WO1992011056A1

WO1992011056A1 - Fluid transfer device and method of use

Info

Publication number: WO1992011056A1
Application number: PCT/US1991/009594
Authority: WO
Inventors: Gary J. Miller; Richard J. Melker
Original assignee: University Of Florida
Priority date: 1990-12-18
Filing date: 1991-12-18
Publication date: 1992-07-09

Abstract

A fluid transfer device (20) for safely transferring fluid from a needleless collection device (28) to a separate container (32). The device includes a housing (10) having a passage (16) therethrough and an integral needle (22). A first, connection section (18) of the housing is adapted to connect to a needleless collection device (28) from which fluid is to be transferred and a second, shield section (20) of the housing is adapted to accept the container (32) into which fluid is to be transferred. One end (24) of the needle is formed integrally with the connection section (18) of the housing. The penetration end (26) of the needle extends into the shield section (20) of the housing (10) and is fully covered by the shield section (20). When a container (32) is inserted into the shield section (20) of the housing (10) the needle enters the container and fluid may be transferred from a collection device (28) connected to the connection section (18) of the housing.

Description

FLUID TRANSFER DEVICE AND METHOD OF USE

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to safety devices for preventing needle stick injuries to individuals who collect body fluid samples from patients. More particularly, the invention relates to devices which permit the transfer of fluid from a collection device such as a syringe to a separate container without the need to mount a needle onto either the collection device or the separate container.

2. Description of Related M Accidental needle sticks with contaminated needles represent a major health problem to hospital and medical facility patients and personnel. While needle sticks have been a problem since the invention of hypodermic needles, recognition of the transfer of the AIDS virus by needle sticks has amplified concern over this problem. A number of other viral and bacterial infections (such as hepatitis B, tuberculosis, and malaria) can also be transmitted by accidental needle stick injuries.

Many situations exist in the medical facility environment where blood and other body fluids are drawn into a syringe and must then be transferred to separate containers (e.g., evacuated containers) for laboratory analysis. For example, blood is frequently drawn into a syringe during insertion of a plastic IV catheter into a vein. Also, blood and other body fluids are often drawn from already placed catheters using a syringe.

Typically, once the fluid has been collected in the syringe, a hypodermic needle is placed on the fluid filled syringe to transfer the fluid through the covering of a separate container, typically an evacuated container. Medical personnel hold an evacuated container in one hand and the fluid-filled needle-bearing syringe in the other hand. The needle of the syringe must then be directed toward the rubber cap typically covering the top of the evacuated container. No shield exists between the needle and the hand holding the container. An improper aim thus easiiy results in a needle stick. Frequently, the problem is exacerbated by the practice of filling numerous evacuated containers with one syringe since the needle becomes contaminated after the first transfer.

Unprotected needles additionally present a high risk to clean-up personnel and others who may come into contact with the contaminated needle after the used needle-bearing syringe has been set aside or discarded.

To alleviate the risks of needlestick injuries, it is desirable to transfer body fluids from collection devices such as syringes to separate containers without requiring the mounting of a needle to the collection device. The present invention provides a device which permits such a transfer.

SUMMARY OF THE INVENTION

The present invention provides a fluid transfer device which substantially eliminates the risk of needle stick injuries by contaminated needles. More specifically, the present invention provides a device which obviates the need to mount an exposed needle onto a collection device to enable the transfer of fluid from the collection device to a separate container.

The fluid transfer device of the present invention includes a housing provided with an integral, shielded needle. A first, connection section of the housing is shaped to connect to a needleless collection device. A second, shield section of the housing is shaped to accept a separate container. A first, attached end of the shielded needle of the inventive fluid transfer device is formed integrally with the connection section of the housing. A second, penetration end of the needle extends into and is shielded by the shield section of the housing.

The fluid transfer device may be used to substantially prevent the occurrence of needle sticks by contaminated needles to medical personnel transferring fluid and to others exposed to discarded needle-bearing medical devices, as follows:

Fluid to be transferred (e.g., a patient's blood) is drawn into a collection device (e.g., a syringe). The collection device is then mounted to the connection section of the housing. Next, a separate container (e.g., an evacuated container) is inserted into the shield section of the housing whereby the penetration end of the integral needle penetrates the cap covering the top of the container. Fluid from the collection device is then transferred into the container. After fluid has been transferred into the container, the container is removed. Additional containers may then be inserted until all fluid in the collection device has been transferred.

Following transfer of the fluid, the fluid transfer device (with or without the syringe) may be set aside or, preferably, discarded.

Use of the inventive fluid transfer device permits the transfer of fluid to occur without the use of an exposed needle. Instead, the only needle used remains safely shielded during and after the transfer from a collection device. The risk to medical and clean-up personnel of needle sticks by contaminated needles is thus substantially eliminated.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGURE 1 is a perspective view of the preferred embodiment of the present invention.

FIGURE 2 is another perspective view of the preferred embodiment of the present invention looking into the interior of the shield section of the housing.

FIGURE 3 is a side cross-sectional view of the preferred embodiment of the invention.

Like reference characters in the various drawings refer to like elements.

DETAILED DESCRIPTION OF THE INVENTION

The following description is of the best presently contemplated mode of carrying out the invention. This description is made for the purpose of illustrating the general principles of the invention and should not be taken in a limiting sense. The scope of the invention is best determined by reference to the appended claims.

Referring now to the drawings, FIGURES 1 and 2 show perspective views of a preferred embodiment of the inventive fluid transfer device. The device includes a housing 10 having an outer surface 12 and an inner surface 14. The inner surface 14 defines a passage 16 through the housing 10.

In a first, connection section 18 of the housing 10, the inner surface 14 is shaped into a standard female Luer-lock connector to connect to the male Luer-lock end provided on many collection devices. In a second, shield section 20 of the housing 10, the passage 16 is sufficiently large to accept a separate container, such as a Vacutainer™. For convenience, the invention will be described hereafter with reference to a syringe as the collection device and an evacuated container covered with a self-sealing cover as the separate container. However, the scope of the invention includes needleless collection devices other than syringes and separate containers other than such evacuated containers.

In the preferred embodiment, the housing 10 is further provided with a short needle 22 having an attachment end 24 formed integrally with the inner surface 14 of the connection section 18 of the housing 12. A sharp penetration end 26 of the needle 22 extends into the passage 16 of the shield section 20 of the housing 12 and is fully covered by the shield section 20.

The housing 10 of the inventive fluid transfer device is preferably made of a suitable, non-toxic plastic (e.g., polytetrafluroethylene). The needle 22 may be a standard metal hypodermic needle. However, in the preferred embodiment, the needle 22 may be formed of the same material as the housing 10. The inventive device may be manufactured in a single unit using an injection molding technique and may therefore be manufactured at a relatively low cost. (If a metal needle is utilized, it may be affixed during the molding process.)

In typical usage of the preferred embodiment of the fluid transfer device, an operator draws fluid (e.g., blood from a catheter during or after placement in a vein or artery of a patient) into a syringe 28. The syringe 28 is then connected to the connection section 18 of the housing 10 by connecting the male Luer-lock end 30 of the syringe 28 to the female Luer-lock-shaped inner surface 14 of the connection section 18 (see FIGURE 3). An evacuated container 32 is then inserted into the shield section 20 whereby the penetration end 26 of the needle 22 pierces the self-sealing cap 34 of the evacuated container 32 and fluid drains into the evacuated container 32 until the syringe 28 is empty or the container 32 is full. The evacuated container 32 is then removed from within the shield section 20. A new container may be inserted if fluid remains to be transferred from the syringe 28. After all fluid has been removed from the syringe 28, the syringe 28 and fluid transfer device may be disposed or set aside as a single unit or separated. The needle 22 remains safely shielded even after disposal.

The inventive fluid transfer device 10, as described above, provides a cost-efficient method of substantially eliminating the risk of needle stick injuries by contaminated needles to medical and clean-up personnel both during and after fluid transfer from a collection device to a separate container.

While one embodiment of the present invention has been described, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. For example, the various elements can be made of different materials and in different general shapes. Thus, the inventive device may be adapted for use with collection devices which do not include a male Luer-lock section by reshaping the inner surface 1 and/or outer surface 12 of the connection section 18 of the housing 10 to provide alternate connection opportunities. For example, the connection section 18 may be adapted to snap onto a collection device. Accordingly, it is to be understood that the invention is not to be limited by the specific illustrated embodiment, but only by the scope of the appended claims.

Claims

1. A fluid transfer device for transferring fluid from a needleless collection device to a separate container provided with a penetrable cover, comprising: a housing having an interior surface and an exterior surface, the interior surface defining a passage therethrough, the housing further having:

(a) means for connecting to the collection device from which fluid is to be transferred;

(b) means for accepting the container into which fluid is to be transferred; and

(c) means for piercing the cover of the container, the means for piercing being integrally formed with the housing and being fully shielded by the housing.

2. The fluid transfer device of claim 1 , wherein the means for connecting to the collection device comprises a first, connection section of the housing, the means for accepting a container comprises a second, shield section of the housing, and the means for piercing comprises a needle through which the passage connects the connection and shield sections.

3. The fluid transfer device of claim 2, wherein the needle has a first, attachment end and a second, sharp end, the attachment end being formed integrally with the inner surface of the housing at its connection section and the second end extending into the passage of the shield section and being fully shielded by the shield section.

4. A fluid transfer device for transferring fluid from a needleless collection device to a separate container having a penetrable cover, comprising: a housing having an interior surface and an exterior surface, the interior surface defining a passage therethrough, the housing further having:

(a) a first, connection section adapted to connect to a collection device from which fluid is to be transferred;

(b) a second, shield section adapted to accept a container into which fluid is to be transferred; and (c) a needle having a first end formed integrally with the connection section of the housing and a second, sharp end extending into the shield section of the housing and being shielded by the shield section of the housing, the passage connecting the connection and shield sections through the needle.

5. The fluid transfer device of claim 4, wherein the needle is a metal hypodermic needle.

6. The fluid transfer device of claim 4, wherein the housing is made of a non- toxic plastic.

7. The fluid transfer device of claim 6, wherein the needle is made of the same material as the housing.

8. The fluid transfer device of claim 4, wherein the connection section of the housing is adapted to connect to a syringe and the shield section is adapted to accept an evacuated container, and wherein when the evacuated container is placed in the shield section of the housing, the sharp end of the needle pierces the cover of the evacuated container.

9. The fluid transfer device of claim 8, wherein the interior surface of the housing at the connection section is shaped into a female Luer-lock to connect to the male Luer-lock end of a syringe.

10. A method for transferring fluid from a needleless collection device to a container having a penetrable cover, comprising the steps of:

(a) providing a fluid transfer device comprising a housing having a passage therethrough, the housing having a first, connection section adapted to connect to a collection device from which fluid is to be transferred, a second, shield section adapted to hold a container into which fluid from the collection device is to be transferred, and a needle having an attachment end formed integrally with the connection section of the housing and having a second, sharp end extending into the passage of the shield section and being shielded by the shield section, the passage connecting the connection and shield sections through the needle;

(b) connecting a needleless collection device from which fluid is to be transferred to the connection section of the housing; and (c) inserting a container into which fluid is to be transferred into the shield section of the housing, whereby the sharp end of the needle pierces the cover of the container and enters the container and fluid flows from the collection device into the container.

11. A method for safely transferring fluid drawn from a catheter worn by a patient into a container for evaluation, the container being equipped with a self-sealing cover, comprising the steps of: (a) providing a syringe; (b) drawing a fluid sample into the syringe from the catheter;

(c) providing a fluid transfer device comprising a housing having a passage therethrough, the housing having a first, connection section adapted to connect to the syringe, a second, shield section adapted to hold a container into which fluid from the syringe is to be transferred, and a needle through which the passage connects the connection and shield sections, the needle having an attachment end formed integrally with the connection section of the housing and a second, sharp end extending into the passage of the shield section and being shielded by the shield section; (d) connecting the syringe to the connection section of the housing;

(e) inserting the container into which fluid is to be transferred into the shield section of the housing whereby the sharp end of the needle pierces the cover of the container and fluid from the syringe is transferred directly into the container until the syringe is empty or the container is filled;

(f) removing the container; and

(g) inserting, filling and removing additional containers until all fluid is drained from the syringe.