Abstract:
A support device suitable for urethral support is adjustable for length post operatively. An elongated body has at least one bellows and a line going through a passage in the elongated body. The elongated body is supported in the patient and the line is adjustable by balloon inflation or rotation of a drum. The amount of support can be changed postoperatively using an instrument inserted through the skin with a local anesthetic or even from outside the skin with no surgical intervention. The bellows changes length when adjustments are made.

Description:
FIELD OF THE INVENTION 
     This disclosure is for a novel device to suspend the female urethra thereby supporting the urethra for the treatment of female stress incontinence. The device comprises a sling that is suspended from the pubic bone and contains an inflatable balloon that on inflation or deflation and/or a ratchet mechanism that tensions a pull string which regulates the degree to which the urethra is compressed. 
     BACKGROUND OF THE INVENTION 
     Stress urinary incontinence is an involuntary loss of urine on a sudden rise in the abdominal pressure as in coughing, sneezing or lifting weight. This happens when the urethra closes incompletely due to intrinsic deficiency of the muscles of urethra or hyper mobility of the urethra. Normal urethral muscle function and the normal anatomical contour of the urethra are altered due to over stretching of pelvic organs during vaginal deliveries. Obesity also brings about similar changes in the urethra. Diabetes causes deterioration of nerves and muscles of urethra. Chronic cough due to smoking or other lung conditions is also a risk factor in causing stress incontinence of urine. Stress urinary incontinence varies in the degree of loss of control. It may consist of occasional leakage of a few drops of urine or it may amount to severe loss of urine needing several diapers a day. Most of the time, it interferes in the normal social life of the persons. In severe cases it becomes a big expense for diapers. 
     Stress urinary incontinence is rare in men. Most commonly it is due to injury to the muscles and the nerves of urethra that may occur in radical prostatectomy for the cancer of the prostate. 
     The treatment of stress urinary incontinence can be tried with non-surgical methods. This consists of developing strength in the muscles of urethral sphincter by Kegel exercises. Dr. Arnold Kegel, a gynecologist, has popularized exercises that he designed to strengthen the pelvic floor muscles that work on the urethra. These exercises could be helpful in early cases or could strengthen the muscles before the symptoms develop. A vaginal pessary, which consists of a stiff ring, can be placed in the vagina to press against the urethra to prevent leakage until the bladder contracts to expel the urine. A pessary is often not easy for the patient to insert or remove. As a result, a physician usually inserts the pessary into the patient. In Addition, a pessary can induce vaginal infection. 
     Surgical treatment is the mainstay in stress incontinence of urine. In some cases walls of the urethra can be approximated by injecting contigen via a cystoscope. Contigen is like a thick gel and it is made from bovine tissue. It acts like a bulking agent to approximate the walls of the urethra. However, because it is a foreign material, patient has to undergo allergy test for it. After it is injected, contigen has the tendency to gradually leak out and the injection has to be repeated. Besides contigen, some other bulking materials are also available. However, these bulking agents are successful in very few cases. 
     The main aim in all surgical procedures for stress urinary incontinence is to give support under the urethra against which the urethra is compressed when abdominal pressure suddenly rises as in coughing, sneezing or lifting heavy objects. Several operations have been in vogue over the time. In Marshall Marchetti Krantz urethropexy and in Birch urethropexy, the procedures are carried out through an abdominal approach. These procedures are more invasive and have longer recovery time. Laparoscopic approach through the abdomen has also decreased in popularity. 
     The most commonly performed procedures for stress urinary incontinence are the sling procedures. These procedures have some variations, but all are comparatively minimally invasive surgeries. They all are based on using a sling under the urethra to compress it so that leakage of the urine is prevented during a sudden rise in the abdominal, and consequently the bladder, pressure during coughing, sneezing or lifting heavy objects. While this condition is not fatal, the inconvenience and the lack of freedom for women to control the urge to urinate affect a woman&#39;s lifestyle. There are variations in the sling material such as autologous rectus fascia, porcine skin, homologous fascia, and synthetic sling. There are some variations in the approaches to sling placement. The sling can be placed through supra-pubic approach, vaginal approach, or an obturator approach. As discussed earlier, the most common method for the treatment of female urinary incontinence is to suspend the urethra using an implantable sling. In the past, slings have been supported in different ways in the abdominal region. Most common of these methods is to support the urethra include suspending form the pubic bone. 
     Benderer et. al in U.S. Pat. No. 5,836,314 discloses a procedure for treating female stress incontinence. In his method, Benderer suggests the use of suspension sutures to sling the urethra and one or more bone anchors in the pubic bone to suspend the sutures. 
     Most of the traditional surgical methods for implantable and non-implantable devices are very complicated and cumbersome to use. Any surgical intervention, especially in the pelvic region, is very complicated, requiring long recovery and ambulation. 
     Bouttier in U.S. Pat. No. 7,229,404 B2 describes a device for suspending the urethra using a sling and anchors. 
     Smith et. al. in U.S. Pat. No. 7,261,723 B1 describes a device sling apparatus that is delivered using a needle handle from below the urethra. The device is also suspended from above to provide the compression on the bladder neck. 
     Johan et. al in U.S. Pat. No. 7,083,568 describes a sling wherein the sling apparatus can be permanently changed during and or after implantation. 
     Pretorius et. al. in U.S. Pat. No. 6,786,861 B1 describes a method by which a distensible member is inserted dorsally between the urethra and the pubic bone. By inflating the distensible member via a valve, the distensible member constricts the urethra. 
     In almost all cases, slings made from a biocompatible material, such as polypropylene, have been used to suspend the bladder neck. Various means to suspend the sling have also been disclosed by many inventors. 
     Invariably, the sling is hung from either the abdominal wall or from the pelvic bone. Various attachment methods also have been disclosed. In spite of the many inventions, and the devices that materialized subsequently, female stress incontinence is still essentially unresolved, proving that a simple solution to this annoying problem is still needed. In light of the fact that the physiology of the ailment changes post operatively, it is essential that one would consider a device that can adjust the degree to which the urethra is pinched post operatively, and after few weeks or months. 
     The present invention discloses such methods wherein the device can be adjusted either by a ratcheting mechanism or by inflating balloon that in turn tugs on the sling, compressing or decompressing the bladder neck and/or a combination of the ratchet mechanism and balloon inflation. It is preferred to use a non-distensible balloon for this purpose rather than distensible balloon, as distensible balloons will have a tendency to push the inflating mediums due to the elastomeric forces associated with them. 
     The major problem with all the previous sling procedures is that there is no control on the amount of tension they place on the urethra. The surgeon only guesses the amount of tension he should leave in the sling. During surgery, the patient is usually under general anesthesia. The body is completely relaxed. Therefore, during the operation, the tension on the sling is different than when the patient is no longer under anesthesia. Also, during surgery, the patient is lying down, and the position of the bladder and the urethra is different to when the patient is standing up and in walking state. In the first few days after surgery, there is some edema and swelling due to the surgical trauma. The tension of the sling is comparatively higher during this period, and the sling may get too loose after the swelling subsides. Once the sling is placed and the surgery is completed, there is no way to alter the tension on the sling. Because of these reasons, there is a considerable failure rate in these types of surgeries. As one would expect, there are some cases where the sling is too loose and the surgery has not succeeded in alleviating the urinary stress incontinence. In other cases, the sling is too tight and the patient cannot urinate. The patient would need catheterization to empty the bladder until another surgery is performed to loosen the sling. 
     The amount of the pressure exerted by the sling on the urethra can be a significant issue. If the degree of pressure is low, the incontinence is not cured. On the other hand, if the pressure is high, the urethra would not allow urine pass on active voluntary contraction of the bladder. This delicate balance in the degree of compression needed to achieve normal urination cannot be achieved through guessing or trial and error. Presently, none of the procedures for the treatment of stress urinary incontinence have any control on the degree of compression placed on the urethra. The novel device presented here is the only device where the compression placed on the urethra is adjustable. 
     In addition, clinical evidence has shown that the current procedure to cause complications of infection resulting in osteitis. The suspension of the sling on the pubic bone with metallic or non-metallic screws, and similar fasteners, has resulted in other complications, as the screws are not very stable, and can even detach from the bone. As such, one aspect of the present invention recommends that the sling be hung and supported in the periostium of the pubic bone ramus. 
     SUMMARY OF THE INVENTION 
     A device supports the bladder neck and urethra and is minimally invasive to implant. It comprises:
         1. A sling to support the urethra;   2. An anchor consisting an inflatable balloon from which the sling is suspended; and   3. An implanted fluid reservoir through which the fluid can be transferred into the balloon on the anchor.       

     The proposed sling; unlike slings that have been disclosed in the past (which are mainly polypropylene mesh devices that are often distensible) is preferably a flexible and non-distensible thin-walled tube. The tube preferably has a 3-4 mm. diameter. As the tube is thin-walled, when used as a sling, it will take the shape of a flat belt. The sling tube is typically made from nylon, polyester, irradiated polyethylene, or polypropylene. The tube is made from a bi-axially oriented polymer such that the tube is preferably neither able to expand in diameter or length when a circumferential or lengthwise force is applied. The sling can be silicone coated to minimize tissue adhesion. 
     The non-distensible character of the sling prevents, or minimizes, stretch and yield with time due to the abdominal pressure or urge pressure by the patient. Therefore, the sling will not appreciably relax with time, reducing its ability to compress the urethra. 
     The sling has a neck region at both ends containing an accordion type feature allowing the sling to lengthen or shorten just like an accordion would lengthen or shorten when pulled or pushed. This feature allows the surgeon to adjust the sling length during the procedure. 
     The sling also has a non-stretchable ribbon having strings attached to it at both ends, preferably made from woven polyester, nylon, or silk, and is best when made to a flat ribbon. The ribbon is placed inside the sling tube. Pulling on the ribbon causes the sling to shorten and thereby compressing the urethra. Similarly, releasing the ribbon will allow the sling to lengthen due to the accordion feature, enabling the urethra to decompress. 
     Thus, the sling is able to provide compression on the urethra by applying tension on the ribbon, which is inside the sling tube. The tension in the ribbon provides the means to adjust the degree to which the sling compresses the urethra. 
     The sling components are preferably non stretchable and non distensible to prevent creep and yield after the implantation of the sling. 
     The anchor is also an implantable component, which is placed above or near the pubic bone. Unlike in previous inventions, the anchor of the present invention is not attached to the pubic bone by means of screws or fasteners. Instead, the anchor is provided with at least one tag, (preferably two) with suture holes in it. The anchor is attached to the pubic ramus, and the anchor can be placed in front of, above, or behind the pubic bone. 
     The anchor contains two receptacles for the attachment of the sling. These receptacles have such geometric character that the “barbs” on the sling snap securely when inserted. The anchor may be made from any biomaterial with sufficient strength to hold the sling without significant flexing or yielding. 
     The string of the sling passes over the anchor and is knotted after the surgeon determines the degree to which the sling should be tensioned, which depends on the actual anatomy of the patient. 
     The anatomy of different patients is different, requiring slings of different lengths, and this is resolved during surgery by the surgeon selecting the sling of the correct length and accordion. 
     The anchor also contains the inflatable body, which on inflation tugs on the ribbon, which in turn compresses the urethra. 
     The inflation chamber can be constructed from any biocompatible plastic such as nylon polyester, polypropylene, or silicone. It is preferred that the inflation chamber is made from a material that is not elastomeric, such as silicone rubber, but made from a non distensible balloon, such that there will be no elastomeric forces that could squeeze fluid out of the inflation chamber after implantation. 
     The anchor should be sufficiently stiff to provide adequate support in order to support the sling. Additionally, a stiffener may be placed within the anchor to provide adequate support in order to hang the sling, which may be made from stainless steel, titanium, or stiff plastic. 
     The implanted reservoir holds the fluid that is used to inflate the balloon on the anchor. This fluid reservoir can be a separate component, or it may be designed as part of the anchor system. In any case, the purpose of this reservoir is to allow the surgeon to inflate or deflate the balloon with fluid, from outside, after device has been implanted and after the surgically induced swelling has subsided. 
     The fluid reservoir is implanted just under the skin. When additional tug on the sling is required, fluid can be injected into the reservoir using a needle through the skin accessing the reservoir chamber. 
     The reservoir chamber, typically about 5 mm in diameter and 2 cm long, can be approached through the skin whenever the surgeon locates the port side with his fingers. The chamber in turn contains two sub-chambers. A mechanical valve made from suitable rubber is provided to separate the fluid chamber from the first chamber to prevent contact of the fluid chamber with the body tissue. The valve prevents leakage of fluid out of the chamber. As such, the first chamber separates the actual fluid chamber from the tissue and prevents tissue growing into the valve and causing valve malfunction. 
     Alternatively, the fluid chamber can be activated by a piston mechanism whereby the piston is advanced and retracted by turning a screw. This is accomplished by inserting a tiny screw drive through the skin after infiltration of local anesthetic like lidocaine. 
     The anchor may also be designed such that turning the screw will tug on the ribbon as an alternative to the fluidic means to tug on the ribbon. 
     In summary, the present invention comprises a urethral sling for the treatment of female stress incontinence having a preferably non-distensible sling, which can accordion in order to compress the urethra. This functionality is accomplished by tugging on a ribbon, which is located within the sling sheath. The ribbon is secured to an anchor, which is sutured to the pubic ramus bone. The anchor consists of either an inflatable, non-distensible balloon, or a mechanism, to tug on and adjust the tension on the ribbon by either fluidically inflating the balloon or by mechanically winding the thread ends of the ribbon on a spool using mechanical means. 
     Therefore, this invention allows the surgeon to adjust the degree to which the sling compresses the urethra during and immediately after the surgical implantation of the urethra sling, or after some weeks or months post surgery. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  shows a diagrammatic anatomic view of the pelvic region of the human female human and the general method of the introduction of a needle to pull a urethral sling; 
         FIG. 2  shows a diagrammatic view of the proposed sling; 
         FIG. 3  shows a diagrammatic view of the suspender to which the sling is attached and one alternate method for inflating the balloon that is used to tension the pull threads; 
         FIGS. 3   a  and  3   b  show the means for inflating the balloon using a syringe needle and an alternate syringe to inflate the balloon in the suspender; 
         FIG. 4  shows the operating principle of the proposed sling device; 
         FIG. 5  shows an alternate method of a sling suspender that has a spool and a ratchet mechanism to pull on the pull threads to tension or relax the sling. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       FIG. 1  is an anatomic description of the pelvic region of the human female. The proposed urethral sling  10  is introduced just below the urethra  11  in the space between the urethra  11  and the vagina  12  bilaterally using a curved needle  14  introduced anteriorly and behind the pubic bone on either side of the urethra. Typically the surgeon creates a pocket between the urethra  11  and vagina  12  where the sling  10  will be placed. The needle  14  can be made blunt or sharp. If it is made sharp, the physician must wear a thimble on his finger to receive the needle when it is pushed from above. When the needle  14  is made hollow, it enables the operator to thread a loop guide wire  15  to facilitate threading of the pull thread  16  through the needle. The thread  16  is pulled through the needle  14  along with the sling  10  until one end of the sling  10  exits the skin at the location  17  where the needle  14  was introduced. The same process is repeated so that the other end of the sling  10  is pulled on the opposite side of the urethra  11  the same manner until the sling  10  and the pull thread  16  exits the skin at which place the needle  14  entered. 
       FIG. 2  is a diagrammatic representation of the sling. The sling  10  consists of a tubular portion  20  that is made from a thin wall plastic material such as Nylon, Polyester (PET), Polyester (PBT), Polyethylene, Polypropylene, and other suitable material. The sling  10  is a long elongated tube that is bi-axially or uni-axially oriented in order to impart strength. The sling  10  can also be made from Silicone rubber. The sling  10  has a neck region  21  which is an elongated tube structure containing “barbs”  22 . The barbs  22  are circular in nature, or they can also simply be simply protrusions that are segments of a circular ring. The barbs  22  can be rounded or teeth like. The sling  10  also contains an area that has an accordion or bellows feature  23  such that the sling  10  can expand and contract by stretching or relaxing the accordion portion  23  of the sling  10 . The pull member  24  has the preferred shape of a ribbon and is placed within the sling  10 . This is typically a ribbon in shape and is made from a strong material such as molecular oriented material such as Nylon, Polyester, or multithreaded silk, or suture materials such as catgut. The pull member  24  is used to pull or relax on the sling  10  to constrict or relax the urethra  11 . 
       FIG. 3  shows the sling suspender  25 . The suspender  25  has two tubes  26  on either side made part of the suspender  25 . The suspender  25  is made from a suitable plastic such as Nylon, Polypropylene, and Silicone, etc. The tube members  26  have corrugations  27  in the inner surface to accept the barbs  22  of the sling  10 . When the sling neck  21  is pulled through the tube  26  of the suspender  25 , the barbs  22  will engage with the corrugations  27  on the tube  26  and the sling neck  21  will lock in place securely. The thread ends  16  are then brought over and tied above the suspender  25 . The suspender  25  has an inflatable balloon  28 . The balloon  28  can be made as an integral part of the suspender  25  or can be a separate element. The balloon  28  can be made from an elastic or elastomeric material. The suspender  25  contains one or two suture tabs  29  to suture and anchor the suspender  25  to the adjoining tissue. A stiffener member  30  can be an integral part of the suspender  25 , either molded into it or subsequently placed in the suspender  25  in channel made available (not shown) in the suspender  25 . The balloon  28  is inflated or deflated with a suitable fluid such as saline containing contrast solution for enhanced radio opacity. This is done via the connecting tube  31  from a small implanted syringe  32 , shown in  FIG. 3A . The syringe  32  is especially designed with two membranes  35  and  36 . The first membrane  35  is made typically from an elastomeric rubber and the membrane  36  is made in the form of a dovetail valve that will allow a syringe needle  34  to go through easily without puncturing and when the needle  34  is removed will close and seal fully due to the back pressure created in the balloon compartment. The needle  34 , which is introduced through the skin, will puncture through the membrane  35  but will enter the membrane  36  without puncturing that membrane. Fluid is introduced or withdrawn to inflate or deflate the balloon  28 . The inflation of the balloon  28  will tension the pull threads  16 , thereby pulling on the sling  10  and hence constricting the urethra  11 . On the other hand, by deflating the balloon  28  by withdrawing the fluid, the tension on the strings  16  will be reduced, thereby relaxing the pull threads  16  and hence the sling  10  and relaxing the urethra  11 . Alternatively, the syringe  32  can be designed with a plunger  38 , as shown in  FIG. 3B , having a receptacle  39  that can accept a screwdriver  37 . By advancing the plunger  38 , the balloon  28  can be inflated, or retracting the plunger  38  can deflate the balloon. By doing so, the pull threads  16  and/or the tube members  26  can be tensioned or relaxed, thereby constricting or relaxing the urethra  11 . 
       FIG. 4  diagrammatically explains the principal of the proposed sling  10 . The sling  10  is made from a material that does not stretch substantially. For this reason bi-axially oriented tube material is ideal for this purpose. Such can be made from Nylon, Polypropylene, polyethylene etc. The accordion  23  enables some degree of adjustability in order to provide the expansion and contraction needed for the fine adjustment. The barbed region  21  can be made long enough that it can be trimmed to suit the patient to be treated. For example, a larger female may require a longer sling length while a more petite female may require a shorter sling length. As such the sling  10  can be trimmed at the barbed portion  21  to make it suitable for the patient undergoing the procedure. As shown in  FIG. 4 , by tensioning the sling  10 , the urethra  11  can be constricted. And if the surgeon has over stressed the urethra  11  during the operation, it can be relaxed by reducing the tension of the pull thread  16 . Actually, it is very difficult for the surgeon to estimate the degree to which the sling  10  should be pulled up during surgery as he cannot estimate the inflammation of the tissue post procedure. The proposed device enables the surgeon to go back and adjust the tension and adjust the sling  10  to make it more comfortable for the female to urinate. 
       FIG. 5  is a diagrammatic representation of the proposed sling  10  with a suspender  40  similar to the one earlier presented  25  in  FIG. 3  except that tensioning is done by winding the pull threads  16  on to a spool or drum  42 . The sling used in this alternate method is identical to the sling in  FIG. 2 . The barbs  22  engage to the corrugations  27  of the tube structure  43  to attach the sling to the suspender  40 . The spool  42  is located at the center of the suspender housing  40  and rotates over a spindle  44 . The ratchet wheel  44 A is an integral part of the spool  42 . A trip member  45  locks the ratchet wheel  44 A. When the ratchet wheel  44 A is turned it will ride over the trip member  45  and keeps the ratchet wheel  44 A locked into a place set by the operator. The ratchet wheel  44 A can be turned either way to tension or relax the pull on a line made from a suitable thread material  16 . The trip member  45  can be made as an integral part of the suspender housing  40  or it can a separate component attached by suitable means. The tabs  46  allow the suspender to be sutured to the tissue using normal sutures and help to stabilize the suspender  40 . The space  48  is free and can be filled with saline. The cover  47  has a rim  49  that snaps to the rim  50  of the suspender  40 . This snap mechanism can be designed using many methods available for a lid so long as such snap connection provides a hermetic seal. The face of the cover  47  is elastomeric and contains a pocket  52  that accepts a screwdriver blade. The pocket  52  engages with the receptacle  53 , which is an integral part of the ratchet wheel  42 . By turning the pocket  52 , one is able to turn the ratchet wheel  44 A. Once the pocket  52  is let go, it reverts back to its normal position without turning the ratchet wheel  44 A. This is because it is necessary to press on the pocket  52  to engage the receptacle  53 . In other words, in order to turn the wheel  44 , one must push on the pocket  52  so as to engage the receptacle  53 . 
     The entire assembly, the sling and the suspender  40  is hermetically sealed. Once the sling is in place as previously described, and the sling neck  21  is pushed into the tubes  27  of the suspender  40 , the pull wires  16  are wrapped around the spool  42  such that the turning of the spool  42  winds the pull threads  16 . Once the ratchet wheel  44 A is turned to reach the right tension of the pull threads  16 , the inside space  48  of the suspender  40  is washed and cleaned with saline and filled with saline. The cover plate  47  is then snapped on to the suspender  40  and the suspender  40  is sutured to the adjoining periostium of the pubic bone tissue. The skin incision is closed in the usual manner. 
     Within a few weeks after the surgery, and after the edema has subsided, the surgeon can, under local anesthesia adjust the tension of the pull threads  16  by turning the ratchet wheel  44 A using a screw driver introduced through the skin to turn it either direction to tension or relax the pull thread  16 . On the other hand, it is also possible to provide a knob instead of the pocket  52  such that the knob can be turned without having to puncture the skin in order to turn the ratchet wheel  44 A as the wheel  44 A can be manipulated under skin without having to create an incision. 
     The above description of the device invented here is an introduction of the concepts. No effort was made to provide any engineering details of construction and is not our intension to provide such details. As such, this prosthesis can be redesigned to appear different and can be made from a variety of bio-compatible materials. The advantage of the device is its ability to adjust the sling tension, by a variety of methods, with the preferred techniques described above, immediately after, or a few days or weeks after the surgery, which is not possible in the various previous inventions and products. The sling in the above invention will not attach to the tissue due to its smooth surface and will enable the surgeon to adjust the tension. In addition, it has the accordion feature that allows adjustment in length during and or after sling implantation. The pull threads are located inside the sling tube and are not in contact with body tissue. As such the pull thread will not form “adhesion” with the body tissue allowing free movement required for adjustment. The suspension component of the sling is placed above the pubic bone and is sutured to the tissue to generally anchor the suspender. The sling portion is attached to the suspender using the barbs and the corrugations, and once attached, will provide a hermetic seal. 
     The operation uses two curved needles that are introduced through a small incision in the skin just above the pubic bone and exit on either side of the urethra in the space between the urethra and the wall of the vagina. The invention discussed here proposes a hollow needle with a sharp obturator to facilitate the process of pushing the needle, as discussed above. It is important that the physician wear a thimble in his gloved finger to receive the needle. 
     The device discussed above will enable the female to control the urinating function and will be an excellent solution to the problem of incontinence faced by the millions of patients worldwide. 
     The above description is illustrative of the preferred embodiment and many modifications may be made by those skilled in the art without departing from the invention whose scope is to be determined from the literal and equivalent scope of the claims below.