Patent Application
20240000614
The present invention falls within the technical field of dressings, more specifically in the field of dressings specially designed for the thorax, abdomen and extremities, as well as in the field of suction or pumping devices for medical use and refers in particular to a dressing for the application of negative pressure therapies.
Within the technical field of surgery, negative pressure therapy (hereafter referred to as NPWT) consists of the application of sub-atmospheric pressure to the wound bed as a form of topical, non-invasive wound treatment, facilitating healing through a multimodal action. It is a widely used option that provides a number of benefits to facilitate healing, including reduced wound retraction, removal of exudate and non-viable tissue, improved blood supply, promotion of granulation tissue formation and, finally, physical stimulation of cell mitosis.
NPWT can be broadly divided into three main groupings. The first, known as NPWT in the open abdomen (OA), was designed with the management of abdominal compartment syndrome (ACS) in mind. Damage control surgery, trauma and ACS are common reasons for leaving the OAS. However, surveys such as the International Register of Open Abdomen (IROA) now show that septic problems such as peritonitis and pancreatitis account for more than 50% of the use of OA in the first world.
A key point to optimize outcome is early abdominal closure within 7 days, as failure to do so will increase morbidity, mortality and bowel fistula formation. Temporary abdominal closure (TAC) protects the viscera and drains fluids as part of the treatment of ACS, but the key component of this therapy in OA is the NPWT-associated visceral protection lamina (VPL), which is not present in the other types of NPWT.
VPLs were designed in the various commercial brands to actively remove abdominal fluid and help reduce oedema but have difficulty removing high viscosity fluid and particulate drainage such as that seen in abdominal septic processes and pancreatitis. This drainage, called complex exudate, is a protein-rich fluid that can coagulate in the VPL, and also contains blood, purulent material and various solid and semi-solid particles from clots, fibrin and necrosis removed from tissues such as the pancreas, These accumulate in the device, mainly in the VPL, quickly saturate it and obstruct it, making it difficult to control the septic focus and oedema, prolonging the time of use of the NPWT, which increases the feared complications of OA such as intestinal fistula.
The Spanish utility model with publication number ES1215290, owned by this applicant, describes a multilayer visceral protection dressing incorporating an intermediate layer comprising a plurality of evenly distributed alveoli or bubbles filled with low-pressure air. This multilayer structure optimizes the distribution of negative pressure across the surface of the sheet to the most distal areas and improves the drainage capacity of complex exudate and reduces clogging of the device. It also produces a uniform distribution of the negative pressure over the entire surface in contact with the VPL, however, it may fail in case of having to drain or communicate with the negative pressure source collections, abscesses in sites far from the VPL and difficult to access as for example the omentum transcavity in pancreatitis or an infected collection or isolated abscess such as a retrocolic abscess in a perforated diverticulitis. In these cases, for anatomical reasons, the VPL design may not be effective and may require an extra device to allow better drainage of the cavity and early control of the septic focus.
In the case of chronic wounds secondary to unhealed surgical wounds, traumatic injuries, venous ulcers, pressure ulcers, diabetic foot ulcers, which may be associated with infection, are having a devastating impact on health services in terms of associated complications and expenditure of healthcare resources, in addition to the deterioration in the quality of life of increasingly long-lived patients. In the last 30 years, the incidence of diabetes mellitus has almost quadrupled, affecting more than 422 million adults worldwide.
The time to complete healing-epithelialization varies according to some factors and comorbidities such as diabetes, autoimmune diseases, peripheral vascular disease, obesity, anatomical location of the lesion and medications. However, wound healing will largely depend on the condition of the wound bed, vascular supply, microcirculation, presence of infection and bacterial load.
Several NPWT application systems are currently known for this particular type of wound, as well as specific dressings and drainage components, all based on polyurethane or polyvinyl foam in direct contact with the wound. These foams produce rapid saturation in case of complicated exudate, infection and/or necrosis.
Polyurethane foam is used in multiple commercial devices, but all focus on some small design changes. It is an open pore foam (400-600 microns) that changes structure with negative pressure, which significantly decreases pore size and in wounds with abundant debris, necrosis and infection does not provide an even distribution of vacuum therapy across the wound surface. A phenomenon of foam saturation has also been identified which decreases the effectiveness of the therapy and increases usage times and costs.
Finally, in the case of surgical wounds where infection prevention is sought, and in light and superficial wounds that do not have a lot of exudates, disposable NPWT systems are used to help control low to moderate exudate. These generally consist of a small portable pump without a reservoir, capable of generating a lower negative pressure than conventional devices, as described in Spanish patent publication number ES2555493T3. The pump is connected to a dressing containing an absorbent material composed of cellulose fibres that traps exudate but quickly becomes saturated. Excess exudate can flow through the tube that conducts the negative pressure in the inlet direction into the vacuum pump which, not having a reservoir, is damaged.
Other, also disposable NPWT systems, in which the pump differs in that the pump lasts 30 days, are connected to a dressing in which the layer in direct contact with the wound consists of Sodium Carboxymethicellulose, which gels on contact with the exudate. This is a disadvantage because the gel hinders and even interrupts the distribution of negative pressure.
As can be seen, both dressings present a similar problem, based on rapid saturation and clogging by viscous contents in a real wound, making them of little use in infected wounds. Although they are intended to highlight the benefit of helping to reduce the likelihood of infection in surgical incisions, preferably abdominal, they cease to work in the short term, increasing the cost of therapy. In addition, the high environmental impact of these disposable pumps must be considered.
In view of the state of the art, there is therefore a need for a specific dressing for negative pressure therapy for this type of surgical incisions and mild to moderate wounds to avoid the problems described above.
The subject matter of the invention consists of a dressing for negative pressure therapies comprising a plurality of overlapping laminar layers solidly linked to each other by at least their respective perimeter edges. In the most preferred embodiments, the dressing comprises from two to four layers in total.
Each of these layers has properties and capabilities, including air or other gas-filled housings such as nitrogen or CO2, preferably at low pressure, as well as drainage channels and fluid perfusion channels.
The abdominal viscera protection dressing described above is temporarily placed over an open wound. A sponge body is placed on top of the dressing, on which a negative pressure therapy system is supported.
By applying negative pressure to the dressing, the air-filled pockets prevent the sheets from sticking together in the first place, as this configuration prevents rapid saturation and clogging of the polyurethane sponge by other dressings with more viscous and solid elements such as pus debris, fibrin, clots and necrosis.
The air pockets also prevent adherence to internal organ tissues, and internal organ effluents (fluids, necrotic tissues, clots, etc.) are drained homogeneously through the through holes. The uniform distribution of both air pockets and through holes over the entire surface of the respective layers optimizes the drainage capacity and the distribution of the negative pressure therapy, allowing it to be exerted even in the most distal areas of the cavity.
The dressing is preferably made of a material selected from the group of EVAS, PU, PVC, PE, PET, PTFE, TPE, silicone or a mixture thereof. Furthermore, the dressing can be adjusted in size, depending on the required treatment, by cutting out the necessary surface area.
Among other advantages, the negative pressure therapy dressing thus described provides optimized drainage of exudates, enables debridement of necrotic tissue and offers the possibility of instillation or perfusion for easier diffusion of the instilled or perfused fluid to the wound surface.
The various preferred embodiments of the dressing are able to solve the problems described above. Thus, in the case of NPWT applied in the open abdomen (OA), the dressing can help drain deep or distant areas in the abdomen. It can also be used folded on itself, in the form of a temporary packing to perform site-specific negative pressure limitation by removing or blocking the interlayer with the gaseous lodgments.
In the case of chronic wounds, it must first be considered that these wounds come in a wide variety of shapes and sizes, so the dressings used in NPWT must be able to adapt to these morphologies. As mentioned above, polyurethane foam is the key component of current NPWT dressings for these wounds.
In the embodiments designed for these chronic wounds, the dressing comprises sheets made of polyurethane foam and an element for uniform pressure distribution. In a first embodiment, this element consists of a cylinder made of a fenestrated polyurethane sheet folded on itself, so that the alveoli are arranged in a tubular shape towards the outside, and distal orifices forming a central channel. The combination of both elements allows the administration of a fluid from the NPWT machine, hitherto used for instillation.
In a second embodiment, the internal element consists of an intermediate sheet, also made of polyurethane foam, provided with holes in contact with the wound, so that a network of channels is generated that allows the uniform transmission of the negative pressure and also the infusion of fluids from the NPWT machine.
For chronic wounds located in complex sites, such as the interdigital spaces of the feet, the knitted fabric is reinforced with a bearded thread sewn in a spring form. Currently, materials such as gauze or foam are used for such wounds, which are very difficult to apply and become dislodged with use.
Because of the anatomical complication of placing the therapy in these distal sites, the bearded spring fabric and encapsulated sheet allow for a more comfortable and adapted placement and also allows for an extension of the NP source so that it is not in the same place.
In order to complement the description being made and in order to assist in a better understanding of the features of the invention, in accordance with a preferred example of a practical embodiment thereof, a set of drawings is attached hereto as an integral part of the said description, in which the following is illustratively and non-limitingly depicted:
A detailed explanation of an example of a preferred embodiment of the subject matter of the present invention is given below with the aid of the figures referred to above.
The dressing for negative pressure therapy described is made up of a multilayer structure, which in its first preferred embodiment comprises a first layer (1) and a second layer (2), linked together by their respective perimeter edges, as shown in
The first layer (1) consists of a laminar body with a first inner face (3), which is intended to face inwards and face the second layer (2), and a first outer face (4), which is intended to face outwards. The laminar body also comprises a number of first through holes (5) uniformly distributed, which allow the passage of fluid through it, giving the first layer (1) a fenestrated character that allows an adequate distribution of a negative pressure.
The second layer (2) has geometry and dimensions essentially similar to those of the first layer (1) and is made up of two lamellar bodies (6) solidly linked together by means of a plurality of tubular elements (7) uniformly distributed and inside which a gaseous fluid is housed and maintained at low pressure. The distribution of the tubular elements (7) is such that the mutual separation distance between two adjacent tubular elements (7) is equal to or greater than half their diametrical dimensions. In this first preferred embodiment, the tubular elements (7), of essentially cylindrical geometry, are linked perpendicularly at each of their ends to the respective lamellar bodies (6).
Each of the lamellar bodies (6) incorporates a plurality of second through holes (8) that allow the passage of fluid through them, giving the second layer (2) a fenestrated character that contributes to allow an adequate distribution of negative pressure. Said second through holes (8), which in this preferred embodiment have an essentially rhomboidal geometry, are evenly distributed in each laminar body (6) and so that they are adjacent to, but not coincident with, the inserts of the tubular elements, as illustrated in the detail of
In a second preferred embodiment, illustrated in
The third layer (9) is made up of a laminar body with a second inner face (10), which is intended to face inwards and face the second layer (2), and a second outer face (11). The laminar body also comprises a plurality of third through holes (12) uniformly distributed, which allow the passage of fluid through it, giving the third layer (9) a fenestrated character that allows an adequate distribution of a negative pressure.
In a third preferred embodiment, illustrated in
In the third embodiment, the fourth layer (13) consists of a knitted fabric reinforced with a barbed thread sewn in the form of a spring, so as to allow the passage of fluids into the through holes (5), (8), (12). The fourth layer (13) thus described has a certain resistance to deformation exerted by the application of negative pressure. In this third preferred embodiment, the fourth layer (13) is made of polypropylene and is less than 8 mm thick.
In an example use of this third preferred embodiment, the fourth layer (13) is placed directly over an infected wound, such that the first layer (1) is free to attach to a negative pressure therapy system. By applying negative pressure to the dressing, efficient and homogeneous drainage of wound fluids is achieved through the mesh of the fourth layer (13) and the through holes (5), (8), (12), as the tubular elements (7) allow the negative pressure therapy to be distributed in a homogeneous manner which also optimizes the drainage capacity.
Moreover, the bearded thread of the fourth layer (13) contributes to the maintenance of a fresh wound and the removal of necrotic tissue when the dressing is removed, facilitating faster and more efficient healing.
This encapsulated configuration of the dressing allows it to be inserted and maintained in small wounds, such as those due to surgical incisions, where NPWT is required. The closure element (1) can be either an element external to the dressing, such as a small adhesive strip or a suture thread, or an element of its own, such as a die-cut or a tongue and groove joint.
| Number | Date | Country | Kind |
|---|---|---|---|
| U202030820 | May 2020 | ES | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/ES2021/070302 | 5/3/2021 | WO |
