Intravascular placement apparatus

Abstract: The invention provides an intravascular placement apparatus adapted for operative association with an introducer needle (2). The apparatus provides a cannula (1) provided with a connecter hub (4) at its remote end, a self-sealing septum ( 3) disposed across the internal lumen of the cannula (1) whereby the cannula can be positioned by co-operation with the introducer needle (2), and a blunt hollow adaptor (5) adapted to penetrate a channel in the septum. The invention lies in providing a self-sealing septum (3) of a resilient material which ages rapidly after forming to a point where resilience is not significantly further effected by time. Preferably the channel is formed in situ in the septum (3) when the septum has aged for a predetermined period.

Description: The present invention relates to an intravascular placement apparatus and particularly to such an apparatus adapted to prevent the leakage of body fluids and to alleviate the problem of particles dislodged from a self-sealing septum blocking or interfering with the flow of a drug during administration. The intravascular placement of a plastics cannula by means of an introducer needle is a common medical procedure in order to administer fluids of drugs into the vascular system, or to sample or monitor blood therefrom. A typical method of utilising such an apparatus is to penetrate the skin and the subcutaneous tissue and thus enter, for example, a vein with a needle carrying a plastics cannula so that both can pass into the vein or the blood vessel. When the needle is withdrawn the plastics cannula is left in the vein and a hub disposed on the cannula at its remote end may then be coupled to an administration set or other suitable apparatus. However, during withdrawal of the needle from cannula blood escapes until the cannula is connected to said administration set or other apparatus. Blood spillage during needle withdrawal can often be controlled by digital pressure on the skin adjacent the puncture to compress the vein ahead of the cannula tip. Peripheral veins have internal valves therein to prevent backflow of blood, and therefore pressure on the vein ahead of the cannula in the direction of flow of venus blood tends to control blood spillage from the cannula. This technique is effective but occupies both hands of the operator, is not possible with all veins, and requires a high level of competence. This problem has been addressed in our WO88/00842 which provides an intravascular placement apparatus adapted for operative association with an introducer needle; said apparatus comprising, a cannula provided with a connecter hub ut its remote end, and a self-sealing septum disposed across the internal lumen of the cannula whereby the cannula can be positioned with the introducer needle. The use of a self-sealing septum prevents the back flow of blood or other fluids and allows the cannula to be positioned by less skilled staff. The material from which the septum is formed is usually an elastomeric self-sealing rubber or plastics material. It has been known that a disadvantage of conventional needle tip designs, when utilised for co-operation with such an elastomeric septum is the problem of "coring". Coring occurs when the self-sealing septum material gets held in the needle lumen and either blocks the lumen or becomes discharged into the vascular system of the patient. This problem has been addressed in W089/06553 (Baxter International Inc). The Baxter disclosure provides a blunt hollow adaptor at the distal end of an extension piece of a vascular placement apparatus so that the hollow adaptor will penetrate a preformed channel in the self-sealing septum and thereby form a channel from the extension piece to the cannula. The blunt hollow adaptor may be coupled directly to an administration set or via an extension piece, so that any change over in the administration set, for example to change one fluid for another, does not entail detachment of the adaptor from the cannula. The rigid hollow adaptor is preferably formed of a metal or a rigid plastics material. An advantage of this last type of arrangement is that the substantially rigid blunt adaptor prevents needle-stick. The arrangement of Baxter includes in a first aspect a thin pre-split septum which may be penetrated by a hollow adaptor. This arrangement is prone to problems in that after use over a number of engagement and disengagement cycles, the pre-split disc shaped septum does not necessarily close entirely and this allows of the possibility of infection. In the second aspect of the Baxter disclosure there is provided a relatively large blunt hollow adaptor adapted to enter a pre-split or partially pre-split septum. The relatively large bore of the blunt adaptor necessarily causes an amount of collateral damage to the septum particularly when the resilient material of the septum has lost some of its resilience through aging. We have now found that "coring" can be prevented, or at least reduced to a negligible problem, by providing an entire resilient septum, preferably associated with an introducer needle which both penetrates the septum, passes down the cannula and acts to assist the introduction of the cannula at the injection site. Correctly used, the introducer needle will position the channel in the septum at a position, for example co-axial, where the blunt adaptor will be aligned with the axis of the cannula. The pre-forming of the channel in the septum tends to result in mis-alignment of the channel with the blunt needle. The performance of this arrangement is significantly improved if the resilient septum is of a bio-compatible plastic or rubber material with aging characteristics. As is well known some plastics materials and rubbers, for example natural rubbers, change their characteristics with age. The invention according to claim 1 therefore comprehends a resilient septum of a natural or synthetic resilient material which when initially positioned in in its fresh state in the body of the vascular placement apparatus is fully resilient, thereby forming a good seal with the body components. After a given period of time, the resilient material ages such that relative hardness thereof is increased. This allows the blunt hollow adaptor to penetrate the channel formed in septum by the introducer needle without displacing particles into the lumen of the same. The materials for the septum may be any synthetic or natural plastics or rubber materials which include an aging characteristic. The aging characteristic is the increase in hardness over a short aging period followed by a long period when the hardness does not significantly change as may be graphically characterised by a sigmate curve. An example of this material is bio compatible rubber but other synthetic plastic materials are available with these characteristics which are readily available to those skilled in the art by simple practical experimentation. Accordingly the present invention is characterised in that the self-sealing septum is formed of a resilient material which ages rapidly alter forming to a point where resilience is not significantly further effected by time, and in that a channel is formed in the septum when the septum has aged for the said pre-determined period of time. Preferably the resilient material is a biocompatible natural rubber and the pre-determined period of time is 2-5 weeks, most preferably about 3 weeks. It will be appreciated that the pre-determined period depends upon the precise constituents of the chosen material. We have found by use of this technique a that blunt hollow adaptor can be introduced into the septum without significant coring. In a preferred form the invention the channel is formed by an introducer needle as hereinbefore described, in which case the hub assembly is most preferably provided with a convergent inner-profile to guide the introducer needle point to a position at which it is coaxial with the lumen of the cannula in use. The hub may be adapted for connection with an extension piece carrying said blunt hollow adaptor; the operative end of the blunt hollow adaptor is preferably champhered to produce a low friction surface. The low friction surface may be achieved by electronic smoothing or by the provision of a low friction coating, for example "Teflon" (Registered Trade Mark). One embodiment of the invention will now be described, by way of illustration only, with reference to the accompanying drawing which shows in plan and in part cross-section, in arrangement in accordance to the present invention. With reference to the drawing a plastics cannula (1) is formed with a hub assembly (4) which in this particular instance forms part of a Luer-lock of known type. The cannula (1) has a lumen such that it may be penetrated by an introducer needle (2) to an extent that the introducer needle (2) extends from the end of the cannula (1) in use. The introducer needle (2) with the cannula (1) disposed thereabout may then be introduced into a blood vessel of a patient. The needle (2) may then be withdrawn leaving the cannula (1) in place. In accordance with the present invention a self-sealing septum (3) formed of a bio-compatible natural rubber, is provided within the hub (4) on manufacture. This septum (3) is freshly manufactured before being positioned and is entire (i.e. has no channel therein). An extension piece shown generally at (6) comprises a blunt hollow adaptor (5) which is interconnected with a Luer-taper (7). The Luer-taper (7) is provided with a Luer lock element (8) for inter-engagement with a Luer-lock arrangement on the periphery of the hub (4) in conventional fashion. The extension piece (6) is adapted to inter-connect the Luer-lock with a connector (9) remote therefrom for ready inter-connection of an administration set (10) or any other medical apparatus. In use, the introducer needle (2) is urged through the septum (3) so that is passes along the cannula (1). It will be observed that interior faces of the hub (4) are tapered at (4A) to provide a relatively small "target area" and are still matched to the Luer-taper (7). The withdrawal of the needle (2) when the cannula (1) is located within the blood vessel then leaves the channel in the septum (3) which is sealed by the aged resilient material. The blunt hollow adaptor (5) may then be introduced into the hub (4) and guided towards the central portion of the septum thereby. The blunt hollow adaptor contacts the septum (3) and an end portion thereof presses on the same and enters the channel. The end of adaptor (3) is thus guided into the channel formed by the introducer needle (2) to the extent that continued movement of the Luer-taper (7) towards the septum (3) causes the blunt hollow adaptor (5) to penetrate the septum (3) completely and thereby establish a self-sealed fluid path between the cannula (1) and adaptor (9). The Luer-lock element (8) may then be inter-engaged in the usual way with hub (4) thereby locking the two together. An advantage of the intravascular placement apparatus in accordance to the present invention is that not only do neither the cannula (1) or the adaptor (5) require a sharp point and accordingly the danger of needle stick by this apparatus is largely speaking obviated, but also the problem of coring is at least substantially prevented.

Claims: An intravascular placement apparatus adapted for operative association with an introducer needle (2), said apparatus comprising; a cannula (1) provided with a connecter hub (4) at its remote end, a self-sealing septum (3) disposed across the internal lumen of the cannula, whereby the cannula can be positioned by co-operation with the introducer needle, and a blunt hollow adaptor (5) adapted to penetrate a channel in the septum; characterised in that the self-sealing septum is formed of a resilient material and aged in a first step, and in that a channel is formed in the aged septum by an elongate element after said aging step said element being retained in the aged septum for a predetermined period for a second aging step wherein the resilient material ages further thereby to allow entry of the adaptor (5) into the channel without coring. An apparatus according to Claim 1, wherein the resilient material is a biocompatible natural rubber and the predetermined period of the second aging step is 2-5 weeks. An apparatus according to either proceeding claim, wherein the channel is formed by an introducer needle and wherein the connecter hub (4) is provided with a convergent in a profile (4A) to guide the introducer needle (2) to point at which is generally coaxial with the lumen of the cannula (1). An apparatus according to any preceding claim, wherein the hub (4) is adapted for interconnection with an extension piece (6), carrying said blunt hollow adaptor (5) and wherein the operative end of the hollow adaptor (5) is chamfered to produce a low friction surface. A kit of parts comprising an apparatus according to Claim 1 and an introducer needle (2) therefor, whereby the introducer needle is sized to extend in use from the operative end of the cannula (1) when fully passed through the septum through which it is disposed. A method of avoiding coring in an intravascular placement apparatus having (i) a needle and (ii) a cannula having a self-sealing septum formed from a resilient material disposed across the internal lumen of the cannula, said method preventing coring of said septum when a hollow adaptor is inserted therethrough, comprising the steps of: a) forming said septum and then positioning said septum within said cannula; b) aging said septum, in a first step; c) inserting said needle through said so aged septum, thereby forming a channel therein; d) further aging said septum with said needle inserted therein for a predetermined period of time in a second aging step thereby further increasing the hardness of said septum; e) withdrawing said needle after said predetermined period of time; and f) inserting said hollow adapter through said channel in said septum without coring. A method according to Claim 6, wherein said resilient material is a biocompatible natural rubber and the predetermined period is in the range of 2 to 5 weeks.

Inventors: WALLACE HENRY GEORGE, WALLACE, HENRY GEORGE
Applicants: WALLACE LTD H G, H.G. WALLACE LIMITED
Application year: 1990
Main classification: A61M39
IPC codes: A61M39