Facilitating drainage
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.
Latest Boston Scientific Scimed, Inc. Patents:
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 FIELDThis invention relates to facilitating drainage and, more particularly, to facilitating fluid drainage from the bladder and through the urethra of a patient.
BACKGROUND INFORMATIONThe 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.
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 INVENTIONThe 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.
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.
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.
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.
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.
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.
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 DRAWINGSIn 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.
The invention generally relates to relieving bladder outlet obstruction. After prostate treatment, a patient can experience urinary retention. The invention generally involves treating urinary retention, especially male urinary retention, while still allowing normal operation of the patient's external sphincter (and thus allowing normal voiding of the bladder) even with a stent located temporarily within the prostatic section of the patient's urethra.
After a medical procedure to treat an obstructed prostate, such as thermal prostate therapy, a patient may experience prostate bleeding while the recently-treated prostate recovers. Another consequence of such medical procedures is bladder outlet obstruction which results from the still-slightly enlarged and recovering prostate. After the procedure, the medical professional (e.g., a physician) that performed the procedure or some other medical professional will monitor the amount of urine and prostate bleeding, and attempt to provide the patient with an open urinary passageway. In order to monitor continuously the bodily fluids from the patient's bladder and prostate, the medical professional(s) attending to the patient need to prevent the patient's external sphincter from closing to allow constant and uninterrupted drainage of those bodily fluids. In general, the attending professional(s) only need(s) to monitor the flow of blood and urine from the patient's urinary system for a few hours. It may, however, take several weeks for the patient's prostate to recover. One of the objects of the present invention is to provide devices, systems, and methods which will maintain an open passageway throughout the patient's entire urinary system such that constant drainage can be realized for some period of time just after treatment of the prostate, and which also can thereafter provide an open urinary passageway from the bladder through the prostatic section of the urethra while simultaneously allowing normal operation of the patient's external sphincter such that the patient has full and normal control over bladder voiding.
Referring to
During insertion of the prostatic stent-catheter system 1, the proximal end 28 of the connecting segment 6 is releasably coupled to the distal terminating end 4 of the prostatic stent 3. The coupling of the prostatic stent 3 with the connecting segment 6 creates a single lumen extending from the proximal end 7 of the body member 5 to the distal end 30 of the connecting segment 6. To couple the prostatic stent 3 to the connecting segment 6 a guide 40 is used. The guide 40 is an open ended tubular body member having a slightly smaller diameter than both the connecting segment 6 and the body member 5. The guide 40 is fastened to the proximal end 28 of the connecting segment 6 such that a portion of the guide 40 is within the lumen of the connecting segment 6 and the remaining portion extends out from the proximal end 28 of the connecting segment 6. The remaining portion of the guide 40 is then inserted into the lumen of the body member 5 creating a slip-fit seal between the prostatic stent 3 and the connecting segment 6. Various other couplings are possible, so long as the distal terminating end 4 of the body member 5 and the proximal end 28 of the connecting segment 6 are releasably joined together. For example, in other embodiments, the guide 40 is releasably coupled to the prostatic stent 3 with sutures that can be removed in situ after the prostatic stent 3 is properly positioned.
After a prostatic procedure to treat an obstructed prostate, such as thermal therapy, the patient's prostate typically will still be slightly enlarged and it may bleed. To prevent bladder obstruction and to monitor the amount of urine production and prostate bleeding, a physician can insert the prostatic stent-catheter 1 into a patient's urethra until the proximal tip 2 is located within the bladder and the connecting segment 6 extends through the external sphincter as to allow constant drainage of fluids from the patient's bladder and through the patient's prostate. Once the physician has decided that the patient's bodily fluids no longer need to be monitored, constant fluid drainage from the patient's bladder is no longer necessary. To avoid the potential risk of bladder retention due to the slightly enlarged and recently treated prostate, however, the physician may wish to maintain the prostatic stent 3 within the prostatic section of the urethra until the prostate is completely resolved. The physician, realizing that patient's prostate could take several weeks to resolve and not wishing to inconvenience the patient, can remove the connecting segment 6 from the prostatic stent-catheter system 1 while leaving the prostatic stent 3 in place by simply pulling on the connecting segment 6.
The embodiment of the prostatic stent-catheter system 1 of
The embodiment of the prostatic stent 3 of
As previously discussed, the prostatic stent 3 as illustrated in
Another embodiment of a prostatic stent-catheter system 100 is illustrated in
The prostatic stent-catheter system 100 of the embodiment illustrated in
The prostatic stent-catheter system 100 illustrated in
The prostatic stent-catheter system 1 in
Before a physician can insert the prostatic stent-catheter system 1 including a retaining member 8, the retaining member 8 must be collapsed.
To position the prostatic stent-catheter system 1 within a patient to relieve bladder outlet obstruction and to monitor a patient's bodily fluid excretions (post thermal prostate therapy, for example), a physician inserts the prostatic stent-catheter system 1 into a patient's urethra 58 through the meatus 60. This procedure is schematically illustrated in
The prostatic stent-catheter system 1 remains inside the male urinary system 70 until a decrease in prostate bleeding is observed and a physician decides that it is no longer necessary to monitor a patient's bodily fluid excretions. Even though a patient's bodily fluid excretions no longer require monitoring, the patient's prostate 53 may still be obstructed. To prevent bladder outlet obstruction and to promote prostate 53 recovery, a physician may decide to leave the prostatic stent 3 in position, and to remove only the connecting segment 6 portion of the prostatic stent-catheter system 1. To remove the connecting segment 6, the physician first decouples the prostatic stent 3 and connecting segment 6 by pulling on the connecting segment 6 (
Variations, modifications, and other implementations of what is described herein will occur to those of ordinary skill in the art without departing from the spirit and the scope of the invention. The invention is not to be limited by the preceding illustrative description.
Claims
1. A prostatic stent, comprising:
- (a) a body member including a distal terminating end, a proximal end portion, and a lumen extending within the body member, the body member sized for placement substantially within the prostatic section of the urethra with the distal terminating end located proximal of an external sphincter; and
- (b) a retaining member extending from the proximal end portion of the body member, the retaining member being collapsible and expandable.
2. The device of claim 1 wherein a proximal portion of the retaining member is tapered.
3. The device of claim 1 wherein the retaining member is formed integrally with the body member.
4. The device of claim 1 wherein the retaining member is biased in an expanded state.
5. The device of claim 1 wherein the retaining member comprises at least two arms biased in the expanded state.
6. The device of claim 1 wherein the body member comprises at least one side opening in communication with the lumen.
7. The device of claim 1 wherein the body member includes at least one protrusion to aid retention of the body member substantially within the prostatic section of the urethra.
8. The device of claim 1 wherein the body member comprises a flexible, compliant material capable of maintaining the lumen when located within the urethra.
9. The device of claim 1 further comprising a suture extending from the medical device through the urethra, and terminating externally of the meatus to allow removal of the medical device from the urethra by pulling the suture.
10-19. (canceled)
Type: Application
Filed: Mar 31, 2006
Publication Date: Sep 14, 2006
Applicant: Boston Scientific Scimed, Inc. (Maple Grove, MN)
Inventors: Gaines Hammond (Spartanburg, SC), Barry Gellman (North Easton, MA)
Application Number: 11/396,172
International Classification: A61F 2/04 (20060101);