Patent Application
20220296870
The present invention relates to a non removable connection system for medical devices particularly configured to be connected to a fluid line, such as a blood line, an infusion line or a monitoring line. In particular said connection system may be connected to the fluid lines of a dialysis machine or may be directly attached to the dialysis machine or to an accessory of the disposable set/dialysis machine. The present invention also refers to a disposable comprising fluid lines of a blood treatment apparatus, such as a dialysis machine, and said connection system.
Common connection systems for medical purposes are already known in the state of the art, for example used to connect fluid lines each other or to a medical machine. In blood treatment apparatuses, such as dialysis machines, connectors are commonly used for connecting fluid lines, for example for connecting in a fluid-tight manner return lines and access lines to respective vascular access systems of the patient, and/or for connecting infusion lines or monitoring lines to the blood or fluid circuit. In blood treatment apparatuses, Luer-type connectors are frequently used. Besides the fact of ensuring the fluid-tight sealing and the suitability to be used in the medical field, connectors are required, in specific cases, to avoid voluntary or involuntary disconnections: for example, where the connector is used on a blood line of a dialysis machine, a disconnection during an operative condition of the machine would lead to dangerous consequences potentially lethal for the patient. Any undesired disconnection may lead to sterility issues and requires the operator intervention, sometimes including the interruption of the treatment.
U.S. Pat. No. 8,882,726 is directed to a drug delivery device defining a reservoir for containing a liquid, such as a medicine. The device comprises a distal end presenting an end-piece traversed by a channel along a longitudinal axis. The end-piece is surrounded by a collar extending from the distal end, wherein the collar is provided with a plurality of outer longitudinal ridges running on the whole circumference of the collar: all the longitudinal ridges have each a sloped surface. The device also comprises a tubular wall having an inner duct, wherein an interface of the tubular wall is associable with the end-piece to define a fluid tight connection. The tubular wall is also provided with an outer flange configured to be engaged with a thread arranged in an inner lateral wall of the collar to allow axial engagement between the tubular wall and the end-piece of the device. The tubular wall also comprises a skirt provided with inner longitudinal projections able to cooperate with the longitudinal ridges and their sloped surfaces, to allow a screwing rotation of the tubular wall and to prevent unscrewing rotation of the same. The applicant points out some drawbacks affecting the device described in U.S. Pat. No. 8,882,726, from manufacturing to ease of use, as well as the impossibility of using it in combination with blood treatment apparatuses. In particular, such connector system would cause twist of the fluid line during connection, determining unwanted restrictions of the fluid line cross section, which might reduce drug or blood flow rate or determine damage of the fluid line itself. Moreover, the architecture of the connector comprises several undercuts and recesses, which makes production very complex and, therefore, expensive.
The aim of this invention is therefore to at least partially solve one or more of the drawbacks and/or limitations of the previous solutions.
A first object is to provide a non removable connector for medical applications suitable for connecting disposable components, such as fluid lines. An aim is to avoid the need of multiple interventions and checks during the set-up of a medical apparatus and during the following treatment of a patient. A further aim is to reduce the risk for the connection to untighten, either due to human error or to other causes, such as mechanical/thermal stress on the connectors. Another object is to provide a non removable connector easy to produce and cheap. These objects and more, which will appear more from the following description, are substantially achieved by a connection system and a disposable set in accordance with one or more of the following claims and/or aspects.
An aspect refers to a non-removable connection system (100) for a medical apparatus, said connection system (100) comprising:
A further aspect refers to a non-removable connection system (100) for a medical apparatus, said connection system (100) comprising:
A further aspect refers to a non-removable connection system (100) for a medical apparatus, said connection system (100) comprising:
A further aspect refers to a non-removable connection system (100) for a medical apparatus, said connection system (100) comprising:
In an aspect according to the preceding aspect, the second connector (11) comprises a hooking portion (13), and the collar comprises a respective hooking portion (23) engageable to the hooking portion (13) of the second connector (11) through an engagement rotation along an engagement direction (ER), in a engaged configuration the hooking portion (23) of the collar (20) and the hooking portion (13) of the second connector (11) preventing axial removal of the collar (20) from the second connector (11).
A further aspect refers to a non-removable connection system (100) for a medical apparatus, said connection system (100) comprising:
A first aspect refers to a non-removable connection system (100) for a medical apparatus, said connection system (100) comprising:
In a 2nd aspect according to any one of the preceding aspects, the connection system (100) is configurable, through the engagement rotation, in an unlocked condition, wherein the collar (20) is movable by rotation with respect to the first connector (1) and the at least one locking projection or locking member (24) of the collar (20) and the at least one locking projection or locking member (14) of the second connector (11) are in an uncoupled configuration.
In a 2nd aspect according to any one of the preceding aspects, the connection system (100) is configurable, through the axial engagement displacement, in an unlocked condition, wherein the at least one locking projection or locking member (24) of the collar (20) and the at least one locking projection or locking member (14) of the second connector (11) are in an uncoupled configuration, and optionally the collar (20) is movable by rotation with respect to the first connector (1).
In a 3rd aspect according to any one of the preceding aspects, the connection system (100) is configurable, through the engagement rotation, in a locked condition, wherein the at least one locking projection (24) of the collar (20) and the at least one locking projection (14) of the second connector (11) are in the coupled configuration, and the hooking portion (23) of the collar (20) and the hooking portion (13) of the second connector (11) are in the engaged configuration, in said locked condition the collar (20) being irremovably engaged to the second connector (11) through said engagement rotation and the at least one locking projection (14) and the hooking portion (13) of the second connector (11) respectively cooperating with the at least one locking projection (24) and the hooking portion (23) of the collar (20) preventing disengagement, in particular axial disengagement, of the first connector (1) from the second connector (11).
In a 3rda aspect according to any one of the preceding aspects, the connection system (100) is configurable, through the axial engagement displacement, in a locked condition, wherein the at least one locking projection or member (24) of the collar (20) and the at least one locking projection or locking member (14) of the second connector (11) are in the coupled configuration, and the hooking portion (23) of the collar (20) and the hooking portion (13) of the second connector (11) are in the engaged configuration, in said locked condition the collar (20) being irremovably engaged to the second connector (11) through said axial engagement displacement and the at least one locking projection or member (14) and the hooking portion (13) of the second connector (11) respectively cooperating with the at least one locking projection or member (24) and the hooking portion (23) of the collar (20) preventing disengagement, in particular axial disengagement, of the first connector (1) from the second connector (11).
In a 3rdb aspect according to any one of the preceding aspects, the connection system (100) is configurable, through the axial engagement displacement, in a locked condition, wherein the at least one locking projection or member (24) of the collar (20) and the at least one locking projection or member (14) of the second connector (11) are in the coupled configuration, in said locked condition the collar (20) being irremovably engaged to the second connector (11) through said axial engagement displacement, and the at least one locking projection or member (14) of the second connector (11) cooperating with the at least one locking projection or member (24) preventing disengagement, in particular axial disengagement, of the first connector (1) from the second connector (11).
In a further aspect according to any one of the preceding aspects, a switch from the locked condition to the unlocked condition is prevented by the at least one locking projection or locking member (14, 24).
In a 4th aspect according to any one of the preceding aspects, the first connector (1), in particular the coupling portion (2) of the first connector (1), extends in length along a fluid flow axis, and the second connector (11), in particular the coupling portion (12) of the second connector (11), extends in length along a respective fluid flow axis, wherein the fluid flow axis of the first connector (1) being aligned, at least when the coupling portion (2) of the first connector (1) is connected to the coupling portion (12) of the second connector (11), to the fluid flow axis of the second connector (11).
In a 5th aspect according to any one of the preceding aspects, the engaged configuration determines an axial constraint between the first and the second connectors (1, 11), in particular said axial constraint being along the fluid flow axis of the first connector (1) and/or of the second connector (11).
In a 6th aspect according to any one of the preceding aspects, the coupled configuration is defined at least at an end stage of the engagement rotation between the collar (20) and the second connector (11).
In a 7th aspect according to any one of the preceding aspects, the first connector (1) comprises a main abutment portion (5) and the collar (20) comprises a respective abutment portion (25) configured to contact the main abutment portion (5) of the first connector (1) when disposed in an abutment configuration.
In a 8th aspect according to the previous aspect, wherein, in said abutment configuration, the collar (20) is axially constrained with respect to the first connector (1) at least along one axial direction, so that, at least when the connection system (100) is disposed in the engaged configuration, the collar (20) axially engages the first connector (1) to the second connector (11), in particular said axial direction being parallel, optionally coincident, to the fluid flow axis of the first connector (1).
In a 9th aspect according to any one of the preceding aspects, the first connector comprises an auxiliary abutment portion (6), said auxiliary abutment portion being configured to block an axial sliding of the collar (20) along a direction opposite to said axial direction.
In a 10th aspect according to any one of the preceding aspects, the collar (20) is:
In an 11th aspect according to any one of the preceding aspects, the first connector (1) comprises a main body having tubular shape defining an internal channel (7) for passage of the fluid.
In a 12th aspect according to any one of the preceding aspects, said main and auxiliary abutment portions (5, 6) radially extend away from said main body.
In a 13th aspect according to any one of the preceding aspects, the first connector (1) further comprising a recess (8) interposed between the main and the auxiliary abutment portions (5, 6).
In a 14th aspect according to any one of the preceding aspects, the abutment portion (25) of the collar (20) is arranged between the main and the auxiliary abutment portions (5, 6) of the first connector (1) into said recess (8).
In a 15th aspect according to any one of the preceding aspects, the collar (20) is axially movable with respect to the first connector (1) of an amount proportional to the distance between the main and the auxiliary abutment portions (5, 6) of the first connector (1).
In a 16th aspect according to any one of the preceding aspects, the fluid coupling portion (2) of the first connector (1) includes a tip portion (2a) defining an internal channel (7) for fluid transport, in particular said tip portion (2a) having a tapered external surface.
In a 17th aspect according to any one of the preceding aspects, the fluid coupling portion (12) of the second connector (11) includes a terminal portion (12a) defining an internal channel (17) for fluid transport.
In a 18th aspect according to any one of the preceding aspects, said terminal portion (12a) of the second connector (11) has a tapered internal surface optionally counter shaped to the tapered external surface of the tip portion (2a) of the first connector.
In a 19th aspect according to any one of the preceding aspects, at least part of the tip portion (2a) of the first connector (1) is configured to enter into the terminal portion (12a) of the second connector (11), in particular said tapered external surface coupling to said tapered internal surface to connect the first and the second connectors (1, 11) in a fluid tight manner.
In a 19tha aspect according to any one of the preceding aspects, the first connector (1) abuts against the second connector (11) at least in the locked condition.
In a 19thb aspect according to any one of the preceding aspects, the external surface of the first connector (1) abuts against said tapered internal surface of the second connector (11) at least in the locked condition.
In a 20th aspect according to any one of the preceding aspects, the collar (20) comprises a main body having tubular shape extending between a first opening (21) configured to receive the second connector (11), in particular to receive the coupling portion (12), the hooking portion (13) and the at least one locking projection (14) of the second connector (11), and a second opening (22) receiving by insertion the first connector (1).
In a 21st aspect according to any one of the preceding aspects, the collar surrounds externally at least part of the first connector (1) and the main body of the collar (20) being coaxial with the first connector (1).
In a 22nd aspect according to any one of the preceding aspects, the second opening (22) is arranged at a recess (8) of the first connector (1) to allow coupling.
In a 23rd aspect according to any one of the preceding aspects, an abutment portion (25) of the collar (20) extends radially inwardly is arranged at the second opening (22).
In a 24th aspect according to any one of the preceding aspects, said at least one locking projection or member (24) of the collar (20) is arranged at an inlet of the first opening (21).
In a 25th aspect according to any one of the preceding aspects, said hooking portion (23) of the collar (20) is interposed between said at least one locking projection (24) and the second opening (22) of the collar (20).
In a 26th aspect according to any one of the preceding aspects, the hooking portion (13) of the second connector (11) is interposed between the at least one locking projection (14) and a terminal portion (12a) of the coupling portion (12) of the second connector (11).
In a 27th aspect according to any one of the preceding aspects, said hooking portion (23) of the collar (20) is arranged at an inlet of the first opening (21), said at least one locking projection (24) of the collar (20) being interposed between said hooking portion (23) and the second opening (22) of the collar (20); and
In a 28th aspect according to any one of the preceding aspects, the hooking portion (23) of the collar (20) and the hooking portion (13) of the second connector both comprise respective threads configured to engage each other, in particular through the engagement rotation, to define the engaged configuration; or respective undercut joints configured to engage each other as a bayonet coupling, in particular through the engagement rotation, to define the engaged configuration.
In a 29th aspect according to any one of the preceding aspects, the collar (20) comprises a main body having tubular shape extending in depth between an internal lateral wall (20a) and an external lateral wall (20b).
In a 30th aspect according to any one of the preceding aspects, the collar (20) is mounted over the first connector (1) so that the main body externally surrounds at least part of the first connector (11), in particular surrounding at least part of the coupling portion (2) of the first connector (1).
In a 31st aspect according to any one of the preceding aspects, said hooking portion (23) of the collar (20), in particular said threads of the collar (20), is arranged on said internal lateral wall (20a) of the collar (20).
In a 32nd aspect according to any one of the preceding aspects, the at least one locking projection (24) of the collar (20) is radially arranged on the same internal lateral wall (20a) of the collar (20).
In a 32nd aspect according to any one of the preceding aspects, said hooking portion (23) of the collar is side by side with said at least one locking projection (24) of the collar (20).
In a 33th aspect according to any one of the preceding aspects, the second connector (11) has tubular shape defining an internal channel (17) for fluid transport, said tubular shape of the second connector (11) comprising an external lateral wall (11a).
In a 34th aspect according to any one of the preceding aspects, said hooking portion (13) of the second connector (11), in particular said threads of the second connector (11), is arranged on said external lateral wall (11a) of the second connector (11), in particular said hooking portion (13) being arranged at the coupling portion (12) of the second connector (11).
In a 35th aspect according to any one of the preceding aspects, the at least one locking projection (14) of the second connector (11) being radially arranged on said external lateral wall (11a) of the second connector (11), in particular said at least one locking projection (14) being arranged at the coupling portion (12) of the second connector (11).
In a 36th aspect according to any one of the preceding aspects, in particular said hooking portion (13) of the second connector (11) is side by side with said at least one locking projection (14) of the second connector (11).
In a 37th aspect according to any one of the preceding aspects, both the at least one locking projection (14) of the second connector (11) and the at least one locking projection (24) of the collar (20) comprise respectively one or more socket teeth, in particular a plurality of socket teeth, in particular said socket teeth being wedge-shaped or having a saw tooth shape.
In a 38th aspect according to any one of the preceding aspects, when the socket teeth of the collar (20) face, in particular contact, the socket teeth of the second connector (11), the engagement rotation is allowed and the disengagement rotation is prevented.
In a 39th aspect according to any one of the preceding aspects, the socket teeth of both the second connector (11) and the collar (20) radially define recesses and protrusions alternately.
In a 40th aspect according to any one of the preceding aspects, the second connector (11) defines a maximum external diameter of encumbrance measured at the locking projections (14), in particular at the protrusions of the one or more socket teeth, wherein the collar (20) has tubular shape and has a minimum internal diameter measured at the locking projections (24), in particular at the protrusions of the socket teeth of the collar (20).
In a 41st aspect according to the previous aspect, said maximum external diameter of encumbrance being higher than said minimum internal diameter so that, when the socket teeth of the second connector (11) are faced to, in particular in contact with, the socket teeth of the collar (20), the protrusions of the socket teeth of the second connector (11) are inserted into the recesses of the socket teeth of the collar (20) and vice versa.
In a further aspect according to any one of the preceding aspects, the at least one locking member (14) of the second connector comprises at least one recess, optionally an aperture, and the at least one locking member (24) of the collar (20) comprises at least one protrusion, the at least one protrusion of the collar (20) being configured in the locked condition to engage the recess of the second connector (11) to define an non removable axial engagement, in particular to enter at least partially into said recess, in particular said protrusion radially extending inwardly.
In a further aspect according to any one of the preceding aspects, the at least one locking member (14) of the second connector comprises at least one protrusion, and the at least one locking member (24) of the collar (20) comprises at least one recess, optionally an aperture, the at least one protrusion of the second connector (11) being configured in the locked condition to engage the recess of the collar (20) to define an non removable axial engagement, in particular to enter at least partially into said recess, in particular said protrusion radially extending outwardly.
In a further aspect according to any one of the preceding aspects, both the at least one locking projection or member (14) of the second connector (11) and the at least one locking projection or member (24) of the collar (20) comprise at least one protrusion respectively radially extending outwardly and inwardly, the protrusions of the collar (20) comprising an abutment portion (24c) facing an inner volume of the collar (20) and the protrusions of the second connector (11) comprising an abutment portion (14c) facing opposite with respect to the fluid coupling portion (12) of the second connector (11), the abutment portion (24c) of the protrusions (24) of the collar (20) abutting against the abutment portion (14c) of the protrusions (14) of the second connector (11) when the connection system is arranged in the locked condition to prevent axial disengagement of the collar from the second connector.
In an aspect according to the preceding aspect, the protrusions of the collar (20) define a minimum internal diameter lower and the protrusions of the second collar define a maximum external diameter, said minimum internal diameter being lower than said maximum external diameter.
In a further aspect according to any one of the preceding aspects, the collar (20) comprises one or more fingers (26) arranged at the first opening (21) and in particular extending substantially parallel to the axis of the collar (20), in particular the collar comprising a plurality of fingers arranged at the first opening angularly distributed about the axis of the collar, said fingers (26) carrying the at least one locking projections or member (24) of the collar (20), in particular carrying the protrusions of the collar (20).
In an aspect according to the preceding aspect, the locking projections or member (24) of the collar define a minimum inner diameter smaller than a maximum outer diameter defined by the locking projections or members (14) of the second connector (11), wherein the said fingers (26) of the collar (20) are configured to radially flex outwardly during coupling of the locking projections (14) of the second connector with the locking projections (24) of the collar (20).
In a 42nd aspect according to any one of the preceding aspects, the first connector is a male connector and the second connector is a female connector.
In a 43th aspect according to any one of the preceding aspects, at least when the connection system (100) is disposed in the engaged configuration, at least part of the second connector (11), in particular at least part of the coupling portion (12) of the second connector (11), is interposed between the collar (20) and at least part of the first connector (1), in particular interposed between the collar (20) and at least part of the coupling portion (2) of the first connector (1).
In a 44th aspect according to any one of the preceding aspects, both the first and the second connectors (1, 11) are Luer type connectors.
In a 45th aspect according to any one of the preceding aspects, the first connector (1) extends in length between its coupling portion (2) and a connection port (9) configured to be connected to a fluid line (51), such as a blood circuit (50a) or an infusion line (54) or a monitoring line (55) of a medical machine (200), in particular a blood treatment apparatus, more in particular a dialysis machine.
In a 46th aspect according to any one of the preceding aspects, the second connector (11) extends in length between its coupling portion (12) and a connection port (19) configured to be connected to a fluid line (51), such as a blood circuit (50a) or an infusion line (54) or a monitoring line (55) of a medical machine (200), in particular a blood treatment apparatus, more in particular a dialysis machine.
In a 47th aspect according to any one of the preceding aspects, the connection system (100) comprises a fluid line (51), said connection port (9) being fixed to an end of said fluid line (51), such as a blood circuit (50a) or an infusion line (54) or a monitoring line (55) of a medical machine (200), in particular a blood treatment apparatus, more in particular a dialysis machine, or said connection port (9) of the first connector (1) being fixed to the medical machine (200) directly.
In a 48th aspect according to any one of the preceding aspects, the connection system (100) comprises a fluid line (51), wherein the second connector (11) extends in length between its coupling portion (12) and a respective connection port (19), said connection port (19) being fixed to an end of said fluid line (51), such as a tube, in particular a plastic tube, of a medical machine (200), in particular a blood treatment apparatus, more in particular a dialysis machine, or said connection port (19) of the second connector (11) being fixed to the medical machine (200) directly.
In a 49th aspect according to any one of the preceding aspects, said fluid line (51) is a blood circuit (50a) or an infusion line (54) or a monitoring line (55) of a disposable set (50) of a blood treatment apparatus (200), such as a dialysis machine.
In a 50th aspect according to any one of the preceding aspects, the collar (20) is coaxial to the first connector (1).
In a 51st aspect according to any one of the preceding aspects, the first connector (1) and the collar (20) are made in two separate pieces subsequently axially coupled, the collar (20) being free to rotate with respect to the first connector (1) at least when the second connector (11) is not coupled to the collar (20) and to the first connector (1).
In a further aspect according to any one of the preceding aspects (but aspect 51), the first connector (1) and the collar (20) are made in one piece, in particular the collar (20) being both axially and rotationally coupled to the first connector (1).
In a 52nd aspect according to any one of the preceding aspects, the first connector (1) is made of plastic material.
In a 53rd aspect according to any one of the preceding aspects, the collar (20) and/or the second connector (11) is made of plastic material.
In a 54th aspect according to any one of the preceding aspects, the locking portion (14) of the second connector (11) and/or the locking portion (24) of the collar (20) have a width, measured parallel to the fluid flow axis, higher than a thread pitch of the hooking portion of the collar (20) and/or than a thread pitch of the hooking portion of the second connector (11), particularly in order to prevent decoupling.
In a 55th aspect according to any one of the preceding aspects, the first connector (1), the second connector (11) and the collar (20) are made of the same material.
A 56th aspect refers to a non-removable connection system (100) for a medical apparatus, said connection system (100) comprising:
wherein through the engagement rotation, the connection system (100) is configurable in a locked condition, wherein the at least one locking projection (24) of the collar (20) and the at least one locking projection (14) of the second connector (11) are in the coupled configuration, and the hooking portion (23) of the collar (20) and the hooking portion (13) of the second connector (11) are in the engaged configuration, in said locked condition the collar (20) being irremovably engaged to the second connector (11) through said engagement rotation and the at least one locking projection (14) and the hooking portion (13) of the second connector (11) respectively cooperating with the at least one locking projection (24) and the hooking portion (23) of the collar (20) preventing disengagement of the first connector (1) from the second connector (11), wherein the collar (20) has a tubular shape extending between an internal lateral wall (20a) and an external lateral wall (20b), both the hooking portion (23) and the at least one locking projection (24) being arranged on said internal lateral wall (20a).
In a 57th aspect according to the previous aspect, said non-removable connection system (100) is according to any one of the aspects from 1 to 55.
A 58th aspect refers to a disposable set (50) for a blood treatment apparatus, said disposable set comprising:
In a 59th aspect according to the previous aspect, said disposable (50) set comprises:
In a 60th aspect according to any one of the preceding aspects 58 or 59, the disposable set (50) comprises a monitoring line (55) connected to the blood circuit (50a) or to the infusion line (54).
In a 61st aspect according to any one of the preceding aspects 58 or 59 or 60, the disposable set (50) comprises at least one connection system (100) according to any of the aspects from 1 to 57 connected to at least one between the access line (52), the return line (53), the infusion line (54) and the monitoring line (55).
In a 62nd aspect according to any one of the preceding aspects from 58 to 61, the infusion line (54) comprises a calcium solution container (60b), wherein the infusion line (54) includes one end connected to the calcium concentrated solution container (60b), the connection system (100) being coupled to the infusion line (54), for example one of the first and second connectors (1, 11) being connected to said one end, the other of said first and second connectors (1, 11) being connected to the calcium solution container (60b).
In a 63rd aspect according to any one of the preceding aspects from 58 to 62, the calcium solution container (60b) is a syringe, an end of the syringe including, or being connected to, one of the first and second connectors (1, 11).
In a 64th aspect according to any one of the preceding aspects from 58 to 63, the infusion line (54) comprises a citrate solution container (60a), wherein the infusion line (54) includes one end connected to the citrate concentrated solution container (60a), one of the first and second connectors (1, 11) being connected to said one end, the other of said first and second connectors (1, 11) being connected to the citrate solution container (60a).
In a 65th aspect according to any one of the preceding aspects from 58 to 64, the citrate solution container (60a) is a bag, an end of said bag including or being connected to one of the first and second connectors (1, 11).
In a 66th aspect according to any one of the preceding aspects from 58 to 64, the disposable set comprises a blood warmer accessory (70) connected to the blood circuit (50a), particularly placed on the return line, an inlet (70a) and/or an outlet (70b) of said blood warmer accessory (70) being connected to the blood circuit (50a) through said at least one connection system (100).
In a 67th aspect according to any one of the preceding aspects from 58 to 66, the disposable set comprises the infusion line (54) connected to the return line (53), particularly through said at least one connection system (100).
In a 68th aspect according to any one of the preceding aspects from 58 to 67, the disposable set comprises the monitoring line (55) connected to the blood circuit through said at least one connection system (100), said monitoring line (55) being configured to be connected to a pressure or temperature gauge or to be used as a site access for blood sampling.
In a 69th aspect according to any one of the preceding aspects from 58 to 68, the disposable set comprises an auxiliary disposable accessory (80), such as a gas exchanger, an oxygenator, an auxiliary fluid arrangement, optionally the accessory being connected to the blood circuit (50a) through the connection system (100).
In a 70th aspect according to any one of the preceding aspects from 58 to 69, the disposable set comprises an add-on accessory (81) interposed between the patient vascular access and the blood circuit, the add-on accessory (81) being connected to the blood circuit (50a) through the connection system (100).
A 71st aspect refers to a method of the connection system (100) optionally according to any of the preceding aspects from 1 to 57, said connection method comprising the steps of:
In a 72nd aspect according to any one of the preceding aspects, the engagement rotation is defined by a relative rotation between the collar (20) and the second connector (11).
In a 73rd aspect according to any one of the preceding aspects, the engagement rotation is defined by a relative rotation between the collar (20) and the first connector (1).
In a 74th aspect according to any one of the preceding aspects, the engagement rotation is defined by a relative rotation between the collar (20) and both the first and the second connectors (1, 11), the first and the second connectors (1, 11) being rotationally coupled each other.
In a 75th aspect according to any one of the preceding aspects, in the coupled configuration, and in particular in the locked condition, a rotation of the collar (20) with respect to the second connector (11) is prevented, in particular said prevented rotation being in a direction opposite to the engagement direction.
In a 76th aspect according to any one of the preceding aspects, in the coupled configuration, and in particular in the locked condition, a rotation of the collar (20) with respect to the first connector (1) is prevented, in particular said prevented rotation being in a direction opposite to the engagement direction.
In a 77th aspect according to any one of the preceding aspects, in the locked condition the first connector (1), the second connector (11) and the collar (20) are rotationally coupled or fixed each other defining a single rigid body.
In a 78th aspect according to any one of the preceding aspects, in the locked condition relative movements, in particular axial and rotational movements, between the first connector (1), the second connector (11) and the collar (20) are prevented.
In a 79th aspect according to any one of the preceding aspects, the axial engagement displacement is a displacement directed substantially parallel to the axis of the first and second connectors, in particular said axial engagement displacement being a displacement directed along the axis of the first and second connectors, in particular along the axis of the connection system.
Some embodiments and some aspects of the invention will be described below with reference to the attached drawings, provided for illustrative purposes only, wherein:
In this detailed description, corresponding parts illustrated in the various figures are indicated with the same numerical references. The figures may illustrate the invention by means of non-scale representations; therefore, parts and components illustrated in the figures relating to the object of the invention may relate exclusively to schematic representations.
Upstream and/Downstream
The terms upstream and downstream refer to a direction or trajectory of advancement of a fluid configured to flow within the connector or along the fluid line during normal usage of the apparatus.
By the wording ‘non-removable’ is meant that the connection system is in a locked condition under normal use. As below explained, in the locked condition of the connection system at least one locking projection 24 of the collar 20 and at least one locking projection 14 of the second connector 11 are in a coupled configuration, and a hooking portion 23 of the collar 20 and a hooking portion 13 of the second connector 11 are in an engaged configuration; in said locked condition the collar 20 is irremovably engaged to the second connector 11 through an engagement rotation and the locking projection 14 and the hooking portion 13 of the second connector 11 respectively cooperating with the locking projection 24 and the hooking portion 23 of the collar 20 prevent disengagement of the first connector 1 from the second connector 11.
Reference number 100 is directed to a connection system, as shown in figures from 1 to 4, for a medical apparatus: the connection system 100 may be used to connect, in a fluid tight manner, fluid lines 51 of a medical machine 200, such as a blood treatment apparatus, in particular a dialysis machine, wherein the fluid lines 51 may be a blood circuit 50a of a disposable set 50, an infusion line 54, a monitoring line 55, an access line 52 or a return line 53.
The connection system 100 comprises a first connector 1, shown in the exploded view of
The first connector 1 further comprises a main abutment portion 5 arranged on an external lateral wall of the main body, wherein the main abutment portion 5 defines a protrusion radially extending outward from the main body. The abutment portion 5 may have circular shape, for example a ring coupled to the main body extending outwardly. In an embodiment, the first connector 1 may further comprise an auxiliary abutment portion 6 arranged on the external lateral wall of the main body, wherein the auxiliary abutment portion 6 is axially distal from the main abutment portion 5 by an axial gap, so that a recess 8 is defined between the main abutment portion 5 and the auxiliary abutment portion 6. As shown in
In the shown embodiment, the first connector 1 is a male connector and it is made in one single piece preferably in plastic material, such as PVC, MBS, PC, or in metallic material, such as stainless steel. The connection system 100 further comprises a second connector 11, shown in the exploded view of
The second connector 11 may further comprise a hooking portion 13 arranged on an external lateral wall 11a of the main body of the second connector 11: in particular the hooking portion 13 may comprise a thread, preferably arranged in the proximity of the coupling portion 12 of the second connector 11. The threads of the hooking portion 13 preferably extend from the terminal end 12a of the second connector 11 and preferably emerge from the external lateral wall 11a of the main body of the second connector 11. In an alternative embodiment, the hooking portion 13 of the second connector 11 may comprise a respective groove or recess to define an undercut joint, such as a bayonet coupling (embodiment shown in
The second connector 11 further comprises at least one locking projection or member 14 arranged on the same external lateral wall 11a of the main body of the second connector 11. In an embodiment, shown in
In the embodiment, the second connector 11 is a female connector and it is made in one single piece preferably in plastic material, such as PVC, MBS, PC or in metallic material, such as stainless steel. The second connector 11 may also comprise gripping means arranged on the external lateral wall 11a at the connection port 19: the gripping means are configured to allow an operator to grab firmly the second connector 11 especially when connection with the first connector 1 is required. The gripping means 15 preferably comprise tabs, in particular two tabs diametrically opposed, emerging radially outwardly from the main body of the second connector 11.
The connection system 100 further comprises a collar 20, shown in the exploded view of
In the disclosed embodiment shown in
In this specific embodiment, the second opening 22 has an internal diameter lower than an external diameter of the main abutment portion 5 of the first connector 1, preventing in this way the axial movement. In other words, the first connector 1 and the collar, although they are distinct bodies both made in a single piece, are axially coupled each other, being the collar 20 movable by rotation with respect to the first connector 1. In an alternative embodiment not shown in the attached figures, the collar 20 and the first connector 1 are made in one single piece. In an embodiment, the collar 20 has a length, measured along an axis of its tubular main body, comprised between 8 mm and 25 mm, and a diameter comprised between 7 mm and 15 mm. The collar 20 may further comprise a respective hooking portion 23 configured to be engaged with the hooking portion 13 of the second connector 11 through an engagement rotation ER along an engagement direction (see
In an alternative embodiment, the hooking portion 23 of the collar 20 comprises an undercut joint (see
Since the collar 20 is axially coupled to the first connector 1, when the connection system 100 is disposed in this engaged configuration the first connector 1 is axially coupled to the second connector 11, so that disconnection of the first and second connectors 1, 11 is prevented. In particular, at an end stage of the engagement rotation, the hooking portions 13, 23 respectively of the second connector 11 and of the collar 20 contribute to tighten the connection and to prevent disconnection between the coupling portion 2 of the first connector 1 and the coupling portion 12 of the second connector 11. During an engagement rotation ER wherein the collar 20 rotates to determine the engagement rotation, the coupling portion 2 of the first connector 1 is allowed to stay aligned with the coupling portion 12 of the second connector 11 due to the fact that the collar 20 is freely movable by rotation with respect to the first connector 1: once the connection between the coupling portion 2 of the first connector 1 and the coupling portion 12 of the second connector 11 is established, the collar 20 is still freely movable by rotation with respect to the first and second connectors 1, 11, so that the subsequent engagement rotation ER does not determined friction between the coupling portion 2 of the first connector 1 and the coupling portion 12 of the second connector 11. In other words and according to an embodiment, during the engagement rotation the first and the second connectors 1, 11 may be aligned each other without reciprocal rotation, while the collar 20 rotates with respect both the first and second connectors 1, 11 to determine engagement of the hooking portions 13, 23.
The hooking portion 23 of the collar 20 may comprise, as shown in
In an embodiment, this locking projections 24 are arranged on the internal lateral wall 20a of the collar, so that the locking projection 24 and the hooking portion 23 of the collar 20 are arranged side by side. In particular, the at least one locking projection 24 of the collar may comprise a plurality of socket teeth, wherein the socket teeth are wedge-shaped or have a saw tooth shape. The at least one locking projection 14 radially emerges inwardly from the internal lateral wall 20a of the collar, as shown in
The socket teeth of both the second connector 11 and the collar 20 are arranged circumferentially all around the external lateral wall 11a of the second connector 11 and circumferentially all around the internal lateral wall 20a of the collar 20. The socket teeth radially define recesses and protrusions alternately, so that the second connector 11 defines a maximum external diameter of encumbrance measured at the protrusions of the socket teeth, and wherein the collar 20 defines a minimum internal diameter measured at the protrusions of the socket teeth of the collar 20: this maximum external diameter of encumbrance is higher than this minimum internal diameter so that, when the socket teeth of the second connector 11 are faced to or in contact with the socket teeth of the collar 20, the protrusions of the socket teeth of the second connector 11 are placed into the recesses of the socket teeth of the collar 20 and vice versa. This is clearly shown in the cross section view of
In an embodiment, the socket teeth of the second connector 11 and of the collar 20 comprise each a respective slide surface 14a, 24a (
In an embodiment shown in
In an alternative embodiment not shown in the attached figures, the at least one locking projection 14 of the second connector 11 is interposed between the hooking portion 13 and the terminal portion 12a of the coupling portion 12, and the hooking portion 23 of the collar 20 is arranged at the inlet of the first opening 21 so that the at least one locking projection 24 of the collar 20 is interposed between the hooking portion 23 and the second opening 22 of the collar 20. The connection system 100 is configurable in an unlocked condition, wherein the collar 20 is movable by rotation with respect to the first connector 1 and the at least one locking projection 24 of the collar 20 and the at least one locking projection 14 of the second connector 11 are in an uncoupled configuration wherein the locking projections do not cooperate each other. The unlocked condition is shown in
In an embodiment, the collar 20, when engaged to the second connector 11 by the respective threads, may present a slight axial movement with respect to the second connector 11, especially at an initial or intermediate stage of the engagement rotation: this may happen if the width of the thread wire of the second connector 11, is lower than the thread pitch of the collar 20, defining a gap in between, which leads to an axial movement of the collar with respect to the second connector. In this case, the locking portions 14 and 24 respectively of the second connector 11 and of the collar 20 should have a width, measured parallel to the fluid flow axis, higher than this gap, in order to prevent decoupling. In the shown embodiment, when the connection system 100 is in the locked condition and/or in the engaged configuration, the fluid flow axis of the first connector 1 coincides with the fluid flow axis of the second connector 11, and the collar is coaxial with this fluid flow axis.
The locking projections 14 of the second connector 11 and the locking projections 24 of the collar 20 comprise at least one protrusion respectively extending radially outwardly and inwardly. The protrusions of the collar 20 comprise an abutment portion 24c facing the inner volume of the collar 20, while the protrusions of the second connector 11 comprise an abutment portion 14c facing opposite with respect to the fluid coupling portion 12 of the second connector 11. The abutment portion 24c of the protrusions 24 of the collar 20 are configured to abut against the abutment portion 14c of the protrusions 14 of the second connector 11, as shown in the section of
According to the previously embodiments, the locking projections 14, 24 of the second connector and collar comprise protrusions, such as wedge shaped socket teeth: anyhow, as shown in
According to the above description, it is to be understood that the invention is not supposed to be limited to the disclosed embodiments, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and the scope of the appended claims.
The invention also refers to a disposable set 50, shown in
The disposable set 50 further comprises at least one connection system 100 as previously described, which may be connected to the access line 52, the return line 53, to the infusion line 54 and the monitoring line 55. In
| Number | Date | Country | Kind |
|---|---|---|---|
| 19191551.1 | Aug 2019 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2020/072498 | 8/11/2020 | WO |
