WO2008001234A2 - Coupling device for controlling a fluid flow, in particular for peritoneal dialysis - Google Patents

Coupling device for controlling a fluid flow, in particular for peritoneal dialysis Download PDF

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Publication number
WO2008001234A2
WO2008001234A2 PCT/IB2007/051705 IB2007051705W WO2008001234A2 WO 2008001234 A2 WO2008001234 A2 WO 2008001234A2 IB 2007051705 W IB2007051705 W IB 2007051705W WO 2008001234 A2 WO2008001234 A2 WO 2008001234A2
Authority
WO
WIPO (PCT)
Prior art keywords
container
closure
cap member
receiving housing
end portion
Prior art date
Application number
PCT/IB2007/051705
Other languages
French (fr)
Other versions
WO2008001234A3 (en
Inventor
Paolo Cerasoli
Fabio Arrizza
Original Assignee
Iperboreal Pharma 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 Iperboreal Pharma S.R.L. filed Critical Iperboreal Pharma S.R.L.
Publication of WO2008001234A2 publication Critical patent/WO2008001234A2/en
Publication of WO2008001234A3 publication Critical patent/WO2008001234A3/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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/28Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • A61M39/223Multiway valves

Definitions

  • the present invention is related to a coupling device for controlling a fluid flow, in particular in the peritoneal dialysis.
  • the known coupling device comprises a cylindrical container provided with a cap, having a bottom and a peripheral wall from which, in connection with the peritoneal dialysis use, a fitting for a peritoneal catheter, a supply fitting for the connection to a peritoneal dialysis solution source and a discharge fitting for the discharging of exhausted solution come out.
  • a plate revolving, due to an external manual driver, around a pin.
  • a receiving housing apt to receive and hold a first closure means, consisting of a first plug, from the end portion of the peritoneal catheter; and a releasing housing apt to hold and release a second closure means, i.e.
  • the peritoneal catheter provided with a first closure means ath the end portion thereof, is coupled to the first fitting for peritoneal catheter, to the second fitting of the peritoneal dialysis solution source and, at the end, to the third fitting for the discharge.
  • the end portion is slid through the first fitting to engage the first closure means with the receiving housing, and then the end portion is retracted, in such a way setting the first closure means free.
  • the driver is operated so as to rotate the revolving plate and to move the receiving housing, isolating the first closure means, away, and thus allowing the peritoneal dialysis solution to flow through the first fitting to the peritoneal catheter, so as to carry out a peritoneal dialysis treatment .
  • the driver is operated again so as to rotate the revolving plate and to allow the peritoneal dialysis solution to pass through the third fitting for the discharge. Then the driver is operated so as to further rotate the revolving plate and to drive the releasing housing with a second closure means for the end portion of the peritoneal catheter. The end portion is slid through the fitting so as to engage the second closure means, and then the end portion, closed by the second closure means, is retracted.
  • a first task of the present invention is to realise, e.g. in a manual outpatient operation of peritoneal dialysis, a condition of absolute sterility in the handling operations of the coupling device .
  • Another task of the invention is to make easier the use of a peritoneal dialysis device, also for patient with poor manual ability.
  • a further task of the invention is to make the use of the peritoneal dialysis device cleared of errors, regardless the medical training of the user.
  • the technical problem at the root of the present invention consists in the achievement of the above outlined tasks.
  • the present invention provides a coupling device for controlling a fluid flow, in particular in the peritoneal dialysis, comprising:
  • closure members each of them apt to be partially inserted within an end portion of a first tubular member; * catching and releasing means of said closure members, associated to said plate; and
  • the coupling device assures the coupling between an end portion of a tubular member, e.g.
  • a peritoneal catheter and another or more tubular members linked, for instance, to one or more peritoneal exchange bags in a protected environment, not opened to the exterior, substantially preventing the contamination of the end or of the inside of the peritoneal exchange device by bacteria, mycetes and viruses and by any other polluting material.
  • the operation of the coupling device according to the present invention can be easily and intuitively understood by the patient, so as to virtually render not strictly required a specific training of technical personnel.
  • the device can be used also by hyposighted persons, by utilising suitable indicia on the device itself.
  • the device according to the present invention repeals the peritoneal dialysis technique contraindications implied in the social problems and overcoming the election limits for candidate patients to the peritoneal dialysis having physical, psychical or social handicaps.
  • One embodiment of the present invention will be now described in detail, with reference to the annexed drawings.
  • Figure 1 is a top view of the device according to the present invention in one of the preferred embodiments thereof, for the use as coupling device for peritoneal dialysis, in a configuration wherein a closure member is transferred to an end portion of a tubular member, i.e. a peritoneal catheter, or from the latter;
  • Figure 2 is a sectional view according to a plane identified by the line A-A in figure 1;
  • Figure 3 is an exploded perspective view of the device of figure 1;
  • Figure 4 is a side view of the device of figure 1;
  • Figure 5 is a sectional view according to a plane identified by a line B-B in figure 4, with a closure member into the end portion of the above peritoneal catheter;
  • Figure 6 is a sectional view according to a plane identified by a line B-B in figure 4, with a closure member pulled out of the peritoneal catheter.
  • a coupling device which, in the embodiment described herein, is particularly indicated to be used in the sphere of the peritoneal dialysis, for coupling the end portions of two tubular members, i.e. of two peritoneal catheters.
  • FIG. 1 a top view of the above mentioned embodiment of the coupling device for controlling a fluid flow according to the present invention. It comprises a container 1 and a fastening device 2, for putting in fluid communication the container 1 with a tubular member 3 which, in the present embodiment, can be a peritoneal catheter, through an opening 11 acting as fitting and constituted by a projecting nozzle, externally provided with a threading for being a screw-type link or with an analogous fastening system, as a bayonet-type coupling.
  • a tubular member 3 which, in the present embodiment, can be a peritoneal catheter, through an opening 11 acting as fitting and constituted by a projecting nozzle, externally provided with a threading for being a screw-type link or with an analogous fastening system, as a bayonet-type coupling.
  • One of the preferred coupling systems usually employed in the field of the medical devices, is that known as luer lock.
  • the container 1 is provided with walls, and in particular it is equipped with a lid 4, on which a knob is placed, so as to be secured, e.g. for being integrally formed thereto, to a grooved plate which will be described hereinafter.
  • a lid 4 On the lid 4, references of the visible kind for an operator are formed, e.g. point-shaped and generally indicated as 7, whose function will be clarified in the following.
  • the container has a fluid communication with a pair of further tubular members, not shown, through two fittings 8, 9, respectively for the supply and for the surcharge, passing through the peripheral wall thereof.
  • the container 1 can have only one fitting.
  • An embodiment of this kind is neither shown in the drawings, nor illustrated further on, but it has to be taken into consideration as in the range of the man skilled in the art .
  • the fastening device 2 comprises a pair of coaxial bushings, one proximal 10 and the other distal 12, partially sliding one inside the other.
  • the proximal bushing 10 has a fastening portion 13 having an internal thread with respect to the fitting 11, to be screwed on it, and an internal cylindrical portion 14, acting as guide for the peritoneal catheter 3.
  • the peritoneal catheter is instead secured to be applied to the fitting 11 of the container 1.
  • a helicoidal spring 15 is positioned or another similar resilient counter pressing means.
  • a spring- guiding sleeve 16 is positioned between the peritoneal catheter 3 and the distal bushing 12, engaged with the distal bushing 12 to prevent interferences between the counter- pressing spring 15 and the peritoneal catheter 3.
  • a coaxial grip 17 is incorporated for easing the operation of the fastening device 2.
  • gripping surfaces 18 are formed on the coaxial grip 17, gripping surfaces 18 are formed.
  • a tooth 19 is provided projecting toward the container 1, with the function which will be detailed hereinafter.
  • FIG 2 is a cross-sectional view according to a plane identified by a line A-A of the device in figure 1, the inside of the container 1 is shown.
  • the container 1 substantially hollow, has a bottom 20 and a peripheral wall 21 delimiting, in cooperation with the lid 4, an internal chamber 22. Inside the chamber 22, preferably near the bottom 20, a second plate 23 is rotatably mounted.
  • the container 1 is cylindrical, but other shapes are not excluded, even for the internal chamber 22 itself.
  • the rotating plate 23 is made integral to a spindle 24, preferably integrally formed with the knob 5 and with the grooved plate 6 and passing through the lid 4 of the container 1.
  • the spindle 24 is rotatably supported below in a blind hole formed at the internal side of the bottom 30 of the container 1.
  • This bottom 20 is externally moulded for appropriately integrating the above mentioned blind hole within the thickness thereof.
  • Manually operating on the knob 5, the plate 23 can be rotated with respect to the peripheral wall 21 of the container 1.
  • the knob 5 having indentations 25, 26 in its body for the application of the user's fingers, generally the thumb and the forefinger of the right hand, ends with an indicating point 27 or with another similar shape for exploiting the same function, serving to indicate the position of the revolving plate 23, and thus of the components of the device integrally mounted therewith.
  • the knob is suitably integrally formed with the grooved plate 6.
  • an arrow 28 is outlined clockwise, indicating the rotation of the knob in the peritoneal dialysis.
  • a hollow 29 is formed to surround an area identified by one of the indicia 7.
  • the grooved plate identifies the positioning of the revolving plate 23, simultaneously indicated by the point 27 of the knob 5 and by the hidden overcome indicia, related to the already executed steps in the dialysis treatment.
  • the grooved plate 6 has a curved band 30 projecting from the peripheral wall- The curved band 30 is provided to cooperate with the tooth 19, integral with the bushing 10, to prevent erroneous operations due to a wrong use of the device.
  • the tooth 19 is rotated so as to be laterally adjacent to the projecting band 30 and to prevent the possible attempt to rotate the knob 5.
  • the fastener 2 cannot be unscrewed from the container, unless the knob 5 has been rotated for the angular interval leading to the index "with four dots", i.e. when the projecting band 30 has overcome, with the end 31 thereof, at the opposite side with respect to the hollow 29, the tooth 19.
  • the above mentioned tooth 19 and curved band 30 constitute means for disabling the rotation of the knob 5, i.e. of the revolving plate 23, associated to the fastening device 2.
  • a first receiving housing 31 is secured, apt to receive and hold a first closure member 33 extracted from the end portion 34 of the peritoneal catheter 3.
  • a second receiving housing 35 is securely formed , apt to contain and release a second closure member 36 into the end portion 34 of peritoneal catheter 3, after the extraction of the first closure member 33.
  • the receiving and release housings 32, 35 are positioned on the plate 23 according to a radial direction (see figure 2), and have a radial opening for the passage of the closure means, faced toward the peripheral wall 21 of the container 1.
  • the housings 32, 35 have longitudinal axes orthogonal to the peripheral wall 21 itself, they are closed with the exception of the radial opening and they have partially tapered walls toward the centre of the container 1, to help a correct holding of the closure means and an easier transfer from and to the end portion 34 of the peritoneal catheter 3. They constitute catching and releasing means of said closure members 32, 25, which substantially are plugs apt to be held by elastic interference within said end 34 of the catheter 3.
  • the closure means 33, 36 can be identical to each other, and they are apt to be at least partially inserted inside the end portion 34 of the catheter 3.
  • they are substantially plug-shaped and comprise a sealing end 37, intended to be received into the end portion 34 of peritoneal catheter 3, and a head 38, intended to externally project from said end 34.
  • the sealing end 37 suitably tapered and/or blunted, has an ogival shape to be inserted into the end portion of cylindrical tubular members, even if other tube section shapes and hence other sealing end shapes cannot be excluded. It is essential that the sealing end is liquid-tight for the peritoneal catheter.
  • the head 38 of the closure members 33, 36 is substantially cylindrical, but it may have other shapes.
  • a cap member 39 is intended to be applied so as to completely surround it, apt to determine a sterile protection at the head 38 of the first closure member 33.
  • the cap member 38 Before being applied on the head 38 of the closure member 33, as shown in figure 5, the cap member 38 is placed inside the connection nozzle 11 near the receiving housing 32, and there held by mechanical interference.
  • suitable holding means can be provided, associated to the connection nozzle 11, in particular fins 42.
  • the holding fins 42 can be seen in figure 3, 5 and ⁇ in the end part of the fitting 11 faced toward the inside of the container 1. It is understood that the cap member 39 is placed into the nozzle 11 with the cavity thereof faced toward the exterior, so as it can receive the head of the closure member 33, pushed down by the fastening device 2.
  • the respective receiving housing for containing both the closure member 33 and the cap member 39, has a greater size than the release housing 35.
  • the receiving housing walls project with an extension 40 having a circumferential shape, as a rim extending from each side of the opening.
  • the circumferentially shaped extension 40 at the portion thereof facing the bottom 20 of the container 1, engages a rail 41, formed by a circumferential rib, projecting from the bottom 20 itself, which, apart from preventing the contact between the first closure member and the liquid inside the container 1, also operates as stroke stop limiting the angular movement of the revolving plate 23, constituting therefore a stopper on the receiving housing 32.
  • the orientation of the receiving housing 32 over the revolving plate 23 is such that the longitudinal axis thereof is parallel to the main axis of the knob 5 and, as shown in the figures, and it is positioned, with respect the dial on the lid 4, in the position "one dot" of the reference index 7.
  • the orientation of the release housing 35 is such that the longitudinal axis thereof is perpendicular to the main axis of the knob 5.
  • the fitting 8 is connected to a first flexible hose determining a fluid communication with a source of peritoneal dialysis solution, e.g. a bag (not shown), and the fitting 9 is connected to a second flexible hose determining a fluid communication with a discharge, e.g. a suitable bag (not shown) .
  • the spindle 24 of the knob 5 has a central portion 44 with a greater diameter (figure 2), having a polygonal portion intended to be engaged in a corresponding seat 46 of a ring gear 47 centrally formed in the revolving plate 23.
  • the teeth of said ring gear are equidistant, circumferentially arranged and parallel to the axis of the spindle 24, and they form interspaces wherein the edges of the central portion 44 are inserted, causing a stepped movement.
  • the distance between teeth, arranged on the plate 23, thus causes a movement stepping with an acoustic effect.
  • the teeth are intended to engage with a projecting counter-tooth (not shown), e.g. formed in the lid 4. In such a way, it is possible evaluate, for example, a unidirectional stepped rotation of the knob by said acoustic effect.
  • the plate 23, advantageously has a slot 48.
  • the projections 49, 50 operate as flow cut off and also as stopper members for the rotation of the revolving plate 23.
  • the revolving plate 23 has a raised edge 51 having sags 52, 53 intended to be positioned facing the fittings and below a projecting portion 43 form the lid, visible in figure 3 in the portion below the latter, respectively.
  • the raised edge with the sags 52, 53 and the cooperating projecting portion 43 of the lid 4, operate on the above mentioned end portions of the flexible hoses passing through the fittings 8 and 9, respectively for admitting and for preventing the fluid flow through the fitting 8 and through the fitting 9, in the step of introducing dialysis liquid and in the discharge step respectively, in combination with the fixed vertical grooved projections 49, 50.
  • the operation of the device allows the exchange of fluids in a peritoneal dialysis system, in particular in a CAPD system or continuous peritoneal dialysis.
  • it is required to carry out the exchange of the closure member 33 of the catheter 3, coming from a preceding dialysis cycle and hence potentially contaminated, with a new closure member 36 contained in the device and intended to seal the catheter at the end of the dialysis cycle so as to ensure the non- contamination of the system.
  • the fitting 8 is coupled to a source of peritoneal dialysis solution and the fitting 9 to a discharge.
  • the knob 5 is arranged to be directed to the first dot of the indicia 7 (as shown in figure 1) .
  • the fastening device 2 is grasped on the grip 17 and is pushed toward the container 1, to let the end portion 34 slide through the fitting 11 until the first closure member 33 and the cap member 39 are engaged with the receiving housing 32.
  • the catching occurs by mechanical interference between the walls of the receiving housing 32 and the cap member 39, because the diameter of the receiving housing is equal or slightly smaller than that of the cap member 39 which can be conveniently elastically deformable. Further holding means however can be provided as further ratchet fins inside the housing 32.
  • the knob 5 is operated to move it in the second position tagged two dots in the indicia 7.
  • the revolving plate 23 is rotated and the receiving housing 32 is moved away, for allowing the peritoneal dialysis solution to pass through the fitting 8 to the catheter 3, so executing the dialysis treatment.
  • the sag 52 of the revolving plate 23 is placed facing the fitting 8, while the raised edge 51 closes the outlet to the discharge of the fitting 9.
  • the knob 5 is further operated until it is placed in the third position tagged by three dots of the indicia 7: in such a position, the revolving plate 23 is placed with the sag 53 facing the fitting 9, so as to allow the solution coming from the peritoneal catheter 3 to flow through the fitting 9 to the discharge.
  • the knob 5 is further operated until it is placed in the fourth position tagged by four dots of the indicia 7, so as to have the revolving plate 23 rotated and the release housing 35, with the second closure member 36, driven at the end portion 34 of the catheter 3.
  • the grip 17 of the fastening device 2 as in the above described phase, so as to have the end portion 34 slid through the fitting 11 to engage the second closure member 36 inside the release housing 35 and to slide back the end portion 34 provided with said closure means.
  • the fastener 2 can be unscrewed from the fitting 11, since the tooth 19 of the proximal bushing 10 is no longer thwarted by the projecting band 30 integral with the knob 5.
  • the peritoneal dialysis assembly is constituted by a part related to the peritoneal catheter, i.e. the fastener, and by a part related to the bags of source-discharge. It is apparent that the peritoneal catheter is permanent, while the other part must be disposed after any peritoneal dialysis treatment.
  • the fastener surrounding the peritoneal catheter closed by its closure means is coupled to the exchange device, i.e. the disposable portion of the device including the bags of source-discharge and the flow splitter.
  • the catheter is fully protected from contaminations.
  • the housing 32 for receiving and holding the old closure member 33 can be filled by a disinfecting member or agent, e.g. a sponge soaked by a disinfecting agent which may be Povidone gel. This gel damps the exterior of the catheter still closed by the closure means used when the catheter is inserted into the device, reducing the bacterial charge outside the catheter, as further and additional safety system.
  • the device of the invention can be realised according to a variant apt to be used in automatic or semi-automatic peritoneal dialysis apparels.
  • the modifications to be adopted in this variant can be found in the range of the skilled man, and therefore they are not illustrated.

Abstract

A coupling device for controlling a fluid flow, particularly suitable to be used as connector in the sphere of the peritoneal dialysis, comprises: fitting openings, for the coupling of respective tubular members, formed within the walls of a container (1); a plate (23) positioned inside said container (1) and rotatable from the outside of said container (1); closure members (33, 36), each of them apt to be partially inserted within an end portion (34) of a first tubular member (3); catching and releasing means (32, 35) of said closure members (33, 36), associated to said plate (23); and a cap member (39), apt to enclose a projecting portion (38) of said closure members (33, 36) projecting from said end portion (34), held at one of said fitting openings (11) in engagement with said first tubular members (3), said cap member (39) being interposed between a closure member (33) inserted in said end portion (34) and said catching and releasing means of the closure members (33, 36), before the closure member (33) is caught by the catching and releasing means (32, 35).

Description

COUPLING DEVICE FOR CONTROLLING A FLUID FLOW, IN PARTICULAR FOR PERITONEAL DIALYSIS
Description
Field of the invention The present invention is related to a coupling device for controlling a fluid flow, in particular in the peritoneal dialysis.
State of the Art
The same applicant has already described, in the patent application WO 2005/082437, a device for applying and removing a closure means to and end portion of a tubular element. There, it is explained a use of the device in the peritoneal dialysis, with the purpose of totally . or substantially cutting the risk of peritonitis involved therein, i.e. the risk of contaminating the organic fluid passing through the device.
The known coupling device comprises a cylindrical container provided with a cap, having a bottom and a peripheral wall from which, in connection with the peritoneal dialysis use, a fitting for a peritoneal catheter, a supply fitting for the connection to a peritoneal dialysis solution source and a discharge fitting for the discharging of exhausted solution come out. Inside the container, it is received a plate revolving, due to an external manual driver, around a pin. Onto the plate are secured: a receiving housing, apt to receive and hold a first closure means, consisting of a first plug, from the end portion of the peritoneal catheter; and a releasing housing apt to hold and release a second closure means, i.e. a second plug, to the end portion of the peritoneal catheter. The reception and the release of the closure means occur through said fitting, when the receiving and the releasing housings, both provided with an opening for the passage of the closure means, are positioned at the first fitting of the peritoneal catheter. In connection with the use of the known coupling device, for instance in relationship with the peritoneal dialysis, the peritoneal catheter, provided with a first closure means ath the end portion thereof, is coupled to the first fitting for peritoneal catheter, to the second fitting of the peritoneal dialysis solution source and, at the end, to the third fitting for the discharge. The end portion is slid through the first fitting to engage the first closure means with the receiving housing, and then the end portion is retracted, in such a way setting the first closure means free.
Hence, the driver is operated so as to rotate the revolving plate and to move the receiving housing, isolating the first closure means, away, and thus allowing the peritoneal dialysis solution to flow through the first fitting to the peritoneal catheter, so as to carry out a peritoneal dialysis treatment .
After, the driver is operated again so as to rotate the revolving plate and to allow the peritoneal dialysis solution to pass through the third fitting for the discharge. Then the driver is operated so as to further rotate the revolving plate and to drive the releasing housing with a second closure means for the end portion of the peritoneal catheter. The end portion is slid through the fitting so as to engage the second closure means, and then the end portion, closed by the second closure means, is retracted.
Summary of the Invention
Starting from the above described general construction and operation principles of the coupling device, a first task of the present invention is to realise, e.g. in a manual outpatient operation of peritoneal dialysis, a condition of absolute sterility in the handling operations of the coupling device .
Another task of the invention is to make easier the use of a peritoneal dialysis device, also for patient with poor manual ability.
A further task of the invention is to make the use of the peritoneal dialysis device cleared of errors, regardless the medical training of the user. The technical problem at the root of the present invention consists in the achievement of the above outlined tasks. According the most general concept thereof, the present invention provides a coupling device for controlling a fluid flow, in particular in the peritoneal dialysis, comprising:
* fitting openings, for the coupling of respective tubular members, formed within the walls of a container;
* a plate positioned inside said container and rotatable from the outside of said container;
* closure members, each of them apt to be partially inserted within an end portion of a first tubular member; * catching and releasing means of said closure members, associated to said plate; and
* a cap member, apt to enclose a projecting portion of said closure members projecting from said end portion, held at one of said fitting openings in engagement with said first tubular members, said cap member being interposed between a closure member inserted in said end portion and said catching and releasing means of the closure members, before the closure member is caught by the catching and releasing means. Thank to the features thereof, the coupling device according to the present invention assures the coupling between an end portion of a tubular member, e.g. a peritoneal catheter, and another or more tubular members linked, for instance, to one or more peritoneal exchange bags in a protected environment, not opened to the exterior, substantially preventing the contamination of the end or of the inside of the peritoneal exchange device by bacteria, mycetes and viruses and by any other polluting material.
For the construction features thereof, the operation of the coupling device according to the present invention can be easily and intuitively understood by the patient, so as to virtually render not strictly required a specific training of technical personnel. In a particularly advantageous way, the device can be used also by hyposighted persons, by utilising suitable indicia on the device itself.
Thank to the features which will be illustrated hereinafter, the device according to the present invention repeals the peritoneal dialysis technique contraindications implied in the social problems and overcoming the election limits for candidate patients to the peritoneal dialysis having physical, psychical or social handicaps. One embodiment of the present invention will be now described in detail, with reference to the annexed drawings.
Brief description of the drawings
Figure 1 is a top view of the device according to the present invention in one of the preferred embodiments thereof, for the use as coupling device for peritoneal dialysis, in a configuration wherein a closure member is transferred to an end portion of a tubular member, i.e. a peritoneal catheter, or from the latter;
Figure 2 is a sectional view according to a plane identified by the line A-A in figure 1;
Figure 3 is an exploded perspective view of the device of figure 1;
Figure 4 is a side view of the device of figure 1;
Figure 5 is a sectional view according to a plane identified by a line B-B in figure 4, with a closure member into the end portion of the above peritoneal catheter; and
Figure 6 is a sectional view according to a plane identified by a line B-B in figure 4, with a closure member pulled out of the peritoneal catheter. Detailed description of an embodiment of the invention
The following description is referred to a coupling device which, in the embodiment described herein, is particularly indicated to be used in the sphere of the peritoneal dialysis, for coupling the end portions of two tubular members, i.e. of two peritoneal catheters.
With reference to the drawings, in particular to figure 1, there is shown a top view of the above mentioned embodiment of the coupling device for controlling a fluid flow according to the present invention. It comprises a container 1 and a fastening device 2, for putting in fluid communication the container 1 with a tubular member 3 which, in the present embodiment, can be a peritoneal catheter, through an opening 11 acting as fitting and constituted by a projecting nozzle, externally provided with a threading for being a screw-type link or with an analogous fastening system, as a bayonet-type coupling. One of the preferred coupling systems, usually employed in the field of the medical devices, is that known as luer lock. The container 1 is provided with walls, and in particular it is equipped with a lid 4, on which a knob is placed, so as to be secured, e.g. for being integrally formed thereto, to a grooved plate which will be described hereinafter. On the lid 4, references of the visible kind for an operator are formed, e.g. point-shaped and generally indicated as 7, whose function will be clarified in the following. The container has a fluid communication with a pair of further tubular members, not shown, through two fittings 8, 9, respectively for the supply and for the surcharge, passing through the peripheral wall thereof. In different conditions of use, like the automatic peritoneal dialysis, the container 1 can have only one fitting. An embodiment of this kind is neither shown in the drawings, nor illustrated further on, but it has to be taken into consideration as in the range of the man skilled in the art .
The fastening device 2 comprises a pair of coaxial bushings, one proximal 10 and the other distal 12, partially sliding one inside the other. As shown also in figures 5 and 6 according to a longitudinal sectional view, the proximal bushing 10 has a fastening portion 13 having an internal thread with respect to the fitting 11, to be screwed on it, and an internal cylindrical portion 14, acting as guide for the peritoneal catheter 3. In one end portion of the distal bushing 12, intended to slide over the proximal bushing 10, the peritoneal catheter is instead secured to be applied to the fitting 11 of the container 1. Between the free end of the proximal bushing 10 and the distal bushing 12, jointed to each other, a helicoidal spring 15 is positioned or another similar resilient counter pressing means. Moreover, a spring- guiding sleeve 16 is positioned between the peritoneal catheter 3 and the distal bushing 12, engaged with the distal bushing 12 to prevent interferences between the counter- pressing spring 15 and the peritoneal catheter 3. On the distal bushing 12, which has to be manually operated along a longitudinal direction to draw up and move away the end the peritoneal catheter 3 with respect to the container 3, a coaxial grip 17 is incorporated for easing the operation of the fastening device 2. On the coaxial grip 17, gripping surfaces 18 are formed. On the proximal bushing 10 a tooth 19 is provided projecting toward the container 1, with the function which will be detailed hereinafter.
With reference to figure 2, which is a cross-sectional view according to a plane identified by a line A-A of the device in figure 1, the inside of the container 1 is shown. The container 1, substantially hollow, has a bottom 20 and a peripheral wall 21 delimiting, in cooperation with the lid 4, an internal chamber 22. Inside the chamber 22, preferably near the bottom 20, a second plate 23 is rotatably mounted. For construction easiness, it is advantageous that the container 1 is cylindrical, but other shapes are not excluded, even for the internal chamber 22 itself.
The rotating plate 23 is made integral to a spindle 24, preferably integrally formed with the knob 5 and with the grooved plate 6 and passing through the lid 4 of the container 1. The spindle 24 is rotatably supported below in a blind hole formed at the internal side of the bottom 30 of the container 1. This bottom 20 is externally moulded for appropriately integrating the above mentioned blind hole within the thickness thereof. Manually operating on the knob 5, the plate 23 can be rotated with respect to the peripheral wall 21 of the container 1.
As shown in figure 1, the knob 5, having indentations 25, 26 in its body for the application of the user's fingers, generally the thumb and the forefinger of the right hand, ends with an indicating point 27 or with another similar shape for exploiting the same function, serving to indicate the position of the revolving plate 23, and thus of the components of the device integrally mounted therewith. The knob is suitably integrally formed with the grooved plate 6.
Further, on the grooved plate 6 an arrow 28 is outlined clockwise, indicating the rotation of the knob in the peritoneal dialysis. Appropriately, on the grooved plate 6 a hollow 29 is formed to surround an area identified by one of the indicia 7. The grooved plate identifies the positioning of the revolving plate 23, simultaneously indicated by the point 27 of the knob 5 and by the hidden overcome indicia, related to the already executed steps in the dialysis treatment. The grooved plate 6 has a curved band 30 projecting from the peripheral wall- The curved band 30 is provided to cooperate with the tooth 19, integral with the bushing 10, to prevent erroneous operations due to a wrong use of the device. If, by way of example, the bushing 10 of the fastening device 2 is not perfectly screwed on the fitting 11, the tooth 19 is rotated so as to be laterally adjacent to the projecting band 30 and to prevent the possible attempt to rotate the knob 5. At the same time, the fastener 2 cannot be unscrewed from the container, unless the knob 5 has been rotated for the angular interval leading to the index "with four dots", i.e. when the projecting band 30 has overcome, with the end 31 thereof, at the opposite side with respect to the hollow 29, the tooth 19. Only at the end of the rotation of the knob 5 until the indicia 7 "with four dots", and hence of the projection band 30 beyond the tooth 19, it is possible to rotate the fastener 2 for unscrewing the portion 13 of the bushing 10 from the fitting 11 of the container.
The above mentioned tooth 19 and curved band 30 constitute means for disabling the rotation of the knob 5, i.e. of the revolving plate 23, associated to the fastening device 2. Making particularly reference to figure 5 and 6, it is shown that, on the revolving plate 23, a first receiving housing 31 is secured, apt to receive and hold a first closure member 33 extracted from the end portion 34 of the peritoneal catheter 3. Further, on the revolving plate 23 a second receiving housing 35 is securely formed , apt to contain and release a second closure member 36 into the end portion 34 of peritoneal catheter 3, after the extraction of the first closure member 33. The receiving and release housings 32, 35 are positioned on the plate 23 according to a radial direction (see figure 2), and have a radial opening for the passage of the closure means, faced toward the peripheral wall 21 of the container 1. The housings 32, 35 have longitudinal axes orthogonal to the peripheral wall 21 itself, they are closed with the exception of the radial opening and they have partially tapered walls toward the centre of the container 1, to help a correct holding of the closure means and an easier transfer from and to the end portion 34 of the peritoneal catheter 3. They constitute catching and releasing means of said closure members 32, 25, which substantially are plugs apt to be held by elastic interference within said end 34 of the catheter 3.
The holding of the closure members in the respective housings, possibly even by a cap member 39 for the first closure member, occurs for interference. However, also other holding means can be provided for a suitable operation of the coupling device.
The closure means 33, 36 can be identical to each other, and they are apt to be at least partially inserted inside the end portion 34 of the catheter 3. In this embodiment, they are substantially plug-shaped and comprise a sealing end 37, intended to be received into the end portion 34 of peritoneal catheter 3, and a head 38, intended to externally project from said end 34.
The sealing end 37, suitably tapered and/or blunted, has an ogival shape to be inserted into the end portion of cylindrical tubular members, even if other tube section shapes and hence other sealing end shapes cannot be excluded. It is essential that the sealing end is liquid-tight for the peritoneal catheter.
Preferably, the head 38 of the closure members 33, 36 is substantially cylindrical, but it may have other shapes. On the cylindrical body 38 a cap member 39 is intended to be applied so as to completely surround it, apt to determine a sterile protection at the head 38 of the first closure member 33. Before being applied on the head 38 of the closure member 33, as shown in figure 5, the cap member 38 is placed inside the connection nozzle 11 near the receiving housing 32, and there held by mechanical interference. By way of example, suitable holding means can be provided, associated to the connection nozzle 11, in particular fins 42. The holding fins 42 can be seen in figure 3, 5 and β in the end part of the fitting 11 faced toward the inside of the container 1. It is understood that the cap member 39 is placed into the nozzle 11 with the cavity thereof faced toward the exterior, so as it can receive the head of the closure member 33, pushed down by the fastening device 2. _ g -
It is obvious that the respective receiving housing, for containing both the closure member 33 and the cap member 39, has a greater size than the release housing 35. Further, just to prevent a germ proliferation inside the container 1, the receiving housing walls project with an extension 40 having a circumferential shape, as a rim extending from each side of the opening. The circumferentially shaped extension 40, at the portion thereof facing the bottom 20 of the container 1, engages a rail 41, formed by a circumferential rib, projecting from the bottom 20 itself, which, apart from preventing the contact between the first closure member and the liquid inside the container 1, also operates as stroke stop limiting the angular movement of the revolving plate 23, constituting therefore a stopper on the receiving housing 32. The orientation of the receiving housing 32 over the revolving plate 23 is such that the longitudinal axis thereof is parallel to the main axis of the knob 5 and, as shown in the figures, and it is positioned, with respect the dial on the lid 4, in the position "one dot" of the reference index 7. The orientation of the release housing 35 is such that the longitudinal axis thereof is perpendicular to the main axis of the knob 5.
It is understood that the above described orthogonal arrangement is not binding, and that the axes of the two housings 32, 35 could form between them an angle different from a right angle. Such right angle is however preferred to indicate to the operator of the container when one of the housings 32, 35 of the other of the closure means is coaxial to the end portion 34 of the peritoneal catheter 3, in such a way that even the sealing end 37 of the closure member 33, 36 is coaxial to the latter.
After having defined the main features of the coupling device for controlling a fluid flow according to the present intention, it is appropriate to consider again figure 3 for detailing some structural features of the container 1. Even if not shown, the fitting 8 is connected to a first flexible hose determining a fluid communication with a source of peritoneal dialysis solution, e.g. a bag (not shown), and the fitting 9 is connected to a second flexible hose determining a fluid communication with a discharge, e.g. a suitable bag (not shown) . The spindle 24 of the knob 5 has a central portion 44 with a greater diameter (figure 2), having a polygonal portion intended to be engaged in a corresponding seat 46 of a ring gear 47 centrally formed in the revolving plate 23. The teeth of said ring gear are equidistant, circumferentially arranged and parallel to the axis of the spindle 24, and they form interspaces wherein the edges of the central portion 44 are inserted, causing a stepped movement. The distance between teeth, arranged on the plate 23, thus causes a movement stepping with an acoustic effect. The teeth are intended to engage with a projecting counter-tooth (not shown), e.g. formed in the lid 4. In such a way, it is possible evaluate, for example, a unidirectional stepped rotation of the knob by said acoustic effect. As illustrated in figures 5 and 6, the plate 23, advantageously has a slot 48. On the bottom 20 of the container 1, fixed vertical grooved projections 49, 50 are provided, housed inside the slot 48 of the revolving plate 23. The projections 49, 50 operate as flow cut off and also as stopper members for the rotation of the revolving plate 23. The revolving plate 23 has a raised edge 51 having sags 52, 53 intended to be positioned facing the fittings and below a projecting portion 43 form the lid, visible in figure 3 in the portion below the latter, respectively. The raised edge, with the sags 52, 53 and the cooperating projecting portion 43 of the lid 4, operate on the above mentioned end portions of the flexible hoses passing through the fittings 8 and 9, respectively for admitting and for preventing the fluid flow through the fitting 8 and through the fitting 9, in the step of introducing dialysis liquid and in the discharge step respectively, in combination with the fixed vertical grooved projections 49, 50.
The operation of the device allows the exchange of fluids in a peritoneal dialysis system, in particular in a CAPD system or continuous peritoneal dialysis. In this case, it is required to carry out the exchange of the closure member 33 of the catheter 3, coming from a preceding dialysis cycle and hence potentially contaminated, with a new closure member 36 contained in the device and intended to seal the catheter at the end of the dialysis cycle so as to ensure the non- contamination of the system.
In this case, the closure member 33 already engaged into the end portion 34 of the peritoneal catheter 3, in the connection of the fastening device 2 to the container, is caught by the cap member 39 placed inside the fitting 11 and, in this phase, held in place by the fins 42, 42 of the fitting 11 of the device according to the present invention, as shown in figure 5. The fitting 8 is coupled to a source of peritoneal dialysis solution and the fitting 9 to a discharge. The knob 5 is arranged to be directed to the first dot of the indicia 7 (as shown in figure 1) . The fastening device 2 is grasped on the grip 17 and is pushed toward the container 1, to let the end portion 34 slide through the fitting 11 until the first closure member 33 and the cap member 39 are engaged with the receiving housing 32.
The catching occurs by mechanical interference between the walls of the receiving housing 32 and the cap member 39, because the diameter of the receiving housing is equal or slightly smaller than that of the cap member 39 which can be conveniently elastically deformable. Further holding means however can be provided as further ratchet fins inside the housing 32.
After, the grip 17 is pulled back and the first closure member 33 is held by interference inside the receiving housing 32 as shown in figure 6.
The knob 5 is operated to move it in the second position tagged two dots in the indicia 7. In such a way, the revolving plate 23 is rotated and the receiving housing 32 is moved away, for allowing the peritoneal dialysis solution to pass through the fitting 8 to the catheter 3, so executing the dialysis treatment. As a matter of fact, in this position the sag 52 of the revolving plate 23 is placed facing the fitting 8, while the raised edge 51 closes the outlet to the discharge of the fitting 9.
When this phase is finished, the knob 5 is further operated until it is placed in the third position tagged by three dots of the indicia 7: in such a position, the revolving plate 23 is placed with the sag 53 facing the fitting 9, so as to allow the solution coming from the peritoneal catheter 3 to flow through the fitting 9 to the discharge.
After the discharge, the knob 5 is further operated until it is placed in the fourth position tagged by four dots of the indicia 7, so as to have the revolving plate 23 rotated and the release housing 35, with the second closure member 36, driven at the end portion 34 of the catheter 3. Operating the grip 17 of the fastening device 2 as in the above described phase, so as to have the end portion 34 slid through the fitting 11 to engage the second closure member 36 inside the release housing 35 and to slide back the end portion 34 provided with said closure means. Now, the fastener 2 can be unscrewed from the fitting 11, since the tooth 19 of the proximal bushing 10 is no longer thwarted by the projecting band 30 integral with the knob 5. As understood from the preceding description, the peritoneal dialysis assembly is constituted by a part related to the peritoneal catheter, i.e. the fastener, and by a part related to the bags of source-discharge. It is apparent that the peritoneal catheter is permanent, while the other part must be disposed after any peritoneal dialysis treatment.
Hence, the fastener surrounding the peritoneal catheter closed by its closure means, is coupled to the exchange device, i.e. the disposable portion of the device including the bags of source-discharge and the flow splitter. The catheter is fully protected from contaminations. The housing 32 for receiving and holding the old closure member 33 can be filled by a disinfecting member or agent, e.g. a sponge soaked by a disinfecting agent which may be Povidone gel. This gel damps the exterior of the catheter still closed by the closure means used when the catheter is inserted into the device, reducing the bacterial charge outside the catheter, as further and additional safety system.
The device of the invention can be realised according to a variant apt to be used in automatic or semi-automatic peritoneal dialysis apparels. As previously said, the modifications to be adopted in this variant can be found in the range of the skilled man, and therefore they are not illustrated.

Claims

Claims
1. Coupling device for controlling a fluid flow, in particular in the peritoneal dialysis, comprising:
* fitting openings, for the coupling of respective tubular members, formed within the walls of a container (1) ;
* a plate (23) positioned inside said container (1) and rotatable from the outside of said container (1) ;
* closure members (33, 36) , each of them apt to be partially inserted within an end portion (34) of a first tubular member (3) ;
* catching and releasing means (32, 35) of said closure members (33, 36) , associated to said plate (23) ; and
* a cap member (39), apt to enclose a projecting portion (38) of said closure members (33, 36) projecting from said end portion (34), held at one of said fitting openings (11) in engagement with said first tubular members (3) , said cap member (39) being interposed between a closure member (33) inserted in said end portion (34) and said catching and releasing means of the closure members (33, 36) , before the closure member (33) is caught by the catching and releasing means (32, 35).
2. Device according to claim 1, wherein said fitting opening is constituted by a nozzle (11) projecting from said container (1) , the cap member (39) being arranged inside the nozzle (11) with the cavity thereof faced toward the exterior.
3. Device according to claim 2, wherein the cap member (39) is held by mechanical interference inside the nozzle (11) .
4. Device according to claim 3, wherein said mechanical interference is realised by holding means associated to said nozzle (11) .
5. Device according to claim 3, wherein said holding means comprise holding fins (42) projecting inside said nozzle (11) •
6. Device according to any one of the preceding claims, wherein said catching and release means (32, 35) of said closure members (33, 36) have a receiving housing (32) shaped so as to receive a head (38) of a closure member (33) surrounded by said cap member (39) .
7. Device according to claim 6, wherein the catching of the cap member (39) and of the respective closure member (33) inside the corresponding receiving housing (32) occurs by mechanical interference between the walls of the receiving housing (32) and the cap member (39) .
8. Device according to claim 7, wherein the diameter of the receiving housing (32) is equal or slightly smaller than that of the cap member (39) .
9. Device according to claim 8, wherein the cap member (39) is elastically deformable.
10. Device according to any one of claims 6 to 9, wherein holding means are provided inside the receiving housing (32) .
11. Device according to any one of claims 6 to 10, wherein the walls of the receiving housing (32) project with an extension (40) to prevent the contact between the closure member (33) and the liquid inside the container (1) .
12. Device according to claim 11, wherein said extension (40) engages a rail (41) , formed on a bottom wall (20) of the container (1) .
13. Device according to claim 2, comprising a fastening device (2) wherein said end portion (34) of the tubular member (3) is inserted, engaging said connection nozzle (11).
14. Device according to claim 13, wherein the engagement between the fastening device (2) and connection nozzle (11) is realised by screw-type coupling, a bayonet-type coupling or a luer lock coupling.
15. Device according to claim 13 o 14, wherein the fastening device (2) comprises:
* a pair of coaxial bushings, one proximal (10) and the other distal (12) , partially slidable one inside the other, the proximal bushing having a fastening portion (13) , apt to engage said connection nozzle (11) , and an internal portion (14) acting as guide for the tubular member (3) , and the distal bushing (12) being apt to be driven along a longitudinal direction to draw up and move away the end of the tubular member (3); and
* resilient counter pressing means (15) arranged between the free end of the proximal bushing (10) and the distal bushing (12) .
16. Device according to claim 15, wherein said resilient counter pressing means comprises a counter pressing helicoidal spring (15) .
17. Device according to claim 16, wherein the resilient counter pressing means further comprises a spring-guiding sleeve (16), engaged with the distal bushing (12) to prevent interferences between the counter-pressing spring (15) and the tubular member (3) .
18. Device according to claim 15, wherein a grip (17) is incorporated on the distal bushing (12) for easing the operation of the fastening device (2) .
19. Device according to any one of claims 15 to 18, comprising means for disabling the rotation of the revolving plate (23), associated to said fastening device, apt to prevent the rotation of the revolving plate (23) when the fastening device is not perfectly engaged with the connection nozzle (11) .
20. Device according to claim 19, wherein said means for disabling the rotation comprises a tooth (19) frontally integral with said fastening device (2) and a peripheral band (30) connected to the revolving plate (23) , the tooth (19) preventing the rotation of peripheral band (30) when the fastening device (2) is not completely engaged with the container (1) .
21. Device according to claim 6, wherein the receiving housing (32) contains a disinfectant.
22. Device according to claim 21, wherein the receiving housing (32) contains a sponge soaked with a disinfecting agent.
23. Device according to claim 22, wherein said disinfecting agent contains Povidone gel.
24. Use of the coupling device as defined in any one of the claims 1 to 23, as connector for peritoneal dialysis.
PCT/IB2007/051705 2006-05-09 2007-05-07 Coupling device for controlling a fluid flow, in particular for peritoneal dialysis WO2008001234A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITRM2006A000249 2006-05-09
IT000249A ITRM20060249A1 (en) 2006-05-09 2006-05-09 DEVICE FOR CONTROLLING A FLUID FLOW IN THE ARTICULAR IN PERITONEAL DIALYSIS

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WO2008001234A2 true WO2008001234A2 (en) 2008-01-03
WO2008001234A3 WO2008001234A3 (en) 2008-05-08

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US9186707B2 (en) 2007-04-02 2015-11-17 C. R. Bard, Inc. Insert for a microbial scrubbing device
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EP2457006A4 (en) * 2009-07-20 2016-06-01 David R Duncan Multi-port stopcock valve and flow designating system

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