Abstract:
A medical device is provided including a mesh having a first mesh portion of natural material positioned between second and third mesh portions of a synthetic material. The mesh is adapted, when implanted in a female patient, to provide support to the urethra with the first mesh portion positioned below the urethra. A method is also provided for treating female urinary incontinence including providing such a mesh, and implanting the mesh to provide support for the urethra so that the first mesh portion is positioned below the urethra.

Description:
CROSS REFERENCE TO RELATED APPLICATION  
       [0001]    The present invention is a divisional of co-pending U.S. patent application Ser. No. 09/873,571, filed on Jun. 4, 2001, which is a continuation-in-part of co-pending U.S. patent application Ser. No. 09/521,801, filed on Mar. 9, 2000, which claims the benefit of earlier-filed U.S. provisional patent application serial No. 60/138,231, filed on Jun. 9, 1999, which are both incorporated by reference in their entirety herein. 
     
    
     
       BACKGROUND OF THE INVENTION  
         [0002]    1. Field of the Invention  
           [0003]    The present invention relates generally to a surgical instrument and a method for treating female urinary incontinence and in particular to a needle and mesh configuration for creating a sling beneath the urethra.  
           [0004]    2. Background Discussion  
           [0005]    Women account for more than 11 million of incontinence cases. Moreover, a majority of women with incontinence suffer from stress urinary incontinence (SUI). Women with SUI involuntarily lose urine during normal daily activities and movements, such as laughing, coughing, sneezing and regular exercise.  
           [0006]    SUI may be caused by a functional defect of the tissue or ligaments connecting the vaginal wall with the pelvic muscles and pubic bone. Common causes include repetitive straining of the pelvic muscles, childbirth, loss of pelvic muscle tone, and estrogen loss. Such a defect results in an improperly functioning urethra. Unlike other types of incontinence, SUI is not a problem of the bladder.  
           [0007]    Normally, the urethra, when properly supported by strong pelvic floor muscles and healthy connective tissue, maintains a tight seal to prevent involuntary loss of urine. When a woman suffers from the most common form of SUI, however, weakened muscle and pelvic tissues are unable to adequately support the urethra in its correct position. As a result, during normal movements when pressure is exerted on the bladder from the diaphragm, the urethra cannot retain its seal, permitting urine to escape. Because SUI is both embarrassing and unpredictable, many women with SUI avoid an active lifestyle, shying away from social situations.  
           [0008]    U.S. Pat. No. 5,112,344 describes a method and apparatus for treating female incontinence. The surgical instrument for the application of a filamentary element into the body comprises a tubular shaft having a handle at one end and a flexible needle slidably receivable in the shaft and adapted at one end to receive a filamentary element. The method of treating female incontinence comprises looping a filamentary element between the wall of the vagina and the rectus abdominis sheath in the anterior wall of the abdomen whereby it passes to each side of the urethra, tightening the loop to bring the vaginal wall and the urethra into the correct spatial relationship to the pubis allowing the development of scar tissue between the vaginal wall and the anterior wall of the abdomen pubic symphysis and removing the filamentary element.  
           [0009]    U.S. Pat. No. 5,899,909 discloses a surgical instrument comprising a shank having a handle at one end and connecting means at the other end to receive, one at a time, two curved needle-like elements which are connected at one end to one end of a mesh intended to be implanted into the body. In practice, the mesh is passed into the body via the vagina first at one end and then at the other end at one side and the other, respectively, of the urethra to form a loop around the urethra, located between the urethra and vaginal wall. The mesh is extended over the pubis and through the abdominal wall and is tightened. The mesh ends are cut at the abdominal wall, and the mesh is left implanted in the body. This trans-vaginal procedure is exemplified by the TVT product sold by the Gynecare franchise of Ethicon Inc., a Johnson &amp; Johnson Company, of Somerville, N.J., USA. In this procedure two 5 mm needles pass a PROLENE mesh trans-vaginally and through the abdomen to create a tension-free support around the mid urethra. U.S. Pat. No. 5,899,909 is incorporated herein by reference in its entirety.  
           [0010]    An alternate method to treat SUI is the sling procedure. In this procedure a needle or other suture-retrieving device is first inserted through the abdomen, above the pubic bone. The needle is guided behind the pubic bone, through the subrapubic fascia around the urethra, and out of the body through an incision in the anterior vaginal wall. At this point sutures are attached to the needle(s) and pulled up back through the abdominal cavity, where the sutures are fastened to the rectus muscle.  
           [0011]    Techniques for protecting against the puncture of the internal structures during this type of procedure have included laparoscopic procedures. This involves making an incision in the abdomen and inserting a video scope to watch the progress of the needles as they pass through the abdominal cavity. These additional incisions are not optimal for the patient. Also, the needles which pass through the abdomen are not designed to capture a mesh but rather a suture which has been previously attached to the mesh or harvested fascia. These needles are generally in the diameter range of about 0.090 ins. to about 0.120 inches. Therefore, the needles do not create a large channel through the fascia. The channel is only wide enough to pass the suture. Accordingly, the sutures do not possess the elongation properties of the PROLENE mesh and therefore can not provide the tension-free support of the TVT. Also attaching a mesh directly to these needles is not optimal because it is very difficult, if at all possible, to pull the mesh through the narrow channel created by the needle.  
           [0012]    It would be beneficial to provide a surgical system for use in implanting a mesh within a female body to prevent incontinence that can be implanted either through a trans-vaginal approach or a trans-abdominal approach.  
           [0013]    This invention addresses that need and overcomes the deficiencies of the prior art.  
         SUMMARY OF THE INVENTION  
         [0014]    The present invention provides a medical device for implanting in a female patient to treat urinary incontinence. The device includes a mesh having a first mesh portion comprised of a synthetic material and having first and second ends, and second and third mesh portions comprised of a synthetic material and coupled to and extending outwardly from the first and second ends of the first mesh portion respectively. The mesh is adapted, when implanted in the patient, to provide support to the urethra with the first mesh portion positioned below the urethra.  
           [0015]    According to one embodiment, the device further comprises a removably protective sheath substantially covering the mesh. In another embodiment the second and third mesh portions are comprised of polypropylene, and in yet another embodiment the first mesh portion is comprised of one or more of an autologous material, an allograft, a xenograft and a tissue engineered matrix. In yet another embodiment the mesh is a substantially flat, flexible mesh, and may have a thickness of about 0.7 mm and a width of about 1 cm.  
           [0016]    A mesh is also provided for implanting in a female patient to treat urinary incontinence including a first mesh portion comprised of a natural material and second and third mesh portions comprised of a synthetic material, with the first mesh portion positioned between the second and third mesh portions.  
           [0017]    A method for treating female urinary incontinence is also disclosed. The method includes providing a mesh having a first mesh portion comprised of a natural material and second and third mesh portions comprised of a synthetic material, wherein the first mesh portion is position between the second and third mesh portions. The method further includes implanting the mesh into a female patient to provide support to the urethra with the first mesh portion positioned below the urethra.  
           [0018]    These and other features and advantages of the present invention will become apparent from the following more detailed description, when taken in conjunction with the accompanying drawings which illustrate, by way of example, the principles of the invention.  
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0019]    [0019]FIG. 1 is a side view of the needle in one embodiment thereof;  
         [0020]    [0020]FIG. 2 a  is a side view of two needles and a mesh interconnecting the needles;  
         [0021]    [0021]FIGS. 2 b - d  are alternate embodiments of the mesh and connecting means between the mesh and needle;  
         [0022]    [0022]FIG. 3 a  is an assembly diagram for two needles and a connector;  
         [0023]    [0023]FIGS. 3 b - d  are alternate embodiments of a connector for use in FIG. 3 a;    
         [0024]    [0024]FIGS. 4 a - j  diagrammatically illustrate several surgical steps of a trans-abdominal method utilizing two needles and guide needle according to the invention to treat SUI;  
         [0025]    [0025]FIGS. 5 a - d  illustrate alternate embodiments of coupling the guide needle to the needle;  
         [0026]    [0026]FIGS. 6 a - h  diagrammatically illustrate several surgical steps of a trans-abdominal method utilizing a single needle according to an alternate embodiment of the invention to treat SUI;  
         [0027]    [0027]FIGS. 7 a - g  illustrate alternate embodiments of coupling the needle to the mesh; and  
         [0028]    [0028]FIGS. 8 a - i  diagrammatically illustrate several surgical steps of a trans-abdominal method utilizing two needles and two guide needles according to the invention to treat SUI. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0029]    Before explaining the present invention in detail, it should be noted that the invention is not limited in its application or use to the details of construction and arrangement of parts illustrated in the accompanying drawings and description, because the illustrative embodiments of the invention may be implemented or incorporated in other embodiments, variations and modifications, and may be practiced or carried out in various ways.  
         [0030]    The invention discloses an apparatus and method for treating SUI. A mesh or tape is passed through pelvic tissue and positioned between the urethra and vaginal wall, creating a supportive sling. The mesh provides a structure means for tissue ingrowth and thereby provides a newly created body tissue supporting means for the urethra. When pressure is exerted upon the lower abdomen, such as during a cough or sneeze, the mesh provides support to the urethra, allowing it to keep its seal and prevent the unwanted discharge of urine.  
         [0031]    Referring to FIGS. 1 and 2 a , in one embodiment the surgical instrument comprises a needle-like element  10  that attaches to a mesh  12 . Needle element  10  defines a certain radius R to perform the surgical procedure discussed herein. The distal end of needle element  10  terminates at a conical section  14  having a tip  16 . Alternate configurations, such as a blade-like, arrow or burr tips are also possible. Preferably, tip  16  is blunt, wherein the tip  16  has a radius of about 0.6 millimeters. A blunt tip is preferred since it is less likely to stick in bone or penetrate bladder wall tissue or blood vessel wall tissue as will be appreciated from the method of implanting the mesh as described below.  
         [0032]    The proximal end of needle  10  terminates in an attachment segment  20  that is adapted to mate and lock into a handle  21  as disclosed in U.S. Pat. No. 5,899,909.  
         [0033]    Disposed between tip  14  and segment  20  is a curved shaft segment  18  having a distal end  17  and a proximal end  19 . The shape of shaft  18  extends substantially a quarter of a circle in order to follow substantially the profile of the pubis between the vagina and the abdominal wall. For the purposes of the method as will be discussed in more detail below, shaft  18  has a preferred radius R of about 106 millimeters. The diameter of shaft  18  may be constant, for example, about 5 mm. Alternatively, the diameter of segment  18  may transition from a smaller diameter at distal end  17  to a larger diameter at proximal end  19 . The minimum diameter of distal end  17  may be as small as 0.5 mm due to the minimal stresses at this point. The minimal diameter of proximal end  19  is about 4 mm.  
         [0034]    Needle  10  is preferably tubular with a circular cross section and is made from a material that is compatible with the human body. Preferably, needle  10  is made from AISI 303 stainless steel. The surface of shaft  18  may be smooth, preferably polished, to facilitate penetration of the soft tissue. Alternatively, the surface of needle  10  may have a somewhat rougher surface. A rougher surface would result in slightly additional tissue trauma, which in turn stimulates fibroblast activity around the mesh  12 . The surface of needle  10  may also be darkened in shade or color to provide higher visibility while in place in the body during a cystoscopy.  
         [0035]    Needle  10  may be manufactured as a single, continuous unit, or alternatively, curved portion  18  may be manufactured separately from linear portion  20 . In this manner the two pieces would attach using any conventional attaching means, such as, screwing, or other conventional means as is known to those skilled in the art.  
         [0036]    Referring to FIGS. 2 a - d , mesh  12  comprises any tissue-compatible synthetic material, or any natural material, including, but not limited to, autologous, allograft, xenograft, a tissue engineered matrix, or a combination thereof. An exemplary synthetic material is PROLENE® polypropylene mesh, a mesh having a thickness of 0.7 mm and openings of about 1 mm manufactured by Ethicon, Inc., Somerville, N.J., U.S.A. This material is approved by the U.S. Food and Drug Administration for implantation into the human body. A still further embodiment of the mesh  12  is a combination of a synthetic material  11  and a natural material  13  centered between the synthetic material  11  as shown in FIGS. 2 b - c . A still further embodiment of the mesh  12  includes a combination of synthetic material  11  and natural material  13 , whereby the natural material is placed over or incorporated within a generally central portion of the synthetic material  11 . One advantage of the mesh configurations is that natural material  13  is along the center region of mesh  12  so that after installation of mesh  12 , natural material  13  is positioned below the urethra and eliminates possible erosion issues at the interface of the urethra and mesh. Natural material  13  may be connected to the synthetic material  11  by means of sewing, a bio-compatible glue, cell culturing techniques or other known means.  
         [0037]    Mesh  12  may be of any convenient shape that suits the intended purpose of the invention. An exemplary width is about 1 cm and the length would be dependent upon the size of the female undergoing the procedure. Mesh  12  may be single or double ply, generally planar in structure, or tubular (FIG. 2 d ) to provide additional supporting strength and more surface area on which tissue fibers may attach. Moreover, mesh  12  may consist of different types of material, such as a bioabsorbable and non-bioabsorbable material. Mesh  12  may also be coated with an antimicrobial additive to prevent or minimize infection and a lubricous coating, for example, a bioabsorbable hydrogel, to facilitate the mesh passing through the tissue as discussed below. Preferably, mesh  12  is covered by a removal plastic sheath as disclosed in U.S. Pat. No. 5,899,909. The mesh may also be made radio-opaque and/or of a contrasting color to the body tissue to allow for future diagnostic visualization.  
         [0038]    In one embodiment mesh  12  may be attached to needle segment  20  by means of tying, gluing or other suitable attaching means. Preferably, a biocompatible heat shrink tube fixes mesh  12  onto needle portion  20 , FIG. 2 a.    
         [0039]    [0039]FIG. 3 a  illustrates a needle  10  for use in conjunction with a guide needle  110  and coupler  112 . Guide needle  110  may be configured to have a similar radius R as needle  10 . Preferably, guide needle  110  has a smaller diameter, about 2 mm. It is possible, however, for guide needle  110  to have the same diameter as needle  10 . A coupler  112  acts as an interfacing element useful to couple guide needle  110  to needle  10 . Coupler  112  is substantially elliptical-shaped having a first bore opening  114  for accepting distal end  17  and a second bore opening  116  for accepting the distal end of guide needle  110 . Preferably, openings  116  and  114  are configured to allow for a press fit connection with needles  110  and  10 , respectively. Alternatively, openings  114  and  116  may comprise a bio-compatible glue or high-friction material to facilitate a strong connection between the needles  10 / 110  and coupler  112 . Coupler  10  may be made from any bio-compatible metal, such as stainless steel or polyurethane, silicone, rubber or other similar compound.  
         [0040]    [0040]FIGS. 3 b - d  illustrate alternate connector means utilizing a high friction tube  170 , such as Tygon. FIG. 3 b  discloses a tube having a constant O.D., but a varying I.D. The larger I.D. would accept needle  10  and the smaller I.D. accepts the guide needle  110 . FIG. 3 c  illustrates a tube  172  having both a varying O.D. and I.D. As the needles are placed within the tube the decreasing I.D. compresses around the distal ends of the respective needles and the high coefficient of friction securely anchors the needles. FIG. 3 d  illustrates the needles within the tube  172 . Preferably, the ends of tube  170  and  172  are tapered to eliminate any abrupt surface that adds additional drag to the needles as they are pulled through the abdominal cavity.  
         [0041]    The surgical procedure for trans-abdominally implanting mesh  12  using two needles is shown in FIGS. 4 a - j . In the figures the relevant parts of the female lower abdomen are disclosed, the vagina being  50 , the uterus  52 , the urethra  54 , the pubic bone  56 , the urinary bladder  58  and the abdominal wall  60 . A guide needle  110  penetrates the abdominal wall  60 , anterior to the pubic bone  56 , FIG. 4 a  and follows the contour of the pubic bone  56  to one side of the urethra  54  and exits the body through an incision having been made in the anterior wall of the vagina  50 . Coupler  112  attaches to the distal end of guide needle  110 , extending out from the body, and needle  10   a , FIG. 4 b . One end of mesh  12  is attached to the proximal end of needle  10   a . The surgeon then retracts guide needle  110  back through the abdomen and advances needle  10   a  through the vaginal incision following the same path guide needle  110  created, FIG. 4 c . The needles pass through the vaginal wall and through the soft tissue on one side of the urethra  54 , the needles then according to FIG. 4 d  being passed close to the back of the pubic bone  56 , through additional layers of fat, muscle and fascia, and then out the abdominal wall  60  above the pubic bone  56 . The surgeon uncouples handle  21  from the needle  10   a  and pulls needle  10   a  out of the body through the abdominal wall  60 , FIG. 4 e.    
         [0042]    Guide needle  110  is disconnected from needle  10   a , and the surgeon repeats the same procedure, but passing the guide needle  110  on the opposite side of the urethra  54 , FIGS. 4 f - j , to complete the implantation of the mesh between the mid-urethra and vaginal wall using needle  10   b.    
         [0043]    [0043]FIGS. 8 a - i  illustrate an alternate preferred embodiment. A first guide needle  110   a  penetrates the abdominal wall  60 , anterior to the pubic bone  56  and follows the contour of the pubic bone  56  to one side of the urethra  54  and exits the body through an incision having been made in the anterior wall of the vagina  50 . A second guide needle  110   b  penetrates the abdominal wall  60 , anterior to the pubic bone  56  and follows the contour of the pubic bone  56  to the opposite side of the urethra  54  as guide needle  110   a  and exits the body through an incision having been made in the anterior wall of the vagina  50 , FIG. 8 a . At this point, the surgeon may perform a single cystoscopy to confirm the integrity of the bladder  58 . Couplers  112   a,b  attach to the distal ends of needles  10   a,b . Needle  10   a , having one end of mesh  12  attached to the proximal end of needle  10   a  attaches to guide needle  110   a  via coupler  112   a , FIG. 8 b . The surgeon then retracts guide needle  110   a  back through the abdomen and advances needle  10   a  through the vaginal incision following the same path guide needle  110   a  created. The needles pass through the vaginal wall and through the soft tissue on one side of the urethra  54 , the needles being passed close to the back of the pubic bone  56 , through additional layers of fat, muscle and fascia, and then out the abdominal wall  60  above the pubic bone  56 , FIGS. 8 c - d . The surgeon uncouples handle  21  from the needle  10   a  and pulls needle  10   a  out of the body through the abdominal wall  60 , FIG. 8 e.    
         [0044]    The surgeon repeats the same procedure, but removing guide needle  110   b  and advancing needle  10   b  on the opposite side of the urethra  54 , to complete the implantation of the mesh between the mid-urethra-and vaginal wall using needle  10   b , FIGS. 8 f - i.    
         [0045]    [0045]FIGS. 5 a - d  illustrate alternate embodiments for coupling needle  10  to guide needle  110  to implant a mesh  12  trans-abdominally as indicated above. In FIGS. 5 a - b,  the distal end of needle  10  is modified to include a bore opening  118  to allow for a press fit connection with the distal end of guide needle  110 . Alternatively, bore-opening  118  may comprise other connection means, such as glue or a high-friction material.  
         [0046]    In FIG. 5 c , the distal end of needle  10  is modified to include a bore opening  120  and a locking pin  122 . Guide needle  110  is modified to include an L-shaped groove  124 . The distal end of guide needle  110  inserts into opening  120  and groove  124  engages locking pin  122  and locks thereto with a quarter-turn twist. FIG. 5 d  illustrates a bore opening  126  in guide needle  110  to accept a protruding element  128  at the distal end of needle  10 . Protruding element  128  press fits into bore opening  126 .  
         [0047]    One advantage of the embodiment shown in FIG. 3 is that the needle  10  can be used for either a trans-abdominal approach or a trans-vaginal approach. In this approach, a kit comprising two needles  10 , attached to a mesh  12 , at least one coupler and at least one guide needle may be distributed for use by multiple surgeon specialists. For example, a gynecologist may prefer the trans-vaginal approach and will simply discard the connector and guide needle from the kit. On the other hand, a urologist may prefer the trans-abdominal approach and utilize the connector(s) and guide needle(s).  
         [0048]    Referring now to FIGS. 6 a - h , an alternate embodiment of the invention utilizes the needle  10  to penetrate the abdominal wall  60  and couple to the mesh  12 . In this embodiment, the mesh  12  is modified to create a connection means for connecting to the distal end of the needle  10 . The connection means is preferably detachable so that when the mesh is pulled out of the abdominal wall, the mesh may be detached from the needle and the needle reused to retrieve the other end of the mesh. This embodiment allows for the use of a single needle for the procedure. This embodiment also allows for the use of a mesh constructed, at least in part, of natural materials, which are otherwise not suitable in the pre-affixed embodiment due to the inability of the natural material to survive extended periods in inventory.  
         [0049]    A needle  10  with coupling means at the distal end penetrates the abdominal wall  60 , anterior to the pubic bone  56 , FIG. 6 a  and follows the contour of the pubic bone  56  to one side of the urethra  54  and exits the body through an incision having been made in the anterior wall of the vagina  50 , FIG. 6 b . A first end of mesh  12  attaches to the distal end of needle  10  via coupling means. The surgeon then retracts needle  10  back through the pelvic cavity, following the same path created by needle  10 , while at the same time causing mesh  12  to follow the needle, FIG. 4 c . The needle  10  and mesh  12  pass through the vaginal wall and through the soft tissue on one side of the urethra  54 . The needle and mesh then according to FIG. 4 f  being passed close to the back of the pubic bone  56 , through additional layers of fat, muscle and fascia, and then out the abdominal wall  60  above the pubic bone  56 .  
         [0050]    Needle  10  disconnects from the first mesh end, and the surgeon repeats the same procedure, but this time passes the needle  10  on the opposite side of the urethra  54 , FIGS. 6 d - h , to complete the implantation of the mesh  12  between the mid urethra and vaginal wall.  
         [0051]    Referring to FIGS. 7 a - g , alternate embodiments for connecting the needle  10  to the mesh  12  are disclosed. FIGS. 7 a - b  disclose a coupler  130  having a proximal end  132  configured to accept the mesh  12  and a distal end  134  for accepting the distal end  17  of needle  10 . Distal end  17  comprises a contiguous groove  120  for detachably coupling with coupler  130 . Coupler  130  further comprises two spring tabs  136  and  138 , each with fingers  140  and  142  for engaging groove  120 . Mesh  12  is preferably attached to the distal end  132  using a biocompatible glue or other appropriate mechanical fastening means. The surgeon may simply attach or detach needle  10  from coupler  130  by depressing spring tabs  136  and  138  forcing fingers  140  and  142  upward to allow distal end  17  to slide in or out of coupler  130 . Fingers  140  and  142  engage groove  120  to hold needle  10  firmly in place within coupler  130 .  
         [0052]    [0052]FIGS. 7 c - e  illustrate a coupling mechanism  150  similar in function to a safety pin. Spring arm  152  engages with a bore  154  at the distal end  17  of needle  10 .  
         [0053]    [0053]FIGS. 7 f - g  illustrate a loop coupling mechanism  160  attached to mesh  12  for engaging groove  120 .  
         [0054]    As would be appreciated by one skilled in the art, there exist multiple means for detachably connecting the mesh to the needle.  
         [0055]    Since all procedures may be performed using a local anesthesia, the patient is able to provide feedback to the surgeon after mesh  12  is in place. Typically, the urinary bladder  58  is filled with a fluid, such as water, using a catheter and the patient is requested to cough. The surgeon is able to determine the operation of the urethra and may adjust the placement of the mesh  12 , as necessary, by adjusting the ends of mesh  12  located at the outside of the abdomen  60 , FIGS. 4 h  and  5   h . After adjustments, the surplus mesh at the abdomen is cut off, and the ends of the mesh are secured within the abdomen and the abdomen is closed. Likewise, the incision at the vaginal wall is closed whereby the tissue flap seals the mesh between the urethra  54  and the wall of vagina  50 .  
         [0056]    Mesh  12  is left in the body and forms an artificial ligament attached to the abdominal wall that provides the support for the urethra as required in order to restore urinary continence to the patient.  
         [0057]    It will be apparent from the foregoing that, while particular forms of the invention have been illustrated and described, various modifications can be made without departing from the spirit and scope of the invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.