Intermittent catheters and methods

Abstract

Disclosed herein are intermittent catheters and methods. In one example of an intermittent catheter, the intermittent catheter may include a catheter tube, a lubricant disposed on a surface of at least a distal portion of the catheter tube, and a funnel coupled to a proximal portion of the catheter tube. The catheter tube is made of a polymeric material. The lubricant may have a liquid state above 20° C. (68° F.) such that the lubricant transitions to a liquid state upon insertion into the urethra of a patient or user. The funnel may include a funnel opening at a proximal end of the funnel for draining urine. In one example of a method of an intermittent catheter, the method may include a method of manufacturing or using an intermittent catheter.

Description

[Background technology]

[0001] In order to insert an intermittent catheter into the urethra, the intermittent catheter generally needs to be lubricated. In one example, a dry intermittent catheter is manually lubricated by application of a lubricant prior to urethral insertion. In another example, an intermittent catheter coated with a water-activated hydrophilic coating is used for urethral insertion. Water swells the hydrophilic coating immediately upon contact with the water, forming a very smooth surface on the intermittent catheter for urethral insertion. Wetting the water-activated hydrophilic coating of the intermittent catheter is accomplished by bursting a pouch of water contained in the package holding the intermittent catheter, followed by moving the catheter back and forth in the water in the package prior to urethral insertion. In yet another example, the intermittent catheter is already wetted in the package for urethral insertion. In each of the above cases, the intermittent catheter can be dirty to handle during urethral insertion as well as thereafter, for example, when disposing of the intermittent catheter. There is a need for a clean and unsoiled intermittent catheter both before and after urethral insertion. Summary of the Invention

[0002] Disclosed herein are intermittent catheters and methods that address the above. Disclosed herein is an intermittent catheter, in some embodiments, the intermittent catheter includes a catheter tube, a lubricant disposed on a surface of at least a distal portion of the catheter tube, and a funnel coupled to a proximal portion of the catheter tube. The catheter tube is comprised of a polymeric material. The lubricant is configured to transition from a solid state to a liquid state upon insertion into a patient's or user's urethra. The funnel includes a funnel opening at a proximal end of the funnel for draining urine.

[0003] In some embodiments, the lubricant is disposed on the surface of the catheter tube in the form of particles of the lubricant. In some embodiments, the lubricant is substantially free of water.

[0004] In some embodiments, the lubricant has a melting point between 21° C. (70° F.) and 35° C. (95° F.). In some embodiments, the lubricant is a natural oil, a synthetic oil, or a combination thereof.

[0005] In some embodiments, the lubricant is coconut oil, cocoa butter, palm oil, shea butter, or a mixture thereof. In some embodiments, the polymeric material is a thermoplastic polyurethane (TPU), silicone, polyvinyl chloride, or rubber.

[0006] In some embodiments, the surface of the catheter tube is modified by plasma treatment. In some embodiments, the surface energy of the polymeric material at the surface of the catheter tube is at least 5 dyn / cm greater than the surface energy of the lubricant.

[0007] In some embodiments, the surface energy of the polymeric material at the surface of the catheter tube is at least 10 dyn / cm greater than the surface energy of the lubricant.

[0008] Also disclosed herein is another intermittent catheter, in some embodiments, the intermittent catheter includes a hydrophilic coating disposed on a surface of at least a distal portion of the catheter tube, a lubricant disposed on the hydrophilic coating, and a funnel coupled to a proximal portion of the catheter tube. The catheter tube is made of a polymeric material. The lubricant is configured to transition from a solid state to a liquid state upon insertion into a patient's or user's urethra. The funnel includes a funnel opening at a proximal end of the funnel for draining urine.

[0009] In some embodiments, the lubricant is disposed on the hydrophilic coating in the form of particles of the lubricant. In some embodiments, the lubricant is substantially free of water.

[0010] In some embodiments, the lubricant has a melting point between 21° C. (70° F.) and 35° C. (95° F.). In some embodiments, the lubricant is a natural oil, a synthetic oil, or a combination thereof.

[0011] In some embodiments, the lubricant is coconut oil, cocoa butter, palm oil, shea butter, or a mixture thereof. In some embodiments, the surface energy of the hydrophilic coating surface is at least 0.005 N / m (5 dyn / cm) greater than the surface energy of the lubricant.

[0012] In some embodiments, the surface energy of the hydrophilic coating surface is at least 10 dyn / cm greater than the surface energy of the lubricant. Also disclosed herein is a method of manufacturing an intermittent catheter. The method, in some embodiments, includes a heating step, a lubricant disposing step, and a cooling step. The heating step includes heating a reservoir of lubricant such that the lubricant transitions from a solid state to a liquid state. The lubricant disposing step includes immersing at least a distal portion of a catheter tube of an intermittent catheter into the reservoir when the lubricant is in a liquid state. The lubricant disposing step includes disposing the lubricant on a surface of at least the distal portion of the catheter tube. The cooling step includes allowing the lubricant disposed on the surface of the catheter tube to cool such that the lubricant transitions from the liquid state of the lubricant to a solid state of the lubricant.

[0013] In some embodiments, the lubricant has a melting point between 21° C. (70° F.) and 35° C. (95° F.). In some embodiments, the lubricant is a natural oil, a synthetic oil, or a combination thereof.

[0014] In some embodiments, the lubricant is coconut oil, cocoa butter, palm oil, shea butter, or a mixture thereof. In some embodiments, the method further comprises a surface modification step, the surface modification step comprising treating at least the distal portion of the catheter tube with a plasma treatment prior to the lubricant disposing step to modify the surface of the catheter tube.

[0015] In some embodiments, the catheter tube is made of a polymeric material selected from TPU, silicone, polyvinyl chloride, and rubber. In some embodiments, the lubricant placement step comprises dwelling the catheter tube in the lubricant for 5 to 7 seconds.

[0016] In some embodiments, the method further comprises a withdrawing step, the withdrawing step comprising gradually withdrawing the catheter tube from the reservoir after the lubricant depositing step.

[0017] In some embodiments, the method further comprises a repeating step, which includes repeating the lubricant depositing step until a desired thickness of the lubricant is disposed on a surface of the catheter tube.

[0018] In some embodiments, the method further comprises a hanging step, the hanging step comprising hanging the intermittent catheter on a rack for the cooling step. Also disclosed herein is a method of manufacturing another intermittent catheter. The method, in some embodiments, includes a hydrophilic coating disposing step, a heating step, a lubricant disposing step, and a cooling step. The hydrophilic coating disposing step includes disposing a hydrophilic coating on a surface of at least a distal portion of a catheter tube of an intermittent catheter. The heating step includes heating a reservoir of lubricant such that the lubricant transitions from a solid state to a liquid state. The lubricant disposing step includes immersing at least the distal portion of the catheter tube into the reservoir when the lubricant is in a liquid state. The lubricant disposing step includes disposing the lubricant on the hydrophilic coating. The cooling step includes allowing the lubricant disposed on the hydrophilic coating to cool such that the lubricant transitions from the liquid state of the lubricant to a solid state of the lubricant.

[0019] In some embodiments, the lubricant has a melting point between 21° C. (70° F.) and 35° C. (95° F.). In some embodiments, the lubricant is a natural oil, a synthetic oil, or a combination thereof.

[0020] In some embodiments, the lubricant is coconut oil, cocoa butter, palm oil, shea butter, or a mixture thereof. In some embodiments, the lubricant placement step comprises dwelling the catheter tube in the lubricant for 5 to 7 seconds.

[0021] In some embodiments, the method further comprises a withdrawing step, the withdrawing step comprising gradually withdrawing the catheter tube from the reservoir after the lubricant depositing step.

[0022] In some embodiments, the method further comprises a repeating step, which includes repeating the lubricant disposing step until a desired thickness of the lubricant is disposed on the hydrophilic coating.

[0023] In some embodiments, the method further comprises a hanging step, the hanging step comprising hanging the intermittent catheter on a rack for the cooling step. Also disclosed herein is a method of using an intermittent catheter. The method, in some embodiments, includes an obtaining step, a removing step, an inserting step, and an emptying step. The obtaining step includes obtaining a packaged intermittent catheter including an intermittent catheter disposed within an outer sheath. A catheter tube of the intermittent catheter includes a lubricant in a solid state disposed on a surface of at least a distal portion of the catheter tube. The removing step includes removing the intermittent catheter from the outer sheath through a funnel of the intermittent catheter. The inserting step includes inserting the catheter tube into the urethra. Upon insertion, the lubricant disposed on the surface of the catheter tube transitions to a liquid state for lubrication of the catheter tube. The emptying step includes emptying urine from the bladder.

[0024] In some embodiments, the method further comprises a withdrawal step, which comprises withdrawing the catheter tube from the bladder after the draining step. Concurrent with the withdrawal step, any remaining lubricant disposed on the surface of the catheter tube transitions to a solid state for clean and clean disposal of the intermittent catheter. The transition of the lubricant to a solid state is subject to exposing the lubricant to an ambient temperature below body temperature.

[0025] In some embodiments, the method further comprises a deploying step and a resealing step, the deploying step comprises deploying the intermittent catheter within the sheath, the resealing step comprises resealing the intermittent catheter within the sheath, the resealing step prevents residual urine leakage from the intermittent catheter.

[0026] In some embodiments, the method further comprises a deploying step, the deploying step comprising deploying the intermittent catheter. These and other features of the concepts provided herein will become more apparent to those of ordinary skill in the art in view of the accompanying drawings and the following description, which describe in more detail certain embodiments of such concepts. [Brief description of the drawings]

[0027] [Figure 1] 1 illustrates a male intermittent catheter according to some embodiments. [Diagram 2] 1 illustrates a female intermittent catheter according to some embodiments. [Diagram 3] 1 illustrates a method of use for a male intermittent catheter according to some embodiments. [Figure 4] 1 illustrates a method of use for a female intermittent catheter according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0028] Before some specific embodiments are disclosed in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein can have features that can be easily separated from the specific embodiment and, optionally, combined with or substituted for features of any of the other numerous embodiments disclosed herein.

[0029] With regard to the terms used herein, it should also be understood that the terms are intended to describe certain embodiments, and that the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps, and do not provide sequential or numerical limitations. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. In addition, any of the aforementioned features or steps may further include one or more features or steps. Labels such as "left", "right", "up", "down", "front", "rear", etc. are used for convenience and do not imply, for example, a particular fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one", "one", and "said" also include plural references unless the context clearly dictates otherwise.

[0030] With respect to "proximal," for example, a "proximal portion" or "proximal end portion" of a catheter includes the portion of the needle intended to be near the clinician when the catheter is used with a patient or user. Similarly, for example, a "proximal length" of a catheter includes the length of the catheter intended to be near the clinician when the catheter is used with a patient or user. For example, the "proximal end" of a needle includes the end of the catheter intended to be near the clinician when the catheter is used with a patient or user. Although a proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter, a proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless otherwise suggested by context, a proximal portion, proximal end portion, or proximal length of a catheter is not a terminal portion or terminal length of a catheter.

[0031] With respect to "distal," for example, a "distal portion" or "distal end portion" of a catheter disclosed herein includes a portion of the catheter that is intended to be near or within a patient or user when the catheter is used with the patient or user. Similarly, for example, a "distal length" of a catheter includes a length of the catheter that is intended to be near or within a patient or user when the catheter is used with the patient or user. For example, the "distal end" of a needle includes an end of the catheter that is intended to be near or within a patient or user when the catheter is used with the patient or user. A distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter, but a distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless otherwise suggested by context, a distal portion, distal end portion, or distal length of a catheter is not a terminal portion or terminal length of a catheter.

[0032] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Intermittent catheter 1 and 2 show a male intermittent catheter 100 and a female intermittent catheter 200, respectively, according to some embodiments.

[0033] As shown, the intermittent catheter 100 or 200 includes a catheter tube 102 or 202 and a funnel 104 coupled to a proximal portion of the catheter tube 102 or 202. The catheter tube 102 or 202 includes a lubricant 106 disposed throughout the catheter tube 102 or 202 on a surface of at least a distal portion of the catheter tube 102 or 202. However, in some embodiments, the catheter tube 102 or 202 includes a hydrophilic coating disposed throughout the catheter tube 102 or 202 on a surface of at least a distal portion of the catheter tube 102 or 202, and the lubricant 106 is disposed on the hydrophilic coating. A description of the catheter tube 102 or 202 and the funnel 104 is provided below, and a description of the lubricant 106 is provided below.

[0034] The catheter tube 102 and the catheter tube 202 differ in that the catheter tube 102 is longer than the catheter tube 202, but each of the catheter tubes 102 and 202 includes a plurality of eyelets 108 around the catheter tip 110. The eyelets 108 are in fluid communication with a funnel opening 112, which will be described later. Additionally, each of the catheter tubes 102 and 202, including the surface, is made of a polymeric material. The polymeric material is TPU, silicone, polyvinyl chloride, or rubber. The rubber can be natural rubber, synthetic rubber, or a combination thereof, such as red rubber, including a blend of natural rubber and styrene butadiene rubber. Optionally, the surface of the catheter tube 102 or 202 is modified by plasma treatment to increase the surface energy SE of the polymeric material at the surface of the catheter tube 102 or 202. With or without plasma treatment, the surface energy SE of the polymeric material at the surface of the catheter tube 102 or 202 is at least 0.005 N / m (5 dyn / cm), 0.010 N / m (10 dyn / cm), 0.015 N / m (15 dyn / cm), or 0.020 N / m (20 dyn / cm) greater than the surface energy of the lubricant.

[0035] The funnel 104 includes a funnel opening 112 that opens at the proximal end of the funnel 104 opposite the catheter tube 102 or 202 for draining urine. The eyelet 112 is in fluid communication with a funnel opening 108, described below. Additionally, the funnel 104 includes a number of ridges 114 integrated into the exterior surface of the funnel 104. The ridges 114 are configured to grip the funnel 104 as a handle during removal of the intermittent catheter 100 or 200 from the outer casing 116 or 216 of the packaged intermittent catheter 118 or 218, described below. Additionally or alternatively, the ridges 114 are configured to grip the funnel 104 as a handle during insertion of the intermittent catheter 100 or 200 into the urethra.

[0036] As shown in Figures 3 or 4, the intermittent catheter 100 or 200 may be disposed within a sheath 116 or 216 to form a packaged intermittent catheter 118 or 218. In particular, the intermittent catheter 100 or 200 disposed within the sheath 116 or 216 includes a lubricant 106 that is in a substantially water-free solid state.

[0037] Lubricants Again, the lubricant 106 is disposed on the surface of at least the distal portion of the catheter tube 102 or 202 and throughout the catheter tube 102 or 202. However, in some embodiments, the lubricant 106 is disposed on a hydrophilic coating (if present) on the surface of the catheter tube 102 or 202.

[0038] The lubricant 106 has a solid state below normal temperature and pressure (NTP) and a liquid state above NTP. NTP is defined as a temperature of 20° C. (68° F.) and an atmospheric pressure of 101 kPa (760 mmHg) according to the National Institute of Standards and Technology (NIST). Such a lubricant is advantageous in that the lubricant 106 has a solid state below 20° C. (68° F.), such as while the intermittent catheter 100 or 200 is packaged and stored as a packaged intermittent catheter 118 or 218, or immediately prior to insertion into the ureter. The solid state lubricant 106 also has the advantage of being clean and free of dirt, in that it can take the form of a relatively dry particulate on the hydrophilic coating or surface of the catheter tube 102 or 202. The lubricant 106 contains less than 0.5% water, less than 1% water, such as less than 0.3%, less than 0.2%, or less than 0.1% water, but is substantially free of water. The lubricant 106 is further advantageous in that it has a liquid state above 20° C. (68° F.) such that the lubricant 106 transitions to a liquid state immediately upon insertion into the patient's or user's urethra.

[0039] The aforementioned lubricants may be fats, such as natural fats, semi-synthetic fats, synthetic fats, or combinations thereof, having a melting point between 70°F and 95°F. For example, the lubricant 106 may include natural fats, including, but not limited to, coconut oil (melting point 76°F), cocoa butter (melting point 93°F), palm oil (melting point 95°F), shea butter (melting point 90°F), or mixtures thereof. The use of semi-synthetic fats, including hydrogenated natural fats, such as hydrogenated coconut oil, can increase the melting point of the lubricant 106 as desired in warmer environments. Although melting point is used herein, it should be understood that melting is a physical change that occurs over a small temperature range, for example, 2-3°F, even in the purest materials. Not only is the lubricant 106 very lubricant in its liquid state, but certain oils, such as coconut oil, are further advantageous as lubricants 106 in that such oils may be beneficial to skin health and organ health, such as the urinary system. In fact, coconut oil even has antioxidant and antibacterial properties, which may help alleviate urinary tract infections (UTIs).

[0040] The wettability or spreadability of the lubricant 106 (e.g., palm oil) appears to be governed by the surface energy SE of the lubricant 106 and the surface of the catheter tube 102 or 202. Such wettability can be understood by considering the spreading parameter S of the lubricant 106 in the liquid state, where S represents the difference between the work of adhesion Wa and the work of cohesion Wc, as follows:

[0041] S = Wa - Wc = γS - (γSL + γL) Equation 1 In Equation 1, γS is the surface energy of a solid, such as the surface of the catheter tube 102 or 202, γL is the surface tension of a liquid, such as the lubricant 106 in the liquid state, and γSL is the interfacial tension between the solid and the liquid. For the lubricant 106 in the liquid state to spread over the surface of the catheter tube 102 or 202, it is desirable that S≧0. For the lubricant 106 in the liquid state to spread very well over the surface of the catheter tube 102 or 202, it is desirable that S≧10. For example, coconut oil has a surface tension of 0.027 N / m (27.413 dyn / cm) in the liquid state. For coconut oil to adequately wet the surface of the catheter tube 102 or 202, the surface energy SE of the catheter tube 102 or 202 must be at least 0.010 N / m (10 dyn / cm) greater than the surface energy SE of coconut oil. However, if such conditions are not met, the surface of the catheter tube 102 or 202 may be treated with a plasma treatment as described above that increases the SE for proper wetting of the surface of the catheter tube 102 or 202.

[0042] method The method of the intermittent catheter 100 or 200 includes a method of manufacturing the intermittent catheter 100 or 200. For example, the method of manufacturing the intermittent catheter 100 or 200 can include one or more steps selected from a surface modification step, a hydrophilic coating disposing step, a heating step, a lubricant disposing step, a drawing step, a repeating step, a hanging step, a cooling step, and a packaging step.

[0043] If performed, the surface modification step includes treating at least the surface of the distal portion of the catheter tube 102 or 202 with a plasma treatment throughout the catheter tube 102 or 202 prior to performing the hydrophilic coating disposing step, the lubricant disposing step, or both, to modify the treated surface of the catheter tube 102 or 202. As discussed above, the catheter tube 102 or 202, including the surface of the catheter tube 102 or 202, is made of a polymeric material selected from TPU, silicone, polyvinyl chloride, and rubber.

[0044] If performed, the hydrophilic coating disposing step includes disposing a hydrophilic coating on the surface of at least the distal portion of the catheter tube 102 or 202 and throughout the entire catheter tube 102 or 202 .

[0045] The heating step includes heating a reservoir of lubricant 106 such that lubricant 106 transitions from a solid state to a liquid state. As discussed above, a solid state lubricant 106 is below 20° C. (68° F.) and a liquid state lubricant 106 is above 20° C. (68° F.). For example, lubricant 106 may have a melting point between 70° F. and 95° F. (inclusive), such as coconut oil, cocoa butter, palm oil, or shea butter, which have melting points of 24° C. (76° F.), 93° F., 95° F., and 90° F., respectively. To ensure that the lubricant 106 maintains a liquid state during the heating step and during certain subsequent steps, such as a lubricant disposing step, the reservoir of lubricant 106 may be heated to a temperature above the melting point of the lubricant 106, such as 5°F, 10°F, 15°F, 20°F, or 25°F above the melting point of the lubricant 106. For example, if the lubricant 106 is coconut oil, the reservoir of lubricant 106 may be heated to at least about 100°F.

[0046] The lubricant placement step includes immersing at least a distal portion of the catheter tube 102 or 202, up to the entire catheter tube 102 or 202, into a reservoir when the lubricant 106 is in a liquid state. The lubricant placement step also includes dwelling the catheter tube 102 or 202 in the lubricant 106 for 5 to 7 seconds to provide the lubricant 106 with sufficient time to interact with the hydrophilic coating or one or more surface elements (e.g., pores, charged species, etc.) on the surface of the catheter tube 102 or 202. The lubricant placement step includes, if a hydrophilic coating is disposed on the surface of the catheter tube 102 or 202, placing the lubricant 106 on the hydrophilic coating. Alternatively, if a hydrophilic coating is not disposed on the surface of the catheter tube 102 or 202, placing the lubricant 106 on the surface of the catheter tube 102 or 202.

[0047] The withdrawal step involves gradually withdrawing the catheter tube 102 or 202 from the reservoir after the lubricant deposition step. Notably, in some embodiments, the withdrawal step can be considered part of the lubricant deposition step. In any case, the withdrawal step provides the lubricant 106 initially deposited on the hydrophilic coating or surface of the catheter tube 102 or 202 with sufficient time to thermally equilibrate with the lubricant 106 in the reservoir at the interface therebetween, which can affect the thickness of the lubricant 106 on the hydrophilic coating or surface of the catheter tube 102 or 202.

[0048] If the repeating step is not part of the lubricant placement step, the repeating step includes repeating the lubricant placement step and the drawing step until the lubricant 106 on the hydrophilic coating or surface of the catheter tube 102 or 202 is at a desired thickness. Depending on the surface energy SE, in some embodiments, the repeating step need not be performed. That is, in other embodiments, the repeating step can be performed any number of times, including once, twice, three times, or four or more times. For example, if the catheter tube 102 or 202, including the surface of the catheter tube 102 or 202, is silicone or PVC, the repeating step can be performed once or multiple times due to the lower surface energy of silicone and PVC. However, if the catheter tube 102 or 202, including the surface of the catheter tube 102 or 202, is TPU and the lubricant 106 is coconut oil, the repeating step does not need to be performed.

[0049] The hanging step involves hanging the intermittent catheter 100 or 200 on a rack for the cooling step. The cooling step includes allowing the lubricant 106 disposed on the hydrophilic coating or on the surface of the catheter tube 102 or 202 to cool such that the lubricant 106 transitions from the liquid state of the lubricant 106 to a solid state.

[0050] The packaging process includes packaging the intermittent catheter 100 or 200 in an outer sheath 116 or 216. The methods of the intermittent catheter 100 or 200 include methods of using the intermittent catheter 100 or 200. For example, the methods can include one or more steps selected from a removing step, an inserting step, an evacuation step, a withdrawing step, and a placing step.

[0051] The obtaining step includes obtaining a packaged intermittent catheter 118 or 218 including the intermittent catheter 100 or 200 disposed within the outer sheath 116 or 216. As described above, if a hydrophilic coating is disposed on the surface of the catheter tube 102 or 202, the intermittent catheter 100 or 200 includes a lubricant 106 disposed on the hydrophilic coating. Alternatively, if a hydrophilic coating is not disposed on the surface of the catheter tube 102 or 202, the intermittent catheter 100 or 200 includes a lubricant 106 disposed on the surface of the catheter tube 102 or 202.

[0052] The removal step includes removing the intermittent catheter 100 or 200 from the sheath 116 or 216 via the funnel 104 of the intermittent catheter 100 or 200 . The insertion step includes inserting the catheter tube 102 or 202 into the urethra. Upon insertion, the lubricant 106 disposed on the hydrophilic coating or on the surface of the catheter tube 102 or 202 transitions to a liquid state for lubrication of the catheter tube 102 or 202. The transition of the lubricant 106 to a liquid state is subject to exposing the lubricant 106 to body temperature above 20° C. (68° F.), such as body temperature of about 37° C. (about 98.6° F.).

[0053] The emptying step includes emptying urine from the bladder. The method further includes a withdrawal step, which includes withdrawing the catheter tube 102 or 202 from the bladder after the drainage step. Concurrent with the withdrawal step, any remaining lubricant 106 disposed on the hydrophilic coating or on the surface of the catheter tube 102 or 202 transitions to a solid state for clean and unsoiled disposal of the intermittent catheter 100 or 200. The transition of the lubricant 106 to the solid state is subject to exposing the lubricant 106 to an ambient temperature below 20° C. (68° F.).

[0054] The placement step includes placing the intermittent catheter 100 or 200 within the sheath 116 or 216. The resealing process involves resealing the intermittent catheter 100 or 200 within the sheath 116 or 216. The resealing process prevents residual urine leakage from the intermittent catheter 100 or 200.

[0055] The placing step includes placing the intermittent catheter 100 or 200. Although some specific embodiments are disclosed herein and the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Further adaptations or modifications may become apparent to those skilled in the art, and the broader aspects of the invention encompass these adaptations or modifications as well. Thus, departures from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. An intermittent catheter comprising: a catheter tube made of a polymeric material; a lubricant disposed on a surface of at least a distal portion of the catheter tube, the lubricant configured to transition from a solid state to a liquid state upon insertion into a patient's or user's urethra; a funnel attached to a proximal portion of the catheter tube, the funnel including a funnel opening at a proximal end of the funnel for draining urine; An intermittent catheter comprising:

2. The intermittent catheter of claim 1 , wherein the lubricant is disposed on the surface of the catheter tube in the form of particles of the lubricant.

3. The intermittent catheter of claim 1 or 2, wherein the lubricant is substantially free of water.

4. 4. The intermittent catheter of claim 1, wherein the lubricant has a melting point of between 21° C. (70° F.) and 35° C. (95° F.).

5. The intermittent catheter according to claim 1 , wherein the lubricant is a natural oil, a synthetic oil, or a combination thereof.

6. The intermittent catheter of any one of claims 1 to 5, wherein the lubricant is coconut oil, cocoa butter, palm oil, shea butter, or a mixture thereof.

7. The intermittent catheter of claim 1 , wherein the polymeric material is thermoplastic polyurethane (TPU), silicone, polyvinyl chloride, or rubber.

8. The intermittent catheter according to claim 1 , wherein the surface of the catheter tube is modified by plasma treatment.

9. 9. The intermittent catheter of claim 1, wherein the surface energy of the polymeric material at the surface of the catheter tube is at least 0.005 N / m (5 dyn / cm) greater than the surface energy of the lubricant.

10. 9. The intermittent catheter of claim 1, wherein the surface energy of the polymeric material at the surface of the catheter tube is at least 10 dyn / cm greater than the surface energy of the lubricant.

11. An intermittent catheter comprising: a catheter tube made of a polymeric material; a hydrophilic coating disposed on a surface of at least a distal portion of the catheter tube; a lubricant disposed on the hydrophilic coating, the lubricant configured to transition from a solid state to a liquid state upon insertion into a patient's or user's urethra; a funnel attached to a proximal portion of the catheter tube, the funnel including a funnel opening at a proximal end of the funnel for draining urine; An intermittent catheter comprising:

12. The intermittent catheter of claim 11 , wherein the lubricant is disposed on the hydrophilic coating in the form of particles comprised of the lubricant.

13. The intermittent catheter of claim 11 or 12, wherein the lubricant is substantially free of water.

14. 14. The intermittent catheter of any one of claims 11 to 13, wherein the lubricant has a melting point of between 21°C (70°F) and 35°C (95°F).

15. The intermittent catheter of any one of claims 11 to 14, wherein the lubricant is a natural oil, a synthetic oil, or a combination thereof.

16. 16. The intermittent catheter of any one of claims 11 to 15, wherein the lubricant is coconut oil, cocoa butter, palm oil, shea butter, or a mixture thereof.

17. 17. The intermittent catheter of any one of claims 11 to 16, wherein the surface energy of the hydrophilic coating surface is at least 0.005 N / m (5 dyn / cm) greater than the surface energy of the lubricant.

18. 17. The intermittent catheter of any one of claims 11 to 16, wherein the surface energy of the hydrophilic coating surface is at least 0.010 N / m (10 dyn / cm) greater than the surface energy of the lubricant.

19. 1. A method of manufacturing an intermittent catheter, comprising: heating a reservoir of lubricant such that the lubricant transitions from a solid state to a liquid state; disposing the lubricant on a surface of at least a distal portion of a catheter tube of an intermittent catheter by immersing the lubricant in the reservoir while the lubricant is in a liquid state; allowing the lubricant disposed on the surface of the catheter tube to cool such that the lubricant transitions from the liquid state of the lubricant to the solid state of the lubricant; The method includes:

20. 20. The method of claim 19, wherein the lubricant has a melting point between 21°C (70°F) and 35°C (95°F).

21. 21. The method of claim 19 or 20, wherein the lubricant is a natural oil, a synthetic oil, or a combination thereof.

22. 22. The method of any one of claims 19 to 21, wherein the lubricant is coconut oil, cocoa butter, palm oil, shea butter, or a mixture thereof.

23. 23. The method of any one of claims 19 to 22, further comprising treating at least the distal portion of the catheter tube with a plasma treatment to modify the surface of the catheter tube prior to immersing the catheter tube in the reservoir.

24. 24. The method of any one of claims 19 to 23, wherein the catheter tube is made of a polymeric material selected from thermoplastic polyurethane (TPU), silicone, polyvinyl chloride, and rubber.

25. 25. The method of any one of claims 19 to 24, wherein immersing the catheter tube in the reservoir comprises dwelling the catheter tube in the lubricant for 5 to 7 seconds.

26. 26. The method of any one of claims 19 to 25, further comprising slowly withdrawing the catheter tube from the reservoir after immersing the catheter tube in the reservoir.

27. 27. The method of any one of claims 19 to 26, further comprising repeatedly dipping the catheter tube into the reservoir until a desired thickness of the lubricant is disposed on the surface of the catheter tube.

28. 28. The method of any one of claims 19-27, further comprising hanging the intermittent catheter on a rack to allow the lubricant disposed on the surface of the catheter tube to cool.

29. 1. A method of manufacturing an intermittent catheter, comprising: disposing a hydrophilic coating on a surface of at least a distal portion of a catheter tube of the intermittent catheter; heating a reservoir of lubricant such that the lubricant transitions from a solid state to a liquid state; disposing the lubricant on the hydrophilic coating by immersing at least the distal portion of the catheter tube in the reservoir while the lubricant is in a liquid state; allowing the lubricant disposed on the hydrophilic coating to cool such that the lubricant transitions from the liquid state of the lubricant to a solid state of the lubricant; The method includes:

30. 30. The method of claim 29, wherein the lubricant has a melting point between 21°C (70°F) and 35°C (95°F).

31. 31. The method of claim 29 or 30, wherein the lubricant is a natural oil, a synthetic oil, or a combination thereof.

32. 32. The method of any one of claims 29 to 31, wherein the lubricant is coconut oil, cocoa butter, palm oil, shea butter, or a mixture thereof.

33. 33. The method of any one of claims 29 to 32, wherein immersing the catheter tube in the reservoir comprises dwelling the catheter tube in the lubricant for 5 to 7 seconds.

34. 34. The method of any one of claims 29 to 33, further comprising slowly withdrawing the catheter tube from the reservoir after immersing the catheter tube in the reservoir.

35. 35. The method of any one of claims 29 to 34, further comprising repeatedly dipping the catheter tube into the reservoir until a desired thickness of the lubricant disposed on the hydrophilic coating is achieved.

36. 36. The method of any one of claims 29-35, further comprising hanging the intermittent catheter on a rack to allow the lubricant disposed on the surface of the catheter tube to cool.

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