one of the preceding claims, wherein the information identifies a serial number, a lot number, a batch number, a manufacturer of the medical device, a model of the medical device, or a combination thereof.

5. The medical device of any one of the preceding claims, wherein the medical device is a suture.

6. The medical device of any one of claims 1-4, wherein the medical device is suture tape.

7. The medical device of any one of claims 1-4, wherein the medical device is a mesh.

8. The medical device of any one of claims 1-4, wherein the medical device comprises a suture anchor physically associated with the identification element.

9. The medical device of claim 8, wherein the suture anchor comprises the identification element.

10. The medical device of any one of the preceding claims, comprising a plurality of identification elements each encoding same information.Page 75 of 9512747491 vlAttorney Docket No. : 2019150-001911. The medical device of claim 10, wherein the identification elements are spatially separated on the medical device.

12. The medical device of claim 11, wherein the identification elements are spatially separated along a long axis of the medical device.

13. The medical device of any one of claims 10-12, wherein each of the identification elements is no more than 3 cm in a longest dimension.

14. The medical device of any one of claims 10-13, wherein adjacent ones of the identification elements are separated by a distance of no more than 3 cm.

15. The medical device of any one of claims 10-14, wherein the identification elements repeat at a linear density of at least 0.2 per cm.

16. The medical device of any one of the preceding claims, comprising an environmental status element that is structured to be readable to indicate one or more characteristics of a local environment for the medical device.

17. The medical device of claim 16, wherein the environmental status element is pH sensitive.

18. The medical device of claim 17, wherein the environmental status element or the medical device is coated with a pH sensitive coating that causes a change in state of the environmental status element upon a change in local pH near the environmental status element.

19. The medical device of claim 18, wherein the state is a conformational state.

20. The medical device of any one of claims 16-19, wherein the environmental status element is tension sensitive.Page 76 of 9512747491 vlAttorney Docket No. : 2019150-001921. The medical device of any one of claims 16-20, wherein the environmental status element is structured to be readable to indicate a tension state of the medical device.

22. The medical device of any one of claims 16-21, wherein the environmental status element is temperature sensitive.

23. The medical device of any one of claims 16-22, wherein the environmental status element is pressure sensitive.

24. The medical device of any one of claims 16-23, wherein the environmental status element comprises one or more radiopaque portions.

25. The medical device of any one of claims 16-24, wherein the environmental status element is readable using x-rays, radio waves, sound waves, or more than one of these.

26. The medical device of any one of claims 16-25, wherein the identification element is the environmental status element.

27. The medical device of claim 26, wherein the identification element encodes the information in a different manner from a manner in which the environmental status element is structured to be readable to indicate the one or more characteristics.

28. The medical device of any one of claims 16-25, wherein the identification element and the environmental status element are different elements.

29. The medical device of any one of claims 1-25, comprising a plurality of environmental status elements that are each structured to be readable to indicate one or more characteristics of a local environment for the medical device.Page 77 of 9512747491 vlAttorney Docket No. : 2019150-001930. The medical device of claim 29, wherein the environmental status elements are spatially separated on the medical device.

31. The medical device of claim 30, wherein the environmental status elements are spatially separated along a long axis of the medical device.

32. The medical device of any one of claims 29-31, wherein each of the environmental status elements is no more than 3 cm in a longest dimension.

33. The medical device of any one of claims 29-32, wherein adjacent ones of the environmental status elements are separated by a distance of no more than 3 cm.

34. The medical device of any one of claims 29-33, wherein the environmental status elements repeat at a linear density of at least 0.2 per cm.

35. The medical device of any one of claims 29-34, wherein each of the environmental status elements is each structured to be readable to indicate a same one or more characteristics of the local environment.

36. The medical device of any one of claims 29-34, wherein at least two of the environmental status elements are structured to be readable to indicate at least one different characteristic of the local environment from each other.

37. The medical device of any one of claims 29-36, wherein one of the environmental status elements is the identification element.

38. The medical device of claim 37, wherein the identification element encodes the information in a different manner from a manner in which the one of the environmental status elements is structured to be readable to indicate the one or more characteristics.Page 78 of 9512747491 vlAttorney Docket No. : 2019150-001939. The medical device of any one of claims 29-38, wherein each of the environmental status elements is an identification element that encodes information.

40. The medical device of any one of claims 29-36, wherein the identification element and the environmental status element are different elements.

41. The medical device of any one of the preceding claims, wherein the identification element comprises one or more radiopaque encoding portions.

42. The medical device of any one of the preceding claims, wherein the identification element comprises one or more threads, one or more filaments, and / or one or more fibers that encode the information.

43. The medical device of any one of the preceding claims, wherein the identification element comprises one or more threads, one or more filaments, and / or one or more fibers that are radiopaque.

44. The medical device of any one of the preceding claims, wherein the information comprises one or more characters and the identification element comprises one or more encoding portions that each encode one of the one or more characters.

45. The medical device of claim 43 or claim 44, wherein the one or more encoding portions are spatially arranged, spatially distributed, phased, positioned, oriented, or a combination thereof such that the one or more encoding portions encode the information.

46. The medical device of any one of the preceding claims, wherein the information comprises one or more characters and the identification element comprises a plurality of encoding portions, wherein two or more of the plurality of encoding portions together encode one of the one or more characters.Page 79 of 9512747491 vlAttorney Docket No. : 2019150-001947. The medical device of any one of the preceding claims, wherein the identification element comprises one or more encoding portions that are spatially arranged, spatially distributed, phased, positioned, oriented, shaped, sized, constructed to produce a responsive signal, or a combination thereof such that the one or more encoding portions encode the information.

48. The medical device of any one of the preceding claims, wherein the information is encoded by a spatial distribution, phase position, and / or size of one or more encoding portions of the identification element.

49. The medical device of any one of the preceding claims, wherein the identification element comprises one or more encoding portions that form a readable pattern that encodes the information.

50. The medical device of any one of the preceding claims, wherein the identification element comprises one or more encoding portions that form a readable pattern that is the information.

51. The medical device of any one of the preceding claims, wherein the identification element comprises one or more braided elements that encode the information based on one or more spacings between adjacent portions of the one or more braided elements.

52. The medical device of any one of the preceding claims, wherein the identification element is readable using x-rays, radio waves, sound waves, or a combination thereof.

53. The medical device of any one of the preceding claims, wherein the identification element comprises one or more materials of variable radio-density that encode at least a portion of the information.

54. The medical device of any one of the preceding claims, wherein the identification element comprises a plurality of radiopaque elements that together encode at least a portion of the information.Page 80 of 9512747491 vlAttorney Docket No. : 2019150-001955. The medical device of any one of the preceding claims, wherein the identification element comprises a plurality of radiopaque elements that each encode a character in the information.

56. The medical device of any one of the preceding claims, wherein the information is unique to the medical device.

57. The medical device of any one of the preceding claims, wherein the identification element is not visible to unaided human eyes.

58. The medical device of any one of the preceding claims, wherein the information is no more than 50 characters long.

59. The medical device of any one of the preceding claims, wherein the identification element encodes the information in a base that is not base 10.

60. The medical device of any one of the preceding claims, wherein one or more first encoding portions of the identification element encode a first portion of the information and one or more second portions of the identification element encode a second portion of the information distinct from the first portion.

61. The medical device of any one of the preceding claims, wherein the identification element comprises one or more first encoding portions that encode a first portion of the information in a first manner and one or more second encoding portions that encode a second portion of the information in a second manner different from the first manner.

62. The medical device of any one of the preceding claims, wherein the information is encoded by a single portion of the identification element.

63. The medical device of any one of the preceding claims, wherein the information is encoded by one or more encoding portions disposed on an outer surface of the medical device.Page 81 of 9512747491 vlAttorney Docket No. : 2019150-001964. The medical device of any one of the preceding claims, wherein the information is encoded by one or more encoding portions adhered to an outer surface of the medical device.

65. The medical device of any one of the preceding claims, wherein the information is encoded by one or more encoding portions that are integrated with the medical device.

66. A medical device for connecting tissue, the device comprising an environmental status element that is structured to be readable to indicate one or more characteristics of a local environment for the medical device.

67. The medical device of claim 66, wherein the medical device is a suture.

68. The medical device of claim 66, wherein the medical device is suture tape.

69. The medical device of claim 66, wherein the medical device is a mesh.

70. The medical device of claim 66, wherein the medical device comprises a suture anchor physically associated with the environmental status element.

71. The medical device of claim 70, wherein the suture anchor comprises the environmental status element.

72. The medical device of any one of claims 66-71, wherein the environmental status element is pH sensitive.

73. The medical device of claim 72, wherein the environmental status element or the medical device is coated with a pH sensitive coating that causes a change in state of the environmental status element upon a change in local pH near the environmental status element.Page 82 of 9512747491 vlAttorney Docket No. : 2019150-001974. The medical device of claim 73, wherein the state is a conformational state.

75. The medical device of any one of claims 66-74, wherein the environmental status element is tension sensitive.

76. The medical device of any one of claims 66-75, wherein the environmental status element is structured to be readable to indicate a tension state of the medical device.

77. The medical device of any one of claims 66-76, wherein the environmental status element is temperature sensitive.

78. The medical device of any one of claims 66-77, wherein the environmental status element is pressure sensitive.

79. The medical device of any one of claims 66-78, wherein the environmental status element comprises one or more radiopaque portions.

80. The medical device of any one of claims 66-79, wherein the environmental status element is readable using x-rays, radio waves, sound waves, or more than one of these.

81. The medical device of any one of claims 66-80, wherein the environmental status element is an identification element that encodes information.

82. The medical device of claim 81, wherein the identification element encodes the information in a different manner from a manner in which the environmental status element is structured to be readable to indicate the one or more characteristics.

83. The medical device of any one of claims 66-82, wherein the environmental status element is not also an identification element that encodes information.Page 83 of 9512747491 vlAttorney Docket No. : 2019150-001984. The medical device of any one of claims 66-83, comprising a plurality of environmental status elements that are each structured to be readable to indicate one or more characteristics of a local environment for the medical device.

85. The medical device of claim 84, wherein the environmental status elements are spatially separated on the medical device.

86. The medical device of claim 85, wherein the environmental status elements are spatially separated along a long axis of the medical device.

87. The medical device of any one of claims 84-86, wherein each of the environmental status elements is no more than 3 cm in a longest dimension.

88. The medical device of any one of claims 84-87, wherein adjacent ones of the environmental status elements are separated by a distance of no more than 3 cm.

89. The medical device of any one of claims 84-88, wherein the environmental status elements repeat at a linear density of at least 0.2 per cm.

90. The medical device of any one of claims 84-89, wherein each of the environmental status elements are each structured to be readable to indicate a same one or more characteristics of the local environment.

91. The medical device of any one of claims 84-89, wherein at least two of the environmental status elements are structured to be readable to indicate at least one different characteristic of the local environment from each other.

92. The medical device of any one of claims 84-91, wherein one of the environmental status elements is an identification element that encodes information.Page 84 of 9512747491 vlAttorney Docket No. : 2019150-001993. The medical device of claim 92, wherein the identification element encodes the information in a different manner from a manner in which the one of the environmental status elements is structured to be readable to indicate the one or more characteristics.

94. The medical device of any one of claims 84-93, wherein each of the environmental status elements is an identification element that encodes information.

95. The medical device of any one of claims 84-91, comprising one or more identification elements that each encode information, wherein none of the environmental status element is an identification element.

96. A non-transitory medical image of tissue connected by a medical device, wherein information identifying the medical device is discernable in the image.

97. The image of claim 96, wherein the information comprises a serial number, a lot number, a batch number, or a combination thereof.

98. The image of any one of claims 96-97, wherein the information comprises a manufacturer and / or a model of the medical device.

99. The image of any one of claims 96-98, wherein the image is a radiological image.

100. The image of any one of claims 96-98, wherein the image is a sonogram.

101. The image of any one of claims 96-99, wherein the image is an MRI image.

102. The image of any one of claims 96-99, wherein the image is a CT image.

103. The image of any one of claims 96-99, wherein the image is an x-ray image.Page 85 of 9512747491 vlAttorney Docket No. : 2019150-0019104. The image of claim 103, wherein the image is a dual energy x-ray absorptiometry image.

105. The image of any one of claims 96-104, wherein the medical device is a suture.

106. The image of any one of claims 96-104, wherein the medical device is suture tape.

107. The image of any one of claims 96-104, wherein the medical device is a mesh.

108. The image of any one of claims 96-104, wherein the medical device comprises a suture anchor.

109. The image of any one of claims 96-108, wherein the medical device comprises an identification element that encodes the information.

110. The image of any one of claims 96-109, wherein the medical device is a medical device according to any one of claims 1-95.

111. The image of any one of claims 96-110, wherein the tissue is internal tissue.

112. The image of any one of claims 96-111, wherein the tissue is human tissue.

113. The image of any one of claims 96-111, wherein the tissue is tissue of a non-human animal.

114. The image of any one of claims 96-113, wherein the image has been acquired from outside of a body.

115. The image of any one of claims 96-114, wherein the tissue connected by the medical device is two or more tissues.Page 86 of 9512747491 vlAttorney Docket No. : 2019150-0019116. A non-transitory medical image of tissue connected by a medical device, wherein at least a portion of the medical device is discernable in the image such that one or more characteristics of a local environment near the medical device are discernable based on the at least a portion of the medical device.

117. The image of claim 116, wherein the one or more characteristics comprise a relative pH.

118. The image of claim 116 or claim 117, wherein the one or more characteristics comprise whether the medical device is under tension.

119. The image of any one of claims 116-118, wherein the one or more characteristics comprise a relative temperature.

120. The image of any one of claims 116-119, wherein the one or more characteristics comprise a relative pressure.

121. The image of any one of claims 116-120, wherein the image is a radiological image.

122. The image of any one of claims 116-120, wherein the image is a sonogram.

123. The image of any one of claims 116-121, wherein the image is an MRI image.

124. The image of any one of claims 116-121, wherein the image is a CT image.

125. The image of any one of claims 96-99, wherein the image is an x-ray image.

126. The image of claim 125, wherein the image is a dual energy x-ray absorptiometry image.

127. The image of any one of claims 116-126, wherein the medical device is a suture.Page 87 of 9512747491 vlAttorney Docket No. : 2019150-0019128. The image of any one of claims 116-126, wherein the medical device is suture tape.

129. The image of any one of claims 116-126, wherein the medical device is a mesh.

130. The image of any one of claims 116-126, wherein the medical device comprises a suture anchor.

131. The image of any one of claims 116-130, wherein the medical device comprises an identification element that encodes the information.

132. The image of any one of claims 116-131, wherein the medical device is a medical device according to any one of claims 1-65.

133. The image of any one of claims 116-132, wherein the tissue is internal tissue.

134. The image of any one of claims 116-133, wherein the tissue is human tissue.

135. The image of any one of claims 116-133, wherein the tissue is tissue of a non-human animal.

136. The image of any one of claims 116-135, wherein the image has been acquired from outside of a body.

137. The image of any one of claims 116-136, wherein the tissue connected by the medical device is two or more tissues.

138. The medical image of any one of claims 96-137, wherein the medical image is a printed image.

139. The medical image of any one of claims 96-137, wherein the medical image is a film image.Page 88 of 9512747491 vlAttorney Docket No. : 2019150-0019140. One or more non-transitory computer-readable media having one or more medical images according to any one of claims 96-137 stored thereon.

141. A method comprising acquiring the medical image of any one of claims 96-137.

142. A method comprising rendering, by a processor of a computing device, the medical image of any one of claims 96-137.

143. A method comprising displaying, by a processor of a computing device, the medical image of any one of claims 96-137.

144. A method comprising constructing the medical image of any one of claims 96-137.

145. A method comprising developing the medical image of any one of claims 96-137.

146. One or more non-transitory computer-readable media having instructions stored thereon that, when executed by a processor, cause the processor to perform the method according to any one of claims 142-144.

147. A method of characterizing a local environment near a medical device that is connecting tissue, wherein the medical device comprises an environmental status element, the method comprising: receiving an image of the tissue in which the environmental status element is discernable; and characterizing the local environment near the medical device based on how the environmental status element appears in the image.

148. The method of claim 147, comprising acquiring the image.Page 89 of 9512747491 vlAttorney Docket No. : 2019150-0019149. The method of claim 148, wherein acquiring the image comprises applying x-rays, radio waves, or sound waves to the medical device.

150. The method of claim 148 or claim 149, wherein acquiring the image comprises forming an x-ray image, a CT scan, an MRI image, or a sonograph in which the environmental status element is discernable.

151. The method of any one of claims 147-150, wherein the local environment is a region of the tissue, wherein no portion of the region is more than 5 cm from the medical device.

152. The method of any one of claims 147-150, wherein the local environment is a region of tissue that contacts the medical device.

153. The method of any one of claims 147-152, wherein the tissue is discernable in the image.

154. The method of any one of claims 147-153, wherein characterizing the local environment comprises determining a qualitative status of the local environment.

155. The method of claim 154, wherein the qualitative status comprises a relative acidity of the local environment.

156. The method of claim 154, wherein the qualitative status comprises a relative temperature of the local environment.

157. The method of claim 154, wherein the qualitative status comprises a relative pressure of the local environment.

158. The method of any one of claims 147-157, wherein characterizing the local environment comprises determining a quantitative status of the local environment.Page 90 of 9512747491 vlAttorney Docket No. : 2019150-0019159. The method of claim 1 8, wherein the quantitative status comprises an amount of tension that the medical device is under in the local environment.

160. The method of claim 158 or claim 159, comprising determining a health status of the tissue based on the quantitative status.

161. The method of any one of claims 147-160, wherein the image is of an internal portion of a body.

162. The method of any one of claims 147-161, wherein the medical device is disposed internally in a body.

163. The method of any one of claims 147-162, wherein the medical device is disposed inside of a human body.

164. The method of any one of claims 147-162, wherein the medical device is disposed inside of a non-human animal.

165. The method of any one of claims 147-164, wherein the medical device is closing a wound.

166. The method of any one of claims 147-164, wherein the medical device is closing an incision.

167. The method of any one of claims 147-166, wherein the medical device has been placed as part of a surgical procedure.

168. The method of any one of claims 147-167, wherein the local environment is a surgical site and the characterizing comprises an indication of health of the surgical site.Page 91 of 9512747491 vlAttorney Docket No. : 2019150-0019169. The method of any one of claims 147-168, wherein the local environment is a surgical site and the method comprises determining health of the surgical site based on the characterizing.

170. A method of characterizing pH of tissue near a medical device that is connecting the tissue, the method comprising: receiving an image of the tissue in which the medical device is discernable; and characterizing pH of the tissue based on how the medical device appears in the image.

171. The method of claim 170, wherein characterizing the pH comprises determining a relative pH relative to a baseline.

172. The method of claim 171, wherein the baseline corresponds to healthy corresponding tissue.

173. The method of any one of claims 170-172, wherein determining the relative pH comprises determining that the pH is higher or lower than a previously determined relative pH.

174. The method of any one of claims 170-173, wherein the characterizing is based on a configuration of the medical device that is discernable in the image.

175. The method of claim 174, wherein the configuration is a configuration of an environmental status element comprised in the medical device.

176. A method of determining health of tissue that is connected by a medical device, the method comprising: receiving an image of tissue in which the medical device is discernable; and determining whether the tissue is infected and / or whether the tissue is healed based on how the medical device appears in the image.Page 92 of 9512747491 vlAttorney Docket No. : 2019150-0019177. The method of claim 176, comprising determining whether the tissue is infected and / or whether the tissue is healed based on how an environmental status element of the medical device appears in the image.

178. The method of claim 176 or claim 177, wherein determining whether the tissue is infected and / or whether the tissue is healed is based on a configuration of the medical device discernable in the image.

179. The method of claim 178, wherein the configuration is a configuration of an environmental status element comprised in the medical device.

180. A method of determining an identity of a medical device that connects tissue, the method comprising: receiving an image in which the medical device is discernable; and determining an identity of the medical device based on how the medical device appears in the image.

181. The method of claim 180, wherein (i) the medical device comprises an identification element that encodes information that identifies the medical device, (ii) the identification element is discernable within the image, (iii) the method comprises determining the information based on the image and (iv) determining the identity is based on the information.

182. The method of claim 180 or claim 181, wherein the identity comprises a serial number, a lot number, a batch number, or a combination thereof.

183. The method of any one of claims 180-182, wherein the identity comprises a manufacturer of the medical device and / or a model of the medical device.

184. The method of any one of claims 180-183, comprising acquiring the image.Page 93 of 9512747491 vlAttorney Docket No. : 2019150-0019185. The method of claim 184, wherein acquiring the image comprises applying x-rays, radio waves, or sound waves to the medical device.

186. The method of claim 184 or claim 185, wherein acquiring the image comprises forming an x-ray image, a CT scan, an MRI image, or a sonograph in which the environmental status element is discernable.

187. The method of any one of claims 147-186, wherein the medical device is a medical device according to any one of claims 1-95.Page 94 of 9512747491 vl

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