LUER LOCK CONNECTOR DEVICE.

Description

TITLE INV. OES. PRIORITY BAXTER TRAVENOL LABORATORIES INC. OEERFIELD ILLINOIS USA LUER LOCK CONNECTOR DEVICE. T. MICHAEL DENNEHEY USA DOM. 0REV. N. 101246 OF DECEMBER 7, 1979 Rome, li___________ ........................................................ Register A Protocol No. 26470 A / 80 MINISTRY OF INDUSTRY, COMMERCE AND CRAFTS Provincial Office of Industry, Commerce and Crafts of Milan COPY OF THE MINUTES OF THE FILING OF A PATENT FOR INDIVIDUAL INVENTION In the year 1980 '' the olngue day of the month of dioember the Company BAXTER TRAVENOL LABORATORIES, INC. xxtxgccxi American £££^- in Illinois <U,S,A.) di nazionalità’ statunitense ίπ Via MODIANO & ASSOCIATI Sas di dr.ing. G. MODIANO & C, through an agent (Italian Patent and Trademark Agency) and with domicile for legal purposes in Milan - Via Meravigli 1G at >· the agent has presented to me, the undersigned: - Stamped application for the granting of a patent for an INDUSTRIAL invention entitled: LUER LOCK CORRECTOR DEVICE”, Designated Inventor 0> Michael DETAINED. Priority of the patent application in: USA No. 101246 of December 7, 1979, accompanied by: - Description in duplicate of n, 18 pages of writing. - Drawings, plates no. 1 in duplo. - Letter of appointment - - Priority document and Italian translation (with reservation) - Authorization or deed of transfer, (oon rieerva) - Act of designation of the inventor. • Proof of payment into postal account no. 006680Q4 in the name of the Tax and Concession Registry Office of Rome of L.69*000 issued by the Post Office of Milan 28 on 2.12.1980 n-135 - Revenue stamp of L. 2,000. The depositor refuses to sign the declaration referred to in circular no. 149 for the following reason: he does not believe he should, on principle, make declarations not required by law. The application, the descriptions and the drawings listed above have been signed by the applicant and countersigned by me and stamped with the official seal. THE DEPOSITOR For a copy compliant with the original OFFICER ROG, Pktro.Mc8eiiieo.......j......... / χ p. the Director (Salvatore Ravalli) THE HEAD OF THE PATENT OFFICE (ReHù) [folciti) 71879-ah I \ I, Hon. MINISTRY OF INDUSTRY, TRADE AND CRAFTS Central Patent Office - R 0 MA2 6 47 0 A / 80 The Company BAXTER TRAVENOL LABORATORIES, INC. UPiOAMiLANO ' ì r;ì c :F\*, . C 5. V. t G 0 2 0 ί ιι American national * Deerfield, Illi|@ig... SteeffldjeaajtJBx: (USA) through Agent MODIANO & ASSOCIATI Sas of Dr.Ing.G.MCDIANO & C.(Italian Patent and Trademark Agency) and with domicile for legal purposes in Milan Via Meravigli 16, requests the granting of a patent for the invention entitled: M CONNECTOR DEVICE A LOCKING LU1SR irun. Designated Inventor: T. Michael ΓΕΝΝΕΗΕΥ. Priority of Patent Application in: USA» No. 101246 of December 7, 1979. Attached Documentation: a) Description in duplicate. b) Drawings of n. 1 table in duplicate. c) Letter of assignment d) Priority document with Italian translation (subject to availability) e) Authorization or deed of transfer (with reservation). f) Act of designation of the inventor. h) Revenue stamp of L, 2,000,jf ~ GA Date t, . ' / ù Signature: 71879 / TRUZ / sg (AO-996) LUER LOCK CONNECTOR DEVICE BAXTER TRAVENOL LABORATORIES, INC., in Deerfield, Illinois (USA) Designated Inventor: T. Michael DENNEHEY. e. i', ',,L|ì Deposited on ' ......at N. 2 6^7 0 A / 80 * * » * « SUMMARY A Luer lock connector device for medical use, such as in continuous ambulatory peritoneal dialysis, in which a solution container is coupled via flexible tubing to a patient tube that communicates with the patient's peritoneal cavity. The Luer lock connector device includes a cooperating male Luer lock connector and a cooperating female Luer lock connector, with visual indicator means provided to indicate that the male and female connectors are properly assembled for use when in a predetermined relationship. The male and female Luer lock connectors are structured to create a double 'seal' arrangement to assist in maintaining a pristine connection. DESCRIPTION The present invention relates to a Luer lock connector device and, more particularly, to a Luer lock connector device that can be used in continuous ambulatory peritoneal dialysis. - 2 It is understood, however, that this Luer lock connector device is also suitable for use in other medical applications. In continuous ambulatory peritoneal dialysis, a dialysis solution is introduced into the patient's peritoneal cavity, left there for several hours, and then drained from the patient's peritoneal cavity, the process being repeated on a substantially continuous basis. One way to perform this type of dialysis is described in a parallel application by T. Michael Dennehey, Richard J. Greff and Ludwig Wolf Jr., filed in the United States Patent and Trademark Office on January 23, 1979, under serial number 5,748, and entitled Solution Container For Continuous Ambulatory Peritoneal Dialysis. One method of performing continuous ambulatory peritoneal dialysis involves connecting a container of dialysis solution to a catheter connected to the patient's peritoneal cavity, unblocking the tubing between the container of dialysis solution and the patient's peritoneal cavity to allow the dialysis solution to flow from the container into the peritoneal cavity, then re-blocking the tubing, thus allowing the dialysis solution to remain within the patient's peritoneal cavity for several hours, such as four hours, unblocking the tubing and draining the solution from the patient's peritoneal cavity back into the container of dialysis solution, detaching the container of dialysis solution from the catheter tubing and connecting a new container of dialysis solution to the catheter tubing, and repeating the above steps.The above-mentioned pending patent application No. 5,748 describes a connection and disconnection system between the dialysis solution container and the patient's catheter tube using a Luer lock connector system. To this end, the transfer tube extending from the dialysis solution container has a first Luer connector, and the catheter tube extending from the patient's peritoneal cavity has a complementary locking connector. To prevent the occurrence of peritonitis, it is extremely desirable to achieve and maintain a clean connection at the Luer connector. The technical task that the present invention sets itself is therefore to provide a Luer lock connector device capable of ensuring and maintaining an uncontaminated connection. Another object of the present invention is to provide a Luer lock connector device that is simple in construction and efficient in manufacturing. A further object of the present invention is to provide a Luer lock connector device which offers a double form of sealing at the connection — 4 — It is yet another object of the present invention to provide a Luer lock connector device that provides the user with a visual means of identifying when the connectors are properly assembled for use. Other objects and advantages of the present invention will become apparent as the description follows. 1 In accordance with the present invention, a Luer lock connector device is provided comprising a cooperating male Luer lock connector and a female Luer lock connector. The male Luer lock connector has a central tubular portion defining an axial bore or hole with at least a portion of the central tubular portion enclosed by an outer sheath having a generally circular cross-sectional configuration. The outer sheath has internal connecting means adapted to cooperate with external connecting means of the female Luer lock or connector. The female Luer locking connector comprises a main tubular member adapted to receive the central tubular portion and having external connecting means adapted to cooperate with the internal connecting means of the outer sheath of the male manifold. The main tubular member of the female Luer connector has visual indicator means positioned to indicate that the male and female connectors have been properly assembled for use when the outer sheath and the visual indicator means are in a predetermined relationship. - 5 In the illustrative embodiment, the visual indicating means comprises an outwardly extending member adapted to engage the outer sheath when the male and female connectors are properly assembled. In the illustrative embodiment, the outer surface of the central tubular portion of the male Luer lock connector is arranged to form a sealing engagement with the inner wall of the main tubular member of the female Luer lock connector. Additionally, the outer surface of the female Luer lock connector is arranged to form a sealing engagement with the inner wall of the outer sheath. In this manner, a double seal is created. In the illustrative embodiment, the intended relationship between the outer sheath and the outwardly extending member is represented by an abutment relationship that provides for an overtravel position of the main tubular member relative to the central tubular portion. In the following description and in the attached claims, a more detailed explanation of the present invention is given, illustrated in the attached drawings, where: Figure 1 is a perspective view of a diolysis solution vessel, further illustrating a Luer connector or lock device made in accordance with the principles of the present invention; Figure 2 is a perspective view of a cooperating male Luer lock connector and a female Luer lock connector, both made in accordance with the principles of the present invention; Figure 3 is a front view of a male Luer lock connector made in accordance with the principles of the present invention; Figure 4 is a side elevation view, with portions broken away for clarity; Figure 5 is one seen from the rear; Figure 6 is a rear view of a female Luer locking connector made in accordance with the principles of the present invention; Figure 7 is a side elevation view; Figure 8 is a front view; Figure 9 is a side view of male and female Luer lock connectors in a position as they are assembled for use; and Figure 10 is a side view of Luer lock connectors, similar to the view in Figure 9, but showing the Luer lock connectors properly assembled for use. Referring to Figures 1 and 2, a bag 20 of dialysis solution is shown with ports 22 and 24 extending from a side 26 of the bag 20. Port 24, in the illustrative embodiment, is closed by an injection member 28. Solution vessel 20 is preferably made from a flexible, sheet plastic material that is heat-sealed at its edges to form a solution bag. Port 22 includes flexible plastic tubing that has a female Luer lock connector 30 at its distal end. A frangible member 32 is positioned in series with transfer port 22 and female Luer lock connector 30 within the bore defined by the flexible tubing. Frangible member 32 intercepts fluid flow from the transfer port until frangible member 32 is ruptured. Frangible member 32 is preferably made from a plastic material that fills the flow path of the transfer port and tubing 22, but defines a central hole through the plastic material that is hermetically sealed by a rupture member.When the rupture member is manually ruptured, the dialysis solution contained in the solution vessel 20 is allowed to flow through the frangible member 32, downstream thereof. In this manner, the dialysis solution within the solution vessel 20 is held adjacent to the transfer port 22 until the frangible member 32 is ruptured, and not before the rupture of the frangible member 32 allows the solution contained in the solution vessel 20 to flow downstream of the frangible member 32. The female Luer-lock connector 30 is connected to a male Luer-lock connector 34 worn at the far end of the patient's peritoneal tube, 36, which is coupled to the patient's peritoneal cavity. Further details regarding the construction of the novel Luer-lock connection system consisting of the female Luer-lock connector 30 and the male Luer-lock manifold 34 will be provided later and are illustrated in Figures 2-10. The male Luer connector 34 is illustrated in detail in FIGS. 3-5. Referring to these figures, the male Luer connector 34 includes a central tubular portion 38 defining an axial bore or hole 40, the central tubular portion 38 tapering outwardly and rearwardly to a certain point, but not tapering further rearwardly from said certain point. As a specific example, though not in a restrictive sense, the central tubular portion 38 tapers outwardly from its forward end to a point 0.25 inches (6.35 mm) rearward thereof, with the further portion rearward of the central tubular member 38 not being tapered. The central tubular portion 38 is enclosed by an outer sheath 42 having a generally circular cross-sectional configuration. The outer sheath 42 is internally threaded with threads 44 that engage with the external threads of a female Luer connector, as will be explained below. The outer sheath 42 helps prevent contact contamination during locking and / or unlocking of the Luer lock connection system and serves to carry the threads 44 that are engaged by the external threads carried by the female Luer lock connector 30. The male Luer lock connector 34 carries a radially extending flange 46 and a graspable body portion 48 having equally spaced, outwardly extending members 50 which serve to permit the operator to grasp the body portion 48. A rear coupling member 52, which lies coaxial with the central tubular portion 38, is provided for coupling the male Luer connector to flexible plastic tubing 36, by solvent bonding or other means known in the art. Referring to Figures 6-8, where the female Luer locking connector 30 appears in detail, it can be observed that the connector 30 comprises a main tubular member 54 having an externally threaded front or anterior portion 56. The threaded portion 56 is sized to engage in screwing internal threads 44 of the male Luer connector 34. The main tubular member 54 tapers outward and rearward to form a hermetic engagement with the inner wall of the outer sheath 42. Thus, when the threaded portions 56 and 44 are threaded together, the inner wall of the outer sheath 42 comes to rest on the outwardly tapered outer surface of the main tubular member 54, thereby creating an effective hermetic seal. It is preferred that the male and female Luer lock connectors be made of a relatively resilient material, such as an elastomer material. As a specific example, although not in a restrictive sense, the use of a material such as PL-1109 polyester is suggested. The main tubular member 54 carries visual indicator means 60 in the form of outwardly extending ribs, each having a forward end 62 adapted to abut the forward end 64 of the outer sheath 42 when the male and female connectors are properly assembled for use. The female Luer lock connector 30 has a radially extending circular flange 66 and a rearwardly extending body portion 68 intended to be grasped by the operator that is structurally similar to the rearwardly extending body portion 48 of the male Luer connector 34. Similarly, the female Luer lock connector 30 has four outwardly extending members 70 that are structurally similar to the members 50 of the Luer lock connector 34, as well as a rearwardly extending coupling member 72 that is similar to the coupling member 52 of the connector. Luer male 34, The mating of the male Luer connector 34 to the female Luer connector 30 is more clearly illustrated in FIGS. 2, 9 and 10. When the male and female connectors are assembled, the external threads 56 engage the internal threads 44, and when the connectors are screwed together, the central tubular portion 38 is received within the bore defined by the main tubular member 54, creating a hermetic seal as the internal wall of the main tubular member 54 engages the end of the tapered portion of the outer surface of the central tubular portion 38. At the same time, a double seal is created as the internal wall of the outer sheath 42 forms a hermetic sealing engagement with the outwardly flared outer wall of the main tubular member 54. Thus, the double seal is produced when the male and female connectors are in the general position illustrated in FIG. 9.However, to ensure that the double seal is maintained, the user continues to screw the connectors into each other until the forward end 64 of the outer sheath 42 abuts the end 62 of the ribs 60, as illustrated in FIG. 10. In this manner, the sealing area between the outer surface of the central tubular portion 38 and the inner wall of the main tubular member 54 is physically forced or overtraveled an additional distance, which in the illustrative embodiment will be 1 / 16 inch (1.5875 mm). Since one or both members are made of an elastomeric material, a mutual adaptation of the parts occurs, and the internal sealing is not compromised. By not continuing to taper the Luer, the interference between the parts is reduced, and this reduction in interference assists in achieving the overtravel or overtravel characteristic.without compromising the internal seal. At the same time, the visual indicator consisting of the mating of the front end 64 with the ends 62 provides the user with a visual verification of the correct assembly of the connectors. No tactile perception or tightening of the connection is required. Although an illustrative embodiment of the invention has been illustrated and described, it will be clear that various modifications and substitutions can be made without departing from the spirit and scope of the present inventive concept. For example, an elastomeric material may be used for only one of the connectors. While the use of threads is convenient for the purpose of bringing the two units together and retaining them, a bayonet system may be used for the same purpose. The rib or ribs used as visual indicators may take on other configurations, such as that of a raised ring. Furthermore, the term Luer used in the present application identifies not only connectors featuring conventional tapers Luer, but also connectors with different tapers or without taper.

Claims

1. CLAIMS 1. Luer lock connector device comprising: a male Luer lock connector and a female Luer lock connector cooperating; said male Luer connector or lock having a central tubular portion defining an axial bore with at least a portion of said central tubular portion enclosed by an outer sheath having a generally circular cross-sectional configuration; said outer sheath being provided with internal connection means for cooperating with external connection means of said female 13-Luer locking connector; said female Luer lock connector comprising a main tubular member orthoid to receive said central tubular portion and having said external connecting means for cooperating with the internal connecting means of said outer sheath of the male Luer connector; and said tubular member of said Luer connector socket being provided with visual indicating means positioned to indicate that the male and female connectors have been correctly fitted or assembled for use, when said outer sheath and said visual indicating means are in a predetermined relationship.

2. The Luer lock connector device of claim 1 wherein said visual indicating means comprises an outwardly extending member adapted to grip said outer sheath when said male and female connectors are properly fitted or assembled.

3. The Luer lock connector device of claim 2 wherein said outwardly extending member comprises an outer rib having one end thereof adapted to abut against the forward end of said outer sheath when said male and female connectors are properly assembled. or assembled.

4. A Luer lock connector device according to claim 1, wherein said internal connecting means comprises an internally threaded portion; and said external connection means comprise external threads for cooperating obviously 14 with said internally threaded portion 0 The Luer lock connector device according to claim 1 wherein said central tubular portion of said male Luer lock connector is tapered outwardly and rearwardly or define a sealed engagement with the inner wall of said main tubular member of said female Luer connector or lock. The Luer lock connector device of claim 5 wherein the outer surface of said female Luer lock connector is tapered outwardly and rearwardly to form a sealed engagement with the inner wall of said outer sheath. , . · · - 7. A Luer lock connector device according to claim 1, wherein the outer surface of said center tubular portion of said male Luer lock connector is capable of defining sealing engagement with the inner wall of said main tubular member of said connector. or female Luer lock; and the outer surface of said female Luer lock connector is adapted to form a sealing engagement with the inner wall of said outer sheath.

8. A Luer locking or connector device according to claim 7 wherein said predetermined relationship provides for an overtravel position of said main tubular member with respect to said central tubular portion.

9. A Luer lock connector device according to claim 15 wherein said central tubular portion is tapered outwardly and rearwardly to define a sealing area with said main tubular member, but without tapering at a zone corresponding to the zone of the overtravel position. A Luer lock connector device comprising: a male Luer lock connector and a female Luer lock connector cooperating; said male Luer lock connector having a central tubular portion defining an axial bore with at least a portion of said central tubular portion enclosed by an outer sheath having a generally circular cross-sectional configuration; said outer sheath having internal connection means for cooperating with external connection means of said female Luer lock connector; said female Luer lock connector comprising a main tubular member adapted to receive said central tubular portion and having said external connection means for cooperating with the internal connection means of said outer sheath of the male Luer lock connector; the outer surface of said central tubular portion of said male Luer lock connector being adapted to form sealing engagement with the inner wall of said main tubular member of said female Luer lock connector; the outer surface of said female Luer lock connector being adapted to form a sealing engagement with the inner wall of said outer sheath; and said main tubular member of said female Luer connector or lock having visual indicator means positioned to indicate that the male and female connectors have been properly assembled for use when said outer sheath and said visual indicator means are in one predetermined relationship, said visual indicator means comprising an outer rib having an obtuse end thereof to abut on the front end of said outer sheath, 11. The Luer lock connector device according to claim 10, wherein said internal connecting means comprises an internally threaded portion and said external connecting means comprises external threads for threaded cooperation with said internally threaded portion; said central tubular portion tapering outwardly and rearwardly or defining sealing engagement with the inner wall of said main tubular member of said female Luer lock connector; the outer surface of said female Luer lock connector being tapered outwardly and rearwardly to define sealing engagement with the inner wall of said outer sheath. A Luer lock connector device comprising: a male Luer lock connector and a female Luer lock connector cooperating; said male Luer lock connector having a central tubular portion defining an axial hole with at least a portion of said central tubular portion enclosed by an outer sheath having a generally circular cross-sectional configuration; said outer sheath being provided with internal connection means for cooperating with external connection means of said female Luer lock connector; said female Luer locking connector comprising a main tubular member adapted to receive said tubular portion and having said external connection means for cooperating with the internal connection means of said outer sheath of the male Luer connector; said main tubular member of said female Luer connector being provided with visual indicating means positioned to indicate that the male and female connectors have been properly assembled for use when said outer sheath and said visual indicating means are in a predetermined relationship, said visual indicator means including a member extending outwardly and adapted to engage said outer sheath when said male and female connectors are properly mounted or assembled; said predetermined relationship comprising an overtravel or forcing position of said main tubular member relative to said central tubular portion, said central tubular portion being tapered outwardly and rearwardly to form a sealing area with said main tubular member, but presenting no tapering in correspondence with a raised area. corresponding to the overtravel position area or for - 18 Il Mandatario ,ί-Uffjoiftl· Rogante Settimo) ι