Urethral catheter and method

Abstract

Disclosed herein is a urinary catheter, a method of manufacture, and a method of use. The urinary catheter includes a catheter tube, a lubricious coating on a surface of at least a distal portion of the catheter tube, and a funnel attached to a proximal portion of the catheter tube. The catheter tube is made of a polymeric material. The lubricious coating includes a hydrophilic coating on a surface of the catheter tube and a lubricant on the hydrophilic coating. The funnel includes a funnel opening at a proximal end of the funnel for draining urine. In one example of a urinary catheter method, the method includes a method of manufacture and a method of use of the urinary catheter.

Description

[Technical field]

[0001] The present disclosure relates to urinary catheters and methods. [Background technology]

[0002] A urinary catheter user or their caregiver has a limited time for catheter insertion when opening a urinary catheter package that includes a catheter coated with a pre-wetted hydrophilic coating. This is because the water in the hydrophilic coating begins to evaporate quickly when the urinary catheter package is opened. As the water begins to evaporate, the coating begins to become sticky, which significantly increases the difficulty of catheter insertion. What is needed is a urinary catheter that reduces such water evaporation and the resulting stickiness, thereby allowing the urinary catheter user or their caregiver sufficient time for successful urethral insertion.

[0003] Disclosed herein are urinary catheters and methods that address the above. Summary of the Invention

[0004] Disclosed herein, in some embodiments, is a urinary catheter including a catheter tube, a lubricious coating on a surface of at least a distal portion of the catheter tube, and a funnel attached to a proximal portion of the catheter tube. The catheter tube is a polymeric material. The lubricious coating includes a hydrophilic coating on a surface of the catheter tube and a lubricant on the hydrophilic coating. Water of the lubricant is at least partially absorbed by the hydrophilic coating. The funnel includes a funnel opening at a proximal end of the funnel for draining urine.

[0005] In some embodiments, the hydrophilic coating is a polyvinylpyrrolidone-based coating or a hyaluronic acid-based coating. In some embodiments, the lubricant is a combination of glycerin, water, glyceryl acrylate / acrylic acid copolymer, and propylene glycol.

[0006] In some embodiments, the glycerin, glyceryl acrylate / acrylic acid copolymer, and propylene glycol limit the evaporation of any water from the lubricious coating.

[0007] In some embodiments, the polymeric material is a thermoplastic polyurethane ("TPU"), silicone, polyvinyl chloride, or rubber. In some embodiments, the surface of the catheter tube is a plasma treated surface having a surface energy that promotes adhesion of the hydrophilic coating.

[0008] Also disclosed herein is a method of making a urinary catheter, which in some embodiments includes a hydrophilic coating application step and a lubricant dipping step. The hydrophilic coating application step includes applying a hydrophilic coating onto a surface of a catheter tube of a urinary catheter. The lubricant dipping step includes dipping at least a distal portion of the catheter tube into a reservoir of lubricant, thereby disposing the lubricant on the hydrophilic coating. Water of the lubricant is at least partially absorbed by the hydrophilic coating.

[0009] In some embodiments, the lubricant dipping step comprises dipping the catheter tube into the lubricant at a dip rate of about 0.15 inches (0.38 cm) / second to about 0.50 inches (1.27 cm) / second.

[0010] In some embodiments, the lubricant dipping step comprises dipping the catheter tube into the lubricant at a dip rate of about 0.33 inches (0.84 cm) per second. In some embodiments, the lubricant immersion step comprises withdrawing the catheter tube from the lubricant at a withdrawal rate of about 0.05 inches (0.13 cm) / second to about 0.20 inches (0.51 cm) / second.

[0011] In some embodiments, the lubricant immersion step comprises withdrawing the catheter tube from the lubricant at a withdrawal speed of about 0.12 inches (0.30 cm) per second. In some embodiments, the lubricant soaking step includes substantially no residence time in the lubricant.

[0012] In some embodiments, the lubricant immersion step comprises a single immersion in the lubricant. In some embodiments, the lubricant is a combination of glycerin, water, glyceryl acrylate / acrylic acid copolymer, and propylene glycol.

[0013] In some embodiments, the glycerin, glyceryl acrylate / acrylic acid copolymer, and propylene glycol limit the evaporation of any water from the lubricious coating.

[0014] In some embodiments, the method further comprises a catheter packaging step, which comprises packaging the urinary catheter without air drying after the lubricant soaking step.

[0015] In some embodiments, the method further comprises a surface treatment step, which comprises plasma treating at least the distal portion of the catheter tube to modify the surface of the catheter tube prior to the hydrophilic coating application step.

[0016] In some embodiments, the catheter tube is a polymeric material selected from thermoplastic polyurethane ("TPU"), silicone, polyvinyl chloride, and rubber. In some embodiments, the hydrophilic coating is a polyvinylpyrrolidone-based coating or a hyaluronic acid-based coating.

[0017] Also disclosed herein is a method of using a urinary catheter. The method, in some embodiments, includes the steps of obtaining a catheter package, opening, inserting a catheter, and urinating. The step of obtaining the catheter package includes obtaining a packaged urinary catheter. The packaged urinary catheter includes a urinary catheter disposed within an outer package. The catheter tube of the urinary catheter includes a lubricious coating of a hydrophilic coating on a surface of at least a distal portion of the catheter tube, and a lubricant on the hydrophilic coating. The step of opening includes removing the urinary catheter from the outer package by a funnel of the urinary catheter. The step of inserting the catheter includes inserting the catheter tube into the urethra. The lubricious coating provides a user or a caregiver sufficient time to successfully insert the catheter tube into the urethra by limiting evaporation of moisture from the lubricious coating, which would otherwise cause stickiness, from the opening step to the catheter insertion step. The step of urinating includes draining urine from the bladder.

[0018] In some embodiments, the method further comprises the step of removing the catheter, the step of removing the catheter tube from the urethra after the step of voiding. In some embodiments, the method further includes a repackaging step and a resealing step. The repackaging step includes placing the urinary catheter within the outer packaging. The resealing step includes resealing the urinary catheter within the outer packaging, thereby preventing residual urine from leaking from the urinary catheter.

[0019] In some embodiments, the method further comprises a discarding step, the discarding step comprising discarding the urinary 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]

[0020] [Figure 1] 1 illustrates a male urethral catheter according to some embodiments. [Diagram 2] 1 illustrates a female urinary catheter according to some embodiments. [Diagram 3] 1 shows a cross section of a male or female urinary catheter according to some embodiments. [Figure 4] 1 illustrates a method of use for a male urethral catheter according to some embodiments. [Diagram 5] 1 illustrates a method of use for a female urinary catheter according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts presented herein. It should also be understood that a specific embodiment disclosed herein may have features that can be easily separated from the specific embodiment and can be optionally combined or substituted with features of any of the other embodiments disclosed herein.

[0022] With regard to the terms used herein, it should also be understood that each term is intended to describe certain embodiments and does not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps from one another within a group of features or steps, and do not impose any order or numerical limitations. For example, the "first," "second," and "third" features or steps do not necessarily have to appear in this order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Also, unless otherwise indicated, any of the features or steps may be sequential, and may further include one or more features or steps. Designations such as "left," "right," "upper," "lower," "front," and "rear" are used for convenience and do not, for example, imply any particular fixed position, orientation, or direction. Rather, such designations are used to indicate, for example, relative positions, orientations, or directions. Unless the context clearly indicates otherwise, the singular forms "a," "an," and "the" include the plural.

[0023] With respect to "proximal," for example, a "proximal portion" or "proximal end portion" of a catheter disclosed herein includes a portion of the catheter intended to be near a clinician when the catheter is used with a patient or user. Similarly, for example, a "proximal length" of a catheter includes a length of the catheter intended to be near a 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 a 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.

[0024] 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 when the catheter or user is used with the patient. 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 the end of the catheter that is intended to be near or within a patient when the catheter is used with the patient or user. Although a distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter, 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.

[0025] 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. As discussed above, a urinary catheter user or their caregiver has a limited time to catheterize when opening a urinary catheter package that includes a catheter coated with a pre-moistened hydrophilic coating. This is because the water in the hydrophilic coating begins to evaporate quickly when the urinary catheter package is opened. As the water begins to evaporate, the coating begins to become sticky, which significantly increases the difficulty of catheterization. What is needed is a urinary catheter that reduces such water evaporation and the resulting stickiness, thereby allowing the urinary catheter user or their caregiver sufficient time to achieve successful urethral insertion.

[0026] Disclosed herein are urinary catheters and methods that address the above. Urethral catheter 1 and 2 show a male urinary catheter 100 and a female urinary catheter 200, respectively, according to some embodiments.

[0027] As shown, the urinary 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 lubricious coating 106 disposed on at least a distal portion of the catheter tube 102 or 202 and throughout the catheter tube 102 or 202. A description of the catheter tube 102 or 202 and the funnel 104 is provided immediately below. A description of the lubricious coating 106 is provided in the next section.

[0028] The catheter tube 102 and the catheter tube 202 differ in that the catheter tube 102 is longer than the catheter tube 202. However, 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, described below, by a lumen 114 that runs through the catheter. In addition, each of the catheter tubes 102 and 202, including its surface, is 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, which includes a blend of natural rubber and styrene butadiene rubber. If desired, the surface of the catheter tube 102 or 202 can be modified by plasma treatment to increase the surface energy SE of the polymeric material at the surface of the catheter tube 102 or 202, thereby promoting adhesion of the hydrophilic coating 116, described below.

[0029] 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 funnel opening 112 is in fluid communication with the eyelet 108 described above. Additionally, the funnel 104 includes a number of ridges 117 integrated into the exterior surface of the funnel 104. The ridges 117 are configured to grip the funnel 104 as a handle during removal of the urinary catheter 100 or 200 from the outer packaging 120 or 220 of the packaged urinary catheter 122 or 222 described below. Additionally or alternatively, the ridges 117 are configured to grip the funnel 104 as a handle during insertion of the urinary catheter 100 or 200 into the urethra.

[0030] As shown in Figure 4 or Figure 5, the urinary catheter 100 or 200 can be disposed within an outer packaging 120 or 220 to form a packaged urinary catheter 122 or 222. In particular, the urinary catheter 100 or 200 disposed within the outer packaging 120 or 220 includes a water-free lubricious coating 106 in addition to a lubricious coating of lubricant 118 described below.

[0031] Lubricious Coating FIG. 3 shows a cross section of a male urinary catheter 100 or a female urinary catheter 200 according to some embodiments.

[0032] The lubricious coating 106 is disposed on the entire catheter tube 102 or 202 from the surface of at least the distal portion of the catheter tube 102 or 202. The lubricious coating 106 includes a hydrophilic coating 116 on the surface of the catheter tube 102 or 202 and a lubricant 118 on the hydrophilic coating 116.

[0033] The hydrophilic coating 116 can be a polyvinylpyrrolidone-based coating, such as a hydrogel, or a hyaluronic acid-based coating. Also, the surface of the catheter tube 102 or 202 can be modified by plasma treatment to increase the surface energy SE of the polymeric material at the surface of the catheter tube 102 or 202, thereby promoting adhesion of the hydrophilic coating 116.

[0034] The lubricant 118 can be a combination of glycerin, water, glyceryl acrylate / acrylic acid copolymer, and propylene glycol. For example, the lubricant 118 can be 59.4-72.6% by weight glycerin, 28.0-34.0% by weight water, 1.58-1.93% by weight glyceryl acrylate / acrylic acid copolymer, and 0.9-1.1% by weight propylene glycol. Such lubricants include Lubrajel® CG by Ashland (Covington, KY).

[0035] Advantageously, the water of the lubricant 118 is at least partially absorbed by the hydrophilic coating 116 upon immersion of the catheter tube 102 or 202 into a reservoir of lubricant 118, as described below, thereby activating the hydrophilic coating 116. The glycerin, glyceryl acrylate / acrylic acid copolymer, and propylene glycol limit evaporation of any water from the lubricant coating 106, such that no water, in addition to the water of the lubricant 118, is required for urethral insertion by the urinary catheter user or their caregiver.

[0036] method The method of the urinary catheter 100 or 200 includes a method of making the urinary catheter 100 or 200. For example, the method of making the urinary catheter 100 or 200 can include one or more steps selected from a surface treatment step, a hydrophilic coating application step, a lubricant immersion step, and a catheter packaging step.

[0037] If performed, the surface treatment step includes plasma treating the surface of at least the distal portion of the catheter tube 102 or 202 up to the entire catheter tube 102 or 202 prior to performing the hydrophilic coating step to modify the surface of the catheter tube 102 or 202. As mentioned above, the catheter tube 102 or 202, including the surface of the catheter tube 102 or 202, is a polymeric material selected from TPU, silicone, polyvinyl chloride, and rubber.

[0038] The hydrophilic coating application step involves applying a hydrophilic coating 116 onto the surface of the catheter tube 102 or 202 of the urinary catheter 100 or 200. The hydrophilic coating application step involves allowing the hydrophilic coating 116 sufficient time to interact with one or more surface elements (e.g., pores, charged surface species from the surface treatment step, etc.) on the surface of the catheter tube 102 or 202 prior to performing the lubricant soaking step.

[0039] The lubricant immersion step includes immersing at least a distal portion of the catheter tube 102 or 202 into a reservoir of the lubricant 118 described above, thereby disposing the lubricant 118 on the hydrophilic coating 116. The lubricant immersion step includes immersing the catheter tube 102 or 202 into the lubricant 118 at an immersion rate of about 0.15 inches / second to about 0.50 inches / second, for example, about 0.33 inches / second. The lubricant immersion step also includes withdrawing the catheter tube 102 or 202 from the lubricant 118 at a withdrawal rate of about 0.05 inches / second to about 0.20 inches / second, for example, about 0.12 inches / second. In particular, the lubricant immersion step includes substantially no residence time in the lubricant 118 between immersing the catheter tube 102 or 202 into the lubricant 118 and withdrawing the catheter tube 102 or 202 from the lubricant 118. Although the lubricant soaking step can be repeated any number of times, a single dip in the lubricant 118 for the lubricant soaking step provides sufficient lubricity for urethral insertion of the catheter tube 102 or 202.

[0040] The catheter packaging process includes packaging the urinary catheter 100 or 200 in an outer wrapper 120 or 220 without air drying the urinary catheter 100 or 200 after the lubricant soaking process.

[0041] The urinary catheter 100 or 200 method includes a method of using the urinary catheter 100 or 200. For example, the method can include one or more steps selected from the steps of obtaining a catheter package, opening the catheter, inserting the catheter, urinating, removing the catheter, repackaging, resealing, and disposing.

[0042] The catheter package obtaining step includes obtaining a packaged urinary catheter 122 or 222 including the urinary catheter 100 or 200 disposed within an outer packaging 120 or 220. As described above, the catheter tube 102 or 202 of the urinary catheter 100 or 200 includes a lubricious coating 106 of a hydrophilic coating 116 on the surface of at least a distal portion of the catheter tube 102 or 202, and a lubricant 118 on the hydrophilic coating 116.

[0043] The opening step involves removing the urinary catheter 100 or 200 from the outer packaging 120 or 220 by the funnel 104 of the urinary catheter 100 or 200 . The catheter insertion step involves inserting the catheter tube 102 or 202 into the urethra. The lubricious coating 106 provides the user or caregiver with sufficient time to successfully insert the catheter tube 102 or 202 into the urethra from the opening step to the catheter insertion step by limiting the evaporation of moisture from the lubricious coating 106, which would otherwise cause stickiness.

[0044] The process of urination involves the expulsion of urine from the bladder. The catheter removal step involves removing the catheter tube 102 or 202 from the urethra after the urination step.

[0045] The repackaging process involves placing the urinary catheter 100 or 200 within the outer packaging 120 or 220. The resealing process involves resealing the urinary catheter 100 or 200 within the outer packaging 120 or 220. The resealing process prevents residual urine from leaking out of the urinary catheter 100 or 200.

[0046] The disposal step involves discarding the urinary 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. Additional adaptations and / or modifications may be understood by those skilled in the art. In the broader aspects, these adaptations and / or modifications are also encompassed. Thus, one may deviate from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. 1. A urinary catheter comprising: a catheter tube made of a polymeric material; a lubricious coating on a surface of at least a distal portion of the catheter tube, the lubricious coating comprising a hydrophilic coating on the surface of the catheter tube and a lubricant on the hydrophilic coating, wherein water of the lubricant is at least partially absorbed by the hydrophilic coating; 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; A urethral catheter comprising:

2. The urinary catheter according to claim 1, A urinary catheter, wherein the hydrophilic coating is a polyvinylpyrrolidone-based coating or a hyaluronic acid-based coating.

3. The urinary catheter according to claim 1 or 2, A urinary catheter, wherein the lubricant is a combination of glycerin, water, glyceryl acrylate / acrylic acid copolymer, and propylene glycol.

4. The urinary catheter according to claim 1 or 2, Glycerin, glyceryl acrylate / acrylic acid copolymer, and propylene glycol limit any evaporation of water from the lubricious coating, urinary catheter.

5. The urinary catheter according to claim 1 or 2, A urinary catheter, wherein the polymeric material is thermoplastic polyurethane ("TPU"), silicone, polyvinyl chloride, or rubber.

6. The urinary catheter according to claim 1 or 2, A urinary catheter, wherein the surface of the catheter tube is a plasma treated surface having a surface energy that promotes adhesion of a hydrophilic coating.

7. 1. A method of making a urinary catheter, comprising: applying a hydrophilic coating onto a surface of a catheter tube of a urinary catheter; immersing at least a distal portion of the catheter tube into a reservoir of lubricant, thereby disposing the lubricant on the hydrophilic coating, such that water in the lubricant is at least partially absorbed by the hydrophilic coating; A method comprising:

8. 8. The method of claim 7, The method, wherein dipping the catheter tube into a reservoir of lubricant includes dipping the catheter tube into the lubricant at a dip rate of about 0.15 inches (0.38 cm) / second to about 0.50 inches (1.27 cm) / second.

9. 8. The method of claim 7, The method, wherein immersing the catheter tube into a reservoir of lubricant includes immersing the catheter tube into the lubricant at a dip rate of about 0.33 inches (0.84 cm) per second.

10. 9. The method according to claim 7 or 8, The method, wherein immersing the catheter tube in a reservoir of lubricant includes withdrawing the catheter tube from the lubricant at a withdrawal rate of about 0.05 inches (0.13 cm) / second to about 0.20 inches (0.51 cm) / second.

11. 9. The method according to claim 7 or 8, The method, wherein immersing the catheter tube in a reservoir of lubricant includes withdrawing the catheter tube from the lubricant at a withdrawal rate of about 0.12 inches (0.30 cm) per second.

12. 9. The method according to claim 7 or 8, The method, wherein immersing the catheter tube in a reservoir of lubricant includes substantially no residence time in the lubricant.

13. 9. The method according to claim 7 or 8, The method, wherein dipping the catheter tube into a reservoir of lubricant comprises a single dipping into the lubricant.

14. 9. The method according to claim 7 or 8, The method wherein the lubricant is a combination of glycerin, water, glyceryl acrylate / acrylic acid copolymer, and propylene glycol.

15. 15. The method of claim 14, The glycerin, glyceryl acrylate / acrylic acid copolymer, and propylene glycol limit the evaporation of any water from the lubricious coating.

16. The method according to claim 7 or 8 further comprises:

1. A method comprising: immersing a urinary catheter in a reservoir of lubricant and then packaging the urinary catheter without allowing the urinary catheter to air dry.

17. The method according to claim 7 or 8 further comprises:

1. The method of claim 1, further comprising plasma treating at least a distal portion of the catheter tube to modify the surface of the catheter tube prior to applying a hydrophilic coating on the surface of the catheter tube.

18. 9. The method according to claim 7 or 8, The method, wherein the catheter tube is a polymeric material selected from thermoplastic polyurethane ("TPU"), silicone, polyvinyl chloride, and rubber.

19. 9. The method according to claim 7 or 8, The method, wherein the hydrophilic coating is a polyvinylpyrrolidone-based coating or a hyaluronic acid-based coating.

20. 1. A method of using a urinary catheter, comprising: obtaining a packaged urinary catheter including a urinary catheter disposed within an outer packaging, the catheter tube of the urinary catheter including a lubricious coating of a hydrophilic coating on a surface of at least a distal portion of the catheter tube and a lubricant on the hydrophilic coating; removing the urinary catheter from the outer packaging by means of a urinary catheter funnel; inserting a catheter tube into the urethra, the lubricious coating limiting the evaporation of moisture from the lubricious coating, which causes stickiness, between the time of removing the urinary catheter from the outer packaging and the time of inserting the catheter tube into the urethra, thereby providing a user or his / her caregiver with sufficient time to successfully insert the catheter tube into the urethra; To expel urine from the bladder A method comprising:

21. The method of claim 20 further comprising: removing the catheter tube from the urethra after draining urine from the bladder.

22. 22. The method according to claim 20 or 21, placing a urinary catheter within an outer packaging; Resealing the urinary catheter within the outer packaging, thereby preventing residual urine from leaking from the urinary catheter. A method comprising:

23. 22. The method according to claim 20 or 21, Discarding the urinary catheter.

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