GB2044388A

GB2044388A - Method of Mounting an Injection Site on a Tube End

Info

Publication number: GB2044388A
Application number: GB7941104A
Authority: GB
Original assignee: Baxter Travenol Laboratories Inc
Current assignee: Baxter International Inc
Priority date: 1979-03-12
Filing date: 1979-11-28
Publication date: 1980-10-15
Also published as: GB2044388B; DE2941291A1; AU536612B2; JPS5552761A; BE882177A; SE7909307L; FR2451198A1; AU5125879A; CA1131526A

Abstract

A unitary, moulded injection site is provided having a skirt 14 extending away from a needle-receiving portion 12. The skirt is temporarily convoluted so as to surround the needle receiving portion, which is placed adjacent the end of a support tube 18. The skirt is then returned to its original unstressed configuration so as to surround the end of the tube and grip the latter, to mount the site on the tube. <IMAGE>

Description

SPECIFICATION Method of Mounting an Injection Site on a Tube End In U.S. Patent No. 4,133,441 a moulded injection site is shown on an end of a flared support tube, which may be an access tube for a flexible parenteral solution container, a blood bag, a solution or blood administration set, a blood set for a dialyzer or blood oxygenator, or the like. The injection site is moulded in unitary manner, and is formed of self-sealing, piercable resilient material, comprising a central, needle-receiving portion, and a skirt portion carried by the central portion and extending in a direction away from the central portion.

To install the injection site on a support tube, the needle-receiving portion is positioned on the tube, and then the generally cylindrical skirt portion is convoluted out of its original, unstressed configuration into a position which surrounds the outer end of the tube.

Rings, positioned circumferentially about the skirt portion, are originally moulded on the inside of the skirt portion, but in the stressed, installed position, they reside on the outside of the structure to serve as compression members to assist in holding the skirt portion in squeezing relation to the tube.

In accordance with this invention, there is provided a method of mounting a unitary, moulded injection site formed of self-sealing, piercable, resilient material, on an end of a support tube, said injection site comprising a central, needle-receiving portion and a skirt portion contiguous therewith and extending, in its original, unstressed configuration, in a first direction therefrom, said method comprising: temporarily convoluting said skirt portion in a direction opposed to said first direction out of its original, unstressed configuration into a position surrounding said central portion, to expose an inner surface of said central portion; bringing said end of the support tube adjacent to said inner surface; and bringing said skirt portion back towards its original, unstressed configuration with said skirt portion surrounding the end portion of said tube in telescoping relation, whereby said injection site is positioned on said support tube in relatively unstressed condition.

The tendency of the injection site to "pop off" the end of the support tube is significantly reduced as compared with the prior art. This is so because the injection site fits on the end of the support tube in substantially unstressed configuration, so that the forces, if any, tending to pop the injection site off the tube for example, are greatly reduced, when a needle is being withdrawn from the site after penetrating it.

Preferably, a prior step may be performed of heat sealing a needle-piercable membrane across the outer end of the support tube, while simultaneously flaring the outer end of the tube, prior to surrounding the end with the skirt portion.

The flared end of the support tube can interact with a plurality of sealing rings which may be defined on the inner surface of the skirt portion in its original, unstressed configuration, in which the rings are adapted to sealingly bear against the support tube. If withdrawing forces on the injection site tend to cause it to start to be removed, the uppermost sealing ring will engage the flared outer end of the support tube, preventing accidental removal of the injection site from the tube.

The invention also resides in a moulded injection site, formed of self-sealing, needlepiercable, resilient material, comprising a central, needle-receiving portion and a tubular skirt portion contiguous therewith and extending in a first direction therefrom in its original unstressed condition, said skirt portion surrounding and gripping the end of a support tube in telescoping relation thereto while extending in said first direction, said skirt portion defining, on its inner surface, a plurality of sealing rings which sealingly bear against said support tube.

It is also desirable for the central, needlereceiving portion to be at least one half as thick as it is wide, to provide resealing characteristics after penetration by an injection needle.

Reference is made to the accompanying drawings, wherein:~ Figure 1 is a vertical sectional view of a unitary, moulded injection site, for use in the present invention, in its original, as-moulded unstressed configuration.

Figure 2 is an elevational view, taken partly in vertical section and with portions broken away, showing how the skirt of the injection site can be convoluted about the central portion and how the end of a support tube may be brought adjacent the inner surface of the central portion.

Figure 3 is an elevational view, taken partly in vertical section and with portions broken away, showing the further step of the installation method of this invention in which the skirt portion is brought back toward its original, unstressed configuration while surrounding the end portion of the tube in telescoping relation, so that the injection site is positioned on the support tube in relatively unstressed condition.

Referring to the drawings, unitary, moulded injection site 10, which may be made of natural latex, is shown to comprise a central, needlereceiving portion 12 which preferably is at least one half as thick as it is wide to provide abundant resealing capability against needle penetration.

Tubular skirt portion 14 is contiguous with central portion 12, and extends in a first direction from the central portion 12. A plurality of sealing rings 16 are provided, and are adapted sealingly to bear against support tube 1 8 after installation of the injection site 10 on tube 18.

Support tube 18 carries a sealed, needlepiercable membrane 20 across the bore of the tube adjacent its flared end 22. Needle-piercable membrane 20 may be made, for example, of polyvinylchloride and may have a thickness of 0.003 to 0.01 inch, preferably about 0.005 inch.

The support tube 1 8 and membrane 20 may be assembled by a heat sealing step which may simultaneously produce the flare 22 of the outer end of tube 1 8, prior to applying injection site 1 0.

Figure 2 shows initial steps of the injection site application process. Skirt portion 14 is convoluted in a direction opposed to the first direction out of its original, unstressed configuration into a position surrounding central portion 12. The flared end 22 of support tube 18 may then be brought adjacent the inner surface 24 of the central portion 12.

Thereafter, as shown in Figure 3, the skirt portion 14 is unconvoluted again, to bring it back toward its original, unstressed configuration, with the skirt portion surrounding convoluted end 22 of tube 18 in telescoping relation. This brings sealing rings 16 into sealing relation against the exterior of support tube 1 8. As a result of this, the injection site 10, as shown in Figure 3, is positioned on support tube 18 in relatively unstressed condition when compared with, for example, the injection site of U.S. Patent No.

4,133,441. The result of this is to cause injection site 10 to be much less capable of accidental removal from the end of tube 18, since the forces present, if any, urging skirt 14 to roll upwardly out of telescoping relation with tube 18, are greatly reduced and possibly non-existent. In fact, the residual stresses of the mounted injection site will primarily be directed toward squeezing tube 18, and resisting roll up and pop off, since injection site 10 will be in substantially unstressed, asmoulded configuration.

When a needle pierces injection site 10, it passes through central portion 12 and membrane 20 for access to tube 18. Tube 18 may be part of any desired type of medical device, as specified above, for example, a parenteral solution bag, a parenteral solution set, etc.

Membrane 20 is provided to assure the cleanliness of the interior tube 18 prior to application of injection site 10, and also to provide a further guarantee of sterility after application of the injection site but before needle penetration has taken place.

The needle may then be withdrawn, with sealing taking place in the thick mass of central portion 12 in reliable, aseptic manner.

Claims

1. A method of mounting a unitary, moulded injection site formed of self-sealing, piercable, resilient material, on an end of a support tube, said injection site comprising a central, needle receiving portion, and a skirt portion contiguous therewith and extending, in its original, unstressed configuration, in a first direction therefrom, said method comprising: temporarily convoluting said skirt portion in a direction opposed to said first direction out of its original, unstressed configuration into a position surrounding said central portion, to expose an inner surface of said central portion; bringing said end of the support tube adjacent to said inner surface; and bringing said skirt portion back towards its original, unstressed configuration with said skirt portion surrounding the end portion of said tube in telescoping relation, whereby said injection site is positioned on said support tube in relatively unstressed condition.

2. A method according to Claim 1 in which said support tube has a flared end which is surrounded by said skirt portion, the method including the step of causing sealing rings positioned on said skirt portion to engage said tube.

3. A method according to Claim 1 or 2 including the step of heat-sealing a needlepiercable membrane across the outer end of said support tube and simultaneously flaring said outer end of the tube, prior to surrounding said end with said skirt portion.

4. A method according to Claim 1, substantially as herein described with reference to the accompanying drawings.

5. A moulded injection site, formed of selfsealing, needle-piercable, resilient material, comprising a central, needle-receiving portion and a tubular skirt portion contiguous therewith and extending in a first direction therefrom in its original, unstressed condition, said skirt portion surrounding and gripping the end of a support tube in telescoping relation thereto while extending in said first direction, said skirt portion defining, on its inner surface, a plurality of sealing rings which sealingly bear against said support tube.

6. An injection site according to Claim 5 in which said support tube defines a flared end which is surrounded by said skirt.

7. An injection site according to Claim 5 or 6 in which said central, needle-receiving portion is at least one half as thick as it is wide.

8. An injection site according to Claim 5, 6 or 7 in which said self-sealing, needle-piercable, resilient material is natural rubber latex.

9. An injection site according to Claim 5, 6, 7 or 8 in which the outer end of said support tube carries a sealed, needle-piercable membrane across the bore of said tube adjacent said flared end.

10. An injection site in combination with a support tube on which the site is mounted, the combination being substantially as herein described with reference to the accompanying drawings.