Distributed Pressure Fenestrated Urethral Compression Apparatus for Treatment of Male Urinary Sphincter Deficiency with Preservation of Blood Flow
1. Urinary incontinence control apparatus, comprising:
- a semi-cylindrical dorsal hood defining a semi-cylindrical channel and having an exterior surface, an interior surface facing the semi-cylindrical channel, and at least one fenestration;
a urethral compressor;
a strap interconnecting the dorsal hood and the urethral compressor and such that the urethral compressor is retained caudad to the dorsal hood.
An urethral compression apparatus is defined by a semi-cylindrical fenestrated dorsal hood that is worn dorsally on the penis and which is interconnected with a strap to a urethral compressor that is oriented ventrally to apply compressive pressure on the urethra to prevent urine leakage. The dorsal hood and the urethral compressor apply distributed pressure that prevents compromised venous and arterial circulation but eliminate incontinence. The device may be worn continually and is easily removed to allow voiding, then reattached. The fenestration in the dorsal hood (or plural fenestrations as the case may be) allows distribution of pressure to avoid venous and arterial blood flow interruption. The dorsal hood partially encircles the penile shaft and the urethral compressor is oriented ventrally and applies the desired pressure to the soft ventral tissues and the urethra. A strap applies tension between the dorsal hood and the urethral compressor, and thus the necessary compression between these two components.
- 1. Urinary incontinence control apparatus, comprising:
a semi-cylindrical dorsal hood defining a semi-cylindrical channel and having an exterior surface, an interior surface facing the semi-cylindrical channel, and at least one fenestration; a urethral compressor; a strap interconnecting the dorsal hood and the urethral compressor and such that the urethral compressor is retained caudad to the dorsal hood.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
- 13. Urinary incontinence control apparatus, comprising:
a substantially C-shaped dorsal hood having an interior surface adapted for positioning on the dorsal aspect of a penis and at least partially surrounding the penile shaft, the dorsal hood having at least one fenestration; a urethral compressor caudad to the dorsal hood and having a urethral compressing component facing the interior surface of the dorsal hood such that the urethral compressing component applies pressure to the ventral aspect of the penile shaft to thereby occlude the urethra.
- View Dependent Claims (14, 15, 16, 17)
- 18. Urinary incontinence control apparatus, comprising:
a semi-cylindrical component adapted for at least partially encircling a penile shaft in a semi-cylindrical channel extending therethrough and having at least one opening corresponding to the dorsal aspect of the penis; a urethra compressor having a urethral compression component facing the semi-cylindrical channel; and strap means for connecting the semi-cylindrical component to the urethra compressor.
- View Dependent Claims (19, 20)
The present invention relates to medical devices and more particularly devices used to treat urinary incontinence in males. More specifically the present invention relates to a urethral compression apparatus that uses a fenestrated dorsal hood that applies distributed pressure to the dorsum of the penis and a ventral urethral compressor so that incontinence is resolved and blood flow is maintained.
Urinary incontinence in male patients has been an increasingly common problem over the past years in part because of a general trend toward increased longevity, and also due to an increase in urinary tract surgery. Thus, with an increasingly aging population and an increasing number of surgical interventions to treat prostate cancer, the number of males experiencing urinary incontinence has markedly increased. There are a variety of approaches to control of the urine stream from incontinence in males, including management surgically at the bladder neck level, through the use of intra-urethral devices or valves, and by apparatus worn externally and which apply pressure to the penis to compress the urethra.
As examples of surgical management, an implantable controlled valve device known as the AMS 800 is commonly regarded as the surgical standard solution. The AMS 800 is a relatively complex surgical solution; it provides a device that encircles the bulbar urethra with a water-filled ring that is fluidly connected to a valve and a reservoir. The device has been moderately successful in controlling incontinence but while it is very expensive it fails to control urine flow around 30% of the time. Moreover, surgical management always carries risk of complications such as infection and is not indicated for all patients.
Male sling procedures are available examples of other surgical control techniques but like all surgical procedures have some negative outcomes that limit use to very experienced surgical centers.
Another surgical management approach is with magnetic and non-magnetic valves surgically placed at the bladder neck, but these devices have not achieved popularity in clinical practice. Among other reasons for the relatively low levels of acceptance for these devices is the risk of infection that may accompany any device that is positioned in the urethra at the bladder outlet as the foreign body eventually attracts bacterial growth, which cannot be completely eliminated without removal of the nidus of infection.
Intra urethral blocking devices are currently under development and may soon be marketed to compete with the many penile clamps that are known in the marketplace. Examples of current standard penile clamps include the “Dribble Stop” device, the “Cunningham Clamp,” a device called the “Squeezer Klip” and others. Yet these centuries old technologies are little better than a clothes peg because of the use of directly opposed compressive parts.
Most early external clamps compromise blood circulation. As an example, the Baumrucker innovation, which is described in U.S. Pat. No. 3,866,611, uses two bars on one side of the clamp and 1 bar on the opposing side. When applied, the opposed clamps guide the penis in a pronounced curve to address incontinence but the device applies pressure to the blood supply in proportion to the pressure on the urethra. The patent describes applying maximal pressure to the dorsal vascular bundle because the single bar of the clamp crosses the top of the penis.
Convenience of use and concern about pressure symptoms are notable factors in acceptance of any externally worn device. Application of sufficient external pressure to the penile shaft to control the increased pressure of a filling bladder has usually resulted in impaired blood flow to or from the penis. The Cunningham Clamp mentioned above is preferred by users in some studies but it has been shown to markedly reduce penile blood flow. It is thus recommended that it be removed every few hours during the day and not used at night because off the risk to the viability of the penile shaft. Generally speaking, there is a dearth of successful devices that have a balance of pressure and leakage that produces a comfortable solution, but in which some amount of urine leakage must be expected. But clamps typically are not used at night because of the pressure symptoms and the concern that continuous 24 hour pressure will cause irritation to the penis, skin, and in the worst possible case ischemic necrosis of the organ. Excessive pressure could result in serious tissue damage when applied at night to users who are non-compos mentis or who have drug-induced sleep.
There are many examples of patented apparatus for treatment of male urinary incontinence. The device described in U.S. Pat. No. 5,842,968 attempted to solve the problem of leakage by using a soft circumferential clamp device that compresses all of the structures of the penis with the same pressure. The device utilizes an inflatable mechanism to produce even distribution of pressure. But the device is inconvenient because it is necessary to carry and use a syringe to relieve or add pressure and there is no attempt to relieve or offset the forces applied on the part of the device that covers the dorsal portion of the penis.
In U.S. Pat. No. 6,349,727, inventor Edward Stewart describes a two-armed device with elastic memory that had a special arm extension that brought pressure to bear on the urethral area. The devise is essentially a transverse clamp with opposing pressure elements that would be expected to impair blood flow through vessels whenever it applies pressure to constrain urethral flow.
U.S. Pat. No. 6,289,895 describes an attempt to provide specific urethral pressure by using a piston that was advanced into a constricted circular penile clamp that provided counter-pressure from the top, in a manner this is not dissimilar to most clamping devices. There is no attempt to diminish the compression of the dorsal arteries with this devise and this results in vascular compression, as with the other known prior art devices. Inventor Shah in U.S. Pat. No. 6,805,662 describes a cylindrical compression device with multiple linear chambers to accommodate greater or lesser amounts of fluid. This device fails to provide pressure selectively to the urethra and there is no circulatory protection.
Finally, the device known as the Jackson Medical J Clamp has been developed in the field and is featured by a large hood and a narrow rubber urethral occluder that has a prominent lever that extends outwardly from the device. Users report that the occluder is position-sensitive, with some positions resulting in leakage. Plus, according to some users the device is difficult to position and requires the user to take care that it does not slip from its position just above the glans penis. The device, which has increased surface area, is not recommended for continuous use.
In view of the foregoing it is clear that there is an ongoing need for a device that is better suited to control incontinence while eliminating the constrained blood flow that is characteristic of the prior art external devices and which makes such prior art devices potentially hazardous to wear at night, and painful due to pressure symptoms.
The present invention is a urinary incontinence control apparatus that addresses the shortcomings of known devices. The invention as described herein and shown in the drawings defines an effective apparatus for controlling incontinence while allowing a patient to wear the apparatus continually without discomfort and without impairment of circulation. The apparatus may be worn by the patient throughout the range of normal activity for the patient, including patients who are active in sports and the like.
The device according to the present invention addresses these shortcomings of the prior art and includes at least the following characteristics:
- Provides improved control of urine flow so that fewer pads are required for backup;
- Provides for preferential pressure to the penile urethra while avoiding excessive pressure to the arterial input or venous outflow of blood, thereby alleviating pain and risk resulting from impaired blood flow;
- Provides for stable and consistent positioning to avoid slippage during development of increased pressure as the column of urine from the bladder increases;
- Provides a solution that is devoid of symptoms caused by mechanical factors related to the weight of the device and interference of the device during movement; the device may be used during sporting activity such as skiing, cycling, running and swimming and the device may be worn during sexual activity;
- Allows for effective control of urine leakage with upright posture and during exercise;
- Superior comfort such that the user does not feel the presence of the device in a manner that would discourage use;
- Provides a single-use foam or other body-contact insert that allows for size adjustment and increased cleanliness by allowing weekly changes of the compression foam, optionally with adhesive backing;
- May be worn during erections and sexual activity because, unlike many devices that are designed to sustain erection by constraining the venous return of blood via the dorsal vein and other venous channels, the inventive device does not constrain arterial blood flow;
- Does not cause urethritis or skin irritation during use, caused by mechanical properties;
- Provides the user with a means for simple adjustment of the quantity of pressure applied during use and determination of whether the pressure should be increased or decreased during use to achieve desired control of leakage;
- Allows for continuous use even 24 hours per day, 7 days per week and 365 days per year if the loss of sphincter control causes significant night time leakage;
- In one embodiment allows for monitoring and tracking of the pressure applied to the dorsal and urethral side of the penis and creation of an historical record for patients and managers—the amount of pressure applied to the urethra can be compared to leaking events to optimize pressure levels;
- Data obtained from monitoring and tracking of pressure from the inventive device, especially during the treatment recovery period following prostatic resection will produce an individual history and create a body of knowledge that will inform clinicians;
- Sensors that may be placed in the urethral compression pad and in the dorsal hood provide periodic measurements that are recorded remotely via transmission to remote computers;
- In one embodiment, data from the sensors may be used to inform an increase or decrease in urethral pressure by means of a remotely controlled pressure actuator;
- In another embodiment the sensors may be defined by a pulse oximeter for monitoring oxygen saturation and/or temperature sensors.
The so-called Rapoport Protocol, which was developed by Dr. Daniel Rapoport, a specialist urological surgeon, describes a supportive guide that specifies care for patients in the post “radical prostatectomy care” situation. The protocol teaches that after catheter removal and a healing period of approximately three weeks the urethral compression device described herein will provide the patient with control of urine flow until restoration of sphincter function occurs. A fundamental problem for such patients is that 60% of postoperative males have incontinence that lasts for 6-12 months and a residual 5-30% of such patients have ongoing urine leakage that can typically be managed only by pads and diapers. A vascular preservation urethral compression device enables postoperative patients to have control of their bodies but a key factor is eliminating the risk of vascular impairment, which could lead to serious adverse conditions including gangrene and venous thrombosis. The present invention provides a solution that solves these problems and addresses the needs of such patients.
The device according to the present invention solves additional problems. There is significant need for a urinary leakage control device for use in nursing facilities to provide round-the-clock urinary control to avoid bed wetting and excessive use of urinary absorption pads. Pads are known to lead to major skin problems, add costs and are associated with offensive odors. The device according to the present invention defines an alternative solution that is safe for use 24 hours per day, 7 days per week, year around. The device is safe because when used with consistent and appropriate distributed pressure the vascular supply to the penis is not compromised and the patient is thus not at risk of necrosis of the external genitalia. Further, the inventive device may be used with the non-compos mentis patient.
There is a compelling need for a device that meets the foregoing challenges. More specifically, there is a documented need for a device that provides excellent control of urine leakage during the day and night without compromising circulation of blood. Known devices exemplified by those described above rely on hourly or other periodic release of pressure to prevent damaging vascular effects and to relieve pain and discomfort.
In a first preferred and illustrated embodiment the urethral compression apparatus according to the invention is defined by a semi-cylindrical fenestrated dorsal hood that is worn dorsally on the penis and which is interconnected with a strap to a urethral compressor that is oriented ventrally to apply compressive pressure on the urethra to prevent urine leakage. The dorsal hood and the urethral compressor apply distributed pressure that prevents compromised circulation but complete prevention of incontinence. The device may be worn continually and is easily removed to allow voiding, then reattached. The fenestration in the dorsal hood (or plural fenestrations as the case may be) allows distribution of pressure to avoid venous and arterial blood flow interruption. And because the urethral compression apparatus 10 is worn either midway along the penile shaft or toward the base of the shaft, urine does not pool in the urethra.
The dorsal hood is generally C-shaped and, when worn on the dorsal aspect of the penile shaft partially encircles the shaft. The urethral compressor is oriented ventrally and applies the desired pressure to the soft ventral tissues and the urethra. A strap applies tension between the dorsal hood and the urethral compressor, and thus the necessary compression between these two components.
The invention defined herein contemplates use of the urethral compression apparatus in clinical and non-clinical settings and, particularly in the nursing home setting, use of a variety of sensors such as pulse oximetry, temperature and pressure sensors so that clinical staff may monitor the patient'"'"'s condition. Data from the sensors is transmitted to a remote monitoring station and a cloud based system may be utilized to monitor and inform some nurse-patient interactions such as periodic voiding.
The invention will be better understood and its numerous objects and advantages will be apparent by reference to the following detailed description of the invention when taken in conjunction with the following drawings.
Reference is now made to the drawings filed herewith. Because the apparatus according to the present invention is especially designed for use with the human penis, it is appropriate to include a brief discussion of some aspects of the anatomy and physiology of the penis; conventional anatomical terminology is used throughout this description. With specific reference to
Those of skill in the art will readily understand that the penis 200 is a complex organ and the anatomy is far more complex than illustrated herein; the anatomical detail shown in the drawings is appropriate to the description of the structure and operation of the invention but is not meant to illustrate the full anatomy.
A first illustrated embodiment of the invention will now be described with particular reference to
Preferably, the dorsal hood 12 is fabricated from a semi-rigid or rigid material because, as detailed below, the dorsal hood 12 is designed specifically to apply distributed pressure to, and avoid excessive pressure on the dorsal aspect 218 of penis 200 and to thereby avoid interference with blood flow, especially through dorsal arteries 216 and dorsal vein 210. In practice the dorsal hood 12 (and other components such as urethral compressor 14) may beneficially be fabricated from a medical grade plastic such as K-RESIN medical grade plastic, although this is but one example. A strap-receiving channel 30 extends over the top of the outer surface 32 of body 18 between edges 34 and 36 and as detailed below, the strap 16 resides generally in the strap-receiving channel 30.
The C-shaped body 18 shown in most of the figures includes a single fenestration 24. It will be appreciated, however, that plural fenestrations may be incorporated into a dorsal hood 12 according to the invention. For example, and by way of illustration with reference to
Turning now to
The ridge 44 is referred to as being a “transverse ridge” because when the urethral compression apparatus 10 is in use (see, e.g.,
With reference now to
A second illustrated embodiment of a urethral compressor 14 is illustrated in
Two additional embodiments of a urethral compressor 14 according to the invention are illustrated in
From the several embodiments of the urethral compressors 14 shown in the figures it will be appreciated that there are several differently shaped structures that provide the equivalent functionally desired attributes described below when paired with the dorsal hood 12 illustrated and described herein.
A third illustrated embodiment of a urethral compression apparatus 10 is illustrated in
When urethral compression apparatus 10 is applied to penis 200 as shown in
The pressure applied by dorsal hood 12 with its fenestration 24 is distributed over a substantial area of the penile shaft, defined by the interior surface area of interior surface 40 of dorsal hood 12. By distributing pressure over an increased surface area, combined with the fenestration(s) significantly decreases the amount of point pressure that is applied to the dorsal aspect of penis 200 so that circulation in the nearby arteries and veins is not compromised, yet allowing sufficient pressure to be applied to the ventral aspect of the penis 200 to occlude the urethra 208. This orientation is shown in
Testing has confirmed that the transverse ridge 46 of the urethral compressor 14 shown in
Testing has also confirmed that the rigidity or semi rigidity of the dorsal hood 12 prevents circumferential compression of the penis during use of apparatus 10 so that normal physiological enlargement and shrinking of the penis does not interfere with the primary function of the apparatus 10, namely, prevention of urine leakage. Periodic removal of apparatus 10 to allow urine voiding is a very simple procedure, as is reinstallation of apparatus 10 subsequent to voiding.
All of the embodiments of the urethral compressor illustrated in
It will be appreciated that the strap 16 defines a readily and easily adjustable means of attaching and securing the dorsal hood 12 to the urethral compressor 14 and that there are numerous equivalent ways of attaching the two parts together other than the described hook and loop fabric. Thus, other types of tensioning bands such as a band with holes in one end with anchoring pins on the overlapping portion may be used. In addition, the dimensions of the dorsal hood 12 may be varied so that a size appropriate to individual patient may be selected.
Reference is now made to
Control module 86 includes a power supply 88 and circuitry and associated software and/or firmware to facilitate operation of the pulse oximeter 80 and preferably is wirelessly enabled (with standard wireless communication protocols such as Bluetooth) so that data from the pulse oximeter may be transmitted to a remote monitoring station 90. This allows clinical staff to remotely monitor patients wearing the urethral compression apparatus 10 to insure adequate circulation.
Other types of sensors may be incorporated into urethral compression apparatus 10, including for example temperature and pressure sensors. As an example, a temperature sensor 92 may be incorporated in dorsal hood 12 (or in urethral compressor 14) and/or a pressure sensor such as a foil-type strain gage 94 or other equivalent pressure sensor may be incorporated in urethral compressor 14 (and/or in dorsal hood 12). Each of these types of sensors is attached with appropriate circuitry to control module 86 so that temperature and/or pressure data may be transmitted to remote monitoring station 90 for evaluation by clinical staff. Software in remote monitoring station 90 includes threshold alarms to alert staff to out-of-bounds conditions such as low oxygen saturation values, increased temperature or pressure values. A urethral compression apparatus 10 may further include conventional electronics connections to allow the apparatus to be connected by hard wiring to the monitoring station 90 in clinical settings where wireless connections cannot be utilized.
In addition to data from the various sensors may being transmitted to the remote monitoring station 90, data may be transmitted to and stored in a cloud computing environment for access by care providers. The system may be set up to provide routine and periodic notifications to the healthcare professionals, for example, making sure that the patient voids urine regularly.
The strap 16 defines a means for adjusting the pressure applied to the penis by urethral compression apparatus 10 but the strap described above and shown in the drawings may be replaced with other equivalent devices for accomplishing the same function. As just one example, an automated (and if desired, remotely controlled) pressure actuator such as a pneumatic or electrically drive actuator may be used as a pressure application means.
While the present invention has been described in terms of preferred and illustrated embodiments, it will be appreciated by those of ordinary skill that the spirit and scope of the invention is not limited to those embodiments, but extend to the various modifications and equivalents as defined in the appended claims.