The present invention relates to a device for use in the treatment of prolapses of pelvic organs and/or urinary incontinence, particularly by means of single-incision surgery with a supporting mesh acting as an anatomical support.

Known medical devices for use in surgical procedures for the treatment of pelvic disorders are for example described in US 8,585,578; US 8,597,173; US 8,628,465; US 2010/0105979; US 2014/0058193 and US 2014/0257026.

An object of the present invention is to provide an improved device compared to those described in the prior art.

According to the invention, such object is achieved by means of a device having the features referred to specifically in the following claim 1. Preferred embodiments of the device of the invention are described in the dependent claims hereinafter.

The device of the invention has the advantage of allowing a supporting mesh to be anchored to the transobturator membrane and/or sacrospinous ligament of a patient and the tension thereof to be reversibly regulated after anchoring.

A further object of the present invention is a kit comprising at least one device of the type indicated above and a supporting mesh.

Further advantages and features of this invention will become apparent from the detailed description that follows, provided by way of non-limiting example with reference to the accompanying drawings, wherein:

figure 1 is a schematic view illustrating the implantation of a supporting mesh with the aid of devices of the invention,

figure 2 is a perspective view of a device of the invention,

figure 3 is an exploded perspective view of the distal portion of the device of figure figure 4 is a sectional view along the line IV-IV of figure 2.

Figure 1 illustrates a supporting mesh to be implanted with a single-incision surgical procedure so as to act as an anatomical support for the treatment of prolapses of pelvic organs.

Such mesh - in itself conventional and of any kind currently used for the purpose - has a substantially rectangular central portion 10, from each corner of which departs a respective arm 12 which may have the same mesh structure or be made of a simple suture thread, and to which is associated a respective device.

In principle, each of these latter devices includes (figures 2-4) an anchoring element 16, a fixing member 18, and a handle 20. It should be noted, however, that the same handle 20 may be advantageously used to manipulate the other components of various anchoring devices. The anchoring element 16 and the fixing member 18 are made of bioabsorbable or non-bioabsorbable polymeric material.

The anchoring element 16 extends along a central longitudinal axis 22 and has a pointed distal portion 24 which has on its lateral surface a plurality of circumferentially offset winglets 26 and a substantially cylindrical proximal portion 28 which has a wall defining in its interior an open cylindrical cavity extending along the longitudinal axis 22, the inner surface 30 of which is threaded. The wall is crossed by a through-hole 32 directed radially relative to the axis 22 and having a circular cross section. In embodiments of the invention not shown in the figures, the hole 32 may be directed non-radially with respect to the axis 22 and/or have a buttonhole-shaped cross-section. Two pins 34 protrude radially outward from diametrically opposed positions of the proximal portion 28.

The fixing member 18 is formed by a base 36 and a threaded stem 38 engaging with the internal threaded surface 30 of the wall of the proximal portion 28 of the anchoring element 16. The fixing member 18 also has a hole 40 extending centrally in its interior along the longitudinal axis 22 for the entire length of the fixing member 18. The handle 20 has a hollow body 42 extending along the longitudinal axis 22 and is provided with means for controlling the rotation of the stem 38 of the fixing member 18 within the cavity of the anchoring element 16. The handle 20 is also provided, interacting with corresponding means of the anchoring element. 16, with means for selectively blocking in the axial direction the anchoring element 16 and the fixing member 18 with respect to the handle 20 itself, i.e. to prevent the separation of these assembled components when subjected to a separating force acting only in the axial direction. The hollow body 42 has ends 42a, 42b radially expanded with respect to a central part 42c having a somewhat thin wall and a curvature to conform to the anatomical part with which it is Intended to interact (see figure 2).

The rotation control means comprise a knob 44 having a head 44a rotatably mounted around the proximal end 42a of the hollow body 42 and from which departs a shaft 44b extending along the axis 22 and carrying a flange 46 which d efines a distal end of the shaft 44b, which protrudes from the flange 46 and is inserted within the hole 40 of the fixing member 18.

The selective blocking means include a sleeve 48 which is coaxial!y mounted around a length of the shaft 44b and from the proximal end of which departs a lever 50 protruding radially across a lateral opening 52 of the hollow body 42, sweeping approximately 90° in a circumferential direction. On the other hand, the distal end of the sleeve 48 is bell-shaped and has, in diametrically opposite positions, two L-shaped slots 54, each of which is formed by an axial branch 54a and a circumferential branch 54b. Each slot 54 is adapted to receive a median portion of one of the pins 34, the top portion of which is inserted within a respective groove 56 extending in an axial direction along an inner surface of the distal end 42b of the hollow body 42. As will be apparent from the following description of operation, such selective blocking means constitute a sort of bayonet coupling.

The device just described is typically designed so that one of the arms 12 of the central portion 10 of the mesh is held within the through-hole 32 of the anchoring element 16 by the threaded shaft 18, which is screwed into the cylindrical cavity of the proximal portion 28 of the element 16. In turn, both the fixing member 18 and the anchoring element 16 are linked to the handle 20. Such link occurs because each pin 34 of the anchoring element 16 has its top portion inserted within the respective groove 56 of the end 42b of the hollow body 42 and its median portion inserted at the bottom of the circumferential branch 54b of the respective slot 54 of the distal end of the sleeve 48. Moreover, the distal end of the shaft 44b is inserted into the axial hole 40 of the fixing member 18 with a coupling such that a torsion imparted to the shaft 44b is transmitted to the fixing member 18.

In such conditions, the anchoring element 16, the fixing member 18 and the handle 20 are secured axially, allowing only a rotation motion of the knob 44 and the fixing member 18 integral with it around the longitudinal axis 22.

Therefore, after the surgeon has implanted the anchoring element 16 in the patient's tissue by pushing axially the handle 20, a rotation motion again provided by the surgeon to the knob 44 causes the screwing/unscrewing of the stem 38 within the cavity of the proximal portion 28 of the anchoring element 16 and thus allows the sliding of the arm 12 of the mesh into the through-hole 32 to be blocked/allowed (see figure 1). Such operations are reversible such that they may be repeated a desired number of times by the surgeon until the arm 12 is sufficiently tensioned and is maintained anchored to the patient's tissue by the anchor element 16. As already indicated, the execution of these operations is facilitated by the curvature of the central part 42c of the body 42 of the handle 20.

At this point, the handle 20 must be disengaged from the remaining components of the device that remain implanted together with the mesh and, if made of bioabsorbable material, are intended to degrade over time.

To perform such disengagement, the surgeon first rotates the lever 50 within the opening 52 of the body 42 so that he/she also rotates the distal end of the sleeve 48, which is integral with the lever 50. Consequently, the circumferential branch of each slot 54b slides toward the respective pin 34, until the latter is at the bottom of the axial branch 54a of the slot 54. At this point, when the surgeon pulls the handle 20 axially towards him/herself, the axial branches 54a of the slots 54 may slide freely with respect to the respective pin 34, without this movement in the axial direction encountering any obstacle. Indeed, the distal end of the shaft 44b, although capable of transmitting by interference/friction a torque moment to the threaded stem 38, is not axially bound within the hole 40 of the fixing member 18 so that it is also not able to prevent an axial displacement of the handle 20.

This latter, complete with knob 44 and sleeve 48 with the related lever 50, is therefore separated from the anchoring element 16 and the fixing member 18 already implanted and, if applicable, may be reused for the implantation of an additional anchoring element and fixing member pair.

In each case - with reference to the supporting mesh shown in figure 1 - the operations just described must be repeated for each of the arms 12, which will remain anchored to the tissue by a respective anchoring element 16. However, it is to be understood that it is possible to implant a mesh with a number of arms other than four, such as a sling, i.e. a band having two end arms, using in principle two devices of the invention. In this regard, however, it should be noted that - as already mentioned previously - two different devices may use the same handle.

Naturally, without altering the principle of the invention, the details of implementation and embodiments may vary widely with respect to those described purely by way of example, without thereby departing from the invention as defined in the appended claims.