Devices for treating urinary incontinence include slings, supports, and other scaffold-like devices that are implanted in a patient's body to support the urethra.
A sub-urethral sling is a urinary incontinence treatment device that is surgically implanted under the urethra to support the urethra and inhibit urine from leaking out of the urethra during a provocative event such as coughing or sneezing. Such an incontinence treatment device is typically implanted through one or more incisions and is anatomically secured to supporting tissue(s).
Other urinary incontinence treatment devices, such as injected bulking liquids, are applied to coaptate the urethra. Injected bulking agents have proven effective. However, most injected bulking agents are associated with reduced efficacy over time, the solution of which is to re-inject more bulking agent.
Improved incontinence treatment methods and devices would be welcomed by both the patient and the surgical staff.
One aspect provides an incontinence treatment device having a solid rod connected between a proximal portion and a distal portion. The proximal portion is insertable into a urinary bladder. The solid rod is configured for placement in the urethra. The solid rod has a length that adapts the distal portion to be positioned outside and distal to the urethra with the proximal portion positioned in the urinary bladder. The proximal portion has a lateral dimension that is at least a factor of 3 greater than a lateral dimension of the solid rod and is so configured to block an exit of the urinary bladder and impede flow of urine out of the urinary bladder. A force applied to the distal portion displaces the proximal portion away from the exit of the urinary bladder to allow urine to exit the urinary bladder.
One aspect provides an incontinence treatment device including an inflatable proximal portion that is insertable into a urinary bladder, a pump, and a tube connected between the proximal portion and the pump. The pump is positionable distal to an exit of the urethra. The pump is operable to inflate the proximal portion to an expanded dimension that blocks an exit of the urinary bladder to impede flow of urine out of the urinary bladder. The pump is operable to deflate the proximal portion to a contracted dimension that allows urine to flow from the urinary bladder through the urethra.
The accompanying drawings are included to provide a further understanding of embodiments and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts.
In the following Detailed Description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. In this regard, directional terminology, such as “top,” “bottom,” “front,” “back,” “leading,” “trailing,” etc., is used with reference to the orientation of the Figure(s) being described. Because components of embodiments can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.
It is to be understood that the features of the various exemplary embodiments described herein may be combined with each other, unless specifically noted otherwise.
Tissue includes soft tissue, which includes dermal tissue, sub-dermal tissue, ligaments, tendons, or membranes. As employed in this specification, the term “tissue” does not include bone.
The urethra is normally supported by connective and other tissues. Over time, and particularly with parous women, the support of the urethra erodes, which can give rise to hyper-mobility of the urethra. Hyper-mobile urethras are susceptible to the undesirable leaking of urine during provocative events such as sneezing, laughing, or coughing (the persistence of which is sometimes referred to as stress urinary incontinence).
Embodiments provide an incontinence treatment device configured for urethral placement into the bladder. The device includes a proximal portion that is inserted into the urinary bladder and a distal portion that is accessible by the user. The proximal portion is configured to block the exit of the urinary bladder to impede the flow of urine out of the bladder. The distal portion is operable to displace the proximal portion and allow urine to flow out of the urinary bladder. The device is initially placed through the urethra into the bladder, preferably by a surgeon, a gynecologist, or a urologist, without creating an incision. In one embodiment the device is removable by the user (for example for cleaning) and replaceable by the user.
The device 20 includes a rod 22 connected between a proximal portion 24 and a distal portion 26. The rod 22 is provided with a length L that adapts the distal portion 26 to be positioned outside and distal to the urethra when the proximal portion 24 is positioned in the urinary bladder. The proximal portion 24 is insertable into the urinary bladder and has a lateral dimension W that is at least a factor of 3 greater than a lateral dimension D of the rod 22 and is so configured to block a neck of the urinary bladder to impede flow of urine out of the urinary bladder.
In one embodiment, the length L of the rod 22 is between 2-10 cm, with one acceptable length L of the rod 22 being about 3 cm. In one embodiment, the lateral dimension D of the rod 22 is between 0.5-6 mm, with one acceptable lateral dimension D of the rod 22 being about 1 mm. In one embodiment, the lateral dimension W of the proximal portion 24 is at least a factor of 3 times the lateral dimension D of the rod 22 and has a width ranging from about 1.5-20 mm.
The device 20 is sized according to user anatomy. In one embodiment, the device 20 is provided in sizes of small, medium, and large. The small device 20, in one example, is provided with a length L of the rod 22 of about 3 cm, a lateral dimension D of the rod 22 of about 1.5 mm, and a lateral dimension W of the proximal portion 24 of about 10 mm. The large device 20, in one example, is provided with a length L of the rod 22 of about 5 cm, a lateral dimension D of the rod 22 of about 4 mm, and a lateral dimension W of the proximal portion 24 of about 16 mm.
The device 20 is adapted to be inserted through the urethra with the proximal portion 24 inserted into the bladder while permitting the user to manually displace the proximal portion to allow urine to flow of the bladder. In one embodiment, the rod 22 is oriented along a longitudinal direction such as the longitudinal axis A, and the proximal portion 24 has a substantially triangular shape in longitudinal cross-section that is configured to block the neck to the urinary bladder and prevent urine from exiting the bladder until desired by the user. In one embodiment, the proximal portion 24 is substantially circular in lateral cross-section. The distal portion 26 is configured to be comfortable and identifiable by the user, and in one embodiment is provided in a spherical shape.
The rod 22 provides a connection between the distal portion 26 and the proximal portion 24 and is not provided as a urine conduit or other form of tubular urinary catheter. To this end, in one embodiment the rod 22 is a solid rod having sufficient column strength to rigidly attach the proximal portion 24 and the distal portion 26.
To accommodate insertion of the proximal portion 24 into the bladder through the urethra, in one embodiment the proximal portion 24 is fabricated from a compressible, flexible material that can be compacted for insertion into and removal from the bladder through the urethra.
One typical lifecycle envisioned for the system 10 is for a potential user to be evaluated in a clinic or other setting by a healthcare provider such as a uro-gynecologist; fitted for one of many available sizes of the device 20; tested/observed by the uro-gynecologist for continence with the device 20 in place; instructed in the use of the device 20; and discharged from the clinic, after which the user may remove the device 20 for cleaning or other reasons before self-replacing the device 20.
In one embodiment, the proximal portion 24 is flexible and the lateral dimension W is selected to prevent the proximal portion from passing distal the exit of the urinary bladder in the trigone region; the lateral dimension D of the solid rod 22 is sized to allow urine to pass by the solid rod and exit the urethra; and a distal end of the distal portion 26 is sized to prevent the distal end from passing proximal to an exterior exit of the urethra.
The urinary sphincter is generally located at the upper one third proximal portion of the urethra. The urinary sphincter is a muscle that operates to contract against the urethra to impede the flow of urine out of the bladder. Generally, the tissue of the urethra is soft and pliable and has been described as having a nearly gelatinous consistency. Some people experience stress urinary incontinence or the sphincter muscle is deficient in fails to fully coapt the urethra to fully impede the flow of urine out of the bladder. The device 20 provides the beneficial advantage in that the rod 22 occupies some amount of space within the urethra that combines with the thickness of the wall of the urethra to allow the sphincter muscle to compress against the urethra and a portion of the rod, thus providing an improved seal in the area of the sphincter that impedes the flow of urine out of the bladder.
Embodiments of the device 20 provide a convenient and minimally invasive approach to providing urinary incontinence. The device 20 is configured to be biologically inert and functionally usable for months or years. With this in mind, in one embodiment the device 20 is fabricated as a single monolithic unit that is adapted for insertion through the urethra until the proximal portion 24 is inserted into the urinary bladder. In one embodiment, the device 20 is fabricated from plastic such as a thermoplastic elastomer, or polyethylene, or a silicone that is configured to allow the device 20 to move within the urethra and the bladder as the patient moves. That is, the device 20 is flexible and moves with the user.
The proximal portion 24 is desirably flexible and compressible to allow the proximal portion 24 to be inserted within the insertion tool 12 (
In one embodiment, the device 20 is fabricated as a single integral or monolithic piece from a thermoplastic polymer in which the rod 22 has a first higher durometer than a durometer of the proximal portion 24. As an example, in one embodiment the durometer of the proximal portion 24 is less than approximately 25 on the durometer A scale and the durometer of the rod 22 is greater than approximately 25 on the durometer A scale. Exemplary values for the durometer of the device 20 include a durometer A scale of approximately 20 for the proximal portion 24 and a durometer A scale of approximately 40 for the durometer of the rod 22. In one embodiment, the durometer of the proximal portion 24 is low and configures the proximal portion 24 to be pliable enough to allow the user to remove the device 20 from her body by passing the proximal portion 24 out of the urinary bladder and out of the urethra.
In one embodiment, at least a portion of the device 20 is fabricated from metal such as stainless steel or a shape memory alloy such as the nickel-titanium alloy referred to as NiTiNOL. However, when the device 20 is formed of metal it can be expected to be less flexible and not move with the patient at the patient moves. Although fabrication of the device 20 from metal is acceptable from an engineering standpoint it may not be acceptable from a medical or end-user patient standpoint.
In one embodiment, the proximal portion 64 is configured to fold or otherwise align with the rod 62 to reduce a cross-sectional area of the device 60, which is useful when passing the device 60 through the urethra into the bladder.
The tube 102 is preferably a kink resistant tube. Inflatable proximal portion 104 is configured to be collapsed when empty of liquid to assist in the placement through the urethra and the bladder. The proximal portion 104 is inflatable to provide a large area stopper that is configured to fit within the trigone region of the bladder to impede the flow of urine from the bladder through the urethra. The inflatable proximal portion 104 and the tube 102 are both flexible and so configured to move as the user moves. Suitable material for fabricating the inflatable proximal portion 104 and the tube 102 include plastic material, such as silicone or polyethylene or thermoplastic elastomers.
The pump 106 is sized for implantation, for example, subcutaneously within the labia majora of the user. It may become desirable to eventually replace the tube 102 or the inflatable proximal portion 104, and with this in mind one embodiment provides a connector 110 that allows the tube 102 and the proximal portion 104 to be replaced and reconnected with the pump 106.
In one embodiment, the device 100 is a closed system containing the liquid Q and the pump is configured to move the liquid Q out of the tube 102 into the inflatable proximal portion 104. For example, in one embodiment the check valve 108 is configured to retain the liquid Q in the inflatable proximal portion 104 after operation of the pump 106 to provide the user with a state of continence. The proximal portion 104 will cover the trigone region of the bladder and impede the exit of urine from the bladder after inflation of the proximal portion 104. In one embodiment, the check valve 108 is conveniently located within the pump 106 to allow the user to selectively displace a valve off of a valve seat to allow the liquid Q to drain from the proximal portion 104 back into the pump 106. With this in mind, the check valve 108 is suitably provided as a ball valve that is biased by a spring or other such suitable valve arrangements.
In one embodiment, the tube 102 is inserted into the urethra and a lateral dimension of the tube is less than approximately 4 mm and so configured to allow urine to pass an exterior of the tube 102 and exit the urethra.
In one embodiment, the inflatable proximal portion 104 is insertable through the urethra into the urinary bladder and the pump 106 is placed alongside or even attached to the labia majora, for example with adhesive. When inflated, the inflatable proximal portion 104 is substantially circular in lateral cross-section and so configured to block the exit of the urinary bladder to the urethra.
Embodiments provide for placement of the device 100 in a male user in which the proximal portion 104 is placed within the bladder and the pump 106 is implanted in the scrotum. The pump 106 is operable to inflate the proximal portion 104 to prevent urine from exiting the bladder and is also operable to deflate the proximal portion 104 to allow urine to exit the bladder alongside the tube 102.
Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a variety of alternate and/or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present invention. This application is intended to cover any adaptations or variations of medical devices as discussed herein. Therefore, it is intended that this invention be limited only by the claims and the equivalents thereof.
Number | Date | Country | Kind |
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PA 2011 70523 | Sep 2011 | DK | national |
Number | Date | Country | |
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61538129 | Sep 2011 | US |