High-strength porous material for emission control

Abstract

High-strength biomedical materials and methods for their manufacture are disclosed. Included in this disclosure are nanoporous hydrophilic solids that can be extruded with high aspect ratios to create strong medical catheters and other devices with lubricious, biocompatible surfaces. Biologically active agents can be encapsulated within the pores of the material to provide controlled release of the biologically active agents.

Description

[Technical Field] 【0001】 (Related applications) This application claims priority to U.S. Provisional Application No. 62 / 782186, filed on 19 December 2018 under 35 U.S. SC 119(e), the contents of which are incorporated herein by reference in their entirety. 【0002】 The technical field of the present invention generally relates to porous biomaterials, including high-strength hydrophilic nanoporous biomaterials, for example, controlled release of biological activators. [Background technology] 【0003】 Biomaterials possessing high strength, low thrombotic properties, and lubricating surface characteristics, and containing biologically active agents, are useful in medical technology. The porosity of biomaterials allows for both high-strength bulk materials for medical devices and channels for controlled dissolution of biologically active agents. These biologically active properties can prevent or reduce biofilm formation, microbial colonization, infection, fibrin sheath formation, inflammation, pain, and / or tumor growth, and / or treat biological conditions such as tumor reduction, fungal and bacterial infections, inflammation, and pain. Complications seen with such devices prolong hospital stays and increase patient morbidity and mortality. Therefore, improved devices and methods are needed. [Overview of the project] 【0004】 This specification discloses biomaterials useful for the manufacture of medical devices. In some embodiments, materials and methods for producing tough, lubricating, biocompatible biomaterials for various medical device applications are provided herein. Processing techniques are disclosed for creating materials having superior properties such as strength, hemocompatibility, and sustained release compared to polyurethanes and silicones. Included here is a method for extruding hydrophilic polymers to create high-strength, hemocompatibility, nanoporous biomaterials, etc. The porous materials may further have polymers or biological activators within the pores of the material. These processes can be carried out without the use of chemical crosslinking agents or radiation crosslinking. Integrating polymers collectively into the pores of the material is in contrast to processes that rely solely on coating or bonding processes that cover the pores, or on bonding surface treatment materials to the surface of the bulk material. 【0005】 In one embodiment, a device is provided. In some embodiments, the device includes a body portion, the body portion is formed from a polymer material comprising a first water-soluble polymer, and comprises a biological activator associated with the polymer material, the biological activator being substantially homogeneously distributed within the polymer material, the device having a break elongation of 50% or more, and / or the device having an increase in overall length at equilibrium water content of 1% or more compared to the overall length in a dehydrated state. 【0006】 In some embodiments, the device comprises a body portion, the body portion being formed from a polymer material comprising a first water-soluble polymer, the body portion comprising a plurality of pores, a second water-soluble polymer disposed within at least a portion of the plurality of pores of the body portion, and a biological activator associated with the first water-soluble polymer and / or the second water-soluble polymer, wherein the biological activator is substantially homogeneously distributed within the first water-soluble polymer. 【0007】 In some embodiments, the device comprises a body portion, which is formed from a polymer material containing a first water-soluble polymer, and comprises a biological activator associated with the polymer material, the biological activator being substantially homogeneously distributed within the polymer material, and the polymer material having a Young's modulus of 500 MPa or more in a dehydrated state and a Young's modulus of 300 MPa or less and 5 MPa or more in an equilibrium water content state. 【0008】 In some embodiments, the device comprises a main body, the main body being formed from a polymer material containing a first water-soluble polymer and a biological activator associated with the polymer material, wherein the biological activator is substantially homogeneously distributed within the polymer material, the polymer material is less than 5 w / w% and 0.1 w / w% or more in a dehydrated state, and the polymer material is configured to swell from a dehydrated state to an equilibrium moisture content state by an amount of 5 w / w% to 50 w / w% within 60 minutes at 25°C. 【0009】 In some embodiments, the device includes a main body portion, the main body portion is formed from a polymer material, the polymer material comprises a water-soluble polymer and a biological activator related to the polymer material, the biological activator being present in the device in an amount of 0.01 w / w% or more. The polymer material is characterized by having a Young's modulus of 500 MPa or more in a dehydrated state and a Young's modulus of 5 to 300 MPa in an equilibrium moisture content state. 【0010】 In some embodiments, the device is formed from a polymer material, the polymer material comprising a first water-soluble polymer and a biological activator associated with the polymer material, the biological activator being substantially homogeneously distributed within the polymer material, and the biological activator being released from the polymer material at a first average rate determined 24 hours after release, and at a second average rate of at least about 1% of the first average rate after 30 days. 【0011】 In some embodiments, the device includes a body portion, which is formed from a polymer material comprising a first water-soluble polymer and a humectant, wherein the polymer material has a water content of 6 w / w% or more and 40 w / w% or less, which is less than the equilibrium water content, and the polymer material is configured to swell by an amount of 2 w / w% or more relative to the equilibrium water content. 【0012】 In some embodiments, the device includes a body portion, which is formed from a polymer material comprising a first water-soluble polymer, the polymer material having a water content of 6 w / w% to 40 w / w%, the water content being below the equilibrium water content state, and the polymer material is configured to swell to the equilibrium water content state by an amount of 2 w / w% or more within a time of 60 minutes or less at 25°C. 【0013】 In some embodiments, the device comprises a body portion, the body portion is formed from a polymer material containing a first water-soluble polymer, the body portion has an inner diameter, an outer diameter, and a length, and the polymer material has a water content of 6 w / w% or more and 40 w / w% or less. The water content is below the equilibrium water content state, the polymer material is configured to swell by an amount of 2 w / w% or more relative to the equilibrium water content state, and the polymer material is configured to swell such that the inner diameter and / or outer diameter increase at a rate greater than the rate of increase in length. 【0014】 In another embodiment, a catheter is provided. In some embodiments, the catheter includes a body portion, the body portion being formed from a polymer material configured to be administered to a subject, and comprising the polymer material and a biological activator substantially homogeneously dispersed within the polymer material. 【0015】 In some embodiments, the catheter includes a body portion, the body portion is formed from a polymer material configured to be administered to a target, and comprises the polymer material and a biological activator dispersed within the bulk of the polymer material, wherein the biological activator is present in the catheter in a dehydrated state at an amount of 0.01 w / w% relative to the total weight of the catheter. 【0016】 In yet another embodiment, a kit is provided. In some embodiments, the kit provides a device comprising a main body portion, wherein the main body portion comprises a polymer material comprising a first water-soluble polymer and a humectant, wherein the polymer material has a water content, the water content is below the equilibrium water content state, and the polymer material is configured to swell by an amount of 2 w / w% or more relative to the equilibrium water content state. 【0017】 In some embodiments, the kit is a device including a body portion, the body portion comprising a polymer material comprising a first water-soluble polymer; and The polymer material is characterized in that it has a water content, the water content is less than the equilibrium water content, and the polymer material is configured to swell by an amount of 2 w / w% or more relative to the equilibrium water content within a time of 60 minutes or less at 25°C. 【0018】 In some embodiments, the kit includes a body portion, the body portion includes a polymer material comprising a first water-soluble polymer, the body portion has an inner diameter, an outer diameter, and a length, the polymer material has a water content, the water content is less than the equilibrium water content state. The polymer material is configured to swell by an amount of 2 w / w% or more relative to the equilibrium water content state, and the polymer material is configured to swell such that the inner diameter and / or outer diameter increase at a rate greater than the rate of increase in length. 【0019】 In yet another aspect, methods such as a method for treating a subject are provided. In some embodiments, the method uses a mixture comprising a first water-soluble polymer and a salt, wherein the first water-soluble polymer is present in the mixture in an amount of 13 w / w% or more based on the total weight of the mixture, and extrudes the mixture onto a core material at a temperature of 65° C or higher to form a polymer material disposed on the core material, and exposes the polymer material to a non-solvent of the polymer material for 15 minutes or more at a temperature of 28° C or lower. A solution containing a biologically active agent is introduced into the polymer material, the polymer material and the solution are heated to a temperature of 30° C or higher, the solution is flowed adjacent to the polymer material, and the polymer material is dried, wherein the biologically active agent is substantially uniformly distributed within the polymer material and is within a range of 50% or less of the average addition amount of the biologically active agent within the polymer material. 【0020】 In some embodiments, a method for treating a subject comprises administering into an orifice of the subject a device comprising: a body portion, the body portion comprising a polymer material comprising a first water-soluble polymer; and a humectant, the polymer material having a water content that is less than the equilibrium moisture content; and swelling the polymer material in an amount of 2 w / w% or more to the equilibrium moisture content state. 【0021】 In some embodiments, a method for treating a subject comprises administering into an orifice of the subject a device comprising: a body portion, the body portion comprising a polymer material comprising a first water-soluble polymer; the polymer material having a water content that is less than the equilibrium moisture content; and swelling the polymer material to the equilibrium moisture content state in an amount of 2 w / w% or more within 60 minutes at 25° C. 【0022】 In some embodiments, a method of treating a subject includes administering to a hole of the subject a device comprising a body portion, wherein the body portion is made of a polymeric material comprising a first water-soluble polymer, the body portion has an inner diameter, an outer diameter, and a length, the polymeric material has a moisture content, and the moisture content is less than the equilibrium moisture content, and increasing the inner diameter and / or the outer diameter at a rate greater than the rate of increase of the length by swelling the polymeric material in an amount of 2 w / w% or more relative to the equilibrium moisture content. 【0023】 In some embodiments, the method includes administering to an external hole of the subject a device comprising a body portion, the body portion comprising a polymeric material comprising a water-soluble polymer and a biologically active agent associated with the polymeric material, the device having an aspect ratio of 3:1 or greater, and the biologically active agent being substantially homogeneously distributed within the polymeric material. 【0024】 Other advantages and novel features of the present invention will become apparent from the following detailed description of various non-limiting embodiments of the present invention when considered in conjunction with the accompanying drawings. In the case where the documents incorporated by reference herein include disclosures that are contrary and / or conflicting, this specification shall govern. 【Brief Description of the Drawings】 【0025】 Non-limiting embodiments of the present invention will be illustratively described with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. In the figures, each identical or substantially identical component shown is typically represented by one numeral. For clarity, not all components are labeled in all figures, and not all components of each embodiment of the present invention are shown where illustration is not necessary for those skilled in the art to understand the present invention. [Figure 1A] FIG. 1 is a schematic cross-sectional view of an exemplary device according to a set of embodiments. [Figure 1B]This is a schematic cross-sectional view of an exemplary device containing multiple holes, according to one embodiment. [Figure 1C] This is a schematic cross-sectional view of an exemplary device containing multiple holes, according to one embodiment. [Figure 1D] This is a schematic diagram of an exemplary extrusion device for forming a continuous shape, showing a cutaway view of the side of a bathtub according to one embodiment. [Figure 1E] This is an enlarged view of a portion of the device shown in Figure 1D, depicting the die head as seen through the bath from the outside, according to one embodiment. [Figure 1F] This is a magnified view of a portion of the device in Figure 1D, showing a die head placed in a bath according to one embodiment. [Figure 1G] This is a schematic cross-sectional view of an exemplary device according to one embodiment. [Figure 2] This is a side view of a catheter illustrating the dimensional changes before and after swelling, according to one embodiment. [Figure 3A] This is a schematic diagram of a process for bulk incorporation of polymers into porous solids according to one embodiment. [Figure 3B] This is a cross-section of a portion of the tube taken along line 3B-3B in Figure 3A, according to one embodiment. [Figure 4A] This is a process flowchart of an embodiment for bulk incorporating a surface polymer into a porous solid, according to one set of embodiments, and includes an extrusion step for creating the porous solid. [Figure 4B] This is a process flowchart for an embodiment of incorporating a biological activator and a polymer into a porous solid, according to one set of embodiments. [Figure 5] The results of the blood contact experiment described in Example 1 are provided as a plot of relative thrombus accumulation (Figure 5A) or as a photograph of the tested sample (Figure 5B). [Figure 6] This is a plot of the chlorhexidine load accumulation and release profile for one embodiment at 2.5 w / w%. [Figure 7]This is a plot of the cumulative release profile of 6.0 w / w% chlorhexidine loading according to one embodiment. [Figure 8] This is a plot of the standard curve for chlorhexidine free radicals according to one embodiment. [Figure 9] This is a plot of the total amount of chlorhexidine released per squeeze in 2.21 mL of 0.9% physiological saline, according to one embodiment. [Figure 10] This is a plot of chlorhexidine release amount versus squeeze number for one embodiment. [Figure 11] This is a plot of the time course of chlorhexidine release according to one embodiment. [Figure 12] This is a time-course plot of bupivacaine release in one embodiment. [Figure 13A] This is a schematic diagram of an exemplary extrusion device for forming a device comprising two or more layers of polymer material, according to one set of embodiments. [Figure 13B] This is a schematic diagram of an exemplary extrusion device for forming a device comprising two or more layers of polymer material, according to one set of embodiments. [Figure 14] This plot shows the inner diameters in millimeters of 24 dry samples from one embodiment. [Figure 15] This shows a plot of the inner diameter in millimeters of 24 samples in the swollen state according to one embodiment. [Figure 16] Figure 14 shows a plot of the outer diameter in millimeters of 24 samples in a dry state, according to one embodiment. [Figure 17] Figure 14 shows a plot of the outer diameter in millimeters of 24 samples in the swollen state according to one embodiment. [Figure 18] This is a plot of typical stress-strain curves for a heat-treated composite PVA / PAA hydrogel according to one embodiment. [Figure 19]This is a plot of the measured average Young's modulus versus the calculated crosslink density for each heat treatment group according to one embodiment. [Figure 20] This shows plots of representative stress-strain curves for an untreated composite PVA / PAA hydrogel, a PVA / PAA composite hydrogel heat-treated at 150°C, and two conventional TPUs, according to one embodiment. [Figure 21] This is a box plot of the mean ± standard deviation of the maximum injection pressure of a TPU control sample compared to a composite hydrogel device, based on one embodiment. [Figure 22A] This is a photograph of a 2 microliter (μL) water droplet on a dehydrated PVA / PAA composite hydrogel tube, according to one embodiment. The scale bar is 1 mm. [Figure 22B] This is a photograph of a 2 microliter (μL) water droplet on a dehydrated PVA / PAA composite hydrogel tube, according to one embodiment. The scale bar is 1 mm. [Figure 22C] This is a photograph of a 2 microliter (μL) water droplet on a hydrated control 1 TPU tube. The scale bar is 1 mm. [Figure 22D] This is a photograph of a 2 microliter (μL) water droplet on a hydrated control 2 TPU tube. The scale bar is 1 mm. [Figure 23] This bar graph shows the rate of change in length over time between the 30% glycerol group and the 10% poloxamer 407 group, according to one embodiment. [Figure 24] This bar graph shows that, according to one embodiment, the addition of a humidity-controlling sponge during packaging improved thermal stability by eliminating waviness and pigtails through 5 minutes of hydration after exposure to extreme temperature changes. [Modes for carrying out the invention] 【0026】 High-strength porous materials incorporating water-soluble polymers are generally provided. For example, materials, methods, and applications of biomaterials, including medically acceptable porous solids, are described herein. The disclosed compositions and devices are useful for administration to a subject (e.g., a patient). Advantageously, the compositions and / or devices described herein may be substantially non-thrombotic, lubricating, and / or biocompatible. In some embodiments, the devices described herein are useful for delivering biologically active agents (e.g., therapeutic agents such as drugs) to a subject. In some embodiments, the compositions and / or devices described herein are considered suitable for administration to a subject and / or delivery of biologically active agents over relatively long periods of time, for example, without forming thrombi, without contamination, and / or without absorbing (or adsorbing) one or more substances (e.g., therapeutic agents, proteins, blood, plasma) present inside the subject. Methods for forming such compositions and / or devices are also provided. 【0027】 The devices described herein are useful for a wide variety of applications, including, for example, the administration of biologically active drugs. In some embodiments, therapeutic, antimicrobial, or antiseptic activators may be incorporated into the bulk material (e.g., polymer material) of the device so that the drug is released from the bulk material. In some such embodiments, the biological activators can favorably prevent or reduce biofilms, microbial colonization, infection, fibrin sheath formation, inflammation, pain, and / or tumor growth, and / or treat physiological conditions such as tumor reduction, fungal and bacterial infections, inflammation, and pain. The devices described herein can, in some cases, be used to make blood-contact devices or devices that come into contact with bodily fluids, including ex vivo and / or in vivo devices such as blood-contact implants. Examples of drug delivery devices that may embody or incorporate the devices described herein include medical tubes, wound dressings, contraceptives, feminine hygiene products, endoscopes, grafts (including small diameters of 6 mM or less), pacemakers, implantable cardioverter-defibrillators, cardiac resynchronization devices, cardiovascular device leads, ventricular assist devices, catheters (including cochlear implants, endotracheal tubes, tracheostomy tubes, ports, shunts), implantable sensors (including intravascular, percutaneous, and intracranial), ventilator pumps, and ophthalmic devices including drug delivery systems. 【0028】 In some embodiments, the devices described herein constitute a body portion. For example, as illustrated in Figure 1A, the device 10 comprises a body portion 20. In some embodiments, the body portion 20 is formed from and / or includes a polymer material. The polymer material may include a first water-soluble polymer. In some embodiments, a biological agent 50 is associated with the polymer material. 【0029】 In some embodiments, one or more biological activators are present throughout the bulk of the polymer material (e.g., distributed throughout the polymer material matrix). For example, in some embodiments, a first arbitrary section 52 within the cross-section of the body portion 20 constitutes a non-zero concentration of the biological activator. In some embodiments, a second arbitrary section 54 within the cross-section of the body portion 20, distinct from the first arbitrary section 52, constitutes a non-zero concentration of the biological activator. Those skilled in the art will understand, based on the teachings herein, that the presence of a biological activator in the bulk of the polymer material (e.g., embedded in the polymer matrix of the polymer material) is not intended to refer to a coating of the biological activator on the polymer material, but rather, conversely, to a biological activator dispersed throughout the bulk of the polymer material. However, in some embodiments, a coating containing the biological activator may optionally be present. Examples of sections are described in more detail below. 【0030】 Although the main body portion 20, sections 52 and 54 in Figure 1A are depicted as circular, those skilled in the art will understand, based on the teachings herein, that the main body portion and other sections in the embodiments disclosed herein do not need to be circular, and other cross-sectional shapes (e.g., planar, rectangular, square, elliptical, oblong, S-shaped, etc.) are also possible. For example, in some embodiments, the main body portion is S-shaped, which may, in some cases, provide ease of implantation into the target, achieve a lower penetration rate, and reduce the possibility of dislodgement within the target. 【0031】 In some embodiments, the biological activator is present in a bulk polymer material formed as a layer within the device. For example, in some embodiments, the polymer material includes a first surface and a second surface, and the first surface and / or the second surface may be coated. In some embodiments, the first surface and / or the second surface are coated with a polymer, a second biological activator (same as or different from the biological activator present in the polymer material), or a combination thereof. In some embodiments, the device comprises two or more layers of polymer material in its body portion. In some embodiments, each layer of polymer material is composed of the same, different, or non-biological activator. In an exemplary embodiment, the body portion of the device comprises a first polymer material layer containing the first biological activator and a second polymer material layer disposed on the first polymer material layer and containing the second biological activator. Other combinations of layers are also possible. 【0032】 In some embodiments, the biological activator is substantially homogeneously distributed within the polymer material (of the main body) and / or the first water-soluble polymer. For example, in some embodiments, the amount of the biological activator does not vary by more than 50% across any given cross-section (e.g., cross-sections 52 and 54 in Figure 1A) of the cross-sectional area of ​​the main body and / or the first water-soluble polymer, compared to the average amount of the biological activator in the main body and / or the first water-soluble polymer. 【0033】 In some embodiments, the biological activator is distributed heterogeneously within the polymer material (i.e., on one or more surfaces of the polymer material). For example, in some embodiments, the amount of the biological activator varies by 50% or more at any predetermined cross-section (e.g., cross-sections 52 and 54 in Figure 1A) across the cross-sectional area of ​​the main body and / or the first water-soluble polymer, compared to the average amount of the biological activator in the main body and / or the first water-soluble polymer. 【0034】 In some embodiments, the biological activator is distributed within the main body portion (or polymer material of the main body portion) and / or the first water-soluble polymer in the range of 0.1% or more, 1% or more, 1% or more, 2% or more, 5% or more, 10% or more, 15% or more, 20% or more, 25% or more, 30% or more, 35% or more, 40% or more, 45% or more, 50% or more, 50% or more, 60% or more, 70% or more, 80% or more, 90% or more, 95% or more, or 98% or more of the average amount of the biological activator added to the main body portion (or polymer material) and / or the first water-soluble polymer. In some embodiments, the biological activator is distributed within the main body (or polymer material of the main body) and / or the first water-soluble polymer in the ranges of 99% or less, 98% or less, 95% or less, 90% or less, 80% or less, 70% or less, 60% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, 5% or less, or 2% or less of the average loading of the biological activator in the main body (or polymer material) and / or the first water-soluble polymer. Combinations of the above ranges are possible (e.g., 0.1% to 99%, 1% to 50%). Other ranges are also possible. 【0035】 The amount of biological activator added can be determined at a location within the main body (or polymer material) by dissecting the main body and then performing extraction and liquid chromatography. For example, an article formed from the main body (e.g., article 10 in Figure 1A) may be cut along the cross-sectional dimensions passing through its central axis and flattened. Three or more sections of the flattened main body (e.g., upper section, middle section, and lower section) may be sliced ​​across the length and / or width of the main body, and the biological activator is extracted from each section. The amount of biological activator present in each section may be determined by liquid chromatography. The highest variation in the measured sections (compared to the average load) constitutes the variation of the article or device. For example, if the biological activator is distributed within the main body with variation levels of 5% of the average amount added from the top, 15% from the middle, and 10% from the bottom, the article / device containing the main body will have a variation of 15% of the average amount added. Such articles / devices are said to have a bioactive agent dispersed within the main body (or the polymer material of the main body) at a rate of 15% or less of the average load of the bioactive agent within the main body (or polymer material), and the bioactive agent is considered to be substantially uniformly dispersed within the main body. In contrast, for example, an article with a bioactive agent coated on the outer surface of the main body (e.g., a coated catheter) where the bioactive agent is not present in the bulk polymer material of the main body, it would not be considered that the bioactive agent is dispersed within the main body at a rate of 15% or less of the average load as a load in the first section (e.g., the upper section including the coating). The load in the first section of the main body (e.g., the upper section constituting the coating) would vary by more than 15% from the average load of the bioactive agent in the main body (or polymer material).Thus, a person skilled in the art will understand, based on the teachings herein, that an article or device containing a coating of a biological agent, in which the biological agent is not present in the bulk polymer material of the main body, does not have a substantially homogeneous distribution of the biological agent within the polymer material (of the main body) (for example, within 50% of the average amount added). 【0036】 In embodiments where two or more layers of polymer material are present within the device, each layer of polymer material may contain a biological activator distributed homogeneously or heterogeneously throughout each polymer material, within one or more of the aforementioned ranges. 【0037】 In some embodiments, the amount of the biological activator does not vary by more than 50% (or any combination of the aforementioned proportions) in any of at least 2, 4, 6, 8, 10, 20, or 30 sections of the main body. In some embodiments, the sections are randomly selected over the length and / or width of the polymer material forming the main body. 【0038】 When multiple biological activators are present (for example, a first and a second biological activator present in the polymer material that forms the majority of the main body), it should be understood that each biological activator may be independently distributed within the polymer material in one or more of the aforementioned ranges. In some embodiments, the main body portion (e.g., polymer material) may include a plurality of pores, as will be described in more detail below. The polymer material of the main body portion may include the first water-soluble polymer described herein. In some embodiments, the biological activator is distributed homogeneously or heterogeneously within the polymer material (e.g., the first water-soluble polymer) but not within the plurality of pores. That is, in some embodiments, the plurality of pores may be substantially free of the biological activator. In some embodiments, the plurality of pores may contain a second biological activator that is the same as or different from the (first) biological activator present in the polymer material forming the bulk of the device (e.g., the polymer material containing the first water-soluble polymer). In yet another embodiment, the biological activator is present only within the plurality of pores. 【0039】 In an exemplary series of embodiments, the device is a catheter. In some embodiments, the catheter is configured for administration to a subject. For example, in some embodiments, the catheter is formed from a polymer material and configured for administration to a subject, and the catheter contains a biological activator dispersed (e.g., homogeneously dispersed) within the polymer material. In some embodiments, the catheter includes a body portion, which is formed from a polymer material containing a first water-soluble polymer as described herein. 【0040】 Suitable biological activators, as described below in detail, include, for example, drugs (e.g., medicinal substances), calcium salts (e.g., calcium chloride), iron salts (e.g., ferrous sulfate), starch, modified silica, and cellulose. As used herein, the term “biological activator” generally refers to a drug that, when administered to a subject, has a biologically significant effect on at least a part of the subject’s body. 【0041】 In some embodiments, the compositions and devices described herein (e.g., device 10 in Figure 1A, device 12 in Figure 1B, and device 14 in Figure 1C) comprise a body portion having a plurality of pores. The body portion may be formed from a polymer material comprising a first water-soluble polymer. In some embodiments, the body portion further comprises a second water-soluble polymer, which is the same as or different from the first water-soluble polymer. For example, in some embodiments, the second water-soluble polymer, which is the same as or different from the first water-soluble polymer, may be located in at least some of the plurality of pores. In some embodiments, the second water-soluble polymer is located within the bulk of the first water-soluble polymer. In some embodiments, the second water-soluble polymer is substantially uniformly dispersed within the bulk of the first water-soluble polymer. In some embodiments, the second water-soluble polymer is substantially heterogeneously dispersed within the bulk of the first water-soluble polymer. The following embodiments generally refer to devices comprising a second water-soluble polymer located within a plurality of pores, but those skilled in the art will understand, based on the teachings herein, that the second water-soluble polymer is not always necessary. While we do not wish to be bound by theory, in some embodiments, the presence of a second water-soluble polymer positioned within the main body portion or within at least some of the pores of the first water-soluble polymer can reduce the thrombogenicity and / or increase the lubricity of a device (e.g., device 12 in Figure 1B, device 14 in Figure 1C) compared to a device without the second water-soluble polymer positioned within the pores (all other factors equal). In an exemplary set of embodiments, the first water-soluble polymer is polyvinyl alcohol. In another exemplary set of embodiments, the second water-soluble polymer is polyacrylic acid. Other water-soluble polymers are also possible, as described herein. 【0042】 In some embodiments, a second water-soluble polymer can be considered identical to the first water-soluble polymer if they are both polymers of the same monomer but differ in other properties such as the number of monomers and / or molecular weight. 【0043】 In some embodiments, the devices and compositions described herein (e.g., device 10 in Figure 1A, device 12 in Figure 1B, device 14 in Figure 1C) are administered to a subject. In some embodiments, the device may be administered orally, rectally, vaginally, nasally, intravenously, subcutaneously, or urethrally. In some cases, the device may be administered to a cavity, epidural space, vein, artery, orifice, external orifice, and / or abscess of the subject. Non-limiting examples of openings include wounds. Non-limiting examples of wounds include wound openings created through the skin for venous access (e.g., created as an insertion site). 【0044】 As described herein, in some embodiments, the compositions, devices, and devices described herein are composed of or formed in such a manner by a polymer material comprising a first water-soluble polymer having a plurality of pores. For example, as shown in Figure 1B, device 12 includes a body portion 20 composed of or formed of a polymer material comprising a first water-soluble polymer and having a plurality of pores 30. In some embodiments, a second water-soluble polymer 40 is located in 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 40 is distributed within a range of 100% or less, 90% or less, 80% or less, 70% or less, 60% or less, 50% or less, 40% or less, 30% or less, 20% or less, or 10% or less of the multiple pores (for example, 10% to 100% of the multiple pores). Combinations of the above ranges are also possible. 【0045】 In some embodiments, the second water-soluble polymer is placed (e.g., dispersed) within the bulk of the first water-soluble polymer (e.g., within the pores and / or gaps of the first water-soluble polymer). In some embodiments, as shown in Figure 1C, the second water-soluble polymer 40 may be present as a coating 45 on at least a portion of the surface of the main body portion 20. Although Figure 1C shows the second water-soluble polymer as a coating on the first water-soluble polymer and within the pores of the first water-soluble polymer, it should be understood that in some embodiments, only the coating 45 is present, and the pores 30 are not substantially filled with the second water-soluble polymer 40. Other configurations are also possible. 【0046】 In some embodiments, the devices and / or devices described herein may be hollow (e.g., having a hollow core). For example, device 10 and / or device 12 may be hollow (e.g., having a hollow core 25). However, although Figures 1A to 1C are depicted as having a hollow core, those skilled in the art will understand from the teachings herein that such a hollow core may not be present. That is, in some cases, the core 25 of a device (e.g., device 10 in Figure 1A, device 12 in Figure 1B, device 14 in Figure 1C) may be a bulk material without a hollow core 25 (e.g., a solid core). 【0047】 As described above, in some embodiments, one or more biological agents may be distributed into the main body portion 20 and / or a plurality of pores 30 (Figures 1B to 1C). In some embodiments, the biological agent is a therapeutic agent. The term “therapeutic agent” or “drug” as used herein refers to a drug administered to a subject for the purpose of treating, alleviating, delaying, improving, and / or preventing, or for preventive purposes, a disease, disorder, or other clinically recognized condition, and in some embodiments, a drug that has a clinically significant effect on the subject’s body for the purpose of treating, alleviating, delaying, improving, and / or preventing a disease, disorder, or condition. Examples of therapeutic drugs, though not limited to those listed, include those described in: United States Pharmacopeia (USP), Goodman and Gilman's The Pharmacological Basis of Therapeutics, 10th edition, McGraw Hill, 2001; Katzung, B. (publisher) Basic and Clinical Pharmacology, McGraw-Hill / Appleton & Lange; 8th edition (September 21, 2000); Pharmacist's Desk Reference (Thomson Publishing); and / or The Merck Manual of Diagnosis and Therapy, 17th edition (1999) or its subsequent 18th edition (2006), Mark H. Beers and Robert Berkow (publishers), Merck Publishing Group; or, for animals, The Merck Veterinary Manual, 9th edition, Kahn, CA (publisher), Merck Publishing Group, 2005. In some embodiments, the therapeutic agent may be selected from the “Approved Drug Products with Therapeutic Equivalence and Evaluations” (“Orange Book”) published by the United States Food and Drug Administration (FDA).In some cases, therapeutic agents whose safety and efficacy in humans and animals have already been established by appropriate government or regulatory agencies may be used. For example, drugs approved for human use are listed by the FDA in 21C.FR §§330.5, 331-361, 440-460, which are incorporated herein by reference. Veterinary drugs are listed by the FDA in 21C.FR §§500-589, which are incorporated herein by reference. All drugs described are considered to be usable in accordance with the present invention. In some embodiments, the therapeutic agent is a low molecular weight. Exemplary classes of drugs include analgesics, anti-analgesics, anti-inflammatory drugs, antipyretics, antidepressants, antiepileptic drugs, antipsychotics, neuroprotective agents, antiproliferative agents, such as anticancer drugs (e.g., anti-cancer agents (taxanes such as paclitaxel and docetaxel, cisplatin, doxorubicin, methotrexate, etc.), antihistamines, anti-migration drugs, etc.), antihistamines, anti-migraine drugs, hormones, prostaglandins, antibacterial agents (antibiotics, antifungals, antivirals, antiparasitic agents, etc.), antimuscarinic agents, anxiolytics, bacteriostatic agents, immunosuppressants, sedatives, hypnotics, antipsychotics, bronchodilators, anti-asthmatics, and cardiovascular drugs. Examples include anesthetics, anticoagulants, enzyme inhibitors, steroids, steroidal or nonsteroidal anti-inflammatory drugs, corticosteroids, dopamine agents, electrolytes, gastrointestinal drugs, muscle relaxants, nutritional supplements, vitamins, parasympathetic stimulants, excitators, appetite suppressants, and anti-narcoleptin agents. Nutritional supplements may also be included. These may include vitamins, supplements such as calcium and biotin, and natural ingredients such as plant extracts and plant hormones. 【0048】 In some embodiments, the biological activator is an anti-inflammatory agent. Non-limiting examples of preferred anti-inflammatory agents include betamethasone, beclomethasone, budesonide, ciclesonide, dexamethasone, desoxymethasone, fluocinolone acetonide, fluocinonide, flunisolide, fluticasone, icometasone, lofreponide, triamcinolone acetonide, fluocortin butyl, hydrocortisone aceboate, hydrocortisone buterate, hydroxycortisone 17-butyrate, prednicarbate, 6-methylprednisolone aceboate, mometasone furoate, elastin, prostaglandins, leukotrienes, and bradykinin antagonists. 【0049】 In some embodiments, the biological activator is an anesthetic. Non-limiting examples of suitable anesthetics include bupivacaine, lidocaine, procaine, and tetracaine. 【0050】 In some embodiments, the biological activator is an antiplatelet agent. Non-limiting examples of suitable antiplatelet agents include clopidogrel, prasugrel, ticagrelor, ticlopidine, cilostazol, borapaxal, absiximab, eptifatide, tirofiban, dipyridamole, and tertroban. 【0051】 In some embodiments, the biological activator is an analgesic. Non-limiting examples of suitable analgesics include paclitaxel, clopidogrel, prasugrel, ticagrelor, aspirin, ibuprofen, naproxen (and other NSAIDs), warfarin, heparin, apixaban, dabigatran, rivaroxaban, and statins. 【0052】 In some embodiments, the biological activator is an anti-cancer agent. Non-limiting examples of suitable anti-cancer agents include paclitaxel, oxaliplatin, fluorouracil (5-FU), docetaxel, methotrexate, doxorubicin, mitoxantrone, teniposide, etoposide, novobiocin, melbaron, and acralubicin. 【0053】 In some embodiments, the biological activator is a preservative. Non-limiting examples of suitable preservatives include chlorhexidine, alexidine, iodine, povidone, octenidine, polybiguanide, cetrimide, biphenol, chlorophene, triclosan, copper, silver, nanosilver, gold, selenium, gallium, tauroridine, cyclotauroridine, N-chlorotaurine, alcohol, lauroyl arginine ethyl, myristamidopropyl dimethylamine (MAPD), and oleamidopropyl dimethylamine (OAPD). 【0054】 In some embodiments, the biological agent is an antimicrobial agent. Non-limiting examples of suitable antimicrobial agents include penicillins: benzylpenicillins (e.g., penicillin-G-sodium, cremizolepenicillin, benzathinepenicillin G); phenoxypenicillins (e.g., penicillin V, propicillin, etc.); aminobenzylpenicillins (e.g., ampicillin, amoxicillin, bacampicillin, etc.); acylaminopenicillins (e.g., azurocillin, mezurocillin, piperacillin, aparcillin, etc.); and Ruboxypenicillins (e.g., carbenicillin, ticarcillin, temocillin, etc.), isoxazolylpenicillins (e.g., oxacillin, cloxacillin, dicloxacillin, flucloxacillin, etc.), amidinepenicillins (e.g., mesilinum), cephalosporins, e.g., cefazolins (e.g., cefazolin, cefazolin, etc.); cefuroximes (e.g., celfoxime, cephamandol, cefotiam); cefoxitins (e.g., : Cefoxitin, cefotetan, latamoxif, flomoxif); Cefotaximes (e.g., cefotaxime, ceftriaxone, ceftizoxime, cefmenoxime); Ceftazidimes (e.g., ceftazidime, cefpirome, cefpime); Cephalexins (e.g., cephalexin, cefaclor, cefadroxil, cefradin, loracalbef, cefprodil); Cefiximes (e.g., cefixime, cefpodoxime proxetine) (Cefuroxime axetil, cefetamet pivoxil, cefotiam hexetil), carbapenems; imipenem; cilastatin; meropenem; biapenem monobactam; gylasase inhibitors: ciprofloxacin, gatifloxacin, norfloxacin, ofloxacin, levofloxacin, pefloxacin, lomefloxacin, fleroxacin, clinafloxacin, sitafloxacin, gemifloxacin, balofloxacin, etc. Other examples include trovafloxacin, moxifloxacin, rifampicin, minocycline, tetracycline, erythromycin, roxithromycin, azithromycin, clarithromycin, sulfonamides, aminoglycosides; and combinations thereof. 【0055】 In some embodiments, the biological activator is a coagulant. Non-limiting examples of suitable coagulants include cellulose, oxidized cellulose, tranexamic acid, aprotinin, epsilon-aminocaproic acid, aminomethylbenzoic acid, fibrinogen, and calcium salts. 【0056】 In some embodiments, the biological activator is a biological entity. Non-limiting examples of preferred biological entities include peptides and peptide oligomers: insulin, adrenocorticotropic hormone, calcitonin, oxytocin, vasopressin, octreotide, leuprorelin, exenatide, carfilzomib, bortezomib, lixisenatide, voclosporine, daptomycin, glatiramer, rindopepimto, and dulaglutide. Trevananib, Lutetium, Romiplostim, Liraglutide, Peginesatide, Zoptarelin, Tesamorelin, Lucinactant, Pasireotide, Linaclotide, Teduglutide, Albiglutide, Dulaglutide, Afamelanotide, Etelcalcetide, Precanatide; Checkpoint inhibitors: PD-1, CTLA-4, PD-L1; Immunotherapy drugs: Tumor-infiltrating lymphocytes (TILs), Chimeric antigen receptors (CARs), Tisagenlucul Examples include: oxycopodium silocel; therapeutic antibodies: trastuzumab, rituximab, ofatumumab, alemtuzumab, adtrastuzumab emtansine, brentuximab vedotin, blinatumomab; therapeutic vaccines: cypreucel-T, tarimozine laherpebeck; and immunomodulatory agents: cytokines, Calmette-Guerin bacillus (BCG), thalidomide, lenalidomide, pomalidomide, and imiquimod. 【0057】 In some embodiments, the biological activator includes natural and / or synthetic cannabinoids or derivatives thereof. 【0058】 When multiple biological activators are present (for example, a first biological activator present in the polymer material forming the bulk of the main body, or a second biological activator present in the pores of the main body), it should be understood that each biological activator may independently be one of the aforementioned activators. 【0059】 The biological activators (e.g., a first biological activator, a second biological activator) may be distributed within the body and / or polymer material and present in the device in any preferred amount. In some embodiments, the biological activator is present in the body or polymer material of the device in an amount of about 0.01% to about 50% by weight of the total weight of the device in a first configuration (e.g., a water content lower than an equilibrium water content state such as a dehydrated state). In some embodiments, the biological activator is present in the body of the device in an amount of at least about 0.01% by weight, at least about 0.05% by weight, at least about 0.1% by weight, at least about 0.5% by weight, at least about 1% by weight, at least about 2% by weight, at least about 3% by weight, at least about 5% by weight, at least about 10% by weight, at least about 20% by weight, at least about 30% by weight, and at least about 40% by weight of the total weight of the device in the first configuration (a water content lower than an equilibrium water content state such as a dehydrated state). In some embodiments, the biological activator is present in the main body or polymer material of the device in amounts of about 50% by weight or less, about 40% by weight or less, about 30% by weight or less, about 20% by weight or less, about 10% by weight or less, about 5% by weight or less, about 3% by weight or less, about 2% by weight or less, about 1% by weight or less, about 0.5% by weight or less, about 0.1% by weight or less, or about 0.05% by weight or less. Combinations of the above ranges are also possible (e.g., about 0.01% by weight to about 50% by weight). Other ranges are also possible. If multiple biological activators are present (e.g., a first biological activator present in the polymer material forming the bulk of the main body, or a second biological activator present in the pores of the main body), it should be understood that each biological activator may be present independently in amounts within one or more of the above ranges. 【0060】 The devices, catheters, kits, and methods described herein may be administered to any suitable subject. The term “subject,” as used herein, refers to an individual organism such as a human or animal. In some embodiments, subjects are mammals (e.g., humans, non-human primates, or non-human mammals), vertebrates, laboratory animals, livestock, farm animals, or companion animals. Non-limiting examples of subjects include humans, non-human primates, cattle, horses, pigs, sheep, goats, dogs, cats, birds, fish, or rodents such as mice, rats, hamsters, and guinea pigs. Generally, the present invention is directed toward human use. In some embodiments, subjects may exhibit health benefits, for example, upon administration of the device. 【0061】 Advantageously, the devices described herein can incorporate activators, such as biological activators, at higher concentrations (by weight percent) compared to certain other devices (e.g., certain devices comprising only a coating of a biological activator). In some embodiments, the biological activator is associated with a first water-soluble polymer and / or a second water-soluble polymer. In some embodiments, the biological activator is dispersed within the first water-soluble polymer and / or the second water-soluble polymer. Furthermore, or alternatively, the devices described herein can enable the extended release of one or more biological activators compared to certain other devices (e.g., certain devices comprising only a coating of a biological activator). 【0062】 In some embodiments, the biological activator may be released from the main body of the device by any preferred means. In some embodiments, the biological activator is released by diffusion from the main body (e.g., the polymer material of the main body). In some embodiments, the biological activator is released by decomposition of at least a portion of the main body (e.g., biodegradation, enzymatic degradation, hydrolysis of the polymer material forming the main body, or hydrolysis of the polymer material within the pores of the main body). In some embodiments, the active substance is released from the device at a specific rate. Those skilled in the art will understand that, in some embodiments, the release rate may depend on the solubility of the biological activator in the medium to which the device is exposed, such as a physiological fluid like blood. In some embodiments, the release rate may depend on the crosslinking density, porosity, pore size distribution, pore interconnectivity (e.g., curvature), crystallinity, and / or the number of biological activator-containing layers in the device (e.g., the main body of the device). 【0063】 In some embodiments, 0.05% to 99% by weight of the biological activator is released between 24 hours and 1000 days after administration to the subject (e.g., immediately after administration, first 24 hours after administration). That is, in some embodiments, the above-mentioned devices and the devices described herein are configured to release the biological activator (e.g., a therapeutically significant amount of the biological activator) for a period of 24 hours or more, 36 hours or more, 72 hours or more, 96 hours or more, 192 hours or more, 15 days or more, 30 days or more, 40 days or more, 50 days or more, 60 days or more, 70 days or more, 80 days or more, 90 days or more, 100 days or more, 120 days or more, 150 days or more, 200 days or more, 300 days or more, 365 days or more, or 600 days or more. In some embodiments, the above-described devices and the devices described herein are configured to release the biological activator within 1000 days, 600 days, 365 days, 300 days, 200 days, 150 days, 120 days, 100 days, and 90 days after administration to the target. They are also configured to release the biological activator within 80 days, 70 days, 60 days, 50 days, 40 days, 30 days, 15 days, 192 hours, 96 hours, 72 hours, and 36 hours. Combinations of the above ranges are also possible. 【0064】 In some embodiments, a biological activator is released from the device at a concentration of approximately 0.05% to 99% by weight after a certain period of time. In some embodiments, after about 24 hours, about 32 hours, about 72 hours, about 96 hours, or about 192 hours, at least about 0.05% by weight, at least about 0.1% by weight, at least about 0.5% by weight, at least about 1% by weight, at least about 5% by weight, at least about 10% by weight, at least about 20% by weight, at least about 50% by weight, at least about 75% by weight, at least about 90% by weight, at least about 95% by weight, or at least about 98% by weight, and / or about 99% by weight or less, about 98% by weight or less, about 95% by weight or less, about 90% by weight or less, about 75% by weight or less, about 50% by weight or less, about 20% by weight or less, about 10% by weight or less, about 5% by weight or less, about 1% by weight or less, about 0.5% by weight or less, or about 0.1% by weight or less of the biological activator associated with the device is released from the device. In some embodiments, at least about 0.05% by weight, at least about 0.1% by weight, at least about 0.5% by weight, at least about 1% by weight, at least about 5% by weight, at least about 10% by weight, at least about 20% by weight, at least about 50% by weight, at least about 75% by weight, at least about 90% by weight, at least about 95% by weight, or at least about 98% by weight, and / or 99% or less by weight, about 98% or less by weight. A biological activator related to polymer components in amounts of approximately 95% by weight or less, approximately 90% by weight or less, approximately 75% by weight or less, approximately 50% by weight or less, approximately 20% by weight or less, approximately 10% by weight or less, approximately 5% by weight or less, approximately 1% by weight or less, approximately 0.5% by weight or less, or approximately 0.1% by weight or less is released from the device (for example, after approximately 1 day, approximately 3 days, approximately 5 days, approximately 7 days, approximately 15 days, approximately 30 days, approximately 40 days, approximately 50 days, approximately 60 days, approximately 70 days, approximately 80 days, approximately 90 days, approximately 100 days, approximately 120 days, approximately 150 days, approximately 200 days, approximately 300 days, approximately 365 days, approximately 600 days, or 1000 days). For example, in some cases, at least about 70% by weight of the biological activity associated with the polymer component is released from the component within the first 24 hours after administration to the subject, and again about 120 days later.If multiple biological activators are present (for example, a first biological activator present in the polymer material forming the bulk of the main body, or a second biological activator present in the pores of the main body), it should be understood that each biological activator may be released independently at one or more rates within the aforementioned ranges. 【0065】 In some embodiments, the biological activator is released from the device at a specific initial mean rate (hereinafter, "initial mean release rate") determined by the first 24 hours of release. In some embodiments, the biological activator is released at an average rate after the first 24 hours of release that is at least about 1%, at least about 2%, at least about 5%, at least about 10%, at least about 20%, at least about 30%, at least about 50%, at least about 75%, at least about 80%, at least about 90%, at least about 95%, or at least about 98% of the initial mean release rate. In some embodiments, the biological activator is released at an average release rate of about 99% or less, about 98% or less, about 95% or less, about 90% or less, about 80% or less, about 75% or less, about 50% or less, about 30% or less, about 20% or less, about 10% or less, about 5% or less, or about 2% or less of the initial mean release rate. Combinations of the above ranges are also possible (for example, approximately 1% to 99%, approximately 1% to 98%, approximately 2% to 95%, approximately 10% to 30%, approximately 20% to 50%, approximately 30% to 80%, approximately 50% to 99%). Other ranges are also possible. If multiple biological activators are present (for example, a first biological activator present in the polymer material forming the bulk of the main body, or a second biological activator present in the pores of the main body), it should be understood that each biological activator may be released independently at a rate within one or more of the aforementioned ranges. 【0066】 The biological activator may be released at an average rate over a predetermined 24-hour period after the initial 24-hour release time. The average release rate may be about 1% to about 99% of the initial average release rate, determined between 48 hours and about 1000 days (e.g., 48 hours to 1 week, 3 days to 1 month, 1 week to 1 month, 1 month to 6 months, 3 months to 1 year, 6 months to 2 years) after the initial release. That is, in some embodiments, the above-described devices and the devices described herein may have a relatively long non-zero release rate of the biological activator (e.g., after hydration, if administered to a subject) after the initial 24-hour release time. In exemplary embodiments, the biological activator is configured to be released from the polymer material at a first average rate determined over 24 hours of release, and at a second average rate of at least about 1% of the first average rate after 30 days. 【0067】 In some embodiments, the biological activator is not released from the device as a burst release. In exemplary embodiments where at least about 0.05 wt% of the biological activator is released from the device after about 24 hours, about 0.05 wt% to about 10 wt% (e.g., at least about 0.05 wt%, at least about 0.1 wt%, at least about 0.5 wt%, at least about 1 wt%, or at least about 5 wt%) is released on day 1 of release, and about 0.05 wt% to about 10 wt% is released on day 2 of release. Those skilled in the art will understand that, depending on the properties of the device and / or the biological activator, further releases of similar amounts of the biological activator may occur during days 3, 4, 5, etc. 【0068】 In some embodiments, at least a portion of the biological activator is released in bursts (e.g., a single burst, two or more bursts, or multiple bursts). For example, in exemplary embodiments, 0.05% by weight or more, 0.1% by weight or more, 0.5% by weight or more, 1% by weight or more, 2% by weight or more, 5% by weight or more, 10% by weight or more, 15% by weight or more, 20% by weight or more, 25% by weight or more, 30% by weight or more, 40% by weight or more, 50% by weight or more, 60% by weight or more, 70% by weight or more, 80% by weight or more, 90% by weight or more, 95% by weight or more, 98% by weight or more, 99% by weight or more, 99.5% by weight or more, or 99.8% by weight or more of the biological activator is released in bursts, relative to the total weight percent of the biological activator present in the device. In some embodiments, biological activators are released in bursts at concentrations of 100% by weight or less, 99.9% by weight or less, 99.8% by weight or less, 99.8% by weight or less, 99.5% by weight or less, 99% by weight or less, 98% by weight or less, 95% by weight or less, 90% by weight or less, 80% by weight or less, 70% by weight or less, 60% by weight or less, 50% by weight or less, 40% by weight or less, 30% by weight or less, 25% by weight or less, 20% by weight or less, 15% by weight or less, 10% by weight or less, 5% by weight or less, 2% by weight or less, 1% by weight or less, 0.5% by weight or less, or 0.1% by weight or less. Combinations of the above ranges are also possible (e.g., 0.05% to 100% by weight, 0.1% to 50% by weight, 10% to 90% by weight, 40% to 100%). Other ranges are also possible. 【0069】 In some embodiments, at least a portion of the bioactive agent is released from the device in a single burst release within one or more of the above ranges. In some embodiments, at least a portion of the bioactive agent is released from the device in two or more burst releases (e.g., three or more, four or more, five or more, six or more), each release occurring within one or more of the above ranges relative to the amount of bioactive agent present in the device after initial addition, or relative to the amount of bioactive agent present in the device after the previous burst release. Each burst release may be divided into any preferred time intervals, including, for example, 0.1 seconds or more, 1 second or more, 5 seconds or more, 10 seconds or more, 30 seconds or more, 1 minute or more, 5 minutes or more, 30 minutes or more, 1 hour or more, 4 hours or more, 12 hours or more, 24 hours or more, 3 days or more, 1 week or more, 1 month or more, or 1 year or more. In some embodiments, each burst release is 2 years or less, 1 year or less, 1 month or less, 1 week or less, 3 days or less, 24 hours or less, 12 hours or less, 4 hours or less, 5 hours or less. The time intervals can be divided into segments of 4 hours or less, 1 hour or less, 30 minutes or less, 5 minutes or less, 1 minute or less, 30 seconds or less, 10 seconds or less, 5 seconds or less, or 1 second or less. Combinations of the above ranges are also possible (for example, 0.1 seconds to 1 year). Other ranges are also possible. 【0070】 As used herein, the term "burst release" is given in the common sense of the art and generally refers to a substantially changing rate of release of a compound (e.g., a biological agent) from a device over a relatively short period of time. In some embodiments, the burst release of a particular weight percent of a biological agent occurs over a period of 60 seconds or less, 30 seconds or less, 15 seconds or less, 10 seconds or less, 5 seconds or less, 2 seconds or less, 1 second or less, 0.5 seconds or less, or 0.1 seconds or less. In some embodiments, the burst release occurs over a period of 0.01 seconds or more, 0.1 seconds or more, 0.5 seconds or more, 1 second or more, 2 seconds or more, 5 seconds or more, 10 seconds or more, 15 seconds or more, or 30 seconds or more. Combinations of the above ranges are also possible (e.g., 0.01 seconds to 60 seconds). Other ranges are also possible. 【0071】 In some embodiments, the device may be configured to release one or more biological agents in combination with burst release and controlled release. In an exemplary example, the biological agents may be released by controlled release of any of the aforementioned amounts, average rates, and / or times, following an initial burst release. In another example, the first biological agent may be released by burst release, and the second biological agent may be released at a specific average rate as described above. In some embodiments, the first and second biological agents may begin to be released at substantially the same time. In some embodiments, the first and second biological agents may be released at different times. 【0072】 The biological activator may be released at a substantially constant average rate (e.g., substantially zero-order average release rate) over a period of at least about 24 hours. In some embodiments, the biological activator is released at a primary release rate (e.g., the release rate of the biological activator is roughly proportional to the concentration of the biological activator) over a period of at least about 24 hours. 【0073】 In some embodiments, the multiple pores (e.g., device 12 in Figure 1B, device 14 in Figure 1C) or the first water-soluble material (optionally having a second water-soluble polymer disposed in at least a portion of the pores) have a specific average pore size. In some embodiments, the average pore size of the multiple pores is 500 nm or less, 450 nm or less, 400 nm or less, 350 nm or less, 300 nm or less, 250 nm or less, 200 nm or less, 150 nm or less, 100 nm or less, 75 nm or less, 50 nm or less, 25 nm or less, 20 nm or less, or 15 nm or less. In some embodiments, the multiple pores have an average pore size of 10 nm or more, 15 nm or more, 20 nm or more, 25 nm or more, 50 nm or more, 75 nm or more, 100 nm or more, 150 nm or more, 200 nm or more, 250 nm or more, 300 nm or more, 350 nm or more, 400 nm or more, or 450 nm or more. Combinations of the above ranges are also possible (e.g., 10 nm to 500 nm). Other ranges are also possible. The average pore size described herein can be determined by mercury intrusion porosimetry of the material in a first configuration (e.g., a moisture content below the equilibrium moisture content state, such as a dehydrated state). 【0074】 In some embodiments, at least a portion of the pores may be characterized as nanopores, for example, pores having an average cross-sectional dimension of less than 1 μm. In some embodiments, at least a portion of the pores may be characterized as micropores, for example, pores having an average cross-sectional dimension of less than 1 mm and 1 μm or more. 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 pores are 1 μm or less, 800 nm or less, 600 nm or less, 500 nm or less, 450 nm or less, 400 nm or less, 350 nm or less, 300 nm or less, 250 nm or less, 250 nm or less, 300 nm or less, 250 nm or less, 250 nm or less, 250 nm or less. The pores have diameters of 250 nm or less, 200 nm or less, 150 nm or less, 100 nm or less, 75 nm or less, 50 nm or less, 25 nm or less, 20 nm or less, or 15 nm or less. In some cases, at least 50% of the multiple pores have diameters of 10 nm or more, 15 nm or more, 20 nm or more, 25 nm or more, 50 nm or more, 75 nm or more, 100 nm or more, 150 nm or more, 200 nm or more, 250 nm or more, 300 nm or more, 350 nm or more, 400 nm or more, 450 nm or more, 500 nm or more, 600 nm or more, or 800 nm or more. Combinations of the above ranges are also possible (e.g., 10 nm to 1000 nm). Other ranges are also possible. 【0075】 The compositions and devices described herein (e.g., device 10 in Figure 1A, device 12 in Figure 1B, and device 14 in Figure 1C) may have a specific porosity in a first configuration (e.g., a water content lower than an equilibrium water content state such as a dehydrated state). In some embodiments, the device (or polymer material) has a porosity of 5% or more, 10% or more, 15% or more, 20% or more, 25% or more, 30% or more, 35% or more, 40% or more, or 45% or more in a first configuration (e.g., a water content lower than an equilibrium water content state such as a dehydrated state). In some embodiments, the device (or polymer material) has a porosity of 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, or 10% or less in a first configuration (e.g., a water content lower than an equilibrium water content state such as a dehydrated state). Combinations of the above ranges are also possible (for example, 5% to 50% in the first configuration (e.g., a moisture content lower than the equilibrium moisture content state such as a dehydrated state)). Other ranges are also possible. 【0076】 As described herein, in some embodiments, the devices, methods, catheters, or kits (or polymer materials) described herein are substantially non-thrombotic. Non-thrombotic properties may be determined as described in Example 1. 【0077】 In some embodiments, the device (e.g., device 10 in Figure 1A, device 12 in Figure 1B, device 14 in Figure 1C) (or body portion (e.g., body portion 20 in Figures 1A-1B)) is hydrophilic. As used herein, the term “hydrophilic” is given in the common sense of the art and refers to a material surface whose water contact angle, as determined by goniometry, is less than 90 degrees. In some embodiments, the polymer material (or its surface) (e.g., of the device) has a water contact angle of 45 degrees or less, 40 degrees or less, 35 degrees or less, 30 degrees or less, 25 degrees or less, 20 degrees or less, 15 degrees or less, 10 degrees or less, 5 degrees or less, or 2 degrees or less at equilibrium water content. In some embodiments, the polymer material (or its surface) has a water contact angle of 1 degree or more, 2 degrees or more, 5 degrees or more, 10 degrees or more, 15 degrees or more, 20 degrees or more, 25 degrees or more, 30 degrees or more, 35 degrees or more, or 40 degrees or more at equilibrium water content. Combinations of the above ranges are also possible (e.g., 1 degree to 45 degrees). Other ranges are also possible. 【0078】 As used herein, the equilibrium moisture content state refers to the steady state of a device (or material) that does not acquire (e.g., absorb) or lose the bulk moisture content determined when submerged in water at 25°C without any external mechanical stress. Those skilled in the art will understand that a steady state (or equilibrium moisture content state) does not require absolute conformity to the strict thermodynamic definition of such a term, but rather demonstrates conformity to the thermodynamic definition of such a term to the extent possible with respect to the requirements characterized in that way, as understood by those skilled in the art most closely relating to such requirements (e.g., considering factors such as passive diffusion and / or Brownian motion). 【0079】 In some embodiments, the equilibrium moisture content of the device (or polymer material) is any of the following: 10 w / w% or more, 20 w / w% or more, 25 w / w% or more, 30 w / w% or more, 35 w / w% or more, 40 w / w% or more, 45 w / w% or more, 50 w / w% or more, 55 w / w% or more, 60 w / w% or more, 65 w / w% or more, or 70 w / w% or more. In some embodiments, the equilibrium moisture content of the device (or polymer material) is any of the following: 80 w / w% or less, 75 w / w% or less, 70 w / w% or less, 65 w / w% or less, 60 w / w% or less, 55 w / w% or less, 50 w / w% or less, 45 w / w% or less, 40 w / w% or less, 35 w / w% or less, 30 w / w% or less, 25 w / w% or less, or 20 w / w% or less. Furthermore, combinations of these ranges are also possible (for example, 10 w / w% to 80 w / w%). Other ranges are also possible. 【0080】 In some embodiments, the devices (e.g., device 10 in Figure 1A, device 12 in Figure 1B, and device 14 in Figure 1C) are substantially lubricating at equilibrium moisture content. For example, in some embodiments, the devices (or the polymer material of the devices) have a surface roughness of 1000 nm (Ra) or less at equilibrium moisture content. In some embodiments, the devices (or the polymer material of the devices) have a surface roughness (Ra) of 500 nm or less, 400 nm or less, 300 nm or less, 250 nm or less, 200 nm or less, 150 nm or less, 100 nm or less, 50 nm or less, 25 nm or less, 10 nm or less, or 5 nm or less at equilibrium moisture content. In some embodiments, the devices (or the polymer material of the devices) have a surface roughness (Ra) of 5 nm or more, 10 nm or more, 25 nm or more, or 50 nm or more at equilibrium moisture content. The ranges are 100nm or greater, 150nm or greater, 200nm or greater, 250nm or greater, 300nm or greater, 400nm or greater, or 500nm or greater. Combinations of the above ranges are also possible (for example, 5nm or greater, 1000nm or less). Other ranges are also possible. 【0081】 In some embodiments, the devices (e.g., device 10 in Figure 1A, device 12 in Figure 1B, device 14 in Figure 1C) have a surface having a coefficient of friction of 0.10 or less in an equilibrium moisture content state. For example, the coefficient of friction of the device surface (or the polymer material of the device) is 0.1 or less, 0.09 or less, 0.08 or less, 0.07 or less, 0.06 or less, 0.05 or less, 0.04 or less, 0.03 or less, or 0.02 or less. In some embodiments, the coefficient of friction of the device surface (or the polymer material of the device) is 0.01 or more, 0.02 or more, 0.03 or more, 0.04 or more, 0.05 or more, 0.06 or more, 0.07 or more, 0.08 or more, or 0.09 or more. Combinations of the above ranges are also possible (e.g., 0.1 or less, 0.01 or more). Other ranges are also possible. 【0082】 Advantageously, the compositions, devices, and other devices described herein may have low sorption of substances such as therapeutic agents (and / or proteins, for example) in the presence of a dynamic fluid containing such substances. Such devices and compositions may be useful for use in subjects where, for example, the presence of the device should not substantially reduce the availability and / or concentration of the therapeutic agent delivered to the subject (e.g., via the device). In some embodiments, administration of a therapeutic agent via a fluid flowing within a device described herein does not substantially reduce the concentration of the therapeutic agent in the fluid. In some cases, the device may not absorb and / or adsorb the therapeutic agent, for example, in flow or during use. 【0083】 In some embodiments, the sorption of the therapeutic agent onto the surface and / or bulk of the first water-soluble polymer is 0.5 w / w% or less, determined by the equilibrium water content after washing five times the volume of the device with an aqueous solution such as water or saline after exposing the polymer to the therapeutic agent. In some embodiments, sorption of the therapeutic agent onto the surface and / or bulk of the first water-soluble polymer occurs at concentrations of 0.5 w / w% or less, 0.4 w / w% or less, 0.3 w / w% or less, 0.2 w / w% or less, or 0.1 w / w% or less. In some embodiments, sorption of the therapeutic agent onto the surface and / or bulk of the first water-soluble polymer occurs at concentrations of 0.05 w / w% or more, 0.1 w / w% or more, 0.2 w / w% or more, 0.3 w / w% or more, or 0.4 w / w% or more. Combinations of the aforementioned ranges are also possible (e.g., 0.5 w / w% or less and 0.05 w / w% or more). Other ranges are also possible. 【0084】 Advantageously, the devices and compositions described herein can have desirable swelling properties (e.g., in water, saline solution, or the fluid environment of interest). 【0085】 In some embodiments, the devices (or polymer materials) described herein have a first configuration (e.g., a water content lower than an equilibrium water content state such as a dehydrated state), the water content of which is 40 w / w% or less, 30 w / w% or less, 20 w / w% or less, 10 w / w% or less, 5 w / w% or less, 4 w / w% or less, 3 w / w% or less, 2 w / w% or less, 1 w / w% or less, 0.8 w / w% or less, 0.6 w / w% or less, 0.4 w / w% or less, or 0.2 w / w% or less. In some embodiments, the devices (or polymer materials) described herein have a first configuration (e.g., a water content lower than an equilibrium water content state such as a dehydrated state), the water content of which is 0.1 w / w% or more, 0.2 w / w% or more, 0.4 w / w% or more, 0.6 w / w% or more, 0.8 w / w% or more, 1 w / w% or more, 2 w / w% or more, 3 w / w% or more, 4 w / w% or more, 5 w / w% or more, 6 w / w% or more, 7 w / w% or more, 8 w / w% or more, 9 w / w% or more, 10 w / w% or more, 15 w / w% or more, 20 w / w% or more, 25 w / w% or more, 30 w / w% or more, or 35 w / w% or more. Combinations of the above ranges are also possible (for example, 0.1 w / w% or more and 5 w / w% or less, 2 w / w% or more and 10 w / w% or less, 2 w / w% or more and 40 w / w% or less, or 6 w / w% or more and 40 w / w% or less). Other ranges are also possible. 【0086】 In some embodiments, the device (or polymer material) described herein has a first configuration (e.g., a water content lower than an equilibrium water content state, such as a dehydrated state). In some embodiments, the device (or polymer material) described herein swells from a first configuration (e.g., a water content lower than an equilibrium water content state, such as a dehydrated state) to a second configuration (e.g., an equilibrium water content state) in 60 minutes or less (e.g., 10 minutes or less, 5 minutes or less, 1 minute or less, or 10 seconds or less). In some embodiments, the device (or polymer material) described herein swells from a first configuration (e.g., a water content lower than an equilibrium water content state, such as a dehydrated state) to a second configuration (e.g., an equilibrium water content state) at 25°C. 【0087】 In some embodiments, the devices (or polymer materials) described herein swell in amounts of 2 w / w% or more, 3 w / w% or more, 4 w / w% or more, 5 w / w% or more, and 10 w / w% or more. At 15 w / w% or more, 20 w / w% or more, 25 w / w% or more, 30 w / w% or more, 35 w / w% or more, 40 w / w% or more, or 45 w / w% or more, they change, for example, from a first configuration (e.g., a water content less than the equilibrium water content state, such as a dehydrated state) to a second configuration (e.g., the equilibrium water content state). In some embodiments, the devices (or polymer materials) described herein swell in amounts of 50 w / w% or less, 45 w / w% or less, 40 w / w% or less, 35 w / w% or less, and 30 w / w% or less. The moisture content can change from, for example, a first configuration (e.g., a moisture content lower than the equilibrium moisture content state, such as a dehydrated state) to a second configuration (e.g., the equilibrium moisture content state) at 25 w / w% or less, 20 w / w% or less, 15 w / w% or less, 10 w / w% or less, 5 w / w% or less, 4 w / w% or less, or 3 w / w% or less. Combinations of these ranges are also possible (e.g., 5 w / w% to 40 w / w%). 【0088】 In some embodiments, the devices described herein (e.g., device 10 in Figure 1A, device 12 in Figure 1B, device 14 in Figure 1C) are in a first configuration (e.g., a water content less than that of an equilibrium water content state such as a dehydrated state). For example, in some embodiments, the devices (or polymer materials) described herein are in a first configuration with a water content of 40 w / w% or less, 30 w / w% or less, 20 w / w% or less, 10 w / w% or less, 5 w / w% or less, 4 w / w% or less, 3 w / w% or less, 2 w / w% or less, 1 w / w% or less, 0.8 w / w% or less, 0.6 w / w% or less, 0.4 w / w% or less, or 0.2 w / w% or less (e.g., a water content less than that of an equilibrium water content state such as a dehydrated state). In some embodiments, the devices (or polymer materials) described herein have a water content of 0.1 w / w% or more, 0.2 w / w% or more, 0.4 w / w% or more, 0.6 w / w% or more, 0.8 w / w% or more, 1 w / w% or more, 2 w / w% or more, 3 w / w% or more, or 4 w / w% or more. Combinations of the above ranges are also possible (e.g., 0.1 w / w% to 5 w / w%, or 2 w / w% to 40 w / w%). Other ranges are also possible. The dehydrated state described herein generally refers to a steady state determined by ambient conditions in which the device (or polymer material) does not experience an evaluable decrease in water content of less than 5 w / w% over 24 hours. In some embodiments, the devices described herein may include coatings such as humectant coatings or unbound pologens, as will be described in more detail below. 【0089】 Advantageously, the devices and compositions described herein may be configured to swell rapidly in the presence of aqueous solutions such as water and / or saline solution. In some embodiments, the device (e.g., device 10 in Figure 1A, device 12 in Figure 1B, device 14 in Figure 1C) (or the main body portion (e.g., main body portion 20 in Figures 1A to 1C) or polymer material) is configured to swell to an amount of 2 w / w% or more, 5 w / w% or more, 10 w / w% or more, 15 w / w% or more, 20 w / w% or more, 25 w / w% or more, 30 w / w% or more, 35 w / w% or more, 40 w / w% or more, or 45 w / w% or more, and can be swelled from a first configuration (e.g., a water content less than the equilibrium water content state such as a dehydrated state) to a second configuration (e.g., the equilibrium water content state) for a specific time (e.g., 60 minutes or less, 10 minutes or less, 5 minutes or less, 1 minute or less, or 10 seconds or less), for example, at 25°C, for example, as will be described in more detail below. In some embodiments, the device or device (or main body) is configured to swell to an amount of 50 w / w% or less, 45 w / w% or less, 40 w / w% or less, 35 w / w% or less, 30 w / w% or less, 25 w / w% or less, 20 w / w% or less, 15 w / w% or less, or 10 w / w% or less, for example, from a first configuration (e.g., a water content less than the equilibrium water content state such as a dehydrated state) to a second configuration (e.g., the equilibrium water content state), for example, at 25°C, for example, for a specific time (e.g., 60 minutes or less, 10 minutes or less, 5 minutes or less, 1 minute or less, or 10 seconds or less). Combinations of the above ranges are also possible (e.g., 5 w / w% to 50 w / w%). Other ranges are also possible. 【0090】 In some embodiments, the device (for example, device 10 in Figure 1A, device 12 in Figure 1B, device 14 in Figure 1C) (or the main body portion (for example, the main body portion 20 in Figures 1A to 1B)) is configured to swell from a first configuration (for example, a water content smaller than the equilibrium water content state, such as a dehydrated state) to a second configuration (for example, the equilibrium water content state) by an amount of 2 w / w% or more and 5 w / w% or more at 25°C for a time of 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, 2 minutes or less, 1 minute or less, 30 seconds or less, or 10 seconds or less. In some embodiments, the device (or polymer material) is configured to swell at 25°C for a period of 5 seconds or more, 15 seconds or more, 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, from a first configuration (e.g., a water content less than the equilibrium water content state, such as a dehydrated state) to a second configuration (e.g., the equilibrium water content state) by an amount of 5 w / w% or more. Combinations of the above ranges are also possible (e.g., 1 minute to 60 minutes). Other ranges are also possible. 【0091】 In exemplary embodiments, the device (e.g., device 10 in Figure 1A, device 12 in Figure 1B, device 14 in Figure 1C) (or the main body portion (e.g., main body portion 20 in Figures 1A to 1B)) is configured to swell in water from a first configuration (e.g., a water content lower than the equilibrium water content state, such as a dehydrated state) (e.g., less than 5 w / w%, or 2 w / w% to 40 w / w%) to an equilibrium water content state (e.g., 5 w / w% or more, or 20 w / w% to 80 w / w%) in 60 minutes or less (e.g., 10 minutes or less, 5 minutes or less, 1 minute or less, or 10 seconds or less). In some embodiments, the device (or polymer material) is configured to swell in 60 minutes or less (e.g., 10 minutes or less, 5 minutes or less, 1 minute or less, or 10 seconds or less) from a first configuration in standard physiological saline (e.g., a water content less than an equilibrium water content state such as a dehydrated state) (e.g., less than 5 w / w%) to an equilibrium water content state (e.g., 5 w / w% or more, or 20 w / w% to 80 w / w%). In another exemplary embodiment, the device (or polymer material) is configured to swell in 60 minutes or less (e.g., 10 minutes or less, 5 minutes or less, 1 minute or less, or 10 seconds or less) from a first configuration in physiological saline (e.g., a water content less than an equilibrium water content state such as a dehydrated state) (e.g., less than 5 w / w%) to an equilibrium water content state (e.g., 5 w / w% or more, or 20 w / w% to 80 w / w%). 【0092】 In some embodiments, the device (e.g., device 10 in Figure 1A, device 12 in Figure 1B, device 14 in Figure 1C) (or body portion (e.g., body portion 20 in Figures 1A-1B)) has a specific length in a first configuration (e.g., a water content less than that of an equilibrium water content state, such as a dehydrated state). In some embodiments, the device (or polymer material) has an increase in overall length in the equilibrium water content state compared to the length in the first configuration (e.g., a water content less than that of an equilibrium water content state, such as a dehydrated state) of 0.1% or more, 0.5% or more, 1% or more, 2% or more, 4% or more, 6% or more, 8% or more, 10% or more, 12% or more, 14% or more, 16% or more, or 18% or more. In some cases, the device (or polymer material) has an increase in total length at equilibrium moisture content compared to the length at a first configuration (e.g., a moisture content lower than the equilibrium moisture content state, such as dehydrated), of 20% or less, 18% or less, 16% or less, 14% or less, 12% or less, 10% or less, 8% or less, 6% or less, 4% or less, 2% or less, 1% or less, or 0.5% or less. Combinations of the above ranges (e.g., 0.1% to 20%) are also possible. Other ranges are also possible. 【0093】 In some embodiments, the device (e.g., device 10 in Figure 1A, device 12 in Figure 1B, device 14 in Figure 1C) (or the main body portion (e.g., main body portion 20 in Figures 1A-1B)) has a specific maximum outer cross-sectional dimension, such as the outer diameter of a cylindrical tube, elliptical tube, oblong tube, or rectangular tube. In embodiments where the device consists of multiple lumens, the outer diameter refers to the maximum outer cross-sectional dimension of one or more lumens. For example, in some embodiments, only one lumen may have the described outer diameter. In other embodiments, all lumens may have independently described outer diameters. In some embodiments, the device (or polymer material) has an increase in the maximum outer cross-sectional dimension (e.g., outer diameter) at equilibrium moisture content of 0.1%, 0.5%, 1%, 2%, 4%, 6%, 8%, 10%, 12%, 14%, 16%, or 18% compared to the maximum cross-sectional dimension in a first configuration (e.g., outer diameter). Compared to the maximum cross-sectional dimension (e.g., outer diameter) in a first configuration (e.g., at a moisture content lower than the equilibrium moisture content state, such as a dehydrated state), the increase is 14%, 16%, or 18%. In some cases, the device (or polymer material) has an increase in the maximum cross-sectional dimensions (e.g., outer diameter) at equilibrium moisture content states of 20% or less, 18% or less, 16% or less, 14% or less, 12% or less, 10% or less, 8% or less, 6% or less, 4% or less, 2% or less, 1% or less, or 0.5% or less compared to the maximum cross-sectional dimensions (e.g., outer diameter) at a first configuration (e.g., a moisture content lower than the equilibrium moisture content state, such as a dehydrated state). Combinations of the aforementioned ranges are also possible (e.g., 0.1% to 20%, 0.1% to 10%). Other ranges are also possible. 【0094】 In some embodiments, the device (or body portion) has a specific inner diameter which is the largest inner cross-sectional dimension, such as the inner diameter of a cylindrical or rectangular tube (or other non-circular device or body portion) (for example, in embodiments where the device constitutes a hollow core). In embodiments where the device (or body portion) includes multiple lumens, the inner diameter refers to the largest inner cross-sectional dimension (i.e., the largest inner cross-sectional dimension of the largest lumen). In some embodiments, the device (or body portion) has an increase in inner diameter at equilibrium moisture content of 0.1% or more, 0.5% or more, 1% or more, 2% or more, 4% or more, 6% or more, 8% or more, 10% or more, 12% or more, 14% or more, 16% or more, or 18% or more, which corresponds to a first configuration (for example, a moisture content smaller than the equilibrium moisture content state, such as a dehydrated state). In some cases, the device (or main body) has an increase in the inner diameter at equilibrium moisture content compared to the inner diameter at a first configuration (e.g., a moisture content lower than the equilibrium moisture content state, such as a dehydrated state) of 20% or less, 18% or less, 16% or less, 14% or less, 12% or less, 10% or less, 8% or less, 6% or less, 4% or less, 2% or less, 1% or less, or 0.5% or less. Combinations of the above ranges (e.g., 0.1% to 20%) are also possible. Other ranges are also possible. 【0095】 In some embodiments, the device (or body portion) increases in overall length at a greater rate than the increase in inner and / or outer diameter when the device (or polymer material) swells from a first configuration (e.g., a water content lower than the equilibrium water content state, such as a dehydrated state) to a second configuration (e.g., the equilibrium water content state). For example, in some embodiments, the overall length may increase by 1-20% (e.g., 5-15%) while the inner and / or outer diameters increase by 0.1-19% (e.g., 1-10%). 【0096】 In some embodiments, the ratio of the increase in total length to the increase in inner and / or outer diameter when the device (or polymer material) swells from a first configuration (e.g., a moisture content lower than the equilibrium moisture content, such as a dehydrated state) to a second configuration (e.g., an equilibrium moisture content state) is 1.1 or greater, 1.5 or greater, 2 or greater, 5 or greater, 7 or greater, or 10 or greater. In some embodiments, the ratio of the increase in total length to the increase in inner and / or outer diameter when the device (or polymer material) swells from a first configuration (e.g., a moisture content lower than the equilibrium moisture content state, such as a dehydrated state) to a second configuration (e.g., an equilibrium moisture content state) is 20 or less, 15 or less, 10 or less, 5 or less, or 2 or less. Combinations of these ranges (e.g., 1.1 to 20) are also possible. 【0097】 In some embodiments, the device (or body portion) increases in inner and / or outer diameter at a greater rate than the total length when the device (or polymer material) swells from a first configuration (e.g., a water content lower than the equilibrium water content state, such as a dehydrated state). As a non-limiting example, in Figure 2, device 320–device 340 swells from a first configuration (e.g., a water content lower than the equilibrium water content state, such as a dehydrated state) to a second configuration (e.g., the equilibrium water content state). According to some embodiments, in Figure 2, the outer diameter 302 and inner diameter 301 of device 320 increase to the outer diameter 305 and inner diameter 304 of device 340, respectively, while the total length 300 increases to the total length 303. According to some embodiments, in Figure 2, the inner diameter 301 and outer diameter 302 increase at a greater rate than the increase in the total length 300 when device 320 swells from the equilibrium water content state to device 340. In some embodiments, the inner diameter and / or outer diameter may increase by 1-20% (e.g., 5-15%) while the overall length may increase by 0.1-19% (e.g., 1-10%). 【0098】 In some embodiments, the ratio of the increase in inner diameter and / or outer diameter to the increase in total length when the device (or polymer material) swells from a first configuration (e.g., a water content lower than the equilibrium water content state, such as a dehydrated state) to a second configuration (e.g., the equilibrium water content state) is 1.1 or greater, 1.5 or greater, 2 or greater, 5 or greater, 7 or greater, or 10 or greater. In some embodiments, the ratio of the increase in inner diameter and / or outer diameter to the increase in total length when the device (or polymer material) swells from a first configuration (e.g., a water content lower than the equilibrium water content state, such as a dehydrated state) to a second configuration (e.g., the equilibrium water content state) is 20 or less, 10 or less, 5 or less, or 2 or less. Combinations of these ranges (e.g., 1.1 to 20) are also possible. 【0099】 In some embodiments, the device (e.g., device 10 in Figure 1A, device 12 in Figure 1B, device 14 in Figure 1C) (or body portion (e.g., body portion 20 in Figures 1A-1B)) comprises a polymer material having desirable mechanical properties. For example, in some embodiments, the polymer material has a Young's modulus (e.g., 100 MPa or more, 250 MPa or more, 500 MPa or more, 600 MPa or more, 750 MPa or more, 800 MPa or more, 900 MPa or more, 1000 MPa or more, 1250 MPa or more, 1500 MPa or more, 1750 MPa or more, 2000 MPa or more, 2500 MPa or more, 3000 MPa or more, 3500 MPa or more, or 4000 MPa or more) in a first configuration (e.g., a water content less than an equilibrium water content state such as a dehydrated state). The Young's modulus in a configuration (for example, a water content less than the equilibrium water content state such as a dehydrated state) corresponds to one of the following ranges: 5000 MPa or less, 4000 MPa or less, 3500 MPa or less, 3000 MPa or less, 2500 MPa or less, 2000 MPa or less, 1750 MPa or less, 1500 MPa or less, 1250 MPa or less, 1000 MPa or less, 900 MPa or less, 800 MPa or less, 750 MPa or less, 600 MPa or less, 500 MPa or less, or 250 MPa or less. Combinations of the above ranges are also possible (for example, 100 MPa to 5000 MPa). Other ranges are also possible. 【0100】 In some embodiments, the polymer material has a Young's modulus at equilibrium moisture content of 300 MPa or less, 250 MPa or less, 200 MPa or less, 150 MPa or less, 100 MPa or less, 75 MPa or less, 50 MPa or less, 25 MPa or less, 20 MPa or less, or 10 MPa or less. In some embodiments, the polymer material has a Young's modulus at equilibrium moisture content of 5 MPa or more, 10 MPa or more, 20 MPa or more, 25 MPa or more, 50 MPa or more, 75 MPa or more, 100 MPa or more, 150 MPa or more, 200 MPa or more, or 250 MPa or more. Combinations of the above ranges are also possible (e.g., 5 MPa to 300 MPa). Other ranges are also possible. 【0101】 In some embodiments, the device (e.g., device 10 in Figure 1A, device 12 in Figure 1B, device 14 in Figure 1C) (or the main body portion (e.g., main body portion 20 in Figures 1A-1B)) contains an osmotic agent. For example, in some embodiments, the osmotic agent may be added during the formation of the device (e.g., to the prepolymer). In some embodiments, the osmotic agent is present in the polymer material in amounts of 0.05 w / w% or more, 0.1 w / w% or more, 0.2 w / w% or more, 0.4 w / w% or more, 0.6 w / w% or more, 0.8 w / w% or more, 0.6 w / w% or more, 0.8 w / w% or more, 8 w / w% or more, 1 w / w% or more, 1.2 w / w% or more, 1.4 w / w% or more, 1.6 w / w% or more, or 1. The moisture content is 8 w / w% or higher, and is 0.2 w / w% or higher, 1.2 w / w% or higher, 1.4 w / w% or higher, 1.6 w / w% or higher, or 1.8 w / w% or higher relative to the total weight of the device in the first configuration (e.g., dehydrated state) and / or the second configuration (e.g., equilibrium moisture content state). The amount is above or 1.8 w / w% or more. In some cases, the osmotic agent may be present in the polymer material (e.g., it can be present in amounts of 2 w / w% or less, 1.8 w / w% or less, 1.6 w / w% or less, 1.4 w / w% or less, 1.2 w / w% or less, 1.6 w / w% or less, 1.4 w / w% or less, 2 w / w% or less, 1 w / w% or less, 0.8 w / w% or less, 0.6 w / w% or less, 0.4 w / w% or less, 0.2 w / w% or less, or 0.01 w / w% or less). The amount is 0.2 w / w% or less or 0.01 w / w% or less relative to the total weight of the device in the first configuration (e.g., dehydrated state) and / or the second configuration (e.g., equilibrium moisture content state). Combinations of the aforementioned ranges are also possible (e.g., 0.05 w / w% to 2 w / w%). Other ranges are also possible. 【0102】 Non-limiting examples of suitable osmotic agents include phosphates, borates, sodium chloride, citrates, ethylenediaminetetraacetates, sulfites, hyposulfites, metal oxides, selenium dioxide, selenium trioxide, selenic acid, nitrates, silicates, and peony acid. 【0103】 In some embodiments, as will be described in more detail below, the composition (e.g., comprising or formed from a polymer material) and / or the first water-soluble polymer do not include covalent crosslinking. However, in other embodiments, the composition and / or the first water-soluble polymer include physical crosslinking (e.g., interpenetration networks, chain entanglement, and / or one or more bonds such as covalent bonds, ionic bonds, and / or hydrogen bonds). In a particular set of embodiments, no covalent crosslinking agent is used to form the polymer material, the first water-soluble polymer of the polymer material, and / or the second water-soluble polymer. 【0104】 The first water-soluble polymer may be present in any suitable amount in the device (e.g., device 10 in Figure 1A, device 12 in Figure 1B, device 14 in Figure 1C) (or in the main body portion (e.g., main body portion 20 in Figures 1A-1B)). For example, in some embodiments, the first water-soluble polymer is present in the device and / or main body portion in amounts of 20 w / w% or more, 25 w / w% or more, 30 w / w% or more, 35 w / w% or more, 40 w / w% or more, or 45 w / w% or more. This is an equilibrium water content state of 50 w / w% or more, 55 w / w% or more, 60 w / w% or more, 65 w / w% or more, 70 w / w% or more, 75 w / w% or more, 80 w / w% or more, 85 w / w% or more, or 90 w / w% or more. In some embodiments, the first water-soluble polymer is present in the device and / or body portion in amounts of 95 w / w% or less, 90 w / w% or less, 85 w / w% or less, 80 w / w% or less, 75 w / w% or less, 70 w / w% or less, 65 w / w% or less, 55 w / w% or less, 50 w / w% or less, 45 w / w% or less, 40 w / w% or less, 35 w / w% or less, 30 w / w% or less, or 25 w / w% or less in equilibrium water content. Combinations of the above ranges are also possible (e.g., 20 w / w% or more, 95 w / w% or less). Other ranges are also possible. 【0105】 In some embodiments, the first water-soluble polymer consists of or is selected from the group including poly(vinyl alcohol), poly(acrylic acid), polyethylene glycol, poly(vinylpyrrolidone), poly(methacrylate sulfobetaine), poly(acrylic sulfobetaine), poly(methacrylate carboxybetaine), poly(acrylic carboxybetaine), poly(acrylic carboxybetaine), povidone, polyacrylamide, poly(N-(2-hydroxypropyl)methacrylamide), polyoxazoline, polyphosphate, polyphosphazene, polyvinyl acetate, polypropylene glycol, poly(N-isopropylacrylamide), poly(2-hydroxymethyl methacrylate), and combinations thereof. In an exemplary series of embodiments, the first water-soluble polymer is poly(vinyl alcohol). 【0106】 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 is comprised of or selected from the group including poly(vinyl alcohol), poly(acrylic acid), polyethylene glycol, poly(vinylpyrrolidone), poly(methacrylate sulfobetaine), poly(acrylic sulfobetaine), and poly(methacrylate carboxybetaine). Examples include poly(acrylic carboxybetaine), povidone, polyacrylamide, poly(N-(2-hydroxypropyl)methacrylamide), polyoxazoline, polyphosphate, polyphosphazene, polyvinyl acetate, polypropylene glycol, poly(N-isopropylacrylamide), poly(2-hydroxymethyl methacrylate), and combinations thereof. The first water-soluble polymer and the other (e.g., third) water-soluble polymer may have different chemical compositions. 【0107】 In some embodiments, the total weight of the first water-soluble polymer and another (e.g., a third) water-soluble polymer in the device is such that the equilibrium water content is 20 w / w% or more, 25 w / w% or more, 30 w / w% or more, 35 w / w% or more, 40 w / w% or more, 45 w / w% or more, 50 w / w% or more, 55 w / w% or more, 60 w / w% or more, 65 w / w% or more, 70 w / w% or more, 75 w / w% or more, 65 w / w% or more, 70 w / w% or more, 75 w / w% or more, 80 w / w% or more, 85 w / w% or more, 90 w / w% or more, 95 w / w% or more, 98 w / w% or more, or 99 w / w% or more. In some embodiments, the total weight of the first water-soluble polymer and another (e.g., a third) water-soluble polymer in the device is 100 w / w% or less, 90 w / w% or less, 98 w / w% or less, 95 w / w% or less, 90 w / w% or less, 85 w / w% or less, 80 w / w% or less, 75 w / w% or less, 70 w / w% or less, 65 w / w% or less, 60 w / w% or less, 55 w / w% or less, 50 w / w% or less, 45 w / w% or less, 40 w / w% or less, 35 w / w% or less, 30 w / w% or less, or 25 w / w% or less. Combinations of the above ranges are also possible (e.g., 20 w / w% or more, 100 w / w% or less). Other ranges are also possible. 【0108】 In some embodiments, the ratio of the first water-soluble polymer to the third water-soluble polymer present in the device is 100:0 or less, 99:1 or less, 95:5 or less, 90:10 or less, 80:20 or less, 70:30 or less, 60:40 or less, or 55:45 or less. In some embodiments, the ratio of the first water-soluble polymer to the third water-soluble polymer present in the device is 50:50 or more, 60:40 or more, 70:30 or more, 80:20 or more, 90:10 or more, 95:5 or more, or 99:1 or more. Combinations of the above ranges are also possible (e.g., 50:50 to 100:0). Other ranges are also possible. 【0109】 As described above and herein, in some embodiments, the device (e.g., device 12 in Figure 1B, device 14 in Figure 1C) comprises a second water-soluble polymer (e.g., a second water-soluble polymer 40) disposed in at least some of the pores (e.g., a plurality of pores 30) of a body portion (e.g., a body portion 20 composed of or formed of a polymer material). In some embodiments, the second water-soluble polymer consists of or is selected from the group including poly(vinyl alcohol), poly(acrylic acid), polyethylene glycol, poly(vinylpyrrolidone), poly(methacrylate sulfobetaine), poly(acrylic sulfobetaine), poly(methacrylate carboxybetaine). Examples include poly(acrylic carboxybetaine), povidone polyacrylamide, poly(N-(2-hydroxypropyl)methacrylamide), polyoxazoline, 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 from the first (and optionally third) water-soluble polymer. 【0110】 A second water-soluble polymer (e.g., second water-soluble polymer 40) may be present in the device in any suitable amount. For example, in some embodiments, the second water-soluble polymer is present in the device in amounts of 0.05 w / w% or more, 0.1 w / w% or more, 0.2 w / w% or more, 0.5 w / w% or more, 1.0 w / w% or more, 2.0 w / w% or more, 3.0 w / w% or more, or 4.0 w / w% or more. These are equilibrium water content states of w / w% or more, 5.0 w / w% or more, 10 w / w% or more, 20 w / w% or more, 30 w / w% or more, 40 w / w% or more, 50 w / w% or more, 60 w / w% or more, 70 w / w% or more, 80 w / w% or more, or 90 w / w% or more. In some embodiments, the second water-soluble polymer 40 is in an equilibrium water content state of 95 w / w% or less, 90 w / w% or less, 80 w / w% or less, 70 w / w% or less, 60 w / w% or less, 50 w / w% or less, 40 w / w% or less, 30 w / w% or less, 20 w / w% or less, 10 w / w% or less, 5.0 w / w% or less, 4.0 w / w% or less, 3.0 w / w% or less, 2.0 w / w% or less, 1.0 w / w% or less, 0.5 w / w% or less, 0.2 w / w% or less, or 0.1 w / w% or less in the device. In some embodiments, 0 w / w% of the second water-soluble polymer is present. Combinations of the aforementioned ranges are also possible (e.g., 0.05 w / w% or more, 95 w / w% or less). Other ranges are also possible. 【0111】 In some embodiments, the water-soluble polymers (e.g., the first water-soluble polymer, the second water-soluble polymer, the third water-soluble polymer) have specific molecular weights. In some embodiments, the molecular weights of the water-soluble polymers (e.g., the first water-soluble polymer, the second water-soluble polymer, or the third water-soluble polymer, each independently) may be 40 kDa or more, 50 kDa or more, 75 kDa or more, 100 kDa or more, 125 kDa or more, 150 kDa or more, 175 kDa or more, 200 kDa or more, 250 kDa or more, 300 kDa or more, 350 kDa or more, 400 kDa or more, 450 kDa or more, 500 kDa or more, 600 kDa or more, 700 kDa or more, 800 kDa or more. The molecular weights are 900kDa or more, 1000kDa or more, 1500kDa or more, 2000kDa or more, 3000kDa or more, or 4000kDa or more. In some embodiments, the molecular weights of the water-soluble polymers (for example, independently, the first water-soluble polymer, the second water-soluble polymer, or the third water-soluble polymer) may be 5000kDa or less, 4000kDa or less, 3000kDa or less, 2000kDa or less, 1500kDa or less, 1000kDa or less, 900kDa or less, 800kDa or less, 700kDa or less, 600kDa or less, 600kDa or less, 500kDa or less, 450kDa or less, 400kDa or less, 350kDa or less, 300kDa or less, 250kDa or less. The molecular weights are 200 kDa or less, 175 kDa or less, 150 kDa or less, 125 kDa or less, 100 kDa or less, 75 kDa or less, or 50 kDa or less. Combinations of the above ranges are also possible (for example, molecular weights between 40 kDa and 5000 kDa). Other ranges are also possible. 【0112】 In some embodiments, the devices (e.g., device 10 in Figure 1A, device 12 in Figure 1B, and device 14 in Figure 1C) are configured for use with medical devices such as catheters, balloons, shunts, wound drains, and infusion devices. The devices described herein (e.g., device 10 in Figure 1A, device 12 in Figure 1B, and device 14 in Figure 1C) are medical devices such as catheters, balloons, shunts, wound drains, infusion ports, drug delivery devices, tubes, contraceptives, feminine hygiene products, endoscopes, grafts, pacemakers, implantable cardioverter-defibrillators, cardiac resynchronization devices, cardiovascular device leads, ventricular assist devices, endotracheal tubes, tracheostomy tubes, implantable sensors, ventilator pumps, and ophthalmic devices. In some embodiments, the catheter is selected from a group including central venous catheters, peripheral central catheters, midline catheters, peripheral catheters, tunnel catheters, dialysis access catheters, urethral catheters, neurological catheters, percutaneous transluminal angioplasty catheters, and / or peritoneal catheters. Other suitable applications are described in detail below. 【0113】 These materials can be fabricated as tough, high-strength materials with lubricating and biocompatible surfaces. This specification particularly describes nanoporous and microporous solids having high Young's modulus and tensile strength. Nanoporous materials are solids containing interconnected pores up to 100 nm in diameter. Processes for fabricating hydrogels are also described. Hydrophilic polymers can be used to fabricate these various porous solids so that hydrophilic solids are obtained. The water content of nanoporous or microporous solids can be high, for example, 50 w / w% EWC. The water content of hydrogels may be higher, for example, up to 90 w / w% in principle. Porous solid materials can be used to fabricate various devices, including medical catheters and implants, in which the adsorption and / or adhesion of biological components to their surface is significantly reduced. 【0114】 These or other porous materials may be processed to include polymers that are bulk incorporated into the pores of the solid. One embodiment of the material of the present invention is a porous material containing a water-soluble polymer incorporated into the pores of the material. Polymers encapsulated in this way have been observed to reside within the pores and remain there even after repeated hydration and dehydration. The incorporated polymer provides a scratch-resistant and effectively permanent surface, and the incorporated polymer provides desirable properties beyond the outer surface of the material. In an aqueous medium, the hydrophilic polymer encapsulated in this way hydrates and extends beyond the surface, enhancing biocompatibility and lubricity. 【0115】 Processes for producing the material are described in International Patent Application Publications WO2018 / 237166 and WO2017 / 112878, which are incorporated herein by reference in their entirety. Processes for producing the material may include extrusion so that devices having a high aspect ratio can be created. One embodiment of a process for producing 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 in a solvent-removed environment to form a mixture resulting in a crosslinked matrix, and continuing to remove the solvent until the crosslinked matrix becomes a microporous or nanoporous solid material. Crosslinking may be carried out while cooling the mixture or in a solvent-removed environment. Further polymers may be incorporated into the pores of the material. 【0116】 This specification discloses molding processes, including extrusion, for producing high-strength porous solids. Guidance on processes and parameters for producing porous solids is disclosed, as well as on porous solids themselves. Guidance on bulk incorporation of polymers into porous solids is disclosed. Porous solids with good properties are disclosed, and further improvements can be obtained by further including bulk-incorporated polymers. 【0117】 Herein, a novel process for extruding high-strength materials is disclosed. Several embodiments of this process provide one or more of the following: removing the solvent from the hydrophilic polymer-solvent mixture as the material is extruded; extruding at a low temperature; extruding in an environment that removes the solvent; and further removing the solvent for a certain period of time after extrusion. Furthermore, an annealing step and / or a bulk incorporation step for further polymers may also be included. 【0118】 Figures 1D–F show one embodiment of a device for making porous solid materials. Device 100 as depicted includes a syringe pump 102 for receiving at least one syringe 104, an optional heating jacket (not shown) for heating the syringe, a die head 106, a heating element 108, and a power cable 109 for the same, which provide heating to the die head 106 as needed (details not shown in Figure 1D). Die head 106 (details in Figure 1D), dispensing spool 110 for core tube 112, winding spool 114 and motor (not shown) for core tube, bath 116 for extruded material 117, the bath is depicted as a heat exchanger 118 including a heat exchange pipe 120 within the bath 116, which has temperature control for cooling or heating. The die head 106 receives the core tube 110 through which it passes. A supply line 122 from the syringe to the die head 106 provides supply to the device 100. The system according to this embodiment may further include a weighing station, a jacketed container for heating and mixing the solution for filling syringes, and a solvent removal environment for further drying the tubes removed from the bath 116. The system may also have a heating station for thermal annealing of tubes or other extruded products, if desired. In addition to PTFE core tubes, materials such as wire, air, gas, and non-solvent liquids may be used as cores. 【0119】 For use, for example, the polymer is heated in a suitable solvent in a jacketed container and placed in syringe 104. One or more polymers may be present, and radiopaque agents or other additives may be added. One or more syringes may be used with the same or different mixtures. The polymer syringe is heated to a predetermined temperature, e.g., 80-95°C or lower, and degassed before extrusion. Syringe 104 is attached to a syringe pump 102 equipped with a wrap heater to maintain the temperature during extrusion. The core 112 is looped through a die head 106, e.g., a heated out-dwell die head, and after being supplied to the extrusion bath 116, is attached to a motor-driven winding spool 114. The bath temperature is controlled using a heat exchanger 118, such as a chiller. The extruded material may be extruded at temperatures in the range of -30°C to 75°C, but other temperatures may be used, with 0°C being a generally useful temperature setting for extrusion. Those skilled in the art will immediately understand that all ranges and values ​​between the specified boundaries are intended, and that, for example, any of the following are available as upper or lower limits: -30, -25, -20, -15, -10.5, 0.5, 10, 15, 20, 25, 30, 35, 40, 45, 50.55, 60, 65, 70, 75°C. The outer diameter gauge size around the core 112 can be adjusted by controlling the motor speed of the winding (e.g., puller) spool 114. Adjusting the die size, material feeding rate, core diameter of the tube, and puller speed plays a role in adjusting the gauge of the final tube, for example, in embodiments for manufacturing catheters. The polymer feeding rate is adjustable, for example, by controlling the syringe pump 102 in this embodiment. The connector 122 connects one or more syringes to the die head 106. Many pumps and other tools are known for controllably supplying polymer solutions. This device and method can be adapted to a drawing process, although alternative feeding processes are available. 【0120】 In some embodiments, a composition (e.g., a prepolymer composition) may be provided prior to the formation of the polymer material (e.g., for extrusion). In some embodiments, the composition comprises an aqueous solution. The aqueous solution may contain an osmotic agent at a concentration of 0.01 M to 8 M, and the aqueous solution may contain a radiopaque agent in an amount of 0 w / w% to 50 w / w% (e.g., 40 w / w% or less). The composition may further contain a water-soluble polymer having a molecular weight of 40 kDa to 5000 kDa and present in the solution in an amount of 10 w / w% to 50 w / w%. 【0121】 In some embodiments, the composition forms a polymer material that can swell upon extrusion. 【0122】 In some embodiments, the osmotic agent is present in the solution at concentrations of 0.01 M or higher, 0.1 M or higher, 0.5 M or higher, 1 M or higher, 2 M or higher, 3 M or higher, 4 M or higher, 5 M or higher, or 6 M or higher. In some embodiments, the osmotic agent is present in the solution at concentrations of 8 M or lower, 6 M or lower, 4 M or lower, 2 M or lower, 1 M or lower, 0.5 M or lower, or 0.1 M or lower. Combinations of the above ranges are also possible (e.g., 0.01 M or higher, 8 M or lower). The osmotic agent will be described in more detail herein. 【0123】 In some embodiments, the radiopaque agent is present in the solution in amounts of 0 w / w% or more, 5 w / w% or more, 10 w / w% or more, 15 w / w% or more, 20 w / w% or more, 25 w / w% or more, 30 w / w% or more, 35 w / w% or more, 40 w / w% or more, or 45 w / w% or more. In some embodiments, the radiopaque agent is present in the solution in amounts of 50 w / w% or less, 45 w / w% or less, 40 w / w% or less, 35 w / w% or less, 30 w / w% or less, 25 w / w% or less, 20 w / w% or less, 15 w / w% or less, 10 w / w% or less, or 5 w / w% or less. Combinations of the above ranges are also possible (e.g., 0 w / w% or more, 50 w / w% or less). Other ranges are also possible. Radiopaque agents are described in more detail below. 【0124】 In some embodiments, the water-soluble polymer is present in the solution in amounts of 10 w / w% or more, 13 w / w% or more, 15 w / w% or more, 20 w / w% or more, 25 w / w% or more, 30 w / w% or more, 35 w / w% or more, 40 w / w% or more, or 45 w / w% or more. In some embodiments, the water-soluble polymer is present in the solution in amounts of 50 w / w% or less, 45 w / w% or less, 40 w / w% or less, 35 w / w% or less, 30 w / w% or less, 25 w / w% or less, 20 w / w% or less, 15 w / w% or less, or 13 w / w% or less. Combinations of the above ranges are also possible (for example, 10 w / w% or more and 50 w / w% or less). In some embodiments, the water-soluble polymer is present in the solution in amounts of 13 w / w% or more. 【0125】 In some embodiments, a method for forming a polymer material and / or device described herein includes providing a mixture comprising a first water-soluble polymer and an osmotic agent (e.g., a salt) as described above. In some embodiments, the mixture is extruded. In some embodiments, the extruded mixture is extruded onto a core material to form a polymer material placed on the core material. In some embodiments, the formed polymer material is exposed to a non-solvent of the polymer material. In some embodiments, a solution comprising a second water-soluble polymer different from the first water-soluble polymer and optionally an osmotic agent is introduced into the polymer material. In some embodiments, the polymer material (e.g., after the solution has been introduced into the osmotic agent) is heated. In some embodiments, the solution is flowed over the polymer material. In some embodiments, the polymer material may be dried. 【0126】 In an exemplary series of embodiments, a method for forming a polymer material and / or device described herein comprises providing a mixture comprising a first water-soluble polymer and an osmotic agent (e.g., a salt), characterized in that the first water-soluble polymer is present in the mixture in an amount of 10 w / w% or more (e.g., 13 w / w% or more and 50 w / w% or less) relative to the total weight of the mixture. The polymer material is present in the mixture in an amount of 10 w / w% or more (e.g., 13 w / w% or more and 50 w / w% or less) relative to the total weight of the mixture, and the following steps are performed: extruding the mixture at a temperature of 65°C or higher (e.g., 65°C or higher). Extruding the mixture onto a core material at atmospheric pressure, at a temperature of 65°C or higher (e.g., 65°C or higher and 100°C or lower) to form a polymer material (e.g., a solid rod or gas) placed on the core material; and exposing the polymer material to a non-solvent of the polymer material at a temperature of 28°C or lower (e.g., exposing the polymer material to a non-solvent of the polymer material at a temperature of 28°C or lower). Exposing the polymer material to a non-solvent of the polymer material at a temperature of 28°C or lower (e.g., 28°C or lower and -20°C or higher) for 15 minutes or more (e.g., 1 hour or more and 240 hours or less), and the polymer material is exposed to a solution containing a biological activator and / or a second water-soluble polymer different from the first water-soluble polymer and / or a penetrating agent (e.g., The polymer material and solution are heated to a temperature of 25°C or higher (e.g., 30°C or higher, or 30°C or higher but 65°C or lower), and the solution adjacent to the polymer material is flowed for, for example, 1 hour or more (e.g., 1 hour or higher but 48 hours or 3 hours or higher but 48 hours or lower) to dry the polymer material. In some embodiments, the biological activator is distributed substantially uniformly within the polymer material within a range of 50% or less of the average amount of biological activator added to the polymer material. In some embodiments, the biological activator is distributed heterogeneously within the polymer material (i.e., on one or more surfaces of the polymer material). 【0127】 In some embodiments, the second water-soluble polymer is placed in at least one (or more) pores of the first water-soluble polymer, as described herein. 【0128】 In some embodiments, the non-solvent includes alcohols. In some embodiments, the non-solvent is ethanol, methanol, propanol, butanol, pentanol, hexanol, heptanol, octanol, decanol, dodecanol, dimethyl sulfoxide, ethyl acetate, acetate, propionate, ether, dimethylformamide, dimethylacetamide, acetone, acetonitrile, ethylene glycol, propylene glycol, glycerol, air, vacuum, or a combination thereof. Other non-solvents are also possible (for example, solvents that are highly soluble in water but less soluble in water-soluble polymers than they are in water). 【0129】 In some embodiments, the step of extruding the mixture is carried out at a temperature of 65°C or higher, 70°C or higher, 75°C or higher, 80°C or higher, 85°C or higher, 90°C or higher, 95°C or higher, 100°C or higher, or 10.5°C or higher, under atmospheric pressure. In some embodiments, the step of extruding the mixture is carried out at a temperature of 110°C or lower, 10.5°C or lower, 100°C or lower, 95°C or lower, 90°C or lower, 85°C or lower, 80°C or lower, 75°C or lower, or 70°C or lower, under atmospheric pressure. Combinations of the above ranges are also possible (e.g., 65°C or higher, 110°C or lower). Other ranges are also possible. Those skilled in the art will understand, based on the teachings herein, that additional pressures (e.g., greater than atmospheric pressure, less than atmospheric pressure) and / or temperatures are also possible. 【0130】 In some embodiments, the step of exposing the polymer material to a non-solvent of the polymer material is carried out at temperatures of 28°C or below, 25°C or below, 20°C or below, 15°C or below, 10°C or below, 5°C or below, 0°C or below, -5°C or below, -10°C or below, or -15°C or below. In some embodiments, the step of exposing the polymer material to a non-solvent of the polymer material is carried out at temperatures of -20°C or above, -15°C or above, -10°C or above, -5°C or above, 0°C or above, 5°C or above, 10°C or above, 15°C or above, 20°C or above, or 25°C or above. Combinations of the above ranges are also possible (e.g., 28°C or below, -20°C or above). Other ranges are also possible. 【0131】 In some embodiments, the step of exposing the polymer material to a non-solvent of the polymer material is performed for 1 hour or more, 2 hours or more, 4 hours or more, 6 hours or more, 8 hours or more, 10 hours or more, 15 hours or more, 20 hours or more, 30 hours or more, 40 hours or more, 50 hours or more, 60 hours or more, 80 hours or more, 100 hours or more, 120 hours or more, 140 hours or more, 160 hours or more, 180 hours or more, 200 hours or more, or 220 hours or more (at a temperature of 28°C or less and -20°C or higher). In some embodiments, the step of exposing the polymer material to a non-solvent of the polymer material is performed for 240 hours or less, 220 hours or less, 200 hours or less, 180 hours or less, 160 hours or less, 140 hours or less, 120 hours or less, or 100 hours or less. 80 hours or less, 60 hours or less, 50 hours or less, 40 hours or less, 30 hours or less, 20 hours or less, 15 hours or less, 10 hours or less, 8 hours or less, 6 hours or less, 4 hours or less, or 2 hours or less. Combinations of the above ranges are also possible (for example, 1 hour or more and 240 hours or less). Other ranges are also possible. 【0132】 In some embodiments, the step of introducing a polymer material includes a second water-soluble polymer different from the first water-soluble polymer, and the step of introducing an optional osmotic agent (e.g., a salt) includes heating the polymer material and solution to a temperature of 25°C or higher, 30°C or higher, 35°C or higher, 40°C or higher, 45°C or higher, 50°C or higher, 55°C or higher, or 60°C or higher. In some embodiments, the polymer material and solution are heated to a temperature of 65°C or lower, 60°C or lower, 55°C or lower, 50°C or lower, 45°C or lower, 40°C or lower, 35°C or lower, or 30°C or lower. Combinations of the above ranges are also possible (e.g., 25°C to 65°C). Other ranges are also possible. 【0133】 In some cases, the solution may flow adjacent to (e.g., directly adjacent to) the polymer material for a specific period of time. In some embodiments, the solution is flowed adjacent to the polymer material for 3 hours or more, 5 hours or more, 6 hours or more, 8 hours or more, 10 hours or more, 12 hours or more, 16 hours or more, 20 hours or more, 24 hours or more, 28 hours or more, 32 hours or more, 36 hours or more, 40 hours or more, or 44 hours or more. In some embodiments, the solution is flowed adjacent to the polymer material for 48 hours or less, 44 hours or less, 40 hours or less, 36 hours or less, 32 hours or less, 28 hours or less, 24 hours or less, 20 hours or less, 16 hours or less, 12 hours or less, 10 hours or less, 8 hours or less, 6 hours or less, or 5 hours or less. Combinations of the above ranges are also possible (e.g., 3 hours or more and 48 hours or less). Other ranges are also possible. Combinations of the above temperatures and times are also possible. 【0134】 In some embodiments, the method includes annealing the polymer material at a temperature of 80°C or higher (e.g., 80°C or higher and 250°C or lower) for 60 minutes or more (e.g., 60 minutes or more and 480 minutes or lower). In some embodiments, the polymer material is annealed at temperatures of 80°C or higher, 90°C or higher, 100°C or higher, 120°C or higher, 140°C or higher, 160°C or higher, 180°C or higher, 200°C or higher, 220°C or higher, or 240°C or higher. In some embodiments, the polymer material is annealed at temperatures of 250°C or lower, 240°C or lower, 220°C or lower, 200°C or lower, 180°C or lower, 160°C or lower, 140°C or lower, 120°C or lower, 100°C or lower, or 90°C or lower. Combinations of the above ranges are also possible (e.g., 80°C to 250°C). Other ranges are also possible. 【0135】 In some embodiments, the polymer material is annealed for 30 minutes or more, 60 minutes or more, 80 minutes or more, 100 minutes or more, 120 minutes or more, 160 minutes or more, 200 minutes or more, 240 minutes or more, 280 minutes or more, 320 minutes or more, 360 minutes or more, 400 minutes or more, or 440 minutes or more. In some embodiments, the polymer material is annealed for 480 minutes or less, 440 minutes or less, 400 minutes or less, 360 minutes or less, 320 minutes or less, 280 minutes or less, 240 minutes or less, 200 minutes or less, 160 minutes or less, 120 minutes or less, 100 minutes or less, or 80 minutes or less. Combinations of the above ranges are also possible (e.g., 60 minutes or more to 480 minutes). Other ranges are also possible. Combinations of the above temperatures and times are also possible. 【0136】 In some embodiments, the core material may be air, water, a non-solvent liquid, solid, or gas. In some embodiments, the core material may be removed after the polymer material has formed on the core material. The core material may, in some cases, be physically removed and / or dissolved. 【0137】 In exemplary embodiments, the method includes performing the following steps using a mixture (e.g., the solutions described above and herein) comprising at least one water-soluble polymer, a salt, and water, wherein at least one water-soluble polymer is present in the mixture in an amount of 13 w / w% or more relative to the total weight of the mixture: heating the mixture to a temperature of 65°C or higher; after heating the mixture, cooling the mixture to a temperature at least 20°C below the melting point of the mixture; and mechanically molding the mixture. In some embodiments, after cooling the mixture, the mixture may be extruded onto a core material at a temperature of 65°C or higher to form a polymer material placed on the core material. The method may also include exposing the polymer material to a non-solvent of the polymer material at a temperature of 28°C or lower for 4 hours or more to remove at least a portion of the core material from the polymer material. 【0138】 In some embodiments, the step of cooling the mixture includes cooling it to a temperature at least 20°C, at least 25°C, at least 30°C, at least 35°C, at least 40°C, at least 45°C, at least 50°C, at least 60°C, at least 70°C, at least 80°C, or at least 90°C below the melting point of the mixture. In some embodiments, the step of cooling the mixture includes cooling it to a temperature below the melting point of the mixture, such as 100°C or less, 90°C or less, 80°C or less, 70°C or less, 60°C or less, 50°C or less, 45°C or less, 40°C or less, 35°C or less, 30°C or less, or 25°C or less. Combinations of the above ranges are also possible (e.g., 20°C or more, 100°C or less). Other ranges are also possible. The mixture may be cooled for any preferred time. 【0139】 In some embodiments, the mixture may be mechanically formed. In some embodiments, the composition (e.g., the mixture before extrusion) may be mechanically formed by kneading, rolling, cutting, and combinations thereof. 【0140】 In some embodiments, the mixture is mixed at temperatures of 80°C or higher, 90°C or higher, 100°C or higher, 120°C or higher, 140°C or higher, 160°C or higher, 180°C or higher, 200°C or higher, 220°C or higher, or 240°C or higher. In some embodiments, the mixture is mixed at temperatures of 250°C or lower, 240°C or lower, 220°C or lower, 200°C or lower, 180°C or lower, 160°C or lower, 140°C or lower, 120°C or lower, 100°C or lower, or 90°C or lower. Combinations of the above ranges are also possible (e.g., 80°C to 250°C). Other ranges are also possible. 【0141】 In some embodiments, the method includes sorbing a second water-soluble polymer onto a polymer material, as described above and herein. 【0142】 In some embodiments, the polymer materials and / or devices described herein may be exposed to and / or contain a humectant. For example, in some embodiments, device 10 contains a humectant 70, as illustrated in Figure 1G. In some embodiments, at least a portion of the humectant is disposed on the surface (e.g., the lumen and / or lumen surface) of the polymer material and / or device (e.g., the main body portion). For example, in some embodiments, a portion of the humectant 70 is disposed on the surface of device 10. In some embodiments, 30% or more, 40% or more, 50% or more, 60% or more, 70% or more, 80% or more, 90% or more, or all of the humectant is disposed on the surface of the polymer material and / or device (e.g., the main body portion). In some embodiments, 100% or less, 90% or less, 80% or less, 70% or less, 60% or less, 50% or less, or 40% or less of the humectant is disposed on the surface of the polymer material and / or device (e.g., the main body portion). Combinations of these ranges are also possible (e.g., 40-100%). 【0143】 In some embodiments, at least a portion of the humectant is located inside the polymer material and / or device (e.g., the main body). In some embodiments, at least a portion of the humectant is located inside the polymer material and / or device (e.g., the main body). For example, in some embodiments, a portion of the humectant 70 is located inside the device 10 (e.g., absorbed into the bulk of the device). In some embodiments, 30% or more, 40% or more, 50% or more, 60% or more, 70% or more, 80% or more, 90% or more, or all of the humectant is located inside the polymer material and / or device (e.g., the main body). In some embodiments, 100% or less, 90% or less, 80% or less, 70% or less, 60% or less, 50% or less, or 40% or less of the humectant is located inside the polymer material and / or device (e.g., the main body). Combinations of these ranges are also possible (e.g., 30-100%). 【0144】 In some embodiments, the humectant is a nonionic surfactant (i.e., a surfactant having an uncharged hydrophilic head and a hydrophobic tail) or a zwitterionic 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 group including sugar alcohols, poloxamers, triacetins, hydroxy acids, polyethylene glycol, polypropylene glycol, ethylene glycol, propylene glycol, hexylene glycol, butylene glycol, glycerol, sorbitol, mannitol, xylitol, maltitol, erythritol, slayitol, arabitol, ribitol, galactitol, fukitol, isitol, inositol, boremitol, mariitol, lactitol, maltotriitol, maltotetraitol, polyglycitol, and combinations thereof. In some embodiments, the humectant contains an oil such as vitamin E. In some embodiments, the humectant contains a salt such as sodium chloride, potassium chloride, and / or phosphocholine. 【0145】 In some embodiments, the polymer materials and / or devices described herein are exposed to and / or contain humectants of 0.1 w / w% or more, 0.5 w / w% or more, 1 w / w% or more, 5 w / w% or more, 10 w / w% or more, or 20 w / w% or more. In some embodiments, the polymer materials and / or devices described herein are exposed to and / or contain humectants of 30 w / w% or less, and include humectants of 25 w / w% or less, 20 w / w% or less, 15 w / w% or less, 10 w / w% or less, 5 w / w% or less, or 1 w / w% or less. Combinations of these ranges are also possible (e.g., 0.1 to 30 w / w% humectants or 1 to 10 w / w% humectants). 【0146】 Porous solids (e.g., those made by the devices in Figures 1D-1F) may be annealed. Furthermore, the porous solid may be treated to further contain bulk-integrated polymers, either pre-annealed or pre-treated. In Figure 3A, the material 210 constituting the porous solid matrix 212 is desolvated and exposed to a mixture containing polymers in a re-dissolving solvent, where it is re-dissolved to form material 212 having bulk-integrated polymers 214. A cross-section of the matrix 212 (Figure 3B) reveals the outermost zone 216 where the pores of the matrix 212 are filled, the intermediate zone 218 where the density of polymers in the pores is low, the amount of filling is small, and / or the number of pores occupied is small, and the inner zone 220 where the polymer has not permeated. The matrix may be solventized and / or desolvated before exposure to the mixture, provided that it is desolvated when exposed to the mixture so that water-soluble polymers can migrate into the matrix. 【0147】 In some embodiments, a method for wetting a device and / or polymer material includes placing an extruded segment in a solution containing a humectant (e.g., glycerol or poloxamer). In some embodiments, the solution contains 1 w / w% or more, 5 w / w% or more, 10 w / w% or more, 15 w / w% or more, 20 w / w% or more, or 25 w / w% or more of the humectant. In some embodiments, the solution contains 35 w / w% or less, 30 w / w% or less, 25 w / w% or less, 20 w / w% or less, 15 w / w% or less, 10 w / w% or less, or 5 w / w% or less of the humectant. Combinations of these ranges are also possible (e.g., 1 to 35 w / w%). In some embodiments, the solution contains a surfactant. In some embodiments, the solution contains PBS. 【0148】 In some embodiments, the extruded segments are left in the solution for a certain period of time. In some embodiments, the time is 1 hour or more, 2 hours or more, or 3 hours or more. In some embodiments, the time is 4 hours or less, 3 hours or less, or 2 hours or less. Combinations of these ranges are also possible (e.g., 3 hours, or 1 to 4 hours). 【0149】 In some embodiments, the solution is maintained at a temperature while the extruded segments are exposed to the solution. In some embodiments, the temperature is 20°C or higher, 30°C or higher, 37°C or higher, 40°C or higher, 50°C or higher, or 60°C or higher. In some embodiments, the temperature is 70°C or lower, 60°C or lower, 55°C or lower, 50°C or lower, 40°C or lower, 37°C or lower, or 30°C or lower. Combinations of these ranges are also possible (e.g., 20-70°C, 37-55°C, or 45°C). 【0150】 In some embodiments, the extruded segments can be dried after being removed from the solution (e.g., in a convection oven). In some embodiments, the extruded segments are dried at a certain temperature. In some embodiments, the temperature is 20°C or higher, 30°C or higher, or 40°C or higher. In some embodiments, the temperature is 50°C or lower, 40°C or lower, or 30°C or lower. Combinations of these ranges are also possible (e.g., 30°C or 20-50°C). In some embodiments, the extruded segments are dried for a certain period of time. In some embodiments, the time may be 1 hour or more, 2 hours or more, or 3 hours or more. In some embodiments, the time may be 4 hours or less, 3 hours or less, or 2 hours or less. Combinations of these ranges are also possible (e.g., 3 hours, or 1-4 hours). 【0151】 The biological activator can be incorporated into the devices and / or devices described herein by any preferred method. For example, in some embodiments, the first water-soluble polymer may be mixed with water (e.g., via a solution formulation method with mass ratios of the water-soluble polymer to water of 0.1–99.9, 1–99, 5–95, 10–90, 20–80, 30–70, 33–67, 37–63, 40–60, 42–58, 45–55, 47–53, 50–50). In some embodiments, the biological activator may be suspended or solubilized in water before solution formulation. The biological activator may optionally be micronized, aggregated, and / or untreated when formulated in a solution containing the water-soluble polymer and water. In some embodiments, the biological activator may be mixed with the water-soluble polymer and water before heating the solution as described herein. In some embodiments, the biological activator may be added as the temperature decreases during cooling after bulk incorporation of the polymer as described herein. 【0152】 In some embodiments, to solubilize or suspend the activator in water, the system may include a cosolvent having a boiling point higher than the solubilization temperature of the formulation mixture, such as N,N-dimethylformamide, a suspending agent such as an ionic or nonionic surfactant, oil, and castor oil. If the activator is insoluble, the biological activator may optionally be pulverized and / or made into nanoparticles. The biological activator may optionally be mixed with the molten mixture described herein and solubilized, for example, under high shear. 【0153】 In some embodiments, the biological activator may be incorporated into the main body via sorption of the biological activator. In exemplary embodiments, the water-soluble polymer material is formed to near final dimensions via a molding process (e.g., electrospinning, electrospraying, melt spinning, wet spinning, extrusion, molding, casting, coating, and / or non-solvent entrainment). In some embodiments, the water-soluble biological activator may then be sprayed, absorbed, or adsorbed as a solution into and / or onto a polymer (e.g., PVA) matrix. The adsorption process may optionally be performed in situ after shaping, after annealing, after crosslinking, after sterilization, or before the device is attached to the object. 【0154】 In some embodiments, the biological activator may be solubilized in a solution with a concentration of 100 w / w% or less, 90 w / w% or less, 80 w / w% or less, 70 w / w% or less, 60 w / w% or less, 50 w / w% or less, 40 w / w% or less, 30 w / w% or less, 20 w / w% or less, 15 w / w% or less, 10 w / w% or less, 5 w / w% or less, 4 w / w% or less, 3 w / w% or less, 2 w / w% or less, 1.5 w / w% or less, 1 w / w% or less, 0.5 w / w% or less, or 0.1 w / w% or less. In some embodiments, the biological activator may be solubilized in a solution with a concentration of 0.01 w / w% or more, 0.1 w / w% or more, 0.5 w / w% or more, 1 w / w% or more, 1.5 w / w% or more, 2 w / w% or more, 3 w / w% or more, 4 w / w% or more, 5 w / w% or more, 6 w / w% or more, 7 w / w% or more, 8 w / w% or more, 9 w / w% or more, 10 w / w% or more, 15 w / w% or more, 20 w / w% or more, 30 w / w% or more, 40 w / w% or more, 50 w / w% or more, 60 w / w% or more, 70 w / w% or more, 80 w / w% or more, or 90 w / w% or more. Combinations of the above ranges are also possible (e.g., 0.01% to 100%). Other ranges are also possible. 【0155】 In some embodiments, the biological activator may be present in the device (for example, in the first configuration (e.g., a water content lower than an equilibrium water content state such as a dehydrated state)) in amounts of 50 w / w% or less, 40 w / w% or less, 30 w / w% or less, 20 w / w% or less, 15 w / w% or less, 10 w / w% or less, 5 w / w% or less, 4 w / w% or less, 3 w / w% or less, 2 w / w% or less, 1.5 w / w% or less, 1 w / w% or less, 0.5 w / w% or less, or 0.1 w / w% or less relative to the total weight of the device (e.g., in the first configuration (e.g., a water content lower than an equilibrium water content state such as a dehydrated state)). In some embodiments, the biological activator may be present in the device (for example, in the first configuration (e.g., It may be present in the device (e.g., in the first configuration (e.g., less water than the equilibrium water content state such as a dehydrated state)) in amounts of 0.01 w / w% or more, 0.1 w / w% or more, 0.5 w / w% or more, 1 w / w% or more, 1.5 w / w% or more, 1.5 w / w% or more, 2 w / w% or more, 3 w / w% or more, 4 w / w% or more, 5 w / w% or more, 6 w / w% or more, 7 w / w% or more, 8 w / w% or more, 9 w / w% or more, 10% or more, 15% or more, 20% or more, 30% or more, or 40% or more. And, with respect to the total weight of the device (e.g., in the case of the first configuration (e.g., less water than the equilibrium water content state such as a dehydrated state)), combinations of the above ranges are possible (e.g., 10 w / w% or less and 0.01 w / w% or more, or 1 w / w% or more and 5 w / w% or less). Other ranges are also possible. 【0156】 In some embodiments, the biological activator solution may be further modified to increase solubility (e.g., by adjusting the pH and / or temperature, or by adding an osmotic agent or co-solvent). In some embodiments, hydrolyzable bonds (esters and amides) are used to bond the activator or activator complex to the polymer material. 【0157】 In some embodiments, the biological activator may be encapsulated. For example, in some embodiments, the biological activator may be incorporated into (or mixed with) the third water-soluble polymer described above and herein. 【0158】 In exemplary embodiments, the biological activator is added to the formulation mixture during solubilization. The biological activator / water-soluble polymer mixture may optionally be dehydrated and physically crosslinked, for example, at a temperature of 120°C or higher. While not wishing to be bound by theory, in some embodiments, after crosslinking, the material may be brittle and be pulverized, freeze-dried, and / or sieved to a powder with a maximum particle size of, for example, 50 μm. In some embodiments, the powder is incorporated into the shaping process at the mixing or solubilization stage. In some embodiments, the third water-soluble polymer includes PVA. In some embodiments, the bulk PVA used for initial encapsulation may contain PVA with a molecular weight higher than that of the bulk porous PVA (e.g., the first water-soluble polymer, the second water-soluble polymer). The bulk porous PVA containing the fine powder may optionally be physically crosslinked, for example, at a temperature of 120°C or higher. While we do not wish to be constrained by theory, advantageously, encapsulation and micronization of biological activators may increase the release rate compared to the release rate of biological activators without encapsulation or micronization. 【0159】 In some embodiments, crosslinking of the third water-soluble polymer can be achieved before micronization by UV crosslinking, chemical crosslinking (e.g., glutaraldehyde, bis(hydroxyethyl) sulfone, maleic acid, etc.), and / or radiation crosslinking (e.g., gamma). In some embodiments, conventional encapsulation methods can be used to micronize to less than 50 μm and / or to extend controlled release from microparticles or nanoparticles, for example, via in situ water-in-oil emulsion or water-in-oil emulsion or cavity molding. 【0160】 In some embodiments, particles containing biological agents can be produced in situ using a fully polymerized polymer, a prepolymer containing a crosslinking agent or initiator, monomers and initiators, or two or more self-polymerizing monomers, or a combination thereof. 【0161】 As described herein, in some embodiments, the biological activator may be present in multiple pores of the main body portion of the device (e.g., Figures 1B-1C). In some such embodiments, the biological activator may be released, for example, during hydration and / or expansion / extension of the device. The incorporation of the biological activator into the multiple pores may be carried out using any preferred method. For example, in some embodiments, the biological activator may be mixed with a second water-soluble polymer described herein so that the second water-soluble polymer and the biological activator are placed in the multiple pores. In some embodiments, the biological activator may be adsorbed / absorbed into the multiple pores. 【0162】 In some embodiments, the biological activator may be solubilized through a channel in the device (e.g., the hollow core 25 in Figures 1A-1C) and injected into the main body. Such devices are useful as delayed-release (e.g., long-term release) and / or reloadable devices. 【0163】 In some embodiments, a bioactive agent having a water-soluble polymer is co-extruded as a central layer between an outer layer and an inner layer containing a non-reagent bulk polymer (e.g., PVA). In exemplary embodiments, the bioactive agent is compatible with the bulk polymer (adheres well without peeling). In some embodiments, the bioactive agent layer is separated from the surface, allowing the bondable polymer to be adsorbed and absorbed onto its surface layer. 【0164】 In another exemplary embodiment, a drug-binding complex, such as a counterion system to which an anionic bioactive agent binds upon absorption, may also be added. While not wishing to be constrained by theory, upon swelling with a drug-soluble solution, the bioactive agent may migrate to the matrix and bind to the central layer of the device. The outer / inner layers may, in some cases, be more thoroughly cleaned than if this central layer were absent. In yet another exemplary embodiment, the bioactive agent-containing layer may be located on one or more surfaces or be compatible with the drug complex (e.g., allowing a bindable polymer to be adsorbed and absorbed via the bulk). 【0165】 Figure 4A shows an illustrative flowchart of a process for producing a porous solid containing bulk-integrated polymers. In this process, a radiopaque (RO) agent is included in the extrusion process. The heated hydrophilic polymer solution refers to the polymer bulk-integrated into the pores of the extruded porous solid. 【0166】 Figure 4B shows another exemplary flowchart of a process for producing a porous solid containing bulk-integrated polymers and biological activators. In this process, post-treatment is included in the extrusion process after the extrusion is dried on a steel mandrel. 【0167】 Those skilled in the art who have read this disclosure will be able to adapt the principles of extrusion or other molding techniques to create alternative processes and devices that achieve the same end products as described herein. Scaled-up embodiments of this process can be adapted, for example, for use in a multi-zone screw extruder, where the solvent mixture is supplied via a suitable injector or hopper, and the zones are controlled to provide cold extrusion. Functions such as syringe pumps can be replaced with appropriately metered and controlled liquid or solid polymer supply systems. 【0168】 Fukumori et al. (2013), Open J. Organic Polymer Materials 3: pp. 110-116, reported a freeze-thaw process for producing 181 MPa poly(vinyl alcohol) (PVA) material with a Young's modulus of approximately 5 MPa or higher, requiring at least approximately 3 cycles in the tested samples. The process for producing these gels required multiple freeze-thaw cycles. The resulting materials were tested in a dry state and cannot be compared to strengths measured by EWC. Fukumori et al. reported that the crystal content of the material increased with the number of freeze-thaw cycles, and attributed the material's strength to the formation of larger crystals as the freeze-thaw cycles progressed, with these larger crystals forming excellent crosslinks and increasing the material's Tg. Due to the nature of these processes, dry materials are produced. Furthermore, as will be discussed later, the freeze-thaw process generates macropores. 【0169】 In some embodiments, the processes described herein do not include a freeze-thaw process and / or do not include a freeze process and / or do not include a thaw process. Furthermore, the processes can be used to produce solid porous materials that do not swell much or at all, even in the absence of a covalent crosslinking agent, for example, having a swelling of 0% to 100 w / w% in EWC. Those skilled in the art will immediately understand that all ranges and values ​​between the explicitly stated boundaries are intended: 0.5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 95, and 100 w / w%, % swelling rate = 100 × (total weight in EWC - dry weight) / dry weight Measured as such, dry weight is the weight of the material without water. 【0170】 In some embodiments, the extruded sample has a horizontal chain orientation and alignment along the length of the sample (in the direction of extrusion). This orientation of polymer chains is generated by the extrusion process. While we do not wish to be constrained by theory, in some embodiments, this horizontal chain orientation and alignment along the length of the sample is thought to contribute to an increase in the inner and / or outer diameter at a rate greater than the rate of increase in length as the sample swells. 【0171】 In some embodiments, it is useful to have one or more combinations of extrusion of the hydrophilic polymer in a solvent; cold extrusion; and extrusion into a bath to rapidly remove the solvent from the extruded material. Furthermore, in some embodiments, an additional solvent removal and / or annealing process provides further utility for creating a desired porous solid. 【0172】 In some embodiments, the requirement for nanoporous materials involves a high polymer concentration of about 10 w / w% or more in the polymer-solvent mixture with a high level of crosslinking. Those skilled in the art will immediately understand that all ranges and values ​​between the explicitly stated boundaries are intended, and that any of 10, 12, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 80, 90, 95, 99 w / w% of the polymer in the total weight of the polymer-solvent mixture is available as an upper or lower limit. In some embodiments, the polymer is substantially solvated, meaning it is either a true solution or at least half of the polymer is dissolved and the remainder is at least suspended. In some embodiments, the solvation of the polymer contributes to the alignment of polymer chains and crosslinking between polymers in extrusion. Without being bound by any particular theory, it is considered that a high concentration of the starting polymer-solvent mixture can help this. Also, according to some embodiments, it is considered that both intrapolymer and interpolymer crosslinking are promoted because the chains of the material are more likely to align as they pass through the die. When a mixture formed by extrusion or other means is placed in a solvent-removal environment, either gaseous or liquid, in some embodiments, the pore structure is thought to further collapse before the densely concentrated polymer is fully crosslinked, thereby improving chain proximity and promoting further crosslinking density. Direct deposition of extruded or otherwise formed materials in a solvent-removal environment is useful in some embodiments. In some embodiments, further solvent removal can be continued to collapse the material until the desired endpoint of structure and / or properties is reached. Annealing processes can further contribute to strength in some embodiments. 【0173】 On the other hand, the freezing method can achieve chain proximity and improve crosslinking density by forcing the formation of ultra-concentrated micro-regions, while maintaining macroscopic porosity and increasing strength due to the presence of ice crystals throughout the gel structure. Although ultra-concentrated micro-regions are forcibly formed by desolvation, macroscopic voids are not formed. In contrast, gels established before dehydration or freezing, due to the nature of the process, develop macroporous pores. Furthermore, our research has shown that such nanoporous solids have greater strength than macroporous materials. 【0174】 Hydrogels can also be prepared by reducing the polymer concentration in the polymer-solvent mixture, generally to 10 w / w% or less. Those skilled in the art will immediately understand that all ranges and values ​​between the specified boundaries are intended, and that, for example, any of 2, 5, 7, 8, 9, or 10 w / w% of the polymer in the total weight of the polymer-solvent mixture can be used as upper or lower limits. Furthermore, or alternatively, the polymer-solvent mixture is not extruded into a solvent removal environment. 【0175】 Microporous materials may be produced under intermediate process conditions between those for nanoporous solids and hydrogels. One embodiment involves preparing the material using conditions equivalent to those for producing nanoporous materials, but stopping the solvent removal before it reaches a nanoporous solid structure. 【0176】 To create high-strength materials, extruding hydrophilic polymers in a solvent is effective. Using solvents as starting materials in extrusion molding is, at least, not common. Typically, in extrusion molding, a solid material heated to a flowable temperature is extruded and then cooled in various ways. For example, thermoplastic extrusion of pure PVA is considered possible. However, such an extrusion would lack the polymer structure necessary to create a porous solid and instead exhibit properties closer to conventional thermoplastic materials. According to one operating theory, extruding pure PVA would lack the quality of hydrogen bonding that occurs in an aqueous ionic solvent state. At temperatures suitable for making PVA fluid in extrusion molding, a material with low cohesiveness is formed in the die head, preventing the formation of a continuous shape. It has been difficult to use extruded PVA in high-aspect-ratio shapes, such as tubes, in extrusion molding. The viscosity of PVA and other hydrophilic polymers is high, making them difficult to dissolve. A narrow working band of temperature has been observed to be particularly useful, e.g., 85–95°C. Below approximately 85°C, the PVA did not truly melt, and therefore did not become completely amorphous for extrusion. Above approximately 95°C, losses due to boiling and evaporation occurred, rendering the process ineffective. These temperature ranges can be compensated for by increasing the pressure above atmospheric pressure, but the use of pressurized systems and scale-up are difficult. This process is preferably carried out at temperatures below the boiling points of the polymer and solvent materials. 【0177】 When a mixture of polymer and solvent is flowed, the cohesive force is weaker as it exits the die. Using a core to support the mixture in the die is useful for maintaining its shape in the die. This is in contrast to typical core extrusion used as a coating process, such as coating the wires of a mobile phone charger. In typical processes, the cohesive force is relatively high as it exits the die, making it easier to hold the tube, and it does not rely on active bonding, such as hydrogen bonding of hydrophilic polymers, to form a cohesive shape as it exits the die, thus avoiding the use of solvents or solvents of considerable concentration. 【0178】 It is useful to pass the formed polymer-solvent mixture through a solvent removal environment. Most extrusion processes do not use bath temperatures below room temperature. Furthermore, the use of a solvent removal tank is atypical compared to conventional processes. Tanks and other solvent removal environments help to sufficiently solidify the extruded material, allowing it to maintain a stable, concentric shape on the core. Otherwise, the molten material will become teardrop-shaped, and even if attempts are made to recover it at the end of extrusion, it will break down due to remaining molten material. Also, in conventional water-containing baths, hydrophilic polymer materials such as PVA will lose their shape due to swelling, dissolution, or both. The molding process, in which a polymer-solvent mixture is prepared, formed in a mold, and then processed in a solvent removal environment, does not have the advantage of chain alignment observed in extrusion. However, with properly controlled temperature and solvent removal, materials with high strength and controlled porosity can be obtained. 【0179】 This porous solid is highly lubricated, can be used in a hydrated state, and can be conveniently bonded with other materials. In the case of catheters, for example, extensions, Luer locks, and suture wings are useful. In some embodiments, extrusion molding of the copolymer is useful in the range of 0.1% to 10 w / w% or less of the first polymer, and the range of 5 w / w% or less is also useful. Those skilled in the art will immediately understand that all ranges and values ​​between the specified boundaries are intended, and that any of, for example, 0.1, 0.2, 0.4, 0.5, 0.8, 1, 2, 3, 4, 5, 6, 8, and 10 w / w% can be used as upper or lower limits. 【0180】 In some embodiments, salts are useful for manipulating the strength of materials. Without being limited to any particular theory, salts are considered to be part of physical crosslinking and essentially act as low molecular weight crosslinking agents between polymer chains. 【0181】 Several embodiments for polymer blends include at least one first hydrophilic polymer and at least one second hydrophilic polymer in a solvent extruded as described herein. Examples include one or more combinations of PVA, PAA, PEG, PVP, polyalkylene glycol, hydrophilic polymers, and combinations thereof. Examples of concentrations include at least one second hydrophilic polymer present in amounts from 1 to 10,000 parts of the first hydrophilic polymer. Those skilled in the art will immediately understand that all ranges and values ​​between the explicitly stated boundaries are intended, and that any of, for example, 1, 2, 10, 100, 1000, 1500, 2000, 2500, 3000, 4000, 5000, 6000, 7000, 8000, 9000, and 10000 parts are available as upper or lower limits. Examples of polymer concentrations in a polymer-solvent mixture include a first polymer present at a first concentration and one or more further polymers present at a second concentration, where the first polymer concentration and the further polymer concentrations are independently selected from 0.1 to 99% w / w%, 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, and 95% w / w%. Furthermore, nonhydrophilic blocks may be present in the nonhydrophilic polymer and / or block polymer, and the concentration of such polymer and / or such blocks is generally less than about 10 w / w%, for example, 0.1, 0.2, 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 w / w%. 【0182】 Some embodiments include a porous matrix conditioned with a water-soluble polymer that loses 20–90 w / w% or less of water-soluble polymer under comparable conditions; those skilled in the art will immediately understand that all ranges and values ​​between the explicitly stated boundaries are intended, e.g., 20, 25, 30, 33, 40, 50, 60, 70, 80, 90 w / w%, etc. 【0183】 In some embodiments, the bulk incorporated material may exhibit a monolayer on the surface. The term monolayer means a layer having the thickness of one molecule. The monolayer does not rely on intermolecular cohesive forces to remain stably present on the surface. At least one water-soluble polymer forms a monolayer. In contrast, even a thin polymer coating that is crosslinked on itself has a thickness corresponding to the thickness of the network formed by the crosslinked polymer. For example, it may be possible to create a PVA coating crosslinked on a surface, but such a coating relies on the intermolecular interconnections of the PVA and inevitably forms a crosslinked network. Thus, embodiments include water-soluble polymers that exist on the surface of a porous solid without covalent bonding to the surface and without the polymer being part of a network. 【0184】 In some embodiments, bulk-integrated polymers are durably integrated. In contrast, a layer of water-soluble material simply adsorbed onto a substrate material, for example, applied by dip coating or spraying, means that at least 90 w / w% of the material can be separated from the substrate material in an aqueous solution, for example, physiological saline, at 90°C for 24 hours, and can be essentially removed from hydrophilic substrates in almost all circumstances. Covalently bonded materials may not be removed under these conditions, nor may the physically crosslinked network of the water-soluble polymer, but such networks are undesirable compared to bulk-integrated polymers and may, for example, increase thrombotic properties or reduce durability. Covalent bonding utilizes chemically reactive sites, which can be avoided in bulk integration processes. 【0185】 Processing systems and parameters for creating porous materials This specification provides processes for creating biocompatible porous solids, such as microporous or nanoporous solid materials, that have low protein adsorption properties and serve as the basis for non-biofouling devices. By utilizing changes in the starting polymer concentration, molecular weight, solvent removal, molding process, and curing / annealing process, surface properties such as reduced protein adsorption can be provided. Some embodiments involve creating various continuous shapes by extruding polymer mixtures. These mixtures may be further cured and annealed. These processes may be used to create tough and highly lubricated materials. Embodiments include polymer mixtures extruded into shapes having one or more lumens of varying diameters and wall thicknesses. 【0186】 One embodiment of a process for producing nanoporous solid materials includes heating a mixture containing a polymer and a solvent (polymer mixture), extruding the mixture into a solvent-removal environment, and removing the solvent from the crosslinking matrix until a nanoporous solid material is formed. Depending on the process, one or more of these actions may be combined. Furthermore, cooling the mixture as it passes through the die is also useful. Without being bound by a specific operating theory, it appears that crosslinking the polymer while it passes through the die initially forms a porous matrix. This matrix is ​​not a true nanoporous solid material because, although there are spaces between the polymer strands, it does not have a porous structure. Removing the solvent under favorable conditions causes the crosslinking structure to become a nanoporous solid. Crosslinking begins when the polymer mixture is extruded from the die and the mixture is cooled. Crosslinking can also continue while the solvent is being removed. The transition to forming the nanoporous material occurs as the solvent is removed and is generally considered complete or essentially complete (meaning 90% or more) at this stage. The resulting material may be further processed by annealing, with or without the presence of additional solvents or plasticizers. This process, and other extrusion or other forming processes and / or materials described herein, including bulk assembly processes, may not include one or more of the following: covalent crosslinking agents, agents that promote covalent crosslinking, radiation that crosslinks polymer chains, freezing, thawing, freeze-thaw cycles, one or more freeze-thaw cycles, ice crystal formation, foaming agents, surfactants, hydrophobic polymers, hydrophobic polymer segments, reinforcing materials, wires, blades, non-porous solids, and fibers. 【0187】 Porous materials may be manufactured by an extrusion process that involves passing a polymer mixture through a die into a cooling environment. The cooling environment may further be an environment that removes the solvent. If the solvent is water, it is a dehydrating environment. The die may have a core through which the polymer mixture passes so that it forms around the core. A solvent removal environment and / or an annealing environment may also be used. 【0188】 The extrusion process of the polymer-solvent mixture may be carried out as cold extrusion. Cold extrusion is a process in which the polymer-solvent mixture is passed through a die, and throughout the entire process of preparing and extruding the polymer-solvent mixture, it is not necessary to heat the polymer-solvent mixture above its boiling point. Therefore, in cold extrusion, the die head is kept below the boiling point of the polymer-solvent mixture. Many solvents can be used, but water is often a useful solvent, in which case the die head is kept below 100°C, although as mentioned above, even colder temperatures may be useful in some cases. 【0189】 The term polymer mixture means a polymer in solution, dissolved, or suspended in a solvent. The solvent may be, for example, water, aqueous solution, 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, upon reaching the melting point, the solution transitions from a cloudy state to a clear state. An aqueous solution contains water, for example, 10 to 100% (w / w or v / v) of the liquid is water. Those skilled in the art will immediately understand that all ranges and values ​​between the explicitly stated boundaries, e.g., 10, 20, 30, 40, 50, 60, 70, 80, or 90%, or at least one of them, are intended. 【0190】 Extrusion is a useful process for forming materials. Other forming processes may be used, such as molding, casting, or thermoforming of polymer-solvent mixtures. Generally, polymer-solvent mixtures are prepared without boiling and formed into shapes that are subjected to controlled solvent removal conditions to produce nanoporous or microporous materials using the guidelines provided herein. An annealing step may also be included. Hydrogels that are not microporous or nanoporous materials can also be produced. 【0191】 The heated polymer mixture may be molded while cooling, or it may be molded / formed and then cooled immediately. Molding is a broad term referring to the transfer of a material from an amorphous molten state to a final product or an intermediate shape for further processing. Molding includes casting, layering, coating, injection molding, drawing, and extrusion. Molding can be performed using an injection molding setup, in which case the mold contains a material having thermal conductivity that can be easily heated to facilitate the flow of the injected polymer mixture and can be rapidly cooled in a cooling environment. In other embodiments, the molding process may be achieved by extruding the polymer mixture through a die to form a continuous material. 【0192】 Cooling the polymer mixture may include, for example, cooling the extruded material, such as when passing the polymer material through a die. Embodiments for cooling are a liquid bath at a temperature at least 20°C below the boiling point of the polymer mixture, or alternatively, below the Tm of the polymer mixture, for example: a temperature 20, 30, 40, 50, 60, 70, 80, 90, 100, 110°C below the boiling point or polymer Tm, or alternatively, a bath or other environment at a temperature of -50 to 30°C. Those skilled in the art will immediately understand that all ranges and values ​​between the explicitly stated boundaries are intended, and for example, any of the following are available as upper or lower limits: -50, -45, -25, -20, -10, -5, -4, 0, 15, 20, 25, 30°C. Cooling may be carried out in an environment that removes the solvent. Temperatures below freezing point may be avoided. Without being constrained by a specific operational theory, the polymer chains are cooled to a point where intermolecular hydrogen bonding is promoted and the chain movement is immobilized. This may be done at a high temperature of 30°C, or even higher if time permits. The bath may be aqueous, and by adjusting it with salts or other penetrating agents, it may provide an osmotic pressure value for solvent removal for aqueous substances with relatively low osmotic pressure values ​​through osmosis and diffusion. Alternatively, the bath may be another solvent that freezes at a lower temperature than water, and can be used without freezing the solvent or material at temperatures below 0°C. When using hydrophilic copolymers in combination with PVA, for example, temperatures above 20°C may be used, as crosslinking and chain immobilization occur at much higher temperatures. 【0193】 A solvent removal environment is an environment in which solvent removal is significantly accelerated compared to drying under ambient conditions. Such an environment may be unheated, meaning it is not above ambient temperature, for example, not above 20°C. Such an environment may be a vacuum, such as a vacuum chamber, a salt bath, or a bath for removing solvents from polymer mixtures. For example, an aqueous polymer mixture may be introduced into an ethanol bath and the water may be replaced with ethanol. The ethanol may then be removed. The salt bath may be, for example, a high-salt concentration bath (1M to 6M). The processing time in the solvent removal environment and / or cooling step may be independently selected to be between 1 and 240 hours. Those skilled in the art will immediately understand that all ranges and values ​​between the specified boundaries are intended, and that any of the following are available as upper or lower limits: for example, 1, 2, 5, 10, 24 hours, or 1, 2, 5, 7, 10 days. The salt may be a salt that dissociates to form single, double, or triple charged ions. 【0194】 The environment for removing the solvent may be one or more environments, or one environment may be adjusted with respect to temperature. For example, after using a cooling bath, the solvent may be removed in an oven or vacuum oven. The washing step may be performed before or after cooling or solvent removal, and can be done, for example, by immersion in a series of solvents of different concentrations, different salt solutions, different proportions of ethanol or other solvents. 【0195】 One embodiment involves an extruded material that has undergone a solvent removal process including exposure to a salt bath, where the material is immersed in a series of H2O baths (new or replaced baths) for a set period of time (e.g., 2–48 hours, 4–24 hours) to remove excess salt from the casting material or end-user device. The material is removed from the washing step and dehydrated to remove excess moisture. Dehydration can be carried out using temperatures in the range of 20–95°C, for example. Dehydration is generally carried out at 37°C for 24 hours or more. 【0196】 One embodiment involves extruding a polymer mixture formed by extrusion or the like, and then exposing it to a high-salt bath (1M to 6M) for an inversely correlated time, where high salt reduces the required immersion time, for example, immersion in a 6M NaCl solution for 16 to 24 hours. After immersion, the material is rinsed out of the brine. At this point, the material is strengthened and can be removed from the mold piece carried over from the initial formation. Alternatively, after the salt bath, the material may be immersed in a water bath to dehydrate and remove excess water. Dehydration can be carried out at temperatures in the range of 20 to 95°C. Dehydration can be carried out at 37°C for 4 hours or more, 24 hours or more, or in the range of 2 to 150 hours. Those skilled in the art will immediately understand that all ranges and values ​​between the specified boundaries are intended, and that any of 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, or 150 hours can be used as upper or lower limits. For example, dehydration at 40°C for 6 to 24 hours has been observed to be effective. 【0197】 In another embodiment, NaCl is incorporated into the starting polymer solution at a concentration ranging from 0.1 to 3 M of the volume of the final polymer mixture. The polymer is dissolved in a heated solution under stirring, and then raised above its melting point. To this solution, dry NaCl is slowly added under stirring until completely dissolved. The slightly cloudy solution is drawn into a feed to form a shape by methods such as injection molding, casting, extrusion, or drawing. At the end of each step, a quench is performed to rapidly lower the temperature and form a solid material. In this embodiment, no additional salt soak is required. After the material has cured, if necessary, the material is removed from the molded part, washed with water to remove salt, and dehydrated. 【0198】 In the context of semi-crystalline polymers or solid porous materials, the term annealing refers to a heat treatment at an annealing temperature comparable to the melting temperature of the polymer or the polymer in the material. This temperature is typically lower than the melting temperature on an absolute temperature scale, usually within approximately 0-15%. Plasticizers and other additives can affect this, usually by lowering the melting temperature. For example, in the case of pure PVA, the annealing temperature will be within approximately 10% of the melting point of PVA, but if other materials are present, the annealing temperature will usually be lower. The theory of the operation is that annealing is a process of stress relief combined with an increase in the size of the crystalline regions of the material being annealed. Unlike metals, annealing increases the strength of the annealed material. Annealing can be performed under one or more conditions, such as in air, gas, oxygen-free, water-free, e.g., in nitrogen, vacuum nitrogen, under argon, or with the use of oxygen scavengers. For example, experiments have been conducted to anneal dehydrated PVA nanoporous material. Annealing is used to increase the crystallinity of the PVA network, further reduce the pore size of the PVA network, and decrease the adsorption properties of the final gel surface. Annealing can be carried out at temperatures in the range of 100-200°C, for example, and in a preferred embodiment, this step is performed by immersing the dehydrated gel in a bath of mineral oil. Bulk incorporation of polymers into porous solids may also include an annealing step as already described for porous solids. Annealing may be performed after exposing the desolvented porous solid to a mixture having the polymer to be bulk incorporated. The Tg of the material may increase or decrease depending on the residual solvent content and / or the presence of a second hydrophilic polymer bulk incorporated. As already mentioned, the conditions of the annealing process can be adapted to depend on the temperature, time, ramp rate, and cooling rate of the substrate. 【0199】 Annealing can be performed in a gas or liquid at atmospheric pressure, boosted pressure, or low pressure (vacuum). The liquid may be a low molecular weight polymer (up to 2000 Da) or other material (e.g., mineral oil). Examples of low molecular weight polymers include silicone oil, glycerin, polyols, and polyethylene glycol with less than 500 Da. A useful embodiment involves annealing in a glycerin bath, for example, at 140°C for 1 to 3 hours. Glycerin further reduces the fouling properties of the gel through interaction and neutralization of the free hydroxyl end groups of the PVA network. The annealed nanoporous material is cooled, removed from the annealing bath, and the bath medium is washed away using a series of prolonged immersions. The product is then dehydrated and prepared for end sterilization. 【0200】 Various types of dies may be used, for example, longitudinal, angular, transverse, and spiral extrusion heads, as well as single-polymer extrusion heads used for extruding a single polymer, and multi-layer extrusion heads used for extruding multiple polymer layers or other layers simultaneously. Furthermore, continuous-operation heads or circulating-operation heads may be used. Various materials, such as reinforcing materials, fibers, wires, braids, braided wires, and braided plastic fibers, may be incorporated into the layers or incorporated as layers. Similarly, such materials may be excluded. Moreover, porous solids may have certain properties, such as Young's modulus, tensile strength, solids content, polymer composition, porous structure, or solvent content, that are known and therefore measurable, apart from various other materials. Accordingly, embodiments include materials disclosed herein, described in terms of material properties, without considering various other incorporated materials. For example, nanoporous solids have a known constant Young's modulus, even if their material has reinforcing wires that contribute to further strength. 【0201】 The core may be used with an extrusion die. The core may be air, water, liquid, solid, non-solvent, or gas. Those skilled in the art who have read this disclosure will understand that various extrusion processes may be used with these various types of cores. Cores made of polytetrafluoroethylene (PTFE) tubing are useful. In some embodiments, the core is a wire. 【0202】 Multi-lumen tubes have multiple channels running through their profile. These extruded parts can be custom engineered to match the device design. Multi-lumen tubes have variable outer diameter (OD), numerous custom inner diameters (ID), and various wall thicknesses. These tubes come in a variety of shapes, including circular, elliptical, triangular, square, semicircular, and crescent shapes. These lumens can accommodate guide wires, fluids, gases, wires, and various other needs. The number of lumens in a multi-lumen tube is limited only by the size of the OD. In some embodiments, the outer diameter can be as large as 0.5 inches, the inner diameter as small as 0.002 inches, and the web and wall thickness as thin as 0.002 inches, while maintaining a tight tolerance of ±0.000.5 inches. For example, the upper or lower limits for the outer and / or inner diameters can be any of the following: 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. 【0203】 Braided reinforced tubing comes in various shapes. For example, it is possible to braid round or flat wire, single-ended or double-ended wire, with a thickness of approximately 0.001 inches. Various materials can be used for braided reinforced tubing, including stainless steel, beryllium copper, silver, and monofilament polymers. Furthermore, braids of various lengths can be wrapped around thermoplastic materials such as nylon and polyurethane. The advantages of braided catheter shafts are their high torque characteristics and kink resistance. By changing several elements during the braiding process, the characteristics of the tubing can be modified to suit the required performance. After braiding is complete, a second extrusion molding may be performed on the braided tubing to seal the braid and create a smooth finish. Braided reinforced tubing can be made as thin as 0.007 inches. 【0204】 Porous, microporous, and nanoporous materials The term "porous solid" is a broad term referring to materials that have a solid phase containing open spaces, and is used to describe both true porous materials and hydrogels with an open matrix structure. Because terms related to porosity are used somewhat ambiguously in scientific literature, it is useful to provide specific definitions in this specification. In this specification, the terms "nanoporous material" or "nanoporous solid" are used specifically to refer to solids made of interconnected pores having pore diameters up to approximately 100 nm. The term "diameter" is broad and, as is customary in these arts, encompasses pores of any shape. Similarly, the terms "microporous solid" or "microporous material" are used in this specification to specifically refer to solids made of interconnected pores having pore diameters up to approximately 10 μm. These nanoporous or microporous materials are characterized by their interconnected porous structure. 【0205】 Hydrogels, sometimes called hydrogel sponges by those skilled in the art, are true porous materials having a continuous network of solid material filled with voids, where the voids are pores. However, the open matrix structure found in many hydrogels is not a true porous structure, and it is convenient to generally call them porous materials and to use pore analogies when characterizing diffusivity and other properties, but such hydrogels are not nanoporous or microporous solids as those terms are used herein. The spaces between strands in open matrix hydrogels, and the strands in the matrix, are not interconnected pores. Hydrogels are crosslinked gels, insoluble in solvents, and possess high mechanical strength, and are therefore conveniently called solids in general in this specification and in the art, but they are crosslinked gels that have solid-like properties even if they are not true solids. Hydrogels may have a high water content, for example, 25 w / w% or more in EWC. Experts in hydrogel technology may use the term porous to characterize a net molecular weight cut or to refer to the spacing between strands in an open hydrogel matrix, but in this case, the hydrogel does not have a true porous structure and is not a nanoporous or microporous material as these terms are used herein. Furthermore, the definitions of nanoporous and microporous materials herein are in contrast to the convention that microporous materials have pore sizes less than 2 nm, macroporous materials have pore sizes of 50 nm or more, and mesoporous materials are somewhere in between. 【0206】 The extrusion process for manufacturing the material of the present invention offers several advantages. Extrusion molding has been shown to result in parallel orientation of the polymer, leading to high tensile strength. The extruded and stretched polymer molecules align in the direction of the tube or fiber. The tendency to return to a random orientation is prevented by strong intermolecular forces. Furthermore, it is possible to create materials and devices with higher aspect ratios compared to injection molding. In addition, extrusion molding allows for easy control of dimensions, such as wall thickness and lumen arrangement. Using a high concentration of polymer above its melting point in the solvent was useful in enabling extrusion molding. It is important to note that other attempts to create high-strength materials using similar polymers have often employed other techniques that are unsuitable for actual end-user products due to their inability to extrude, poor efficiency, and lack of practical application. 【0207】 For example, polyvinyl alcohol (PVA) has been used to create nanoporous materials with superior properties, particularly compared to conventionally used PVA medical materials. In fact, PVA is widely used in the medical device industry due to its established biocompatibility. PVA is a linear molecule and has a rich history as a highly biocompatible biomaterial. PVA hydrogels and membranes have been developed for biomedical applications such as contact lenses, artificial pancreases, hemodialysis, and synthetic vitreous fluids, as well as for implantable medical materials to replace cartilage and meniscus tissue. Its high biocompatibility and low protein adsorption, resulting in low cell adhesion, make it an attractive material for these applications. 【0208】 Furthermore, some are attempting to improve the properties of PVA for biomedical purposes. For example, some have experimented with freeze / thaw processes. There are also techniques for forming hydrogels from PVA, such as "salting-out" gelation, which have been shown to form useful polymer hydrogels with different molecular weights and concentrations. Manipulation of Florey interactions has also been studied in the formation of PVA gels by combining two solutions for the use of PVA as an injectable in situ forming gel for intervertebral disc repair (see U.S. Patents No. 7,845,670, 8,637,063, and 7,619,009). In general, prior processes for producing tough PVA materials have been studied in U.S. Patent No. 8,541,484. Methods that do not use radiation or chemical crosslinking agents have also been studied previously, as shown in U.S. Patent No. 6,231,60.5. None of these other PVA-related studies have resulted in the inventions described herein. Some of these other materials were useful in terms of tensile strength, but nevertheless, they were essentially macroporous. 【0209】 In contrast, the processes described herein provide high-strength materials with a true porous structure and other useful properties such as an unexpectedly good combination of biocompatibility and mechanical properties. 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 composition for the material, and further optionally, independently selected end-user devices or intermediate materials having a desired aspect ratio, lumen, multiple lumens, concentrically arranged lumens, or tolerance of thickness for the molded shape: each of these is described in further detail herein. 【0210】 Embodiments include nanoporous materials having pore diameters of 100 nm or less, or in the range of 10 to 100 nm; those skilled in the art will immediately understand that all ranges and values ​​between the explicitly stated boundaries are intended, and for example, any of the following are available as upper or lower limits: 1, 2, 3, 4, 5, 10, 20, 50, 60, 70, 80, 90, 100 nm. 【0211】 Embodiments include nanoporous or microporous materials with a tensile strength at break measured by EWC of at least about 50 MPa, or between 1 and 300 MPa. Those skilled in the art will immediately understand that all ranges and values ​​between the specified boundaries are intended, and that any of, for example, 10, 20, 30, 40, 50, 60, 70, 100, 200, or 300 MPa can be used as upper or lower limits. 【0212】 Embodiments include nanoporous or microporous materials having a Young's modulus strength of at least about 1 MPa or 1 to 200 MPa as measured by EWC. Those skilled in the art will immediately understand that all ranges and values ​​between the specified boundaries are intended, and that any of, for example, 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 80, 90, 100, 120, 140, 160, 180, and 200 MPa are available as upper or lower limits. 【0213】 Embodiments include nanoporous materials or microporous materials or hydrogels with elongation at break of at least about 100% or 50–1500% as measured by EWC. Those skilled in the art will immediately understand that all ranges and values ​​between the specified boundaries are intended, and that any of, for example, 50, 60, 70, 80, 90, 100, 200, 300, 400, 450, or 500% (e.g., 50% or greater or equal to 50%) can be used as upper or lower limits. 【0214】 Embodiments include nanoporous materials or microporous materials or hydrogels having at least 20% solids or 20–90 w / w% solids as measured in EWC. Those skilled in the art will immediately understand that all ranges and values ​​between the explicitly stated boundaries are intended, and for example, any of the following are available as upper or lower limits: 5, 10, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 80, and 90 w / w% solids. The percentage of solids is measured by comparing the total weight in EWC to the dry weight. 【0215】 The values ​​for tensile strength, modulus of elasticity, and elongation can be used in combination within the scope of this disclosure. 【0216】 Embodiments include nanoporous materials or microporous materials or hydrogels having physical crosslinking or covalent crosslinking or a combination thereof. Physical crosslinking is non-covalent, and for example, physical crosslinking is ionic bonding, hydrogen bonding, electrostatic bonding, van der Waals forces, or hydrophobic packing. The material may be free from covalent crosslinking, covalent crosslinking agents and their chemical products. Chemicals may be added during processing to create covalent crosslinking, as is known in polymerization techniques. Alternatively, the process and material may be without such chemicals. 【0217】 Embodiments include nanoporous materials or microporous materials or hydrogels having an internal alignment of polymer structures. Alignment can be visualized using SEM images of a cross-section taken along the extrusion direction, i.e., longitudinally in the case of a tube. Alignment refers to being arranged along the length of the sample (in the extrusion direction) with mostly horizontal chain orientations. 【0218】 Embodiments include nanoporous materials or microporous materials or hydrogels having hydrophilic surfaces and / or materials. Materials made from water-soluble polymers are hydrophilic. Water-soluble polymers are polymers that dissolve in water at a concentration of at least 1 g / 100 ml at 20°C. Water-soluble polymers are hydrophilic. A surface is hydrophilic if the contact angle of a water droplet on the surface is 90 degrees or less (the contact angle is defined as the angle through which the water droplet passes). Embodiments include hydrophilic surfaces having contact angles from 90 degrees to 0 degrees; those skilled in the art will immediately understand that all ranges and values ​​between the explicitly stated boundaries are intended, and that any of 90, 80, 70, 60, 50, 40, 30, 20, 10, 5, 2, or 0 degrees are available as upper or lower limits. The matrix of a material is hydrophilic to a solvent if the matrix is ​​hydrophilic and the contact angle of a solvent droplet on the surface is less than 90 degrees. 【0219】 Materials and / or biomaterials used in the process may include polymers. Hydrophilic polymers are useful and include, for example, one or more polymers selected from polyvinyl alcohol (PVA), polyvinylpyrrolidone (PVP), polyethylene glycol (PEG), polyacrylic acid (PAA), polyacrylamide, hydroxypropyl methacrylamide, polyoxazolines, polyphosphates, polyphosphazenes, poly(vinyl acetate), polypropylene glycol, poly(N-isopropylacrylamide) (PNIPAM), polysaccharides, sulfonated hydrophilic polymers (e.g., sulfonated polyphenylene oxide, Nafion®, sulfobetaine methacrylate), and those with iodine added (e.g., PVA-I, PVP-I), or those with pendant groups added, copolymers thereof, and combinations thereof. Alternatively, two or more hydrophilic polymers may be mixed to form nanoporous materials. The molecular weight of the polymer affects the properties of the biomaterial. As molecular weight increases, strength increases, pore size decreases, and protein adsorption tends to decrease. Therefore, embodiments include polymers or hydrophilic polymers having molecular weights of 40 kDa to 5000 kDa. Those skilled in the art will immediately understand that all ranges and values ​​between the specified boundaries are intended, and that any of the molecular weights of, for example, 40 k, 50 k, 100 k, 125 k, 150 k, 250 k, 400 k, 500 k, 600 k, 750 k, 800 k, 900 k, 1 million, 1.5 million, 2 million, 2.5 million, and 3 million are available as upper or lower limits. 【0220】 The term PEG refers to all polyethylene oxides, regardless of molecular weight or whether the polymer has hydroxyl ends. Similarly, the terms PVA, PVP, and PAA are used without limitation in terms of the chemical sites at the ends or the range of MW. References to polymers made herein include all forms of polymers, including linear polymers, branched polymers, derivatized polymers, and derivatized polymers. Branched polymers have a linear backbone and at least one branch, and are therefore a term that includes star, brush, comb, and combinations thereof. Derivatized polymers have a backbone containing the indicated repeating units and one or more substituents or pendant groups, collectively referred to as derivatized sites. Substitution is the replacement of one atom with another. A pendant group is a chemical site attached to a polymer, which may be the same site as the repeating unit of the polymer or a different site. Thus, the expression polymer includes highly derivatized polymers and polymers containing derivatized sites of 0.01 to 20 w / w% or less, calculated as the total MW of such sites relative to the total weight of the polymer. A person skilled in the art will immediately understand that all ranges and values ​​between the specified boundaries are intended, and that any of the following can be used as upper or lower limits: 0.01, 0.05, 0.1, 0.2, 0.3, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, and 20 w / w%. 【0221】 Porous solids can be formed as monolithic materials, as layers on other materials, devices, or surfaces, as multiple layers, or as one or more layers of nanoporous materials or materials containing nanoporous materials. For example, multiple layers may be extruded, and the layers can be independently selected to form one or more of the following: nanoporous materials, microporous materials, hydrogels, single polymer materials, materials having two or more polymers, and non-nanoporous materials. 【0222】 Furthermore, the process of creating the material affects the material's properties, such as the concentration of the polymer in the polymer mixture passed through the die. The initial concentration of PVA or other hydrophilic polymer may be, for example, in the range of 5–70% by weight-volume (w / w) in water, and generally preferred to be about 10–30% (w / w); those skilled in the art will immediately understand that all ranges and values ​​between the explicitly stated boundaries are intended, and that any of, for example, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, or 70% are available as upper or lower limits. 【0223】 The processes described herein may be truncated before the polymer is crosslinked to become a true nanoporous material, or they may be adapted to avoid nanoporous structures. Generally, such materials have low strength and toughness and low solids content. Such materials generally become hydrogels when hydrophilic polymers are used with relatively low solids content. Thus, such materials, and even hydrogels, are intended herein, and although their properties are somewhat inferior to those of nanoporous materials, they can nevertheless produce materials superior to conventional processes and materials using the same polymer. Similarly, generally speaking, microporous solids will approach the properties of nanoporous materials and have better strength than hydrogels. 【0224】 We are accustomed to quantifying the pore size distribution of materials. In this specification, nanoporous materials, microporous materials, and microporous materials are disclosed, and the control of pore size in such materials is demonstrated. Thus, embodiments include materials having a specific amount or distribution of pore size. These can be measured at the surface, at depth from the surface of a cross-sectional sample, or in the bulk of the material. For example, the pore size of a material at the surface, at depth from the surface, or in the bulk may be in the range of 1 nm to 20 μm, or the percentage of pore sizes falling above or below a certain value may be between 50 and 100%; those skilled in the art will immediately understand that all ranges and values ​​between the explicitly stated boundaries are intended. 10, 20, 30, 40, 50, 60, 65, 70, 75, 80, 90, 95, 98, 99, 99.9 or 100%, and 1, 10, 20, 30, 40.50, 100, 200, 400, 500, 1000, 2000, 3000, 5000, 10000, 15000, or 20000 nm. An example of quantification for depth is, for example, at a depth in the range of at least, or in the range of 1 to 5000 μm, and a person skilled in the art will immediately understand that all ranges and values ​​between the explicitly stated boundaries are intended: 1, 2, 3, 4, 5, 10, 20, 50, 100, 250, 500, 750, 1000, 2000, 3000, 4000, or 5000 μm. For example, the surface may have a certain proportion of holes with a certain diameter or less, or the depth or range of depths may have a certain proportion of holes with a certain diameter or less. 【0225】 Embodiments include a method for producing a polymer material, comprising heating a mixture containing a water-soluble polymer and a solvent to a temperature above the melting point of the polymer, extruding the mixture, cooling the mixture while removing the solvent, and / or cooling the mixture while crosslinking. When multiple polymers are present in the solvent with or without other additives, the melting point of the bonded polymers in the solvent can be easily determined by those skilled in the art, for example, by observing the mixture being heated and changing from a cloudy appearance to a noticeably translucent appearance. Furthermore, some or all of the solvent may be removed from the mixture after or as part of a forming process using the mixture while cooling is taking place. Embodiments include removing at least 50 w / w% of the solvent in less than 60 minutes (or less than 1, 2, 5, or 10 minutes). Embodiments include removing at least 90 w / w (or at least 70 w / w, or at least 80 w / w) of the solvent in less than 60 minutes (or less than 1, 2, 5, 10, or 30 minutes). 【0226】 Bulk incorporation of polymers into porous solids When a porous matrix is ​​desolvated, the polymer can be drawn into the pores by exposing the porous material to a mixture containing a solvated polymer (for bulk-integrated polymers). The solvent in the mixture has an affinity for the matrix, and the polymer is drawn in as the matrix absorbs the solvent. The solvent in the mixture with the bulk-integrated polymer can be selected to have an affinity for the matrix so that it is absorbed by the desolvated matrix, but it does not need to be the same as the solvent in the matrix. Generally, the hydrophilic solvent in the mixture will be at least partially desolvated and absorbed into the hydrophilic porous matrix containing the hydrophilic solvent, and those skilled in the art can prepare various solvents as needed to create suitable conditions when bulk integration is intended. 【0227】 A hydrophilic solvent is a solvent that is freely miscible with water, or a solvent that exists in a mixture that is freely miscible with water at 20°C. 【0228】 Solvent removal means that the matrix is ​​free of solvent, for example, completely dry, or below the EWC of the matrix for any solvent present. If the solvent in the matrix is ​​not water, the EWC can be calculated for the material based on measurements in the solvent. That is, the term EWC can be used for solvents other than water in a suitable context. For example, a hydrophilic matrix may be dissolved in an aqueous solution of alcohol and will have an EWC for that solvent. The embodiments include solvent removal amounts for porous solids from 1 to 100, but those skilled in the art will immediately understand that all ranges and values ​​between the explicitly stated boundaries are intended. 1, 5, 10, 15, 20, 33, 40, 50, 60, 70, 80, 90, 95, 99, and 100 w / w% refer to the total weight of solvent that can be removed. 【0229】 Without being bound by any particular theory, it is believed that by desolventizing a porous material (dehydrating if the solvent of the porous material is water) and exposing the porous material to a polymer in a solution that decomposes the porous material, the polymer is drawn into the pores. Subsequently, the polymer is practically permanently incorporated into the bulk of the material by forming physical bonds with the matrix material that defines the pores, and by at least partially filling the pores, and by physically bonding with the matrix. Alternatively, or additionally, the polymer has a hydrodynamic radius that causes it to present a diameter exceeding the pore opening diameter, so that the polymer is permanently incorporated into the pores of the material, especially when the material is used in water or physiological solutions. Generally, if the bulk-incorporated polymer is dissolved in a polymer that wets the pores of a porous solid, the polymer can be drawn into the matrix pores while dissolving. If the hydrophilic porous matrix is ​​below the EWC of the matrix, the solvent for the polymer is matched to the matrix material, for example, wetting the pores of the material, so the mixture containing the polymer for bulk incorporation is drawn in. For example, a hydrophilic solvent usually wets the pores of a hydrophilic matrix. 【0230】 Materials comprising a porous matrix of non-covalently bonded polymers are preferred embodiments because these materials can be manufactured with a high degree of control over pore size and material properties, including the selection of nanoporous, microporous, or other characteristic pore sizes. The matrix may consist of physically crosslinked water-soluble polymers that define the pores. The solids content concentration of these water-soluble polymers may be at least 33 w / w% of the matrix at the equilibrium water content (EWC), but other concentrations may also be used. 【0231】 Accordingly, one embodiment of the process for incorporating polymers into a porous material includes providing a material comprising a porous hydrophilic matrix in which one or more water-soluble polymers (also referred herein as matrix polymers) are crosslinked with each other to form the matrix. The material having the matrix is ​​exposed to a mixture comprising one or more polymers (also referred to as bulk-integrated polymers, the polymers are preferably water-soluble, and the mixture is also referred to as a conditioning mixture or bulk-integrated mixture) dissolved in a solvent, wherein the matrix is ​​below EWC and hydrophilic to the solvent before exposure to the mixture. The material is desolvented before exposure to the mixture with the bulk-integrated polymers. 【0232】 In some embodiments, the bulk encapsulation process creates an outer zone with filled pores, an intermediate zone with mostly or partially filled pores, and an inner zone with little or no polymer penetration. Bulk encapsulation modifies not only surface pores but also subsurface pores, e.g., pores in the range of at least 1 to 5000 μm. Those skilled in the art will immediately understand that all ranges and values ​​between the specified boundaries, e.g., 1, 2, 3, 4, 5, 10, 20, 30, 40, 50, 75, 100, 250, 500, 750, 1000, 2000, 3000, 4000, or 5000 μm, are intended. The percentage of pores with polymer may be assayed as already described, and the permeability may be graded by a percentage cutoff. For example, there could be a first zone with 100% pores filled, a second zone with 50% pores filled, and a third zone with 0% pores filled. 【0233】 The bulk encapsulation process is preferably carried out using a porous matrix containing a water-soluble polymer, and the polymer does not need to contain hydrophobic domains; for example, a matrix containing only PVA may be used. The polymer may form the matrix by physical crosslinking. Therefore, embodiments include materials containing a matrix made using a water-soluble polymer that does not contain hydrophobic domains or a matrix made using a water-soluble polymer that does not contain hydrophobic domains. However, when creating a hydrophilic matrix using a water-soluble polymer with physical crosslinking, some hydrophobic domains can be tolerated without disrupting the matrix formed thereby. Embodiments of the present invention include the hydrophobic content of the polymer forming the porous matrix being 0, 1, 2, 3, 4, 5, 7, 8, 9, 10, 11, 12, or 15 w / w%. 【0234】 Furthermore, a porous matrix essentially containing water-soluble polymers refers to one in which the polymer content that crosslinks to form the matrix is ​​up to 3 w / w%. RO agents such as salts are not polymers that crosslink to form the matrix. A porous matrix essentially composed of physically crosslinked polymers refers to a matrix that does not contain agents that create covalent bonds between polymers, or has small amounts of such agents such that about 6% or less of the polymers (see polymer number) are not crosslinked with each other by such agents, for example, where the stoichiometric ratio of polymer number to bifunctional crosslinker is at least 100:3. Similarly, a matrix essentially free of covalent bonds is made of crosslinked polymers in which about 6% or less of the polymer(s) are not covalently crosslinked. The number of covalent bonds in the matrix may also be limited to any number in a stoichiometric ratio of 100:3 to 100:100, for example, 100 to 3, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, or 100. For example, hydrogels produced by free radical polymerization typically have 100% polymers bonded to each other by covalent bonds, which is a stoichiometric ratio of polymer:covalent bonds of 100:100. 【0235】 As described elsewhere, porous solids can be made with a controlled pore diameter range and can be made to provide a matrix that does not have pores larger than a certain diameter. The diameter may be measured in a suitable context, for example, by EWC of distilled water. Embodiments thus include polymers encapsulated in a porous matrix that does not have pores larger than 1 to 5000 μm; those skilled in the art will immediately understand that all ranges and values ​​between the explicitly stated boundaries are intended, e.g., 1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 50, 100, 200, 250, 300, 400, 500, 750, 1000, 2000, 3000, 4000, or 5000 μm. 【0236】 Porous solids can contain other materials, as described elsewhere in this specification, such as radiopaque (RO) agents that are added to the matrix but are not part of it. RO agents typically contribute little to the crosslinking that gives strength to the matrix. Similarly, other materials can be present in the matrix but not part of it, such as wires and reinforcing materials. A matrix made by physical crosslinking is one type of matrix that can be made of a material that defines pores of a certain diameter, and can be seen as in contrast to hydrogels, which have polymer strands that are generally separated from each other and connected in a mesh network structure, typically formed using free radical polymerization or by monomer / polymer reactions in solution. Such mesh networks generally cannot be expected to stably incorporate polymers into their pores unless they are covalently bonded using a polymer-imbibing process. Porous materials are described in detail herein and may be freely selected for use with bulk incorporated polymers, as led to the disclosure herein. Porous materials may be selected that have bulk properties such as those described herein. 【0237】 The bulk incorporated polymer may be a polymer described elsewhere in this specification for porous solids. An example is a water-soluble polymer. Water-soluble polymers include, for example, polyvinyl alcohol (PVA), polyvinylpyrrolidone (PVP), polyethylene glycol (PEG), polyacrylic acid (PAA), polyacrylamide, hydroxypropyl methacrylamide, polyoxazolines, polyphosphates, polyphosphazenes, poly(vinyl acetate), polypropylene glycol, poly(N-isopropylacrylamide) (PNIPAM), polysaccharides, sulfonated hydrophilic polymers (e.g., sulfonated polyphenylene oxide, Nafion®, sulfobetaine methacrylate, etc.), and variations thereto with iodine added (PVA-I, PVP-I, etc.), or variations thereto with pendant groups added, copolymers thereto, and combinations thereto. A mixture may contain one or more polymers, meaning polymers with different chemical compositions, such as PVA and PEG. "Polymer" means one or more polymers. 【0238】 The solubility of water-soluble polymers for porous matrices or bulk incorporation may be selected, for example, as at least 1, 2, 5, or 10 g / 100 mL in water at 20°C. The polymer may be selected to be linear or branched. Embodiments include, for example, polymers having molecular weights of 40 kDa to 5000 kDa or hydrophilic polymers; those skilled in the art will immediately understand that all ranges and values ​​between the explicitly stated boundaries are intended, and that any of the molecular weights of 40 kDa, 50 kDa, 100 kDa, 125 kDa, 150 kDa, 250 kDa, 400 kDa, 500 kDa, 600 kDa, 750 kDa, 800 kDa, 900 kDa, 1 million, 1.5 million, 2 million, 2.5 million, and 3 million are available as upper or lower limits. The molecular weight of the polymer can be selected considering the size of the pores available in the porous solid. Nanoporous or microporous materials are preferred. 【0239】 The bulk incorporated polymer can be the same as the polymer forming the porous matrix, the same as at least one of the polymers constituting the matrix, or a different polymer can be selected. 【0240】 The concentration of the bulk incorporated polymer in the mixture may be any concentration at which the polymer is dissolved, with reference to the mixture at the start of the process, keeping in mind that undissolved polymers, or other non-dissolved materials, are not destined to enter the pores. In some embodiments, the concentration is 1 to 50 w / w%. Those skilled in the art will immediately understand that all ranges and values ​​between the indicated ranges, e.g., 1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 33, 35, 40, and 50 w / w%, are intended. 【0241】 The solvent for the mixture is appropriately selected to solvate the polymer and provide a solvent that is absorbed by the porous solid. For hydrophilic matrices, hydrophilic solvents are generally preferred. The solvent may be water, an organic substance, or aqueous, or it may be free of these, for example, free of organic solvents. In some embodiments, the concentration of water is 0 to 99, for example, 0, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 95, or 99 w / w%. 【0242】 The temperature of the preparation mixture should not exceed the melting temperature of the porous solid matrix. The temperature range may be, for example, 10 to 100°C, or for example, 10, 20, 30, 37, 40, 50, 60, 70, 80, or 90°C. 【0243】 The exposure time is preferably the length of time required for the porous solid to reach EWC in the mixture. In some embodiments, the length of time may consist of 2, 4, 6, 8, 10, 12, 16, 20, 24, and 48 hours. Stirring and temperature may be manipulated to affect the exposure time, for example, to promote the achievement of EWC or to control the viscosity of the mixture. The salt and / or osmotic content may be adjusted as appropriate, for example, for solubility, viscosity, and / or EWC. 【0244】 The examples provide guidance on salt concentrations in conditioning mixtures. Examples of salt concentrations range from 0.1 to 2 w / w%. Generally, single-charged cations with small atomic radii are said to penetrate deeply into porous solids, while larger cations reduce penetration. Examples of salts include single-cation, divalent cation, or those containing other cations, such as sodium, potassium, lithium, copper, and quaternary ammonium (NR4). + Examples include salts of magnesium, calcium, copper, iron, or zinc (where R is hydrogen, alkyl, or aryl group). Generally, a physiological pH with a buffer was useful for the mixture. The pH may be adjusted to increase or decrease permeability to the matrix, and the solvent may or may not contain a buffer salt. Examples of pH ranges from 4 to 10, for example, 4, 5, 6, 7, 8, 9, or 10. 【0245】 The viscosity of a conditioning mixture containing a water-soluble polymer and a solvent is influenced by pH (higher pH indicates higher viscosity), polymer concentration and / or molecular weight, and polymer branching; generally, increasing any of these factors results in higher viscosity. Generally, higher viscosity reduces the permeability of the polymer into a porous solid. One embodiment is a porous material in which a water-soluble polymer is encapsulated within the pores of a porous matrix. The matrix may contain physically crosslinked water-soluble polymers that are crosslinked with each other to form the matrix and define the pores. The matrix may have characteristics such as those disclosed herein, e.g., polymer content, polymer weight%, strength, Young's modulus, degree of coverage, pore size, etc. The surface coverage of the water-soluble polymer in the porous matrix may be complete. Complete coverage under SEM conditions where the pores of the substrate surface are not visible indicates coverage in EWC. Coverage may be less than 100%, for example, 50-100%. Those skilled in the art will immediately understand that all ranges and values ​​between the explicitly stated boundaries, e.g., 50, 60, 70, 80, 90, 95, 98, 99, 99.9, or 100%, are intended. 【0246】 Bulk incorporation can degrade the physical properties of porous solids. Therefore, embodiments include porous solids, such as those disclosed herein, that, as a result of conditioned with a water-soluble polymer, have 1–20% less Young's modulus and / or tensile strength compared to the same material not conditioned with a water-soluble polymer; those skilled in the art will immediately understand that all ranges and values ​​between the explicitly stated boundaries, e.g., 1, 2, 3, 4, 5, 7, 9, 10, 12, 15, or 20%, are intended. Example 22 provided a test relating to the exposure of the material for stable incorporation of a water-soluble polymer. The test for stable incorporation of a water-soluble polymer involved immersing a test device in a biologically representative fluid (i.e., PBS) at body temperature conditions, placing the test device directly on the head of a pump in a circulating peristaltic loop, and exposing it at a flow rate of 10–12 mL / sec at 150 rpm for 24 hours, 0.1225 [cm³]. 3 ·s -1 ·cm -2 The volumetric flow rate was approximated to 500,000 mechanical sample compressions. The test results revealed a loss of as much as 25%, but other test criteria may be used, for example, losses of 0-50 w / w%, e.g., 1, 5, 10, 15, 20, 25, 30, 40, 50 w / w%. Alternatively, other tests may be proposed, for example, losses of 0-5 w / w% when left standing in excess PBS for 1-52 weeks, e.g., losses of 1, 2, 3, 4, or 5 w / w%. 【0247】 product By referring to the materials described herein, such as nanoporous materials, microporous materials, and hydrogels, products (final products, intermediate products, materials, etc.) having a desired aspect ratio, for example, at least 3:1, can be manufactured. The aspect ratio increases as the length of the device increases and the width decreases. Those skilled in the art will immediately understand that all ranges and values ​​between the specified boundaries are intended, and that any of, for example, 3:1, 4:1, 5:1, 6:1, 7:1, 8:1, 9:1, 10:1, 50:1, 100:1, or 1000:1 are available as upper or lower limits. High aspect ratios are very advantageous for certain devices, for example, many types of catheters. In principle, thin tubes can be continuously extruded without length limitations. Such devices include, for example, tubes, rods, cylinders, and cross-sections having square, polygonal, or circular profiles. One or more lumens may be provided in any of them. The device may be made of a single material, essentially a single material, or multiple materials including various layers as already described, or it may be made of reinforcing materials, fibers, wires, braiding materials, braided wires, or braided plastic fibers. 【0248】 In particular, in extrusion processes, lumens can be arranged concentrically. Concentric arrangement is in contrast to eccentric arrangement, which means the lumens are off-center. In the case of multiple lumens, the lumens may be arranged symmetrically. This symmetry is in contrast to eccentric arrangement of lumens, which is the result of insufficient control. Embodiments include the aforementioned devices having an aspect ratio of at least 3:1, with lumens arranged without eccentricity, or one lumen concentric with the longitudinal axis of the device. 【0249】 Porous solids such as nanoporous materials, microporous materials, and strong hydrogels may be used to make catheters or medical fibers. These may be made of bulk incorporated polymers and may have the various characteristics similarly described. Examples of catheters include central veins, peripheral insertion centers, midline, peripheral, tunnel type, dialysis access, hemodialysis, vascular access ports, peritoneal dialysis, urinary tract, nerve, peritoneal, intra-aortic balloon pumps, diagnostic, intervention, drug delivery, etc.), shunts, wound drains (external, including ventricles, ventricular peritoneum, lumboperitoneum), and infusion ports. Porous solid materials may be used to make implantable devices, including permanent or temporary, fully implantable and percutaneous implantable devices. Porous solid materials may be used to make devices that come into contact with blood or body fluids (including ex vivo and / or in vivo devices, and blood-contacting implants). Examples of such devices include drug delivery devices (e.g., insulin pumps), tubing, contraceptives, feminine hygiene products, endoscopes, grafts (including those with a diameter of <6 mm), pacemakers, implantable cardioverter-defibrillators, cardiac resynchronization devices, lead wires for cardiovascular devices, and ventricular assist devices. Catheters (including ophthalmic devices such as cochlear implants, endotracheal tubes, tracheostomy tubes, drug delivery ports and tubes, implantable sensors (intravascular, percutaneous, intracranial), ventilator pumps, and drug delivery systems). Catheters can consist of tubular nanoporous materials with fasteners, such as Luer fasteners or fittings, for working with other devices. Radiopaque agents can be added to materials, fibers, or devices. Radiopaque agents refer to agents commonly used in the medical device industry to impart radiopaqueness to materials, such as barium sulfate, bismuth, or tungsten. RO agents can be incorporated at 5-50 w / w% of the total solid weight, for example, 5, 10, 20, 30, 40, or 50%. 【0250】 Medical fibers made from porous solid materials have applications in sutures, threads, medical fibers, braids, meshes, knits or woven fabrics, nonwovens, and devices using these materials. These fibers are strong and flexible. Materials may be made from these fibers to be resistant to fatigue and abrasion. 【0251】 In exemplary embodiments, the method involves administering a device, which includes a body portion, into an external orifice of a target, wherein the body portion includes a polymer material comprising a water-soluble polymer and a biological activator associated with the polymer material. In some embodiments, the device has an aspect ratio of 3:1 or greater. In some embodiments, the biological activator is substantially uniformly distributed within the polymer material. In some embodiments, the biological activator is heterogeneously distributed within the polymer material (i.e., on one or more surfaces of the polymer material). In some embodiments, the administration of the device (e.g., device 10 in Figure 1A, device 12 in Figure 1B, device 14 in Figure 1C) does not involve the use of a sheath introducer. The polymer material is substantially non-thrombotic, and in a first configuration (e.g., a water content lower than the equilibrium water content state, such as a dehydrated state), the polymer material has a water content of less than 5 w / w% and more than 0.1 w / w%, and the polymer material is configured to swell from the first configuration by an amount of 5 w / w% to 50 w / w% (e.g., in 60 minutes or less (e.g., 10 minutes or less, 5 minutes or less, 1 minute or less, or 10 seconds or less) from the first configuration (e.g., a water content lower than the equilibrium water content state, such as a dehydrated state) to the second configuration (e.g., the equilibrium water content state)). 【0252】 Treatment methods In some aspects, methods for processing the object are described. In some embodiments, the method involves administering the device described herein (e.g., any embodiment of the device described herein or a combination thereof) into a hole in the object. In some embodiments, the method includes swelling the polymer material described herein. For example, in some embodiments, the method includes swelling the device and / or polymer material in amounts of 2 w / w% or more, 3 w / w% or more, 4 w / w% or more, 5 w / w% or more, or 10 w / w% or more. At 15 w / w% or more, 20 w / w% or more, 25 w / w% or more, 30 w / w% or more, 35 w / w% or more, 40 w / w% or more, or 45 w / w% or more, the material changes from, for example, a first configuration (e.g., a dehydrated state, or a water content lower than the equilibrium water content state) to a second configuration (e.g., the equilibrium water content state). In some embodiments, the method involves inflating the device and / or polymer material to an amount of 50 w / w% or less, 45 w / w% or less, 40 w / w% or less, 35 w / w% or less, 30 w / w% or less, 25 w / w% or less, 20 w / w% or less, 15 w / w% or less, or 10 w / w% or less, for example, changing from a first configuration (e.g., a water content lower than the equilibrium water content state, such as a dehydrated state) to a second configuration (e.g., the equilibrium water content state). Combinations of these ranges are also possible (e.g., 5 w / w% to 40 w / w%). 【0253】 In some embodiments, the method includes swelling a polymer material to an equilibrium water content state. In some embodiments, the method includes swelling a polymer material to an equilibrium water content state over a duration period of time. In some embodiments, the duration is 60 minutes or less (for example, 10 minutes or less, 5 minutes or less, 1 minute or less, 30 seconds or less, or 10 seconds or less). 【0254】 In some embodiments, the method includes swelling a polymer material at a predetermined temperature. In some embodiments, the temperature is 4°C or higher, 10°C or higher, 16°C or higher, 20°C or higher, 25°C or higher, or 30°C or higher. In some embodiments, the temperature is 40°C or lower, 30°C or lower, 25°C or lower, 20°C or lower, 16°C or lower, or 10°C or lower. Combinations of these ranges are also possible (e.g., 20°C to 40°C). 【0255】 In some embodiments, the method involves swelling a polymer material such that the inner diameter and / or outer diameter increases at a rate greater than the rate of increase in length (as described herein). For example, in some embodiments, the method involves swelling a polymer material such that the inner diameter and / or outer diameter increases by 1 to 20%, while the length increases by 0.1 to 19%. 【0256】 In some embodiments, swelling occurs after administration. In some embodiments, swelling of the polymer material after administration to an orifice in a subject closes the opening of the orifice. For example, in some embodiments, swelling of the polymer material increases its size to a dimension greater than or equal to the size of the opening into which it is inserted. In some embodiments, the opening is a wound. In some embodiments, the swelling of the polymer material causes hemostasis. For example, in some embodiments, a subject (e.g., a human) may have a bleeding opening (e.g., a wound) with a maximum cross-sectional diameter of A, and a device described herein having a maximum outer cross-sectional diameter smaller than A may be administered to the opening. In some embodiments, the maximum outer cross-sectional diameter of the device may then swell to a dimension greater than or equal to A so that the opening is closed. In some embodiments, this can be used to achieve hemostasis. 【0257】 In some embodiments, swelling occurs before administration. In some embodiments, swelling involves rehydrating the device for a duration. In some embodiments, the duration is 60 minutes or less (e.g., 10 minutes or less, 5 minutes or less, 1 minute or less, or 10 seconds or less). In some embodiments, rehydration of the device involves the use of a rehydration medium. In some embodiments, the hydration medium includes water, Ringer's lactate solution (LRS), dextrose (D5W), phosphate-buffered saline (PBS), Hanks' Balanced Salt Solution (HBSS), and / or isotonic salt solution. 【0258】 Kit In some aspects, a kit is described. The kit may include any suitable article described herein. In some embodiments, the kit comprises a device (e.g., any embodiment of the devices described herein or combinations thereof). 【0259】 In some embodiments, the kit further comprises a humidity control sponge. The humidity control sponge may be composed of a woven, non-woven, porous, and / or solid material containing water and / or a hydrating medium. In some embodiments, the humidity control sponge is a porous cellulose non-woven fabric swollen with water. In some embodiments, the humidity control sponge further contains a preservative or anti-infective agent (e.g., bleach, sodium hypochlorite, peroxide, and / or peracetic acid). 【0260】 In some embodiments, the kit further contains a hydrating medium. Non-limiting examples of suitable hydrating media include water, lactated Ringer's solution (LRS), dextrose (D5W), phosphate buffered saline (PBS), Hanks’ Balanced Salt Solution (HBSS), and / or isotonic saline solution. In some embodiments, the kit contains a sufficient amount of the hydrating medium necessary to fully hydrate the device up to EWC. In some embodiments, the hydrating medium is stored in a container, fluid reservoir, tube, syringe, bag, fluid pump, and / or packet. In some embodiments, the hydrating medium is sterilized. In some embodiments, the hydrating medium is buffered at or near physiological pH (e.g., 6.8 - 7.8). 【0261】 In some embodiments, the kit is sterile (or aseptic). In some embodiments, the kit is sealed. 【0262】 In some embodiments, the kit includes instructions for use. In some embodiments, the instructions for use describe the treatment methods described herein. 【0263】 In some embodiments, the kit includes packaging. In some embodiments, the packaging comprises a flexible container. In some embodiments, the flexible container comprises flash-spun high-density polyethylene fibers. In some embodiments, the packaging comprises a tray on which the device can be placed for shipping. 【0264】 Further definition "Medically acceptable" means a non-toxic material that is highly purified to be free of contaminants. "Essentially composed" is a term used in the context of biomaterials or medical devices, meaning that other materials or components make up 3% (w / w) or less of the material or device, and that 3% does not render the device unsuitable for its intended medical use. Equilibrium water content (EWC) is the water content of a material before it degrades, when its wet weight becomes constant. Generally, materials with a high solids content are known to reach equilibrium water content in 24 to 48 hours. Distilled water is used to measure EWC unless otherwise specified. 【0265】 The term w / v means weight per volume, e.g., g / L or mg / mL. The terms biomaterial and biomedical material are used interchangeably herein and include, for example, biologically acceptable materials intended for use in biomedical art for purposes such as implants, catheters, materials in contact with blood, materials in contact with tissue, diagnostic assays, medical kits, tissue sample preparation, or other medical purposes. Furthermore, materials suitable for biomedical applications are not limited to them and can also be created as general-purpose materials. Physiological saline refers to a phosphate buffer with a pH of 7-7.4 at 37°C and the physiological osmotic pressure of humans. 【0266】 Molecular weight (MW) is measured in g / mol. For polymers, MW refers to the weight-average MW unless otherwise specified. If the polymer is part of a porous solid, the term MW refers to the polymer before crosslinking. If the distance between crosslinks is specified, it refers to the weight-average MW between crosslinks unless otherwise specified. k is an abbreviation for thousands, M for ten thousand, and G for billions; 50 kMW means 50,000 MW. Dalton is also a unit of MW and, similarly, refers to the weight-average when used for polymers. 【0267】 The publications, journal devices, patents, and patent applications referenced herein are incorporated herein for all purposes and in the event of any conflict herein shall prevail. The features of the embodiments described herein may be mixed and combined as dictated by the need to create an operational process or product. 【0268】 In this specification, the terms “therapeutic agent” or “medicine” refer to a drug administered to a subject for the treatment or prevention of a disease, disorder or other clinically recognized condition, and which has a clinically significant effect on the subject’s body to treat and / or prevent the disease, disorder or condition. 【0269】 In this specification, when a component is referred to as “adjacent” to another component, it may mean that it is directly adjacent to (e.g., in contact with) that component, or that there are one or more intervening components. A component that is “directly adjacent” to another component means that there are no intervening components. 【0270】 The term "subject" refers to any animal, such as a mammal (e.g., a human). Non-limiting examples of subjects include humans, non-human primates, cattle, horses, pigs, sheep, goats, dogs, cats, or rodents such as mice, rats, hamsters, birds, fish, and guinea pigs. Generally, the present invention is directed toward use in humans. In some embodiments, subjects may exhibit health benefits, for example, when administered with an orthostatic device. 【0271】 In this specification, “fluid” means in its ordinary sense, i.e., a liquid or a gas. A fluid cannot maintain a defined shape and flows during an observable time frame, filling the container in which it is placed. Thus, a fluid can have any suitable viscosity that allows it to flow. If two or more fluids are present, each fluid can be independently selected by a person skilled in the art from essentially any fluid (liquid, gas, etc.). [Examples] 【0272】 The following examples are intended to illustrate some embodiments of the invention described herein, including some aspects of the invention, but are not intended to illustrate the entire scope of the invention. 【0273】 Example 1: Evaluation of thrombus formation in PVA gel 200g of distilled water was placed in a jacketed reaction vessel at 95°C, and the temperature was raised to prepare a PVA extruded sample. 40g of PVA (Sigma-Packard, 146k-186k) was added to this sample over 5 minutes while stirring at 200 RPM. The polymer was mixed at 300 RPM for 1.5 hours. The polymer was degassed at 90°C for 2 hours. The polymer was then extruded into ethanol at -23°C, and subsequently stored in a freezer in ethanol at -25°C for 24 hours. The sample was dried for 6 hours. After drying, the sample was immersed in glycerol at 120°C for 17 hours. After annealing, the sample was removed, cooled, and rinsed with ethanol. After rinsing, the core was removed. The sample was dried at 50°C for 12 hours. 【0274】 A sample of PVA containing barium sulfate was prepared by heating 50 g of water to 90°C in a jacketed reaction vessel. In a side container, 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. This was mixed and heated for 10 minutes. After heating, 16 g of PVA (Sigma, 146 k~186 k) was added and mixed at 360 RPM for approximately 2 hours. The PVA-RO polymer mixture was heated to 90°C and extruded into ethanol at -16°C. The extruded material was dehydrated at -25°C for 24 hours. After removing the core, the sample was dried in a 50°C incubator for approximately 6 hours. After drying, the sample was immersed in glycerol (Sigma) at 120°C for 17 hours. After annealing, the sample was removed, cooled, and washed with distilled water. The sample was dried at 50°C for 12 hours and packaged for testing. 【0275】 The samples underwent non-thrombotic endurance testing at Thrombodyne (Salt Lake City, Utah). Each sample was cut to a length of 15 cm, with N=5 per sample group. Prior to testing, the samples were sterilized by ethylene oxide treatment for 12 hours. In addition, a hydrostatic pressure test was performed with distilled water for approximately 48 hours, simulating clinical use. 【0276】 111 Fresh bovine blood, heparinized and containing In-labeled platelets, was divided into test samples and controls for evaluation. The samples were inserted into an in vitro blood flow loop in 0.25-inch ID polyvinyl chloride tubing for approximately 120 minutes. The blood was maintained at 98°C and pumped into the blood loop using a peristaltic pump during the experiment. The samples were initially checked for thrombus after 45 minutes in the blood flow loop and then removed after 120 minutes. At the end of the experiment, the device was removed from the tubing, washed with saline, and placed in a gamma counter for thrombus quantification. Experimental parameters are shown in Table 1. Each experiment consisted of an independent flow system for each circulating blood sample and / or control from the same animal to allow for simultaneous comparison without crossover effects. 【0277】 The samples were measured for radioactivity and qualitatively evaluated for the accumulation of a specific type of thrombus (i.e., adhesion or fibrin accumulation). The measurement results are shown in Table 1. The thrombus rate was calculated by comparing the average total thrombus rate observed in all test groups and control groups for each animal with circulating blood. The results regarding thrombus accumulation are provided in Tables 2 - 3 and depicted in Figure 5A. The visual evaluation of thrombus is shown in Figure 5B using a commercially available control catheter, 17% PVA extrudate, and 17% PVA - barium sulfate extrudate. 【0278】 TIFF0007875685000001.tif41139 【0279】 TIFF0007875685000002.tif62155 【0280】 TIFF0007875685000003.tif78146 【0281】 As a result, thrombus was reduced in the PVA formulation compared to the commercially available PICC. The PVA - RO (barium as the RO agent) formulation was not superior compared to the control. The possible reasons include that barium was not micronized and there were large barium particles on the surface of the extrudate. 【0282】 Example 2: Hydration rate of extrudate The following example shows the hydration rate of an exemplary extruded PVA tube using a 0.03 inch acetal core filament. <00009�4> A PVA - bismuth subcarbonate polymer solution (e.g., the first water - soluble polymer) was prepared using 42.0 g of bismuth subcarbonate (Lot: Foster, FEI5577), 179.25 g of 6.2 w / w% sodium monophosphate solution, and poly(vinyl alcohol) 28 - 99 (Lot: EMD, K45556756). The substitution components were placed in a sealed polypropylene bottle and heated, and mixed with a Speedmixer manufactured by Flaktech. 【0284】 The polymer was immediately placed on a roller at approximately 70 RPM for 4 hours. Once the polymer had cooled to room temperature, it was cut into 1cm x 1cm x 1cm cubes. 【0285】 This cube-shaped polymer was extruded using a Brabender 3 / 4-inch single-screw ATR. The heated polymer was placed in an ethanol bath at approximately 10°C and extruded onto a 0.039-inch acetal core filament. The extruded PVA tube (extruded material) was cut into 24-inch to 30-inch segments. After dehydration in ethanol for approximately 3 hours, the core filament was removed and a PTFE-coated stainless steel mandrel was inserted into the lumen. 【0286】 A hydrophilic solution was prepared using Carbopol 907 (lot: Lubrizol, 010164597), USP water (lot: Fisher, 1607174), and PBS. This solution was heated and mixed until the solids were completely dissolved. 【0287】 All samples were immersed in a Carbopol 907 solution in a stainless steel circulating tank at 37°C for 16 hours. 【0288】 After the indicated time, the sample was removed from the immersion and mounted on a stainless steel mandrel. The dried sample was annealed in 140°C air for 1.5 hours on the mandrel in a forced-air oven. Subsequently, the sample was hydrated with PBS at room temperature (approximately 21°C for 3 hours). After hydration, the sample was dried at 37°C for 5 hours. 【0289】 The dried samples were cut into sections approximately 20 mm long. For each sample, the length, inner diameter, outer diameter, and mass were recorded. The samples were then immersed in 1×PBS at room temperature (approximately 21-22°C). All air was removed from the lumen using a syringe. 【0290】 Samples were removed from PBS at various time intervals, gently tapped with lint-free lab wipes to remove excess PBS from the lumen and surface, and the length and mass were recorded before quickly returning the samples to PBS. The samples were hydrated for a total of 22 hours. The inner and outer diameters were measured again at 1 hour and 22 hours. 【0291】 The rate of change of length, mass, and inner diameter (ID) / outer diameter (OD) is given by the following formula: The calculations were performed using TIFF0007875685000004.tif1682. The rate of change for each variable was the mean value at each point in time (see Table 4). 【0292】 TIFF0007875685000005.tif93145 【0293】 The rate of mass increase during hydration fluctuated slightly between 22.9% and 33.3% over the 22-hour hydration period, but no significant differences were observed in the rate of mass increase at any point in time. 【0294】 The rate of increase in sample length had a smaller standard deviation than the rate of increase in mass, making it a representative indicator of the sample's hydration level. Length increased by 2.9% after 2.5 minutes of hydration and 4.5% after 5 minutes, but the increase in length leveled off around 10 minutes of hydration, and no significant increase in length was observed thereafter (see Table 4). 【0295】 The inner and outer diameters increased by 4.9% and 18.8% at 60 and 1320 minutes, respectively. While we do not intend to be bound by theory, the large difference between ID and OD is thought to be because ID retains more of its initial sizing due to the limitation of shrinkage during ethanol dehydration, drying, and annealing based on the core diameter, whereas OD is not limited by post-extrusion processing and can swell more upon hydration. No significant changes were observed in OD between 1 and 22 hours after hydration. 【0296】 The 4F catheter extruded with a 0.039-inch core filament did not show any further length increase even after hydration in 1×PBS at 21°C for 10 minutes. 【0297】 Example 3: Formation of macropores containing a biological activator The following examples illustrate the formation of a device containing multiple pores that contain a biological activator. 1. Prepare by adding water and pologen to a slurry using polyvinyl alcohol. Pologen may or may not be miscible with water. In some cases, pologen may be a supersaturated salt solution (e.g., containing alkalis, alkaline earth materials and halides, partially neutralizing inorganic acids, and neutralizing organic acids). For example, pologen may consist of oil (e.g., having a boiling point above 140°C). In some cases, pologen may be dissolved in alcohol. 2. Extrude the slurry into a continuous shape and cut it to size. 3. The slurry is co-extruded onto the base substrate. The base material for item 4 is one of the following: air, metal mesh, metal tube, thermoplastic polyurethane, thermoplastic elastomer, silicone, polyvinyl alcohol (88% or more hydrolyzed), poly(ethylene vinyl acetate), polyvinyl chloride, PETE, PETG, nylon, or PEEK. 5. Remove the pologen with water, alcohol, and / or surfactant. 6. Fill the macropore with a therapeutic solution containing a biologically active agent. 7. Dry and sterilize the device. 8. When using, wet the device with a pressurized fluid, insert it, and expand it to release the biological activator. 【0298】 Example 4: Solid content The following examples demonstrate the release of a biological agent from one or more devices as described herein. 【0299】 Chlorhexidine-containing PVA materials were prepared using 2.5 w / w% or 6.0 w / w% chlorhexidine (CHX) free base (EMD Chemicals), poly(vinyl alcohol) with a molecular weight of approximately 145 kg / mol in the range of 26 w / w%, 30 w / w%, and 33 w / w% (28 cPs per 4 w / w%, 99+% hydrolysis; EMD Chemicals), and bismuth subcarbonate (Shepard) with a ratio of 1 to 2.85 to PVA. This composite material was then heated to 95°C in a 3 / 4-inch Brabender extruder with a 1:1 compression ratio screw and extruded onto acetal (Dunn Industries) cores to form 4Fr tubes with an inner diameter of 0.90 mm. These were then dried and physically crosslinked. Table 5 provides the independent variables for Figures 6 and 7. There is a decrease in release rate with increasing levels of PVA and bismuth subcarbonate. This release rate is generally independent of the amount of CHX added. Figure 11 shows the release of CHX from exemplary devices (D-017-092-B3 and D-017-092-A3) compared to a commercially available product (comparison 6) and extruded hydrophilic polyurethane treated by the CHA immersion and annealing method (RSM-029-002) (comparison 5). 【0300】 TIFF0007875685000006.tif36138 【0301】 Example 5: Drug-eluting patch A solution was prepared by adding 600 ppm of chlorhexidine free base (CHX) to methanol. The CHX / methanol solution appeared to saturate at around 1000 ppm. When this solution was continuously diluted, UV-Vis overload occurred when the concentration exceeded 200 ppm. To avoid UV-Vis overload, absorbance values ​​were collected at concentrations below 100 ppm. Figure 8 and Table 6 show the absorbance data collected from the specifications of chlorhexidine free base. 【0302】 TIFF0007875685000007.tif25124 【0303】 Table 7 and Formula 1 were used to convert the free radical version of chlorhexidine to the digluconate version. Upon introduction of the salt, the biguanide group of chlorhexidine is protonated. 【0304】 TIFF0007875685000008.tif41147 【0305】 To convert the mass balance between different salts of chlorhexidine, use Equation 1: The file TIFF0007875685000009.tif20159 was used. "A" is the conversion coefficient. 【0306】 Analysis of control samples 3 and 4, and the exemplary sample (sample E30) revealed that the exemplary sample released 93% of the theoretical dose (2.28% dry) in 0.9% physiological saline, while control samples 3 and 4 released less than 10% of the total chlorhexidine amount, as shown in Figure 9 (total amount of chlorhexidine released in 2.21 mL of 0.9% physiological saline in one squeeze). 【0307】 TIFF0007875685000010.tif57140 【0308】 To determine whether general bacteria were completely covered, MBC and MIC were compared to the release rates in the squeeze test for control 3, control 4, and sample E30. Comparing the maximum MBC (P. aeruginosa, 128 μg / mL) with the daily release rate in the squeeze test, control 3 had no effect, control 4 was effective for 2-3 days, and sample E30 was effective for 4-5 days. When preparing the incision site, physicians typically use PVP-I or ChloraPrep®. Both are effective in reducing bacteria and yeast by at least 3 logs. If the incision site is properly cleaned, it is generally not necessary to suppress bacterial and yeast growth. Comparing the maximum MIC (A. baumannii, 64 μg / mL) with the daily release rate in the squeeze test, control 3 was effective for 1-2 days, control 4 for 6-7 days, and sample E30 for 5-6 days (Figure 10). Figure 10 shows a comparison of the saturation release rates of chlorhexidine (normalized to free base salt form)-containing foam. The highest known minimum bactericidal concentration (MBC) of chlorhexidine is against P. aeruginosa, and the widely known minimum inhibitory concentration (MIC) of chlorhexidine is against A. baumannii. 【0309】 Example 6: Incorporation of Bupivacaine The following examples demonstrate the release of a biological agent from one or more devices as described herein. 【0310】 Bupivacaine-containing PVA material was prepared using 1.1 w / w% bupivacaine (Cayman Chemical), 26 w / w% poly(vinyl alcohol) with a molecular weight of approximately 145 kg / mol (28 cPs per 4 w / w%, 99+% hydrolyzed; EMD Chemicals), and a 6.3 g / L monosodium phosphate aqueous solution (Sigma Aldrich) with a ratio of 1 to 2.85 of bismuth subcarbonate (Shepard) to PVA. This mixture was then heated to 95°C in a 3 / 4-inch Brabender extruder with a 1:1 compression ratio screw and extruded onto an acetal (Dunn Industries) core to form 4Fr tubes with an inner diameter of 0.90 mm. The tubes were then dried in a forced-air convection oven to physically crosslink them. The % release profile of bupivacaine from the test device (DD010-176) is plotted in Figure 12. 【0311】 Example 7: Suppression range The following examples demonstrate the presence of a Zone of Inhibition (ZOI) for various organisms in response to the exemplary devices described herein. 【0312】 This study evaluated the antimicrobial activity of two test devices and two control devices against three microorganisms. Staphylococcus auereus (S. Auereus, MRSA), Escherichia coli (E. coli), and Candida albicans (C. albicans) were streaked onto Trypticase Soy Agar (TSA) plates and incubated at 37°C for approximately 24 hours. After incubation, cultures were individually collected in sterile PBS using sterile inoculation loops. The concentration of each suspension was adjusted to approximately 1 × 10⁻⁶. 8Adjusted to CFU / mL. Serial dilutions of each suspension were prepared to confirm the concentration of the inoculum. Using the diffusion plating method, a series of 1:10 dilutions were prepared on Mueller Hinton (MH) agar to confirm the concentration of the inoculum used for the bacterial lawns. From the adjusted suspensions, each challenge organism was seeded onto 2 (20) MH agar plates to create a confluent microbial lawn. In each case, a sterile cotton swab was immersed in the adjusted microbial suspension, excess liquid was extruded from the tip, and the swab was used to streak the surface of a 150 mm MH plate. Each test device and control device was applied directly to the surface of 3 MH agar plates seeded with different microorganisms. MH control plates seeded with each of the 3 microorganisms were treated with tetracycline disks and sterile blank disks (negative control disks). To ensure sterility, 0.1 mL - PBS was seeded onto MH agar using the spread plate method. All plates were incubated at 37 °C for 24 hours. The zone of inhibition (ZOI) indicated by the area where growth was inhibited on the plate was observed under each test device and control, and the perimeter was measured in mm. The zone of each control was measured through the diameter of the disk. The zone of each test device was measured across the diameter of the cylinder. 【0313】 The verified concentration of the inoculum was 1.8×10 8 CFU / mL for S. Auereus, 4.1×10 9 CFU / mL for E. coli, and 3×10 6 CFU / mL for C. albicans, calculated. Each inoculum created a thick microbial lawn on the plate. Table 9 shows the measured values of the ZOI measurements for the control and test devices, respectively. The control device's PVA / PAA PICC device (containing poloxamer) showed no ZOI for any of the challenge organisms tested, but growth was seen under the test device. The positive control device (comparative control 7) and two compositions of PVA / PAA tubes containing chlorhexidine showed at least a 5 mm ZOI for all organisms tested. 【0314】 TIFF0007875685000011.tif57140 【0315】 Example 8: Multilayer Extrusion The following examples illustrate exemplary processes for forming the multilayer devices described herein. 【0316】 Multilayer extruded tubes can be fabricated using established multilayer thermoplastic extrusion techniques in combination with the forming techniques described herein. Alternatively, two or more single-screw extruders can be connected with a multilayer extrusion die head. Figure 13A shows an example of a two-layer system. In this example, to design a tube with a drug-eluting lumen and a lumen surface free of the therapeutic agent, extruder A processes a batch-processed aqueous suspension containing PVA, bismuth subcarbonate, sodium phosphate, and chlorhexidine, while extruder B processes a batch-processed aqueous suspension containing PVA, bismuth subcarbonate, and sodium phosphate. The two extruders meet at a multilayer crosshead, with polymer B forming the outer layer and polymer A forming the inner layer. A solid, liquid, or gaseous core can pass through the center of polymer A to form a lumen as described herein. To form a tube with a drug-eluting anti-lumen surface and a lumen free of the therapeutic agent, a reverse process can be designed in which chlorhexidine is added to the suspension in extruder B but not to the suspension in extruder A. 【0317】 Figure 13B shows an example of a three-layer system. In this example, based on the previous example, three separate extruder systems are connected to a single multilayer crosshead. Each layer can have a choice of therapeutic agent (agent 1, agent 2, agent 3, or no agent). In one example, the first therapeutic agent (e.g., chlorhexidine) is added to the central layer, the second therapeutic agent (e.g., bupivacaine) is added to the anti-lumen lateral layer, and the anti-lumen lateral layer contains no therapeutic agent. In this example, the core material (innermost layer) is supplied to the crosshead, while extruder A supplies a polymer suspension containing bupivacaine (the layer surrounding the innermost layer), extruder B supplies a polymer suspension containing chlorhexidine (pink), and extruder C supplies a polymer suspension without a therapeutic agent (the outer layer). When the core filament is removed, a three-layer tube is obtained containing different layers of homogeneously dispersed therapeutic agents. 【0318】 Example 9: Increasing the inner and outer diameters The following examples demonstrate an increase in both the inner and outer diameters. A PVA-bismuth subcarbonate polymer solution (e.g., the first water-soluble polymer) was prepared using 42.0 g of bismuth subcarbonate, 179.25 g of a 6.2 w / w% monobasic sodium phosphate solution, and poly(vinyl alcohol) 28-99. The substituents were heated in a sealed polypropylene bottle and mixed using a Flaktech Speedmixer. 【0319】 The polymer was immediately placed on a roller at approximately 70 RPM for 4 hours. Once the polymer had cooled to room temperature, it was cut into 1cm x 1cm x 1cm cubes. 【0320】 This cubic polymer was extruded using a Brabender 3 / 4-inch single-screw ATR. The heated polymer was placed in an ethanol bath at approximately 10°C and extruded onto a 0.039-inch acetal core filament. The extruded PVA (extruded material) was cut into 24-inch to 30-inch segments. After dehydration in ethanol for approximately 16 hours, the core filament was removed, a PTFE-covered stainless steel mandrel was inserted into the lumen, and the sample was dried in a forced-air convection oven at 95°C for 3 hours. 【0321】 Hydrophilic solutions were prepared using Carbopol 907, USP water, and PBS. The solutions were heated and mixed until the solids were completely dissolved. All samples were immersed in Carbopol 907 solution at 37°C for 17 hours and then placed in a stainless steel circulation tank. 【0322】 After the indicated time, the sample was removed from the immersion and mounted on a stainless steel mandrel. The dried sample was annealed in 150°C air for 1.5 hours on the mandrel in a forced-air oven. Subsequently, the sample was hydrated with PBS at room temperature (approximately 21°C for 3 hours). After hydration, the sample was dried at 55°C for 3 hours. 【0323】 The dimensional changes of N=24 prepared samples were measured using an optical microscope before and after swelling with 1×PBS at 37°C for 2 hours. The water content was approximately 4-6 w / w% in the "dehydrated" state and ~30-35 w / w% in the EWC state. 【0324】 Figure 14 shows the distribution of the inner diameter (in millimeters) of the sample in the dry state, with an average inner diameter of 0.95 millimeters. Figure 15 shows the inner diameter of the sample in the swollen state in millimeters, with an average inner diameter of 1.00 millimeters. It can be seen that the average inner diameter increased by 5.3%, from 0.95 mm to 1.00 mm. 【0325】 Figure 16 shows the distribution of the outer diameter in millimeters for the same sample in a dry state, with an average outer diameter of 1.30 millimeters. Figure 17 shows the distribution of the outer diameter in millimeters for the swollen state, with an average outer diameter of 1.38 millimeters. This indicates an increase in the average outer diameter from 1.3 millimeters to 1.38 millimeters, which is a 6.2% increase. 【0326】 Example 10: Mechanical properties The following examples illustrate the mechanical properties of PVA / PAA hydrogels. To observe the effect of varying heat treatment temperatures on the mechanical response of composite PVA / PAA hydrogels, uniaxial tensile tests at a constant strain rate were employed. Uniaxial tensile tests of dried and fully hydrated hydrogel tubes were performed using an Instron 3343 tensile testing machine equipped with a 500 N load cell. Tubular samples (N=5 per sample set) were cut to a length of approximately 50 mm and stretched at a constant crosshead speed of 406.4 mm / min with a gauge length of 20.3 mm (constant strain rate of 0.33 s). -1 (Corresponding to...). Load-displacement data were converted to engineering stress versus engineering strain using the initial cross-sectional area and gauge length of the specimen, respectively. Samples defined as "dry" were dehydrated in a forced-air convection oven at 55°C for 3 hours, and samples defined as "hydrated" were prepared in 1×PBS at 37°C for at least 2 hours before testing. Tests were performed under ambient conditions using a 25 mm wide rubber-coated 1 kN pneumatic grip. 【0327】 Figure 18 shows a typical stress-strain curve for a heat-treated PVA / PAA composite hydrogel. As shown in Figure 18, an increase in Young's modulus and yield stress was observed with increasing heat treatment temperature. 【0328】 Example 11: Swelling properties The following examples demonstrate the swelling properties of PVA / PAA hydrogels. The swelling of composite PVA / PAA hydrogels at various heat treatment temperatures was evaluated at hydration times of 10, 30, 60, 120, 240, and 480 minutes. Swelling from a dry state was performed under biological conditions (in an isotonic salt aqueous solution at 37°C) to evaluate the time it took for the transplanted PVA / PAA hydrogel to reach EWC. Most PVA-based hydrogels required several hours to reach EWC and often showed mass swelling of more than 100% from a dry state. The heat-treated composite PVA / PAA hydrogels obtained in this study showed rapid initial swelling and a flat region where they reached EWC in approximately 30–60 minutes. 【0329】 According to the theory of rubber elasticity, the relationship between the crosslinking density and Young's modulus of a polymer network structure is as follows: TIFF0007875685000012.tif16157 Here, E represents Young's modulus, ρ represents density, R is the ideal gas constant, T is temperature, and Mc represents the molecular weight between crosslinks. The average molecular weight between crosslinks in a hydrogel can also be calculated from equilibrium swelling theory. Assuming a Gaussian distribution of crosslinked polymer chains, the Flory-Rehner equation can be used to estimate the average molecular weight between crosslinks in a non-ionized hydrogel. TIFF0007875685000013.tif21165 Here, v is the specific volume of the polymer (0.769 cm³ for 99% hydrolyzed PVA). 3 ( / g), V1 is the molar volume of water (18.1 cm³). 3 ( / mol), Mn is the number-average molecular weight of the uncrosslinked polymer (~145,000 g / mol for 28-99 PVA), x is the polymer-solvent interaction parameter (x=0.50 at 37°C for water-PVA), V 2,S This is the polymer volume fraction and is determined as follows. TIFF0007875685000014.tif17158 Here, M S / M0 is the mass swelling ratio of the hydrogel in EWC, ρ p The polymer density is 1.30 g / cm³ for 99% hydrolyzed PVA. 3 ), ρ W This is the solvent density (1.00 g / cm³ in water).3 ) is the crosslink density, ρ c M C It can be calculated from this. TIFF0007875685000015.tif15155 【0330】 Figure 19 shows a plot of the measured average Young's modulus for each heat treatment group against the crosslink density calculated based on Equation 5. As shown in Figure 19, there is a strong correlation between the two values ​​(R² = 0.9687), indicating that the increase in Young's modulus of the PVA / PAA composite hydrogel was mainly due to the increase in physical crosslink density with respect to the heat treatment temperature. 【0331】 Figure 20 shows representative stress-strain curves for an untreated PVA / PAA composite hydrogel, a PVA / PAA composite hydrogel heat-treated at 150°C, and two conventional TPUs. As shown in Figure 20, the curve for the unhydrated PVA / PAA hydrogel showed significantly lower Young's modulus, fracture stress, and tensile energy to fracture (toughness) than the control TPU sample. Heat treatment of the PVA / PAA composite at 150°C for 90 minutes transformed it from a ductile elastomer in the dry state to a brittle fracture reaction, but in the hydrated state, the heat-treated hydrogel exhibited mechanical properties comparable to polyurethanes currently used in vascular catheters. The mechanical properties achieved by the 150°C heat treatment of the PVA / PAA hydrogel in this example were improved by more than an order of magnitude compared to a comparative high-strength PVA hydrogel material produced by freeze-thaw. The composite hydrogel in this example showed a Young's modulus of 24.21 ± 3.98 MPa, while the comparative PVA hydrogel, when fully hydrated, showed a Young's modulus of less than 1 MPa. 【0332】 Table 10 summarizes the mechanical properties and swelling properties of the PVA / PAA hydrogels examined in Examples 10 and 11 as a function of heat treatment temperature. 【0333】 TIFF0007875685000016.tif57146 【0334】 Example 12: Resistance of composite hydrogel to thrombotic occlusion The following examples demonstrate the resistance of composite hydrogels to thrombotic occlusion. In these examples, the resistance of samples to thrombotic occlusion was evaluated using an established two-phase in vitro blood flow loop model. N=6 4F PVA / PAA hydrogel devices, along with TPU samples constituting control devices, were hydrated in sterile saline for approximately 24 hours before testing. Fresh bovine blood was collected by cardiac puncture and heparin was added to a concentration of 0.75 U / mL. The catheter samples were inserted into a blood flow loop of a 1 / 4-inch (6.4 mm) inner diameter polyvinyl chloride tube for approximately 120 minutes (Phase 1: Flow). The blood was kept at 37°C, and to simulate physiological blood flow through the device, the loop was continuously metered at 200 mL / min using a peristaltic pump during the test period. CaCl2 and minimal heparin were also mixed with fresh citrate-treated bovine blood and dispensed into separate vials. After the flow phase, the device was removed from the heparinized blood circuit, and the distal tip of the catheter sample was inserted into a recalcified blood vial and incubated at 37°C until thrombus formation occurred (second phase: stationary). Once the thrombus formation phase was complete, the device was removed from the vial, lightly rinsed with saline, and loosened blood was removed, taking care not to remove any attached thrombi. To assess lumen patency, a four-way stopcock was attached to the Luer hub of each catheter, a pressure gauge was attached to one port, and a syringe filled with saline was attached to the other port. Pressure was applied to the syringe to flow saline into the lumen, and the maximum injection pressure was recorded. The two-phase in vitro blood loop model is useful for evaluating the device's resistance to thrombotic occlusion. A qualitatively large amount of thrombus was observed at the tip of the conventional control 1 TPU catheter device, while only minimal thrombus accumulation was observed at the tip of the control 2 catheter and PVA / PAA composite hydrogel sample. One of the PVA / PAA hydrogel samples leaked at the junction of an overmolded suture wing during the patency check and was therefore excluded from further analysis. 【0335】 Figure 21 is a box plot of the mean ± standard deviation of the maximum injection pressure of TPU control samples compared to the composite hydrogel device. As shown in Figure 21, the composite PVA / PAA hydrogel device showed an average of 67% lower maximum injection pressure compared to the conventional TPU. Furthermore, the typical pressure for adult intravenous infusion devices is less than 150 mmHg, and therefore, a maximum pressure greater than 150 mmHg is considered occluded. Seven out of 12 control catheters exhibited occluded characteristics, but none of the composite PVA / PAA hydrogel devices showed a maximum injection pressure exceeding 150 mmHg (N=0), and therefore all were considered patentable. 【0336】 Example 13: Contact angle measurement of dried and hydrated PVA-based hydrogels The following examples demonstrate contact angle measurements of dried and hydrated PVA-based hydrogels. Contact angle measurements were performed on PVA tubes, PVA / PAA composite hydrogels, and two control catheter bodies. Measurements were performed after exposure to 1×PBS at 37°C for 1 hour, both in the as-packaged and dehydrated state. Contact angle measurements were performed using a custom-made contact angle goniometer (20x magnification) with an Excelis Accu-scope digital camera mounted on a Unitron Z850 optical stereomicroscope. Contact angles were determined by fitting profiles of at least three droplets using ImageJ software and calculating the average of the left and right contact angles, with a total of six angle measurements performed per sample group. Initial contact angles were recorded within 10 seconds after placing a standard volume 2 μL droplet on the surface of the hydrogel or polymer using a pipette. 【0337】 Figure 22 shows representative optical images of a 2 μL water droplet on a dehydrated PVA / PAA composite hydrogel tube (Figure 22A), a hydrated PVA / PAA composite hydrogel tube (Figure 22B), a hydrated TPU tube of control 1 (Figure 22C), and a hydrated TPU tube of control 2 (Figure 22D). The scale bar in each image is 1 mm. Table 2 shows the mean ± standard deviation results for each group. As shown in Table 2, the contact angles of the commercially available TPUs were all slightly hydrophobic in their packaged state compared to the hydrophilic surface of the dehydrated PVA / PAA hydrogel material (17 ± 6°) (Comparative Example 1: 93 ± 7°, Comparative Example 2: 99 ± 7°). After hydration, the contact angles of the commercially available TPU catheters decreased slightly, but the PVA / PAA hydrogel material was found to be completely wetted. 【0338】 TIFF0007875685000017.tif41124 【0339】 Example 14: Use of glycerol as a humidifier The following examples demonstrate the use of glycerol as a humidifier. In contrast to poloxamer, the use of glycerol promoted the initial hydration of the catheter and eliminated undulation and pig tailing during the first 5 minutes of hydration. Catheters treated with glycerol continued to grow after 1 hour. Catheters treated with glycerol matched the hydration profile of 10% poloxamer 407 after 60 minutes. 【0340】 The results of this example showed that using a high concentration of glycerol increased the hydration rate during the first 5 minutes of hydration, but did not significantly improve or decrease the rate of catheter growth between 5 minutes and 24 hours. The glycerol / poloxamer mixture showed a reduction in length of change from 1 hour to 24 hours compared to the pure glycerol group. 【0341】 Furthermore, it was found that when catheters injected with glycerol were exposed to heat for extended periods according to the accelerated aging protocol and ISTA 2A conditioning, the hydration profile changed. Pig tailing occurred after 5 minutes, and the 5-minute hydration criteria were no longer met. To address this issue, a humidity-regulating sponge (Humidichip®, Andersen Products) was placed in the outer bag along with the catheter and sealed in a Tyvek pouch. After 5 minutes, this group passed both visual and quantitative criteria. 【0342】 Figure 23 is a bar graph showing the rate of change in length over time in the 30% glycerol group compared to the 10% poloxamer 407 group. As shown in Figure 23, the length continues to increase significantly even after 1 hour. 【0343】 Figure 24 is a bar graph showing that adding a humidity-controlled sponge to the packaging improved thermal stability, eliminating waviness and pig tailing after 5 minutes of hydration following exposure to extreme temperature changes. 【0344】 Example 15: Glycerol removal during hydration The following examples demonstrate the amount of glycerol removed from the catheter body during a 5-minute hydration period. Glycerol is a powerful humectant, drawing moisture from the surrounding environment into its own solution. This property makes it an ideal material for retaining moisture in the catheter body during storage and hydration of PVA / PAA PICC devices (containing glycerol). While intravenous administration of glycerol is well-tolerated and understood, it was important to assess the amount of glycerol to which the patient would be exposed. In this example, six PVA / PAA PICC devices (containing glycerol) were used. These were sterilized in Tyvek pouches and packaged in secondary foil pouches with humidity-regulating sponges. This method aims solely to remove glycerol by exposing it to normal saline solution and then remove residual moisture by oven drying. Due to its high boiling point and vapor pressure, only a small amount of glycerol would evaporate even when exposed to a drying temperature of 55°C, but it was assumed that a considerable amount of water would evaporate. The catheter body was cut at the suture wing so that it would be 55 cm long when hydrated. 【0345】 TIFF0007875685000018.tif62138 【0346】 The catheter body, removed from the foil pouch and sterile barrier, contained 11.0% ± 0.3% by weight of mobile mass. Mobile mass was defined as substances that could be removed with liquid. It was found that 4.5% ± 0.3% by weight was water and 5.6% ± 0.3% by weight was glycerol. It was understood that the catheter held water through hydrogen bonding. This bound water was considered to be permanently bound to the catheter, as observed during shipping, hydration, and daily use. This bound water began to be removed from the catheter body material at temperatures above 90°C. 【0347】 After hydration with physiological saline for 5 minutes, the catheter body was found to contain 0.6% ± 0.3% by weight of glycerol and an additional 25% ± 2% by weight of physiological saline. Of the total amount of glycerol, 90% ± 6% by weight of the tart catheter body was removed within the first 5 minutes. 【0348】 TIFF0007875685000019.tif36146 【0349】 The total glycerol content per 55 cm segment was 0.030 g ± 0.002 g. After 5 minutes of hydration, the glycerol content decreased to 0.003 g ± 0.002 g (3 mg ± 2 mg). 3 mg ± 2 mg is considered a safe level for venous exposure. 【0350】 TIFF0007875685000020.tif47133 【0351】 In this embodiment, the catheter was dried before hydration, which increased the amount of water required to hydrate the catheter compared to when the physician removed it from the pouch or kit and hydrated it. This additional drying step increased the drying time compared to catheters hydrated directly from the pouch. For these reasons, the additional drying step (D1) was considered the worst-case scenario. 【0352】 According to IFU measurements, most of the glycerol was removed from the catheter 5 minutes after hydration. Gravimetric analysis showed further glycerol removal between 5 minutes and 48 hours after hydration of the catheter body (n=6, paired t-test, p=0.007, CI95%). Furthermore, the mass of glycerol eluted after 5 minutes of hydration was measured. When immersed in saline for 5 minutes from its packaged state (per IFU), the catheter acquired 31±2 wt% saline and lost 5.6±0.7 wt% glycerol. The net mass increase after 5 minutes of hydration was 25±2 wt% after removal from the pouch. 【0353】 Exemplary Embodiments 1. A process for producing a hydrophilic porous solid, comprising heating a mixture comprising at least one water-soluble polymer, a solvent, and at least one therapeutic agent to a temperature above the melting point of the polymer-solvent mixture, and passing the mixture through a solvent removal environment. 2. The process described in item 1, wherein forming the mixture includes extruding, molding, casting, or thermoforming the mixture through a die. 3. The process according to item 1, wherein the formation of the mixture comprises extruding the mixture through a die, the mixture is not heated above the boiling point of the mixture, and the mixture is formed from a temperature below the melting point of the polymer-solvent mixture. 4. The process according to item 1, wherein the formation of the mixture comprises extruding the mixture through a die, further comprising a core passing through the die, and a porous solid being formed around the core. 5. The process described in item 1, wherein the porous solid is a hydrophilic nanoporous solid, and the size of the pores in the solid is 100 nm or less. 【0354】 6. The process according to item 5, wherein the porous solid has a Young's modulus of at least 5 MPa in the EWC of the porous solid. 7. The process according to item 1, wherein the porous solid is a hydrophilic microporous solid containing pores with a diameter of 100 nm or more, and the pores of the solid have a size of 1 μm or less. 8. The process according to item 1, wherein at least one polymer comprises poly(vinyl alcohol), poly(acrylic acid), polyethylene glycol, or poly(vinylpyrrolidone), polyalkyleneimine, polyacrylamide, hydroxypropyl methacrylamide, polyoxazoline, polyphosphate, polyphosphazene, hyaluronic acid, chitosan, or polysaccharide. 9. The process according to item 1, wherein at least one polymer comprises a first polymer at a first concentration and a second polymer at a second concentration, the first concentration being 10% to 60 w / w%, and the second polymer being 1% to 10 w / w%, where w / w is the weight of the polymer relative to the total weight of all polymers and solvents in the mixture. 10. The process according to item 1, further comprising a radiopaque agent in the polymer mixture. 【0355】 11. The process described in item 1, which is carried out without covalently crosslinking at least one water-soluble polymer. 12. The process according to item 1, wherein the porous solid has an aspect ratio of at least 10:1. 13. A medical device (or catheter) for vascular access, comprising a porous, dehydrated, physically crosslinked synthetic hydrophilic polymer hydrogel having a Young's modulus of at least 5 MPa. The medical device (or catheter) for vascular access further comprises a therapeutic agent dispersed via the hydrogel to continuously release an effective amount into the bloodstream (or target site) via the lumen or lumen surface for at least about 1 day at the equilibrium water content (EWC) of the solid, wherein the hydrogel has a water content of at least about 10% by weight or volume when fully hydrated. 14. The catheter according to item 13, characterized in that it is a hydrophilic nanoporous solid in which the pores of the solid are 100 nm or smaller in size. 15. The catheter according to item 13, wherein the porous solid comprises at least one polymer, and at least 50 w / w% of the at least one polymer is poly(vinyl alcohol) (PVA). 【0356】 16. The catheter described in item 13, which consists of a porous solid having a lumen, and is a central venous catheter, a peripherally inserted central catheter (PICC), a tunnel catheter, a dialysis catheter, a central venous catheter, a peripheral central catheter, a midline catheter, a peripheral catheter, or a tunnel catheter. Peripheral catheter, tunnel catheter, dialysis access catheter, urinary catheter, nervous system catheter, peritoneal catheter, intra-aortic balloon pump catheter, diagnostic catheter, interventional catheter, vascular access port, or drug delivery catheter. 17. A device comprising a main body portion, wherein the main body portion is formed from a polymer material comprising a first water-soluble polymer and a biological activator related to the polymer material, wherein the biological activator is substantially homogeneously distributed within the polymer material, the device has a break elongation of 50% or more, and / or the device has an increase in total length at equilibrium water content of 1% or more compared to the total length at dehydrated. 18. A device comprising a main body, wherein the main body is formed from a polymer material comprising a first water-soluble polymer, the main body comprising a plurality of pores, a second water-soluble polymer disposed within at least a portion of the plurality of pores of the main body, and a biological activator associated with the first water-soluble polymer and / or the second water-soluble polymer, wherein the biological activator is substantially uniformly distributed within the first water-soluble polymer. 19. A device as described in paragraph 17 or 18, wherein the device is substantially non-thrombotic. 【0357】 20. A device including a main body, wherein the main body is formed from a polymer material comprising a first water-soluble polymer and a biological activator related to the polymer material, wherein the biological activator is substantially homogeneously distributed within the polymer material, and the polymer material has a Young's modulus of 500 MPa or more in a dehydrated state and a Young's modulus of 300 MPa or less and 5 MPa or more in an equilibrium moisture content state. 21. A device including a main body, wherein the main body is formed from a polymer material comprising a first water-soluble polymer, and comprises a biological activator associated with the polymer material, wherein the biological activator is substantially homogeneously distributed within the polymer material, and the polymer material has a water content of less than 5 w / w% and 0.5 w / w% or more in a dehydrated state. The polymer material has a water content of w / w%, and is configured to swell from a dehydrated state to an equilibrium water content state by an amount of 5 w / w% to 50 w / w% in 60 minutes or less (e.g., 10 minutes or less, 20 minutes or less). This is 60 minutes or less at 25°C (e.g., 10 minutes or less, 5 minutes or less, 1 minute or less, or 10 seconds or less). 22. A device including a main body, wherein the main body is formed from a polymer material containing a water-soluble polymer and a biological activator related to the polymer material, and the biological activator is present in the device in an amount of 0.01 w / w% or more. The biological activator is present in the device in an amount of 0.01 w / w% or more relative to the total weight of the device in a dehydrated state, and the polymer material has a Young's modulus of 500 MPa or more in a dehydrated state and a Young's modulus of 300 MPa or less and 5 MPa or more in an equilibrium moisture content state. 23. A device including a main body, wherein the main body is formed from a polymer material comprising a first water-soluble polymer and a biological activator associated with the polymer material, wherein the biological activator is substantially homogeneously distributed within the polymer material, and the biological activator is configured to be released from the polymer material at a first average rate determined 24 hours after release, and at a second average rate of at least about 1% of the first average rate after 30 days. 24. A catheter configured for administration to a target, comprising a body portion, the body portion being formed from a polymer material comprising a first water-soluble polymer and a biologically active agent substantially homogeneously dispersed within the polymer material. 25. A catheter configured for administration to a subject, comprising a main body portion, the main body portion being formed from a polymer material comprising a first water-soluble polymer and a biological activator dispersed in the bulk of the polymer material, wherein the biological activator is present in the catheter in a dehydrated state at an amount of 0.01% by weight relative to the total weight of the catheter. 【0358】 26. A method for forming a device, comprising the steps of: using a mixture comprising a first water-soluble polymer and a salt, wherein the first water-soluble polymer is present in the mixture in an amount of 13 w / w% or more relative to the total weight of the mixture, extruding the mixture onto a core material at a temperature of 65°C or higher to form a polymer material disposed on the core material; and exposing the polymer material to a non-solvent of the polymer material at a temperature of 28°C or lower for 15 minutes or more. A step of introducing a solution containing a biological activator into a polymer material, heating the polymer material and the solution to a temperature of 30°C or higher, flowing the solution adjacent to the polymer material, and drying the polymer material, wherein the biological activator is substantially uniformly distributed within the polymer material and is within a range of 50% or less of the average amount of biological activator added to the polymer material. 27. The method according to item 26, wherein the solution comprises a second water-soluble polymer which is the same as or different from the first water-soluble polymer. 28. Any method according to the preceding paragraph, wherein a second solution containing the same or different water-soluble polymer as the first water-soluble polymer is flowed adjacent to the polymer material for more than one hour. 29. Any method according to the preceding paragraph, comprising annealing a polymer material at a temperature of 100°C or higher for 30 minutes or more under atmospheric pressure. 30. The method according to the preceding paragraph, characterized in that the core material is a gas. 【0359】 31. A method comprising administering a device including a main body portion into an external orifice of a target, wherein the main body portion comprises a polymer material including a water-soluble polymer and a biological activator associated with the polymer material, the device having an aspect ratio of 3:1 or greater, and the biological activator being substantially homogeneously distributed within the polymer material. 32. The method according to item 31, wherein the polymer material is substantially non-thrombotic. 33. Any method according to the preceding paragraph, wherein the biological activator is present in the device in an amount of 0.01 w / w% or more relative to the total weight of the device. 34. Any method according to the preceding paragraph, wherein the polymer material has a water content of less than 5 w / w% and 0.1 w / w% or more in a dehydrated state, and the polymer material is restored from the dehydrated state to an equilibrium water content state in an amount of 5 w / w% or more and less than 50 w / w% in 60 minutes or less (for example, 10 minutes or less, 5 minutes or less, 1 minute or less, or 10 seconds or less). 35. Any device according to the preceding paragraph, further comprising a polymer material containing a first water-soluble polymer having a plurality of pores, and a second water-soluble polymer, which is the same as or different from the first water-soluble polymer, disposed within at least a portion of the plurality of pores. 【0360】 36. The device according to any one of paragraphs 1 to 3 above, characterized in that the polymer material has a Young's modulus of 500 MPa or more in a dehydrated state, and a Young's modulus of 300 MPa or less and 5 MPa or more in an equilibrium moisture content state. 37. Any of the devices described in the preceding paragraph, wherein the polymer material has a water content of less than 5 w / w% and 0.1 w / w% or more in a dehydrated state, and the polymer material is dehydrated from the dehydrated state to the equilibrium water content state in an amount of 5 w / w% or more and 50 w / w% or less in 60 minutes or less (for example, 60 minutes or less at 25°C (for example, 10 minutes or less, 5 minutes or less, 1 minute or less, or 10 seconds or less)). 38. The device according to any one of paragraphs 1 to 3 above, characterized in that multiple pores have an average pore size of 500 nm or less and 10 nm or more. 39. The device described in the preceding paragraph, wherein at least 50% of the multiple pores have a diameter of 1 μm or less. 40. Any of the devices described in the preceding paragraph, configured to swell from a dehydrated state to an equilibrium moisture content state in an amount of 5 w / w% to 50 w / w% or less. 【0361】 41. Any device described in the preceding paragraph, wherein the device has a coefficient of friction of 0.10 or less in an equilibrium moisture content state. 42. Any of the devices described in the preceding paragraph, wherein the device contains a penetrating agent present in the polymer material in an amount of 0.0.5 w / w% or more and 2 w / w% or less relative to the total weight of the device. 43. The device according to any of the preceding paragraphs, wherein the osmotic agent is selected from the group comprising phosphates, borates, sodium chloride, citrates, ethylenediaminetetraacetates, sulfites, hyposulfites, metal oxides, selenium dioxide, selenium trioxide, selenic acid, nitrates, silicates, and peony acid. 44. Any device according to the preceding paragraph, characterized in that the polymer material has a water contact angle of 45 degrees or less in an equilibrium water content state. 45. Any of the devices described in the preceding paragraph, wherein the first water-soluble polymer does not contain a covalent crosslinking agent. 【0362】 46. ​​Any device as described in the preceding paragraph, wherein the first water-soluble polymer is selected from the group comprising poly(vinyl alcohol), poly(acrylic acid), polyethylene glycol, poly(vinylpyrrolidone), poly(methacrylate sulfobetaine), poly(acrylic sulfobetaine), and poly(methacrylate carboxybetaine). Poly(acrylic carboxybetaine), povidone, polyacrylamide, poly(N-(2-hydroxypropyl)methacrylamide), polyoxazoline, polyphosphate, polyphosphazene, polyvinyl acetate, polypropylene glycol, poly(N-isopropylacrylamide), poly(2-hydroxymethyl methacrylate), and combinations thereof. 47. Any device according to the preceding paragraph, wherein the second water-soluble polymer is selected from the group comprising poly(vinyl alcohol), poly(acrylic acid), polyethylene glycol, or poly(vinylpyrrolidone), poly(methacrylate sulfobetaine), poly(acrylic sulfobetaine), poly(methacrylate carboxybetaine). Poly(acrylic carboxybetaine), povidone polyacrylamide, poly(N-(2-hydroxypropyl)methacrylamide), polyoxazoline, polyphosphate, polyphosphazene, polyvinyl acetate, polypropylene glycol, poly(N-isopropylacrylamide), poly(2-hydroxymethyl methacrylate), and combinations thereof. 48. A device as described in any of the preceding paragraphs, characterized in that the device is configured for use in conjunction with medical devices such as catheters, balloons, shunts, wound drains, infusion ports, drug delivery devices, tubes, contraceptives, feminine hygiene products, and endoscopes. Grafts, pacemakers, implantable cardioverter-defibrillators, cardiac resynchronization devices, cardiovascular device leads, ventricular assist devices, endotracheal tubes, tracheostomy tubes, implantable sensors, ventilator pumps, and ophthalmic devices. 49. The device described in item 48, wherein the catheter is selected from the group including central venous catheters, peripheral central catheters, midline catheters, peripheral catheters, tunnel catheters, dialysis access catheters, urinary catheters, nervous system catheters, percutaneous transluminal angioplasty catheters, and peritoneal catheters. 50. Any of the devices described in the preceding paragraph, wherein the second water-soluble polymer is disposed within a bulk of the first water-soluble polymer. 51. Any device described in the preceding paragraph, wherein, at an equilibrium water content after flushing with five times the volume of water or normal saline, less than 0.5 w / w% of the therapeutic agent is adsorbed onto the bulk of the first water-soluble polymer. 【0363】 While several embodiments of the present invention have been described and illustrated herein, those skilled in the art will understand that the advantages of readily performing and / or obtaining the function and / or the benefits of assuming a variety of other means and / or structures for one or more purposes are described herein, and each of such variations and / or modifications is considered to be within the scope of the present invention. More generally, those skilled in the art will understand that all parameters, dimensions, materials, and configurations described herein are illustrative, and that actual parameters, dimensions, materials, and / or configurations depend on the specific application, and therefore the teachings of the present invention are used accordingly. There are many equivalents to some embodiments of the present invention described herein that those skilled in the art will recognize or can verify using only routine experiments. It should be understood that the embodiments described herein are presented as merely examples, within the scope of the appended claims and their equivalents, and the present invention can be carried out in ways other than those specifically described and claimed. The present invention covers the individual features, systems, articles, materials, and / or methods described herein. Furthermore, any combination of such features, systems, articles, materials, and / or methods is included in the scope of the present invention if two or more such features, systems, articles, materials, and / or methods are not inconsistent with each other. 【0364】 As used in the specification and claims, the indefinite articles "a" and "an" should be understood to mean "at least one" unless explicitly stated otherwise. 【0365】 As used in the specification and claims, the phrase “and / or” should be understood to mean “either or both” of the combined elements, i.e., elements that exist in some cases together and in others separately. Unless explicitly stated, other elements may optionally exist in addition to those specifically identified by the “and / or” phrase, whether related to or unrelated to those specifically identified elements. Thus, as a non-restrictive example, when used in conjunction with an open-ended phrase such as “including ~”, it means, in one embodiment, A without B (optionally including elements other than B); in another embodiment, B without A (optionally including elements other than A); in yet another embodiment, both A and B (optionally including other elements); and so on. 【0366】 As used in the specification and claims, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when separating items in a list, “or” or “and / or” is inclusive, i.e., It should be interpreted that a number of elements or a list of elements includes at least one, including more than one, and optionally, any further items not listed. Only clearly indicated items, such as "only one of ~" or "exactly one of ~," or "consisting of ~" as used in claims, mean to include exactly one of a number of elements or a list of elements. In general, the term "or" as used herein should be interpreted only as indicating an exclusive choice (i.e., "one or both, but the other") when preceded by an exclusive term such as "either," "one of ~," "only one of ~," or "exactly one of ~." "Essentially consisting of ~" as used in claims has its usual meaning as it is used in the field of patent law. 【0367】 As used in the specification and claims, the phrase “at least one” relating to a single list of one or more elements should be understood to mean at least one element selected from one or more elements in the list of elements, but not necessarily including at least one of each element specifically listed in the list of elements, nor necessarily excluding combinations of elements in the list of elements. This definition also allows for the possibility that there may be elements other than those specifically identified in the list of elements, meaning whether or not they are related to those specifically identified elements. Therefore, as a non-restrictive example, “at least one of A and B” (equivalently, “at least one of A or B,” or equivalently, “at least one of A and / or B”) could mean, in one embodiment, at least one A (including any element other than B) in which B is absent; in another embodiment, at least one B (including any element other than A) in which A is absent; in yet another embodiment, at least one A (including any element other than A) in which A is absent; and so on. 【0368】 In the claims as well as in the specification, all such transitional clauses as “comprising,” “including,” “carrying,” “having,” “containing,” “involving,” and “holding” are understood to be open-ended, meaning they include not being limited to them. Only the transitional clauses “consisting of” and “essentially consisting of” are closed or semi-closed transitional clauses, as described in the United States Patent Office Manual of Patent Examining Procedures, Section 2111.03. 【0369】 The terms used herein relate, for example, to the shape, orientation, alignment, and / or geometric relationships of one or more devices, structures, forces, fields, flows, directions / trajectories, and / or their subcomponents, and / or combinations thereof, and / or other tangible or intangible elements not described above that are characterized by such terms. Unless otherwise defined or indicated, there is no requirement for absolute conformity to the mathematical definitions of such terms, but rather it is understood that conformity to the mathematical definitions of such terms is to the extent possible with respect to the characterized requirements, as understood by those skilled in the art in the most relevant field. Examples of terms relating to shape, direction, and / or geometric relationships include, but are not limited to, terms describing the following: Shape—e.g., circle, square, rubber box, circle / circle, rectangle / rectangle, triangle / triangle, cylinder / cylinder, ellipse / ellipse, (n) polygon / (n) polygonal body, etc.; Angular direction—e.g., perpendicular, orthogonal, parallel, vertical, horizontal, collinear, etc.; Contour and / or trajectory—e.g., perpendicular, orthogonal, parallel, vertical, horizontal, collinear, etc.; Contour and / or trajectory (plane, coplane, hemisphere, semi-hemisphere, line, straight line, hyperbola, parabola, plane, curve, straight line, arc, sine wave, tangent / tangent, etc.); Direction (north, south, east, west, etc.). The properties of the surface and / or bulk material and / or the spatial / temporal resolution and / or distribution (smoothness, reflectivity, transparency, clarity, opacity, rigidity, impermeability, uniformity, inertness, non-wettability, insolubility, stability, invariance, constant, homogeneity, etc.), as well as many others that will become apparent to those skilled in the art. As one example, a manufactured device described herein as “square” does not require that such a device be a perfect plane or straight line and have faces or sides intersecting at exactly 90-degree angles (in fact, such a device may exist only as a mathematical abstraction), but rather the shape of such a device should be understood as approximating a “square” as mathematically defined, to the extent that it is typically achievable and attainable for the manufactured art described, as will be understood by those skilled in the art, or as specifically described.As another example, two or more manufacturing devices described herein as "aligned" need not have perfectly aligned faces or sides (indeed, such devices exist only as mathematical abstractions), rather, the placement of such devices should be understood as approximating being "aligned" as mathematically defined within the scope typically achievable in the described manufacturing techniques as would be understood by one of ordinary skill in the art or as specifically described. 【Description of the Reference Numerals】 【0370】 10, 12, 14, 100, 320, 340... devices 20... body portion 25... core 30... hole 40... water-soluble polymer 50... biologically active agent 102... syringe pump 104... syringe 106... die head 108... heating element 109... power cable 110... dispensing spool 112... core 114... spool 116... bath 117... extruded material 118... heat exchanger 120... heat exchange pipe 122... supply line 212... porous solid matrix 214... bulk incorporated polymer 216... outermost peripheral zone 218... intermediate zone 220... inner peripheral zone 300... overall length 301... inner diameter 302... outer diameter 304... inner diameter 305... outer diameter

Claims

[Claim 1] A main body portion formed from a polymer material containing a first water-soluble polymer, having a plurality of pores, A second water-soluble polymer is disposed in at least a portion of the multiple pores of the main body, and Biological activators Includes, The first water-soluble polymer is selected from the group consisting of poly(vinyl alcohol), a blend of poly(vinyl alcohol) and poly(acrylic acid), and a blend of poly(vinyl alcohol) and polyethylene glycol. The biological activator is substantially uniformly distributed within the first water-soluble polymer. A device in which the plurality of holes are a plurality of interconnected holes having an average hole size of 10 nm to 500 nm. [Claim 2] The device according to claim 1, wherein the polymer material is configured to swell by an amount of 5 w / w% or more relative to the equilibrium water content state. [Claim 3] The device according to claim 1 or 2, wherein the polymer material is configured to swell to an equilibrium water content state within a period of 60 minutes or less at 25°C. [Claim 4] The device according to any one of claims 1 to 3, wherein the device includes a humectant. [Claim 5] The main body portion has an inner diameter, an outer diameter, and a length. The device according to any one of claims 1 to 4, wherein the polymer material is configured to swell such that the inner diameter and / or outer diameter increase at a rate greater than the rate of increase of the length. [Claim 6] The device according to any one of claims 1 to 5, wherein the main body portion has a plurality of holes. [Claim 7] The device according to any one of claims 1 to 6, wherein the biological activator is present in the device in an amount of 0.01 w / w% or more relative to the total weight of the device. [Claim 8] The polymer material has a water content of less than 5 w / w% and 0.1 w / w% or more in a dehydrated state. The device according to any one of claims 1 to 7, wherein the polymer material is configured to swell from a dehydrated state to an equilibrium moisture content state in an amount of 5 w / w% to 50 w / w% within 60 minutes. [Claim 9] The device according to any one of claims 1 to 8, wherein the device is a catheter. [Claim 10] The device according to claim 3, wherein the aforementioned period is 10 minutes or less. [Claim 11] The device according to claim 3, wherein the aforementioned period is 5 minutes or less. [Claim 12] The device according to claim 3, wherein the aforementioned period is 1 minute or less. [Claim 13] The device according to claim 3, wherein the aforementioned period is 30 seconds or less. [Claim 14] The device according to claim 3, wherein the aforementioned period is 10 seconds or less. [Claim 15] The device according to claim 4, wherein the humectant comprises a sugar alcohol and / or poloxamer. [Claim 16] The device according to claim 4, wherein the humectant comprises poloxamer, polyethylene glycol, glycerol, propylene glycol, ethylene glycol, butylene glycol, erythritol, slaytol, arabitol, xylitol, ribitol, mannitol, sorbitol, galactitol, fukitol, iditol, inositol, boremitol, mariitol, lactitol, maltotriitol, maltotetraitol, and / or polyglycitol. [Claim 17] The device according to claim 4, wherein the humectant comprises poloxamer, sorbitol, mannitol, glycerol, ethylene glycol, and / or xylitol. [Claim 18] The device according to claim 4, wherein the humectant comprises glycerol. [Claim 19] A device according to any one of claims 1 to 18, comprising 0.1 to 30 w / w% of a humectant. [Claim 20] A device according to any one of claims 1 to 19, comprising 1 to 10 w / w% of a humectant. [Claim 21] The device according to claim 4, wherein at least a portion of the humectant is disposed on the surface of the main body portion. [Claim 22] The device according to any one of claims 1 to 21, wherein at least a portion of the humectant is located inside the bulk of the main body. [Claim 23] The device according to claim 5, wherein the inner diameter and / or outer diameter increases by 1 to 20%, while the length increases by 0.1 to 19%. [Claim 24] The device according to claim 2 or 3, wherein the equilibrium water content state is 20 w / w% or more and 80 w / w% or less. [Claim 25] The device according to claim 8, wherein the water content is 6 w / w% or more and 40 w / w% or less. [Claim 26] The device according to claim 8, wherein the water content is 2 w / w% or more and 10 w / w% or less. [Claim 27] The device according to any one of claims 1 to 26, wherein the polymer material has a Young's modulus of 500 MPa or more in a dehydrated state and a Young's modulus of 5 MPa or more and 300 MPa or less in an equilibrium moisture content state. [Claim 28] The polymer material has a water content of less than 5 w / w% and 0.1 w / w% or more in a dehydrated state. The device according to any one of claims 1 to 27, wherein the polymer material is configured to swell from a dehydrated state to an equilibrium moisture content state by an amount of 5 w / w% to 50 w / w% within 60 minutes at 25°C. [Claim 29] The device according to any one of claims 1 to 28, wherein at least 50% of the plurality of holes have a diameter of 1 μm or less. [Claim 30] The device according to any one of claims 1 to 29, wherein the device is configured to swell from a dehydrated state to an equilibrium moisture content state in an amount of 5 w / w% to 50 w / w%. [Claim 31] The device according to any one of claims 1 to 30, wherein the device has a coefficient of friction of 0.10 or less in an equilibrium moisture content state. [Claim 32] The device according to any one of claims 1 to 31, wherein the device contains an osmotic agent present in the polymer material in an amount of 0.05 w / w% to 2 w / w% with respect to the total weight of the device. [Claim 33] The device according to claim 32, wherein the osmotic agent is selected from the group comprising phosphates, borates, sodium chloride, citrates, ethylenediaminetetraacetates, sulfites, sulfates, hyposulfites, metal oxides, selenium dioxide, selenium trioxide, selenite, selenic acid, nitrates, silicates, and plant acids. [Claim 34] The device according to any one of claims 1 to 33, wherein the polymer material has a water contact angle of 45 degrees or less in an equilibrium water content state. [Claim 35] The device according to any one of claims 1 to 34, wherein the first water-soluble polymer does not contain a covalent crosslinking agent. [Claim 36] The device according to any one of claims 1 to 35, wherein the second water-soluble polymer is selected from the group consisting of poly(vinyl alcohol), poly(acrylic acid), polyethylene glycol, or poly(vinylpyrrolidone), poly(methacrylate sulfobetaine), poly(acrylate sulfobetaine), poly(methacrylate carboxybetaine), poly(acrylate carboxybetaine), povidone polyacrylamide, poly(N-(2-hydroxypropyl)methacrylamide), polyoxazoline, polyphosphate, polyphosphazene, polyvinyl acetate, polypropylene glycol, poly(N-isopropylacrylamide), poly(2-hydroxymethyl methacrylate), and combinations thereof. [Claim 37] The device according to any one of claims 1 to 36, wherein the device is configured to be used in conjunction with medical devices such as catheters, balloons, shunts, wound drains, infusion ports, drug delivery devices, tubes, contraceptives, female hygiene devices, endoscopes, grafts, pacemakers, implantable cardiac defibrillators, cardiac resynchronization devices, cardiovascular device leads, ventricular assist devices, endotracheal tubes, tracheostomy tubes, implantable sensors, ventilator pumps, and ophthalmic devices. [Claim 38] The device according to claim 37, wherein the catheter is selected from the group consisting of a central venous catheter, a peripheral central catheter, a midline catheter, a peripheral catheter, a tunnel catheter, a dialysis access catheter, a urethral catheter, a neurological catheter, a percutaneous transluminal angioplasty catheter, and a peritoneal catheter. [Claim 39] The device according to any one of claims 1 to 38, wherein the second water-soluble polymer is disposed within a bulk of the first water-soluble polymer. [Claim 40] The device according to any one of claims 1 to 39, wherein less than 0.5 w / w% of the therapeutic agent is sorbed onto the bulk of the first water-soluble polymer at an equilibrium water content after flushing the device with five times its volume of water or saline solution. [Claim 41] The device according to any one of claims 1 to 40, wherein the device and / or polymer material is substantially non-thrombotic.

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