Patent Publication Number: US-2018043135-A1

Title: Dynamic Catheterization Devices Configured to Facilitate Drainage

Description:
CROSS-REFERENCE TO RELATED APPLICATION(S) 
     This application is a non-provisional of and claims priority to U.S. Provisional Patent Application No. 62/372,888 filed on Aug. 10, 2016 and entitled “Dynamic Catheterization Devices Configured to Facilitate Drainage”, which is incorporated herein by reference in its entirety. 
    
    
     FIELD 
     The present disclosure is generally related to catheter devices configured to facilitate drainage, such as fluid drainage from the bladder and through the urethra of a patient. 
     BACKGROUND 
     The term “urinary retention” generally implies that the body produces urine normally but that the body is retaining the urine within the bladder due to primary detrusor dysfunction or an obstruction at or distal to the bladder neck. Prostatic obstruction causes an increased workload on the bladder musculature resulting in two successive phases; 1) compensation, where bladder emptying still takes place, and 2) decompensation, characterized by increasing amounts of residual urine and ultimately urine retention. Although urinary retention is not usually life threatening, it can produce discomfort and may be an indication of a more serious underlying disease process. 
     In general, bladder outlet obstruction producing urinary retention may result from benign prostatic hypertrophy, prostate cancer, acute prostatitis, other causes, or any combination thereof. Urinary retention occurs primarily in males, with benign prostatic hypertrophy being the most common cause in men over the age of 50 years. It has been estimated that one in four men in the United States will have been treated for symptomatic benign prostatic hypertrophy by the time they reach 80 years of age. 
     Management of urinary retention related to prostate obstruction typically involves bladder drainage generally accomplished by placement of a transurethral or suprapubic catheter. This catheter provides a fluid passageway between the bladder and the exterior of the body, which passageway allows a continual free flow of urine to the outside. 
     Recently, temporary stents have been tested for obviating the use of indwelling urinary catheters. Various designs of the temporary stents have been tried; however, the medical industry has been slow to adopt the temporary stents treatment of urinary retention issues, probably due to the difficulties and trauma related to their insertion and removal as well as to a high rate of migration of the devices in situ. 
     SUMMARY 
     In certain embodiments, a dynamic catheterization device can be used to facilitate drainage and, more specifically, but not by way of limitation, to facilitate fluid drainage from the bladder and through the urethra of a patient. The dynamic catheterization device may be used in patients who need long-term, intermittent self-catheterization and may be particularly suited for males and females with neurogenic bladders (e.g., spinal cord injury, or other neurological insults), atonic bladders, and other bladder functional abnormalities. The dynamic catheterization device may be configured to convert dynamically, in situ, from a urinary drainage catheter into an indwelling device. 
     In some embodiments, a catheterization device includes a tip and includes a body member having a proximal end and a distal end. The body member can define a lumen that extends from the proximal end to the distal end. The catheterization device further includes an expandable portion extending between the tip and the proximal end of the body member. The expandable portion can include a plurality of arms (or segments) bent to form a resting shape. The expandable member may be configured to expand to allow the body member to extend in response to tension applied to the body member and to retract to the resting shape when tension is withdrawn. 
     In some embodiments, the dynamic catheterization device may include an umbrella-like expandable catheter that can be positioned within the bladder or body cavity and which may be controlled by a user to expand to drain the bladder or body cavity and then to contract. The umbrella-like expandable catheter comprises a body member and an expandable retaining member. The body member includes a distal terminating end, a proximal end portion, and a lumen extending within the body member to allow fluid drainage through the body member. The expandable retaining member may be coupled to the proximal end portion of the body member and may be configured to expand in response to a tension applied to the body member and to retract when the tension is released. 
     In some embodiments, the body member may be sized for placement substantially within the urethra, with the distal terminating end located proximal to an external urethral sphincter to allow normal operation of the external sphincter. An expandable retaining member may extend from the proximal end portion of the body member. In a first state (resting or relaxed), the expandable retaining member may be bent or formed in an umbrella-like shape, which can secure the catheter device within the bladder. When tension is applied to the body member, the expandable retaining member can be straightened into a second state to allow extension of the body member of the catheter into the urethra to facilitate bladder drainage. When the tension is released, the expandable retaining member may retract into the umbrella-like shape (returning to the first state), retracting the body member and holding the body member in place substantially within the bladder. In some aspects, the umbrella-like catheter system may include an user-adjustable body member that can be adjusted by the user to fit the anatomy of the patient and may include one or more user-accessible sutures (lines, threads, or strings). The catheter system can be inserted using either a stylet or an outer sleeve. 
     The expandable retaining member of the umbrella-like expandable catheter can be formed from a tube having a lumen and configured to have “snap-back” or elastic shape memory. In some embodiments, the tube may be formed from silicone, C-FLEX®, thermoplastic elastomers, or other flexible material that can be configured to provide a resting state shape memory. In some embodiments, the expandable retaining member may be rounded at the ends to enhance user comfort during insertion of the catheter into the patient&#39;s urethra. Further, in some embodiments, the catheterization device including the umbrella-like expandable catheter may be coated with an anti-microbial material coathing, such as silver or another anti-microbial coating, which may assist the patient in resisting infection. 
     Prior to and during insertion of the umbrella-like expandable catheter into the patient&#39;s urethra, the expandable retaining member can be held in a straightened first state. The expandable retaining member may return to the second umbrella-like resting state once inserted into the patient&#39;s bladder, such as when the stylet or outer sleeve is removed. The expandable retaining member may act as an anchor to keep the body member of the catheter substantially within the urethra. Further, the expandable retaining member may expand to advance a body member portion of the catheter through the sphincter during use. 
     In one embodiment, the body member can include one or more side openings to allow fluid to drain from the urethra. The lumen of the body member can be designed to be equivalent to a 14 French catheter. In another embodiment, the body member of the catheter can also include of a wound micro wire spring. The micro wire spring can be embedded within a soft polymer. The micro wire spring would allow for the catheter to be thinner and lighter in weight, but have a greater shape memory. 
     In one embodiment, the catheterization device can include one or more sutures that can be accessed by a user to facilitate bladder drainage. The one or more user-accessible sutures can be long enough to extend from the body member to the outside of the patient&#39;s body. In some embodiments, the one or more sutures may include monofilament nylon, which may be black or another color. In some embodiments, the umbrella-like expandable catheter can be removed from the patient&#39;s body by pulling on the one or more sutures outwardly or distally away from the bladder. In some embodiments, the end of the one or more sutures can be connected to an anti-migration device or structure (e.g., a ball, a ring, a coil, or another structure) that can be entirely outside of the body. The ball, ring, coil or other structure at the end of the one or more sutures may facilitate location of the end of the sutures and then removal of the umbrella-like expandable catheter by the patient or by a medical professional, simply by pulling on the anti-migration device. In some embodiments, it may also be used to expand the expandable portion to drain the bladder. 
     In still other embodiments, an umbrella-like expandable catheter system for draining fluid from a patient&#39;s body (e.g., from the bladder, through the urethra, and out of the patient&#39;s body, or from the colon or ileum and out of the patient&#39;s body) may include an umbrella-like expandable retaining member and a removable connecting segment. The umbrella-like expandable retaining member may include a body member having a distal terminating end, a proximal end portion, and a lumen extending within the body member. The body member may be sized for placement substantially within the urethra with the distal terminating end located proximal of the external sphincter to allow normal operation of the external sphincter. The removable connecting segment can include an elongated body member having a distal end, a proximal end, and a lumen. The proximal end of the removable connecting segment may be releasably coupled to the distal terminating end of the expandable retaining member. 
     In some embodiments, the umbrella-like expandable catheter system may have at least two modes of operation after insertion into the patient&#39;s urethra. In a first mode, the umbrella-like expandable retaining member and removable connecting segment may be coupled together, enabling continuous drainage of fluid from the bladder. In a second mode, the removable connecting segment may be decoupled from the umbrella-like expandable retaining member in situ, and the removable connecting segment can then be removed from the patient&#39;s urethra for disposal. The umbrella-like expandable portion of the catheter may be configured to anchor or otherwise retain the catheter system within the bladder. 
     In certain embodiments, the catheter system includes a catheter having a body member and an expandable retaining member extending proximally away from the body member. When the expandable catheter system is properly positioned, the expandable retaining member may be located in the patient&#39;s bladder. In one embodiment, the expandable retaining member may include a proximal umbrella-like expandable tip that can act as an anchor within the bladder opening to prevent distal migration of the catheter. The expandable retaining member may be straightened prior to and during the insertion of the catheter into the patient&#39;s urethra. Further, the expandable retaining member may return to the umbrella-like state once located in the patient&#39;s bladder and thereby act as an anchor to prevent catheter migration. The straightening and expanding of the expandable retaining member can be controlled through either a stylet or an outer sleeve while the umbrella-like expandable catheter is being inserted within the patient&#39;s body. 
     In still another aspect, a method of placing an umbrella-like expandable catheter system within the urethra may include holding the umbrella-like expandable catheter device in a straightened position via a stylet or an outer sleeve holds for easy insertion through the urethra. The umbrella-like expandable catheter device can include an umbrella-like expandable catheter and a removable connecting segment releasably coupled to one another. The method may further include advancing, by a medical professional (such as a physician), the umbrella-like expandable catheter system through the urethra until at least a portion of the catheter is positioned substantially within the urethra. In some embodiments, the catheter system may include an opening sized to receive a guide wire, and the catheter system may be delivered to the bladder by advancing the catheter system along the guide wire. When properly positioned, at least a portion of the umbrella-like expandable catheter will reside within the urethra, while the removable connecting segment will extend through the external sphincter, through the rest of the urethra, and outside of the patient&#39;s body. The method can also include determining that the umbrella-like expandable catheter system is properly positioned when urine or other bodily fluid is observed draining through the distal end of the removable connecting segment. The method may then include removing the removable connecting segment and stylet or the outer sleeve from the urethra in response to observing the urine or other bodily fluid. In some embodiments, the method may also include attaching an external anti-migration device to the suture to ensure that the device does not migrate and retreat into the patient. 
     In still another embodiment, a method of removing an indwelling umbrella-like expandable catheter may include pulling on one or more sutures attached to a portion of the catheter. The one or more sutures typically may extend from the catheter through the urethra to an outside of the patient&#39;s body, making it easy to locate by the patient or a medical professional, such as a doctor, a nurse, a clinician, or any combination thereof. 
     In yet another aspect, the indwelling umbrella-like expandable catheter includes a tethering structure external to the body and accessible to a user to manipulate the catheter to drain the bodily fluid. By applying tension to the tethering structure, the user may enable transition of the mode or state of the catheter from a passive (resting) state of the device to an active state, causing a body member portion of the umbrella-like catheter to extend from within the bladder through the external sphincter to open a fluid passage, which changes the fluid dynamics to favor voiding or continence. To void, the user can pull on the tethering structure (such as the one or more sutures extending out from the urethra), causing the proximal end of the umbrella-like retaining member to move into the bladder neck and through the sphincter valve, allowing the bladder to void. When the one or more sutures are released, the umbrella-like retaining member can return to its resting state, drawing back into the bladder like a folded umbrella. Thus, upon completion of voiding, the retaining member may return to a folded state to withdraw the body member portion of the device behind the external sphincter. In some aspects, a removable connecting segment can either be left connected to the umbrella-like retaining member by a suture loop for self-catheterization or can be pulled off for disposal. 
     In some embodiments, if the patient is unable to void, a user can gently pull on the tethering structure (the one or more sutures) to stretch the device into an engagement position at the bladder neck. For ultimate removal of the catheter system, the patient, doctor, or nurse can pull moderately on the one or more sutures and continue pulling steadily. In response to the tension applied through the tethering structure, the catheter will straighten out, allowing the catheter to pass through the urethra and out the patient&#39;s body. 
     It should be appreciated that the catheter devices and systems described herein may embody elements that can improve continence. Further, components of the devices and systems described herein may have multiple purposes. For example, such devices may also be used to facilitate drug delivery, to deliver an endoscopic device for viewing something within the bladder, to perform other functions, or any combination thereof. In some instances, the continence device can include an apron configured to engage a bladder neck, prevent urine flow in a resting state, and enable urine flow in an expanded state. 
     Embodiments of devices, systems, and methods are disclosed below that can include, but are not limited to, a catheter device that can be delivered into the bladder and configured to engage the bladder neck to facilitate bladder drainage. The device may included an expandable retaining portion that is configured to retain at least a portion of the device within the bladder in a resting (retracted) state and that can expand or extend in response to tension to allow a body member coupled to the expandable retaining portion to extend past the external sphincter to provide a fluid flow path through the body member to drain the bladder. Once drainage is complete, the device can retract into the bladder when tension on the connecting suture is removed. The catheter device can be used in male patients requiring bladder drainage by a device. The catheter device may also be used in female patients requiring bladder drainage. The catheter device may be controlled using an external device (such as one or more threads coupled to an anti-migration device outside of the patient&#39;s anatomy), which allows the user to apply tension to expand or extend the catheter device and to release tension to allow the catheter device to retract. In one possible embodiment, the catheter device may also be used as a drug delivery platform to enable enhanced delivery of drugs into the bladder or body cavity. 
     In one particular alternative embodiment, the catheter may be used for cervical dilation to induce labor. In another particular embodiment, the catheter system can be used to facilitate drainage of waste (e.g., from the colon or ileum). In still another alternative embodiment, the catheter can be used to widen the nasal passages to treat sleep disorders (e.g., sleep apnea) or to expand a fluid passage, for example, to facilitate the passage of air (e.g., from the windpipe). In still another alternative embodiment, the device can be used to facilitate the passage of matter into a patient (e.g., feeding tubes). In yet another alternative embodiment, the expandable retaining member can be used to secure a gastrostomy button. Other embodiments are also possible. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1A  shows a catheterization device in situ within the bladder, in accordance with certain embodiments of the present disclosure. 
         FIG. 1B  depicts the catheterization device including a lumen, in accordance with certain embodiments of the present disclosure. 
         FIG. 2A  depicts a catheterization device within a bladder and extending beyond a sphincter of a patient, in accordance with certain embodiments of the present disclosure. 
         FIG. 2B  depicts the catheterization device of  FIG. 2A  in a retracted (resting) state, in accordance with certain embodiments of the present disclosure. 
         FIG. 2C  illustrates the catheterization device of  FIG. 2A  in an extended (active) state, in accordance with certain embodiments of the present disclosure. 
         FIG. 3A  shows a catheterization device in an insertion mode (or state), in accordance with certain embodiments of the present disclosure. 
         FIG. 3B  depicts the catheterization device of  FIG. 3A  after insertion and including a connecting segment, in accordance with certain embodiments of the present disclosure. 
         FIG. 3C  illustrates a cross-sectional view of a releasable joining member of the catheterization device taken along line C-C in  FIG. 3B , in accordance with certain embodiments of the present disclosure. 
         FIG. 3D  illustrates a top view of the catheterization device of  FIG. 3A , in accordance with certain embodiments of the present disclosure. 
         FIG. 4A  depicts a side view of a catheterization device in an insertion mode (or state), in accordance with certain embodiments of the present disclosure. 
         FIG. 4B  depicts a catheterization device configured for a male patient, in accordance with certain embodiments of the present disclosure. 
         FIG. 4C  depicts a catheterization device configured for a female patient, in accordance with certain embodiments of the present disclosure. 
         FIG. 5  shows a catheterization device in one mode of operation wherein the umbrella-like expandable catheter is attached to an optionally-removable connecting segment and wherein a stylet is inserted to straighten the catheter, in accordance with certain embodiments of the present disclosure. 
         FIG. 6A  shows a catheterization device including an anti-migration device, in accordance with certain embodiments of the present disclosure. 
         FIG. 6B  shows a catheterization device including a removable connecting segment and an anti-migration device, in accordance with certain embodiments of the present disclosure. 
         FIG. 7A  shows a catheterization device coupled to a connecting segment attached, in accordance with certain embodiments of the present disclosure. 
         FIG. 7B  depicts a catheterization device in situ and in its loosened, non-engaged (resting) state and in its active, engaged state, in accordance with certain embodiments of the present disclosure. 
         FIG. 8A  illustrates a removable connecting segment disengaged from a body member of the catheter and including a delivery mechanism for delivering medicine to an area of the body, in accordance with certain embodiments of the present disclosure. 
         FIG. 8B  depicts a portion of a catheterization device including a suture wrapped around a body member, in accordance with certain embodiments of the present disclosure. 
         FIG. 9A  depicts a view including a portion of a body member that includes a micro wire spring, in accordance with certain embodiments of the present disclosure. 
         FIG. 9B  depicts a view of a portion of a cylindrical member configured to operate as a delivery mechanism for introducing a drug into a patient&#39;s body, in accordance with certain embodiments of the present disclosure. 
         FIG. 10A  illustrates a catheterization device including a sleeve shown in partial cross-section and configured to straighten the catheter, in accordance with certain embodiments of the present disclosure. 
         FIG. 10B  depicts a perspective view of the sleeve of  FIG. 10A . 
         FIG. 11  depicts a perspective view of a portion of a catheterization device for a male patient, in accordance with certain embodiments of the present disclosure. 
         FIG. 12  depicts a perspective view of the catheterization device of  FIG. 11  and including tapered segments that be cut to fit the particular patient, in accordance with certain embodiments of the present disclosure. 
         FIG. 13  depicts a perspective view of a catheterization device for a female patient, in accordance with certain embodiments of the present disclosure. 
         FIG. 14  depicts the catheterization device of  FIG. 12  in situ and in a retracted state, in accordance with certain embodiments of the present disclosure. 
         FIG. 15  depicts the catheterization device of  FIG. 13  in situ and in a retracted state, in accordance with certain embodiments of the present disclosure. 
     
    
    
     In the following discussion, the same reference numbers are used in the various embodiments to indicate the same or similar elements. 
     DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS 
     Embodiments of dynamic catheterization devices, systems, and methods are described below that may include a catheterization device including an umbrella-like expandable portion (or a pyramidal expandable portion) that can be positioned in a patient&#39;s bladder and that can be controlled by an external feature, such as a suture (line or string that can extend outside of the patient&#39;s body). In some embodiments, the expandable catheter can include a body member and an expandable retaining member. The body member may include a distal terminating end, a proximal end portion, and a lumen extending within the body member between the distal terminating end and the proximal end portion to allow fluid drainage through the body member. As used herein, the term “proximal” refers to a direction that points into the patient&#39;s body, while the term “distal” refers to a direction that points away from the patient&#39;s body. The body member may be sized for placement substantially within the urethra, with the distal terminating end located proximal to an external urethral sphincter to allow normal operation of the external sphincter. In some embodiments, the body member may include a plurality of chamfered segments, which can be selectively removed to size the body member to fit the anatomy of the patient. 
     The expandable retaining member can extend from the proximal end portion of the body member. The expandable retaining member may include one or more segments or arms that can be formed in a folded or bent configuration (such as an umbrella-like shape). The expandable retaining member may be formed from an elastic material that, in response to tension, can expand or extend to allow the body member to advance past the external sphincter and that, in response to removal of the tension, can retract to the folded or bent configuration. The expandable retaining member can be straightened into a first state to allow passage of the catheter into the urethra and into the bladder. Once inserted, the stylet or sleeve may be removed, and the expandable retaining member can retract into a second (resting) state when located in a bladder. In this second (resting) state, the expandable retaining member may resemble a closed umbrella or pyramid, and the expandable retaining member may be configured to hold the body member in place substantially within the urethra. To drain the bladder, the patient may apply tension to a suture, which may cause the expandable retaining member to expand into a third (expanded or extended) state, such that the body portion extends past the sphincter to provide a fluid path from the bladder and through the sphincter to facilitate bladder drainage. One possible example of an expandable catheterization device is described below with respect to  FIG. 1 . 
       FIG. 1A  shows a view  100  of a catheterization device  102  in situ within the bladder  104 , in accordance with certain embodiments of the present disclosure. The view  100  depicts a neck  106  of the bladder  104 . The neck  106  may be coupled to a urethra  116 , which extends past the prostate  108  and through an external sphincter  110 . The urethra  116  continues past the bulbous urethra  112  and through the penis  114 . The anatomical features are depicted for illustrative purposes and are described here in simplified form to provide context for the catheterization device  102 . 
     The catheterization device  102  may include a proximal end  120 , a body member  122 , and an umbrella-like expandable portion  124 . In some embodiments, the catheterization device  102  may be formed from a length of tubing. The umbrella-like expandable retaining portion  124  includes a plurality of flexible members that have shape memory (either via processing of the material to produce the shape memory or by embedding a spring-like material within each of the flexible members). The umbrella-like expandable portion  124  may couple the proximal end  120  to the body member  122 , which may be coupled to one or more sutures  126 . The one or more sutures  126  may extend through the urethra  116  to the outside of the patient&#39;s body. In some embodiments, the one or more sutures  126  may be coupled to an anti-migration device  128 , such as a flexible tab, which can prevent the catheterization device  102  from migrating into the bladder  104  and that can secure the end of the one or more sutures  126  outside of the patient&#39;s body. Thus, the anti-migration device  128  may serve a dual purpose by preventing migration of the device  102  into the bladder  104  and by providing a means by which the patient, a doctor, or a nurse may apply tension to the catheterization device  102  to drain the bladder  104 . 
     In certain embodiments, by applying tension to the catheterization device  102  via the one or more sutures  126  (such as by tugging on the anti-migration device  128 ), the catheterization device  102  may be stretched, transitioning into an active state wherein the body member  122  extends through the sphincter  110  to enable a fluid flow path from the bladder  104  through the lumen of the body member  122  and past the sphincter  110  to drain the bladder  104 . Once tension is released, the catheterization device  102  may be configured to retract to its resting state (as shown in  FIG. 1 ). 
       FIG. 1B  depicts a view  140  of the catheterization device  102  including a lumen, in accordance with certain embodiments of the present disclosure. The catheterization device  102  includes a body member  122  that includes a lumen  142  extending from an opening  144  to an opening generally indicated at  146 . The proximal end  120  may also include a lumen  148  extending from the opening  146  to the opening  150 . In some embodiments, the proximal end  120  may be tapered, and, in some embodiments, the lumen  148  may have a consistent internal diameter to facilitate fluid drainage. 
     In certain embodiments, the catheterization device  102  may be formed from a tube of a selected length and having a lumen ( 142  and  148 ) extending the length of the tube. The tube may be formed from silicone, C-FLEX®, thermoplastic elastomers, or other flexible material that can be configured to provide a resting state shape memory. In other embodiments, the lumen may extend at least two-thirds of the length of the tube. The tube may be cut (two or more times) lengthwise in a middle area of the tube between a first end and a second end, where the cuts extend from an exterior surface into the lumen. In some embodiments, a plurality of incisions may be made. In a particular embodiment, the plurality of incisions may include three incisions. After the incisions are made, one of the ends of the tube may be compressed toward the other end, causing the cut portions to bow outward away from the lumen. Holding the ends in a compressed state, the bowed portions may be secured in a folded umbrella-type of shape and then exposed to heat, which can cause the bowed portions to retain the folded umbrella-type shape. After cooling, the bowed portions may be released, and the catheterization device  102  can retain a folded umbrella type shape while in its resting state. Since the catheterization device is formed from a flexible material, the bowed portions may be deformable or expandable when tension is applied. In some embodiments, the bowed portions may include a deformable metal material (such as a spring) to facilitate a return to the folded (resting) state when tension is removed. Other embodiments are also possible. 
     In some embodiments, a stylet can be used to facilitate placement over a guide wire in a difficult placement. In other embodiments, a sleeve may be used to keep the umbrella-like expandable retaining portion  124  in a straightened position during placement, and the sleeve may be removed using a stylet once the catheterization device  102  is correctly positioned. Other embodiments are also possible. 
       FIG. 2A  depicts a view  200  of a catheterization device  102  within a bladder  104  and extending beyond a sphincter  110  of a patient, in accordance with certain embodiments of the present disclosure. During insertion, a sleeve or stylet may extend through the body member  122  and straighten the catheterization device  102  to facilitate insertion through the urethra  116 . When the sleeve or stylet is removed, the catheterization device  102  may return to a resting state, where the umbrella-like expandable retaining portion  124  retracts into a “folded umbrella” state. 
     In the illustrated example, the catheterization device  102  may be coupled to a connecting segment  202 , which may remain coupled to the body member  122  during operation. The connecting segment  202  may extend through the sphincter  110 , and drainage of fluid from the bladder  104  may occur substantially continuously. 
       FIG. 2B  depicts a view  210  of the catheterization device  102  of  FIG. 2A  in a retracted (resting) state, in accordance with certain embodiments of the present disclosure. In this example, the umbrella-like expandable portion  124  of the catheterization device  102  is retracted, pulling the body member  122  toward the bladder  104  and allowing the sphincter  110  to close. The sutures  126  extend from the body member  122 , through the urethra  116  and through the sphincter  110 . 
       FIG. 2C  illustrates a view  220  of the catheterization device  102  of  FIG. 2A  in an extended (active) state, in accordance with certain embodiments of the present disclosure. In the illustrated example, tension may be applied to the sutures  126 , pulling the body member  122  down into the urethra  116  and through the sphincter  110  to open a fluid flow path from the bladder  104  to the urethra  116  past the sphincter  110 . 
     Once tension is released from the sutures  126 , the umbrella-like expandable portion  124  may return to its resting state, drawing the body member  122  toward the bladder  104  and allowing the sphincter  110  to close. Other embodiments are also possible. 
       FIG. 3A  shows a view  300  of a catheterization device  102  in an insertion mode (or state), in accordance with certain embodiments of the present disclosure. In this mode, the proximal end  120  and the body member  122  are stretched apart, retracting the umbrella-like expandable portion  124  so that the bowed out portions are drawn in to form a substantially straight device. 
       FIG. 3B  depicts a view  310  of the catheterization device  102  of  FIG. 3A  after insertion and including a connecting segment  312 , in accordance with certain embodiments of the present disclosure. The connecting segment  312  may include a releasable joining member  314  configured to fit within a lumen of the body member  122  to secure the connecting segment  312  to the body member  122 . After insertion, the expandable portion  124  may retract to a resting state, which may be similar to an open umbrella (e.g., a folded umbrella-type shape). The connecting segment  312  may be coupled to the body member  122 , and optionally may be removed after insertion of the catheterization device  102 . 
       FIG. 3C  illustrates a cross-sectional view  320  of a releasable joining member  314  of the catheterization device  102  taken along line C-C in  FIG. 3B , in accordance with certain embodiments of the present disclosure. The releasable joining member  314  may be formed from a first portion associated with an interior surface of the body member  122  and a second portion associated with the exterior surface of the connecting segment  312 . 
     In some embodiments, the first portion may be formed within the distal end of the body member  122 . The first portion may include a flared opening  326  and a ridge or other catch element  328  configured to engage a lip or catch portion  332  of an exterior surface of a connecting segment  312 . 
     In some embodiments, the second portion may be fastened to or integrally formed with the proximal end of the connecting segment  312 . The second portion may include a tapered portion  330  and the catch portion  332  configured to interface with the corresponding catch portion  328  of the interior surface of the lumen  322  of the body member. 
     In some embodiments, the tapered portion  330  of the connecting segment  312  may be sized to fit within the flared portion  326  of the body member  122 . To couple the connecting segment  312  to the body member  122 , the tapered portion  330  of the connecting segment  312  may be inserted into the flared portion  326  of the body member  122  until the catch portion  332  engages the corresponding catch portion  328 . In some embodiments, the catch portion  328  may be a ridge or recess, and the catch portion  332  may be a lip or protrusion configured to engage the ridge or recess to secure the connecting segment  312  to the body member  122 . 
       FIG. 3D  illustrates a top view  340  of the catheterization device  102  of  FIG. 3A  in the retracted state, in accordance with certain embodiments of the present disclosure. In this illustrated example, the proximal end  120  may be a closed cone or another shape. Further, the expandable portion  124  may extend outward from a longitudinal axis of the catheterization device  120  to provide an anchor function. 
       FIG. 4A  depicts a side view  400  of a catheterization device  102  in an insertion mode (or state), in accordance with certain embodiments of the present disclosure. The body member  122  has a length (L) that may be selected based on the gender of the patient. For example, the spacing between the neck of the bladder  104  and the sphincter  110  may be longer for a male patient than for a female patient, and the length of the body member  122  may be fabricated to provide a suitable length. 
     In some embodiments, as described below with respect to  FIG. 12 , the body member  122  may be formed with a one-size fits all initial length. The body member  122  may include a plurality of chamfered segments, which may facilitate trimming of the length of the body member  122  to fit the anatomy of the particular patient. Further, the proximal end of the catheterization device  102  may be curved or may include a coude tip to facilitate insertion. Other embodiments are also possible. 
       FIG. 4B  depicts views  410  of a catheterization device  102  configured for a male patient, in accordance with certain embodiments of the present disclosure. At  412 , the male version of the catheterization device  102  is depicted in a retracted (resting) state. The body member  122  has a length (L 1 ). At  414 , the male version of the catheterization device  102  is shown in an expanded (active) state, where tension is applied that moves the body member  122  through the sphincter  110  in the direction of the arrow  416 . 
       FIG. 4C  depicts views  420  of a catheterization device  102  configured for a female patient, in accordance with certain embodiments of the present disclosure. At  422 , the female version of the catheterization device  102  is depicted in a retracted (resting) state. The body member  122  has a length (L 2 ), which is less than the length (L 1 ) of the male version in  FIG. 4B . At  424 , the female version of the catheterization device  102  is shown in an expanded (active) state, where tension is applied that moves the body member  122  through the sphincter  110  in the direction of the arrow  426 . Other embodiments are also possible. 
       FIG. 5  shows a catheterization device  102  in one mode of operation wherein the umbrella-like expandable catheter  102  is attached to an optionally-removable connecting segment  312  and wherein a stylet (not shown) is inserted to straighten the catheter  102 , in accordance with certain embodiments of the present disclosure. The stylet (or alternatively an insertion sleeve) may extend the length of the catheterization device  102  by pushing the proximal end  120  away from the body member  122 . 
     In some embodiments, the catheterization device  102  may be held in a stretched, straightened or extended state using an insertion mechanism, such as a stylet or outer sleeve for easy insertion through the urethra. The catheterization device  102  may include includes an umbrella-like expandable catheter  102  and a connecting segment  312  releasably coupled to one another, and the assembly may be inserted into the urethra of the patient. A medical professional such as a physician can advances the catheterization device  102  and the connecting segment  312  through the urethra until at least a portion of the umbrella-like expandable catheter is within the bladder and extends within the urethra, while the connecting segment will extend through the external sphincter, through the rest of the urethra, and outside of the patient&#39;s body. The physician can determine that the catheter device is properly positioned when urine or other bodily fluid is observed draining through the distal end of the connecting segment. The connecting segment and stylet can then be removed from the urethra. 
       FIG. 6A  shows a view  600  of a catheterization device  102  including an anti-migration device  128 , in accordance with certain embodiments of the present disclosure. The catheterization device  102  may be coupled to one or more sutures  126 , which may be coupled to the anti-migration device  128 . The one or more sutures  126  may be sufficiently long to extend from the body member, through the sphincter  110  and through the urethra  116  to the outside, which it may be connected to the anti-migration device  128 . 
       FIG. 6B  shows a view  610  of a catheterization device  102  including a removable connecting segment  312  and an anti-migration device  128 , in accordance with certain embodiments of the present disclosure. In the illustrated example, the one or more sutures  126  extends from the catheterization device  102  through the removable connecting segment  312  and couples to the anti-migration device  128 . 
       FIG. 7A  shows a side view  700  of a catheterization device  102  coupled to a connecting segment  312 , in accordance with certain embodiments of the present disclosure. In the illustrated example, the one or more sutures  126  and the anti-migration device  128  are shown. In some embodiments, the one or more sutures  126  may be coupled to the body member  122  during manufacturing. In other embodiments, the one or more sutures  126  may be coupled to the body member  122  by a clinician prior to insertion. Further, the anti-migration device  128  may be coupled to the sutures  126  at a desired position along the suture  128 , and excess thread of the sutures  126  may be trimmed by the clinician. 
       FIG. 7B  depicts views  710  and  720  of a catheterization device  102  in situ and in its loosened, non-engaged (resting) state (view  710 ) and in its active, engaged state (view  720 ), in accordance with certain embodiments of the present disclosure. In the resting state  710 , the expandable portion  124  of the catheterization device  102  is retracted. In the active state  720 , the expandable portion  124  of the catheterization device  102  is stretched, and the body member  122  extends through the sphincter  110 . Other embodiments are also possible. 
       FIG. 8A  illustrates a view  800  of a portion of a body member  122  coupled to one or more sutures  126 , in accordance with certain embodiments of the present disclosure. The body member  122  may include a plurality of side openings  804  to allow fluid to drain from the urethra. 
       FIG. 8B  depicts a portion  810  of a body member  122  of a catheterization device  102  including one or more sutures  126  wrapped around the body member  122 , in accordance with certain embodiments of the present disclosure. In an example, the sutures  126  may be wrapped or otherwise attached to the body member  122  and may extend through the urethra and out of the patient&#39;s body. The patient, a doctor, or a nurse may utilize the sutures  126  to control the operating state of the catheterization device  102 , and optionally to remove the catheterization device  102 . 
       FIG. 9A  depicts a view  900  including a portion of a body member  122  that includes a micro wire spring  902 , in accordance with certain embodiments of the present disclosure. The micro wire spring  902  may be embedded along a length of an interior side wall of the body member  122 . In certain embodiments, the micro wire spring  902  may provide structural support for the body member  122  that allows the body member  122  to be made of lightweight and flexible material. 
       FIG. 9B  depicts a view  910  of a portion of a cylindrical member  912  configured to operate as a delivery mechanism for introducing a drug into a patient&#39;s body. The cylindrical member  912  may be a portion of the body member  122 , a portion of a connecting segment  312 , an attachment configured to couple to either the body member  122  or the connecting segment  312 , or any combination thereof. The cylindrical member  912  may include medicine (generally indicated at  914 ) that can be released into the patient&#39;s body. In some embodiments, the medicine  914  may be released over time or in response to tension from the sutures  126 , which may trigger release. Other embodiments are also possible. 
       FIG. 10A  illustrates a view  1000  of a catheterization device  102  including a sleeve  1002  shown in partial cross-section and configured to straighten the catheter  102 , in accordance with certain embodiments of the present disclosure. The sleeve  1002  may include a lumen  1012  (depicted in  FIG. 10B ) that is sized to receive the catheterization device  102  and that extends over the umbrella-like expandable portion  124  and over at least a portion of the body member  122 . 
     In some embodiments, the sleeve  1002  may be coupled to an end of the connecting segment  1004 . In certain embodiments, after insertion, the sleeve  1002  may be removed with the removal of the connecting segment  1004 . The sleeve  1002  may extend over at least part of the body member  122  and over enough of the umbrella-like expandable portion  124  to straight out the catheterization device  102  to facilitate insertion. 
       FIG. 10B  depicts a perspective view  1010  of the sleeve  1002  of  FIG. 10A . The sleeve  1002  may have a substantially cylindrical shape and may define the lumen  1012 , which may be sized to receive the catheterization device  102 . The sleeve  1002  may be formed from a flexible material, such as a silicone rubber or other flexible material. Other embodiments are also possible. 
     In conjunction with the devices, systems, and methods described above with respect to  FIGS. 1-10B , a catheterization device is disclosed that can include a proximal end, a body member, and an expandable retaining member that couples the proximal end to the body member. The catheterization device can be a tube formed from silicone or another flexible material with shape memory. In some embodiments, the expandable retaining member may be rounded or curved at the ends of the tubing to provide user comfort during insertion of the catheter device into the patient&#39;s urethra. 
     Prior to and during insertion of the umbrella-like expandable catheter into the patient&#39;s urethra, the expandable retaining member may be held in a straightened first state, using an insertion mechanism, such as a stylet, a sleeve, or another mechanism. When the insertion mechanism is removed, the expandable retaining member can return to a second “umbrella-like” state, anchoring the catheterization device within the patient&#39;s bladder to keep the body member of the catheter substantially within the urethra. 
     In certain embodiments, the expandable portion  124  may extend (or expand) and contract in response to application of tension to or removal of tension from the sutures  126 . When tension is removed, the expandable portion  124  may return to its umbrella-like shape inside the bladder. The suture can be left extending from the urethra outside of the patient&#39;s body, and therefore can be easily located by the patient or a medical professional, such as a doctor or nurse. An external anti-migration device can be attached to a distal end of the suture to ensure that the device does not migrate and retreat into the patient. Removal of the indwelling catheterization device can be accomplished by pulling on the suture. 
     In some embodiments, the tip of the catheterization device  102  may be curved or bent to facilitate insertion. In a particular example, such as that shown in  FIG. 11  below, the tip may be curved and may include an opening sized to receive a guide wire to facilitate insertion. Other embodiments are also possible. 
       FIG. 11  depicts a perspective view of a portion of a catheterization device  1100  for a male patient, in accordance with certain embodiments of the present disclosure. In the illustrated example, the catheterization device  1100  may include a coude tip  1102  having a curvature configured to facilitate insertion of the device  1100 . The end of the coude tip  1102  may include an opening  1104  configured to receive a guide wire to facilitate placement. Further, the catheterization device  1100  may include an umbrella-like portion  1106 , which may retain its umbrella-like shape in a resting state and which may expand as the body member  1108  extends past the sphincter. The umbrella-like portion  1106  may include a plurality of arms or sections that provide the retraction and expansion functionality. 
     It should be understood that anatomy of patients may vary. Accordingly, it may be desirable to adjust a length of the body member  1108  to fit the patient. In the example described below with respect to  FIG. 12 , the body member  1108  may include one or more chamfered segments that provide a tapered or sloped surface for comfort and which may also provide cutting marks to facilitate sizing. One possible example is described below with respect to  FIG. 12 . 
       FIG. 12  depicts a perspective view  1200  of the catheterization device  1100  of  FIG. 11  and including tapered segments  1202  that be cut to fit the anatomy of the particular patient, in accordance with certain embodiments of the present disclosure. In the illustrated example, the body member  1108  may include a plurality of tapered segments  1202 . The physician or medical provider may cut the body member  1108  near a distal end of one of the tapered segments  1202  to adjust the size of the catheterization device  1100  to fit the anatomy of the particular patient. In some embodiments, the tapered segments  1202  may provide some comfort for the user, and may also facilitate extraction. Further, the tapered segments  1202  may operate to push through the sphincter when tension is applied to the suture. Other embodiments are also possible. 
       FIG. 13  depicts a perspective view of a catheterization device  1300  for a female patient, in accordance with certain embodiments of the present disclosure. The device  1300  includes a rounded tip  1302 , an umbrella-like portion  1306  including a plurality of arms or sections  1310 , and a body portion  1308 . The body portion  1308  may significantly shorter than the body portion for the catherization device  1100  in  FIGS. 11 and 12 . 
       FIG. 14  depicts a view  1600  of the catheterization device  1100  of  FIG. 12  in situ and in a retracted state, in accordance with certain embodiments of the present disclosure. In the view, a portion of the anatomy of a male is shown, including bladder  1402 , prostate gland  1404 , external sphincter  1406 , and meatus  1408 . The device  1100  includes the coude tip  1102  with the opening  1104 . Further, the device  1100  includes the expandable portion  1106  including a plurality of arms or sections  1110  formed into an umbrella-like shape in a retracted state. Further, the device  1100  includes the body member  1108 , which can be an extended catheter with a chamfered section  1202 . The device  1100  may further include a suture  1410  that extends from the body member  1108  through the external sphincter  1406  and the meatus  1408  and outside of the patient&#39;s anatomy. An anti-migration device  1412  may be coupled to the suture  1410  (or thread) to prevent the suture  1410  from pulling back into the opening of the meatus and to prevent the device  1100  from falling into the bladder  1402 . 
       FIG. 15  depicts a view  1500  of the catheterization device  1300  of  FIG. 13  in situ and in a retracted state, in accordance with certain embodiments of the present disclosure. The view  1500  includes urinary bladder  1502 , bladder neck  1504 , and external urethral sphincter  1506 . The device  1300  includes a rounded tip  1302 , the expandable portion  1306 , and the body member  1308 . The expandable portion  1306  may include a plurality of arms or segments  1310 . The device  1300  may further include a thread (string or suture)  1510  coupled to the body member and extending from the body member, through the urethra, and to an anti-migration device  1512  coupled to a distal end of the thread  1510  outside of the body. In the view  1500 , the device  1300  is in a retracted state. 
     While the above-described embodiments have been directed to catheterization devices, which allow an engagement into the bladder neck to facilitate bladder drainage, the present disclosure is not so limited and can include other uses. For example, in some embodiments, the catheterization device (or a version thereof) may be used to encourage cervical dilation to induce labor. In another example, in some embodiments, the catheterization device (or a version thereof) may be used to facilitate drainage of waste (e.g., from the colon or ileum). In still another embodiment, the catheterization device, or a version thereof may be used to expand the nasal passages to treat sleep disorders (e.g., sleep apnea) or to facilitate the passage of air (e.g., through the windpipe). In another embodiment, the catheterization device (or a version thereof) can be used to facilitate the passage of matter into a patient (e.g., feeding tubes). In still another embodiment, the catheterization device can be used as a retaining member for a gastrostomy button. Other embodiments are also possible. 
     In conjunction with the devices depicted and described above with respect to  FIGS. 1-15 , a catheterization device is disclosed that can include a rounded tip or a coude tip, an expandable portion, and a body member. The expandable portion may be formed from a shape-retaining elastic material, which is flexible, has a high elasticity, and a low compression rating. The expandable portion may include a plurality of segments or sections, which may be formed by cutting a tube, bending the section to the desired shape, and applying heat to deform the material to accept the shape (such as an umbrella shape or another shape). In some embodiments, the device may be molded or otherwise formed into an initial resting shape, and the device may be deformed during implantation to facilitate insertion and may be deformed during use to facilitate bladder drainage. A device (such as one or more sutures, strings, or threads) may be coupled to the body member and may be coupled to an anti-migration device outside of the body so that a user may apply tension to the body member of the device via the thread in order to expand or extend the expandable portion to facilitate drainage. Other embodiments are also possible. 
     Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the scope of the invention.