Abstract:
The invention relates to a an incontinence strap ( 66 ) for treating urinary incontinence, in particular, urinary incontinence in females, that is configured such that it is flexible.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The invention relates to an incontinence strap for treating urinary incontinence, in particular, urinary incontinence in females. 
     2. Description of Related Art 
     Various operative methods and specially designed operating utensils and implants have been developed for remedying urinary incontinence. Several operative methods require opening the abdominal cavity in order to introduce items, similar to prostheses, that either encircle the urethra in the vicinity of the neck of the bladder or press against it from above or below (cf. WO 00/18319, WO 90/01016, WO 91/00069, U.S. Pat. No. 4,709,690, and WO 85/02993). 
     The so-called “plastic rein” was developed in the 1960&#39;s. In the case of this particular device, a strap that is wrapped around the underside of the urethra in order to raise the bladder, along with the neck of the bladder, which will be particularly helpful if the bladder has sagged, is attached within the abdominal cavity. The minimally invasive introduction of an incontinence strap in the form of a U-shaped noose that reaches around the underside of the urethra and, for example, in the case of female patients, is emplaced in the abdominal cavity by inserting it through the wall of the vagina, where the free ends of the noose terminate on the peritoneum, but, for the time being, are not attached thereto, has proven particularly beneficial. The strap is anchored by the ingrowth of connective tissue. Such straps and the associated instruments for inserting them into the lower abdomen are described in WO 90/03766, WO 96/06567, WO 97/13465, and WO 2001/030246. 
     SUMMARY OF THE INVENTION 
     The subject matter of the invention is an incontinence strap for treating urinary incontinence, in particular, urinary continence in females, whose properties yield further opportunities for its application and supplementary benefits. 
     The incontinence strap is designed to be flexible and consists of biocompatible material. It may be a textile strap, in particular, such that is coated or impregnated. The coating or impregnation may serve to ease introduction of the, inherently, open-pored strap, in particular, due to the presence of a smooth surface. The coating or impregnation may consist of biodegradable and/or resorbable material. The incontinence strap may also be in the form of a strip of foil that has a smooth, closed surface over at least part, or portions, of its length. Its surface may be textured in order to anchor it. In the case of a preferred embodiment, the materials employed and/or its construction may vary over its length. It may also have a shape that varies over its length and/or longitudinal sections having varying properties. A matter that is of particular importance to its longitudinal midsection, which is intended to be arranged in the vicinity of the urethra. The strap is usually wrapped around the underside of the urethra. However, embodiments that may be arranged above the urethra are also feasible, particularly if their thickness is variable, a matter that shall be taken up below. 
     Since the urethra is highly sensitive to irritations and such irritations may cause undesirable proliferation of tissue, the midsection of the strap preferably has a smooth surface. Part(s) of the strap, in particular, its midsection, which is intended to be arranged in the vicinity of the urethra, may consist of resorbable material, in particular, resorbable plastic. Mechanical irritations caused by the incontinence strap due to, for example, its surface texturing and/or pores, and/or irritations of biological origin occurring during resorption as a result of accelerated metabolic processes, may cause growth of new connective tissue that will yield a desired lifting, or supporting, of the urethra. This supporting connective tissue may take over the task of an incontinence strap, in which case, the latter will no longer be needed. At least part of the strap will disappear due to resorption. If it consists entirely of biodegradable or resorbable material, then all of it will disappear in the course of time. If just its midsection consists of resorbable material and its other sections at least partially consist of non resorbable material, then those other sections may remain in the body indefinitely. 
     The resorbable materials employed are preferably of non biological origin, in particular, resorbable plastics, in order to prevent infections and defensive immuno-reactions. Known polymers and copolymers of lactide, glycolide, trimethylene carbonate, dioxanone, and ε-caprolactone represent suitable plastics. Also particularly suitable is polyvinyl alcohol, whose solubility and resorption rate may be influenced by suitably choosing its molecular weight, chemical modification, and/or physical treatment (formation of crystallites by cyclic freezing and thawing). 
     The strap may also be configured from several, longitudinal, essentially parallel strips having differing resorbabilities in order to, in particular, eliminate foreign matter as soon as it is no longer needed. Variations occurring along the length of the incontinence strap, in particular, variations affecting its longitudinal midsection, may also be related to the mechanical properties of the strap. For example, the lateral edges of the strap may beneficially be smooth, at least along its longitudinal midsection. The other longitudinal sections of the strap may have textured edges and/or surfaces in order to provide better anchoring. For example, its longitudinal midsection preferably has a closed, in particular, smooth, surface. Its longitudinal midsection of the strap may also have a width and/or thickness exceeding those of its other sections. 
     In the case of a special embodiment of the invention, the strap is configured such that its thickness may be varied, in particular, may be varied at least over, and particularly over its midsection. The longitudinal midsection of the strap may be double-walled, preferably tubular. This double-walled, and, in particular, tubular, construction may be provided over the entire length of the strap. In the case of a preferred embodiment, the strap has a chamber that may be filled with fluid located on its longitudinal midsection. The chamber may expand and contract when the volume of fluid contained therein is varied, due to its flexible walls. The tubing, or the chamber&#39;s walls, may also be at least partially formed from elastic, stretchable, material. The walls of the chamber that may be filled with fluid may also at least partially consist of a material, in particular, silicone rubber, that is pierceable by a cannula and self-sealing, which will allow subsequently, i.e., subsequent to emplacement of the strap in the body, altering the chamber&#39;s size and shape by adding, or drawing off, fluid. The embodiment having a variable thickness is also suitable for emplacement above the urethra, and may be used for exerting pressure on the urethra, without encircling it. 
     The chamber that may be filled with fluid may also be provided with a fluid line, through which its fill level may be altered, extending to at least one end of the strap. Such a chamber and a fluid line connected thereto may, in the case of a strap fabricated from thermoplastic foil, be formed by welding the walls of tubing having the desired contouring, which will also be possible in the case of straps fabricated from thermoplastic elastomers. In the case of pure elastomeric materials, the chamber, and the fluid line, if any, may be formed either when the strap, in particular, tubing, is fabricated, or by subsequent vulcanization thereof. 
     The ends of the incontinence strap may be sutured to the abdominal wall in the traditional manner. However, it will be preferable if they will self-anchor to the abdominal wall. Those sections of the incontinence strap that are intended to be arranged in the abdominal wall, i.e., sections thereof in the vicinities of its ends, may have a crinkled surface and/or porous structure that will promote self-anchoring in the abdominal wall. Such crinkled surfaces promote both mechanical retention by connective tissue and additional anchoring by ingrowth, or penetrative growth, of new tissue. 
     The strap is preferably configured such that it may be drawn through the abdominal cavity, in particular, the vicinity of the urethra, employing minimally invasive operating techniques, i.e., without opening the abdominal cavity. It will be beneficial if both ends of the strap are configured for attachment to a shaft, in particular, a curved shaft, to be used for emplacing the strap within the abdominal cavity. The ends of the strap may be reinforced for that purpose. The ends of the strap may also be narrower than the remainder of the strap. The ends of the strap may be provided with a hole, a matter that shall also be taken up in greater detail later in conjunction with the descriptions of other embodiments. The ends of the strip may also be attached to couplers that may be attached to the shaft. 
     In the case of a preferred embodiment of the invention, the strap is attached to the shaft such that it cannot twist, which will allow predetermining an orientation of the strap during its insertion into the lower abdomen. 
     The strap may preferably be attached to the shaft such that the plane of the strap lies in the plane of flexure of the shaft. The strap may be such that it may be attached to the shaft over its full width, particularly if the shaft is also configured such that it has a flat shape. In the case of shafts having an essentially circular cross-section, the orientation of the strap may also be predetermined by folding its ends such that they will have U-shaped, V-shaped, or Z-folded cross-sections, which will provide that the orientation of the contours of the strap will be predetermined over the remainder of its length. For example, the strap may be attached, in a predetermined form, to couplers that may be attached to the shaft such that they cannot twist. The ends of the strap may be narrower than the remainder of the strap in order to ease insertion. The ends of the strap may be stiffer than the remainder of its flexible section. 
     In the case of a preferred embodiment of the invention, the strap and, in particular, the coupler(s), is/are permanently attachable, or attached, to the shaft. This will provide that a shaft may be used only once during an operation, which is preferable on hygienic grounds. 
     In the case of another embodiment, the strap is arranged in a sheath that is configured such that it may be withdrawn from the strap. The sheath both protects the strap and eases insertion of the strap into the lower abdomen, particularly if the strap has a textured outer surface or has any rough spots on its outer surface. The sheath is preferably transversely split at its midsection, or may be transversely split there, in order that a segment of the sheath on either end of the strap may be withdrawn from the strap following implantation of the strap. The ends of the sheath may be permanently attached to the strap in order that segments of the sheath will remain accessible after the ends of the strap have been cut off the shaft. The ends of the strap may also be allocated to devices for securing the strap outside the abdominal wall. Such securing aids may serve to secure the ends of the strap outside the abdominal wall while the sheath is being pulled over its ends. They may be, for example, strap extensions, temporary thickenings, or mechanical braking mechanisms, such as slit rubber buttons. 
     A grip, to which the shaft may be attached, in particular, attached such that it will be secured against both axial and rotational displacements, and subsequently detached, may be associated with the shaft. The shaft may have insertion tips for penetrating the lower abdomen on both ends, or be configured to allow attaching such thereto. The shaft may also be configured such that either end thereof may be attached to the grip and subsequently detached therefrom. The shaft may additionally configured such that a strap may be attached to either end thereof, which will allow using either end of the shaft for penetrating the lower abdomen, attaching the grip, or attaching the strap. In the case of a detachable union of shaft and grip, it will be preferable if the strap may be attached to an end of the shaft only while the grip is removed from that end of the shaft. 
     As mentioned above, it may be provided that the shaft may be used once only, at least during a single surgical session. Each end of the strap is thus preferably allocated to its own shaft. A safety device that will preclude reuse of the shaft during an operation may be provided. The end of the strap, in particular, the coupler thereon, may be configured such that it may be attached to the shaft such that it cannot be subsequently detached therefrom for that purpose. If the strap becomes detached from the shaft, the end of the strap, or coupler, will remain on the shaft when the strap becomes detached from the shaft and preclude the latter&#39;s reuse, since attaching another strap thereto will be precluded. The end of the strap and the coupler are preferably configured in the form of mating, plug-and-socket connectors. The union between shaft and strap may be self-locking in order that it cannot be separated without use of special tools. 
     The shaft normally has a circular cross-section. However, as mentioned above, the shaft may have a noncircular cross-section within a section thereof that is intended for insertion into the body. In particular, the shaft&#39;s cross-section may have an extension in one direction that is much greater than that in the orthogonal direction. This broadening may be orthogonal to the plane of curvature of the shaft, but preferably lies in the plane of curvature of the shaft, which will favor oriented insertion of the strap into the lower abdomen, in particular, oriented penetration of strap through the abdominal wall. For example, a longitudinal section of the shaft may have a width that approximately equals the width of the strap to be attached thereto. The shaft may also be broadened over its entire length. The shaft may also be broader than the strap over at least certain sections thereof, which is preferred in the case of adipose patients. Any changes in the width of the strap should preferably be gradual. 
     The shaft and grip may also be permanently joined to one another, in particular, may be configured in the form of a single, monolithic unit. A device for attaching the strap may then be provided on the free end of the shaft. That device preferably has a securing mechanism that will prevent unintentional detachment of the strap. 
     In the case of another embodiment, the shaft may be enclosed in a flexible sheath, from which the shaft may be withdrawn, in particular, may be withdrawn when the strap is pulled through the sheath. The shaft&#39;s flexible sheath may consist of resorbable material and be designed to temporarily remain in the body. The flexible sheath may also be designed to be itself an incontinence strap, in which case, at least part of the strap, along with the shaft, may be inserted into the lower abdomen. 
     In the case of another preferred embodiment of a strap having a sheath, at least one end of the strap has an attachment device for attaching the strap to application aids provided for the purpose of assisting its emplacement in the abdominal cavity. The strap is beneficially reinforced in the vicinity of that device. The reinforced attachment device preferably has a low profile and is situated in the plane of the strap. 
     As stated above, the strap is preferably configured such that it may be drawn into the abdominal cavity, in particular, into the vicinity of the urethra, through the vaginal wall or abdominal wall, employing minimally invasive surgical techniques, i.e., without opening the abdominal cavity. In order to allow emplacing the strap at the right location in the body as simply as possible and in a manner that will be gentle to the patient, the strap is usually implanted using application aids. These application aids are usually attached to the ends of the strap and, in addition to the aforementioned shafts, may also consist of, for example, implantation needles or cords. The reinforcements in the vicinity of the attachment device on the incontinence strap according to the invention prevent tearing of the strap in the vicinities of the attachment devices due to the effects of tensioning by the application aids. 
     The incontinence strap is preferably reinforced in the vicinity of the attachment device by thermally bonding it to another material (In this conjunction, “thermally bonding” one or more materials to the strap means that one or more materials are thermally softened, or melted, and flow into the pores of the unmelted strap and harden there). The strap is thermally bonded to the sheath of the incontinence strap, in particular, thermally bonded thereto in that vicinity. Such thermal bonding of the strap to the sheath in the vicinity of the attachment device allows reinforcing the strap in that vicinity in a simple manner. Employing other weldable material in the process may also modify its flexibility. 
     In order to further reinforce the strap in the vicinity of the attachment device, additional, thermally bondable material, in particular, thermoplastic material, may be employed in the process. In the case of a preferred embodiment of an incontinence strap according to the invention, at least the sheath may be folded over in the vicinity of the attachment device and thermally bonded to the strap. This folding over may be accomplished in various manners. For example, the corners of the sheath may be folded over in order to configure the reinforcement in the form of an equilateral triangle, which has the benefit that the incontinence strap will then have tapered ends, and thus may be more easily drawn through tissue, while maintaining its orientation. In the case of another embodiment, the edges of the ends of the sheath may be folded over in order that the reinforcement will have a rectangular, or square, shape. In the case of yet another embodiment, both the corners and edges on the ends of the sheath may be folded over, which will yield particularly strong reinforcements in the vicinities of the attachment devices. 
     An embodiment where both the sheath and the ends of the strap are folded over, which will yield even greater strengthenings in those vicinities, will also be feasible. 
     In the case of yet another preferred embodiment, the ends of the strap are rounded. The end, or ends, of the strap may be shaped by thermal cutting. 
     It will be beneficial if the strap, in particular, the sheath, is encased in at least one other ply, preferably several plies, of thermally bondable material(s), in particular, in at least one other sheath, in the vicinities of the attachment devices and at least partially thermally bonded thereto. This will contribute to further reinforcing it in the vicinities of the strap&#39;s attachments devices. It will be beneficial if at least one of the plies has a film thickness exceeding that of the sheath. These plies also preferably consist thermally bondable, thermoplastic material. 
     The types of bonds, with which the reinforcements in the vicinities of the attachment devices may be accomplished, may differ. As a rule, they will be bonds that cover extended areas, and will preferably be flexible. Bonds that cover extended areas should preferably allow bending them through 180° without fracturing occurring. If required, the bonds may also be a set, or sets, of partial bonds, each of which covers an extended area, or point bonds in order to allow configuring them such that certain portions thereof will be more flexible and softer. Combinations of the various types of bonds will also be feasible. It will be beneficial if the plies to be bonded may consist of materials having differing softening ranges or melting ranges in order that, in the case of certain bonds, certain plies will preferentially soften or melt. For example, in the case of a preferred embodiment, initially, a basic bond in the vicinities of the attachment devices may be formed at a low temperature, at which, initially, only the low-melting-range plies, e.g., the sheath, which may consist of polyethylene, will soften. Following completion of this basic bond, a set, or sets, of partial bonds, each of which covers an extended area, in the vicinity thereof may be formed at a higher temperature. Point bonding at an even higher temperature, e.g., at a temperature at which the material of the strap, which may consist of polypropylene, polyethylene terephthalate, PVA, or other non absorbable, or absorbable, polymers, such as polylactides, polydioxanones, or mixtures of glycolides, lactides, caprolactones, or similar, will soften, may then be formed over certain sections in the vicinity/vicinities of the set(s) of partial bonds. Such combinations of bonds covering extended areas, set(s) of partial bonds, each of which covers an extended area, and point bonds will allow forming reinforcements that are stiffer at their centers than at their edges, which will allow achieving spatially varying flexibilities. The strap may be in the form of a textured foil or a fabric, and preferably has a softening range that lies at higher temperatures than both that of the sheath and that/those of the reinforcing material(s), if any. 
     In the case of a particularly preferred embodiment of the incontinence strap according to the invention, the attachment device has at least one through hole in the vicinity of the reinforcement. An application aid, for example, a cord, may be attached to this hole, or a surgical instrument may enter through it. The through hole may be punched, but is preferably formed by thermal cutting, and beneficially has an edge zone where all plies are permanently bonded to one another. Unlike the known straps, which have permanently attached application aids, the strap according to the invention provides the benefit that the application aid may be attached to it in a simple manner, subsequently detached therefrom, and reused. In the case of the aforementioned combination of bonds covering extended areas, set, or sets, of partial bonds, each of which covers an extended area, and point bonds, a through hole is punched in the vicinity of the bonds, in particular, in the vicinity of the point bonds. The through hole may have various shapes, in particular, may have an angular shape, but is preferably circular or oval. 
     The dimensions of the ends of the incontinence strap are preferably less than those of the sheath enclosing the incontinence strap. 
     In the case of a particularly preferred embodiment of the incontinence strap according to the invention, at least the sheath, and other material or other plies employed, if any, consist of thermoplastic material. It will be beneficial if the strap consists of thermoplastic material whose melting range lies at temperatures exceeding those of the melting range of the plies lying on the strap. The material involved may be either a material that is totally resorbable by the body, a material that is partially resorbable by the body, or a material that is non resorbable by the body. 
     Other features of the invention will be evident from the following descriptions of embodiments of the invention, together with the figures and subordinate Claims, where the individual features involved may, in the case of an embodiment of the invention, be implemented either alone, or in the form of combinations of several such. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The figures depict: 
         FIG. 1 : a perspective view of an embodiment of an instrument for inserting an incontinence strap that has a curved shaft and a handling grip for the shaft, which is shown here with the shaft and grip separated; 
         FIG. 2 : another perspective view of the embodiment shown in  FIG. 1 ; 
         FIG. 3 : a sectioned view of the same arrangement of shaft and handling grip shown in  FIG. 1 ; 
         FIG. 4 : a longitudinal section through the shaft and grip, where the shaft has been inserted into the grip, but has not yet been locked therein; 
         FIG. 5 : a longitudinal section through the shaft and grip, where the shaft and grip are in the locked state; 
         FIG. 6 : a perspective view of the shaft and grip, where the shaft and grip are in the locked state; 
         FIG. 7 : the shaft, viewed normal to its plane of curvature; 
         FIG. 8 : a view of part of the shaft, where an incontinence strap has been attached thereto; 
         FIG. 9 : a view of an end of a shaft of another embodiment that may either be attached to a grip, have an incontinence strap attached to it, or have a tip installed on it, drawn on a larger scale; 
         FIG. 10 : a side view of another embodiment of an instrument for inserting an incontinence strap; 
         FIG. 11 : a top view of the same embodiment shown in  FIG. 10 ; 
         FIG. 12 : an embodiment of an incontinence strap; 
         FIG. 13 : another embodiment of an incontinence strap; 
         FIG. 14 : an embodiment of an incontinence strap according to the invention having reinforced attachment devices; 
         FIG. 15 : a longitudinal section through the strap shown in  FIG. 14 , where the sectioning is along the line A-A′ indicated in  FIG. 14 , drawn on a much larger scale; 
         FIG. 16   a : a schematized view of the cross-section of an unbonded section of another embodiment of an incontinence strap according to the invention; and 
         FIG. 16   b : a schematized view of the cross-section of the incontinence strap shown in  FIG. 16   a  in the vicinity of an attachment device, i.e., of a bonded section thereof. 
     
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
     In the case of the embodiment of an instrument  1  for emplacing an incontinence strap  2  shown in  FIGS. 1-9 , a shaft for inserting the incontinence strap is provided in the form of a curved, solid, stainless-steel needle  3  in the form a curved, circular rod  4 . The needle has a conical tip  6  on an insertion end  5 . That may also be ground off at an angle such that the edge of the ground-off section lies on the inner side of the curvature. The tip of the needle is not sharp in order to prevent injuries to the abdominal organs when the incontinence strap is inserted. Since incisions in the abdominal wall and vaginal wall will, in any case, be made using other instruments, such as scalpels, the needle essentially acts as a guiding appendage only. The end of the needle opposite that bearing the tip  6  is configured in the form of an attachment end  7  and has devices for attaching it either to a grip  8 , or to the incontinence strap  2 . 
     The grip  8  consists of plastic or steel. It has a longitudinal section  9  that is essentially configured in the form of a hollow cylinder that is used both for accommodating and attaching the end  7  of the needle, and for gripping with the hand. The butt of the grip has a laterally broadened section  10  that essentially gives the grip a T-shape, is also used for gripping, and allows precisely controlled, lateral excursions of the needle. 
     As may be seen from  FIG. 7 , the attachment end  7  of the needle  3  has a cylindrical section  11  having a diameter that is less than the normal diameter of the needle, has a beveled surface  12  on one side, or either side, and is separated from the circular rod  4  of the needle  3  by a circumferential groove  13  that forms an intervening cylindrical section having an even smaller diameter. This end of the needle is also is provided with an anti rotation lug that has a cross-section differing from the circular cross-section of the needle, in particular, an anti rotation lug in the form of a stamped flat  14 , in the vicinity of that section of the needle where the needle has its full diameter. 
     The grip  8  is symmetric with respect to the central plane of intersection orthogonal to the plane of the “T” and has in its interior a receptacle for holding the needle. For that purpose, on its conically tapered attachment end  15  the grip has an insertion bore  16  whose inner diameter equals the normal diameter of the needle and also has a pair of lateral, flat-bottomed, longitudinal grooves  17  whose dimensions equal those of the stamped flat  14  on the needle and guarantee seating of the needle such that it will be constrained from rotating and be in the correct orientation with respect to the grip. When in that orientation, the plane of curvature of the needle is orthogonal to the plane of the T-shaped grip. 
     The walls of the hollow, cylindrical, longitudinal section  9  of the grip have a pair of thinner sections formed by mirror-image, with respect to the plane of the “T,” window-like recesses on diametrically opposite sides that are configured in the form of detenting prongs  18 . These detenting prongs  18  are longitudinal leaf springs whose end facing the insertion aperture of the grip forms a unit with the material of the longitudinal section  9  and whose free end has a detenting protuberance  19  that faces inward. As shown in  FIG. 4 , the detenting prongs  18  latch into position with their detenting protuberance  19  situated in the circumferential groove  13  on the end  7  of the needle, but are not self-locking. On the contrary, their detenting protuberances  19  have flats on their sides facing toward, and away from, the direction of insertion, and may be flexed and spread apart both by the beveled surfaces  12  on the end of the needle aligned on them when the end  7  of the needle is inserted and by the shoulder  20  on the circumferential groove  13  when the end  7  of the needle is withdrawn. The detenting prongs are locked by a slide  21  in the form of a sleeve arranged within the grip that may be slid along the longitudinal axis of the grip that engages the outer surfaces of the detenting prongs  18  when in its locking position (cf.  FIG. 5 ) and rests with its engaging, free end  22  abutting against the broadened section  10  on the end of the grip, where it self-locks onto the housing of the grip by flexing. In the disengaged position (cf.  FIGS. 3 and 4 ), the slide  21  releases the detenting prongs  18  and overlaps the end of the grip. Detenting elements  23  on the slide, together with associated active elements  24  on the grip, prevent the slide  21  from falling off the grip when in its disengaged position. The grip may be disassembled for cleaning, i.e., the slide  21  may be slid over the active elements  24  on the grip  8  and off the grip in order to remove it. The interior of the grip also has a hollow section  25  that has an inner diameter that is less than that of the grip and equals the outer diameter of the cylindrical section  11  on the end  7  of the needle, and serves as a receptacle for that cylindrical section, which guarantees wobble-free seating of the needle in the grip. 
     The strap  2  is formed from a flat strip of cloth netting. Both ends of the strap are folded along the centerline  26  of the strap in order that its end sections  27  will be half as wide as the remainder of the strap and their planes will be orthogonal to the plane of the strap. These end sections  27  are firmly clamped in the flattened ends  28  of a retaining sleeve  29  on the end  7  of the needle that fits on the cylindrical section  11  thereof having a smaller diameter, and latches into position thereon. The retaining sleeve has the same outer diameter as the circular rod  4  of the needle. The free end  30  of the retaining sleeve  29  is longitudinally slit, where the tips of the prongs formed thereby are either bent inward or configured such that they are thicker, snap into place in the circumferential groove  13  on the end of the needle, and reach around, and abut against, the circumferential shoulder  20 , in order that it may be attached to the end  7  of the needle. The strap  2  may be attached to the needle  3  such that it cannot twist, in particular, is attached thereto oriented such that the plane of the strap lies in the plane of curvature of the needle. The single flat  12  (cf.  FIG. 7 ) or pair of flats on the cylindrical section  11  of the needle interact with the sloping surfaces  31  formed by the stamped flats on the retaining sleeve  29  for that purpose. However, other configurations of the anti twisting mechanism are feasible. 
     In the case of the embodiment of the invention shown, the means for attaching the strap may be such that they prevent successively attaching opposing ends of the strap to the same needle, i.e., prevent the same needle from being used twice during an operation. The retaining sleeve  29  on the end  7  of the needle is thus either permanently attached thereto, or may only be removed therefrom using a tool that has been specially designed for that purpose. This will preclude attachment of the other end of the strap to the end  7  of the needle and prevent reuse of the needle during the same operation. In the case of a permanent attachment of the strap to the needle, the needle  3 , together with the retaining sleeve  29 , are discarded after the strap  2  has been cut off. If the needle  3  is to be reused, the retaining sleeve  29  may be removed from the needle using the special tool before the needle is cleaned and sterilized. 
     It may also be provided that the needle  3 ′ has tips  6 ′ on both ends by, for example, providing that its attachment end  7  is also pointed or has been ground off an angle. Alternatively, it may also be provided that tips for the needle are configured such that they may be attached to the needle  3 ′, in particular, to the circular rod  4 ′, as shown in  FIG. 9 . Both ends of the needle may be configured such that tips  6 ′ may be attached thereto. For example, both ends of the needle may be configured similarly to its attachment end  7 ′. A sleeve  29 ′ having a tip  6 ′, instead of a retaining sleeve, may then be slipped onto the needle. It may also be provided that the tips are designed to be detachable and the retaining sleeve attached to the strap is slipped onto the needle once the tips have been detached. 
     The instruments shown in  FIGS. 1-9  have a wide variety of applications due to the opportunities for varying their configurations that they provide, and may be used in surgery in which their shaft is inserted through the abdominal wall from above and guided downward, or, in the case of female patients, for example, inserted through the vaginal wall and guided upward to the abdominal wall from below. The strap may be pulled through by the needle, as in suturing, by guiding the needle through the lower abdomen and allowing the needle to transport the strap along with it. The strap may also be picked up by, for example, guiding the needle downward from the abdominal wall, attaching the strap to the accessible tip of the needle, and withdrawing the needle, along with the strap. 
     The embodiment of an instrument for emplacing an incontinence strap shown in  FIGS. 10 and 11  has fewer prospective applications than the aforementioned instruments. However, the instrument  41  shown there is more simply constructed and has several special features. The surgical instrument  41  has a grip  42  and a shaft  43  that are configured in the form of a single, monolithic unit and beneficially consist of stainless steel. The grip  42  is long and flat, but may also have another shape suitable for use on surgical instruments. The shaft  43  follows a gentle S-curve. It has a broadened section  44  that is essential contiguous to the grip  42  in the form of a flat rod having blunt, parallel, lateral edges terminating in a curved section  45  having an essentially circular cross-section that has a hook  47  opening sideward for attaching an incontinence strap to its tip  46 . The transition from the broadened section  44  to the narrow section  45  is gradual, and achieved by tapering the broadened section. The plane of the broadened section lies in the plane of curvature of the curved section  45 . The lateral edges of the broadened section  44  curve slightly upward relative to those of the grip  42 , and those of the curved section  45  on which it terminated curve slightly downward relative thereto. However, the shaft may also be configured in the form of a curved rod having an essentially circular cross-section. 
     The embodiment according to  FIG. 10  is intended for use in cases where the shaft is guided through the abdominal wall and downward, into the abdominal cavity. The purpose of the broadened section  44  is giving the incision channel through the abdominal wall and the connective tissues and fatty tissues lying thereunder, and extending downward to the vaginal wall, a broadened shape that will roughly correspond to that of the incontinence strap. This broadening may essentially extend over the entire length of the shaft. Once the shaft has been inserted into the abdominal cavity, the strap may be attached to the tip  46  of the shaft  43 , which has been guided through from below, for example, guided through the vaginal wall, and withdrawn along with the instrument when the instrument is withdrawn. In the case of two incisions in the abdominal wall, to the right and left of the center thereof, or, preferably, a central incision above the pubic bone, the ends of the strap on the right and left of the urethra, respectively, may be pulled upward, yielding a U-shaped noose reaching around the underside of the urethra. 
     The tip of the shaft may be configured such that it will allow attaching the strap such that the strap may be subsequently detached therefrom, in particular, may be configured such that it provides an attachment mechanism having a securing device that will prevent the strap from becoming unintentionally detached from the shaft. In the case of the embodiment shown, the tip  46  of the shaft is preferably configured in the form a so-called “Reverdin needle.” The latter has an eye that may be opened and closed and has a hooked shape when in the opened state. However, the attachment mechanism on the tip  46  may also be configured differently, for example, by configuring the tip in the form of a simple eye, or by configuring the tip in the form of a detachable cap and providing that a coupling element, to which a mating coupling element on the strap may be attached, will be exposed when the tip is removed, as has been described in conjunction with  FIG. 9 . The eye may also be closed by means of a cap nut. 
     In the case of an embodiment of an incontinence strap according to  FIG. 12 , the incontinence strap  51  has longitudinal sections that differ from one another. Two end sections  52 , each about 10 cm to 20 cm long and about 2 cm wide, are configured in the form of coarse-weave textile straps that have rounded or tapered, V-shaped ends and holes, or other facilities, for attaching them to an insertion instrument. A midsection  53  consists of resorbable plastic and is broadened, compared to its end sections  52 , on one side by a sort of curved extension. This section consists of smooth foil material, has smooth edges. It is intended to reach around the underside of the urethra. Its smooth contours, and the fact that it has been designed to protect the urethra, will help prevent injuries to the urethra due to undesired, unrestrained proliferation of newly formed, connective tissue. Insertion of this section of the strap, which represents a foreign object, will provide that sufficient tissue for supporting the urethra from below will be formed. Since the implant will thus have served its purpose, this particular section of the strap may be configured from resorbable material. 
     The degradation period and resorption time of the material used for configuring the midsection may be predetermined in a known manner employing suitable copolymerization processes. The polymers that come into question are synthetic polymers, in particular, such that may be obtained by polymerizing lactide, glycolide, trimethylene carbonate, dioxanone, ε-caprolactone, or mixtures thereof. 
     In the case of the embodiment shown in  FIG. 13 , an incontinence strap that is intended to remain in the body indefinitely is provided. Once again, the incontinence strap  61  is subdivided into various sections, where at least one midsection  62  is configured in the form of a chamber that may be filled with a fluid, for example, water or liquid contrast media. The midsection  62 , or even the entire strap, may be configured in the form of a tube for that purpose. Various types of designs and materials are available for configuring the strap. In the case of the embodiment shown in  FIG. 13 , at least the strap&#39;s midsection and at least a channel section  63  bordering on its midsection consist of thermoplastic material. Seam-welding opposing walls of the tubing will allow configuring the chamber  64  and the communicating fluid channel  65  extending along the channel section  63 , through which the chamber may be filled and the fill-volume of the chamber may be subsequently corrected whenever necessary. The fluid channel  65  may be closed, for example, welded closed, once the chamber has been filled. It may also be accessible beneath the abdominal skin via a valve, for example, a pierceable membrane, that is accessible from outside. 
     Alternatively, the chamber may also be formed from an elastomer, for example, silicone rubber, that is pierceable and self-sealing, in which case, no separate fluid channel will be required. It will also be feasible to configure the entire strap in the form of a tube and merely seal both ends. The only essential feature is that strap, complete with the chamber that may be filled, be in the form of a strip, which will allow the minimally invasive emplacement of the strap, without opening of the abdominal cavity being required. 
       FIG. 14  depicts another embodiment of an incontinence strap  66  according to the invention. This incontinence strap is preferably configured such that it is elastic and porous, in particular, configured such that it consists of knit fabric, which will allow the ingrowth of tissue. This incontinence strap  66  has an attachment device  67  on each end. These attachment devices are in the form of blunted tips. This will allow them to be easily guided through tissue in the desired directions, more safely than would be the case if they had corners or edges. Both attachment devices are identically configured. The incontinence strap  66  also has an enshrouding sheath  68  that is configured such that it may be withdrawn therefrom due to the fact that it consists of two, separate segments ( 68   a ,  68   b ), one of which is preferably inserted into the other at the middle of the strap, and overlaps the other. However, the sheath may also be a one-piece construction, in which case it will have a perforation, preferably at its middle, that will simplify its separation into two segments. This sheath preferably consists of a thermoplastic material, in particular, polyethylene. These sheaths simplify inserting the strap and protect it against contamination. 
     The attachment devices  67  are of multilayered construction. The upper layer consists of a casing  69  that surrounds the sheath  68  in the vicinities of its attachment devices. Lying below, i.e., inward from, this casing  69  is a second layer, i.e., the sheath  68 . Another layer  70  of thermally bondable material lies beneath the sheath  68 , i.e., between the sheath  68  and the strap  66 . A final layer, i.e., the incontinence strap  66  itself, lies below this layer  70 . The strap  66 , the layer  70 , the sheath  68 , and the casing  69  are bonded together at the extremities of the incontinence strap. A rear section  71  of the attachment devices  67  is left unbonded. The strap is bonded and reinforced over its full width, which will prevent its knit fabric from tearing off the laminate. A through hole  73  that may be punched during bonding in order that its edges will be compression bonded when the through hole is punched is situated within the bonded section  72  of the laminate. The punched through hole may have various shapes, such as a triangular, rectangular, square, or, preferably, a circular or an elongated oval, shape. 
     Each segment  68   a  and  68   b  of the sheath also has an asymmetrically arranged, identifying line  75   a  and  75   b . These identifying lines preferably have a readily recognized coloration. Within the overlapping sections of the pair of transparent segments  68   a  and  68   b  of the sheath, which preferably lie in the vicinity of the middle of the strap, the two identifying lines  75   a  and  75   b  are parallel to one another in order that the operator may recognize the middle of the strap. 
     All materials employed are preferably thermoplastic materials. The strap itself preferably consists of polypropylene, and, as mentioned above, the sheath preferably consists of, for example, polyethylene. The film thickness of the casing  69  and the layer  70  of bondable materials preferably exceeds the film thickness of the sheath  68 . It will be beneficial if the sheath  68  has a film thickness of about 70 μm. The film thicknesses of the casing  69  and layer  70  of bondable material should preferably be about 200 μm. 
       FIG. 15  depicts a longitudinal section through the attachment device  67  at the transition zone between its bonded section  72  and unbonded section  71 , drawn on a much larger scale. The incontinence strap  66  is situated at the center of the attachment device  67 . The incontinence strap  66  is sandwiched between two layers  70  of bondable material. These layers of bondable material are followed by the sheath  68 . The film thickness of the sheath  68  is much less than that of the layers  70  of bondable material. The outer faces of the attachment device  67  are bounded by the casing  69 . The film thickness of the casing  69  is approximately equal to the film thickness of the layers of bondable material. Within section  72 , the aforementioned layers are thermally bonded together by welding covering an extended area. Within section  71 , these layers are not unbonded together. However, it would be feasible to also bond, e.g., pointwise bond, these layers together, within section  71 . Following implantation, the attachment devices, together with the ends of the strap, may be cut off and the segments  68   a  and  68   b  of the sheath withdrawn along opposing directions. It will also be feasible to cut off just one half of the sheath and the ends of the strap, together with the attachment devices, and withdraw the ends of the strap, together with the segments of the sheath, along opposing directions. 
       FIG. 16   a  depicts a schematized view of the cross-section of an, as yet, unbonded section of the ends of another embodiment of an incontinence strap according to the invention. The incontinence strap  66 ′ and sheath  68 ′ have an overall length of 31 cm and a width of 2 cm. As has already been mentioned in conjunction with the descriptions of  FIGS. 14 and 15 , the incontinence strap  66 ′ is knitted and has pores, which will allow ingrowth of tissue. The ends of the incontinence strap  66 ′ is encased in a casing  74  that has a length falling within the range 2 cm to 8 cm. The casing  74  is, in turn, encased in the sheath  68 ′, which has already been described in conjunction with the preceding example of an embodiment. The casing  74 , which is arranged between the sheath  68 ′ and the end of the strap, encloses only a few centimeters of the long ends of the incontinence strap and serves as reinforcing material. The casing  74  has a lower melting point than the incontinence strap  66 ′. That property of the casing  74  will allow it to act as a thermoplastic bond joining the sheath to the incontinence strap  66 ′ in the vicinities of the attachment devices (cf.  FIG. 16   b ) and effect a certain strengthening of the strap within the adjacent unbonded sections. The sheath  68 ′ has a film thickness of about 70 μm and the casing  74  has a film thickness of about 200 μm. Both the sheath  68 ′ and the casing  74  consist of polyethylene. 
       FIG. 16   b  depicts a schematized view of the cross-section of the incontinence strap shown in  FIG. 16   a  in the vicinity of an attachment device, i.e., of a bonded section thereof. Pressure and thermal treatment of the incontinence strap  66 ′, including its encasings, in the vicinities of its long ends have provided that its casing has melted and acts as a thermoplastic bond  74 ′ joining the sheath  68 ′ to the incontinence strap  66 ′. In addition to acting as an adhesive, the material  74 ′ of the casing also acts as a filler for filling the pores of the incontinence strap  66 ′. In the case of this example of an embodiment as well, a through hole is situated within the bonded section, which, however, has not been depicted here. The total thickness of the laminate in the vicinity of the attachment device is about 650 μm.