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  Facilitating drainageUSPTO Application #: 20060206213Title: Facilitating drainage Abstract: A prostatic stent comprises a body member and a 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 body member is sized for placement substantially within the prostatic section of the urethra, with the distal terminating end located proximal of an external sphincter to allow normal operation of the external sphincter. The retaining member extends from the proximal end portion of the body member. The retaining member is collapsible into a first state to allow passage of the prostatic stent into the urethra, and the retaining member is expandable into a second state when located in a bladder to hold the body member in place substantially within the prostatic section of the urethra. (end of abstract) Agent: Edwards & Angell, LLP - Boston, MA, US Inventors: Gaines W. Hammond, Barry N. Gellman USPTO Applicaton #: 20060206213 - Class: 623023660 (USPTO) Related Patent Categories: Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor, Implantable Prosthesis, Hollow Or Tubular Part Or Organ (e.g., Bladder, Urethra, Bronchi, Bile Duct, Etc.), Urethra The Patent Description & Claims data below is from USPTO Patent Application 20060206213. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This claims priority to and the benefit of each of the following two provisional U.S. patent applications: Ser. No. 60/180,131 filed on Feb. 3, 2000, and Ser. No. 60/188,002 filed on Mar. 9, 2000. TECHNICAL FIELD [0002] This invention relates to facilitating drainage and, more particularly, to facilitating fluid drainage from the bladder and through the urethra of a patient. BACKGROUND INFORMATION [0003] The prostate is a gland in the male urinary system located directly below the bladder and around the urethra. In some men, especially men over fifty years of age, the prostate can become swollen or enlarged due to disease or infection. The enlarged prostate constricts the urethra causing discomfort and/or bladder outlet obstruction. [0004] One of the known procedures for treating an enlarged prostate is thermal prostatic therapy. During thermal prostatic therapy, the prostate is heated above body temperature to remove the diseased tissue, whereby returning the prostate to normal size. Immediately after treatment, however, the prostate is still swollen or enlarged due to the therapeutic trauma induced by the procedure. It may take several weeks before the treated prostate recovers and no longer inhibits bladder drainage. SUMMARY OF THE INVENTION [0005] The invention involves providing drainage of fluid from the bladder of a patient. Systems and methods of the invention typically are used after the patient has undergone prostate treatment such as thermal therapy. Systems and methods according to the invention involve converting in situ a urinary drainage catheter into an indwelling device. The device maintains the prostatic section of the urethra open and able to pass fluid while also allowing normal operation of the patient's external sphincter such that the patient has full and normal control over the retention and discharge of urine from the bladder even with the device in place within the prostatic section of the urethra. [0006] In general, in one aspect, the invention relates to a prostatic stent. The prostatic stent comprises a body member and a 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 to drain through the body member. The directional terms proximal and distal require a point of reference. In this application, the point of reference in determining direction is in the perspective of the patient. Therefore, the term proximal will always refer to a direction that points into the patient's body, whereas distal will always refer to a direction that points out of the patient's body. The body member is sized for placement substantially within the prostatic section of the urethra. The distal terminating end is positioned proximal of an external sphincter so as to allow normal operation of the external sphincter. The retaining member extends from the proximal end portion of the body member. The retaining member is collapsible into a first state to allow the passage of the prostatic stent into the urethra in the first instance. The retaining member also is expandable into a second state when located in the bladder to hold the body member in place substantially within the prostatic section of the urethra. [0007] Embodiments of this aspect of the invention can include the following features. The retaining member of the prostatic stent can be tapered to provide comfort to the patient during insertion of the stent into the patient's urethra. The retaining member also can comprise two or more retaining arms, and the retaining arms can be biased in the second state. Prior to and during insertion of the prostatic stent into the patient's urethra, the retaining member is in the first state. The retaining member returns to substantially the second state once in the patient's bladder and thereby acts as an anchor to keep the body member of the prostatic stent substantially within the prostatic section of the urethra. The body member of the prostatic stent can include one or more side openings to allow fluid to drain from the prostatic section of the urethra into the lumen. To help prevent migration of the prostatic stent, the body member also can have one or more protrusions. The protrusions are designed to engage the wall of the prostatic urethra and thereby provide a source of friction that limits the motion of the prostatic stent within the urethra. The body member also can include a suture attached to the distal terminating end. The suture should be long enough to extend from the body member to the patient's meatus. The prostatic stent can be removed easily from the patient's body by pulling on the suture. The end of the suture can be connected to a ball, ring, coil, or other structure that either extends out of the body entirely or is located within the meatus. The point of the ball, ring, coil or other structure at the end of the suture is to facilitate location of the end of the suture and then removal of the stent by the patient himself or by a medical professional, simply by pulling on the located suture. [0008] In another aspect, the invention relates to a prostatic stent-catheter system for draining fluid from the bladder, through the prostatic urethra, and out of the patient's body. The prostatic stent-catheter comprises a stent and a connecting segment. The stent includes a body member comprising a distal terminating end, a proximal end portion, and a lumen extending within the body member. The body member is sized for placement substantially within the prostatic section of the urethra with the distal terminating end located proximal of the external sphincter to allow normal operation of the external sphincter. The connecting segment comprises an elongated body member including a distal end, a proximal end, and a lumen. The proximal end of the connecting segment is releasably coupled to the distal terminating end of the stent. The prostatic stent-catheter system has at least two modes of operation after being inserted into the patient's urethra. In a first mode, the stent and connecting segment are coupled together, and drainage of fluid from the bladder occurs continuously. In a second mode, the connecting segment is decoupled from the stent in situ, and the connecting segment then is removed from the patient's urethra. After the connecting segment is removed from the patient's body, the patient's external sphincter contracts and is allowed to function normally to allow the patient have full control over voiding of urine. [0009] Embodiments of this aspect of the invention can include the following features. The stent portion of the prostatic stent-catheter can further include a retaining member extending proximally away from the body member. When the stent-catheter system is properly positioned, the retaining member will be located in the patient's bladder. In one embodiment the retaining member comprises a proximal curved tip that acts as an anchor within the bladder opening to prevent the distal migration of the stent. In another embodiment, the retaining member includes at least two retaining arms biased in an expanded state. The retaining arms are collapsible and are collapsed prior and during the insertion of the prostatic stent-catheter into the patient's urethra. The retaining arms in the present embodiment return to the expanded state once located in the patient's bladder and thereby act as an anchor to prevent stent migration. The contraction and the expansion of the retaining arms can be controlled through a pushing device while the prostatic stent-catheter is within the patient's body. The stent portion of the prostatic stent-catheter system can further include a body member comprising of a large pore mesh. The large pore mesh can be fabricated from any biocompatible, self-expanding material such as a nickel-titanium based alloy. The body member including the large pore mesh frictionally engages the patient's prostate, whereby anchoring the stent to prevent migration. [0010] In general, in still another aspect, the invention relates to a method of placing a prostatic stent-catheter system within the urethra. The prostatic stent-catheter system, which includes a stent and a connecting segment releasably coupled to one another, is inserted into the urethra of the patient. A medical professional such as a physician advances the prostatic stent-catheter system through the urethra until at least a portion of the stent is positioned substantially within the prostatic section of the urethra. When properly positioned, at least a portion of the stent will reside within the prostatic section of the urethra, while the connecting segment will extend through the external sphincter, through the rest of the urethra, and outside of the patient's body. The physician will know that the prostatic stent-catheter system is properly positioned when urine or other bodily fluid is observed draining through the distal end of the connecting segment. Bodily fluids such as urine and blood draining through the prostatic stent-catheter system are monitored. If the procedure is being done after treatment (e.g., surgery) on the prostate, the medical professional must determine when the patient's prostate has recovered or is recovering sufficiently from the treatment, and then the professional decouples the connecting segment from the stent and withdraws the connecting segment entirely from the patient's body. The stent thus remains within the prostatic section of the urethra to prevent bladder outlet obstruction and to keep the prostatic section of the urethra open and passing fluid(s) from the bladder while allowing normal operation of the patient's external sphincter. Once the prostate has fully recovered and poses no risk of obstructing fluid drainage, the stent can be removed. Removal of the indwelling stent can be accomplished by pulling on a suture attached to the stent. The suture typically is left extending from the urethra outside of the patient's body, or it can be left just within the meatus and therefore easily located by the patient himself or a medical professional such as a doctor or nurse. [0011] The foregoing and other objects, aspects, features, and advantages of the invention will become more apparent from the following description and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS [0012] In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. [0013] FIG. 1 is a schematic view of a prostatic stent-catheter system according to one embodiment of the present invention. [0014] FIG. 2 is an exploded view of the prostatic stent-catheter system shown in FIG. 1. [0015] FIG. 3 is a schematic view of one embodiment of a prostatic stent. [0016] FIG. 4 is a schematic view of another embodiment of a prostatic stent. [0017] FIG. 5 is a schematic view of another embodiment of a prostatic stent. [0018] FIG. 6 is a schematic view of another embodiment of a prostatic stent. [0019] FIG. 7 is a schematic view of one embodiment of a pushing device of a prostatic stent-catheter system according to the invention. Continue reading... Full patent description for Facilitating drainage Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Facilitating drainage patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. 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