Urethral catheter with insertion aid

Abstract

Catheter products including urethral catheters with insertion aids. More specifically, urethral catheters having insertion aids and associated antimicrobial agents.

Description

Technical Field

[0006] , , , , ,

[0001] This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 497,926, filed Apr. 24, 2023, which is incorporated herein by reference.

[0002] The present disclosure generally relates to urethral catheter products including an introducer aid. More specifically, the present disclosure relates to intermittent urethral catheter products having an antimicrobial agent associated with the introducer aid.

Background Art

[0003] Intermittent catheterization is a good option for many users with various urinary system abnormalities. With the advent of intermittent urethral catheters, individuals with urinary system-related problems can conveniently insert a catheter themselves to void urine from their bladder. Individuals with urinary incontinence insert a catheter themselves several times a day.

[0004] Catheters are typically prepared in a sterile environment and provided with instructions for safe handling, but catheter users are at risk of developing urinary tract infections due to several different factors. For example, a catheter may be contaminated during use and introduce bacteria into the urethra. A catheter may also carry bacteria along the urinary tract.

Summary of the Invention

Problems to be Solved by the Invention

[0007] In one embodiment, a urethral catheter product is provided. The urethral catheter product includes an intermittent urethral catheter. The intermittent urethral catheter includes a catheter tube having a proximal insertion end and a distal discharge end, as well as an outer surface and an inner surface. The inner surface defines a discharge lumen. The intermittent urethral catheter also includes a hydrophilic coating on the outer surface of the catheter tube. The intermittent urethral catheter also includes an insertion aid. The insertion aid assists in introducing the catheter tube into the urethra. The insertion aid includes an insertion aid lumen, which includes an inner surface defining an insertion aid lumen configured to receive the catheter tube through it. In addition, the intermittent urethral catheter includes a layer of antimicrobial agent located on the inner surface of the insertion aid. The antimicrobial agent is deposited on the hydrophilic coating as the catheter tube moves through the insertion aid lumen.

[0008] In another embodiment, a method for producing an antimicrobial catheter is provided. The method includes dissolving a polysaccharide in an aqueous solution, adding an antimicrobial agent to the aqueous solution, drying the aqueous solution to obtain an antimicrobial gel, coating a layer of the antimicrobial gel on the inner surface of a catheter and associated introduction aid, and releasing the antimicrobial agent from the antimicrobial gel. [Brief explanation of the drawing]

[0009] [Figure 1] This is a perspective view of an embodiment of a catheter product. [Figure 2] This is a perspective view of an embodiment of the introduction support device. [Figure 3]Figure 3 is a cross-sectional view of a part of the insertion aid device, showing that the catheter tube is located inside the insertion aid device. [Figure 4] This is a perspective view of another embodiment of the catheter product. [Figure 5] This is a cross-sectional view of a gripping portion having a catheter tube. [Modes for carrying out the invention]

[0010] A more detailed description of the devices provided in this disclosure is given below. The descriptions of the specific devices below are intended to be illustrative and should not be understood as encompassing all possible modifications or uses. Therefore, the scope of this disclosure should be understood as not intended to be limiting, but to include modifications or embodiments that a person skilled in the art could conceive of.

[0011] Figure 1 shows an embodiment of the urethral catheter product 10. Optionally, the urethral catheter product 10 may be an intermittent urethral catheter product with a sleeve. The urethral catheter product 10 includes a catheter tube 12 having a proximal insertion end 14 and a distal discharge end 16. The catheter tube 12 also includes an outer surface 18 and an inner surface. The inner surface defines a lumen extending from the proximal insertion end 14a to the distal discharge end 16a.

[0012] The urethral catheter tube 12 may include a hydrophilic polymer coating on the outer surface 18 of the tube. The hydrophilic polymer coating may be configured to absorb a hydrating medium in order to make the catheter slippery in order to facilitate insertion into the urethra.

[0013] In addition, the proximal insertion end 14a of the catheter tube includes one or more openings 20 for receiving urine in communication with the lumen. In one embodiment, the one or more openings 20 for receiving urine may be small holes. In another embodiment, the one or more openings 20 for receiving urine may be multiple small holes. The one or more openings 20 for receiving urine may vary in shape, size and position without departing from the scope of the present disclosure.

[0014] Furthermore, the distal discharge end 16a of the catheter tube includes a discharge opening for draining urine from the lumen. In one embodiment, the distal discharge end 16 of the catheter includes a discharge member 22. The discharge member 22 may be attached to the distal discharge end 16a of the catheter tube and may be in fluid communication with the discharge opening. The discharge member 22 may be, for example, a funnel or connector for connecting to a discharge bag (not shown), but is not limited. Other discharge members known in the art may be used without departing from the scope of this disclosure.

[0015] The urethral catheter product 10 may optionally include a sleeve 24. The sleeve 24 may be a protective or shielding sleeve. The sleeve 24 has a proximal end 26 and a distal end 28. The sleeve 24 may define an internal cavity in which the catheter tube 12 may be located. In one embodiment, the sleeve 24 surrounds at least a portion of the catheter tube 12. In another embodiment, the sleeve 24 extends over the length of the catheter tube 12 and surrounds it.

[0016] In this embodiment, the introduction aid 30 may be located at the proximal end 26 of the sleeve. If the introduction aid 30 is present, the proximal end 26 of the sleeve may be attached to the barrel portion 32 of the introduction aid 30 by, for example, welding or adhesive. The distal end 28 of the sleeve may be attached to the discharge member 22 or the catheter tube 12. The distal end 28 of the sleeve may be attached to the discharge member 22 or the catheter tube 12 by, for example, welding or adhesive.

[0017] The sleeve 24 may be made of a flexible material that is vapor-permeable or vapor-impermeable, depending on the desired use and packaging. The material of the sleeve 24 may also be liquid-impermeable or liquid-permeable. The sleeve 24 may be formed of any of various thin flexible polymer film materials, such as polyethylene, plasticized PVC, or polypropylene, but elastomer film materials, such as polyurethane and especially elastomer hydrogel materials, may be preferred. In some embodiments, the sleeve 24 may contain a hydration medium.

[0018] Referring to Figure 2, an embodiment of the guide assist device 30 is shown. The guide assist device 30 includes a main body 31 having a proximal end 34 and a distal end 36. The inner surface 48 of the guide assist device (shown in Figure 3) defines the lumen extending from the proximal end 34 to the distal end 36. The proximal end 34 includes the guide tip 38. The proximal end 34 also includes a portion 40 extending distally from the guide tip 38.

[0019] The inlet tip 38 has a proximal end configured to be openable. For example, the inlet tip 38 can be opened by advancing the catheter tube 12 through it. In an embodiment, the proximal end of the inlet tip 38 is defined by one or more slits between one or more flexible petals 42. The petals 42 can move from a substantially closed configuration to an open configuration as shown in Figure 2, bend and / or elastically deform as the catheter tube is advanced through it. In another embodiment, the inlet tip 38 may include a ruptureable proximal end.

[0020] In addition, the distal end 36 of the introduction aid includes a barrel portion 32 having an opening for receiving the catheter tube 12. The barrel portion 32 of the introduction aid 30 may include a textured outer surface to assist the user in grasping the introduction aid 30.

[0021] In some embodiments, the introducer aid 30 may include an intermediate flange 44. The flange 44 may function as a retainer that contacts the user around the urethral opening and restricts insertion of the distal tip 38 of the introducer portion into the urethra. The flange 44 may also assist in positioning the user's finger on the barrel portion 32.

[0022] In some embodiments, the catheter product 10 may include a cap 46 (shown in FIG. 1). The cap 46 includes a cavity configured to receive at least the distal tip 38 of the introducer aid 30. The cap 46 may be attached to the introducer aid 30, for example, but not limited to, via frictional engagement. For example, the cap 46 may be attached to the intermediate flange 44.

[0023] Further, the urethral catheter product 10 may include an antibacterial agent associated with the introducer aid 30. As shown in FIG. 3, the antibacterial agent layer 50 may be located on the inner surface of the introducer aid 30. In an embodiment, the antibacterial agent layer 50 may be located on the inner surface of the distal tip 38 of the introducer portion. For example, the antibacterial agent layer 50 may be located on the inner surface of the petals 42. Optionally or in addition to the antibacterial agent on the petals 42, the antibacterial agent layer 50 may be located on the inner surface of the portion 40 extending distally from the distal tip 38 of the introducer portion. For example, in some alternative forms, the antibacterial agent layer 50 may be located over the entire inner surface of the proximal end of the introducer aid 30, including the inner surface of the distal tip 38 and the portion 40 extending distally therefrom, or the layer 50 may be located on its selected portion. In other alternative forms, the antibacterial agent layer 50 may be located over the entire inner surface 48 of the introducer aid 30, including the barrel portion 32, the distal tip 38 of the introducer portion, and the portion 40 extending distally therefrom. In some alternative forms, the antibacterial agent layer 50 may be continuous. In other alternative forms, the layer 50 may include a plurality of discrete segments along the inner surface 48 having interruptions therebetween.

[0024] The antibacterial agent layer 50 may be applied to the introducer aid 30 prior to assembly of the catheter product 10. For example, the antibacterial agent layer 50 may be applied to the inner surface 48 of the introducer aid 30 by spray coating, painting, or other methods known in the art.

[0025] An antibacterial agent can be a compound that at least reduces the risk of urinary tract infections. This can be a biocide, an agent that reduces or prevents adhesion to a surface, an agent that reduces or prevents the growth of microorganisms, etc. In one embodiment, the antibacterial agent is a biocide. Suitable biocides include silver, antibiotics with biocidal properties such as vancomycin, sparfloxacin, minocycline, and rifampin, and poly(catechin)-antibiotic complexes, such as polycatechin combined with trimethoprim (TMP) and / or polycatechin combined with TMP and sulfamethoxazole (SMZ). In another embodiment, the antibacterial agent can have steric repulsion force, electrostatic repulsion force, and / or low surface energy properties. In yet another embodiment, the antibacterial agent can be an antifouling material. Suitable antifouling materials include, but are not limited to, hydrophilic materials such as SAM-OEG, PEG, and POEGMA, polyzwitterions such as polyMPC, polyCBMA, and polySBMA, phosphorylcholine, sulfobetaine, and carboxybetaine. In yet another embodiment, the antibacterial agent can be any other suitable antibacterial agent, such as chlorhexidine, amphotericin, bacteriophage, nitrofurazone, triclosan, antibacterial peptides, and / or allantoin. In another embodiment, the antibacterial agent can be an enzyme. Suitable enzymes include hydrolases such as proteases (e.g., subtilisin and lysostaphin), polysaccharide hydrolases (e.g., alpha-amylase, dispersin B, chitinase, beta-glucanase, lysozyme, and alginate lyase), deoxyribonuclease, and bacteriophage lysin. In yet another embodiment, the antibacterial agent can be nitric oxide. In yet another embodiment, the antibacterial agent can be a liposome, such as a spherical lipid vesicle composed of one or more lipid bilayers. Without departing from the scope of the present disclosure, other antibacterial agents known in the art can be used. In another embodiment, the antibacterial agent can be, among other things, any combination of the agents described herein.

[0026] In the embodiment, the antimicrobial agent layer 50 may be applied to the introduction aid device 30 as a coating, lubricant, grease, capsule and / or pouch. For example, the antimicrobial agent may be incorporated into a polyol (e.g., glycerol, PEG, etc.), mineral oil, silicone oil, vegetable oil, paste, viscous liquid or semi-solid, jelly, gel and / or hydrogel.

[0027] In another embodiment, the antimicrobial agent layer 50 may be an antimicrobial agent incorporated into a gel that may be a plurality of capsules (e.g., microcapsules) or a hard or soft gel. The gel or capsules may be applied to the insertion aid 30 before the assembly of the catheter product 10. The gel or capsules may break down and become liquid when exposed to radiation during sterilization of the catheter product, thus releasing the antimicrobial agent to provide a liquid film on the inner surface of the insertion aid 30. For example, the gel or capsules may break down when exposed to an electron beam or gamma radiation used for sterilization. By liquefying the gel or capsules, the antimicrobial agent may be released and can be rubbed against the hydrated hydrophilic coating of the catheter tube 12 as the catheter tube 12 is pushed through the insertion aid 30. Thus, the antimicrobial agent may be applied directly to the urethral surface when the catheter tube 12 is inserted through the insertion tip 38. In another alternative embodiment, the gel or capsules may break down and release the antimicrobial agent due to exposure to temperature, pH, biodegradation over time and / or heat.

[0028] In the embodiment, when the antimicrobial agent layer 50 includes a gel coating, the gel coating may include gellan gum and citric acid.

[0029] In embodiments, when the antimicrobial agent layer 50 includes microcapsules, the microcapsules may include encapsulated materials that contain the antimicrobial agent. The encapsulated materials may be made from a variety of materials, such as starch, starch derivatives, proteins, gelatin, rubber, lipids, natural and synthetic polymers, or any combination of such encapsulated materials. Examples of natural polymers include, but are not limited to, protein-based polymers and polysaccharide-based polymers. Natural polymers may be highly biodegradable. Suitable protein-based polymers include, but are not limited to, albumin and gelatin. Suitable polysaccharide-based polymers include, but are not limited to, agarose, alginate, hyaluronic acid, dextran, chitosan, and gellan gum. Examples of synthetic polymers include, but are not limited to, poly(ε-caprolactone), poly(lactic acid-glycolic acid copolymer), and polyethylene glycol. Other encapsulated materials known in the art may be used without departing from the scope of this disclosure.

[0030] Microcapsules can be produced by dissolving a polysaccharide in a solute to form a homogeneous solution. In one alternative configuration, gellan gum at a concentration of 1.0% w / w is dissolved in deionized water at a temperature above 75°C. Once dissolved, a selected amount / concentration of antimicrobial agent can be added to the polysaccharide aqueous solution. After the antimicrobial agent is added, the solution is dried to encapsulate the antimicrobial agent within the polysaccharide. For example, the solution may be cooled to a selected temperature to solidify the polysaccharide and form microcapsules containing the antimicrobial agent. When gellan gum is a polysaccharide, the solution may be cooled to below 37°C, thereby initiating the solidification of the gellan gum. In alternative configurations, spray drying and dehydration methods may be used to assist in drying the polysaccharide encapsulated material at temperatures above 37°C. Other methods of encapsulation, such as freeze-drying, vacuum drying, extrusion, spray cooling, fluidized bed coating, centrifugal extrusion, cocrystallization, molecular inclusion, pan coating, air suspension coating, droplet formation, solvent evaporation, and polymerization, are also used. Furthermore, in some embodiments, about 0.05% w / w to 0.25% w / w of citric acid may be added to help harden the gel or capsule into a solid.

[0031] In another embodiment, the microcapsules may be those described in U.S. Provisional Patent Application No. 63 / 339172, filed on May 6, 2022, and International Application PCT / US2023 / 066163, filed on April 25, 2023, which are incorporated in their entirety herein.

[0032] To use the catheter product 10, the user can grasp the barrel portion 32 of the introduction aid 30 and insert the introduction tip 38 into the urethra. The user then grasps the catheter tube 12 through the sleeve 24 and advances the catheter tube 12 through the introduction aid 30 and into and through the urethra until one or more openings 20 enter the bladder. As the catheter tube 12 advances through the introduction aid 30, the antimicrobial layer 50 on the inner surface 48 of the introduction aid 30 may be deposited on the hydrophilic coating of the catheter tube 12.

[0033] Referring to Figure 4, another embodiment of the urethral catheter product 110 is shown. The catheter product 110 may have similar features to the urethral catheter product 10 described herein. The urethral catheter product 110 may include a catheter tube 112 having a proximal insertion end 114a and a distal discharge end 116a. The catheter tube 112 may include an outer surface 118 and an inner surface. The inner surface defines a lumen extending from the proximal insertion end 114a to the distal discharge end 116a. The proximal insertion end 114a includes one or more openings 120 for receiving urine in communication with the lumen. In one embodiment, the one or more openings 120 for receiving urine may be small holes. In another embodiment, the one or more openings 120 for receiving urine may be multiple small holes. The one or more openings 120 for receiving urine may vary in shape, size and position without departing from the scope of the present disclosure.

[0034] Furthermore, the distal discharge end 116a of the catheter tube includes a discharge opening for draining urine from the lumen. In one embodiment, the distal discharge end 116 of the catheter product 110 includes a discharge member 122. The discharge member 122 may be attached to the distal discharge end 116a of the catheter tube and may be in fluid communication with the discharge opening. The discharge member 122 may be, for example, a funnel or connector for connecting to a discharge bag (not shown), but is not limited. Other discharge members known in the art may be used without departing from the scope of this disclosure.

[0035] The urethral catheter product 110 may include a gripping portion 130. The gripping portion 130 may be provided to assist the user in manipulating the catheter product 110. For example, the user can grasp and manipulate the gripping portion 130 to assist in oriented the insertion of the catheter tube 112 into the urethra.

[0036] The gripping portion 130 includes a proximal end 132 and a distal end 134. The gripping portion 130 also includes an outer surface 136 and an inner surface 138 (shown in Figure 5). The inner surface 138 defines a lumen extending from the proximal end 132 to the distal end 134. The catheter tube 112 can be positioned within the lumen of the gripping portion 130. The outer surface 136 of the gripping portion may be textured to assist the user in gripping or to indicate the gripping position. The gripping portion 130 may be movable along the length of the catheter tube 112. Furthermore, the gripping portion 130 may be flexible or elastic so that the user can compress the gripping portion 130 to grip the catheter tube 112. When the user releases the gripping portion 130, the gripping portion 130 substantially returns to its original shape, allowing the gripping portion 130 to move or slide along the catheter tube 112. Optionally, the gripping portion may include a flap or petal 131 that contacts the catheter tube 112 to help maintain the gripping portion 130 in place along the catheter tube 112.

[0037] In embodiments, the gripping portion 130 may contain an antimicrobial agent. The antimicrobial agent may be a layer 150 of the antimicrobial agent located at any location along the inner surface 138 of the gripping portion. The antimicrobial agent layer 150 may cover the entire inner surface 138 or a selected portion thereof. The antimicrobial agent layer 150 may consist of a plurality of spaced segments that are continuous or have interruptions in between. The antimicrobial agent may be any of the antimicrobial agents described herein. For example, the antimicrobial agent layer 150 may be an antimicrobial agent incorporated into a plurality of capsules (e.g., microcapsules) or a gel that may be hard or soft gel. When exposed to irradiation such as an electron beam or gamma radiation used to sterilize the catheter product 110, the gel or capsules may break and release the antimicrobial agent.

[0038] The antimicrobial agent layer 150 may be applied to the gripping portion 130 before assembly of the catheter product 110. For example, the antimicrobial agent layer 150 may be applied to the inner surface 138 of the gripping portion by spray coating, painting, or other methods known in the art.

[0039] To use the catheter product 110, the user can move the gripping portion 130 toward the proximal end 114 of the catheter tube and compress the gripping portion 130 to grasp the catheter tube 112. While grasping the catheter tube 112, the user can insert the catheter tube 112 into the urethra. After insertion, the user can move the gripping portion 130 distally and compress the gripping portion 130 to advance the catheter tube 112 further into the urethra. This can be repeated until the catheter tube 112 enters the bladder. As the gripping portion 130 moves along the length of the catheter tube 112, the antimicrobial agent on the inner surface 138 of the gripping portion may accumulate on the hydrophilic coating of the catheter tube 112.

[0040] It is understood that the embodiments and examples described above are intended to illustrate some of the applications of the principles of the subject matter of the present invention. Many modifications, including combinations of features individually disclosed or claimed herein, can be made by those skilled in the art without departing from the spirit and scope of the claimed subject matter. For these reasons, it is understood that the scope of this specification is not limited to the foregoing, but is shown in the following claims, which may cover features including combinations of features individually disclosed or claimed herein.

Claims

1. Urethral catheter products, It is an intermittent urethral catheter, A catheter tube having a proximal insertion end and a distal discharge end, and an outer surface and an inner surface of the catheter tube, wherein the inner surface of the catheter tube defines a discharge lumen, Hydrophilic coating on the outer surface of the catheter tube An intermittent urethral catheter including, An introduction aid device for assisting the introduction of the catheter tube into the urethra, comprising an introduction aid device lumen, the introduction aid device including an inner surface defining the introduction aid device lumen configured to receive the catheter tube through it, A layer of antimicrobial agent located on the inner surface of the introduction aid device, wherein the antimicrobial agent is deposited on the hydrophilic coating as the catheter tube moves through the lumen of the introduction aid device. Urethral catheter products including...

2. The urethral catheter product according to claim 1, wherein the layer includes a coating, and the antimicrobial agent is incorporated into the coating.

3. The urethral catheter product according to claim 1, wherein the layer comprises microcapsules, and the antimicrobial agent is incorporated into the microcapsules.

4. The urethral catheter product according to any one of claims 1 to 3, wherein the layer contains a polysaccharide.

5. The urethral catheter product according to claim 4, wherein the polysaccharide is gellan gum.

6. The urethral catheter product according to any one of claims 1 to 5, wherein the layer further comprises citric acid.

7. The urethral catheter product according to claim 6, wherein the citric acid is concentrated in the range of 0.05% w / w to 0.25% w / w.

8. The urethral catheter product according to any one of claims 1 to 7, wherein the antimicrobial agent comprises a biocide, an antifouling material, an antimicrobial agent, an enzyme, a nitric oxide agent, a liposome, or any combination thereof.

9. The urethral catheter product according to any one of claims 3 to 8, wherein the microcapsule comprises an encapsulated substance, the encapsulated substance comprises starch, starch derivatives, proteins, gelatin, rubber, lipids, natural polymers, synthetic polymers, or any combination thereof.

10. The urethral catheter product according to any one of claims 1 to 9, wherein the antibacterial agent is released when the layer is exposed to electron beam irradiation.

11. The urethral catheter product according to any one of claims 1 to 10, wherein the main body of the introduction aid device includes a proximal introduction tip configured to be inserted into the urethral opening.

12. The urethral catheter product according to claim 11, wherein the antibacterial agent layer is located on the inner surface of the tip of the proximal introduction portion.

13. The urethral catheter product according to claim 11 or 12, wherein the main body includes a portion extending distally from the tip of the proximal introduction portion, and the antibacterial agent layer is located on the inner surface of the portion.

14. The urethral catheter product according to any one of claims 1 to 10, wherein the introduction assist device is a gripping portion that is movable along the outer surface of the catheter tube.

15. A method for creating an antibacterial catheter, Dissolving polysaccharides in an aqueous solution, Adding an antibacterial agent to the aqueous solution, The aforementioned aqueous solution is dried to yield an antibacterial gel, The antibacterial gel layer is applied to the inner surface of the catheter and the associated introduction aid device. The antibacterial agent is released from the antibacterial gel. A method that includes this.

16. The aforementioned catheter is A catheter tube having a proximal insertion end and a distal discharge end, an outer surface of the catheter tube and an inner surface of the catheter tube, The hydrophilic coating on the outer surface of the catheter tube, An introduction aid lumen, the introduction aid including an inner surface of the introduction aid defining the introduction aid lumen, which is configured to receive the catheter tube through it; The method according to claim 15, including the method described in claim 15.

17. The method according to claim 16, further comprising depositing the antimicrobial agent onto the hydrophilic coating as the catheter tube moves through the lumen of the introduction aid device.

18. The method according to any one of claims 15 to 17, wherein the layer includes a coating.

19. The method according to any one of claims 15 to 17, wherein the layer comprises microcapsules.

20. The method according to any one of claims 15 to 19, wherein the polysaccharide is gellan gum.

21. The method according to any one of claims 15 to 20, wherein the gel further comprises citric acid.

22. The method according to any one of claims 21, wherein the citric acid is concentrated in the range of 0.05% w / w to 0.25% w / w.

23. The method according to any one of claims 15 to 22, wherein the antimicrobial agent comprises a biocide, an antifouling material, an antimicrobial agent, an enzyme, a nitric oxide agent, a liposome, or any combination thereof.

24. The method according to any one of claims 15 to 23, wherein the antimicrobial agent is released when the gel is exposed to electron beam irradiation.

25. The method according to any one of claims 15 to 24, wherein the main body of the introduction aid device includes a proximal introduction tip configured to be inserted into the urethral opening.

26. The method according to claim 25, wherein the antibacterial gel layer is located on the inner surface of the tip of the proximal introduction portion.

27. The method according to claim 25 or 26, wherein the main body includes a portion extending distally from the tip of the proximal introduction portion, and the antibacterial agent is located on the inner surface of the portion.

28. The method according to any one of claims 15 to 24, wherein the introduction assist device is a gripping portion that is movable along the outer surface of the catheter tube.

Images