Systems and devices for enhancing detection of in VIVO connection mechanisms

Abstract

The present disclosure provides for systems and devices for facilitating at least partial visibility of at least one portion of at least one in vivo connection mechanism in vivo. In some aspects, an in vivo medical imaging contrast connection system may comprise at least one medical modality contrast element and at least one in vivo connection mechanism. In some implementations, the in vivo medical imaging contrast connection system may comprise one or more of: at least one suture, an amount of suture tape, at least one mesh insert, at least one staple, or an amount of tubing. In some aspects, one or more medical modality contrast elements may be added to an in vivo connection mechanism to facilitate at least partial visibility of the in vivo connection mechanism in one or more medical imaging modalities.

Description

Attorney Docket No.: 2019150-0018SYSTEMS AND DEVICES FOR ENHANCING DETECTION OF IN VIVO CONNECTION MECHANISMS CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims priority to and benefit of U.S. Provisional Patent Application No. 63 / 640,037 filed April 29, 2024, the disclosure of which is incorporated by reference herein in its entirety. BACKGROUND

[0002] It was nearly 120 years ago that the first X-radiation, or "X-ray," machine was discovered. X-rays use electromagnetic energy beams to generate imaging of internal bones, organs, and other tissues. X-ray beams pass through different parts of the body in varying quantities to produce dark gray pictures of different shades. For example, an X-ray can reveal a broken or fractured bone by passing through the broken or fractured area, appearing as a dark spot within or adjacent to lighter areas that are representative of the bone itself X-Ray technology has been improved upon and developed since its inception, becoming more sophisticated and contributing to the development of similar diagnostic procedures such as computed tomography ("CT") scans, fluoroscopy, and arteriograms.

[0003] With the common usage of X-ray and other diagnostic machines and procedures, including, for example, magnetic resonance imaging ("MRI"), there is an advantage gained in being able to view, monitor, and trace many features and items, both naturally present and foreign, within a human or animal body. The ability to detect various internal aspects of an organism has facilitated substantial progress in medical treatments.

[0004] One of the most common treatments in medicine, dating back to ancient Egypt, is suturing. Suturing involves the stitching together of body tissues to hold different portions of an incision, wound, breakage, tear, or other injury together to promote healing.

[0005] Recently, a new type of suturing material, often referred to as "suture tape" has been developed that has led to even further advancements in making injury repairs, especially those within a human or animal body. While sutures and suture tape are a very powerful tools for tissue repair and connection, it has recently been discovered that the materials that comprise sutures and suture tape do not readily appear within different medical imaging modalities, including X-rays,Attorney Docket No.: 2019150-0018MRIs, and CT scans. Meshes of filaments or fibers have also gained use as a tissue repair and connect device. Meshes also suffer from the issue of not being detected by various medical imaging modalities. This can be very troublesome for doctors, surgeons, and other healthcare professionals who may rely on accurate knowledge of the location, orientation, and position of sutures, suture tape, and meshes to assess the recovery state of a patient's injury as well as to diagnose any complications related thereto or recommend different types of follow-up care. SUMMARY OF THE DISCLOSURE

[0006] What is needed are systems and devices for enhancing the detection of in vivo connection mechanisms configured to connect tissue, such as tissue within a patient's body. By adding at least one medical modality contrast element to an in vivo connection mechanism, medical professionals may be able to more easily locate an in vivo connection mechanism within the body of a patient using one or more various medical imaging modalities. This will, for example, allow medical professionals to provide more comprehensive follow-up care to patients after medical procedures, and ultimately, provide better patient care.

[0007] The present disclosure provides for systems and devices for enhancing the contrast and imaging of in vivo connection mechanisms, such as within a patient body. According to some embodiments of the present disclosure, an in vivo medical imaging contrast connection system may comprise at least one medical modality contrast element and at least one in vivo connection mechanism. In some aspects, the in vivo connection mechanism may comprise one or more of: at least one suture, an amount of suture tape, at least one mesh insert. In some embodiments, one or more medical modality contrast elements may be added to the at least one in vivo connection mechanism to facilitate at least partial detection of at least one portion of the in vivo connection mechanism utilizing one or more medical imaging modalities.

[0008] The term “in vivo” is Latin for “within the living”. It is a term of art in the medical field utilized to describe processes or actions internal to a living organism. The term “in vivo” is the qualified antonym of “in vitro”, a Latin phrase that literally means “within the glass”, a reference to lab glassware, petri dishes, and other vessels or containers that are not “within the living”. Here, in vivo is apropos to describe the use of the connection mechanisms such as sutures, meshes, and suture tapes due to the use of sutures, meshes, and suture tapes within the body of a patient or a living organism.

[0009] Adhesives are also utilized for in vivo closure of incisions or other tissue separationsAttorney Docket No.: 2019150-0018that require closure. The strength of closure for adhesives, however, is much lower in relation to in vivo connection mechanisms such as sutures, suture tape, anchored meshes, and anchored patches. The intermolecular forces between adhesives and tissues include chemically covalent interactions and physical interactions such as hydrogen bonding, ionic interactions, electrostatic interactions and van der Waals forces. These forces are much weaker than the physical connection provided by sutures, suture tape, anchored meshes, and anchored patches. Here, the term “anchored” typically mean sutured in place however it can also mean that the material, such as a mesh or a patch, is screwed or stapled or otherwise affixed to body tissue.

[0010] Synthetic sutures have been utilized in vivo from approximately 3000 years BC. Plant fibers, hair, tendons, and wool threads have all been found in mummified remains. The first known document specifically discussing suturing techniques is the Samhita, written by the Indian surgeon Susruta in approximately 500 BC. Hippocrates continued to contribute to the surgical and medical aspects of suturing beginning in 300 BC and Roman medical journalist and teacher Aurelius Cornelius Celsus, 25 BC to 50 A.D., wrote the eight volume De Re Medicina in which he described the use of a braided suture. Modern-day surgery and suturing owes much to the 1867 treatise The Aseptic System: On a New Method of Treating Compound Fracture, Abscesses, etc., With Observations on the Conditions of Suppurration by Lord Joseph Lister where Lister was the first to make a connection between the presence of germs and infection in sutures.

[0011] Sutures are utilized to connect similar or dissimilar types of tissue through several different types of connection processes. In one such process, the suture is looped through body tissue by successively passing through one piece of tissue and then another so as to connect the two tissue pieces. As an example, sutures are utilized to close a surgical opening and tissue through the successive looping between two different pieces of tissue and anchoring the suture on either end of the tissue connection. This process is typically accomplished utilizing a needle that is comprised of two ends with a sharp end that is distal to a suture material connection to the needle material. The suture connection to the needle is typically through either an eye in the needle material or a atraumatic needle connection where the suture material is swaged into the end of the needle material that is distal to the sharp end of the needle. The needle material is typically metal, such as a stainless steel.

[0012] Sutures may also be utilized to connect dissimilar types of tissue such as bone and ligaments. As an example, suture anchors may be utilized to repair a torn rotator cuff. The sutureAttorney Docket No.: 2019150-0018anchor is screwed into the bone tissue, or otherwise affixed, where the screw or fixture mechanism is attached to the suture material, and the suture material is looped through the torn connective tissue such as the ligament or tendon at least one time and then connected back to the bone tissue, typically again through a screw mechanism that is attached to the suture.

[0013] Sutures may be distinguished as a class into various subclasses including synthetic and natural suture materials, coated and uncoated suture materials, monofilament, multi-filament, and barb structure sutures, absorbable and non-absorbable suture materials, the multi-filament suture materials may be braided or woven into different geometric shapes such as round, oval or flat. A flat braid is also known as a suture tape. The multifilament braided suture materials, in some configurations, are also braided or woven about a core material that is similar or dissimilar to the multifilament braided or weave. Meshes may also be a suture-type component. Woven into sheets of medical fabric, filaments of materials, such as UHMWPE, can be configured into a variety of shapes including used a mesh, patch, vascular tubular graft either with a single channel or branched vascular graft. These materials are utilized in shaped fabrics such as a pelvic sling, leaflets of artificial heart valves or as a component of an endovascular stent or stent-graft.

[0014] A mesh that is utilized in vivo is typically comprised of multiple filaments or fibers. These multiple filaments or fibers are typically arranged in a pattern such as a crosshatch pattern. The mesh may also be a weave where the X and Y components of the weave are combined so as to form an interwoven configuration. Terms such as a warp and a weft are utilized in some instances to describe a mesh where the warp fibers or filaments are held stationary intention on a loom or a frame while the horizontal weft filaments or fibers are drawn through, and inserted over and under, the warp filaments or fibers. The fibers or filaments may be polymeric in nature, natural or synthetic fibers or filaments, or metallic fibers or filaments, or combinations thereof.

[0015] A patch may be utilized to close an incision or other separated tissue. A patch may also cover an otherwise connected tissue to prevent abrasion by other structures or to deliver medication, growth factors, or other biologic molecules over a length of healing time. The patch may be permanent or bioabsorbable and degradable. The patch may act as the primary object holding two tissues together or as a secondary structure. The patch may be fixed in place utilizing suture materials to connect the patch to the tissue by threading the suture through the patch material and through the tissue then tying off the suture.

[0016] In some implementations, at least one medical modality contrast element mayAttorney Docket No.: 2019150-0018be affixed to, integrated with, embedded within, coextruded, coated, printed, or otherwise added to at least one internal or external portion of the in vivo connection mechanism. The in vivo connection mechanism integrated with at least one medical modality contrast element may also be described as an in vivo medical imaging contrast connection system. In some aspects, an in vivo medical imaging contrast connection system may comprise one or more of: at least one contrast agent, an amount of at least one elongated fibrous or filamentous material in a structural weaving or braided configuration, an amount of at least one elongated fibrous or filamentous material configured as a tracer line, one or more contrast particles, one or more metallic elements, or an amount of at least one hydrogel, as non-limiting examples. In some non-limiting exemplary embodiments, the at least one medical modality contrast element may be at least partially visible in one or more medical imaging modalities, such as, by way of example and not limitation, an X-radiation ("X-ray") image, a magnetic resonance imaging ("MRI") procedure or the results thereof, a computerized tomography ("CT") scan or image, or a sonography ("ultrasound") test or the results thereof. In some implementations, the at least onemedical modality contrast element may be added to the in v ivo connection mechanism duringone or more stages of the manufacturing process of the in vivo connection mechanism, or the medical modality contrast element may be added to one or more existing in vivo connection mechanisms after manufacturing has been completed. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The accompanying drawings that are incorporated in and constitute a part of this specification illustrate several embodiments of the disclosure and, together with the description, serve to explain the principles of the disclosure:

[0018] Fig. 1 illustrates an exemplary system comprising at least one in vivo connection mechanism.

[0019] Fig. 2 illustrates an exemplary in vivo medical imaging contrast connection system comprising at least one in vivo connection mechanism comprising at least one medical modality contrast element.

[0020] Fig.3 illustrates an exemplary in vivo medical imaging contrast connection system comprising at least one in vivo connection mechanism comprising at least one medical modality contrast element.

[0021] Fig.4 illustrates an exemplary medical image of an in vivo medical imagingAttorney Docket No.: 2019150-0018contrast connection system comprising at least one in vivo connection mechanism comprising at least one medical modality contrast element.

[0022] Fig. 5 illustrates an exemplary in vivo medical imaging contrast connection system comprising a plurality of exemplary in vivo connection mechanisms each comprising at least one medical modality contrast element.

[0023] Fig.6 illustrates an exemplary in vivo medical imaging contrast connection system comprising at least one in vivo connection mechanism comprising at least one medical modality contrast element along with a suture needle and a suture closure of an incision.

[0024] Fig.7 is a surgical mesh that includes at least one medical modality contrast element and is sutured in vivo to a patient’s tissue.

[0025] Fig.8 is a surgical patch utilized along with sutures comprised of medical modality contrast elements and anchors holding the sutures to the tissue.

[0026] Fig.9 is a depiction of a patch over a set of sutures forming an in vivo medical imaging contrast connection system comprised of medical modality contrast elements.

[0027] Fig.10 is a configuration of anchors and sutures forming an in vivo medical imaging contrast connection system comprised of medical modality contrast elements.

[0028] Fig.11 is a different configuration from Fig.10 of anchors and sutures forming an in vivo medical imaging contrast connection system comprised of medical modality contrast elements.

[0029] Fig.12 is a different configuration from Fig.10 and Fig.11 of anchors and sutures forming an in vivo medical imaging contrast connection system comprised of medical modality contrast elements. DETAILED DESCRIPTION

[0030] The present disclosure provides for systems and devices for facilitating at least partial detection of at least one portion of at least one in vivo connection mechanism, such as within the body of a human or animal. According to some embodiments of the present disclosure, an in vivo medical imaging contrast connection system may comprise at least one in vivo connection mechanism that comprises at least one medical modality contrast element. In some aspects, the in vivo connection mechanism may comprise one or more of: at least one suture, an amount of suture tape, at least one mesh insert or patch. In some implementations, one or more medical modality contrast elements may be added to at least one in vivo connection mechanism to increase detection of the in vivo connection mechanism within the body of a patient using one orAttorney Docket No.: 2019150-0018more medical imaging modalities.

[0031] In some aspects, at least one medical modality contrast element may be affixed to, integrated with, embedded within, or otherwise added to or integrated into at least one internal or external portion of at least one in vivo connection mechanism. In some embodiments, the in vivo medical imaging contrast connection system may comprise one or more of: at least one contrast agent, an amount of at least one elongated fibrous or filamentous material in a structural weaving configuration, an amount of at least one elongated fibrous or filamentous material configured as a tracer line, one or more particles, one or more metallic material elements, or an amount of at least one hydrogel, as non-limiting examples. In some aspects, the at least one medical modality contrast element may be at least partially detectable in one or more medical imaging modalities, such as, by way of example and not limitation, an X-radiation ("X-ray") image, a magnetic resonance imaging ("MRI") procedure or the results thereof, a computerized tomography ("CT") scan or image, or a sonography ("ultrasound") test or the results thereof. In some embodiments, the at least one medical modality contrast element may be added to at least one in vivo connection mechanism during one or more stages of the manufacturing process of the at least one in vivo connection mechanism, or the at least one medical modality contrast element may be added to at least one existing in vivo connection mechanism after the manufacturing process has been completed.

[0032] In the following sections, detailed descriptions of examples and methods of the disclosure will be given. The descriptions of both preferred and alternative examples, though thorough, are exemplary only, and it is understood to those skilled in the art that variations, modifications, and alterations may be apparent. It is therefore to be understood that the examples do not limit the broadness of the aspects of the underlying disclosure as defined by the claims.

[0033] In vivo connection mechanism or internal connection mechanisms may be at least one medical material, structure, apparatus, tool, component, or device used or usable internally to a human or animal body. Internally to a human or animal body may also be identified as “in vivo”. In some aspects, an in vivo connection mechanism may be configured to at least temporarily connect two or more sections or portions of one or more tissues or other internal structures or compositions within the body of a human or animal. By way of example and not limitation, an in vivo connection mechanism may comprise one or more of: at least one suture, an amount of suture tape, at least one mesh structure, or a patch.

[0034] A mesh as utilized in this embodiment is configured to connect tissue together. AsAttorney Docket No.: 2019150-0018an example, a preconfigured polypropylene mesh is secured to tissue using at least two separate in vivo connection mechanisms, such as sutures.

[0035] One important aspect of in vivo connection mechanisms disclosed here is the ability to identify the location and configuration of the in vivo connection mechanism, such as a suture, mesh, or suture tape, once it has been incorporated in vivo to a human or animal body, and the surgical opening that has been utilized to incorporate the in vivo connection mechanism into the human or animal body is closed by means of suturing or other medical closure methods. A medical modality contrast element refers to any element, structure, substance, composition, or material that may be added to at least one internal or external portion of at least one in vivo connection mechanism, wherein the medical modality contrast element may be at least partially detectable utilizing at least one medical imaging modality, thereby making the in vivo connection mechanism easier to locate when the in vivo connection mechanism is within the body of a human or animal. By way of example and not limitation, an in vivo medical imaging contrast connection system may comprise a form that comprises one or more of: at least one contrast agent, an amount of at least one filamentous or fibrous material in a structural weaving, braiding, or other such combination of fibers, an amount of at least one fibrous or filamentous material configured as a tracer line, one or more substantially particles or pieces, one or more metallic elements, or an amount of at least one hydrogel that may be integrated with, embedded within, or affixed or applied to one or more internal or external portions of at least one in vivo connection mechanism. In some non-limiting exemplary embodiments, one or more medical modality contrast elements may be used within one or more portions of the body of a patient without being affixed to, integrated with, embedded within, or otherwise added to at least one in vivo connection mechanism.

[0036] A non-limiting list of contrast agents for medical modalities consist of an amount of titanium, an amount of iron oxide, an amount of barium sulfate, an amount of manganese chloride or other manganese salt, an amount of aluminum, an amount of bismuth or bismuth oxide or one or more agents for enhancing regeneration of tissue(s), or one or more particles comprising any combination thereof. The particles are finely divided in size. As an example, the particles are equal to or less than 1,000 micrometers (μm) in size, preferably equal to or less than 500 μm in size, more preferably equal to or less than 100 μm, more preferably equal to or less than 1 μm in size. In some aspects, while an additive may not be exclusively intended to facilitate at least partial detection in one or more medical imaging modalities of at least one in vivo connection mechanismAttorney Docket No.: 2019150-0018to which it may be added, an additive may be at least partially detectable in medical imaging.

[0037] Medical imaging through the use of a medical modality may be used to detect one or more locations within the body of a human or animal. In some aspects, medical imaging may comprise radiological imaging that may be used for testing or diagnostic purposes. By way of example and not limitation, medical imaging may comprise X-radiation ("X-ray"), magnetic resonance imaging ("MRI"), computerized tomography ("CT"), or sonography ("ultrasound"). Fibrous material may be any substance, material, or member that comprises at least one fiber. In some aspects, a fibrous or filamentous material may comprise one or more of: an amount of thread, an amount of cord, or an amount of string, as non-limiting examples.

[0038] Referring now to Fig.1, an exemplary system 100 comprising at least one in vivo connection mechanism 110, according to some embodiments of the present disclosure, is illustrated. In some embodiments, at least one in vivo connection mechanism 110 may be used to at least temporarily connect two or more internal portions of a patient's body, whether the patient be a human or an animal. In some non-limiting exemplary embodiments, at least one in vivo connection mechanism 110 may be used to connect two or more portions of one or more bones, muscles, tissues, ligaments, tendons, or similar internal structures or compositions within the body of a patient. By way of example and not limitation, at least one in vivo connection mechanism 110 may be at least temporarily secured inside a patient to at least one joint, such as a shoulder 120, to tightly hold two or more portions of the joint together to assist with healing after a surgical a repair or injury. The humorous 150 is stabilized by the anchors 130 to the supraspinatus tendon 170 utilizing the in vivo connection mechanism 110. The in vivo connection mechanism may also be comprised of medical modality contrast elements, forming an in vivo medical imaging contrast connection system and affixed to tissue utilizing the interior anchors 140 beneath the supraspinatus tendon 170. The lateral edge of the supraspinatus tendon 160 is on either side of the in vivo medical imaging contrast connection system.

[0039] In some aspects, at least one in vivo connection mechanism 110 may comprise one or more devices or materials that may be substantially invisible or visually imperceptible in one or more medical imaging modalities. For example, the at least one in vivo connection mechanism 110 may comprise one or more of: at least one suture, an amount of suture tape, at least one mesh insert, a patch, or any similar device or material that, due its composition or structure, may not be visible via one or more types of medical imaging. For instance, an in vivo connection mechanism 110 in the form of suture tape may comprise a braided structure that is not visible inAttorney Docket No.: 2019150-0018X-rays, MRIs, or CT scans. Additionally, an in vivo connection mechanism 110 may comprise one or more materials that may be substantially translucent or transparent, thereby making them difficult, if not impossible, to see in various types of medical imaging.

[0040] In some aspects, the inability to use medical imaging to view the at least one in vivo connection mechanism 110 within the body of a patient may hinder the ability of a medical care provider to locate the in vivo connection mechanism 110 during a follow-up visit, potentially causing complications that may be associated with the application, placement, or structural integrity of the in vivo connection mechanism 110 to go misdiagnosed or undiagnosed completely. For example, any dehiscence of the at least one in vivo connection mechanism 110 may go undetected until the at least one in vivo connection mechanism 110 comes apart completely or fails entirely, or an infection associated with the at least one in vivo connection mechanism 110 may be difficult to treat if the at least one in vivo connection mechanism 110 cannot be located to be removed. Additionally, an inability to view one or more in vivo connection mechanisms 110 at or near the site of an upcoming medical procedure, such as a surgery, may cause a medical professional to be required to make one or more adjustments to the procedure as it is being performed, or cancel the procedure altogether, if the in vivo connection mechanism(s) 110 prove to be a hindrance to the procedure once they are discovered. It is therefore desirable to incorporate a medical modality contrast element into the in vivo connection mechanism 110 to form an in vivo medical imaging contrast connection system.

[0041] Referring now to Fig.2, an exemplary in vivo medical imaging contrast connection system 200 comprising at least one in vivo connection mechanism 210 and further comprising at least one medical modality contrast element, according to some embodiments of the present disclosure, is illustrated. In some embodiments, at least one in vivo connection mechanism 210 may be at least temporarily secured within an in vivo portion of the body of a patient, such as, by way of example and not limitation, by connecting two or more portions of one or more tissues within the patient's body. By way of example and not limitation, the at least one in vivo connection mechanism 210 may be used to connect two or more portions of a joint, such as a shoulder 220, during a medical procedure to facilitate recovery and / or healing. In some aspects of the present disclosure, the at least one in vivo connection mechanism 210 may comprise one or more devices or materials that may be substantially invisible or visually imperceptible via one or more medical imaging modalities. These materials include ultra-high-molecular-weight polyethylene ("UHMWPE"), nylon, or polypropylene, as non-limiting examples. It is therefore desirable toAttorney Docket No.: 2019150-0018incorporate a medical modality contrast element into the in vivo connection mechanism 210 to form an in vivo medical imaging contrast connection system.

[0042] In some implementations, the at least one in vivo connection mechanism 210 may comprise one or more of: at least one suture, an amount of suture tape, at least one mesh insert as non-limiting examples, the composition or structure of which may cause the at least one in vivo connection mechanism 210 to not appear in one or more medical imaging modalities, such as, for example and not limitation, an X-ray, an MRI, or a CT scan. In some implementations, if a medical care provider is not be able to locate the at least one in vivo connection mechanism 210 via medical imaging during a patient's follow- up visit, one or more healing or recovery complications associated with the at least one in vivo connection mechanism 210 may go misdiagnosed or undiagnosed, or the administration of medical care at or near the location of the at least one in vivo connection mechanism 210 may be thwarted or delayed.

[0043] In some embodiments, at least one medical modality contrast element may be added to one or more in vivo or external portions of the at least one in vivo connection mechanism 210 to facilitate the ability of the in vivo connection mechanism 210 to be seen in one or more types of medical imaging and so form a medical modality detectable in vivo medical imaging contrast connection system. As a non-limiting example, when the at least one in vivo connection mechanism 210 comprises at least one medical modality contrast element, the at least one in vivo connection mechanism 210 may be detected and at least partially visible in medical imaging. By way of example and not limitation, an in vivo medical imaging contrast connection system may comprise a form that comprises one or more of: at least one medical modality contrast element, an amount of at least one elongated fibrous or filamentous material in a structural weaving configuration, an amount of at least one elongated fibrous or filamentous material configured as a tracer line, one or more substantially rigid particles, one or more metallic elements, or an amount of at least one hydrogel.

[0044] In some non-limiting exemplary embodiments, in aspects wherein the at least one medical modality contrast element may comprise at least one contrast agent, the at least one contrast agent may at least partially comprise an amount of gadolinium, an amount of iodine, or a combination thereof. In some embodiments, at least one medical modality contrast element in the form of at least one contrast agent may be added to one or more in vivo or external portions of an existing in vivo connection mechanism 210 or may be integrated into or affixed upon one or more in vivo or external portions of an in vivo connectionAttorney Docket No.: 2019150-0018mechanism 210 during one or more stages of the manufacturing process of the in vivo connection mechanism 210.

[0045] In some embodiments, at least one medical modality contrast element may be added as a coating to the at least one in vivo connection mechanism 210, wherein the at least one medical modality contrast element may be applied to the at least one in vivo connection mechanism 210 while in a liquid, resin, or gel form and may solidify to form a coating upon one or more portions of the surface of the at least one in vivo connection mechanism 210 as it dries. In some implementations, an amount of at least one medical modality contrast element in a liquid, resin, or gel form may be placed in at least one container, and the at least one container may then be inserted within an in vivo portion of the medical modality contrast element comprising a portion of the in vivo connection mechanism 210.

[0046] In some aspects, an amount of thread, cord, string, or similar elongated fibrous or filamentous material includes at least one medical modality contrast element in the form of at least one contrast agent, and the elongated fibrous or filamentous material may be used to form structural weaving or braiding that may be integrated within and / or upon at least one portion of at least one in vivo connection mechanism 210, such as, for example and not limitation, via stitching or sewing, wherein the structural weaving may comprise one or more of a plurality of different patterns or configurations upon and / or within the at least one in vivo connection mechanism 210. In some embodiments, the at least one medical modality contrast element may be woven into the at least one in vivo connection mechanism 210 either during or after the manufacturing of the in vivo connection mechanism 210.

[0047] In some implementations, at least one medical modality contrast element comprising at least one elongated fibrous or filamentous material may be integrated with at least one in vivo connection mechanism 210 so as to physically secure one or more additional medical modality contrast elements to one or more portions of the at least one in vivo connection mechanism 210. By way of example and not limitation, a first at least one medical modality contrast element may comprise at least one elongated fibrous or filamentous material in a structural weaving configuration that may be configured to at least partially wrap around a second at least one medical modality contrast element comprising one or more at least partially rigid elongated elements, such as, for example and not limitation, one or more cylindrical or rod-shaped structures, to secure the elongated element(s) to the at least one in vivo connection mechanism 210, such as, for example and not limitation, an amount of suture tape. In some non-limitingAttorney Docket No.: 2019150-0018exemplary embodiments, at least one of the one or more elongated elements may at least partially comprise a metallic material to enable the elongated element(s) to be at least partially detected or visible in one or more medical imaging modalities, such as, for example and not limitation, an X- ray.

[0048] In some aspects, at least one of the one or more elongated elements may at least partially comprise at least one contrast agent, such as, for example and not limitation, an amount of gadolinium and / or an amount of iodine, wherein the at least one contrast agent may be contained within an in vivo portion of the elongated element(s) or infused with or bonded to one or more portions of the elongated element(s). In some aspects, elongated element(s) that at least partially comprise at least one contrast agent may comprise one or more at least partially translucent or transparent materials, such as, for example and not limitation, one or more plastics or other polymers.

[0049] In some embodiments, at least one medical modality contrast element comprising at least one additive may be added to the at least one in vivo connection mechanism 210. By way of example and not limitation, the at least one additive may comprise one or more antibiotics and / or one or more agents for enhancing regeneration of tissues. In some aspects, a medical modality contrast element comprising one or more additives may allow the at least one in vivo connection mechanism 210 that comprises the at least one medical modality contrast element to comprise enhanced functionality within the body of a patient, such as by preventing infection or fostering tissue regeneration, as non-limiting examples.

[0050] Referring now to Fig.3, an exemplary in vivo medical imaging contrast connection system 300 comprising at least one in vivo connection mechanism 310 comprising at least one medical modality contrast element 315, according to some embodiments of the present disclosure, is illustrated. In some embodiments, at least one in vivo connection mechanism 310 may be at least temporarily secured at one or more locations within the body of a patient, such as a human or animal. By way of example and not limitation, the at least one in vivo connection mechanism 310 may be secured during a medical procedure to connect two or more portions of a joint, such as a knee 320 utilizing anchors 305 to secure the in vivo medical imaging contrast connection system 310 which is comprised of medical modality contrast elements 315... In some aspects of the present disclosure, the at least one in vivo connection mechanism 310 may comprise one or more devices or materials that may be substantially invisible or visually imperceptible in at least one type of medical imaging.Attorney Docket No.: 2019150-0018

[0051] In some non-limiting exemplary embodiments, an in vivo connection mechanism 310 may comprise one or more of: at least one suture, an amount of suture tape, at least one mesh insert, a patch, or any similar configuration that, due to its structure and / or composition, may make the in vivo connection mechanism 310 unable to be seen in various types of medical imaging, such as, by way of example and not limitation, an X-ray, an MRI, or a CT scan. In some implementations, various complications may arise if a medical care provider is not be able to locate one or more in vivo connection mechanisms 310 via medical imaging during a follow-up visit with a patient.

[0052] In some embodiments, at least one medical modality contrast element 315 may be added to one or more in vivo or external portions of the at least one in vivo connection mechanism 310 to facilitate the ability of the at least one in vivo connection mechanism 310 to be seen in one or more medical imaging modalities. In some aspects, by way of example and not limitation, the at least one medical modality contrast element 315 may be incorporated into the in vivo medical imaging contrast connection system comprising one or more of: at least one contrast agent, an amount of at least one fibrous or filamentous material in a structural weaving configuration, an amount of at least one fibrous or filamentous material configured as a tracer line, one or more substantially rigid particles, one or more metallic elements, or an amount of at least one hydrogel. In some non-limiting exemplary embodiments wherein the at least one medical modality contrast element 315 may comprise at least one contrast agent, the at least one contrast agent may at least partially comprise an amount of gadolinium, an amount of iodine, or a combination thereof. In some implementations, the at least one contrast agent may be added to or integrated with one or more in vivo or external portions of an in vivo connection mechanism 310 during or after the manufacturing process of the in vivo connection mechanism 310.

[0053] In some aspects, an amount of thread, cord, string, or similar elongated fibrous or filamentous material may include at least one medical modality contrast element 315 in the form of at least one contrast agent, and the elongated fibrous or filamentous material may be used to form a mesh overlay that may be integrated with or affixed upon at least one in vivo connection mechanism 310, wherein the mesh overlay may comprise one or more of a plurality of different patterns or configurations. In some embodiments, the at least one medical modality contrast element 315 is incorporated into the form of a mesh overlay and may be affixed to one or more portions of an in vivo connection mechanism 310 during or after the manufacturing process of the in vivo connection mechanism 310.Attorney Docket No.: 2019150-0018

[0054] The in vivo connection mechanism 310 may be comprised of the medical modality contrast element 315 and is affixed to the patella 301 utilizing anchors 305 and is affixed to the patellar tendon 340 utilizing anchors 325. The anchoring systems, 305 and 325, may also be comprised of medical modality contrast elements. The in vivo connection mechanism 310 is utilized to stabilize the tibia 335 with the femur 330 by connecting the patella 3052 the patellar tendon 340.

[0055] Referring now to Fig. 4, exemplary medical images 430 of an in vivo medical imaging contrast connection system 400 comprising at least one in vivo connection mechanism 410 comprising at least one medical modality contrast element 415 according to some embodiments of the present disclosure, is illustrated. In some embodiments, at least one in vivo connection mechanism 410 may be at least temporarily secured at one or more locations within the body of a patient, such as a human or animal. By way of example and not limitation, the at least one in vivo connection mechanism 410 may be secured during a medical procedure to connect two or more portions of a joint, such as a knee 420. A second secured section of the in vivo connection mechanism 440 is secured in a different section of the knee 420. In some aspects of the present disclosure, the at least one in vivo connection mechanism 410 may comprise one or more devices or materials that may be substantially invisible or visually imperceptible in at least one type of medical imaging 430 In some non-limiting exemplary embodiments, the at least one in vivo connection mechanism 410 may comprise at least one of: at least one suture, an amount of suture tape, at least one mesh insert, at least one patch, or any similar configuration that, due to its composition or structure, may cause the at least one in vivo connection mechanism 410 to be unable to be seen in one or more types of medical imaging 430 such as, for example and not limitation, an X-ray, an MRI, or a CT scan. In some implementations, various complications may arise if a medical care provider is not be able to locate one or more in vivo connection mechanisms 410 within a patient via medical imaging 430 during a follow-up visit.

[0056] In some embodiments, at least one medical modality contrast element 415 may be added to the at least one in vivo connection mechanism 410 to facilitate the ability of the at least one in vivo connection mechanism 410 to be detected or seen in one or more types of medical imaging 430. In some aspects, the at least one in vivo connection mechanism 410 may comprise at least one medical modality contrast element 415 to facilitate the ability of the at least one in vivo connection mechanism 410 to be detected or seen via one or more modalities of medical imaging 430. In some non-limiting exemplary embodiments, the at least one medical modality contrastAttorney Docket No.: 2019150-0018element 415 may comprise one or more of: at least one contrast agent, an amount of at least one fibrous or filamentous material in a structural weaving configuration, an amount of at least one fibrous or filamentous material configured as a tracer line, one or more substantially rigid particles, one or more metallic elements, or an amount of at least one hydrogel. In some implementations wherein the at least one medical modality contrast element 415 may comprise at least one contrast agent, the at least one contrast agent may at least partially comprise an amount of gadolinium, an amount of iodine, or a combination thereof. In some embodiments, a medical modality contrast element 415 in the form of at least one contrast agent may be added to an existing in vivo connection mechanism 410 or may be added to or integrated with at least one in vivo connection mechanism 410 during the manufacturing process of the at least one in vivo connection mechanism 410 to form an in vivo medical imaging contrast connection system.

[0057] In some embodiments, at least one medical modality contrast element 415 may be added as a coating to the at least one in vivo connection mechanism 410, wherein the at least one medical modality contrast element 415 may be applied to the at least one in vivo connection mechanism 410 while in a liquid, resin, or gel form and may solidify to form a coating upon one or more portions of the surface of the at least one in vivo connection mechanism 410 as it dries. In some implementations, an amount of at least one medical modality contrast element 415 in a liquid, resin, or gel form may be placed in at least one container, and the at least one container may then be inserted within an in vivo portion of the at least one in vivo connection mechanism 410.

[0058] In some aspects, an amount of thread, cord, string, or similar elongated fibrous or filamentous material may include at least one medical modality contrast element 415in the form of at least one contrast agent, and the elongated fibrous or filamentous material may be used to form structural weaving or braiding that may be integrated with at least one in vivo connection mechanism 410, wherein the structural weaving may comprise one or more of a plurality of different patterns or configurations upon and / or within the at least one in vivo connection mechanism 410. In some embodiments, the at least one medical modality contrast mechanism 415 may be woven into the at least one in vivo connection mechanism 410 either during or after the manufacturing of the at least one in vivo connection mechanism 410.

[0059] In some implementations, an in vivo connection mechanism 410 that comprises at least one medical modality contrast element 415 may be visible in one or more modalities of medical imaging 430 that may normally not be able to detect or show the at least one in vivo connection mechanism 410. This may allow one or more medical professionals to monitor or trackAttorney Docket No.: 2019150-0018a patient's healing process, wherein the healing may be facilitated by the at least one in vivo connection mechanism 410 that comprises at least one visibility enhancing element 415.

[0060] As an illustrative example, a patient with an injured knee 420 may seek treatment from an orthopedic surgeon, who may use an in vivo connection mechanism 410 in the form of suture tape to tightly hold two or more portions of the knee 420 together to facilitate healing of the knee. The process of holding tightly to her more portions of the knee 420 is accomplished through the use of at least one in vivo connection mechanism where the in vivo connection mechanism is anchored into at least two different portions of the knee construction to facilitate an in vivo connection between the at least two different portions of the knee. The suture tape may comprise a medical modality contrast element 415 in the form of a thread, a filament, or a fibrous material, as an example, that has incorporated a contrast agent that comprises a combination of gadolinium and iodine, wherein the thread, filament, or fibrous material may have been woven through one or more portions of the suture tape during or after the manufacturing of the suture tape. This may allow the surgeon to be able to locate the suture tape using an X-ray during a follow-up appointment with the patient so that the surgeon may be able to confirm that the patient's knee is healing as intended.

[0061] Referring now to Fig.5, an exemplary in vivo medical imaging contrast connection system 500 comprising a plurality of exemplary in vivo connection mechanisms 540, 550, 560, 570 each comprising at least one medical modality contrast element 515, 516, 517, 518, according to some embodiments of the present disclosure, is illustrated. In some aspects, an in vivo connection mechanism 540, 550, 560, 570 may comprise at least one medical modality contrast element 515, 516, 517, 518 in one or more of a plurality of potential configurations to facilitate the detection and / or visibility of the in vivo connection mechanisms 540, 550, 560, 570 in one or more medical imaging modalities. In some non-limiting exemplary embodiments, one or more of the exemplary in vivo connection mechanisms 540, 550, 560, 570 may comprise an amount of suture tape, a suture, a mesh, or a patch.

[0062] In some implementations, an in vivo connection mechanism 540 may comprise at least one medical modality contrast element 515 in the form of one or more metallic elements, wherein the metallic element(s) may allow the in vivo connection mechanism 540 to be detectable and visible via at least one medical imaging modality, such as, for example and not limitation, an X- ray. In some non-limiting exemplary embodiments, the metallic element(s) may be configured as small particles, bands, or staples that may be integrated with or affixed to one or more in vivoAttorney Docket No.: 2019150-0018or external portions of an in vivo connection mechanism 540 during or after the manufacturing of the in vivo connection mechanism 540. In some aspects, by way of example and not limitation, a medical modality contrast element 515 that comprises one or more metallic elements may be particularly useful for applications wherein an in vivo connection mechanism 540 may comprise at least one suture, an amount of suture tape, or a mesh insert.

[0063] In some implementations, an in vivo connection mechanism 550 may comprise at least one medical modality contrast element 516 in the form of at least one elongated fibrous or filamentous material in a structural weaving configuration or configured as a tracer line, wherein at least a portion of the elongated fibrous or filamentous material includes at least one contrast agent to facilitate its detection or visibility in one or more medical imaging modalities, such as, by way of example and not limitation, an X-ray, MRI, or CT scan. In some non-limiting exemplary embodiments, the at least one elongated fibrous or filamentous material may comprise an amount of thread, cord, or string that may be integrated with or affixed to one or more in vivo or external portions of the in vivo connection mechanism 550 during or after the manufacturing of the in vivo connection mechanism 550 via stitching, sewing, or weaving, as non-limiting examples. In some aspects, the at least one elongated fibrous or filamentous material may be configured in one or more of a plurality of potential structural weaving patterns, as a single tracer line, or as a plurality of individual tracer lines or bands, as non- limiting examples.

[0064] In some embodiments, an in vivo connection mechanism 560 may comprise at least one medical modality contrast element 517 in the form of a mesh overlay, wherein the mesh overlay may comprise one or more fibrous or filamentous materials arranged in a mesh configuration, wherein at least a portion of the fibrous or filamentous material(s) includes at least one contrast agent before the mesh overlay is applied or affixed to one or more portions of the in vivo connection mechanism 570, wherein the at least one contrast agent may facilitate the detection and / or visibility of the mesh overlay and the in vivo connection mechanism 560 with which it may be integrated in one or more medical imaging modalities, such as an X-ray, MRI, or CT scan, as non-limiting examples. In some implementations, by way of example and not limitation, a medical modality contrast element 517 that comprises a mesh overlay may be applied to one or more portions of an in vivo connection mechanism 560 during or after a manufacturing process of the in vivo connection mechanism 560, via stitching, sewing, or weaving, as non-limiting examples.Attorney Docket No.: 2019150-0018

[0065] In some aspects, an in vivo connection mechanism 570 may comprise at least one medical modality contrast element 518 in the form of at least one polymer, such as a non-limiting example of a hydrogel, wherein one or more contrast agents may be integrated with the at least one hydrogel such that the hydrogel and its associated in vivo connection mechanism 570 may be at least partially detectable or visible via one or more medical imaging modalities, such as, for example and not limitation, an X-ray, MRI, or CT scan. By way of example and not limitation, a contrast agent may be integrated with the hydrogel that at least partially comprises iodine, and one iodine moieties may be linked to the hydrogel molecules to bind the contrast agent to the hydrogel. In some non-limiting exemplary embodiments, a medical modality contrast element 518 that comprises at least one hydrogel may be added to or embedded or otherwise configured within an in vivo portion of an in vivo connection mechanism 570 during or after the manufacturing process of the in vivo connection mechanism 570. In some implementations, a hydrogel used as a medical modality contrast element 518 may expand or swell when exposed to one or more fluids within the body of a patient without experiencing dissolution, thereby causing the in vivo connection mechanism 570 with which it may be integrated to become stronger and form a tighter and more secure connection once it is attached to two or more in vivo portions, structures, or compositions within the body.

[0066] Referring now to Fig. 6, an exemplary in vivo medical imaging contrast connection system 600 comprising at least one in vivo connection mechanism 640 further comprising at least one medical modality contrast element, according to some embodiments of the present disclosure, is illustrated. In some non-limiting exemplary embodiments, at least one in vivo connection mechanism 640 may be used to facilitate closure and / or healing of at least one incision 660 or wound within an in vivo portion 620 of the body of a patient. In some aspects, the in vivo connection mechanism 640 may be configured to remain within the body of the patient indefinitely, as the in vivo connection mechanism 640 and the at least one medical modality contrast element integrated therewith may be substantially biocompatible and nondegradable. As an example, a needle 635 with a sharp distal end 665 and a proximal end 670 where the proximal and is connected to the in vivo medical imaging contrast connection system 640. The connecting at the proximal end 670 of the needle 635 may be accomplished either by threading through an eyelid in the proximal end 670 of the needle 635, swaging the in vivo medical imaging contrast connection system 640 into the proximal and 670Attorney Docket No.: 2019150-0018of the needle 635 through pressure and cramping of the proximal end 670 or any other means of connecting the in vivo medical imaging contrast connection system 640 to the proximal end 670 of the needle 635 such that the sharp distal end 665 of the needle 635 may be threaded through tissue 645 thus closing an incision 660 or other types of openings in the tissue 645 that require surgical closure. A retractor 650 may be utilized to pull back areas of the tissue 645 so as to facilitate the threading of the in vivo medical imaging contrast connection system 640 through the tissue 645 utilizing the needle 635 connected to the in vivo connection mechanism 640. Several passages of the needle 635 attached to the in vivo connection mechanism 640 will allow for closure of an incision 660 utilizing a closing mechanism, such as a suture line 655. The in vivo connection mechanism 640 may contain a medical modality contrast element so as to be identified by a medical modality such as x-ray, MRI, or CT scan once the incision 660 into the tissue 645 is completely closed.

[0067] Turning now to Fig.7 the depiction of a mesh, typically comprised of a polymeric material, is shown. The term mesh 707 may describe any of the aforementioned materials. An incision in a patient with a mesh 700 depicts several aspects of the embodiment. A suture needle 702 has a distal end 701 that is typically a sharp point and a proximal end 703 that is attached to the in vivo medical imaging contrast connection system 711. The in vivo medical imaging contrast connection system 711 is comprised of an in vivo connection mechanism, such as a suture, and a medical modality contrast element. The attachment to the proximal end 703 of the needle 702 is accomplished through either a eyelet in the proximal end 703 of the needle 702 or through swaging of the in vivo medical imaging contrast connection system 711, such as a suture, into the proximal end 703 of the needle 702. Swaging is a process or a metal-forming technique in which the metal of one part is deformed to fit around another part by either pressing or hammering, or by forcing the material through a die. The in vivo medical imaging contrast connection system 711 is then threaded through the tissue 704 of the patient and then through the mesh 707 to secure the mesh 707 to the patient’s tissue. The trailing end of the in vivo medical imaging contrast connection system 705 is of sufficient length to allow for several tied or secured in vivo medical imaging contrast connection system attachments 708 where the in vivo medical imaging contrast connection system is secured and cut to provide an attachment point of the mesh 707 to the patient’s tissue 704. The surgical opening 710 is held open using retractors 709. Several tied or secured in vivo medical imaging contrast connection systems 708Attorney Docket No.: 2019150-0018are formed on the periphery of the mesh 707 to secure it to the patient’s tissue 704. The mesh 707 also includes medical modality contrast elements 706 where the medical modality contrast elements 706 produce different responses to a medical imaging modality such as x-rays, MRI or CT scans.

[0068] In Fig.8, a depiction of a surgical patch is shown. The surgical repair of a shoulder 800 may utilize in vivo medical imaging contrast connection systems comprised of a patch 801 and suture tape 803. The patch 801 is intricately secured to the shoulder 800 utilizing suture tape 803 where the suture tape 803 is anchored to the tissue utilizing anchors 802 and 804. One set of anchors 8044 the suture tape 803 are screwed into or otherwise affixed to the proximal end of the humerus 805. The patch 801 may be modified with a medical modality contrast element. The patch 801 is typically a monolithic material as opposed to a mesh where the mesh is a woven material. However, the patch 801 may also be a mesh substrate that is subsequently modified, such as coated or injected, with polymeric material, to form a solid material. The patch 801 is typically placed over tissue that has been modified during a surgical procedure.

[0069] In Fig.9 the depiction of a repaired shoulder 900 is shown with a patch 901 affixed over suture tape 903 there has been secured to the proximal end of the humerus 906 utilizing anchors 905. The edge of the patch 901 has a thickness 904 so as to protect the suture tape 903 that is underneath the patch 901. The patch 901 is affixed to the tissue of the shoulder 900 utilizing an in vivo medical imaging contrast connection system comprising a suture 902. The patch 901, the suture 902 the suture tape 903 and the anchor 905 may all include medical modality contrast elements so as to be detectable by x-ray, MRI, CT scans or any other imaging medical modality.

[0070] Fig.10 is a depiction of two different tissues 1000 that are secured together utilizing an in vivo medical imaging contrast connection system. Here, any of the elements of the in vivo medical imaging contrast connection system may also be modified with a medical modality contrast element.

[0071] Fig.11 is yet a different in vivo medical imaging contrast connection system from Fig.10 where two different tissues 1100 are connected utilizing an in vivo medical imaging contrast connection system. Here, any of the elements of the in vivo medical imaging contrast connection system may be modified with a medical modality contrast element.Attorney Docket No.: 2019150-0018

[0072] Fig.12 is yet a different in vivo medical imaging contrast connection system from Fig.10 and Fig.11 where two different tissues 1200 are connected utilizing an in vivo medical imaging contrast connection system. Here, any of the elements in the in vivo medical imaging contrast connection system may be modified with a medical modality contrast element.

[0073] Medical imaging has undergone a great deal of evolution to improve the detection and imaging of tissues in humans and animals, also known as in vivo imaging. As an example, X-rays have increased the kilo electron Volt (keV) detection range and refinement, as well as the K absorption edge (K – edge) where the abrupt increase in the photoelectric absorption of x-ray photons is observed.

[0074] The K-absorption edge (K-edge) refers to the abrupt increase in the photoelectric absorption of x-ray photons observed at an energy level just beyond the binding energy of the k- shell electrons of the absorbing atom. Utilization of materials with high K edges, such as iodine or barium, improve the contrast at higher kV. Through the process of varying the amounts of high K-edge materials, such as iodine or barium, a signature of the medical modality connection mechanism may be identified for different materials and configurations. As an example, an ultrahigh molecular weight polyethylene (UHMWPE) braided suture tape with differentiated material properties and configurations, such as a specialty braid or weave, where medical modality contrast elements are incorporated into the UHMWPE, is readily identified by the signature of the medical modality contrast elements with specific ratios and thus specific K-edge responses.

[0075] Improvement in x-ray detectors, such as a photo accounting detector, may be utilized in computed tomography x-ray to increase the spectral separation along with improved material decomposition. As a result, the discrimination of contrast media from normal or pathologic tissues in the discrimination of two or more contrast elements that characterize different tissues is possible.

[0076] As an example, each contrast agent used in the embodiment has a different x-ray (20 keV - 160 keV) attenuation curve thereby resulting in different attenuation at a given x-ray energy and identification of the medical modality contrast elements by evaluation using more than one x-ray energy.

[0077] Similarly, magnetic resonance imaging (MRI) has seen an increase in the magnetic strength of the technique from 1.5 Tesla magnets to 7.0 Tesla magnets. This, along withAttorney Docket No.: 2019150-0018improvements with radiofrequency receiver coils is allowed for improved detection utilizing the MRI medical imaging technique. Also, lower Tesla MRI machines may also be utilized where fixed or permanent magnets are used instead of superconductive cooled magnets.

[0078] As an example, the differentiated medical modality contrast elements generate at least two decreases of the spin–lattice T1 relaxation time for magnetic resonance imaging where the different medical modality contrast agents possess different spin-lattice and spin-spin relaxation times at a given thermodynamic equilibrium state after excitation by an appropriate Lamor frequency input. The increase in signal intensity may be on T1 weighted, T2 weighted or other weighted MRI sequence.

[0079] A CT scan is obtained when an x-ray beam rotates around a patient, allowing x- rays to pass through the patient. As he x-rays leave the patient a picture is taken by a detector in the information is transmitted to a computer for further processing. A standard detector utilizes a two-step process where the x-rays are typically turned into white and then the light is converted to an electrical signal. A new type of CT detector, holiday photon counting detector, utilizes a one-step process where the x-ray is immediately transformed into an electrical signal, bypassing the step of turning the x-rays into light. The photon counting detector is also known as a dual energy CT. The dual energy CT allows for improved detection of different materials. Typically, a dual energy CT requires lower amounts of contrast elements for CT imaging. Here, smaller amounts of medical modality contrast elements may be incorporated into the in vivo connection medical imaging contrast systems when a dual energy CT scanner is utilized.

[0080] The medical imaging technique of ultrasound is also undergone improved evolution where high-frequency ultrasound (HFU) allows for greater frequency differentiation of tissues in vivo, such as in human and animal bodies.

[0081] As an example, the medical modality contrast elements generate at least two different nonlinear vibrational patterns when excited by ultrasonic radiation. In particular fluorinated polymers allow for an improved response to ultrasonic radiation

[0082] Along with the evolution of medical imaging techniques, new contrast agents are available to provide further differentiation of in vivo tissues. These contrast agents include lanthanide series elements, transition metals, and post transition metals, alkaline metals, and halogens and organic chemistry derivatives thereof. The incorporation of the medical modality contrast agents into in vivo connection mechanisms provides for improved detection andAttorney Docket No.: 2019150-0018differentiation of the in vivo connection mechanisms. As an example, the incorporation of multiple medical modality contrast agents into the in vivo connection mechanisms allows for multiple detection responses and thus improved analysis of in vivo connection mechanisms.

[0083] As an example of the use of medical modality contrast agents incorporated into in vivo connection mechanisms, dual energy x-ray absorptiometry (DXA), a method originally developed for the measurement of bone density and mass, may be used to measure both soft- tissue composition and the detection response of contrast agents that are incorporated within a human or animal body. Through the use of multiple contrast agents and multiple keV responses, further information may be gained concerning tissue compositions. Multiple contrast agents may also be utilized for in vivo connection mechanisms to provide improved detection and information through the use of DXA.

[0084] The addition of medical modality contrast elements, while improving the detection of in vivo connection mechanisms, also changes the physical properties of the in vivo connection mechanisms such as sutures and suture tape. For instance, ultrahigh molecular weight polyethylene (UHMWPE) has a tensile strength of approximately 750 mega Pascals (MPa) with the Young’s modulus of 33 giga Pascals (GPa) and an elongation of 4 to 5%. Depending upon the type of filler material in the UHMWPE, the physical properties will increase or decrease based on the type and shape of material that is coextruded / incorporated into the UHMWPE. It is therefore critical to determine the type and amount of medical modality contrast elements that are incorporated into the in vivo connection mechanisms, such as UHMWPE.

[0085] UHMWPE has a weight average molecular weight (MW) of typically greater than 1 million atomic mass units (AMU) and more typically between 3 million and 6 million. One AMU is equal to 1 g / mole is equal to 1 Dalton. The microcrystalline structure of UHMWPE has the greatest effect on the properties of the polymer. UHMWPE is a semi-crystalline polymer contains fully crystalline and fully amorphous phases as an interfacial all trans phase. Disruption of the microcrystalline laminar shape dramatically changes the properties of the polymer. As an example, the addition of zeolite particles will decrease the coefficient of friction, reduce the elongation at break as well as the tensile strength. However, the modulus of the UHMWPE will typically be increased.

[0086] The radiation of UHMWPE will generate free radicals and create interchange andAttorney Docket No.: 2019150-0018covalent bonds, leading to the formation of cross-linking in the polymer. However, the diffusion of oxygen into the polymer as a result of a radiation can lead to the development of oxidize moieties within the polymer, specifically subsurface oxidized molecules. As a result, while radiation-induced cross-linked UHMWPE shows higher where performance mechanical performance of the UHMWPE is reduced. Vitamin E has been found to work as an antioxidant to help alleviate some of the oxidative process in radiation-induced cross-linked UHMWPE.

[0087] Suture materials may also be comprised of other polymers such as polyesters (polyethylene terephthalate as an example), polyamides (various nylon materials such as nylon 6 , nylon 66 and nylon 612 as examples), polyolefins (such as polypropylene as an example), high molecular weight polyethylene (HMWPE), polyurethanes (polyester polyurethanes and polyether polyurethanes as examples), and other suitable polymers.

[0088] The in vivo connection medical imaging contrast systems materials may also be comprised of biocompatible and semipermanent materials such as poly glycolic acid, poly lactic acid and combinations thereof.

[0089] A number of embodiments of the present disclosure have been described. While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any disclosures or of what may be claimed, but rather as descriptions of features specific to particular embodiments of the present disclosure.

[0090] Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination or in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in combination in multiple embodiments separately or in any suitable sub- combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or variation of a sub-combination.

[0091] Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In certain circumstances, multitasking and parallel processing may be advantageous.

[0092] Moreover, the separation of various system components in the embodimentsAttorney Docket No.: 2019150-0018described above should not be understood as requiring such separation in all embodiments, and it should be understood that the described program components and systems can generally be integrated together in a single software product or packaged into multiple software products.

[0093] Thus, particular embodiments of the subject matter have been described. Other embodiments are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results. In addition, the processes depicted in the accompanying figures do not necessarily require the particular order show, or sequential order, to achieve desirable results. In certain implementations, multitasking and parallel processing may be advantageous. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the claimed disclosure.

Claims

Attorney Docket No.: 2019150-0018CLAIMS What is claimed is:

1. A system comprising: at least one in vivo connection mechanism, wherein the in vivo connection mechanism is configured to connect in vivo body tissue; where the in vivo connection mechanism comprises a medical modality contrast element, wherein the medical modality contrast element is identifiable by a medical imaging modality; and where the medical modality contrast element is incorporated into the in vivo connection mechanism.

2. An in vivo medical imaging contrast connection system comprising: at least one in vivo connection mechanism, wherein the in vivo connection mechanism is configured to connect in vivo body tissue; and where the in vivo connection mechanism further comprises a medical modality contrast element, wherein the medical modality contrast element is identifiable by a medical imaging modality and; where the medical modality contrast element is incorporated into the in vivo connection mechanism; and where the in vivo medical imaging contrast connection system is incorporated into a human or non-human animal.

3. The system of any one of the preceding claims, where the in vivo medical imaging contrast connection system does not include an adhesive.

4. The system of any one of the preceding claims, where the in vivo medical imaging contrast connection system is comprised of sutures, suture tape, tubing, meshes and patches.

5. The system of any one of the preceding claims, where the in vivo medical imaging contrast connection system is comprised of one or more mono filaments.

6. The system of any one of the preceding claims, where the in vivo medical imaging contrast connection system is comprised of one or more multi-filaments.

7. The system of any one of the preceding claims, where the medical modality contrast element is coextruded, printed, coated, or co-mingled with the in vivo medical imaging contrast connection system.

8. The system of any one of the preceding claims, where the medical modality contrast element comprises materials from the lanthanide series of the periodic table of elements.

9. The medical modality contrast elements in claim 6 where the medical modality contrast elements are comprised of chelated materials.Attorney Docket No.: 2019150-001810. The system of any one of the preceding claims, where the medical modality contrast element is comprised of transition metals from the periodic table of elements.

11. The system of any one of the preceding claims, where the medical modality contrast element is comprised of post-transition metals from the periodic table of elements.

12. The system of any one of the preceding claims, where the medical modality contrast element is comprised of alkaline metals from the periodic table of elements.

13. The system of any one of the preceding claims, where the medical modality contrast element is comprised of halogens from the periodic table of elements.

14. The system of any one of the preceding claims, where the medical modality contrast element is comprised of gadolinium, iodine, barium, manganese, bismuth, or fluorine.

15. The system of any one of the preceding claims, where the connection mechanism is comprised of at least one plastic filament.

16. The system of any one of the preceding claims, where the connection mechanism is comprised of at least one metallic filament.

17. The system of any one of the preceding claims, where the connection mechanism is comprised of a bundle of fibers or filaments in a braided configuration.

18. The system of any one of the preceding claims, where the connection mechanism is comprised of a bundle of fibers or filaments in a woven configuration.

19. The system of any one of the preceding claims, where the connection mechanism is comprised of different color fibers or filaments where the different color fibers or filaments are visible from 700 nm to 400 nm of the visible spectrum.

20. The system of claim 19, where the different color fibers or filaments are of the same design and configuration as the medical modality contrast element.

21. An in vivo medical imaging contrast connection system comprising: at least one connection mechanism, wherein the connection mechanism comprises a medical device configured to connect in vivo body tissue; and where the in vivo medical imaging contrast connection system further comprises medical modality contrast elements, wherein the medical modality contrast elements are identifiable by a medical imaging modality and; where the medical modality contrast elements are incorporated into the in vivo medical imaging contrast connection system, and; where the medical modality contrast elements are differentiated medical modality contrastAttorney Docket No.: 2019150-0018elements that respond differently to the medical modality imaging.

22. The system of claim 21, where the differentiated medical modality contrast elements generate at least two different peaks in the keV X-ray spectrum.

23. The system of claim 21, where the differentiated medical modality contrast elements generate at least two decreases of the spin–lattice T1 relaxation time for magnetic resonance imaging.

24. The system of claim 21, where the differentiated medical modality contrast elements generate at least two different nonlinear vibrational patterns.

25. A method for producing an in vivo medical imaging contrast connection system comprising combining at least one plastic filament and at least one medical modality contrast element where the plastic filament is thermoplastic or thermoset and; where the medical modality contrast element is distinguishable by medical imaging from surrounding tissue and non-medical modality contrast element containing materials and; where the medical modality contrast element is on the exterior or interior of the plastic filament.

26. The method of claim 25, where the medical modality contrast element is coextruded with the plastic filament.

27. The method of claim 25, where the medical modality contrast element is printed or coated on the exterior of the plastic filament.

28. A system comprising: a tissue connection mechanism and medical modality contrast elements, wherein the medical modality contrast elements are identifiable by a medical imaging modality, where the medical modality contrast elements are incorporated with the tissue connection mechanism, and where the medical modality contrast elements are differentiated medical modality contrast elements that respond differently to the medical modality imaging.

29. The system of claim 28, where the differentiated medical modality contrast elements generate at least two different peaks in the keV X-ray spectrum.

30. The system of claim 28, where the differentiated medical modality contrast elements generate at least two decreases of the spin–lattice T1 relaxation time for magnetic resonance imaging.

31. The system of claim 28, where the differentiated medical modality contrast elements generate at least two different nonlinear vibrational patterns.

Images