Extendable introducer tip

Abstract

A urinary catheter assembly (10, 110, 410) includes a grip (20, 520) having a grip proximal end (28, 228, 528), a proximal end opening (30), and an inner passage (32) in communication with the proximal end opening, a catheter tube (24) configured for movement relative to the grip within the inner passage and through the proximal end opening, the catheter tube having a tube proximal end (36), and an introducer tip (22, 122, 222, 322, 422, 522) configured for movement in the inner passage of the grip, the introducer tip having a tip distal end (44) and a tip proximal end (46, 546). The introducer tip is moveable from a retracted position substantially within the inner passage to an extended position extending at least partially through the proximal end opening such that the tip proximal end is positioned proximally of the grip proximal end.

Description

EXTENDABLE INTRODUCER TIPDESCRIPTIONThe present application claims the benefit of and priority to U.S. Provisional Application No. 63 / 560,892, 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 extendable 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 through which a proximal portion of the catheter tube is advanced during catheterization. In use, the introducer tip is inserted into the urethra before advancing proximal portion of the catheter tube into and through the urethra to the bladder.

[0004] A known introducer tip has a length of about 15 mm for insertion into the urethra and is configured to hold the catheter assembly in position during catheterization by way of contact with the urethral wall. The introducer tip is also configured to prevent contact between the proximal portion of the catheter tube and the urethra while the catheter tube is advanced through the introducer tip. Accordingly, the proximal portion of the catheter tube may avoid contact with any bacteria that may be present in the urethra along the length of the introducer tip.Thus, transporting bacteria into the bladder by way of the catheter tube may be substantially avoided.

[0005] However, the known introducer tip may be visually intimidating to the patient or potential user of the catheter assembly and / or may be uncomfortable when inserting into the urethra because of the length. As a result, the patient may opt against use of the known introducer tip, and instead, select an alternative catheter assembly perceived to be less intimidating (i.e. a catheter assembly with a shorter introducer tip or no introducer tip at all). However, such an alternative catheter assembly may be susceptible to additional movements or slipping during catheterization which may cause discomfort and / or expose the proximal portion of the catheter tube to bacteria the first 15 mm of the urethra (where bacteria is most likely to be present). Bacteria present on the proximal portion of the catheter may be introduced into the bladder and cause infection.

[0006] Thus, it would be desirable to provide a urinary catheter assembly for intermittent catheterization having an introducer tip of sufficient length to hold the catheter assembly in position and avoid exposing the catheter tube to bacteria in the urethra while reducing the length of the introducer tip visible to the patient before 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 grip 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, the catheter tube having a tube proximal end, and an introducer tip configured for movement in the inner passage of the grip, the introducer tip having a tip distal end and a tip proximal end. The introducer tip is moveable from a retracted position substantially within the inner passage to an extended position extending at least partially through the proximal end opening such that the tip proximal end is positioned proximally of the grip proximal end.

[0009] In another aspect, a grip assembly for a urinary catheter assemblyincludes a grip having a grip proximal end, a proximal end opening, and an inner passage in communication with the proximal end opening, and an introducer tip configured for movement in the inner passage, the introducer tip having a tip distal end and a tip proximal end. The introducer tip is moveable from a retracted position substantially within the inner passage to an extended position extending at least partially through proximal end opening such that the tip proximal end is positioned proximally of the grip proximal end.Brief Description of Drawings

[0010] FIG. 1 is a cut away side view illustrating an example of a urinary catheter assembly having an introducer tip in a retracted position;

[0011] FIG. 2 is a cut away side view of the urinary catheter assembly of FIG. 1 , having the introducer tip in an extended position.

[0012] FIGS. 3 and 4 are perspective and cut away side views, respectively, illustrating an example of a urinary catheter assembly with an introducer tip having a first length;

[0013] FIGS. 5 and 6 are perspective and cut away side views, respectively, illustrating the urinary catheter assembly of FIGS. 3 and 4, with an introducer tip having a second length;

[0014] FIGS. 7 and 8 are perspective and cut away side views, respectively, illustrating the urinary catheter assembly of FIGS. 3 and 4, with an introducer tip having a third length.

[0015] FIGS. 9-11 are side views illustrating examples of a urinary catheter assembly having an introducer tip in retracted (FIG. 9), partially extended (FIG.10) and extended positions (FIG. 11 ); and

[0016] FIGS. 12 and 13 are perspective views illustrating examples of a urinary catheter assembly having an introducer tip in a retracted position (FIG. 12) and an extended position (FIG. 13).DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

[0017] The embodiments disclosed herein are for the purpose of providing a description of the present subject matter, and it is understood that the subjectmatter 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.

[0018] With reference to FIGS. 1-3, a urinary catheter assembly 10 according to present embodiments generally includes a grip 20 having an extendable 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 26 (FIG. 3). When included the no-touch sleeve 26 surrounds the catheter tube 24 and the user handles or grasps the catheter tube 24 through the no-touch sleeve 26.

[0019] According to an example, the grip 20 has a grip proximal end 28, a proximal end opening 30 and an inner passage 32 in communication with the proximal end opening 30. The grip 20 may also include an insertion tip 34 at the grip proximal end 28 arranged about the proximal end opening 30. The insertion tip 34 may be 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.

[0020] The catheter tube 24 generally includes a tube proximal end 36, 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 32) in an insertion, or proximal, direction D1 such that the tube proximal end 36 may be advanced through the proximal end opening 30 and extend proximally beyond the proximal end 28 of the grip 20. In this manner, the catheter tube 24 may be advanced in a patient’s urethra toward the bladder.

[0021] The catheter tube 24 may be formed as an elongated hollow member having a tube wall 38 surrounding a hollow tube interior 40. One or more openings 42 (also referred to as “drainage eyes”) may be provided through thetube wall 38 at or adjacent to the tube proximal end 36 and are arranged in fluid communication with hollow tube interior 40. 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 40 through the one or more openings 42 to drain the bladder.

[0022] Advancement of the catheter tube 24 to extend outwardly from the proximal end 28 may be part of a catheterization procedure as previously indicated. In the catheterization procedure, the tube proximal end 36 may be disposed in the patient’s bladder, while the tube distal end (not shown) 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 .

[0023] With further reference to FIGS. 1 and 2, the introducer tip 22 is configured for movement in the inner passage 32 of the grip 20 from a retracted position (FIG. 1) to an extended position (FIG. 2). The introducer tip 22 has a tip distal end 44 and a tip proximal end 46. In the retracted position, the introducer tip 22 is disposed substantially within the inner passage 32, and in the extended position, the introducer tip 22 extends at least partially through the proximal opening 30 such that the tip proximal end 46 is positioned proximally of the grip proximal 28. In one example, in the retracted position, the tip proximal end 46 may be positioned within the inner passage 32. In the extended position, the tip distal end 44 may be positioned in the inner passage 32.

[0024] In one example, the introducer tip 22 has a width at the tip distal end 44 greater than a width of the proximal end opening 30. In this manner, a portion of the introducer tip 22 may be retained in the inner passage 32 in the insertion or proximal direction D1 . With reference to FIG. 2, a tip retainer 48 may be provided in the inner passage 32 configured to retain the introducer tip 22 in the extended position by substantially preventing or limiting movement of the introducer tip 22 in the retraction or distal direction D2. In one example, the tip retainer 48 may be aninternally formed protrusion, collar, lug and / or other internally formed feature for reducing a width of the inner passage to less than the width of the tip distal end 44. When moving from the retract position to the extended position, the introducer tip 22 may elastically deform or otherwise deflect to pass by the tip retainer 48.

[0025] The introducer tip 22 may also include a tip abutment 50 configured for interaction with the tube proximal end 36. For example, the tube proximal end 36 may bear against the tip abutment 50 in the inner passage 32 as the catheter tube 24 is advanced in the insertion direction D1 . In this manner, the introducer tip 22 may be advanced within the inner passage 32 in the insertion or proximal D1 with corresponding movement of the catheter tube 24, and in turn, may be moved from the retracted position to the extended position. In the illustrated example, the introducer tip 22 may be moved from retracted position to the extended position by sliding translation in the inner passage 32.

[0026] In one example, as described below, the tip abutment 50 may be a membrane configured to be punctured or ruptured by the tube proximal end 28 to accommodate further advancement of the catheter tube 24 in the insertion or proximal direction D1 when the introducer tip 22 is in the extended position. That is, the membrane 50 may be punctured or ruptured in response to a sufficient force applied by the tube proximal end 36 to the membrane 50 with advancement of the catheter tube 24 in the proximal direction D1 .

[0027] With further reference in FIGS. 1 and 2, the introducer tip 22 includes an inner tip passage 52 substantially surrounded by a tip wall 54. The inner tip passage 52 is configured to receive the tube proximal end 36 and facilitate passage of the tube proximal end 36 and a portion of the catheter tube 24 through the introducer tip 22 and into the urethra. For example, the tube proximal end 36 may rupture or punction the tip abutment 50 with the introducer tip 22 in the extended position. In this manner, the tube proximal end 36 may be received into the inner tip passage 52 with advancement of the catheter tube 24 in the insertion or proximal direction D1 . The tip proximal end 46 may be provided with any known suitable configuration for allowing the tube proximal end 36 to advance through the tip proximal end 46. For example, the tip proximal end 46 may be provided with one or more flexible members 560 (see FIGS. 12 and 13)urged or positioned inward toward a longitudinal axis to substantially close the tip proximal end 46 before passage of the catheter tube 24. The one or more flexible members 560 may be deflected outward by the tube proximal end 36 with advancement of the catheter tube 24 through the introducer tip 22. In the example of FIGS. 12 and 13, the one or more flexible members 560 are shown as four petals configured to deflect outward and in the proximal direction with passage of the tube proximal end 36 through the tip proximal end 46.

[0028] In some examples, the grip 20 includes an insertion tip 34 at the proximal end 28. The insertion tip 34 may be a relatively short proximally extending collar or other similar projection extending about the proximal end opening 30. The insertion tip 34 may be inserted a relatively short distance into the urethra in a catheterization process, to assist the patient or user with positioning of the grip 20.

[0029] In the present examples, the introducer tip 22 may be moved from the retracted position to the extended position 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 36 during insertion through an initial length of the urethra, e.g., about 15 mm, where the urethra may be more susceptible to bacterial infections.

[0030] The introducer tip 22 may be made from a relatively soft, flexible material of a type known for suitability in urinary catheter applications. The introducer 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 36 during initial insertion in a catheterization process. In addition, as shown in FIGS. 1 and 2, because the retracted position of the introducer tip 22 is within the grip 20, the tube proximal end 36 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 or anxiety perceived by the patient compared to when such portionsare visible prior to insertion.

[0031] 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. Accordingly, the introducer tip 22, in the present examples, may have a length sufficient to extend approximately 15 mm into the urethra in the extended position. The introducer tip 22 substantially surrounds and may cover a leading end of the of the tube proximal end 36. 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 36 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 36 such that the patient may experience improved comfort during catheterization.

[0032] In addition, the introducer tip 22 and the catheter tube 24, including tube proximal end 36, may be sterilized and maintained in a sterile environment until catheterization. In some examples, the tube proximal end 36 is substantially covered by the introducer tip 22 until advancing proximally from introducer tip 22 in the extended state. Accordingly, the catheter tube 24 and / or tube proximal end 36 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 36 being exposed to bacteria from the initial distance in the urethra and / or from the grip 20, and in particular, the insertion tip 34, may be reduced or eliminated. In turn, transmission of bacteria to the bladder via the tube proximal end 36 may be substantially avoided.

[0033] Further still, the urinary catheter assembly 10 having the extendable introducer tip 22 as described herein, may provide increased control and protection against bacteria without the need for cap. For instance, because the tube proximal end 36 (i.e. , the catheter tip) is arranged in the introducer tip 22, which is retracted inside the grip 20 when the patient or user removes it from the packaging and up until the user begins to insert, the tube proximal end 36 does not encounter foreign bacteria that could be pushed into the urethra. In addition, itwill be appreciated that the introducer tip 22 may be extended to different lengths, which may be selected by the patient according to individual preferences, comfort levels, and the like. The introducer tip 22, in the extended position, also engages the urethral walls of a relatively large surface area. In this manner, the grip 20 may be more securely held in place and a possibility of slipping out during use may be reduced because of the greater surface area contact with the urethral wall.

[0034] FIGS. 3-13 illustrate various examples of urinary catheter assemblies having an extendable introducer tip 22 according to the present embodiments. It will be appreciated that the grip 20 and extendable introducer tip 22 illustrated in FIGS. 1 and 2 may be used together with the catheter assemblies of the examples in FIG. 3-13, and / or may replace similar or corresponding features of those examples. It will also be appreciated that the extendable introducer tip(s) of FIGS. 3-13, unless described otherwise below, generally include the same or corresponding features of FIGS. 1 and 2 perform the same or corresponding functions as those features described with reference to FIGS. 1 and 2.

[0035] FIGS. 3 and 4 show perspective and side views of a urinary catheter assembly 110 in which an extendable introducer tip 122, of the type described in relation to FIGS. 1 and 2, for example, is in a retracted position. As detailed above, the introducer tip 22 may be provided in different lengths according to user preferences. In FIGS. 3 and 4, the introducer tip 122 has a first length L1 proximally beyond the grip proximal end 128, while in FIGS. 5 and 6, the introducer tip 222 has a second length L2 proximally beyond the grip proximal end 228 and greater than the first length L1 . The introducer tip 322 of FIGS. 7 and 8 has a third length L3 proximally beyond the grip proximal end 328 and greater than the second length L2. Varying the lengths of the introducer tips 22, 122, 222, 322 may vary a visible portion of the introducer tips prior to catheterization, which may be considered by the patient when selecting a desired length.

[0036] FIGS. 9-11 illustrate diagrams of a urinary catheter assembly 410 having an extendable introducer tip 422 at varied extension positions. For example, in FIG. 9, the introducer tip 422 is retracted, in FIG. 10, the introducer tip422 is partially extended, and in FIG. 11 , the introducer tip 422 is fully extended. As shown in FIGS. 9-11 , the introducer tip 422 is extended in response to advancement of the tube proximal end 436 (i.e., the catheter tip) in the insertion or proximal direction D1.

[0037] FIGS. 12 and 13 show examples of the introducer tip 522 in a retracted position (FIG. 12) at which tip proximal end 546 is recessed relative to proximal end 528 of the grip 520, and in an extended position (FIG. 13) at which the tip proximal end 546 is at its further proximal extent relative to the grip proximal end 528.

[0038] 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.-I Q-

Claims

CLAIMS1 . A urinary catheter assembly comprising: a grip having a grip 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, the catheter tube having a tube proximal end; and an introducer tip configured for movement in the inner passage of the grip, the introducer tip having a tip distal end and a tip proximal end, wherein the introducer tip is moveable from a retracted position substantially within the inner passage to an extended position extending at least partially through the proximal end opening such that the tip proximal end is positioned proximally of the grip proximal end.

2. The urinary catheter assembly according to claim 1 , wherein in the retracted position, the tip proximal end is positioned within the inner passage.

3. The urinary catheter assembly according to claim 1 , wherein in the extended position, the tip distal end is positioned in the inner passage.

4. The urinary catheter assembly according to claim 1 , wherein the tip distal end has a width greater than a width of the proximal end opening.

5. The urinary catheter assembly according to any of claims 1 through 4, wherein the introducer tip further includes an inner tip passage between the tip distal end and the tip proximal end.

6. The urinary catheter assembly according to claim 5, wherein the introducer tip further comprises a tip abutment, and the tube proximal end is configured to interact with the tip abutment to move the introducer tip from the retracted position to the extended position with movement of the tube proximal end in a proximaldirection.

7. The urinary catheter assembly according to claim 6, wherein the tip abutment is a membrane, and the membrane is configured to rupture in response to a force applied by the tube proximal end from further movement in the proximal direction with the introducer tip in the extended position.

8. The urinary catheter assembly according to claim 7, wherein the tube proximal end is configured for movement into the inner tip passage through the membrane.

9. The urinary catheter assembly according to claim 8, wherein the tube proximal end is configured for movement through the tip proximal end with the introducer tip in the extended position, such that the tube proximal end extends beyond the tip proximal end in the proximal direction.

10. The urinary catheter assembly according to claim 9, wherein the introducer tip includes one or more flexible members at the tip proximal end, the one or more flexible members configured to deflect in response to movement of the tube proximal end through the tip proximal end.1 1 . The urinary catheter assembly according to any of claims 1 through 10, wherein the grip includes a tip retainer arranged in the inner passage, wherein the tip retainer is configured to retain the introducer tip in the extended position.

12. The urinary catheter assembly according to any of claims 1 through 11 , wherein the grip is provided without a cap at the grip proximal end.

13. The urinary catheter assembly according to any of claims 1 through 12, wherein the introducer tip is movable from the retracted position to the extended position by sliding translation in the inner passage.

14. The urinary catheter assembly according to any of claims 1 through 13, wherein the grip further includes an insertion tip positioned about the proximal end opening and extending in the proximal direction from the grip proximal end.

15. A grip assembly for a urinary catheter assembly, the grip assembly comprising: a grip having a grip proximal end, a proximal end opening, and an inner passage in communication with the proximal end opening; and an introducer tip configured for movement in the inner passage, the introducer tip having a tip distal end and a tip proximal end, wherein the introducer tip is moveable from a retracted position substantially within the inner passage to an extended position extending at least partially through proximal end opening such that the tip proximal end is positioned proximally of the grip proximal end.

16. The grip assembly according to claim 15, wherein in the retracted position, the tip proximal end is positioned within the inner passage.

17. The grip assembly according to claim 15, wherein in the extended position, the tip distal end is positioned in the inner passage.

18. The grip assembly according to claim 15, wherein the tip distal end has a width greater than a width of the proximal end opening.

19. The grip assembly according to any of claims 15 through 18, wherein the introducer tip further comprises tip abutment at the tip distal end, wherein the tip abutment is configured to rupture to provide an opening to a tip inner passage of the introducer tip.

20. The grip assembly according to any of claims 15 through 19, further comprising a tip retainer arranged in the inner passage, wherein the tip retainer is configured to retain the introducer tip in the extended position.

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