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WO2019038791A1 - Groupe de canules pour irrigation à travers des orifices corporels naturels, dispositif et kit de poignée - Google Patents

Groupe de canules pour irrigation à travers des orifices corporels naturels, dispositif et kit de poignée Download PDF

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Publication number
WO2019038791A1
WO2019038791A1 PCT/IT2017/000177 IT2017000177W WO2019038791A1 WO 2019038791 A1 WO2019038791 A1 WO 2019038791A1 IT 2017000177 W IT2017000177 W IT 2017000177W WO 2019038791 A1 WO2019038791 A1 WO 2019038791A1
Authority
WO
WIPO (PCT)
Prior art keywords
cannula
irrigation
group
fluid
handle
Prior art date
Application number
PCT/IT2017/000177
Other languages
English (en)
Inventor
Luigi Giacomo 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 CN201790001811.0U priority Critical patent/CN215460752U/zh
Priority to PCT/IT2017/000177 priority patent/WO2019038791A1/fr
Publication of WO2019038791A1 publication Critical patent/WO2019038791A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0233—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs
    • A61M3/025—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs supplied directly from the pressurised water source, e.g. with medicament supply
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0204—Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity
    • A61M3/0208—Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity before use
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0204—Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity
    • A61M3/0212—Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity after use
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0204—Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity
    • A61M3/0216—Pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0204—Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity
    • A61M3/022—Volume; Flow rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0266—Stands, holders or storage means for irrigation devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0279—Cannula; Nozzles; Tips; their connection means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1042—Alimentary tract
    • A61M2210/1064—Large intestine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1042—Alimentary tract
    • A61M2210/1067—Anus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/14—Female reproductive, genital organs
    • A61M2210/1475—Vagina
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0201—Cassettes therefor

Definitions

  • the present invention relates to an irrigation cannula and a cannula group for 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 body irrigation device and a cannula handle kit, directly usable on a toilet bowl or on a bidet for example for colon cleansing (colon hydrotherapy), for vaginal lavage or for similar uses.
  • Body irrigation devices for removing fecal residues or stools from inside the colon or for vaginal lavage are known and have been in use for a long time. In both applications, it is necessary that the natural orifice is abundantly irrigated and saturated with a treatment liquid, e.g. water. For example, in the case of colon hydrotherapy, adequate irrigation is important to allow for effective removal of fecal residue and for a gradual evacuation .
  • a treatment liquid e.g. water
  • the devices of the prior art are not provided with the necessary measures to ensure that the treatment liquid is as safe as possible from a hygienic perspective, depending on the type of treatment (anal or vaginal) to be carried out.
  • the current known devices are intended for use by experienced healthcare professionals or they are particularly uncomfortable for home use and difficult to transport, for example in the case of long journeys.
  • the internal body lavage device described in O2013035115 is inconvenient to use and is difficult to transport because it requires the attachment of a special bulky seat on the toilet bowl.
  • one of the purposes of the present invention is to overcome the aforementioned drawbacks, thus ensuring a reduction in the risks associated with the insertion of the cannula into the patient, such as internal lesions or loss of the cannula in the orifice.
  • a further object of the invention is to improve the quality of the treatment liquid irrigated in the patient from a hygienic point of view.
  • figure 1 is a perspective view of a device for body irrigation according to an embodiment of the present invention, mounted on a toilet bowl;
  • figure 2 shows an overall view of a body irrigation device according to an embodiment in accordance with the present invention
  • figure 2a shows a sectional view of a flow and pressure control group according to an embodiment in accordance with the present invention
  • FIG. 3 shows a perspective view of an irrigation cannula group according to an embodiment in accordance with the present invention
  • FIG. 3a shows a longitudinal sectional view of the irrigation cannula group of figure 3;
  • FIG. 4 shows a perspective view of an irrigation cannula group according to a variant of embodiment in accordance with the present invention
  • FIG. 5 shows a longitudinal sectional view of the irrigation cannula group of figure 4;
  • figure 6 is a perspective view of a device for body irrigation according to a further embodiment in accordance with the present invention.
  • FIG. 7 shows a perspective view of a handle kit for body irrigation according to an embodiment of the present invention and a hose connector;
  • figure 7a shows a longitudinal sectional view of the handle kit and the hose connector in figure 7;
  • FIG. 7b shows a perspective view of a cannula handle group, an irrigation cannula group, and a locking component of the cannula group, the latter prior to insertion around the cannula, according to an embodiment of the invention
  • figure 7c shows a perspective view of the cannula handle group, the irrigation cannula group, and the locking component of the cannula group of figure 7c, the latter inserted around the cannula and anchored to the cannula handle group.
  • a device for body irrigation through a natural body orifice for example for anal or vaginal lavages, suitable for independent home use, is indicated collectively at 1.
  • the device 1 comprises a cannula group 2 suitable for insertion into the body orifice and a fluid supply line 3, suitable for supplying a treatment fluid to an irrigation cannula 21 (also known as a specula) of the cannula group 2.
  • the fluid supply line 3 comprises a flow and pressure control group 4, adapted to regulate the flow (flow rate) and the pressure of the treatment fluid, and a connecting group 5 which is adapted to be removably connected to a source 6 of treatment fluid.
  • the flow and pressure control group 4 comprises pressure control means, for example a pressure regulator 41, for controlling the pressure of the treatment fluid towards the cannula 2, and therefore towards the irrigation cannula 21.
  • the pressure regulator 41 is a manual pressure reducer, wherein the output pressure to the regulator is adjustable by means of a regulating knob. In this way, the operator may adjust the pressure of the treatment fluid exiting the cannula .
  • the fluid supply line 3 comprises a filter 7 with an antibacterial filter cartridge 71.
  • the antibacterial filter cartridge comprises a casing containing a double layer sterilizing grade membrane classified at 0.2 micrometers.
  • the fluid supply line comprises a filter 7 with a removable charbon filter cartridge 71.
  • the supply line 3 comprises a frame 8, suitable to be removably supported by a toilet bowl 10, for example between an upper edge of the ⁇ toilet bowl and a normal seat axis (as shown, for example, in figure 1) .
  • the frame 8 is suitable to support the cannula group 2 and to connect it fluidically with the flow and pressure control group 4, preferably arranged laterally to the toilet seat 10.
  • the cannula group 2 is removably fixed to the frame 8.
  • Such frame 8 is preferably shaped with a central part 81 suitable for extending transversely and inwardly within the bowl 10, and two side arms 82, 83 adapted to be locked between the seat and the bowl 10.
  • the frame 8 comprises a passage for the treatment liquid (e.g., water) preferably extending from a side arm 83 along the support frame, ending in an upwardly oriented tubular fitting 84 for the sealed coupling of the cannula group 2.
  • the treatment liquid e.g., water
  • a first automatic release valve 85 is connected to the passage duct of the treatment liquid, oriented downward and toward the inside of the bowl for releasing the pressure of the treatment liquid in order to avoid the risk of causing injuries in case of incorrect regulation of the pressure of the treatment liquid .
  • the central part 81 of the frame 8 is vertically spaced along a vertical direction X with respect to the side arms 82, 83 so that the cannula group 2, once inserted into the tubular fitting 84, protrudes beyond the upper edge of the toilet bowl 10 to partially penetrate, the rectum of a patient seated directly on the bowl 10.
  • the fluid supply line 3 preferably extends between the tubular fitting 84 and the source 6 of the pressurized treatment fluid, consisting, for example, of a mixer or tap for hot water and cold water.
  • the connection group 5 comprises at least one connecting element 51 which may be screwed to the source 6, using, for example, a three-way connection: a first route 510 for connection to the source 6, a second route 511 for the fluidic connection with the cannula group and a third route 512 for the bypass and drainage of the treatment fluid outside the supply line 3.
  • the connection group 5 further comprises a tap 52 for opening/closing the passage of the treatment fluid outside the supply line 3 (towards the third route 512) . In this way, the user may check the temperature of the treatment liquid before directing it to the cannula 3 group.
  • one of the side arms 83 and the central part 81 on one side of the cannula group 2 comprise a passage duct for the treatment liquid, which fluidically connects the fitting element 84 with the flow and pressure control group 4.
  • such flow and pressure control group 4 is supported on one side of the frame 8 by a support plate 86 which constitutes an extension of the side arm 83 itself.
  • the flow and pressure control group 4 in addition to the pressure regulator 41, also comprises a manual reset safety device 43, which is suitable for blocking the flow of treatment liquid to the cannula group 2 when a predefined flow threshold is exceeded.
  • a manual reset safety device 43 is, for example, a safety valve, comprising a ball 430 suitable to sealingly engage a 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 41 toward a fluid outlet duct 44 of the control group 4.
  • 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 431 so as to restore the passage of fluid to below a threshold flow rate (manual reset) .
  • the pressure and flow control group 44 comprises a single body 45 on which the pressure regulator 41 and the safety valve 43 are installed.
  • 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 41 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.
  • thermometer for displaying the temperature of the treatment liquid is also provided on the single body 45.
  • the irrigation cannula 21 is shaped so as to be suitable for insertion into the natural body orifice and for irrigation with the treatment liquid, for example for anal or vaginal lavages.
  • the irrigation cannula 21 comprises a tubular body 210 extending principally along a central axis Y, at least one portion of which may be inserted through the natural body orifice.
  • Such tubular body 210 comprises an inner cavity 213, a treatment liquid inlet opening 211, and at least one treatment liquid outlet hole 212 communicating with the inner cavity 213.
  • this irrigation cannula 21 is at least partially made out of a polymeric material having a Shore D hardness of less than 45 measured by the ASTM D2240 test method. This allows a cannula with mechanical properties to be obtained that is suitable for use within natural body orifices, especially for the anal or vaginal orifice.
  • the irrigation cannula 21 is made at least partially or totally of a material having a Shore A hardness less than or equal to 100, measured according to the standard DIN 53505.
  • the irrigation cannula 21 is made at least partially or totally of a material having a Shore A hardness of between 70 and 90, and more preferably 80, measured according to the standard DIN 53505. This allows the irrigation cannula 21 to be provided with mechanical properties such as to avoid the collapse of the cannula on itself (hence the closure of the inner cavity 213) and at the same time an adequate softness and flexibility so as not to cause internal injury to the patient when the cannula is inserted into the natural orifice.
  • the aforementioned mechanical properties are obtained in an advantageous embodiment of the irrigation cannula 21 made at least partially or wholly of a silicone material having the aforementioned SHORE A or D hardness properties, for example a silicone with SHORE A hardness 80.
  • the material with which the irrigation cannula is made has a flexural modulus less than or equal to 120 MPa .
  • the tubular body 210 comprises at least one ridge 214 or a groove arranged circumferentxally on an inner wall 210' which faces the inner cavity 213 of the irrigation cannula 21.
  • ridge 214 or groove is suitable to hold a valve body 22' of a one-way valve 22 (such as a ball valve), so that the valve body 22', due to the thrust of the treatment liquid or the patient's movements, does not rise along the inner wall 210' towards the end 216 of the cannula 21 arranged opposite to the liquid inlet opening 211 (i.e., near the outlet hole 212) .
  • the tubular body 210 comprises a pair of ridges 214, 215 or grooves spaced apart from each other along the direction of the central axis Y so as to hold the valve body 22' both in the direction toward the end 216 and toward the liquid inlet opening 211.
  • the irrigation cannula 21, downstream of such ridge (s) 214, 215, or groove (s) in the inlet-outlet direction of the treatment fluid comprises a tapered region 217, for example toward the central axis Y of the cannula 21.
  • the tapered region 217 connects a larger diameter region 218, wherein the inner cavity 213 is sized such that the ball 23 is free to move along the fluid inlet-outlet direction Y to a region with a smaller diameter 219, wherein the inner cavity 213 has dimensions such as to obstruct the passage of the ball 23.
  • the diameter D calculated on the cross section of the cannula 21 is greater than the diameter of the ball 23 at a cross section in the larger diameter region 218, while it is less than the diameter of the ball 23 at a cross section in the region with a smaller diameter 219.
  • This tapered region 217 is thus suitable to prevent the passage of a ball 23 of the oneway valve into the region with a smaller diameter 219.
  • the tapered region is preferably arranged in an intermediate region along the central axis Y between the fluid inlet opening 211 and the outlet hole 212.
  • the tapered region is not located near the outlet hole 212, but is rather located around half the total length of the cannula 21 along the axial direction of the central axis Y.
  • protrusions 221, 222 for example, in the form of fins
  • the passage of the treatment liquid to the outlet hole 212 is not obstructed.
  • the ball 23 would completely obstruct the opening of the inner cavity 213, thus obstructing the passage of treatment liquid to the outlet hole 212.
  • protrusions 221, 222 Due to the presence of the protrusions 221, 222, when the ball 23 enters into contact with such protrusions 221, 222, there is at least a space 223 between the ball 23 and the inner wall 210 which allows the passage of the treatment liquid. In particular, as many spaces 223 are created as there are gaps between one protrusion 221 and the adjacent protrusion 222.
  • the cannula group 2 thus comprises a cannula 21 described in the preceding paragraphs and a one-way valve housed in the inner cavity 213 of the irrigation cannula 21 and held in support by at least one ridge 214, 215 or a groove.
  • the cannula group 2 comprises a locking component 25, adapted to prevent the irrigation cannula 21 from being disengaged from the body irrigation device, i.e. from the frame 8, due to the pressure of the treatment liquid or the movement of the patient's body.
  • the locking component 25 is separable from the irrigation cannula and comprises an engagement surface 251 with the irrigation cannula 21 adapted to prevent the irrigation cannula 21 from being disengaged from the body irrigation device, preventing the related movement between the locking component 25 and the tubular body 210 of the cannula at least in the direction of the flow of the treatment liquid.
  • the locking component 25 includes an annular element 252 suitable to be fitted around the irrigation cannula 21 and wherein the engagement surface 251 is formed on an annular ridge 251' or groove suitable for engaging with a corresponding annular groove or ridge 224 of the irrigation cannula 21.
  • the locking component 25 comprises a safety tab 253 comprising a coupling portion 254 suitable to connect to the frame 8 in such a way as to ensure that the cannula group 2 remains anchored to the frame 4, even in the case wherein the cannula group 2 slips off the tubular fitting 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 fitting 84.
  • the safety tab 253 protrudes radially from the annular element 252 and the locking portion 254 comprises a safety ring 254' suitable to be fitted to a cylindrical protrusion 85' protruding from the frame 8, preferably from the part turned toward the inner cavity of the toilet bowl or in any case opposite the extraction direction of the irrigation cannula 21.
  • the locking component is made of a material having a Shore D or Shore A hardness greater than the material of which the irrigation cannula 21 is made. This allows the cannula 21 to be held more firmly to the tubular fitting 84.
  • the locking component 25 is made in one piece with the irrigation cannula 21, preferably of the same material as the cannula 21, for example of silicone.
  • the annular element 252 in this case is not fitted around the cannula 21, but is integral with it, being made in one piece with the tubular body 210, i.e. being incorporated in the tubular body 210 of the cannula 21.
  • the locking component may include a safety tab 253 and a coupling portion 254. Consequently, the safety tab 253 is directly joined to the tubular body 210 of the cannula 21.
  • weakened areas 255, 256 are made on the tubular body 210 suitable to be torn by the traction of the safety tab 253. This facilitates the extraction of the cannula 21 from the fitting 84. In addition, by doing thusly, it is ensured that the cannula group 2 is disposable because once the weakened area has been torn, the cannula 21 is no longer reusable.
  • the irrigation cannula 21, at its upper end 216 (suitable to initiate the entry into the natural orifice) , is provided with further outlet holes 260, 261, preferably arranged so that the jet of treatment liquid exiting from said further holes 260, 261, is perpendicular to the jet exiting from the outlet hole 212.
  • the supply line 3 comprises a spirally wound extendable tube 31 which allows the pressure and water flow to be reduced, ensuring an adequate pressure drop before the treatment liquid reaches the flow and pressure control group 4.
  • the extendable tube 31 is preferably connected at its ends with quick coupling fittings 32, 33.
  • a quick coupling fitting 32 is connectable to the control group 4 and the other is directly connectable to the connection group 5 or to the filter 7 or by a thermostatic safety valve 9.
  • the supply line 3 comprises the aforementioned thermostatic safety valve 9, for example of a normally open type, comprising thermostatic actuation means suitable to actuate the valve in closure when the temperature of the incoming treatment fluid at the thermostatic safety valve exceeds a predetermined threshold temperature value that is considered dangerous.
  • the thermostatic safety valve 9 is suitable to be connected between the connecting group 5 and the filter 7.
  • the thermostatic safety valve is located immediately downstream of the control group 5 and immediately upstream of the filter 7 and connected to them by means of quick coupling fittings. It should also be noted that the terms v upstream' and ownstream' should be understood in the sense of the direction of flow of the treatment liquid.
  • Figure 6 shows a variant of embodiment of the device 1 for body irrigation through a natural body orifice, particularly suitable for vaginal lavages, but also usable for anal lavages, in the independent home healthcare field.
  • the device 1 comprises the cannula group 2, which comprises the irrigation cannula 21, suitable to be inserted into the natural body orifice, and the safety locking element 25 of the cannula 21.
  • the fluid supply line 3 comprises the flow and pressure control group 4, the connecting group 5 and all the other elements installed on the supply line already described in the preceding paragraphs and comprising the same features.
  • the device 1 does not comprise the support frame 8, but comprises a cannula handle group 100 comprising a handle 105 with a shape elongated along a preferred direction Z, in which 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.
  • a connection tube 300 is connected, which in turn is fluidically connected to the flow and pressure control group 4.
  • 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 and opposite to the fluid outlet end 103 along the preferred direction Z.
  • 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 and opposite to the fluid outlet end 103 along the preferred direction Z.
  • the cannula handle group 100 comprises a tubular coupling 84 (equivalent to the tubular fitting of the embodiment of figure 2) connected to the fluid outlet end 103 for the sealed coupling of the cannula group 2 (i.e., of the 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 in 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 that 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 fluid supply line 3 extends preferably between the tubular coupling 84 and the pressurized treatment fluid supply source 6.
  • the device 1 may be used in different places, for example at home or at a hotel.
  • the locking component 25 is suitable to prevent the irrigation cannula 21 from being disengaged from the cannula handle group 100, for example due to the pressure of the treatment liquid or the movements of the patient's body, in an equivalent manner to that which has already been described previously.
  • the safety tab 253 of the locking component 25 comprises 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 safety ring 254' is suitable to be fitted on the anchoring seat 85.
  • the device 1 comprises a hose connector 400 connected to the flow and pressure control group 4 and to the connection tube 300, which makes it easier to connect the flow and pressure control group 4 to the connection tube and the handle group.
  • the control group comprises a threaded portion 401, formed, for example, on the single body 45, on which a corresponding threaded portion 402 of the hose connector 400 may be screwed.
  • this allows the same flow and pressure control group 4 to be adapted in a quick and ergonomic way, both for use with the variant of embodiment comprising the frame 8 (figure 2), and for use without the frame 8 (figure 6) .
  • the device 1 comprises a flow adjustment device 500 of the treatment fluid toward the handle group 100, such as a tap, connected to the fluid inlet end 102 and to the connection tube 300. This allows the irrigation cannula to be changed without necessarily closing the water flow of the main water source.
  • the irrigation cannula and the cannula group according to the present invention allow the risks associated with inserting the cannula into the patient to be reduced.
  • the irrigation device according to the present invention provides improved hygienic features of the treatment liquid by the presence of an antibacterial filter and/or a carbon filter.
  • the presence of at least one ridge or groove on the tubular body of the irrigation cannula guarantees an adequate tightness of the valve body against the inner wall of the irrigation cannula, avoiding possible risks of strain on the one-way valve toward the end of the cannula or possible leakage.
  • This is particularly advisable in the case of irrigation cannulae according to the present invention which, having a lower hardness than the irrigation cannulae of the prior art, are more susceptible to easy deformations by manipulation that could move the one-way valve from its predetermined seat for operation.
  • the presence of the locking component 25 in the cannula group 2, whether it is separable or non-separable, ensures that there is no risk of accidentally releasing the cannula group 2 from the frame 8 or from the handle group 100. Also in this case, this is particularly advantageous especially for cannulae made of a material with a lower hardness than the known irrigation cannulae, the former being susceptible to crushing and deformation.

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

Abstract

Une canule d'irrigation (21) destinée à être insérée dans un orifice corporel naturel et à irriguer avec un liquide de traitement pour lavages anal ou vaginal à usage domestique comprend un corps tubulaire (210) ayant une cavité interne (213), une ouverture d'entrée (211) de liquide de traitement et au moins un trou de sortie (212) de liquide de traitement communiquant fluidiquement avec la cavité interne (213). Une telle canule d'irrigation (21) est au moins partiellement constituée d'un matériau ayant une dureté Shore D inférieure à 45. Un dispositif d'irrigation de corps (1) comprend la canule (21), une conduite d'alimentation en fluide (3), et un groupe de commande d'écoulement comprenant un régulateur de pression (41) et un dispositif de sécurité à réarmement manuel (43) approprié pour bloquer l'écoulement de liquide de traitement vers le groupe de canules (2) lorsqu'un seuil d'écoulement prédéterminé est dépassé. Un kit de poignée comprend un groupe de poignée de canule (100) ayant un couplage tubulaire (84) pour le couplage étanche de la canule et un siège d'ancrage (85) approprié pour loger un élément de verrouillage de sécurité (25) pour maintenir la canule d'irrigation (21) ancrée au groupe de poignée de canule (100).
PCT/IT2017/000177 2017-08-22 2017-08-22 Groupe de canules pour irrigation à travers des orifices corporels naturels, dispositif et kit de poignée WO2019038791A1 (fr)

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CN201790001811.0U CN215460752U (zh) 2017-08-22 2017-08-22 灌洗插管、插管组、身体灌洗设备及手柄套件
PCT/IT2017/000177 WO2019038791A1 (fr) 2017-08-22 2017-08-22 Groupe de canules pour irrigation à travers des orifices corporels naturels, dispositif et kit de poignée

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Publication number Priority date Publication date Assignee Title
US20230211070A1 (en) * 2020-06-03 2023-07-06 Mbh-Internation A/S An Enema Nozzle and an Enema Device Comprising Said Enema Nozzle
US11980731B2 (en) * 2020-06-03 2024-05-14 Qufora A/S Enema nozzle and an enema device comprising said enema nozzle

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