Abstract:
An implant for a pelvis is provided, wherein suturing is not necessary for anchoring the implant in place. The implant includes a flexible sheet and a solid frame, wherein the frame can be compressed or expanded. Upon insertion through the narrow openings of the pelvis, the frame is compressed, and upon delivery at the site, the frame is expanded, and is designed to anchor to the surrounding anatomical structures.

Description:
FIELD AND BACKGROUND OF THE INVENTION  
       [0001]     The present invention relates to an implant for the pelvis and, more particularly, to an implant which can be held in place without suturing.  
         [0002]     Pelvic floor disorders include cystocele, rectocele, enterocele and uterine and vaginal prolapse. These disorders are often a consequence of weakness or damage to pelvic muscles and ligaments, caused by childbearing, hysterectomy, connective tissue defects, atrophy, or physical injury. Two basic approaches to remedying this condition have been the use of a removable device known as a pessary, or surgery to replace or repair parts of the pelvic supporting structures.  
         [0003]     A pessary is a vaginal insert, having a specified geometric configuration such as, for example, a cube or a donut, which can be temporarily placed in the vaginal canal. Examples of such devices are disclosed in U.S. Pat. Nos. 6,645,137; 6,189,535, and many others.  
         [0004]     The surgical approach includes reconstruction of the damaged support tissue using sutures or replacement of the support tissue with an implant or device. An example of such a device is disclosed in U.S. Pat. No. 6,786,861 to Pretorius. The device disclosed therein is a sling having a flexible elongate member and a distensible portion, and is configured to be inserted dorsally between the urethra and pelvic bone, with ends of the elongate member attachable to retropubic or ischial structures: Another such device is disclosed in U.S. Pat. No. 6,755,781 to Gellman. The device disclosed therein is a medical sling having one or more cuts are disposed in the material. The cuts on the sling provide open areas to permit tissue ingrowth and crosslinkng when the sling is implanted inside the body of the patient. These types of slings and supporting devices are configured to treat urinary incontinence rather than prolapse, and as such, they are generally located under the urethra or bladder neck.  
         [0005]     Other devices for implantation within a pelvis are described. U.S. Pat. No. 6,592,515 to Thierfelder, for example, discloses an implant useful for a sacral colpopexy procedure for treating vaginal prolapse. The implant includes tissue engagement portions, which are configured for anchoring the implant into bone. World Publication WO 00/27304 to Ory et al. discloses a suspension device for treating prolapse and urinary incontinence, including a suspension cord, non-absorbable material, and anchoring parts which are designed to be fixed by suturing or stapling means to implanting walls.  
         [0006]     All of these devices require suturing to anchor the device to the anatomical structures within the pelvis. This leads to difficulties and potential complications, as sharp needles must be placed deep within the pelvis into an area which is difficult to access. Furthermore, the stability of these implants depends on the strength of the suture, a material which can sometimes tear, and on the strength of the supporting ligaments, which may also be weak due to disease, old age, or wear from childbirth. The sutures are inflexible, and cannot accommodate dynamic pressures from the abdomen above. Finally, the use of sutures requires sharp comers or edges on the implant material, which are not suited to the contoured shape of the anatomy of the pelvis.  
         [0007]     There is thus a widely recognized need for, and it would be highly advantageous to have, a surgical implant devoid of the above limitations.  
       SUMMARY OF THE INVENTION  
       [0008]     According to one aspect of the invention there is provided a device for implantation in a pelvis. The device includes a sheet having a perimeter and a frame for holding the sheet at a portion of the perimeter, wherein the frame includes a first arm, a second arm, and a connecting element connecting the first arm and the second arm.  
         [0009]     According to another aspect of the invention, there is provided a device for treating prolapse of a pelvic organ. The device includes a flexible sheet and a frame in contact with the sheet, the frame having a first configuration in which the frame is compressed, thereby causing the sheet to be configured in a compressed position, and the frame having a second configuration in which the frame is expanded, thereby allowing the sheet to be configured in an expanded position.  
         [0010]     According to another aspect of the invention, there is provided a sutureless implantable device for supporting a pelvic organ, the device having contoured edges.  
         [0011]     According to further features in preferred embodiments of the invention described below, the sheet includes a first layer and a second layer, and the frame is positioned between the first and second layers. The sheet generally has a substantially flat configuration, and is a mesh, a sheath, a diaphragm or a divider and may be comprised of biological material.  
         [0012]     According to yet further features in preferred embodiments of the invention, the frame comprises biodegradable, flexible material. The connecting element can include a pivot or a ratchet, and may be an angled member. Alternatively, the connecting element comprises an elastic material. In preferred embodiments, the device also includes an adjusting element for controlling a proximity of the first arm of the frame to the second arm. The adjusting element can be a wire, a ratcheting device or a pulley wire.  
         [0013]     According to yet another aspect of the invention, there is provided a method for treating prolapse of a pelvic organ. The method includes providing a device having a sheet, and a frame in contact with the sheet, the frame having a first configuration in which the frame is compressed and having a second configuration in which the frame is expanded, compressing the frame into the first configuration, introducing the device through a vagina, inserting the device into a space between the vagina and the pelvic organ, and expanding the frame into the second configuration, wherein the expanding includes anchoring the frame into an anatomical structure.  
         [0014]     According to further features in preferred embodiments of the invention described below, the compressing and expanding can include pulling a wire, ratcheting, or bending a portion of the frame. The inserting can include inserting the device into a space between the vagina and a bladder, or between the vagina and a rectum.  
         [0015]     Unless otherwise defined, all 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. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0016]     The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.  
         [0017]     In the drawings:  
         [0018]      FIGS. 1   a  and  1   b  are illustrations of an implant in accordance with one embodiment of the present invention, shown in its compressed and expanded states, respectively,  
         [0019]      FIGS. 2   a - c  are illustrations of an implant in accordance with another embodiment of the present invention, shown in its compressed, expanded and delivered states;  
         [0020]      FIGS. 3   a  and  3   b  are illustrations of an implant in accordance with yet another embodiment of the present invention, shown in its compressed and expanded states, respectively;  
         [0021]      FIGS. 4   a  and  4   b  are illustrations of an implant in accordance with yet another embodiment of the present invention, shown in its compressed and expanded states, respectively,  
         [0022]      FIG. 5  is a cross sectional illustration of the implant of  FIGS. 1-4 , implanted between the vagina and bladder; and  
         [0023]      FIG. 6  is an upper view of the delivered implant in position between the vagina and bladder. 
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0024]     The present invention is of a pelvic implant which can be used to temporarily or permanently support the organs of a pelvis. Specifically, the present invention can be used to prevent or treat vaginal prolapse, prolapse of the bladder (Cystocele), prolapse of the uterus, prolapse of the rectum (Rectocele), or any other herniation of organs through the pelvic floor.  
         [0025]     The principles and operation of a device according to the present invention may be better understood with reference to the drawings and accompanying descriptions.  
         [0026]     Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.  
         [0027]     Referring now to the drawings,  FIGS. 1-4  are illustrations of an implant device  10  for insertion into a pelvis, in accordance with various embodiments of the invention. Device  10  includes a frame  12  and a sheet  14 . For the purposes of the present application, the term “sheet” can be understood to include, but not be limited to, a mesh, sheath, diaphragm, divider or multi-layered sheet. Frame  12  is an anchoring system for anchoring sheet  14  into place in the pelvis. Frame  12  is designed to be adjustable, such that upon insertion into the pelvis, device  10  is compressible to a satisfactory size for introduction through the passageway leading into the pelvis, and such that once device  10  is situated within the pelvis, device  10  is expandable to a size at which frame  12  can anchor device  10  in place.  
         [0028]     Reference is now made to  FIGS. 1   a  and  1   b , which are illustrations of device  10  in a compressed configuration and an expanded configuration, respectively, in accordance with a first embodiment of the present invention. Frame  12  includes two arms  16 ,  17  each of which has a proximal end  18 ,  19  and a distal end  20 ,  21 . The two arms  16  and  17  are connected to one another at proximal ends  18  and  19  by a connecting element  22 . Connecting element  22  has at least two configurations, such that in a first configuration, proximal ends  18  and  19  of arms  16  and  17  are together, as shown in  FIG. 1   a , and in a second configuration, proximal ends  18  and  19  of arms  16  and  17  are apart, as shown in  FIG. 1   b . In the embodiment shown in  FIGS. 1   a  and  1   b , connecting element  22  includes two connectors  24 ,  25  and a pivot  23 . Pivot  23  allows connectors  24 ,  25  to bend with respect to one another, thereby allowing for multiple configurations of connecting element  22 . Connecting element  22  can be positioned in its open or closed configuration by the use of an adjusting element  28 . In the embodiment shown in  FIGS. 2   a  and  2   b , adjusting element  28  is a fastener  30 , for holding proximal ends  18  and  19  together. Fastener  30  can be a wire (as shown), a ratchet, or any other mechanical means suitable for pulling and holding proximal ends  18  and  19  together. Specifically, in the embodiment shown, a wire is attached to proximal ends  18  and  19  of arms  16  and  17 . By pulling on a portion of the wire, connecting element  22  changes configuration and proximal ends  18  and  19  are joined together. This leads to a moving apart of distal ends  20  and  21 , thereby causing an expansion of frame  12 .  
         [0029]     Reference is now made to  FIGS. 2   a - 2   c , which are illustrations of device  10  in a compressed configuration and expanded configurations, in accordance with another embodiment of the present invention. Frame  12  includes two arms  16 ,  17  each of which has a proximal end  18 ,  19 , a distal end  20 ,  21 , and a body  13 ,  15  between said proximal and distal ends. The two arms  16  and  17  are connected to one another somewhere along the length of body  13 ,  15 , preferably at a mid-point thereof, by a connecting element  22 . Connecting element  22  has at least two configurations, such that in a first configuration, arms  16  and  17  are close together, as shown in  FIG. 2   a , and in a second configuration, arms  16  and  17  are relatively far from one another, as shown in  FIGS. 2   b  and  2   c . In the embodiment shown in  FIGS. 2   a  and  2   b , connecting element  22  includes two connectors  24 ,  25  and a ratchet  27 . Ratchet  27  allows connectors  24 ,  25  to move together or apart from one another, thereby allowing for multiple configurations of connecting element  22 . Connecting element  22  can be positioned in its open or closed configuration by the use of an adjusting element  28 . In the embodiment shown in  FIGS. 2   a - 2   c , adjusting element  28  is a separate ratcheting device  31 , for bringing arms  16  and  17  together or pushing them apart. During introduction of device  10  into the pelvis, connecting element  22  is configured such that arms  16  and  17  are close together, a shown in  FIG. 2   a . When the desired location within the pelvis is reached, connecting device is configured such that arms  16  and  17  are apart, thereby causing an expansion of frame  12  as shown in  FIG. 2   b . When expansion of frame  12  is complete, ratcheting device  31  can be removed, leaving device  10  in place in the body.  
         [0030]     Reference is now made to  FIGS. 3   a  and  3   b , which are illustrations of device  10  in a compressed configuration and an expanded configuration, respectively, in accordance with yet another embodiment of the present invention. Frame  12  includes two arms  16 ,  17  each of which has a proximal end  18 ,  19  and a distal end  20 ,  21  and a body  13 ,  15 . The two arms  16  and  17  are connected to one another at a point along bodies  13 ,  15  by a connecting element  22 . Connecting element  22  has at least two configurations, such that in a first configuration, arms  16  and  17  are close together, as shown in  FIG. 3   a , and in a second configuration, arms  16  and  17  are relatively far from one another, as shown in  FIG. 3   b . In the embodiment shown and described herein with respect to  FIGS. 3   a  and  3   b , connecting element  22  is an angled member, configured at an angle with respect to arms  16  and  17  and set up as a pulley system with a wire. Pulling on the wire causes connecting element  22  to be pulled down at one end, changing the angle between connecting element  22  and arms  16  and  17 , causing arms  16  and  17  to be pushed apart from one another. Connecting element  22  can be positioned in its open or closed configuration by the use of an adjusting element  28 . In the embodiment shown in  FIGS. 3   a  and  3   b , adjusting element  28  is a pulley wire  32 , for holding proximal ends  18  and  19  together. Specifically, in the embodiment shown, pulley wire  32  is connected to both arms  16  and  17  and connecting element  22 . By pulling on a portion of pulley wire  32 , the angle between connecting element  22  and arms  16  and  17  changes, leading to a moving apart of arms  16  and  17 .  
         [0031]     Reference is now made to  FIGS. 4   a  and  4   b , which are illustrations of device  10  in a compressed configuration and an expanded configuration, respectively, in accordance with a most preferred embodiment of the present invention. Frame  12  includes two arms  16 ,  17  each of which has a proximal end  18 ,  19  and a distal end  20 ,  21 . The two arms  16  and  17  are connected to one another at proximal ends  18  and  19  by a connecting element  22 . Connecting element  22  is a flexible, elastic band, capable of compressing or expanding. In a first configuration, arms  16  and  17  are relatively close together, as shown in  FIG. 4   a , and in a second configuration, arms  16  and  17  are apart, as shown in  FIG. 4   b . In this embodiment, no separate adjusting element  28  is necessary.  
         [0032]     Sheet  14  is a flexible member, comprised of a nylon mesh, a biological material (such as animal tissue, for example), or any other flexible biocompatible material. For example, sheet  14  may be comprised of Prolene™, nylon, polypropylene, Deklene™, polylactic acid, polyethylene glycol, polyester, synthetic biomaterials, allografts, autologous tissue, xenografts, heterografts, or any combination of the above, or any other biocompatible material which is flexible and suitable for supporting a pelvic organ. In a preferred embodiment, sheet  14  includes two layers, so that frame  12  can fit into the space between the two layers, without the need separate connectors for connecting the frame  12  to the sheet  14 . In a preferred embodiment, both layers of sheet  14  are comprised of the same material. In an alternative embodiment, a combination of materials is used. Frame  12  is comprised of a solid, supportive material, such as a polymer, a metal, or any other biocompatible material. For example, frame  12  may be comprised of polylactic acid, polyethylene glycol, synthetic biomaterials, titanium, stainless steel, shape-memory alloys, or any combination of the above, or any other biocompatible material which is flexible and suitable for providing support to sheet  14 . In a preferred embodiment, frame  12  is comprised of a biodegradable material so that over time, frame  12  will degrade and be replaced by scar tissue which can then act as a support for sheet  14 .  
         [0033]     A method for treating bladder prolapse is described with reference to  FIGS. 5 and 6 . A patient is set up for surgery, placed in a gynecological position, and anesthetized. A weighted speculum is placed in the lower vaginal wall to expose the prolapsed upper vaginal wall. An incision is made along the center of the upper wall of the vagina  40 . In a preferred embodiment, the incision is approximately 1 mm deep and 4 cm long. Using a sharp instrument such as a scissor, the vagina  40  is separated from the bladder wall through the initial incision. Alternatively, the vagina is separated from the bladder wall  42  using blunt dissection—such as with the tip of a finger. These types of incisions and separations are well-known in the art, and the methods of the present invention are not limited to the details included herein. Device  10  is compressed and inserted through the vagina and situated between the vagina and the bladder. Device  10  is then expanded into its expanded position, wherein arms  16  and  17  are situated against the pelvic sidewalls  44  in gentle tension holding it in place. The vaginal incision is then sutured closed under the implanted device  10 . As shown in  FIG. 5 , device  10  is situated between the vagina and the bladder, supporting the bladder and preventing it from descending into the vaginal canal.  
         [0034]     In a preferred embodiment, connecting element  22  is in an anterior portion of device  10  upon insertion, as shown in  FIG. 6 . In an alternative embodiment, connecting element  22  is in a posterior portion of device  10  upon insertion.  
         [0035]     In an alternative embodiment, an incision is made between the vagina and the bladder, and device  10  is inserted into a position that provides support of the bladder, with the frame compressed against the para-rectal compartment. In this embodiment, device  10  would be similar in shape, but generally smaller in size than device  10  used for bladder support.  
         [0036]     Device  10  can include several different sizes for different sized patients.  
         [0037]     In alternative embodiments, device  10  or portions thereof may be coated or incorporated with therapeutic materials.  
         [0038]     It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.  
         [0039]     Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.