Devices and accessories for the treatment of complex wounds in newborns.

Description

/ 12 Devices and accessories for the treatment of complex wounds in newborns. Field of invention

[01] The present invention is situated in the field of Health and relates to a device and its accessories for treating complex wounds in newborns using negative pressure. Its main objective is to accelerate the healing process of complex wounds by stimulating angiogenesis, reducing exudate and decreasing the risks of possible infections, thus contributing to minimizing the neonate's hospitalization time, strengthening bonds with their families and ultimately reducing hospital costs.

[02] Given the particularities of the newborn, as well as its specific anatomical and physiological characteristics, the device and its accessories aim to promote the healing of complex wounds, using specific pressures to stimulate the growth of granulation tissue, as well as favoring the wound closure process. It will also be able to control, measure and monitor the sequestration of exudative debris, monitor the temperature of the internal wound site, as well as provide information on the therapeutic process for assertive clinical decision-making. Fundamentals of the invention

[03] Wound care in newborns is seen as a challenge for various health professionals, highlighting the management of complex wounds in this population as an indispensable element for patient safety, stimulating the creation of technologies that provide better results in the therapeutic context. Neonates may present with complex wounds, including gastrointestinal malformations such as gastroschisis, deep tissue injuries, surgical wounds, infiltrations resulting from the hospitalization process, and even burns; such wounds may require the use of advanced practices for their closure (CHOI, WW; MCBRIDE, CA; & KIMBLE, RM Negative pressure wound therapy in the management of neonates with complex gastroschisis. Pediatric Surgery International. 2011.27(8), 907-911; JESUS, LE, et al, Negative pressure wound therapy Petition 870250013756, dated 20 / 02 / 2025, p. 7 / 26 / 12 in pediatric surgery: How and when to use. Journal of Pediatric Surgery 53.2018. 585591).

[04] Advanced practice refers to progressive healing techniques that utilize hard technologies in the wound healing process, with Negative Pressure Therapy (NPT) being a prominent example. This practice, widely used in the adult population, has been described in the clinical literature since 1940 and has seen a constant increase in use to the present day, including its indication for the treatment of pediatric wounds. (CABO, CMS; PERFEIFFER, CC What does negative topical pressure therapy consist of? Is it effective and efficient in healing complex wounds? Review of the topic. Gerokomos. 2014. 25(1): 44-47).

[05] In 1997, Argenta and Morykwas described the successful use of this practice in adult patients. The procedure consists of applying a porous sponge to the wound site, connected to an extension tube coupled to a vacuum pump and covered with an adhesive plate. (ARGENTA, LC; MORYKWAS, MJ Vacuum-assisted closure: a new method for wound control and treatment: clinical experience. Ann Plast Surg. 1997; 38: 563 76).

[06] The negative pressure system acts intensely in the wound healing process and its physiological mechanisms. Due to the pressure, the volume of the foam is reduced, providing cell expansion, wound contraction and reduction of its exudate. Also regarding the healing process, the so-called negative pressure favors the rapid evolution from the inflammatory phase to the proliferative phase (CABO, CMS; PERFEIFFER, CC Enqué consiste lapresión tópica negativa? Es eficazeficiente en cierre de heridas complejas? Revision del tema. Gerokomos. 2014. 25(1): 44-47).

[07] According to Philbecket et al. (1999), the benefits of NPWT justify the implementation of the practice in the care of complex wounds. Among the mechanisms, the following stand out: increased blood flow to the wound area, reduction of edema, stimulation of granulation tissue production, reduction of bacterial load, union of the margins in less time, and stimulation of the proliferative phase. (PHILBECK, T.; E.; Jr.; WHITTINGTON, K.; T.; MILLSAP, M.; H.; BRIONES, R.; B.; WIGHT, D.; G.; SCHROEDER, W.; J. The clinical and cost effectiveness of externally applied negative pressure wound therapy in Petition 870250013756, dated 02 / 20 / 2025, p. 8 / 26 / 12 the treatment of wounds in home healthcare Medicare patients. Ostomy Wound Manage 1999; 45: 41-50).

[08] Studies indicate that 80% of neonates develop some skin damage by the first month of life, especially premature newborns (CARNEIRO, RK; ALVES, BR; GOMES, MR; LIMA, LM; PESSOA, GE; Persistence of the semipermeable membrane in the newborn's skin: a differentiated care. Rev. da Rede de Enfermagem do Nordeste. 2010. 11(1) 144-151). The effectiveness of PNWT in the pediatric population, with increasing use in the neonatal population, has been discussed by many researchers in the last ten years (EYER, L.; J. de; MARTINS, AB; OLIVEIRA, PB; GOMES, FLT; DEKERMACHER, S. Negative pressure wound therapy in pediatric surgery: How and when to use. J Pediatr Surg. 2018 Apr;53(4):585-591. Doi: 10.1016 / j.jpedsurg.2017.11.048. Epub 2017 Nov 21; FILIPPELLI, S.; PERRI, G.; BRANCACCIO, G.; IODICE, F. G.; ALBANESE, S. B.; TRIMARCHI, E.; CAROTTI, A. Vacuum-assisted closure system in newborns after cardiac surgery. J Card Surg. 2015 Feb; 30(2):190-3. Doi: 10.1111 / jocs.12463. Epub 2014 Nov3; STOFFAN, A. P.; RICCA, R.; LIEN, C.; QUIGLEY, S.; LINDEN, B. C. Use of negative pressure wound therapy for abdominal wounds in neonates and infants. J Pediatr Surg. 2012 Aug; 47(8):1555-9. Doi: 10.1016 / j.jpedsurg.2012.01.014).

[09] In clinical practice, studies describe the main wounds indicated for the use of NPWT, highlighting wounds of traumatic origin, wounds with large areas of soft tissue and infected wounds (LEININGER, BE; RASMUSSEN, TE; SMITH, DL; JENKINS, DH; COPPOLA, C. Experience with wound VAC and delayed primary closure of contaminated soft tissue injuries in Iraq. J Trauma. 2006; 61 (5): 120711. In the treatment of complex wounds involving the neonatal population, the practice of NPWT has been adopted in the management of Abdominal Compartment Syndrome, in wounds with exposure of the muscle fascia and bone structures, in malformation of the abdominal wall in newborns, including premature infants (EYER, L.; J. de; MARTINS, AB; OLIVEIRA, PB; GOMES, FLT; DEKERMACHER, S. Negative pressure wound therapy in pediatric surgery: How and when to use. J Pediatr Surg. 2018 Apr;53(4):585591. doi: 10.1016 / j.jpedsurg.2017.11.048. Epub 2017 Nov 21; BINET, A.; GELAS, T.; JOCHAULT-RITZ, S.; NOIZET, O.; BORY, J. P.; LEFEBVRE, F.; BELOUADAH, M.;. Petição 870250013756, de 20 / 02 / 2025, pág. 9 / 26 / 12 JAMES-ROBERT, I.; AUBERT, D.; BOUCHE-PILLON, P. M. A.; POLI-MEROL, M. L.; FRANÇOIS-FIQUET, C. VAC® therapy a therapeutic alternative in giant omphalocele treatment: a multicenter study. J Plast Reconstr Aesthet Surg. 2013 Dec; 66(12): e3735. Doi: 10.1016 / j.bjps.2013.05.010. Epub 2013 May 28; MCBRIDE, C.; A.; STOCKTON, K.; STOREY, K. et al. Negative pressure wound therapy facilitates closure of large congenital abdominal wall defects. Pediatr SurgInt (2014) 30: 1163. https: / / doi.org / 10.1007 / s00383-014-3545-3; LOPEZ G., CLIFTON-KOEPPEL, R.; EMIL S. Vacuum-assisted closure for complicated neonatal abdominal wounds. J Pediatr Surg. 2008 Dec; 43(12):2202-7. Doi: 10.1016 / j.jpedsurg.2008.08.067).

[10] The ideation and construction of the device is part of a technological study for product development. The steps were: searching indexed scientific databases for the appropriation of the subject under study, including scientific articles published on the subject, prior art search in international databases for patent applications, namely: the United States Patent and Trademark Office - USPTO, the Espace net patent and the World Intellectual Property Organization - WIPO, in addition to the Brazilian database at the National Institute of Industrial Property - INPI.

[11] Market research, along with prior art searches, made it possible to identify equipment used in wound treatment through TPN. However, their summaries and functional descriptions did not address the use / indication of these devices in the neonatal population, which stimulated not only the construction of technologies, machines and accessories aimed at the specificities of this population, but also the development of specific functions for the control and management of the healing process in the newborn.

[12] Patent application number PI 0614325 - 3 A2 dated March 2011 refers to a pressure control and monitoring system in a wound irrigation device including a pressure housing configured to be coupled to a vacuum source and a diaphragm sealingly coupled to the pressure housing. The system has connections with interconnected wound dressings with a fluid supply, which is connected to a fluid source that may include an aqueous topical antibiotic solution or isotonic saline for use in providing therapy to the wound. Petition 870250013756, dated 20 / 02 / 2025, page 10 / 26 / 12

[13] Patent application number WO 2012 / 161723 Al dated November 2012 refers to a device for use with dressings using negative pressure composed of a control module including CPU boards and electronic support, check valves and pressure controllers, a pump with its own power supply and a dressing system with the ability to absorb exudate.

[14] Patent application number WO 2013 / 175306 A2 dated November 2013 refers to an apparatus intended to provide suction at the wound site constructed through layers, including liquid-impermeable material. It presents the description of the interface between the machine and the lesion with features in 3D tissue material, remaining open after application of negative pressure, absorbent layer coupled to a sealing surface interconnected to a fluid collector.

[15] Patent application number WO 2016 / 018448 Al dated February 2016 describes a system and method for treating wounds using Negative Pressure Therapy. It features a pressure source that communicates with a dressing and fluid aspiration, has a pressure sensor and controller, flow rates, leak detectors and therapy management via graphs.

[16] Based on an analysis of the patent applications described above, it was not possible to identify the use of technologies aimed at the neonatal population, meeting the specific needs of this age group in human development. The proposed technology focuses on three important pillars for the therapeutic control of wounds and their impacts on the hemodynamics of the newborn.In this context, noteworthy aspects include measuring the temperature of the wound site, which can define healing processes capable of accelerating or delaying closure, thus facilitating timely decision-making; assessing significant volume losses essential for hemodynamic control in neonates; precise pressure values ​​applied to wounds presented by the neonatal population; and finally, two accessories (sandwich-type dressing) capable of accelerating the healing process of complex neonatal wounds in conjunction with complementary therapies, and an accessory (octopus-type dressing) capable of accelerating the closure process of the abdominal wall in complex wounds (gastroschisis) resulting from malformation in newborns. Petition 870250013756, dated 20 / 02 / 2025, page 11 / 26 / 12

[17] The care of complex wounds in newborns is a major challenge for various health professionals. The treatment of neonatal wounds involving advanced practices, although a reality in some developed countries, is incipient in Brazil. The anatomical and physiological specificities of the neonatal population require greater precision in the choice of pressures when using TPN, favoring the accelerated closure of wounds.

[18] Congenital malformations stand out as the second leading cause of death in the neonatal population, among them are gastrointestinal anatomical dysfunctions, such as gastroschisis and omphalocele, contributing to the hospitalization of the neonate, increased costs with therapeutic processes and overload of the network for the adaptation of hospital beds and professionals specialized in the management of the problem. Advantages of the invention

[19] Wound care in newborns remains a major challenge for professionals working in this context. Although wound management in neonates has advanced, driven by the pharmaceutical industry, knowledge is still lacking. Many of the dressings and coverings used in neonates are based on their use in adult patients. In this context, greater scientific and technological investments are needed to implement advanced practices in wound treatment in the neonatal population.

[20] The use of advanced healing practices has been growing substantially within wound care units. Several studies point to the increasing acceptance of hyperbaric therapy techniques and the use of Negative Pressure Therapy (NPT) in the adult population. In a study developed by Cabo and Perfeiffer (2014), the authors point to the implementation of NPT in clinical practice since 1940 and it has been growing steadily to the present day.

[21] In 1997, Argenta y Morykwas described the successful use of this practice in adult patients. The procedure consists of applying a porous sponge to the wound bed, connected to an extension tube connected to a vacuum pump and covered with Petition 870250013756, dated 20 / 02 / 2025, page 12 / 26 / 12 an adhesive plate. A search in scientific databases using the descriptors "Wounds", "Negative pressure therapy" and "Newborns" yielded only 3 internationally written works referencing the use of NPPT in the treatment of wounds involving the neonatal population. National production on the subject indicates only one study on the use of the dressing, in the form of an experience report.

[22] The vacuum system acts intensely in the wound healing process and its physiological mechanisms. Due to the pressure, the volume of the foam is reduced, providing cell expansion, wound contraction and reduction of its exudate. Also regarding the healing process, the pressure called negative pressure favors the rapid evolution from the inflammatory phase to the proliferative phase (CABO and PFEIFFER 2014).

[23] The TPN described in the literature is based on the application of a porous dressing over the wound associated with a sealing process using an impermeable adhesive dressing. This dressing is connected to a vacuum system that reduces atmospheric pressure in the wound bed to therapeutic levels ranging from -90 to -120 mm Hg (KAMOTO, 2016).

[24] The pressure used at wound sites in the neonatal population is still a matter to be widely discussed in the national and international literature. Case studies presented by Capdevilaet et al. (2016) show the use of pressures varying between 100 and 120 mmHg, however, the authors point out that current trends recommend lower pressures in neonates, around 75 mmHg.

[25] According to Philbecket et al. (1999), the benefits of TPN justify the implementation of the practice in wound care. Among the mechanisms highlighted are: increased blood flow to the injury area, reduction of edema, stimulation of granulation tissue production, reduction of bacterial load, union of margins in less time and stimulation of the proliferative phase.

[26] Another relevant factor that reinforces pressure control in the neonatal population, compared to adults, is fluid loss due to excessive vacuum pressure and consequent dehydration. In this respect, the group of Arca et al reported that negative pressure therapy has a significant advantage over other techniques. Petition 870250013756, dated 20 / 02 / 2025, page 13 / 26 / 12 traditional methods of fluid loss control, as they compared the weight of the foam before and after changes, estimating the amount of fluid lost near the wound.

[27] With regard to the neonatal population, which is routinely exposed to temperature changes with significant impacts on its hemodynamics, the management of this variable is an important factor for better therapeutic responses in the treatment of complex wounds. The temperature of the wound bed is an interesting parameter to be known, because according to Dini et al. in a study correlating wound temperature and clinical status, they commented that different in vitro studies showed that neutrophils, fibroblasts, and skin cells perform better, reducing activity below 33°C.

[28] A reduction in wound site temperature can occur due to exudate evaporation; however, as pointed out by Pedrazzi, TPN contributes to reducing this phenomenon. Dini et al. also showed that an increase in wound site temperature is a classic sign of infection and inflammation, and monitoring it can be useful in assessing the clinical picture, as well as outlining interventional strategies for the control and management of adverse situations such as bleeding and / or ischemia.

[29] Timely management of thermal sensations in the wound bed can be valuable for surgical patients. According to Horzic and colleagues, they demonstrated that in post-surgical patients, the persistence of increased skin temperature after the third day is a predictive sign of infection and reduced healing capacity.

[30] The wounds that affect the newborn with indication of the therapeutic proposal under discussion may be congenital resulting from gastrointestinal malformation, such as omphalocele and gastroschisis; acquired in the neonatal period, such as pressure injury, diaper rash, infiltration and extravasation of drugs and complications related to surgical wounds.

[31] In the treatment of wounds involving the neonatal population, the practice of TPN has been adopted in the treatment of Abdominal Compartment Syndrome, in complex wounds with exposure of the muscle fascia and bone structures, in malformation of the abdominal wall in newborns, including premature infants (EYER et al. 2018; BEAU et al. 2016; MCBRIDE et al. 2014; BINET et al. 2013; LOPEZ, CLIFTON and EMIL 2008). Petition 870250013756, dated 20 / 02 / 2025, page 14 / 26 / 12

[32] Studies developed by Fox et al. (2015) indicate the use of the therapy in the treatment of ulcerated infantile hemangioma with a satisfactory response in the healing process. It has also been used in the closure of complex sternal wounds in newborns undergoing cardiac surgery with complete healing after therapeutic application and reduction of local infection (FILIPPELLI et al. 2014 and OELTJEN et al. 2009).

[33] The effectiveness of PNWT in the pediatric population, with increasing use in the neonatal population, has been discussed by many researchers in the last ten years (EYER et al. 2018, FILIPPELLI et al. 2014, STOFFAN et al. 2012). PNWT demonstrates effectiveness in the healing process of these complex wounds; however, this therapeutic approach, although already showing satisfactory results internationally for newborns, is still underutilized in Brazil.

[34] In addition to treating complex wounds in neonatal patients, this context includes early discharge home, strengthening family ties, reducing harm to the patient and their family resulting from hospitalization processes, lowering hospital costs and consequently reducing costs for the health system. Brief description of the drawings Figure 1 illustrates the electronic system consisting of a network of mechanical structures and circuit components. Figure 2 illustrates the closed-loop system for controlling pressure on the wound during therapy. Figure 3 illustrates the functional system of dressing I, sandwich type (accessories) coupled to the operating system of the pressure control machine. Figure 4 illustrates the functional system of dressing II, Octopus type (accessories) in interface with the viscera (gastroschisis) and the operating system of the pressure control machine. Description of the invention

[35] The equipment consists of a touchscreen display (1), electronic circuit (2), pneumatic pump (3), collector (4), load cell (5). In addition, a dressing Petition 870250013756, dated 20 / 02 / 2025, page 15 / 26 / 12 disposable (6) must be connected by extenders and attached to the wound site. This dressing (6) consists of a foam covered by a transparent film capable of sealing the wound during the therapeutic process, helping to maintain the subatmospheric pressure in the wound desired by the user that attends to the healing process.

[36] The microcontroller (2.1) of the electronic circuit (2) is responsible for processing the data received by the user of the equipment through interaction with the touchscreen display (1), in order to monitor the pressure sensors (2.3, 2.4), load cell (5), temperature sensor (6.1) and control the power of the pump (3) to perform the therapy, as well as being able to interrupt therapy in case of failure when necessary or by user intervention.

[37] Pressure measurement is performed at two locations by two sensors (2.3 and 2.4) connected respectively by hoses to the dressing (6) attached to the wound, and between the pump (3) and the collection container (4).

[38] Pressure control at the wound site is performed during therapy by a closed-loop system (figure 2) whereby the microcontroller (2.1) controls the power of the pneumatic pump (3) by means of the pump power driver (2.2) in order to keep the measured pressure as close as possible to the pressure set by the equipment user.

[39] The pressure measurement between the pump (3) and the collection container (4) during therapy serves to identify any fault in the pneumatic system, such as hose obstruction, pressure leaks or poor connection of the dressing to the wound. For example, if the absolute pressure value of the sensor at the wound site (2.3) is much lower than the pressure sensor of the collector (2.4), the exudate suction hose may be obstructed or the dressing may be poorly connected to the wound, favoring pressure leakage, thus causing automatic interruption of therapy by the microcontroller (2.1).

[40] The pneumatic pump (3) is connected indirectly to the wound by hoses passing through a collection container (4) responsible for retaining the exudate during therapy, this being supported by a load cell (5) intended for monitoring the mass and, consequently, the flow of retained exudate. Petition 870250013756, dated 20 / 02 / 2025, page 16 / 26 / 12

[41] The temperature in the wound is monitored by the microcontroller (2.1) by reading the signal provided by the sensor (6.1) embedded in the dressing (6) and processed by the conditioning circuit (2.5).

[42] Accessory I is called a sandwich dressing consisting of two layers of foam (4 and 5), a hollow connection for pressure control (2), a wound site temperature sensor (3), a space between the foam layers that can be filled with complementary therapies, such as antibiotics (6), partial silicone sealing (7) and a final sealing film (1) - Figure 3.

[43] Accessory II is called an octopus-type dressing, consisting of a bellows-like structure of perforated foams (1), a wound site temperature sensor (2), an exudate outlet duct (3), a mobile polyethylene structure for accommodating viscera (4), a silicone sealing film (5) and a pressure-controlling inlet duct (6). Examples of embodiments of the invention

[44] This invention presents a technological device built on the pillars of research involving multimethods, with emphasis on Quality Function Deployment, aimed at creating equipment, exploring the different phases of an operational chain for the production of a product. These are the final products of a doctoral thesis and a master's dissertation.

[45] Bench tests to validate the effectiveness of pressure levels imposed on the device, and prototype accessories (dressings) developed in experimental laboratories, facilitated the construction, along with the prototyping phase, of a technology aimed at treating complex wounds in a specific population such as the neonatal population.

[46] Documentary analyses (scientific articles, patents examined throughout the investigations, including field research with health professionals who are experts in the subject, concomitant with the development of the machine and its healing accessories, created in technological innovation laboratories, provided comparative evaluations with other inventions. Table 1 - Comparative Examples Petition 870250013756, dated 20 / 02 / 2025, page 17 / 26 / 12 Patents Examined Invention PI 0614325 - 3 A2 Does not describe specifications for the neonatal population. WO 2012 / 161723 A1 Does not indicate control of sensitive losses. WO 2013 / 175306 A2 Does not present specific accessories for complex wounds in newborns. WO 2016 / 018448 A1 Does not control wound site temperature. Petition 870250013756, dated 20 / 02 / 2025, page 18 / 26

Claims

CLAIMS 1. Device and attachments for the treatment of complex wounds in newborns, characterized by having a multifunctional electronic control system for wound healing in the neonatal population, all described in figures 01, 02, 03 and 04; 2. As per claim no. 1, characterized by having pressure controls to meet specific needs for injuries in patients younger than 28 days old, as evidenced by the literature described in item 23 of this document; 3. As per claim no. 1, characterized by having sensors that measure the internal temperature of the wound site in neonatal patients, in accordance with the scientific evidence described in items 26 to 29 of this document; 4. As per claim no. 1, characterized by having sensors that measure sensitive bodily losses in neonatal patients with complex injuries, in accordance with the scientific evidence described in item 26 of this document; 5. As per claims 1, 2, 3 and 4, characterized by having an accessory (sandwich-type dressing) capable of accelerating the healing process of complex neonatal wounds in conjunction with complementary therapies as described in figure 3; 6. As per claims 1, 2, 3 and 4, characterized by possessing an accessory (octopus-type dressing) capable of accelerating the abdominal wall closure process in complex wounds (gastroschisis) resulting from malformation in newborns, as described in figure 4. Petition 870250013756, dated 20 / 02 / 2025, pp. 23 / 26

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