WO2009034437A2

WO2009034437A2 - Table and sterile cloth for collecting infected materials

Info

Publication number: WO2009034437A2
Application number: PCT/IB2008/002329
Authority: WO
Inventors: Giuseppe Mario Iudicello
Original assignee: Giuseppe Mario Iudicello
Priority date: 2007-09-12
Filing date: 2008-09-09
Publication date: 2009-03-19
Also published as: WO2009034437A3; ITME20070008A1

Abstract

A sterile set, associable to a sanitary table (100, 101, 102) for collecting and disposal of infected materials and the like, comprising at least a sterile doth for covering a work plane (110, 111, 112) of the sanitary table (100, 101,102), which sterile covering cloth (200,201,202) is provided with at least a bag (37, 38, 39, 40, 41, 50, 51, 52, 70, 71) for collecting at least a type of the infected materials. The bag (37, 38, 39, 40, 41, 50, 51, 52, 70, 71) can be inserted in a seating (31, 32, 33, 34, 35, 60, 61, 62, 80, 81) afforded in the working plane (110, 111, 112) following a spreading of the sterile cloth (200, 201, 202) to cover the work plane (110, 111, 112). In further embodiments of the invention, the sterile set can further comprise: a sterile cannula (36), connectable to an aspirating plant for aspirating infected liquid materials; and a rigid container (42) for collecting needles and blades.

Description

A TABLE AND A STERILE SET FOR COLLECTING AND DISPOSING OF INFECTED MATERIALS AND THE LIKE

TECHNICAL FIELD

The invention relates to a table and a sterile set for collecting up and disposing of infected materials and the like, which can be used where sterile operations are required, especially in operating theatres.

BACKGROUND ART

As is known, in an operating theatre it is necessary to maintain the bacteria level at an absolute minimum, especially during a surgical operation, and in particular in a low-microbe zone in proximity of the surgical site, isolated by the use of sterile cloths, A further requirement is to remove or recycle, safely and under controlled conditions, the refuse produced during the operation (gauzes, blades and needles, cleaning liquids, metal instruments used during the operation etc.) up to now underestimated in the field of risk management, which the invention intends to concentrate on. During a surgical operation various operatives are usually present in the theatre, having specific functions, in particular: one or more surgeons operating on the patient; a specialist theatre nurse managing instruments and passing the required materials to the surgeons; and an assistant nurse who gathers, manages and passes the materials to be used during the operation. The surgeons and the specialist theatre nurse are therefore directly in contact with the patient and the instruments used during the operation, in the low-microbe zone, improperly also known as the "sterile zone". It is therefore of absolutely fundamental importance that these operators do not perform manoeuvres which place the sterile gloves and equipment used at risk, as the success of the operation to some extent depends on this. The positions assumed by the staff during the surgical operation and the layout of an operating theatre 10 in the prior art are schematically illustrated in figure 1.

Generally a theatre nurse 4 is in proximity of a serving table 3 which is covered by a sterile cloth and is used by the nurse for managing the instruments required for the operation.

A further, assistant nurse 2 is positioned in front of the theatre nurse 4, at the other- side of the serving table 3, such as to prevent any accidental contact with the theatre nurse 4 or the surgeon 5 operating internally of a zone surrounded by cloths and apparatus, already defined as low-microbe.

The surgeon 5 operates on the patient 8 lying on the operating table 7, aided by the specialist theatre nurse 4 who passes the instruments required for the operation (metal tools, needles and cutting tools, gauzes, disinfecting liquids, etc.).

As illustrated in figure 1, the operating theatre 10 includes a first corridor 11 and a second corridor 1 , known as the "dirty" corridor.

At the start of the operation the container for infected materials 6 enters through the first corridor 11 , in which there is a filter zone 9 for decontamination of the materials using known radiation techniques^'.

At the end of the operation the container 6 is removed from the theatre 10 through the second corridor 1, such that the infected material follows a different circuit from the one used by the clean materials; thus the first corridor 11 is used only for the material entering the operating theatre 10.

The container for infected material 6 comes from a non-sterile stockroom and, notwithstanding the decontamination process performed in the filter zone 9, introduces a residua! bacteria level into the operating theatre 10. The container 6 is positioned internally of the operating theatre 10 in proximity of the low-level microbe zone, isolated by the sterile cloths and comprised between the serving table 3, the theatre nurse 4, the surgeon 5, the patient 8 and the operating table 7; this exposes the surgeon's 5 and the theatre nurse's 4 gowns, in particular during movements of the surgical operatives, which make more probable some form of contact with the external part of the container 6.

Also present in the operating theatre 10 are a container 12 for throwing away gauzes used during the operation, and a container 13 for throwing away scatpel blades and hypodermic needles at the end of the operation.

During a surgical operation various types of instruments and materials are used and/or managed, which at the end of the operation are either disposed of or recycled in various ways, for example:

scalpel blades and syringe needles;

gauzes and suture thread; cleaning liquids and disinfectants; metal instruments used during the operation;

biological materials to be subjected to histological examination (coming from the patient);

other materials (inner packs of suture threads and other sterile apparatus polluted by contact with the gloves of the theatre nurse 4 etc,)-

In the following, the methods of collection and disposal of infected refuse and the like in the prior art will be described, in an operating theatre, with the aim of facilitating comprehension of the prior art in the sector. Suture needles and forceps are of single-use disposable type and are placed by the theatre nurse 4 in non-stable containers rested on the serving table 3, after they have been used by the surgeon 5.

At the end of the operation, the theatre nurse 4 uses pincers to recuperate and dispose of the blades and needles, throwing them into a rigid container 13, in agreement with the existing health and safety measures. It is stressed that the rigid container 13 is generally rather large and is used many times, in order for blades and needles from various operating sessions to be thrown away, even over a period of longer than a day, up until the container is full, after which it is disposed of in the infected-materials container 6.

This leads to a possible proliferation of germs in the rigid container 13, with the risk of contamination in the operating theatre 10.

Gauzes used during the operation are disposed of in the gauze container 12 and have to be counted at the end of an operation before the suturing of the surgical wound begins, prior to being disposed of in the infected-materials container 6.

This operation is of particularly critical importance, as the gauzes are generally thrown by the theatre nurse 4 into the gauze container 12 in order to prevent contamination of gloves and introducing infecting agents into the low-microbe zone (serving table 3, theatre nurse 4, surgeon 5, patient 8. operating table 7); this throwing-away gesture however leads to contamination of the external surface of the container 12 and/or the operating theatre 10 with drips of the patient's biological material.

The suture threads are instead deposited in the infected-material container B.

The residues of the threads and the internal paGks of each apparatus used, which are sterile when first placed on the serving table 3, are disposed of in the infected- materials container 6.

The container recipients of the liquids used for cleaning and disinfecting are emptied into the infected-materials container 6, with the risk of dripping and contaminating the floor of the operating theatre 10.

In an operating theatre 10 of the prior art, aspiration plants for liquid refuse, for preventing the above-described type of risks, are not provided.

The metal instruments used during the operation, if contaminated by draining of abscesses or disinfecting of mucous membranes (and therefore no longer usable in the surgical area) are passed by the theatre nurse 4 to the other nurse 2, by a tossing movement; this manoeuvre, apart from requiring care to avoid risk of - S -

contamination of the theatre nurse's gloves, also exposes both nurses (2, 4) to the risk of cutting or pricking accidents, and constrains the out-of-zone assistant nurse 2 to be at the beck of the theatre nurse 4, which means leaving aside other theatre tasks. The material to be subjected to histological examination is generally deposited by the theatre nurse 4 on the serving table 3 or passed, using the same method illustrated above for the metal apparatus, to the nursing assistant 2 who is outside the operating zone. This too requires excellent synchrony between the two operators and a certain level of caution in order to prevent accidental contamination of the sample, the risk of infection for the two operators and the contamination of the theatre nurse's gloves. It also involves the necessary presence of the assistant nurse 2, provided with suitable gloves, in proximity of the serving table 3 at a precise moment of the operation.

It is stressed that the presence in the operating theatre of various containers located in various positions means that the theatre nurse 4 must remove her or his attention from the operating table in order to locate the particular container of interest, which adds to fatigue and the consequent risk of error.

DISCLOSURE OF INVENTION The aim of the present invention is to provide a table and a sterile set for collection and disposing of infected materials and the like, especially aimed at the health and sanitary sector, which enables simplification of the disposal procedures of the various infected materials and increases security and sterility in the operating theatre during an operation. A further aim of the present invention is to free up the activities of the out-of-zone assistant nurse from those of the theatre nurse during the surgical operation, enabling optimal and more secure management of the passages of material and/or apparatus between the two operatives.

The above-described aims are achieved with what is set out in the claims in regard to the sterile set for collection and disposal of infected materials and the like, comprising at least a sterile cloth for covering a work plane of a theatre serving table, characterised in that the sterile covering cloth is provided with at least a bag for collecting at least a type of the infected materials Which bag can be inserted in a seating afforded in the work plane following a spreading of the sterile cloth to cover the work plane.

BRIEF DESCRIPTION QF THE DRAWINGS

The characteristics of the invention will better emerge from the following description of some preferred embodiments of the invention, in agreement with what is set out in the claims and with the aid of the accompanying figures of the drawings, in which:

figure 1 is a schematic illustration of the layout and arrangement of the personnel during an operation in an operating theatre of the prior art; figure 2 is a schematic illustration of the layout and arrangement of the personnel during an operation in an operating theatre in which the sterile set and the table of the invention are used;

figure 3 is a perspective view of the work plane of- the table of the present invention in a preferred embodiment thereof;

figure 4 is a perspective view of a table provided with the work plane of figure 3 and the sterile set of the invention; figure 5 is an enlarged perspective view of a component of the sterile set associated to the table; figure 6 is an exploded perspective view of a further component of the sterile set- figure 7 is a perspective view from above of the table in a further embodiment thereof; figure 8 is a perspective view of the work plane of the table and the sterile set in a further embodiment thereof; figure 9 is a view from above of the work plane of the table of figure 8: figure 10 is a perspective view of the work plane of the table and the sterile set of a further embodiment of the invention;

figure 11 is a view from above of the work plane of the table illustrated in figure 10.

BEST MODE FOR CARRYING OUT THE INVENTION

With reference to the accompanying figures of the drawings, 100, 101 and 102 denote the table of the invention and 200, 201 and 202 denote the sterile covering cloth, usable for collecting and disposing of infected materials and the like.

In a preferred embodiment of the invention, the sterile set for collecting and disposing of infected materials and the like, associable to a sanitary serving table 100 for covering the work plane 110 thereof, comprises a sterile covering cloth 200 which includes five bags 37, 38, 39, 40 and 41, for collecting and disposing of infected materials and the like, insertable following the placing of the sterile set 200 to cover the work plane 110, internally of the relative seatings 31, 32, 33, 34, 35 afforded in the work plane 110.

The sterile set can also include a sterile cannula 36, connectable to an aspirating plant for aspirating infected liquid materials, and a rigid container 42 for collecting needles and blades destined to be inserted internally of a bag 41.

This embodiment, destined mainly to be used in an operating theatre, is better illustrated in figures from 3 to 6,

The sterile set thus composed is associated to a table 100 the work plane 110 of which is made of steel and includes six seatings 30, 31, 32, 33, 34, and 36, preferably through-seatings, having variable sizes and also having non-jagged rounded edges. The sterile covering cloth 200 completely covers the table 100 on three sides and partially on one side, to afford access and possible opening of some bags 38, 39 by a specialised operative.

The bags 37, 38, 39, 40 and 41 of the sterile set 200, in this preferred embodiment, are made in a single body with the sterile covering cloth 200; however a possible variant (not illustrated) might further include realising the sterile set with one or more bags that are removable with respect to the covering cloth 200.

Each bag 37, 38. 39, 40 and 41 of the covering cloth 200 is preferably dedicated to the collecting of a particular type of infected material and the like, in particular:

a bag 38, housed internally of the seating 31, is openable from the outside and is destined to be used to collect metal implements used during the operation;

a bag 39, housed internally of the seating 32, is openable from the outside and is destined to collect samples to be sent on to the histological laboratory;

a bag 37 housed internally of the seating 33, is for collecting gauzes and cloths used during the operation; a bag 40, housed internally of the seating 34, is for collection of generic material which may not be infected, for example internal packages of suture thread, internal packages of other apparatus which has entered into contact with biological materials, etc.;

a bag 41, housed internally of the seating 35, receives the rigid single-use disposable container 42 for collecting needles and blades.

The container 42 is externally provided with a thread 49 which couples, with an interposing of the bag 41, with a corresponding thread realised in the seating 35 of the table 100.

The container 42 is provided with tabs 47 which facilitate the operation of screwing/unscrewing and a V-shaped gully 45 made on the upper surface 46, partially open, in order to facilitate the extraction of the needles from the syringe body.

The following is a description of the disposal procedure of the various types of infected material and the like internally of an operating theatre 14 in which the sterile set of the present invention is used.

The metal apparatus used by the surgeon 5 during the operation are deposited by the theatre nurse 4 internally of the openable bag 38 and only after this will the out-of-zone assistant nurse 2, from the region below the work plane 110, open the bag 38 laterally to extract the apparatus, such as to sterilise them for further use. The removal operation does not require any synchrony between the theatre nurse 4 and the assistant nurse 2 who thus manages the collection of the metal parts in total autonomy.

Any samples to be sent to the histological laboratory are deposited by the theatre nurse 4 into the openable bag 39 and only after this will the out-of-zone assistant nurse 2, from the region below the work plane 110, open the bag 39 laterally to extract the samples and send them on to the analysis laboratory.

This advantageously prevents any danger of accidental contamination of the gloves in the above-mentioned tossing operations and does not require any synchrony between the theatre nurse 4 and the assistant nurse 2 who is outside the operating zone.

The gauzes and the cloths used during the operation are thrown by the theatre nurse 4 into the bag 37 and at the end of the operation the same theatre nurse 4, before each suture, counts them while putting them in the bag 40 set aside for generic materials. The disposing operation is therefore easier for the theatre nurse 4 since the nurse 4 avails of a container for the gauze 37 at the working height; the same operation is more secure for the patient 8 as the theatre nurse 4 entirely autonomously performs the counting operations and does not risk losing her or his sterility by coming into contact with potentially non-sterile containers, as the material has been placed in the bag and the theatre nurse 4 has not performed manoeuvres involving a non-sterile container during the operation, as happened in the prior art,

The generic material, such as for example the wrapper of a gauze pack, other cloths and so on_s is deposited by the out-of-zone assistant nurse 2 in the bag 40. After use the syringe needles are extracted from the body of the syringe with the aid of the gully 45 present on the upper surface 46 of the rigid container 42, while the blades of the forceps are disposed of by the theatre nurse 4 directly in the rigid container 42.

The needles and blades are thrown by the theatre nurse 4 into the rigid container 42 which at the end of the operation is closed with a cap 44 and unscrewed from the seating 35 of the table 100.

At the end of each operation the container 42 is closed inside the sterile cloth together with the remaining material to be disposed of, is removed from the operating theatre 14 and deposited in the second corridor 1, i.e. the "dirty" corridor, such that it can be removed by specialised personnel and plaGβd in the container for infected material 6, in full respect of the existing norms, and preventing any risk of loss of sterility in the operating theatre 14,

The residual disinfecting liquids and/or the cleaning liquids are aspirated by the cannula 36 of the sterile set which is first inserted through a hole 53 afforded in a predefined zone of the covering cloth 200, and then positioned in the housing 30 afforded in the table 100.

The cannula 36 is connected by a tubing to an aspirating plant and is advantageously provided with a ring 43 keyed on it in order to increase the section thereof, such that the ring 43 abuts the work plane 110 of the table 100 without allowing the cannula 36 to slide vertically in the housing 30.

The aspirated liquids are advantageously stocked internally of the aspirating system in a further container which is generally emptied at the end of the operation in order to be newly sterilised for future use, thus preventing any potential contamination of the operating theatre during the course of and at the end of the operation. At the end of the operation the specialised operative first unhooks the container 42 from the table 100 and the cannula 36 from the respective connecting tubing to the aspirating plant Then the operative lifts the covering cloth 200 from the table 100, and deposits it in the second corridor, i.e. the "dirty" corridor, in preparation for being inserted in turn in the container for infected refuse 6.

This operation is advantageously risk-free for the specialised operatives inasmuch as the risk of contamination with the infected materials in the bags 37, 38, 39, 40 and 41 of the covering cloth 200 is very remote.

Further, with the use of the sterile set and the table of the present invention, the container for infected materials 6 is not brought into the operating theatre as it is deposited in the "dirty" corridor, thus preventing any risk of contamination of the operating theatre.

In a preferred embodiment, the sanitary table 100 of the present invention can be fixed on a trolley structure 300 which supports the work plane 110, as illustrated in figure 4.

In a further variant, not illustrated in the figures of the drawings, the sterile set comprises the covering cloth 200 with one or more bags and the cannula 36,

In a further embodiment, illustrated in figure 7, the table 100 illustrated in figures from 3 to 6 is provided with a further plane 120, preferably parallel to the work plane 110; advantageously both the work plane 110 and the further plane 120 are hinged to the trolley support structure 300 such as to be able to vary the angle formed between them according to the requirements concerning the approach to the patient.

In a further embodiment, illustrated in figures 8 and 9, the sterile set of the invention comprises: a sterile cloth 201 provided with three bags 50, 51 , 52 for collecting and disposal of infected materials, to be inserted in relative seatings 60, 61, 62 provided in a work plane 111 of the table 101; and a rigid container 42 for collecting needles and blades destined to be inserted in a bag 52.

In this variant, destined in particular for use in delivery rooms or gynaecological surgeries, the cannula 36 might also be used. By way of example, the work plane 111 of the table 101 is shaped to guarantee a greater ease of work for surgeons and nurses.

In this case too the bags 50, 51 , 52 can be associated to the sterile set 201 in a single body or removably. Each bag 50, 51, 52 is dedicated to the collection of a special type of infected material, in particular the collection of gauzes 50, placenta 51 or the rigid container 42, 52.

In a further embodiment, illustrated in figures 10 and 11. the sterile set comprises: a sterile cloth 202 which includes two bags 70, 71 which insert in relative seatings 80, 81 included in the work plane 112 of the table 102; and a rigid container 42 for the collection of needles and blades destined to be placed in a bag 71.

This variant is mainly destined for use in hospital wards and services for actuation of activities requiring sterility.

Further variants (not illustrated) of the proposed sanitary table include the seatings in the work plane not being thrαugh-seatings.

From the above it is clear how the sterile set of the invention and the associated sanitary table for collection and disposing of infected materials and the like, enables a more secure management of the collection and disposal of the various types of infected materials and the like on the part of the operatives, and also increases sterility internally of the operating theatre.

The sterile set of the invention further enables a simplification in the work of the theatre personnel and the organisation of the work stages, avoiding any need for synchrony between categories of operatives, as occurs in the prior art.

Claims

1). A sterile set, associable to a sanitary table (100, 101, 102) for collection and disposal of infected materials and the like, comprising at least a sterile cloth for , covering a work plane (110, 111, 112) of the sanitary table (100, 101,102) characterized in that the sterile covering cloth (200,201 ,202) is provided with at least a bag (37, 38, 39, 40, 41, 50, 51, 52, 70, 71) for collecting at leas* a type of the infected materials, which at least a bag (37, 38, 39, 40, 41, 60, 51, 52, 70, 71) can be inserted in a seating (31, 32, 33, 34, 35, 60, 61, 62, 80, 81) afforded in the work plane (110, 111, 112) following a spreading of the sterile doth (200, 201, 202) to coverthework plane (110, 111, 112).

2). The sterile set of claim 1 , characterised in that it comprises a sterile cannula (36), connectable to an aspirating plant for aspirating infected liquid materials, which cannula (36) inserts in a through-hole (53) provided in the sterile covering cloth (200) in order to removably insert in a housing (30) afforded in the wort- plane (110).

3). The sterile set of claim 2, characterised in that it includes abutting means (43) associated to the cannula (36), destined to abut the work plane (110) in order to enable a correct positioning of the cannula (36).

4)- The sterile set of one of claims from 1 to 3₃ characterised in that it comprises a rigid container (42) for collecting needles and blades destined to be inserted in a bag (41, 52, 71) of the sterile covering cloth (200, 201, 202) and being fixable to the seating (35, 62, 31 ) of the working plane (110, 111 , 112) in which the bag (41 , 62, 71) is inserted.

5). The sterile set of claim 4, characterised in that the container (42) is fixable to the seating (35, 62, 81) by means of a threading, or via a snap-fit, or a friction coupling.

6). The sterile set of any one of claims from 1 to 5, characterised in that the bag (38, 39) is laterally provided with opening means for enabling a removal of the infected material contained therein from an underlying region of the work plane (110) of the table.

7). The sterile set of any one of claims from 1 to 6, characterised in that the collection bag (37, 38, 39, 40, 41, 50, 51, 52, 70, 71) is removably associated to the sterile covering cloth (200, 201 , 202).

8). The sterile set of any one of claims from 1 to 6, characterised in that the collection bag (37, 38, 39, 40, 41, 50, 51, 52, 70, 71) is realised in a single body with the sterile covering cloth (200, 201, 202).

9). A sanitary table (100, 101 , 102) for collecting and disposal of infected materials and the like, of a type comprising at least a work plane, characterised in that the work plane (110, 111, 112) is provided with at least a seating (31, 32, 33, 34, 35, 60, 61, 62, 80, 81) for removably receiving a bag (37, 38, 39, 40, 41, 50, 51, 52, 70, 71) comprised in a sterile covering cloth (200, 201, 202) of the sterile set for collecting infected material and the like of one of claims from 1 to 8.

10). The sanitary table of claim 9, characterised in that it comprises, in the work plane (110), a housing (30) for removably couplably receiving a sterile cannula (36) of the sterile set which is connectable to an aspiration plane for aspirating infected liquid materials, the cannula (36), during the coupling, inserting in a hole (53) afforded in the sterile covering cloth (200) of the sterile set.

11). The table of claim 9 or 10, characterised in that it comprises means associated to the seating (35, 62, 81) for fastening a rigid sterile container (42) of the sterile set for collecting needles and blades.

12). The table of one of claims from 9 to 11 , characterised in that the seating (31 , 32, 33, 34, 35, 60, 61, 62, 80, 81) is a through-seating passing through the work plane (110, 111 , 112).