WO1994005205A1

WO1994005205A1 - Apparatus for protecting workers from accidental sticks with a piercing element

Info

Publication number: WO1994005205A1
Application number: PCT/US1993/008347
Authority: WO
Inventors: George A. Lopez; David C. Arnold
Original assignee: Icu Medical, Inc.
Priority date: 1992-09-03
Filing date: 1993-09-03
Publication date: 1994-03-17
Also published as: AU4847893A

Abstract

The invention provides an apparatus that protects a healthcare worker from accidentally being stuck with a piercing element used to draw fluids from the body of a donor through tubing and into a fluid receptacle bag. The apparatus includes a first elongate clamshell component (3) having an elongate axis along which the tubing (42) can be positioned, and a second elongate clamshell component (3') that engages the first elongate clamshell component (3) such that when the second elongate clamshell component (3') is engaged with the first elongate clamshell component (3), the tubing (42) lies between the first and second elongate clamshell components generally along said elongate axis. The two clamshell components (3, 3') formed a cavity when engaged. The piercing element (38) can be positioned into the cavity and a test tube (34) placed thereover. In another embodiment, the invention provides a unitary apparatus having a slot (110) into which the tubing (34) fits. Methods of use of the apparatus are also provided.

Description

APPARATUS FOR PROTECTING WORKERS FROM ACCIDENTAL STICKS WITH A PIERCING ELEMENT

Field of the Invention This invention relates to an apparatus for protecting a piercing element so that a health worker is prevented from injuring himself on the piercing element. The invention is used in connection with a conventional fluid receptacle bag for drawing fluids, such as blood, from the body of a donor.

Background of the Invention In the collection and testing of bodily fluids, such as blood, a system comprising a fluid receptacle bag connected through a length of tubing to a piercing element, such as a needle, which is inserted into the body of a donor to draw fluids therefrom is conventionally used. After the fluid receptacle bag is filled, the piercing element is withdrawn from the donor. This exposed piercing element can be contaminated with any of a variety of blood- borne diseases, and thus can constitute a health risk to healthcare workers.

Further, it is customary to withdraw samples of the contents of the fluid receptacle bag through the use of a vacuum tube, such as a "Vacutube" brand test tube, by piercing the septum or seal of the test tube with the piercing element. This process greatly increases the risk involved to healthcare workers due to their manual manipulation of the piercing element.

U.S. Patent No. 4,943,283 ("the '283 Patent") discloses a pilot tube stabilizer that is manually placed over a piercing element, such as a needle, in order to protect workers in the healthcare industry from risks associated with manipulation of the needle. Because a healthcare worker must manually insert the piercing element into the device disclosed in the '283 Patent, it is possible that the healthcare worker can accidentally stick himself or herself in the hand used to hold the device. In addition, there is a risk associated with a healthcare worker gaining a solid grasp on the piercing element in order to insert it into this device.

Moreover, healthcare workers have been known to shatter test tubes when attempting to obtain samples of the fluid in the fluid receptacle bag. The test tube can be shattered when contacting the piercing element during withdrawal of samples from the fluid receptacle bag through retrograde flow to the test tube. Therefore, the device disclosed in the '283 Patent has many shortcomings.

Summary of the Invention

In one embodiment, the invention provides an apparatus that protects a healthcare worker from accidentally being stuck with a piercing element, such as a needle, used to draw fluids from the body of a donor through tubing and into a fluid receptacle bag. The apparatus of this embodiment is comprised of a first elongate clamshell component that has an elongate axis along which the tubing can be positioned, a second elongate clamshell component that engages the first elongate clamshell component so that when the second elongate clamshell component is engaged with the first elongate clamshell component, the tubing lies between the first and second elongate clamshell components generally along the elongate axis, and a cavity, which is preferably cylindrical, formed when the first and second elongate clamshell components are engaged into which the piercing element can be positioned and a test tube placed thereover. The first elongate clamshell component and the second elongate clamshell component can be joined by a hinge. Preferably, the piercing element is mounted on a shank, and the apparatus of this embodiment preferably has a - shank stop that prevents the piercing element from being pulled further than the point where the shank hits the shank stop. Another preferred but optional feature of this apparatus is a test tube stop that prevents a test tube from being pushed further than the point where the test tube hits the test tube stop. The test tube stop can have a hole therethrough which allows the tubing to be pulled therethrough. In a preferred form of this embodiment, the apparatus has a first engaging element on the first clamshell component and a second engaging element on the second clamshell component, the first and second engaging elements engaging so as to lock the first and second clamshell components together. Further, this embodiment of the apparatus preferably has one or a plurality of tubing grips located distally of the cavity within the apparatus. The tubing grips engage the tubing such that the tubing can only be moved distally relative to the apparatus.

In another aspect, the present invention provides a method of drawing fluid from a patient into a test tube making use of a fluid collection apparatus of a type that has a piercing element at the proximal end of tubing and has a fluid receptacle bag at the distal end thereof. The fluid collection apparatus is used to draw fluid from the body of the patient into the fluid receptacle bag. The method involves:

1. placing a first elongate clamshell component that has an elongate axis in position relative to the tubing, such that the tubing lies generally along the elongate axis;

2. engaging a second elongate clamshell component in position with respect to the first clamshell component, such that the first and second clamshell components form a unitary projector apparatus that has a cavity at the proximal end thereof; 3. sliding the protector apparatus proximally along the tubing until the piercing element lies within the cavity; and

4. placing the test tube in fluid communication with the piercing element, such that any fluid in the fluid receptacle bag can be drawn into the test tube. This method preferably utilizes a test tube that has a seal at an end thereof, and the placing step (step 4 above) involves piercing the seal with the piercing element. Preferably the first and second clamshell components utilized in this method are connected by a hinge, and the engaging step (step 2 above) involves folding the second clamshell component about the hinge. This method can utilize a piercing element which is mounted on a shank. Thus, in a preferred embodiment, the protector apparatus includes a shank stop located distally of - the cavity, and the sliding step (step 3 above) comprises sliding the protector apparatus until the shank reaches the shank stop. Preferably, the sliding step (step 3 above) of this method - results in sliding the protector apparatus until the piercing element is located entirely within the cavity. This step also preferably involves sliding the protector apparatus proximally with substantially no movement of the protector apparatus relative to the tubing in the distal direction.

In an alternative embodiment of the invention, there is provided a unitary apparatus that protects a healthcare worker from accidentally being stuck with a piercing element used to draw fluids from the body of a donor through tubing and into a fluid receptacle bag. This embodiment includes an axially elongate flange barrel that has an open end and a surrounding well with a discontinuity therein into which the tubing can fit. A base that has a perimeter at the distal end of the flange barrel is also provided. The base has the open end of the flange barrel on its first side and also has a second side. This embodiment further includes a tubing slot extending from the perimeter of the base. The tubing slot has a first end at the perimeter and a second end disposed away from the perimeter. The tubing slot is sufficiently aligned with the discontinuity in the flange barrel such that the tubing can fit through both the tubing slot and the discontinuity. Finally, this embodiment also has an axially elongate tubing guide on the second side of the base, such that the tubing guide has a concave cavity into which the tubing can fit and slide therealong. The apparatus of this alternative embodiment preferably has a tubing aperture at the second end of the tubing slot through which the tubing can slide. Further, this apparatus can be mounted on tubing that has a needle shank at an end thereof, wherein the tubing aperture has a diameter smaller in diameter than the needle shank. This apparatus preferably has a pair of tubing guide extensions on opposite sides of the tubing guide. The flange barrel can have a cylindrical barrel curve at the open end thereof. Further, the second end of the tubing slot of this alternative embodiment can be substantially in the center of the base. In a preferred form, this embodiment has an axial tubing grip extending from the second side of the base along the tubing guide. Both embodiments of the present invention can be used with a method of drawing fluid from a patient into the test tube making use of a fluid collection apparatus of the type that has a piercing element on a shank at the proximal end of tubing and that has a fluid receptacle bag at the distal end thereof. In this method, the fluid collection apparatus is used to draw fluids from the body of the patient into the fluid receptacle bag. Thus, this aspect of the present invention provides a method with the following steps:

1. placing a protector apparatus that has an axially elongate flange barrel with an open proximal end and a base at a distal end thereof, the base having a tubing slot therein extending away from a perimeter thereof, such that the tubing lies within the barrel, through the slot and generally along the elongate axis; 2. sliding the protector apparatus proximally along the tubing until the piercing element lies within the barrel; and

3. placing the test tube in fluid communication with the piercing element, such that any fluid in the fluid receptacle bag can be drawn into the test tube.

The protector apparatus used in connection with the above method has a tubing guide and additionally, the placing step (step 1 above) involves placing the tubing within the tubing guide and the sliding step (step 2 above) involves sliding the tubing along the tubing guide.

The placing step (step 1 above) can further involve:

1. placing a first elongate clamshell component that has an elongate axis in position relative to the tubing, such that the tubing lies generally along the elongate axis; and

2. engaging a second elongate clamshell component in position with respect to the first clamshell component, such that said first and second clamshell components form a unitary protector apparatus that has the barrel at the proximal end thereof.

The barrel described in connection with this method preferably has a surrounding wall with a discontinuity therein so that the tubing can fit through the surrounding wall, and the placing step (step 3 above) involves placing the tubing through the discontinuity. Brief Description of the Drawings The foregoing and other objects and advantages of the invention will become apparent from the following detailed description and accompanying drawings, in which like reference characters designate like parts throughout these several views, and wherein: Figure 1 is a perspective view of a preferred embodiment of the needle protector of the present invention in the open or unlocked position.

Figure 2 is a cross-sectional view of a preferred embodiment of the needle protector of the present invention in the closed or locked position with a piercing element and tubing in its protected position. Figure 3 is a cross-sectional view of a preferred embodiment of the needle protector of the present invention in the closed or locked position with a piercing element and tubing in its protected position, as well as tubing positioned to withdraw fluid from a fluid - receptacle bag.

Figure 4 is a top plan view of a preferred embodiment of the needle protector of the present invention in the open or unlocked position.

Figure 5 is a side elevational view of a preferred embodiment of the needle protector of the present invention in the open or unlocked position taken along line 5-5 in Figure 4.

Figure 6 is a side elevational view of a preferred embodiment of the needle protector of the present invention in the open or unlocked position taken along line 6-6 in

Figure 4.

Figure 7 is a schematic view of a conventional single needle fluid drawing unit being used to withdraw blood from a donor with a preferred embodiment of the present invention correctly positioned for closure around the tube. Figure 8 is a perspective view of a preferred embodiment of the present invention in the closed or locked position.

Figure 9 is a schematic view of a preferred embodiment of the needle protector of the present invention being manually slid proximally on the tubing in order to protect the piercing element or needle of the conventional fluid receptacle bag and single needle system. Figure 10 is a perspective view of an alternative embodiment of the needle protector of the present invention.

Figure 11 is a side elevational view ol the embodiment of the needle protector illustrated in Figure 10.

Figure 12 is a perspective view of the embodiment of the needle protector shown in Figure 10.

Figure 13 is a front elevational view of the needle protector illustrated in Figure 12.

Figure 14 is a bottom plan view of the needle protector shown in Figure 12.

Figure 15 is a perspective view of the needle protector illustrated in Figure 10. Detailed Description of the Preferred Embodiment

Referring more specifically to the drawings, the needle protector 2 of the present invention consists of a unitary clam shell-type apparatus for attachment to tubing 42 of a conventional single needle fluid collecting system comprising a piercing element 38, needle shank 40, tubing 42 and fluid receptacle bag 43 (see Figure 7). Throughout this detailed description of the preferred embodiment, figure numbers with primes indicate a corresponding feature on each side of the clam shell-type apparatus.

Referring to Figure 1, the present invention consists of a clam shell-like needle - protector consisting of a first elongate clam shell component 3 and a second elongate clam shell component 3'. Preferably, a hinge 8 connects the first elongate clam shell component 3 and the second elongate clam shell component 3', although the needle protector 2 of the present invention can be constructed from multiple pieces, as will be apparent to one skilled in the art. As shown in its open or unlocked state, the present invention consists of a cylindrical barrel 10 and 10', with a test tube aperture 32 at the proximal end thereof and a base 33 at the distal end thereof. The length of the cylindrical barrel is preferably from about 2 cm to about 15 cm and the cylindrical tube 10 and 10' preferably has a diameter of from about 0.5 cm to about 2 cm in the closed or locked position shown in Figure 8. A test tube stop 12 and 12' is preferably disposed away from the base in order to restrict a test tube 34 inserted through the test tube aperture 32 from contacting a needle shank 40 when a piercing element or needle 38 is in its final position in the needle protector 2 (see Figure 3).

In a preferred embodiment, the test tube stop 12 and 12' contains a circular aperture

14 and 14' with a diameter large enough to enable a needle shank 40 to be drawn through the test tube stop 12 and 12' when the needle protector 2 is in its closed or locked position, but not wide enough in diameter to allow a test tube 34 to traverse the test tube stop 12 and 12'.

A needle shank stop 16 and 16' can be provided on the base 33 or disposed away from the base. The needle shank stop 16 and 16' can be provided with a circular tubing aperture 18 and 18' of a diameter large enough to allow tubing 42 to be pulled through the tubing aperture 18 and 18' such that a segment of tubing 42 enters the needle protector 2 through the proximal end thereof and leaves the needle protector 2 through the distal end thereof when the needle protector 2 is in the closed or locked position, but not large enough in diameter to allow a needle shank 40 to traverse the needle shank stop 16 and 16'.

In the preferred embodiment, the base 33 can be provided with an annular flange tubing guide 20 and 20' in which tubing 42 is enclosed when the needle protector 2 is in the closed or locked position, as shown in Figures 2, 3 and 8. Referring to Figure 2, the interior of the tubing guide 20 and 20' preferably contains multiple tubing grips 22 and 22' to contact tubing 42 when the needle protector 2 is in the closed or locked position. Preferably, when the needle protector 2 is in the closed or locked position, the tubing grips 22 and 22' advantageously allows tubing 42 to be pulled through the needle protector 2 in only one direction such that a portion of tubing 42 enters the proximal end of the needle protector 2 as it is being pulled manually through the needle protector 2 and exits -the needle- protector 2 through the distal end thereof. Preferably, the tubing 42 can be pulled through a closed or locked needle protector 2 only in this one direction. As shown in Figure 1, first engaging elements 24 and 26 are provided on the outer surface of the tubing guide 20 and 20', as well as second engaging elements 28 and 30. In the closed or locked position illustrated in Figure 8, the first locking elements 24 and 26 are inserted into the second locking elements 28 and 30, such that the needle protector 2 remains in a closed or locked position, and advantageously the needle protector 2 cannot be reopened to the position of Figure 1. Although the first locking elements 24 and 26 can consist of male locking protrusions, and the second locking elements 28 and 30 can consist of female locking catches, several other devices for locking the first elongate clam shell component 3 and the second elongate clam shell component 3^* will be apparent to one of skill in the art. Extending in a perpendicular direction to the tubing guide 20 and 20' are preferably hinge plates 9 and 9'. The hinge plates 9 and 9^' can intersect at hinge 8. Preferably, the hinge 8 and hinge plates 9 and 9' allow a healthcare worker to easily manipulate the needle protector 2 from the open or unlocked position illustrated in Figure 1 to the closed or locked position illustrated in Figure 8. Further, the first engaging elements 24 and 26, and the second engaging elements 28 and 30 remain aligned by the hinge plates 9 and 9'.

Referring now to Figure 4. a top plan view of the preferred embodiment of the needle protector 2 of the present invention is shown. Referring to Figure 5, an end elevational view taken from line 5-5 of Figure 4 is shown. This figure illustrates the base 33 and 33' of the cylindrical tube 10 and 10' with tubing guides 20 and 20^' and tubing grips -S-

22 and 22'. Figure 6 illustrates an end elevational view of the preferred embodiment taken from line 6-6 of Figure 4. This view illustrates the cylindrical barrel 10 and 10', test tube stop 12 and 12', and needle shank stop 16 and 16^'.

The clam shell mechanism of the needle protector 2 is advantageous from a manufacturing standpoint because the needle protector 2 does not have to be placed on the tubing 42 before either the fluid receptacle bag 43 or the needle shank 40 is placed on either end of the tubing 42. This saves manufacturing costs. A further advantage of the locking mechanism is that the needle protector 2 cannot be removed from a protected piercing element 38, thus eliminating the risk of accidental injury due to accidental removal of the needle protector 2.

Method of Use of the Present Invention

The method of using needle protector 2 is illustrated schematically in Figures 7 and 9. Referring to Figure 7, an open or unlocked needle protector 2 is manually positioned adjacent tubing 42 such that the tubing grip 22 is closest to the fluid receptacle bag 43, and the test tube aperture 32 is closest to the needle shank 40. That is, the distal end of the needle protector 2 is closest to the fluid receptacle bag 43, and the proximate end of the needle protector 2 is closest to the piercing element 38. Next, the open or unlocked needle protector 2 shown in Figure 7 is folded at hinge 8 so that the first engaging elements 24 and 26 contact the second locking elements 28 and 30 (see Figure 1), thus closing or locking the needle protector 2 (see Figure 8).

As shown in Figure 9, a healthcare worker can then slide the needle protector 2 in the proximal direction toward the needle shank 40 and piercing element 38 by gripping the tubing 42 with one hand and exerting a force on the needle protector 2 so that it travels along tubing 42 in the proximal direction. In the preferred embodiment, the needle protector 2 can only slide on tubing 42 in one direction, preventing a protected piercing element 38 from becoming unprotected and creating a risk for healthcare workers. In addition, since the needle protector 2 is manually slid down tubing 42 toward the piercing element 38, the healthcare worker does not come in contact with the risks associated with grasping the piercing element 38 or attempting to insert the piercing element 38 into a device held in the other hand of the healthcare worker.

Once the needle shank 40 contacts the needle shank stop 16 and 16'. the piercing element 38 is irreversibly contained within the preferred embodiment of the needle protector 2 (see Figures 2 and 3). Therefore, at no time during or after the procedure for protecting a piercing element 38 does the healthcare worker contact the piercing element 38.

Referring more specifically to Figure 3, a test tube 34 can be inserted through the test tube aperture 32 of the needle protector 2 and advance until the test tube 34 is resting against the test tube stop 16 and 16'. During the insertion of the test tube 34, the seal or septum 36 of the test tube 34 is pierced by the piercing element 38 so that fluid can be drained retrograde from the fluid receptacle bag 43 through the tubing 42 in order to obtain sample test tubes without risk to healthcare workers.

The clam shell mechanism of the preferred embodiment of the needle protector 2 is advantageous from a manufacturing standpoint because the needle protector 2 does not have to be placed on the tubing 42 before either the fluid receptacle bag 43 or the needle shank 40 is placed on either end of the tubing 42. This saves manufacturing costs. A further advantage of the locking mechanism is that the needle protector 2_cannot be - removed from a protected piercing element 38, thus eliminating the risk of accidental injury due to accidental removal of the needle protector 2. As discussed above, a further advantage of the preferred embodiment of the present invention consists of the face that once tubing 42 is placed in an open needle protector 2, and the needle protector 2 is closed or locked around said tubing 42 (see Figure 9), the needle protector 2 can only slide in the proximal direction because tubing guides 22 and 22' only allow tubing 42 to slide through needle protector 2 in one direction. That is, a healthcare worker can slide the needle protector 2 in the proximal direction on tubing 42 closer to the needle shank 40 and piercing element 38, but can not slide the needle protector 2 in the distal direction on tubing 42 closer to the fluid receptacle bag 43.

Is it advantageous for a healthcare worker to only be able to slide the needle protector 2 in the proximal direction so that the healthcare worker can avoid any contact whatsoever with the piercing element 38. In fact, the piercing element 38 is never grasped or manipulated by the healthcare worker.

Referring to Figure 3, another advantage of the present invention is that the test tube 34 can be placed within the cylindrical barrel 10 through the test tube aperture 32 so that the test tube seal 36 can be pierced by the piercing element 38 to withdraw fluid from the fluid receptacle bag 43 through the tubing 42, needle shank 40 and piercing element 38 utilizing retrograde flow. It is important that the inner diameter of the cylindrical barrel 10 is slightly larger than the outer diameter of the test tube 34 to facilitate the test tube 34 being properly inserted in the needle protector 2. A further advantage of the present invention is that when the test tube 34 is in place in the needle protector 2, the piercing - - element 38 can not come in contact with the test tube 34. thus avoiding the risk of shattering the test tube 34 with the piercing element 38.

The test tube 34 which can be inserted into the needle protector 2 of the preferred embodiment will come to rest against the test tube stop 16, and fluid can be drained retrograde from the fluid receptacle bag 43 through the tubing 42 to fill sample test tube 34 without risk to healthcare workers.

The preferred embodiment of the present invention can also include alternative apparatus or methods for locking the present invention in the closed or locked position, as shown in Figure 8. These locking mechanisms will be readily apparent to one of skill in the art.

Although the preferred embodiment of the present invention contains a unitary needle protector 2, it is possible to construct the present invention through the use of a plurality of pieces which, when engaged, utilize the method of the present invention. Alternative Embodiment Referring to Figure 10, an alternative embodiment of a needle protector 100 is provided. In this embodiment, the needle protector 100 has a flange barrel 104, preferably generally annular in shape, with a base 102. The base 102 is preferably a circular disk, although the base 102 can be of other shapes that will protect a health care worker from being stuck with a piercing element 38 on the end of tubing 42, such as is described above. The diameter of the base 102 is preferably the same as the overall diameter of the flange barrel 104, although a different size base can be accommodated. This diameter is generally from about 0.5 cm to about 5 cm or larger, however diameters greater than about 1 cm will allow a health care worker to insert his or her finger into the barrel and be stuck with a needle or other piercing element disposed therein. In a preferred embodiment, the barrel 104 is slightly larger than the diameter of a test tube to be used to contact the needle. The thickness of the base should be such that it prevents the piercing element from being pulled therethrough.

Extending in the proximal direction from the outer circumference of base 102, flange barrel 104 can be provided. The barrel 104 preferably has a length from about 2 cm to about 15 cm in order to prevent a healthcare worker from contacting an enclosed piercing element. Preferably, cylindrical barrel 104 is provided with an axial opening to allow tubing (not shown) to be placed in the needle protector 100 which is discussed in greater detail below. Cylindrical barrel opening 105 preferably leaves a portion of the circumference of base 102 without an annular flange cylindrical barrel 104. At the proximal end of cylindrical barrel 104 a test tube aperture 106 s provided. Utilizing the method of the present invention discussed above, a test tube (not shown) can be inserted into the test tube aperture 106. Therefore, it is preferable that the inner diameter of the cylindrical barrel 104 is larger than the outer diameter of a test tube (not shown). In this alternative embodiment, a cylindrical barrel curve 108 is preferably provided. The cylindrical barrel curve 108 creates a smooth transition from the test tube aperture 106 to the cylindrical barrel opening 105. Therefore, healthcare workers contacting the proximal end of the cylindrical barrel 104 will not be injured by contacting a sharp corner. Referring to Figure 11, the base 102 is preferably provided with a tubing slot 110.

The width of the tubing slot is preferably from about 0.1 cm to about 2 cm. This distance is preferably slightly smaller than the outer diameter of the tubing (not shown). At the center of the base, a circular tubing aperture 112 is provided. The diameter of the cylindrical tubing aperture 112 is preferably approximately 0.1 cm to approximately 2 cm. This diameter is slightly smaller than the outer diameter of the tubing but can be larger than the width of the tubing slot 110.

When the needle protector 100 is placed on the tubing with the proximal end thereof closest to the piercing element, the tubing can be compressed as it is inserted into the tubing slot 110 and the tubing slightly expands when it enters its final position within the tubing aperture 112. This preferably keeps the needle protector 100 firmly in contact with the tubing. In addition, the tubing will not readily become disconnected with the needle protector 100. The tubing aperture 112 is preferably smaller in diameter than the needle shank (not shown) so that in its final position, the needle protector 100 contains the piercing element (not shown) within the cylindrical barrel 104. Thus, the piercing element can not be drawn through the tubing aperture which would create a hazard to healthcare workers.

Referring to Figure 10, a tubing grip 120 is provided in an axial direction to the base

102 in the distal direction. The inner diameter of the tubing grip 120 is slightly smaller than the outer diameter of the tubing with which the needle protector 100 is used. Therefore, the tubing grip 120 will firmly contact the tubing when the needle protector 100 is in place on a conventional fluid receptacle bag connected through a length of tubing to a piercing element. Further, the inner diameter of the tubing grip 120 is preferably identical to the diameter of the tubing aperture 1 12. This promotes smooth movement of the needle protector 100 on the tubing.

Preferably, the tubing grip has a length sufficient to allow the protector 100 to slide along the tubing 42 without slippage. Further, tubing grip 120 preferably has a tubing grip aperture 119 which allows tubing placed in tubing slot 1 10 to proceed to its final position in the tubing aperture 112 and tubing grip 120.

Extending axially in the distal direction perpendicular to base 102 tubing guide extensions 114 and 114' are preferably provided. Tubing guide extensions 114 and 114' can be used to provide support for a tubing guide 116 and tubing grip 120. A semi-cylindrical tubing guide 116 is provided medially to tubing guide extensions 114 and 114'. The tubing guide 116 can contact the outer diameter of tubing grip 120. Tubing guide 116 preferably is attached to base 102 and extends axially in the distal direction to guide the needle protector 100 proximally on the tubing of the conventional fluid receptacle bag and single piercing element system when the tubing of the system is placed in the tubing aperture 112 and tubing grip 120. The distal ends of the tubing guide 1 16 and tubing guide- extensions

114 and 114' are preferably rounded so that healthcare workers will avoid injury due to contacting a sharp edge on needle protector 100. Referring to Figure 15, a tubing guide support 118 is provided which runs axially in the distal direction from the base 102. The tubing guide support 118 provides stability to the needle protector 100 such that any risk of the needle protector 100 breaking in two pieces is eliminated.

Referring to Figure 12, a perspective view of the needle protector 100 of this embodiment is illustrated.

Referring to Figure 13, a front elevational view of the needle protector of Figure 12 is illustrated. Further, Figure 14 shows a bottom plan view of the needle protector 100 illustrated in Figure 12.

The needle protector 100 can be made from a variety of materials as will be readily apparent to one of skill in the art. Preferred materials are any of a variety plastics.

The material of this alternative embodiment can be transparent so that a healthcare worker can see the location of a piercing element at all times. The method of using the needle protector 100 is practically identical to the method disclosed above for .the preferred embodiment, although an advantage of the needle protector 100 of the alternative embodiment is that it can be reused. Tubing is inserted through the tubing slot 110, cylindrical barrel opening 105 and tubing grip opening 119 into the tubing aperture 112 and tubing grip 120. The needle protector 100 is then moved manually in the proximal direction so that the needle shank comes in contact with the base 102 and the piercing element is safety protected within the cylindrical barrel 104. A test tube can be inserted through the cylindrical barrel opening 106 so that the septum or seal ot the test tube is pierced by the piercing element and samples of the fluid in the fluid receptacle bag can be obtained through retrograde flow.

Once samples are obtained, the tubing can be moved from the needle protector 100 and the needle protector 100 can be reused.

Although the needle protector 100 of this embodiment is preferably a unitary piece, it will be readily apparent to one of skill in the art that the needle protector 100 can be constructed of multiple pieces. Thus, this alternative embodiment can also be in a form essentially identical to that of the embodiment described above with the exception of being formed of a unitary piece with a longitudinal slit therethrough to allow the protector 100 to be placed over tubing 42.

The invention has been described herein with reference to particular embodiments.

However, it is to be understood that these embodiments are merely illustrative of the application of the principles of the invention. Numerous modifications can be made therein, and other arrangements can be devised by others skilled in the art without departing from the spirit and scope of the invention.

Claims

IN THE CLAI MS:

1. An apparatus that protects a healthcare worker from accidentally being stuck with a piercing element used to draw fluids from the body of a donor through tubing and into a fluid receptacle bag, said apparatus comprising: a first elongate clamshell component having an elongate axis along which said tubing can be positioned; a second elongate clamshell component that engages said first elongate clamshell component such that when said second elongate clamshell component is engaged with said first elongate clamshell component, the tubing lies between said first and second elongate clamshell components generally along said elongate axis; a cavity formed when said first and second elongate clamshell components are engaged into which the piercing element can be positioned and a test tube placed thereover.

2. The apparatus of Claim 1, additionally comprising a hinge connecting said first and second elongate clamshell components.

3. The apparatus of Claim 1, wherein said cavity is generally cylindrical.

4. The apparatus of Claim 1, wherein said piercing element comprises a needle.

5. The apparatus of Claim 1, wherein said piercing element is mounted on a shank, and wherein said apparatus additionally comprises a shank stop that prevents said piercing element from being pulled further than the point where said shank hits said shank stop.

6. The apparatus of Claim 1, additionally comprising a test tube stop that will prevent a test tube from being pushed further than the point where said test tube hits said test tube stop, said test tube stop having a hole therethrough that allows the tubing to be pulled therethrough.

7. The apparatus of Claim 1, additionally comprising a first engaging element on the first clamshell component and a second engaging element on the second clamshell component, said first and second engaging elements engaging so as to lock the first and second clamshell components together.

8. The apparatus of Claim 1, additionally comprising tubing grips located distally of said cavity within said apparatus, said tubing grips engaging said tubing such that the tubing can only be moved distally relative to said apparatus.

9. The apparatus of Claim 8, wherein there are a plurality of tubing grips on each of said first and second clamshell components.

10. A method of drawing fluid from a patient into a test tube making use of a fluid collection apparatus of the type having a piercing element at the proximal end of tubing that has a fluid receptacle bag at the distal end thereof, said fluid collection apparatus being used to draw fluids from the body of the patient into the fluid receptacle bag, said method comprising: placing a first elongate clamshell component having an elongate axis in position relative to the tubing, such that the tubing lies generally along the elongate axis; engaging a second elongate clamshell component in position with respect to the first clamshell component, such that said first and second clamshell components form a unitary protector apparatus having a cavity at the proximal end thereof; sliding the protector apparatus proximally along the tubing until the piercing - element lies within the cavity; and placing the test tube in fluid communication within the piercing element such that any fluid in the fluid receptacle bag can be drawn into the test tube.

11. The method of Claim 10, wherein the test tube has a seal at an end thereof, and wherein the placing step comprises piercing said seal with said piercing element.

12. The method of Claim 10, wherein said first and second clamshell components are connected by a hinge, and wherein the engaging step comprises folding said second clamshell component about said hinge.

13. The method of Claim 10, wherein said piercing element is mounted on a shank, wherein said protector apparatus includes a shank stop located distally of said cavity, and wherein the sliding step comprises sliding the protector apparatus until the shank reaches the shank stop.

14. The method of Claim 10, wherein the sliding step comprises sliding the protector apparatus until the piercing element is located entirely within the cavity.

15. The method of Claim 10, wherein the sliding step comprises sliding the protector apparatus proximally with substantially no movement of the protector apparatus relative to the tubing in the distal direction.

16. A unitary apparatus that protects a healthcare worker from accidentally being stuck with a piercing element used to draw fluids from the body of a donor through tubing and into a fluid receptacle bag, said apparatus comprising: an axially elongate flange barrel having an open end and a surrounding wall

) with a discontinuity therein into which said tubing can fit; a base having a perimeter at the distal end of said flange barrel, said base having a first side and a second side, wherein said open end of said flange barrel is the first side of said base; a tubing slot extending from the perimeter of said base, said tubing slot having a first end at said perimeter and a second end disposed away from said perimeter, said tubing slot being sufficiently aligned with said discontinuity in said flange barrel such that said tubing can fit through both said tubing slot and said discontinuity; and an axially elongate tubing guide on the second side of said base, said tubing guide having a concave cavity into which said tubing can fit and slide therealong.

17. The apparatus of Claim 16, additionally comprising a tubing aperture at said second end of said tubing slot through which said tubing can slide.

18. The apparatus of Claim 17, wherein said apparatus is mounted on tubing having a needle shank at an end thereof, wherein said tubing aperture has a diameter smaller in diameter than said needle shank.

19. The apparatus of Claim 16, additionally comprising a pair of tubing guide extensions on opposite sides of side tubing guide.

20. The apparatus of Claim 16, wherein the flange barrel comprises a cylindrical barrel curve at said open end thereof.

21. The apparatus of Claim 16, wherein said second end of said tubing slot is substantially in the center of said base.

22. The apparatus of Claim 16, additionally comprising an axial tubing grip extending from said second side of said base along said tubing guide.

23. A method of drawing fluid from a patient into a test tube making use of a fluid collection apparatus of the type having a piercing element on a shank at the proximal end of tubing that has a fluid receptacle bag at the distal end thereof, said fluid collection apparatus being used to draw fluids from the body of the patient into the fluid receptacle bag, said method comprising: placing a protector apparatus having an axially elongate flange barrel with an open proximal end and a base at a distal end thereof, said base having a tubing slot therein extending away from a perimeter thereof, such that the tubing lies within said barrel, through said slot and generally along the elongate axis; sliding the protector apparatus proximally along the tubing until the piercing element lies within the barrel: and placing the test tube in fluid communication within the piercing element such that any fluid in the fluid receptacle bag can be drawn into the test tube.

24. The method of Claim 23, wherein said protector apparatus additionally comprises a tubing guide and wherein the placing step additionally comprises placing said tubing within said tubing guide and the sliding step comprises sliding the tubing along said tubing guide.

25. The method of Claim 23, wherein the placing step comprises: placing a first elongate clamshell component having an elongate axis in position relative to the tubing, such that the tubing lies generally along the elongate axis; engaging a second elongate clamshell component in position with respect to the first clamshell component, such that said first and second clamshell components form a unitary protector apparatus having said barrel at the proximal end thereof.

26. The method of Claim 23, wherein said barrel has a surrounding wall with a discontinuity therein so that said tubing can fit through said surrounding wall, and wherein the placing step comprises placing said tubing through said discontinuity.