Patent Application
20140323988
The present invention relates to a connection device for a medical line such as an infusion or drainage line, and serves to keep the lines at a correct surgical position in case they are suddenly stretched.
Connection devices, briefly connectors, are known that are configured to connect two lines together, e.g. a couple of cables or tubular elements for conveying a fluid. In particular, the connector serves to separate the two lines if it receives a pulling force higher than a predetermined force, in order to prevent the two lines, and to the devices connected with them, from being damaged. In detail, the connector is arranged at a predetermined separation point to prevent an accidental pulling force from damaging devices that can be arranged upstream of the connector.
Examples of such mechanical connectors are described in U.S. Pat. No. 7,143,877, or in U.S. Pat. No. 7,080,572 or also in U.S. Pat. No. 4,716,635. In particular, other types of connectors are used to connect coaxial cables, as disclosed in U.S. Pat. No. 7,264,479.
Mechanical connectors are also known for use in the medical field for connecting two medical lines together, such as the tubular elements arranged between a patient and a catheter. An example of medical connector is disclosed in U.S. Pat. No. 5,405,336 and provides an engagement between two tubular portions and sealing elements arranged at the end portion of each tubular portion in order to ensure a fluid-tight coupling.
In U.S. Pat. No. 7,766,394, a connector is described that comprises two coupling elements that engage with each other through a friction-free sealing device. In a possible exemplary embodiment, the sealing device comprises two inclined cylindrical rollers that are connected to each other, which are arranged on a coupling element that is in contact with an outer surface of the other coupling element. The outer surface can comprise a groove for receiving the rollers when they are coupled. The sealing action is provided by a rubber portion where the needle is inserted, which ensures a unidirectional tightness.
A further connector is disclosed in US20050015075 and comprises a coupling device for coupling a patient medical line with a medical device line.
In particular, the connector comprises two portions that are configured to engage with each other, and that are provided with respective sealing devices configured to block the flow of the fluid when the two portions are disconnected. On the contrary, when the two portions are connected, the sealing devices allow the flow of the fluid from one side to the other side. In detail, the two portions are releasably connected by a click mechanism comprising a boundary lever that has a projection at an end portion, said projection arranged to engage with a corresponding groove made on the other portion, in order to keep them joined together. When they receive a predetermined force, they detach from each other by a disengagement of the projection from the groove.
A further example of connector is disclosed in EP0795342 and in U.S. Pat. No. 6,146,374. In this case, the connector comprises a first part and a second part respectively provided with a first duct and a second duct. A normally closed valve is provided at each duct.
If an accidental detachment occurs, the connectors of EP0795342 and of U.S. Pat. No. 6,146,374 make it possible to connect the two portions to each other again. However, a contamination could occur of the fluid contained in the medical lines. In fact, a contact of the end portions of the two parts with bacteria of the surrounding environment could occur after the accidental disengagement. Once the connection has been restored between the two parts, the bacteria could pollute the fluid, since the valve is unable to block the flow of the fluid between the two medical lines.
At the same time, a loss of the desired coupling conditions between the two parts would also affect the the sealing devices, thus reducing the fluid-tightness and making the coupling less reliable against possible contamination from the outside.
In an exemplary embodiment, each valve comprises two flexible walls that tend to approach to each other due to the elasticity of the material in which they are made, and in use they are forced to stay at a predetermined distance from a central duct hydraulically connecting the two valves. More in detail, the central duct keeps the walls of each valve at a distance from each other and, accordingly, it keeps the valve open, at a respective engagement portion. Moreover, a spring is provided that is fastened to the outer surface of the central duct, and that, in use, is pressed between two walls, each arranged at each valve. Accordingly, the spring tends to separate the two parts of the connector. Moreover, the first half and the second half of the connector are mechanically connected by a connection member that is provided with a tear-off line. If a predetermined force is exceeded, the connection member tears at the tear-off line, and the resilient force of the spring causes the engagement portions of the central duct to be removed from the valves. Therefore, the central duct escapes from the walls of the valves which, thanks to their elasticity, move to an adjacent arrangement and cause the valves to close.
However, this kind of connector has various drawbacks that can affect the patient's safety.
Firstly, the effectiveness of the connector depends upon the force that tends to close the resilient walls of the valves, and upon the force of the connection member at the tear-off line.
If imperfections are present at the elastic walls, or at the connection member, the resilient force of the spring can accidentally and unpredictably open the connector, and the valves cannot be closed, which causes relevant troubles and hazards for the patient's safety.
Moreover, the resilient walls of the valves described in EP0795342 cannot effectively close each valve and, accordingly, a pollution of the medical line can take place even in the closed position by microorganisms, as well as a fluid loss due to an imperfect fluid-tightness.
Normally, the connectors that are used in the medical field and that provide a mechanical form matching between the two parts can loose their elastic properties with time, and can not be able to ensure that the detachment takes place in the predetermined conditions, i.e. if a predetermined value of the force is exceeded, which can therefore cause serious problems to the patient.
It is therefore a feature of the present invention to provide a connection device for a medical line that has not the drawbacks of the prior art, and that makes it possible to preserve a quick release that is allowed by design construction features.
It is another feature of the present invention to provide a connection device for a medical line that prevents a medical fluid contamination and loss and ensures safety for the patient.
It is a further feature of the present invention to provide a connection device for a medical line that can be used for a wide range of clinical applications, by easily changing the release parameters.
It is still a feature of the present invention to provide a connection device for a medical line that is easy and inexpensive to be manufactured.
These and other objects are achieved by a connection device for a medical line comprising:
Advantageously, the pushing means is integrated in said or each valve.
In particular, the connection device, according to an embodiment of the present invention, allows ensuring the required safety conditions of a patient. In fact, in case of accidental hit, or other events, causes the disengagement of the first portion and of the second portion, the presence of the pushing means, which biases the opening of the valve, ensures an immediate closure of the or each valve, and then prevents any outward fluid loss, or any pollution of the medical line by bacteria, or by microorganisms that are present in the outer environment.
Furthermore, the above-described structure ensures that the connection device can be used only for a specific application, which maintains the predetermined force parameters for disengaging the first and the second portion.
In particular, the pushing means can be a resilient-type pushing means, such as a spring, and is arranged to apply a resilient force that biases the movement of said or each valve from the open configuration to the closed configuration.
Advantageously, a first valve and a second valve are arranged at said first portion and at said second portion, respectively, said first valve and said second valve configured, in said decoupled configuration, to be brought to said closed position. This way, if an accidental disengagement takes place between the two parts, a fluid loss is prevented from both lines. Furthermore, the fluid is prevented from being contaminated, which would occur if the fluid came into contact with the outside environment. This is a particularly sensible issue when the line that is directly connected to a patient is interrupted.
Preferably, fastening elements are provided, in particular male/female Luer-Lock elements arranged to connect the first valve and the second valve to said first line and to said second line, respectively.
Advantageously, closure valves are provided on said first line and on said second line for allowing/blocking the flow of the fluid that flows through respective lines. In particular, the closure valves on the lines are operated if the connector has to be replaced after a disengagement of the same has occurred since the break threshold had been exceeded.
In particular, the central duct comprises a tubular inner portion that is equipped with two mouths at opposite end portions. More in detail, during the passage of said first portion and of said second portion from the decoupled configuration to the coupled configuration, the end portion mouths are arranged to push an actuation element of the valve to cause a shifting movement of the same that is opposed by a resilient means, which can be the same means as said pushing means, and to cause said at least one valve to pass from said closed position to said open position. The actuation element has a longitudinal recess that extends up to the surface that in the above-described coupled configuration is arranged in contact with, or proximate to, the mouth of the central duct. Therefore, when the mouth of the central duct is in contact with the surface of the actuation element, the tubular portion is in hydraulic communication with the first duct and/or with the second duct.
On the contrary, when a passage occurs from the coupled configuration to the decoupled configuration, the above-described mouths loose their contact with the actuation element from which they move away, therefore the above-mentioned resilient means, which is no longer biased, bring said at least one valve back to said normally closed position.
In particular, said central duct has a predetermined length that corresponds to said predetermined break threshold value, said length selected in such a way to correspond to a predetermined break threshold value. In fact, by changing the length of the central duct, a change occurs of the balance of forces that determines the break threshold value, i.e. the threshold at which the first portion and second portion are disengaged from each other. In particular, by changing the length of the central duct, a change occurs of the resilient force of the spring that tends to separate the two portions. Accordingly, the resistance of the magnets or of the flexible wings is calibrated by taking into account the above-described resilient force that pushes the valves with more or less intensity.
Advantageously, two connection fittings are provided at said end portion mouths that are configured to be connected with a connection portion of said first and second valve, respectively, such that an axial reference is formed in order to cause said end portion mouths to match said actuation element.
Advantageously, said central duct comprises at least one first part and at least one second part arranged to releasably connect configured to be separated from each other when said first portion and said second portion pass from said coupled configuration to said decoupled configuration. This way, the central duct is separated into a plurality of parts if a disengagement occurs, which makes it easier to close the valves that push a portion of central duct. Moreover, this prevents a further use of the central duct.
In particular, said connection means comprises a substantially bush-shaped first junction fitting and a substantially bush-shaped second junction fitting outside of said central duct in particular, within which, in use, said central duct is arranged.
Advantageously, the first junction fitting and the second junction fitting have a removable-type mutual engagement means that is configured to cause said first junction fitting and said second junction fitting to be separated from each other when a pulling force is applied that is stronger than a predetermined threshold force value, and is configured to allow a disengagement of said central duct.
Advantageously, the first junction fitting and the second junction fitting are mutually coupled along a coupling line by a mutual engagement means selected from the group consisting of:
In particular, at least one junction fitting selected among the first junction fitting and the second junction fitting has a predetermined number of clamp members, for example two clamp members arranged at opposite sides with respect to each other, said clamp member configured to snap engage with a respective clamp engagement portion, in particular protruding, made on a respective valve, said clamp members and said clamping engagement portion configured such that, when said pulling force exceeds said predetermined value, at least one of said plurality of clamp members is configured to break, in order to allow a separation between said first portion and said second portion and to allow the disengagement of said central duct.
Preferably, said mutual engagement means comprises at least one pin integral to said first bush and arranged to engage with a housing made in said second bush. The pin and the housing can advantageously be screw-threaded. As an alternative, the first and the second bush can be connected to each other by gluing at the coupling line.
Advantageously, each clamp member comprises a flexible wing that is provided with a clamping tooth at one end thereof, and said clamping engagement portion is a protrusion that, in particular, is made at the outer surface of one of the valves, said clamping tooth configured to snap engage with said protrusion, in order to retain in the coupled configuration said first bush with said first valve and said second bush with said second valve and, therefore, said first portion and said second portion.
Advantageously, said flexible wings are configured to establish the pulling force value FT that is required to break them, i.e. the pulling force value beyond which the disengagement occurs of said first portion and of said second portion.
In a second exemplary embodiment, said first bush and said second bush comprise, at said coupling line, a first permanent magnet and a second permanent magnet that are arranged with their with polarity opposite, each permanent magnet housed within a respective housing made in said first bush and in said second bush, respectively.
In particular, said first bush and said second bush comprise a sealing means that is arranged at said coupling line.
Preferably, said sealing means comprises a boundary groove made at an edge of at least one bush selected among said first bush and said second bush, with which a sealing element, such as an 0-ring, engages.
The invention will be now illustrated with the following description of an exemplary embodiment thereof, exemplifying but not limitative, with reference to the attached drawings in which:
finally,
With reference to
Connector 100 also comprises a second portion 20 configured to couple with first portion 10. Second portion 20 comprises in turn a second passage duct 21 configured to connect with a second medical line 154, in order to allow a flow of the fluid towards/away from second passage duct 21.
Furthermore, connection device 100 comprises a releasable connection means 30 that is configured to releasably connect first portion 10 and second portion 20 in such a way to pass from a coupled configuration A (
Connector 100 also comprises at least one valve 40, 42.
For instance, as shown in the longitudinal cross section of
For example, valve 40,42 can provide a dividing wall 41 that is slidingly mounted within the body of the valve biased by a pushing means, for example a resilient means 46. More in detail, pushing means 46 is arranged at opposite sides with respect to said dividing wall 41 and is arranged to apply a resilient force that biases the movement of valve 40,42 from the closed configuration to the open configuration, i.e. biases the opening of valve 40,42. This technical feature makes it possible to ensure the required safety conditions, since springs 46 close immediately valves 40,42 if an accidental disengagement takes place between portions 10 and 20.
As still shown in
The releasable connection means 30 is adapted to maintain central duct 50 between first portion 10 and second portion 20 when these are in coupled configuration A, and are configured to be detached when a pulling force FT, which tends to separate first portion 10 and second portion 20, exceeds a predetermined threshold value, such that central duct 50 is detached and the or each valve 40,42 is returned to normally closed position C.
This way, connector 100 can be used only one time, which allows to fix the predetermined force parameters for disengaging first portion 10 and second portion 20. Furthermore, such a connector ensures a full safety with respect to any contamination of the fluid within the medical lines 152,154 that are brought in communication by said connector, which overcomes a drawback of the prior art connectors.
In particular, as said above and shown in the pictures, a first valve 40 and a second valve 42 are provided arranged on first portion 10 and on second portion 20, respectively. In decoupled configuration B, valves 40 and 42 keep first line 152 and second line 154 segregated from the outside. This way, if an accidental disengagement occurs between the two portions 10 and 20, any loss of the fluid contained in both lines 152,154 is prevented. Furthermore, the fluid is prevented from being contaminated, which would occur if the fluid came into contact with the outside environment. This is a particularly sensible issue when the line that is directly connected to a patient is interrupted.
Fastening elements 11a,21a are provided associated with first valve 10 and with second valve 20, for example male Luer-Lock elements 21a and female Luer-Lock elements 11a, configured to form the connection with first line 152 and with second line 154.
More in particular, as shown in
In decoupled configuration B, instead, end portion mouths 51,53 loose their contact with surface 48 of actuation element 45, therefore springs 46 push dividing wall 41 of valve 40,42 to the closed position.
Central duct 50 can also be split into at least two parts that are releasably connected to each other. In this case, central duct 50 is split into two portions, or even into more portions, when the disengagement occurs, assisting the closure of valves 40,42, which push a portion of central duct that is smaller than a central duct made of a single part. This also ensures that central duct 50 cannot be used again for a subsequent application. However, it is worth to point out that central duct 50 is split into a plurality of portions, since releasable means 30 moves to the detachment position of portions 10 and 20, unlike the prior art solutions, and that, instead, the separation of central duct 50 does not cause the medical line to be closed. This difference makes it possible to ensure the patient's safety conditions that are required for the devices to be used in a medical application.
Two connection fittings 51a,53a can be provided at end portion mouths 51,53, that are configured to be connected with a connection portion 40a,42a, respectively, of first valve 40 and of the second valve 42 such that an axial reference is formed. This allows causing end portion mouths 51,53 to match precisely with the respective actuation element 45. Furthermore, sealing elements 52 can be provided on the bottom of connection fittings 51a,53a, which ensures a better fluid-tightness.
More in particular, each actuation element 45 is associated with a resilient means, for example with a spring 46, which pushes actuation element 45 and brings it back to normally closed position C.
In coupled configuration A, actuation element 45 is pushed towards open position D by tubular portion 52, since the bias force of spring 46 is exceeded.
If a portion 10,20 is decoupled, on the one hand, the portion that causes the corresponding valve 40,42 to close is detached, whereas duct 50 remains inserted within connection portion 40a,42a, but it is pushed by spring 46 until valve 40,42 is brought to normally closed position C again. This way, if a disengagement occurs, both valves 40,42 are closed ensure that both lines 152,154 are maintained in a sterilised condition. Accordingly, the technical solution of the present invention, which comprises using springs 46 arranged to apply a resilient force that biases the opening of the or each valve 40,42, makes it possible to ensure the required patient's safety conditions.
Therefore, the above description points out an important difference with respect to the prior art inventions in which, on the contrary, the spring of the collector tends to separate the two portions. This known solution, in fact, cannot satisfactorily ensure the patient's safety due to the above-described reasons.
Structurally, the releasable connection means 30 comprises a first junction fitting 32 and a second junction fitting 34 outside of central duct 50, in particular, bush-shaped junction fittings. For instance, a first bush 32 and a second bush 34 are provided arranged to be separated from each other when the pulling force FT exceeds a predetermined threshold value FT*.
In a first exemplary embodiment, as shown in
As shown in
First bush 32 can comprise a couple of clamp members 37 that are configured to snap engage with a respective clamping engagement portion 38. Clamping engagement portion 38 is made on a respective portion 10,20, in such a way that, when the pulling force exceeds a predetermined threshold value, at least one clamp member selected among the couple of clamp members 37 is configured to break in order to allow a separation between first portion 10 and second portion 20 and, therefore, to allow the disengagement of central duct 50.
In particular, each clamp member 37 comprises a couple of flexible wings 37, each of which has a respective clamping tooth 37a, while clamping engagement portion 38 is a protrusion portion made on the outer surface of portion 10, or 20, to which tooth 37a is snap engaged, in order to retain two lines 152,154 in coupled configuration A (
More in particular, flexible wings 37 are configured to determine the pulling force value FT that is required for their deformation. In this way, clamping tooth 37a is broken simultaneously, and disengages therefore first portion 10 from second portion 20.
Moreover, or as an alternative, wings 37 can comprise at least one weakened portion to achieve the predetermined break force value.
In the exemplary embodiment, as diagrammatically shown in
In a second exemplary embodiment, as shown in
In particular, in this exemplary embodiment, first bush 32 and second bush 34 comprise a sealing means 55 that is arranged at coupling line 35. In particular, sealing means 55 comprises a boundary groove 56 made at an edge 57 of at least one bush selected among first bush 32 and second bush 34, in which a sealing element 58, such as an O-ring, is engaged. This way, a high fluid-tightness is ensured at coupling line 35.
In the exemplary above-described embodiments, central duct 50 has a predetermined length that corresponds to the predetermined break threshold value. This length is therefore selected to match a predetermined break threshold value.
More precisely, by changing the length of central duct 50, a change occurs of the balance among the forces, achieving the break threshold value, and then the detachment, between first portion 10 and second portion 20.
In other words, by changing the length of central duct 50 a change occurs of the resilient force of spring that tends to separate the two portions 10,20. Accordingly, the resistance of magnets 60,62 or of the flexible wings 37 is calibrated by taking into account the above-described resilient force that pushes the valves with more or less intensity.
For example, a connector 100 can be made that has a break value, expressed in Newton, set between 5N and 30N, according to the application to which they are intended for.
In the light of the above, it is clear that springs 46 can be more or less compressed according to the length and to the thickness of wings 37, and to the length of duct 50, and that a precise breaking force can be accordingly established, as required to cause connection device 100 to pass from coupled configuration A to decoupled configuration B.
The foregoing description of various specific embodiments will so fully reveal the invention according to the conceptual point of view, so that others, by applying current knowledge, will be able to modify and/or to adapt in various applications such specific embodiments without further research and without parting from the invention and, accordingly, it is meant that such adaptations and modifications will have to be considered as equivalent to the specific embodiments. The means and the materials to carry out the different functions described herein could have a different nature without, for this reason, departing from the field of the invention. It is to be understood that the phraseology or terminology that is employed herein is for the purpose of description and not of limitation.
| Number | Date | Country | Kind |
|---|---|---|---|
| PI2011A000130 | Nov 2011 | IT | national |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/IB2012/056601 | 11/21/2012 | WO | 00 | 5/21/2014 |
