Barrier for protecting surgical and non-surgical wounds and isolating tissues

Abstract

The present invention pertains to the field of tissue engineering or regenerative medicine, and more specifically relates to a barrier composed of a biocompatible polypropylene film for protecting surgical and non-surgical wounds by preventing direct contact with the external environment, thus ensuring healing without interference from irritants that could delay the process and even contaminate the surgical wound, preventing against the onset of infections.

Description

[0001] PROTECTIVE BARRIER FOR SURGICAL AND NON-SURGICAL WOUNDS AND TISSUE ISOLATION

[0002] Technological Sector of Invention

[0003]

[0001] The present invention belongs to the tissue engineering or regenerative medicine sector, and refers, more specifically, to a barrier consisting of a biocompatible polypropylene film, to protect surgical wounds or otherwise, avoiding direct contact with the external environment, ensuring healing without interference from irritants that may delay and even contaminate the surgical wound, preventing the installation of infectious processes.

[0004] State of the art

[0005]

[0002] Many materials are used to act as a barrier to protect wounds, with the purpose of protecting and isolating areas affected by surgical or non-surgical wounds.

[0006]

[0003] Some materials have certain drawbacks that make them difficult or even impossible to use routinely. Among them: Market availability; Acquisition cost; Need for highly qualified personnel for application; Difficulties in removal due to adhesion with the newly formed tissue.

[0007]

[0004] For example, polypropylene meshes are widely used to reinforce the abdominal wall in cases of hernias. The meshes are perforated, which differs from the product revealed here, which consists of a 100% waterproof polypropylene film, that is, it does not present porosities.

[0008]

[0005] Taking these complicating factors into account, the material used in this patent is an effective solution for covering and protecting surgical and non-surgical wounds, being easy to handle, highly biocompatible, safe, and low-cost. In addition to these factors, in specific situations, it is necessary to maintain moisture in the wound bed; maintain the temperature at around 37°C in the wound bed; prevent infection, as it is impermeable, preventing the colonization of microorganisms and the accumulation of foreign bodies that could be deposited in the protected area; allow easy removal without causing trauma to the newly formed tissue; leave no residue in the wound bed; and protect against mechanical trauma.

[0009] Novelties of the Invention

[0010]

[0006] Many dressings used to protect wounds become adherent during the healing process, causing discomfort and making removal difficult. One advantage of the barrier of the present patent is that it is non-adherent, easy to handle, and offers an accessible, reproducible, and low-cost installation technique. It also functions as a dressing and can be easily removed when the healing process is already advanced, eliminating the risk of an infectious process developing at the wound site.

[0011]

[0007] It also has the advantage of being able to be combined with routine medications without interfering with each other, maintaining the medications for the time necessary for them to perform their functions, should they be used.

[0008] Barriers should be left over raw areas, offering protection and comfort to the patient. Depending on the extent and location of the wound, they should be kept immobile over the raw area by means of simple sutures on the barrier or even fixed with sutures along its edges or even maintained with bandages without exerting pressure on it. Available in various sizes, they can be applied to a variety of wounds, providing excellent protection without interfering with the healing process.

[0012]

[0009] When used to protect and isolate the tissues where it is inserted, the barrier meets all the requirements for its use, protecting and isolating the tissues, thus preventing tissue adhesion, even when used over grafts in their various forms or when placed over biomaterials. It is also indicated for closing oroantral communications where there is no acute process. It is biocompatible, easy to handle clinically, and isolates compromised tissues, preventing the penetration of food debris (due to its impermeability). In open wounds in the oral cavity, especially in the palate region, where rigid material plates are used to protect these areas and cause discomfort, interfering with speech and chewing, the barrier revealed here, on the contrary, protects, isolates, and provides comfort to the patient, due to its flexibility and thickness, avoiding such inconveniences.When exposed to the oral environment, it maintains its integrity, acting as an impermeable, non-resorbable mechanical barrier.

[0013]

[0010] Because it is impermeable, it differs from porous materials that can interfere with the healing process. It can be customized to fit different wound sizes. It is used on both dry and moist wounds. It fits perfectly over the wound, ensuring complete protection and does not contain degradation products that interfere with the healing process.

[0014]

[0011] Another novelty is that it can also be used to promote tissue separation, when used on autogenous, allogeneic or xenogeneic bone grafts, or even particulate or block biomaterials. It is also indicated for use in cases of grafts associated with medullary blood, aspirated blood or in decorticated areas, thus ensuring the containment of stem cells.

[0015]

[0012] In light of the above, the use of polypropylene film as a barrier for wound protection, for application as a temporary dressing, is unknown. The film is used for guided bone regeneration in dentistry, which does not rule out the possibility of also protecting the surgical wound; however, this is not its intended use in the case of guided bone regeneration. There is only this reference to the use of polypropylene.

[0016]

[0013] Therefore, the present invention has the advantage of being able to be used both for covering and protecting wounds, as well as for isolating tissues, preventing adhesion between them, after all it is easy to handle and can be customized according to each application.

[0017] Description of the attached drawings

[0018]

[0014] In order for the present invention to be fully understood and put into practice by any technician in this technological sector, it will be described in a clear, concise and sufficient manner, based on the attached drawings, which illustrate and support it, listed below:

[0019] Figure 1 represents the use of the invention in dressings held in position by bandages, in different parts of the body;

[0020] Figure 2 represents the use of the invention covering and protecting surgery performed on the palate and fixed with sutures;

[0021] Figure 3 represents the use of the invention on allogenic bone block grafts; Figure 4 represents photographs of a finger with a severed phalanx, in which polypropylene film was used as a temporary dressing and protective material for the wound.

[0022] Detailed Description of the Invention

[0023]

[0015] The present invention consists of a biaxially oriented polypropylene film, biocompatible and biotolerable with a thickness ranging from 17 to 80 micrometers, sterilized by gamma radiation or ethylene oxide. The fact that it is sterile is important because it will not carry to the site any type of microorganism that could come into contact with the injured tissue, causing an infectious process.

[0024]

[0016] It is indicated for single-use use. It comes in various sizes to suit the specific case and its intended use. It can take on appropriate shapes and dimensions to meet different treatment needs, both for wound protection and tissue isolation. Both the inner and outer surfaces of the film can be in contact with the oral or external environment, outside the mouth, or in contact with any form of graft or biomaterial. It can also be inserted between different tissues, preventing adhesion between them. Thus, there is no concern about which side should be exposed, either in the oral or external environment. Taking into account the standard deviation found in the roughness tests, both can be considered equal regarding the outer or inner side of the film. Although the sides may differ in roughness to some degree.

[0017] The use of polypropylene mesh is already widely used in medicine.The advantage of using a film and not a polypropylene mesh is that the film, being waterproof and containing no porosities (unlike the mesh) or spaces between the weaves, can easily be a temporary substitute for covering fabrics anywhere on the human or animal body where this is indicated, for example: skin, connective tissue, burns, bedsores.

[0025]

[0018] Another advantage is that, because the material is biocompatible, it can be associated with the use of grafts or biomaterials, when necessary.

[0026]

[0019] The polypropylene film, being biocompatible, also offers the advantage of being able to remain submerged even after the tissue has been repaired. This is another advantage of this invention, and even if it has to be removed, the film does not adhere to the repaired tissue, making it easier to remove, unlike meshes that are sutured into the tissue and cannot be removed.

[0027]

[0020] It is important to emphasize that the figures and descriptions provided do not have the power to limit the forms of execution of the inventive concept proposed herein, but rather to illustrate and make understandable the conceptual innovations revealed in this solution. Therefore, the descriptions and images must be interpreted in an illustrative and not limitative manner, and there may be other equivalent or analogous forms of implementation of the inventive concept disclosed herein that do not escape the spectrum of protection outlined in the proposed solution.

Claims

CLAIMS 1- PROTECTIVE BARRIER FOR SURGICAL AND NON-SURGICAL WOUNDS AND TISSUE ISOLATION, composed of a biaxially oriented polypropylene film, biocompatible and biotolerable, characterized by having a thickness varying between 17 and 80 micrometers. 2- PROTECTIVE BARRIER FOR SURGICAL AND NON-SURGICAL WOUNDS AND TISSUE ISOLATION, according to claim 1, and characterized by being sterilized by gamma radiation or ethylene oxide.

Images