Compressible urinary catheter tip

Abstract

A compressible catheter tip (34) for a urinary catheter assembly includes a rounded tip section (40) and a neck section (42) arranged distally of the rounded tip section. The rounded tip section has a tip width (44) greater than a neck width (46) of the neck section. A catheter tube (20) includes the compressible catheter tip, a proximal end (24) and a tube section (32) extending distally from the compressible catheter tip. The tube section includes a tube drainage passage and the compressible catheter tip extends from the tube section to the proximal end. The catheter tube having the compressible catheter tip may be formed using a tipping die having a contact surface with one or more shaped sections, and a core pin.

Description

COMPRESSIBLE URINARY CATHETER TIPThe present application claims the benefit of and priority to U.S.Provisional Patent Application No. 63 / 601 ,078, filed November 20, 2023, which is hereby incorporated herein by reference.DESCRIPTIONTECHNICAL FIELD

[0001] The present disclosure generally relates to a urinary catheter assembly, and more particularly, to a urinary catheter assembly having a compressible catheter tip extending from a proximal end of a catheter member.BACKGROUND

[0002] Intermittent catheterization is a suitable intervention for some users experiencing incomplete bladder emptying. A urinary catheter used for intermittent catheterization is typically provided as a single use, individually packaged item and may include a gel lubricant or hydrophilic coating to reduce friction during insertion into the urethra. With the advent of intermittent urinary catheters, users experiencing urinary system disfunction can conveniently self- catheterize to drain the bladder. Users experiencing urinary incontinence may self-catheterize several times per day.

[0003] Self-catheterization involves removing the catheter assembly from its package and inserting and advancing the catheter tube through the urethra.Some catheter assemblies include an introducer tip in which a leading (insertion) end of the catheter tube is initially housed to aid insertion of the catheter tube into the urethra. The leading end of the catheter tube is fed through the introducer tip and advanced through the urethra until insertion into the bladder.

[0004] The catheter tube is sufficiently rigid or stiff to avoid undesirable deformations when advancing the catheter tube in the urethra. Such deformations may cause discomfort to the user and / or may impede further advancement of the catheter tube in the urethra. In addition, the catheter tube may not be able to deflect or flex when encountering a restriction in the urethra. Thus, further advancement of the catheter tube may be impeded, and / or the user mayexperience discomfort during attempts to overcome the restriction.

[0005] Thus, it would be desirable to provide a urinary catheter assembly for intermittent catheterization having a relatively soft, compressible catheter tip for improved comfort when advancing the catheter tube in the urethra during selfcatheterization.SUMMARY

[0006] There are several aspects of the present subject matter. In one aspect, a compressible catheter tip for a urinary catheter assembly includes a rounded tip section and a neck section arranged distally of the rounded tip section. The rounded tip section has a tip width greater than a neck width of the neck section.

[0007] In another aspect, a catheter tube of a urinary catheter assembly includes a compressible catheter tip having a rounded tip section and a neck section arranged distally of the rounded tip section, the rounded tip section has a tip width greater than a neck width of the neck section. The catheter tube also includes a tube section having a tube drainage passage, and a proximal end. The compressible catheter tip extends from the tube section to the proximal end.

[0008] In another aspect, a method of manufacturing a compressible catheter tip of a urinary catheter tube includes inserting a portion of the catheter tube into a tipping die, the tipping die having a contact surface with one or more shaped sections forming a catheter tip profile, receiving at least a portion of a core pin in an inner passage of the catheter tube, and heating the catheter tube in the tipping die to form the compressible catheter tip section on the catheter tube.Brief Description of Drawings

[0009] FIG. 1 is a perspective view showing an example of a urinary catheter assembly having a compressible catheter tip;

[0010] FIG 2. is a diagram schematically representing a profile of the compressible catheter tip of FIG. 1 ;

[0011] FIG. 3 is a perspective view showing another example of a urinary catheter assembly having a compressible catheter tip with an overmold;

[0012] FIG. 4 is a perspective view showing the urinary catheter assembly of FIG. 3 with the overmold in a compressed condition;

[0013] FIG. 5 is a perspective view showing another example of a urinary catheter assembly having a compressible catheter tip;

[0014] FIG. 6 is a diagram showing a urinary catheter assembly having a compressible catheter tip being advanced past a stricture in a urethra, according to a present example;

[0015] FIG. 7 is a diagram showing insertion of a catheter tube into a tipping die according to an example method for manufacturing a compressible catheter tip;

[0016] FIG. 8 is a diagram showing the catheter tube of FIG. 7 having a compressible catheter tip being formed in the tipping die;

[0017] FIG. 9 is a diagram showing removal of the catheter tube having a compressible catheter tip of FIG. 8 from the tipping die;

[0018] FIG. 10 is a diagram showing an enlarged view of the removal of the catheter tube of FIG. 9;

[0019] FIG. 11 is a diagram showing insertion of a catheter tube into a tipping die according to another example method for manufacturing a compressible catheter tip;

[0020] FIG. 12 is a diagram showing the catheter tube of FIG. 11 having a compressible catheter tip being formed in the tipping die; and

[0021] FIG. 13 is a diagram showing removal of the catheter tube having a compressible catheter tip of FIG. 12 from the tipping die.DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

[0022] The embodiments disclosed herein are for the purpose of providing a description of the present subject matter, and it is understood that the subject matter may be embodied in various other forms and combinations not shown in detail. Therefore, specific embodiments and features disclosed herein are not to be interpreted as limiting the subject matter as defined in the accompanying claims.

[0023] With reference to FIG. 1 , a urinary catheter assembly 10 according topresent embodiments generally includes a catheter tube 20 and a grip 22. The catheter tube 20 includes a catheter proximal end 24 and a catheter distal end (not shown) opposite to the catheter proximal end 24. The catheter proximal end 24 is the leading or insertion end of the catheter tube 20 and is configured to be inserted into and advanced within the urethra and into the bladder.

[0024] The grip 22 is generally formed as a grip body 28 having a longitudinal internal passage configured to receive at least a portion of the catheter tube 20. The catheter tube 20 is configured for movement in the longitudinal internal passage relative to the grip body 28 in an insertion direction D1 along which the catheter tube 20 is advanced within the urethra toward the bladder and a removal direction D2 along which the catheter tube 20 is removed from the urethra. Insertion and removal directions D1 , D2 extend along longitudinal axis L in opposite directions.

[0025] The grip 22 also includes an insertion tip 30 configured for initial advancement into the urethra. In the catheterization process, the catheter proximal end 24 may be positioned distally of the insertion tip 30, for example, within the internal passage of the grip 22. The catheter tube 20 may be advanced in the insertion direction D1 such that the catheter proximal end 24 is advanced through, then extends from, the insertion tip 30 for advancement within the urethra toward the bladder.

[0026] With further reference to FIG. 1 , according to the present examples, the catheter tube 20 generally includes a tube section 32 and a compressible catheter tip 34 extending proximally from the tube section 32. The tube section 32 may be formed as an elongated hollow member having a tubular wall portion surrounding a hollow interior forming a tube drainage passage to accommodate drainage of bodily fluid from the bladder. As described further below, in some examples, the tube section 32 and the compressible catheter tip 34 may be integrally formed as a one-part construction. In other examples, the tube section 32 and the compressible catheter tip 34 may be formed as a two-part construction.

[0027] As shown in FIGS. 1 and 2, according to the present examples, the compressible catheter tip 34 includes a rounded tip section 40 and a neck section42 arranged distally relative to the rounded tip section 40. The rounded tip section 40 is the proximal-most section of the compressible catheter tip 34. Accordingly, the catheter proximal end 24 coincides with proximal ends of the compressible catheter tip 34 and the rounded tip section 40. Thus, in the present examples, the catheter proximal end 24 and proximal ends of the compressible catheter tip 34 and the rounded tip section 40 may be referenced interchangeably.

[0028] The rounded tip section 40 has a tip width 44 which is greater than a neck width 46 of the neck section 42. The width of the rounded tip section 40, and in some examples, the neck section 42, may vary along the length of the compressible catheter tip 34. Accordingly, in the present examples, unless described otherwise, the tip width 44 refers to a maximum width of the rounded tip section 40 and the neck width 46 may refer to a minimum width of the neck section 42. Still referring to FIGS. 1 and 2, the rounded tip section 40 may include a first rounded section 48 having an increasing width and a second rounded section 50 having a decreasing width in an axial direction of the compressible catheter tip 34. In non-limiting examples, the rounded tip section 40 is formed having a bulbous, teardrop or substantially spherical shape.

[0029] The rounded tip section 40, and optionally, the neck section 42, may be hollow. In this manner, the rounded tip section 40 may be compressible (including elastically deformable or deflectable) in response to application of a sufficient external force. For example, in a catheterization procedure, the rounded tip section 40 may compress, deflect and / or elastically deform in response to encountering a stricture in the urethra during movement in the insertion D1 and / or removal directions D2. In this manner, the compressible catheter tip 34, may be compressed (including elastically deformed or deflected) to advance past a stricture in the urethra. Accordingly, user comfort may be improved compared to conventional catheter tips, which instead of compressing, may push against and through resistance from a stricture in the urethra.

[0030] With further reference to FIGS. 1 and 2, according to an example of the present disclosure, the compressible catheter tip 34 may also include a proximal end opening 52 arranged at the catheter proximal end 24, which coincides with the proximal end of the rounded tip section 40, and a tip drainage passage 54arranged in fluid communication with proximal end opening 52. The tip drainage passage 54 extends generally in a longitudinal direction (i.e. along longitudinal axis L) through the rounded tip section 40 and neck section 42, and is configured to receive a bodily fluid through the proximal end opening 52. With such a configuration, the insertion distance of the compressible catheter tip 34 into the bladder may be reduced or minimized. More complete drainage of the bladder may be realized with such a configuration as well.

[0031] In some examples, the rounded tip section 40, and optionally the neck section 42, may be hollow between an inner wall section surrounding the catheter tip drainage passage 54 and an outer wall section forming an outer surface of the compressible catheter tip 34. In other examples, instead of being hollow, the compressible catheter tip 34 may be formed from an easily compressed material. Such a material may be elastically deformed when encountering forces typically associated with advancing a catheter tube past a stricture in the urethra.

[0032] The tip drainage passage 54 may also be arranged in fluid communication with the tube drainage passage, for example, via a distal end opening of the compressible catheter tip 34. Accordingly, the tube drainage passage may receive a fluid (e.g., a bodily fluid from the bladder), through the compressible catheter tip 34.

[0033] The tube section 32 and the compressible catheter tip 34 may be formed as a two-part construction in which the compressible catheter tip 34 is secured to the tube section 32. In such an example, the tube section 32 and the compressible catheter tip may be formed from different materials. In addition, the compressible catheter tip 34 may have a first Shore hardness and the tube section 32 may have a second Shore hardness greater than the first Shore hardness. In this manner, the compressible catheter tip 34 may be perceived as relatively soft compared to the tube section 32.

[0034] The compressible catheter tip 34 may be secured to the tube section 32 by securing techniques suitable for use with catheter tubes, including, for example, heat sealing, chemical bonding, 2-part extrusion, laser welding and adhesives. In some examples, the compressible catheter tip 34 and the tube section 32 may be separately formed and then secured to one another.

[0035] The compressible catheter tip 34 may be secured to the tube section 32 generally at a distal end 62 of the compressible catheter tip 34 (also referred to as a “tip distal end”). In some examples, the tip distal end 34 includes an end surface (also referred to as an “axial end surface”) facing substantially in an axial direction which is configured to be secured to a corresponding portion of the tube section using suitable securing techniques. In other examples, the compressible catheter tip 34 may include a plug section 66 configured for insertion into the tube section 32. The plug section 66 may be secured to the tube section 32 by the securing techniques described above, and / or by interference or friction fit with the tube section 32. It will be appreciated that the configuration of the compressible catheter tip 34 at the tip distal end 62) and the manner in which the compressible catheter tip 34 is secured to the tube section 32 may affect the stiffness or flexibility of compressible catheter tip 34, and in turn, the catheter tube 20. Thus, in some examples, the compressible catheter tip 34 configuration and manner of securing may be selected to provide a desired stiffness or flexibility.

[0036] FIGS. 3-6 show another example of the urinary catheter assembly 1 10 including the catheter tube 120 and grip 122. It will be appreciated that like parts of the urinary catheter assembly 10 above may be referenced using the same terminology below, and that description of like parts previously detailed may be omitted below, except where differences are noted. In the illustrated example, the catheter tube 120 includes the tube section 132 and the compressible catheter tip 134. The tube section 132 may be provided with one or more lateral drainage openings 156 arranged in fluid communication with the tube drainage passage 158. In this manner, fluid may be drained from the bladder through the one or more lateral drainage openings 156 and the tube drainage passage 158. In such an example, the proximal end opening 52 described above with respect to FIG. 1 , may optionally be omitted.

[0037] The compressible catheter tip 134 may further include a compressible overmold 160, which may be an overmold layer, disposed over the rounded tip section 140 and the neck section 142 of the compressible catheter tip 134. The overmold 160 may be made from an elastic material such that the overmold may deflect from an uncompressed condition to a compressed condition uponapplication of a sufficient external force on the overmold 160, and return to the uncompressed condition when the force is removed. The overmold 160 may be made from a hydrophilic material having suitable elastic characteristics.

[0038] In the example shown in FIGS. 3-6, in the uncompressed condition (FIG. 3), the overmold 160 has a first inner width W1 and is spaced from the neck section 142 in a radial direction. In the compressed condition (FIG. 4), the overmold 160 is compressed radially inward toward the neck section 142 and has a second inner width W2 less than the first inner width W1 .

[0039] With reference to FIG. 6, in use, the overmold 160 may be compressed (i.e., moved to compressed condition) in response to interaction with a stricture S in the urethra U while advancing or removing the catheter tube 120. In the compressed condition, the compressible catheter tip 134 may have increased flexibility and maneuverability to navigate around or past strictures, at least in part, due to the reduced width of the overmold 160 and the neck section 142.

[0040] Referring now to FIGS. 7-10, a method of manufacturing a catheter tube 220 having a compressible catheter tip 234 includes inserting a portion of a catheter tube 220 into a tipping die 270 and receiving at least a portion of a core pin 272 in the inner passage 254 of the catheter tube 220. The tipping die 270 includes at least one contact surface 274 configured to come into contact with the portion of the catheter tube 220 disposed in the tipping die 270. The at least one contact surface 274 has one or more shaped sections 276 forming a catheter tip profile. The one or more shaped sections 276 may include, for example, a shaped section forming a rounded tip profile and a shaped section forming a neck profile.

[0041] The tipping die 270 is configured to heat the catheter tube 220, for example, by heating the contact surface 274 and contacting the contact surface 274 to the catheter tube 220. The tipping die 270 may also apply pressure to the catheter tube 220, for example, by pressing the contact surface 274 against catheter tube 220. Such pressure may be applied, for example, by claiming opposing portions of the tipping die 270 together.

[0042] The portion of the catheter tube 220 in the tipping die 270 is heated to temperature sufficient to allow the catheter tube to conform to the one or moreshaped sections 276 of the one or more contact surfaces 274. In this manner, the portion of the catheter tube 220 in the tipping die 270 may be formed as a compressible catheter tip 234 having a rounded tip section 240 corresponding to the rounded tip profile and a neck section 242 corresponding to the neck profile. The portion of the catheter tube 220 outside of the tipping die 270 may be considered a tube section 232.

[0043] During the process of heating the catheter tube 220, a width of the drainage passage 254 may be formed depending on a width of the core pin 272, which internally supports the catheter tube 220 during the heating process. The proximal end opening 252 may be formed around the core pin 272 as well. Further, the core pin 272 includes a radiused shoulder 278 which provides the profile for forming proximal end of the catheter tube 220 at the proximal end opening 252.

[0044] The molded catheter tube 220 may cool, for example, until the material of the catheter tube 220 at the compressible catheter tip 234 retains its shape.The core pin 272 may be retracted from the molded catheter tube 220 and at least partially removed from the tipping die 270. The molded catheter tube 220 may be removed from the tipping die 270 as well.

[0045] The catheter tube 220 having the compressible catheter tip 234 manufactured according to the method above, may be formed as an integral, one- part construction. That is, the tube section 232 and compressible catheter tip 234 may be formed as a single, continuous part.

[0046] FIGS. 11 -13 illustrate another method of manufacturing a catheter tube 320 having the compressible catheter tip 334. The method of FIGS. 1 1 -13 is the same as the method above described with respect to FIGS. 7-10, except that the catheter tube 320 is formed as a two-part construction. That is, the catheter tube 320 includes a tube section 332 and a compressible catheter tip 334 secured to the tube section 332. Accordingly, the compressible catheter tip 334 and the tube section 332 may be formed by different materials and may have Shore hardnesses different from one another. The compressible catheter tip 334 includes the rounded tip section 340 and neck section 342 as described in examples above.

[0047] It will be understood that the embodiments described above are illustrative of some of the applications of the principles of the present subject matter. Numerous modifications may be made by those skilled in the art without departing from the spirit and scope of the claimed subject matter, including those combinations of features that are individually disclosed or claimed herein. For these reasons, the scope hereof is not limited to the above description but is as set forth in the following claims, and it is understood that claims may be directed to the features hereof, including as combinations of features that are individually disclosed or claimed herein.

Claims

CLAIMS1 . A compressible catheter tip for a urinary catheter assembly, the compressible catheter tip comprising: a rounded tip section; and a neck section arranged distally of the rounded tip section, wherein the rounded tip section has a tip width greater than a neck width of the neck section.

2. The compressible catheter tip according to claim 1 , wherein the rounded tip section is configured to be elastically deformed in response to application of an external force.

3. The compressible catheter tip according to claim 1 or 2, wherein the rounded tip section is hollow.

4. The compressible catheter tip according to claim 3, wherein the neck section is hollow.

5. The compressible catheter tip according to any one of claims 1 -4, wherein the rounded tip section has a first rounded section of increasing width and a second rounded section of decreasing width along a longitudinal axis.

6. The compressible catheter tip according to any of claims 1 -5, wherein the rounded tip section has a bulbous, teardrop or substantially spherical shape.

7. The compressible catheter tip according to any one of claims 1 -6, further comprising a plug section arranged distal of the neck section and configured for insertion into a catheter tube, wherein the plug section is configured to be secured to the catheter tube.

8. The compressible catheter tip according to any one of claims 1 -7, further comprising a proximal end opening, a distal end opening and a tip drainage passage between the proximal end opening and the distal end opening, wherein the proximal end opening, tip drainage passage and distal end opening are arranged in fluid communication with one another.

9. The compressible catheter tip according to any one of claims 1 -7, further comprising a compressible overmold layer extending over the rounded tip section and the neck section.

10. The compressible catheter tip according to claim 9, wherein in an uncompressed condition, the compressible overmold has a first inner width and is spaced from the neck section, and in a compressed condition, the compressible overmold is compressed inward toward the neck section and has a second inner width less than the first inner width.1 1. A catheter tube of a urinary catheter assembly comprising: the compressible catheter tip according to any one of claims 1-6; a tube section having a tube drainage passage; and a proximal end, wherein the compressible catheter tip extends from the tube section to the proximal end.

12. The catheter tube according to claim 11 , wherein the compressible catheter tip and the tube section are integrally formed as a one-part construction.

13. The catheter tube according to claim 12, wherein the compressible catheter tip further comprises a proximal end opening and tip drainage passage arranged in fluid communication with the proximal end opening and the tube drainage passage.

14. The catheter tube according to claim 11 , wherein the compressible catheter tip and the tube section are formed as a two-part construction.

15. The catheter tube according to claim 14, wherein the compressible catheter tip further comprises a proximal end opening, a distal end opening and tip drainage passage arranged in fluid communication with the proximal end opening, the distal end opening and the tube drainage passage.

16. The catheter tube according to any one of claims 14 or 15, wherein the compressible catheter tip has a first Shore hardness and the tube section has asecond Shore hardness, wherein the second Shore hardness is higher than the first Shore hardness.

17. The catheter tube according to any one of claims 14-16, wherein the tube section and the compressible catheter tip are formed separately from one another and the compressible catheter tip is secured to the tube section.

18. The catheter tube according to claim 17, wherein the compressible catheter tip includes a plug section inserted into the tube section.

19. The catheter tube according to any one of claims 14-18, wherein the compressible catheter tip is secured to the tube section by one of heat sealing, chemical bonding, 2-part extrusion, laser welding and an adhesive.

20. The catheter tube according to any one of claims 14-19, wherein the compressible catheter tip and the tube section are made from different materials.21 . The catheter tube according to any one of claims 11 -20, wherein the tube section further comprises one or more lateral drainage openings arranged in fluid communication with the tube drainage passage.

22. The catheter tube according to any one of claims 11 -20, wherein the compressible catheter tip further comprises a proximal end opening and a tip drainage passage arranged in fluid communication with the proximal end opening and the tube drainage passage.

23. The catheter tube according to any of claims 11 -21 , further comprising a compressible overmold layer extending over the compressible catheter tip.

24. The catheter tube according to claim 23, wherein in an uncompressed condition, the compressible overmold has a first inner width and is spaced from the neck section, and in a compressed condition, the compressible overmold is compressed radially inward toward the neck section and has a second inner width less than the first inner width.

25. A method of manufacturing a compressible catheter tip section of a urinary catheter tube, the method comprising: inserting a portion of the catheter tube into a tipping die, the tipping die having a contact surface with one or more shaped sections forming a catheter tip profile; receiving at least a portion of a core pin in an inner passage of the catheter tube; and heating the catheter tube in the tipping die to form the compressible catheter tip section on the catheter tube.

26. The method according to claim 25, further comprising: retracting the core pin from the catheter tube; and removing catheter tube from the tipping die.

27. The method according to claim 25 or 26, wherein the one or more shaped sections of the contact surface include a one or more shaped sections forming a rounded tip section profile and a neck section profile, and wherein the compressible catheter tip section includes a rounded tip section extending to a proximal end of the catheter tube and a neck section extending distally from the rounded tip section.

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