WO2015048864A1

WO2015048864A1 - Surgical kit for treating peritonitis

Info

Publication number: WO2015048864A1
Application number: PCT/BR2013/000397
Authority: WO
Inventors: Adilson Costa RODRIGUES Junior
Original assignee: Rodrigues Junior Adilson Costa
Priority date: 2013-10-04
Filing date: 2013-10-04
Publication date: 2015-04-09
Also published as: WO2015048864A8

Abstract

Surgical kit for treating peritonitis, constituted by: a catheter (1) with a multi-way outlet (2) for liquid to be infused into the abdominal cavity; a permeable barrier (3) of plastic film extending over said catheter after same has been positioned in the abdominal cavity; two sheets (4A) and (4B) of polymeric foam, the first being for extension over said permeable barrier (3) of plastic film and on top of the aponeurosis (A), whilst the second is positioned between the aponeurosis (A) and the skin (P), with both likewise being suitably aligned with the wound opening; the customary suture (5) and the components thereof for partial closure and stability of the wound opening; an adherent closure (6) of impermeable plastic film extending and fully covering the wound opening; a customary negative-pressure unit (7) with a suction line (8) with an intermediate collection reservoir (9) and with the respective suction cup (10), the latter having means allowing use over the closure (6); and a customary supply source (11) of infusion liquid coupled at the corresponding end of said catheter (1) for washing the interior of the abdominal cavity; lastly there is a closed peritoneal washing circuit combined with a negative-compression peritoneostomy, suitable for use in different diagnostic situations in which an abdominal wound has to be kept open during treatment.

Description

SURGICAL KIT FOR TREATMENT OF PERITONITES. Field of the Invention.

More particularly the present invention relates to a disposable set with all means necessary for the treatment of the most varied peritonitis, whether generalized or not, using the continuous peritoneal lavage process in a closed peritoneal lavage system with the aid of of a negative pressure peritoneostomy.

As is well known to those skilled in the art, diffuse abdominal cavity infection is a serious and potentially fatal condition. When left untreated, mortality is about 90%. Surgery is the main treatment modality for the management of intra-abdominal infection caused by perforation of a hollow viscera or transmural necrosis of the gastrointestinal tract.

The cornerstones of operative treatment are elimination — or — control of the source of peritoneal contamination, removal of contaminated and purulent material, and drainage. Administration of parenteral antibiotic and hemodynamic and respiratory support in an intensive care setting are necessary to complete the treatment of intra-abdominal sepsis.

In recent decades this combined approach has resulted in complete recovery in most patients with intra-abdominal infection. However, in patients with severe intra-abdominal infection, with development of severe sepsis and septic shock, as in diffuse peritonitis or in patients with immunosuppressed, treatment becomes more complex and difficult.

This is because in these situations, despite controlling the source of contamination and removing most of the contaminated material, the persistence of infecting particles perpetuate the inflammatory process (tertiary peritonitis), requiring relaparotomies (demand or programmed) in an attempt to adequate control.

In addition, poor tissue perfusion, especially intra-abdominal hollow viscera, is known to play an important role in the perpetuation of severe sepsis / septic shock. Increased permeability of the intestinal epithelium and endothelium results in the release of inflammatory mediators that propagate the systemic inflammatory reaction. The edema and ascites formation itself, resulting from this exudate, lead to an increase in the intra-abdominal pressure regimen, increasing the i-n-es-os- malfusion, generating a devastating cycle.

In view of the awareness of treatment deficiencies, the search for new approaches in the whole field of abdominal sepsis has been stimulated, from treatment with systemic anticytokine, new antibiotics and immunomodulatory diet, to new surgical management modalities of this type of patient.

Currently, the surgical modalities of treatment of generalized peritonitis, after the primary approach, are relaparotomies (scheduled or demanded), combined with modalities of closure abdominal wall. Demand relaparotomies choose to close the abdominal wall after removal of the infectious focus and cleaning the cavity. But in case of tertiary peritonitis, new approaches to the abdominal cavity are often required. In scheduled relaparotomies, it is generally chosen to keep the abdomen open and new approaches established until resolution of the condition, when the abdominal cavity is definitively closed. Usually scheduled relaparotomies are reserved for the most severe cases. This is because the temporary closure techniques present a series of associated morbidities such as enteric fistulas, retraction of the abdominal fascia with loss of domain, besides the difficult management by the nursing staff. However, following the introduction of negative-pressure peritoneostomies, especially with the advent of vacum assisted closure (VAC), the use of open abdomen-programmed laparotomies has gained strength. Experimental work involving negative-pressure peritoneostomy has shown promising results. Scholars have conducted an experimental study using a porcine abdominal sepsis model to analyze the effect of negative pressure peritoneostomy. In the control group, the animals, after establishing septic shock of abdominal focus, underwent passive drainage peritoneostomy. The other group underwent the same procedure, but using negative pressure. Hemodynamic, inflammatory and histological parameters were analyzed. showed better results in the negative pressure group.

Peritoneal lavage as an adjuvant in the treatment of diffuse peritonitis has not yet been well established. Its applicability has been discussed since the beginning of the last century. The use of this method has been questioned for some reasons: the spread of a contaminating focus throughout the cavity; the difficulty of removing bacteria adhering to the peritoneal mesothelium; and the fact that it removes proinflammatory factors that would help resolve intra-abdominal infection. Results in experimental studies are conflicting and human studies are scarce and show no significant differences in the use of peritoneal lavage.

A more extreme embodiment of peritoneal lavage is continuous peritoneal lavage. This is based on the fact that continuous intra-abdominal irrigation would assist in the continued removal of infectious and inflammatory particles collaborating in the resolution of peritonitis. However, its use is also controversial for the same reasons already mentioned above. Studies conducted are inconclusive and the applicability is uncertain.

Looking at studies involving continuous peritoneal lavage, there is no concern in designing a lavage system that provides a correct abdominal clearance mechanism. In general, intracavitary catheters are located and it is expected that irrigation without adequate removal of infused fluid will resolve intra-abdominal infection. Also, it keeps. if the abdominal cavity is closed, which contributes to increased abdominal pressure. There are no studies that mention the use of peritoneostomy with continuous peritoneal lavage.

Similarly, these studies are mostly conducted with saline solutions, and recent studies have shown that the use of saline solutions is harmful to the peritoneal mesothelium and may contribute negatively to the analysis of this peritoneal lavage technique. The literature lacks more elaborate studies that propose a more effective mechanism in the continuous peritoneal lavage system, so that it could be better evaluated and compared with the techniques currently used.

Thus, the treatment of diffuse peritonitis continues for a long time based on surgical treatment (control of the contamination focus followed by relaparotomies) in association with clinical support.

However, after contamination control, the role of relaparotomies (demand or scheduled) has been the cavity washing in an attempt to remove contamination residues and inflammatory mediators, reducing the local inflammatory process. But this approach has the drawback of subjecting the patient to a new surgical procedure, with the burden of removing and transporting the patient from the intensive care unit, new invasive procedures (orotracheal intubation, new catheters) and exposing the abdominal cavity to the external environment. Thus, the hypothesis is that continuous peritoneal lavage may still be a solution for the treatment of severe peritonitis, as it would allow peritoneal lavage in the intensive care setting without the burden of a new procedure as mentioned above.

In view of this, it is desirable to create more efficient means for peritoneal lavage. One way out would be to associate continuous peritoneal lavage with negative pressure peritoneostomy. Such a system could maintain a closed flushing system, with the possibility of more efficient infused fluid clearance. But this association of peritoneal lavage with vacuum peritoneostomy has not yet been tested.

The present invention combines peritoneal lavage with vacuum peritoneostomy and creates a system that contributes to the removal of remaining contaminant particles, can increase clearance of inflammatory mediators and cytokines, and maintain a lower intra-abdominal pressure regimen. These factors provide better control of int_f_e_c_ç_ao_int_ ^. reducing the circulation of proinflammatory substances that would lead to worsening septic shock and multiple organ dysfunction.

State of the art.

There is currently considerable variation in methods and means for treating wounds and other similar situations in the abdominal regions, many of these known methods and means use pressure reducing apparatus in the treated region, as exemplified by the documents: BRPI001560 - 08/11 / 2000, BRPI0110682 - 05/09/2001, publication US20040030304 - 02/12/2004, BRPI0706847 - 01/23/2007, US8192409 06/06/2012, publication US20080103462 - 01/05/2008, publication US20090099519 - 04/16/2009, publication US20100106115 - 04/29/2010, WO2010 / 141271 - 12/09/2010, US8469935 6/25/2013 and US8460257 - 6/11/2013.

As mentioned before, no methods or means of combining peritoneal lavage continue with negative pressure peritoneostomy are not known.

Objectives of the Invention.

A kit for carrying out the treatment of generalized peritonitis using continuous peritoneal lavage in a closed system. peritoneal lavage with the aid of a negative pressure peritoneostomy.

More particularly, the present invention relates to a kit for continuous or intermittent washing of the entire abdominal peritoneal surface.

Briefly, the kit includes a multipath liquid catheter to be infused into the abdominal cavity, which, when positioned on the patient, is covered by a permeable barrier of perforated plastic film and a blanket is spread over it. of polymeric foam positioned below the abdomen opening and over it extends an impermeable closure of adherent plastic film which in turn forms the watertight barrier for positioning the suction cup of the negative pressure system and also in this same watertight barrier, passes the multipath catheter, which is also made of sealed way to prevent loss of negative pressure.

Thus, the kit in question has all the necessary means for peritoneal lavage to remove infectious and inflammatory material resulting from a peritoneal infection. In secondary peritonitis, appendicitis, cholecystitis, intestinal perforation, pancreatitis and others, surgical infectious focus removal and subsequent lavage are required to remove these infectious residues. But in. In the case of more severe abdominal infections, sometimes more than one lavage is required after removal of the infectious focus and in extreme situations until the abdomen is kept open (laparostomy or peritoneostomy) for faster access to the abdominal cavity for lavage, which is accomplished by using this kit. There is also the concept of continuous peritoneal lavage, which consists of keeping the abdominal cavity under constant lavage after surgery. Thus, the present invention solves the lack of a more efficient system because, with known peritoneal continuous lavage methods, there is no system that permits effective lavage that reaches the entire abdominal cavity, which is a closed system, with more precise control of what is infused and aspirated from the abdominal cavity.

The present invention is a kit which, as has been said, has a single catheter with multipath outlets or branches into two or more irrigation tubes, preferably three or four, for infusion of fluids into the abdominal cavity and providing ample irrigation of the said fluid for bathing the desired regions of said abdominal cavity. An integral part of the assembly is a negative pressure apparatus which, associated with other components, forms a closed circuit for aspirating infused fluid through said catheter, thereby providing adequate flushing to remove infectious waste. The advantage of this wash is that it is repeated without the need for any changes to the patient or the system itself.

For even distribution of infused fluid throughout the abdominal cavity, the present invention includes an accurate infusion catheter with multi-perforated branches throughout so that each branch can be positioned so that the assembly reaches a desired area in the abdominal cavity. Of course, the length of the branches as well as their gauge and the size of the infused liquid outlet holes are proportional for fluid distribution to occur throughout the catheter. Fluid infusion may be continuous or intermittent as required. The operating parameters of the negative pressure device are adjusted and adapted to this new set. Separate nylon sutures are made on the aponeurosis and skin so that the edges of the wound are as close as possible. The cover plastic also encompasses the infusion catheter inlet so that negative pressure does not escape through these holes.

Since fluid infusion is independent of aspiration, these two mechanisms may work in (continuous aspiration and infusion), or intermittently. To make bathing or washing more effective, the fluid is infused with the aspiration turned off, so that the fluid first occupies the entire abdominal cavity and then the aspiration step begins by turning off the infusion and thus all that is required. has been infused be aspirated.

Due to this independent functioning, this peritoneal bath apparatus can also be applied for peritoneal dialysis and for intrabdominal chemotherapy application.

Description of the drawings.

For a better understanding of the present invention, a detailed description of the present invention is then made, with reference to the accompanying drawings, where all the figures are schematic and the dimensioning of the components have been exaggerated to better understand the functioning of the kit. :

FIGURE 1 represents an exploded perspective highlighting all components of the assembly;

FIGURE 2 shows a front view of the abdominal region of a patient with the present kit;

FIGURE 3 illustrates an enlarged longitudinal sectional detail, also schematic, showing the positioning of the kit inside and outside the abdominal box;

FIGURE 4 is an isometric view of the catheter; and the

FIGURE shows a side view of said catheter.

Detailed description of the invention. According to these illustrations and their details, more particularly figures 1 to 4, the present invention, PERI TONI S S SURGICAL TREATMENT KIT, is characterized by the fact that it comprises:

- a catheter (1) with multipath outflow (2) to be infused into the abdominal cavity;

a plastic film permeable barrier (3) for extending over the abdominal content after said catheter is positioned in the abdominal cavity;

Two polymeric foam blankets (4A) and (4B), the first of which is to extend over said plastic film permeable barrier (3) and under the aponeurosis (A), while the second is positioned between the aponeurosis. (A) and skin (P), as well as both are properly aligned with the opening of the wound;

usual suture (5) and its components for partial closure and stability of wound opening;

an adherent closure of impermeable plastic film (6) to extend and fully cover the opening of the wound;

- a usual set of negative pressure (7) with a suction line (8) interspersed by a collection reservoir (9) and the respective suction cup (10), the latter with means to be applied over the closure (6); and

- a suitable infusion fluid supply source (11) coupled to the corresponding end of said catheter (1) for washing the interior of the abdominal cavity.

The catheter (1) with multipath liquid outlet (2) to be infused into the abdominal cavity is illustrated in detail in FIGS. 4 and 5, showing that it comprises a main flexible tube (12) which at one end , has perforation lance (13), near which it is cut to form a connection point with the infusion liquid supply source (11), while at the opposite end, said main tube (12) includes a connector ( 14) with two or more exits, preferably 3 or 4, each for a track (2), equally flexible, but with a smaller gauge than the main pipe (12), as well as each track (2) has a closed terminal. (15) and conveniently distributes number of radial holes (16).

The gauge of the main pipe (12), the gauge and length of each track (2) and the diameter of the holes (16) are suitably sized. also taking into consideration the flow offered by the liquid source (11), so that all these dimensional parameters can guarantee a uniform irrigation through all radial holes (16) and, consequently, every area of the abdominal cavity to be washed receives sufficient amount of infusion fluid.

The permeable plastic film barrier (3) for extending over the abdominal content after the catheter has been positioned in the cavity exhibits permeability through a plurality of holes or microfores (17). With respect to the polymeric foam blankets 4A and 4b for extending above and below the aponeurosis, many other precautions inherent in the object of the invention are adopted, especially regarding density, as well as their dimensioning. shared with the other components of the set.

The sutures (5) and their components for partial closure and stability of the wound opening should be made at the aponeurosis and skin so that the edges of the wound stay as close as possible.

The waterproof plastic cling closure (6) for extending and fully covering the wound opening is a market component, such as that made with the 3M "tegaderm" brand, said closure having to extend long enough to be through the main tube (12) of the catheter (1) and define watertight means so that negative pressure does not escape.

With regard to the negative pressure assembly (7) with a suction line (8), collection reservoir (9) and its suction cup (10), it is understood that this set adds up all the adaptations necessary to meet the established criteria. by the kit in question.

Similarly, the infusion fluid supply source (11) flush from the interior of the abdominal cavity is tailored to meet the kit's usage criteria.

6 fluid infusion circuit defined by source (11) and catheter (1) is independent of set defined by the negative pressure device (7, 8, 9 and 10), consequently, the two systems operate independently of each other, which allows continuous and intermittent aspiration and infusion. To make bathing or washing more effective, the set allows the fluid to be infused with the aspiration turned off so that the fluid occupies the entire abdominal cavity and then the aspiration starts by turning off the infusion so that all that has been infused is aspirated.

WHAT IF

Object i

Establishing an animal model of peritoneal lavage continues in a closed system with the aid of negative pressure contained peritoneostomy.

Method

The protocol was submitted and approved by the Animal Research Ethics Committee of the School of Medicine of the University of São Paulo (USP).

Four pigs were anesthetized, kept under mechanical ventilation, receiving 5ml / kg / h Ringer lactate solution, continuous monitoring with swan-ganz catheter and invasive blood pressure. They underwent mediated laparotomy, through which 2 .8mm multiperforated tubes were positioned on the flanks and a vacuum peritoneostomy was applied. Through the 2 tubes was infused saline solution (0.9% NaCl) with flow 400ml / h and alternating, every 30 minutes, periods with and without negative pressure of 125mmHg. The experiment had a total time of 9 hours.

RESULTS

• The integrity of the peritoneostomy was not compromised throughout the procedure, even when aspiration was interrupted.

• There were no catheter blockages or leaks during the procedure

^• There were no variations in intra-abdominal pressure even when aspiration was interrupted.

Conclusion

This negative pressure continuous peritoneal lavage model is technically feasible and may be an option in the treatment of diffuse peritonitis. serious.

It will be appreciated that certain features and combinations of the components forming the kit may vary considerably while maintaining the same functional concept for the assembly, therefore, it is noted that the construction now described in detail by way of example is clearly subject to constructive variations, however, always within the scope of the disclosed inventive concept of an outlet multipath catheter system combined with a continuous peritoneal lavage aspiration system associated with negative pressure peritoneostomy and how many modifications can be made to the detailed configuration hereinbelow. the descriptive requirements of the law, it is understood that the present details are to be construed as illustrative and not limiting.

Claims

1) SURGICAL KIT FOR TREATMENT OF PERITONITES, characterized by the fact that it comprises:

Two polymeric foam blankets (4A) and (4B), the first of which is to extend over said plastic film permeable barrier (3) and under the aponeurosis (A), while the second is positioned between the aponeurosis. (A) and skin (P), as well as both are properly aligned with the sutured wound opening;

- usual suture (5) and its components for partial closure and stability of wound opening;

an adherent closure of impermeable plastic film 6) which extends and fully covers the wound opening;

- a usual source of infusion fluid supply (11) coupled to the corresponding end of said catheter (1) for flushing the interior of the abdominal cavity.

2) SURGICAL KIT FOR TREATMENT OF PERITONITES according to claim 1, characterized in that the catheter (1) with multipath liquid outlet (2) to be infused into the abdominal cavity comprises a main flexible tube (12) which at one end has a perforation lance (13) near which it is cut to be connected to the infusion liquid supply source (11), while at the opposite end, said main tube (12) includes a connector (14) with outlets (2), also with a flexible tube, but with a smaller gauge than main pipe (12), as well as each lane (2) has closed terminal (15) and distributes convenient number of radial holes (16).

A surgical peritonitis treatment kit according to claim 1, characterized in that the catheter (1) has two or more routes (2), preferably three or four.

4. The peritonitis treatment surgical kit according to claim 1, characterized in that the permeable plastic film barrier (3) extends over the abdominal content after the catheter has been positioned in the cavity to permeate through the skin. plurality of holes or micro holes (17).

5. PERITONITE TREATMENT SURGICAL KIT according to claim 1, characterized in that the fluid infusion circuit defined by the source (11) and the catheter (1) is independent of the aspiration assembly defined by the negative pressure device. (7, 8, 9 and 10).

6) SURGICAL KIT FOR PERITONITES TREATMENT according to claim 5, characterized in that it allows continuous aspiration and infusion or intermittently. A PERITONITE TREATMENT SURGICAL KIT according to claim 1, characterized in that it forms a closed peritoneal lavage circuit combined with a negative pressure peritoneostomy.