IE53247B1

IE53247B1 - Universal piercing pin for intravenous administration sets

Info

Publication number: IE53247B1
Application number: IE2011/82A
Authority: IE
Original assignee: Abbott Lab
Priority date: 1981-08-24
Filing date: 1982-08-20
Publication date: 1988-09-14
Also published as: GB2105695A; CA1190108A; IE822011L; AU8636782A; GB2105695B; IT8222931A0; IT1234914B

Abstract

A universal piercing device for vented and unvented I.V. administration sets comprises a spike 100 having ports 105, 107 for liquid and air respectively. In use, the spike is inserted sufficiently through the seal of the I.V. container to expose only port 105 for unvented systems or to expose bolt ports for vented systems. A hydrophobic filter 112 is used to prevent the passage of liquid from the vent, but allow the passage of air. In another embodiment, an air vent passage exposed to the interior of a container is blocked when the device is used in a non-vented system. In the device of Fig. 13 there are two spikes and the air vent spike is not used in a non-vented system. In a further device (Fig. 14), two passages 604, 605 open into a drip chamber 607 provided with a vent winder 609 covered by a hydrophobic filter 610.

Description

The present invention relates to systems and equipment for the administration of medical liquids to a patient, and more particularly to piercing pins usable in both vented and V unvented systems for administering such liquids.

The parenteral administration of medical liquids to patients is a long established practice. Liquids, including amino acids, blood, dextrose, electrolytes and saline are commonly administered to patients over prolonged periods of time. Generally, these liquids are administered from a glass bottle or plastic bag suspended above the patient, containing 250 to 2000 milliliters of the liquid.

Abbott Laboratories, North Chicago, Illinois manufactures a Y-type set for the sequential administration of primary and secondary medical liquids. These Venosetr* piggyback sets allow the prolonged infusion of a primary liquid to be temporarily halted by means of a back-check valve in the primary liquid flow path so as to permit administration of a secondary liquid without the need for a new venipuncture. Similar systems are disclosed in U.S. Patents 3,886,937 Bobo, et al; and 4,105,029, Virag.

One of the problems with the above systems is that in order to dispense liquids from a rigid container, air must be admitted into the container as liquid is being withdrawn.

Thus, each of these systems employs venting mechanisms to allow air entrance into the medical liquid container as the medical liquid is being withdrawn. The conventional means of venting the container is through a vented piercing pin insertable into a puncturable closure of the medical liquid container. The piercing pin may also contain an integral drip chamber so as to measure the flow of liquid by drops. Also conventionally used is an integral filtered air vent extending from the combination drip chamber and piercing pin. An example of such a piercing pin may be found in U.S. Design Patent No. D-229,518, Dispensing Pin for Medical Administration Equipment issued to Albert F. Bujan and assigned to Abbott Laboratories.

In order to avoid the necessity of venting the system, and to reduce costs, a recent innovation in intravenous solution administration has been the use of blow-molded .. ' .1 · collapsible containers which dispense medical liquids without the requirement of venting. An example of such a container may be found in U.S. Patent No. 4,049,033, Ralston, et al.

A problem has arisen, however, in the manufacture of equipment sets in general and piercing pins in particular in that different piercing pins must be used for vented and unvented systems. It has been found in fact that on some occasions, vented piercing pins have been used with unvented systems resulting in risk of air embolism to the patient.

Conversely, in some instances unvented piercing pins and equipment sets have been used with containers requiring venting, thereby rendering the system inoperative.

It is, therefore, an aim of the present invention to provide a universal piercing pin which may be used in both vented and unvented systems.

According to the invention, there is provided a piercing pin for use with both rigid vented and flexible unvented liquid containers to enable liquid to flow downwardly out of the container, comprising: a spike member that is used in an upright disposition and has a piercing tip at its upper end for piercing a penetrable sealing member at the bottom of the container; a lumen for the passage of liquid extending substantially axially through said spike member and having a distal port opening at or adjacent said piercing tip and a proximal port opening at the lower end of said spike member, remote from said piercing tip; an air passage extending upward from a lower proximal port opening to an upper distal port opening, the distal port opening of the air passage being situated at an intermediate position along the spike member below the distal port opening of the liquid passage; and a hydrophobic membrane positioned within said air passage; only the two distal port openings being pushed through -above the penetrable sealing member when the piercing pin is used with a rigid vented container, and only the distal port opening of the liquid passage being pushed through when the piercing pin is used with a flexible unvented container, and at the region of the distal port opening of the air passage the piercing pin having an enlargement of its external cross-section such that after the spike member has been pushed through a penetrable sealing member far enough to expose the distal port opening of the liquid passage above the sealing member a perceptible extra push is required to be exerted before the distal port opening of the air passage is also exposed.

In a preferred arrangement, the air passage communicates at its lower end with a plurality of ducts at 15 least one of which contains said hydrophobic membrane while at least one other contains a penetrable self-sealing plug. The piercing pin may have an enlargement at its lower end which acts as an abutment limiting penetration of the spike member through the penetrable sealing member of a container. Preferably, the plurality of ducts are formed in this enlargement.

The invention further provides an I.V. administration set including a piercing pin as aforesaid that is inserted into the penetrable sealing member of a rigid or flexible liquid container and of which the proximal port opening of the liquid passage is connected by flexible tubing bearing an adjustable flow control clamp to means for administering liquid to a patient.

Arrangements according to the invention will now be 5 described by way of example with reference to the accompanying drawings in which:Figure 1 of the drawings is a front view of a vented I.V. administration set.

Figure 2 of the drawings is a front view of an unvented 10 I.V. administration set.

Figure 3 of the drawings is a vertical section of an improved universal piercing pin.

Figure 4 of the drawings is a vertical section of an alternative embodiment of the universal piercing pin of Figure 3 in the port of an unvented container.

Figure 5 of the drawings is a vertical section of an additional alternative embodiment of the universal piercing pin of Figure 3 in the port of a vented container.

Figure 6 of the drawings is a cross-sectional 20 view taken along line 6-6 of the universal piercing pin of Figure 3.

Figure 7 of the drawings is a vertical section of a portion of the universal piercing pin of Figure 3 showing in particular an alternative tip configuration comprising a conically shaped cap member affixed to the tip of the pin. 53347 As best seen In Figure 1 of the drawings, vented I.V. administration set 10 comprises a medical liquid container 11 having a resilient resealable, penetrable sealing member 12 at first end 13. Extending through resilient penetrable sealing member 12 is a piercing pin 14, which in this case has a side vent 15 and a drip chamber 16 attached thereto. Extending from drip chamber 16 is a length of flexible tubing 17, upon which is affixed a flow control device 18, (in this case a roller clamp), for controlling the flow of medical liquid 19 from container 11. At the opposite end of flexible tubing 17 is a hypodermic needle 20, which is inserted into the arm of a patient for administration of medical liquid 19. In operation, as medical liquid 19 exits container 11, air is drawn in through vent 15 and up into container 11 displacing the liquid that has been removed.

As best seen in Figure 2 of the drawings, unvented I.V. administration system 21 comprises a collapsible medical liquid container 22 having a resilient rubber reseal 23 affixed at first end 24. Extending through resilient rubber reseal 23 is a conventional piercing pin 25 having a lumen running therethrough. Extending from piercing pin 25 is a drip chamber 26 which may be used to count the number of drops per minute and thereby determine the rate of flow of medical liquid 19 from container 22. Extending from drip chamber 26 is a length of flexible tubing 17, a roller clamp 18 and a hypodermic needle 20 at the opposite end.

In order to alleviate the requirements for 5 separate unvented or vented piercing pins as seen in Figures 1 and 2, we provide, as seen in Figure 3, a universal piercing pin 100, adapted for use in either vented I.V. administration system 10 or unvented I.V. administration system 21. Universal piercing pin 100 as seen in Figure 3, comprises a spike member 101 having a sharpened tip 102 constructed and arranged for penetration of penetrable sealing member 12 or 23 •(Figures 1 and 2). Extending longitudinally through spike member 101 is lumen 102 and disposed around spike 101 is a bushing with its distal end sharpened and which defines between itself and the spike a lumen 103. At the distal end 104 of spike member 101 the lumen 102 terminates in a port 105. At the distal end 106 of lumen 103 is port 107.

When universal piercing pin 100 is to be used in unvented system 21, spike member 101 is inserted only sufficiently far through sealing member 23 to expose port 105 to the medical liquid 19 contained within container 22. This allows the medical liquid to pass through lumen 102 and out the proximal end 108 of universal piercing pin 100 through exit port 109.

When universal piercing pin ICO is to be used with vented I.V. administration system 10, spike member 101 is inserted sufficiently through resilient sealing member 12 to expose both ports 105 and 107 to medical liquid 19. In order to expose port 107 it is necessary for the user to exert a perceptible extra push on the spike member in order to force the larger diameter bushing defining the lumen 103 through the penetrable sealing member.

The bushing defining the lumen 103 is a distal extension of a larger diameter body member that is a close fit around the spike 101 near its proximal end and which serves as an abutment that limits insertion of the spike member through the penetrable sealing member. A plurality of ducts 110 and 111 extend laterally outward within this body member, being in communication at their inner ends with lumen 103 and at their outer ends with ambient.

As best seen in Figure 6 of the drawings, lumen 103 is comprised of a plurality of interconnected channels 112, 113, 114 and 115 circumferentially spaced around spike 101.

In order to prevent medical liquid 19 from passing through lumen 103 and out of ducts 110 and 111, they must be sealed in some manner. At least one of the ducts 110 contains a hydrophobic membrane 112 which prevents the passage of medical liquid 19 out through lumen 103. At the same time, due to its hydrophobic ΊΟ properties, air may pass through hydrophobic membrane 112 into and through duct 103 and thereby into medical liquid container 22. In order to provide a method of adding additional medicaments to medical liquid container 22, a resilient rubber reseal plug 113 may be used to seal hollow duct 111. When additional medicaments are required, a hypodermic syringe may be inserted through resilient rubber reseal plug 113 and discharged into duct 111, thereby passing liquid through lumen 103 and into medical liquid container 22.

An alternative embodiment 200 may be seen in Figure 4 of the drawings. In this embodiment spike member 201 has a lumen 202 extending therethrough, and a sharpened tip 204 at the distal end. However, rather than extending circumferentially around spike 201 as does lumen 103 in Figure 3, lumen 203 is a bore extending axially, parallel with the lumen 202, within a projecting axial rib along one side of the spike 201. Hydrophobic membrane 212 is disposed at the proximal end of lumen 203 which opens into a lateral duct 210 that allows the passage of air therethrough. Again port 205 is provided at the distal end of spike 201. Port 207 at the distal end of lumen 203 is spaced proximally from port 205 sufficiently to allow use of port 205 separately from port 207 in unvented systems. Disposed at the end 24 of container 22 is resilient rubber reseal plug 23.

Plug 23 is adapted for penetration of spike 201 as far as to expose port 205 to medical liquid 19. At the same time resilient rubber reseal plug 23 is constructed so as to prevent port 207 from being exposed to medical liquid 19, thereby preventing the venting of system 21. Alternatively, as seen in Figure 5, resilient rubber reseal plug 12 in vented system 10 is adapted for penetration of spike 201 so as to expose both ports 205 and 207 to medical liquid 19, thereby venting container 11 in system 10.

As best seen in Figure 7 of the drawings, in a further embodiment of the invention rather than having its tip 104 sharpened spike 101 can be fitted with a cap member 120 which is conical in shape and is attached to the distal end 104 of spike member 101. Cap 120 is fixedly attached to spike member 101 by means of ultrasonic sealing, or adhesives. Alternatively, cap 120 may be integrally formed as a part of spike member 101.

Cap member 120 has a pointed portion 121 at the distal end thereof adapted to pierce penetrable sealing member 12. A cap port 122 extends through the cap 120 for the passage of liquid when the piercing pin 101 is inserted into and through the penetrable sealing member. A base portion of cap 120 is flared, i.e., larger in diameter than the remainder, and is of sufficient size to resist, but not entirely prevent, penetration of the cap through the penetrable sealing member. The flared base portion effectively seals the region about the cap as it is inserted through the penetrable sealing member 12. As shown in Figure 4 of the drawings, penetrable sealing member 23 may be adapted to prevent the passage of a flared portion such as that on the cap 120 through the penetrable sealing member.

As seen in Figure 7, the medical liquid container 11 may be vented through a side opening port 123 at the distal end of lumen 124 extending axially within spike 101. Spike 101 may be inserted in unvented systems sufficiently to expose only port 122, or, in vented systems to expose both port 122 and port 123.

Claims

1. CLAIMS :1. A piercing pin for use with both rigid vented and flexible unvented liquid containers to enable liquid to flow downwardly out of the container, comprising: a spike member that is used in an upright disposition and has a piercing tip at its upper end for piercing a penetrable sealing member at the bottom of a container; a linen for the passage of liquid extending substantially axially through said spike member and having a distal port opening at or adjacent said piercing tip and a proximal port opening at the lower end of said spike member remote from said piercing tip; an air passage extending upward from a lower proximal port opening to an upper distal port opening, the distal port opening of the air passage being situated at an intermediate position along the spike member below the distal port opening of the liquid passage; and a hydrophobic membrane positioned within said air passage; only the two distal port openings being pushed through above the penetrable sealing member when the piercing pin is used with a rigid vented container, and only the distal port opening of the liquid passage being pushed through when the piercing pin is used with a flexible unvented container, and at the region of the distal port opening of the air passage the piercing pin having an enlargement of its external cross-section such that after the spike member has been pushed through a penetrable sealing member far enough

2. A piercing pin as defined in Claim 1, 10 wherein said hydrophobic membrane is positioned in the proximal port of said air passage.

3. A piercing pin as defined in Claim 1, wherein an annular member surrounds the spike member along part of its length and the air passage is defined between the 15 annular member and the spike member.

4. A piercing pin as defined in Claim 1 or Claim 2, wherein the air passage is a lumen parallel to the liquid passage lumen and extending within a projecting axial rib along one side of the spike member. 20 5. A piercing pin as defined in Claim 1 or Claim 3, wherein the air passage communicates at its lower end with a plurality of ducts at least one of which contains said hydrophobic membrane while at least one other contains a penetrable self-sealing plug. 53347

5. Of a container. 5 to expose the distal port opening of the liguid passage above the sealing member a perceptible extra push is required to be exerted before the distal port opening of the air passage is also exposed.

6. A piercing pin as defined in any one of the preceding claims, having an enlargement at its lower end which acts as an abutment limiting penetration of the spike member through the penetrable sealing member

7. A piercing pin as defined in Claims 5 and 6, wherein said plurality of ducts are formed in said I enlargement.

8. An l.V. administration set including a 10 piercing pin as defined in any one of the preceding claims that is inserted into the penetrable sealing member of a rigid or flexible liquid container and of which the proximal port opening of the liquid passage is connected by flexible tubing bearing an adjustable 15 flow control clamp to means for administering liquid to a patient.

9. A piercing pin substantially as described with reference to Figures 3 and 6, or Figures 4 and 5, or Figure 7, of the accompanying drawings. F. R. KELLY & CO., AGENTS FOR THE APPLICANTS. ABBOTT LABORATORIES