Patent Description:
The present disclosure relates to a medical catheter and more particularly to a medical catheter for guiding body fluid such as urine.

Urinary retention is the inability to empty the bladder. It is a common and serious problem resulting from numerous reasons, one of which is aging. Moreover, urinary retention in males often is caused by obstruction of the urethra, nerve problem, improper medication or weakened bladder muscle.

An obstruction occurs when urine is blocked from flowing freely through the urinary track. The common causes of obstructive urinary retention include: benign prostate hyperplasia (BPH), urethral stricture, and kidney or bladder stones. As for non-obstructive ones (e.g., weakened bladder muscle, improper medication or nerve problem), signals between the brain and the bladder are interfered. The common causes of non-obstructive urinary retention include stroke, pelvic injury, trauma, nerve disease, impaired muscle, nerve dysfunction due to medication, anesthesia, and accidents that injure the brain or spinal cord.

According to studies, the overall incidence rate of urinary retention is <NUM> to <NUM> per <NUM>,<NUM> men between the age of <NUM> to <NUM>. Specifically, for men in their <NUM>, the overall incidence rate increases to <NUM> per <NUM>,<NUM> men. The incidence rate of acute urinary retention increases up to <NUM> per <NUM>,<NUM> men in their <NUM>. Patients with acute or chronic urinary retention develop different symptoms. Those with acute urinary retention may experience inability to urinate, pain or urgent need to urinate, severe pain or discomfort in the lower abdomen, and bloating of the lower abdomen. Immediate medical attention is needed.

Treatments for urinary retention include catheterization, urethral dilation, urethral stent, prostate-specific medicine, and surgery. However, such treatments are not always suitable for all patients. For example, neurogenic urinary retention patients may only have the option of catheterization. Present catheterization techniques include the Foley catheter (urethral catheter), suprapubic drainage tube, or intermittent catheterization.

The Foley catheter (i.e., the indwelling catheter) includes two separated channels or lumens running down its length. One of the channels has openings at both ends and is responsible for draining the urine into a collection bag. The other channel has a valve at its outer end and a balloon at its inner tip. When the balloon is placed inside the bladder, it is filled with sterile water so as to serve as an anchor to prevent the catheter from slipping out. However, the Foley catheter has several disadvantages, including encrustation, blockage, structural damage to urethra and bladder, facilitate development of bladder or kidney stones, and infection (e.g., urinary tract infections (UTI), kidney infection, and blood infection).

Comparing to the Foley catheter, suprapubic catheter may result in a lower rate of urethral injury and stricture. However, it still causes upper tract damage, vesicoureteral reflux, renal or bladder calculi, and urinary tract infections.

Intermittent catheterization is the insertion and removal of a catheter several times a day to empty the bladder, and it reduces the need of the long-term indwelling catheter. However, intermittent catheterization involves patient acceptance and manual handling. It requires up to <NUM> minutes to complete the entire procedure, i.e., insertion or the removal of the catheter, each time. It is inconvenient for patients and often creates embarrassment when, e.g., operating the procedure away from home. Additionally, several reports show that the complications of applying intermittent catheterization with spinal cord injury patients include epididymitis (about <NUM>% incidence rate), urethritis (about <NUM>% incidence rate), and prostatitis (about <NUM>% incidence rate).

As discussed, conventional treatments/devices have a relatively high infection rate and are also inconvenient for patients and caregivers. As a result, urinary retention patients may experience discomfort and are less motivated to participate in social activities, resulting in deteriorated life quality.

To overcome issues above, <CIT> disclosed a device (i.e., the urethral prosthesis) to relieve urinary retention. The device includes a first and a second tubular elements with an interposed bridge segment. The first tubular element further includes a drainage hole, a channel for fluid flow, and an inflatable balloon for maintaining the position of the urethral prosthesis. Further, the device includes a valve disposed in the second tubular element to control urine flow. The device does not require an external tube or collection bag. Furthermore, the patient can actively control the device to empty his/her bladder. However, the balloon is deposited near the tubular tip and thus may result in incomplete drain of the urine. The residual urine in the bladder, after prolonged period, may cause irritation and eventually induce bladder infection. Similar design of such devices can be found in <CIT>, <CIT>, <CIT> and <CIT>.

<CIT> and <CIT> disclosed a urinary flow control system (i.e., the CymActive™ System). The system can be placed and retained in the bladder and the urine tract, and further pass through two sphincters. More specifically, the system utilizes the malecot anchor to retain its position in the bladder. The system further includes a magnetic valve at the distal end, through which the patient can control the opening and closing of the valve by an actuator magnet. The system is self-retaining and allows cyclical bladder to be filled and emptied without an external appliance. The malecot anchor can be further used to enhance drainage. However, the magnetic valve may cause patient discomfort due to its size. Moreover, the patient needs to carry the actuator magnet at all times. Without the actuator magnet, urine accumulation will occur and may lead to pressure increase in the kidneys. This may cause kidney failure or even permanent damage to the kidney. Similar designs of magnetic actuation urethral valve can be found in <CIT> and <CIT>.

<CIT> disclosed an indwelling urinary catheter.

International publication Nos. <CIT> disclosed a urinary catheter.

<CIT> disclosed a urinary flow control device and method.

<CIT> and U. <CIT> disclosed an indwelling urinary catheter with a self-retaining mechanism. The self-retaining mechanism of the catheter operates by means of an actuating linkage wire to control the catheter between an "opened state" and a "closed state". Hence, no extra anchoring element is needed to prevent the catheter from being pulled out of the patient accidentally. Moreover, such self-retaining mechanism results in continuous drainage of the bladder, which may lower the chance of urine residue and infection. Although the catheter provides an improved retaining mechanism to facilitate the introduction and removal of the catheter, it still has several defects. For example, in order to provide enough force to maintain the catheter in the opened state, the material of the actuating mechanism needs to be hard, rigid plastic such as PP (polypropylene), PE (polyethylene), PC (polycarbonate), and etc. However, these materials are prone to cause discomfort and pain to patients.

<CIT> disclosed a self-deploying catheter assembly. The primary structure of the catheter assembly includes an anchoring device mounted to a tube. The anchoring device automatically maintains a tubular shape with the ends spaced apart during insertion into a body cavity, and converts into a mushroom shape when the catheter is fully inserted and the tube is slightly withdrawn from the body cavity. Also, the catheter includes a suture, which is designed to be releasable from the distal end of the anchor so as to facilitate the tubular shape. However, the inlet of the catheter is at the end of the anchor, which is not at the bottom of the bladder when the catheter is disposed. Consequently, urine in the bladder may not be completely drained, causing irritation and infection of the bladder. Furthermore, an operator is required to manually convert the catheter to a mushroom shape. Specifically, the operator needs to use a wire to control whether the anchor is converted to the mushroom shape. In other words, an additional element is needed for the catheter to maintain the anchor at the mushroom shape. Such additional element adds more difficulty to the manufacturing process and lowers the easiness of operability. Essentially, the foregoing is materially the same as a Lotus catheter and thus possesses identical disadvantages.

The object of the present disclosure is to provide a device that can properly drain the bladder and is easy to operate. Therefore, the device can not only reduce the possibility of complications, but also make it easier to install or remove.

The present invention is directed to a catheter for guiding a body fluid of a subject according to claim <NUM>. Further aspects of the invention are defined in dependent claims.

The present disclosure provides a catheter for guiding the body fluid of a subject. The catheter includes an elongated body having a proximal tip and a distal tip and an adjusting mechanism with two opposite ends. In one aspect, the catheter further includes a first portion, a second portion and a flexible portion between the first and the second portions. The second portion includes a circumferential wall defining a passageway for the body liquid, and the passageway further includes an inlet and an outlet. In another aspect, the first end of the adjusting mechanism connects the first portion of the catheter, and the second end of the adjusting mechanism engages the second portion of the catheter proximate to the inlet of the passageway. The adjusting mechanism is adapted to alter between different states. Furthermore, the flexible portion of the catheter expands to anchor the catheter inside the subject when the adjusting mechanism is in a first state, and the adjusting mechanism alters to a second state when the flexible portion retracts to allow insertion or withdrawal of the catheter to/from the subject. Also, the body fluid is directed to enter the passageway via the inlet of the second portion and exit via the outlet of the second portion.

In some embodiments, the first portion of the elongated body further includes a compartment, and the adjusting mechanism further includes a biasing element close to the first end. Furthermore, the biasing element is received within the compartment.

In some embodiments, the biasing element is compressed in the second state.

In some embodiments, the adjusting mechanism is stretched in the second state.

In some embodiments, the second end of the adjusting mechanism does not block the passageway.

In some embodiments, the catheter further includes an extraction wire connected to the second portion, said extraction wire is adapted to extend outside the subject such that it can be easily pulled to withdraw the catheter.

In some embodiments, a length of the second portion is about <NUM>-<NUM> centimeters.

In some embodiments, the second end of the adjusting mechanism includes a first valve mechanism proximate to the inlet of the passageway, the body fluid can enter the passageway via the inlet when the first valve mechanism is opened and the body fluid is blocked from entering the passageway when the first valve mechanism is closed.

In some embodiments, the first portion of the elongated body further includes a compartment, and the adjusting mechanism further includes a biasing element near the first end. Moreover, the biasing element is received within the compartment.

In some embodiments, the adjusting mechanism includes a controlling wire configured to open or close the first valve mechanism.

In some embodiments, the flexible portion further expands such that the flexible portion and the first portion are more securely anchored within the subject when the controlling wire is pulled to open the first valve mechanism.

In some embodiments, the catheter further includes a locking module and a second valve mechanism. Moreover, the locking module received within the first portion of the catheter and engages with the adjusting mechanism. The second valve mechanism is at a distal end of the controlling wire and it controls the body fluid from leaving the passageway via the outlet. Furthermore, the locking module controls the opening and closing of the inlet when the adjusting mechanism is not in the second state.

In some embodiments, the outlet of the passageway is outside the subject.

In some embodiments, the flexible portion comprises at least two arms.

In some embodiments, a material of the catheter comprises polyvinyl chloride (PVC), silicon, thermoplastic polyurethane (TPU), thermo-plastic-rubber (TPR) or any combination thereof.

In some embodiments, only the first portion and the flexible portion are placed in a cavity of the subject when the catheter is not in the second state.

In some embodiments, the cavity is defined by a bladder.

The present disclosure also provides a catheter for guiding a body fluid of a subject. The catheter includes an elongated body having a proximal tip and a distal tip, an adjusting mechanism with a first end and an opposite second end, and a valve mechanism at the second end of the adjusting mechanism. In one aspect, elongated body further includes a first portion, a second portion and a flexible portion between the first and the second portions. The portion includes a circumferential wall defining a passageway for the body liquid. The passageway further includes an inlet and an outlet. In another aspect, the first end of the adjusting mechanism engages the first portion of the catheter. The valve mechanism engages the second portion proximate to the inlet of the passageway. Furthermore, the body fluid can enter the passage via the inlet when the valve mechanism is opened and the body fluid is blocked from entering the passageway when the valve mechanism is closed. Specifically, the adjusting mechanism is in a first state when the flexible portion expands to anchor the catheter inside the subject, and the adjusting mechanism alters to a second state when the flexible portion retracts to allow the insertion or withdrawal of the catheter to/from the subject. Hence, the body fluid is directed to enter the passageway via the inlet of the second portion and exit via the outlet of the second portion.

One or more embodiments are illustrated by way of example, and not by limitation, in the figures of the accompanying drawings, wherein elements are having the same reference numeral designations represent like elements throughout. The drawings are not to scale, unless otherwise disclosed.

The making and using of the embodiments of the disclosure are discussed in detail below. It should be appreciated, however, that the embodiments provide many applicable inventive concepts that can be embodied in a wide variety of specific contexts. The specific embodiments discussed are merely illustrative of specific ways to make and use the embodiments, and do not limit the scope of the disclosure.

Throughout the various views and illustrative embodiments, like reference numerals are used to designate like elements. Reference will now be made in detail to exemplary embodiments illustrated in the accompanying drawings. Wherever possible, the same reference numbers are used in the drawings and the description to refer to the same or like parts. In the drawings, the shape and thickness may be exaggerated for clarity and convenience. This description will be directed in particular to elements forming part of, or cooperating more directly with, an apparatus in accordance with the present disclosure. It is to be understood that elements not specifically shown or described may take various forms. Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. It should be appreciated that the following figures are not drawn to scale; rather, these figures are merely intended for illustration.

It will be understood that when an element is referred to as being "on" another element, it can be directly on the other element or intervening elements may be present.

It will be understood that singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

The term "about," as used herein, when referring to a measurable value such as an amount, a temporal duration, and the like, is meant to encompass variations of ±<NUM>% and more preferably ±<NUM>% from the specified value, as such variations are appropriate to perform the disclosed methods.

It will be further understood that terms; such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and the present disclosure, and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

The present disclosure provides a catheter, which can be placed inside the body mass of a patient to help drain urine. <FIG> is a schematic view of a catheter <NUM> (i.e., a frame) without a valve mechanism for guiding a body fluid (e.g., urine <NUM>), placed at a correct position in a bladder <NUM>. As the figure shows that only a second portion <NUM> of the catheter <NUM> passes through a prostate <NUM> (i.e., only the second portion of the catheter <NUM> is deposited within the urethra <NUM>) when the catheter <NUM> is correctly placed in the body cavity (e.g., bladder <NUM>) of a subject. Further, a flexible portion <NUM> of the catheter <NUM> is expanded and acts as an anchor to maintain the catheter <NUM> in a correct position when the catheter <NUM> is in a normal state. Hence, the urine <NUM> inside the bladder <NUM> is drained out through the second potion <NUM> of the catheter <NUM>.

<FIG> include three sectional views (<FIG>) of the catheter <NUM> without the valve mechanism for guiding a body fluid. According to <FIG>, the catheter <NUM> includes an elongated body having a proximal tip and a distal tip and an adjusting mechanism <NUM> with two opposite ends (i.e., a first end <NUM> and a second end <NUM>). Furthermore, the elongated body of the catheter <NUM> includes a first portion <NUM>, a second portion <NUM> and a flexible portion <NUM> situated between the first and the second portions. The second portion <NUM> includes a circumferential wall defining a passageway <NUM> for the body fluid to flow, and the passageway <NUM> further includes an inlet <NUM> and an outlet <NUM>. In some embodiments, the second portion <NUM> may further include an extraction wire <NUM> connecting to the second portion <NUM> near the outlet <NUM> for an operator to remove the catheter <NUM>. Furthermore, the inlet <NUM> of the second portion <NUM> further includes a sheath <NUM>. In another aspect, the first end <NUM> of the adjusting mechanism <NUM> is affixed to the first portion <NUM> of the catheter <NUM>, and the second end <NUM> of the adjusting mechanism <NUM> engages the sheath <NUM> of the second portion <NUM> near the inlet <NUM> of the passageway <NUM>. The adjusting mechanism <NUM> can be made of a biasing element (e.g., a spring) or an elastic element (e.g., an elastic wire). The length of the adjusting mechanism <NUM> changes when it is being compressed or stretched from its resting (i.e., equilibrium) position. When the adjusting mechanism <NUM> is in its resting, equilibrium state, i.e., when no stretching or compressing force is applied and the adjusting mechanism <NUM> is at its default length, the flexible portion <NUM> is expanded, allowing the catheter to anchor inside the body cavity. When the adjusting mechanism <NUM> is stretched (which causes the adjusting mechanism <NUM> to lengthen), the flexible portion <NUM> will retract to allow the catheter <NUM> to change to a tubular shape. When the adjusting mechanism <NUM> is compressed (which causes the adjusting mechanism <NUM> to shorten), the flexible portion <NUM> expands further to ensure that the catheter cannot be easily removed from the body cavity. According to the present disclosure, the adjusting mechanism <NUM> is adapted to alter between different states, i.e., changing in lengths, to correspond to the expansion or retraction of the flexible portion <NUM>.

When the adjusting mechanism <NUM> is in a resting position (i.e., at its default length), the adjusting mechanism <NUM> is defined as being in a first state. In the first state, the flexible portion <NUM> of the catheter <NUM> is expanded and acts an anchor to maintain the catheter <NUM> inside the body cavity of the subject. The inlet <NUM> of the catheter <NUM> is at or near the bottom of the body cavity when the catheter <NUM> is properly inserted, allowing the body fluid inside the body cavity to be drained completely.

<FIG> is a cross section view, in the direction of line A-A', of the inlet of the second portion <NUM> in <FIG>. The structure of the second end <NUM> of the adjusting mechanism (not shown) is a ring or any similar shape that would not obstruct the body fluid from flowing into the passageway <NUM>.

<FIG> illustrates the catheter <NUM> in a tubular shape, i.e., when the flexible portion <NUM> retracts. The adjusting mechanism <NUM> is stretched and is defined as in a second state when the catheter <NUM> is in such tubular shape. When an operator attempts to remove the catheter <NUM>, the operator may pull the extraction wire <NUM> to remove the catheter <NUM> from the body cavity of the subject. The extraction wire <NUM> is configured to attach to or near the end of the second portion. When the operator pulls the extraction wire <NUM> to withdraw the catheter, the muscle surrounding the urethra forces the flexible portion to retract and the adjusting mechanism to stretch, and the catheter <NUM> becomes tubular. In another words, the flexible portion retracts when the adjusting mechanism alters to a second state to allow the catheter to be removed from the subject.

In another aspect, when an operator attempts to insert the catheter <NUM> into the body cavity of the subject, the operator wants the flexible portion <NUM> to retract so the catheter <NUM> is in a tubular shape for easier insertion. The operator applies a force directly to the flexible portion to make it retracts, thereby stretching the adjusting mechanism <NUM>. When the first portion <NUM> and the flexible portion <NUM> of the catheter <NUM> are inserted into the body cavity, the restoring force of the adjusting mechanism <NUM> will return it to its resting position and expand the flexible portion <NUM> accordingly.

It is to be noted that each of the flexible portion element (i.e., the flexible portion alone), when not applied with external force, is in a retracted state. In certain embodiment, the flexible portion is continuously longitudinally extended when not receiving a force. In such situation, the catheter is readily removable from the body cavity because the flexible portion does not provide a blocking function. Consequently, when the catheter is not to be removed from the body cavity (catheter not in the second state), a force is applied through the adjusting mechanism so as to deform the flexible portion. Specifically, the flexible portion becomes in the shape of a cage so as to serve as a blocker, stopping the catheter from being extracted from the body cavity. Further, the flexible portion may include at least two flexible arms, and the preferable arm number is three. The catheter <NUM> maintains a passage through the prostate of the subject, and the preferred length of the second portion of the catheter <NUM> is about <NUM>-<NUM> centimeters.

The present disclosure also provides another catheter for draining the body fluid where the operator of such catheter can control whether the urine flows out of the subj ect.

<FIG> discloses a catheter <NUM> with a first valve mechanism <NUM> that is closed when an adjusting mechanism <NUM> is in a resting position (i.e., the first state). As the <FIG> shows, the catheter <NUM> has a first portion <NUM>, a second portion <NUM>, a flexible portion <NUM> and an adjusting mechanism <NUM>, and the second portion <NUM> further includes an inlet <NUM> and outlet <NUM> in the two opposite ends, a sheath <NUM> close to the inlet <NUM>, and a passageway <NUM>. The catheter <NUM> further includes the first valve mechanism <NUM> at the second end of the adjusting mechanism <NUM>, and a controlling wire <NUM> connecting to the first valve mechanism <NUM> that extends outside the subject's body. The first valve mechanism <NUM> is slidably received within the passageway <NUM> and detachably engaged with the sheath <NUM>. As described previously, after the operator inserts the tubular catheter <NUM> into the body cavity, the restoring force of the adjusting mechanism <NUM> induces the flexible portion <NUM> to expand, thereby anchoring the catheter <NUM> properly inside the cavity. <FIG> shows the catheter <NUM> with flexible portion <NUM> (e.g., three flexible arms) expanded, and the adjusting mechanism <NUM> in the first state. Further, the first valve mechanism <NUM> (e.g., the globe valve) is engaged with the sheath <NUM> and block the inlet <NUM> to keep out the body fluid from flowing into the passageway <NUM>. In other words, the restoring force of the adjusting mechanism <NUM> helps the first valve mechanism <NUM> to more securely engage with the sheath <NUM> to block the inlet <NUM>.

<FIG> shows the catheter <NUM> in a tubular form when the adjusting mechanism <NUM> is in a second state. As previously described, the operator can retract the flexible arms of the flexible portion <NUM> to make the catheter <NUM> tubular, allowing easier insertion or withdrawal in/from the body cavity. In some embodiments, the catheter <NUM> may further includes an extraction wire <NUM> that can help withdrawing the catheter <NUM>.

<FIG> discloses the catheter <NUM> with the first valve mechanism <NUM> opened when the adjusting mechanism <NUM> is not in the first and the second state. When the operator needs to drain the body fluid (e.g., urine), the operator can simply pull the controlling wire <NUM> to disengage the first valve mechanism <NUM> from the sheath <NUM> (i.e., let the inlet <NUM> open). Specifically, when the pulling force that the operator applies to the controlling wire <NUM> is greater than the restoring force of the adjusting mechanism <NUM>, the first valve mechanism <NUM> moves away from the sheath <NUM>.

Furthermore, if the operator continues to pull the controlling wire <NUM> after the adjusting mechanism is stretched to its maximal length, the pulling force of the controlling wire <NUM> will cause the position of the adjusting mechanism <NUM> relatives to the catheter <NUM> to shift. Since the first end <NUM> is affixed to the first portion <NUM>, the shifting of the adjusting mechanism <NUM> will shorten the distance between the first end <NUM> and the inlet <NUM>. Accordingly, the flexible portion <NUM> expands further, and the diameter of the cage formed by the flexible arms increases more. Such configuration may better anchor the first portion <NUM> and the three flexible arms (i.e., the flexible portion <NUM>) within the body cavity. If the operator wants to close the inlet <NUM>, the operator simply releases the controlling wire <NUM>, and the adjusting mechanism <NUM> will restore the catheter <NUM> back to the state as <FIG> shows.

In one aspect, the number of the flexible arms is at least two, and the preferred number is three. In another aspect, the adjusting mechanism <NUM> can be made of a spring or an elastic wire. Furthermore, the length of the second portion <NUM> of the catheter <NUM> is about <NUM>-<NUM> centimeters.

<FIG> further disclose another catheter <NUM> with the first valve mechanism <NUM>. The different between the catheter <NUM> and the previous catheters is the structure of the adjusting mechanism. <FIG> illustrates the catheter <NUM> with the first valve mechanism <NUM> closed when the adjusting mechanism is in a first state. As <FIG> shows, the adjusting mechanism includes a biasing element <NUM> (e.g., a spring) and a connecting wire <NUM>. Further, the first portion <NUM> of the catheter <NUM> has a compartment <NUM> for receiving the biasing element <NUM> and a portion of the connecting wire <NUM>. When the biasing element <NUM> has a maximal length inside the compartment <NUM>, it is defined as in a first state (i.e., a default state), and the biasing element <NUM> induces the first valve mechanism <NUM> to engage with the sheath <NUM> to block the inlet <NUM>.

<FIG> discloses the catheter <NUM> in tubular form when the adjusting mechanism is in a second state. The operator retracts the flexible portion <NUM> (e.g., the flexible arms) for easy insertion or withdrawal of the catheter <NUM>. When the catheter <NUM> is in the tubular shape, the biasing element <NUM> inside the compartment <NUM> is compressing to a minimal length and is defined as in a second state. The compressing biasing element <NUM> is capable of inducing the first valve mechanism <NUM> to securely block the inlet <NUM>.

<FIG> discloses the catheter <NUM> with the first valve mechanism <NUM> opened when the biasing element <NUM> is not in the first and the second state. When the operator needs to open the first valve mechanism <NUM> to drain the body fluid, the operator simply tugs the controlling wire <NUM> to disengage the first valve mechanism <NUM> from the sheath <NUM>. Simultaneously, the diameter of the cage formed by the flexible portion <NUM> lengthens and provides better anchoring ability.

The present disclosure further provides an unembedded catheter. As <FIG> shows, the unembedded catheter <NUM> has an elongated second portion <NUM>, and therefore a section of the second portion <NUM> extends outside the subject's body when it is inserted. <FIG> disclose the detailed structure of the unembedded catheter <NUM>. As <FIG> shows, the catheter <NUM> includes not only the elongated second portion <NUM> but also a locking module inside the compartment <NUM> of the first portion <NUM>, a second valve mechanism <NUM> at the end of a connecting wire <NUM> away from the first valve mechanism <NUM>, and a cylindrical block <NUM> protruding from the end of the first portion <NUM> that closes to the inlet <NUM>. Furthermore, the locking module includes multiple teeth <NUM> on the inner wall of the first portion <NUM> and a locking gear <NUM> that connects to the end of the connecting wire <NUM> and is slidably received within the compartment <NUM>. Moreover, the multiple teeth <NUM> are capable of maintaining the locking gear <NUM> in multiple positions (e.g., two different positions) for controlling the first valve mechanism <NUM> and the second valve mechanism <NUM>. As <FIG> shows, when the catheter <NUM> is in a normal state, the biasing element <NUM> is in a first state with a maximal length, and the locking gear <NUM> is in a first position relative to the teeth <NUM>. When the locking gear <NUM> is in the first position, the catheter <NUM> is properly inserted and position thereof is maintained because the flexible arms are expanded by the biasing element <NUM>. Further, the first valve mechanism <NUM> blocks the inlet <NUM> of the second portion <NUM>, and the second valve mechanism <NUM> blocks the outlet <NUM> of the second portion <NUM>. In other words, the body fluid cannot flow in or out of the catheter <NUM>. It is worth to note that the locking gear <NUM> is secured by the teeth <NUM> when the locking gear <NUM> is in the first position.

As <FIG> shows, the operator retracts the flexible arms to make the catheter <NUM> tubular for easy insertion or withdrawal. Here, the biasing element <NUM> is in the second state and is compressed, and the locking gear <NUM> moves to a second position relative to the teeth <NUM>. Moreover, the inlet <NUM> and the outlet <NUM> of the second portion <NUM> are closed, and the locking gear <NUM> is secured by the teeth <NUM> in the second position. In other words, the catheter <NUM> will maintain in the tubular shape when the operator moves the locking gear <NUM> to the second position. It is important to note that the catheter <NUM> only becomes readily removable from the subj ect' s body when the locking gear <NUM> is at the second position. The locking gear <NUM> serves to prevent the catheter <NUM> from accidentally becoming tubular and readily removable from the subject's body. Here, the strength of the biasing element <NUM> in this embodiment is specifically configured such that the flexible portion cannot be retracted easily, as shown in <FIG>. In particular, the biasing element <NUM> is designed to sustain a substantial amount of away-pulling force applied to the second portion <NUM>. Such sustention serves to maintain the flexible portion <NUM> in a caged shape, without being deformed by the counterforce from the muscle surrounding the urethra. Only when the locking gear <NUM> is at the second position will the catheter <NUM> become tubular. In sum, the locking module (i.e., the teeth <NUM> and the locking gear <NUM>) serves to switch the catheter <NUM> between different shapes/states and to prevent users from accidentally remove the catheter in an undesirable manner or when unwanted.

Furthermore, <FIG> illustrates the intermediate state of the catheter <NUM> between the tubular shape/state (as <FIG> shows) and the normal state (as <FIG> shows). As <FIG> shows, when the operator adjusts the second vale mechanism <NUM> so as to move the cylindrical block <NUM> to engage with the inlet <NUM>, the biasing element <NUM> is compressed and the locking gear <NUM> is moved to a third position relative to the teeth <NUM>. It is worth to know that the locking gear <NUM> is not secured at the third position (as opposed to its first and second positions) by the teeth <NUM>. In other words, <FIG> intends to demonstrate the operation of the catheter <NUM> between when the locking gear <NUM> is in the first position (as <FIG> shows) or the second position (as <FIG> shows). Particularly, in the <FIG> operation, an operator applies a force to the second valve mechanism <NUM>. Depending on its strating state, the catheter <NUM> either goes from <FIG> then to 6B, or from <FIG> and then 6A. The operation in <FIG> toggles the catheter <NUM> such that it becomes readily-removable (or not) from the subject's body. The foregoing is achieved by the restoring force of the biasing element <NUM> in response to the operator releasing the second valve mechanism <NUM> after applying force to it, as shown in <FIG>.

Note that the conventional catheter with elongated tube has the problem of urine retaining within the catheter. The dual valve mechanism and the locking module of the catheter <NUM> resolves such problem. As <FIG> shows, when the operator pulls the second valve mechanism <NUM> and puts the catheter <NUM> in the intermediate state, the first valve mechanism <NUM> and the second valve mechanism <NUM> are respectively disengaged from the inlet <NUM> and the outlet <NUM>, and the cylindrical block <NUM> securely engages and blocks the inlet <NUM>. In other words, the inlet <NUM> is closed but the outlet <NUM> is open. Accordingly, the urine inside the passageway <NUM> can be drained out completely. As a result, the issue of urine residue in the catheter itself may be better avoided.

<FIG> illustrates a schematic diagram of using the catheter <NUM> to drain the body fluid (e.g., urine) inside the body cavity (e.g., bladder) when the catheter <NUM> is in the normal state/shape. As <FIG> shows, when the operator needs to drain the urine, he/she simply pulls out the second valve mechanism <NUM> to slightly move the locking gear <NUM> away from the first position but not to the third position and to compress the biasing element <NUM>. Hence, the inlet <NUM> and the outlet <NUM> are opened, and the body fluid is drained out through the second portion <NUM> of the catheter <NUM>. Here, if the operator releases the second valve mechanism <NUM>, the catheter <NUM> will return to the normal state (as <FIG> shows) due to the restoring force of the biasing element <NUM> (i.e., the locking gear <NUM> being secured at the first position by the teeth <NUM>). In other words, the amount of force applied by the operator in <FIG> (for draining urine in the body cavity) is smaller than that in <FIG> (for draining urine residue in the catheter). The force applied in the operation of <FIG> needs to be substantial so as to switch the locking gear <NUM> between first and second positions. On the other hand, the force applied in the operation of <FIG> is not meant to achieve the foregoing. That it, the operator only intends to drain the urine from the body cavity, as opposed to switch the catheter <NUM> to a state readily removable from the subject's body.

Claim 1:
A catheter (<NUM>) for guiding a body fluid of a subject, comprising:
an elongated body having a proximal tip, a distal tip and further including a first portion (<NUM>), a second portion (<NUM>) and a flexible portion (<NUM>) between the first and the second portions, and the second portion includes a circumferential wall defining a passageway (<NUM>) for the body liquid, the passageway further includes an inlet (<NUM>) and an outlet (<NUM>); and
an adjusting mechanism (<NUM>) with two opposite ends, the first end engages the first portion and the second end engages the second portion proximate to the inlet (<NUM>) of the passageway, the adjusting mechanism (<NUM>) is adapted to alter between different states;
wherein the adjusting mechanism (<NUM>) is in a first state when the flexible portion (<NUM>) expands to anchor the catheter (<NUM>) inside the subject, and the adjusting mechanism (<NUM>) alters to a second state when the flexible portion (<NUM>) retracts to allow insertion or withdrawal of the catheter (<NUM>) to/from the subject;
wherein the body fluid is directed to enter the passageway via the inlet (<NUM>) of the second portion and exit via the outlet (<NUM>) of the second portion, characterised in that the second
end of the adjusting mechanism (<NUM>) comprises a first valve mechanism (<NUM>) proximate to the inlet (<NUM>) of the passageway, the body fluid can enter the passageway via the inlet (<NUM>) when the first valve mechanism (<NUM>) is opened and the body fluid is blocked from entering the passageway when the first valve mechanism (<NUM>) is closed, wherein the adjusting mechanism (<NUM>) comprises a controlling wire (<NUM>) configured to open or close the first valve mechanism (<NUM>), and the flexible portion (<NUM>) further expands such that the flexible portion (<NUM>) and the first portion (<NUM>) are more securely anchored within the subject when the controlling wire (<NUM>) is pulled to open the first valve mechanism (<NUM>).