Device for the non-invasive sutureless closure of the open...

Surgery – Instruments – Sutureless closure

Reexamination Certificate

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C606S216000

Reexamination Certificate

active

06176868

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to a device for the non-invasive, sutureless closure of the open edges of a wound in the skin of a mammal, such as an animal or a human being, and for maintaining the open edges of the wound against one another, as well as the subcutaneous tissues, thus promoting the healing process with aeration at the level of the wound. The invention allows a tight closure of the skin, without traversing it, while allowing an aeration of the wound, i.e. the device according to the invention does not cover the wound.
Various devices for treating a traumatic or surgical wound are well known to the person skilled in the art, each device presenting advantages and drawbacks, either in terms of long-term aesthetic result or in the implementation time or in comfort, i.e. in terms of pain felt by the patient during the period of scarring or when the device in question is being placed in position or removed.
The most simple device is a yarn which sews together the open edges of the wound to ensure cohesion of the superficial layers. However, this property of cohesion is offered to a lesser degree at the level of the deep layers of the skin. It presents the drawback, on traversing the skin, of creating pain and scarring. The so-called Blair-Donati technique solves the problem of the faulty approximation of the deep layers of the skin, thus creating more pain and subsequent scarring, with the result that the period of healing of the wound is increased.
A technique of intradermic oversew is also known, which offers a better superficial scarring but which does not retain the subcutaneous tissues sufficiently, hence a subsequent widening of the scar. The drawback of this technique is that of necessitating a longer procedure which is very difficult to carry out.
The clip system is also known, of which various models exist, presenting the advantage of being very quick to install, but maintaining the drawback of a foreign body within the different structures of the skin, and of traversing the skin and therefore generating subsequent scars.
The use of adhesive tape, of the “sticking plaster” type, is also known, which presents an adhesive-less area at the level of the wound to retain the two edges of the wound in approximated position without touching the wound. A similar device is described in U.S. Pat. No. 5,665,108, but the major drawback of the adhesive tapes solutions is that aeration is very limited at the level of the wound, this generating fermentation processes which prevent healing.
U.S. Pat. No. 4,815,468 proposes a sutureless closure device for drawing together and closing the open edges of a wound while retaining them firmly in place, based on an inverted V spring system, the ends of the V presenting base plates cooperating with an adhesive tape. By drawing the arms of the V together, this inverted V system makes it possible to bring the open edges of the wound in contact with each other. However, this system presents the major drawback of preventing any aeration at the level of the wound.
It is a principal object of the present invention to solve the novel technical problem of providing a device for the non-invasive, sutureless closure of the open edges of a wound in the skin, while ensuring forces of cohesion of the subcutaneous tissues for a sufficiently long period to obtain joining thereof, allowing a long-term scarring of better quality to be obtained.
It is another object of the invention to solve the new technical problem set forth above by a solution which conserves the possibility of care, asepsis, visual inspection and aeration at the level of the wound during the scarring phase.
Another object of the invention is to solve the new technical problems set forth above by a solution which presents the advantage of not employing a foreign body within the integuments, thus limiting the risk of infection.
It is a further object of the invention to solve the new technical problems set forth above by a solution which is particularly simple, which requires only a minimum of components constituting the device, and which is particularly easy for any user without particular training to employ, thus making it accessible to every home, and also at a low cost price.
All the technical problems set forth hereinabove are simultaneously solved for the first time by the present invention, in particularly simple manner and at a low cost.
SUMMARY OF THE INVENTION
The present invention thus relates to a device for closing the open edges of a wound in the skin of a mammal, such as an animal or a human being, without suture, which retains the edges of the wound against each other, promoting the healing process, characterized in that it comprises:
a) at least one first elongated element comprising a first and a second end, said first end being intended to come into abutment on the skin near a first open edge of the wound, said second end being connected to first traction means which are provided, opposite the wound, to exert a traction to turn the first end towards the wound;
b) at least one second elongated element comprising a first and a second end, said first end being intended to come into abutment on the skin near the second open edge of the wound, and the second end being connected to second traction means which are provided, opposite the wound, to exert a traction to turn the first end towards the wound; and
c) at least one connecting means is provided between said first and second elements to join the two elements together, said connecting means being disposed between said first and second ends of each first and second element in order to define a pivoting point of each first and second element.
The connecting means is advantageously made of a substantially non-extensible material.
According to an advantageous embodiment of the invention, the first end of each element presents a sufficient surface to exert a minimum pin-point compression on the skin.
According to another advantageous embodiment of the invention, the traction means comprise adhesive means connected to the second end, intended to adhere to a healthy area of the skin at a predetermined distance from the wound.
According to another advantageous embodiment of the device according to the invention, said first element is substantially identical to said second element, thus facilitating the manufacturing procedure.
According to another advantageous embodiment of the invention, said first element and said second element present a lower part and an upper part, said connecting means being disposed substantially at the join between the lower part and the upper part.
According to a particular embodiment, the upper part progressively tapers up to said traction means.
According to a presently preferred embodiment, said connecting means comprises at least one yarn, preferably at least two yams, of predetermined length to allow each first and second element to be disposed on either side of the wound. This yarn is advantageously made of a substantially inextensible material presenting a good mechanical strength, such as nylon or the like.
According to another advantageous embodiment of the invention, the first end of each of said first and second elements is made of a material ensuring adherence and respect of the skin near the edge of the wound, regrouping the energy of approximation transmitted to the latter, such as for example a hydrocolloidal material or a material performing the same finction.
If the open wound is very long, closure thereof is advantageously obtained with a plurality of devices disposed side by side.
In order to reduce the risk of tear, an aerated protective upper layer, for example of the “non-woven” type, may be provided.
It will be noted that, thanks to the invention which comprises a connecting means such as a yam, it is easy to ensure mechanical connection between the first element and the second element of the device according to the invention disposed on either side of a wound, while ensuring passage of air and possibly of care agents or products which may be necessary i

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