Abstract:
An implantable system for supporting anatomical structures and, more particularly, a sling-like implant for the treatment of incontinence and method of implementing the same is provided. The implant comprises a support portion and at least one anchor portion extending therefrom. The anchors are inserted through the supporting portion and have a removable filament extending therefrom. An end of the removable filament extends from an entry point into the patient&#39;s body and can be used so as to guide the delivery tool back to the anchor of the implant in the event that it is necessary to adjust the anchor.

Description:
RELATED APPLICATIONS 
       [0001]    This application claims priority to U.S. Provisional Application Ser. No. 61/142,604 filed Jan. 5, 2009, entitled Implantable Anchors For Use With Mesh Within The Body, and is related to U.S. application Ser. No. (Not yet assigned), filed Jan. 5, 2010, entitled Implants And Procedures For Supporting Anatomical Structures For Treating Conditions Such As Pelvic Organ Prolapse, and U.S. application Ser. No. (Not yet assigned), filed Jan. 5, 2010, entitled Implants And Procedures For Supporting Anatomical Structures, all of which are hereby incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention pertains to the field of medical devices for anchoring and supporting anatomical structures and, more particularly, to implantable slings that are operative to provide support for a portion of a urethra of a patient. 
       BACKGROUND OF THE INVENTION 
       [0003]    There are an estimated 19 million North American adults suffer from urinary incontinence, ranging in severity from partial to complete loss of bladder control. Adults with light incontinence, for example, may experience minimal leakage during the occurrence of a provocative event, such as laughing or coughing, whereas adults with heavy incontinence may experience continuous urine leakage. Moveover, the degree to which an adult is afflicted may change over time. 
         [0004]    Generally, urinary incontinence is not considered a disease, but rather a symptom or side effect of another medical condition. For example, female incontinence may be caused by weakened and (or) stretched pelvic muscles, which is associated with child-birth, pregnancy, trauma, prior surgical procedures, and estrogen loss. 
         [0005]    Each case of incontinence, however, is unique and no two people are affected by incontinence in the same way. There are, however, well-recognized types of incontinence and various ways to treat the same. Stress incontinence, which is a common type of incontinence, may be characterized as urine leakage during a provocative event such as sneezing, laughing, lifting heavy objects, or when the patient engages in any type of exercise that puts pressure on the bladder. Urge incontinence occurs when the patient wants to urinate but is incapable of exercising restraint until reaching a restroom. Additional types of incontinence include overflow incontinence, which occurs when the quantity of urine exceeds the capacity of the patient&#39;s bladder, and functional incontinence, which occurs when the patient has knowledge of the need to urinate but simply cannot access a restroom quickly enough due to a physical obstruction or debilitation. 
         [0006]    To treat urinary incontinence, several options are available. Among the more effective types of recognized treatment include behavioral techniques, such as biofeedback, bladder training, and pelvic muscle exercises, and modifications of the patient&#39;s diet and fluid intake. With respect to the latter, it is known that eliminating or cutting back on certain types of substances, such as caffeine and alcohol, can help alleviate incontinence. Additionally, there are medications available, such as dicyclomine (Bentyl), flavoxate (Urispas), hyoscyamine sulfate (Anaspaz), imipramine (Tofranil), oxybutynin (Ditropan), tolterodine (Detrol), and propantheline (Pro-Banthine), phenylpropanolamine (Dexatrim), and pseudoephedrine (Sudafed) that are helpful in controlling urinary incontinence. 
         [0007]    Surgery may additionally be an option to treat urinary incontinence. Along these lines, surgical implants are available that provide structural support to the urethra for the treatment of stress incontinence. In this regard, the implant is operative to provide structural support to the urethra such that during a provocative event, the device will provide structural support to the urethra thus causing the urine to be retained within the bladder and not leak through the urethra. Implants for females, such as the In-Fast Ultra device, produced by American Medical Systems, Inc., of Minneapolis, Minn. is a commercially available surgical implant that may be operative to provide structural support to the urethra for the treatment of stress incontinence. 
         [0008]    Utilizing these supportive or sling implants to treat incontinence, however, has been known to have numerous drawbacks. Securing suburethral sling implants into position typically requires the use of bone screws, which are well-known in the art to be difficult and time consuming to deploy, and can result in significant patient discomfort, especially within the first couple of weeks following the surgical implantation. 
         [0009]    In addition, implanting suburethral slings are often times difficult to secure into position with the optimal degree of tension. Indeed, the implantation of suburethral slings for the treatment of incontinence is well-recognized as complex, time consuming and can produce suboptimal clinical outcomes. Moreover, it is well recognized among surgeons that perform such implant procedures that sutures attached to bone anchors and/or sutures attached to bone screws utilized to secure the sling into position frequently break and that often times additional bone anchors or screws must be secured into position. In fact, each suture attached to bone anchors and or bone screws must typically be re-tensioned two to three times before optimal sling positioning and structural support to the urethra is achieved. 
         [0010]    Accordingly, there is a substantial need in the art for a suburethral sling implant for the treatment of incontinence that is substantially easier to surgically secure into position and that can further provide an optimal degree of urethral support to thus effectively treat urinary incontinence. There is additionally a need in the art for an implant that is of simple construction, easy to surgically manipulate, and can be manufactured at relative low cost utilizing known implant materials, whether it be synthetic materials, natural tissues, or combinations thereof. There is yet a further need in the art for such an implant that can be secured into position such that the implant defines a suburethral sling portion operatively positioned at or distal to the mid-urethral region that remains securely anchored following implantation. 
       OBJECTS AND SUMMARY OF THE INVENTION 
       [0011]    The present invention addresses and alleviates the above-identified deficiencies in the art. In this regard, the present invention is directed to an implant for supporting an anatomical structure comprising a support member and a plurality of anchors extending through the support member proximate the ends of the support member. The present invention is further directed to a system for implanting an implant for supporting an anatomical structure comprising an implant having a support member and at least one anchor and a delivery tool comprising a handle, a shaft and a cavity for engaging the implant. The present invention is also directed to a method for supporting an anatomical structure comprising the steps of engaging an implant with a delivery tool; and advancing the tool to a target tissue and securing the implant in the target tissue. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]    These and other aspects, features and advantages of which embodiments of the invention are capable of will be apparent and elucidated from the following description of embodiments of the present invention, reference being made to the accompanying drawings, in which 
           [0013]      FIG. 1  is a plan view of an implant according to an embodiment of the present invention. 
           [0014]      FIG. 2  is a front elevation view of an implant according to an embodiment of the present invention. 
           [0015]      FIG. 3  is a perspective view of an implant according to an embodiment of the present invention. 
           [0016]      FIG. 4  is a plan view of one end of an implant according to an embodiment of the present invention. 
           [0017]      FIG. 5  is a perspective view of an anchor according to an embodiment of the present invention. 
           [0018]      FIG. 6  is a cross-sectional view of an anchor according to an embodiment of the present invention. 
           [0019]      FIG. 7  is a perspective view of an anchor according to an embodiment of the present invention. 
           [0020]      FIG. 8  is a perspective view of an anchor according to an embodiment of the present invention. 
           [0021]      FIGS. 9A and 9B  are cross-sectional views of an anchor according to an embodiment of the present invention. 
           [0022]      FIGS. 10A-10F  is a series of drawings showing a process of assembling an implant according to an embodiment of the present invention. 
           [0023]      FIG. 11A  is a plan view of an anchor according to an embodiment of the present invention. 
           [0024]      FIGS. 11B-11D  is a series of drawings showing a process of assembling an implant according to an embodiment of the present invention. 
           [0025]      FIGS. 12A-12D  are plan views of one end of an implant according to certain embodiments of the present invention. 
           [0026]      FIGS. 13A-13C  is a series of drawings showing a process of assembling an implant according to one embodiment of the present invention. 
           [0027]      FIG. 14  is a side elevation view and a cut-away view of a delivery system according to an embodiment of the present invention. 
           [0028]      FIG. 15  is a cutaway view of a delivery system according to an embodiment of the present invention. 
           [0029]      FIG. 16  is a cross-sectional view of a delivery system taken along section line A-A  FIG. 15 . 
           [0030]      FIG. 17  is a perspective view of and implant and a delivery system according to an embodiment of the present invention. 
       
    
    
     DESCRIPTION OF EMBODIMENTS 
       [0031]    Specific embodiments of the invention will now be described with reference to the accompanying drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention. In the drawings, like numbers refer to like elements. 
         [0032]    Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein. 
         [0033]    The implant according to the present invention may, for example, be employed to provide suburethral support and thereby prevent or minimize the leakage of urine or incontinence. In this respect, the implant is operative to act as a suburethral sling, as is known in the art, but is advantageously operative to be more easily secured into position than prior art sling implants. The implant of the present invention is further capable of being deployed in a manner that is far less traumatic than prior art sling implants and methods of surgically implanting the same, and further utilizes a novel attachment approach that provides for optimal suburethral positioning of the implant. 
         [0034]    As shown in  FIGS. 1-3 , according to certain embodiments of the present invention, an implant  10  employs a support member  20  through which two or more anchors  30  are inserted. The anchors  30  are employed to pierce a target tissue, such as obturator internus muscle, obturator internus fascia, obturator membrane, arcus tendineus levator ani, and levator ani muscle, thereby suspend the support member across an internal regions of the body. Extending from the anchors  30  are anchor sutures  40  that facilitate locating the relevant anchor  30  and reengagement of a delivery system with the anchors  30 . As shown in  FIG. 3 , extending from the support member  20  is one or more support member suture  50 . The support member suture  50  thereby provides a marker indicating an approximate position of the mid-point of the support member  20  during and after implantation. 
         [0035]    With respect to the support member  20 , the support member  20  is a piece of material having a generally rectangular or oblong shape. The support member  20  may be fabricated of a synthetic material, such as surgical mesh and the like, natural tissues, such as tissues harvested from either an animal, cadaverous source or the patient himself, and/or combinations of synthetic and natural materials. In a preferred embodiment, the support member  20  is fabricated of a mesh or weave. The support member  20  may, for example, be 5-30 mm wide by 30-150 mm long, and preferably 8-15 mm wide by 50-90 mm long. 
         [0036]    As seen in  FIGS. 3 and 17 , in certain embodiments, the support member suture  50  is advantageously attached to the support member  20 . The support member suture  50  is looped through, tied to, or otherwise associated with the support member  20 . Preferably, the support member suture  50  is affixed to the support member  20  at a proximate mid-point of the support member  20 . As would be understood by one of ordinary skill in the art, it may also be advantageous to employ a plurality of the support member sutures  50  at predetermined positions on or within the support member  20  in order to provide a plurality of markers along a length of the support member. In order to distinguish the various individual sutures, the support member sutures, as well as the anchor sutures, may be provided in different colors, lengths, or other indicating means that would allow a user to distinguish one suture from another. 
         [0037]    Turning next to  FIGS. 4-8 ,  FIGS. 4-8  show various embodiments of the anchor  30  of the present invention. The anchor  30  has a distal portion  60  and a proximal portion  70  associated with one another by mid-portion  80 . A proximal end of the distal portion  60  of the anchor  30  is associated with or attached to a distal end of the mid-portion  80 . Conversely, a distal end of the proximal portion  70  is associated with or attached to a proximal end of the mid-portion  80  of the anchor  30 . The mid-portion  80  of anchor  30  is formed as a shaft or spacer that serves to provide space between the distal portion  60  and the proximal portion  70  to, for example, accommodate a depth of tissue through which the distal portion  60  has penetrated. 
         [0038]    The distal portion  60  of the anchor  30  employs a piercing tip  62  for penetrating tissue and a tissue-retention protrusion  64  proximal of the piercing tip  60  that anchors or secures the distal portion  30  within tissue. The distal portion  60  may have, for example, an arrowhead-like shape as shown in  FIGS. 5-7 . Alternatively, distal portion  60  may have a more complex shape configured to employ more than two, for example as shown in  FIG. 8 , four tissue-retention protrusions  64 . The distal portion  60  may further employ a conical or cone-like shape having a circular tissue-retention protrusion  64 . One of ordinary skill in the art would recognize that alternative shapes and configuration of the distal portion  60  are possible while still achieving the desired objective. For example, distal portion  60  may employ resilient, spring loaded and/or self-tensioning tissue-retention protrusions  64 . 
         [0039]    The proximal portion  70  of anchor  30  comprises a shoulder  72  for providing a back-stop for the support member  20  and a guide member  74  for engagement with a delivery system, as discussed in greater detail below. The proximal portion  70  may, optionally, further employ recesses  76  and eyelet  78 . The anchor suture  40  passes through the eyelet  78  and is, for example, secured back to itself to form a loop. The recesses  76  may be positioned on one or both side of the eyelet  78  and configured so as to accept the anchor suture  40  such that the presence of the anchor suture  40  does not add to or change an outer dimension of the guide member  74 . 
         [0040]    The anchor  30  may be formed from a variety of materials, including but not limited to metal alloys, such as titanium, stainless steel, or cobalt-chome alloys, polymeric materials, such as polyethylene (PE), polypropylene (PP), polysulfone, polyether ether ketone (PEEK), polyether imide (PEI), and biodegradable materials, such as polylactic acid (PLA) and polyglycolic acid (PGA) based materials. The anchor  30  may be formed of a single material or a combination thereof. For example, as illustrated in  FIGS. 9A and 9B , the anchor  30  may be formed of a combination of primary material  90 , such as titanium, and a biodegradable material  92  assembled or molded over the primary material  90 . 
         [0041]    Turning next to  FIGS. 10A-10F ,  FIGS. 10A-10F  show the steps of assembling the implant  10  according to various embodiments of the present invention. For the sake of clarity,  FIGS. 10A-10F  show only the assembly of one side of the implant  10 . First, a tool  90  is used to form an opening  110  through the support member  20  proximate an end of the support member  20  by penetrating, stretching, or spreading the mesh or knitted material of the support member  20 . The tool  90  has a tapered or pointed end and a cross-section shape in the form of a circle, rectangle, oval or most any other shape. The distal portions  60  of the anchors  30  are then inserted through the openings  110  in the support member  20  until the support member  20  rests against the shoulders  72  of the proximal portions  72  of the anchors  30 . In a preferred embodiment, the openings  110  are formed interior of the outer perimeter of the support member  20  such that there is sufficient material of supporting member  20  so that the openings  110  do not substantially expand or rip though the outer perimeter of the support member  20 . With the anchors  20  inserted through the support member  20 , the implant  10  may then be implanted into the patient. 
         [0042]    In an alternative embodiment of the present invention, as shown in  FIG. 11A-11D , the shoulder of the anchor  31  is formed of a plastic or metal pin  73  that is inserted through a receiving hole  75  formed through the proximal portion of the anchor  31 . During assembly of the implant  10 , once the openings  110  are formed through the support member  20 , the guide  74  and/or proximal portion  70  of anchor  31  is placed through the opening  110  and the pin  73  is inserted through the receiving hole  75  to form a element functionally similar to the shoulder  72  previously described. As one of ordinary skill in the art would recognize, this embodiment provides the advantage that a smaller opening  110  may be formed when assembling the implant  10 . The smaller opening  110 , in turn, provides the advantage of the support member  20  having a greater resistance to tearing and deformation. 
         [0043]    In certain other embodiments of the present invention, the assembled implant  10  as described above may be subjected to additional fabrication steps. For instance, as shown in  FIGS. 1-3 , and  12 - 14 , after insertion of the anchor  30  through the opening  110  of support member  20 , a portion of the support member  20  between the opening  10  and the outer perimeter of the support member  20  is folded over the shoulder of the anchor  30  back on to itself to form a folded portion  22 . The folded portion  22  may then be bonded, sutured, welded, or tacked to it self to form bond  24  to better maintain the fold. Formation of the folded portion  22  serves, in part, to decrease resistance to penetration of the anchor  30  into tissue. The fold  22  may additionally help insure that the anchor  30  remains inserted through the support member  20  during handling and implantation of the implant  10 , as well as provide a more visually appealing appearance to the implant  10 . As shown in  FIGS. 12A-12D  and  13 , the shape of the portion of the support member  20  that forms the fold  22  may be manipulated so as to, for example, result in an implant  10  that has a tapered end. A tapered end may be formed by forming a portion of the support member  20  so as to have a width that narrows at a fold line  26 , as shown in  FIG. 12A . A tapered end may also be formed through a secondary folding of the extremities or corners of the fold  22  towards one another, as shown in  FIG. 12B . Alternatively, as shown in  FIG. 12C , once the folded portion  22  is formed a suture may be threaded through the fold  22  and cinched and bound to itself so as to form a tapered end of the anchor  30 . A tapered end may also be formed in the implant  10  by cutting or trimming the corners of the fold  22  after the fold  22  has been formed, as shown in  FIG. 12D . 
         [0044]      FIGS. 13A-C  show yet another embodiment of the implant  10  in which, prior to formation of the fold  22 , the support member  20  is twisted 180 degrees or more. Again, this method of assembly decreases resistance to penetration of the anchor and helps ensure that the anchor  30  remains inserted through the support member  20  during handling and implantation. One of ordinary skill in the art will, however, recognize that other methods of assembling the support member  20  and the anchor  30  to achieve the desired characteristics of the implant  10  are known in the art. 
         [0045]    Turning now to the delivery system of the present invention. Broadly speaking, the delivery system is configured to receive a portion of the anchor  30  of the assembled implant  10 .  FIG. 14  shows a delivery system  120  having a handle  130  and a shaft  140 . The handle  130  is preferably ergonomically shaped to facilitate grasping and manipulating. The handle  130  is preferably marked, colored, textured or otherwise configured so as to indicate to a user the orientation of the delivery system  120 . The shaft  140  protrudes from or is an extension of the handle  120 . The shaft  130  is, for example, formed of stainless steel or other metal in the general shape of a needle. A curved distal portion  142  of the shaft  140  includes a cavity  144  and a slot  146 . 
         [0046]    Referring now to  FIGS. 15 and 16 ,  FIG. 15  shows the implant  10  and delivery system  120  assembled ready for implantation of the implant  10 .  FIG. 16  shows a cross-sectional view of the assembled implant  10  and delivery system  120  viewed along section line A-A of  FIG. 15 . As will be noted, the shape of the cavity  144  corresponds to the shape of the guide  74  of the anchor  30 . That is to say that the guide  74  of the anchor  30  of the implant  10  and the cavity  144  of the shaft  140  of the delivery system  120  are complementary elements, the cavity  144  forms a female receiving element for the male guide  74 . Preferably, the cavity  144  and the guide  74  are formed in the shape of a square, rectangle, oval, triangle, star, or other shape that resists the guide  74  rotating within the cavity  144 . In certain embodiments of the present invention, the cavity  144  and the guide  74  form a friction fit such that the guide  74  is maintained within the cavity  144  during handling and deployment of the implant  10  but is readily released from the cavity  144  upon engagement of the distal portion  60  of the anchor  30  with tissue. 
         [0047]    A portion of the slot  146  penetrates radially through the shaft  140  into the cavity  174  and extends axially along a length of the distal portion  142  of the shaft  140 . Preferably, the slot  146  extends axially along the shaft  140  to a greater extent than the cavity  174 . The slot  146  thereby receives and forms a channel through which the anchor suture  40  of anchor  30  is positioned along an axis of the shaft  140 . 
         [0048]    A method for deploying or implanting the implant  10  according to certain embodiments of the present invention will now be described. First, a single incision or entry point is made in the patient followed by blunt dissection as necessary or desired. For example, the entry point may be made in the anterior wall of the vagina. One side of the implant  10  that is engaged with the delivery system  120 , as previously described, is then inserted through the entry point and the anchor  30  that is engaged with the delivery system  120  is forced into or through a portion of the target tissue. The delivery system  120  is retracted away from the anchor  30  that has penetrated the target tissue thereby breaking the engagement between the delivery system  120  and the anchor  30 . During this process and particularly while the delivery system  120  is being retracted, the user secures the corresponding anchor suture  40  such that the delivery system  120  is retracted while an end of the anchor suture  40  is maintained extending out from the entry point. A second side of the implant  10  that is engaged with the delivery system  120  is then implanted as described with regard to the first side. Substantially concurrent with the implantation of the second side of the implant  10 , the support member  20  of the implant  10  is positioned so as to support the desired organ, for example a portion of the urethra. The support member suture  50 , shown in  FIGS. 3 and 17 , may be used to determine the position and/or tension of the implanted support member  20 . The tension of the support member  20  of the implant  10  is initially adjusted by pushing the delivery system  20  such that the second side of the implant  10  is forced further into the target tissue. The delivery system  120  is then retracted from the second side of the implant  10 . An end of the second anchor suture  30  is also maintained such that it extends out from the entry point. 
         [0049]    Should it be determined that greater tension is desired or if it is otherwise desirable to reengage of the delivery system  120  with one of the anchors  30 , the present invention provides a particularly advantageous means for achieving such. As shown in  FIG. 17 , the end of the anchor suture  40  of the relevant anchor  30  that extends from the entry point is tensioned and secured. The slot  146  of the delivery system  120  is then positioned such that the anchor suture  40  passes through the slot  146 , and serves as a guide for the delivery system  120  to the relevant anchor  30 . The delivery system  120  is advanced towards the relevant anchor  30  along the anchor suture  40 . The guide  74  of the anchor  30  is thereby received by the cavity  144  of the delivery system  120  and, if desired, the friction fit between the anchor  30  and the delivery system  120  is reestablished. It is then possible to adjust the tension of the support member  20  of the implant  10  by pushing the delivery system  120  so as to drive the anchor further into the target tissue. The implant  10  can be retracted by pulling on the anchor suture  40  thereby releasing all or a portion of the tension present in the implant  10 . 
         [0050]    Upon completion of the implantation of the implant  10 , the anchor sutures  40  and support member sutures  50  can be left in place for possible use in a follow-up procedure or may be removed from the patient. 
         [0051]    While the present invention has been described for use in slings for treating incontinence, it would be understood by one of skill in the art that the present invention, either in part in its entirety, can also be used for treating pelvic floor disorders, for supporting a broad range of organs within the body, and for fixing tissue or implants within the body. 
         [0052]    Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.