Disposable device for treatment of infections of human limbs

Technical field The present invention can be used in the field of surgical instruments, and in particular relates to disposable devices for the treatment of human limb infections, more particularly limbs having long bones that are suitable for intramedullary nail stabilization.

Background Art [0002] It is known to stabilize long bones of the human body, following fractures, developmental anomalies or similar pathological situations, achieved by the use of well-known devices such as intramedullary nails consisting of more or less curved hollow or full metal rods that are fitted to the intramedullary bone cavity to stabilize and are attached to stumps or parts, which will be stabilized by transverse pins or screws, usually in the proximal or distal area of ​​the limb. When the fracture has been stabilized and repaired, the pins are removed and the nail is extracted from the medullary canal.

[0003] One problem associated with such treatment, in addition to the invasiveness of the implantation procedure, is the creation of an outbreak of infection that can develop locally as a result of incompatibility of the metal with the myeloid spongy tissue and due to bacteria that usually come into contact with the implantation site.

[0004] In order to reduce such defects, it is highly advisable that the implantation of the above devices takes place under completely sterile conditions, and the relevant part is treated with substances adapted to prevent and / or treat such infections.

[0005] To prevent at least some of the above disadvantages, solutions have been developed enabling the in situ use of the above substances, alone or added to bone cement.

[0006] A solution is known in which a sheath for a stabilizing device is made by using molds at the factory, or directly at the surgical site, just prior to implantation of such a device.

[0007] This solution also has several obvious disadvantages.

[0008] First, it is essentially a manual solution that requires special skills from the operator who must be properly trained. Such an operation also causes a lot of processing waste, thus causing a great waste of material and an increase in overall costs.

[0009] The device thus protected is also exposed for a sufficient period of time to air and contact with foreign materials, which entails a high risk of attack by bacteria and contaminants.

[0010] Furthermore, the sheathed device that exits the mold will have many burrs along its length that will have to be removed for proper alignment, resulting in longer implantation time and, as a result, patient discomfort.

[0011] Document DE 19605 735 A1 discloses a system comprising a tubular member which is made of polymerized bone cement.

[0012] A further aspect of the invention relates to the need for temporary nail replacement for one of many different reasons, such as collapse or displacement of the implant, usually following infection of the surgical site.

[0013] In these situations, the existing nail must be removed and the implant site must be healed before inserting a new nail. In the meantime, the geometry of the site should remain unchanged to prevent tissue shortening and deformation, by providing a spacer device that can also prevent and / or treat infections caused by old and new implants.

Summary of the Invention [0014] The main object of the present invention is to overcome the above-mentioned disadvantages by providing an infection treatment device that shows high efficiency and cost effectiveness.

[0015] A particular purpose is to provide a ready-to-use device for treating infection that does not require the use of trained personnel.

[0016] A further object is to provide a device for treating infection that reduces the time it is exposed to ambient conditions (exposure) and provides highly sterile conditions.

[0017] Another object is to provide an infection treatment device that allows optimizing the use of materials.

[0018] Another object is to provide an infection treatment device that allows the sheath to be removed quickly.

[0019] These goals, as well as other goals that will become more apparent below, are filled by the disposable device according to claims 1 to 14.

[0020] This particular system according to the invention provides a ready-to-use device for treating infection, avoiding the need for it to be created by qualified personnel. In addition, this particular arrangement according to the invention allows optimization of the materials used, and completely eliminates waste from treatment, while reducing the time required for fitting such a cover on the nail.

[0021] Preferably the infection treatment device may be made of materials selected from the group consisting of bone cement and reabsorbable or biodegradable bone cement. In this way, the device will be biologically compatible with the treated limb.

[0022] This tubular member may preferably be hollow to allow fitting on the intramedullary nail.

[0023] Thanks to this arrangement, the device according to the invention can be quickly removed from the nail, allowing simple placement back after proper sterilization.

Advantageously, the device according to the invention may have a connecting element for attaching the tubular member to the intramedullary nail, which element preferably consists of an adhesive material, essentially uncured bone cement, intended to partially cover both the tubular member and the intramedullary nail on which it is placed .

[0025] Preferably, the device of the invention may be substantially continuous and have a predetermined length corresponding to the distance between the distal and proximal holes of the intramedullary nail.

[0026] Thanks to this additional feature of the invention, the device can be connected to the intramedullary nail in an even more durable and less invasive manner.

[0027] Preferably, the connecting element may comprise an opening in the proximal or distal region of the tubular member. This will allow the insertion of a screw to attach the treated limb to the intramedullary nail to increase treatment durability.

[0028] In a further embodiment, the tubular member may be a strip of base material that is rolled into a substantially spiral shape in which the turns can be evenly spaced to define through holes, also having a substantially spiral shape.

[0029] Thanks to this feature, the device according to the invention enables the most advantageous use of the base material and increases profitability.

[0030] According to a further aspect of the invention, it provides a kit for the treatment of human limb infections according to claim 20, which comprises a sterile closure or blister which is intended to contain a tubular member as described above.

[0031] This particular system according to the invention provides devices for treating infection that ensures high sterility.

Brief Description of the Drawings [0032] Further features and advantages of the invention will become more apparent from the detailed description of preferred, non-exclusive embodiments of the disposable device of the invention, which is described by non-limiting examples with the help of the attached drawings, in which:

Fig. 1 is a cross-sectional view of one embodiment of the device according to the invention;

Fig. 2a is a cross-sectional view of the device which is shown in Fig. 1 taken along the plane IIa-IIa;

Fig. 2 is a cross-sectional view of the device as shown in Fig. 1 taken along the plane IIb -IIb;

Fig. 3 is a side view of a further embodiment of the device according to the invention;

Fig. 3a is a cross-sectional view of the device as shown in Fig. 3, taken along the plane IIIa-IIIb;

Fig. 3b is a cross-sectional view of the device as shown in Fig. 1 taken along the plane IIIb-IIIb;

Fig. 4 is an axonometric view of another system according to the invention;

Fig. 4a is a cross-sectional view of the device as shown in Fig. 4 taken along the plane IVa-IVa;

Fig. 4b is a cross-sectional view of the device as shown in Fig. 4 taken along the plane IVb-IVb;

Fig. 5 is a side view of another embodiment of the device of Fig. 4;

Fig. 5a is a cross-sectional view of the device as shown in Fig. 5, taken along the plane Va-Va;

Fig. 6 is a side view of another arrangement of the device according to the invention;

Fig. 7 is another side view of the device of Fig. 6;

Fig. 8 is a cross-sectional view of the device as shown in Fig. 7, taken along the plane VIIIb -VIIIb;

Fig. 8b is a cross-sectional view of the device as shown in Fig. 7, taken along the plane VIIIa-VIIIa;

Fig. 8c is an enlarged view of a detail of Fig. 8a;

Fig. 9 is a side view of the kit according to the invention;

Fig. 10 is another side view of the kit according to the invention.

EP 1 850 774 B1

Detailed Description of the Preferred Embodiment [0033] With reference to the above figures, the device according to the invention, generally designated with the number 1, is of the disposable type and will be particularly intended for stabilizing limbs having long bones by inserting an intramedullary nail.

[0034] The device comprises a tubular member 2 made of a relatively rigid and biologically compatible material, preferably selected from bone cements, which can also be of the re-absorbable or biodegradable type.

[0035] According to the invention, the tubular member 2 has 2 'pores for saturation with pharmaceuticals or drugs for the treatment of infections, such as antibiotics, growth promoters, anti-inflammatory and / or anti-cancer drugs, before or during its introduction into the stabilization site. According to the first arrangement of the invention, the tubular member 2 may have a central axial recess 3 for the intramedullary nail C passageway.

[0036] Furthermore, the tubular member 2 may comprise a connecting member 4 for fixing it on a nail, which connecting member preferably comprises an adhesive material interacting with an intramedullary nail C on which it is mounted. Suitably, the material 5 may be unhardened bone cement, preferably located or inserted in at least one through cavity 6 of the member 2.

[0037] According to a preferred embodiment of the invention, the tubular member 2 may be substantially continuous and have a predetermined length, preferably corresponding to at least the distance between the holes F and F 'in the distal and proximal regions D, P of the intramedullary nail C, respectively.

Advantageously, as shown in detail in Fig. 3, in addition to the recess 6, an opening 7 may be arranged in the proximal region P ', or distal region D', of the member 2 for passage of respective screws for fastening the intramedullary nail C, not shown in drawings. The screws will secure the nail C firmly, with device 1 on it, with the bone to be stabilized.

[0039] According to another preferred, non-exclusive embodiment of the invention, the member 2 may be a strip 8 of base material which is wound into a substantially spiral shape. Accordingly, the turns 9 of such a spiral shape can be evenly spaced to define a through recess 10, also having a substantially spiral shape.

[0040] Preferably, the strip 8 may comprise an inner and / or outer reinforcing layer 11, made of woven or non-woven fibrous material, preferably of the mesh type. According to a further arrangement of the invention, the cement bone member 2 may be placed on a stable reinforcing core 12 which is made of a relatively rigid metal or non-metallic material to define the spacer as a whole.

[0041] Preferably, the core 12 may have an irregular outer surface 13 defining an externally threaded fastening area Z for member 2.

[0042] Furthermore, the gripping member 14, preferably the ring, can be placed on the proximal end of the reinforcing core to facilitate removal of the spacer.

[0043] Here again, the tubular member 2 may be saturated with pharmaceuticals or drugs for the treatment of infections, such as antibiotics, growth promoters, anti-inflammatory and / or anti-cancer drugs. Saturation may occur before the device is packaged, or when it is brought back into place during surgery.

[0044] Kit 20 for the treatment of infections of human limbs, especially limbs having long bones capable of being stabilized by insertion of an intramedullary nail, comprises a sterile closure or blister 15, which is designed to contain device 1 to provide superior sterility and guarantee preservation before installation.

[0045] This particular system of the invention provides a ready-to-use device for treating infection that does not require qualified personnel. The device also optimizes material consumption by significantly reducing processing waste.

[0046] Finally, the design of the above assembly provides a device for treating infection that allows reducing its exposure time to ambient conditions and provides highly sterile conditions. [0047] The device of the present invention may be subjected to a number of modifications and changes falling within the scope disclosed in the appended claims. All of its details may be replaced by other technically equivalent parts, and the materials may vary according to different needs, without departing from the scope of the invention. Although the device has been described with particular reference to the accompanying drawings, references to which the disclosure and claims have been made are given only for a better understanding of the invention and are not intended to limit the scope of the claimed scope in any way.