US20150320992A1 - Secure fluids transfer system for medical use - Google Patents

Abstract

A fluid transfer system includes Luer male and female connectors. The male connector has a main body with a longitudinal internal opening and an internal threading; the female connector has a main body containing an internal channel for the passage of fluids, a collar that surrounds at least a portion of an end of the main body, and external threading on the portion that is surrounded by the collar. The corresponding threadings are configured to engage and ensure a secure fit between the male and female connectors. An external surface of the male connector at the end where the threading is located forms a conical male portion, the internal surface of the collar of the female connector forms a conical female connecting surface, and the conical male portion is configured to fit against the conical female connecting surface and onto the collar when the male and female connectors are fitted together.

Description

BACKGROUND OF THE INVENTION
• 1. Domain of the Invention
• This invention is in the field of Luer connections, specifically a secure mechanism for the transfer of medical use solutions.
• 2. Technological Background
• It is a well-known practice to use Luer connections to connect for example medical devices to each other for introducing medical solutions from a primary recipient to ducts within human bodies.
• FIGS. 1 and 2 show state of the art Luer male and female connectors. ALuer male connector1 comprises acollar2 encircling at least a part of theconical male part3 whose external surface joins to the female conical connecting surface of the Luerfemale connector4 when these Luer male1 and female4 connectors are joined together.
• Thecollar2 of the Luermale connector3 features aninternal threading5 whereas the Luerfemale connecter4 contains the largest of therims6 that fit to theinternal threading5 of thecollar2 of the Luer male connector so that the two parts can join.
• Connecting the twoLuer connections1,4 is accomplished simply by means of a tightening torque. The application of this tightening torque, or twisting movement, gives rise to a rotating movement of the Luerfemale connection4 around theinternal threading5 of themale connector collar2.
• When the twoLuer connectors1,4 are thus engaged and directly attached to each other, abrupt separation and contamination from without of these Luer connectors are prevented as described in ISO standard 594-2 of the International Organization of Standardization.
• This standard also prescribes specific dimensions for each of the Luer connections.
• While theseLuer connectors1,4 are easy to use, handling errors by users have been observed during the coupling action in a large number of Luer connectors.
• In particular, where handling is required in aphaeresis, there is a risk of inverting the two lines, for example anticoagulants and saline solution, when the lines both have identical Luer connectors.
• As such, there is an urgent need to come up with other connectors that are different from state of the art connectors so as to avoid handling errors that could result in a risk to the health of patients.
• Moreover, fluids transfer systems recognized as state of the art that prevent improper connections are generally complex structures comprised of a large number of initially distinct parts. It takes a lot of time to assemble these fluid transfer systems and they are costly.
• The objective of this invention is to overcome this drawback by providing a fluids transfer system for medical use that is particularly simple in terms of design and operational use, that is aseptic and low cost and that affords a fully secure connection of Luer male and female connectors.
BRIEF DESCRIPTION OF THE INVENTION
• The invention involves a fluids transfer system for medical use comprising a Luer male connector and a Luer female connector, of which the said Luer female connector comprises a main body containing an internal channel for the passage of said fluids and a collar surrounding at least a part of the end of the main body, while the said Luer male connector comprises a main body with a longitudinal internal opening.
• According to the invention,
• The main body of the female connector contains a first threading on at least a part of the external surface of that portion that is surrounded by the collar, located at least in part facing an internal surface of the collar,
• One of the ends of the main body of the said Luer male connector contains a second threading on at least a part of its internal surface delineating the longitudinal internal opening, which engages into and fits in the initial threading to ensure joining between the Luer male and female connectors,
• At least the external surface of the Luer male connector end where the second threading is located forms a conical male portion having a conical axis of revolution, while the said interior surface of the collar of the said female connector forms a conical female connecting surface having a conical axis of revolution, so that the external surface of the said male conical part fits against the conical connecting surface of the collar of the Luer female connector to provide a sealed joint when the Luer male and female connectors are fitted together.
• Luer male and female connectors are disengaged by means of a disconnecting torque motion.
• The locking system made up by the first and second helix threads of the Luer male and female connectors is located between the fluids passage area and the sealing space of the fluids transfer system, formed by the contact between the conical male portion and the conical female connecting surface. This locking system works to dispel constraints by reducing pressure exerted on the sealing space during fluids transfer in such a way as to preserve the space, thus preventing any occurrence of contamination or leakage.
• In order to reinforce the sealed fit of the Luer male and female connectors, the collar of the Luer female connector may be elongated so as to present a larger conical female connection surface, while the external surface of the conical male portion is also increased through an elongation of the male conical piece.
• In the various particular embodiments of this system, each with its particular advantages and possibilities for implementing numerous technical combinations:
• At least one of the Luer male and female connectors is made as a single piece of plastic material,
• The Luer male connector features a collar, or skirt, that surrounds the male conical portion having a conical axis of revolution, at least partially so as to protect this conical male portion.
• This advantageously protects against the risk of scratches forming on the conical male portion and against external contamination during storage of the Luer connector.
  Naturally, the internal diameter of the collar is such that the collar of the Luer female connector fits within this collar surrounding the conical male portion when the Luer male and female connectors are joined.
• The diameter of the internal longitudinal opening of the said Luer male connector at the base of the said second threading is equal, within 0.2 mm, to the diameter of the main body of the Luer female connector with respect to its exterior threading,
• Some play will apply advantageously in the initial joining assembling part of the Luer male and female connector so that engaging the screw is facilitated for users, but this play will be reduced at the end of the screw phase to prevent any transfer of fluid. Consequently, there may be a forced connection acting on these two connectors on a part of the threaded connection corresponding to the end joining phase of the Luer male and female connectors.
• said Luer male connector, and/or the Luer female connector, contains an internal wall located in its internal longitudinal opening, respectively and/or in its internal channel, with the said internal wall comprising an orifice for the flow of fluids.
• It is preferable, concerning the Luer male connector with an internal wall onto which an orifice is located at its internal longitudinal opening, that the orifice contain a truncated part located on the side of the end of the internal longitudinal opening that contains a second threading, so as to ensure that fluids are directed into the internal channel at the end of the main body of the female Luer connector when this end is placed close to the orifice in the internal wall.
• The Luer female connector collar rotates or does or does not rotate around the female conical connector
• At least one of the Luer male and female connectors has a sealed end that ensures a link to the main body that is either whole or can be split. This end is, from a purely illustrative perspective, a split blocking element to guarantee its asepsis.
• The invention also concerns a Luer male connector intended for use in the fluids transfer system for medical use as described previously.
• According to the invention, this connector comprises
• A main body containing a longitudinal internal opening,
• One of the ends of the main body of the Luer connector contains a thread on at least a part of its internal surface delineating the longitudinal internal opening, which engages into and fits in the threading of a Luer female connector to ensure a secure fit between the Luer male and female connectors,
• At least the external surface of the Luer male connector end where the said threading is located forms a conical male portion having a conical axis of revolution, said conical male portion fitting against the conical female connecting surface onto the collar of the Luer female connector when the said Luer male and female connectors are fitted together.
• The end of the male connector opposite that forming a conical male portion having a conical axis of revolution may contain gripping elements on its external surface to facilitate handling.
• The invention also concerns a Luer female connector intended for use in the fluids transfer system for medical use as described previously.
• According to the invention, this Luer female connector comprises:
• A main body containing an internal channel for the passage of fluids and a collar surrounding at least a part of the end of the said main body,
• The main body of the female connector contains a first threading on at least a part of the external surface of that portion that is surrounded by the collar, located at least in part facing an internal surface of the collar,
• the internal surface of the collar of the said female connector forms a conical female connecting surface having a conical axis of revolution so that the external surface of the conical male part of a Luer male connector fits against said conical female connecting surface when the Luer male and female connectors are fitted together, said conical male part having a conical axis of revolution.
• The main body of the Luer female connector surrounded by the collar includes at least a single orifice opening laterally that can advantageously allow communication of fluids between the internal channel and the area comprising the internal surface of the collar and the external surface of the piece in order to limit any loss of fluids during their transfer.
• The invention also pertains to a medical device comprising at least one recipient containing a medical use fluid equipped with a fluid transfer system for medical uses as described previously.
• This recipient may be, for purely illustration purposes, a flexible pouch or a bottle.
• The invention also concerns a medical device consisting of a syringe with a Luer male connector or Luer female connector attached as described previously.
BRIEF DESCRIPTION OF DRAWINGS
• Other particular benefits, objectives and features of this invention will appear from the following description, which is done with regard to the appended drawings for the purposes of description and which are in no way limiting, in which:
• FIG. 1 is an overall view of the Luer male/female connector using prior art embodiment;
• FIG. 2 is a partial section of the Luer male connecter ofFIG. 1,
• FIG. 3 is a side view of the fluids transfer system for medical use consisting of a Luer male connector and a Luer female connector, from an initial embodiment of the invention,
• FIG. 4 is a partial view in longitudinal section of the fluids transfer system shown inFIG. 3,
• FIG. 5 is a side view of the Luer female connector of the fluids transfer system shown inFIG. 3,
• FIG. 6 is a side view of the Luer male connector of the fluids transfer system shown inFIG. 3,
• FIG. 7 is a partial sectional view of the fluids transfer system for medical use consisting of a Luer male connector and Luer female connector, from a second embodiment of the invention,
• FIG. 8 is a side view of the Luer female connector of the fluids transfer system shown inFIG. 7,
• FIG. 9 is a side view of the Luer male connector of the fluids transfer system shown inFIG. 7,
• FIG. 10 is a partial side view of the fluids transfer system for medical use consisting of a Luer male connector and a Luer female connector, from a third embodiment of the invention,
• FIG. 11 is a partial side view of the fluids transfer system for medical use consisting of a Luer male connector and a Luer female connector, from a fourth embodiment of the invention,
• FIG. 12 represents partial sectional views showing unsuccessful attempts at joining a Luer male or female connector ofFIGS. 3 to 6 and a prior art connector, specifically:
• FIG. 12a) represents a Luer male connector shown inFIG. 6 and a state of the art female connector
• FIG. 12b) represents a Luer male connector shown inFIG. 6 and a state of the art male connector
• FIG. 12c) represents a Luer female connector shown inFIG. 5 and a state of the art male connector
• FIG. 12d) represents a Luer female connector shown inFIG. 5 and a state of the art female connector
• FIG. 12e) represents a Luer male connector shown inFIG. 6 and a state of the art Slip fit Luer connector
• FIG. 12f) represents a Luer female connector shown inFIG. 5 and a state of the art Slip fit Luer connector
DETAILED DESCRIPTION OF THE EMBODIMENTS OF THE INVENTION
• It should first be noted that the drawings are not to scale.
• FIGS. 3 to 6 are schematic representations of a fluids transfer system for medical use indicating the preferred embodiment of the invention. This transfer system consists of aLuer male connector10 and a Luerfemale connector11 to be joined by means of tightening torque to enable the transfer of fluids.
• The Luerfemale connector11 features a fixed collar, or askirt12 with aninternal surface13 and an external surface. While the external surface of thiscollar12 is cylindrical, itsinternal surface13 presents a conical surface having a conical axis of revolution, said conical surface being smooth. Thisinternal surface13 thus forms a cone trunk with a taper angle of 6%, this surface being known as the female conical connection surface.
• Thiscollar12 surrounds one end of amain body14 of the Luerfemale connector11. Thismain body14 consists of aninternal channel15 for the passage of fluids.
• Thisinternal channel15 has a diameter superior or equal to the diameter of the internal channel of the male conical portion of the Luer male connector set out in ISO standard 594-2. Thus the Luerfemale connector11 presents a flow of medical solution at least equal to that of prior art Luer connectors.
• However, the diameter of theinternal channel15 is such that it is not possible to insert a male conical portion of a Luer male connector described in ISO standard 594-2.
• Thismain body14 also features aninitial thread16 on the external surface of its end surrounded by acollar12, located opposite of theinternal surface13 of thecollar12.
• Alternatively, themain body14 end could be placed protruding from thecollar12, with a portion of thefirst thread16 being located facing theinternal surface13 of thecollar12, while another portion of this threading would be located protruding from the collar.
• This initial threading16 is a constant pitch propeller as defined by ISO standard 594-2 and presents a trapezoidal profile that offers good resistance to wrenching.
• The diameter of themain body14 of the said Luerfemale connector11 with respect to its exterior threading is beneficially too large to be able to be accidentally inserted into the internal channel of a Luer female connector described by ISO standard 594-2.
• Themain body14 of the Luerfemale connector11 features a conical profile on itsend17 opposite that surrounded by thecollar12, so that it can be inserted in a conduit such as tubing (not shown). Thisconical end17 of themain body14 of the Luerfemale connector11 can alternatively be attached divisibly to thecollar12.
• The end of theinternal channel15 located at the truncated end of themain body14 of the Luerfemale connector11 is advantageously blocked here by a removable stopping element.
• TheLuer male connector10 includes amain body18 containing an internal longitudinal opening. This internal longitudinal opening delineating an initial connectingarea19 that contains asecond thread20 which engages and fits into the initial threading to ensure a secure fit between the Luer male and female connectors, and a second connectingarea21 for receiving a tube.
• This could be assembled at the wall of themain body18 of theLuer male connector10 delineating thesecond connection area21 through joining by means of an adhesive solvent.
• These twoconnection areas19,21 are separated by a wall bearing anorifice22 that provides communication between these entities. This wall also constitutes a stopping point for the insertion of a tube in thesecond connection area21.
• Theorifice22 on this wall advantageously presents a flaredportion23 on the side of theconnection area19 so that with the Luer male and female connectors being joined, and an end of the internal channel of themain body14 of the Luer female connector being located near thisorifice22, fluids leaving theinternal channel15 are directed toward thesecond connection area21 of theLuer male connector10 without contact with thesecond thread20.
• It should be noted that the internal diameter of theconnection area19 between the tops of two screw threads located facing each other is such that it cannot ensure that the conical male portion of a Luer male connector as described by ISO standard 594-2 will be maintained in place if inadvertently inserted in theconnection area19 when Luer male and female connectors are joined.
• The end of themain body18 of theLuer connector10 that contains aconnection area19 presents anexterior surface24 with a conical profile of a 6% taper.
• This maleconical portion24 rests against the femaleconical connecting surface13 of thecollar12 of the Luerfemale connector11 when the Luer male andfemale connectors10,11 are joined so as to ensure a sealed fit.
• Moreover, the main body of theLuer male connector10 containsgripping elements25 on its external surface so as to facilitate handling, as well as aflange36 located at the non-free end of the maleconical portion24. Thisflange36 delineates the end of the maleconical portion24 and prevents contamination of this conical portion with the stopper.
• TheseLuer male10 and female11 connectors are one piece units obtained through a mold by means of injecting a medically inert thermoplastic material. They may, for purely illustrative purposes, be of polycarbonate, polystyrene, acrylonitrile butadiene styrene (ABS) or PC-ABS copolymers, polyolefin (such as polyethylene, polypropylene, a homopolymer or a copolymer of polypropylene) or of a polyolefin comprising a thermoplastic elastomer (TPE) such as SEB (styrene, ethylene or butylene block copolymers), SEBS (styrene, ethylene, butylene, styrene block copolymers) or of cyclopolyolefin, etc.
• The fluids transfer system of this invention is therefore particularly low cost to produce and does not require the assembly of several elements that would render the structure complex.
• Advantageously, a user who must connect several pairs of connectors cannot erroneously connect a state of the art Luer female or male connector with a Luer male or female connector produced as a result of this invention.
• FIGS. 7 to 9 are schematic representations of a fluids transfer system for medical use according to another embodiment of the invention.
• The elements ofFIGS. 7 to 9 bear the same references as the elements ofFIGS. 3 to 6 that represent the same objects, which will not be described again here.
• The fluids transfer system inFIG. 7 differs from that described above in that the end of the main body of the Luerfemale connector11 surrounded by thecollar12 is made up of two halfcylindrical parts27,28 that are spaced apart from each other and parallel.
• Each of theparts27,28 contain a portion of thehelical thread29 on its rounded exterior surface, with the threads on the exterior surface of one of the parts continuing on the exterior surface of the other half-cylindrical part such that a semi-continuous threading is formed that will match the threading20 located on the internal surface of themain body18 of theLuer male connector10 to ensure that the Luer male and female connectors join up.
• Moreover, following joining of the Luer male and female connectors, the internal cylindrical surface of the connectingarea19 of the Luer male connector, containing thesecond threading20, surrounds the two half-cylindrical parts27,28 on at least a part of their longitudinal extension.
• The component formed by the internal surface parts of theconnection area19 between the two half-cylindrical parts27,28 that are spaced apart from each other and theflat surfaces30,31 facing the two half-cylindrical parts make up a channel for the circulation of fluids. These fluids are then directed toward thesecond connection area21 in the internal longitudinal opening of theLuer male connector10.
• The channel thus formed by the assembly of the Luer male and female connectors is in fluid communication with achamber32 formed at the base of the two half-cylindrical parts27,28, thischamber32 being itself in fluid communication with both aninternal channel15 of the Luerfemale connector11 for the passage of fluids with saidchannel15 located at the other end of the
• Luerfemale connector11, and with thebase33 of thecollar12 connected to the Luerfemale connector11.
• In this way any discharge that may occur along the threads between the internal cylindrical surfaces of the connection area of the Luer male connector and rounded exteriors of the two half-cylindrical parts will be recovered. Consequently, this ensures the minimizing of any loss of transferred fluid and the possible stagnation of fluids.
• FIG. 10 shows a partial view of the fluids transfer system for medical use in a third embodiment of the invention. The fluids transfer system inFIG. 10 differs from that described inFIGS. 3 to 6 in that theLuer male connector10 with an internal wall containing anorifice22 in its internal longitudinal opening has a truncatedportion23 located at the end of the internal longitudinal opening that has the said second threading20, and the end of the main body of the Luerfemale connector11 is conical34 so that with this end being located near theorifice22,23 of the said internal wall, fluids are directed through the orifice. Advantageously, no fluid retention is observed with this fluids directional system.
• Theseconical parts23,34 are kept away from contact with each other in order to avoid dual alignment.
• FIG. 11 shows a partial view of the fluids transfer system for medical use in a fourth embodiment of the invention. The fluids transfer system inFIG. 11 differs from that described inFIGS. 3 to 6 in that theLuer male connector10 with an internal wall containing anorifice22 in its internal longitudinal opening and this orifice has aportion35 protruding from the said wall being located at the end of the internal longitudinal opening that has the before-mentionedsecond threading20. This protrudingportion35, here for illustrative purposes a portion of a tube, has an external diameter inferior to the diameter of theinternal channel15 of the main body of the Luerfemale connector11 so formed that it can be received in theinternal channel15 when the saidLuer male10 and female11 connectors are joined so as to direct fluids through the saidorifice22.
• This protrudingpart35 and the wall of the main body of the Luer female connector delineating theinternal channel15 are kept away from contact with each other so as to avoid dual alignment.

Claims (11)

1. A Luer male connector (10) for use in a fluid transfer system, comprising

a main body containing a longitudinal internal opening (19,21),

one of the ends of the main body comprising a threading on at least a part of its internal surface delineating the longitudinal internal opening (19,21), the threading configured to engage with and fit in a corresponding threading of a Luer female connector (11) to provide a secure fit between the male and female connectors, and

an external surface of the Luer male connector (10) at the end where the threading is located forms a conical male portion (24) having a conical axis of revolution, said conical male portion (24) configured to fit against a conical female connecting surface (13) and onto a collar (12) of the Luer female connector (11) when the male and female connectors are fitted together.

2. The Luer male connector according toclaim 1, wherein an end of the male connector opposite to the end forming the conical male portion (24) comprises gripping elements on its external surface.

3. The Luer male connector according toclaim 1, wherein the Luer male connector comprises a flange ring that forms a stopping point for the collar (12) of the Luer female connector (11).

4. The Luer male connector according toclaim 1, wherein the connector is a single piece made of plastic.

5. The Luer male connector according toclaim 1, further comprising an internal wall located in the longitudinal internal opening (19,21), the internal wall comprising an orifice for the flow of fluids.

6. The Luer male connector according toclaim 5, wherein the orifice comprises a portion having a second threading (20) located at an end of the longitudinal internal opening (19,21).

7. The Luer male connector according toclaim 6, wherein the orifice comprises a second portion that protrudes from the internal wall located at the end of the longitudinal internal opening (19,21).

8. A Luer female connector (11) for use in a fluid transfer system, comprising

a main body (14) containing an internal channel (15) for the passage of fluids, and comprising a collar (12) that surrounds at least a portion of an end of the main body,

the main body (14) of the female connector containing a threading (16) on the external surface of the portion that is surrounded by the collar (12), the threading located at least in part facing an internal surface of the collar (12), and

said internal surface of the collar (12) forms a conical female connecting surface (13) having a conical axis of revolution and configured to fit against an external surface of a conical male portion (24) of a Luer male connector (10) when the male and female connectors are fitted together.

9. The Luer female connector according toclaim 8, wherein the portion that is surrounded by the collar (12) comprises at least one orifice opening laterally that allows communication of fluids between the internal channel (15) and an area located between the interior surface of the collar (12) and the external surface of the portion surrounded by the collar.

10. The Luer female connector according toclaim 8, wherein the connector is a single piece made of plastic.

11. The Luer female connector according toclaim 8, further comprising an internal wall located in the internal channel (15), the internal wall comprising an orifice for the flow of fluids.

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