Article comprising a marker and related methods

Abstract

Articles containing markers (e.g., catheters) and related methods are generally provided. Articles described herein can be configured to exhibit one or more desired properties. For example, in some embodiments, the article includes markers spaced apart from each other at known distances. Such markers can be used to assist the user of the article in distance measurement. As another example, the article can be configured to swell upon exposure to a fluid such that the markers placed thereon do not break or delaminate. The article can also be configured to swell in a known, predictable, and / or uniform manner upon exposure to a fluid. This swelling can result in an increase in the spacing between the markers, and such an increase can also occur in a known, predictable, and / or uniform manner. When the fluid causing the article to swell is a bodily fluid (e.g., the fluid the article will be exposed to when implanted in a patient) and the article swells such that the markers have a known spacing within the patient, the markers can be advantageously used to measure distances within the patient, and / or variations in marker spacing can be used to determine the swelling of the article within the patient.

Description

[0001] Related Applications

[0002] This application claims priority to co-pending U.S. Provisional Application No. 63 / 046499, filed June 30, 2020, pursuant to 35 USC § 119(e), which is incorporated herein by reference in its entirety for all purposes. Technical Field

[0003] This invention generally relates to articles containing markings, such as catheters. The articles can be medical devices configured to be at least partially placed within a patient's body, such as articles and / or devices comprising elongated shafts configured to be placed in a blood vessel or other patient conduit. Background Technology

[0004] Current catheters and other medical devices inserted into patients have demonstrated a variety of complications, including those related to thrombosis when placed in the patient's bloodstream (e.g., when placed in a patient's vein, artery, and / or heart). Thrombosis can increase the risk and / or lead to: infection; symptomatic deep vein thrombosis (DVT); pulmonary embolism (PE); asymptomatic thrombosis, vascular trauma, and / or vascular occlusion. Complications arising from the use of such devices prolong hospital stays and increase morbidity and mortality.

[0005] Devices are needed that reduce complications, such as reducing thrombosis when placed in a patient and / or having other enhanced properties. Summary of the Invention

[0006] Methods and articles relating to marked catheters are generally provided.

[0007] In some embodiments, a series of methods are provided. In some embodiments, the method includes: performing the following steps with a labeled conduit containing a mark, the mark comprising a plurality of separate segments spaced apart along at least a portion of the conduit, wherein the average shortest distance between each segment and its nearest neighboring segment is a first distance in a first configuration of the labeled conduit; introducing fluid into the labeled conduit; and swelling at least a portion of the labeled conduit from the first configuration to a second configuration, wherein the average shortest distance between each segment in the second configuration and its nearest neighboring segment becomes a second distance, and wherein the ratio of the second distance to the first distance is greater than or equal to 1.02:1 and less than or equal to 2:1.

[0008] In some embodiments, the method includes: performing the following steps with a labeled catheter containing a plurality of separate segments spaced apart along at least a portion of the catheter, wherein the average shortest distance between each segment and its nearest neighboring segment is a first distance in a first configuration of the labeled catheter; introducing fluid into the labeled catheter; and swelling at least a portion of the labeled catheter from the first configuration to a second configuration, wherein the average shortest distance between each segment in the second configuration and its nearest neighboring segment is a second distance, and wherein the second distance is equal to about 1 mm, about 10 mm, about 100 mm, about 1 cm, or about 10 cm.

[0009] In some embodiments, a series of articles are provided. In some embodiments, the articles comprise a conduit having a plurality of markings. The markings comprise a plurality of separate segments spaced apart along at least a portion of the surface of the conduit. The articles have a first configuration having a first moisture content greater than or equal to 2 w / w% and less than or equal to 40 w / w%. In the first configuration, the average shortest distance between each segment and its nearest neighboring segment is a first distance. The articles have a second configuration having a second moisture content greater than or equal to 20 w / w% and less than or equal to 99.9 w / w%. In the second configuration, the average shortest distance between each segment and its nearest neighboring segment is a second distance. The second moisture content is greater than the first moisture content. The ratio of the second distance to the first distance is greater than or equal to 1.02:1.

[0010] In some embodiments, the article comprises a conduit with a plurality of markings. The markings comprise a plurality of separate segments spaced apart along at least a portion of the surface of the conduit. The article has a first configuration having a first moisture content greater than or equal to 2 w / w% and less than or equal to 40 w / w%. In the first configuration, the average shortest distance between each segment and its nearest neighboring segment is a first distance. The article has a second configuration having a second moisture content greater than or equal to 20 w / w% and less than or equal to 99 w / w%. In the second configuration, the average shortest distance between each segment and its nearest neighboring segment is a second distance. The second moisture content is greater than the first moisture content. The second distance is equal to about 1 mm, about 10 mm, about 100 mm, about 1 cm, or about 10 cm.

[0011] In some embodiments, the article comprises a catheter and a marker. The marker comprises a plurality of separate segments spaced apart along at least a portion of the surface of the catheter. At least a portion of the catheter does not contain the marker. In some embodiments, the article is substantially free of thrombus accumulation. The thrombus accumulation level of the marker is within 50% of the thrombus accumulation level of the portion of the catheter that does not contain the marker.

[0012] In some embodiments, the article comprises a labeling composition comprising a salt, a dye, and a first water-soluble polymer.

[0013] In some embodiments, the method includes setting a labeling composition onto a conduit such that the labeling composition penetrates into the conduit by at least 10 nm, and locking the labeling composition within the conduit. The setting step includes automated inkjet deposition. The locking step includes thermal annealing, heat treatment, dehydration, lyophilization, or a combination thereof.

[0014] In some embodiments, the article comprises a catheter and a marker. The marker comprises a plurality of separate segments spaced apart along at least a portion of the surface of the catheter. At least a portion of the marker penetrates into the catheter to a depth of 10 µm to 10 mm.

[0015] Other advantages and novel features of the invention will become apparent when considered in conjunction with the accompanying drawings and the following detailed description of several non-limiting embodiments thereof. In the event of any conflicting and / or inconsistent disclosures between this specification and any documents incorporated herein by reference, this specification shall prevail.

[0016] All publications, patents and patent applications mentioned in this specification are incorporated herein by reference to the same extent as each individual publication, patent or patent application is specifically and individually indicated to be incorporated by reference. Brief description of the attached diagram

[0018] Non-limiting embodiments of the invention will be described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. In the drawings, each identical or substantially identical component shown is generally represented by a single number. For clarity, not every component is labeled in every drawing, nor is every component of every embodiment of the invention shown, where illustration is not required to enable those skilled in the art to understand the invention. In the drawings:

[0019] Figure 1A A cross-sectional view of an exemplary device including markings according to a set of embodiments is shown;

[0020] Figure 1B A perspective view of a medical device consistent with some implementation schemes and a schematic diagram of a system for manufacturing the medical device are shown.

[0021] Figure 2 Data comparing normalized thrombus accumulation across different channels are shown, consistent with some implementation schemes;

[0022] Figures 3 to 7 Photographs of a dried catheter consistent with some implementation schemes and a catheter after hydration in phosphate-buffered saline are shown;

[0023] Figure 8 Methods for manufacturing, preparing, and inserting a medical device consistent with some embodiments are shown;

[0024] Figure 9 A perspective view of a medical device including an S-shaped tube, consistent with some implementation schemes, is shown;

[0025] Figures 10A to 10C Perspective and end views of clamps for fastening or securing pipes, consistent with some implementations, are shown;

[0026] Figures 11A to 11B A perspective view of a hydration device for hydrating pipes, consistent with some implementation schemes, is shown.

[0027] Figure 12 A flowchart of a method for producing pipelines, consistent with some implementation schemes, is shown;

[0028] Figure 13 A method for batching polymer materials, consistent with some embodiments, is shown;

[0029] Figure 14 A method for extruding polymer materials consistent with the concept of this invention is shown;

[0030] Figure 15 A method for hydrophilic treatment of materials, consistent with some embodiments, is shown;

[0031] Figure 16 A method for annealing materials consistent with some embodiments is shown;

[0032] Figure 17 A method for overmolding materials, consistent with the concept of this invention, is shown;

[0033] Figure 18 A method for keeping materials moisturized, consistent with some implementation schemes, is shown;

[0034] Figures 19 to 20 An article containing multiple holes, consistent with some embodiments, is shown; and

[0035] Figures 21 to 22 An article comprising two components is shown, consistent with some implementation schemes.

[0036] Figures 23A to 23B A photograph of an exemplary labeled catheter according to some implementation schemes is shown. Detailed Implementation

[0037] Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings. Similar reference numerals may be used to refer to similar components. However, this description is not intended to limit the present disclosure to particular embodiments and should be construed as including various modifications, equivalents, and / or alternatives to the embodiments described herein.

[0038] Typically, articles containing markings (e.g., catheters) and related methods are provided. The articles described herein can be configured to exhibit one or more desired properties. For example, in some embodiments, the article includes markings spaced apart from each other at known distances. Such markings can be used to assist the user of the article in distance measurement and / or identification of the article. As another example, the article can be configured to swell upon exposure to a fluid such that the markings placed thereon do not break or delaminate. The article can also be configured to swell in a known, predictable, and / or uniform manner upon exposure to a fluid. This swelling can result in an increase in the spacing between the markings, and such an increase can also occur in a known, predictable, and / or uniform manner. When the fluid causing the article to swell is a bodily fluid (e.g., the fluid the article will be exposed to when implanted in a patient) and the article swelling results in a known spacing between the markings within the patient, the markings can be advantageously used to measure distances with respect to the patient (e.g., the depth to which the article has been inserted into the patient) and / or changes in the marking spacing can be used to determine the swelling of the article within the patient.

[0039] Another advantageous characteristic that some of the articles described herein may exhibit is resistance to thrombus accumulation, which is advantageous (e.g., consistent with hydrophilic, non-thrombus-forming surfaces, such as those of the articles described herein) and / or consistent throughout the article. Resistance to thrombus accumulation consistent with hydrophilic, non-thrombus-forming surfaces can be expected to prevent thrombus formation and / or significantly reduce the rate of thrombus formation when the article is placed in a patient. A portion of the article implanted in a patient with relatively low resistance to thrombus formation, even when placed within an article with generally relatively high resistance to thrombus formation, can contribute to nucleate thrombi, which can grow unfavorably on the article. Therefore, uniform resistance to thrombus formation can be particularly beneficial.

[0040] The methods and articles described herein advantageously provide high-strength materials with a truly porous structure and other useful properties, such as an unexpectedly good combination of biocompatibility and mechanical properties. Several embodiments of porous solid materials are provided, having a combination of structural features independently selected from pore size, tensile strength, Young's modulus, solid concentration, type and degree of crosslinking, internal arrangement, hydrophilicity, and material composition, and optionally independently selected from end-user devices or intermediate materials having a desired aspect ratio for a molded shape, cavities, multiple cavities, tubes with concentrically placed cavities or thickness tolerances, or specific medical devices; each of these is further detailed herein.

[0041] Advantageously, in some implementations, the marker can be seamlessly integrated with the body of the catheter. In some such implementations, the marker provides measurement results (e.g., for clinical insertion) without serving as a landmark for thrombus accumulation.

[0042] The methods and compositions described herein can be used to provide artwork, markings, product descriptions, branding, identification, etc., to a variety of articles (e.g., catheters, suture wings, medical devices, polymer materials). For example, labels, markings, and / or identifiers can be provided to the articles described herein.

[0043] In one set of exemplary embodiments, the method includes swelling a marked conduit (e.g., a marked conduit) from a first unswelled configuration to a second swollen configuration. The markings may take the form of a plurality of separate segments spaced apart along at least a portion of the surface of the conduit. This swelling may result in an increase in the average shortest distance between the markings from a first average shortest distance to a second average shortest distance. For example, the method may include swelling the conduit such that the ratio of the first average shortest distance to the second average shortest distance is greater than or equal to 1.02:1 and less than or equal to 2:1. As another example, the method may include swelling the conduit such that the second average shortest distance is equal to about 1 mm, about 1 cm, or about 10 cm. In another set of exemplary embodiments, an article is provided. The article may comprise a conduit, such as a conduit, containing a plurality of markings. The conduit may be configured such that it has a first unswelled configuration containing a relatively small amount of water (e.g., greater than or equal to 2 w / w% and less than or equal to 40 w / w%) and a second swollen configuration containing a larger amount of water (e.g., greater than or equal to 20 w / w% and less than or equal to 99 w / w%). The average shortest distance between markers can take the form of multiple separate segments spaced apart along at least a portion of the surface of the pipe, which can be greater in a swollen configuration than in a non-swollen configuration. In some embodiments, the ratio of the average shortest distance between markers in a swollen configuration to the spacing between markers in a non-swollen configuration is greater than or equal to 1.02:1 and less than or equal to 2:1. In some embodiments, the average shortest distance in the swollen pipe is equal to about 1 mm, about 1 cm, or about 10 cm.

[0044] In a third set of exemplary embodiments, an article is provided. The article may comprise a conduit (e.g., a catheter) with markings in some sections and lacking markings in others. Both the markings and the conduit may be substantially resistant to thrombosis. For example, the article as a whole may be substantially free of thrombosis and / or thrombus accumulation on the markings may be within 50% of the thrombus accumulation on the unmarked conduit sections.

[0045] In a fourth set of exemplary embodiments, a labeling composition is provided. The labeling composition is adaptable for deposition onto a conduit (such as a conduit) to form a labeled conduit. The labeling composition may contain salts, dyes, and water-soluble polymers.

[0046] In a fifth set of exemplary embodiments, a method for forming an article of article is provided. The method includes placing a marking composition onto a conduit (such as a conduit) to form a mark thereon. In some embodiments, the marking composition may be deposited and subsequently allowed to penetrate a distance (e.g., at least 10 nanometers, at least 10 micrometers) into the conduit. The mark may then be locked in the conduit. Locking the mark may include preventing it from penetrating into the conduit and / or chemically bonding it to the conduit. This can be achieved by applying a stimulus (e.g., heat) to the conduit and / or the marking composition. A variety of suitable deposition techniques may be employed, including automated inkjet deposition and / or pad printing. In some embodiments, locking includes heat treatment, dehydration, lyophilization, thermal annealing, or a combination thereof.

[0047] In some implementations, the markings are deposited on the surface of the article.

[0048] In the sixth set of exemplary embodiments, an article comprising a conduit (e.g., a tubing) and a marking is provided. At least a portion of the marking is permeable to the interior of the conduit. The penetration depth can be from 10 nanometers to 10 micrometers, or from 10 nanometers to 10 mm, or from 10 micrometers to 10 mm. The marking can take the form of a plurality of separate segments spaced apart along the surface of the conduit.

[0049] For example, such as Figure 1A As shown in the cross-sectional view, device 100 includes a conduit 110 (e.g., a tubing) and markers 112 spaced apart along at least a portion of the conduit 110. In some embodiments, the tubing 110 may have a first configuration 110A (e.g., an unswelled configuration) and a second configuration 110B (e.g., a swollen configuration). In some embodiments, the markers have an average shortest distance 113 between the markers. For example, swelling between the first configuration 110A and the second configuration 110B results in an increase in the average shortest distance 113 between the markers.

[0050] It should also be understood that some methods may include implanting the article described herein at least partially into a patient, some methods may include manufacturing the article described herein, and some embodiments may involve an article manufactured by the methods described herein.

[0051] An example of the articles provided herein is a medical device (e.g., a catheter) that includes reinforcing materials, such as materials configured to prevent thrombosis or provide other enhancing properties when placed in a patient. Methods for manufacturing these articles and / or medical devices are also provided. The reinforcing materials described herein can be used to produce catheter shafts and / or other device components having relatively high water content and / or neutral surface charge (e.g., to minimize the body's foreign body response). These reinforcing materials can provide increased strength (e.g., for insertion into a blood vessel) and improved lumen patency while reducing trauma to the blood vessel into which the associated device is inserted. The reinforcing materials may comprise materials having: hydrophilic properties; high strength; enhanced flexibility; and / or a nanoporous structure. The medical devices conceived in this invention may include catheters that can be inserted into a patient's blood vessel without the need for an intubator (reducing vascular-related trauma).

[0052] The apparatus described herein, as well as the related techniques for setting markings on the apparatus, can also be applied to devices other than medical devices. For example, some embodiments involve PVA films (e.g., as used in detergent pods), PVA films, and / or methods associated with such apparatus.

[0053] Now for reference Figure 1B It provides a perspective view of an example of an artifact: a medical device containing tubing and a schematic diagram of the system used to produce the medical device. Figure 1B The system 10 shown includes a medical device 100 and various components for manufacturing, packaging, and / or sterilizing the device 100. The device 100 can be transported to a hospital, physician's office, and / or other clinical setting (“clinical location”) for placement in a patient. The device 100 can be implanted in a patient at an “implantation site” (e.g., during surgery). Alternatively, the device 100 can be inserted into a patient through the skin at an “insertion site” (e.g., when the device 100 passes through the patient's skin and enters a blood vessel). Implantation or insertion (“insertion” herein) operations can be performed in an operating room, catheterization laboratory, and / or other locations where aseptic procedures can be performed (“operation site”).

[0054] Device 100 may include a tube, i.e., a conduit 101, comprising a proximal portion 104 having a proximal end 103, a distal portion 108 having a distal end 109, and a lumen 106 therebetween. The conduit 101 may include a wall 102 surrounding the lumen 106, such that the wall 102 includes an inner surface (e.g., the interior of the conduit 101) and an outer surface (e.g., the exterior of the conduit 101). The conduit 101 may be constructed of polymeric material 20 or otherwise manufactured, as described below. Device 100 may also include a mechanically interlocking connector (e.g., a Luer connector), i.e., a connector 120, which may be configured to operatively attach (e.g., fluidly attach) device 100 to another device. System 10 may include an extrusion device (extruder 500) configured to produce one or more components of device 100, such as the conduit 101 of device 100. System 10 may also include a variety of tools, containers, solutions, equipment, devices and / or other components that can be used to manufacture, package and / or store device 100 and / or its components (e.g., pipes 101).

[0055] In some embodiments, another component of the apparatus 100, the extruder 500, and / or the system 10 has a similar structure and arrangement to similar components described in the applicant’s co-pending application.

[0056] Device 100 may include at least a portion of a medical device, such as a device configured to be implanted or otherwise inserted into a patient. In some embodiments, device 100 includes a conduit 101 attached to or capable of being attached to another medical device, for example when device 100 includes a catheter attached to a pump (e.g., an implantable pump, such as one configured to deliver drugs or other substances to a location within the patient's vascular system, ventricles, spinal space (e.g., epidural or intrathecal space of the spine), and / or the patient's gastrointestinal system (e.g., the stomach or intestine). Device 100 may include catheters selected from: central venous catheters; peripheral central catheters; peripheral port catheters; central venous port catheters; midline catheters; peripheral catheters; tunneled catheters; dialysis access catheters; urinary catheters; nerve catheters; peritoneal catheters; intra-aortic balloon counterpulsation catheters; diagnostic catheters; interventional catheters; drug delivery catheters; drainage catheters; central nervous system catheters; hemodialysis catheters; and combinations thereof.

[0057] Additionally or alternatively, device 100 may include a medical device selected from: a shunt; a wound drainage tube, such as an external drainage tube (e.g., ventricular, ventriculoperitoneal, or lumbar cisternose-peritoneal); an infusion port; a soft tissue patch; a drug delivery device, such as an insulin pump; an infusion tubing; a contraceptive device; a feminine hygiene device; an endoscope; a graft; a pacemaker; an implantable cardioverter-defibrillator; a cardiac resynchronization device; a cardiovascular device guide, wherein conduit 101 may also include an insulating layer for the guide; a ventricular assist device; a cochlear implant; an endotracheal tube; a tracheostomy tube; an implantable sensor device (e.g., intravascular, percutaneous, or intracranial); a ventilator pump; an ophthalmic device, such as an ophthalmic drug delivery device; and combinations thereof.

[0058] At least a portion of the device 100 may be configured to contact bodily fluids within a patient's body. For example, the device 100 may include ex vivo and / or in vivo devices, such as blood-contact implants.

[0059] At least a portion of device 100 may include a device for insertion into a patient, such as a percutaneous device. At least a portion of device 100 may include a permanently inserted device. For example, device 100 may remain inserted in the patient for more than five years. At least a portion of device 100 may include a temporarily inserted device. For example, device 100 may remain inserted in the patient for no more than five years, such as no more than one year, no more than six months, or no more than three months.

[0060] The conduit 101 may comprise one, two, or more nanoporous materials, microporous materials, and / or high-strength hydrogels. The conduit 101 may be configured to prevent or otherwise reduce (e.g., reduce compared to other conduits) thrombus buildup when implanted in a patient. As a whole, the conduit may be configured such that it exhibits reduced thrombus buildup compared to polyurethane materials, and / or substantially no thrombus buildup (when placed in one or more relevant environments (e.g., body fluids, a patient)). For example, in some embodiments, the conduit may exhibit substantially no thrombus buildup compared to other equivalent conduits formed of polyurethane. In some embodiments, the conduit 101 comprises one, two, or more polymeric materials 20 configured to reduce thrombus buildup. Such polymeric materials may comprise water-soluble polymers suitable for inclusion in the conduit as described elsewhere herein. An exemplary method for determining thrombus buildup (e.g., non-thrombotic) is described in Example 1.

[0061] The applicant has conducted research to evaluate the thrombotic resistance of a suitable type of conduit 101 (HydroPICC catheter) within an extracorporeal blood flow circuit system, thereby assessing platelet adhesion and thrombosis against catheter 101 in the presence of blood. The blood flow circuit system allows for the assessment of inherent device thrombotic characteristics. Hematological parameters (e.g., hemodynamics, anticoagulation) in this in vitro model are considered more controllable than in in vivo models, allowing for a direct semi-quantitative assessment of thrombotic activity. External dynamic parameters (e.g., vascular geometry, animal physiology, activity, variable hemostasis and in vivo homeostasis, and infection) that could confound in vivo assessments can be eliminated in the in vitro blood flow circuit model. This is believed to allow the assessment of thrombotic resistance to focus on the surface and chemical properties of conduit 101, while other parameters remain relatively constant. The in vitro blood flow circuit model is considered capable of separately quantifying platelet adhesion. Since platelet adhesion is considered a fundamental and critical step in thrombosis, its quantification is considered a conservative measure of thrombus accumulation.

[0062] For the applicant's study, the blood flow circuit comprised a ¼-inch inner diameter polyvinyl chloride tube. The tubing 101, containing lumen 106, was immersed in sterile saline for approximately 24 hours before insertion into the blood flow circuit. Subsequently, tubing 101 was cut into samples containing approximately 15 cm in length. The proximal opening of lumen 106 was plugged with epoxy resin to simulate a "locked" catheter. Fresh bovine blood was collected via cardiac puncture, and heparin was added to achieve a concentration of 0.75 U / mL. Autologous platelets were purified, labeled with 111-indium, and then re-added to the bovine blood. Tube 101 was inserted into the blood flow circuit and held within the circuit for approximately 120 minutes. The bovine blood was maintained at 37°C and pumped through the blood flow circuit at a flow rate of 200 mL / min using a peristaltic pump to simulate physiological blood flow through tubing 101. Thrombus buildup in tubing 101 was assessed after 45 minutes, and tubing 101 was removed from the blood flow circuit after 60 to 120 minutes. Once removed from the blood flow circuit, tubing 101 is flushed with saline and placed inside a gamma counter for analysis.

[0063] In addition to tubing 101, the applicant similarly evaluated two commercially available peripherally inserted central catheters (PICCs): PowerPICC® from Bard Access Systems, Inc. and BioFlo® PICC from AngioDynamics, Inc. Thrombus accumulation was assessed in samples of PowerPICC® and BioFlo® PICC according to the blood flow circuit system described above. The applicant observed significant thrombus accumulation in both PowerPICC® and BioFlo® PICC samples, while minimal thrombus accumulation was observed in tubing 101. Given that some hematological parameters could not be consistently controlled across experimental groups, the irradiation counts of tubing 101 and BioFlo® PICC samples were normalized to the irradiation counts of PowerPICC®. Figure 2 The image shows a normalized thrombus accumulation map of PowerPICC®, BioFlo® PICC, and pipe 101.

[0064] Based on paired, two-sided t-tests (p values ​​of 0.017 and 0.035, respectively), both the Pipeline 101 and BioFlo® PICC showed statistically significant reductions in thrombus formation compared to PowerPICC®. A statistically significant reduction in thrombus accumulation was also observed in Pipeline 101 compared to BioFlo® PICC (p value of 0.033). Compared to PowerPICC®, BioFlo® PICC showed a 71±30% reduction in thrombus accumulation, while Pipeline 101 showed a 97±2% reduction.

[0065] The conduit 101 may comprise one, two, or more polymer materials 20 configured to limit dimensional changes in the device 100 (e.g., limit dimensional changes in the conduit 101). In some embodiments, the included polymer materials are configured to limit dimensional changes (e.g., length, outer diameter, inner diameter) of the conduit 101 to less than 15%, such as less than 10%, such as less than 5%, when exposed to water, solvents, non-solvents, aqueous solutions, or mixtures thereof. The polymer material 20 may be configured to limit dimensional changes in the conduit 101 to a minimum change in length (e.g., close to 0%) and / or no more than 10% of the outer diameter, such that the conduit 101 exhibits anisotropic swelling.

[0066] For example, in some embodiments, the ratio of the swelling of the inner diameter to the swelling of the outer diameter is greater than or equal to 0.1, greater than or equal to 0.2, greater than or equal to 0.5, greater than or equal to 0.8, greater than or equal to 0.9, greater than or equal to 1, greater than or equal to 1.1, greater than or equal to 1.2, greater than or equal to 1.5, greater than or equal to 2, greater than or equal to 5, or greater than or equal to 8. In some embodiments, the ratio of the swelling of the inner diameter to the swelling of the outer diameter is less than or equal to 10, less than or equal to 8, less than or equal to 5, less than or equal to 2, less than or equal to 1.5, less than or equal to 1.2, less than or equal to 1.1, less than or equal to 1, less than or equal to 0.9, less than or equal to 0.8, less than or equal to 0.5, or less than or equal to 0.2. Combinations of the above reference ranges are also possible (e.g., greater than or equal to 0.1 and less than or equal to 10). Other ranges are also possible.

[0067] In some embodiments, the conduit 101 is configured to reduce its length upon exposure to water, solvents, non-solvents, aqueous solutions, or mixtures thereof. The outer diameter of the conduit 101 may be configured to increase as its length decreases. Such embodiments can be used for anatomical features (e.g., blood vessels) that may require widening for support and / or further manipulation.

[0068] Another portion of conduit 101 and / or device 100 may be configured to swell and / or deswell according to its water content. Additionally or alternatively, in some embodiments, another portion of conduit 101 and / or device 100 is further configured to swell and / or deswell according to its sodium chloride content. In some embodiments, device 100 may contain 10% by weight of sodium chloride, which is configured to reduce or otherwise limit its swelling capacity. The conduit may swell when exposed to a variety of suitable fluids including: water, body fluids, isotonic salt solutions (e.g., 1× phosphate-buffered saline, physiological saline), lactated Ringer's solution (LRS), dextran (D5W), phosphate-buffered saline (PBS), and / or Hanks' Balanced Salt Solution (HBSS), physiological saline, and / or physiological body fluids.

[0069] Another portion of pipe 100 and / or device 100 may also be dissolved and / or configured to dissolve upon exposure to the fluid described in the preceding paragraph.

[0070] In some embodiments, when hydrated (e.g., with a high water content), a mandrel of system 10 (e.g., mandrel 614 described below) is slidably inserted into a cavity 106 of conduit 101. The inserted mandrel 614 may have a larger diameter than the diameter of the cavity 106 when the device 100 is dehydrated (e.g., at a low water content), for example, to provide radial expansion force on conduit 101. In some embodiments, the diameter of the mandrel is less than or equal to the inner diameter of the hydration conduit 101, but greater than or equal to the inner diameter of the dehydration conduit 101.

[0071] Another portion of the conduit 101 and / or device 100 may be dehydrated and annealed (one or both may be carried out under vacuum or in the presence of one or more gases), for example when maintained at temperatures between 90°C and 180°C, for example at temperatures between 130°C and 160°C, for example at 150°C (for example when components of system 10 are maintained within a specific temperature range).

[0072] In some embodiments, and prior to annealing, one, two, or more molding elements (not shown) may be inserted into at least a portion of the cavity 106 of the conduit 101. In some embodiments, and prior to annealing, one, two, or more molding elements may be slidably received and surround at least a portion of the conduit 101. The molding elements may be configured to cause the conduit 101 to take a desired shape (e.g., curvature). The annealed conduit 101 having the molding elements may be configured to be "locked into" the desired shape. The molding elements may comprise materials selected from: steel; polypropylene; nylon; polysulfides; polysulfone; nickel-titanium alloys; and combinations thereof.

[0073] The dehydrated and annealed conduit 101 can be configured to compress around an inserted mandrel 614, for example, to increase hydrogen bonding and / or polymer chain orientation within the conduit 101. Compression can occur around the mandrel during dehydration and diameter changes. This compression can induce chain orientation radially through hydrogen bonding, much like an extruder can be linearly drawn from a die. Increased hydrogen bonding and / or polymer chain orientation can be achieved (e.g., through dehydration of the mandrel 614 via the conduit 101) to improve the overall strength of the device 100 and / or reduce subsequent swelling of the device 100 upon subsequent hydration (e.g., reducing the expansion of the device 100). In some embodiments, the annealing process can be repeated multiple times, with hydration and drying steps performed between cycles to increase the degree of hydrogen bonding and / or polymer chain orientation. These mechanical properties (e.g., Young's modulus, peak tensile strength, yield stress, fracture strain, tensile energy at fracture, elongation, etc.) can be altered upon solvation in water above the glass transition temperature of the base polymer.

[0074] In some embodiments, when pipe 101 is annealed in water for one or more cycles at a temperature of 120°C to 180°C, the dimensions (e.g., outer and inner diameters) of pipe 101 change by no more than 5%. For example, dehydration pipe 101 may contain an inner diameter of about 1.0 mm and an outer diameter of about 1.33 mm, while the same pipe 101 may contain an inner diameter of about 1.2 mm and an outer diameter of about 1.5 mm when hydrated. In this example, the inner diameter increases by about 0.83%, and the outer diameter increases by about 0.88%. Additionally or alternatively, in some embodiments, the total length of pipe 101 changes by no more than 5%.

[0075] Polymer material 20 may include a water-soluble polymer, namely polymer 21. In some embodiments, the water-soluble polymer 21 comprises one, two, or more polymers selected from: poly(vinyl alcohol); poly(acrylic acid); polyethylene glycol; poly(vinylpyrrolidone); poly(methacrylic acid sulfonyl betaine); poly(acrylic acid sulfonyl betaine); poly(methacrylic acid carboxybetaine); poly(acrylic acid carboxybetaine); povidone; polyacrylamide; poly(N-(2-hydroxypropyl)methacrylamide); poly(... Azoline, polyphosphate, polyphosphazene, polyvinyl acetate, polypropylene glycol, poly(N-isopropylacrylamide), poly(2-hydroxymethyl methacrylate); and combinations thereof. In some embodiments, the polymeric material comprises copolymers of the water-soluble polymers listed above.

[0076] Polymer material 20 may comprise one, two, or more radiopaque materials, substance 22. In some embodiments, radiopaque substance 22 comprises one, two, or more substances selected from: bismuth subcarbonate; barium sulfate; bismuth trioxide; bismuth oxychloride; tungsten; platinum; gold; titanium dioxide; tantalum; palladium; silver; and combinations thereof.

[0077] The polymer material 20 may comprise one, two, or more phosphate solutions, i.e., solution 23. In some embodiments, the phosphate solution 23 comprises one, two, or more solutions selected from: sodium dihydrogen phosphate; disodium hydrogen phosphate; trisodium phosphate; and combinations thereof.

[0078] Polymer material 20 may contain one, two, or more plasticizers, namely plasticizer 29. In some embodiments, plasticizer 29 comprises materials selected from: polyols, such as glycerin; propylene glycol; water; ethylene glycol; butylene glycol; erythritol; threitol; arabinitol; xylitol; ribitol; mannitol; sorbitol; galactitol; fucoidan; idoterol; inositol; lactulose; maltitol; lactitol; maltotriol; maltotetratitol; polyglycitol; and combinations thereof. In some embodiments, polyols are included in material 20 for plasticizing and as humectants to improve the hydration efficiency of pipe 101. Polyols may be added to material 20 before and / or after annealing (in a secondary rehydration step). Plasticizer 29 may be included to prevent cracking and / or breakage of pipe 101 during storage in a dry (e.g., unhydrated) state. In addition to humectants, plasticizer 29 can be added to improve hydration performance.

[0079] In some embodiments, pipe 101 is at a specific temperature (e.g., below the T0 of the base polymer material). g The conduit 101 is immersed in an immersion solution (water-based or solvent-based) containing plasticizers and / or humectants. The immersion solution may be stagnant or configured to flow through at least a portion of the conduit 101. After immersion, the conduit 101 may be dried (e.g., purged by ambient, convection, vacuum, or dry gas) and annealed. Alternatively, the conduit 101 may be immersed after the drying and annealing processes.

[0080] The mixture containing water-soluble polymer 21, radiopaque substance 22, sodium phosphate solution 23 and / or plasticizer 29 used herein is generally referred to as polymer material 20.

[0081] The proximal portion 104 and / or distal portion 108 of conduit 101 may include blunt ends, radiation ends, beveled ends, tapered shapes, and / or other modified ends (e.g., modified proximal portion 104 and / or modified distal portion 108). In some embodiments, radio frequency (RF) energy is applied to portions 104 and / or 108 (e.g., to ends 103 and / or 109, respectively) to achieve modified ends. In some embodiments, a tipping process (e.g., a melt-feed process) is applied to portions 104 and / or 108 to obtain modified ends. In some embodiments, a solvent and / or a solvent mixture is applied to portions 104 and / or 108 to obtain modified ends.

[0082] In some embodiments, conduit 101 includes one, two, or more markings along one or more sections of conduit 101, the markings being shown as 112. One or more sections of conduit 101 may also be unmarked (e.g., in addition to the sections containing markings). Marking 112 may be placed relative to a single point on conduit 101. The marking may contain multiple separate segments. For example, some markings may be marked with graduations (e.g., to indicate one or more distances). In some embodiments, marking 112 is configured to provide a “ruler” to assist in determining the depth at which device 100 is inserted into the patient. The marking may also contain text and / or words. For example, in some embodiments, the marking contains numbers and / or phrases indicating distances (e.g., “5 cm”). When the marking contains text and / or words, the text and / or words may indicate a distance from the distal end of the catheter and / or may have numerical values ​​increasing from the distal end to the proximal end of the catheter. Some catheters may contain some markings in the form of segments and some markings in the form of text and / or words. As an example, a conduit may contain markers that are more closely spaced (e.g., every 1 cm) in the form of segments and some markers that contain text and / or words that are less closely spaced (e.g., every 5 cm). The markers containing text and / or words may also contain segments. The markers that are in the form of segments may be placed between the markers that contain text and / or words.

[0083] In some embodiments, the mark 112 is configured to provide identification features of the device 100, such as model number, manufacturing date, etc. In some embodiments, the mark is placed on at least a portion of the surface of the pipe. As an example, when the pipe is a conduit, the mark may be placed along at least a portion of the surface of the conduit.

[0084] The label can be made from a variety of suitable materials. In some embodiments, the label comprises a polymer, such as a water-soluble polymer. Non-limiting examples of suitable water-soluble polymers include: poly(vinyl alcohol), poly(acrylic acid), polyethylene glycol, poly(vinylpyrrolidone), poly(methacrylic acid sulfonyl betaine), poly(acrylic acid sulfonyl betaine), poly(methacrylic acid carboxylic betaine), polyvinylpyrrolidone, polyacrylamide, poly(N-(2-hydroxypropyl)methacrylamide), poly... The label may contain azoline, polyphosphate, polyphosphazene, polyvinyl acetate, polypropylene glycol, poly(N-isopropylacrylamide), and / or poly(2-hydroxymethyl methacrylate). When both the conduit and the label thereon contain one or more water-soluble polymers, the conduit and the label may have the same chemical composition or may have different chemical compositions in one or more ways. For example, the conduit and the label thereon may contain only the same type of water-soluble polymer, may contain some common water-soluble polymers and some water-soluble polymers that differ between the two, or may each contain water-soluble polymers not present in the other. The label may also contain a polymer that is insoluble in water. In one set of exemplary embodiments, the label is formed of a material selected from poly(vinyl alcohol) and poly(vinyl acetate). In some embodiments, the label material contains greater than or equal to 75% by weight (solids content, e.g., greater than or equal to 80% by weight, greater than or equal to 85% by weight, greater than or equal to 90% by weight, greater than or equal to 95% by weight, or greater than or equal to 98% by weight) of poly(vinyl alcohol). In some embodiments, the labeling material comprises less than or equal to 100% by weight (solids content, e.g., less than or equal to 99% by weight, less than or equal to 98% by weight, less than or equal to 95% by weight, less than or equal to 90% by weight, less than or equal to 85% by weight, or) less than or equal to 80% by weight relative to the total weight of the labeling material. Combinations of the above reference ranges are also possible (e.g., greater than or equal to 75% by weight and less than or equal to 100% by weight). Other ranges are also possible.

[0085] The label may also contain one or more other substances. For example, in some embodiments, the label contains a dye, such as a reactive dye. Non-limiting examples of suitable reactive dyes include tetrasodium; 4-amino-5-hydroxy-3,6-bis[[4-(2-sulfonyloxyethylsulfonyl)phenyl]diazeninyl]naphthalene-2,7-disulfonate (Reactive Black 5), copper; 33-[[4-(2-hydroxyethylsulfonyl)phenyl]aminosulfonyl]-2,11,20,29,39,40-hexaaza-37,38-diimine nonacyclo[28.6.1.13,10.112,19.1] 21,28.04,9.013,18.022,27.031,36]tetracosane-1,3(40),4(9),5,7,10,12(39),13(18),14,16,19,21,23,25,27,29,31(36),32,34-nonadene-6,15,24-trisulfonic acid (Active Blue 21), 2-naphthalenesulfonic acid, 7-(acetamido)-4-hydroxy-3-[[4-[[2- [Sulfooxy)ethyl]sulfonyl]phenyl]azo]-, disodium salt (9CI) (Active Orange 78), Active Yellow 15, disodium 1-amino-9,10-dioxo-4-[(3-{[2-(sulfonyloxy)ethyl]sulfonyl}phenyl)amino]-9,10-dihydro-2-anthraquinone sulfonate (Active Blue 19), 1-amino-4-[3-(4,6-dichlorotriazine-2-ylamino)-4-sulfophenylamino]anthraquinone-2-sulfonic acid (Active Blue) 4) CI Reactive Red 11,4-[2-(5-carbamoyl-1-ethyl-4-methyl-2,6-dioxopyridin-3-ylylene)hydrazino]-6-[(4,6-dichloro-1,3,5-triazin-2-yl)amino]phenyl-1,3-disulfonate (CI Reactive Yellow 86), tetrasodium 6,13-dichloro-3,10-bis[[4-[(4,6-dichloro-1,3,5-triazin-2-yl)amino]sulfonate phenyl]amino]triphenyl di Azine disulfonate (CI Reactive Blue 163), and / or 5-(benzoylamino)-4-hydroxy-3-[[1-sulfon-6-[[2-(sulfonoxy)ethyl]sulfonyl]-2-naphthyl]azo]-, tetrasodium salt (CI Reactive Red 180).

[0086] In some embodiments, the label comprises inactive dyes, pigments, and / or radiopaque agents. Inactive dyes, pigments, and / or radiopaque agents can enhance the contrast between the label and other parts of the catheter (e.g., when the catheter is viewed by the eye and / or by a microscope (e.g., fluoroscopy)). Non-limiting examples of suitable inactive dyes include: phthalocyanine blue, phthalocyanine green, carbazole violet, CI reducing orange, 1,2-[[2,5-diethoxy-4-[(4-methylphenyl)thiol]phenyl]azo]-1,3,5-phenylpyrogallol, 16,23-dihydrodinaphthalo[2,3-a:2′,3′-i]naphthalene[2′,3′:6,7]indolo[2,3-c]carbazole-5,10,15,17,22,24-isohexanone, N,N′-(9,10-dihydro-9,10-dioxo-1,5-anthratridiyl)bisbenzamide, 7,16-dichloro-6,15-dihydro-5,9,14,18-pyridazinetetraone, 16,17-dimethoxydinaphthalo[1,2,3-cd:3′,2′,1′-lm] -5,10-dione, 4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one, 6-ethoxy-2-(6-ethoxy-3-oxobenzo[b]thiophene-2(3H)-ylyl)benzo[b]thiophene-3(2H)-one, disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulfonate-phenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulfonate, and combinations thereof. Non-limiting examples of suitable non-reactive pigments include: carbon black, modified carbon black, titanium dioxide, chromium-cobalt-alumina, chromium oxide green, iron oxide, mica-based pearlescent pigments, and combinations thereof. Non-limiting examples of radiopaque dyes include platinum, palladium, bismuth oxychloride, bismuth subcarbonate, tantalum, barium sulfate, silver, gold, silver sulfadiazine, titanium dioxide, and iodine-based compounds such as Omnipauqe. In some embodiments, the label comprises a fluorescent dye (e.g., fluorescein isothiocyanate (FIT-C), fluorescein-N-hydroxysuccinimide, eosin Y, etc.).

[0087] In some embodiments, the label contains a salt. Non-limiting examples of suitable salts include phosphates (e.g., MSP, DSP, TSP), borates, sodium chloride, citrates, ethylenediaminetetraacetic acid, sulfites, sulfates, hyposulfites, metal oxides, selenium dioxide, selenium trioxide, selenite, selenic acid, nitrates, silicates, and phytic acids.

[0088] In some implementations, the markings contain TPU pad printing inks, such as Tampa® Pur 980 Black TPU and / or Tampa® Star 980 Black TPR, Marabu GmbH & Co.

[0089] Regardless of whether the label has a similar (or identical) composition to or different from that of the tubing, when the tubing is placed in one or more environments (e.g., bodily fluids, a patient), the label and the unlabeled portion of the tubing (if present) may exhibit similar thrombus accumulation. In some embodiments, in one or more such environments, the thrombus accumulation level of the label is within 50%, 40%, 30%, 20%, 10%, 5%, 2%, or 1% of the thrombus accumulation level of the unlabeled portion of the tubing. In some embodiments, the label is configured such that it substantially does not exhibit thrombus accumulation when the tubing is placed in a patient.

[0090] As described elsewhere herein, some embodiments include swelling the pipe from a non-swellable state (e.g., a first configuration) to a swollen state (e.g., a second configuration). In some embodiments, the swelling of the pipe can cause morphological changes in the markings. For example, in some embodiments, if the pipe swells (e.g., in the presence of a fluid, such as any fluid described elsewhere herein that can cause pipe swelling), the distance between the markings, which take the form of multiple segments spaced apart along the pipe, can change. The markings may have a first average shortest distance between their nearest neighbors before pipe swelling (e.g., a "first distance") and a different second average shortest distance after pipe swelling (e.g., a "second distance"). The second average shortest distance may be greater than the first average shortest distance. In some implementations, the ratio of the second average shortest distance to the first average shortest distance is greater than or equal to 1.02:1, greater than or equal to 1.05:1, greater than or equal to 1.075:1, greater than or equal to 1.1:1, greater than or equal to 1.2:1, greater than or equal to 1.5:1, or greater than or equal to 1.75:1. In some implementations, the ratio of the second average shortest distance to the first average shortest distance is less than or equal to 2:1, less than or equal to 1.75:1, less than or equal to 1.5:1, less than or equal to 1.2:1, less than or equal to 1.1:1, less than or equal to 1.075:1, or less than or equal to 1.05:1. Combinations of the above reference ranges are also possible (e.g., greater than or equal to 1.02:1 and less than or equal to 2:1, or greater than or equal to 1.05:1 and less than or equal to 1.1:1).

[0091] The shortest distance between two markers can be determined by identifying the shortest line segment connecting the two markers. Each marker can be considered as having a nearest neighbor marker, i.e., a marker with the smallest shortest distance to it. The average shortest distance between the nearest neighbors of multiple markers can be determined by determining the shortest distance between each marker and its nearest neighbor, and then averaging these values.

[0092] In some embodiments, it is particularly advantageous for the swollen article (e.g., a conduit) to include markers having an average shortest distance between its nearest neighbors. The average shortest distance between the nearest adjacent markers in the swollen conduit (e.g., the conduit in the second configuration) may be greater than or equal to 1 mm, greater than or equal to 5 mm, greater than or equal to 10 mm, greater than or equal to 50 mm, greater than or equal to 0.1 cm, greater than or equal to 0.2 cm, greater than or equal to 0.5 cm, greater than or equal to 0.75 cm, greater than or equal to 1 cm, greater than or equal to 1.25 cm, greater than or equal to 1.5 cm, greater than or equal to 2 cm, greater than or equal to 2.5 cm, greater than or equal to 3 cm, greater than or equal to 4 cm, greater than or equal to 5 cm, greater than or equal to 7.5 cm, or greater than or equal to 10 cm. The average shortest distance between the nearest adjacent marks in the swelling conduit can be less than or equal to 20 cm, less than or equal to 10 cm, less than or equal to 7.5 cm, less than or equal to 5 cm, less than or equal to 4 cm, less than or equal to 3 cm, less than or equal to 2.5 cm, less than or equal to 2 cm, less than or equal to 1.5 cm, less than or equal to 1.25 cm, less than or equal to 1 cm, less than or equal to 0.75 cm, less than or equal to 0.5 cm, less than or equal to 0.2 cm, less than or equal to 0.1 cm, less than or equal to 5 mm, less than or equal to 50 mm, less than or equal to 10 mm, or less than or equal to 10 mm. Combinations of the above reference ranges are also possible (e.g., greater than or equal to 1 mm and less than or equal to 10 mm, greater than or equal to 0.1 cm and less than or equal to 10 cm, or greater than or equal to 0.5 cm and less than or equal to 5 cm). Other ranges are also possible.

[0093] In some embodiments, the article has an average shortest distance (e.g., greater than or equal to 1 mm and less than or equal to 10 mm, greater than or equal to 0.1 cm and less than or equal to 10 cm, or greater than or equal to 0.5 cm and less than or equal to 5 cm) between its nearest neighbors in the unswollen state within one or more of the above ranges. For example, the average shortest distance between the nearest neighbors in an unswollen pipe (e.g., the pipe in the second configuration) may be greater than or equal to 1 mm, greater than or equal to 5 mm, greater than or equal to 10 mm, greater than or equal to 50 mm, greater than or equal to 0.1 cm, greater than or equal to 0.2 cm, greater than or equal to 0.5 cm, greater than or equal to 0.75 cm, greater than or equal to 1 cm, greater than or equal to 1.25 cm, greater than or equal to 1.5 cm, greater than or equal to 2 cm, greater than or equal to 2.5 cm, greater than or equal to 3 cm, greater than or equal to 4 cm, greater than or equal to 5 cm, greater than or equal to 7.5 cm, or greater than or equal to 10 cm. The average shortest distance between the nearest adjacent marks in an unswelled pipe can be less than or equal to 20 cm, 10 cm, 7.5 cm, 5 cm, 4 cm, 3 cm, 2.5 cm, 2 cm, 1.5 cm, 1.25 cm, 1 cm, 0.75 cm, 0.5 cm, 0.2 cm, 0.1 cm, 50 mm, 10 mm, or 5 mm. Other ranges are also possible.

[0094] In some embodiments, the above ranges may include catheter gauges (e.g., French scales). For example, the average shortest distance between the nearest adjacent markers may be greater than or equal to 3 Fr, greater than or equal to 5 Fr, greater than or equal to 10 Fr, greater than or equal to 15 Fr, greater than or equal to 20 Fr, or greater than or equal to 30 Fr. In some embodiments, the average shortest distance between the nearest adjacent markers is less than or equal to 34 Fr, less than or equal to 30 Fr, less than or equal to 20 Fr, less than or equal to 15 Fr, less than or equal to 10 Fr, or less than or equal to 5 Fr. Combinations of the above reference ranges are also possible (e.g., greater than or equal to 3 Fr and less than or equal to 34 Fr). Other ranges are also possible.

[0095] The values ​​in the preceding paragraphs may refer to characteristics of pipes containing various water volumes. Generally, the water volume in a swollen and / or second configuration pipe is greater than the water volume in a non-swollen and / or first configuration pipe. In some embodiments, a pipe in the non-swollen or first configuration has a water content greater than or equal to 2 w / w%, greater than or equal to 5 w / w%, greater than or equal to 7.5 w / w%, greater than or equal to 10 w / w%, greater than or equal to 15 w / w%, greater than or equal to 20 w / w%, greater than or equal to 25 w / w%, greater than or equal to 30 w / w%, or greater than or equal to 35 w / w. In some embodiments, the pipe in the unswelled or first configuration has a water content of: less than or equal to 40 w / w%, less than or equal to 35 w / w%, less than or equal to 30 w / w%, less than or equal to 25 w / w%, less than or equal to 20 w / w%, less than or equal to 15 w / w%, less than or equal to 10 w / w%, less than or equal to 7.5 w / w%, or less than or equal to 5 w / w%. Combinations of the above reference ranges are also possible (e.g., greater than or equal to 2 w / w% and less than or equal to 40 w / w%, or greater than or equal to 20 w / w% and less than or equal to 40 w / w%). Other ranges are also possible.

[0096] In some embodiments, the pipe in the swollen or second configuration has a water content of: greater than or equal to 3 w / w%, greater than or equal to 5 w / w%, greater than or equal to 7.5 w / w%, greater than or equal to 10 w / w%, greater than or equal to 15 w / w%, greater than or equal to 20 w / w%, greater than or equal to 25 w / w%, greater than or equal to 30 w / w%, greater than or equal to 35 w / w%, greater than or equal to 40 w / w%, greater than or equal to 45 w / w%, greater than or equal to 50 w / w%, greater than or equal to 55 w / w%, greater than or equal to 60 w / w%, greater than or equal to 65 w / w%, greater than or equal to 70 w / w%, greater than or equal to 75 w / w%, greater than or equal to 80 w / w%, greater than or equal to 85 w / w%, greater than or equal to 90 w / w%, greater than or equal to 95 w / w, greater than or equal to 98 w / w%, or greater than or equal to 99 w / w. In some embodiments, the pipe in the swollen or second configuration has a water content of: less than or equal to 99.9 w / w%, less than or equal to 99 w / w%, less than or equal to 95 w / w%, less than or equal to 90 w / w%, less than or equal to 85 w / w%, less than or equal to 80 w / w%, less than or equal to 75 w / w%, less than or equal to 70 w / w%, less than or equal to 65 w / w%, less than or equal to 60 w / w%, less than or equal to 55 w / w%, less than or equal to 50 w / w%, less than or equal to 45 w / w%, less than or equal to 40 w / w%, less than or equal to 35 w / w%, less than or equal to 30 w / w%, less than or equal to 25 w / w%, less than or equal to 20 w / w%, less than or equal to 15 w / w%, less than or equal to 10 w / w%, less than or equal to 7.5 w / w%, or less than or equal to 5 w / w. Combinations of the above reference ranges are also possible (e.g., greater than or equal to 3 w / w% and less than or equal to 99.5 w / w%, greater than or equal to 3 w / w% and less than or equal to 80 w / w%, greater than or equal to 40 w / w% and less than or equal to 80 w / w%). Other ranges are also possible. In some embodiments, the second or swollen state comprises a volume of water equivalent to the equilibrium moisture content of the pipe.

[0097] In some embodiments, the method includes: performing the following steps with a labeled conduit containing a plurality of separate segments spaced apart along at least a portion of the conduit, wherein the average shortest distance between each segment and its nearest neighboring segment is a first distance in a first configuration of the labeled conduit; introducing fluid into the labeled conduit; and swelling at least a portion of the labeled conduit from the first configuration to a second configuration, wherein the average shortest distance between each segment in the second configuration and its nearest neighboring segment becomes a second distance, and wherein the ratio of the second distance to the first distance is greater than or equal to 1.02:1 and less than or equal to 2:1.

[0098] In some embodiments, the method includes: performing the following steps with a labeled catheter containing a plurality of separate segments spaced apart along at least a portion of the catheter, wherein the average shortest distance between each segment and its nearest neighboring segment is a first distance in a first configuration of the labeled catheter; introducing fluid into the labeled catheter; and swelling at least a portion of the labeled catheter from the first configuration to a second configuration, wherein the average shortest distance between each segment in the second configuration and its nearest neighboring segment is a second distance, and wherein the second distance is equal to about 1 mm, about 10 mm, about 100 mm, about 1 cm, or about 10 cm.

[0099] In some embodiments, the method includes swelling the polymer material (and / or conduit) to an equilibrium water content state. In some embodiments, the method includes swelling the polymer material (and / or conduit) to an equilibrium water content state over a period of time. In some embodiments, the duration is less than or equal to 60 minutes (e.g., less than or equal to 10 minutes, less than or equal to 5 minutes, less than or equal to 1 minute, less than or equal to 30 seconds, or less than or equal to 10 seconds).

[0100] In some embodiments, the method includes swelling the polymer material (and / or conduit) at a given temperature. In some embodiments, the temperature is greater than or equal to 4°C, greater than or equal to 10°C, greater than or equal to 16°C, greater than or equal to 20°C, greater than or equal to 25°C, or greater than or equal to 30°C. In some embodiments, the temperature is less than or equal to 40°C, less than or equal to 30°C, less than or equal to 25°C, less than or equal to 20°C, less than or equal to 16°C, or less than or equal to 10°C. Combinations of these ranges are also possible (e.g., 20°C to 40°C).

[0101] In some embodiments, the method includes swelling the polymer material (and / or the conduit) such that the percentage increase in inner and / or outer diameter is greater than the percentage increase in length (as described herein). For example, in some embodiments, the method includes swelling the polymer material such that the inner and / or outer diameter increases by 1% to 20% while the length increases by 0.1% to 19%.

[0102] In some embodiments, swelling occurs after application. In some embodiments, the swelling of the polymeric material after application to an orifice of the object seals the opening of the orifice. For example, in some embodiments, the swelling of the polymeric material causes the size to increase to a size greater than or equal to the size of the orifice into which it is inserted. In some embodiments, the orifice is a wound. In some embodiments, the swelling of the polymeric material causes hemostasis. For example, in some embodiments, the object (e.g., a person) may have an orifice (e.g., a wound) with a maximum cross-sectional diameter A and is bleeding, and a device described herein with a maximum external cross-sectional diameter less than A may be applied to the orifice. In some embodiments, the maximum external cross-sectional diameter of the device may then swell to a size greater than or equal to A, such that the orifice is sealed. In some embodiments, this can lead to hemostasis.

[0103] In some embodiments, swelling occurs prior to application. In some embodiments, swelling includes rehydrating the device for a duration. In some embodiments, the duration is less than or equal to 60 minutes (e.g., less than or equal to 10 minutes, less than or equal to 5 minutes, less than or equal to 1 minute, or less than or equal to 10 seconds). In some embodiments, rehydrating the device includes using a rehydration medium. In some embodiments, the rehydration medium comprises water, lactated Ringer's solution (LRS), dextrose (D5W), phosphate-buffered saline (PBS), Hanks' balanced salt solution (HBSS), and / or isotonic salt solution.

[0104] In some implementations, any markings present on the tubing may not undergo rupture or delamination when the tubing swells from the first configuration to the second configuration. The presence of rupture or delamination can be assessed by visually examining the swollen tubing using optical microscopy. For example, no delamination was observed when exposed to alcohol / water sterilization solutions (such as ethanol, isopropanol (70% / 30% water), povidone, chlorhexidine). (TD-082 reference).

[0105] Markings placed on pipes can penetrate from their surface to a variety of suitable depths. In some implementations, the depth of penetration into the pipe is marked as greater than or equal to 0.1 micrometer, greater than or equal to 0.2 micrometer, greater than or equal to 0.5 micrometer, greater than or equal to 0.75 micrometer, greater than or equal to 1 micrometer, greater than or equal to 2 micrometer, greater than or equal to 5 micrometer, greater than or equal to 7.5 micrometer, greater than or equal to 10 micrometer, greater than or equal to 20 micrometer, greater than or equal to 30 micrometer, greater than or equal to 40 micrometer, greater than or equal to 50 micrometer, greater than or equal to 60 micrometer, greater than or equal to 70 micrometer, greater than or equal to 80 micrometer, greater than or equal to 100 micrometer, greater than or equal to 125 micrometer, greater than or equal to 150 micrometer, greater than or equal to 175 micrometer, greater than or equal to 200 micrometer, greater than or equal to 250 micrometer, greater than or equal to 300 micrometer, greater than or equal to 400 micrometer, greater than or equal to 500 micrometer, greater than or equal to 750 micrometer, greater than or equal to 1 mm, greater than or equal to 2 mm, greater than or equal to 5 mm, or greater than or equal to 7.5 mm. In some implementations, the depth of the marking penetrating into the pipe is less than or equal to 10 mm, less than or equal to 7.5 mm, less than or equal to 5 mm, less than or equal to 2 mm, less than or equal to 1 mm, less than or equal to 750 micrometers, less than or equal to 500 micrometers, less than or equal to 400 micrometers, less than or equal to 300 micrometers, less than or equal to 250 micrometers, less than or equal to 200 micrometers, less than or equal to 175 micrometers, less than or equal to 150 micrometers, less than or equal to 125 micrometers, less than or equal to 100 micrometers, less than or equal to 80 micrometers, less than or equal to 70 micrometers, less than or equal to 60 micrometers, less than or equal to 50 micrometers, less than or equal to 40 micrometers, less than or equal to 30 micrometers, less than or equal to 20 micrometers, less than or equal to 10 micrometers, less than or equal to 7.5 micrometers, less than or equal to 5 micrometers, less than or equal to 2 micrometers, less than or equal to 1 micrometer, less than or equal to 0.75 micrometers, less than or equal to 0.5 micrometers, or less than or equal to 0.2 micrometers. Combinations of the above ranges are also possible (e.g., greater than or equal to 0.1 micrometers and less than or equal to 10 mm, greater than or equal to 10 micrometers and less than or equal to 200 micrometers, or greater than or equal to 50 micrometers and less than or equal to 60 micrometers). Other ranges are also possible.

[0106] Marking 112 can be applied to at least a portion of pipe 101 in a variety of suitable ways. In some embodiments, marking is formed by applying a marking composition to at least a portion of the surface of pipe. Suitable marking compositions are described elsewhere herein. One suitable way to apply marking to at least a portion of the surface of pipe is inkjet printing, as described elsewhere herein. Marking can also be deposited by liquid deposition, pad printing, screen printing, electrostatic spraying, hot stamping, laser etching, and / or dip coating.

[0107] The markings described herein can include any suitable size and shape. In some embodiments, the markings include shapes, letters, numbers, combinations of letters and / or numbers, identifiers, and images. Non-limiting examples of suitable shapes include lines, zigzags, squares, rectangles, circles, ovals, polygons (e.g., pentagons, hexagons, heptagons, octagons, nonagons, dodecagons, etc.), tubes, rings, stars, or star-shaped markings (e.g., three-armed stars, four-armed stars, five-armed stars, six-armed stars, seven-armed stars, eight-armed stars), etc. In one set of exemplary embodiments, the markings include combinations of lines and numbers (e.g., depicting along the length of the article). In another set of exemplary embodiments, the markings include identifiers and / or images (e.g., for identifying the article and / or the manufacturer of the article). Other markings are also possible.

[0108] Another example of a suitable method for applying markings to pipes is pad printing. The applicant conducted studies to evaluate the durability of two 1-part pad printing ink resins: Tampa® Pur 980 Black TPU and Tampa® Star980 Black TPR, both manufactured by Marabu GmbH & Co. The applicant applied each ink to an extruded section (e.g., pipe 101) containing a polymer material 20 containing at least poly(vinyl alcohol) (PVA) and after immersion in a solvent-free bath, as described below. Figure 14 As described in step 1270, but before soaking in the hydrophilic bath, refer to the following: Figure 15 As described in step 1350. The applicant observed that each ink adhered well to the extruded segment in the dry state. However, after being immersed in 1× phosphate-buffered saline (PBS) at a temperature of 20°C to 25°C (e.g., room temperature) for approximately 15 minutes, the extruded segment swelled and the ink cracked, as... Figure 3 As shown.

[0109] Marking 112 can be applied to at least a portion of pipe 101 by UV-curable pad printing. The applicant conducted studies to evaluate the durability of the following UV-curable pad printing inks: 747 series PC Lot# 747-8005 manufactured by Deco Technology Group, Inc. The applicant applied each ink to an extruded section (e.g., pipe 101) containing at least poly(vinyl alcohol) (PVA) polymer material 20. Specifically, the applicant evaluated the durability of UV-curable inks applied to: extruded sections containing PVA; and sections containing PVA and referenced below. Figure 15The extruded segment, as described in step 1350, is immersed in a hydrophilic bath containing a poly(acrylic) solution (PAA). The applicant allows the ink to dry at a temperature of 20°C to 25°C (e.g., room temperature) for approximately two hours. Subsequently, the extruded segment is transferred to a UV sterilizer for curing for approximately 4 hours. In some embodiments, see reference below. Figure 9 As described in method 1400, the extruded segments are further annealed. In other embodiments, the extruded segments are not annealed. The applicant examined each extruded segment in both dry and hydrated states, as follows: Figure 4 As shown. The applicant observed that after hydration in 1×PBS, the ink separated from the surface of each extruded segment. Additionally, the applicant observed that the extruded segments containing PAA also exhibited significant discoloration after exposure to a UV sterilizer.

[0110] Marking 112 can be applied to at least a portion of pipe 101 by laser etching. The applicant conducted studies to evaluate the durability of uniaxial 355 nm diode-pumped solid-state laser etching. The applicant etched black stripes and numbers onto the surface of an extruded section (e.g., pipe 101) containing at least poly(vinyl alcohol) (PVA). Specifically, the applicant evaluated the durability of laser etching applied to: extruded sections containing PVA; and sections containing PVA and referenced below. Figure 8 The extruded segment following step 1350, which involves immersion in a hydrophilic bath containing a poly(acrylic acid) solution (PAA). The applicant allows the ink to dry at a temperature of 20°C to 25°C (e.g., room temperature) for approximately 2 hours. In some embodiments, see the following references. Figure 16 As described in method 1400, the extruded segments are further annealed. In other embodiments, the extruded segments are not annealed. The applicant examined each extruded segment in both dry and hydrated states, as follows: Figure 5 As shown. The applicant observed that after hydration in 1×PBS at 37°C for 24 hours, the laser etching detached from the surface of each extruded segment.

[0111] Marking 112 can be applied to at least a portion of pipe 101 using a poly(vinyl alcohol)-based ink. The applicant conducted studies to evaluate the durability of two custom-made PVA-based inks: one ink containing 0.01 w / w% Reactive Black 5 (CAS#17095-24-8) in a 15 w / w% mixture of 28-99 PVA in 1× PBS, and another ink containing 0.01 w / w% Pigment Green 7 (CAS#14832-14-5) in a 10 w / w% mixture of 28-99 PVA in 1× PBS. The applicant applied each ink to an extruded section (e.g., pipe 101) comprising a polymer material 20 containing at least polyvinyl alcohol (PVA). Specifically, the applicant evaluated the durability of the PVA-based inks applied to: extruded sections containing PVA; and sections containing PVA and referenced below. Figure 15 The extruded segment following step 1350, which involves immersion in a hydrophilic bath containing a poly(acrylic acid) solution (PAA). The applicant allows the ink to dry under ambient conditions for approximately one hour. In some embodiments, see the following references. Figure 16 As described in method 1400, the extruded segments are further annealed. In other embodiments, the extruded segments are not annealed. The applicant examined each extruded segment in both dry and hydrated states, as follows: Figure 6 As shown. The applicant observed that the ink adhered well to the PAA-free extruded sections, while the ink adhered poorly and delaminated to the PAA-containing extruded sections. Additionally, the applicant observed that Reactive Black 5 ink penetrated the bulk of the extruded sections. After approximately 24 hours in 1× PBS with water, delamination occurred in each extruded section.

[0112] Mark 112 can be applied to at least a portion of pipe 101 by dye impregnation with an aqueous solution. The applicant conducted studies to evaluate the durability of a custom dye solution containing 0.01 w / w% Reactive Black 5 (CAS#17095-24-8) in distilled water. The applicant applied each ink to an extruded section (e.g., pipe 101) comprising a polymer material 20 containing at least poly(vinyl alcohol) (PVA). Specifically, the applicant evaluated the durability of the dye in an extruded section, such as when applied to a PVA-containing section and then immersed in a hydrophilic bath containing a poly(acrylic acid) (PAA) solution, as referenced below. Figure 15 As described in step 1350. The applicant dries the dye under ambient conditions. Then, the applicant transfers the extruded segments to a convection oven for 3 hours of drying and annealing at 150°C for 90 minutes. The applicant examines each extruded segment in both hydration states, as follows: Figure 7As shown. The extruded fragment was hydrated in 1×PBS at 37°C for 24 hours and then in 1×PBS at 55°C for two weeks. The applicant observed that the dye adhered to and entered the body of the extruded fragment. Furthermore, the applicant observed that the dye remained in the extruded segment after two weeks of hydration.

[0113] In some embodiments, Mark 112 is applied to at least a portion of pipe 101 by dye impregnation with a solvent solution. The applicant conducted studies to evaluate the durability of a custom dye solution containing 0.01 w / w% Reactive Black 5 (CAS#17095-24-8) in a Carbopol® (PAA) solution. The applicant applied each ink to an extruded section (e.g., pipe 101) comprising a polymer material 20 containing at least poly(vinyl alcohol) (PVA). Specifically, the applicant evaluated the durability of the dye applied to an extruded section containing PVA and subsequently immersed in a hydrophilic bath containing a poly(acrylic acid) (PAA) solution, as referenced below. Figure 15 As described in step 1350. The applicant dries the dye under ambient conditions. Then, the applicant transfers the extruded segments to a convection oven for drying for 3 hours and annealing at 150°C for 90 minutes. The extruded segments are then hydrated in 1×PBS at 37°C for 24 hours. Figure 7 The results shown were similar; the applicant observed that the dye adhered to and entered the body of the extruded segment.

[0114] In some embodiments, the mark 112 can be applied to at least a portion of the conduit by hot stamping. The hot stamping process involves a die and occasionally involves hot stamping foil or pre-dried ink. For example, heating the die and pressing it onto the foil or pre-dried ink transfers the ink into the conduit.

[0115] In some embodiments, the mark 112 can be applied to at least a portion of the pipe via inkjet printing. The applicant investigated using a custom dye solution consisting of poly(vinyl alcohol), copper phthalocyanine, and water. The applicant used a system capable of projecting inkjet printing to apply the custom dye to the extruded segment. This system uses an electrically piezoelectrically driven dispensing valve to dispense the ink. The system is pressurized by compressed air, and the procedure specifies the time (pulse) for opening the piezoelectrically driven dispensing valve and the time (cycle) between the valve deposition. The system is capable of dispensing ink in a wide range of geometries. The applicant used a 0.30 ms pulse, a cycle of 18.0 to 21.0 ms, and a pressure of 3 to 15 psi to place the mark onto the extruded segment. The marked extruded segment was then dried at 95°C for 6 hours. Rubberization tests as defined in TD-082 Rev A were performed on the marked portion of the extrudate over a period of 123 days. The results concluded that the application method and ink were sufficient to place and adhere the mark to the extruded portion of the extrudate. Figure 23A and Figure 23B An exemplary labeled catheter is shown in the figure.

[0116] Device 100 may include one, two, or more patient fixation devices, such as the suture wing 160 shown. The conduit 101 and suture wing 160 may have similar stiffness and / or flexibility. For example, suture wing 160 may comprise 42% poly(vinyl alcohol) 28-99, a deionized water slurry, which is injection molded (e.g., at 96°C) into a suture wing shape and subsequently dried (e.g., at 55°C for 6 hours). Suture wing 160 may be dehydrated to cause a volume change of -52% (or approximately the initial water content of the injection-molded material) to match the stiffness of conduit 101. As another example, suture wing 160 may comprise 18% poly(vinyl alcohol) 28-99, a 0.9% sodium chloride solution slurry, which is injection molded (e.g., at 96°C) into a suture wing shape and dried (e.g., at 55°C for 6 hours). Dehydration of suture wing 160 may cause a volume change of -81% in suture wing 160, for example, to match the stiffness of conduit 101. Similarly, the stitching wing 160 can be heat-treated at 150°C for 90 minutes and can undergo a volume change of -81%, for example, to match the hardness of the pipe 101. As another example, the stitching wing 160 may comprise a thermoplastic or thermosetting material configured not to exhibit volume change upon exposure to an aqueous solution.

[0117] The device 100 may include one or more linear elements, namely the linear element 123 shown. The linear element 123 may include a needle, guide wire, core needle, or other filament, which is inserted into the cavity 106 of the conduit 101, for example, to straighten the conduit 101, which is elastically biased in a non-linear geometry, as referenced below. Figure 8 As stated above.

[0118] The device 100 may include one or more accessories, namely accessory 170 as shown. In some embodiments, accessory 170 includes pipe clamps, such as those referenced below. Figures 11A to 11B The described clamp 170a.

[0119] Device 100 may include packaging, i.e., package 180, in which other components of device 100 (e.g., at least tubing 101) are packaged, sterilized, and transported to a clinical site for insertion into a patient. Package 180 may include a flexible container containing flash-spun high-density polyethylene fibers. In some embodiments, package 180 also includes a tray in which device 100 is placed for transport.

[0120] Device 100 may include one or more sensors, converters, and / or other functional elements, such as functional element 199 described below. Functional element 199 may include one or more functional elements disposed on and / or within conduit 101 (as shown), connector 120, belt 122, stitching wing 160, and / or another component of device 100. Functional element 199 may be connected to one or more wires, optical fibers, tubes (e.g., fluid delivery tubes, hydraulic tubes, and / or pneumatic tubes), waveguides, and / or other conduits (not shown) for transmitting signals (e.g., information), energy, fluid, light, and / or sound from another component (e.g., another component of system 10) to functional element 199 and / or from functional element 199 to another component (e.g., another component of system 10). In some embodiments, system 10 includes functional device 999 configured to connect to functional element 199, as described below.

[0121] As described below, extruder 500 may be configured and arranged to produce a conduit 101 containing polymer material 20. Extruder 500 may include a die 502, an auger 504, and a screw 506. Extruder 500 may be configured to produce a conduit 101 with a fixed cross-sectional profile, such that polymer material 20 is propelled through die 502 containing a desired cross-section. Die 502 may include an opening / closing disk with an opening configured and arranged to the desired size and shape of the conduit 101. A auger 504 may be configured to rotate adjacent to extruder 500, for example, to move polymer material 20 into extruder 500 and toward screw 506. Screw 506 may be configured to rotate within extruder 500, for example, to move polymer material 20 toward die 502 for extrusion.

[0122] In some implementations, extruder 500 comprises a single-screw extruder, such as an extruder with a ¾-inch diameter, a 25:1 L / D ratio, and a 1:1 compression ratio.

[0123] System 10 may also include one or more mixing devices, namely device 602 shown, configured to combine two or more substances to form an acceptable material mixture (e.g., a well-mixed combination of materials, for example, to form polymer material 20). In some embodiments, mixing device 602 includes a high-speed dual asymmetric centrifuge. In some embodiments, the mixture is heated in a sealed or ventilated vessel to a temperature below the boiling point of the soaking solution and mixed in a dual asymmetric centrifuge at a speed of up to 3500 rpm until homogeneous. In some embodiments, the mixture is heated to a temperature below the boiling point of the soaking solution and mixed using a stirrer, belt stirrer, paddle mixer, static mixer, emulsifier, homogenizer, and / or drum mixer until homogeneous.

[0124] System 10 may also include one or more tube pullers, namely tube puller 604 as shown, configured to assist material (e.g., polymer material 20) in advancing through an extrusion apparatus (e.g., extruder 500). In some embodiments, tube puller 604 includes one or more conveyor belts that may be positioned downstream of die 502 and configured to move tube 101 away from extruder 500 in a controlled manner. In some embodiments, tube puller 604 is configured to operate in a controlled manner to maintain a uniform outer diameter of tube 101 as it is conveyed. In some embodiments, tube puller 604 is configured to selectively increase or decrease the outer diameter of one, two, or more segments of tube 101. In some embodiments, tube puller 604 is configured to pull tube 101 down at a speed configured to impart polymer chain orientation.

[0125] System 10 may also include one or more containers, namely the tank 606 shown, which includes an elongated container with a top opening, into which an object (e.g., polymer material 20) can be at least partially immersed. The tank 606 may be filled or at least partially filled (hereinafter “filled”) with one or more fluids, namely solutions 630 (e.g., alcohol solutions, hydrophilic polymer solutions, hydrophobic polymer solutions). In some embodiments, the tank 606 comprises a closed, elongated container containing one or more fluids (e.g., solution 630) maintained under vacuum.

[0126] System 10 may also include one or more drying systems, such as the dryer 608 shown, which includes a manifold configured to apply a gas to the surface of an object (e.g., polymer material 20). Dryer 608 may apply a gas modified to extract solvent from the surface of the object. Dryer 608 may apply a gas selected from oxygen; nitrogen; argon; and combinations thereof. Dryer 608 may be configured to apply at least one of an ambient gas, a heating gas, and a cooling gas.

[0127] System 10 may also include one or more containers for immersion components, namely chamber 618 shown, in which an object (e.g., pipe 101) may be at least partially immersed in a fluid and / or semi-fluid, such as solution 630 described herein. In some embodiments, tank 606 contains chamber 618 (e.g., tank 606 and chamber 618 contain the same components of system 100).

[0128] As described above with reference to tank 606 and chamber 618, system 10 may also contain one or more solutions, namely solution 630 shown. As used herein, one, two or more of solutions 631 to 635 are generally referred to as solution 630. Tank 606 and / or chamber 618 may be filled with solution 630, for example to expose one or more components of system 10 and / or device 100 to solution 630. Solution 630 may contain a homogeneous mixture of two or more substances. In some embodiments, tank 606 is filled with solution 630, which contains a solution selected from: water; ethanol; methanol; propanol; butanol; and combinations thereof.

[0129] In some embodiments, solution 630 further comprises a poly(acrylic acid) solution, namely solution 631.

[0130] In some embodiments, solution 630 further comprises a buffer solution, namely solution 632.

[0131] In some embodiments, solution 630 further comprises a polymer solution, namely solution 633. Solution 630 may comprise a hydrophilic and / or hydrophobic polymer solution 633 configured to permeate polymer material 20 to provide enhanced hydrophilicity and / or enhanced nonthrombotic properties. In some embodiments, tank 606 is filled with solution 630, which comprises a hydrophilic polymer solution 633 selected from: poly(vinyl alcohol); poly(acrylic acid); polyethylene glycol; poly(vinylpyrrolidone); poly(methacrylic acid sulfonyl betaine); poly(acrylic acid sulfonyl betaine); poly(methacrylic acid carboxybetaine; poly(acrylic acid carboxybetaine); povidone; polyacrylamide; poly(N-(2-hydroxypropyl)methacrylamide); poly Azoline; polyphosphate; polyphosphazene; polyvinyl acetate; polypropylene glycol; poly(N-isopropylacrylamide); poly(2-hydroxymethyl methacrylate); and combinations thereof. In some embodiments, tank 606 is filled with solution 630 comprising a hydrophobic polymer solution 633 selected from: polyurethane; polysiloxane; polybutadiene; styrene-butadiene copolymer; natural rubber; and combinations thereof.

[0132] In some embodiments, solution 630 contains a dye, namely dye 634.

[0133] In some embodiments, solution 630 comprises a surfactant solution, i.e., solution 635. Solution 630 may comprise a surfactant solution 635 containing a humectant. The humectant may comprise a nonionic surfactant (i.e., a surfactant having an uncharged hydrophilic head and a hydrophobic tail) or an amphoteric surfactant (i.e., a surfactant having a net uncharged hydrophilic head and a hydrophobic tail). In some embodiments, the humectant is a nonionic surfactant selected from the following: poloxamer; glyceryl acetate; α-hydroxy acid; poly(ethylene glycol); poly(propylene glycol); glycerin; propylene glycol; ethylene glycol; butylene glycol; hexanediol; glycerin; erythritol; threitol; arabinitol; xylitol; ribitol; mannitol; sorbitol; galactitol; fucitol; idoterol; inositol; lactitol; maltitol; lactitol; maltotriol; maltotetratitol; polyglycidol; and combinations thereof. In some embodiments, the humectant comprises an oil, such as vitamin E. Some humectants may contain one or more salts (such as sodium chloride, potassium chloride, and / or choline phosphate).

[0134] System 10 may also include a non-solvent bath 612, in which an object (e.g., pipe 101) may be at least partially immersed in a non-solvent solution. The non-solvent bath 612 may contain a non-solvent solution selected from: ethanol; methanol; propanol; butanol; pentanol; hexanol; heptanol; octanol; decanol; dodecanol; dimethyl sulfoxide; ethyl acetate; acetate; propionate; ethers; dimethylformamide; dimethylacetamide; acetone; acetonitrile; ethylene glycol; propylene glycol; glycerol; gases; and combinations thereof.

[0135] System 10 may also include one or more mandrels, namely mandrel 614 shown, which can be configured to be slidably inserted into an object having a cavity therethrough (e.g., a conduit 101 through cavity 106). In some embodiments, mandrel 614 includes a non-adhesive surface, such as a polytetrafluoroethylene, parylene, and / or phenolic coating surface.

[0136] The mandrel 614 can be configured to impart one, two, or more geometric features to an object (e.g., pipe 101). In some embodiments, the mandrel 614 comprises a tapered shape. In some embodiments, the mandrel comprises a non-linear shape, such as an arc or curved shape. In some embodiments, the mandrel 614 comprises a non-cylindrical cross-section.

[0137] The mandrel 614 may include a textured surface. In some embodiments, the mandrel 614 imparts texture to the inner diameter of the object (e.g., the surface of a cavity). The textured surface may be configured to reduce flow resistance within the cavity of the object by inducing turbulence around the fluid film. The textured surface may be configured to reduce resistance and pressure within the cavity of the object from high-flow environments, such as dynamic injections at flow rates of 3 mL / s to 10 mL / s.

[0138] System 10 may also include one or more filaments, such as filament 608 shown, around which material (e.g., polymer material 20) may be formed or otherwise deposited. In some embodiments, mandrel 614 includes filament 608.

[0139] System 10 may also include one or more clamps, namely clamp 200 shown, configured to connect one component of system 10 to another component. Clamp 200 may include one or more clamps, as described below. Figures 10A to 10C As stated above.

[0140] System 10 may also include a hydration device, i.e., a hydration apparatus 300. The hydration apparatus 300 may include a tube or other container, i.e., an outer tube 301 shown, which may be at least partially filled (“filled” herein) with a hydration medium, i.e., a fluid 365 shown. The fluid 365 may contain one or more materials (e.g., one or more solutions or other fluids) for hydrating one or more portions of the device 100 placed within the outer tube 301 (e.g., all or part of the conduit 101) (before and / or after filling the outer tube 301 with the fluid 365). In some embodiments, the fluid 365 may contain multiple different fluids 365, such as fluids 365a, 365b, and / or 365c shown. The hydration apparatus 300 may also include one or more fluid reservoirs, i.e., fluid reservoirs 360, for storing one, two, or more fluids 365 prior to the hydration process (e.g., prior to transporting the hydration apparatus 300 to a clinical site). Fluid reservoir 360 may include one, two, or more fluid sources selected from: syringes; gravity-driven fluid bags; fluid pumps (e.g., having reservoirs); and combinations thereof. In some embodiments, two or more fluid reservoirs 360 contain two or more different fluids 365.

[0141] The hydration device 300 can be configured similarly to those described below. Figure 11A and Figure 11B The hydration devices 300a and / or 300b are described.

[0142] Hydration Fluid 365 may contain sterile or sterile materials. Hydration Fluid 365 may contain one, two, three, or more substances selected from: humectants; saline; lactated Ringer's solution; dextran; water for injection (WFI); custom isotonic salt solutions; poloxamer; glycerin; sorbitol; xylitol; polyethylene glycol; starch; heparin; and combinations thereof. Fluid 365 may be provided at specific pH, temperature, and / or volume. In some embodiments, Hydration Fluid 365 comprises sterile physiological saline (isotonic) at body temperature (e.g., 37°C).

[0143] The hydration device 300 can be configured to provide the water content (e.g., hydration) of the device 100 during storage and / or transportation.

[0144] In some embodiments, hydration can be performed using a hydration device 300 or otherwise to increase the size of the cavity 106 of the conduit 101. In some embodiments, the conduit 101 and the hydration device 300 are configured to increase the diameter of the cavity 106 by 0 to 25% between the dehydrated and rehydrated states.

[0145] In some embodiments, during the manufacturing process, one or more portions of device 100 (e.g., all or part of conduit 101) are dehydrated and / or annealed under stress, such that subsequent hydration using hydration device 300 or otherwise results in anisotropic swelling. In some embodiments, conduit 101 and hydration device 300 are configured to allow conduit 101 to swell only in the axial direction, thereby maintaining the outer diameter and the diameter of lumen 106 to allow physicians to better sized conduit 101 for insertion sites. In some embodiments, conduit 101 and hydration device 300 are configured to allow conduit 101 to swell only in the radial direction, such that the length of conduit 101 remains constant to allow for precise placement of the proximal and / or distal ends of conduit 101, and allows radial swelling of conduit 101 to seal the insertion site and / or reduce pressure drop across conduit 101.

[0146] In some embodiments, during the manufacturing process, one or more portions of device 100 are freeze-dried, while one or more portions (e.g., pipe 101) are in a swollen state such that when a subsequent hydration process is performed (e.g., using hydration device 300), the size and / or other dimensions of the pores included in the freeze-dried portions do not change significantly.

[0147] In some embodiments, one or more hydration devices 300 are used to perform multiple hydrations of the device 100, such as one or more hydrations during manufacturing, and / or one or more hydrations at the surgical site just before the tube 101 is inserted into the patient. In some embodiments, two or more hydrations may be performed using different fluids 365. In some embodiments, the hydration device 300 includes a fluid 365 configured to hyperswell the tube 101, such as a low-pH aqueous solution, a hypotonic solution, and / or a solution at a temperature above body temperature (e.g., 37°C) but below the TT of the polymer material. g The solution is at a certain temperature. The second hydration device 300 may contain an isotonic solution at body temperature (e.g., 37°C), which is configured to neutralize the conduit 101 and maintain the desired swelling level.

[0148] In some embodiments, device 100 includes one or more hydration devices 300. In these embodiments, device 100 may be packaged together with the hydration devices 300, for example, when all or part of the tubing 101 is placed within the outer sleeve 301 of the hydration device 300 in a transport container (package 180). This arrangement simplifies the hydration process performed at the surgical site. In some embodiments, device 100 is transported in a bag or other storage container (package 180), and a reservoir 360 containing fluid 365 is also included in the storage container. In these embodiments, reservoir 360 may include a bag or other container configured to rupture or otherwise open (e.g., at the surgical site) while inside package 180, thereby allowing fluid 365 to surround and hydrate device 100 before package 180 is opened.

[0149] In some embodiments, the hydration device 300 and system 10 are configured to perform the hydrophilic polymer incorporation process at elevated temperatures (e.g., temperatures above body temperature, e.g., above 37°C). In these embodiments, the conduit 101 may be configured to be “superhydrated” or “super-swelled” relative to swelling observed at body temperature, for example, to incorporate additional substances. In some embodiments, a high-temperature hydration process is performed to incorporate a substance comprising one or more plasticizers, humectants, and / or hydrophilic polymers (e.g., one or more additional plasticizers, humectants, and / or hydrophilic polymers), as described above.

[0150] Any hydration steps performed (e.g., initial hydration step, subsequent hydration steps) can be carried out for a period of time that can be selected as needed. In some embodiments, the hydration steps are performed relatively quickly (e.g., within a time period of less than or equal to 10 minutes).

[0151] System 10 may also include an air knife 610, which is configured to blow or otherwise remove solutions, solvents, volatiles and / or other substances from the surface of an object (e.g., pipe 101).

[0152] System 10 may also include one or more retaining and securing devices, i.e., racks 622, for holding one or more pipes 101 and / or one or more components of pipes 101 (typically “pipes 101”) in a desired position. Racks 622 may include upper rack 622a (shown), lower rack 622b (also shown), and / or other racks 622, each rack including a support, seat, or grating on which an object (e.g., pipe 101) is placed and / or attached.

[0153] System 10 may also include one or more temperature-controlled environmental chambers, such as the oven 620 shown. Oven 620 may include an insulated chamber configured for heating and / or drying objects (e.g., pipe 101). In some embodiments, oven 620 includes a convection oven. In some embodiments, oven 620 is configured to extract or otherwise remove materials (e.g., solvents, water, etc.) from the object. In some embodiments, oven 620 includes a chamber where temperature and pressure can be controlled. In some embodiments, oven 620 includes a chamber where humidity can also be controlled. In some embodiments, oven 620 includes a chamber where gases (e.g., air, nitrogen, argon, etc.) can be purged.

[0154] The device 100 may include a circumferential (or partially circumferential) securing element, namely the band 122 shown, which may be configured to secure the connector 120 to the conduit 101. For example, the connector 120 may include a barbed or other elongated end that is inserted (e.g., during manufacturing) into a cavity 106 at the end of the conduit 101. The band 122 may be disposed around or at least proximate (“around” herein) the inserted end of the connector 120 to secure the connector 120 to the conduit 101. The band 122 may be configured to provide a fluid seal between the connector 120 and the conduit 101. The band 122 may comprise a material configured to shrink upon heating, such as heat shrink tubing, which is positioned to surround the insertion end of the conduit 101 and the connector 120, and subsequently heated to cause radial shrinkage (shrinkage to secure the connector 120 to the conduit 101). In some embodiments, the band 122 comprises heat shrink tubing configured to shrink at temperatures from 120°C to 350°C. The band 122 may comprise materials selected from: polytetrafluoroethylene; fluorinated ethylene propylene; perfluoroalkoxy copolymer; ethylene tetrafluoroethylene; polyethylene terephthalate; polyether ether ketone; polyether block amide; poly(vinyl chloride); polyethylene; polyolefin; and combinations thereof. In some embodiments, the band 122 comprises materials configured to elastically stretch (e.g., radially expand via a tool to…) The tape 122 is then placed around the end of the conduit 101 with an increased diameter. The tape 122 is then released, allowing it to transition back to a smaller diameter, resiliently biased state, which provides the desired connection between the tape 122 and the conduit 101. In some embodiments, the tape 122 comprises a material configured to plastically deform by radial compression, the resulting reduced diameter being configured to create a robust connection between the connector 120 and the conduit 101. In some embodiments, the tape 122 comprises a material configured to radially expand upon exposure to chemicals (e.g., solvents) and is subsequently disposed around the conduit 101 at a location surrounding the insertion end of the connector 120. Removal of the chemicals (e.g., by evaporation or other means) causes the tape 122 to radially contract to provide the desired robust connection.

[0155] System 10 may also include one or more marking devices, namely device 616 shown. The marking devices can be used to apply markings to the surface of the conduit. In some embodiments, marking device 616 includes a laser, such as a solid-state laser. In some embodiments, marking device 616 includes a pad printing machine. In some embodiments, marking device 616 includes an inkjet printer, such as a valve jet printer. The inkjet printer can be configured to perform pressurized liquid deposition to deposit ink (e.g., liquid ink). These devices can operate automatically (e.g., in a manner that allows the marking device to autonomously execute a set of instructions previously provided by an operator). In some embodiments, marking device 616 includes a marking composition, such as ink 617, which is deposited into conduit 101 in a dehydrated state (e.g., fully or partially dehydrated) to allow the marking composition (e.g., ink 617) to be absorbed into the bulk of conduit 101.

[0156] Subsequently, the marked conduit 101 can be dried and / or annealed. Drying and / or annealing the conduit can lock the marking to the conduit, for example, by physically binding and / or chemically crosslinking the marking composition (e.g., ink 617) to a portion of the conduit (e.g., a portion of the base polymer material 20). The marking device 616 can be configured to deposit the marking composition (e.g., ink 617) as droplets onto the polymer material 20 in a dehydrated state. The marking device 616 can be configured to apply the marking composition (e.g., ink 617) by spraying or jetting in a liquid state. The marking device 161 can be configured to deposit the marking composition (e.g., ink 617) in a liquid state by pad printing, screen printing, or other ink transfer methods. The marking device 616 can be configured to inject the marking composition (e.g., ink 617) into the polymer material 20 in a dehydrated or partially hydrated state.

[0157] The marking device 616 may also include a post-processing element configured to bond (e.g., physically, chemically, or ionicly) ink 617 to the polymer material 20, such as elements selected from: heat treatment elements; chemical treatment elements; ultraviolet treatment elements; radiation treatment elements; and combinations thereof.

[0158] When the marking composition is applied to the surface of a pipe, it allows the composition to penetrate into the pipe to a variety of suitable depths before being locked in. In some embodiments, the marking composition is allowed to penetrate into the pipe to depths greater than or equal to 10 micrometers, greater than or equal to 20 micrometers, greater than or equal to 30 micrometers, greater than or equal to 40 micrometers, greater than or equal to 50 micrometers, greater than or equal to 60 micrometers, greater than or equal to 70 micrometers, greater than or equal to 80 micrometers, greater than or equal to 100 micrometers, greater than or equal to 125 micrometers, greater than or equal to 150 micrometers, or greater than or equal to 175 micrometers. In some embodiments, the marking composition is allowed to penetrate into the pipe to depths less than or equal to 200 micrometers, less than or equal to 175 micrometers, less than or equal to 150 micrometers, less than or equal to 125 micrometers, less than or equal to 100 micrometers, less than or equal to 80 micrometers, less than or equal to 70 micrometers, less than or equal to 60 micrometers, less than or equal to 50 micrometers, less than or equal to 40 micrometers, or less than or equal to 30 micrometers. Combinations of the above ranges are also possible (e.g., greater than or equal to 10 micrometers and less than or equal to 200 micrometers, or greater than or equal to 50 micrometers and less than or equal to 60 micrometers). Other ranges are also possible.

[0159] System 10 may also include one or more marking compositions (e.g., printing inks and / or compositions containing printing inks), such as ink 617 shown, which can be configured to physically bond and / or chemically crosslink with polymer material 20. The marking composition (e.g., ink 617) may contain dyes or pigments. In some embodiments, the dyes or pigments may be reactive. For example, they may be dyes or pigments selected from: tetrasodium; 4-amino-5-hydroxy-3,6-bis[[4-(2-sulfonyloxyethylsulfonyl)phenyl]diazeninyl]naphthalene-2,7-disulfonate (Reactive Black 5); copper; 33-[[4-(2-hydroxyethylsulfonyl)phenyl]aminosulfonyl]-2,11,20,29,39,40-hexaaza-37,38-diimine-nonane[28.6.1.13,10.112,19] .121,28.04,9.013,18.022,27.031,36]tetradecane-1,3(40),4(9),5,7,10,12(39),13(18),14,16,19,21,23,25,27,29,31(36),32,34-nonadene-6,15,24-trisulfonic acid (Active Blue 21), 2-naphthalenesulfonic acid, 7-(acetamido)-4-hydroxy-3-[[4-[[2 -(sulfonyloxy)ethyl]sulfonyl]phenyl]azo]-, disodium salt (9CI) (Active Orange 78), Active Yellow 15, disodium 1-amino-9,10-dioxo-4-[(3-{[2-(sulfonyloxy)ethyl]sulfonyl}phenyl)amino]-9,10-dihydro-2-anthraquinone sulfonate (Active Blue 19), 1-amino-4-[3-(4,6-dichlorotriazine-2-ylamino)-4-sulfophenylamino]anthraquinone-2-sulfonic acid (Active Blue 4), CI Reactive Red 11,4-[2-(5-carbamoyl-1-ethyl-4-methyl-2,6-dioxopyridin-3-ylylene)hydrazino]-6-[(4,6-dichloro-1,3,5-triazin-2-yl)amino]phenyl-1,3-disulfonate (CI Reactive Yellow 86), Tetrasodium 6,13-dichloro-3,10-bis[[4-[(4,6-dichloro-1,3,5-triazin-2-yl)amino]sulfonate phenyl]amino]triphenyl di Azine disulfonate (CI Reactive Blue 163), and / or 5-(benzoylamino)-4-hydroxy-3-[[1-sulfon-6-[[2-(sulfonoxy)ethyl]sulfonyl]-2-naphthyl]azo]-, tetrasodium salt (CI Reactive Red 180).

[0160] In some embodiments, the dye or pigment reacts with the labeled polymeric material. In one illustrative embodiment, the reaction may occur in the presence of poly(acrylic acid) with a cationic salt and PVA. In another illustrative embodiment, the dye or pigment may be incorporated (e.g., embedded) within the polymeric material matrix.

[0161] In some embodiments, the labeling composition comprises a non-reactive dye, pigment, and / or a radiopaque agent. Non-limiting examples of suitable non-reactive dyes include: phthalocyanine blue, phthalocyanine green, carbazole violet, titanium copper blue with 0 to 15 halogenated groups, pigment blue 15, pigment green 7, carbon black, modified carbon black, Congo red 17, FD&C blue 2, (FD&C violet 2, carbazole violet, FD&C yellow 8, FD&C yellow 10, chromium cobalt (see 21 CFR Part 73, Subsection D and 21...) CFR Part 74, Sub-part D), CI Reduction Orange 1,2-[[2,5-diethoxy-4-[(4-methylphenyl)thiol]phenyl]azo]-1,3,5-phenylpyrogallol, 16,23-dihydrodinaphthalo[2,3-a:2′,3′-i]naphthalene[2′,3′:6,7]indolo[2,3-c]carbazole-5,10,15,17,22,24-isohexanone, N,N′-(9,10-dihydro-9,10-dioxo-1,5-anthradinyl)bisbenzamide, 7,16-dichloro-6,15-dihydro-5,9,14,18-pyridazintetone, 16,17-dimethoxydinaphthalo[1,2,3-cd:3′,2′,1′-lm] -5,10-dione, 4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one, 6-ethoxy-2-(6-ethoxy-3-oxobenzo[b]thiophene-2(3H)-ylyl)benzo[b]thiophene-3(2H)-one, disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulfonate-phenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulfonate, and combinations thereof. Non-limiting examples of suitable non-reactive pigments include: carbon black, modified carbon black, titanium dioxide, chromium-cobalt-alumina, chromium oxide green, iron oxide, mica-based pearlescent pigments, and combinations thereof.

[0162] Dyes or pigments (e.g., reactive dyes or pigments, inactive dyes or pigments) can constitute a variety of suitable amounts of the labeling composition. In some embodiments, the dye constitutes ≥0.001 w / w%, ≥0.002 w / w%, ≥0.005 w / w%, ≥0.0075 w / w%, ≥0.01 w / w%, ≥0.02 w / w%, ≥0.05 w / w%, ≥0.075 w / w%, ≥0.1 w / w%, ≥0.2 w / w%, ≥0.5 w / w%, or ≥0.75 w / w% of the labeling composition. In some embodiments, the dye constitutes less than or equal to 1 w / w%, less than or equal to 0.75 w / w%, less than or equal to 0.5 w / w%, less than or equal to 0.2 w / w%, less than or equal to 0.1 w / w%, less than or equal to 0.075 w / w%, less than or equal to 0.05 w / w%, less than or equal to 0.02 w / w%, less than or equal to 0.01 w / w%, less than or equal to 0.0075 w / w%, less than or equal to 0.005 w / w%, or less than or equal to 0.002 w / w%. Combinations of the above reference ranges are also possible (e.g., greater than or equal to 0.001 w / w% and less than or equal to 1 w / w%, greater than or equal to 0.01 w / 2% and less than or equal to 0.05 w / w%). Other ranges are also possible.

[0163] When a labeling composition contains two or more types of dyes and / or pigments, it should be understood that each dye or pigment can independently constitute a certain amount of the labeling composition within the above-mentioned range one or more, and / or all dyes and pigments together can constitute the amount of the labeling composition within the above-mentioned range one or more.

[0164] The marking composition (e.g., ink 617) may comprise a dye or pigment, which further comprises a solvent suspension or solution containing a water-soluble polymer selected from: poly(vinyl alcohol); poly(acrylic acid); polyethylene glycol; or poly(vinylpyrrolidone); poly(methacrylic acid sulfonyl betaine); poly(acrylic acid sulfonyl betaine); poly(methacrylic acid carboxybetaine); poly(acrylic acid carboxybetaine); poly(methacrylic acid sulfonyl betaine); poly(methacrylic acid carboxybetaine); povidone; polyacrylamide; poly(N-(2-hydroxypropyl)methacrylamide); poly Azoline; polyphosphate; polyphosphazene; polyvinyl acetate; polypropylene glycol; poly(N-isopropylacrylamide); poly(2-hydroxymethyl methacrylate); and combinations thereof.

[0165] Water-soluble polymers can be used to form a variety of suitable amounts of the labeling composition. In some embodiments, the water-soluble polymer accounts for ≥10 w / w%, or ≥12.5 w / w%. In some embodiments, the water-soluble polymer accounts for ≤15 w / w%, or ≤12.5 w / w%. Combinations of the above reference ranges are also possible (e.g., ≥10 w / w% and ≤15 w / w%). Other ranges are also possible.

[0166] In some embodiments, the solvent suspension and / or solution further comprises water and / or salt. Non-limiting examples of suitable salts include phosphates (e.g., MSP, DSP, TSP), borates, sodium chloride, citrates, ethylenediaminetetraacetic acid, sulfites, sulfates, hyposulfites, metal oxides, selenium dioxide, selenium trioxide, selenite, selenic acid, nitrates, silicates, and phytic acids.

[0167] In some embodiments, ink 617 may be configured to diffuse into polymer material 20, for example to produce colored markings within the polymer material 20.

[0168] System 10 may also include one or more pressure chambers, namely chamber 640 shown, which can be configured to generate and / or maintain a specific pressure (e.g., pressure above or below room temperature) within the chamber. In some embodiments, pressurization device 640 includes a low-pressure source, such as a low-pressure oven. In some embodiments, pressurization device 640 includes a high-pressure source, such as a chamber with a high-pressure fan. In some embodiments, chamber 640 includes a chamber in which both pressure and temperature can be controlled. In some embodiments, chamber 640 includes a chamber in which humidity can also be controlled.

[0169] System 10 may also include one or more tensioning devices, namely tensioner 650 shown, which can be configured to apply axial tension to an object (e.g., pipe 101).

[0170] System 10 may also include one or more molding machines, namely molding machine 660 shown, which may be configured to form an overmolded material (e.g., material 665 described below) or otherwise apply the overmolded material to an object (e.g., pipe 101). In some embodiments, the overmolded material 665 comprises thermoplastic polyurethane (TPU) containing thermoplastic materials selected from: aromatic polyethers; aromatic polyesters; aliphatic polyethers; aliphatic polyesters; polycarbonate; silicone; polypropylene; polyethylene; poly(vinyl chloride); poly(ether ether ketone); polyamide; liquid crystal polymers; polystyrene; nylon; and combinations thereof. In some embodiments, the overmolded material 665 comprises silicone, such as a silicone polyurethane copolymer. Overmolding of first and second water-soluble polymers is also possible.

[0171] In some implementations, one or more core pins, i.e., pins 661 shown, are configured to slide into an object (e.g., pipe 101) onto which the molding machine 660 applies overlapping injection molding material 665.

[0172] System 10 may also include one or more tipping devices, namely tipping device 670 shown, which may be configured to form to the tip of conduit 101, such as a distal tip and / or a proximal tip. Tipping device 670 may be configured to deliver an energy source selected from: heat; solvent; laser; radio frequency; ultrasound; and combinations thereof. Tipping device 670 may be configured to form a tip having a shape selected from: flat (e.g., vertical); beveled (e.g., inclined); blunt (e.g., rounded); tapered; funnel-shaped; and combinations thereof. In some embodiments, the tip is formed prior to annealing of conduit 101 (see reference below). Figure 16 (as described in method 1400). In some embodiments, the tip is formed after annealing of the dehydrated pipe 101 and before incorporation of a humectant (see below for reference). Figure 18 (as described in method 1600). In some embodiments, the tip is formed after annealing and after incorporation of a humectant.

[0173] System 10 may include one or more sensors, converters, and / or other functional elements, such as functional element 99 described below. Functional element 99 may include functional element 99a (as shown), located on, within, and / or near the extruder 500, functional element 99b (as shown), located near the hydration device 300, and / or another functional element 99 (e.g., located near one or more other components of system 10). Functional element 99 may be operatively connected to one or more wires, optical fibers, tubes (e.g., fluid delivery tubes, hydraulic tubes, and / or pneumatic tubes), waveguides, and / or other conduits (not shown) for transmitting signals (e.g., information), energy, fluid, light, and / or sound between functional element 199 and / or another component (e.g., another component of system 10). In some embodiments, system 10 includes functional device 999 configured to connect to functional element 199, as described below.

[0174] In some implementations, functional elements 99 and / or 199 include one or more sensors, one or more converters, and / or one or more other functional elements.

[0175] System 10 may include functional devices 999 configured to operatively interact with one or more functional elements 99 and / or 199.

[0176] Now for reference Figure 8This illustrates a method of inserting an article (such as a device containing a conduit, e.g., a catheter device, as described elsewhere herein) into a patient. Other components of the device 100 and system 10 will be described with reference to FIG1. Figure 8 Method 2000. As described above, device 100 may comprise an article of catheter-device, such as a nanoporous hydrophilic catheter, which can be inserted into a patient's vascular system via an over-the-wire (OTW) method, having vasodilatory (e.g., venous dilation) without the use of a sheath introducer.

[0177] exist Figure 8 In step 2010, as described herein, device 100 is manufactured, for example when device 100 includes at least a conduit 101 already placed (e.g., sealed in) package 180. Device 100 may be assembled, sterilized, and ultimately shipped to a customer for insertion into a patient (e.g., inserting a distal portion of conduit 101 into a skin location (“insertion location”) and into a patient’s vein, artery, and / or other body conduit). In some embodiments, step 2010 includes complete or partial hydration of at least a portion of device 100 (e.g., using hydration device 300 to hydrate at least a portion of conduit 101 prior to sterilization). For example, a partial hydration process may be performed where device 100 is packaged with a high equilibrium weight content (EWC). The hydration process may be time-limited (e.g., limited to less than 10 minutes), for example, to achieve a desired level of hydration. In some embodiments, multiple hydration processes are performed (e.g., using similar or dissimilar solutions 365). In some implementations, the device 100 is packaged and transported without undergoing a specific hydration process (e.g., in a dehydrated state).

[0178] As used herein, dehydration can be defined as a total water content of <5 w / w%. Partial hydration can be defined as having an equilibrium water content (EWC) of 5 w / w% to 90%, for example, 30 to 40 w / w%. Complete hydration can be defined as having a water content of less than 10% EWC, for example, 90 to 100% EWC.

[0179] exist Figure 8In step 2020, the device 100, still including package 180, is transported to the clinical site where the tubing 101 will be inserted into the patient. At the location where the insertion operation will be performed (“operation site”), and using standard aseptic techniques, package 180 can be opened, and the remaining components of device 100 (hereinafter referred to as device 100) can be removed from package 180. As detailed below, step 2020 may include a complete or partial hydration operation performed on one or more portions of device 100. As described herein, the hydration operation may be time-limited.

[0180] exist Figure 8 In step 2030, the conduit 101 of the device 100 is inserted into the patient's body, for example, through the skin and into a vein or artery using a modified Seldinger technique. The distal end of the conduit 101 may be advanced (e.g., through a wire) to one or more locations within the patient's body, such as to one or more locations within the patient's cardiovascular system, for example, to the patient's heart or at least close to the patient's heart.

[0181] In some embodiments where the device 100 is transported in a fully hydrated state, in step 2020, once the package 180 is opened, patient insertion in step 2030 is performed.

[0182] In some embodiments where the device 100 is transported in a partially hydrated state, the device 100 may be further hydrated in step 2020 and then inserted into the patient. Alternatively, the device 100 may be inserted into the patient in a partially hydrated state (e.g., the hydrated state of the transport device 101, which is configured to be fully hydrated to allow the conduit 101 to be safely and easily inserted into the patient), for example to provide additional column stiffness in the conduit 101 while still exhibiting substantial lubricity.

[0183] In embodiments where device 100 is transported in a dehydrated state, device 100 may be partially or fully hydrated at the operating site prior to insertion into the patient. As described above, partial hydration of device 100 can be performed, which achieves sufficient hydration to allow for safe insertion while providing increased column stiffness (relative to full hydration).

[0184] Device 100, inserted into a patient in a partially hydrated state (e.g., from partial hydration performed prior to sterilization and / or at the insertion site), can be configured to continue hydration (e.g., continued swelling) after insertion into the patient. Post-insertion swelling (e.g., post-insertion swelling of tubing 101) can be configured to produce hemostasis at the insertion site.

[0185] Hydration of one or more parts of device 100 can be performed using the hydration device 300 described herein. Hydration is performed at the operating site using aseptic techniques.

[0186] Now for reference Figure 9 This image shows a perspective view of an article of manufacture comprising a medical device including an S-shaped conduit. Similar to other articles of manufacture and / or medical devices described herein, Figure 9 The article shown may be a catheter and / or includes a catheter. Device 100 may include an S-shaped conduit 101' configured to provide ease of implantation in a patient, achieve a low infiltration rate, and reduce the likelihood of displacement within the patient. Conduit 101' may include a first bend 114 and a second bend 118. Parts 114 and 118 may have similar or different radii of curvature. In some embodiments, the first part 114 has a relatively small radius (e.g., a sharp curvature), and the second part 118 has a relatively large radius (e.g., a wide curvature). The distance between parts 114 and 118 (i.e., distance D1) may range from 1 mm to 200 mm, for example, from 2 mm to 20 mm, for example, a distance of 10 mm. The radius of curvature of parts 114 and / or 118 may be greater than 1 mm, for example, from 2 mm to 50 mm, for example, a radius of 10 mm.

[0187] In some embodiments, when the device 100 is implanted in a patient, the first portion 114 may be configured to remain above the dermis, while the second portion 118 may be configured to remain within the dermis and / or within a blood vessel (e.g., a vein).

[0188] In some implementation schemes, and as referenced below Figure 16 The conduit 101 may be annealed or otherwise processed on an S-shaped mandrel (mandrel 614) to form an S-shaped conduit 101'. When the S-shaped mandrel 614 is removed, the conduit 101' may retain its S-shape (e.g., the material of the conduit 101' may be elastically biased or otherwise incorporate shape memory features). In some embodiments, the device 100 slidably receives a linear element 123 (e.g., a needle) such that the conduit 101' has a relatively straight geometry, such as a straight geometry that may be desired during storage, transport, and / or patient insertion of the device 100. When the linear element 123 is removed, the device 100 (e.g., the conduit 101') may exhibit an S-shape produced by annealing or other manufacturing methods.

[0189] Now for reference Figures 10A to 10C The diagram shows a perspective view and an end view of a clamp used for fastening or securing pipes. The clamp 200 may comprise a pair of elongated members 220, 240, hinged or pivoted together by an offset assembly 210 (e.g., a structure and arrangement similar to clothespins). See, for example, below. Figure 15 and 16The clamp 200 can be used to secure the pipe 101 and / or another component of the system 10 to other individual components of the device or system 10. In some embodiments, one or more clamps 200 are included and used to secure the pipe 101 and / or another component of the system 10. The biasing assembly 210 may include a biasing element 211 configured to rotate about an axis 215. The biasing element 211 may include a spring with two arms 214a, b, such that arm 214a engages the elongated member 220 and arm 214b engages the elongated member 240. The clamp 200 can be configured in an open position (e.g., Figure 10A (as shown) and the closing position (as shown) Figure 10B (as shown) switching between. In some embodiments, the bias assembly 210 is configured to bias the clamp 200 in the closed position. The clamp 200 and the bias assembly 210 may comprise a high heat-resistant material selected from: metal; stainless steel; nitinol; polyetheretherketone; liquid crystal polymer; polyoxymethylene; polyamide; polysulfone; polyethersulfone; polyphenylene sulfone; polyamide-imide; polyetherimide; polyimide; and combinations thereof.

[0190] The elongated member 220 may include a first portion 223 and a second portion 227, and an intermediate portion 225 therebetween. In some embodiments, the first portion 223 and / or the second portion 227 are linearly offset from the intermediate portion 225 (e.g., the first portion 223, the second portion 227, and the intermediate portion 225 are not linearly arranged). The first portion 223 may include an inner surface 224, which includes one, two, or more longitudinal recesses 226. The recesses 226 slidably receive at least a portion of a conduit, such as conduit 101 of device 100 (e.g., conduit 101 including a proximal portion 104 and a distal portion 108). The second portion 227 may be configured and arranged to include a cavity 228 that may receive or otherwise engage a rod of a support (e.g., a drying rack, oven rack, etc.).

[0191] The elongated member 240 includes a first portion 243, a second portion 247, and an intermediate portion 245 therebetween. In some embodiments, the first portion 243 and / or the second portion 247 are linearly offset from the intermediate portion 245 (e.g., the first portion 243, the second portion 247, and the intermediate portion 245 are not linearly arranged). The first portion 243 may include an inner surface 244, which includes one, two, or more longitudinal recesses 246. The recesses 246 slidably receive at least a portion of a conduit, such as conduit 101 of device 100 (e.g., conduit 101 including a proximal portion 104 and a distal portion 108). The second portion 247 may include a cavity 248 that may receive or otherwise engage a rod of a support (e.g., a drying rack, oven rack, etc.).

[0192] The inner surface 224 of the first portion 223 may be configured to frictionally engage the inner surface 244 of the first portion 243, such that the recesses 226, 246 are aligned to define one, two or more lumens 260 (e.g., Figure 10C (As shown in the three examples). Lumen 260 may include a diameter D1 configured to surround and secure at least a portion of a conduit, such as conduit 101 of device 100. In some embodiments, lumen 260 surrounds and secures a portion of conduit 101 (e.g., proximal portion 104 or distal portion 108). Lumen 260 may include a cross-section having a geometry selected from: circular; elliptical; polygonal; triangular; hexagonal; pentagonal, rectangular, square, and / or trapezoidal. In some embodiments, lumen 260 includes a cross-section equivalent to the cross-section of the proximal portion 104 and / or distal portion 108 of conduit 101 of device 100.

[0193] Now for reference Figure 11A The figure shows a perspective view of a hydration device for hydrating pipes, consistent with the concept of the present invention. As shown, system 10 includes device 100 and hydration device 300a. Figure 11A The hydration device 300a may include similar components (e.g., an outer tube 301, a fluid reservoir 360, and / or a fluid 365) and / or have a similar construction and arrangement to the hydration device 300 described above with reference to FIG1. ​​The hydration device 300a may include an outer tube 301 configured to surround at least a portion of the medical device to be hydrated, such as a conduit 101 surrounding device 100, as shown. The outer tube 301 may have a length greater than or equal to the length of conduit 101 and / or device 100, for example, to hydrate a substantial portion of the length of conduit 101 and / or device 100.

[0194] The outer cannula 301 may include a proximal end 303 and a distal end 309, and a lumen 306 located therebetween. The proximal end 303 and lumen 306 are sized and configured to slidably receive a portion of the medical device (e.g., all the parts of the medical device to be hydrated), such as slidably receiving conduit 101 (e.g., up to approximately the entire portion of the device 100 to be hydrated contained within the lumen 306 of the outer cannula 301). The proximal end 303 is further sized and configured such that, upon insertion, the proximal end or at least a proximal portion of the device 100 forms a seal with the proximal end 303 of the outer cannula 301, for example, preventing or at least limiting (“preventing”) fluid flow from between the proximal portion and the proximal end 303 of the device 100. In some embodiments, the device 100 includes a suture wing 160, and the distal portion of the suture wing 160 forms a seal with the proximal end 303, for example... Figure 11A As shown in the image.

[0195] Once the device 100 is placed within the outer tube 301, an operator (e.g., a clinician, nurse, manufacturer's employee, and / or other qualified operator) can cause fluid 365 to fill the lumen 306 of the outer tube 301 (e.g., after passing through the lumen 106 of the tube 101). The device 100 and / or the hydration device 300a are configured such that the portion of the device 100 to be hydrated reaches a desired hydration level (e.g., a desired water content for storage, transport, and / or insertion into a patient).

[0196] The hydration device 300a may include a syringe or other fluid reservoir, such as the fluid reservoir 360 shown, which may contain fluid 365. Fluid 365 may contain one or more solutions or other fluids, such as those described above with reference to FIG1. ​​The fluid reservoir 360 is configured to be fluidly attached to a device inserted into the outer sleeve 301, for example, when the fluid reservoir 360 is fluidly attached to the connector 120 of the device 100 as shown (e.g., when the connector 120 includes a Luer connector or other connector configured to be fluidly attached to the mating connector of the fluid reservoir 360).

[0197] The hydration device 300a may include a flow restrictor, namely flow restrictor 340, positioned at the distal end of the outer sleeve 301, for example to restrict fluid exit from the outer sleeve 301 (e.g., providing back pressure to limit the exit of fluid 365 introduced by the fluid reservoir 360). During hydration operation, fluid 365 may be introduced into conduit 101 (via fluid reservoir 360 and connector 120), and lumen 106 may be filled such that fluid 365 contacts the inner surface of conduit 101, after which fluid 365 may exit from the distal end 109 of conduit 101. Flow restrictor 340 is sized and configured such that a portion of the fluid 365 exiting conduit 101 travels proximally within the outer sleeve 301 toward the proximal end 303 (e.g., toward the seam flap 160), causing fluid 365 to contact the outer surface of conduit 101. In some embodiments, clamp 170a is activated (e.g., clamped) to prevent backflow after flushing fluid 365 has passed through conduit 101.

[0198] Now for reference Figure 11B The diagram shows a perspective view of a hydration device for merging piped water into a closed end, consistent with the concept of the present invention. Figure 11B The hydration device 300b shown may include the same components as referenced above. Figure 1B The hydration device 300 described and / or the above references Figure 11A The hydration device 300a described has similar components and / or has a similar construction and arrangement. Figure 11AIn some embodiments, the distal end 309' of the outer sleeve 301 is closed (e.g., sealed) to prevent fluid from leaving the closed distal end 309'. In some embodiments, during hydration using the hydration device 300b, fluid 365 is introduced into the conduit 101 (via the fluid reservoir 360 and connector 120) and the lumen 106 is filled such that fluid 365 contacts the inner surface of the conduit 101, after which fluid 365 leaves the distal end 109 of the conduit 101. The closed distal end 309' allows fluid 365 leaving the conduit 101 to travel proximally within the outer sleeve 301 toward the proximal end 303 (e.g., toward the seam flap 160), such that fluid 365 contacts the outer surface of the conduit 101. The outer sleeve 301 may include an opening (i.e., port 305 shown) located near the proximal end 303, allowing a continuous flow of fluid 365 to exit port 305. In some embodiments, port 305 includes a valve, such as a pressure threshold valve and / or a check valve. In some implementations, after the flushing fluid 365 passes through the conduit 101, the clamp 170a is activated (e.g., clamped) to prevent backflow.

[0199] Now for reference Figure 5 A flowchart of a method for generating a pipe, consistent with the inventive concept, is shown below. References are made to the following: Figures 13 to 18 The above, Figure 5 The illustrated method 1000 includes a series of sub-methods, methods 1100, 1200, 1300, 1400, 1500, and 1600. Method 1100 may include a method for batching polymer material. Method 1200 may include a method for extruding the polymer material produced in method 1100. Method 1300 may include a method for hydrophilic treatment of the material produced in method 1200. Method 1400 may include a method for annealing the material produced in method 1300. Method 1500 may include a method for overmolding the material produced in method 1400. Method 1600 may include a method for moisturizing the material produced in method 1500. See below for reference. Figures 13 to 18 The methods 1100 to 1600 described herein can be used to produce a single device 100 comprising a single conduit 101 from a batch of polymer material. However, it should be understood that these methods 1100 to 1600 can be similarly performed to produce two, three, or more conduits 101 to be included in one, two, three, or more devices 100. Multiple conduits 101 and / or devices 100 can be produced simultaneously (e.g., in batch mode), such that the methods are modified to utilize multiple tools and / or devices (e.g., mandrel 614, wire 608, clamp 200, etc.) to produce multiple conduits 101 and / or devices 100 from one or more batches of polymer material.

[0200] Now for reference Figure 13 This illustrates a method 1100 for batching polymer materials, consistent with the concept of the present invention.

[0201] exist Figure 13 In step 1110, the water-soluble polymer 21, the radiopaque agent 22, and / or the sodium phosphate solution 23 are combined in a container (this combination of materials is referred to herein as "polymer material 20"). Polymer material 20 may contain at least 10 w / w%, for example at least 20 w / w%, or at least 30 w / w% of the water-soluble polymer 21 concentration. For example, the water-soluble polymer 21 may contain 10 g to 150 g of total mass, for example 25 g to 120 g, or for example about 78 g of mass. Polymer material 20 may contain at least 1 w / w%, for example at least 10 w / w%, or at least 20 w / w% of the radiopaque agent 22 concentration. For example, the radiopaque agent 22 may contain 0.15 g to 100 g of total mass, for example 30 g to 60 g, or for example about 43 g of mass. Polymer material 20 may contain at least 20 w / w% of the sodium phosphate solution concentration, for example at least 40 w / w%, or at least 50 w / w%. For example, sodium phosphate solution 23 may contain a total mass of 100 g to 300 g, such as 150 g to 200 g, such as about 179 g.

[0202] exist Figure 13 In step 1120 shown, a lid is placed on the container, and the polymer material 20 is preheated to a temperature above the softening point of the polymer material. In some embodiments, the polymer material 20 is preheated to a temperature of 50°C to 120°C, for example, 60°C to 95°C, for example, about 65°C.

[0203] exist Figure 13 In step 1130, the polymer material 20 is mixed into a homogeneous mixture. The polymer material 20 can be mixed using a mixing device (e.g., the mixing device 602 described above), such as a high-speed double asymmetric centrifuge. In some embodiments, the polymer material 20 is centrifuged at 2000 rpm for 10 minutes. During centrifugation, the polymer material 20 can be heated, for example, when it is heated to a temperature of 50°C to 120°C, for example, at 80°C to 100°C, for example, at about 95°C. Figure 13 In step 1140 shown, the polymer material 20 is cooled, for example to a temperature of 16°C to 24°C (e.g., cooled to room temperature).

[0204] exist Figure 13In step 1150 shown, the polymer material 20 is cut or otherwise divided into two or more segments (“segments” herein). The two or more segments may contain similar or dissimilar sizes and / or shapes. In some embodiments, the segments comprise cubes of approximately 1 cm.

[0205] Now for reference Figure 14 This illustrates a method 1200 for extruding polymer materials, consistent with the inventive concept. Method 1200 can be configured to extrude materials as described above. Figure 13 The polymer material produced in the described method 1100.

[0206] exist Figure 14 In step 1210 shown, the extruder (e.g., the extruder 500 described above) is positioned perpendicular to the tube puller (e.g., the tube puller 604 described above).

[0207] exist Figure 14 In step 1220, a fluid channel (e.g., channel 606 described above) is positioned near the face of the extruder die 502. In some embodiments, channel 606 is positioned approximately 15 cm from the extruder die 502. Channel 606 may contain (e.g., at least partially filled) an alcohol solution to be incorporated into the polymeric material 20. The alcohol solution may be cooled to a temperature from -20°C to 20°C, for example, from 0°C to 15°C, for example, 10°C. In some embodiments, the alcohol solution is configured to cure the polymeric material 20.

[0208] The tank 606 may also contain a hydrophilic and / or hydrophobic polymer solution for incorporation into the polymer material 20. In some embodiments, the hydrophilic polymer solution may be configured to cause the polymer material 20 to swell or otherwise expand so that the polymer material 20 can be incorporated into another polymer solution (e.g., a hydrophilic, hydrophobic polymer solution).

[0209] In some embodiments, a second tank 606 is located near the first tank 606. The second tank 606 may contain a hydrophilic and / or hydrophobic polymer solution for incorporation into the polymer material 20. In some embodiments, a third tank 606 is located near the second tank 606. The third tank 606 may contain an alcohol solution for incorporation into the polymer material 20. The alcohol solution may be cooled to a temperature from -20°C to 20°C, for example, from 0°C to 15°C, for example, when cooled to a temperature of approximately 10°C. In some embodiments, the alcohol solution is configured to deswell the polymer material, for example, to “lock in” the hydrophilic and / or hydrophobic polymer solution.

[0210] exist Figure 14In step 1230, one, two, or more regions of the extruder 500 are configured as one, two, or more temperature spectrums. For example, the extruder 500 may include four regions: a first region may provide a temperature of approximately 80°C; a second region may provide a temperature of approximately 95°C; a third region may provide a temperature of approximately 95°C; and a fourth region may provide a temperature of approximately 40°C. In some embodiments, at least one region includes a die 502 of the extruder 500.

[0211] exist Figure 14 In step 1240, the segment from step 1114 is fed into extruder 500. Extruder 500 (e.g., sampling drill 504 of extruder 500) may be configured to operate at a rotational speed of 1 rpm to 100 rpm, such as 2 rpm to 40 rpm, or approximately 10 rpm. Extruder 500 (e.g., screw 506 of extruder 500) may be configured to operate at a rotational speed of 5 rpm to 120 rpm, such as 20 rpm to 80 rpm, or approximately 60 rpm. Extruder 500 may be configured to maintain a pressure at the tip of screw 506 between 20 psi and 2000 psi, such as 100 psi to 200 psi. Extruder 500 may be configured to maintain a melt temperature of 70°C to 110°C at the tip of extruder screw 506, such as 80°C to 85°C.

[0212] exist Figure 14 In step 1250 shown, polymer material 20 is drawn through extruder die 502 and slot 606 to form an extruded tube, such as a hollow extruded tube (e.g., a tube with walls surrounding one, two, or more lumens) or a solid extruded tube (e.g., a tube without lumens). The extruded material can be drawn through extruder die 502 and slot 606 at a speed of 0.25 m / min to 10 m / min, for example, 1 m / min to 4 m / min, for example, about 2 m / min.

[0213] As used below, and unless otherwise stated, "extruded tube," "extruded material," and "extruded section" refer to a hollow tube containing a single lumen. It should be understood that method 1200 can be modified to produce a solid extruded tube (e.g., avoiding the insertion of mandrel 614, wire 608, etc.). It should also be understood that method 1200 can be modified to produce a hollow extruded tube containing multiple lumens (e.g., by inserting multiple mandrels 614, wire 608, etc.).

[0214] In some embodiments, polymer material 20 is drawn through extruder die 502 to form a hollow tube surrounding a solid filament (e.g., filament 608 described above). Solid filament 608 may comprise materials selected from: acetal; silicone; polytetrafluoroethylene; fluorinated ethylene propylene copolymer; polyetheretherketone; polyamide; stainless steel; nitinol; silver; copper; and combinations thereof.

[0215] In some embodiments, the extruded material is further drawn through an air knife (e.g., air knife 610 described above), which is configured to remove an alcohol solution (e.g., an alcohol solution within the groove 606 as described herein) from the surface of the extruded material. In some embodiments, as described herein, the extruded material is further drawn through a tube puller 604. For example, the extruded material may be drawn through the extruder die 502, through the groove 606, through the air knife 610, and then through the tube puller 604.

[0216] In some implementations, multiple stretching and forming techniques are applied to the extruded material during the extrusion process. These stretching and forming techniques can be configured to provide anisotropic mechanical compliance to the extruded material.

[0217] exist Figure 14 In step 1260 shown, the extruded material is cut or otherwise divided (“extruded segments” herein). In some embodiments, the extruded segments comprise a length of approximately 90 cm.

[0218] exist Figure 14 In step 1270 shown, the extruded segment is placed in an ethanol bath (e.g., ethanol bath 612 described above) for 10 minutes to 48 hours, for example, 3 hours to 24 hours, for example, for about 16 hours. Ethanol bath 612 may be a room temperature bath.

[0219] Now for reference Figure 15 This illustrates a method 1300 for hydrophilic treatment of polymer materials, consistent with the inventive concept. Method 1300 can be configured to reference above... Figure 14 The extruded material produced in method 1200 described is subjected to hydrophilic treatment.

[0220] exist Figure 15 In step 1310, the filament 608 (if present in the extruded section) is removed from the extruded section such that the relevant extruded section contains a lumen passing through it.

[0221] exist Figure 15In step 1320, the mandrel (e.g., mandrel 614 described above) is slidably placed within the extruded section. A mechanical interlock connector (e.g., connector 120 described above) may be inserted into one end of the extruded section (e.g., placed on the proximal end of conduit 101 and configured to fluidly attach to a syringe, infusion line or other fluid delivery device or conduit).

[0222] exist Figure 15 In step 1330, the extruded segment is dried in a convection oven (e.g., oven 620 described above). In some embodiments, the extruded segment is dried in the convection oven 620 at a temperature of 20°C to 100°C for a duration of 1 hour to 24 hours, for example, at 55°C for 3 hours.

[0223] In some embodiments, a first clamp 200 secures a first end of the extruded segment, and a second clamp 200 secures a second end of the extruded segment, as described above. Figures 10A to 10C The first clamp 200 (e.g., cavities 228, 248) engages the inner rod of the upper drying rack (e.g., the top rack 622a described above), and the second clamp 200 (cavities 228, 248) engages the inner rod of the lower drying rack (e.g., the bottom rack 622b described above), such that the extruded section extends from the upper drying rack 622a to the lower drying rack 622b. In this embodiment, the clamps 200 are used in conjunction to prevent twisting or other axial deformation of the extruded section during this step (e.g., the clamps 200 are used in conjunction to straighten the extruded section during this step).

[0224] exist Figure 15 In step 1340, an external heat shrink (e.g., the strip 122 described above) is placed above or around the interface between the mechanical interlock connector 120 and the extruded section. In some embodiments, and prior to proceeding to step 1350, the mandrel 614 is slidably removed from the extruded section.

[0225] In some embodiments, one, two, or more markings (e.g., marking 112 described above) are formed along the length of the extruded segment. Marking 112 can be configured to expand and contract as the extruded segment expands and contracts (e.g., swells and deswells). Marking 112 can be placed relative to a single point on the extruded segment. For example, a solid-state laser (e.g., laser 616 described above) can be configured to apply one, two, or more dashed lines, dots, or other markings 112 along the length of the extruded segment (e.g., markings 112 placed at fixed intervals, for example, to provide a “ruler” to aid in determining the depth to which the device is inserted into the patient).

[0226] exist Figure 15In step 1350, the extruded segment is placed in a hydrophilic soaking chamber (e.g., soaking chamber 618 described above). The hydrophilic soaking chamber may be configured to facilitate the incorporation of a hydrophilic polymer into at least a portion of the extruded segment. In some embodiments, the hydrophilic soaking chamber 618 contains a poly(acrylic acid) solution (e.g., solution 631 described above) such that the acrylic acid solution is incorporated into the extruded segment. For example, the hydrophilic soaking chamber 618 may contain a 1 w / w% solution of poly(acrylic acid) in 5× phosphate-buffered saline. In some embodiments, and prior to proceeding to step 1360, the extruded segment slidably accommodates a mandrel 614.

[0227] exist Figure 15 In step 1360, the poly(acrylic) solution is circulated through and around the extruded section. In some embodiments, the poly(acrylic) solution is circulated at a temperature of about 37°C for 16 to 20 hours.

[0228] In some embodiments, one, two, or more substances are incorporated into the extruded segment. The substances may be configured to provide dual or multiple functionalities to the extruded segment. The substances may be configured to interact with, act on, or perform at least one of the following: promoting tissue adhesion, inward growth, and coagulation. In some embodiments, the substances are configured to bind at least one of collagen and albumin. In some embodiments, the substances are configured as precursors that bind specific proteins. Alternatively or complementary, the substances may be configured to reduce thrombotic activity along at least a portion of the extruded segment. Each substance may be incorporated along a specific length, portion, and / or area of ​​the extruded segment.

[0229] A first method of incorporating the substance may comprise processing the hydrophilic polymer as described above with reference to steps 1350 and 1360, and subsequently stripping the first hydrophilic polymer from at least a portion of the extruded segment. In some embodiments, steps 1350 and 1360 are repeated with a substance such that the substance is incorporated into the portion from which the first hydrophilic polymer has been stripped. Other substances may be incorporated similarly (e.g., stripping the first substance from at least a portion of the extruded segment). In other embodiments, the substance is specifically applied to at least a portion of the extruded segment from which the hydrophilic polymer is stripped. Other substances may be incorporated similarly (e.g., specifically applied to extruded segments that do not contain the hydrophilic polymer and / or the first substance).

[0230] A second method of incorporating a substance may include processing the hydrophilic polymer as described above with reference to steps 1350 and 1360, wherein one or more portions of the extruded segment are excluded or otherwise shielded from processing such that the hydrophilic polymer is not incorporated into the excluded portions. In some embodiments, steps 1350 and 1360 are repeated with the substance such that the substance is incorporated into the excluded portions. Similarly, other substances may be incorporated (e.g., one or more portions of the extruded segment exclude or otherwise shield the first substance). In other embodiments, the substance is specifically applied to the excluded portions. Similarly, other substances may be incorporated (e.g., specifically applied to excluded portions that do not contain the hydrophilic polymer and / or the first substance).

[0231] As a non-limiting example, a first hydrophilic polymer may be incorporated along at least a portion of the interior (e.g., lumen) of the outer segment and may be configured to reduce thrombotic activity. A second hydrophilic polymer may be incorporated along at least a portion of the exterior of the extruded segment and may be configured to promote tissue adhesion and / or inward growth. In this example, the interior of the extruded segment is configured to be non-thrombotic, and the exterior is configured to interact with surrounding tissue.

[0232] Now for reference Figure 16 This illustrates a method 1400 for annealing materials, consistent with the inventive concept. Method 1400 can be configured to, as referenced above... Figure 15 The material produced in the method 1300 is annealed.

[0233] exist Figure 16 In step 1410, the extruded section is removed from the hydrophilic soaking chamber 618.

[0234] In some embodiments, one, two or more plasticizers (such as plasticizer 29 described above) are incorporated into the extruded segment. Plasticizer 29 may be configured to prevent or otherwise reduce cracking and / or breakage of the extruded segment.

[0235] exist Figure 16In step 1420, the mandrel (e.g., mandrel 614 described above) is slidably placed within the extruded segment. In some embodiments, the mandrel includes a non-adhesive surface, such as a PTFE coating. In some embodiments, the mandrel includes a nickel-titanium alloy. The mandrel may include any specified geometry to generate a conformal shape memory geometry for the extruded segment. In some embodiments, the mandrel includes a non-cylindrical shape and / or a non-circular cross-section, such that the lumen of the associated extruded segment is configured to present a non-cylindrical and / or non-circular shape of the mandrel. In some embodiments, the mandrel includes a diameter that varies along the length of the mandrel. In some embodiments, the mandrel includes a non-linear shape (e.g., a bend, fold, or other composite shape), such that the associated extruded segment is configured to present a non-linear shape of the mandrel. For example, the mandrel may include as described above. Figure 9 The aforementioned relative "S" shape. In some embodiments, the mandrel comprises an oversized mandrel (e.g., a mandrel with an outer diameter larger than the lumen diameter of the segment), which is configured to stretch or otherwise expand the diameter of the wall of the associated extruded segment. This stretching of the wall of the extruded segment can be configured to provide anisotropic mechanical compliance to the extruded segment, and / or other effects described below with respect to applying a pressure differential on the wall of the extruded segment.

[0236] As a supplement or alternative, a pressure differential (pressure difference between the inner and outer surfaces of the wall) can be applied to the wall of the extruded segment (e.g., a reduced pressure applied to the outside of the extruded segment and / or an increased pressure applied within the lumen) to cause radial expansion of the wall of the extruded segment (e.g., similar to expansion caused by the insertion of the mandrel 614 described above, so that the insertion of the mandrel is not required to achieve the desired effect). The pressure differential can be configured to allow increased crystallinity, which is significantly formed during the compression of the polymer material 20 as bound water is removed. Increased crystallinity may be associated with increased strength and / or a decrease in equilibrium moisture content. The pressure differential can be applied by a pressurizing device (e.g., pressurizing device 640 described above). In some embodiments, a high pressure is applied to the lumen of the extruded segment, and a low pressure is applied to the outer surface of the extruded segment. As a supplement or alternative, the pressure differential can be increased by locking one, two, or more fluids within the lumen of the extruded segment. Each end of the extruded segment can be sealed or otherwise closed to lock the fluid within the lumen. The lock-in fluid can be configured to expand in response to an increase in temperature. The lock-in fluid may contain a fluid selected from: dimethylacetamide; dimethyl sulfoxide; silicone oil; mineral oil; air; nitrogen; argon; and combinations thereof. The lock-in fluid may contain a non-solvent with a phase change temperature less than 0°C. The lock-in fluid may contain a non-solvent with a phase change temperature greater than 180°C.

[0237] exist Figure 16In step 1430, the extruded segment is dried and / or annealed. Drying and / or annealing can be performed thermally, for example in a convection oven 620. The drying time is typically selected as desired; for example, it may be 30 minutes or longer. In some embodiments, the extruded segment is dried in the convection oven 620 at a temperature from 30°C to 100°C for a duration of 1 hour to 24 hours, for example, drying at 55°C for 3 hours. Annealing can also be performed at higher temperatures (e.g., above 100°C). Annealing can be carried out at atmospheric pressure.

[0238] In some embodiments, a first clamp 200 secures a first end of the extruded segment, and a second clamp 200 secures a second end of the extruded segment, as described above. Figures 10A to 10C The first clamp 200 (e.g., cavities 228, 248) engages the inner rod of the upper drying rack (e.g., the top rack 622a described above), and the second clamp 200 (cavities 228, 248) engages the inner rod of the lower drying rack (e.g., the bottom rack 622b described above), such that the extruded section extends from the upper drying rack 622a to the lower drying rack 622b. In this embodiment, the clamps 200 are used in conjunction to prevent twisting or other axial deformation of the extruded section during this step (e.g., the clamps 200 are used in conjunction to straighten the extruded section during this step).

[0239] In some embodiments, one, two, or more markers (e.g., marker 112 described above) are formed along the length of the extruded section. Marker 112 may be configured to expand and contract with the expansion and contraction (e.g., swelling and deswelling) of the extruded section. For example, one, two, or more drops of dye solution (e.g., solution 634 described above) may be deposited along the length of the extruded section. The dye solution may be configured to penetrate the extruded section to a depth of 10 μm to 200 μm, such as 50 μm to 60 μm. The dye solution may contain 0.01 w / w% to 5.0 w / w% of Reactive Black 5 in USP water, such as 0.2 w / w% Reactive Black 5 in USP water, and may be deposited via a blunt-tipped needle (e.g., a 24-gauge needle). In some embodiments, the dye solution is configured to dry under ambient conditions for at least 10 minutes, such as about 2 hours prior to step 1440. In some embodiments, the dye solution may contain 0.01 w / w% to 5.0 w / w% of Reactive Black 5 in the poly(acrylic acid) solution from step 1350 or 1360.

[0240] exist Figure 16In step 1440, the extruded segment is annealed in a convection oven (e.g., oven 620 described above). In some embodiments, the extruded segment is annealed in the convection oven 620 at a temperature of 120°C to 200°C for 30 minutes to 24 hours, for example, at a temperature of about 150°C for about 90 minutes. In some embodiments, a first clamp 200 secures a first end of the extruded segment, and a second clamp 200 secures a second end of the extruded segment, as referred to above. Figures 10A to 10C The first clamp 200 (e.g., cavities 228, 248) engages the inner rod of the upper drying rack (e.g., the top rack 622a described above), and the second clamp 200 (cavities 228, 248) engages the inner rod of the lower drying rack (e.g., the bottom rack 622b described above), such that the extruded section extends from the upper drying rack 622a to the lower drying rack 622b. In this embodiment, the clamps 200 are used in conjunction to prevent twisting or other axial deformation of the extruded section during this step (e.g., the clamps 200 are used to stretch the extruded section during this step).

[0241] In some embodiments, the extruded segment is annealed using selective or gradient temperatures. The gradient temperature can be configured to provide different mechanical properties (e.g., compliance) along the length of the extruded segment. In some embodiments, the gradient can be generated by a convection heating element oriented at a portion of the extruded segment. In some embodiments, the extruded segment can be placed in an oven 620 such that a portion of the extruded segment falls outside the oven 620. In some embodiments, the extruded segment is annealed using selective or gradient solvent exposure and / or extraction of a solvent component (e.g., salt, additive, secondary hydrophilic polymer, etc.). Selective or gradient exposure and / or extraction can be configured to provide different mechanical properties (e.g., compliance) along the length of the extruded segment.

[0242] In some embodiments, the extruded segment is subsequently exposed to a hydrophilic polymer solution (e.g., solution 633 described above). The hydrophilic polymer solution may comprise an aqueous solution selected from: polyvinyl alcohol; polyvinylpyrrolidone; polyethylene glycol; polyacrylic acid; polyacrylamide; hydroxypropyl methacrylamide; poly... Azoline; polyphosphate; polyphosphononitrile; poly(vinyl acetate); polypropylene glycol; poly(n-isopropylacrylamide); polysaccharide; sulfonated hydrophilic polymers, such as sulfonated polyphenylene oxide, sulfonated tetrafluoroethylene, sulfobetaine methacrylate; and combinations thereof. In some embodiments, the aqueous solution also contains iodine. The hydrophilic polymer solution may contain a temperature of at least 45°C, for example, about 70°C. In some embodiments, the extruded segment is second-dried in a convection oven (e.g., oven 620 described above). The extruded segment may be dried in the convection oven at a temperature of about 55°C for about 3 hours. In some embodiments, the extruded segment is second-annealed in the convection oven 620. This second annealing may be configured to increase the overall strength of the extruded segment (relative to a single annealing). The extruded segment may be second-annealed in the convection oven 620 at a temperature of at least 120°C for about 90 minutes. The second annealing temperature may be at least 30°C higher than the first annealing temperature performed in step 1440.

[0243] In some embodiments, the axial tensioning device (e.g., the tensioning device 650 described above) is configured to apply axial tension to the extruded section during annealing. Applying axial tension to the extruded section can be configured to provide anisotropic mechanical compliance to the extruded section.

[0244] exist Figure 16 In step 1450, the extruded segment is placed in a buffer solution (e.g., solution 632 described above). The buffer solution may contain a solution at room temperature. In some embodiments, the extruded segment is retained in the buffer solution for approximately 60 minutes. The buffer solution may contain a solution selected from: PBS; physiological saline; monosodium phosphate; disodium phosphate; trisodium phosphate; lactated Ringer's solution; and combinations thereof.

[0245] exist Figure 16 In step 1460, the extruded segment is dried in a convection oven (e.g., oven 620 described above). In some embodiments, the extruded segment is dried in convection oven 620 at about 55°C for about 3 hours.

[0246] In some embodiments, a first clamp 200 secures a first end of the extruded segment, and a second clamp 200 secures a second end of the extruded segment, as described above. Figures 10A to 10CThe first clamp 200 (e.g., cavities 228, 248) engages the inner rod of the upper drying rack (e.g., the top rack 622a described above), and the second clamp 200 (cavities 228, 248) engages the inner rod of the lower drying rack (e.g., the bottom rack 622b described above), such that the extruded section extends from the upper drying rack 622a to the lower drying rack 622b. In this embodiment, the clamps 200 are used in conjunction to prevent twisting or other axial deformation of the extruded section during this step (e.g., the clamps 200 are used in conjunction to straighten the extruded section during this step).

[0247] exist Figure 16 In step 1470, the extruded section is removed relative to the mandrel 614.

[0248] Now for reference Figure 17 A method 1500 for overlapping injection molding of materials, consistent with the inventive concept, is shown. Method 1500 can be configured for overlapping injection molding as described above. Figure 16 The material produced in method 1400 as described.

[0249] exist Figure 17 In step 1510, the molded core pin (e.g., pin 661 described above) is slidably positioned within the extruded section (the combined pin 661 and the extruded section are referred to herein as an “overlapping injection assembly”). In some embodiments, the molded core pin 661 includes an extension tube and a Luer connector.

[0250] exist Figure 17 In step 1520, the overlapping injection-molded assembly is placed into a molding machine (e.g., molding machine 660 described above). In some embodiments, molding machine 660 comprises a reciprocating screw injection molding machine. Molding machine 660 may be configured to apply overlapping injection molding material 665 onto the overlapping injection-molded assembly.

[0251] exist Figure 17 In step 1530, the overlapping injection-molded assembly is removed from the molding machine 660. Additionally, the core pin 661 is removed from the extruded section.

[0252] In some embodiments, one, two, or more markings (e.g., marking 112 described above) are formed along the length of the extruded segment. Marking 112 can be configured to expand and contract as the extruded segment expands and contracts (e.g., swells and deswells). Marking 112 can be placed relative to a single point on the extruded segment. For example, a solid-state laser (e.g., laser 616 described above) can be configured to apply one, two, or more dashed lines, dots, and / or other markings 112 along the length of the extruded segment (e.g., markings 112 placed at fixed intervals, for example, to provide a “ruler” to aid in determining the depth to which the device is inserted into the patient).

[0253] Figures 23A to 23B A photograph of an exemplary labeled catheter according to a set of embodiments is shown.

[0254] Now for reference Figure 18 The present invention illustrates a method 1600 for moisturizing materials, consistent with the inventive concept. Method 1600 can be configured to... (refer to above) Figure 17 The material produced in method 1500 described is moisturized.

[0255] exist Figure 18 In step 1610, the extruded segment is placed in a surfactant solution (e.g., surfactant solution 635 described above). In some embodiments, the extruded segment is retained in the surfactant solution for approximately 3 hours. Surfactant solution 635 may contain a solution of 10 w / w% poloxamer 407 in 1× PBS or a solution of 30 w / w% glycerol in 1× PBS. In some embodiments, surfactant solution 635 is maintained at a temperature of 20°C to 70°C, for example, 37°C to 55°C, for example, approximately 45°C.

[0256] exist Figure 18 In step 1620, the extruded segment is removed from the surfactant solution.

[0257] exist Figure 18 In step 1630, the mandrel (e.g., mandrel 614 described above) is slidably placed within the extruded section. In some embodiments, mandrel 614 includes a non-stick surface, such as a PTFE coating.

[0258] exist Figure 18 In step 1640, the extruded segment is dried in a convection oven (e.g., oven 620 described above). In some embodiments, the extruded segment is dried in convection oven 620 at about 30°C for about 3 hours.

[0259] In some implementation schemes, as referred to above Figures 10A to 10C The first clamp 200 secures a first end of the extruded segment, and the second clamp 200 secures a second end of the extruded segment. The first clamp 200 (e.g., cavities 228, 248) engages an inner rod of an upper drying rack (e.g., the top rack 622a described above), and the second clamp 200 (cavities 228, 248) engages an inner rod of a lower drying rack (e.g., the bottom rack 622b described above), such that the extruded segment extends from the upper drying rack 622a to the lower drying rack 622b. In this embodiment, the clamps 200 are used in conjunction to prevent twisting or other axial deformation of the extruded segment during this step (e.g., to straighten the extruded segment during this step).

[0260] exist Figure 18 In step 1650, the extruded segment is removed relative to mandrel 614. In some embodiments, the extruded segment is freeze-dried. Freeze-drying can be configured to prevent or otherwise reduce swelling of the extruded segment during subsequent rehydration (e.g., when fluid contacts the extruded segment). In some embodiments, the extruded segment from step 1650 is frozen at a temperature below 0°C, then evacuated to below 5 Torr, for example, below 500 mTorr, and the extruded segment is heated to a temperature above 0°C, for example, about 25°C, to allow sublimation of the ice from the extruded segment.

[0261] exist Figure 18 In step 1660, the extruded segment (e.g., pipe 101) is placed into a protective sleeve for packaging. The extruded segment may be sterilized before being placed into the protective sleeve. In some embodiments, the extruded segment is sterilized by ethylene oxide exposure, peroxide exposure, peracetic acid exposure, gamma radiation, X-ray radiation, or electron beam radiation. Alternatively or supplementally, the extruded segment may be hydrated before being placed into the protective sleeve. In some embodiments, the extruded segment is hydrated using a hydration device 300, as referenced above. Figure 1B , Figure 11A and / or Figure 11B As stated above.

[0262] Although the conduit 101 has been described primarily in the context of device 100 containing conduit devices (e.g., elongated tubes with lumens), it should also be understood that the conduit 101 using the manufacturing, hydration and other methods described herein may comprise a variety of tubular (e.g., hollow or solid) and non-tubular shapes.

[0263] The above embodiments should be understood as illustrative examples only; other embodiments are also contemplated. Any feature described herein in relation to any embodiment may be used alone or in combination with other described features, and may also be used in combination with one or more features of any other embodiment, or in any combination of any other embodiments. Furthermore, equivalents and modifications not described above may be employed without departing from the scope of the invention as defined by the appended claims.

[0264] In some embodiments, the compositions and articles described herein (e.g., Figure 19Article 1710 and Article 1712 of Figure 10 comprise: a polymeric material containing a first water-soluble polymer having a plurality of pores, and a second water-soluble polymer, which may be the same as or different from the first water-soluble polymer, disposed within at least a portion of the plurality of pores. Not wishing to be bound by theory, in some embodiments, articles (e.g., those not having a second water-soluble polymer disposed within the pores) are also included. Figure 19 Products 1710 Figure 20 Compared to article 1712, the presence of a second water-soluble polymer disposed within at least a portion of the plurality of pores of the first water-soluble material can reduce the article (e.g., Figure 19 Products 1710 Figure 20 The product 1712) is thrombogenic and / or has improved smoothness. In one set of exemplary embodiments, the first water-soluble polymer is polyvinyl alcohol. In another set of exemplary embodiments, the second water-soluble polymer is polyacrylic acid. Other water-soluble polymers are also possible as described herein.

[0265] In some embodiments, the articles and compositions described herein are applied to a subject. In some embodiments, the articles may be administered orally, rectally, vaginally, nasally, intravenously, subcutaneously, or transurethral. In some cases, the articles may be applied to a subject's cavity (e.g., in the venous system), epidural space, and / or abscess.

[0266] As described herein, in some embodiments, the compositions and articles described herein comprise a polymeric material containing a first water-soluble polymer having multiple pores. For example, as... Figure 19 As shown, article 1710 comprises a polymeric material containing a first water-soluble polymer 1720 and having a plurality of pores 1730. In some embodiments, a second water-soluble polymer 40 is disposed within at least a portion of the plurality of pores (e.g., at least 10%, at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, at least 95%, at least 98%, at least 99%, at least 99.99%). In some embodiments, the second water-soluble polymer 1740 is disposed within less than or equal to 100%, less than or equal to 90%, less than or equal to 80%, less than or equal to 70%, less than or equal to 60%, less than or equal to 50%, less than or equal to 40%, less than or equal to 30%, less than or equal to 20%, or less than or equal to 10% of the plurality of pores 30. Combinations of the above ranges are also possible.

[0267] In some embodiments, the second water-soluble polymer is disposed within the body of the first water-soluble polymer (e.g., within the pores and / or voids of the first water-soluble polymer). In some embodiments, such as Figure 20As shown, the second water-soluble polymer 1740 may exist as a coating 1745 on at least a portion of the surface of the polymer material 1720. Although Figure 20 The diagram shows a coating on a first water-soluble polymer and a second water-soluble polymer within the pores of the first water-soluble polymer; however, it should be understood that in some embodiments, only the coating 1745 is present and the pores 1730 are substantially unfilled with the second water-soluble polymer 1740. Other configurations are also possible.

[0268] In some embodiments, article 1710 and / or article 1712 may be hollow (e.g., containing a hollow core 1725). However, although Figure 19 and Figure 20 While described as having a hollow core, those skilled in the art will understand from the teachings of this specification that such a hollow core may not exist. In other words, in some cases, the core 1725 of the article may be a body material without a hollow core 1725.

[0269] In some embodiments, a plurality of pores (e.g., a plurality of pores in an article or a first water-soluble material, the first water-soluble material optionally having a second water-soluble polymer disposed within at least a portion of the pores) have a specific average pore size. In some embodiments, the average pore size of the plurality of pores is less than or equal to 500 nm, less than or equal to 450 nm, less than or equal to 400 nm, less than or equal to 350 nm, less than or equal to 300 nm, less than or equal to 250 nm, less than or equal to 200 nm, less than or equal to 150 nm, less than or equal to 100 nm, less than or equal to 75 nm, less than or equal to 50 nm, less than or equal to 25 nm, less than or equal to 20 nm, or less than or equal to 15 nm. In some embodiments, the average pore size of multiple pores is greater than or equal to 10 nm, greater than or equal to 15 nm, greater than or equal to 20 nm, greater than or equal to 25 nm, greater than or equal to 50 nm, greater than or equal to 75 nm, greater than or equal to 100 nm, greater than or equal to 150 nm, greater than or equal to 200 nm, greater than or equal to 250 nm, greater than or equal to 300 nm, greater than or equal to 350 nm, greater than or equal to 400 nm, or greater than or equal to 450 nm. Combinations of the above ranges are also possible (e.g., less than or equal to 500 nm and greater than or equal to 10 nm). Other ranges are also possible. The average pore size as described herein can be determined by mercury intrusion porosity determination of the material in a dehydrated state (i.e., having less than 5 w / w% water).

[0270] In some embodiments, at least a portion of the plurality of pores may be characterized as nanopores, such as pores with an average cross-sectional size of less than 1 micrometer. In some embodiments, at least a portion of the plurality of pores may be characterized as micropores, such as pores with an average cross-sectional size of less than 1 mm and greater than or equal to 1 micrometer. In some embodiments, at least 50% (e.g., at least 60%, at least 70%, at least 80%, at least 90%, at least 95%, at least 98%, at least 99%, at least 99.9%) of the plurality of pores have diameters of less than 1 micrometer, less than or equal to 800 nm, less than or equal to 600 nm, less than or equal to 500 nm, less than or equal to 450 nm, less than or equal to 400 nm, less than or equal to 350 nm, less than or equal to 300 nm, less than or equal to 250 nm, less than or equal to 200 nm, less than or equal to 150 nm, less than or equal to 100 nm, less than or equal to 75 nm, less than or equal to 50 nm, less than or equal to 25 nm, less than or equal to 20 nm, or less than or equal to 15 nm. In some cases, at least 50% of the diameters in multiple pores are greater than or equal to 10 nm, 15 nm, 20 nm, 25 nm, 50 nm, 75 nm, 100 nm, 150 nm, 200 nm, 250 nm, 300 nm, 350 nm, 400 nm, 450 nm, 500 nm, 600 nm, or 800 nm. Combinations of the above ranges are also possible (e.g., less than or equal to 1000 nm and greater than or equal to 10 nm). Other ranges are also possible.

[0271] The compositions and articles described herein may have specific porosities, for example, in a dehydrated state. In some embodiments, the porosity of the article (or polymer material) in the dehydrated state is greater than or equal to 5%, greater than or equal to 10%, greater than or equal to 15%, greater than or equal to 20%, greater than or equal to 25%, greater than or equal to 30%, greater than or equal to 35%, greater than or equal to 40%, or greater than or equal to 45%. In some embodiments, the porosity of the article (or polymer material) in the dehydrated state is less than or equal to 50%, less than or equal to 45%, less than or equal to 40%, less than or equal to 35%, less than or equal to 30%, less than or equal to 25%, less than or equal to 20%, less than or equal to 15%, or less than or equal to 10%. Combinations of the above ranges are also possible (e.g., greater than or equal to 5% and less than or equal to 50% in the dehydrated state). Other ranges are also possible.

[0272] As described herein, in some embodiments, the article (or polymer material) is substantially non-thrombotic.

[0273] In some embodiments, the article (or polymer material (e.g., Figures 19 to 20 The polymer material 1720 is hydrophilic. As used herein, the term "hydrophilic" is given its common meaning in the art and refers to a material surface having a water contact angle of less than 90 degrees, as determined by goniometrics. In some embodiments, the surface of the polymer material of the article has a water contact angle in equilibrium moisture content of less than or equal to 45 degrees, less than or equal to 40 degrees, less than or equal to 35 degrees, less than or equal to 30 degrees, less than or equal to 25 degrees, less than or equal to 20 degrees, less than or equal to 15 degrees, less than or equal to 10 degrees, less than or equal to 5 degrees, or less than or equal to 2 degrees. In some embodiments, the surface of the polymer material has a water contact angle in equilibrium moisture content of greater than or equal to 1 degree, greater than or equal to 2 degrees, greater than or equal to 5 degrees, greater than or equal to 10 degrees, greater than or equal to 15 degrees, greater than or equal to 20 degrees, greater than or equal to 25 degrees, greater than or equal to 30 degrees, greater than or equal to 35 degrees, or greater than or equal to 40 degrees. Combinations of the above ranges are also possible (e.g., greater than or equal to 1 degree and less than or equal to 45 degrees). Other ranges are also possible.

[0274] As used herein, equilibrium moisture content state refers to the steady state of an article (or material) that, when immersed in water at 25°C without externally applied mechanical stress, does not increase (e.g., absorb) or lose a significant amount of moisture content. Those skilled in the art will understand that steady state (or equilibrium moisture content state) should not be understood to require absolute conformity to the strict thermodynamic definition of such a term, but rather to indicate conformity to the thermodynamic definition of such a term to the extent that the subject matter being characterized can be understood by those skilled in the art in the most relevant field (e.g., considering factors such as passive diffusion and / or Brownian motion).

[0275] In some embodiments, the article is substantially smooth at its equilibrium moisture content. For example, in some embodiments, the surface roughness (Ra) of the article (or the polymer material of the article) at its equilibrium moisture content is less than or equal to 1000 nm. In some embodiments, the surface roughness (Ra) of the article (or the polymer material of the article) at its equilibrium moisture content is less than or equal to 500 nm, less than or equal to 400 nm, less than or equal to 300 nm, less than or equal to 250 nm, less than or equal to 200 nm, less than or equal to 150 nm, less than or equal to 100 nm, less than or equal to 50 nm, less than or equal to 25 nm, less than or equal to 10 nm, or less than or equal to 5 nm. In some embodiments, the surface roughness (Ra) of the article (or the polymer material of the article) is greater than or equal to 5 nm at equilibrium moisture content, greater than or equal to 10 nm, greater than or equal to 25 nm, greater than or equal to 50 nm, greater than or equal to 100 nm, greater than or equal to 150 nm, greater than or equal to 200 nm, greater than or equal to 250 nm, greater than or equal to 300 nm, greater than or equal to 400 nm, or greater than or equal to 500 nm. Combinations of the above ranges are also possible (e.g., greater than or equal to 5 nm and less than or equal to 1000 nm). Other ranges are also possible.

[0276] In some embodiments, the article has a surface with a coefficient of friction less than or equal to 0.10 at equilibrium moisture content. For example, the surface of the article (or the polymer material of the article) has a coefficient of friction less than or equal to 0.1, less than or equal to 0.09, less than or equal to 0.08, less than or equal to 0.07, less than or equal to 0.06, less than or equal to 0.05, less than or equal to 0.04, less than or equal to 0.03, or less than or equal to 0.02. In some embodiments, the surface of the article (or the polymer material of the article) has a coefficient of friction greater than or equal to 0.01, greater than or equal to 0.02, greater than or equal to 0.03, greater than or equal to 0.04, greater than or equal to 0.05, greater than or equal to 0.06, greater than or equal to 0.07, greater than or equal to 0.08, or greater than or equal to 0.09. Combinations of the above ranges are also possible (e.g., less than or equal to 0.1 and greater than or equal to 0.01). Other ranges are also possible.

[0277] Advantageously, the compositions and articles described herein exhibit low adsorption of such substances in the presence of a dynamic fluid containing substances such as therapeutic agents (and / or, for example, proteins). Such articles and compositions can be used in objects in which, for example, the presence of the article should substantially not reduce the availability and / or concentration of the therapeutic agent delivered (e.g., via the article) to the object. In some embodiments, application of the therapeutic agent via a fluid flowing in the article described herein does not substantially reduce the concentration of the therapeutic agent in the fluid. In some cases, the article may not absorb and / or adsorb the therapeutic agent, for example, during flow or use.

[0278] In some embodiments, as determined at equilibrium water content after exposing the polymer to the therapeutic agent and rinsing with an aqueous solution (e.g., water or saline) at 5 times the volume of the product, the adsorption of the therapeutic agent to the surface and / or bulk of the first water-soluble polymer is less than or equal to 0.5 w / w%. In some embodiments, the adsorption of the therapeutic agent to the surface and / or bulk of the first water-soluble polymer is less than or equal to 0.5 w / w%, less than or equal to 0.4 w / w%, less than or equal to 0.3 w / w%, less than or equal to 0.2 w / w%, or less than or equal to 0.1 w / w%. In some embodiments, the adsorption of the therapeutic agent to the surface and / or bulk of the first water-soluble polymer is greater than or equal to 0.05 w / w%, greater than or equal to 0.1 w / w%, greater than or equal to 0.2 w / w%, greater than or equal to 0.3 w / w%, or greater than or equal to 0.4 w / w. Combinations of the above ranges are also possible (e.g., less than or equal to 0.5 w / w% and greater than or equal to 0.05 w / w%). Other ranges are also possible.

[0279] Advantageously, the articles and compositions described herein may have desired swelling characteristics (e.g., in water, in salt water, in the fluid environment of the object).

[0280] In some embodiments, the articles described herein are in a dehydrated state. For example, in some embodiments, the articles (or polymer materials) described herein in a dehydrated state have a water content of less than or equal to 5 w / w%, less than or equal to 4 w / w%, less than or equal to 3 w / w%, less than or equal to 2 w / w%, less than or equal to 1 w / w%, less than or equal to 0.8 w / w%, less than or equal to 0.6 w / w%, less than or equal to 0.4 w / w%, or less than or equal to 0.2 w / w%. In some embodiments, the articles (or polymer materials) described herein have a water content of greater than or equal to 0.1 w / w%, greater than or equal to 0.2 w / w%, greater than or equal to 0.4 w / w%, greater than or equal to 0.6 w / w%, greater than or equal to 0.8 w / w%, greater than or equal to 1 w / w%, greater than or equal to 2 w / w%, greater than or equal to 3 w / w%, or greater than or equal to 4 w / w. Combinations of the above ranges are also possible (e.g., less than 5 w / w% and greater than or equal to 0.1 w / w%). Other ranges are also possible. The dehydration state described herein generally refers to a steady state determined under environmental conditions, wherein the water content of the article (or polymer material) does not decrease significantly (less than 5 w / w%) over 24 hours. In some embodiments, the article described herein may contain a coating or unbonded pore-forming agent, such as a humectant coating, as described in more detail below.

[0281] Advantageously, the articles and compositions described herein can be configured to swell rapidly in the presence of an aqueous solution, such as water and / or brine. In some embodiments, the articles (or polymeric materials, e.g., Figures 19 to 20The polymer material 1720 is configured to swell from a dehydrated state to an equilibrium moisture content state at 25°C in amounts greater than or equal to 5 w / w%, greater than or equal to 10 w / w%, greater than or equal to 15 w / w%, greater than or equal to 20 w / w%, greater than or equal to 25 w / w%, greater than or equal to 30 w / w%, greater than or equal to 35 w / w%, greater than or equal to 40 w / w%, or greater than or equal to 45 w / w%, for example, in a specific time amount (e.g., less than or equal to 60 minutes), as described in more detail below. In some embodiments, the article (or polymer material) is configured to swell from a dehydrated state to an equilibrium moisture content state at 25°C in amounts less than or equal to 50 w / w%, less than or equal to 45 w / w%, less than or equal to 40 w / w%, less than or equal to 35 w / w%, less than or equal to 30 w / w%, less than or equal to 25 w / w%, less than or equal to 20 w / w%, less than or equal to 15 w / w%, or less than or equal to 10 w / w%, for example, in a specific time period (e.g., less than or equal to 60 minutes), as described in more detail below. Combinations of the above ranges are also possible (e.g., greater than or equal to 5 w / w% and less than or equal to 50 w / w%). Other ranges are also possible.

[0282] In some embodiments, the article (or polymer material (e.g., Figures 19 to 20 The polymer material 1720 is configured to move from a dehydrated state to a swelling equilibrium moisture content state at 25°C for 60 minutes or less, 50 minutes or less, 40 minutes or less, 30 minutes or less, 20 minutes or less, 10 minutes or less, 5 minutes or less, or 2 minutes or less, in an amount greater than or equal to 5 w / w%. In some embodiments, the article (or polymer material) is configured to move from a dehydrated state to a swelling equilibrium moisture content state at 25°C for 1 minute or more, 2 minutes or more, 5 minutes or more, 10 minutes or more, 20 minutes or more, 30 minutes or more, 40 minutes or more, or 50 minutes or more, in an amount greater than or equal to 5 w / w%. Combinations of the above ranges are also possible (e.g., less than or equal to 60 minutes and greater than or equal to 1 minute). Other ranges are also possible.

[0283] In one exemplary embodiment, the article (or polymer material, for example, Figures 19 to 20The polymer material 20) is configured to swell in water from a dehydrated state (e.g., less than 5 w / w%) to an equilibrium water content (e.g., greater than or equal to 5 w / w%) in less than or equal to 60 minutes. In some embodiments, the article (or polymer material) is configured to swell in standard physiological saline from a dehydrated state (e.g., less than 5 w / w%) to an equilibrium water content (e.g., greater than or equal to 5 w / w%) in less than or equal to 60 minutes. In another exemplary embodiment, the article (or polymer material) is configured to swell in physiological saline from a dehydrated state (e.g., less than 5 w / w%) to an equilibrium water content (e.g., greater than or equal to 5 w / w%) in less than or equal to 60 minutes.

[0284] In some embodiments, the article (or polymer material (e.g., Figures 19 to 20 The polymer material 1720 has a specific length in the dehydrated state. In some embodiments, the total length of the article (or polymer material) in the equilibrium moisture content state is increased by greater than or equal to 0.1%, greater than or equal to 0.5%, greater than or equal to 1%, greater than or equal to 2%, greater than or equal to 4%, greater than or equal to 6%, greater than or equal to 8%, greater than or equal to 10%, greater than or equal to 12%, greater than or equal to 14%, greater than or equal to 16%, or greater than or equal to 18% compared to its length in the dehydrated state. In some cases, the total length of the article (or polymer material) in the equilibrium moisture content state is increased by less than or equal to 20%, less than or equal to 18%, less than or equal to 16%, less than or equal to 14%, less than or equal to 12%, less than or equal to 10%, less than or equal to 8%, less than or equal to 6%, less than or equal to 4%, less than or equal to 2%, less than or equal to 1%, or less than or equal to 0.5% compared to its length in the dehydrated state. Combinations of the above ranges are also possible (e.g., greater than or equal to 0.1% and less than or equal to 20%). Other ranges are also possible.

[0285] In some embodiments, the article (or polymer material (e.g., Figures 19 to 20The polymer material 1720 has a specific maximum external cross-sectional dimension, such as outer diameter, in the dehydrated state. In some embodiments, the maximum external cross-sectional dimension (e.g., outer diameter) of the article (or polymer material) in the equilibrium moisture content state is increased by greater than or equal to 0.1%, greater than or equal to 0.5%, greater than or equal to 1%, greater than or equal to 2%, greater than or equal to 4%, greater than or equal to 6%, greater than or equal to 8%, greater than or equal to 10%, greater than or equal to 12%, greater than or equal to 14%, greater than or equal to 16%, or greater than or equal to 18% compared to the maximum cross-sectional dimension (e.g., outer diameter) in the dehydrated state. In some cases, the maximum cross-sectional dimension (e.g., outer diameter) of the article (or polymer material) in the equilibrium moisture content state is increased by less than or equal to 20%, less than or equal to 18%, less than or equal to 16%, less than or equal to 14%, less than or equal to 12%, less than or equal to 10%, less than or equal to 8%, less than or equal to 6%, less than or equal to 4%, less than or equal to 2%, less than or equal to 1%, or less than or equal to 0.5% compared to the maximum cross-sectional dimension (e.g., outer diameter) in the dehydrated state. Combinations of the above ranges are also possible (e.g., greater than or equal to 0.1% and less than or equal to 20%, greater than or equal to 0.1% and less than or equal to 10%). Other ranges are also possible.

[0286] In some embodiments, the article (or polymer material) has a specific inner diameter in the dehydrated state (e.g., in embodiments where the article comprises a hollow core). In some embodiments, the inner diameter of the article (or polymer material) in the equilibrium moisture content state is increased by greater than or equal to 0.1%, greater than or equal to 0.5%, greater than or equal to 1%, greater than or equal to 2%, greater than or equal to 4%, greater than or equal to 6%, greater than or equal to 8%, greater than or equal to 10%, greater than or equal to 12%, greater than or equal to 14%, greater than or equal to 16%, or greater than or equal to 18% compared to the inner diameter in the dehydrated state. In some cases, the inner diameter of the article (or polymer material) in the equilibrium moisture content state is increased by less than or equal to 20%, less than or equal to 18%, less than or equal to 16%, less than or equal to 14%, less than or equal to 12%, less than or equal to 10%, less than or equal to 8%, less than or equal to 6%, less than or equal to 4%, less than or equal to 2%, less than or equal to 1%, or less than or equal to 0.5% compared to the inner diameter in the dehydrated state. Combinations of the above ranges are also possible (e.g., greater than or equal to 0.1% and less than or equal to 20%). Other ranges are also possible.

[0287] In some embodiments, the article comprises a polymeric material having the desired mechanical properties. For example, in some embodiments, the polymeric material has a Young's modulus in a dehydrated state (e.g., less than 5 w / w% water content) greater than or equal to 500 MPa, 600 MPa, 750 MPa, 800 MPa, 900 MPa, 1000 MPa, 1250 MPa, 1500 MPa, 1750 MPa, 2000 MPa, 2500 MPa, 3000 MPa, 3500 MPa, or 4000 MPa. In some embodiments, the Young's modulus of the polymer material in a dehydrated state (e.g., less than 5 w / w% water content) is less than or equal to 5000 MPa, less than or equal to 4000 MPa, less than or equal to 3500 MPa, less than or equal to 3000 MPa, less than or equal to 2500 MPa, less than or equal to 2000 MPa, less than or equal to 1750 MPa, less than or equal to 1500 MPa, less than or equal to 1250 MPa, less than or equal to 1000 MPa, less than or equal to 900 MPa, less than or equal to 800 MPa, less than or equal to 750 MPa, or less than or equal to 600 MPa. Combinations of the above ranges are also possible (e.g., greater than or equal to 500 MPa and less than or equal to 5000 MPa). Other ranges are also possible.

[0288] In some embodiments, the Young's modulus of the polymer material at equilibrium moisture content is less than or equal to 300 MPa, less than or equal to 250 MPa, less than or equal to 200 MPa, less than or equal to 150 MPa, less than or equal to 100 MPa, less than or equal to 75 MPa, less than or equal to 50 MPa, less than or equal to 25 MPa, less than or equal to 20 MPa, or less than or equal to 10 MPa. In some embodiments, the Young's modulus of the polymer material at equilibrium moisture content is greater than or equal to 5 MPa, greater than or equal to 10 MPa, greater than or equal to 20 MPa, greater than or equal to 25 MPa, greater than or equal to 50 MPa, greater than or equal to 75 MPa, greater than or equal to 100 MPa, greater than or equal to 150 MPa, greater than or equal to 200 MPa, or greater than or equal to 250 MPa. Combinations of the above ranges are also possible (e.g., less than or equal to 300 MPa and greater than or equal to 5 MPa). Other ranges are also possible.

[0289] In some embodiments, the article comprises a penetrating agent. For example, in some embodiments, the penetrating agent may be added during the formation of the article (e.g., added to the prepolymer). In some embodiments, the penetrating agent is present in the polymer material in the following amounts (e.g., after the formation of the polymer material): greater than or equal to 0.05 w / w%, greater than or equal to 0.1 w / w%, greater than or equal to 0.2 w / w%, greater than or equal to 0.4 w / w%, greater than or equal to 0.6 w / w%, greater than or equal to 0.8 w / w%, greater than or equal to 1 w / w%, greater than or equal to 1.2 w / w%, greater than or equal to 1.4 w / w%, greater than or equal to 1.6 w / w%, or greater than or equal to 1.8 w / w. In some cases, the penetrant may be present in the polymer material in the following amounts (e.g., after the polymer material has been formed): less than or equal to 2 w / w%, less than or equal to 1.8 w / w%, less than or equal to 1.6 w / w%, less than or equal to 1.4 w / w%, less than or equal to 1.2 w / w%, less than or equal to 1 w / w%, less than or equal to 0.8 w / w%, less than or equal to 0.6 w / w%, less than or equal to 0.4 w / w%, less than or equal to 0.2 w / w%, or less than or equal to 0.01 w / w%. Combinations of the above ranges are also possible (e.g., greater than or equal to 0.05 w / w% and less than or equal to 2 w / w%). Other ranges are also possible.

[0290] Non-limiting examples of suitable penetrants include phosphates, borates, sodium chloride, citrates, ethylenediaminetetraacetic acid, sulfites, sulfates, hyposulfites, metal oxides, selenium dioxide, selenium trioxide, selenite, selenic acid, nitrates, silicates, and phytic acids.

[0291] In some embodiments, the composition (e.g., comprising a polymeric material) does not contain covalent crosslinks, as described in more detail below. However, in other embodiments, the composition contains physical crosslinks (e.g., interpenetrating networks, chain entanglements, and / or one or more bonds, such as covalent bonds, ionic bonds, and / or hydrogen bonds). In a specific set of embodiments, no covalent crosslinking agent is used to form the polymeric material, the first water-soluble polymer of the polymeric material, and / or the second water-soluble polymer.

[0292] The first water-soluble polymer may be present in the article in any suitable amount. For example, in some embodiments, the first water-soluble polymer is present in the article in the following amounts at equilibrium moisture content: greater than or equal to 20 w / w%, greater than or equal to 25 w / w%, greater than or equal to 30 w / w%, greater than or equal to 35 w / w%, greater than or equal to 40 w / w%, greater than or equal to 45 w / w%, greater than or equal to 50 w / w%, greater than or equal to 55 w / w%, greater than or equal to 60 w / w%, greater than or equal to 65 w / w%, greater than or equal to 70 w / w%, greater than or equal to 75 w / w%, greater than or equal to 80 w / w%, greater than or equal to 85 w / w%, or greater than or equal to 90 w / w. In some embodiments, the first water-soluble polymer is present in the article at an equilibrium moisture content in the following amounts: less than or equal to 95 w / w%, less than or equal to 90 w / w%, less than or equal to 85 w / w%, less than or equal to 80 w / w%, less than or equal to 75 w / w%, less than or equal to 70 w / w%, less than or equal to 65 w / w%, less than or equal to 60 w / w%, less than or equal to 55 w / w%, less than or equal to 50 w / w%, less than or equal to 45 w / w%, less than or equal to 40 w / w%, less than or equal to 35 w / w%, less than or equal to 30 w / w%, or less than or equal to 25 w / w%. Combinations of the above ranges are also possible (e.g., greater than or equal to 20 w / w% and less than or equal to 95 w / w%). Other ranges are also possible.

[0293] In some embodiments, the first water-soluble polymer comprises or is selected from: poly(vinyl alcohol), poly(acrylic acid), polyethylene glycol, poly(vinylpyrrolidone), poly(sulfonyl betaine methacrylate), poly(sulfonyl betaine acrylate), poly(carboxymethyl betaine methacrylate), poly(carboxymethyl betaine acrylate), povidone, polyacrylamide, poly(N-(2-hydroxypropyl)methacrylamide), poly(... Azoline, polyphosphate, polyphosphazene, polyvinyl acetate, polypropylene glycol, poly(N-isopropylacrylamide), poly(2-hydroxymethyl methacrylate), and combinations thereof. In one set of exemplary embodiments, the first water-soluble polymer is poly(vinyl alcohol).

[0294] In some embodiments, the polymer material comprises a mixture containing a first water-soluble polymer and another (e.g., a third) water-soluble polymer. In some embodiments, the third water-soluble polymer comprises or is selected from: poly(vinyl alcohol), poly(acrylic acid), polyethylene glycol, poly(vinylpyrrolidone), poly(methacrylic acid sulfonyl betaine), poly(acrylic acid sulfonyl betaine), poly(methacrylic acid carboxylic betaine), poly(acrylic acid carboxylic betaine), povidone, polyacrylamide, poly(N-(2-hydroxypropyl)methacrylamide), poly... Azoline, polyphosphate, polyphosphazene, polyvinyl acetate, polypropylene glycol, poly(N-isopropylacrylamide), poly(2-hydroxymethyl methacrylate), and combinations thereof. The first and additional (e.g., the third) water-soluble polymers may have different chemical compositions.

[0295] In some embodiments, the total weight of the first water-soluble polymer and another (e.g., a third) water-soluble polymer in the article is greater than or equal to 20 w / w%, greater than or equal to 25 w / w%, greater than or equal to 30 w / w%, greater than or equal to 35 w / w%, greater than or equal to 40 w / w%, greater than or equal to 45 w / w%, greater than or equal to 50 w / w%, greater than or equal to 55 w / w%, greater than or equal to 60 w / w%, greater than or equal to 65 w / w%, greater than or equal to 70 w / w%, greater than or equal to 75 w / w%, greater than or equal to 80 w / w%, greater than or equal to 85 w / w%, greater than or equal to 90 w / w%, greater than or equal to 95 w / w%, greater than or equal to 98 w / w%, or greater than or equal to 99 w / w, at equilibrium moisture content. In some embodiments, the total weight of the first water-soluble polymer and another (e.g., a third) water-soluble polymer in the article, at equilibrium moisture content, is: less than or equal to 100 w / w%, less than or equal to 90 w / w%, less than or equal to 98 w / w%, less than or equal to 95 w / w%, less than or equal to 90 w / w%, less than or equal to 85 w / w%, less than or equal to 80 w / w%, less than or equal to 75 w / w%, less than or equal to 70 w / w%, less than or equal to 65 w / w%, less than or equal to 60 w / w%, less than or equal to 55 w / w%, less than or equal to 50 w / w%, less than or equal to 45 w / w%, less than or equal to 40 w / w%, less than or equal to 35 w / w%, less than or equal to 30 w / w%, or less than or equal to 25 w / w%. Combinations of the above ranges are also possible (e.g., greater than or equal to 20 w / w% and less than or equal to 100 w / w%). Other ranges are also possible.

[0296] In some embodiments, the ratio of the first water-soluble polymer to the third water-soluble polymer in the article is less than or equal to 100:0, less than or equal to 99:1, less than or equal to 95:5, less than or equal to 90:10, less than or equal to 80:20, less than or equal to 70:30, less than or equal to 60:40, or less than or equal to 55:45. In some embodiments, the ratio of the first water-soluble polymer to the third water-soluble polymer in the article is greater than or equal to 50:50, greater than or equal to 60:40, greater than or equal to 70:30, greater than or equal to 80:20, greater than or equal to 90:10, greater than or equal to 95:5, or greater than or equal to 99:1. Combinations of the above ranges are also possible (e.g., less than or equal to 100:0 and greater than or equal to 50:50). Other ranges are also possible.

[0297] As described above and herein, in some embodiments, the article comprises a second water-soluble polymer (e.g., second water-soluble polymer 1740) disposed within at least a portion of a plurality of pores (e.g., plurality of pores 1730) of a polymer material (e.g., polymer material 1720). In some embodiments, the second water-soluble polymer comprises or is selected from: poly(vinyl alcohol), poly(acrylic acid), polyethylene glycol, poly(vinylpyrrolidone), poly(methacrylic acid sulfonyl betaine), poly(acrylic acid sulfonyl betaine), poly(methacrylic acid carboxylic betaine), poly(acrylic acid carboxylic betaine), povidone, polyacrylamide, poly(N-(2-hydroxypropyl)methacrylamide), ... Azoline, polyphosphate, polyphosphazene, polyvinyl acetate, polypropylene glycol, poly(N-isopropylacrylamide), poly(2-hydroxymethyl methacrylate), and combinations thereof. In some embodiments, the second water-soluble polymer is poly(acrylic acid). The second water-soluble polymer may have a different chemical composition than the first (e.g., and optionally a third) water-soluble polymer.

[0298] The second water-soluble polymer (e.g., second water-soluble polymer 1740) may be present in the article in any suitable amount. For example, in some embodiments, the second water-soluble polymer is present in the article in the following amounts at equilibrium moisture content: greater than or equal to 0.05 w / w%, greater than or equal to 0.1 w / w%, greater than or equal to 0.2 w / w%, greater than or equal to 0.5 w / w%, greater than or equal to 1.0 w / w%, greater than or equal to 2.0 w / w%, greater than or equal to 3.0 w / w%, greater than or equal to 4.0 w / w%, greater than or equal to 5.0 w / w%, greater than or equal to 10 w / w%, greater than or equal to 20 w / w%, greater than or equal to 30 w / w%, greater than or equal to 40 w / w%, greater than or equal to 50 w / w%, greater than or equal to 60 w / w%, greater than or equal to 70 w / w%, greater than or equal to 80 w / w%, or greater than or equal to 90 w / w. In some embodiments, the second water-soluble polymer 40 is present in the article at equilibrium moisture content in the following amounts: less than or equal to 95 w / w%, less than or equal to 90 w / w%, less than or equal to 80 w / w%, less than or equal to 70 w / w%, less than or equal to 60 w / w%, less than or equal to 50 w / w%, less than or equal to 40 w / w%, less than or equal to 30 w / w%, less than or equal to 20 w / w%, less than or equal to 10 w / w%, less than or equal to 5.0 w / w%, less than or equal to 4.0 w / w%, less than or equal to 3.0 w / w%, less than or equal to 2.0 w / w%, less than or equal to 1.0 w / w%, less than 0.5 w / w%, less than 0.2 w / w%, or less than 0.1 w / w%. In some embodiments, 0 w / w% of the second water-soluble polymer is present. Combinations of the above ranges are also possible (e.g., greater than or equal to 0.05 w / w% and less than or equal to 95 w / w%). Other ranges are also possible.

[0299] In some embodiments, the water-soluble polymer (e.g., a first water-soluble polymer, a second water-soluble polymer, a third water-soluble polymer) has a specific molecular weight. In some embodiments, the molecular weight of the water-soluble polymer (e.g., the first water-soluble polymer, the second water-soluble polymer, or the third water-soluble polymer, each independently) may be greater than or equal to 40 kDa, greater than or equal to 50 kDa, greater than or equal to 75 kDa, greater than or equal to 100 kDa, greater than or equal to 125 kDa, greater than or equal to 150 kDa, greater than or equal to 175 kDa, greater than or equal to 200 kDa, greater than or equal to 250 kDa, greater than or equal to 300 kDa, greater than or equal to 350 kDa, greater than or equal to 400 kDa, greater than or equal to 450 kDa, greater than or equal to 500 kDa, greater than or equal to 600 kDa, greater than or equal to 700 kDa, greater than or equal to 800 kDa, greater than or equal to 900 kDa, greater than or equal to 1000 kDa, greater than or equal to 1500 kDa, greater than or equal to 2000 kDa, greater than or equal to 3000 kDa, or greater than or equal to 4000 kDa. In some embodiments, the molecular weight of the water-soluble polymer (e.g., the first water-soluble polymer, the second water-soluble polymer, or the third water-soluble polymer, each independently) may be less than or equal to 5000 kDa, less than or equal to 4000 kDa, less than or equal to 3000 kDa, less than or equal to 2000 kDa, less than or equal to 1500 kDa, less than or equal to 1000 kDa, less than or equal to 900 kDa, less than or equal to 800 kDa, less than or equal to 700 kDa, less than or equal to 600 kDa, less than or equal to 500 kDa, less than or equal to 450 kDa, less than or equal to 400 kDa, less than or equal to 350 kDa, less than or equal to 300 kDa, less than or equal to 250 kDa, less than or equal to 200 kDa, less than or equal to 175 kDa, less than or equal to 150 kDa, less than or equal to 125 kDa, less than or equal to 100 kDa, less than or equal to 75 kDa, or less than or equal to 500 kDa. kDa. Combinations of the above ranges are also possible (e.g., molecular weights greater than or equal to 40 kDa and less than or equal to 5000 kDa). Other ranges are also possible.

[0300] In some embodiments, the articles of manufacture (and / or polymeric materials) described herein are medical devices or configured for use in medical devices, such as catheters, balloons, shunts, wound drainage tubes, infusion ports, drug delivery devices, tubing, contraceptive devices, feminine hygiene devices, endoscopes, grafts, pacemakers, implantable cardioverter-defibrillators, cardiac resynchronization devices, cardiovascular device guides, ventricular assist devices, endotracheal tubes, tracheostomy tubes, implantable sensors, ventilator pumps, and ophthalmic devices. In some embodiments, the catheter is selected from: central venous catheters, peripheral central catheters, midline catheters, peripheral catheters, peripheral port catheters, central venous port catheters, tunneled catheters, dialysis access catheters, urinary catheters, nerve catheters, epidural catheters, percutaneous endovascular angioplasty catheters, and / or peritoneal catheters. Some catheters are suitable for drainage, urinary, and / or dialysis applications. Other suitable uses are described in more detail below.

[0301] In some embodiments, the article comprises a first component containing a polymeric material (e.g., a water-soluble polymer) and a second component adjacent to the first component. For example, in some cases, the second component is mechanically coupled to the first component. In some such embodiments, the second component may include a plurality of surface features configured to mechanically hold the second component within or on the first component. In some embodiments, such as Figures 21 to 22 As shown, article 3300 includes a first component 3310 (e.g., article, for example...). Figure 19 Product 1710 or Figure 20 Article 1712) and a second component 3320 (e.g., extension, connector, luer lock, suit wing) adjacent to the first component 3310, and a second article (e.g. Figure 19 Product 1710 or Figure 20 Article 1712). In some embodiments, a first thermoplastic layer 3330 is disposed between the first component 3310 and the second component 3320. In some embodiments, an optional second thermoplastic layer 3340 is adjacent to the first component 3310 (e.g., in contact with the outer surface of the first component 3310). In some cases, the second component 3320 may include a plurality of surface features 3350 associated with the first component 3310, such that the second component is mechanically held to the first component 3310 (e.g., within, above, or adjacent to it).

[0302] In some embodiments, the second component may be a connector (e.g., a connector for a medical component and / or medical device). In some embodiments, the second component may be selected from: an extension, a connector, a Luer lock, and a suture wing. In some embodiments, the second component may be another article comprising a polymer material, such as the article described herein.

[0303] In some embodiments, the article includes a first thermoplastic layer disposed between the first component and the second component (e.g., to facilitate mechanical retention between the first and second components). In some cases, the second thermoplastic layer may contact the outer surface of the first component. For example, the second thermoplastic layer may cover a portion of the second component and a portion of the first component. Each thermoplastic layer may contain a suitable thermoplastic material. In some embodiments, the first thermoplastic material and / or the second thermoplastic material each independently comprise or are selected from: polyurethane elastomers, silicone elastomers, silicone-polyurethane copolymers, polyethylene, polypropylene, styrene-isoprene-butadiene copolymers, homopolymers and copolymers of vinyl acetate (e.g., ethylene-vinyl acetate copolymers), polyvinyl chloride, homopolymers and copolymers of acrylates and methacrylates, polyvinylpyrrolidone, 2-pyrrolidone, polyacrylonitrile-butadiene, polycarbonate, polyamide, polyether block amide, fluoropolymers (including homopolymers and copolymers of polytetrafluoroethylene and polyvinyl fluoride), fluorinated ethylene propylene, polystyrene, homopolymers and copolymers of styrene-acrylonitrile, homopolymers and copolymers of styrene-butadiene, cellulose acetate, homopolymers and copolymers of acrylonitrile-butadiene-styrene, polymethylpentene, polysulfone, polyester, polyimide, polyisobutylene, polymethylstyrene, polyoxymethylene, and homopolymers and copolymers of poly(lactic acid), poly(glycolic acid), and poly(caprolactone). In some embodiments, the first thermoplastic material and / or the second thermoplastic material swell at least partially in water at 25°C.

[0304] In some embodiments, the second component is thermally bonded to the first component. In some embodiments, the second component is solvent-bonded to the first thermoplastic material. In some embodiments, the solvent may be selected based on its ability to solubilize both the first and / or second components. Non-limiting examples of suitable solvents include: tetrahydrofuran, toluene, N,N-dimethylformamide, N,N-dimethylacetamide, chloroform, dichloromethane, ethyl acetate, acetone, acetonitrile, dimethyl sulfoxide, nitromethane, propylene carbonate, diethyl ether, 1,4-dioxane, benzene, cyclohexane, hexane, cyclopentane, pentane, formic acid, n-butanol, isopropanol, ethanol, methanol, acetic acid, hexafluoroisopropanol, trifluoroacetic acid, water, and combinations thereof. In one exemplary embodiment, tetrahydrofuran is used to bond the water-swellable polyurethane to a hydrophobic polyurethane solvent.

[0305] In some embodiments, the Young's modulus of the second component is greater than that of the first component in the dehydrated state and / or at equilibrium moisture content. In some embodiments, the Young's modulus of the second component is greater than that of the first component at equilibrium moisture content, but less than that of the first component in the dehydrated state.

[0306] In some embodiments, the second component includes multiple surface features, such as protrusions or spikes. These surface features may be present at the interface between the first and second components to mechanically maintain the connection between the two components. In some embodiments, the multiple surface features include rounded edges. In some embodiments, the multiple surface features include rounded edges, sharp edges, blunt edges, flairs, protrusions, and / or raised features. In some embodiments, the multiple surface features include multiple barbs and / or protrusions. Other surface features are also possible.

[0307] In some embodiments, multiple surface features may have specific radii of curvature (e.g., at a surface adjacent to the first component). For example, in some cases, the radius of curvature of at least a portion of the multiple surface features is greater than or equal to 0.1 times, greater than or equal to 0.2 times, greater than or equal to 0.3 times, greater than or equal to 0.5 times, greater than or equal to 0.7 times, greater than or equal to 0.9 times, greater than or equal to 1 times, greater than or equal to 1.1 times, greater than or equal to 1.2 times, greater than or equal to 1.5 times, greater than or equal to 2 times, greater than or equal to 2.5 times, greater than or equal to 3 times, greater than or equal to 3.5 times, greater than or equal to 4 times, or greater than or equal to 4.5 times the radius of curvature of the inner surface of the article (e.g., the hollow portion of the article). In some embodiments, the radius of curvature of at least a portion of the multiple surface features is less than or equal to 5 times, less than or equal to 4.5 times, less than or equal to 4 times, less than or equal to 3.5 times, less than or equal to 3 times, less than or equal to 2.5 times, less than or equal to 2 times, less than or equal to 1.5 times, less than or equal to 1.2 times, less than or equal to 1.1 times, less than or equal to 1 time, less than or equal to 0.9 times, less than or equal to 0.7 times, less than or equal to 0.5 times, less than or equal to 0.3 times, or less than or equal to 0.2 times. Combinations of the above ranges are also possible (e.g., greater than or equal to 0.1 times and less than or equal to 5 times). Other ranges are also possible.

[0308] In some embodiments, the bond strength between the first and second components (e.g., at the interface between the first and second components) is greater than or equal to 10 N, greater than or equal to 15 N, greater than or equal to 20 N, greater than or equal to 25 N, greater than or equal to 30 N, greater than or equal to 40 N, greater than or equal to 50 N, greater than or equal to 60 N, greater than or equal to 70 N, or greater than or equal to 75 N. In some embodiments, the bond strength is less than or equal to 100 N, less than or equal to 75 N, less than or equal to 70 N, less than or equal to 60 N, less than or equal to 50 N, less than or equal to 40 N, less than or equal to 30 N, less than or equal to 25 N, less than or equal to 20 N, or less than or equal to 15 N. Combinations of the above ranges are also possible (e.g., greater than or equal to 10 N and less than or equal to 100 N). Other ranges are also possible. The bond strength can be determined by measuring the maximum load at fracture using an INSTRON tensile testing machine (model 3343, 500 N load cell), which has... @ 40 psi pneumatic clamp and 1 kN clamp strength. The assembly can be pulled at a speed of 400 mm / min, starting from a 20 mm gap distance.

[0309] In some embodiments, the interface between the first component and the second component is fluid-tight. For example, in some embodiments, the interface between the first component and the second component is configured to withstand the following injection pressures (for injecting fluid through the first component and into the second component, which is in fluid communication with the first component): greater than or equal to 50 PSI, greater than or equal to 75 PSI, greater than or equal to 100 PSI, greater than or equal to 125 PSI, greater than or equal to 150 PSI, greater than or equal to 175 PSI, greater than or equal to 200 PSI, greater than or equal to 225 PSI, greater than or equal to 250 PSI, greater than or equal to 300 PSI, or greater than or equal to 350 PSI. In some implementations, the interface between the first and second components is configured to withstand the following injection pressures: less than or equal to 500 PSI, less than or equal to 400 PSI, less than or equal to 350 PSI, less than or equal to 300 PSI, less than or equal to 250 PSI, less than or equal to 225 PSI, less than or equal to 200 PSI, less than or equal to 175 PSI, less than or equal to 150 PSI, less than or equal to 125 PSI, less than or equal to 100 PSI, or less than or equal to 75 PSI. Combinations of the above ranges are also possible (e.g., greater than or equal to 50 PSI and less than or equal to 500 PSI). Other ranges are also possible.

[0310] As described herein, in some embodiments, the article comprises at least a first thermoplastic layer disposed between the first component and the second component. In some embodiments, the second component is placed on or adjacent to the first component prior to adsorption of the second water-soluble polymer. In some embodiments, the second component is placed on or adjacent to the first component after adsorption of the second water-soluble polymer and after re-extraction of the second water-soluble polymer with a solvent. In some embodiments, the article comprises: a first component comprising a water-soluble polymer and a plurality of pores; a second component comprising a first thermoplastic material disposed within at least a portion of the plurality of pores; and a third component associated with (e.g., adjacent to, directly adjacent to, or on top of) the second component, comprising the second thermoplastic material.

[0311] These materials can be fabricated into tough, high-strength materials with smooth, biocompatible surfaces. Nanoporous and microporous solids with exceptionally high Young's modulus and tensile strength are described in this paper. Nanoporous materials are solids containing interconnected pores with diameters up to 100 nm. Methods for manufacturing hydrogels are also described. Hydrophilic polymers can be used to fabricate these diverse porous solids, resulting in hydrophilic solids. The water content of nanoporous or microporous solids at EWC can be high, for example, 50% w / w. The water content of hydrogels can, in principle, be even higher, for example, up to 90% w / w. Porous solid materials can be used to fabricate a variety of devices, including medical catheters and implants, with significantly reduced adsorption and / or adhesion of biological components to their surfaces.

[0312] These or other porous materials can be processed to incorporate polymers bulked into the pores of a solid. One embodiment of the material is a porous material comprising a water-soluble polymer embedded in the pores of the material. It has been observed that polymers embedded by this method are present in the pores and remain in the pores after repeated hydration and dehydration. The embedded polymer provides a scratch-resistant and effectively permanent surface, wherein the incorporated polymer provides desired properties beyond the outer surface of the material. In aqueous media, hydrophilic polymers embedded by this method are hydrated and extended beyond the surface to enhance biocompatibility and smoothness. Methods for manufacturing the material may include extrusion, resulting in devices with a high aspect ratio. One embodiment of a method for manufacturing the material involves: heating a mixture comprising at least one water-soluble polymer and a solvent to a temperature above the melting point of the polymer solution, molding the mixture in a solvent-removing environment to produce a crosslinked matrix, and continuing solvent removal until the crosslinked matrix is ​​a micron-porous or nanoporous solid material. Crosslinking may occur simultaneously with cooling of the mixture and / or in a solvent-removing environment. Additional polymers may be incorporated into the pores of the material.

[0313] The articles described herein (e.g., catheters) can be made using any suitable method. Exemplary methods of manufacturing such catheters can be found, for example, in U.S. Patent Publication No. 2018 / 0369454, entitled "HIGH STRENGTH POROUS MATERIALS INCORPORATING WATER SOLUBLE POLYMERS" and U.S. Patent Publication No. 2020 / 0230295, entitled "HIGH STRENGTH POROUS MATERIALS FOR CONTROLLED RELEASE", each of which is incorporated herein by reference for all purposes.

[0314] Those skilled in the art, upon reading this disclosure, will be able to adapt its principles based on what is known about extrusion or other molding technologies to obtain alternative methods and apparatus for achieving the same end product as described herein. An expanded embodiment of this method can be adapted for, for example, a multi-zone screw extruder that provides the solvent mixture via a suitable injector or hopper and has zones controlled to provide cold extrusion. Features such as those of an injector pump can be replaced by a properly metered and controlled liquid or solid polymer feeding system.

[0315] In some embodiments, the methods described herein do not involve freeze-thaw processes and / or freezing and / or thawing processes. Furthermore, the methods can be used to produce solid porous materials with little or no swelling, for example, swelling from 0% to 100% w / w at EWC, even in the absence of covalent crosslinking agents. Those skilled in the art will readily recognize that all ranges and values ​​between clearly defined limits are to be expected, wherein, for example, any of the following may be used as upper or lower limits: 0, 5%, 10%, 15%, 20%, 25%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, 100% w / w, wherein swelling is measured as: swelling% = 100 × (total weight at EWC - dry weight) / dry weight, where dry weight is the weight of the material without water.

[0316] In some embodiments, the extruded sample has a horizontal chain orientation and arrangement along the sample length (in the extrusion direction). This refers to the polymer chain orientation generated during extrusion. It is not intended to be theoretically constrained, but it is believed that in some embodiments, this horizontal chain orientation and arrangement along the sample length contributes to an increase in inner and / or outer diameter by a percentage greater than the percentage increase in length as the sample expands.

[0317] In some embodiments, a combination of one or more of the following is useful: extrusion of a hydrophilic polymer in a solvent; cold extrusion; and extrusion into a bath to rapidly remove the solvent from the extrudate. Furthermore, in some embodiments, additional solvent removal and / or annealing processes provide further utility for producing the desired porous solids.

[0318] In some embodiments, the requirement for nanoporous materials includes a high polymer concentration of more than about 10% w / w in the polymer-solvent mixture with a high level of crosslinking. Those skilled in the art will readily recognize that all ranges and values ​​between well-defined limits are to be expected, where, for example, any of the following can be used as an upper or lower limit: 10%, 12%, 15%, 16%, 17%, 18%, 19%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 70%, 80%, 90%, 95%, or 99% w / w of polymer by weight of the total polymer-solvent mixture. In some embodiments, the polymer is substantially solvated, meaning it is a true solution, or at least half of the polymer is dissolved and the remainder is at least suspended. In some embodiments, solvation of the polymer facilitates the alignment of polymer chains during extrusion and crosslinking between polymers. High concentrations of the starting polymer-solvent mixture may contribute to this, without being limited by any particular theory. According to some embodiments, it is considered that the possible chain alignment of the material as it passes through the die promotes more intrapolymer crosslinking relative to interpolymer crosslinking. In some embodiments, it is believed that extrusions or otherwise formed mixtures entering a desolvation environment (whether gaseous or liquid) will further collapse the pore structure before the dense, concentrated polymer is fully crosslinked, thereby improving link closeness and promoting additional crosslinking density. In some embodiments, it is helpful to deposit the extruded or otherwise formed material directly into a solvent-removed environment. In some embodiments, further solvent removal may continue to cause the material to collapse until a desired endpoint in terms of structure and / or properties is reached. In some embodiments, an annealing process may further enhance strength.

[0319] On the other hand, freezing methods rely on enhancing reinforcement by forcing the hyperconcentrated microregions to also achieve link proximity and improve crosslinking density, while maintaining macroporosity due to the presence of ice crystals in the overall gel structure. Desolvation produces forced hyperconcentrated microregions, but these do not create macropores. Conversely, gels pre-formed prior to dehydration or freezing form with macropores due to the nature of the method. Furthermore, the inventors' work demonstrates that such nanoporous solids exhibit greater strength than macroporous materials.

[0320] Hydrogels can also be manufactured by using a lower polymer concentration in the polymer-solvent mixture, typically less than 10% w / w of polymer in the polymer-solvent mixture. Those skilled in the art will readily recognize that all ranges and values ​​between well-defined limits are to be expected, where, for example, any of the following can be used as upper or lower limits: 2%, 5%, 7%, 8%, 9%, or 10% w / w of polymer by weight of the total polymer-solvent mixture. Alternatively or concurrently, the polymer-solvent mixture is not extruded into a solvent removal environment.

[0321] Micron-porous materials can be fabricated under process conditions intermediate between nanoporous solids and hydrogels. One embodiment involves fabricating the material using conditions comparable to those for manufacturing nanoporous materials, but stopping solvent removal before reaching the nanoporous solid structure.

[0322] Extruding hydrophilic polymers in solvents can help produce high-strength materials. At least, the use of solvents in extrusion starting materials is uncommon. Typically, extrusion uses a solid material that has been heated to a flowable temperature, then extruded and subsequently cooled by various methods. For example, thermoplastic extrusion of pure PVA is considered feasible. However, such extrusion lacks the polymeric structure required to create porous solids and instead exhibits properties more similar to conventional thermoplastic plastics. According to operational theory, pure PVA extrusion will lack the quality of hydrogen bonding that occurs in aqueous ionic solvents. The temperatures suitable for preparing flowable PVA in extrusion will produce poorly cohesive material at the die, preventing the formation of continuous shapes. It is difficult to produce extruded PVA to form high aspect ratio shapes, such as tubes, and it is difficult to use them in extrusion methods. PVA and other hydrophilic polymers have high viscosity and are difficult to dissolve. A narrow operating temperature band has been observed to be particularly useful, for example, 85°C to 95°C. Below approximately 85°C, PVA cannot truly melt and therefore cannot be completely transformed into an amorphous form for extrusion. Above approximately 95°C, losses from boiling and evaporation render the method inefficient. These temperature ranges can be compensated for by increasing the pressure above atmospheric pressure, but the use and scaling up of pressurized systems present challenges. These methods are effective at temperatures below the boiling point of the polymer-solvent materials.

[0323] When exiting the mold, the cohesive strength of the flowing polymer-solvent mixture is relatively weak. Using a core to support the mixture at the mold is useful for maintaining its shape there. This contrasts with typical core extrusion used as a coating method (e.g., coated wires for mobile phone chargers). Typical methods that avoid the use of solvents or significant solvent concentrations have relatively high cohesive strength, allowing them to easily retain the tube after exiting the mold and not rely on active bonding, such as hydrogen bonding in hydrophilic polymers that form a coherent shape as the solid material is removed from the mold.

[0324] It is useful to place the molded polymer-solvent mixture in a solvent-removing environment. Most extrusions do not use bath temperatures equal to or below room temperature. Furthermore, the use of a solvent-removing bath is atypical compared to conventional methods; the bath, or other solvent-removing environment, helps the extruded material to solidify sufficiently to remain stable at the core and concentric, otherwise the melt would become teardrop-shaped. It would also be destroyed at the end of extrusion when attempting to collect it, as it is still molten. Conventional baths containing water cause PVA or similar hydrophilic polymer materials to lose their shape due to swelling, dissolution, or both. Molding methods involving the preparation of polymer-solvent mixtures (forming them in a mold and subsequently placing them in a solvent-removing environment) do not have the advantage of the chain alignment observed in extrusion. However, properly controlled temperature and solvent removal can produce materials with high strength and controlled pore structure.

[0325] Porous solids are highly smooth and can be used in a hydrated state, and can be readily bonded to other materials. In the case of conduits, for example, extensions, Luer locks, suture wings, etc., are available. In some embodiments, it is useful to extrude the copolymer in a range of 0.1% to 10% w / w or not exceeding 10% w / w of the second polymer, and not exceeding 5% w / w is also useful. Those skilled in the art will readily recognize that all ranges and values ​​between clearly defined limits are contemplated, wherein, for example, any of the following may serve as upper or lower limits: 0.1, 0.2, 0.4, 0.5, 0.8, 1, 2, 3, 4, 5, 6, 8, 10% w / w.

[0326] In some implementations, salt is useful for controlling the strength of the material. Not limited to any particular theory, salt can be part of physical cross-linking, effectively acting as a low-molecular-weight cross-linking agent between polymer chains.

[0327] Some embodiments of polymer blends include at least one first hydrophilic polymer and at least one second hydrophilic polymer in a solvent, which are extruded as described herein. Some examples include PVA, PAA, PEG, PVP, polyalkylene glycol, combinations of one or more hydrophilic polymers, and combinations thereof. Some examples of concentrations include at least one second hydrophilic polymer present in amounts from 1 part to 10,000 parts of the first hydrophilic polymer. Those skilled in the art will readily recognize that all ranges and values ​​between the clearly defined limits are contemplated, wherein, for example, any of the following may be used as an upper or lower limit: 1, 2, 10, 100, 1000, 1500, 2000, 2500, 3000, 4000, 5000, 6000, 7000, 8000, 9000, 10000 parts. Some examples of polymer concentrations in polymer-solvent mixtures include a first polymer present at a first concentration and one or more additional polymers present at a second concentration, wherein the concentrations of the first polymer and the additional polymers are independently selected from: 0.1% to 99%, for example, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 25%, 30%, 33%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% w / w. In addition, non-hydrophilic polymers and / or non-hydrophilic blocks in block polymers may be present, wherein the concentration of such polymers and / or such blocks is typically less than about 10% w / w, for example, 0.1%, 0.2%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10% w / w.

[0328] Some implementations include a porous matrix conditioned with a water-soluble polymer, which loses no more than 20% to 90% w / w of the water-soluble polymer under comparable conditions; those skilled in the art will immediately recognize that all ranges and values ​​between well-defined limits are to be expected, such as 20%, 25%, 30%, 33%, 40%, 50%, 60%, 70%, 80%, and 90% w / w.

[0329] In some embodiments, the bulk-incorporated material can be presented as a monolayer on the surface. The term monolayer means a layer the thickness of a single molecule. A monolayer does not depend on the cohesion between molecules within the monolayer to remain stably present on the surface. At least one water-soluble polymer forms the monolayer. In contrast, even the thickness of a thin polymer coating that is self-crosslinked corresponds to the thickness of a network formed by the crosslinked polymer. For example, a crosslinked PVA coating can be formed on the surface, but such a coating depends on the interconnection between PVA molecules and necessarily forms a crosslinked network. Therefore, some embodiments include water-soluble polymers that are present on the surface of a porous solid but are not covalently bonded to the surface and that are not part of the network.

[0330] In some embodiments, the bulk-incorporated polymer is persistently incorporated. In contrast, in most or all cases, only layers adsorbed to the underlying material, such as water-soluble materials applied by dip coating or spraying, can be substantially removed from the hydrophilic substrate, meaning that at least 90% w / w of the material can be separated from the underlying material in aqueous solution (e.g., in physiological saline at 90°C for 24 hours). Covalently bonded material will not be removed under these conditions, and some physical cross-linked networks of the water-soluble polymer may not be removed, but such networks are not preferred compared to bulk-incorporated polymers; for example, they may have greater thrombogenicity or lower persistence. Covalent bonding involves the use of chemically reactive components, which can be avoided by bulk incorporation methods.

[0331] This document provides methods for producing biocompatible porous solids, such as micron- or nanoporous solid materials with low protein adsorption properties, providing a basis for non-biofouling devices. Surface properties and other properties with reduced protein adsorption can be provided by modifying the starting polymer concentration, molecular weight, solvent removal, molding process, and hardening / annealing process. Some embodiments involve producing a variety of continuous shapes by extruding polymer mixtures. The mixtures can be further hardened and annealed. These processes can be used to produce tough and highly smooth materials. Some embodiments involve extruding polymer mixtures into shapes with single or multiple cavities having different diameters and wall thicknesses.

[0332] One embodiment of a method for manufacturing nanoporous solid materials includes: heating a mixture comprising a polymer and a solvent (the polymer mixture), extruding the mixture into a solvent-removing environment, and removing the solvent from the crosslinked matrix until a nanoporous solid material is formed. According to the method, one or more of these actions can be combined. Additionally, cooling the mixture as it exits the mold is useful. Not limited to any particular operational theory, it is shown that crosslinking the polymer during passage through the mold initially forms a porous matrix that is not a true nanoporous solid material because, although it has spaces between the polymer strands, it lacks a pore structure. When the solvent is removed under suitable conditions, the crosslinked structure becomes a nanoporous solid. Crosslinking begins when the polymer mixture is extruded through the mold and as the mixture cools. Crosslinking can continue during solvent removal. The transformation to form a nanoporous material occurs with solvent removal and is generally considered to be complete or substantially complete (meaning 90% or more) at this stage. The resulting material can be further processed by annealing, with or without additional solvents or plasticizers. The process, as well as other extrusion or other molding processes and / or materials (including bulk incorporation processes) described herein, may not contain one or more of the following: covalent crosslinking agents, agents that promote covalent crosslinking, radiation that crosslinks polymer chains, freezing, thawing, freeze-thaw cycles, more than one freeze-thaw cycle, ice crystal formation, foaming agents, surfactants, hydrophobic polymers, hydrophobic polymer segments, reinforcing materials, wires, braids, non-porous solids, and fibers.

[0333] Porous materials can be manufactured via an extrusion process that involves passing a polymer mixture through a die into a cooling environment. The cooling environment can also be a solvent removal environment. It is a dehydration environment when the solvent is water. The die may have a core through which the polymer mixture can be shaped to form around the core. Additional solvent removal and / or annealing environments may be used.

[0334] Extrusion processes for polymer-solvent mixtures can be carried out in the form of cold extrusion. The term cold extrusion refers to a process involving passing a polymer-solvent mixture through a die without heating the mixture above its boiling point throughout the preparation and extrusion of the mixture. Therefore, in cold extrusion, the die is kept below the boiling point of the polymer-solvent mixture. While many solvents can be used, water is often a useful solvent, in which case the die is kept at 100°C or lower; however, as discussed above, even lower temperatures can be beneficial.

[0335] The term polymer mixture refers to a polymer in solution dissolved or suspended in a solvent. The solvent can be, for example, water, an aqueous solution, an organic solvent, or a combination thereof. Heating a polymer mixture may involve heating the mixture to a temperature above the melting point of the polymer. Generally, when a solution reaches its melting point, it changes from a turbid state to a clear state. Aqueous solutions contain water, for example, 10% to 100% (w / w or v / v) of the liquid; those skilled in the art will readily recognize that all ranges and values ​​between well-defined limits are expected, such as 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90%, or at least one of these.

[0336] Extrusion is a method that can be used to shape materials. Other shaping methods can be used, such as molding, casting, or thermoforming of polymer-solvent mixtures. Generally, polymer-solvent mixtures are prepared without boiling and shaped into a certain form, which is then exposed to controlled solvent removal conditions using the guidance provided herein to produce nanoporous or microporous materials. Annealing processes may be included. Hydrogels that are not microporous or nanoporous materials can also be produced.

[0337] Heated polymer mixtures can be molded or otherwise shaped as they cool, or molded / shaped and immediately cooled. Molding is a broad term referring to transforming material from an amorphous molten state into an end-user product or into an intermediate shape for further processing. Molding includes casting, layering, coating, injection molding, drawing, and extrusion. Molding can be performed using injection molding settings, where the mold is made of a material with thermally conductive properties, making it easy to heat to enhance the flow of the injected polymer mixture and to cool rapidly in a cooling environment. In other embodiments, the molding process can be accomplished by extruding the polymer mixture through a mold to form a continuous material.

[0338] Cooling the polymer mixture may include, for example, cooling the extruded material, such as when passing the polymer material through a die. One embodiment of cooling is a temperature at least 20°C lower than the boiling point of the polymer mixture or, alternatively, at least 20°C lower than the polymer mixture's Tm, for example, a liquid bath at 20, 30, 40, 50, 60, 70, 80, 90, 100, or 110°C below the boiling point or polymer Tm, or, alternatively, a bath or other environment at a temperature between -50 and 30°C; those skilled in the art will readily recognize that all ranges and values ​​between clearly defined limits are contemplated, wherein, for example, any of the following may be used as upper or lower limits: -50, -45, -25, -20, -10, -5, -4, 0, 15, 20, 25, 30°C. Cooling can be carried out in a solvent-free environment. Freezing temperatures are avoided. The polymer chains are cooled to a point that promotes intermolecular hydrogen bonding and immobilizes chain motion, without being limited by any particular operating theory. This can occur at temperatures up to 30°C, or even higher if time permits. The bath can be aqueous and, by adjusting it with salt or other penetrants, can be provided with a certain osmotic value to remove solvents from aqueous materials with relatively lower osmotic values ​​through osmotic pressure and diffusion. The bath can also be other solvents that freeze at lower temperatures than water, thus allowing the use of temperatures below 0°C without freezing the solvent or material. For example, in the case of hydrophilic copolymers used in conjunction with PVA, temperatures above 20°C can be used for crosslinking, and chain fixation will occur at much higher temperatures.

[0339] A solvent removal environment refers to an environment that significantly accelerates solvent removal compared to drying under ambient conditions. Such an environment can be unheated, meaning it is not higher than ambient temperature, for example, not higher than 20°C. Such an environment can be a vacuum, such as a vacuum chamber, a salt bath, or a bath for removing solvents from a polymer mixture. For example, an aqueous polymer mixture can be introduced into an ethanol bath, replacing the water with ethanol. The ethanol can then be removed. A salt bath can be, for example, a high salt concentration bath (1 M to 6 M). The treatment time in the solvent removal environment and / or during cooling can be independently selected from 1 to 240 hours; those skilled in the art will immediately recognize that all ranges and values ​​between clearly defined limits are to be expected, where, for example, any of the following can be used as an upper or lower limit: 1, 2, 5, 10, 24 hours; 1, 2, 5, 7, 10 days. The salt can be a salt that dissociates to produce ions with single, double, or triple charges.

[0340] One or more solvents can be used to remove the environment, or an environment can be adjusted for temperature. Therefore, a cooling bath can be used, followed by solvent removal in an oven or vacuum oven. Washing steps can be performed before or after cooling or solvent removal, for example, by immersion in a series of solvents of different concentrations, different salt solutions, different proportions of ethanol, or other solvents.

[0341] One implementation involves immersing extruded material, which has already undergone solvent removal processes (including exposure to salt baths), in a series of H2O baths (new or replaced) for a period of time (e.g., 2 to 48 hours, 4 to 24 hours) to remove excess salt from the casting material or end-user equipment. The material is then removed from the washing step and dehydrated to remove excess water. Dehydration can be carried out at temperatures, for example, from 20°C to 95°C. Dehydration is typically carried out at 37°C for more than 24 hours.

[0342] One embodiment involves a polymer mixture that has been extruded or otherwise molded, subsequently exposed to a high-salt concentration bath (1 M to 6 M) for an inversely related duration; the high salt concentration shortens the required soaking time; for example, soaking it in a 6 M NaCl solution for 16 to 24 hours. After soaking, the material is rinsed to remove the salt solution. This material is now tough and can be removed from any molded part that has been present since the initial molding. Alternatively, after salt or other baths, the material is soaked in a water bath and dehydrated to remove excess water. Dehydration can be carried out at temperatures from 20 to 95°C. Dehydration can be carried out at 37°C for more than 4 hours, more than 24 hours, or 2 to 150 hours; those skilled in the art will immediately recognize that all ranges and values ​​between the clearly defined limits are to be expected, of which, for example, any of the following can be used as upper or lower limits: 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 150 hours. For example, it has been observed that dehydration at 40°C for 6 to 24 hours is useful.

[0343] In another embodiment, NaCl is incorporated into the starting polymer solution at a concentration of 0.1 to 3 M per volume of the final polymer mixture. The polymer is dissolved in the heated solution under stirring, which is then allowed to reach above its melting point. Dry NaCl is slowly added to the solution under stirring until completely dissolved. The slightly turbid solution is then introduced into the feed for shaping by injection molding, casting, extrusion, and / or drawing. At the end of each process, quenching is performed to rapidly reduce the temperature and form a solid material. In this embodiment, additional salt soaking is not required. After the material has hardened, if necessary, it is removed from any molding process component and rinsed in water to remove salt and dehydrate.

[0344] When used in the context of semi-crystalline polymers or solid porous materials, the term annealing refers to heat treatment at an annealing temperature comparable to the melting temperature of the polymer in the relevant material. This temperature is typically lower than the melting temperature on an absolute temperature scale and is within about 0 to 15% of the melting temperature. Plasticizers or other additive materials can affect the melting temperature, usually by lowering it. For example, for pure PVA, the annealing temperature will be within about 10% of the melting point of PVA; in the presence of other materials, the annealing temperature is typically lower. One operational theory is that annealing is a stress-mitigating process combined with an increase in the size of the crystalline regions in the annealed material. Unlike metals, annealing increases the strength of the annealed material. Annealing can be performed in one or more of the following conditions: in air or in a gas or in the absence of oxygen or water, such as in nitrogen, in a vacuum nitrogen atmosphere, under argon, using an oxygen scavenger, etc. For example, experiments have been conducted to anneal dehydrated PVA nanoporous materials. Annealing is used to increase the crystallinity of the PVA network, further reducing the pore size of the PVA network and decreasing the adsorption properties of the final gel surface. Annealing can be carried out at temperatures, for example, 100 to 200°C; in a preferred embodiment, this step is performed by immersing the dehydrated gel in a mineral oil bath. Incorporating the polymer bulk into the porous solid may also include the annealing process already described above for the porous solid. Annealing can be performed after exposing the desolvated porous solid to a mixture containing the polymer to be incorporated. Depending on the residual solvent content and / or the presence of a second hydrophilic polymer to be incorporated, the Tg of the material can be increased or decreased. As already described, the annealing process conditions can therefore be adjusted to depend on the temperature, time, heating rate, and cooling rate of the substrate.

[0345] Annealing can be performed in a gas or liquid under ambient pressure, elevated pressure, or low pressure (vacuum pressure). The liquid can be a low molecular weight polymer (up to 2000 Da) or other materials (e.g., mineral oil). Some examples of low molecular weight polymers are silicone oil, glycerol, polyols, and polyethylene glycol with a molecular weight of less than 500 Da. A useful embodiment involves annealing in a glycerol bath at, for example, 140°C for 1 to 3 hours; glycerol is used to further reduce the fouling properties of the gel through the interaction and neutralization of free hydroxyl terminal groups in the PVA network. The annealed nanoporous material is then cooled, removed from the annealing bath, and rinsed off the bath medium using a series of extended soaking rinses. The product is then dehydrated in preparation for final sterilization.

[0346] Various types of dies can be used, such as longitudinal, angular, transverse, and helical extruders, as well as single-polymer extruders for extruding a single polymer and multilayer extruders for simultaneously extruding multiple polymer layers or other layers. Continuous operation heads and cyclic extruders can be used. Various materials can be incorporated into the layers or as layers: for example, reinforcing materials, fibers, wires, braided materials, braided yarns, braided plastic fibers, etc. Similarly, such materials may not be excluded. Furthermore, porous solids can be made with certain properties, such as Young's modulus, tensile strength, solids content, polymer composition, porous structure, or solvent content, which are known and therefore can be measured independently of a variety of other materials. Therefore, some embodiments include the materials disclosed herein, which are described based on the properties of these materials, without regard to a variety of other incorporated materials. For example, nanoporous solids have a known specific Young's modulus, even if the material has reinforcing wires that contribute to further strength.

[0347] The core can be used with an extrusion die. The core can be air, water, liquid, solid, non-solvent, or gas. Those skilled in the art will recognize that a variety of extrusion methods can utilize these different types of cores. Cores made of polytetrafluoroethylene (PTFE) tubing are useful. In some embodiments, the core is a wire.

[0348] Multi-lumen tubes have multiple channels running through their profile. These extrudates can be custom-modified to meet device designs. Multi-lumen tubes are available with variable outer diameters (OD), various custom inner diameters (ID), and multiple wall thicknesses. These tubes are available in a variety of shapes: round, oval, triangular, square, semi-circular, and crescent-shaped. The lumens can be used for wires, fluids, gases, cables, and a variety of other applications. The number of lumens in a multi-lumen tube is limited only by the size of the OD. In some implementations, the OD can be as large as 0.5 inches, the ID as small as 0.002 inches, and the core and wall thicknesses as thin as 0.002 inches. Tight tolerances are maintained at + / - 0.0005 inches. A skilled technician will immediately recognize that all ranges and values ​​within the clearly defined limits are predictable, where any of the following may be used as upper or lower limits for OD and / or ID: 0.002, 0.003, 0.004, 0.007, 0.01, 0.02, 0.03, 0.04, 0.05, 0.1, 0.2, 0.3, 0.4, and 0.5 inches. Tolerances may be, for example, 0.0005 to 0.1 inches; a skilled technician will immediately recognize that all ranges and values ​​within the clearly defined limits are predictable, where any of the following may be used as upper or lower limits: 0.0005, 0.001, 0.002, 0.003, 0.006, 0.01, 0.02, 0.03, 0.06, 0.8, 0.9, and 1 inch.

[0349] Braided reinforced tubing can be manufactured in a variety of structures. For example, it can be braided using round or flat, single-ended or double-ended wires as small as 0.001 inches. A variety of materials are available for manufacturing braided reinforced tubing, including stainless steel, beryllium copper, and silver, as well as monofilament polymers. The braid can be wound at varying weft densities on many thermoplastic substrates, such as nylon or polyurethane. The advantages of braided tubing shafts are their high torsional strength and kink resistance. By changing several factors during the braiding process, the characteristics of the tubing can be altered to suit performance requirements. After braiding is complete, a secondary extrusion can be applied to the top of the braided tubing to encapsulate the braid and provide a smooth finish. Wall thicknesses as thin as 0.007 inches can be achieved when braided reinforced tubing is required.

[0350] Porous solids, such as nanoporous materials, microporous materials, and strong hydrogels, can be used to manufacture catheters or medical fibers. These can be formulated as polymers with bulk incorporation and can possess a variety of characteristics described for them. Some examples of catheters include central venous catheters, peripheral central catheters, midline catheters, peripheral catheters, tunneled catheters, dialysis access catheters, urinary catheters, nerve catheters, peritoneal catheters, intra-aortic balloon pump catheters, diagnostic catheters, interventional catheters, drug delivery catheters, etc.), shunts, wound drainage devices (external, including ventricular, intra-abdominal, and intra-lumbar cisterns-peritoneal), and infusion ports. Porous solids can be used to manufacture implantable devices, including permanent or temporary fully implantable and percutaneous implantable devices. Porous solid materials can be used to manufacture blood-contact devices or devices that contact body fluids, including ex vivo and / or in vivo devices, and include blood-contact implants. Examples of such devices include: drug delivery devices (e.g., insulin pumps), tubing, contraceptive devices, feminine hygiene products, endoscopes, implants (including those with a diameter <6 mm), pacemakers, implantable cardioverter-defibrillators, cardiac resynchronization devices, cardiovascular device guides, ventricular assist devices, catheters (including cochlear implants, endotracheal tubes, tracheostomy tubes, drug delivery ports and tubes, implantable sensors (intravascular, percutaneous, intracranial), ventilator pumps, and ophthalmic devices, including drug delivery systems. Catheters may contain tubular nanoporous materials that engage with other devices using fasteners (e.g., Luer fasteners or fittings). Radiopaque agents can be added to the materials, fibers, or devices. The term radiopaque agent refers to a reagent commonly used in the medical device industry to add radiopaque properties to materials, such as barium sulfate, bismuth, or tungsten. RO agents can be incorporated, for example, at 5% to 50% w / w of the total solids weight, such as 5%, 10%, 20%, 30%, 40%, or 50%.

[0351] Medical fibers made from porous solid materials include, for example, sutures, yarns, medical textiles, braids, meshes, knitted or woven meshes, nonwoven fabrics, and applications based on them. The fibers are strong yet flexible. These fibers can be used to manufacture materials that resist fatigue and abrasion.

[0352] In one exemplary embodiment, the method includes applying a polymeric material comprising a water-soluble polymer and having an aspect ratio greater than or equal to 3:1 to the external opening of an object, wherein the application of the article does not involve the use of a sheath guide. The polymeric material is substantially non-thrombotic, has a water content in a dehydrated state of less than 5 w / w% and greater than or equal to 0.1 w / w%, and is configured to swell from a dehydrated state to an equilibrium water content state in an amount greater than or equal to 5 w / w% and less than or equal to 50 w / w% over a period of less than or equal to 60 minutes.

[0353] Example

[0354] Example 1

[0355] A sample of PVA extruded was prepared by heating 200 g of distilled water in a jacketed reaction vessel at 95°C and allowing heating to that temperature. 40 g of PVA (Sigma, 146k-186k) was added over a 5-minute interval while mixing at 200 RPM. The polymer was mixed at 300 RPM for 1.5 hours. The polymer was then degassed at 90°C for less than 2 hours. The polymer was then extruded into ethanol at -23°C and stored in ethanol at -25°C in a freezer for 24 hours. The sample was dried for 6 hours.

[0356] After drying, the sample was immersed in glycerol at 120°C for 17 hours. After annealing, the sample was removed and cooled, then rinsed with ethanol; the core was removed after rinsing. The sample was then dried at 50°C for 12 hours.

[0357] A PVA sample containing barium sulfate was prepared by heating 50 g of water in a jacketed reaction vessel at 90 °C. 4 g of barium sulfate and 50 g of water were homogenized at 11 k RPM for 15 minutes and then added to the jacketed vessel. The mixture was stirred for 10 minutes and then heated. After heating, 16 g of PVA (Sigma, 146 kJ-186 kJ) was added, and the mixture was stirred at 360 RPM for approximately 2 hours.

[0358] The PVA-RO polymer mixture was heated to 90°C and extruded into -16°C ethanol. The extrudate was dehydrated at -25°C for 24 hours. The core was removed, and the sample was dried in an incubator at 50°C for approximately 6 hours. After drying, the sample was immersed in 120°C glycerol (Sigma) for 17 hours. After annealing, the sample was removed and cooled, then rinsed with distilled water. The sample was dried at 50°C for 12 hours and packaged for testing.

[0359] Nonthrombotic durability testing was performed on the samples at Thrombbodyne, Inc. (Salt Lake City, UT). Each sample was cut into 15 cm lengths, with N=5 samples per sample group. Prior to testing, the samples were sterilized using 12 hours of ethylene oxide exposure; the samples were then hydrated in distilled water for approximately 48 hours before evaluation to represent clinical use.

[0360] Will have self 111 Fresh heparinized bovine blood labeled with platelets was aliquoted into multiple portions for test samples and control evaluation. Samples were inserted into an extracorporeal blood flow circuit in a 0.25-inch ID PVC tube for approximately 120 minutes. Blood was maintained at 98°C and pumped through the blood circuit using a peristaltic pump during the test. Thrombosis was initially detected in the sample after 45 minutes in the blood flow circuit and removed at 120 minutes. At the end of the experiment, the device was removed from the tube, rinsed with saline, and placed in a gamma counter for thrombus quantification. Each experiment consisted of an independent flow system for each test sample and / or circulating blood from a control from the same animal to allow for simultaneous comparison without cross-effects.

[0361] The radioactivity of the samples was measured, and the specific type of thrombus accumulation (i.e., adhesion or fibrin accumulation) was also qualitatively assessed. The percentage of thrombus formation was calculated relative to the mean thrombus formation observed in the circulating blood of each animal across all test and control groups.

[0362] Other definitions

[0363] The term "medically acceptable" refers to a highly purified material that is free of contaminants and non-toxic. The term "consistently composed of..." as used in the context of biomaterials or medical devices refers to a material or device having no more than 3% w / w of other materials or components, and said 3% will not render the device unsuitable for its intended medical use. Equilibrium water content (EWC) is a term that refers to the water content of a material when its wet weight becomes constant and before the material degrades. Generally, materials with high solids content are observed to be at equilibrium water content after 24 to 48 hours. For the purpose of measuring EWC, distilled water is used unless otherwise specified.

[0364] The term w / v refers to weight per volume, such as g / L or mg / mL. The terms biomaterials and biomedical materials are used interchangeably herein and include biomedically acceptable materials for use in the biomedical field, such as for implants, catheters, blood contact materials, tissue contact materials, diagnostic assays, medical devices, tissue sample processing, or other medical purposes. Furthermore, while the materials described are suitable for biomedical applications, they are not limited thereto and can be produced as general-purpose materials. Physiological saline refers to a phosphate buffer solution having a pH of 7 to 7.4 and a human physiological osmolarity at 37°C.

[0365] The term molecular weight (MW) is measured in g / mol. Unless otherwise specified, the MW of a polymer refers to weight-average MW. When the polymer is part of a porous solid, the term MW refers to the polymer before crosslinking. When specifying the distance between crosslinks, unless otherwise specified, it is the weight-average MW between crosslinks. The abbreviations k for thousand, M for million, and G for billion, so 50k MW means 50,000 MW. Dalton is also a unit of MW, and when used for polymers, it also refers to the weight-average value.

[0366] Publications, journal articles, patents, and patent applications cited herein are incorporated herein for all purposes, wherein, in the event of conflict, this specification shall prevail. Features of the embodiments described herein may be combined and matched as directed by the need to produce an operable method or product.

[0367] The term "therapeutic agent" or "medicine" as used herein refers to an agent which is administered to a subject to treat a disease, disorder or other clinically recognized condition or for preventative purposes, and which has a clinically significant effect on the subject's body to treat and / or prevent the disease, disorder or condition.

[0368] As used herein, when a component is referred to as being “adjacent” to another component, it may be directly adjacent to that component (e.g., in contact with it), or there may be one or more intervening components. A component that is “directly adjacent” to another component means that there are no intervening components.

[0369] "Object" means any animal, such as a mammal (e.g., a human). Some non-limiting examples of objects include humans, non-human primates, cattle, horses, pigs, sheep, goats, dogs, cats, or rodents (e.g., mice, rats, hamsters), birds, fish, or guinea pigs. Generally, the invention is directed to use with humans. In some embodiments, the object may exhibit health benefits, such as after administration of a self-righting article.

[0370] As used herein, “fluid” is provided in its common sense, namely, liquid or gas. A fluid cannot maintain a definite shape and flows over an observable time period to fill the container in which it is placed. Therefore, a fluid can have any suitable viscosity that allows it to flow. If two or more fluids are present, a person skilled in the art can independently select each fluid in substantially any fluid (liquid, gas, etc.).

[0371] Although several embodiments of the invention have been described and illustrated herein, those skilled in the art will readily contemplate a variety of other methods and / or structures for performing the functions described herein and / or obtaining the results and / or one or more advantages described herein, and each of such variations and / or modifications is considered to be within the scope of the invention. More generally, those skilled in the art will readily understand that all parameters, dimensions, materials, and constructions described herein are intended to be exemplary, and actual parameters, dimensions, materials, and / or constructions will depend on one or more specific applications using the teachings of the invention. Those skilled in the art will recognize, or can determine, many equivalents of the specific embodiments of the invention described herein using only conventional experimentation. Therefore, it should be understood that the foregoing embodiments are given by way of example only, and that the invention may be practiced in ways other than those specifically described and claimed within the scope of the appended claims and their equivalents. The invention relates to each individual feature, system, article, material, kit, and / or method described herein. Furthermore, if such features, systems, articles, materials, kits and / or methods are not inconsistent with each other, any combination of two or more such features, systems, articles, materials, kits and / or methods is included within the scope of this invention.

[0372] Unless otherwise expressly stated, nouns without quantifiers used in the specification and claims herein shall be understood to mean “at least one / type”.

[0373] The phrase “and / or” as used in this specification and claims should be understood to mean “one or both” of elements that are co-existing in some cases and separate in others. Unless explicitly stated otherwise, other elements may optionally exist in addition to those specifically identified by the “and / or” clause, whether related to or unrelated to those specifically identified. Thus, as a non-limiting example, when used in conjunction with open-ended language such as “comprising / including,” reference to “A and / or B” may in one embodiment refer to A without B (optionally including elements other than B); in another embodiment, refer to B without A (optionally including elements other than A); in yet another embodiment, refer to both A and B (optionally including other elements); and so on.

[0374] As used herein in the specification and claims, “or / or” should be understood to have the same meaning as “and / or” as defined above. For example, when items in a list are separated, “or / or” or “and / or” should be interpreted as inclusive, i.e., including multiple elements or at least one of the elements in the list, but also including more than one, as well as optional additional items not listed. Only explicitly indicating the opposite terms, such as “only one” or “exactly one”, or when used in the claims, “consisting of” will refer to including multiple elements or an exact one of the elements in the list. In general, the term “or / or” as used herein, when preceded by an exclusive term (e.g., “any,” “one,” “only one,” or “exactly one”), should be understood only to indicate an exclusive alternative (i.e., “one or the other but not both”). “Substantially consisting of” when used in the claims should have its ordinary meaning as used in the field of patent law.

[0375] As used herein in the specification and claims, when referring to a list of one or more elements, the phrase "at least one" should be understood to mean at least one element selected from any one or more elements in the list, but does not necessarily include each and at least one of each element specifically listed in the list, and does not exclude any combination of elements in the list. This limitation also allows for the optional presence of other elements besides those specifically identified in the list, whether related to or unrelated to those specifically identified elements, in addition to those referred to by the phrase "at least one". Therefore, as a non-limiting example, "at least one of A and B" (or equivalently, "at least one of A or B", or equivalently, "at least one of A and / or B") in one embodiment may refer to at least one A, optionally including more than one A, while B is absent (and optionally including elements other than B); in another embodiment, it may refer to at least one B, optionally including more than one B, while A is absent (and optionally including elements other than A); in yet another embodiment, it may refer to at least one A, optionally including more than one A, and at least one B, optionally including more than one B (and optionally including other elements); etc.

[0376] In the claims and the above description, all conjunctions such as “comprising,” “including,” “with,” “having,” “containing,” “involving,” “holding,” etc., should be understood as open-ended, that is, as meaning including but not limited to. As described in Section 2111.03 of the U.S. Patent Examination Procedure Manual, only the conjunctions “consisting of” and “substantially consisting of” should be closed or semi-closed conjunctions, respectively.

[0377] Unless otherwise specified or indicated, any term used herein relating to, for example, one or more articles, structures, forces, fields, flows, directions / trajectories, and / or their subcomponents, and / or combinations thereof, and / or any other tangible or intangible element not listed above that is suitable for being characterized by such terms, or the shape, orientation, alignment and / or geometric relationship between them, shall be understood not to require absolute conformity to the mathematical definition of such terms, but rather to indicate conformity to the mathematical definition of such terms to the extent that the subject matter so characterized can be understood by a person skilled in the art most closely related to such subject matter. Examples of such terms relating to shape, orientation, and / or geometric relationships include, but are not limited to, terms describing the following: shape – e.g., circle, square, gomboc, ring, rectangle, triangle, cylinder, ellipse, (n) polygon, etc.; angular orientation – e.g., vertical, orthogonal, parallel, vertical, horizontal, collinear, etc.; contour and / or trajectory – e.g., planar, coplanar, hemispherical, semi-hemispherical, etc. Linear / linear, hyperbolic, parabolic, flat, curved, straight, arc-shaped, sinusoidal, tangent / tangent, etc.; direction - e.g., north, south, east, west, etc.; surface and / or bulk material properties and / or spatial / temporal resolution and / or distribution - e.g., smooth, reflective, transparent, clear, opaque, rigid, impermeable, homogeneous, inert, non-wetting, insoluble, stable, invariant, constant, homogeneous, etc.; and many other terms obvious to those skilled in the art. As an example, a manufactured article described herein as "square" does not require that such an article have perfectly planar or linear faces or sides intersecting at exactly 90-degree angles (in fact, such an article may exist only as a mathematical abstraction), but rather, as understood by those skilled in the art or as specifically described, the shape of such an article should be understood to approximate, to the extent generally achievable and realized by the exemplified manufacturing techniques, as mathematically defined as "square." As another example, two or more manufactured articles described herein as “aligned” will not be required to have perfectly aligned faces or sides (in fact, such articles may exist only as a mathematical abstraction), but rather, as those skilled in the art will understand or as specifically described, the arrangement of such articles should be understood to be close to “aligned” as mathematically defined to the extent that the exemplified manufacturing techniques are generally achievable and have been achieved.

Claims

1. An in vitro method, comprising: The following steps are performed using a marked catheter containing a plurality of separate segments spaced apart along at least a portion of the catheter, wherein the average shortest distance between each segment and its nearest neighboring segment is a first distance in a first configuration of the marked catheter: Introduce fluid into the labeled conduit; and At least a portion of the marked conduit is swollen from a first configuration to a second configuration, wherein the second configuration is at the equilibrium water content of the conduit. In the second configuration, the average shortest distance between each segment and its nearest neighbor segment is called the second distance, and The ratio of the second distance to the first distance is greater than or equal to 1.02:1 and less than or equal to 2:

1.

2. An in vitro method, comprising: The following steps are performed using a marked catheter comprising a plurality of separate segments spaced apart along at least a portion of the catheter, wherein the average shortest distance between each segment and its nearest neighboring segment is a first distance in a first configuration of the marked catheter: Introduce fluid into the labeled conduit; and At least a portion of the marked conduit swells from the first configuration to the second configuration. In the second configuration, the average shortest distance between each segment and its nearest neighbor segment is called the second distance, and in: (i) The second distance is equal to about 1 mm, about 1 cm, or about 10 cm; and / or (ii) The marker includes a number depicting the average shortest distance between the nearest neighbor markers of the catheter in the second configuration, wherein the average shortest distance between the nearest neighbor markers of the catheter in the second configuration is greater than or equal to 3 Fr and less than or equal to 34 Fr.

3. The method of claim 2, wherein the second configuration is at the equilibrium water content of the conduit.

4. The method of claim 1, wherein the second distance is greater than or equal to 0.5 cm and less than or equal to 5 cm.

5. The method of any one of claims 1 to 3, wherein the fluid comprises water, lactated Ringer's solution, dextrose, phosphate-buffered saline, Hanks' balanced salt solution, physiological saline, and / or physiological fluids.

6. The method of any one of claims 1 to 3, wherein the fluid comprises an isotropic salt solution.

7. The method of any one of claims 1 to 3, wherein the catheter comprises a first water-soluble polymer.

8. The method of claim 7, wherein the label comprises a second water-soluble polymer and a dye.

9. The method of claim 8, wherein the first water-soluble polymer and the second water-soluble polymer are different.

10. The method of claim 8, wherein the first water-soluble polymer and the second water-soluble polymer are the same.

11. The method of claim 1 or 2, further comprising: A labeling composition is placed on a conduit, wherein the placement includes automated inkjet deposition; The labeling composition is allowed to deposit into the catheter by at least 10 nm; as well as The marking composition is locked into the catheter, wherein the locking includes heat treatment, dehydration, lyophilization, or a combination thereof.

12. The method of claim 11, wherein the locking comprises thermal annealing.

13. The method of claim 11, wherein the labeling composition comprises water.

14. The method of claim 11, wherein the labeling composition comprises a water-soluble polymer.

15. The method of claim 11, wherein the marking composition comprises a dye.

16. The method of claim 11, wherein the labeling composition comprises a salt.

17. The method of any one of claims 1 to 3, wherein the second distance is equal to about 1 cm.

18. The method of any one of claims 1 to 3, wherein the second distance is equal to about 1 mm.

19. The method of any one of claims 1 to 3, wherein the second distance is equal to about 10 cm.

20. The method of any one of claims 1 to 3, wherein the catheter is selected from central venous catheters, peripheral catheters, dialysis access catheters, urinary catheters, nerve catheters, percutaneous endovascular angioplasty catheters, and peritoneal catheters.

21. The method of any one of claims 1 to 3, wherein the catheter is selected from peripheral central catheters, midline catheters, peripheral port catheters, central venous port catheters, and tunnel catheters.

22. The method of any one of claims 1 to 3, wherein the catheter is a venous catheter.

23. The method of any one of claims 1 to 3, wherein the catheter is a nerve catheter or an epidural catheter.

24. The method of any one of claims 1 to 3, wherein the catheter is configured for use in drainage, urinary, and / or dialysis applications.

25. The method of any one of claims 1 to 3, wherein the mark does not break or delaminate when the catheter swells from the first configuration to the second configuration.

26. The method of any one of claims 1 to 3, wherein the marker is configured such that when the catheter is placed in the patient, the marker does not substantially exhibit thrombus accumulation.

27. The method of any one of claims 1 to 3, wherein the catheter is configured such that when the catheter is placed in a patient, the catheter does not substantially exhibit thrombus accumulation.

28. The method of any one of claims 1 to 3, wherein the level of thrombus accumulation of the marker is within 50% of the level of thrombus accumulation in the portion of the catheter not containing the marker.

29. The method of any one of claims 1 to 3, wherein the marker is deposited or penetrates into the conduit to a depth greater than or equal to 0.1 μm and less than or equal to 200 μm.

30. The method of any one of claims 1 to 3, wherein the marker is deposited or penetrates into the conduit to a depth of greater than or equal to 1 μm.

31. The method of any one of claims 8 and 15, wherein the dye comprises greater than or equal to 0.001 w / w% of the mark and less than or equal to 1 w / w of the mark.

32. The method of any one of claims 8 and 15, wherein the dye comprises more than or equal to 0.001 w / w% of the mark and less than or equal to 0.1 w / w% of the mark.

33. The method of any one of claims 8 and 15, wherein the dye comprises an inactive dye.

34. The method of any one of claims 1 to 3, wherein the marking is applied to the conduit by liquid deposition, pad printing, screen printing, electrostatic spraying, hot stamping, and / or laser etching.

35. The method of any one of claims 1 to 3, wherein the marking is applied to the conduit by inkjet deposition and / or dip coating.

36. The method of claim 35, wherein the inkjet deposition method comprises performing pressurized liquid deposition.

37. The method of any one of claims 1 to 3, wherein the conduit is annealed.

38. The method of claim 37, wherein the annealing comprises heat annealing or dehydration.

39. The method of claim 38, wherein the heat annealing is performed at a temperature greater than or equal to 90°C and at atmospheric pressure or below atmospheric pressure for a time of greater than or equal to 30 minutes.

40. The method of any one of claims 1 to 3, wherein the first configuration has a water content greater than or equal to 20 w / w% and less than or equal to 40 w / w%.

41. The method of any one of claims 1 to 3, wherein the second configuration has a water content greater than or equal to 3 w / w% and less than or equal to 80 w / w%.

42. The method of any one of claims 1 to 3, wherein the ratio of the first distance to the second distance is greater than or equal to 1.02:1 and less than or equal to 2:

1.

43. The method of any one of claims 1 to 3, wherein the ratio of the first distance to the second distance is greater than or equal to 1.05:1 and less than or equal to 1.10:

1.

44. The method of any one of claims 1 to 3, wherein the conduit comprises a moisturizer.

45. The method of claim 44, wherein the moisturizer comprises glycerin.

46. ​​The method of any one of claims 1 to 3, wherein the conduit is rehydrated.

47. The method of claim 46, wherein the catheter is hydrated with a fluid comprising water, lactated Ringer's solution, dextrose, phosphate-buffered saline, Hanks' balanced salt solution, physiological saline, and / or physiological fluids.

48. The method of claim 46, wherein the hydration is performed for less than or equal to 10 minutes.

49. The method of any one of claims 1 to 3, wherein the swelling of the catheter is anisotropic with respect to the length, inner diameter, outer diameter, and / or total mass of the catheter.

50. Articles produced by the method of any one of claims 1-49.

51. Articles, which include: A catheter with multiple markings; The markings comprise a plurality of separate segments spaced apart along at least a portion of the surface of the conduit; The article has a first configuration having a first moisture content greater than or equal to 2 w / w% and less than or equal to 40 w / w%, and wherein the average shortest distance between each segment and its nearest neighboring segment in the first configuration is a first distance; The article has a second configuration having a second moisture content greater than or equal to 20 w / w% and less than or equal to 99 w / w%, wherein the average shortest distance between each segment in the second configuration and its nearest neighboring segment is a second distance; The second moisture content is greater than the first moisture content; The second configuration is at the equilibrium water content of the conduit; and The ratio of the second distance to the first distance is greater than or equal to 1.02:

1.

52. Articles comprising: A catheter with multiple markings; The markings comprise a plurality of separate segments spaced apart along at least a portion of the surface of the conduit; The article has a first configuration having a first moisture content greater than or equal to 2 w / w% and less than or equal to 40 w / w%, and wherein the average shortest distance between each segment and its nearest neighboring segment in the first configuration is a first distance; The article has a second configuration having a second moisture content greater than or equal to 20 w / w% and less than or equal to 99 w / w%, wherein the average shortest distance between each segment in the second configuration and its nearest neighboring segment is a second distance; Wherein the second moisture content is greater than the first moisture content, and in: (i) The second distance is equal to about 1 mm, about 1 cm, or about 10 cm; and / or (ii) The marker includes a number depicting the average shortest distance between the nearest neighbor markers of the catheter in the second configuration, wherein the average shortest distance between the nearest neighbor markers of the catheter in the second configuration is greater than or equal to 3 Fr and less than or equal to 34 Fr.

53. The article of claim 51, wherein the second configuration is at the equilibrium water content of the conduit.

54. The article of any one of claims 51 to 53, wherein the conduit comprises a first water-soluble polymer.

55. The article of claim 54, wherein the marking comprises a second water-soluble polymer and a dye.

56. The article of claim 55, wherein the first water-soluble polymer and the second water-soluble polymer are different.

57. The article of claim 55, wherein the first water-soluble polymer and the second water-soluble polymer are the same.

58. The article of claim 51 or 52, wherein at least a portion of the catheter does not contain the marking; The product described herein is substantially free of thrombus formation; and The level of thrombus accumulation at the mark is less than 50% of the level of thrombus accumulation in the portion of the catheter excluding the mark.

59. The article of claim 58, wherein the conduit comprises a first water-soluble polymer.

60. The article of claim 59, wherein the marking comprises a second water-soluble polymer and a dye.

61. The article of claim 60, wherein the first water-soluble polymer and the second water-soluble polymer are different.

62. The article of claim 60, wherein the first water-soluble polymer and the second water-soluble polymer are the same.

63. The article of claim 60, wherein the dye comprises a compound selected from the group consisting of: 4-amino-5-hydroxy-3,6-bis[[4-(2-sulfonyloxyethylsulfonyl)phenyl]diazeninyl]naphthalene-2,7-disulfonic acid tetrasodium, 33-[[4-(2-hydroxyethylsulfonyl)phenyl]aminosulfonyl]-2,11,20,29,39,40-hexaaza-37,38-diimine nonacyclo[28,6]. 1.13,10.112,19.121,28.04,9.013,18.022,27.031,36]tetradecane-1,3(40),4(9),5,7,10,12(39),13(18),14,16,19,21,23,25,27,29,31(36),32,34-nonadene-6,15,24-copper trisulfonate,2-naphthalenesulfonic acid,7-(ethyl Disodium 4-hydroxy-3-[[4-[[2-(sulfonyloxy)ethyl]sulfonyl]phenyl]azo], Active Yellow 15, 1-amino-9,10-dioxo-4-[(3-{[2-(sulfonyloxy)ethyl]sulfonyl}phenyl)amino]-9,10-dihydro-2-anthraquinone disodium, 1-amino-4-[3-(4,6-dichlorotriazine-2-ylamino)-4-sulfophenylamino]anthraquinone-2 -Sulfonic acid, CI Reactive Red 11,4-[2-(5-carbamoyl-1-ethyl-4-methyl-2,6-dioxopyridin-3-ylylene)hydrazyl]-6-[(4,6-dichloro-1,3,5-triazin-2-yl)amino]phenyl-1,3-disulfonate, 6,13-dichloro-3,10-bis[[4-[(4,6-dichloro-1,3,5-triazin-2-yl)amino]sulfonate phenyl]amino]triphenyl di Tetrasodium azinonidenasulfonate, and / or tetrasodium 5-(benzoylamino)-4-hydroxy-3-[[1-sulfon-6-[[2-(sulfonoxy)ethyl]sulfonyl]-2-naphthyl]azo] 64. The article of claim 58, wherein the marking further comprises salt.

65. The article of claim 51 or 52, further comprising: A labeling composition comprising salt, dye and a first water-soluble polymer.

66. The article of claim 65, further comprising a conduit, wherein the marking composition is disposed on at least a portion of the surface of the conduit.

67. The article of claim 66, wherein the conduit comprises a second water-soluble polymer.

68. The article of claim 67, wherein the second water-soluble polymer comprises: poly(vinyl alcohol), poly(acrylic acid), polyethylene glycol, poly(vinylpyrrolidone), poly(sulfonyl betaine methacrylate), poly(sulfonyl betaine acrylate), poly(carboxymethyl betaine methacrylate), poly(carboxymethyl betaine acrylate), povidone, polyacrylamide, poly(N-(2-hydroxypropyl)methacrylamide), poly(... Azoline, polyphosphate, polyphosphazene, polyvinyl acetate, polypropylene glycol, poly(N-isopropylacrylamide), poly(2-hydroxymethyl methacrylate), and combinations thereof.

69. The article of claim 67, wherein the second water-soluble polymer comprises PVA.

70. The article of claim 65, wherein the first water-soluble polymer comprises: poly(vinyl alcohol), poly(acrylic acid), polyethylene glycol, poly(vinylpyrrolidone), poly(sulfonyl betaine methacrylate), poly(sulfonyl betaine acrylate), poly(carboxymethyl betaine methacrylate), poly(carboxymethyl betaine acrylate), povidone, polyacrylamide, poly(N-(2-hydroxypropyl)methacrylamide), poly(... Azoline, polyphosphate, polyphosphazene, polyvinyl acetate, polypropylene glycol, poly(N-isopropylacrylamide), poly(2-hydroxymethyl methacrylate), and combinations thereof.

71. The article of claim 65, wherein the first water-soluble polymer comprises PAA.

72. The article of claim 65, wherein the dye comprises Reactive Black 5, Reactive Blue 21, Reactive Orange 78, Reactive Yellow 15, Reactive Blue 19, Reactive Blue 4, CI Reactive Red 11, CI Reactive Yellow 86, CI Reactive Blue 163, and / or CI Reactive Red 180.

73. The article of claim 65, wherein the salt comprises a substance selected from: phosphates, borates, sodium chloride, citrates, ethylenediaminetetraacetic acid, sulfites, sulfates, hyposulfites, metal oxides, selenium dioxide, selenium trioxide, selenite, selenic acid, nitrates, silicates, and phytic acids.

74. The article of claim 65, wherein the marking composition further comprises water.

75. The article of claim 51 or 52, wherein at least a portion of the mark penetrates into the catheter to a depth of 10 µm to 10 mm.

76. The article of claim 75, wherein the mark penetrates into the conduit to a depth of 0.1 mm to 10 mm.

77. The article of claim 75, wherein the conduit comprises a first water-soluble polymer.

78. The article of claim 77, wherein the marking comprises a second water-soluble polymer and a dye.

79. The article of claim 78, wherein the first water-soluble polymer and the second water-soluble polymer are different.

80. The article of claim 78, wherein the first water-soluble polymer and the second water-soluble polymer are the same.

81. The article of any one of claims 51 to 53, wherein the second distance is equal to about 1 cm.

82. The article of any one of claims 51 to 53, wherein the second distance is equal to about 1 mm.

83. The article of any one of claims 51 to 53, wherein the second distance is equal to about 10 cm.

84. The article of any one of claims 51 to 53, wherein the catheter is selected from central venous catheters, peripheral catheters, dialysis access catheters, urinary catheters, nerve catheters, percutaneous endovascular angioplasty catheters, and peritoneal catheters.

85. The article of any one of claims 51 to 53, wherein the catheter is selected from peripheral central catheters, midline catheters, peripheral port catheters, central venous port catheters, and tunnel catheters.

86. The article of manufacture according to any one of claims 51 to 53, wherein the catheter is a venous catheter.

87. The article of any one of claims 51 to 53, wherein the catheter is a nerve catheter or an epidural catheter.

88. The article of manufacture according to any one of claims 51 to 53, wherein the catheter is configured for use in drainage, urinary, and / or dialysis applications.

89. The article of any one of claims 51 to 53, wherein the mark does not break or delaminate when the conduit swells from the first configuration to the second configuration.

90. The article of manufacture according to any one of claims 51 to 53, wherein the marking is configured such that when the catheter is placed in a patient, the marking does not substantially exhibit thrombus accumulation.

91. The article of manufacture according to any one of claims 51 to 53, wherein the catheter is configured such that when the catheter is placed in a patient, the catheter substantially does not exhibit thrombus accumulation.

92. The article of any one of claims 51 to 53, wherein the level of thrombus accumulation of the mark is within 50% of the level of thrombus accumulation in the portion of the catheter not containing the mark.

93. The article of any one of claims 51 to 53, wherein the mark is deposited or penetrates into the conduit to a depth greater than or equal to 0.1 μm and less than or equal to 200 μm.

94. The article of any one of claims 51 to 53, wherein the mark is deposited or penetrates into the conduit to a depth of greater than or equal to 1 μm.

95. The article of any one of claims 55, 60, 63, 72 and 78, wherein the dye comprises more than or equal to 0.001 w / w% of the mark and less than or equal to 1 w / w of the mark.

96. The article of any one of claims 55, 60, 63, 72 and 78, wherein the dye comprises more than or equal to 0.001 w / w% of the mark and less than or equal to 0.1 w / w% of the mark.

97. The article of any one of claims 55, 60, 63, 72 and 78, wherein the dye comprises a non-reactive dye.

98. The article of any one of claims 51 to 53, wherein the marking is applied to the conduit by liquid deposition, pad printing, screen printing, electrostatic spraying, hot stamping, and / or laser etching.

99. The article of any one of claims 51 to 53, wherein the marking is applied to the conduit by inkjet deposition and / or dip coating.

100. The article of claim 99, wherein the inkjet deposition method comprises pressurized liquid deposition.

101. The article of any one of claims 51 to 53, wherein the conduit is annealed.

102. The article of claim 101, wherein the annealing comprises heat annealing or dehydration.

103. The article of claim 102, wherein the heat annealing is performed at a temperature greater than or equal to 90°C and at atmospheric pressure or below atmospheric pressure for a time of greater than or equal to 30 minutes.

104. The article of any one of claims 51 to 53, wherein the first configuration has a moisture content greater than or equal to 20 w / w% and less than or equal to 40 w / w%.

105. The article of any one of claims 51 to 53, wherein the second configuration has a moisture content greater than or equal to 3 w / w% and less than or equal to 80 w / w%.

106. The article of any one of claims 51 to 53, wherein the ratio of the first distance to the second distance is greater than or equal to 1.02:1 and less than or equal to 2:

1.

107. The article of any one of claims 51 to 53, wherein the ratio of the first distance to the second distance is greater than or equal to 1.05:1 and less than or equal to 1.10:

1.

108. The article of any one of claims 51 to 53, wherein the conduit comprises a humectant.

109. The article of claim 108, wherein the moisturizer comprises glycerin.

110. The article of any one of claims 51 to 53, wherein the conduit is rehydrated.

111. The article of claim 110, wherein the catheter is hydrated by a fluid comprising water, lactated Ringer's solution, dextrose, phosphate-buffered saline, Hanks' balanced salt solution, physiological saline, and / or physiological fluids.

112. The article of claim 110, wherein the hydration is performed for less than or equal to 10 minutes.

113. The article of any one of claims 51 to 53, wherein the swelling of the conduit is anisotropic with respect to the length, inner diameter, outer diameter, and / or total mass of the conduit.

114. The article of any one of claims 51 to 53, comprising a gradually tapering portion.

115. The article of claim 97, wherein the inactive dye enhances the contrast between the marking and the other parts of the catheter.

116. The article of any one of claims 51 to 53, wherein the mark comprises a shape.

117. The article of manufacture according to any one of claims 51 to 53, wherein the marking comprises letters or numbers.

118. The article of manufacture according to any one of claims 51 to 53, wherein the marking comprises a combination of letters, a combination of numbers, or a combination of letters and numbers.

119. The article of manufacture according to any one of claims 51 to 53, wherein the mark comprises text.

120. The article of manufacture of claim 119, wherein the text is a number and / or phrase indicating distance.

121. The article of claim 119, wherein the text indicates the distance from the distal end of the catheter and / or has a numerical value that increases from the distal end of the catheter to the proximal end.

122. A method comprising manufacturing the article of any one of claims 51-121 by setting a marking composition on a catheter.

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