WO2019038790A1 - Portable regulator group for professional-type irrigation through natural body orifices and related device and kit - Google Patents

Portable regulator group for professional-type irrigation through natural body orifices and related device and kit Download PDF

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Publication number
WO2019038790A1
WO2019038790A1 PCT/IT2017/000176 IT2017000176W WO2019038790A1 WO 2019038790 A1 WO2019038790 A1 WO 2019038790A1 IT 2017000176 W IT2017000176 W IT 2017000176W WO 2019038790 A1 WO2019038790 A1 WO 2019038790A1
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WO
WIPO (PCT)
Prior art keywords
irrigation
portable
group
regulator
fluid
Prior art date
Application number
PCT/IT2017/000176
Other languages
French (fr)
Inventor
Katy GNALI
Original Assignee
Gnali Bocia S.R.L.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Gnali Bocia S.R.L. filed Critical Gnali Bocia S.R.L.
Priority to PCT/IT2017/000176 priority Critical patent/WO2019038790A1/en
Publication of WO2019038790A1 publication Critical patent/WO2019038790A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00Medical syringes, e.g. enemata; Irrigators
    • A61M3/02Enemata; Irrigators
    • A61M3/0204Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity
    • A61M3/0216Pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00Medical syringes, e.g. enemata; Irrigators
    • A61M3/02Enemata; Irrigators
    • A61M3/0204Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity
    • A61M3/022Volume; Flow rate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00Medical syringes, e.g. enemata; Irrigators
    • A61M3/02Enemata; Irrigators
    • A61M3/0229Devices operating in a closed circuit, i.e. recycling the irrigating fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00Medical syringes, e.g. enemata; Irrigators
    • A61M3/02Enemata; Irrigators
    • A61M3/0233Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs
    • A61M3/025Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs supplied directly from the pressurised water source, e.g. with medicament supply
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00Medical syringes, e.g. enemata; Irrigators
    • A61M3/02Enemata; Irrigators
    • A61M3/0266Stands, holders or storage means for irrigation devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow
    • A61M2205/3334Measuring or controlling the flow rate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow
    • A61M2205/3344Measuring or controlling pressure at the body treatment site
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3368Temperature
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/75General characteristics of the apparatus with filters
    • A61M2205/7518General characteristics of the apparatus with filters bacterial
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00Ancillary equipment
    • A61M2209/08Supports for equipment
    • A61M2209/084Supporting bases, stands for equipment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/10Trunk
    • A61M2210/1042Alimentary tract
    • A61M2210/1064Large intestine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/10Trunk
    • A61M2210/1042Alimentary tract
    • A61M2210/1067Anus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/14Female reproductive, genital organs
    • A61M2210/1475Vagina

Definitions

  • the present invention relates to a portable regulator group and a device for irrigation through natural body orifices, in particular for anal or vaginal lavages, by means of a treatment fluid, preferably water, inoculated through such orifices.
  • a treatment fluid preferably water
  • the invention is also aimed at a device for body irrigation, colon cleansing (colon hydrotherapy) or for similar uses, such as vaginal irrigations.
  • Body irrigation devices for removing fecal residues or stools from inside the colon are known and have been in use for a long time.
  • a treatment liquid such as water
  • professional devices operated by an experienced operator on a patient reclining in a supine position or laying on his/her side, as well as home healthcare devices that do not require the intervention of a professional operator and that may be used by the patient independently in his/her home.
  • professional devices of the prior art are of a fixed type and comprise a single technical block, usually in a box-like shape.
  • Such technical block generally includes, in a single solution, a hydraulic system for connection to the water mains, a thermostatic mixer, a tap for opening/closing the water supply, a pressure stabilizer, a tap for the opening/closing the discharge of the water coming from the patient during the treatment and means to manage the flow and water pressure during treatment by the professional therapist.
  • One of the purposes of the present invention is to overcome the drawbacks of the devices of the prior art while maintaining the quality of treatment by a professional therapist at home and in an outpatient clinic .
  • figure 1 shows an overall view of a body irrigation device comprising a portable regulator group in accordance with an embodiment according to the present invention
  • FIG. 2 is a perspective view of a professional- type body irrigation unit comprising a portable regulator group in accordance with an implementation according to the present invention
  • FIG. 3 shows a perspective view of a portable regulator group in accordance with an embodiment according to the present invention
  • FIG. 3a shows a sectional view of a pressure regulator device and a manual reset safety device in accordance with an embodiment according to the present invention
  • FIG. 4 shows a portable kit for body irrigation in accordance with an embodiment of the present invention, wherein the regulator group is anchored to a support surface of a trolley;
  • FIG. 5 shows a detail of a collection container and a treatment liquid outlet tube inserted into an access mouth of the collection container of the portable kit of figure 4;
  • FIG. 6 shows a portable kit for body irrigation in accordance with a further embodiment of the present invention, in particular for vaginal irrigation;
  • FIG. 7 shows a sectional view of a cannula handle group of the portable kit of figure 6.
  • a device for body irrigation through a natural body orifice for professional-type treatment performed by a professional therapist is indicated collectively at 1.
  • the device 1 for body irrigation is, for example, illustrated in one embodiment in figure 2 and comprises a portable regulator group 10, an irrigation cannula 21, suitable for introduction into the natural orifice for irrigation with the treatment liquid, and a fluid supply line 3, suitable to supply a treatment fluid to the irrigation cannula 21.
  • the treatment fluid is water coming from a water source.
  • the fluid supply line 3 comprises a connection group 5 to a source of treatment liquid, for example a water tap, and an extensible tube 31, preferably spiral, connected at its ends with quick coupling fittings 32, 33.
  • a source of treatment liquid for example a water tap
  • an extensible tube 31 preferably spiral, connected at its ends with quick coupling fittings 32, 33.
  • the therapist after connecting the fluid supply line 3 to a source of treatment liquid (e.g. a household water tap, or a connection of a technical block 2 of a professional- type body irrigation unit 1' ) , regulates the flow of treatment liquid to be inoculated into the natural orifice of the treated patient by means of a regulating action on the portable regulator group 10.
  • a source of treatment liquid e.g. a household water tap, or a connection of a technical block 2 of a professional- type body irrigation unit 1'
  • the portable regulator group 10 comprises a support frame 11 suitable to be removably fixed to a support surface 200, e.g. a support surface of a portable regulator group 10, and/or a technical block 2 of a unit for professional-type body irrigation 1', e.g., shown in figure 2.
  • the portable regulator group 10 comprises a treatment liquid inlet opening 121 and a treatment liquid outlet opening 122, the latter connectable by means of an irrigation connection tube 123, 123' to the irrigation cannula 21 to be inserted into the natural orifice.
  • the treatment liquid inlet opening 121 and the treatment liquid outlet opening 122 are supported directly or indirectly by the support frame 11.
  • the portable regulator group 10 comprises a pressure regulator device 12, supported directly or indirectly by the support frame 11.
  • the pressure regulator device 12 is fluidically connected to the treatment liquid inlet opening 121 and is suitable to regulate the pressure level of the treatment liquid to be delivered, for example at a predefined pressure level, preferably a pressure level lower than the pressure of the treatment liquid inlet to the device 12 (pressure reducer) .
  • the portable regulator group 10 furthermore comprises a flow regulator device 13, it, too, supported directly or indirectly by the support frame 11, for example a flowmeter, fluidically connected to the pressure regulator device 12 and operable by the operator to regulate the flow of water dispensed and comprising an indicator device of the amount of water dispensed, for example a graduated scale 130.
  • a flow regulator device 13 it, too, supported directly or indirectly by the support frame 11, for example a flowmeter, fluidically connected to the pressure regulator device 12 and operable by the operator to regulate the flow of water dispensed and comprising an indicator device of the amount of water dispensed, for example a graduated scale 130.
  • directly supported means to be attached directly to the support frame, whereas the term “indirectly supported” means fixed to a component, the latter being in turn directly attached to the support frame .
  • the portable regulator group 10 comprises a first pressure gauge 14 fluidically connected to the flow regulator device 13 downstream of the latter in the flow direction proceeding from the treatment liquid inlet opening 121 to the treatment liquid outlet opening 122.
  • the first pressure gauge 14 is directly and immediately connected in cascade to the flow regulator device 13 without any other intermediate flow or flow rate regulating device, so as to make the regulator group more compact.
  • the first pressure gauge 14 is directly connected to the cannula 21 via the irrigation connection tube 123, 123' without any other intermediate device (for example without any other intermediate flow or pressure regulating device) .
  • the first pressure gauge 14 measures the internal pressure of the treatment liquid in the treated patient (e.g. the internal pressure in the colon) and the therapist may accurately and safely confirm the pressure of the liquid delivered into the treated patient.
  • the portable regulator group 10 comprises a second pressure gauge 15, supported by the support frame 11 directly or indirectly via the pressure regulator device 12, and fluidically connected to the pressure regulator device 12.
  • Such second pressure gauge 15 is disposed upstream of the flow regulating device 13 in the flow direction of the treatment liquid from the fluid source to the treated patient.
  • Such second pressure gauge 15 is suitable for detecting the pressure of the liquid immediately downstream of the pressure regulator 12.
  • the pressure gauge 12 is of a fixed type, i.e. calibrated to regulate the outlet pressure at a predetermined pressure level (regardless of the inlet pressure to the regulator)
  • the pressure gauge detects such predetermined pressure level.
  • the predetermined pressure level is about 0.5 bar.
  • a temperature indicator 17 of the treatment liquid is included in the regulator group 10 for checking the temperature of the treatment liquid by the therapist.
  • the regulator group 10 comprises a device for measuring and indicating time 16, such as a timer supported by the support frame 11.
  • a device for measuring and indicating time 16 such as a timer supported by the support frame 11. The presence of the time indication allows the amount of treatment liquid injected in the patient during treatment to be controlled based on the flow rate level read on the flow regulator device 13.
  • the pressure regulator device 12 comprises a manual reset safety device 43, suitable for blocking the flow of treatment liquid to the outlet opening 122 when a predetermined flow threshold is exceeded, for example a maximum flow rate of 1.5 or 2 L/min.
  • the manual reset safety device 43 is, for example, a safety valve, comprising a ball 430 suitable to sealingly engage on a treatment fluid inlet mouth 431 when a certain fluid flow threshold is exceeded.
  • the fluid inlet mouth 431 is an opening arranged to allow the passage of the treatment fluid coming from the pressure regulator device 12 toward a fluid outlet duct 44 toward the flow regulator 13.
  • the safety valve further comprises a rod 432 suitable to interact with the ball 430 at the user' s request to disengage it from the fluid inlet mouth 431, so as to restore the passage of fluid to below a threshold flow rate (manual reset) .
  • the pressure regulator device 12 and the safety device 43 are installed on a single body 45.
  • the safety valve is integrated into the single body.
  • the ball 430 and the rod 432 are housed in the single body 45, the rod having a head portion 432' protruding from the single body 45 and suitable to be pressed by the user.
  • a communication duct 434 is made directly in fluidic communication with the low-pressure chamber 435 of the pressure regulator device 12 and with the valve chamber 436 wherein the ball 430 is housed, both the low- pressure chamber 435 and the valve chamber 436 also being made in the single body 45.
  • the portable regulator group 10 further comprises a plate 110 connected to the supporting frame 11 or made in one piece with such support frame 11.
  • Such plate 110 comprises connection means, for example holes, for removably fixing the plate on the professional-type body irrigation unit 1' or on a support surface 200, for example a support surface of a rigid travel case 600 or a trolley.
  • the supply line 3 comprises a thermostatic safety valve 9, for example of a normally open type, comprising thermostatic actuation means suitable to actuate the valve to close when the temperature of the treatment fluid entering the thermostatic safety valve exceeds a predetermined threshold temperature value that is considered dangerous .
  • the fluid supply line 3 comprises a filter 7 with an antibacterial filter cartridge or a filter 7 with a removable carbon filter cartridge.
  • a first quick coupling fitting 32 is connectable to the treatment liquid inlet opening 121 and the other quick coupling fitting 33 is connectable directly to the connection group 5 or to the filter 7 or to the thermostatic safety valve 9.
  • the portable regulator group 10 may be used by a therapist to perform professional-type irrigations directly at the home of the treated patient.
  • the portable regulator group 10 may also be used in a professional outpatient treatment facility, being connectable to a fixed type technical block 2 and forming with the latter a professional-type body irrigation unit (as shown in figure 2).
  • the term "portable” means that the regulator group 10 has small dimensions such as to allow it to be easily carried by the therapist and is also suitable to be connected directly by means of the supply line 3 either to a source of domestic water, or to a technical block 2 of a professional unit 1' .
  • a professional type body irrigation unit 1' (for example shown in figure 2) comprising a portable regulator group 10, as described herein, and a box-shaped technical block 2 containing a hydraulic system for connection to the water mains, a thermostatic mixer 200, a supply tap for opening/closing the water inlet 203, a tap 201 for opening/closing the discharge of the treatment fluid coming from the patient during the treatment, i.e. exiting the irrigation cannula 21 and an inspection window 202 of the treatment liquid exiting the patient.
  • the hydraulic system of the technical block 2 is therefore fixably connectable to the black water drain in the wall and the hot- and cold-water outlets of the water system of a building.
  • the therapist after having fixed the regulator group to the upper part of the technical block 2, for example, by fixing it by means of suitable tightening screws 205 through the holes of the plate 110, couples the thermostatic valve 9 to the treatment liquid outlet valve 300.
  • the antibacterial filter 7 is also coupled downstream of the thermostatic valve.
  • a connection tube 31' for example similar to the extensible tube 31, is connected by means of quick coupling fittings at the outlet of the antibacterial filter 7 and the treatment liquid inlet opening 121 of the regulator group 10.
  • An irrigation connection tube 123 (not shown in figure 2) is connected on one side to the treatment liquid outlet opening 122 of the regulator group 10 and on the other side to the irrigation cannula 21.
  • the irrigation cannula 21 is provided with a fecal liquid outlet opening 21a, suitable to be connected by means of a liquid outlet tube 207 (not shown in figure 2 but visible in a variant of embodiment in figure 4) to a fecal liquid inlet mouth 206 of the technical block 2.
  • Such fecal liquid inlet mouth 206 is fluidically connected to a transparent tubing visible through the inspection window 202 such that the therapist may monitor the fecal liquid coming from the patient during treatment until the cleansing is complete.
  • the therapist opens the flow of treatment liquid by turning the knob 131 of the flowmeter 13 until a desired flow value, for example 0.8-1 L/min, is reached.
  • the treatment liquid will begin to circulate in the cannula 21 and in the liquid outlet tube 207 without entering in the patient to allow the therapist to check the set parameters.
  • the therapist closes the tap 201 for opening/closing the discharge of the water coming from the patient. At this point the water begins to enter the intestine.
  • the therapist checks the first pressure gauge 14 that detects the inlet pressure to the intestine.
  • the therapist opens the drain tap 201. Consequently, the softened feces will pass through the liquid outlet tube 207, reaching the transparent tubing, and will be visible through the inspection window 202. Downstream of the transparent tubing, the evacuation is conveyed through the drain outlet 208 into tubing connected to the black water drain of the building. When the evacuation is clear it means that the patient is ready for another lavage. The above operations can then be carried out several times at the decision of the therapist.
  • the body irrigation treatment may be carried out by the therapist even without the presence of a technical block 2, i.e. without the need for hydraulic connections to the black water drain.
  • the treatment may be carried out directly at the patient's home, due to the portability of the regulator group 10.
  • the regulator group may be associated with a portable-type collection container 500. Therefore, the present invention is also aimed at a portable kit 1' ' for body irrigation through natural orifices, for example shown in figure 4 in one embodiment thereof.
  • the portable kit 1' ' includes a device 1 for body irrigation through natural orifices, for example colon hydrotherapy, comprising the features already described in the preceding paragraphs, the liquid outlet tube 207 and the collection container 500.
  • the regulator group 10 is anchorable to a support surface 200, e.g. a table, or to an upper surface of a rigid traveling case 600 e.g. a trolley, also suitable to contain all of the components of the portable kit 1' ' .
  • the collection container 500 for example a collapsible plastic container, includes an access mouth 501 to the inner cavity of the container, which allows the liquid coming from the treated patient to be contained.
  • the access mouth 501 is suitable to house sealingly the liquid outlet tube 207 therein.
  • the access mouth 501 is preferably formed on a cap 502, which may be coupled to a coupling opening of the collection container 500, such as a threaded neck.
  • a coupling opening of the collection container 500 such as a threaded neck.
  • at least one vent opening 503, 504 is made, suitable to drain the air from the collection container 500 gradually as the liquid coming from the patient fills the collection container 500.
  • a mixture of ingredients suitable to neutralize any unpleasant odors is contained, for example, a chemical disintegrator suitable for breaking up the feces. This makes it advantageous for preventing the access mouth 501 from becoming blocked while the container 500 is being emptied due to undissolved stools blocking the passage .
  • the portable kit 1' ' described above allows for a professional treatment at the home of the treated patient to be carried out without requiring the use of a technical block 2, which must be connected to the water mains and the building's drains.
  • the evacuated material is stowed in the storage container 500, which is easily storable and transportable.
  • liquid outlet tube 207 being preferably translucent or transparent, the therapist may advantageously check the color and type of liquid and feces exiting the treated patient and thus perform continuous monitoring throughout the treatment also in the home .
  • the portable kit 1' ' ' does not require the use of a collection container 500.
  • the portable kit 1' ' ' comprises a device 1 for body irrigation through natural orifices, comprising the features already described in the preceding paragraphs, and a cannula handle group 100.
  • the cannula handle group 100 comprises a handle 105 with an elongated shape along a preferred direction Z, wherein an inner cavity 101 is formed suitable for the passage of the treatment fluid from one of its fluid inlet ends 102 to one of its fluid outlet ends 103, opposite the fluid inlet end 102.
  • an irrigation connection tube 123' is connected, which in turn is fluidically connected to the regulator group 10 at the treatment liquid outlet opening 122.
  • the handle 105 is in the form of a solid of rotation, for example, a substantially tubular shape, wherein the preferred direction Z is the axis of the solid of rotation (e.g., the axis of the cylinder) and wherein the fluid inlet end 102 is aligned with and opposite to the fluid outlet end 103 along the preferred direction Z.
  • the cannula handle group 100 comprises a tubular coupling 84 connected to the fluid outlet end 103 for the sealed coupling of a cannula group 2' , comprising the cannula 21.
  • the cannula group 2' comprises the locking component 25, suitable to prevent the irrigation cannula 21 from disengaging from the handle group 100 by the pressure of the treatment liquid or movement of the patient's body.
  • the locking component 25 is separable from the irrigation cannula and comprises an annular element 252 suitable to be fitted around the irrigation cannula 21 and comprising an annular engagement surface 251, suitable to engage with a corresponding annular groove or ridge 224 of the irrigation cannula 21.
  • the cannula handle group 100 comprises an anchoring seat 85 suitable to house the safety locking element 25 to keep the irrigating cannula 21 anchored to the cannula handle group 100 in case of an attempt to partially disengage the cannula 21 from the tubular coupling 84 (for example due to the pressure of the treatment fluid being too strong or due to improper movements by the operator who maneuvers the cannula handle group) .
  • the anchoring seat is a groove or protrusion made on the handle 105 or the tubular coupling 84, for example, a groove extending annularly on the handle 105 or on the tubular coupling 84.
  • the cannula group 2 is removably fixed to the tubular coupling 84.
  • the locking component 25 comprises a safety tab 253 of the locking component 25 and a coupling portion 254 suitable to couple with the anchoring seat 85 so as to ensure that the cannula group 2 remains anchored to the handle group 100, even if the cannula group 2 slips off the tubular coupling 84. This avoids the risk that the cannula group 2 will continue its route within the natural orifice, for example, if it becomes disengaged from the tubular coupling 84.
  • the coupling portion 254 is a safety ring 254' suitable to be fitted on the anchoring seat 85, preferably snap-fitted.
  • the portable kit 1' ' ' comprises a hose connector 400 connected to the regulator assembly 10 and to the irrigation connection tube 123' , which makes it easy to connect the regulator group 10 to the connection tube 123' .
  • the hose connector comprises a threaded portion 402 screwable to a corresponding threaded portion close to the treatment liquid outlet opening 122 of the regulator group 10.
  • the regulator group 10 is anchorable in a stable and, at the same time, removable way to a support surface 200 such as a table, or to an upper surface of a rigid traveling case 600, such as a trolley, suitable for containing all components of the portable kit 1'', 1'''.
  • stable couplings are threaded couplings, e.g. screws, mechanical-type couplings or bayonet couplings, as well as joints or any couplings that allow constraining at least 2 degrees of freedom.
  • the same regulator 10 is also anchorable to a technical block 2 of a professional unit 1' .
  • the present invention allows, with a single regulatory group, the quality of treatment by a professional therapist to be maintained both at home and in outpatient clinics or hospitals.
  • the regulator group due to the compact arrangement of the pressure regulator device 12, the flow regulator device 13 and the pressure gauge 14 on a single frame 11 suitable to be anchored removably, makes the system portable and adaptable both at home and in outpatient clinics/hospitals.
  • the total size of the regulator group does not exceed the volume of a cube with a 30-cm edge.
  • the realization in a single body 45 of both the pressure regulator device 12 and the manual reset safety device 43 guarantees at the same time compactness and safety during treatment (at least equal to or greater than the professional-type devices of the prior art) .
  • the presence of the locking component 25 in the cannula group 2' ensures that there is no risk of accidentally releasing the cannula group 2 from the handle group 100. Moreover, due to the presence of a comfortable handle that supports the cannula group, more simplicity and greater ergonomics in use are guaranteed, as well as, synergistxcally with the transportable regulator group, an improved transportability of the device, allowing vaginal irrigations to be carried out also at home.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Sustainable Development (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

A portable regulator group (10) for a body irrigation device (1) through a natural body orifice comprises a support frame (11) suitable to be removably secured to a support surface (200). The support frame (11) supports a pressure regulator device (12) suitable to regulate the pressure level of the treatment liquid to be delivered, a flow regulator device (13) operable by the therapist to regulate the flow rate of the water dispensed and a pressure gauge (14) fluidically connected to the flow regulator device (13) downstream thereof. A device (1) for body irrigation comprises the portable regulator group (10), an irrigation cannula (21), and a fluid supply line (3), suitable to supply a treatment fluid to the irrigation cannula (21). A portable kit (1'') for professional-type body irrigation comprises the device (1) and a portable collection container (500) of the treatment liquid coming from the treated patient.

Description

"PORTABLE REGULATOR GROUP FOR PROFESSIONAL-TYPE IRRIGATION THROUGH NATURAL BODY ORIFICES AND RELATED
DEVICE AND KIT"
DESCRIPTION
The present invention relates to a portable regulator group and a device for irrigation through natural body orifices, in particular for anal or vaginal lavages, by means of a treatment fluid, preferably water, inoculated through such orifices. The invention is also aimed at a device for body irrigation, colon cleansing (colon hydrotherapy) or for similar uses, such as vaginal irrigations.
Body irrigation devices for removing fecal residues or stools from inside the colon are known and have been in use for a long time. In order to effectively remove the fecal residue, it is necessary to thoroughly spray and saturate it with a treatment liquid such as water, so that it may be evacuated gradually.
For the aforementioned type of treatment, currently known are professional devices, operated by an experienced operator on a patient reclining in a supine position or laying on his/her side, as well as home healthcare devices that do not require the intervention of a professional operator and that may be used by the patient independently in his/her home. Generally, professional devices of the prior art are of a fixed type and comprise a single technical block, usually in a box-like shape. Such technical block generally includes, in a single solution, a hydraulic system for connection to the water mains, a thermostatic mixer, a tap for opening/closing the water supply, a pressure stabilizer, a tap for the opening/closing the discharge of the water coming from the patient during the treatment and means to manage the flow and water pressure during treatment by the professional therapist.
The use of professional-type devices according to the prior art involves the need for a patient to go to an outpatient clinic or a specialized treatment center, given that, due to the high volume of professional-type devices and because of the need to provide at least one connection with a hydraulic discharge, the possibility of transporting professional-type devices to the patient's home is very limited. Therefore, the need exists to facilitate the treatment of home-based patients by a professional therapist by means of a professional-type device that is easily transportable, ergonomic and does not require hydraulic installations by a hydraulic technician at the patient's home and at the same time is comparable and compatible with a professional-type treatment at an outpatient clinic or a specialized center.
One of the purposes of the present invention is to overcome the drawbacks of the devices of the prior art while maintaining the quality of treatment by a professional therapist at home and in an outpatient clinic .
The aforementioned object is achieved by a portable regulator group, a device for irrigation through natural body orifices, by a professional-type unit, and a portable kit according to the accompanying independent claims. The claims dependent on the same describe preferred variants of embodiment.
The features and advantages of the present invention will be apparent from the description given below, provided by way of illustrative and non-limiting example, in accordance with the accompanying figures, wherein :
figure 1 shows an overall view of a body irrigation device comprising a portable regulator group in accordance with an embodiment according to the present invention;
- figure 2 is a perspective view of a professional- type body irrigation unit comprising a portable regulator group in accordance with an implementation according to the present invention;
- figure 3 shows a perspective view of a portable regulator group in accordance with an embodiment according to the present invention;
- figure 3a shows a sectional view of a pressure regulator device and a manual reset safety device in accordance with an embodiment according to the present invention;
- figure 4 shows a portable kit for body irrigation in accordance with an embodiment of the present invention, wherein the regulator group is anchored to a support surface of a trolley;
- figure 5 shows a detail of a collection container and a treatment liquid outlet tube inserted into an access mouth of the collection container of the portable kit of figure 4;
- figure 6 shows a portable kit for body irrigation in accordance with a further embodiment of the present invention, in particular for vaginal irrigation;
- figure 7 shows a sectional view of a cannula handle group of the portable kit of figure 6.
In accordance with the accompanying figures, a device for body irrigation through a natural body orifice for professional-type treatment performed by a professional therapist, therefore not of an independent homecare type (the latter generally used independently by the patient), is indicated collectively at 1.
The device 1 for body irrigation is, for example, illustrated in one embodiment in figure 2 and comprises a portable regulator group 10, an irrigation cannula 21, suitable for introduction into the natural orifice for irrigation with the treatment liquid, and a fluid supply line 3, suitable to supply a treatment fluid to the irrigation cannula 21. Preferably, the treatment fluid is water coming from a water source.
For example, the fluid supply line 3 comprises a connection group 5 to a source of treatment liquid, for example a water tap, and an extensible tube 31, preferably spiral, connected at its ends with quick coupling fittings 32, 33.
During the operation of the device, the therapist, after connecting the fluid supply line 3 to a source of treatment liquid (e.g. a household water tap, or a connection of a technical block 2 of a professional- type body irrigation unit 1' ) , regulates the flow of treatment liquid to be inoculated into the natural orifice of the treated patient by means of a regulating action on the portable regulator group 10.
The portable regulator group 10 comprises a support frame 11 suitable to be removably fixed to a support surface 200, e.g. a support surface of a portable regulator group 10, and/or a technical block 2 of a unit for professional-type body irrigation 1', e.g., shown in figure 2.
The portable regulator group 10 comprises a treatment liquid inlet opening 121 and a treatment liquid outlet opening 122, the latter connectable by means of an irrigation connection tube 123, 123' to the irrigation cannula 21 to be inserted into the natural orifice. The treatment liquid inlet opening 121 and the treatment liquid outlet opening 122 are supported directly or indirectly by the support frame 11.
Furthermore, the portable regulator group 10 comprises a pressure regulator device 12, supported directly or indirectly by the support frame 11. The pressure regulator device 12 is fluidically connected to the treatment liquid inlet opening 121 and is suitable to regulate the pressure level of the treatment liquid to be delivered, for example at a predefined pressure level, preferably a pressure level lower than the pressure of the treatment liquid inlet to the device 12 (pressure reducer) .
The portable regulator group 10 furthermore comprises a flow regulator device 13, it, too, supported directly or indirectly by the support frame 11, for example a flowmeter, fluidically connected to the pressure regulator device 12 and operable by the operator to regulate the flow of water dispensed and comprising an indicator device of the amount of water dispensed, for example a graduated scale 130.
The term "directly supported" means to be attached directly to the support frame, whereas the term "indirectly supported" means fixed to a component, the latter being in turn directly attached to the support frame .
Furthermore, the portable regulator group 10 comprises a first pressure gauge 14 fluidically connected to the flow regulator device 13 downstream of the latter in the flow direction proceeding from the treatment liquid inlet opening 121 to the treatment liquid outlet opening 122. Preferably, the first pressure gauge 14 is directly and immediately connected in cascade to the flow regulator device 13 without any other intermediate flow or flow rate regulating device, so as to make the regulator group more compact.
Furthermore, preferably, the first pressure gauge 14 is directly connected to the cannula 21 via the irrigation connection tube 123, 123' without any other intermediate device (for example without any other intermediate flow or pressure regulating device) . In this way, the first pressure gauge 14 measures the internal pressure of the treatment liquid in the treated patient (e.g. the internal pressure in the colon) and the therapist may accurately and safely confirm the pressure of the liquid delivered into the treated patient.
Preferably, the portable regulator group 10 comprises a second pressure gauge 15, supported by the support frame 11 directly or indirectly via the pressure regulator device 12, and fluidically connected to the pressure regulator device 12. Such second pressure gauge 15 is disposed upstream of the flow regulating device 13 in the flow direction of the treatment liquid from the fluid source to the treated patient. Such second pressure gauge 15 is suitable for detecting the pressure of the liquid immediately downstream of the pressure regulator 12. For example, in the embodiment wherein the pressure regulator 12 is of a fixed type, i.e. calibrated to regulate the outlet pressure at a predetermined pressure level (regardless of the inlet pressure to the regulator) , the pressure gauge detects such predetermined pressure level. Advantageously, this allows the therapist to directly check the presence or absence of treatment liquid in the circuit and, hence, the proper functioning of the device. Preferably, the predetermined pressure level is about 0.5 bar.
Preferably, a temperature indicator 17 of the treatment liquid is included in the regulator group 10 for checking the temperature of the treatment liquid by the therapist.
Additionally, the regulator group 10 comprises a device for measuring and indicating time 16, such as a timer supported by the support frame 11. The presence of the time indication allows the amount of treatment liquid injected in the patient during treatment to be controlled based on the flow rate level read on the flow regulator device 13.
In an advantageous embodiment, the pressure regulator device 12, comprises a manual reset safety device 43, suitable for blocking the flow of treatment liquid to the outlet opening 122 when a predetermined flow threshold is exceeded, for example a maximum flow rate of 1.5 or 2 L/min.
With illustrative reference to figure 3a, the manual reset safety device 43 is, for example, a safety valve, comprising a ball 430 suitable to sealingly engage on a treatment fluid inlet mouth 431 when a certain fluid flow threshold is exceeded. The fluid inlet mouth 431 is an opening arranged to allow the passage of the treatment fluid coming from the pressure regulator device 12 toward a fluid outlet duct 44 toward the flow regulator 13. The safety valve further comprises a rod 432 suitable to interact with the ball 430 at the user' s request to disengage it from the fluid inlet mouth 431, so as to restore the passage of fluid to below a threshold flow rate (manual reset) .
Preferably, the pressure regulator device 12 and the safety device 43 are installed on a single body 45. In this embodiment, the safety valve is integrated into the single body. In other words, the ball 430 and the rod 432 are housed in the single body 45, the rod having a head portion 432' protruding from the single body 45 and suitable to be pressed by the user.
Furthermore, preferably, in the single body 45, a communication duct 434 is made directly in fluidic communication with the low-pressure chamber 435 of the pressure regulator device 12 and with the valve chamber 436 wherein the ball 430 is housed, both the low- pressure chamber 435 and the valve chamber 436 also being made in the single body 45.
In one embodiment, the portable regulator group 10 further comprises a plate 110 connected to the supporting frame 11 or made in one piece with such support frame 11. Such plate 110 comprises connection means, for example holes, for removably fixing the plate on the professional-type body irrigation unit 1' or on a support surface 200, for example a support surface of a rigid travel case 600 or a trolley.
In one embodiment of the device 1, the supply line 3 comprises a thermostatic safety valve 9, for example of a normally open type, comprising thermostatic actuation means suitable to actuate the valve to close when the temperature of the treatment fluid entering the thermostatic safety valve exceeds a predetermined threshold temperature value that is considered dangerous .
Preferably, the fluid supply line 3 comprises a filter 7 with an antibacterial filter cartridge or a filter 7 with a removable carbon filter cartridge.
With regard to the extensible tube 31, advantageously a first quick coupling fitting 32 is connectable to the treatment liquid inlet opening 121 and the other quick coupling fitting 33 is connectable directly to the connection group 5 or to the filter 7 or to the thermostatic safety valve 9.
As may be seen from the description herein, the portable regulator group 10 may be used by a therapist to perform professional-type irrigations directly at the home of the treated patient. At the same time, the portable regulator group 10 may also be used in a professional outpatient treatment facility, being connectable to a fixed type technical block 2 and forming with the latter a professional-type body irrigation unit (as shown in figure 2).
The term "portable" means that the regulator group 10 has small dimensions such as to allow it to be easily carried by the therapist and is also suitable to be connected directly by means of the supply line 3 either to a source of domestic water, or to a technical block 2 of a professional unit 1' .
Therefore, also object of this invention is a professional type body irrigation unit 1' (for example shown in figure 2) comprising a portable regulator group 10, as described herein, and a box-shaped technical block 2 containing a hydraulic system for connection to the water mains, a thermostatic mixer 200, a supply tap for opening/closing the water inlet 203, a tap 201 for opening/closing the discharge of the treatment fluid coming from the patient during the treatment, i.e. exiting the irrigation cannula 21 and an inspection window 202 of the treatment liquid exiting the patient. The hydraulic system of the technical block 2 is therefore fixably connectable to the black water drain in the wall and the hot- and cold-water outlets of the water system of a building.
For the use of the unit 1' , the therapist, after having fixed the regulator group to the upper part of the technical block 2, for example, by fixing it by means of suitable tightening screws 205 through the holes of the plate 110, couples the thermostatic valve 9 to the treatment liquid outlet valve 300. Preferably, the antibacterial filter 7 is also coupled downstream of the thermostatic valve.
A connection tube 31' , for example similar to the extensible tube 31, is connected by means of quick coupling fittings at the outlet of the antibacterial filter 7 and the treatment liquid inlet opening 121 of the regulator group 10. An irrigation connection tube 123 (not shown in figure 2) is connected on one side to the treatment liquid outlet opening 122 of the regulator group 10 and on the other side to the irrigation cannula 21. In the case of colon hydrotherapy, the irrigation cannula 21 is provided with a fecal liquid outlet opening 21a, suitable to be connected by means of a liquid outlet tube 207 (not shown in figure 2 but visible in a variant of embodiment in figure 4) to a fecal liquid inlet mouth 206 of the technical block 2. Such fecal liquid inlet mouth 206 is fluidically connected to a transparent tubing visible through the inspection window 202 such that the therapist may monitor the fecal liquid coming from the patient during treatment until the cleansing is complete.
Operatively, for the treatment of a patient, once the irrigation cannula is inserted in the anal orifice, the therapist opens the flow of treatment liquid by turning the knob 131 of the flowmeter 13 until a desired flow value, for example 0.8-1 L/min, is reached. The treatment liquid will begin to circulate in the cannula 21 and in the liquid outlet tube 207 without entering in the patient to allow the therapist to check the set parameters. To begin introducing water into the patient, the therapist closes the tap 201 for opening/closing the discharge of the water coming from the patient. At this point the water begins to enter the intestine. The therapist checks the first pressure gauge 14 that detects the inlet pressure to the intestine. When the patient feels the need to evacuate or when the therapist deems it necessary (or for example at a pressure of between 50 and 70 mbar) , the therapist opens the drain tap 201. Consequently, the softened feces will pass through the liquid outlet tube 207, reaching the transparent tubing, and will be visible through the inspection window 202. Downstream of the transparent tubing, the evacuation is conveyed through the drain outlet 208 into tubing connected to the black water drain of the building. When the evacuation is clear it means that the patient is ready for another lavage. The above operations can then be carried out several times at the decision of the therapist.
According to an embodiment of the invention, the body irrigation treatment may be carried out by the therapist even without the presence of a technical block 2, i.e. without the need for hydraulic connections to the black water drain. For example, the treatment may be carried out directly at the patient's home, due to the portability of the regulator group 10. For this type of use, the regulator group may be associated with a portable-type collection container 500. Therefore, the present invention is also aimed at a portable kit 1' ' for body irrigation through natural orifices, for example shown in figure 4 in one embodiment thereof.
The portable kit 1' ' includes a device 1 for body irrigation through natural orifices, for example colon hydrotherapy, comprising the features already described in the preceding paragraphs, the liquid outlet tube 207 and the collection container 500. In this embodiment, the regulator group 10 is anchorable to a support surface 200, e.g. a table, or to an upper surface of a rigid traveling case 600 e.g. a trolley, also suitable to contain all of the components of the portable kit 1' ' .
As may best be seen in figure 5, the collection container 500, for example a collapsible plastic container, includes an access mouth 501 to the inner cavity of the container, which allows the liquid coming from the treated patient to be contained. The access mouth 501 is suitable to house sealingly the liquid outlet tube 207 therein.
The access mouth 501 is preferably formed on a cap 502, which may be coupled to a coupling opening of the collection container 500, such as a threaded neck. In this embodiment, on the cap 502, around the access mouth 501, spaced from the edge of the mouth 501', which is sealingly engaged with the liquid outlet tube 207, at least one vent opening 503, 504 is made, suitable to drain the air from the collection container 500 gradually as the liquid coming from the patient fills the collection container 500. Preferably, in the inner cavity of the collection container 500, a mixture of ingredients suitable to neutralize any unpleasant odors is contained, for example, a chemical disintegrator suitable for breaking up the feces. This makes it advantageous for preventing the access mouth 501 from becoming blocked while the container 500 is being emptied due to undissolved stools blocking the passage .
Advantageously, the portable kit 1' ' described above allows for a professional treatment at the home of the treated patient to be carried out without requiring the use of a technical block 2, which must be connected to the water mains and the building's drains. Advantageously, furthermore, the evacuated material is stowed in the storage container 500, which is easily storable and transportable.
In addition, the liquid outlet tube 207 being preferably translucent or transparent, the therapist may advantageously check the color and type of liquid and feces exiting the treated patient and thus perform continuous monitoring throughout the treatment also in the home .
The aforementioned advantages are also achieved by a portable kit 1' ' ' for body irrigation, particularly for vaginal irrigations, shown in one of its variants of embodiment in figure 6.
In this variant of embodiment and use, the portable kit 1' ' ' does not require the use of a collection container 500. In this variant, the portable kit 1' ' ' comprises a device 1 for body irrigation through natural orifices, comprising the features already described in the preceding paragraphs, and a cannula handle group 100.
The cannula handle group 100 comprises a handle 105 with an elongated shape along a preferred direction Z, wherein an inner cavity 101 is formed suitable for the passage of the treatment fluid from one of its fluid inlet ends 102 to one of its fluid outlet ends 103, opposite the fluid inlet end 102. On the fluid inlet end 102, an irrigation connection tube 123' is connected, which in turn is fluidically connected to the regulator group 10 at the treatment liquid outlet opening 122.
Preferably, the handle 105 is in the form of a solid of rotation, for example, a substantially tubular shape, wherein the preferred direction Z is the axis of the solid of rotation (e.g., the axis of the cylinder) and wherein the fluid inlet end 102 is aligned with and opposite to the fluid outlet end 103 along the preferred direction Z. The cannula handle group 100 comprises a tubular coupling 84 connected to the fluid outlet end 103 for the sealed coupling of a cannula group 2' , comprising the cannula 21.
In this way, when the cannula group 2' is coupled to the tubular coupling 84, the cannula 21 is aligned along the preferred direction Z. Advantageously, this makes it possible to obtain an ergonomic, easy-to-use device .
In accordance with one embodiment, the cannula group 2' comprises the locking component 25, suitable to prevent the irrigation cannula 21 from disengaging from the handle group 100 by the pressure of the treatment liquid or movement of the patient's body.
In one embodiment, the locking component 25 is separable from the irrigation cannula and comprises an annular element 252 suitable to be fitted around the irrigation cannula 21 and comprising an annular engagement surface 251, suitable to engage with a corresponding annular groove or ridge 224 of the irrigation cannula 21.
Preferably, the cannula handle group 100 comprises an anchoring seat 85 suitable to house the safety locking element 25 to keep the irrigating cannula 21 anchored to the cannula handle group 100 in case of an attempt to partially disengage the cannula 21 from the tubular coupling 84 (for example due to the pressure of the treatment fluid being too strong or due to improper movements by the operator who maneuvers the cannula handle group) .
Preferably, the anchoring seat is a groove or protrusion made on the handle 105 or the tubular coupling 84, for example, a groove extending annularly on the handle 105 or on the tubular coupling 84.
The cannula group 2 is removably fixed to the tubular coupling 84.
Preferably, the locking component 25 comprises a safety tab 253 of the locking component 25 and a coupling portion 254 suitable to couple with the anchoring seat 85 so as to ensure that the cannula group 2 remains anchored to the handle group 100, even if the cannula group 2 slips off the tubular coupling 84. This avoids the risk that the cannula group 2 will continue its route within the natural orifice, for example, if it becomes disengaged from the tubular coupling 84.
Preferably, the coupling portion 254 is a safety ring 254' suitable to be fitted on the anchoring seat 85, preferably snap-fitted.
Preferably, the portable kit 1' ' ' according to the present invention comprises a hose connector 400 connected to the regulator assembly 10 and to the irrigation connection tube 123' , which makes it easy to connect the regulator group 10 to the connection tube 123' . In this case, preferably, the hose connector comprises a threaded portion 402 screwable to a corresponding threaded portion close to the treatment liquid outlet opening 122 of the regulator group 10.
In the embodiments described above (for example, with reference to figures 1, 2, 3, 4 and 6) , the regulator group 10 is anchorable in a stable and, at the same time, removable way to a support surface 200 such as a table, or to an upper surface of a rigid traveling case 600, such as a trolley, suitable for containing all components of the portable kit 1'', 1'''. Examples of stable couplings are threaded couplings, e.g. screws, mechanical-type couplings or bayonet couplings, as well as joints or any couplings that allow constraining at least 2 degrees of freedom.
As said, the same regulator 10 is also anchorable to a technical block 2 of a professional unit 1' .
As may be deduced from the description, the present invention allows, with a single regulatory group, the quality of treatment by a professional therapist to be maintained both at home and in outpatient clinics or hospitals. In other words, the regulator group, due to the compact arrangement of the pressure regulator device 12, the flow regulator device 13 and the pressure gauge 14 on a single frame 11 suitable to be anchored removably, makes the system portable and adaptable both at home and in outpatient clinics/hospitals. In addition, the total size of the regulator group does not exceed the volume of a cube with a 30-cm edge.
Furthermore, advantageously, the realization in a single body 45 of both the pressure regulator device 12 and the manual reset safety device 43 guarantees at the same time compactness and safety during treatment (at least equal to or greater than the professional-type devices of the prior art) .
Advantageously, the use of filters on the supply line allows for higher standards of hygiene.
Moreover, advantageously, the presence of the locking component 25 in the cannula group 2', ensures that there is no risk of accidentally releasing the cannula group 2 from the handle group 100. Moreover, due to the presence of a comfortable handle that supports the cannula group, more simplicity and greater ergonomics in use are guaranteed, as well as, synergistxcally with the transportable regulator group, an improved transportability of the device, allowing vaginal irrigations to be carried out also at home.
It is clear that one skilled in the art, in order to meet specific needs, may make changes to the invention described above, all contained within the scope of protection defined by the following claims.

Claims

1. A portable regulator group (10) for a body irrigation device (1) through a natural body orifice, for example for anal or vaginal lavages, comprising a support frame (11) suitable to be fixed removably to a support surface (200) and/or a technical block (2) of a professional body irrigation unit (l ) operable by a therapist, being supported directly or indirectly by said support frame ( 11 ) :
- a treatment liquid inlet opening (121) and a treatment liquid outlet opening (122);
- a pressure regulator device (12) , fluidically connected to the treatment liquid inlet opening (121) and suitable to regulate the pressure level of the treatment liquid to be delivered, for example at a predetermined pressure level;
- a flow regulator device. (13) , for example a flowmeter, fluidically connected to the pressure regulator device (12) and operable by the therapist to regulate the flow rate of the delivered water and comprising an indicator device of the quantity of water dispensed, e.g. a graduated scale;
- a first pressure gauge (14) fluidically connected to the flow regulator device (13) downstream of the latter in the flow direction proceeding from the treatment liquid inlet opening (121) to the treatment liquid outlet opening (122) .
2. A portable regulator group (10) according to claim 1, wherein the first pressure gauge (14) is directly and immediately connected in cascade to the flow regulator device (13), without any other intermediate flow or flow rate regulating device.
3. A portable regulator group (10) according to claim 1 or 2, wherein the first pressure gauge (14) is directly connected to the cannula (21) via the irrigation connection tube (123, 123' ) without any other intermediate device.
4. A portable regulator group (10) according to any one of the preceding claims, comprising a second pressure gauge (15), fluidically connected to the pressure regulating device (12), said second pressure gauge (15) being arranged upstream of said flow regulating device (13) in the flow direction of the treatment liquid from the fluid source to the treated patient .
5. A portable regulator unit (10) according to any one of the preceding claims, further comprising a temperature indicator (17) of the treatment liquid.
6. A portable regulator group (10) according to any one of the preceding claims, further comprising a device for measuring and indicating time (16), such as a timer, supported by the support frame (11). 7. A portable regulator group (10) according to any one of the preceding claims, further comprising a plate (110) connected to the support frame (11) or made in one piece with said support frame (11) , said plate (110) comprising connection means, for example, holes, for removably fixing the plate onto the technical block 2 of the professional type body irrigation unit (1') and on the support surface (200) of a rigid travel case (600) or a trolley.
8. A portable regulator group (10) according to any one of the preceding claims, wherein the pressure regulator device (12) comprises a manual reset safety device (43), suitable for blocking the flow of treatment liquid towards the outlet opening (122) when a predetermined pressure threshold is exceeded. 9. A portable regulator group (10) according to claim
8, wherein the safety device (43) is a safety valve comprising a ball (430) suitable, on the user's request, to engage sealingly on a treatment fluid inlet mouth (431) when a certain flow rate of the fluid is surpassed, and a rod (432) suitable to interact with the ball (430) to disengage it from the fluid inlet mouth (431) in such a way as to restore the passage of fluid at a flow rate below threshold, said pressure regulator device (12) and said safety valve being mounted on a single body (45) .
10. A device (1) for body irrigation comprising:
- a portable regulator group (10) according to any of the claims 1 to 9; an irrigation cannula (21), suitable for introduction into the natural orifice for irrigation with the treatment fluid; a fluid supply line (3) , suitable to feed a treatment fluid to the irrigation cannula (21) .
11. A body irrigation device (1) according to claim 10, wherein the fluid supply line (3) comprises a filter (7) with an antibacterial filter cartridge.
12. A body irrigation device (1) according to claim 10 or 11, wherein the fluid supply line (3) comprises a filter (7) with a removable carbon filter cartridge. 13. A body irrigation device (1) according to any one of claims 10 to 12, wherein the fluid supply line (3) comprises a connection group (5) to a source of treatment liquid, such as a water tap, an extensible tube (31) , connected at its ends with quick coupling fittings (32, 33) , wherein a first quick coupling fitting (32) is connectable to the treatment liquid inlet opening (121) and another quick coupling fitting (33) is connectable directly to the connection group (5) or to the filter (7) or to a thermostatic safety valve (9) .
14. A body irrigation device (1) according to any one of claims 10 to 13, wherein the supply line (3) comprises a thermostatic safety valve (9), for example of a normally open type, comprising thermostatic actuation means suitable to actuate the valve to close when the temperature of the treatment fluid entering the thermostatic safety valve exceeds a predetermined threshold temperature value that is considered dangerous.
15. A unit (1') for professional-type body irrigation, comprising : a box-shaped technical block (2) comprising a hydraulic system for connecting to a water supply, a thermostatic mixer (200) , a supply tap for opening/closing the inlet water (203) , a tap (201) for opening/closing the discharge of the water from the patient during the treatment, an inspection window
(202) of the treatment liquid leaving the patient; - a regulator group (10) according to any of the claims 1 to 9.
16. A portable kit (1'') for professional-type body irrigation through natural orifices, comprising a device (1) according to any one of the claims 10 to 15, a liquid outlet tube (207) which may be coupled to the irrigation cannula (21) at one of its fecal liquid outlet openings (21a) and a portable collection container (500) of the treatment fluid coming from the treated patient.
17. A portable kit (1'') according to claim 16, wherein the collection container (500) , for example a collapsible plastic container, comprises an access mouth (501) to the inner cavity of the container (500), said access mouth (501) being suitable to sealingly house the liquid outlet tube (207) therein.
18. A portable kit (1'') according to claim 17, wherein the access mouth (501) is made on a cap (502) which may be coupled to a coupling opening of the collection container (500) , and wherein on said cap
(502), around the access mouth (501) and distanced from the edge of the mouth (501' ) which engages sealingly with the liquid outlet tube (207), at least one vent opening (503, 504) is formed suitable to gradually release air from the collection container (500) as the liquid coming from the patient fills the collection container (500) .
19. A portable kit (1'') for professional-type body irrigation through natural orifices, e.g. for vaginal irrigation, comprising:
- a device (1) according to any of the claims 10 to 15, a cannula group (2' ) comprising the irrigation cannula (21) and a locking component (25) , suitable to prevent the irrigation cannula (21) from disengaging from the handle group (100) by the pressure of the treatment liquid or movement of the patient' s body,
- a cannula handle group (100) comprising a handle (105) with an elongated shape along a preferred direction (Z) and comprising an inner cavity (101) suitable for the passage of the treatment fluid from one of its fluid inlet ends (102) to one of its fluid outlet ends (103), opposite the fluid inlet end (102), a connection tube (123' ) being connected on said fluid inlet end (102) suitable to be fluidically connected to the regulator group (10) , said cannula handle group comprising a tubular coupling (84) connected to the fluid outlet end (103) for the sealed coupling of the cannula group (2' ) , and an anchoring seat (85) suitable to house the safety locking element (25) to hold the irrigation cannula (21) anchored to the cannula handle group (100) in case of attempting partial disengagement of the cannula (21) from the tubular coupling (84).
20. A portable kit {!''') according to claim 19, wherein the anchoring seat (85) is a groove or protrusion made on the handle (105) or on the tubular coupling (84), for example, a groove extending annularly on the handle (105) or on the tubular coupling ( 84 ) .
21. A portable kit according to claim 19 or 20, wherein the handle (105) is in the form of a solid of rotation, for example a substantially tubular shape, wherein the preferred direction (Z) is the axis of the solid of rotation and wherein the fluid inlet end (102) is aligned with and opposite to the fluid outlet end (103) along the preferred direction (Z) .
PCT/IT2017/000176 2017-08-22 2017-08-22 Portable regulator group for professional-type irrigation through natural body orifices and related device and kit WO2019038790A1 (en)

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