Device for placing an implant made from flexible material under tension

p0001The invention relates to a tensioning device, in particular for incontinence implant.

p0002The invention finds an advantageous application in the treatment of urinary incontinence due to sphincter insufficiency, male incontinence, and more generally when a support implant an internal anatomical body must be tensioned with various setting possibilities .

p0003Is known, for example, the use of an implant in the form of a tension adjustable strip for the surgical treatment of stress incontinence in men and women. The system used, known under the brand "REMEEX" includes, essentially, under urethral, ​​an inverter connected to a controller by two traction son. The tensioning system is placed subcutaneously in such fascia of the abdominal muscles. The son tensioning is done via a screwdriver to act on the drive. This solution requires an incision for insertion of the end of the tool.

p0004Also in the treatment of urinary incontinence, a solution of the patent teaching the spring <patcit id="pcit0001" dnum="US6117067A"><text>US 6117067</text></patcit> which describes a hydraulic tensioning system for implant of urinary incontinence. In this system, non-invasive, the voltage of the traction son is based on the deformation of a silicone balloon by injecting a liquid through an implantable chamber. Under the effect of the injection of liquid, the inflation of the balloon takes on the son connected to the implant thereby exert a corresponding tensile stress, concomitantly, to the enhancement of the anatomical organ considered. It is also possible to relax the implant by aspiration of the liquid corresponding to a loosening of the son. This solution is not totally satisfactory.

p0005As shown, to exert a traction force at the ends of the implant, it is necessary to inflate the balloon causing unsightly deformation of the epidermis visible from the outside. It is also observed that the tension exerted on each end of the implant is not always symmetrical resulting from the difficulty of perfectly identical flask walls over the entire surface. In addition, the adjustment of capacity is not always sufficient.

p0006The invention has set itself the goal to remedy these drawbacks simply, safely, effectively and efficiently.

p0007The problem to be solved by the invention is to ensure the implant tensioning without incision and without deformation of the skin, with a large adjustment range.

p0008To solve such a problem, it has been designed and developed a voltage of a flexible material implant formatting device subject to at least one puller wire and intended to cooperate with an internal anatomical organ. The device comprises, accommodated in a housing sealingly and protection implantable, rotary drive means of a disc where the mated or (s) Tensile son, said drive means being controlled by injection of a fluid from a chamber (implantable) which the said housing.

p0009To solve the problem of obtaining an intensity equal tensile force at each end of the implant, the drive is fitted with a piston displacement capacity guided and sealed in a housing the dwelling is injected the fluid.

p0010To solve the problem of rotating the disk under the effect of movement of the piston, the clutch disc or wire (s) has a projecting part in the bore of the housing and can be acted upon addition a piston displacement effect to cause, concomitantly, the driving in rotation of said disk.

p0011Advantageously, the piston has a semi-circular shape in a manner complementary to that of its housing.

p0012According to another characteristic, the implantable chamber is fixed in a coaxial carrier to the housing and in communication with at least one orifice with the piston housing.

p0013To solve the problem of ensuring a symmetrical tensioning of the implant, the implant tensile son, are coupled to two diametrically opposed holes formed in the thickness of the disc close to its periphery.

p0014According to other features, the housing has a generally disc-shaped. The fluid is a liquid or air.

p0015The device has a particularly advantageous application for the tensioning of an implant incontinence.

p0016The invention is described hereinafter more in detail with the figures appended hereto in which:<ul><li>the <figref idrefs="f0001">figure 1</figref> is a perspective view before assembly of the main components of the device according to the invention;</li><li>the <figref idrefs="f0001">2</figref> is a perspective view of the device after assembly of the various elements;</li><li>the <figref idrefs="f0002">3</figref> is a longitudinal sectional view of the device;</li><li>the <figref idrefs="f0003">Figures 4 and 5</figref> are purely schematic views showing an example of non-limiting application of the device according to the invention:<ul><li>✔ the <figref idrefs="f0003">4</figref>, The son between the implant device are not subject to tensile load;</li><li>✔ while the <figref idrefs="f0003">5</figref>The implant is energized following the tractive force exerted on the coupling son.</li></ul></li></ul>

p0017As stated, the invention finds an advantageous application in the case of any type of retaining implant with an internal anatomic implant to which it is necessary to exert pressure with adjusting capacity to act on said anatomical organ. This is particularly the case of an implant incontinence which occurs, for example, in the form of a strip (B) made of flexible material and intended to cooperate, for example, with the urethra (O) . Each end of the strip (B) or other implant is connected to tensile son (F1) and (F2) intended to be coupled to the tensioning device.

p0018According to the invention the tensioning device comprises, accommodated in a sealed and implantable protective housing (1), a drive means for rotating a disc (2) which are coupled to the traction son (F1) and (F2).

p0019As will be described in the following description, the driving means of the disc (2) is controlled by injecting a fluid from an implantable chamber (7) that has a housing part (1).

p0020The disc (2) is rotatably mounted in a circular free base (3) from which are introduced tensile son (F1) and (F2). More particularly, the son (F1) and (F2) are introduced respectively from two diametrically opposed holes or openings (3a) and (3b) for coupling in orifices or other arrangements (2a) and (2b) containing a manner diametrically opposite to near the periphery of the disc (2).

p0021The driving means of the disc (2) consists of a piston (4) mounted with capacity of movement guided and sealed in a housing (1a) that present the housing (1). As shown in particular in <figref idrefs="f0001">figure 1</figref>, The piston (4) has a generally semi-circular in a manner complementary to that of the slot (1a).

p0022In the illustrated embodiment, the housing (1) is in the form of two assembled half shells (1b) and (1c) defining the housing (1a) for moving the piston (4) and injecting the fluid . One part (1b) or (1c) of the housing has an arrangement (1) acting as a stop to the piston (4).

p0023The disk (2) coaxially has a finger (5) angularly indexed to allow rotating the disc in a movement of the piston effect (4) resulting from the injection of the fluid. For this purpose, the finger (5) has a lug (5a) projecting into the housing (1a) of the housing (1). It refers to the<figref idrefs="f0002">3</figref> which shows an exemplary embodiment of the mounting of the disc (2) relative to the housing. In this embodiment, the disc (2) has a circular range centering (2c) on which is mounted the bottom part (1b) of the housing. This circular range centering (2c) has a coaxial boss (2c1) of flattened section cooperating with a complementary section of this slot that the finger (5).

p0024The housing (1) has a coaxial recess in which is mounted a support (6) for receiving a subcutaneous chamber (7). The bottom of the chamber (7) has a circular recess (7a) in communication with the channels (7b) with the support (6) itself communicating via orifices (6a) with the housing (1a) of the housing (1 ). A cover (8) ensures the connection of the chamber (7) and its support (6) relative to the housing (1).

p0025The chamber (7) is made of a deformable material of any type known and appropriate, and shaped to enable a manner perfectly known to a skilled person, to plant the needle of a syringe for example (9) to injecting a liquid or gaseous fluid.

p0026The operation of the device for tensioning the strip (B) is particularly simple and effective.

p0027it is considered that is suitably implanted in the anatomy of the human body. The considered anatomical body, the urethra (O) for example, cooperating with the strip (B) of which ends are connected by the son (F1) and (F2) to the rotatable disc (2) under the conditions indicated previously. When the fluid is injected through the implantable chamber (7) in the housing (1a) of the housing (1), the piston (4) abuts against the spigot (5a) of the finger (5) which is moved under the effect of the thrust of the fluid causing, concomitantly, the circular movement of the entire disk (2) and its driving pin (5). The displacement of the disc (2), to which are coupled the son (F1) and (F2), said son subjected to a tensile stress (Figure 6) corresponding to the tensioning of the strip (B). The tensile force can be easily adjusted depending on the fluid flow in combination, for example, with radiopaque witnesses that this part of the disc (2) to permit identification by radiography, to adjust its angular position by therefore this tensile force said son (F1) and (F2).

p0028To sagging, it suffices to remove by means of the syringe, the injected fluid, the piston (4) back in position under the effect of the drive in the opposite direction of the disc (2) by the weight of the anatomical organ considered.

p0029Of course, all the major organs of the device, as described, are made of any material compatible implantable and to avoid any phenomenon and rej.

p0030The advantages are apparent from the description, in particular, emphasized and recalled:<ul><li>tension or loosening of the implant is effected by means of a syringe through an implantable chamber without incision;</li><li>the voltage of the son is effected by circular movement of a disk, in a completely symmetrical manner, avoiding deformation problems;</li><li>the ability to obtain an adjustment of up to 80 millimeters without distortion; </li><li>the small dimensions of the device form a compact whole.</li></ul>