DE202006016866U1 - Implantation system for treatment of incontinence, comprises mesh material loop with end connectors and matching surgical tool with curved needle used for implantation - Google Patents

Abstract

The loop is suitable for implantation in a tissue passage, to treat incontinence. It comprises a lengthy mesh material (40) body with connectors at each end. These are molded-on, and each includes a molded-on base section. Implantation instruments are included in the system. Each comprises a handle with a needle. The needle extends away from the handle, becoming curved (spirally to the left or right). The tip structure is configured to engage the first or second loop connector during loop implantation in the tissue passage.

Description

The The present invention relates generally to surgically implantable Slings made of a mesh which are suitable for Urethra of one To support patients to treat urinary incontinence and sling implantation tools.

incontinence is a condition caused by being out of control a person standing involuntary Loss of urine or feces material is characterized and to a Loss or a reduction in ability leads to the urinary sphincter muscle or the anal sphincter keep closed when the bladder or rectum is with urine or Fill feces material. Reasons for this condition is a damage and / or a loss of support the urinary sphincter, for various reasons may occur, for example, due to damage to the pelvis and a Aging with an impairment of muscle and connective tissue by which the urethra is supported.

One recognized method of treating incontinence is a sling to support the urethra to implant and then surrounding the respective loop ends in the urethra to attach retropubic space. For elongated "self-fixing" or "tension-free" loops is no mechanical attachment on tissue or bone he required, but they are based on the Ingrowth of tissue into loop pores, which stabilizes the loop becomes. Such loops are described, for example, in US Pat. Nos. 6382214, US Pat. 6641524, 6652450 and 6911003 and publications cited therein and patents, each incorporated herein by reference in their entirety Reference is made.

The Implantation of tension-free urethral or urethral slings involves the use of implantation needles and other instruments, the transvaginal, transobturial, suprapubic or prepubic passages near the urethra produce. The needles also have a Connection system for connecting the loop ends to the needle ends on, so that the loop end sections by the desired passages can be pulled.

As in 1 is shown as an example, has a urethral sling 10 generally an elongated mesh 40 and removable protective covers 26 . 28 put on the mesh at each end section 22 . 24 the noose 10 envelop. Preformed dilators 12 . 14 are using an adhesive or by threading the sheath ends through an opening in the dilators 12 . 14 and then heat sealing the sheath ends to the respective ends of the sheaths.

The loop 10 is using a surgical instrument, for example, in the 2 and 3 illustrated surgical instruments, the handles 52 and needles 54 implanted in a patient. These needles 50 have opposing coils adapted to form a right and a left passageway through each obturator foramen between a lateral incision and an incision in the vagina of a patient. Every instrument 50 will then be with the dilators 12 . 14 connected. The dilators 12 . 14 Make a relatively permanent attachment to the ends 62 the needles 50 ready. The end sections of the sling 10 are then passed through the right or left obturator (ROF / LOF) port of the pelvis (P), as in FIGS 5 and 6 and described in more detail in US Patent Application Nos. 2005/0043580 and 2005/0065395 and US Patent No. 6911003.

That is, the needle ends 62 become axial in the dilators 12 . 14 introduced, and the end sections 22 . 24 the urethral sling 10 are pulled through the passages, with the loop connectors 12 . 14 and the needles are pulled along to a central support section 30 to pull against the urethra to treat urinary incontinence. The fixation of the needle ends 62 on the dilators 12 . 14 is stable to prevent inadvertent detachment when the connectors expand the passages and the end sections 22 . 24 the urethral sling 10 be pulled through the passages. The connectors 12 . 14 are pulled out through the skin incisions, and the urethral sling 10 and the covers 26 . 28 be near the connector 12 . 14 separated. The sheath sections 26 . 28 and the connectors 12 . 14 are from the right and left passages over the end sections 42 . 44 pulled out of the loop mesh material, whereby the mesh material of the urethral sling is exposed to the body tissue. The end sections 42 . 44 of the sling mesh may optionally be sutured to subcutaneous tissue layers. Tissue pressure stabilizes the exposed mesh in the passageway. Similar methods of installing an elongated urethral sling to support the male urethra to reduce incontinence are described in U.S. Patent No. 6652450 described above, and the invention described herein is also suitable for treating male incontinence.

The needles described in US Published Patent Application No. 2005/0043580 have a single plane curvature and generally conform to the disposable BioArc ^™ and SPARC ^™ loop needles sold by American Medical Systems, Inc. U.S. Patent No. 6911003 describes needles having a curvature in a three-dimensional space suitable for advancing and positioning a loop along transobthurgical passages. These needles generally conform to Monarc ^TM needles sold by American Medical Systems.

Even though the above-described implantable slings and surgical Needles work properly, there is a need for slings with Compounds that are easily attached to appropriate surgical Needles attachable and detachable are.

It It is an object of the present invention to provide a system for treating of urinary and fecal incontinence. The system has a Sling adapted to be implanted in a tissue passageway to treat urinary or fecal incontinence. The loop has a first and a second loop connector with a Base section, which by an injection molding process on the first and the second end of the noose is infused, and one at each Base portion attached and extending from each base portion Thread loop on.

The System further includes a first and a second surgical instrument for implanting the sling. The first and the second surgical Instrument have a handle and a clockwise or a left-handed spiral-shaped needle section on. The spiral Needle sections have a extending from the handle portion proximal end of the needle and a distal end of the needle forming a structure which is configured to be during the Implant the loop in the tissue passage with the loop connectors solvable can be brought into engagement.

It Another object of the present invention is an implantable device To provide a sling that has an elongated mesh, the width of the first and second ends of the mesh material diminished and then poured a connector on each stitch end becomes.

In an embodiment is the casting process an injection molding process. In another embodiment The mesh ends are shrouded by one or two sheaths, and the connectors become on the covers poured.

1 shows a urethral sling, referred to in connection with embodiments of the present invention;

2 shows a surgical instrument for implanting a sling, the instrument having a handle and a helical needle adapted to be inserted into a transobturial passageway of a patient;

3 shows a surgical instrument for implanting a sling, the instrument having a handle and a helical needle adapted to be inserted into a transobturial passageway of a patient;

4 shows a connection system for connecting a loop end to a surgical instrument;

5 shows the surgical instrument of 3 which extends along the left transobtrural passageway of a patient;

6 shows the surgical instrument of 2 which extends along the right transobturial passageway of a patient;

7 shows an embodiment of an implantable loop with connectors having openings for connecting the loop to a surgical instrument;

8th shows an end to the in 7 and the end of a surgical instrument having a structure adapted to connect the instrument to the sling;

9 shows the loop end and the needle end of 7 which are detachably connected to each other, as would be the case with an implantation of the loop;

10 shows a loop end according to another embodiment of the present invention with a connector with a loop;

11 shows a loop end with a loop connector and a needle end releasably connected to the loop end, as would be the case with the implantation of the loop;

12 shows a loop end according to another embodiment of the present invention with a connector with a loop;

13 shows a loop end according to another embodiment of the present invention with a connector with a loop;

14 shows a loop end according to another embodiment of the present invention with a connector with a loop;

15 shows a loop end according to another embodiment of the present invention with a connector with a loop;

16 shows a needle end according to another embodiment of the present invention with an opening for receiving a loop or a similar loop connector;

17 shows a loop fastening system according to another embodiment of the present invention with a loop connector with a loop and a needle end with a slot and a recess for receiving the loop;

18 shows a loop connection system according to another embodiment of the present invention;

19 shows a loop fastening system according to another embodiment of the present invention with a loop connector with a loop having a reinforcing portion and a needle end with a slot for receiving the loop;

20 shows a needle end having an opening, a slot and a recess for releasable connection to a loop connector, such as a loop connector;

21 shows a needle end having a plurality of slots for receiving a loop connector, such as a loop connector;

22 shows a plurality of needle ends having different slot configurations for releasable connection to a loop end connector, such as a loop connector;

23 shows a loop connection system according to another embodiment of the present invention;

24 shows a sling implantation system or kit according to an embodiment of the present invention;

25 shows the loop connection system of in 24 illustrated implantation system;

26 shows an end view of the surgical needle of FIG 24 illustrated implantation system;

27 shows a cross-sectional view of the needle end of the in 24 illustrated implantation system;

28 shows a close-up of the needle end of in 24 illustrated implantation system;

29 shows a sling connection system according to another embodiment of the present invention with a sling with a connector with a ball and cable structure and a slot for releasably receiving the ball and cable structure;

30 shows an alternative embodiment of the in 29 illustrated connector;

31 shows a plan view of an alternative embodiment of the in 29 illustrated needle end;

32 shows a bottom view of in 31 illustrated embodiment; and

33 FIG. 10 is a block diagram illustrating the steps for manufacturing cast-cast loop connectors. FIG.

In the detailed below Description will be given to exemplary embodiments of devices to run of the invention. Within the scope of the present Invention can but also other embodiments be implemented. Furthermore can within the scope of the present invention Aspects of the illustrated embodiments combined become. In particular, the connection system described herein according to the invention with various types Slings, needles and implantation procedures are used.

7 shows an exemplary embodiment of an incontinence loop according to the invention 110 for treating urinary or fecal incontinence. The loop 110 has loop connectors 112 . 114 at respective end portions of the sling 110 on. The loop connectors 112 . 114 have integrally molded loop sections 146 . 148 on a surgical needle, such as the one in the 8th - 9 illustrated needle 150 , easy to attach and detachable. A sling body 120 has a middle section 130 and end sections 132 . 134 on that in sheaths 122 . 124 are shrouded. Each of the loop connectors 112 . 114 is by one below with reference to 33 illustrated injection molding process on mesh ends 142 . 144 and / or respective envelope ends 126 . 128 poured.

The middle section 130 and the end sections 132 . 134 can be made of a synthetic material, such as a polypropylene mesh material. Alternatively you can some or all loop portions are made of a biocompatible material, such as mammalian skin.

As in the 8th and 9 is shown, the needle points 150 a distal end 160 with a hook-shaped needle end 162 on. Suitable needle shapes 150 are in the 1 - 6 shown spiral forms and other suitable for implanting incontinence loops surgical needles. The hook-shaped needle end 162 has a tip or a hook 164 on, which is dimensioned so that he in the holes 146 . 148 can be added to the end sections 132 . 134 (Comp. 7 ) of the noose 110 through the through the needles 150 (Comp. 5 and 6 ) to pull formed tissue passages. In conjunction with the in the 7 - 9 Also, other suitable hook configurations described herein may be used.

The 10 - 24 show further embodiments of the present invention in which the loop connector has a loop formed integrally with the loop cover and / or the mesh end. For example, needles suitable for use with this embodiment have the hook-shaped configuration described above and other configurations described herein. It will be understood by those skilled in the art that although only one loop end is illustrated and described, a second loop end having the same features is present.

10 shows an embodiment of a loop according to the invention 110 with a loop connector 112 who is at the end of the loop 110 and in particular on an envelope end 126 and / or a mesh end 142 is infused. The loop connector 112 has a base section 150 and one at the base section 150 attached thread loop 154 on. The base section 150 can for this and other embodiments by injection molding a polymer material, such as polypropylene or polyethylene, on the loop end 110 are formed, as described in more detail below. Suitable thread loops 154 or other filaments or wires have sufficient stability to withstand the implantation process while still possessing a substantial degree of flexibility. Polyester threads are suitable for certain embodiments because of their higher melting point. In other embodiments of the present invention, the various natural and synthetic fibers and / or filaments or filaments, coated filaments (including reinforcing coatings), braided filaments or other suitable filament or filament materials are used. The length of the thread loop 154 may vary depending on the nature of the loop to be implanted, the configuration of the corresponding needle connector, and the preferences of the clinician (clinician) who is performing the treatment.

11 Figure 1 shows a hook in one embodiment of the present invention 164 the needle 150 releasably attached thread loop 154 , That way the sling can 110 be pulled through surgical passages, as with respect to the 1 - 6 has been described (or by other conventional implantation procedures), and then the needle can 150 slightly from the thread loop 154 be resolved or disengaged.

The 12 - 16 show various methods for attaching the thread loops 154 at the base section 150 of the connector 112 , at the shell end 126 and / or at the mesh end 142 , 12 shows a cross-sectional view of another embodiment of the present invention, wherein each end 160 . 162 a loop in a through hole 164 in the base section 150 and then proximally from the base section 150 a knot 166 is generated around the thread loop 154 finish and prevent the thread loop 154 during implantation through the base section 150 is pulled. In this embodiment, the thread end 160 directly at the mesh end 142 or at the end of the envelope 126 be tied down. If two sutures are used, another knot may be made at the distal end of the sutures to complete the suture loop. In the 13 embodiment shown is that of 12 similar, except that the thread ends 160 . 162 through separate through holes 164 . 165 be introduced.

The 14 and 15 show embodiments in which the thread loop 154 during a casting process, eg while referring to 33 described injection molding process, at the base section 150 is attached. In the in 14 illustrated embodiment, the through hole extends 164 in the transverse direction to the length of the base sections 150 ,

The 16 - 23 show further embodiments of the present invention in which loops with thread loops on each end and on the thread loops releasably fastened connectors are used. 16 shows an embodiment in which a needle end 160 a through hole 170 has and the thread loop 154 with the needle end 160 releasably connected by the thread loop 154 through the through hole 170 threaded and then the loop 154 around the end of the needle 160 is hooked. Alternatively, the needle end could 160 both a through hole 170 as well as one Have hooks, so that the thread loop 154 first through the through hole 170 threaded and then held by the hook.

17 shows an embodiment in which the thread loop 154 a narrowed section 172 which, in a corresponding slot 174 and a recess 175 in the end of the needle 160 fits, so the loop 154 during implantation in the depression 175 is held until the narrowed section 172 with the slot 174 is aligned.

18 shows an embodiment in which the base portion 150 a pipe 176 in which the needle end 160 can be introduced to the base section 150 during implantation with the needle end 160 align. 19 shows an embodiment in which a portion of the thread loop 150 a stiffening element 178 having, in a corresponding slot arrangement 180 that have an opening 182 for receiving the stiffening element 178 and a narrow slot 182 for holding the stiffening element 178 has, used and can be kept detachable.

20 shows a needle hook embodiment with a slot 174 , a recess 186 and a through hole 188 , In this embodiment, a thread loop through the slot 174 and the through hole 188 threaded and then looped over the needle 160 and in the slot 174 be traced back so that they are in the recess 186 is held. By this arrangement, the likelihood that the loop unintentionally from the needle end can be reduced 160 solves.

21 shows an embodiment in which the needle end 160 several (2 or more) openings 188 and 190 through which a thread loop can be threaded before the loop on the needle end 160 is held. The needle end 160 can optionally have a hook or similar support structure. 22 shows another structure of the needle end 160 that have different slots 192 for holding a thread loop.

23 shows an embodiment in which the thread loop 154 through a through hole 194 in the end of the needle 160 and then instead of on the needle end described in the preceding embodiments 160 on the base section 150 the loop connector is hooked. The base section 150 has a pipe section in the illustrated embodiment 196 on, the orientation of the needle end 160 supported. The base section 112 could also have a recess, a slot, a groove or other structure to better hold the loop during loop implantation.

24 shows an embodiment of a sling implantation arrangement according to the invention 200 , The order 200 has a container 205 , a noose 210 and surgical needles 212 . 214 on. The loop 210 has loop ends 216 . 218 with connectors 220 . 222 on. The connectors 220 . 222 have respective basic sections 224 . 226 and loops 228 . 300 on.

The needles 212 . 214 have opposite spiral sections 232 . 234 for creating tissue passages through the right obturator foramen and the left obturator foramen of a patient and needle ends 236 . 238 for a detachable connection with the loop connectors 220 . 222 on. As in the 25 - 28 is shown in more detail, the needle ends 236 . 238 slots 240 . 242 for picking up loops 228 . 230 and depressions 244 . 246 for releasably holding the loops 228 . 230 during an implantation. In the in 27 perspective shown form the slots 240 . 242 and the depressions 244 . 246 "H" shaped connectors.

29 shows another embodiment of the present invention, in which each loop end is a connector 112 with a base section 250 , one from the base section 250 extending cable 252 and one at a distal end of the cable 252 trained ball section 254 having. A corresponding needle end 160 has a slot 256 with an opening 258 at one end. During use, the ball section 254 in the opening 258 be introduced, whereupon the cable 252 through the slot 256 can be pulled to make a detachable connection.

30 shows an embodiment in which the base portion 250 made of a different material than the cable 252 and the ball section 254 , In these embodiments, the base portion 250 on the end of the loop 112 and around the cable 252 and the ball section 254 be infused around, as with reference to 33 has been described. One end of the cable 252 can also anchor 260 for holding the cable in the base section 250 exhibit. The cable 252 and the ball section 254 can be made of the same material as the base section 250 getting produced. Alternatively, the base section could 250 be made of a polymer, and the cable 252 and the ball section 254 could be formed of a metal or other polymer.

The 31 and 32 show different views of a needle end 160 with a slot and opening arrangement according to another embodiment of the present invention. As shown, the needle end has a through hole 270 , a seat arranged on one side of the needle 272 and a channel extending therebetween 274 on. On the seat 272 opposite side of the needle end 160 extends the channel 274 to a distal tip section 276 of the needle end 160 , In this embodiment, the through hole has 270 such a size that the ball portion 254 of the loop connector (cf. 29 ) can be included in the ball section 254 is allowed to pass through both sides of the through hole 270 to extend. The channel 274 is configured so that the cable 252 can extend through until the ball section 254 through the depression 272 is recorded. The seat 272 has a size such that the ball portion 254 in the seat 272 is recorded. After the ball section 254 in the seat 272 is included, the cable can 252 to the distal tip 276 in the canal 274 be aligned. The loop connector can be from the needle end 160 be solved by the Kabal 252 moved in the opposite direction in the channel and then the ball section 254 through the through hole 270 is extracted.

The in the 31 and 32 The illustrated needle embodiments could be modified such that each side of the slot assembly can hold the ball and cable by providing a recess and a groove on both sides of the needle. In addition, although in the above-described embodiments, a ball portion is shown at the end of the cable, other shapes may be used, such as a hemispherical, a frusto-conical or a disk-shaped structure. In addition, in another embodiment, a slot portion could be poured onto each loop end, and the ball and cable could be attached to the end of the needle.

Below, with reference to 33 the steps of forming and integrally securing the loop connectors to the sheath and / or to the stitching ends for selected embodiments are described. In step 100 a suitable mold is provided, the mold cavity of which is shaped to receive an end portion of the loop body therein and to integrally form a base portion on the loop end. The sling is formed in step S102 in accordance with a suitable manufacturing process in which a sling is made from an elongated knit material which is generally received in a protective cover. End portions of the resulting loop are trimmed and folded in length or otherwise shaped in step S104 to obtain a substantially conical configuration that fits within a portion of the mold cavity. A molding compound containing a polymer, eg, polyprobylene or a derivative thereof, is injected into the mold cavity and cured in step S106. In step S108, the loop connector is removed from the mold after curing and dressed.

In Embodiments, in which the base section and other sections of the connector (e.g., the suture loop) are composed of separate components Separate connection components formed separately and then in the mold cavity are used before the base section on the loop ends are infused. In this way, the separate connection components integral with the base portion educated. In other embodiments the separate connection components through through holes, tight fit, etc. attached to the base portion and / or to the loop ends, after the base section has been poured onto the loop ends.

If the loop ends and connectors are fastened in this way, arise several possible Advantages. For example, the injection molding process tends to be more effective because no separate dilator needs to be formed. In addition, the injection molding on a commercial scale be automated more easily. In addition, by a injection molding allows that separate connection components, such as a thread loop, in a single step at the end of the loop can be attached.

Within The scope of the present invention is also various alternative embodiments imaginable. For example, could the mesh sections of the loop described herein are biological have active material in the middle section. In addition, the middle section could be formed with a greater width compared to the loop ends, so that the noose for a fecal incontinence treatment in which the sling is suprapubic, retropubic, transvaginal, transurethral, transobturial or Obturator near passages is implanted. In other embodiments, the Replaced loop ends replaced by tissue anchors be easily connected to a surgical needle and over a vaginal or perineal incision in hard or soft tissue can be fixed.

Although embodiments of the present invention have been described above with respect to the treatment of female urinary incontinence, it will be appreciated that many of these embodiments also suitable for implanting and repairing various pelvic conditions of both males and females. For example, embodiments of the present invention are suitable for various pelvic floor repairs and / or treatments, such as pelvic organ prolapse repair, levatortor repair, fecal incontinence treatment, male urinary incontinence treatment, perineal body support, and hysterectomy support.

Claims (21)

Loop implantation system with: one Noose suitable for implanted in a tissue passageway to treat incontinence, with the noose one elongated mesh body with having a first and a second end; a first and a second loop connector connected to the first and the second end are connected, wherein the loop connector a have base portion cast on each end of the loop; and at least one instrument for implanting the loop, the instrument having a handle and a needle, wherein the needle has a proximal portion extending from the handle, a curved portion disposed adjacent to the proximal portion and a distal portion having a structure such as is configured during that the implantation of the loop in the tissue passage with the first or second loop connector removably engaged. The system of claim 1, wherein the first and second Connector a loop portion extending from the base portion exhibit. The system of claim 2, wherein the loop portion having a thread loop portion. The system of claim 3, wherein the connector is mounted on the Thread loop portion is poured. The system of claim 2, wherein the structure is at the distal End of the needle has a hook which is suitable with the loop portion of the first or the second connector releasably in To be taken. The system of claim 2, wherein the structure is at the distal End of the needle has a recess suitable for to receive the loop portion of the first or second connector. The system of claim 1, wherein the first and second Connectors extending from the base portion ball portion exhibit. The system of claim 7, wherein the structure is at the distal End of the needle has a slot which is suitable with the ball portion of the first or the second connector releasably in To be taken. The system of claim 1, wherein the at least one surgical instrument for implanting the loop a helical Needle section nearby having the proximal end of the needle. Implantable sling for treating incontinence With: an oblong, rectangular mesh of such size and shape, that it can be fixed in a tissue passage of a patient, to treat incontinence, the mesh material being a first and a second end and a midsection extending therebetween, wherein the first and second ends are one compared to the middle section have reduced width; and a first and a second Connectors which are poured on the first and the second end, wherein each of the first and second connectors has a structure, according to them while an implantation releasably connectable with a surgical instrument are. A sling according to claim 10, wherein the first and the second connectors have a base portion and a separate loop portion and wherein the base portion on the loop end and the separate loop portion is poured. A sling according to claim 10 or 11, wherein the sling at least one shell comprising the first and second ends of the mesh material, and wherein the first and second connectors are at least one of Shell poured are. Implantable sling made with the steps: Provide an oblong, rectangular mesh material of such a size and shape that it can be fixed in a tissue passage of a patient, to treat incontinence, the mesh material being a first and a second end and a midsection extending therebetween having; Vimers the width of the first and second ends in terms of the middle section of the sling; and Pouring a first connector around the first end and a second connector around the second end the first and second connectors at the first and second ends to fix. The sling of claim 13, further manufactured by wrapping the first and second mesh material ends through a sleeve, and wherein the Casting step comprising casting the first and second connectors around the shell. The sling of claim 14, wherein the wrapping step the wrapping the first loop end by a first sheath and the second loop end through a second shell having. A sling according to claim 15, wherein the first and the second shell at the middle section of the elongated one Overlap mesh. A sling according to claim 13, wherein the casting step the injection molding the first and the second connector to the first and the second End has. A sling according to claim 17, wherein the injection molding step a step for inserting each loop end into a mold and forming the first and second connectors on the loop ends. A sling according to claim 13, wherein the connector comprises a Base portion and a separate loop portion, and wherein the casting step forming the base portion on the loop end and the has separate th loop portion for forming the connector. A sling according to claim 13, wherein the casting step a step for injection molding an integral connector with a cast on the loop end Base portion, a cable portion extending from the base portion and a ball portion at the distal end of the cable section. A sling according to claim 13, wherein the casting step a step for injection molding an integral connector having a base portion and a loop portion which is made of the same material as the Base section.