Double layer dynamic prosthesis for surgical treatment of the in

Surgery – Internal organ support or sling

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A61F 200

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active

058139753

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BRIEF SUMMARY
FIELD OF THE INVENTION

The invention relates to a prosthesis for inguinal hernia treatment of the type made with one thin layer of prosthesic material, which frequently includes mesh.


REVIEW OF THE RELATED TECHNOLOGY

The dynamic prosthesis is a prosthetic set constituted by two layers which may be reabsorbable or mixed materials which is applied to the floor of the inguinal canal as a treatment of an original or relapsing inguinal hernia. The two prosthetic layers are independent one from the other or are reciprocally fixed along a line or only in one point.
Examining surgical methodologies, performed presently all over the world, for applying a prosthesis for the inguinal hernia treatment, it is possible to determine two great groups of operations: aponeurotic structures, such as Lichtenstein's operation (free tension); as Gilbert's operation (sutureless).
The problems and limits of Lichtenstein's methodology are the excessive tension and bad distribution of the prosthesis which, being externally (that is along its periphery) sutured, isn't able to dynamically suit the modification of relationships among the anatomic structures of the inguinal canal. This produces pain that the patient frequently feels during the movements of the muscular-aponeurotic structures in the inguinal region (cough, effort, passage from the sitting to the upright position and so on).
Furthermore, the suture itself may cause possible traumas, whose consequences can be long term drawbacks or complications (lesions of vessels owing to stitches or traction, tissue lacerations, nerve lesions).
The surgeon who applies the above mentioned method, faces two problems: the first relating to the cutting out and defining of the shape of the prosthesis, which can be too large or too small; the second relating to the positioning of the prosthesis in the inguinal region; in fact, a too relaxed or stretched prosthesis or with tensions distributed in a faulty manner can be responsible for complications and persistent pains in the immediate post-operative period and/or in the long term.
In order to overcome the drawbacks caused by the operation with perimetric suture of the prosthesis (Liechtenstein's methodology), Gilbert and others thought to apply the mesh, without suturing it by previously including an underfascial "plug" in the internal inguinal orifice (a plug is a sort of prosthetic material cap of various shape and dimension inserted into the internal inguinal orifice in order to prevent an external oblique hernia).
This foreign body gives rise to several drawbacks, including for example: the presence of the plug, which is felt by the patient with some discomfort; the extraperitoneal organs (bladder, sigmoid colon, caecun) and cause possible bedsores on the viscera themselves; the presence of the underfascial plug that cannot be cleaned with a simple superficial dressing.
Furthermore, if we consider the hernia rate in the population, the constant use of properitoneal underfascial plug would cause a great number of patients to run the risk of prosthetic infection if an operation were necessary for a pelvic septic pathology (tumor of the colon, appendicitis, prostate, bladder).
If the plug tends to displace on the operating table, during short coughs, previously workers who themselves emphasise its application, are forced to fix it with suture stitches, thus denying the principle of "sutureless".
Since the only passage from the supine position to the upright position modifies the reciprocal relationships among the inguinal muscular aponeurotic structures, it should be taken into consideration that the sutureless mesh in the upper facial region, connected to the plug, can later displace and assume an incorrect position with respect to that performed by the surgeon during the operation.
In this way, the possibility of the rising of the prosthesis increases, mainly in the pubis region; such a complication is attested by the frequent relapses in this area even during the operations when the prosthesis is sutured.
Additionally, in the case of

REFERENCES:
patent: 4204282 (1980-05-01), Bolt
patent: 4769038 (1988-09-01), Bendavid et al.
patent: 4786276 (1988-11-01), Haber
patent: 5176693 (1993-01-01), Wilk et al.
patent: 5433996 (1995-07-01), Kranzler et al.
patent: 5507811 (1996-04-01), Koike et al.
patent: 5593441 (1997-01-01), Lichtenstein et al.

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