Abstract: Disclosed herein is ureteral stent. The ureteral stent includes a proximal end, a distal end, and a middle portion. The proximal end includes a retention feature having a coiled shape. The distal end is opposite the proximal end. The middle portion is between the proximal end and the distal end.

Abstract: An endovascular apparatus is provided for treating the effects of vascular disease including aneurysms and arterial blockages using a percutaneous, minimally invasive technique. In one embodiment the endovascular apparatus includes a tubular sleeve having a cranial end, a first caudal branch, and a second caudal branch such that the tubular sleeve is shaped like an upside down “Y.” The apparatus further includes at least one expandable attachment device attached to the tubular sleeve for securing the endovascular apparatus to an interior wall of a vessel. The at least one expandable attachment device includes a plurality of telescoping segments similar to the telescoping segments of a presentation pointer. Accordingly, during percutaneous insertion of the endovascular apparatus into a patient the attachment device can be collapsed into a small profile.

Abstract: A ureteral stent that includes a tubular member and a retaining end adapted to be placed inside a kidney or a bladder of a patient. The retaining end includes a plurality of loops. Each of the loops are centered about a loop axis, and two or more of the loop axes extend in different directions relative to other loop axes.

Abstract: A surgical sheath adapted for use in the nasal cavity has an elongated hollow body made of a braided material having interstitial spaces with a dimension of 0.25 mm to 1.50 mm. The interstitial spaces filled with a filling material, such as silicone. The sheath has a low profile configuration during placement into the naris, and may be stretched into an expanded configuration. In methods of placing the sheath in the naris, the sheath is folded and then pulled into the naris using a surgical tool.

Abstract: The present disclosure relates generally to stents, systems, and methods for gastrointestinal treatment. In some embodiments, a stent may include a tubular scaffold having a first end opposite a second end, wherein a lumen extends between the first and second ends. The tubular scaffold may include a flared section and a medial section extending from the flared section, wherein a first diameter of the flared section is greater than a second diameter of the medial section. The stent may further include a liner extending partially along a surface of the tubular scaffold, wherein the liner is spaced from an anchoring region of the flared section to promote tissue ingrowth with the flared section.

Abstract: Ureteral catheters and assemblies are provided including: a drainage lumen including a proximal portion configured to be positioned in at least a portion of a patient's urethra and a distal portion configured to be positioned in a patient's ureter and/or kidney, the distal portion including a coiled retention portion including at least a first coil having a first diameter and a second coil having a second diameter, the first diameter being less than the second diameter; or wherein the retention portion extends radially outwardly from a portion of the distal end of the drainage lumen portion, the retention portion including a proximal end having a first diameter, a distal end having a second diameter, and a wall and/or surface extending therebetween, the retention portion having a second diameter is greater than the first diameter when deployed; or wherein the retention portion includes a plurality of drainage tubes.

Abstract: The present invention is directed toward an intragastric device used to treat obesity that includes a wire mesh structure capable of changing from a compressed pre-deployment shape to an expanded post-deployment shape with a greatly increased volume. The post-deployment shape contains a light weight at the top and a heavier weight at the bottom to ensure proper positioning within the stomach. In the post-deployment shape, the device contains larger spaces in the upper portion and smaller spaces in the lower portion to sequester food and delay gastric emptying. Alternatively, the device can be enveloped by a membrane containing larger holes at the top and smaller holes at the bottom to sequester food and delay gastric emptying. The device has a dynamic weight where the weight of the device in the pre-feeding stage is less than the weight of the device in feeding or post-feeding stage.

Abstract: An illustrative stent may comprise an elongated tubular member having a first end and a second end and an intermediate region disposed therebetween. The elongated tubular member configured to move between a collapsed configuration and an expanded configuration. The elongated tubular member may comprise at least one twisted filament, such as a knitted filament having a plurality of twisted knit stitches with intermediate rung portions extending between adjacent twisted knit stitches, or a plurality of helical filaments twisted with a plurality of longitudinal filaments.

Abstract: Motion correction of a three-dimensional (3D) image dataset reconstructed from a plurality of two-dimensional (2D) projection images acquired by an X-ray device is provided. In order to acquire the projection images, each of two acquisition assemblies covers an angular range of projection angles, and pairs of projection images of a region under examination are acquired at least substantially simultaneously at each acquisition time instant. For each pair of projection images, at least one marker object lying in the region under examination is automatically localized in order to determine 2D location information. 3D position information about the marker object is determined using acquisition geometries of the respective pair of projection images. Motion information describing a motion profile of the marker object over the acquisition period is ascertained from the position information at different acquisition time instants, and the motion information is used for motion correction of the image dataset.

Abstract: Methods of quickly and easily implanting a quick-connect heart valve prosthesis during a surgical procedure are provided. The heart valve may include a substantially non-expandable, non-compressible prosthetic valve and a plastically-expandable frame, thereby enabling attachment to the annulus without sutures. A system and method for deployment includes an integrated handle shaft and balloon catheter. A safety member disposed between the balloon catheter and handle shaft prevents premature catheter advancement prior to heart valve placement at the annulus, and also may prevent premature balloon inflation prior to full catheter advancement.

Abstract: A mitral valve prosthesis, a tricuspid valve prosthesis and a stent thereof. The stent is configured to support the heart valves of the mitral valve prosthesis and has a contracted configuration for delivery and an expanded configuration for deployment. The stent comprises, along its axial direction, an inflow section, a transition section and an outflow section, and the transition section is connected to the inflow section at one end and to the outflow section at the other end. When in the expanded configuration, the inflow section is located upstream of the outflow section with respect to the blood flow direction. The inflow section is less radially rigid than the outflow section and/or the transition section. Due to such a small radial rigidity, the inflow section can well adapt itself to the anatomy of the native mitral annulus.

Abstract: A delivery tool for an implantable medical device to be introduced into a human or animal body, in particular, an implantable leadless pacemaker, the delivery tool having an outer sheath and an inner sheath, wherein the inner sheath is configured to be retractable into a lumen of the outer sheath, wherein a distal side of the inner sheath is configured to provide regions which are reversibly collapsible and non-collapsible in diameter, wherein a non-collapsible region is arranged at the distal end of the inner sheath. A system including a delivery tool and an implantable medical device is also provided.

Abstract: The present invention relates to a stent and a method for manufacturing the same. The stent includes: a first hollow cylindrical body portion formed by weaving a metal wire; a second hollow cylindrical body portion formed by weaving a metal wire, and configured to surround the first body portion; an expanded portion configured to form two adjacent ends of the first body portion and the second body portion integrally; and a membrane inserted between the first body portion and the second body portion, and configured to surround the outside of the first body portion. According to the present invention, there is no risk of the film being torn when the stent is bent, an additional connection wire is not required, the process of manufacturing the stent is simple, and the costs required for the manufacture of the stent are not high.

Abstract: A stent, the stent including a first coating composition disposed on at least a portion of the outer surface of the stent, the first coating composition having at least one bioadhesive and a second coating composition disposed over the first coating composition, the second coating composition having at least one biodegradable polymer, and methods of making and using the same.

Abstract: The present invention provides a hydrophilic substrate including a hydrophilic polymer layer having a smooth surface and formed of a special polymer (hydrophilic polymer). Included is a hydrophilic substrate including on its surface a hydrophilic polymer layer formed of a hydrophilic polymer having a number average molecular weight of 40,000 or more.

Abstract: A vaso-occlusive device includes an inner braided member having an unconstrained deployed configuration and a constrained delivery configuration. The inner braided member includes a first plurality of filaments made of a first material composition, where a pair of filaments of the first plurality defines a first braid angle when the inner braided member is in the deployed configuration. The device also includes an outer braided member disposed at least partially around the inner braided member, and having an unconstrained deployed configuration and a constrained delivery configuration. The outer braided member includes a second plurality of filaments made of a second material composition different from the first material, where the first material has a greater radiopacity than the second material. A pair of filaments of the second plurality defines a second braid angle, substantially equal to the first braid angle, when the outer braided member is in the deployed configuration.

Abstract: Disclosed herein is ureteral stent. The ureteral stent includes a proximal end, a distal end, and a middle portion. The proximal end includes a retention feature having a coiled shape. The distal end is opposite the proximal end. The middle portion is between the proximal end and the distal end.

Abstract: The invention relates to compositions of co-polymers having hydrophilic and biodegradable hydrophobic units or blocks, resulting in improved properties and functionalities suitable for biomedical applications as self-fitting tissue scaffolds or minimally invasive surgical implants.

Abstract: A convertible nephroureteral catheter is used in the treatment of urinary system complications, particularly on the need for a single surgically delivered device to treat patients who must be seen by an interventional radiologist (IR). In many current procedures, patients need to return to the operating room to remove a previously delivered nephroureteral catheter to exchange this catheter with a fully implanted ureteral stent delivered though the same access site at the flank. The present convertible nephroureteral catheter reduces the need to return for a second surgical procedure. Two weeks after initial implantation, the proximal portion of the convertible nephroureteral catheter extending out from the body may simply be removed. A simple action at the catheter hub allows this proximal portion to be removed, leaving behind the implanted ureteral stent within the patient's urinary system. Other medical procedures, devices, and technologies may benefit from the described convertible catheter.

Abstract: A medical device adapted to be fixed in a hollow organ or cavity lined with mucosa includes a wall having an outer surface with a size and shape that is configured to a portion of a cavity or hollow organ lined with mucosa and a fixation mechanism. The fixation mechanism is adapted to fix the wall with the portion of the cavity or hollow organ. The fixation mechanism has at least two adjacent openings in the wall between proximal and distal ends of the wall. The openings being large enough to receive a section of the mucosa extending in the openings when said wall is positioned in the hollow organ or cavity. The openings are separated by a bridge and are close enough together that the mucosa that extends into the openings comes together over the bridge to fix the medical device in the hollow organ or cavity.

Abstract: Disclosed herein is a close-cell structured stent which is composed of curved struts that intersect at a crossing angle of 90 to 170 degrees in the longitudinal direction. Methods for making the stent, use of the stent as a vascular stent, an esophagus stent, an intestine stent, a bile conduct stent, or a urinary tract stent, and use of the stent in the manufacture of stent graft for the treatment of abdominal aortic aneurysms are also provided. The stent has both excellent longitudinal flexibility and radial strength.

Abstract: A personalized prosthesis for implantation at a treatment site of a patient includes a self-expanding mesh and/or membrane having collapsed and expanded configurations. The collapsed configuration is adapted to be delivered to the treatment site, and the expanded configuration is oversized relative to the treatment site and configured to engage the personalized prosthesis with the treatment site. The self-expanding mesh is configured to reduce in one or more dimensions in response to being constrained in the one or more dimensions, such that the mesh in the expanded configuration self-adjusts to the treatment site without buckling of the mesh. The self-expanding mesh or membrane forms a central lumen configured to allow blood or other body fluids to flow therethrough. Methods of manufacturing and delivery of the personalized prosthesis are also disclosed.

Abstract: Methods of quickly and easily implanting a quick-connect heart valve prosthesis during a surgical procedure are provided. The heart valve may include a substantially non-expandable, non-compressible prosthetic valve and a plastically-expandable frame, thereby enabling attachment to the annulus without sutures. A system and method for deployment includes an integrated handle shaft and balloon catheter. A safety member disposed between the balloon catheter and handle shaft prevents premature catheter advancement prior to heart valve placement at the annulus, and also may prevent premature balloon inflation prior to full catheter advancement.

Abstract: Disclosed are a nanofiber mat, a manufacturing method thereof, and applications thereof as a mat for cell culturing or as a barrier membrane for guided bone regeneration (GBR). The nanofiber layer includes a nanofiber layer and a reinforcement pattern that is disposed on the nanofiber layer and adhesively connected with the nanofiber layer. The nanofiber layer and the reinforcement pattern are combined with each other by at least one of the melting-solidification of at least a part of the nanofiber layer together with the reinforcement pattern, the dissolution-solidification of the same, and the penetration of a part of the reinforcement pattern into the nanofiber layer, followed by solidification.

Abstract: In some embodiments, a stent includes an elongate member and a distal retention member. The elongate member is configured to be disposed within a ureter of a patient and has a first portion, a second portion and a plurality of beads bonded together. The plurality of beads define a plurality of spaces between the plurality of beads. The plurality of spaces are configured to allow fluid to flow from the first portion of the elongate member to the second portion of the elongate member. The distal retention member is configured to help maintain a portion of the stent within a kidney of the patient.

Abstract: The present disclosure relates generally to medical devices, including airway stents, and additive manufacturing (3D printing) processes for producing the same. Using certain materials and novel printing techniques, the present systems and methods can directly print nearly any size or shape medical device in a few hours. For example, in certain embodiments, the present systems and methods leverage fused deposition modeling (“FDM”) and polycarbonate urethane (“PCU”) to produce custom medical devices, including airway stents.

Abstract: A laryngeal mask airway (LMA) device includes an inflatable annular cuff, which, when disposed in free space, is characterized by a pressure-volume curve that represents the pressure in the cuff when inflated, from a deflated negative pressure, by different volumes of ambient-pressure air, which include a low-pressure volume that results in a low pressure of 10 cm H2O. The pressure-volume curve includes (a) a low-pressure-range average rate of change over a low-pressure volume interval between 1.0 and 1.2 times the low-pressure volume, (b) a medium-pressure-range average rate of change over a medium-pressure volume interval between 2.0 and 2.2 times the low-pressure volume, and (c) a medium pressure at a medium volume of the cuff equal to 2.0 times the low-pressure volume. The medium-pressure-range average rate of change is less than 0.5 times the low-pressure-range average rate of change, and the medium pressure is between 20 and 200 cm H2O.

Abstract: An intragastric implant for obesity treatment is disclosed. The device delays digestion by providing a duodenal sleeve, and may also slows gastric emptying by limiting flow through the pyloric sphincter. The implant includes an elongated axially-compressible duodenal sleeve having a non-tissue-piercing anchor on a proximal end sized to lodge within the duodenal bulb. The anchor may have oppositely-directed anchoring flanges to resists migration in both directions. The sleeve may also have barbed ribs to resist proximal movement back up into the stomach. A method of implant includes collapsing/compressing the device and transorally advancing it through the esophagus to be deployed within the duodenum. A dissolvable jacket may constrain the implant for delivery and naturally dissolve upon implant. Removal of the implant may occur in the reverse.

Abstract: A lacrimal duct tube including: a pair of tubular members each of which has an terminal end opening at one end; and a central member that connects other ends of the tubular members, at least one of the tubular members includes: a cylindrical part extended from the terminal end opening to the central member side and has an opening for bar-like operative instrument at an end portion at the central member side; and an arc-shaped part that is extended from the end portion of the cylindrical part at the central member side further to the central member side and has an almost arc-shaped wall portion on a cross section orthogonal to a longitudinal side of the tubular member, and the almost arc-shaped wall portion is formed at the arc-shaped part continuously over a length of ? or more and 9/10 or less of an entire length of the tubular member.

Abstract: Methods and devices quickly and accurately locate the sphenopalatine ganglion (SPG) while performing a sphenopalatine ganglion block procedure that introduces a medication to the SPG. The methods and devices also prevent the medication applied to the SPG from flowing down a patient's throat during the procedure.

Abstract: An internal tissue including a lesion region in the human body is modeled as a three-dimensional model. By reconstructing thickness or flexibility of a lumen wall portion including the lesion region and making it possible to confirm a motion of the lumen wall or a flow of fluid in the inside of the lumen wall, a state of the lesion region in the lumen can be confirmed clearly by visual inspection or the like. As a result, the diagnosis in the lumen can be made easier.

Abstract: A stent incorporating flexible, preferably polymeric, connecting elements into the stent wherein these elements connect adjacent, spaced-apart stent elements. Preferably the spaced-apart adjacent stent elements are the result of forming the stent from a helically wound serpentine wire having space provided between adjacent windings. Other stent forms such as multiple, individual spaced-apart ring-shaped or interconnected stent elements may also be used. The connecting elements are typically web-shaped and result from creating slits or apertures in a covering of graft material applied to the stent and then, for example, applying heat to cause the slits or apertures to enlarge. The remaining graft material forms the interconnecting webs between the adjacent stent elements.

Abstract: A transorally implanted intragastric balloon or treating obesity and for weight control including a variable size balloon with one or interconnected regions acting to exert a pressure on the stomach, to provide a stomach volume occupying effect, and/or to anchor the balloon within the stomach.

Abstract: A medical device including an elongate member having a distal end portion, a proximal end portion, and a medial portion disposed between the distal end portion an the proximal end portion. The proximal end portion is configured to be disposed within a bladder of a patient. A portion of the proximal end portion is configured to contact an inner wall of the bladder to help retain the bladder in an expanded configuration.

Abstract: Methods and devices for treating obesity. Pressure is applied to gastric walls in at least one segment of a stomach such that the pressure distends the gastric walls and induces satiety. A hollow capsule can be used to distend the gastric walls. Alternatively, a doughnut-shaped ring may be inflated to an amount sufficient to create intragastric tension and induce satiety. A c-ring including at least one balloon may be placed at a segment of the stomach, where the balloon inflates to a size that creates tension at the segment. A biocompatible material can be injected into the fundus and antrum of the stomach to stiffen the gastric wall to create a fullness feeling.

Abstract: Present invention is a stent apparatus wherein a stent covering member holds a stent, which scaffolds a blood vessel from the inside when implanted in the blood vessel, in contracted state. The stent is formed of a biodegradable polylactic acid (PLA) as a tubular shape, shape memorized to a size capable of, when implanted in a vessel, scaffolding the blood vessel from the inside. This stent is held by the stent covering member in contracted state and mounted on a balloon of a balloon. The covering member is formed of a biodegradable polymer having elasticity as a cylindrical shape having an inner diameter to keep the stent in contracted state and, when the stent is expanded to the shape memorized shape, plastically deformed to release the holding of the stent. The stent and the stent covering member disappear in a vessel after they are implanted in the vessel.

Abstract: A graft is used to interconnect two vessels, such as an artery and a vein for hemodialysis. The graft includes a body having first and second ends, and a wall to define a passageway formed in the body. The wall includes a plurality of tubular layers, such as a first layer and one or more second layers disposed radially inward relative to the first layer. Each second layer has first and second ends that can be enclosable. The second layer is removable from the graft body from within the passageway of the graft body after clot formation. A grasper can be used to attach with at least one of the ends of the second layer. In response to withdrawal of the grasper, the corresponding end of the second layer gathers radially inward away from a layer adjacent to the second layer.

Abstract: A prosthesis for monitoring a characteristic of flow includes a first tubular prosthesis having a lumen and a sensor for detecting the characteristic of flow through the lumen. The sensor may be covered with another tubular prosthesis or by a layer of material in order to insulate the sensor from the fluid flow. A pocket may be formed between the tubular prosthesis and the adjacent layer of material or prosthesis and the sensor may be disposed in the pocket.

Abstract: According to various embodiments, a balloon inflating device may be provided. The balloon inflating device may include a balloon, a first substance within the balloon, a second substance within the balloon capable of having a reaction with the first substance to generate a gas within the balloon to inflate the balloon; and an electrical activator configured to activate the reaction between the first and second substances thus inflating the balloon. According to various embodiments, a method for inflating a balloon may be provided. The method for inflating a balloon may include providing a first substance within the balloon, providing a second substance within the balloon; and activating a reaction between the first and second substances electrically to generate a gas within the balloon to inflate the balloon.

Abstract: A stent includes an essentially tubular body formed by a web structure that is composed of a plurality of longitudinally adjacent web rings, each including a plurality of web elements that are disposed circumferentially around the longitudinal axis of the stent and that are adjoined one to the other by a junction bend. Each junction bend in a first web ring is coupled to another junction bend in a neighboring ring by a connector having a step-wise configuration, in which a central segment of the connector is disposed essentially parallel to the longitudinal axis of the stent and may become twisted to absorb torque imposed on the stent.

Abstract: A vascular graft incorporating a stent into a portion of its length. While various materials may be used for the vascular graft, the graft is preferably an ePTFE graft. The stent is preferably a self-expanding stent, although it may alternatively be a balloon expandable stent. The vascular graft preferably has a continuous inner tubular liner that extends between the opposing ends of the graft and provides a continuous luminal surface for blood contact that is uninterrupted by seams or joints. The length portion of the graft that does not include the stent has a greater wall thickness than does the portion including the stent.

Abstract: According to one aspect, the invention pertains to a ureteral stent that includes a proximal retention structure configured for retaining the proximal portion in the urinary bladder, which contains a balloon reservoir for storing a pressurized fluid that contains a urologically beneficial drug. In another aspect, a ureteral stent is provided that includes a reservoir for storing a pressurized fluid that comprises a urologically beneficial drug and an outlet remote from the reservoir, wherein the outlet includes a hydrogel material that, upon implantation of the ureteral stent, shrinks as the salinity of surrounding urine drops and expands as the salinity of surrounding urine increases. In other aspects, the invention pertains to a system for introducing a urinary stent into the body of a patient. In yet other aspects, the invention pertains to methods for treating patients.

Abstract: A method of using a fluorinated polymer having a glass transition temperature below 40 C as a contrast agent in 19F magnetic resonance imaging (MRI) of a solid object, said solid object comprising said contrast agent. The invention relates to a solid object comprising a structural component and an imaging component, wherein the imaging component is at least one fluorinated polymer. The invention relates to a method for 19F MRI in solid state using a contrast agent comprising a fluorinated polymer as well as a method for in vivo visualizing a scaffold. It further relates to a method for in vivo monitoring the degradation of a solid object in time, wherein the degradation is monitored in time by using 19F MRI to visualize the solid object, and wherein the amount of degradation of the solid object is determined based on the decrease in the visibility of the amount of 19F.

Abstract: This invention relates to blends of high, optionally medium, and low molecular weight polyesters where at least the low molecular weight polyester is substituted with an acidic moiety, the biodegradation of the blends being controllable by selection of the mean molecular weigh of each fraction, the quantity of each fraction in the blend and the amount and pKa of the acidic moiety(ies).

Abstract: The embodiments relate generally to medical devices and to methods of their manufacture. One aspect provides devices including chitosan fibers that are a free of chemical cross linking. Another aspect provides a method of manufacturing such devices.

Abstract: A titanium based, ceramic reinforced alloy ingot for use in producing medical implants. An ingot is formed from an alloy having comprising from about 5 to about 35 wt. % niobium, from about 0.5 to about 3.5 wt. % silicon, and from about 61.5 to about 94.5 wt. % of titanium. The alloy has a hexagonal crystal lattice ? phase of from about 20 vol % to about 70 vol %, and a cubic body centered ? crystal lattice phase of from about 30 vol. % to about 80 vol. %. The ingot has an ultimate tensile strength of about 940 MPa or more, and a Young's modulus of about 150 GPa or less. A molten substantially uniform admixture of a niobium, silicon, and titanium alloy is formed, cast into a shape, and cooled into an ingot. The ingot may then be formed into a medical implant and optionally annealed.

Abstract: Provided is a ureteral stent (=50) including a bladder portion (=52) positioned in a bladder of a patient, a kidney portion (=54) positioned in a kidney and ureteral passageway of the patient, and one or more tethers (=56) coupling the bladder portion to the kidney portion. The ureteral stent allows urine to pass around a blockage, and allows a ureter orifice connecting the ureteral passageway to the bladder to move between a compressed state and an uncompressed state to prevent or minimize urinary reflux, flank pain, blood in the urine, etc., while allowing the bladder portion to move freely in the bladder to prevent the bladder portion from irritating the trigone muscle.

Abstract: The present invention comprises systems, methods and devices for the delivery of compositions for occluding or of means for opening conduits. The implantable occlusive material may be delivered pre-formed or in situ cured and, may be a resorbable material that supports tissue ingrowth that eventually replaces the material leaving little or no original material in place. The delivery system is positioned to allow for placement of the occlusive material into the body conduit. Use of delivery systems, methods and devices for re-opening an occluded body conduit are also included.

Abstract: A medical device with an outer surface prepared to reduce crystalline growth or surface fowling thereon is provided. The device includes an elongate member that extends between a distal end and a proximal end, and a lumen defined through at least a central portion of the member. The member is defined from a wire that is coiled to define the lumen therethrough, the coils of the wire are configured such that a plurality of the neighboring coils define a small space therebetween. The coiled wire includes a central metallic core that extends along the entire length of the wire defining the member and a polymeric jacket is wrapped around the core, wherein the polymeric jacket is configured to retain an electric charge disposed therethrough.

Abstract: Ureteral stents include a tubular body defining a lumen and have a distal kidney section, a proximal bladder section, and a ureter section between the distal and proximal sections. The tubular body has a first material layer and a stiffening member that extends through at least a portion of a length of the tubular body. The stiffening member has a stiffness characteristic that varies along its length. This enables different portions of the stent to have different stiffness characteristics that preferably are optimized for the location of those portions within the human body. The stiffening member may be at least a second material layer having a second stiffness that is different from a first stiffness of the first material layer, and/or at least one strand of material that is embedded within the first material layer.