Catheter assembly having expandable introducer

Abstract

A urinary catheter assembly includes an introducer tip (12) having a tip proximal end (14), a tip distal end (16), an inner passage (18) extending between the tip proximal end and the tip distal end, an outer part (20) and a folding part (22). The assembly also includes a catheter member (110) having a catheter proximal end (112) and a catheter distal end (114), the catheter member configured for movement within the inner passage. The introducer tip is configurable in a compressed state having a first width and an expanded state having a second width greater than the first width, and is movable from the compressed state to the expanded state in response to movement of the catheter member through the inner passage in an insertion direction.

Description

CATHETER ASSEMBLY HAVING EXPANDABLE INTRODUCERDESCRIPTIONTECHNICAL FIELD

[0001] The present disclosure generally relates to a urinary catheter assembly, and more particularly, to a urinary catheter assembly having an expandable 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 is equal 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 compressed state for insertion into the urethra and an expanded state while inserted in the urethra. In the compressed state, the introducer tip has a first width or diameter to facilitate relatively easy and comfortable insertion of the introducer tip into the urethra, and in the expanded state, and a second width greater than the first width, in which a catheter member may be accommodated in the introducer tip for intermittent catheterization.SUMMARY

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

[0008] In one aspect, a urinary catheter assembly includes an introducer tip having a tip proximal end, a tip distal end, and an inner passage extending between the tip proximal end and the tip distal end. The introducer tip also includes an outer part and a folding part. The urinary catheter assembly also includes a catheter member having a catheter proximal end and a catheter distal end, the catheter member configured for movement relative to the introducer tip within the inner passage. The introducer tip is configurable in a compressed state having a first width and an expanded state having a second width greater than the first width, and is movable from the compressed state to the expanded state in response to movement of the catheter member through the inner passage in an insertion direction. In the compressed state, the inner passage has a first passage width in the introducer tip, and in the expanded state, the inner passage has a second passage width in the introducer tip greater than the first passage width.Brief Description of Drawings

[0009] FIG. 1 is a cross-section view showing an example of a urinary catheter assembly having an introducer tip configured in a compressed state;

[0010] FIG. 2 is a cross-section view showing the urinary catheter assemblyof FIG. 1 with the introducer tip configured in an expanded state;

[0011] FIG. 3 is a perspective view showing another example of an introducer tip of a catheter assembly configured in a compressed state;

[0012] FIG. 4 is an end view showing a tip proximal end of the introducer tip of FIG. 3 configured in the compressed state;

[0013] FIG. 5 is a perspective view showing the introducer tip of FIG. 3 configured in an expanded state;

[0014] FIG. 6 is an end view showing a tip proximal end of the introducer tip of FIG. 3 configured in the expanded state;

[0015] FIG. 7 is a perspective view showing another example of a urinary catheter assembly having an introducer tip configured in a compressed state;

[0016] FIG. 8 is a perspective view showing the urinary catheter assembly of FIG. 7 with the introducer tip configured in an expanded state;

[0017] FIG. 9 is an end view showing a tip proximal end of the introducer tip of FIG. 7 configured in the compressed state;

[0018] FIG. 10 is a perspective end view showing another example of an introducer tip having a split fold portion;

[0019] FIG. 11 is a perspective end view showing another example of an introducer tip configured in a compressed state and having tri-fold portions;

[0020] FIG. 12 is a perspective end view showing the introducer tip of FIG. 11 with one of the tri-fold portions partially unfolded; and

[0021] FIG. 13 is a perspective end view showing the introducer tip of FIG. 11 with one of the tri-fold portions unfolded.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 and 2, a urinary catheter assembly 10according to present embodiments generally includes an introducer body 11 having an introducer tip 12 and a catheter member 110. The introducer tip 12 has a tip proximal end 14, a tip distal end 16 and an inner passage 18 extending between the tip proximal end 14 and the tip distal end 16. As shown in FIG. 1 , the introducer tip 12 is configurable in a compressed state to have a first outer width W1 or outer diameter, which corresponds to a state in which the catheter member 110 does not extend through the inner passage 18 of the introducer tip 12. W1 and the other widths disclosed herein are cross-sectional widths taken in a plane that is perpendicular to the longitudinal axis of catheter assembly. As shown in FIG. 2, the introducer tip 12 is also configurable in an expanded state to have a second outer width W2 or outer diameter, greater than the first outer width W1 . The expanded state corresponds to a state in which the catheter member 110 has been advanced in an insertion direction D1 to extend through the inner passage 18 of the introducer tip 12.

[0024] In addition, in the compressed state, the inner passage 18 has a first passage width W3 or diameter (FIG. 1), and in the expanded state, the inner passage 18 has a second passage width W4 or diameter (FIG. 2) greater than the first passage width W3. As described further below, the first passage width W3 is relatively small such that the catheter member 110 may be substantially enclosed within the introducer body 11 in the compressed state. In some alternatives, the first passage width W3 is less than the outer diameter of catheter member 110. Accordingly, the catheter assembly 10, with the introducer tip 12 in the compressed state, may be handled by user without the user interacting with or contacting a proximal portion of the catheter member. Thus, exposure of the proximal portion of the catheter member 110 to bacteria or other pathogens through user contact may be substantially avoided. Further, in the compressed state, the introducer tip 12 may substantially enclose the catheter member 110 in the introducer body 11 without a separate cap or other protective cover attached to the introducer tip 12. In the expanded state, the second passage width W4 is substantially the same as, or slightly larger than an outer width or diameter of the catheter member 110. In use, the second width W4, which corresponds to an inner width or diameter of the introducer tip 12, contacts an outer surface of thecatheter member 110 and generally matches an outer profile of the catheter member 110.

[0025] The catheter member 110 has a catheter proximal end 112 and a catheter distal end 114. In the compressed state of the introducer tip 12, the catheter proximal end 112 may be disposed distal of tip proximal end 14, and in some examples distal of the tip distal end 16 as well. The catheter member 110 is configured for movement in the inner passage 18 in the insertion direction D1 such that the catheter member 110 may extend outward from the tip proximal end 14. Such movement of the catheter member 110 moves the introducer tip 12 from the compressed state to the expanded state. That is, the introducer tip 12 is movable from the compressed state to the expanded state in response to movement of the catheter member 110 through the inner passage 18 in the insertion direction D1 . In the expanded state, the catheter proximal end 112 is arranged proximally to the tip proximal end 14.

[0026] The catheter member 110 may be formed as an elongated hollow member extending between the catheter proximal end 112 and the catheter distal end 114. For example, the catheter member 110 may be formed having a tubular wall portion 116 surrounding a hollow interior 118 (FIG. 2). One or more openings 120 (also referred to a “drainage eyes”) may be provided through the tubular wall portion 116 at or adjacent to the catheter proximal end 112. In this manner, with the catheter member 110 inserted in the bladder, bodily fluid from the bladder may be received in the hollow interior 118 through the one or more openings 120 to drain the bladder.

[0027] Advancement of the catheter member 110 to extend outwardly from the tip proximal end 14 may be part of a catheterization procedure. In the catheterization procedure, the catheter proximal end 112 may be disposed in the user’s bladder, while the catheter distal end 114 is arranged distally of the tip distal end 16 and may be connected, for example, to a drainage or collection bag (not shown) to collect fluid drained from the bladder or connected to a drainage member for directing urine into a receptacle, such as a toilet.

[0028] Referring to FIGS. 3 and 4, and with continued reference to FIGS. 1 and 2, in some embodiments, the introducer tip 12 includes an outer part 20 and afolding part 22. In the compressed state, the folding part 22 is folded within the outer part 20 such that an outer periphery or circumference of the introducer tip 12 is formed primarily by the outer part 20, and the inner passage 18 is bounded primarily by the folding part 22. Thus, in the compressed state, the first width W1 is formed by the outer part 20 and the first passage width W3 is formed by the folding part 22. Accordingly, the first width W1 of the introducer tip 12 may be a width or diameter measured between opposing points on an outer surface of the outer part 20, and the first passage width W3 may be a width or diameter measured between opposing points on an inner surface of the folding part 22.

[0029] With reference to FIGS. 5 and 6 in addition to FIGS. 1-4, in the expanded state, the folding part 22 is unfolded from the outer part 20 such that the outer periphery or circumference of the introducer tip 12 is formed by portions of outer surfaces of both the outer part 20 and the folding part 22. The inner passage 18 is also formed by portions of inner surfaces of both the outer part 20 and the folding part 22. Thus, in the expanded state, the second width W2 and the second passage width W4 are both formed by a combination of the outer part 20 and the folding part 22. Accordingly, the second width W2 of the introducer tip 12 may be a width or diameter measured between opposing points on the outer part 20, the folding part 22, or both. Similarly, the second passage width W4 may be a width or diameter measured between opposing points on the outer part, the folding part 22, or both.

[0030] As shown in FIG. 4, in some examples, the outer part 20 includes a plurality of outer parts or outer part sections 20a and the folding part 22 includes a plurality of folding parts or folding part sections 22a. The outer part sections 20a and the folding part sections 22a maybe alternately positioned with one another. The outer part 20 and the folding part 22 may be formed as a single, continuous piece or section, such that the folding part 22 is integrally connected to the outer part 20.

[0031] With general reference to FIGS. 1-9, the introducer tip 12 may include an insertion end 24 extending along a portion of a length of the introducer tip 12 to the tip proximal end 14. As shown in the examples of FIGS. 1 , 3 and 7, in the compressed state, the insertion end 24 may extend radially inwards along adirection toward the tip proximal end 14. In the expanded state, as shown in the examples of FIGS. 2, 5 and 8, the insertion end 24 is displaced radially outward by the catheter member 110, such that a width or diameter of the tip proximal end is greater in the expanded state than in the compressed state. In some examples, in the expanded state, the introducer tip 12 may have a substantially constant width or diameter along its length.

[0032] Referring now to FIGS. 3, 4, 7 and 9, in the compressed state, the outer part 20 and the folding part 22 at the insertion end 24 are arranged substantially in a star-shape about a longitudinal axis of the inner passage 18. That is, folds of the folding part 22 are folded inwards relative to the outer part 20 at the insertion end 24 (including at the tip proximal end 14) to resemble a shape of star in an end view along the longitudinal axis. In this manner, unfolding of the folding part 22 allows for the width of the introducer tip 12 to be expanded or increased when moved to the expanded state. In some examples, the introducer tip 12 includes creases, scores, perforations or other suitable, similar features to promote folding, and / or remaining in the compressed state prior to use, at predetermined locations and / or in predetermined patterns or shapes.

[0033] When moving from the compressed state to the expanded state, the width of the introducer part 12 may be increased by one or more movements of the outer part 20 and / or the folding part 22 relative to one another. Such movements may include, but are not limited to, a circumferential sliding movement, a tangential linear movement, a radial linear movement, a rotational movement including a twisting or unwinding movement, and / or various combinations of such movements.

[0034] With reference now to FIGS. 1-3, 5, 7 and 8, the catheter assembly 10 according to the present examples may further include a grip portion 26 connected to the introducer tip 12. In one example, the grip portion 26 and the introducer tip 12 are continuous with one another and form at least a portion of the introducer body 11 . The grip portion 26 may be connected to the tip distal end 16 and extend distally from the tip distal end 16. The grip portion 26 includes a grip proximal end 28 and a grip distal end 30 opposite to the grip proximal end 28. The inner passage 18 extends through the grip portion 26. In this manner, the cathetermember 110 may be advanced in insertion direction D1 within the inner passage 18 through the grip portion 26 and the introducer tip 12.

[0035] The grip portion 26 may also include a flange 32 generally arranged at the grip proximal end 28 and connected to the introducer tip 12. As shown in FIG. 6, the flange 32 has flange width W5 which is greater than the second width W2 of the introducer tip 12. In some examples, the flange 32 may function as a positioning aid or insertion stop in a catheterization process. For example, the user may insert the insertion tip 12 into the urethra until the flange 32 contacts the urethral opening, thereby indicating sufficient insertion of the insertion tip 12. Subsequently, the catheter member 110 may be advanced through the inner passage 18 to move the insertion tip 12 to the expanded state, and then may be further advanced within the urethra and into the bladder to drain the bladder.

[0036] As shown in FIGS. 1 and 2, the inner passage 18 has a third passage width W6 (FIG. 1) in the grip portion 26 that is greater than the second passage width W4 (FIG. 2) in introducer tip 12 when expanded. In addition, the catheter member 110 has a catheter width W7 that is less than the third passage width W6. In this manner, the catheter member 110 may be received in the inner passage 18 in the grip portion 26 with little to no interference, before advancing through the inner passage 18 of the introducer tip 12 in a catheterization process.

[0037] In further examples, in the compressed state, the catheter proximal end 112 may be arranged distal of the grip proximal end 28. For example, the catheter proximal end 112 may be disposed in the inner passage 18 within the grip portion 26.

[0038] The catheter width W7 is greater than the first passage width W3. Thus, starting from the compressed state, the catheter proximal end 112 may be advanced into the inner passage 18 of the insertion tip 12 to expand the introducer tip 12 by way of interaction between an outer surface of the catheter member 110 and an inner surface of the introducer tip 12.

[0039] Further, in some examples, the catheter width W7 is greater than the first width W1 of the introducer tip 12. Thus, in the compressed state, the introducer tip 12 may have smaller width or diameter than the catheter member 110. A user or potential user of the catheter assembly 10 may find an introducertip 12 sized in this manner as having a less intimidating appearance than conventional introducer tips that are a substantially fixed size matching the diameter of a catheter tube. Moreover, the introducer tip 12 sized in such manner may, in use, be easier and / or more comfortable for the user to insert into the urethra than the larger conventional introducer tips.

[0040] For catheterization, the introducer tip 12, in the compressed state having first width W1 , is inserted into the urethra through the urethral opening. The insertion tip 12 may be advanced in the insertion direction D1 within the urethra until the flange 32 acts as a stop against the urethral opening. The insertion end 24, having a tapered width or diameter toward the tip proximal end 14 may provide further comfort to the user and assist with insertion into the urethra, as the leading end, i.e., the tip proximal end 14, may have an even smaller width or diameter than the first diameter W1 .

[0041] The catheter member 110 may be inserted into the inner passage 18 of the grip portion 26 and advanced in the insertion direction D1 toward the introducer tip 12. The catheter proximal end 112 is advanced into the inner passage 18 of the insertion tip 12 and causes the insertion tip 12 to expand due to interaction between the outer surface of the catheter member 110 and an inner surface of the insertion tip 12, for example, provided on the folding part 22.Further advancement of the catheter member 110 in the insertion direction D1 causes the catheter proximal end 112 to project from and extend beyond (i.e., further in the proximal direction) the tip proximal end 14 for advancement in the urethra to the bladder.

[0042] The introducer tip 12 is moved from the compressed state to the expanded state in response to advancement of the catheter member 110 through the inner passage 18 of the insertion tip 12. In the expanded state, the width or diameter of the insertion tip 12 is increased from the first width W1 to the second width W2 such that an outer surface of the introducer tip 12 is pressed against the urethra wall to adequately hold the introducer tip 12 in the urethra during catheterization. That is, the catheter member 110, when advancing through the introducer tip 12, applies an outward force against an inner surface of the introducer tip 12, due the differences in width of the catheter member 110 and theinner passage 18, and causes the introducer tip 12 to expand. The outward force applied from the catheter member 110 presses the outer surface of the introducer tip 12 against the urethra wall.

[0043] In the examples above, it will be appreciated that the first width W1 and the second width W2 of the insertion tip 12 may refer an outer width or diameter of the insertion tip 12, i.e., a width measured between opposing points on an outer surface of the outer part 20 and / or the folding part 22, and that the first passage width W3 and second passage width W4 may refer to an inner width or diameter of the insertion tip 12, i.e. a width measured between opposing points on an inner surface of the folding part 22 and / or the outer part 20. In addition, the flange width W5 may refer to an outer width or diameter of the flange 32, the third passage width W6 may refer to an inner width or diameter of the grip portion 26 (i.e., a width or diameter of the inner passage 18 in the grip portion 26), and the catheter width W7 may refer to an outer width or diameter of the catheter member 110.

[0044] FIGS. 10-13 illustrate various examples of introducer tips according to other aspects of the present disclosure. For example, in FIG. 10, an introducer tip 312 may be formed with a split fold 314. In such a configuration, the introducer tip 312 may include a split along at least a portion of its length which provides a section of circumferential overlap (also referred to as an “overlap section”).

[0045] Referring to the example of FIG. 10, the introducer tip 312 may include an outer circumferential end 316 and an inner circumferential end 318 spaced apart a circumferential distance C1. The overlap section includes an inner section 320 extending from the inner circumferential end 318 to a circumferential position corresponding to the outer circumferential end 316. This inner section 320 may form a folding part 322 or a portion of a folding part 322 of the introducer tip 312.

[0046] The overlap section also includes an outer section 324 extending from the outer circumferential end 316 to a circumferential position corresponding to the inner circumferential end 318. This outer section 324 may form an outer part 326, or a portion of an outer part 326, of the introducer tip 312.

[0047] In the compressed state, the inner circumferential end 318 is spacedfrom the outer circumferential end 316 by a first circumferential distance. In the expanded state, the inner circumferential end 318 is spaced from the outer circumferential end 316 by a second circumferential distance less than the first circumferential distance. In this manner, the introducer tip 312 may be moved from a compressed state having a first width W1 to an expanded state having a second width W2 greater than the first width W1.

[0048] In FIGS. 11-13, an introducer tip 412 may be formed with a tri-fold 414 instead of the split fold 314 described above with reference to FIG. 10. The introducer tip 412 may include one or more tri-folds 414. It will be appreciated that the tri-fold 414 is formed generally in the same manner as the split fold 314 above to include an outer circumferential end 416, an inner circumferential end 418, an inner section 420, and an outer section 424. In addition, the tri-fold 414 includes an intermediate part 428 connected to the inner circumferential end 418 and the outer circumferential end 416.

[0049] In the compressed state, the intermediate part 428 is folded between the inner section 420 and the outer section 424, and in the expanded state, the intermediate part 428 is at least partially unfolded from between the inner section 420 and the outer section 424. The intermediate part 428 may form the folding part 422 or a portion of the folding part 422 of the introducer tip 412. The inner section 420 may be considered as a portion of the folding part 422 as well. In addition, the outer section 424 may form the outer part 426 or a portion of the outer part 426 of the introducer tip 412.

[0050] In the example of FIG. 11 , the introducer tip 412 includes a plurality of tri-folds 414 and is shown in the compressed state. FIG. 12 shows the introducer tip 412 moving to the expanded state by partially unfolding one of the tri-folds 414 to increase a width of the introducer tip 412. In FIG. 13, the partially unfolded tri-fold 414 of FIG. 12 is fully unfolded to further increase a width or diameter of the introducer tip 412. Although the remaining tri-folds 414 in FIG. 13 are shown in folded state, it will be appreciated that these folded tri-folds 414 may be unfolded in the same manner as the unfolded tri-fold of FIG. 13. In this manner, the width or diameter of the introducer tip 412 may be further increased and the introducer tip 412 may be configured in the expanded state.

[0051] 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: an introducer tip having a tip proximal end, a tip distal end, and an inner passage extending between the tip proximal end and the tip distal end, the introducer tip comprising an outer part and a folding part; and a catheter member having a catheter proximal end and a catheter distal end, the catheter member configured for movement relative to the introducer tip within the inner passage, wherein the introducer tip is configurable in a compressed state having a first width and an expanded state having a second width greater than the first width, and is movable from the compressed state to the expanded state in response to movement of the catheter member through the inner passage in an insertion direction, and wherein in the compressed state, the inner passage has a first passage width in the introducer tip, and in the expanded state, the inner passage has a second passage width in the introducer tip greater than the first passage width.

2. The urinary catheter assembly according to claim 1 , wherein in the compressed state, the folding part is folded within the outer part, and in the expanded state, the folding part is unfolded from the outer part.

3. The urinary catheter assembly according to claim 1 or 2, wherein the outer part includes a plurality of outer parts and the folding part comprises a plurality of folding parts alternately positioned with the outer parts.

4. The urinary catheter assembly according to any of claims 1-3, wherein in the compressed state, the first width is formed by the outer part, and in the expanded state, the second width is formed by a combination of the outer part and the folding part.

5. The urinary catheter assembly according to any of claims 1-4, wherein the introducer tip includes an insertion end extending along at least a portion of a length of the introducer tip to the tip proximal end, wherein in the compressed state, the insertion end extends radially inward.

6. The urinary catheter assembly according to claim 5, wherein in the compressed state the outer part and the folding part at the insertion end are starshaped about a longitudinal axis of the inner passage.

7. The urinary catheter assembly according to claim 5 or 6, wherein in the expanded state, the insertion end is displaced radially outward from the compressed state.

8. The urinary catheter assembly according to any of claims 1-4, wherein the outer part and folding part are formed as a single, continuous section.

9. The urinary catheter assembly according to any of claims 1-8, wherein in the compressed state, the catheter proximal end is arranged distal of the tip proximal end, and in the expanded state, the catheter proximal end is arranged proximal of the tip proximal end.

10. The urinary catheter assembly according to any of claims 1-9, further comprising a grip portion connected to the introducer tip, the grip portion having a grip proximal end and a grip distal end opposite to grip proximal end, wherein the inner passage extends through the grip portion.

11. The urinary catheter assembly according to claim 10, wherein the grip portion further comprises a flange arranged at the grip proximal end connected to the introducer tip.

12. The urinary catheter assembly according to claim 11 , wherein the flange has a flange width greater than the second width.

13. The urinary catheter assembly according to any of claims 10-12, wherein the inner passage has a third passage width in the grip portion greater than the second passage width.

14. The urinary catheter assembly according to any of claims 10-13, wherein the catheter member has a catheter width less than the third passage width.

15. The urinary catheter assembly according to any of claims 10-14, wherein in the compressed state, the catheter proximal end is arranged distal of the grip proximal end.

16. The urinary catheter assembly according to any of claims 1-15, wherein the catheter member has a catheter width greater than the first passage width.

17. The urinary catheter assembly according to any of claims 1-16, wherein the catheter member has a catheter width greater than the first width.

18. The urinary catheter assembly according to any of claims 1 -17, wherein the catheter member includes a tubular wall portion surrounding a hollow interior and one or more openings in the tubular wall portion adjacent to the catheter proximal end, wherein the hollow interior is configured to receive a bodily fluid through the one or more openings.

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