Internal roll introducer tip

Abstract

A urinary catheter assembly (10) includes a grip (20) having a proximal end (26), a proximal end opening (28), and an inner passage (30) in communication with the proximal end opening (28), a catheter tube (24) configured for movement relative to the grip (20) within the inner passage (30) and through the proximal end opening (28), and an introducer tip (22) connected to the grip (20) and having a free end (48). The introducer tip (22) is configurable in: a rolled state in which the introducer tip (22) is arranged within the grip (20)and the free end (48) is a distal end of the introducer tip (22), a transition state in which at least a portion of the introducer tip (22) is inwardly rolled to form a transition end (56) at the distal end of the introducer tip (22) and the free end (48) is arranged proximally relative to the transition end (56), and an unrolled state in which the introducer tip (22) is fully extended proximally relative to the grip (20) and the free end (48) is a proximal end of the introducer tip (22).

Description

INTERNAL ROLL INTRODUCER TIPDESCRIPTIONThe present application claims the benefits and priority to U.S. Provisional Application No. 63 / 560,880, filed March 4, 2024, which is hereby incorporated herein by reference.TECHNICAL FIELD

[0001] The present disclosure generally relates to a urinary catheter assembly, and more particularly, to a urinary catheter assembly having an internally rolled introducer tip for insertion into a urethra.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. The introducer tip includes a proximal end configured for insertion into the urethral opening prior to advancement of the catheter tube. After inserting the proximal end of the introducer tip in the urethra, the catheter tube is advanced through and beyond a leading end (i.e. , the proximal-most end) of the introducer tip.

[0004] The width, or diameter, of the introducer tip is fixed and is sufficiently sized to accommodate passage of the catheter tube during advancement with limited risk of interference that may require excess force to advance the catheter tube. Thus, the known introducer tip has a fixed inner width or diameter which isequal to, or nearly equal to the outer width or diameter of the catheter tube to accommodate passage of the catheter tube through the introducer tip.

[0005] However, an introducer tip sized to accommodate the catheter tube may be relatively large compared to the urethral opening and urethra, and thus, may cause discomfort to an individual while inserting the introducer tip into the urethra. In addition, an introducer tip sized in such a manner may be visually intimidating to a user or potential user of the catheter assembly.

[0006] Thus, it would be desirable to provide a urinary catheter assembly for intermittent catheterization having an introducer tip configurable in a rolled state for initial insertion into the urethra and an unrolled state while inserted in the urethra for catheterization.SUMMARY

[0007] There are several aspects of the present subject matter.

[0008] In one aspect, a urinary catheter assembly includes a grip having a proximal end, a proximal end opening, and an inner passage in communication with the proximal end opening, a catheter tube configured for movement relative to the grip within the inner passage and through the proximal end opening, and an introducer tip connected to the grip and having a free end. The introducer tip is configurable in a rolled state in which the introducer tip is arranged within the grip and the free end is a distal end of the insertion tip, a transition state in which at least a portion of the introducer tip is inwardly rolled to form a transition end at the distal end of the introducer tip and the free end is arranged proximally relative to the transition end, and an unrolled state in which the introducer tip is fully extended proximally relative to the grip and the free end is a proximal end of the introducer tip.

[0009] In another aspect, a grip for a urinary catheter assembly includes a proximal end, a proximal end opening, an inner passage in communication with the proximal end opening, and an introducer tip connected to the proximal end, the introducer tip having a free end. The introducer tip is configurable in a rolled state in which the introducer tip is arranged in the inner passage and the free end is a distal end of the insertion tip, a transition state in which at least a portion ofthe introducer tip is inwardly rolled to form a transition end at the distal end of the introducer tip and the free end is arranged proximally relative to the transition end, and an unrolled state in which the introducer tip is fully extended proximally relative to the proximal end and the free end is a proximal end of the introducer tip.Brief Description of Drawings

[0010] FIG. 1 is a perspective view showing an example of a urinary catheter assembly with an introducer tip configured in a rolled state;

[0011] FIG. 2 is a transparent side view of the urinary catheter assembly of FIG.1 ;

[0012] FIG. 3 is a cross-section diagram showing the urinary catheter assembly of FIG. 1 ;

[0013] FIG. 4 is a perspective view showing an example of the urinary catheter assembly of FIG. 1 with the introducer tip configured in a transition state;

[0014] FIG. 5 is a transparent side view of the urinary catheter assembly of FIG.4;

[0015] FIG. 6 is a cross-section diagram showing the urinary catheter assembly of FIG. 4;

[0016] FIG. 7 is a perspective view showing an example of the urinary catheter assembly of FIG. 1 with the introducer tip configured in an unrolled state;

[0017] FIG. 8 is a transparent side view of the urinary catheter assembly of FIG.7;

[0018] FIG. 9 is a cross-section diagram showing the urinary catheter assembly of FIG. 7;

[0019] FIG. 10 is a transparent side view showing another example of a urinary catheter assembly with an introducer tip configured in a rolled state;

[0020] FIG. 11 is a transparent side view of the urinary catheter assembly of FIG. 10 with the introducer tip configured in the transition state; and

[0021] FIG. 12 is a transparent side view of the urinary catheter assembly of FIG. 10 with the introducer tip configured in the unrolled state.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 FIGS. 1-3, a urinary catheter assembly 10 according to present embodiments generally includes a grip 20 having an internally rolled introducer tip 22. The urinary catheter assembly 10 may further include a catheter tube 24 configured for draining bodily fluid (e.g., urine) from a patient’s bladder. In some examples, the urinary catheter assembly 10 may be an intermittent urinary catheter. Optionally, the urinary catheter assembly 10 may include a protective or no-touch sleeve 25. When included, the no-touch sleeve 25 surrounds the catheter tube 24 and the user handles or grasps the catheter tube 24 through the no-touch sleeve 25.

[0024] According to an example, the grip 20 has a proximal end 26, a proximal end opening 28 and an inner passage 30 in communication with the proximal end opening 28. The grip 20 may also include an insertion tip 32 at the proximal end 26 arranged about the proximal end opening 28. The insertion tip 32 may configured to position the grip 20, and in turn, the catheter tube 24, relative to the urethra, and in some examples, may be inserted a relatively short distance into the urethra to assist with insertion and initial advancement of the catheter tube 24 in the urethra.

[0025] The catheter tube 24 generally includes a tube proximal end 34, which may be formed as, or include, a catheter tip, and a tube distal end (not shown). For catheterization, the catheter tube 24 may be advanced through the grip 20 (in the inner passage 30) in an insertion, or proximal, direction D1 such that the tube proximal end 34 may be advanced through the proximal end opening 28 and extend proximally beyond the proximal end 26 of the grip 20. In this manner, the catheter tube 24 may be advanced in a patient’s urethra toward the bladder.

[0026] The catheter tube 24 may be formed as an elongated hollow member having a tube wall 36 surrounding a hollow tube interior 38. One or more openings 40 (also referred to as “drainage eyes”) may be provided through the tube wall 36 at or adjacent to the tube proximal end 34 and are arranged in fluid communication with hollow tube interior 38. In this manner, with the catheter tube 24 inserted in the bladder, bodily fluid (e.g., urine) from the bladder may be received in the hollow tube interior 38 through the one or more openings 40 and may be drained from the bladder via the hollow tube interior 38.

[0027] Advancement of the catheter tube 24 to extend outwardly from the proximal end 26 may be part of a catheterization procedure as previously indicated. In the catheterization procedure, the tube proximal end 34 may be disposed in the patient’s bladder, while the tube distal end (not show) is arranged distally of the grip 20 and may be connected, for example, to a drainage or collection bag (not shown) to collect fluid drained from the bladder via the catheter tube 24, or connected to a drainage member for directing urine into a receptacle, such as a toilet. The catheter tube 24 may be removed from the bladder through the urethra by moving the catheter 24 in a removal direction D2, substantially opposite to the insertion direction D1 .

[0028] Referring generally to FIGS. 1 -9, the internally rolled introducer tip 22 is configured to move from a rolled state (FIGS. 1 -3) in which it is substantially arranged within the grip 20 (i.e. , in the inner passage 30) to an unrolled state (FIGS. 7-9) in which it is extended proximally outward relative to the proximal end 26. The internally rolled introducer tip 22 also moves through a transition state (FIGS. 4-6) between the rolled state and the unrolled state. In the present examples, the introducer tip 22 may be moved from the rolled state, through the transition state, and to the unrolled state during a catheterization process with advancement of the catheter tube 24 for insertion in the urethra. In this manner, the insertion tip 22 may substantially cover or conceal the catheter tube proximal end 34 during insertion through an initial length of the urethra, e.g., about 15 mm, where the urethra may be more susceptible to bacterial infections.

[0029] The introducer tip 22 may be made from a relatively soft, flexible material of a type known for suitability in urinary catheter applications. Theintroducer tip 22 may provide more comfort to the patient during insertion of the catheter tube 24 because of the relatively softer material of the introducer tip 22 covering the tube proximal end 34 during initial insertion in a catheterization process as described further below. In addition, as shown in FIGS. 1-3, because the rolled state of the introducer tip 22 is within the grip 20, the tube proximal end 34 may not be visible to the patient immediately prior to or during catheterization. Similarly, the introducer tip 22 may not be visible to the patient immediately prior to or during catheterization. Thus, portions of the catheter assembly 10 which are inserted into the urethra beyond the first few millimeters may be hidden from sight, which may provide added visual comfort for the patient and / or reduce some level of intimidation perceived by the patient compared to when such portions are visible prior to insertion.

[0030] With reference to FIGS. 2 and 3, the introducer tip 22 may be an elongated sleeve 22 surrounding a sleeve passage 42. In the following examples, the introducer tip 22 and the sleeve 22 may be referenced interchangeably. As shown in FIG. 3, in one example, the sleeve 22 has a first surface 44 and a second surface 46. The first surface 44 may be an outer surface or inner surface of the sleeve 22 and the second surface 46 may be the other of the outer surface and inner surface of the sleeve 22, depending on whether the introducer tip 22 is in the rolled state or the unrolled state.

[0031] In the illustrated example of the introducer tip 22 in the rolled state, the first surface 44 is the outer surface (i.e., the surface facing outwardly away from longitudinal axis A1 of the sleeve passage 42) and the second surface 46 is the inner surface (i.e., the surface facing inwardly toward the longitudinal axis A1 of the sleeve passage 42). Also, in the rolled state, the introducer tip 22 is substantially or entirely positioned within the grip 20, for example, within the inner passage 30. The introducer tip 22 has a free end 48 which is also arranged in the inner passage 30 in the rolled state. The free end 48 is a distal end of the introducer tip 22 in the rolled state. An opposite end 49 of the introducer tip 22, i.e., a proximal end in the rolled state, is connected to the grip 20.

[0032] A tip opening 50 at the free end 48 is arranged in communication with the sleeve passage 42. The free end 48 is configured to interact with thetube proximal end 34 of the catheter tube 24. As described further below, by way of such interaction, the free end 48 is configured to move with the catheter tube 24 when the catheter tube 24 is advanced in the insertion (or proximal) direction D1 for catheterization. Such movement also moves the introducer tip 22 from the rolled state to the transition state. In one example, the free end 48 is engaged with the tube proximal end 34. For instance, the tube proximal end 34 may frictionally engage the free end 48. In other examples, the free end 48 may be engaged by the tube proximal end 34 at pre-weakened section, such that the tube proximal end 34 and catheter tube may be advanced beyond the free end 48, through the pre-weakened section, when the introducer tip is in the unrolled state.

[0033] Referring now to FIGS. 4-6, in the transition state, movement of the catheter tube 24 in the insertion direction D1 causes an inward rolling motion (indicated by arrows in FIG. 6) of the sleeve 22. Accordingly, in the transition state, the free end 48 moves into the sleeve passage 42 and is advanced in the insertion direction D1 with the catheter tube 24. Thus, at least a part of an unrolled portion 52 of the sleeve 22 moves within a rolled portion 54 of the sleeve 22.

[0034] In the illustrated examples, a transition end 56 is provided at the inward rolling portion of the sleeve 22 caused by movement of the free end 48 in the insertion direction D1. The transition end 56 generally forms a distal end of the introducer tip 22 in the transition state.

[0035] Additionally, in the transition state, the unrolled portion 52 and the transition end 56 move in the insertion direction D1 when the free end 48 is moving in the insertion direction D1 with the catheter tube 24. Thus, the unrolled portion 52 may move relative to the rolled portion 54 in the insertion direction D1 .

[0036] Further, in the transition state, the first surface 44 of the introducer tip 22 may be the outer surface of the rolled portion 54 and the second surface 46 may be the inner surface of the rolled portion 54. The introducer tip 22 is rolled inward on itself at the transition end 56 with movement of the free end 48 in the insertion direction D1. Thus, on the unrolled portion 52, the first surface 44 of the introducer tip 22 faces inward toward a longitudinal axis A1 , and the second surface faces outward away from the longitudinal axis A1 .

[0037] During a first stage of the transition state, the introducer tip 22 remains within the grip 20 while the free end 48 is advanced in the insertion direction D1 toward the proximal end opening 28. During the first stage, the unrolled portion 52 underlies at least part of the rolled portion 54. In a second stage of the transition state, the free end 48 is advanced proximally outward from the grip 20 in the insertion direction D1 . During the second stage, the rolled portion 54 overlies at least part of the unrolled portion 52.

[0038] With reference to FIGS. 7-9, the introducer tip 22 is unrolled to its full length with continued movement of the of the free end 48 in the insertion (proximal) direction D1 , which moves the introducer tip 22 to the unrolled state. In the unrolled state, the introducer tip 22 is extended proximally from the proximal end 26 of the grip 20. The free end 48 is the proximal end of the introducer tip 22 in this state. As with the unrolled portion 52 in the transition state, the first surface 44 is an inward-facing surface toward the longitudinal axis A1 and the second surface is an outward-facing surface away from the longitudinal axis A1 .

[0039] In the unrolled state, continued advancement of the catheter tube 24 in the insertion direction D1 causes the tube proximal end 34 to separate from the introducer tip 22. Thus, introducer tip 22 may be fully extended to its predetermined length (e.g., about 15 mm) while the catheter tube 24 is advanced beyond the introducer tip 22 to reach the bladder.

[0040] In the manner described above, the introducer tip 22 may be unrolled to extend into the urethra with movement of the catheter tube 24 in the insertion direction D1 over a predetermined initial distance. The predetermined initial distance may be a distance within the urethra where bacterial infections are more likely to occur, for example, up to a distance of about 15 mm into the urethra. The introducer tip 22 substantially surrounds and may cover a leading end of the of the tube proximal end 34. Thus, during advancement over the initial predetermined distance, the introducer tip 22 contacts the urethra wall and the catheter tube 24 and / or the tube proximal end 34 may be advanced within the introducer tip 22 over the initial distance without contacting the urethra wall. The introducer tip 22 may be made from a softer, more flexible or compliant material than the catheter tube 24 and / or the tube proximal end 34 such that the patientmay experience improved comfort during catheterization.

[0041] In addition, the introducer tip 22 and the catheter tube 24, including tube proximal end 34, may be sterilized and maintained in a sterile environment until catheterization. In some examples, the tube proximal end 34 is substantially covered by the introducer tip 22 until advancing proximally from introducer tip 22 in the unrolled state. Accordingly, the catheter tube 24 and / or tube proximal end 34 may avoid contact with portions of the urethra and / or grip on which bacteria may be adhered. Thus, a likelihood of the tube proximal end 34 being exposed to bacteria from the initial distance in the urethra and / or from the grip 20, and in particular, the insertion tip 32, may be reduced or eliminated. In turn, transmission of bacteria to the bladder via the tube proximal end 34 may be substantially avoided.

[0042] According to one example, as shown generally in FIGS. 1-9, insertion tip 32 of this grip 20 may be inserted a relatively short distance into the urethra. The catheter tube 24 may be advanced in the insertion direction D1 to move the introducer tip 22 from the rolled state to the transition state. Continued advancement of the catheter tube 24 in the insertion direction D1 unrolls the introducer tip 22 into the urethra. The introducer tip 22 moves from the transition stage to the unrolled state when the introducer tip 22 is fully extended (unrolled) proximally relative to the proximal end 26. In the unrolled state, the catheter tube 24 may be advanced relative to the introducer tip 22 further into the urethra and into the bladder. That is, when the introducer tip 22 is fully extended, further advancement of the catheter tube 24 causes the tube proximal end 34 to move proximally relative to the introducer tip 22 for advancement to the bladder.

[0043] In other examples, as shown in FIGS. 10-12, the grip 20 may be provided with a full-length insertion tip 132 to be inserted in the urethra during catheterization. With the full-length insertion tip 132, unrolling the introducer tip 22 avoids or limits contact of the catheter tube 24 and tube proximal end 34 with bacteria that may be adhered to petals 158 at a proximal end of the insertion tip 132. That is, the introducer tip 22 may substantially cover the tube proximal end 34 and a portion of the catheter tube 24 as the catheter tube 24 is advanced through petals 158 of the insertion tip 132. Accordingly, transmission of bacteriafrom the petals 158 to the bladder via the tube proximal end 34 may be substantially avoided.

[0044] In the rolled state of FIG. 10, the tube proximal end 34 and introducer tip 22 are arranged within the inner passage 30 of the grip 20, and free end 48 is a distal end of the introducer tip 22. In the transition state shown in FIG. 11 , the tube proximal end 34 is advanced in the insertion direction D1 and the free end 48, engaged with the tube proximal end 34, moves with the tube proximal end 34 in the insertion direction D1. In the unrolled state illustrated in FIG. 12, the introducer tip 22 is fully extended and extends beyond a proximal end of the insertion tip 132, where petals 158 may be provided. In the unrolled state, the catheter tube 24 and tube proximal end 34 are advanced further into the urethra relative to the introducer tip 22.

[0045] 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 urinary catheter assembly comprising: a grip having a proximal end, a proximal end opening, and an inner passage in communication with the proximal end opening; a catheter tube configured for movement relative to the grip within the inner passage and through the proximal end opening; and an introducer tip connected to the grip and having a free end, wherein the introducer tip is configurable in: a rolled state in which the introducer tip is arranged within the grip and the free end is a distal end of the introducer tip, a transition state in which at least a portion of the introducer tip is inwardly rolled to form a transition end at the distal end of the introducer tip and the free end is arranged proximally relative to the transition end, and an unrolled state in which the introducer tip is fully extended proximally relative to the grip and the free end is a proximal end of the introducer tip.

2. The urinary catheter assembly according to claim 1 , wherein the catheter tube further comprises a tube proximal end, wherein the tube proximal end is configured to interact with the free end such that movement of the catheter tube in an insertion direction causes movement of the free end in the insertion direction.

3. The urinary catheter assembly according to claim 1 or claim 2, wherein the introducer tip has a first surface formed as one of an outer surface facing outwardly away from a longitudinal axis or an inner surface facing inwardly toward the longitudinal axis, and a second surface formed as the other of the outer surface and the inner surface.

4. The urinary catheter assembly according to claim 3, wherein in the rolled state, the first surface is the outer surface and the second surface is the inner surface.

5. The urinary catheter assembly according to claim 3, wherein in the unrolled state, the first surface is the inner surface and the second surface is the outer surface.

6. The urinary catheter assembly according to claim 3, wherein in the transition state, the introducer tip includes an unrolled portion and a rolled portion and the unrolled portion is positioned at least partially within the rolled portion.

7. The urinary catheter assembly according to claim 6, wherein in the transition state, the first surface is formed as an outer surface of the rolled portion and an inner surface of the unrolled portion, and the second surface is formed as an inner surface of the rolled portion and an outer surface of the unrolled portion.

8. The urinary catheter assembly according to claim 6 or claim 7, wherein the transition end is arranged between the rolled portion and the unrolled portion.

9. The urinary catheter assembly according to any of claims 1 through 8, wherein the introducer tip is a sleeve having an inner sleeve passage and an opening at the free end in communication with the inner sleeve passage.

10. The urinary catheter assembly according to claim 9, wherein the catheter tube is advanced through the inner sleeve passage in the insertion direction.1 1 . The urinary catheter assembly according to claim 2, wherein the tube proximal end is engaged with the free end 48 of the introducer tip in the rolled state and the transition state.

12. The urinary catheter assembly according to claim 11 , wherein the tube proximal end is frictionally engaged with the free end.

13. The urinary catheter assembly according to any of claims 1 through 12,wherein the tube proximal end is covered by the introducer tip in the rolled state and the transition state.

14. The urinary catheter assembly according to any of claims 1 through 12, wherein in the unrolled state, the tube proximal end extends proximally beyond the free end.

15. The urinary catheter assembly according to any of claims 1 through 14, wherein the grip further comprises an insertion tip surround the proximal end opening and extending outward in the proximal direction, wherein the introducer tip, in the unrolled state, extends proximally beyond the insertion tip.

16. A grip for a urinary catheter assembly, comprising: a proximal end, a proximal end opening, an inner passage in communication with the proximal end opening; and an introducer tip connected to the proximal end, the introducer tip having a free end, wherein the introducer tip is configurable in: a rolled state in which the introducer tip is arranged in the inner passage and the free end is a distal end of the introducer tip, a transition state in which at least a portion of the introducer tip is inwardly rolled to form a transition end at the distal end of the introducer tip and the free end is arranged proximally relative to the transition end, and an unrolled state in which the introducer tip is fully extended proximally relative to the proximal end and the free end is a proximal end of the introducer tip.

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