WO2022201209A1 - Plant and process for sterilizing surgical instruments. - Google Patents
Plant and process for sterilizing surgical instruments. Download PDFInfo
- Publication number
- WO2022201209A1 WO2022201209A1 PCT/IT2022/050060 IT2022050060W WO2022201209A1 WO 2022201209 A1 WO2022201209 A1 WO 2022201209A1 IT 2022050060 W IT2022050060 W IT 2022050060W WO 2022201209 A1 WO2022201209 A1 WO 2022201209A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- container
- instruments
- station
- sterilization
- washing
- Prior art date
Links
- 230000001954 sterilising effect Effects 0.000 title claims abstract description 71
- 238000000034 method Methods 0.000 title claims abstract description 33
- 230000008569 process Effects 0.000 title claims abstract description 27
- 238000004659 sterilization and disinfection Methods 0.000 claims abstract description 83
- 238000005406 washing Methods 0.000 claims abstract description 55
- 238000001035 drying Methods 0.000 claims abstract description 17
- 230000000249 desinfective effect Effects 0.000 claims abstract description 13
- 238000011282 treatment Methods 0.000 claims description 43
- 230000008878 coupling Effects 0.000 claims description 3
- 238000010168 coupling process Methods 0.000 claims description 3
- 238000005859 coupling reaction Methods 0.000 claims description 3
- 230000003749 cleanliness Effects 0.000 claims description 2
- 239000007943 implant Substances 0.000 claims description 2
- 230000003287 optical effect Effects 0.000 claims description 2
- 238000007789 sealing Methods 0.000 claims description 2
- 239000002775 capsule Substances 0.000 description 91
- 239000012530 fluid Substances 0.000 description 9
- 238000003860 storage Methods 0.000 description 4
- 238000009825 accumulation Methods 0.000 description 3
- 230000009471 action Effects 0.000 description 2
- 238000000605 extraction Methods 0.000 description 2
- 230000036512 infertility Effects 0.000 description 2
- 238000011144 upstream manufacturing Methods 0.000 description 2
- 230000004913 activation Effects 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 238000010981 drying operation Methods 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 230000000750 progressive effect Effects 0.000 description 1
- 230000010349 pulsation Effects 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 229920006395 saturated elastomer Polymers 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/24—Apparatus using programmed or automatic operation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/10—Apparatus features
- A61L2202/17—Combination with washing or cleaning means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps
Definitions
- the present invention relates to a plant and a process for sterilizing surgical instruments.
- the plant of the invention allows to carry out the washing, the disinfection and/or drying and the sterilization of surgical instruments.
- the need for human intervention determines a series of inconveniences of various kinds that can affect the safety of the operators at work, the correctness and effectiveness of the performed treatments, the execution times, the need to use particularly specialized personnel, the costs of processing, etc.
- a drawback relates to the movement of the instruments between the different stations, often with the need to introduce the instruments into the chambers set up for one or more treatment phases at the stations of the plant.
- W02019/073500 describes an apparatus and a method for the sterilization of endoscopes.
- the apparatus and method of W02019/073500 allow to carry out the washing, disinfection, sterilization and drying of endoscopes in a single operating station, providing the endoscope sterilized and dried inside a hermetic container.
- W02019/073500 is silent in relation to the treatment of instruments of various types contained in containers.
- the present invention relates to a plant and a process which aim to eliminate the drawbacks of the known art, increasing the safety provided in sterilization, as well as the effectiveness and efficiency of the treatments.
- a plant and a process for washing, disinfection, drying, sterilization, and storage in accordance with the present invention has improved characteristics of use, that is, it determines the most effective execution of the washing, disinfection, drying, sterilization and storage phases, together with obtaining a higher degree of safety, both as regards the sterility of the instruments treated, both for the environments in which the treatment takes place, and for any operators involved in the treatment of the instruments.
- the plant and the process allow an extremely significant increase in the safety relating to the sterility of sterilized instruments thanks to the use of the same capsules as chambers within which the various phases of the washing / disinfection / sterilization treatment take place; the plant and the process allow to optimize the times and resources necessary for the entire washing / disinfection / sterilization treatment, as well as for the final storage thanks to an automated management of the movement of the instruments between the various processing stations and any possible waiting stations; the plant and the process provide for a container in which the instruments can be placed, within containing grids, on at least two different horizontal planes for the treatment, as well as stored and used after treatment, with the possibility of being removed from any of these planes without the need to move the instruments placed on a different plane; it is possible to move the containers between the different stations using an autonomous vehicle, preferably provided with a device for reading and writing codes interacting with corresponding identification elements (for example of the radio frequency or RFID type) present on
- an autonomous vehicle preferably provided with a device for reading and writing codes interacting with
- Figs.l and 2 relate to a possible embodiment of a plant according to the invention, schematically represented, respectively in a plan view from above (Fig.l) and in a perspective view (Fig.2);
- FIG.3A shows a possible embodiment of a structure for containing surgical instruments also called container or capsule in the present description and represented, respectively, in a perspective view in closed configuration (Fig.3A), in an open configuration perspective view (Fig.3B), in a bottom plan view (Fig.3C), in a side view (Fig.3D), in a top plan view (Fig.3E), in a front view (Fig.3F) and in a section view along the line III-III of Fig.3D (Fig.3G);
- FIG.4A shows a possible embodiment of an autonomous vehicle for moving a capsule for containing surgical instruments, shown respectively in a perspective view (Fig.4A ), in a plan view from below (Fig.4B), in a side view (Fig.4C), in a front view (Fig.4D), in another side view in which it supports a structure for containing the instruments (Fig.4E), and in a top plan view (Fig.4F);
- FIGs. 5A, 5B, 5C, 5D show a possible embodiment of a station for washing and disinfecting the outside of the capsule, represented, respectively, in a perspective view (Fig.5A), in a front view (Fig.5B), in a plan view from above (Fig.5C) and in a section view along the line V-V of Fig.5B (Fig.5D);
- FIG.6A shows a possible embodiment of a station for washing and disinfecting the inside of the capsule, represented, respectively, in a first perspective view (Fig.6A), in a second perspective view (Fig.6B), in a front view (Fig.6C), in a side view (Fig.6D) and in a top plan view (Fig.6E);
- Figs. 7A, 7B, 7C are side views with an enlarged detail of the embodiment of the station for washing and disinfecting the inside of the capsule of Figs. 6A-E, shown in three different operating configurations;
- Figs 8A, 8B, 8C, 8D, 8E, 8F show a possible embodiment of a station for the control and the composition of the instruments of the capsule, represented, respectively, in a first perspective view (Fig.8 A), in a second perspective view (Fig.8B), in a front view (Fig.8C), in a top plan view (Fig.8D), in a side view (Fig.8E) and in a sectional view according to the line VIII- VIII of Fig.8E (Fig.8F);
- FIG.9A shows a possible embodiment of a station for the sterilization of the capsule, shown, respectively, in a first perspective view (Fig.9A), in a second perspective view (Fig.9B), in a top plan view (Fig.9C), in a front view (Fig.9D), in a second front view (Fig.9E), in a sectional view according to the line IXf-IXf of Fig.9D (Fig.9F) and in a sectional view along the line IXg-IXg of Fig.9E, with a detail represented also enlarged (Fig.9G).
- Fig.9A shows a possible embodiment of a station for the sterilization of the capsule, shown, respectively, in a first perspective view (Fig.9A), in a second perspective view (Fig.9B), in a top plan view (Fig.9C), in a front view (Fig.9D), in a second front view (Fig.9E), in a sectional view according to the line IXf-IX
- a plant (1) made in accordance with the invention is composed of a plurality of stations delegated to different operating phases of a process of reconditioning of surgical instruments, in which the instruments are handled and treated inside a container or capsule (2).
- the plant (1) represented as an example in the drawings includes: a station (A) for washing and disinfecting the outside of the containers, a station (B) for washing and disinfecting the inside of the containers and the relevant instruments therein contained, a station (C) for the control and reassembly of the set of instruments contained in the capsule and a station (D) for sterilization.
- the plant (1) shown in the drawings is also provided with an accumulation station (V), a final deposit for the capsules (Z), a centralized vacuum unit (H) and a centralized steam unit (S).
- a treatment is carried out on the outside of the capsules (2), which are introduced into the station (A) through a vertically sliding door (42), which defines the entry into the treatment area of the plant (1).
- a vertically sliding door (42) which defines the entry into the treatment area of the plant (1).
- the instruments placed inside the capsule (2) are subjected to washing and disinfection thanks to special connections between the station (B) and the inside of the capsule (2) which allow to use the same capsule (2) as a washing chamber for the instruments in the station (B).
- robotic means are provided which are able to check the contents of the capsule (2) by recognizing the type of instruments contained as well as their state of wear or the presence of anomalies.
- the sterilization station (D) consists of an autoclave apparatus in which the capsule (2) constitutes the sterilization chamber for the instruments.
- the station (D) is provided with an appendix (Dl) which can define an additional support surface for the capsule (2).
- the appendix (Dl) is not represented in Figs 9A-9G in which the sterilization station (D) is illustrated in greater detail than in Figs. 1-2.
- an accumulation station (V) is provided in which the capsules (2) can be positioned waiting to complete the treatment; in practice, since the plant is able to recognize the type of instruments contained in each capsule (2), choices can be made regarding the priority of treatment among the capsules (2) received by the plant (1), leaving in waiting for those to be processed later.
- the accumulation station (V) defines a sort of "lung" which helps to optimize the programming of the treatments to be performed on the various capsules (2).
- the final deposit of the capsules is the position in which the already treated capsules (2) are placed.
- the plant (1) is completed by a centralized vacuum group (H) and a centralized steam group (S) designed to supply all the stations that need these resources, optimizing their total use by eliminating the individual groups which instead they could be provided in the single stations of known type.
- H centralized vacuum group
- S centralized steam group
- Figs. 3A-G shows a possible example of embodiment of the capsule (2), that is the container intended to contain the instruments during the washing / disinfection and sterilization process.
- the capsule (2) is composed of a hermetically sealed container formed by a hollow prismatic body (20) closed by two sealed covers (21), provided with gaskets (22).
- the longitudinal development (or maximum extension) of the body (20) is horizontal, the covers (21) being arranged in correspondence with the two open or head ends (23) of the body (2).
- the accesses (24) can advantageously be provided with valve means suitable for keeping the access closed when not affected by the treatment procedures.
- Inside the body (20) of the capsule (2) there are pairs of grooves (25) placed on opposite sides and suitable for receiving corresponding guides (26) for supporting a drawer (27). In this way it is possible to accommodate inside the capsule (2) two or even more drawers (27) (two in the illustrated non-limiting example) for containing the instruments.
- This particular internal conformation allows the capsule (2) to be used also as a container from which to extract the surgical instruments without difficulty, eliminating a drawback of known containers in which, if the instruments are placed on several layers, it is not possible to extract those placed at the bottom without first having to extract those placed at the top.
- the covers (21) provided on both heads (23) further increase the functionality of the container (2), allowing access from both sides.
- One or more identification elements (28) of the capsule (2) may also be present on the same capsule (2); these identifying elements, which in the example are placed on its lower face, can be of the radio frequency or RFID type. Furthermore, the same identifying elements (28) can be used not only to identify a particular container (2) but also to know the state reached in the reconditioning process by the container and the instruments contained therein. In other words, by making the identification element (28) of the container (2) interact with a corresponding device suitable for obtaining data from said identification element (28) and for entering data (in practice, capable of reading and writing on a corresponding memory), the plant (1) is able to know, for example, the progress of the reconditioning process to independently address the container (2) towards the next stage of the process.
- Figs. 4A-4F show a possible example of an autonomous vehicle (3) for moving a capsule (2).
- the autonomous vehicle (3) allows to implement the management system of the reconditioning procedure using a logistics based on AIV (acronym for Autonomous Intelligent Vehicle) in order to allow, within the clean area, to move the capsules (2) between the various stations of the plant (1) without human intervention and communicating with a central unit and thus defining a system of traceability and programming.
- AIV an Autonomous Intelligent Vehicle
- the vehicle (3) comprises a main body (30) provided with an extensible portion (31) which supports a support plane (32) intended for the capsule (2).
- Hooking means (33) are provided on the support surface and are shaped in such a way as to allow a stable association with the capsule (2); in particular, the coupling means (33) are shaped so as to be fixed to the lower bottom of the capsule (2), interacting with corresponding elements provided at the heads (23) of the capsule (2).
- the vehicle is provided with first motor means (not visible in detail) capable of allowing its movement thanks to a pair of driving wheels (34) and a plurality (four in the example) of pivoting support wheels (35).
- the vehicle (3) is also provided with second motor means (also not visible in the drawings) which can comprise an actuator capable of varying the length of the extensible portion (31) to raise and lower the support surface (32) which carries the capsule (2), as schematically indicated by the double arrow (Y) of Fig. 4E.
- second motor means also not visible in the drawings
- the vehicle (3) is also equipped with one or more antennas (36) to allow wireless data exchange with the central management and control unit of the system (1).
- the management and control unit (not shown in the drawings) comprises data processing means capable of programming and controlling the movement of the vehicle(s) (3) within the plan (1) as well as the management of the entire plant (1) and of the capsules (2) in treatment and to be treated.
- the vehicle (3) also comprises a device (37) capable of interacting with the identification elements (28) provided on the capsules (2); in the drawings, the device (37) is arranged on the upper face of the main body (30) of the vehicle (3), i.e. in an area from which the device manages to interface with the identification elements (28) provided on the capsules (2) and with those provided at the various stations of the plant (1).
- the vehicle (3) (and the central unit that manages the entire plan), interfacing with the element (28) of each capsule (2), is able to know which is the state of treatment in which the capsule (2) with which it interacts, so as to automatically position the same capsule (2) in the station for which it is intended; moreover, the vehicle (3) (and the central unit that manages the entire system) is able to enter data on the identification elements (28) of the capsules (2) to change their status, in order to update the relative data with respect to the progress of the process already carried out by the capsule (2).
- the positioning and conformation of the device (37) capable of interacting with the identification elements (28) may also be different with respect to what is illustrated as an example in the drawings, as well as the conformation and arrangement of the antennas (36) may vary.
- At least one of the dimensions (Ml, M2) that the main body (30) has in plan is smaller than the corresponding opening (L) presented by one or more of the stations (A, B, C, D, V, Z) so as to allow the vehicle (3) to be inserted inside a capsule loading and/or unloading station (2), before or after a related processing or storage phase.
- the double arrow (X) represents the direction of approach/entry (or removal/exit) of the vehicle (3) in a specific station of the system (1)
- the double arrow (Y) represents the direction of vertical movement of the relative support surface (32) to bring the capsule (2) to the correct height and ensure descent release (or ascent pickup) at the respective station.
- Figs. 5A-D show the station (A) for washing and disinfecting the outside of the containers (2).
- the station (A) comprises a support structure (4) crossed by one or more pairs of conveyor belts (40) which, moved by relative motors (41), move the capsule (2) from a first inlet station (Al) placed upstream towards a final station (A4) placed at the exit.
- the structure (4) of the station (A) has a tunnel structure and an entrance door (42) which can consist of a transparent wall which vertically slides as indicated by the double arrow (K).
- the capsule Through the door (42) the capsule is placed in the position upstream of the station (A), represented by the position (Al), delegated to washing; supported by the conveyor belts (40) the capsule (2), after having been washed in the station (Al), passes to the station (A2) for disinfection, then to the station (A3) for drying and then expelled from the station (A) through the final release station (A4).
- the direction followed in the operating path in the station (A) is indicated by the arrow (F).
- the means delegated to the washing, disinfection and drying operations are of a type known to those skilled in the art and therefore not described in detail.
- the reference (43) indicates the means delegated to the supply of washing fluids
- the reference (44) indicates the means delegated to the recovery of the washing fluids
- the reference (45) indicates the shielding / coating means of the capsule (2) during the treatments performed.
- the capsule (2) once released from the station (A) where the exterior is treated, is picked up in the release position (A4) by the vehicle (3) which, having an encumbrance smaller than the width value between the two conveyor belts (40), it manages to pass between them and, placing itself in the area indicated with (46) in Fig. 5D, is able to raise the capsule (2) by means of its support surface (32) for carry it at a next station.
- the vehicle (3) will bring the capsule (2) to a subsequent treatment such as, for example, the treatment of washing and disinfection of the inside of the capsule to be carried out at the station (B) or at the waiting station (V) from which the same capsule will be taken on the occasion of its treatment shift.
- a subsequent treatment such as, for example, the treatment of washing and disinfection of the inside of the capsule to be carried out at the station (B) or at the waiting station (V) from which the same capsule will be taken on the occasion of its treatment shift.
- Figs. 6A-E and 7A-C relate to the station which, in the progressive complete treatment performed by the plan (1), follows the station (A) which treats the outside of the capsule (2), i.e. the station (B) for washing and disinfecting the inside of the containers and contained instruments.
- the station (B) for washing and disinfecting the interior of the capsule (2) comprises a substantially parallelepiped support structure (5) which has an access portion (50) defined by two parallel horizontal guides at one of its minor vertical faces. (51).
- the vehicle (3) can pass through said access portion (50) to arrange the capsule (2) to be treated in the station (B).
- the instruments to be washed and disinfected remain inside the capsule (2) which is used as the washing chamber of the station (B).
- the station (B) is provided with a plurality of connectors (54), which are connected to corresponding ducts (53) which can bidirectionally convey the fluids used for washing and disinfection, as well as be connected to a vacuum pump by means the station to which the capsule is connected.
- the reference (52) indicates the connections to the systems for feeding the fluids necessary for the treatment such as, for example, the centralized vacuum unit (H) or the centralized steam unit (S) mentioned above.
- the ducts (53) and the connectors (54) are represented by the duct (53) and the connector (54) visible in detail, but they can be shaped and arranged to couple stably and tightly with all the accesses (24) presented by the capsule (2); in other words, in correspondence with the four inlets (24) presented by the capsule (2) there will be four corresponding ducts (53), all sized so as to allow the passage of the fluid at the relative operating pressure.
- a duct (53) for depressurization that is a duct connected to the centralized vacuum unit (H), allows to perform a washing by exploiting the cavitation determined by the action of the vacuum on the water present in the capsule (2).
- the bubbles generated by cavitation whose instantaneous collapse generates micro-jets at very high pressure, determines a remarkably incisive washing action, with an unnecessary orderly arrangement of the instruments to be reprocessed which can be placed in a random manner, also allowing for overlapping of the same.
- the station (C) in which the control of the instruments contained in the capsule (2) is carried out is shown in Figs.8A-F.
- the control station (C) comprises a support structure (6, 6’) provided with an appendix (60) where the capsule (2) is placed for the control operations.
- An access portion (61) defined by two parallel horizontal guides (62) is provided in the appendix (60).
- the vehicle (3) can pass through the access portion (61) to arrange the capsule (2) on the appendix (60).
- robotic means are provided which are able to check the contents of the capsule (2) by recognizing the type of instruments contained as well as their state of wear and cleaning or the presence of anomalies.
- the robotic means comprise an articulated arm (63) provided with a gripping member (64) in its distal end.
- the articulated arm (63) is formed by several hinged sections supported by a base (603) placed on an extensible portion (602) which protrudes from a main structure (601) of the robotic means.
- the main structure (601) of the robotic means is delimited on three sides by the structure (6, 6’) and by the appendix (60) of the same structure (6, 6’).
- a first portion (6) of the support structure (6, 6’) is placed at the top
- a second portion (6’) of the support structure (6, 6’) is placed on the right, displaced by 90° with respect to the first (6)
- the appendix (60) is placed at the bottom, displaced by 90° with respect to the second portion (6’).
- a first support plane (67) is provided on the second portion (6’) on which a first video camera (66) fixed to a horizontal crosspiece (65) of the second portion (6’) acts.
- the first camera (66) is able to scan what is placed on the support plane (67).
- first portion (6) there is a second support plane (600) on which a second video camera (69) is acting, fixed to a pair of horizontal crosspieces (68) of the first portion (6).
- the second camera (69) is able to scan what is placed on the second support plane (600).
- the capsule (2) arrived at the station (C) is placed on the appendix (60) and is opened, moving the instruments contained therein, for example an entire drawer (27), on the support plane (67).
- the first camera (66) scans the instruments present on the support plane (67) to provide an indication of their nature and arrangement.
- the data detected by the first video camera (66) are used by the articulated arm (63) to pick up the instruments by means of the gripping member (64); in practice, the scan performed by the first video camera (66) allows the gripping member (64) to pick up an instrument knowing where the instrument is on the plane (67) as well as the type of instrument picked up. Therefore, the gripping member (64) can be moved to take a specific instrument and grasps the instrument at a point compatible with the shape of the instrument itself, or with the relative weight distribution on it.
- the instrument taken from the gripping member (64) is placed on the second support plane (600), where the second camera (69) scans the instrument and, comparing it with a series of sample images, is able to provide information relating to the correctness of the treatments carried out up to that point and on the state of wear of the examined instrument.
- the second camera can perform two types of controls, for example of the type called “shape” and “color”.
- the “shape” control allows to compare the actual shapes of the instrument under examination with a series of archived sample images to check, for example, the sharpness of a blade or the presence of dents to determine the state of wear of the instrument and therefore the functionality requirements of the same.
- the “color” control thanks to a different transmission of the received light, allows to check for any residues and/or stains e therefore to control the previous washing operation.
- the opening of the capsule (2) can be done manually, as can the arrangement of an instrument drawer (27) on the first support plane (67).
- the remaining movement of the instruments is preferably performed by robotic means, in which the extensible portion (602) allows the base (601) and the articulated arm (63) supported by it to be moved vertically, while the articulation of the arm (63) allows to move the gripping member (64) freely between the various areas of the structure (6, 6’).
- the sterilization phase is performed in the sterilization station (D), which consists of an autoclave apparatus in which the capsule (2) constitutes the sterilization chamber for the instruments.
- the instruments therefore remain inside the capsule (2) in all stations of the plant, with the exception of the control station (C) in which the capsule (2) is temporarily opened for an accurate examination of the instruments.
- the sterilization station (D) performs the sterilization of the inside and the outside of the capsule (2) and comprises a substantially parallelepiped support structure (8) which has an access portion (80) in correspondence with one of its minor vertical faces defined by two parallel horizontal guides (81).
- the vehicle (3) can pass through said access portion (80) to arrange the capsule (2) to be treated in the station (D).
- a first conveyor (84) is provided which carries the capsule (2) inwards, until reaching an internal chamber (82) delimited by a door (84), beyond which a second conveyor (85) is provided and acts which carries the capsule (2) inside the internal chamber (82).
- connectors (86) Inside the internal chamber (82) there are connectors (86) in a number corresponding to the accesses (24) provided on the capsule (2).
- the connectors (86) are four like the accesses of the capsule (2), of which only two are visible in Figs.9F and 9G because they are arranged aligned in pairs.
- each connector (86) is provided with a nozzle terminal (87) which can be coupled with the access (24) of the capsule (2).
- the nozzle terminal (87) is connected to a relative supply duct (88) through which the fluids used for sterilization pass.
- the conduit (88) can be used for saturated steam, for vacuum extraction, or introduction of external air, for example with the succession of air/vacuum pulsations in the final drying phase of the instruments
- the access (24) is connected to the inside of the capsule (2) through an internal conduit (29) for the sterilization of the instruments and of the inside of the capsule itself.
- the internal chamber (82) is equipped with a dispenser (800) connected to a supply line (89) to introduce flows of steam, steam, or air into the chamber (82), to hit the outer walls of the capsule (2) in the sterilization phase.
- the references (802) and (803) of the station (D) schematically represent the means for dispensing and feeding the fluids used for sterilization.
- the sterilization station (D) can be connected to the feeding systems of the fluids necessary for the treatment such as, for example, the centralized vacuum group (H) or the centralized steam group (S) mentioned in precedence.
- the surveys carried out by the robotic means of the station (C) are sent to a central unit (not described or illustrated) which, being connected at least to the vehicles (3) as well as to the stations (A), (B), (C) and (D), can be delegated to the activation and control of the washing, disinfection and sterilization phases in order to perform these operations automatically.
- Means may also be provided for manual entry of commands (for example a keyboard) for programming the vehicles (3), the operating stations (A, B, C, D) and the central unit itself.
- the invention relates to a plant and a process for sterilizing surgical instruments.
- the implant for the sterilization of surgical instruments can be used to carry out the washing, disinfection and sterilization of surgical instruments.
- the plant (1) is characterized in that it comprises:
- an external washing station (A), equipped with means for washing, disinfecting and drying the external walls of said container (2), as well as a release station (A4) for the containers (2);
- an internal washing station (B) provided with: one or more connectors (54) connectable to the accesses (24) of said container (2); washing, disinfection and drying means shaped and acting so as to perform, by means of said connectors (54), the washing, disinfection and drying of the instruments placed inside said container (2); an access portion (50) for said container (2) in which the container (2) can be positioned during the internal washing treatment;
- a sterilization station provided with: one or more connectors (86) connectable to the accesses (24) of said capsule (2); sterilization means shaped and acting so as to perform, by means of said connectors (86), the washing, disinfection and drying of the instruments placed inside said container (2); an access portion (80) for said container (2) in which the container (2) can be positioned to carry out the sterilization treatment;
- one or more autonomous vehicles (3) for the movement of said containers (2) provided with coupling means (33) conformed and arranged so as to allow a stable association with the container (2), as well as motorization means conformed and arranged in such a way as to allow the movement of the autonomous vehicle (3) between said stations (A, B, D) as well as the withdrawal and / or positioning of the container (2) in correspondence with said release station (A4) and said portions of access (50, 80).
- the plant can comprise a station (C) in which the instruments contained in the container (2) are checked by robotic means (63, 64) conformed and arranged so as to manipulate the instruments and optical scanning means (66, 69) conformed and arranged in such a way as to carry out a recognition of the instruments examined and a check of the state of cleanliness and / or wear of the instruments themselves.
- robotic means 63, 64
- optical scanning means 66, 69
- the hooking means (33) of the vehicle (3) for the containers (2) are arranged on a support plane (32), said hooking means (33) being shaped so as to be fixed to the lower bottom of the container (2); said vehicle (3) being provided with first motor means capable of allowing its movement thanks to a pair of driving wheels (34) and a plurality of pivoting support wheels (35), as well as second motor means comprising an actuator capable of raise and lower said support surface (32).
- At least one of the dimensions (Ml, M2) of said vehicle (3) is smaller than the value of an access port (L) provided at said release station (A4) and said access portions (50, 80).
- the container (2) is preferably provided with an identification element provided with a memory support (28) and said vehicle (3) is provided with recognition means (37) of said identification element (28) as well as with means for the exchange of data with the same identification element (28) and the operating stations of the plant (1) so as to record on said identification element (28) information relating to the progress of the sterilization process performed by the container (2).
- the sterilization station (D) can be provided with an internal chamber (82) in which said container (2) is arranged to carry out the sterilization treatment of the instruments placed inside the capsule itself through said connectors (86), as well as the sterilization of the exterior of the container (2) by means of at least one dispenser (800) acting in said internal chamber (82).
- conveyor means (84, 85) can be arranged and acted to transport said container (2) bidirectionally between the access portion (80) and the internal chamber (82).
- the process for the sterilization of surgical instruments can be used in a plant comprising a plurality of operating stations (A, B, C, D) delegated to carry out corresponding operating steps aimed at a treatment of sterilization or included in the treatment itself.
- the process is characterized in that the surgical instruments are contained in a container (2) provided with a hermetic seal and a plurality of accesses (24) which connect the outside of the container with its interior and in that in at least one of said operating stations (A, B, C, D) the instruments are subjected to the related treatment phase inside the same container (2).
- the instruments are subjected to washing, disinfection, drying and sterilization inside said container (2) at at least three different stations (A, B, D).
- the method actually provides for moving the container (2) among the said stations (A, B, C, D) of the plant (1) using an autonomous vehicle (3) provided with hooking means (33) conformed and arranged in such a way as to allow a stable association with the container (2), as well as motorization means conformed and arranged in such a way as to allow the movement of the autonomous vehicle (3) between said stations (A, B, C, D) as well as the withdrawal and / or positioning of the container (2) in correspondence with the stations themselves.
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Abstract
An plant and a process for sterilizing surgical instruments, to carry out the washing, disinfection and sterilization of surgical instruments. The plant comprises: - a plurality of containers (2) suitable for containing the instruments; - an external washing station (A), provided with means for washing, disinfecting and drying the external walls of the containers (2); - an internal washing station (B) provided with one or more connectors (54) connectable to the accesses (24) of the container (2); - a sterilization station (D) provided with: one or more connectors (86) connectable to the accesses (24) of the container (2); - one or more autonomous vehicles (3) for handling the containers (2) conformed and arranged so as to move between said stations (A, B, D) to pick up and/or position the containers (2).
Description
TITLE
Plant and process for sterilizing surgical instruments.
DESCRIPTION
The present invention relates to a plant and a process for sterilizing surgical instruments. In particular, the plant of the invention allows to carry out the washing, the disinfection and/or drying and the sterilization of surgical instruments.
It is known that the use of surgical instruments requires washing and disinfection/sterilization operations to allow safe reuse of the instruments.
Traditional multi-stage procedures are known which provide for the execution of washing, disinfection and sterilization in different phases and/or operating stations in which the passage of the instruments between the different phases and/or stations requires human intervention.
The need for human intervention determines a series of inconveniences of various kinds that can affect the safety of the operators at work, the correctness and effectiveness of the performed treatments, the execution times, the need to use particularly specialized personnel, the costs of processing, etc.
For example, a drawback relates to the movement of the instruments between the different stations, often with the need to introduce the instruments into the chambers set up for one or more treatment phases at the stations of the plant.
Another drawback relates to the different configuration that the instruments must assume according to the treatment phase to which they are subjected, in particular as a function of the conformation of the station chamber dedicated to this treatment phase. W02019/073500 describes an apparatus and a method for the sterilization of endoscopes. In particular, the apparatus and method of W02019/073500 allow to carry out the washing, disinfection, sterilization and drying of endoscopes in a single operating station, providing the endoscope sterilized and dried inside a hermetic container. Although innovative as regards the treatment of endoscopes, W02019/073500 is silent in relation to the treatment of instruments of various types contained in containers.
The present invention relates to a plant and a process which aim to eliminate the drawbacks of the known art, increasing the safety provided in sterilization, as well as the effectiveness and efficiency of the treatments.
This result has been achieved, in accordance with the present invention, by adopting the
idea of realizing a plant and a process having the features of independent claims. Other features of the present invention are described in the dependent claims.
Advantageously, a plant and a process for washing, disinfection, drying, sterilization, and storage in accordance with the present invention has improved characteristics of use, that is, it determines the most effective execution of the washing, disinfection, drying, sterilization and storage phases, together with obtaining a higher degree of safety, both as regards the sterility of the instruments treated, both for the environments in which the treatment takes place, and for any operators involved in the treatment of the instruments. Among the advantages of the present invention the following can therefore be listed by way of non-limiting: the plant and the process allow an extremely significant increase in the safety relating to the sterility of sterilized instruments thanks to the use of the same capsules as chambers within which the various phases of the washing / disinfection / sterilization treatment take place; the plant and the process allow to optimize the times and resources necessary for the entire washing / disinfection / sterilization treatment, as well as for the final storage thanks to an automated management of the movement of the instruments between the various processing stations and any possible waiting stations; the plant and the process provide for a container in which the instruments can be placed, within containing grids, on at least two different horizontal planes for the treatment, as well as stored and used after treatment, with the possibility of being removed from any of these planes without the need to move the instruments placed on a different plane; it is possible to move the containers between the different stations using an autonomous vehicle, preferably provided with a device for reading and writing codes interacting with corresponding identification elements (for example of the radio frequency or RFID type) present on the containers and in correspondence of the plant stations, so as to allow the univocal identification of each container and the relative stage of treatment performed or to be performed.
These and further advantages and features of the present invention will be better understood by every person skilled in the art thanks to the following description and the attached drawings, provided by way of example but not to be considered in a limiting sense, in which:
- Figs.l and 2 relate to a possible embodiment of a plant according to the invention, schematically represented, respectively in a plan view from above (Fig.l) and in a
perspective view (Fig.2);
- Figs. 3A, 3B, 3C, 3D, 3E, 3F, 3G show a possible embodiment of a structure for containing surgical instruments also called container or capsule in the present description and represented, respectively, in a perspective view in closed configuration (Fig.3A), in an open configuration perspective view (Fig.3B), in a bottom plan view (Fig.3C), in a side view (Fig.3D), in a top plan view (Fig.3E), in a front view (Fig.3F) and in a section view along the line III-III of Fig.3D (Fig.3G);
- Figs. 4A, 4B, 4C, 4D, 4E, 4F show a possible embodiment of an autonomous vehicle for moving a capsule for containing surgical instruments, shown respectively in a perspective view (Fig.4A ), in a plan view from below (Fig.4B), in a side view (Fig.4C), in a front view (Fig.4D), in another side view in which it supports a structure for containing the instruments (Fig.4E), and in a top plan view (Fig.4F);
- Figs. 5A, 5B, 5C, 5D show a possible embodiment of a station for washing and disinfecting the outside of the capsule, represented, respectively, in a perspective view (Fig.5A), in a front view (Fig.5B), in a plan view from above (Fig.5C) and in a section view along the line V-V of Fig.5B (Fig.5D);
- Figs. 6A, 6B, 6C, 6D, 6E show a possible embodiment of a station for washing and disinfecting the inside of the capsule, represented, respectively, in a first perspective view (Fig.6A), in a second perspective view (Fig.6B), in a front view (Fig.6C), in a side view (Fig.6D) and in a top plan view (Fig.6E);
- Figs. 7A, 7B, 7C are side views with an enlarged detail of the embodiment of the station for washing and disinfecting the inside of the capsule of Figs. 6A-E, shown in three different operating configurations;
- Figs 8A, 8B, 8C, 8D, 8E, 8F show a possible embodiment of a station for the control and the composition of the instruments of the capsule, represented, respectively, in a first perspective view (Fig.8 A), in a second perspective view (Fig.8B), in a front view (Fig.8C), in a top plan view (Fig.8D), in a side view (Fig.8E) and in a sectional view according to the line VIII- VIII of Fig.8E (Fig.8F);
- Figs. 9A, 9B, 9C, 9D, 9E, 9F, 9G show a possible embodiment of a station for the sterilization of the capsule, shown, respectively, in a first perspective view (Fig.9A), in a second perspective view (Fig.9B), in a top plan view (Fig.9C), in a front view (Fig.9D), in a second front view (Fig.9E), in a sectional view according to the line IXf-IXf of Fig.9D (Fig.9F) and in a sectional view along the line IXg-IXg of Fig.9E, with a detail
represented also enlarged (Fig.9G).
With reference to the drawings of the attached figures, a plant (1) made in accordance with the invention is composed of a plurality of stations delegated to different operating phases of a process of reconditioning of surgical instruments, in which the instruments are handled and treated inside a container or capsule (2).
In particular, the plant (1) represented as an example in the drawings includes: a station (A) for washing and disinfecting the outside of the containers, a station (B) for washing and disinfecting the inside of the containers and the relevant instruments therein contained, a station (C) for the control and reassembly of the set of instruments contained in the capsule and a station (D) for sterilization. The plant (1) shown in the drawings is also provided with an accumulation station (V), a final deposit for the capsules (Z), a centralized vacuum unit (H) and a centralized steam unit (S).
In practice, in the plant (1) the instruments are subjected to the whole reconditioning process always remaining in the same area, which will therefore have the same level of environment classification. This feature greatly simplifies the management of the area avoiding the three classic zones (dirty, clean, sterile) used in the today’s sterilization stations.
In the station (A) for washing and disinfecting the outside of the containers, a treatment is carried out on the outside of the capsules (2), which are introduced into the station (A) through a vertically sliding door (42), which defines the entry into the treatment area of the plant (1). In other words, from the door (42) downstream, i.e. according to the progress of the treatment, the capsule (2) will always remain within an area having the same contamination level.
In the station (B) for washing and disinfecting the inside of the containers and the contained instruments, as will be better described below, the instruments placed inside the capsule (2) are subjected to washing and disinfection thanks to special connections between the station (B) and the inside of the capsule (2) which allow to use the same capsule (2) as a washing chamber for the instruments in the station (B).
In station (C) robotic means are provided which are able to check the contents of the capsule (2) by recognizing the type of instruments contained as well as their state of wear or the presence of anomalies.
The sterilization station (D) consists of an autoclave apparatus in which the capsule (2) constitutes the sterilization chamber for the instruments. In the drawings of Figs.1-2, the
station (D) is provided with an appendix (Dl) which can define an additional support surface for the capsule (2). The appendix (Dl) is not represented in Figs 9A-9G in which the sterilization station (D) is illustrated in greater detail than in Figs. 1-2.
In the example of plant (1) shown in Figs.l and 2, an accumulation station (V) is provided in which the capsules (2) can be positioned waiting to complete the treatment; in practice, since the plant is able to recognize the type of instruments contained in each capsule (2), choices can be made regarding the priority of treatment among the capsules (2) received by the plant (1), leaving in waiting for those to be processed later. The accumulation station (V) defines a sort of "lung" which helps to optimize the programming of the treatments to be performed on the various capsules (2).
The final deposit of the capsules, identified with (Z) in the drawings, is the position in which the already treated capsules (2) are placed.
The plant (1) is completed by a centralized vacuum group (H) and a centralized steam group (S) designed to supply all the stations that need these resources, optimizing their total use by eliminating the individual groups which instead they could be provided in the single stations of known type.
Figs. 3A-G shows a possible example of embodiment of the capsule (2), that is the container intended to contain the instruments during the washing / disinfection and sterilization process. In particular, the capsule (2) is composed of a hermetically sealed container formed by a hollow prismatic body (20) closed by two sealed covers (21), provided with gaskets (22).
The longitudinal development (or maximum extension) of the body (20) is horizontal, the covers (21) being arranged in correspondence with the two open or head ends (23) of the body (2). On the heads (23) there are also a series of access openings (24) which can be used for the introduction into the capsule (2) of fluids and for their extraction, for example during the washing / disinfection and sterilization phases. The accesses (24) can advantageously be provided with valve means suitable for keeping the access closed when not affected by the treatment procedures. Inside the body (20) of the capsule (2) there are pairs of grooves (25) placed on opposite sides and suitable for receiving corresponding guides (26) for supporting a drawer (27). In this way it is possible to accommodate inside the capsule (2) two or even more drawers (27) (two in the illustrated non-limiting example) for containing the instruments. This particular internal conformation allows the capsule (2) to be used also as a container from which to extract
the surgical instruments without difficulty, eliminating a drawback of known containers in which, if the instruments are placed on several layers, it is not possible to extract those placed at the bottom without first having to extract those placed at the top. Furthermore, the covers (21) provided on both heads (23) further increase the functionality of the container (2), allowing access from both sides.
One or more identification elements (28) of the capsule (2) may also be present on the same capsule (2); these identifying elements, which in the example are placed on its lower face, can be of the radio frequency or RFID type. Furthermore, the same identifying elements (28) can be used not only to identify a particular container (2) but also to know the state reached in the reconditioning process by the container and the instruments contained therein. In other words, by making the identification element (28) of the container (2) interact with a corresponding device suitable for obtaining data from said identification element (28) and for entering data (in practice, capable of reading and writing on a corresponding memory), the plant (1) is able to know, for example, the progress of the reconditioning process to independently address the container (2) towards the next stage of the process.
Figs. 4A-4F show a possible example of an autonomous vehicle (3) for moving a capsule (2).
The autonomous vehicle (3) allows to implement the management system of the reconditioning procedure using a logistics based on AIV (acronym for Autonomous Intelligent Vehicle) in order to allow, within the clean area, to move the capsules (2) between the various stations of the plant (1) without human intervention and communicating with a central unit and thus defining a system of traceability and programming.
The vehicle (3) comprises a main body (30) provided with an extensible portion (31) which supports a support plane (32) intended for the capsule (2). Hooking means (33) are provided on the support surface and are shaped in such a way as to allow a stable association with the capsule (2); in particular, the coupling means (33) are shaped so as to be fixed to the lower bottom of the capsule (2), interacting with corresponding elements provided at the heads (23) of the capsule (2). The vehicle is provided with first motor means (not visible in detail) capable of allowing its movement thanks to a pair of driving wheels (34) and a plurality (four in the example) of pivoting support wheels (35). The vehicle (3) is also provided with second motor means (also not visible in the
drawings) which can comprise an actuator capable of varying the length of the extensible portion (31) to raise and lower the support surface (32) which carries the capsule (2), as schematically indicated by the double arrow (Y) of Fig. 4E.
The vehicle (3) is also equipped with one or more antennas (36) to allow wireless data exchange with the central management and control unit of the system (1). The management and control unit (not shown in the drawings) comprises data processing means capable of programming and controlling the movement of the vehicle(s) (3) within the plan (1) as well as the management of the entire plant (1) and of the capsules (2) in treatment and to be treated.
The vehicle (3) also comprises a device (37) capable of interacting with the identification elements (28) provided on the capsules (2); in the drawings, the device (37) is arranged on the upper face of the main body (30) of the vehicle (3), i.e. in an area from which the device manages to interface with the identification elements (28) provided on the capsules (2) and with those provided at the various stations of the plant (1).
In practice, the vehicle (3) (and the central unit that manages the entire plan), interfacing with the element (28) of each capsule (2), is able to know which is the state of treatment in which the capsule (2) with which it interacts, so as to automatically position the same capsule (2) in the station for which it is intended; moreover, the vehicle (3) (and the central unit that manages the entire system) is able to enter data on the identification elements (28) of the capsules (2) to change their status, in order to update the relative data with respect to the progress of the process already carried out by the capsule (2). The positioning and conformation of the device (37) capable of interacting with the identification elements (28) may also be different with respect to what is illustrated as an example in the drawings, as well as the conformation and arrangement of the antennas (36) may vary.
Advantageously, at least one of the dimensions (Ml, M2) that the main body (30) has in plan is smaller than the corresponding opening (L) presented by one or more of the stations (A, B, C, D, V, Z) so as to allow the vehicle (3) to be inserted inside a capsule loading and/or unloading station (2), before or after a related processing or storage phase. In the drawings, the double arrow (X) represents the direction of approach/entry (or removal/exit) of the vehicle (3) in a specific station of the system (1), while the double arrow (Y) represents the direction of vertical movement of the relative support
surface (32) to bring the capsule (2) to the correct height and ensure descent release (or ascent pickup) at the respective station.
Figs. 5A-D show the station (A) for washing and disinfecting the outside of the containers (2).
The station (A) comprises a support structure (4) crossed by one or more pairs of conveyor belts (40) which, moved by relative motors (41), move the capsule (2) from a first inlet station (Al) placed upstream towards a final station (A4) placed at the exit. The structure (4) of the station (A) has a tunnel structure and an entrance door (42) which can consist of a transparent wall which vertically slides as indicated by the double arrow (K). Through the door (42) the capsule is placed in the position upstream of the station (A), represented by the position (Al), delegated to washing; supported by the conveyor belts (40) the capsule (2), after having been washed in the station (Al), passes to the station (A2) for disinfection, then to the station (A3) for drying and then expelled from the station (A) through the final release station (A4). The direction followed in the operating path in the station (A) is indicated by the arrow (F). The means delegated to the washing, disinfection and drying operations are of a type known to those skilled in the art and therefore not described in detail. By way of example, the reference (43) indicates the means delegated to the supply of washing fluids, the reference (44) indicates the means delegated to the recovery of the washing fluids and the reference (45) indicates the shielding / coating means of the capsule (2) during the treatments performed.
The capsule (2), once released from the station (A) where the exterior is treated, is picked up in the release position (A4) by the vehicle (3) which, having an encumbrance smaller than the width value between the two conveyor belts (40), it manages to pass between them and, placing itself in the area indicated with (46) in Fig. 5D, is able to raise the capsule (2) by means of its support surface (32) for carry it at a next station. Based on the type of instruments contained in the capsule (2), or on the basis of the priority with which it is established to treat the instruments, the vehicle (3) will bring the capsule (2) to a subsequent treatment such as, for example, the treatment of washing and disinfection of the inside of the capsule to be carried out at the station (B) or at the waiting station (V) from which the same capsule will be taken on the occasion of its treatment shift.
Figs. 6A-E and 7A-C relate to the station which, in the progressive complete treatment
performed by the plan (1), follows the station (A) which treats the outside of the capsule (2), i.e. the station (B) for washing and disinfecting the inside of the containers and contained instruments.
The station (B) for washing and disinfecting the interior of the capsule (2) comprises a substantially parallelepiped support structure (5) which has an access portion (50) defined by two parallel horizontal guides at one of its minor vertical faces. (51). The vehicle (3) can pass through said access portion (50) to arrange the capsule (2) to be treated in the station (B).
The instruments to be washed and disinfected remain inside the capsule (2) which is used as the washing chamber of the station (B).
The station (B) is provided with a plurality of connectors (54), which are connected to corresponding ducts (53) which can bidirectionally convey the fluids used for washing and disinfection, as well as be connected to a vacuum pump by means the station to which the capsule is connected. In the drawings, the reference (52) indicates the connections to the systems for feeding the fluids necessary for the treatment such as, for example, the centralized vacuum unit (H) or the centralized steam unit (S) mentioned above. To simplify the drawings, the ducts (53) and the connectors (54) are represented by the duct (53) and the connector (54) visible in detail, but they can be shaped and arranged to couple stably and tightly with all the accesses (24) presented by the capsule (2); in other words, in correspondence with the four inlets (24) presented by the capsule (2) there will be four corresponding ducts (53), all sized so as to allow the passage of the fluid at the relative operating pressure. The possibility of using also a duct (53) for depressurization, that is a duct connected to the centralized vacuum unit (H), allows to perform a washing by exploiting the cavitation determined by the action of the vacuum on the water present in the capsule (2). In practice, the bubbles generated by cavitation, whose instantaneous collapse generates micro-jets at very high pressure, determines a remarkably incisive washing action, with an unnecessary orderly arrangement of the instruments to be reprocessed which can be placed in a random manner, also allowing for overlapping of the same.
The station (C) in which the control of the instruments contained in the capsule (2) is carried out is shown in Figs.8A-F.
The control station (C) comprises a support structure (6, 6’) provided with an appendix (60) where the capsule (2) is placed for the control operations. An access portion (61)
defined by two parallel horizontal guides (62) is provided in the appendix (60). The vehicle (3) can pass through the access portion (61) to arrange the capsule (2) on the appendix (60).
In station (C) robotic means are provided which are able to check the contents of the capsule (2) by recognizing the type of instruments contained as well as their state of wear and cleaning or the presence of anomalies.
The robotic means comprise an articulated arm (63) provided with a gripping member (64) in its distal end. The articulated arm (63) is formed by several hinged sections supported by a base (603) placed on an extensible portion (602) which protrudes from a main structure (601) of the robotic means.
The main structure (601) of the robotic means is delimited on three sides by the structure (6, 6’) and by the appendix (60) of the same structure (6, 6’). In particular, with reference to the positioning of Fig.8D in which the structure (601) of the robotic means is in the center, a first portion (6) of the support structure (6, 6’) is placed at the top, a second portion (6’) of the support structure (6, 6’) is placed on the right, displaced by 90° with respect to the first (6), and the appendix (60) is placed at the bottom, displaced by 90° with respect to the second portion (6’).
A first support plane (67) is provided on the second portion (6’) on which a first video camera (66) fixed to a horizontal crosspiece (65) of the second portion (6’) acts. The first camera (66) is able to scan what is placed on the support plane (67).
On the first portion (6) there is a second support plane (600) on which a second video camera (69) is acting, fixed to a pair of horizontal crosspieces (68) of the first portion (6). The second camera (69) is able to scan what is placed on the second support plane (600).
During the operation of the plant (1), the capsule (2) arrived at the station (C) is placed on the appendix (60) and is opened, moving the instruments contained therein, for example an entire drawer (27), on the support plane (67).
The first camera (66) scans the instruments present on the support plane (67) to provide an indication of their nature and arrangement. The data detected by the first video camera (66) are used by the articulated arm (63) to pick up the instruments by means of the gripping member (64); in practice, the scan performed by the first video camera (66) allows the gripping member (64) to pick up an instrument knowing where the instrument is on the plane (67) as well as the type of instrument picked up. Therefore,
the gripping member (64) can be moved to take a specific instrument and grasps the instrument at a point compatible with the shape of the instrument itself, or with the relative weight distribution on it.
The instrument taken from the gripping member (64) is placed on the second support plane (600), where the second camera (69) scans the instrument and, comparing it with a series of sample images, is able to provide information relating to the correctness of the treatments carried out up to that point and on the state of wear of the examined instrument. The second camera can perform two types of controls, for example of the type called “shape” and “color”. The “shape” control allows to compare the actual shapes of the instrument under examination with a series of archived sample images to check, for example, the sharpness of a blade or the presence of dents to determine the state of wear of the instrument and therefore the functionality requirements of the same. The “color” control, thanks to a different transmission of the received light, allows to check for any residues and/or stains e therefore to control the previous washing operation.
The opening of the capsule (2) can be done manually, as can the arrangement of an instrument drawer (27) on the first support plane (67). The remaining movement of the instruments is preferably performed by robotic means, in which the extensible portion (602) allows the base (601) and the articulated arm (63) supported by it to be moved vertically, while the articulation of the arm (63) allows to move the gripping member (64) freely between the various areas of the structure (6, 6’).
In the process performed by the plant (1), the sterilization phase is performed in the sterilization station (D), which consists of an autoclave apparatus in which the capsule (2) constitutes the sterilization chamber for the instruments. The instruments therefore remain inside the capsule (2) in all stations of the plant, with the exception of the control station (C) in which the capsule (2) is temporarily opened for an accurate examination of the instruments.
The sterilization station (D) performs the sterilization of the inside and the outside of the capsule (2) and comprises a substantially parallelepiped support structure (8) which has an access portion (80) in correspondence with one of its minor vertical faces defined by two parallel horizontal guides (81). The vehicle (3) can pass through said access portion (80) to arrange the capsule (2) to be treated in the station (D).
The instruments to be sterilized always remain inside the capsule (2) which, as
previously mentioned, is therefore used as a sterilization chamber for the instruments. Inside the structure (8), in correspondence with the access portion (80), a first conveyor (84) is provided which carries the capsule (2) inwards, until reaching an internal chamber (82) delimited by a door (84), beyond which a second conveyor (85) is provided and acts which carries the capsule (2) inside the internal chamber (82).
Inside the internal chamber (82) there are connectors (86) in a number corresponding to the accesses (24) provided on the capsule (2). In the example of the drawings, the connectors (86) are four like the accesses of the capsule (2), of which only two are visible in Figs.9F and 9G because they are arranged aligned in pairs.
As better visible in the enlarged detail of Fig.9G, each connector (86) is provided with a nozzle terminal (87) which can be coupled with the access (24) of the capsule (2). The nozzle terminal (87) is connected to a relative supply duct (88) through which the fluids used for sterilization pass. For example, the conduit (88) can be used for saturated steam, for vacuum extraction, or introduction of external air, for example with the succession of air/vacuum pulsations in the final drying phase of the instruments The access (24) is connected to the inside of the capsule (2) through an internal conduit (29) for the sterilization of the instruments and of the inside of the capsule itself.
Station (D) also provides for the sterilization of the outside of the capsule (2); for this reason, the internal chamber (82) is equipped with a dispenser (800) connected to a supply line (89) to introduce flows of steam, steam, or air into the chamber (82), to hit the outer walls of the capsule (2) in the sterilization phase.
In the drawings, the references (802) and (803) of the station (D) schematically represent the means for dispensing and feeding the fluids used for sterilization. Similarly to what is foreseen for other stations, also the sterilization station (D) can be connected to the feeding systems of the fluids necessary for the treatment such as, for example, the centralized vacuum group (H) or the centralized steam group (S) mentioned in precedence.
In the attached drawings some details have not been shown in detail such as, for example, the connection and control devices between the components mentioned; by way of example, the surveys carried out by the robotic means of the station (C) are sent to a central unit (not described or illustrated) which, being connected at least to the vehicles (3) as well as to the stations (A), (B), (C) and (D), can be delegated to the activation and control of the washing, disinfection and sterilization phases in order to
perform these operations automatically. Means may also be provided for manual entry of commands (for example a keyboard) for programming the vehicles (3), the operating stations (A, B, C, D) and the central unit itself.
In conclusion, it is therefore possible to state that the invention relates to a plant and a process for sterilizing surgical instruments.
As indicated above and in the following claims, the implant for the sterilization of surgical instruments can be used to carry out the washing, disinfection and sterilization of surgical instruments.
The plant (1) is characterized in that it comprises:
- a plurality of containers (2) suitable for containing the instruments, provided with hermetic sealing and with a plurality of accesses (24) which connect the outside of the container with its inside;
- an external washing station (A), equipped with means for washing, disinfecting and drying the external walls of said container (2), as well as a release station (A4) for the containers (2);
- an internal washing station (B) provided with: one or more connectors (54) connectable to the accesses (24) of said container (2); washing, disinfection and drying means shaped and acting so as to perform, by means of said connectors (54), the washing, disinfection and drying of the instruments placed inside said container (2); an access portion (50) for said container (2) in which the container (2) can be positioned during the internal washing treatment;
- a sterilization station (D) provided with: one or more connectors (86) connectable to the accesses (24) of said capsule (2); sterilization means shaped and acting so as to perform, by means of said connectors (86), the washing, disinfection and drying of the instruments placed inside said container (2); an access portion (80) for said container (2) in which the container (2) can be positioned to carry out the sterilization treatment;
- one or more autonomous vehicles (3) for the movement of said containers (2), provided with coupling means (33) conformed and arranged so as to allow a stable association with the container (2), as well as motorization means conformed and arranged in such a way as to allow the movement of the autonomous vehicle (3)
between said stations (A, B, D) as well as the withdrawal and / or positioning of the container (2) in correspondence with said release station (A4) and said portions of access (50, 80).
The plant can comprise a station (C) in which the instruments contained in the container (2) are checked by robotic means (63, 64) conformed and arranged so as to manipulate the instruments and optical scanning means (66, 69) conformed and arranged in such a way as to carry out a recognition of the instruments examined and a check of the state of cleanliness and / or wear of the instruments themselves.
The hooking means (33) of the vehicle (3) for the containers (2) are arranged on a support plane (32), said hooking means (33) being shaped so as to be fixed to the lower bottom of the container (2); said vehicle (3) being provided with first motor means capable of allowing its movement thanks to a pair of driving wheels (34) and a plurality of pivoting support wheels (35), as well as second motor means comprising an actuator capable of raise and lower said support surface (32).
Furthermore, at least one of the dimensions (Ml, M2) of said vehicle (3) is smaller than the value of an access port (L) provided at said release station (A4) and said access portions (50, 80).
The container (2) is preferably provided with an identification element provided with a memory support (28) and said vehicle (3) is provided with recognition means (37) of said identification element (28) as well as with means for the exchange of data with the same identification element (28) and the operating stations of the plant (1) so as to record on said identification element (28) information relating to the progress of the sterilization process performed by the container (2).
The sterilization station (D) can be provided with an internal chamber (82) in which said container (2) is arranged to carry out the sterilization treatment of the instruments placed inside the capsule itself through said connectors (86), as well as the sterilization of the exterior of the container (2) by means of at least one dispenser (800) acting in said internal chamber (82). Between said access portion (80) and said internal chamber (82) conveyor means (84, 85) can be arranged and acted to transport said container (2) bidirectionally between the access portion (80) and the internal chamber (82).
As indicated above and in the following claims, the process for the sterilization of surgical instruments can be used in a plant comprising a plurality of operating stations (A, B, C, D) delegated to carry out corresponding operating steps aimed at a treatment
of sterilization or included in the treatment itself.
The process is characterized in that the surgical instruments are contained in a container (2) provided with a hermetic seal and a plurality of accesses (24) which connect the outside of the container with its interior and in that in at least one of said operating stations (A, B, C, D) the instruments are subjected to the related treatment phase inside the same container (2).
In particular, the instruments are subjected to washing, disinfection, drying and sterilization inside said container (2) at at least three different stations (A, B, D). Furthermore, the method actually provides for moving the container (2) among the said stations (A, B, C, D) of the plant (1) using an autonomous vehicle (3) provided with hooking means (33) conformed and arranged in such a way as to allow a stable association with the container (2), as well as motorization means conformed and arranged in such a way as to allow the movement of the autonomous vehicle (3) between said stations (A, B, C, D) as well as the withdrawal and / or positioning of the container (2) in correspondence with the stations themselves.
The details of execution can in any case vary in an equivalent manner in the shape, dimensions, arrangement of the elements, nature of the materials used, without however departing from the scope of the idea of the solution adopted or of the inventive concept and therefore remaining within the limits of the protection granted by the claims.
Claims
1. Plant for sterilizing surgical instruments to carry out the washing, disinfection and sterilization of surgical instruments, an implant characterized in that it includes:
- a plurality of containers (2) apt to contain the instruments, provided with hermetic sealing and with a plurality of accesses (24) which connect the outside of the container with its interior;
- an external washing station (A), provided with means for washing, disinfecting and drying the external walls of said containers (2), as well as a release station (A4) for the containers (2);
- an internal washing station (B) provided with: one or more connectors (54) connectable to the accesses (24) of said container (2); washing, disinfection and drying means conformed and acting so as to perform, by means of said connectors (54), the washing, disinfection and drying of the instruments placed inside said container (2); an access portion (50) for said container (2) in which the container (2) can be positioned during the internal washing treatment;
- a sterilization station (D) provided with: one or more connectors (86) connectable to the accesses (24) of said container (2); sterilization means shaped and acting so as to perform, by means of said connectors (86), the washing, disinfection and drying of the instruments placed inside said container (2); an access portion (80) for said container (2) in which the container (2) can be positioned to carry out the sterilization treatment;
- one or more autonomous vehicles (3) for the movement of said containers (2), provided with hooking means (33) conformed and arranged so as to allow a stable association with the container (2), as well as motorization means conformed and arranged in such a way as to allow the movement of the autonomous vehicle (3) between said stations (A, B, D) as well as the collection and / or positioning of the container (2) in correspondence with said release station (A4) and said portions of access (50, 80).
2. Plan for sterilizing surgical instruments according to claim 1, characterized in that it comprises a station (C) in which the instruments contained in the container (2) are controlled by robotic means (63, 64) conformed and arranged in so as to manipulate the
instruments and optical scanning means (66, 69) conformed and arranged so as to carry out a recognition of the instruments examined and a check of the state of cleanliness and / or wear of the instruments themselves.
3. Plan for sterilizing surgical instruments according to claim 1 and / or 2, characterized in that said hooking means (33) of the vehicle (3) for the containers (2) are arranged on a support surface (32), said hooking means (33) being conformed so as to be fixed to the lower bottom of the container (2); said vehicle (3) being provided with first motor means capable of allowing its movement thanks to drive wheels (34) and a plurality of pivoting support wheels (35), as well as second motor means comprising an actuator capable of raising and lowering said support surface (32).
4. Plan for sterilizing surgical instruments according to one or more of the preceding claims, characterized in that at least one of the dimensions (Ml, M2) of said vehicle (3) is smaller than the value of an access port (L) provided at said release station (A4) and said access portions (50, 80).
5. Plan for sterilizing surgical instruments according to one or more of the preceding claims, characterized in that said container (2) is provided with an identification element provided with a memory support (28) and that said vehicle (3) is provided means for recognizing (37) said identification element (28) as well as means for exchanging data with the same identification element (28) and the operating stations of the plant (1) so as to record on said identification element (28) information relating to the progress of the sterilization process performed by the container (2).
6. Plan for sterilizing surgical instruments according to one or more of the preceding claims, characterized in that said sterilization station (D) is provided with an internal chamber (82) in which said container (2) is arranged to carry out the treatment sterilization of the instruments placed inside the container itself through said connectors (86), as well as the sterilization of the outside of the container (2) through at least one dispenser (800) acting in said internal chamber (82).
7. Plan for sterilizing surgical instruments according to claim 6, characterized in that in said sterilization station (D) between said access portion (80) and said internal chamber (82) are arranged and acted conveyor means (84, 85) conformed to bidirectionally transport said container (2) between the access portion (80) and the internal chamber (82).
8. Process for sterilizing surgical instruments in a plant comprising a plurality of
operating stations (A, B, C, D) delegated to carry out corresponding operating phases aimed at a sterilization treatment or included in the treatment itself, a process characterized in that the surgical instruments are contained in a container (2) provided with a hermetic seal and a plurality of accesses (24) that connect the outside of the container with its interior and in that in at least one of said operating stations (A, B, C, D) the instruments are subjected to the related treatment phase inside the same container (2).
9. Process for sterilizing surgical instruments according to claim 8, characterized in that the instruments are subjected to washing, disinfection, drying and sterilization inside said container (2) at at least three different stations (A, B, D).
10. Process for sterilizing surgical instruments according to claim 8 and/or 9, characterized by moving said container (2) between said stations (A, B, C, D) of the plant (1) using a vehicle autonomous (3) provided with coupling means (33) conformed and arranged so as to allow a stable association with the container (2), as well as motorization means conformed and arranged so as to allow the movement of the autonomous vehicle (3) between the said stations (A, B, C, D) as well as the withdrawal and / or positioning of the container (2) in correspondence with the stations themselves.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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IT102021000007223 | 2021-03-25 | ||
IT102021000007223A IT202100007223A1 (en) | 2021-03-25 | 2021-03-25 | PLANT AND PROCEDURE FOR STERILIZATION OF SURGICAL INSTRUMENTS. |
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WO2022201209A1 true WO2022201209A1 (en) | 2022-09-29 |
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PCT/IT2022/050060 WO2022201209A1 (en) | 2021-03-25 | 2022-03-21 | Plant and process for sterilizing surgical instruments. |
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IT (1) | IT202100007223A1 (en) |
WO (1) | WO2022201209A1 (en) |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1733108A1 (en) * | 2005-02-09 | 2006-12-20 | Luki AB | Sterilization plant, extension module and method of increasing the capacity for a sterilization plant |
EP2501321A2 (en) * | 2009-11-18 | 2012-09-26 | Steelco Spa | Device to transport medical instruments |
WO2016186502A2 (en) * | 2015-05-21 | 2016-11-24 | Nikinc Holding B.V. | Decontamination device and method for medical instruments |
US20180169286A1 (en) * | 2013-03-13 | 2018-06-21 | Stryker Corporation | Sterilization Container Capable Of Providing An Indication Regarding Whether Or Not Surgical Instruments Sterilized In The Container Were Properly Sterilized |
WO2019073500A1 (en) * | 2017-10-13 | 2019-04-18 | Cisa Production S.R.L. | Method and apparatus for sterilizing endoscopes |
-
2021
- 2021-03-25 IT IT102021000007223A patent/IT202100007223A1/en unknown
-
2022
- 2022-03-21 WO PCT/IT2022/050060 patent/WO2022201209A1/en active Application Filing
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1733108A1 (en) * | 2005-02-09 | 2006-12-20 | Luki AB | Sterilization plant, extension module and method of increasing the capacity for a sterilization plant |
EP2501321A2 (en) * | 2009-11-18 | 2012-09-26 | Steelco Spa | Device to transport medical instruments |
US20180169286A1 (en) * | 2013-03-13 | 2018-06-21 | Stryker Corporation | Sterilization Container Capable Of Providing An Indication Regarding Whether Or Not Surgical Instruments Sterilized In The Container Were Properly Sterilized |
WO2016186502A2 (en) * | 2015-05-21 | 2016-11-24 | Nikinc Holding B.V. | Decontamination device and method for medical instruments |
WO2019073500A1 (en) * | 2017-10-13 | 2019-04-18 | Cisa Production S.R.L. | Method and apparatus for sterilizing endoscopes |
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