Urinary catheter and method of catheterizing the bladder using an actively deflectable urinary catheter and deflection mechanism - Patents.com

Abstract

A urinary catheter with a deflectable tip is configured to be inserted into a patient's urethra and comprises a hollow catheter body having an elongated section, a tip portion near the distal end of the elongated section, and an engagement portion spaced from the distal end by which a user can grasp the catheter, wherein the tip portion is deflectable for the purpose of steering the catheter within the urethra and allowing the catheter to follow the natural curvature of the urethra, and the tip portion is movable from a generally straight state to a deflected state in which the tip portion is deflected when the elongated section is generally straight.

Description

[Technical field]

[0001] The present invention relates to a urinary catheter and method of catheterizing the bladder of a male patient using an actively deflectable urinary catheter and deflection mechanism. [Background technology]

[0002] Insertion of a bladder catheter into a male patient's urethra will be required in many medical situations. This is a common task for hospital medical and nursing staff, and the curvature of the male urethra can make this a difficult procedure when passing it up through the prostate, especially if there has been previous prostate surgery. When difficulties are encountered, a urological surgeon is often called in to assist.

[0003] Currently, there are three options commonly used for catheterization of the male urethra: simple straight flexible urethral catheters, fixed curvature coude-tipped catheters, and simple straight catheters inserted with a rigid catheter introducer.

[0004] A simple straight flexible urinary catheter is simply lubricated and pushed up the urethra and in most cases will follow the natural curvature of the urethra and enter the bladder without significant trauma to the urethra. The flexibility of a generally straight urinary catheter is limited because the catheter needs to be stiff enough to be pushed up the urethra. If the urethra is not straightened by the catheter, this limited flexibility will not be sufficient to allow the catheter to follow the curvature of the urethra, resulting in urethral damage or so-called "false passages" in the urethral wall.

[0005] Furthermore, if the urethral covering is slightly irregular, or if there is scarring or larger abnormalities in the urethral canal, the catheter will not pass easily and very often the catheter tip will cause at least some damage to the urethra. Studies have shown that catheter insertion can be difficult in up to 20% of cases. Currently available generally straight catheters do not allow steering during the catheter insertion process.

[0006] In an attempt to solve this problem, catheters with fixed curved tips (coude tips) have been conceived and produced to facilitate passage of the catheter around the curved urethra. However, these catheters are not truly steerable and will only pass easily if the curvature of a particular urethra happens to be the same as the curvature of the catheter tip. The constant curvature of the catheter tip also often makes it difficult for the catheter to pass through the distal portion of the urethra, which is straight. In practice, the curvature chosen during the design of a coude tip catheter is a compromise between the full angle of the curved urethra and the zero angle of the straight portion of the urethra.

[0007] When using a catheter introducer, this curved, rigid metal rod is inserted into a simple, straight, flexible catheter before the catheter is passed up the urethra. The rod is curved to fit the entire curvature of the male urethra, so that passing up the straight portion of the urethra would be difficult and potentially dangerous, but is shaped with an angle of curvature large enough to fit the entire curvature of the urethra. The catheter introducer is rigid and would cause great trauma to the urethra if not inserted perfectly. For this reason, catheter introducers are not typically used by any medical professional who is not a practicing urologist.

[0008] As a result of the above problems, there is a need for a new catheter design that would have all or most of the advantages of both coude-tip catheters and introducers, while having few or preferably none of the disadvantages. What is needed is a truly steerable urethral catheter.

[0009] Steerable devices, including telescopes and catheters, have been developed to navigate through many body organs, including the intestines and blood vessels (e.g., GB1116317, CN1088536689, and CN203183482), as well as through urinary tract sites, including the bladder and kidneys. These devices utilize various types of steering mechanisms, which may include steering wires and steering control mechanisms. Navigation may be achieved by direct visualization through a telescope (e.g., WO2014043586) or camera, or by radiological guidance using various modes, including fluoroscopy (e.g., WO2019152727). Each device will have individual characteristics to suit its particular body location and the exact purpose for which it is intended, but would be entirely unsuitable for use as a steerable urinary catheter within the urethra itself.

[0010] As an example, the cystoscopy catheter described in WO2014043586 is designed to function both as a flexible and potentially steerable sheath for cystoscopic or therapeutic instruments in the bladder, and as an indwelling bladder catheter, but is not designed to be deflected within the urethra or to facilitate passage of the catheter up the urethra.

[0011] As another example, the catheter in WO2019152727 is designed to be deflectable only within the kidney, and is not designed to deflect within the urethra, to easily pass the catheter up the urethra, or to drain the bladder.

[0012] As discussed above, due to the curved and irregular shape of the male urethra, a major challenge in treating male patients requiring a urinary catheter is actually passing the catheter up the urethra and into the bladder. Previous catheter designs have not been able to adequately manipulate the catheter within the urethra to accommodate the individual anatomy of the urethra into which it is being catheterized. What is needed is a steerable catheter with specific design features that make it suitable for this purpose. These features differ in many ways from devices that may have been designed to be steerable in other parts of the urinary system.

[0013] Insertion of a catheter into the bladder via the urethra needs to be performed in the community, in the patient's residence, in a doctor's office, in an emergency department, and in a hospital room. Therefore, it needs to be possible to perform catheter insertion in many cases without the need for telescopic or radiological guidance, which are too expensive and impractical to be routinely used for what are generally minor procedures. Therefore, as described further below, the catheter needs to be insertable by touch or "feel."

[0014] The procedure also needs to be suitable for being performed by the community, hospital nurses, other health care workers, inexperienced doctors and in some circumstances even by the patients themselves (self-catheterization), and complex steering mechanisms are entirely unsuitable for such purposes.

[0015] A suitable catheter should be specifically designed to be steerable within the urethra, without the multi-directional deflection or rotation required within the bladder or kidney, due to the particular anatomical characteristics of the urethra as compared to other parts of the urinary system, and the design should also take into account anatomical reasons that may obstruct the catheter, as will be described in more detail below and illustrated in the figures.

[0016] The angle of curvature of a catheter designed to be steered in the male urethra is quite different from the angles required for catheters or telescopes designed to function optimally in the bladder or kidney. In particular, the curvature of the urethra is usually greater than 45° upwards and not more than 90°. On the other hand, the angle of curvature of a catheter in the kidney must be sharp, ideally greater than 90° in the opposite direction, and have a much smaller radius of arc when fitted within the dense region of the renal collecting system. To obtain the total arc of deflection, the deflectable portion of the tip must be significantly longer, on the order of 5-6 cm. A deflectable device in the bladder must also be deflectable greater than 90° if it is to be able to reach the entire surface of the bladder, including the bladder neck, and the arc of deflection will usually be much smaller than the gradual deflection that is optimal for the urethra. Deflection of a catheter in the urethra at such a sharp angle will only result in the tip of the catheter impinging on the anterior wall of the urethra.

[0017] Because the proximal urethra does not deflect laterally but follows a curved path in the same sagittal plane, the catheter need only be able to deflect upward from the horizontal, and need not be laterally deflectable or rotatable. Therefore, because there is only normal urethral variation in its length and the actual angle of upward curvature, an ideal actively deflectable catheter need only be able to deflect between 0° and 90° to the horizontal in the same sagittal plane. When traction is reduced or removed, the catheter's natural elastic recoil will result in the catheter tip straightening, so only one active deflection in the upward direction is necessary.

[0018] Thus, a fully steerable device is not required, and there is no need for the larger, heavier, and more complex steering mechanisms that would be required for the bladder or kidneys. Such complex mechanisms would be expensive to manufacture and would be unlikely to be suitable for disposable use, a practical requirement for urinary catheters. Moreover, complex mechanisms would also be unlikely to be removable, a highly desirable feature of a deflection mechanism incorporated into a urinary catheter.

[0019] The anatomy of the male urethra is shown in Figure 1. It can be seen that for successful catheterization, the catheter must pass through a number of potential obstruction sites. The path begins at the generally straight penile urethra 110 before encountering the first obstruction at the curved junction of the bulbar urethra 112 and membranous urethra 114. The catheter must then pass through the prostatic urethra 116 before traveling through the bladder neck 118 and entering the bladder 120.

[0020] 2-4, the catheter insertion process is illustrated first using the straight catheter 122a of FIG. 2 and further using the curved coude-tip catheter 122b.

[0021] Just prior to inserting the tip of the catheter into the urethra, it is important that the user manually apply traction to the penis to stabilize it and straighten the penile urethra 110, thereby allowing the catheter tip to more easily pass through this portion of the urethra without resistance. While such traction straightens the penile urethra, the prostatic, membranous, and bulbar portions of the urethra remain fixed relative to the surrounding structures, and the upward curvature of the urethra from the bulbar urethra to the bladder neck is not significantly straightened by such traction. Thus, the catheter needs to be able to pass through the straight portion of the penile urethra, but also needs to be able to pass upward through the curved proximal urethra.

[0022] The catheter is introduced with a lubricant into the penile (distal) urethra and threaded along the straightened distal urethra. This is usually the easiest part of catheter insertion, provided the catheter is straight and the urethral canal is anatomically normal.

[0023] 2, it can be seen that the straight catheter 122a easily passes through the generally straight penile urethra 110, but once the catheter tip reaches the curved junction of the bulbar urethra 112 and membranous urethra 114, difficulties can arise as the generally straight catheter encounters a curve in its path, and significant urethral trauma can now be caused if maneuvering does not proceed. The angle of the curve is typically 45° to 90°, requiring either a significant distortion of the urethra to accommodate the straight catheter or a significant deflection of the catheter to accommodate the curved urethra.

[0024] The problem of having to navigate a catheter through a curved path is mitigated somewhat in catheter 122b (FIGS. 3 and 4) by the curvature of its tip, but impingement of the tip against the anterior wall of the straight penile urethra 110 during insertion can occur and can occur again at the junction of the bulbar urethra 112 and membranous urethra 114, particularly at location X1 shown in FIG. 3.

[0025] As shown in Figure 4, certain angles of the catheter tip are not sharp enough to pass upwards towards the bladder neck, resulting in penetration of the prostatic urethra 116 at location X2, creating a false passageway. Once the false passageway is created, it can become more difficult to pass the catheter 122b into the bladder 120, as the tip will simply re-enter the false passageway created, usually at location X2, as shown in Figure 5. This is a very common scenario in which urinary catheter routing is attempted.

[0026] 6 illustrates a further difficulty with using catheter 122b. In this case, the patient has previously had the prostate removed by previous prostate surgery, such as a TURP (Transurethral Resection of the Prostate) procedure. Catheter 122b impinges below bladder neck 118, preventing catheter 122b from advancing into bladder 120 for successful catheterization. [Prior art documents] [Patent documents]

[0027] [Patent Document 1] GB1116317 [Patent Document 2] CN1088536689 [Patent Document 3] CN203183482 [Patent Document 4] WO2014043586 [Patent Document 5] WO2019152727 Summary of the Invention [Problem to be solved by the invention]

[0028] The above problems indicate that there is a need for a new type of catheter suitable for insertion through the urethra into the bladder, with a deflectable tip of the catheter configured for the specific anatomy of the male urethra and a steering mechanism designed for the requirements of a single-use device.

[0029] The deflection mechanism should preferably be simple, cost effective, very lightweight, easy and inexpensive to manufacture, insensitive to contact with fluids, allow for easy sterilization of the catheter, preferably free of metal components (so that it does not need to be removed from patients requiring MRI scans), easily operable with one finger by persons with disabilities, preferably easily and completely removable without affecting catheter function, and / or at least provide a useful alternative to those currently available. [Means for solving the problem]

[0030] According to one aspect of the present invention, a urinary catheter is provided, the urinary catheter comprising a hollow catheter body configured to be inserted into a patient's urethra, the hollow catheter body having an elongated section, a tip portion near a distal end of the elongated section, and an engagement portion spaced from the distal end by which a user can grip the catheter, the tip portion being deflectable to steer the catheter within the urethra and enable the catheter to follow the natural curvature of the urethra, the tip portion being movable from a generally straight state to a deflected state in which the tip portion is deflected when the elongated section is generally straight, the catheter body comprising a main passageway formed therein for draining urine from the bladder, and at least one additional passageway formed away from the main passageway and capable of accommodating a flexible steering member, each additional passageway extending from the distal end to a position near the engagement portion, the steering member secured within the additional passageway at the tip portion and configured to be engaged by a user outside the catheter to deflect the tip portion.

[0031] According to a preferred embodiment of the invention, the hollow catheter body narrows at the tip.

[0032] Preferably, the wall thickness of the hollow catheter body decreases at the tip section. Preferably, the tip section is configured to deflect around an arc that begins at the intersection of the elongated section and the tip section, and to be generally straight at its distal end.

[0033] Preferably, the elongate portion is stiffer than the tip portion and is configured to remain substantially straight during use. Preferably, the tip portion has a length of about 2cm to 4cm, although it may be less than 2cm or greater than 4cm. Preferably, the tip portion is configured to deflect in a plane coinciding with the longitudinal axis of the elongate portion. Preferably, the tip portion is deflectable up to an angle of 90°.

[0034] Preferably, the catheter includes first and second additional passages, each of which accommodates a steering member and are angularly spaced apart from one another for deflecting the tip of the catheter body without lateral twisting within the urinary tract.

[0035] The first and second paths may be spaced apart from one another at an angle of about 40 degrees.

[0036] The catheter may further include an inflatable balloon spaced from the flexible tip, and a balloon inflation path extending between the balloon and a connector at the proximal end of the catheter for communicating fluid to the balloon for inflation.

[0037] Preferably, the steering member is a nylon string or similar synthetic polymer string.Preferably, the catheter further comprises an engagement member coupled to an end of the steering member for engagement by a user to deflect the tip.

[0038] Preferably, the engagement member is biased to an upright position to facilitate actuation by the user's fingers. More preferably, the engagement member is biased to the upright position by pulling on the steering member. Alternatively, the engagement member is shaped to rest on the catheter body in an upright position. In such an embodiment, the engagement member may have a concave base that abuts an outer surface of the catheter body. Alternatively, the engagement member is a lever connected to the exterior of the catheter body at a point about which it can pivot.

[0039] According to another aspect of the present invention there is provided a method of inserting a catheter into the bladder of a male patient, said method comprising: Providing a catheter of the type described above; inserting the catheter into the patient's urethra; and deflecting the tip once the catheter is inserted into the urethra to steer the catheter through the urethra.

[0040] The method may further comprise the step of slightly retracting the catheter if resistance is encountered during insertion, and then deflecting the tip as the catheter is re-advanced within the urethra.

[0041] In order that the invention may be more readily understood, embodiments will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0042] [Figure 1] FIG. 1 illustrates the anatomy of the male urethra. [Diagram 2] FIG. 1 illustrates a conventional straight catheter and illustrates an attempted insertion of the catheter into the urethra. [Diagram 3] FIG. 1 shows a coude-tipped catheter and attempted insertion of the catheter into the urethra. [Figure 4] FIG. 1 shows a coude-tipped catheter and attempted insertion of the catheter into the urethra. [Diagram 5] FIG. 1 shows a coude-tipped catheter and attempted insertion of the catheter into the urethra. [Figure 6] FIG. 1 shows a coude-tipped catheter and attempted insertion of the catheter into the urethra. [Figure 7a] FIG. 1 is a side view of a urinary catheter in an undeflected state in accordance with one embodiment of the present invention. [Figure 7b] FIG. 7b is a side view of the catheter of FIG. 7a in use in a deflected state. [Figure 8a] FIG. 13 is a side view of a urinary catheter in an undeflected state in accordance with another embodiment of the present invention. [Figure 8b] FIG. 8b is a side view of the catheter of FIG. 8a in use in a deflected state. [Figure 9] FIG. 7b is a close-up view of the catheter of FIG. 7a. [Figure 10a] 10 is a cross-sectional view of the catheter of FIG. 9, showing a cross-section along line AA of FIG. 9. [Figure 10b] 10 is a cross-sectional view of the catheter of FIG. 9, showing a cross-section along line BB of FIG. 9. [Figure 11] FIG. 8b is a close side view of the catheter of FIG. 8a showing the operation of the engagement member. [Figure 12a] 12 is a cross-sectional view of the catheter of FIG. 11, showing a cross-section along line CC of FIG. 11. [Figure 12b] 12 is a cross-sectional view of the catheter of FIG. 11, showing a cross-section along line DD of FIG. 11. [Figure 13a] 10b is a cross-sectional view of a catheter according to another embodiment of the present invention, showing a cross-section taken at a position corresponding to that of FIG. 10a. [Figure 13b] 10b is a cross-sectional view of a catheter according to another embodiment of the present invention, showing a cross-section taken at a position corresponding to that of FIG. 10b. [Figure 14a] 12 is a cross-sectional view of the catheter of FIG. 11, showing a cross-section along line CC of FIG. 11. [Figure 14b] 12 is a cross-sectional view of the catheter of FIG. 11, showing a cross-section along line DD of FIG. 11. [Figure 15] FIG. 2 is a side view of a urinary catheter according to another embodiment of the present invention. [Figure 16] FIG. 2 is a side view of a urinary catheter in which an engagement member is manipulated by a user. [Figure 17] FIG. 2 is a plan view of a urinary catheter showing a configuration of an engagement member that allows a patient to insert the catheter themselves and use the thumb of the inserting hand to manipulate the engagement member. [Figure 18] A catheter of one embodiment of the present invention is shown in the process of inserting the catheter into the urethra, including following a previous transurethral resection of the prostate (TURP) (FIG. 21). [Figure 19] A catheter of one embodiment of the present invention is shown in the process of inserting the catheter into the urethra, including following a previous transurethral resection of the prostate (TURP) (FIG. 21). [Figure 20]A catheter of one embodiment of the present invention is shown in the process of inserting the catheter into the urethra, including following a previous transurethral resection of the prostate (TURP) (FIG. 21). [Figure 21] A catheter of one embodiment of the present invention is shown in the process of inserting the catheter into the urethra, including following a previous transurethral resection of the prostate (TURP) (FIG. 21). DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0043] 7a and 7b show a urinary catheter 10 according to a preferred embodiment of the present invention.

[0044] The urinary catheter 10 includes a hollow catheter body 12. The hollow catheter body 12 is configured to be inserted into a patient's urethra. The catheter body 12 is elongated and has a tip portion 16 near its distal end 13 and an engagement portion 18 spaced from the distal end 13 where a user can grasp the catheter. The tip portion 16 is deflectable to steer the catheter 10 within the urethra.

[0045] The hollow catheter body 12 has a drainage opening 14 at the distal end 13 of the catheter body 12 through which urine can drain from the bladder.

[0046] The catheter body engagement portion 18 may include a handle or grip (not shown) formed on the catheter body 12. In other embodiments, the engagement portion 18 may be formed on the catheter body 12 by having a contour with, for example, a recess, that can receive a finger.

[0047] The catheter body is preferably formed as a unitary piece from conventional material, i.e., silicone-based plastic, using conventional molding / molding techniques, although one of ordinary skill in the art will appreciate that other materials, such as, for example, latex rubber, may also be used.

[0048] 9-10b, the catheter body 12 has a main pathway 20 for draining urine from the bladder and at least one additional pathway 22 formed away from the main pathway 20, and a flexible steering member 24 may be housed in the additional pathway 22. In the embodiment of Figures 10a and 10b, one steering member 24 is used. In the embodiment of Figures 13a and 13b, two steering members are used.

[0049] The passageway(s) 22 extend from the distal end 13 to a location proximate the engagement portion 18, and the steering member 24 is secured within the passageway 22 at the distal end 13 by a plug 15 and configured at an opposite end for deflecting the tip 16 upon engagement by a user external to the catheter 10, such that the catheter 10 may be steered after insertion into the patient's urethra. Engagement of the steering member 24 at the end remote from the distal end 13 is via an engagement member 32, which will be described in more detail below.

[0050] The hollow catheter body 12 is configured to be deflectable at the tip 16. This allows the catheter 10 to mimic the angle of curvature of the urethra and facilitate insertion without the problems mentioned above. The tip 16 is thus actively deflectable by the user with careful movements, facilitating insertion of the catheter 10 into the urethra.

[0051] To accomplish this, in some embodiments, the tip 16 is manufactured to be more flexible than the catheter body, but still retain some resilience. After the user removes the force applied by the engagement member 32 to deflect the tip 16, the tip 16 will straighten, but will not return to a completely straight state due to the natural curvature of the patient's urethra.

[0052] If the entire catheter is made of a uniform material, deflection may also be achieved by narrowing the wall of the catheter body 12 at the tip 16, as shown in FIG. 9. In fact, unless the wall thickness of the deflectable portion of the catheter required is less than that of the remainder of the catheter shaft, the entire catheter will bend into a single arc when traction is applied to the steering member. Curving the entire length of the catheter shaft would actually make insertion of the catheter more difficult. The degree of reduction in wall thickness and the length of the thinned portion at the tip of the catheter need to be custom designed so that the catheter tip has an optimal shape and conforms to the shape of the curved portion of the urethra when traction is applied to the steering member. It is also advantageous to have a thinner wall of the catheter body 1, which makes the tip 16 softer, reducing the risk of injury to the urethra due to wall penetration.

[0053] In other embodiments, the catheter body 12 may be formed with deformation lines that are, for example, straight, curved, radial, or a combination thereof, to facilitate curving of the catheter body at the junction of the tip 16 and the catheter body 12. One skilled in the art will appreciate that other means of causing bending, buckling, kinking, or other distortion of the catheter body 12 are also possible.

[0054] Research has shown that the average length of the curved portion of the urethra in an adult male is 4-5 cm. For this reason, the arc of the deflectable tip of the catheter must be calculated to change direction at 90° over a distance of 4-5 cm. This calculated arc then applies to a deflectable tip that is preferably 2-4 cm long, although it may be longer or shorter. Preferably, the length of tip 16 is 2-4 cm for use with adult males, who are the most common users of such devices, although it will be understood that catheter 10 can be used in other sizes for use with males of other ages.

[0055] As will be described in more detail below, the tip 16 is configured to deflect in a plane coincident with the longitudinal axis of the elongate portion. This single-plane deflection, without lateral or sideways movement, is done to allow the catheter 10 to assume the shape of the urethra for ease of insertion.

[0056] Deflection of the tip 16 is possible through an angular range of 0° to 90°, allowing the catheter body 12 to follow the natural contours of the patient's urethra.

[0057] The hollow catheter body 12 may be narrowed at the tip 16 to also aid in the insertion of the catheter 10 into the urethra.

[0058] The catheter 10 also has a balloon passage 25 (FIGS. 9, 12a, and 12b) in the catheter body 12. The balloon passage 25 allows fluid, such as water, to be communicated from a connector 28 located near the proximal end 40 of the catheter body 12 to an inflatable balloon 26 which, when inflated, helps to hold the catheter 10 in place and allows the patient's bladder to be drained continuously, typically for days. The inflatable balloon 26 is spaced from the tip 16 and is preferably located near or within the deflected portion of the catheter 10. A valve 30 is provided to maintain the balloon 26 inflated for a desired period of time. The above components are typical of commonly used Foley urinary catheters. Although one balloon 26 is illustrated, it will be understood that multiple balloons may be used.

[0059] 13a and 13b, in another embodiment, the catheter body 12 has first and second additional passages 22a, 22b with steering members 24a, 24b housed therein, respectively. The first and second additional passages 22a, 22b are angularly spaced apart such that the steering members 24a and 24b of the passages 22a, 22b, respectively, provide stability to the deflection of the tip section 16 such that the deflection occurs in a plane passing through the midpoints of the steering members 24a, 24b to prevent the catheter tip from twisting upward.

[0060] In the illustrated embodiment, the first and second paths 22a, 22b are spaced apart at an angle of approximately 40. It will be understood that the angle may be less than 40° or greater than 40°.

[0061] In a preferred embodiment, the steering members are flexible nylon strings, although it will be appreciated that the steering members may be formed from other materials, particularly other polymers, and may have other configurations. Additionally, the steering members may comprise metallic members.

[0062] To enable a user to engage the steering member 24 and deflect the tip 16 of the catheter 10, the catheter 10 further includes an engagement member 32 that may be manipulated by a user. In one embodiment, as shown in Figures 7a and 7b, the engagement member 32 is a simple ring that is pulled to extend the steering member 24 and deflect the tip 16. In the embodiment shown in Figures 8a and 8b, the engagement member 32 is a lever.

[0063] The engagement member 32 is biased to an upright position to facilitate manipulation by the user. In this regard, by biasing the engagement member 32 to an upright position, a user can easily engage and manipulate the member 32 with one finger while using the remaining hand to hold the catheter 10 during introduction. Figures 11 and 16 show that the engagement member 32 is engaged and moved to manipulate the tip 16. During use, the user will use one hand to support the catheter body 12 at the engagement portion 18 while pointing the other hand further toward the distal end 13 in an attempt to manipulate the catheter 10. Thus, with limited dexterity, it is important to make the engagement member 32 as easy to use as possible.

[0064] In some embodiments, the engagement members 32 may be biased into the upright position by extension of the steering members 24. Figure 11 shows such a configuration.

[0065] The catheter body 12 may be marked to allow a user to estimate the angle of deflection of the tip 16.

[0066] In other embodiments, the engaging member 32 is shaped to rest on the catheter body 12 in an upright position. In the embodiment of Figures 12a and 12b, the engaging member 32 has a curved or concave base that contacts the exterior surface of the catheter body 12 at one point in the pivot arc. In another example, as shown in Figure 15, the catheter body 12 is formed with a recess into which the engaging member 32 rests.

[0067] As seen in Figures 12a, 12b, 14a, and 14b, the engagement member 32 has a rounded base 35 having a shape complementary to the outer surface of the hollow catheter 12 such that the engagement member 32 rests on the hollow catheter 12. As seen in Figures 12a, 12b, 14a, and 14b, the rounded base 35 is rounded laterally, but may also be generally flat in the depth dimension (as seen in Figure 11) so that it can rest on the catheter 12 in a generally stable manner for easy engagement by a user in use.

[0068] In the embodiment shown in Figure 14a, the rounded shape of the base 35 and the extension of the steering member 24 are sufficient to hold the engaging member 32 in a generally upright position. In the embodiment of Figures 14a and 14b, the engaging member 32 is formed with legs 37 that extend partially around the catheter body 12 and over a point 36 about which the engaging member 32 can pivot.

[0069] In the embodiment of Figures 12a, 12b, 14a, and 14b, the engagement member 32 functions as a lever that connects to the exterior of the catheter body 12 at point 34 (Figure 11). This provides a mechanical advantage and aids in deflection of the tip 16. As seen in Figures 12a, 12b, 14a, and 14b, a knob 36 is formed on the side of the catheter body 12 and a corresponding socket 38 is formed on the engagement member 32, which cooperate to pivotally support the engagement member 32 by legs 37 to allow movement of the engagement member 32. It will be appreciated that in other embodiments, the knob 36 may be formed on the engagement member 32 and the socket 38 may be formed on the catheter body 12. Again, it may be the base 35 of the engagement member 32, or the extension of the steering member 24 (or both) that maintains the engagement member 32 in the proper position and urges it upwardly for easy access by the user.

[0070] During manufacture of the engagement member 32, one or two holes may be incorporated into the engagement member 32 for receiving one or each steering member 24. Then, upon assembly, the engagement member 32 is "clipped" onto the catheter body 12, and the one or two steering members 24 can be pulled through the holes 23 in the engagement member 32 and secured using conventional fastening means.

[0071] The engaging members 32 are essentially clipped onto the catheter body 12 so that they can be easily removed after insertion. To do this, the engaging members 32 are actuated from a rest position to deflect the tip, and one or each steering member 24 is severed. After the steering members 24 are severed, the tip 16 returns to its rest and undeflected position, so that the steering members 24 may be pulled back into the passageway 22. The engaging members 32 can then be unclipped and discarded.

[0072] Aperture 33 is configured to allow a user to insert a finger therein to actuate engagement member 32. Engagement member 32 and aperture 33 may take other forms or shapes, such as an oval, or a more complex shape such as an inverted "trigger" shape, or may be a simple lever without aperture 33.

[0073] The engagement member 32 described above is a simple, reliable, and lightweight means of applying tension to the steering member 24 to deflect the tip 16. This is important when urinary catheters are often retained in the urethra for days at a time after insertion. Since the patient will potentially need to ambulate with the catheter in place and perform daily routines, a heavy or bulky deflection mechanism would be simply inadequate for the purpose. Thus, catheter steering systems used to address problems with curved anatomies in other medical fields are relatively large, heavy, and complex, and simply not suitable for use as urinary catheters.

[0074] The catheter 10 described above is configured for use in catheterizing the bladder of a male patient. In use, the catheter 10 is inserted into the patient's urethra and then the tip 16 is manipulated to facilitate insertion into the bladder. This is done by steering the catheter around the bend in the urethra by deflecting the tip as the catheter is inserted into the urethra. Manipulation of the tip 16 may simply be to remove the catheter from a position where it would otherwise be impacted or pushed in, and continue insertion.

[0075] The catheter insertion process using catheter 10 will be described in more detail with reference to FIGS.

[0076] As mentioned above, just prior to inserting the catheter tip into the urethra, it is important that the user manually apply traction to the penis to stabilize it and straighten the penile urethra 110, so that the catheter tip 13 can more easily pass through this portion of the urethra 110 without resistance.

[0077] The catheter 10 is introduced with a lubricant into the penile (distal) urethra and threaded along the straightened distal urethra 110. This is usually the easiest part of inserting the catheter 110, provided that the catheter 10 is straight and the urethral canal 110 is anatomically normal.

[0078] 18, it can be seen that the catheter 10 is inserted into a generally straight configuration and passes easily through the generally straight penile urethra 110. However, the urethral covering (mucosa) may actually be very irregular and bumpy, especially if there has been previous trauma, infection, instrumentation, or surgery. Urethral irregularities are particularly common after previous prostate surgery, especially TURP procedures.

[0079] As the catheter is gently pushed forward, if the tip hits any obstruction due to irregularities or imperfections in the urethral mucosa, the user can deflect the catheter tip slightly upwards and then gently push it further forward. This upward deflection of the catheter tip pulls the catheter tip away from the posterior wall of the urethra. If the tip cannot go any further, the catheter is then gently retracted, perhaps just a few millimeters, and the catheter tip is deflected a little further. If the catheter then moves forward, no further deflection is performed, and the catheter is pushed through until urine flows from the main catheter lumen.

[0080] With reference to the term "upward," one of ordinary skill in the art will understand that catheter insertion is typically performed with the patient lying on their back, and thus upward would be toward the ceiling, however, catheter insertion may also be performed with the patient lying on their side or prone, in which case the catheter insertion would be biased generally toward the front of the body.

[0081] As the catheter is pushed further forward after bypassing the obstacle, traction on the steering elements can be maintained, resulting in a persistent deflection of the catheter tip, or traction can be released, allowing the catheter tip to passively at least partially straighten before moving further forward. Releasing traction on the steering elements after passing the obstacle will reduce the risk of the deflected catheter tip impinging on the more proximal anterior urethral wall.

[0082] The entire insertion process is performed using only manual resistance sensation and does not rely on visual or radiological guidance, unlike other actively steerable devices.

[0083] When the catheter tip reaches the curved junction of the bulbar urethra 112 and membranous urethra 114, difficulties may arise as the generally straight catheter encounters a curvature in the passageway. When the user receives tactile feedback from the resistance of the tip in this position, the catheter 10 can be withdrawn slightly (perhaps just a few millimeters) and continued advancement of the catheter 10 will engage the engagement member 32 to deflect the tip, allowing the catheter 10 to pass without collision through the curved junction of the bulbar urethra 112 and membranous urethra 114. This avoids significant urethral trauma that could occur at this location, particularly at the false passageway formed at location X1, if it were not possible to maneuver further, as described in connection with FIG. 4.

[0084] As shown in FIGS. 18 and 19, tip deflection may be maintained using engagement member 32 as catheter 10 advances through prostatic urethra 116 and past bladder neck 118 into bladder 120. As shown in FIG.

[0085] Those skilled in the art will appreciate that the insertion process illustrated in connection with Figures 16-19 is much simpler and less traumatic to the local area than that shown in Figures 2-6. This may be especially the case if the patient has previously had their prostate removed by previous prostate surgery, such as a TURP procedure.

[0086] With the above-described configuration of the catheter, catheter insertion can be performed using only tactile feedback from the catheter.

[0087] Utilizing knowledge of the male urethra anatomy has enabled the design of a novel steerable urethral catheter that is specifically adapted for catheterization of the male urethra by anyone, including the patient himself, who can physically pass a urethral catheter. The steering control mechanism in the preferred embodiment is a simple, single member, trigger-like lever requiring a short, unidirectional movement of one finger. This single member can be manufactured very inexpensively from plastic and attached to a simple monofilament nylon string.

[0088] Many steerable devices designed in the past have required the force of metal wire steering elements, some of which are multifilament due to their flexibility. This new design allows for the use of nylon string as the steering member because its relatively large size does not require the force of steel, and sufficient deflection can be achieved with some elasticity in the steering element.

[0089] Advantages of a nylon steering element in a disposable catheter that may need to be retained in the bladder for several months are that it is inexpensive and easy to manufacture; it is easily attached to the catheter tip by heat fusion, a plastic plug, or adhesives; it can have enhanced gliding properties within a silicone passageway; it does not corrode with prolonged contact with fluids; there is no potential for allergies to the metal components; the catheter is easy to sterilize without modified sterilization techniques; it is resistant to biofilm and potential infection, especially compared to multifilament wires; there is no radiation reflection that would interfere with images in ultrasound, CT scan, or MRI; the inability to use metal parts in MRI scans necessitates removal of the catheter, if possible, before the MRI; and the string is easily cut with standard hospital scissors to remove the engagement member.

[0090] Many variations of the above-described embodiments will be apparent to those skilled in the art without departing from the scope of the invention. For example, catheter 12 may be other than round, for example oval, and may not have a uniform cross-sectional shape along its length.

[0091] Throughout this specification and the claims that follow, unless the context is inappropriate, the terms "comprises" and variations such as "a comprises" and "comprising" will be understood to mean the inclusion of the described component or step, or components or steps, but not to the exclusion of any other component or step, or components or steps.

[0092] Reference within this specification to any prior publication (or information derived therefrom) or to any known matter is not, and should not be taken as, an acknowledgment or admission or any form of suggestion that the prior publication (or information derived therefrom) or known matter forms part of the common general knowledge in the field of study to which this specification pertains. [Explanation of symbols]

[0093] 10 Urinary Catheters 12 hollow catheter body 13 Distal end 14 Drainage opening 15 Plug 16 Tip 18 Engagement part 20 Main Route 22 Additional Routes 24 Steering member 25 Balloon Route 26 Inflatable balloon 28 Connectors 29 Fixing points of steering members 30 Valve 32 Engagement member 33 Aperture 34 Pivot Point 35 Round base of engaging member 36 Knob 37 Leg of engagement member 38 Underbite 40 Proximal end of catheter body

Claims

1. 1. A urinary drainage catheter comprising: a hollow catheter body configured to be inserted into a patient's urethra, the hollow catheter body having an elongated section, a tip portion near a distal end of the elongated section, and an engagement portion spaced from the distal end by which a user can grasp the catheter, the tip portion having an opening towards a side, the tip portion having a closed and rounded tip, the hollow catheter body being deflectable relative to the junction between the elongated section and the tip portion by a reduction in diameter of the hollow catheter body at the junction and a reduction in wall thickness of the hollow catheter body at the junction for the purpose of steering the catheter within the urethra, allowing the catheter to follow the natural curvature of the male urethra, the tip portion being movable from a generally straight state to a deflected state in which the tip portion is deflected when the elongated section is generally straight; the catheter body includes a main passageway formed therein for draining urine from a bladder, and at least one additional passageway formed away from the main passageway and capable of accommodating a flexible steering member, the lumen of each additional passageway extending from the distal end to a position proximate the engagement portion, the steering member being secured within the additional passageway at the tip portion and configured to be engaged by a user outside the catheter to deflect the tip portion; and an engagement member coupled to an end of the steering member for engagement by a user to deflect the tip within the urethra. A urinary drainage catheter, wherein the engagement member is biased to an upright position and protrudes from the hollow catheter body to facilitate single finger actuation.

2. In particular, a urinary drainage catheter according to claim 1, configured to navigate within the specific anatomy of the male urethra utilizing an actively deflectable tip.

3. A urinary drainage catheter as described in claim 1 or 2, wherein the reduction in wall thickness of the hollow catheter body at the connection portion is generally maintained throughout the tip portion.

4. 4. A urinary drainage catheter according to claim 1, wherein the tip section is configured to bend in one direction at the junction between the elongated section and the tip section.

5. A urinary drainage catheter according to any one of claims 1 to 4, wherein the elongated section is stiffer than the tip section and is configured to remain in a generally straight state during use.

6. A urinary drainage catheter according to any one of claims 1 to 5, wherein the length of the tip is between 2cm and 4cm.

7. 7. A urinary drainage catheter according to claim 1, wherein the tip is adapted to deflect unidirectionally in a plane coinciding with a longitudinal axis of the elongate portion.

8. 8. A urinary drainage catheter according to claim 7, wherein the passive straightening of the deflected tip is determined by the resilience of the material used to manufacture the catheter.

9. 9. A urinary drainage catheter according to any one of claims 1 to 8, utilising a single steering cable.

10. A urinary drainage catheter according to any one of claims 1 to 9, wherein the tip is deflectable up to an angle of 90°.

11. 11. A urinary drainage catheter according to any one of claims 1 to 10, comprising first and second additional channels, each of which houses a steering member and which are angularly spaced apart from one another to prevent unintended lateral deflection of the tip of the catheter.

12. an inflatable balloon spaced from the flexible tip; 12. A urinary drainage catheter according to any one of claims 1 to 11, further comprising a balloon inflation path extending between the balloon and a connector at the proximal end of the catheter to communicate fluid to the balloon for inflation.

13. 2. The urinary drainage catheter of claim 1, wherein the engagement member facilitates actuation by one finger of a hand grasping the catheter in a typical grip utilized to insert a catheter into the male urethra.

14. The urinary drainage catheter of claim 1 , wherein the engagement member is biased to the upright position by pulling on the steering member.

15. 2. The urinary drainage catheter of claim 1, wherein the engagement member is configured to rest on the hollow catheter body in an upright position, the engagement member having a concave base that abuts an outer surface of the hollow catheter body.

16. A urinary drainage catheter as described in any one of claims 1 to 15, wherein the engagement member is configured to be attached to the outer wall of the hollow catheter body without interfering with the lumen of the hollow catheter body.

17. A urinary drainage catheter as described in any one of claims 1 to 16, wherein the engagement member is removable from the hollow catheter body.

18. A urinary drainage catheter as described in any one of claims 1 to 17, wherein the catheter is configured to be actively steered solely by tactile feedback, independent of any guidance assistance, including telescopic or radiological guidance.

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