Needle free blood collection device with male connector valve

ES 2 383 073 T3

DESCRIPTION

Valveless needleless blood collection device with male connector.

BACKGROUND OF THE INVENTION

The present invention relates generally to blood collection devices and, more specifically, to self-sealing needleless blood collection devices.

Collecting blood from a patient, while a necessary and routine medical procedure, is often a difficult task, particularly in the case of children, young adults, and the elderly, who may have small or "tortuous" veins. As a result, multiple needle sticks of the patient may be necessary to gain proper access to a vein, causing discomfort to both the patient and the healthcare worker. Worse still, this procedure may have to be repeated several times during the patient's hospital stay to draw blood samples for prescribed tests or ongoing patient monitoring.

To obtain blood from the patient in a vial, the conventional method is to employ a device that combines a needle holder with a blood collection vial. This device typically has a double ended pointed cannula with one pointed end that is unprotected for insertion into a vein in the patient's arm and the opposite second pointed end that is located within a flange used to receive a sealed vial of blood. As the vial of blood is pressed into the flange, the second pointed end of the cannula pierces the septum of the blood vial to initiate blood flow from the patient into the vial for collection. Although this approach may be satisfactory for single piercing applications where fluid extraction or administration is to occur at one time, the double-ended cannula and cannula support device are not well suited for multiple or long-term uses. Handling the device when vials are changed can be painful for the patient, and when one vial is disconnected so another can replace it, the patient's blood can flow out of the cannula in the meantime, causing contamination.

To address some of these concerns, as is currently known and widely practiced in the art, a set of intravenous tubes (referred to as an "IV") has been used that includes a venipuncture needle (pointed cannula), a length of plastic tube extending from the needle and a bag of solution at the opposite end of the tube. The tube may also include one or more valve holes along its length to access the IV line. During use, the venipuncture needle is inserted into a patient's vein, as with the typical blood collection device. However, once the IV line is positioned in connection with the venipuncture needle, the needle can remain in position long-term, allowing blood to be drawn and medications and other solutions to be administered intravenously multiple times without having to repeatedly prick the patient. When using the typical IV tubing set, blood is often collected into the solution bag attached to the tube or into a vacuum blood collection bottle through a valve hole located along the tube. Blood collection vials are typically manufactured with a partial vacuum within the vial and are sealed with a pierceable membrane that functions to maintain the partial vacuum within the vial while still allowing access to the vial to collect blood. When the sealing membrane is pierced, the vial draws the patient's blood into the vial due to its partial vacuum. Due to the partial vacuum created in blood collection bottles, they are often referred to as "vacuum".

Prior art valve ports often carry conventional female connectors so that extension sets or gas sampling lines, syringes, or other such medical devices can be connected to an IV line from the patient. The conventional female connector is open or unsealed, so that during disconnection of the medical device, any residual fluids within the connector could come into contact with the patient or healthcare worker, with the risk of contamination. Due to this risk, self-sealing needleless female Luer connectors have been developed and employed in the art such that, during disconnection, the female connector seals itself and traps any residual fluids within the patient's IV line. .

When a venipuncture needle and tube are used and blood is to be drawn through a valve hole in the patient's IV line into a blood collection vial, needle cannula holders have continued to be used Conventional double ended to facilitate the transfer of blood through the valve orifice and into the vial. One of the valve ports in the IV line can be configured with a pierceable septum, so that the free end of the pointed cannula can be inserted into the valve hole through the septum, rather than directly into the patient, and the holder at the opposite end of the cannula can accept a blood collection vial as before. However, this method, while effective, is not as desirable because the use of the pointed cannula for insertion into the valve hole presents opportunities for inadvertent needle punctures and results in patient and caregiver contamination. .

Alternatively, since the IV line valve ports can now also be configured with self-sealing female Luer connectors, art-known bottle holders having a

ES 2 383 073 T3 single pointed cannula that extends into the holder for vial acceptance, while the opposite end is generally configured as a conventional open male connector (no valve) to interface with the female connector on the IV line In this way, the needle-free connection between the vial holder and the patient's IV line is achieved. However, since the male connector is open and unsealed, any residual blood in or around the connector will be exposed when the holder is disconnected from the IV female valve port after use. Furthermore, the single needle cannula, although protected by the vial holder and the required perforation of the vial septum by the cannula still presents a risk of inadvertent needle piercing or cross contamination. Related to this, the required handling of the vials, including removing a full vial and replacing an empty vial in the holder, may present additional risks that could be avoided if the vial and holder were a blood collection unit. self-sealing, integral.

Therefore, those skilled in the art have recognized a need for a needleless blood collection device that includes a self-sealing male Luer connector that can be connected to a female Luer connector for safe and effective blood collection without the associated risks. with the use of pointed cannulas and the exchange of vials on a stand. In addition, those skilled in the art have recognized a need for a self-sealing male Luer connector that can be connected to a female Luer connector that forms part of a patient's IV line. Further further, a need has been recognized for a self-sealing male Luer connector integral with a partial vacuum blood collection vial, so that a blood sample can be taken with the integral device and the device can then be disconnected from a female connector. and sent for analysis.

An example of a prior female Luer connector device is described in US 2003 / 136,932 A1.

SUMMARY OF THE INVENTION

In accordance with one aspect of the invention, a blood collection device for collecting blood from a patient through an IV line having a female connector comprises a body constituting member having distal and proximal ends, a distally projecting male connector formed in the body constituting member with an internal gauge, the external shape of the male connector configured to engage a internal shape of the female connector, the male connector having a side opening, a sealing vial attached to the proximal end of the body member, a valve element disposed within the internal bore of the male connector, the valve element having first and second ends and including a flow passage connecting the first and second ends, the valve element also including a disposed flow opening at the first end and the flow opening being in fluid communication with the flow passage, the valve element including an actuating arm extending beyond the lateral opening of the male connector, wherein mating of the male connector with the female connector causes the female connector to push the actuating arm and valve element toward the proximal end of the male connector thereby causing the flow port of the valve element to open and allow fluid flow between the female connector and the collection bottle, and during disengagement of the female and male connectors, the spring device biases the valve element toward the distal end of the male connector, so that the flow opening of the valve element closes when the female connector disengages from the connector. male, and wherein the passage for flow includes a transverse hole formed substantially in the second end of the valve element and an axial through hole in fluid communication with the first end of the valve element and the transverse hole.

For example, in one embodiment, a needleless vacuum blood collection device is provided for collecting blood from a patient in a vial through a male needleless connector having a valve. Mounted within an internal bore of the male connector is a valve member that opens or closes a passage for flow to the blood collection vial. A spring device biases the valve element distally to a closed or no-flow configuration. During connection of the male connector to a female connector having a blunt or flat front surface, the valve member automatically switches to the flow configuration, so that blood is collected from the patient in the vial. The valve element includes an actuating arm that extends outwardly from the male connector to contact the female connector device to change the valve element to flow configuration.

In another aspect of the invention, a method is provided for collecting blood from a patient through an IV line. having a female connector configured with a tubular cylinder of a predetermined cross section, including providing a needleless vacuum blood collection device comprising a male connector having a distally projecting tubular body including an internal gauge, a section external cross section configured to be sealably coupled to the internal cross section of the female connector and at least one side opening, the male connector further including a proximally projecting support arm, a sealing vial attached to the male connector, and a valve member having a first end and a second end and a passage for flow therethrough. selectively sealed installed within the internal bore and configured to move axially within it, the passageway for flow including a laterally extending transverse hole formed substantially in the second end of the valve element and an axial through hole in fluid communication with the first end of the valve element.

ES 2 383 073 T3 valve element and the transverse bore, the valve element including a flow opening at the first end in fluid communication with the flow passage and further including at least one activation arm extending through of the at least one side opening, the valve element including a proximally projecting spring member disposed at the second end and configured to engage the support arm to bias the valve element distally within the internal bore, insertion of the blood collection device into the female connector causing the female connector to engage at least one activation arm and change the valve element proximally during further insertion of the blood collection device, thereby opening the opening for flow and exposing a portion of the flow passage to allow blood to flow through into the collection bottle, and removing the blood collection device from the female connector when the desired amount of blood has been collected to disengage the activation arm and allow the spring member to displace the valve element distally, the flow opening being operative in response to the distal movement of the valve member to close, thereby preventing further flow therethrough and sealing the collected blood within the device.

These and other features and advantages of the present invention will be apparent from the following detailed description of the preferred embodiments which, taken in conjunction with the accompanying drawings, illustrate by way of example the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a simplified pictorial illustration of an IV patient administration set in relation to an exemplary embodiment of a needleless vacuum blood collection device in accordance with aspects of the present invention, wherein the intravenous blood collection device blood is connected to the IV line of the patient for the collection of a blood sample;

Figure 2 is a perspective view of an exemplary embodiment of a needleless vacuum blood collection device in accordance with aspects of the present invention disconnected from the IV line of the patient of Figure 1, such that the male connector, the valve element and the collection bottle can be seen more clearly;

Figure 3 is an enlarged, cross-sectional perspective view of the male connector and valve element shown in Figure 2 with the collection bottle removed for clarity of illustration of the spring device that biases the valve element into the socket. closed position;

Figure 4 is an enlarged cross-sectional perspective view of the tip of the male connector shown in Figure 2 with the valve member and its flow opening shown more clearly;

Figure 5 is an enlarged top perspective view of the male connector and valve element of the blood collection device shown in Figure 2 showing the threaded collar in more detail and the flange of the member constituting a body within which a jar is mounted;

Figure 5A presents a top view of the male connector of Figure 5 showing the extension of the actuating arms of the valve element away from the male tip for interaction with the female connector to thereby position the valve element in the flow configuration;

Figure 6 is an enlarged, cross-sectional perspective view of the blood collection device shown in Figure 3 showing the configuration of the valve element and the spring device when the valve element is in the due flow configuration. to mating with a female connector;

Figure 7 is an enlarged, cross-sectional perspective view of the male connector tip and valve element of Figure 6 showing greater detail of the element configuration when the valve element is in the valve element configuration. flow;

Figure 8 is an enlarged top perspective view of the blood collection device shown in Figure 5 rotated in part with the valve member activated and in the flow configuration;

Figure 9 is an enlarged, cross-sectional perspective view of the blood collection device shown in Figure 2 with the collection vial removed for simplicity and the view rotated approximately ninety degrees with the valve member in the non-stop configuration. flow;

Figure 10 is an enlarged perspective view of the stiffer valve tube of the valve element with the end plug removed, so that a detail of the rear can be seen more clearly, and also showing an embodiment of a valve device. spring located at the proximal end of the valve tube and formed as an integral part of the tube; Y

Figure 11 is a perspective view of the valve member showing the valve tube having the end plug mounted at its distal end to form the complete valve member.

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DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now in more detail to the drawings for purposes of illustration, in which like reference numerals designate corresponding or similar elements among the various views, a needleless blood collection device 20 is shown in FIG. 1 according to aspects of the present invention operatively connected to the proximal end of a female Luer connector 22 that is part of a patient IV fluid delivery set 24. The IV set The patient 24 is currently used for the collection of blood through the IV line 26 which is part of the administration set 24. As is well known to those skilled in the art, IV fluid administration sets are used to interconnect a source of fluid such as the medical fluid bag 30 with the patient 28 to whom the fluid has been prescribed. In another case, the IV bag can be used to collect blood from the patient. A clamp (s) not shown can be used on IV tube 26 as needed to isolate the bag of points downstream in the IV line.

For reference only, the term "distal" is intended to refer to the direction toward the patient 28 and "proximal" is intended to refer to the direction away from the patient, or toward the collection device 20 or dispensing device such as the solution bag 30. shown. Furthermore, "downstream" is intended to refer to the direction of the patient while "upstream" is intended to refer to the direction of the solution bag 30.

Referring now to Figure 2, an enlarged perspective view of one embodiment of the blood collection device 20 of Figure 1 is shown. The blood collection device comprises a male connector 32 having an internal valve member 34. The male connector in this case is generally configured as a conventional ANSI / AAMI / ISO male Luer connector for "tapered part to tapered part" connection to a complementary female luer connector, such as the one shown in figure 1. The male connector it is surrounded by a threaded collar 36 to engage the rocks of a female connector. The male connector mates via a body member 38 with a body flange 40 on which a blood collection vial 42 is mounted. In this case, the interior of the vial is at partial vacuum to aid in collecting blood from a patient. The flange includes recesses 44, one of which is shown, to aid in mounting a flask. A portion of a stopper 46 can also be seen to assist in mounting the vacuum flask on the body member.

Referring now to Figure 3, there is shown an enlarged, cross-sectional perspective view of the male connector 32 of Figure 2. The male connector is formed as part of the body member 38 in this embodiment and is hollow. The male connector extends distally from the body member, while a spring support 48 extends proximally. The internal bore 50 of the hollow, tubular male connector is configured for sliding reception of the valve element 34, so that a flow passage 52 formed in the valve element can be selectively opened and closed. When the valve member is open, flow may occur into the flask 42 (FIG. 2) but when closed, it re-prevents flow into the flask.

In the embodiment of Figure 3, valve member 34 is formed with two oppositely extending activation arms 54 (one of which is shown) at its distal end 58 extending radially outwardly through Side openings 56 at the distal tip of male connector 32. The activation arms extend far enough out of the male connector to engage a conventional female Luer connector 22 (FIG. 1) as is coupled to the male connector. During coupling, and during further movement of the male and female connectors together, the activation arms and the valve member move in the proximal direction to open the flow passage 52 and allow flow into the bottle. A spring device 60 biases the valve member in the distal direction to the "no flow" configuration shown in Figure 3 to prevent flow into the bottle and flow out of the bottle. The spring device engages spring support 48 which provides support for the biasing forces of the spring device in the distal direction. The spring device is configured to provide sufficient biasing force to move the valve element 34 into the 50 gauge of the male connector 32 to seal the passage for flow 52. This prevents the loss of the partial vacuum that exists within the flask before use and leakage of collected blood into the vial after use.

In the non-flow configuration shown in Figure 3, the valve member 34 is closed, so that flow through the collection device 20 is prevented.

Continuing with reference to Figure 3, as described above, the male connector 32 has an outer surface that tapers from a larger diameter in a proximal direction to a smaller diameter in a distal direction in accordance with ANSI / AAMI / ISO to mate with a conventional female luer having a tubular barrel with a complementary tapering internal surface. In addition, the body constituting member 38 has a distally projecting threaded collar 36 disposed circumferentially around the male connector for threaded receptacle of the tubular barrel of the female connector to ensure interconnection of the female and male connectors during assembly. use. The male connector and threaded collar both project from a flat perpendicular wall 62 of the body member which, in this embodiment, has a generally annular perimeter that forms the base of the male connector.

ES 2 383 073 T3

Projecting in a proximal direction from the flat wall of the body member is the spring support 48. The spring support has two clamps 64 extending proximally, one of which is shown in Figure 3. The two clamps are spaced apart and each is offset from the longitudinal axis 66 of the male connector so as not to interfere with the axial movement of the valve element 34 within the central internal bore 50. A spreader bar 68 connects the two spring bracket clamps 48 to extend below the internal gauge 50 to engage the spring device 60. The combination of the clamps and the spreader bar acts to support the spring device, so that the thrust it develops will be directed distally.

Turning now to spring device 60, in one embodiment the spring device is formed at the proximal end of valve element 34 and is configured as a pair of proximally extending spring legs 70 to be mounted on spacer bar 68. The spring legs can be configured to have a distance between them that is smaller than the transverse width of the spreader bar. As the valve member moves in the proximal direction, the spring legs are biased to flex outward as they pass over the spreader bar thereby developing and storing thrust energy. In the embodiments shown herein, even in the idle or "no-flow" configuration shown in Figure 3, the spring legs flex outward, thereby storing bias energy to hold the valve member in position. non-flow configuration shown. Since the spring legs will attempt to release this stored energy by moving back to their natural resting, unflexed positions, the spring legs will effectively serve to push or force the valve element distally within the internal gauge 50.

To further facilitate energy storage in the spring legs 70 for urging the valve member 34 in the distal direction, the spacer bar 68 may be formed with gradually tapering side surfaces 72. In the embodiment shown in Figure 3, the spacer bar would be wider in the proximal direction than in the distal direction, thereby separating the spring legs further as the valve member moves in the proximal direction. As a result, the outward deflection of the spring legs increases as the valve element moves proximally within the bore, thereby increasing the amount of potential energy stored in the spring legs to push the valve element in the direction distal. This increase in stored energy will further allow the valve element to overcome any inherent starting friction and will ensure that the valve element will return fully to the distal end of the inner gauge 50. This same effect could be achieved by gradually tapering the inner edges of the valve distally. the spring legs, rather than the outer surfaces of the spacer. Various other spring devices, and consequently various spring support configurations, may be possible for incorporation into the present blood collection device.

Referring now to FIG. 4, an enlarged partial sectional perspective view of the distal tip 58 of the male connector 32 is shown with the valve member 34 in its most distal position in its non-flow configuration. As can be seen in this enlarged view, the valve member includes an opening 74 at its distal end 76, although it is compressed closed in this non-flow configuration. It will also be appreciated that a distal tip 58 of the male connector includes a tapering internal gauge 77 in which the gauge has a larger diameter at the most proximal position relative to a smaller diameter 78 at the distal tip. At that smaller diameter location 78, the valve member is radially compressed, causing opening 74 to close. To produce this compression of the valve element and the closing of the opening, the valve element comprises a component of the elastic distal end 80. In this case, it is a plug of the elastic end 80. It can also be seen from the figure 4 that the activation arms 54, one of which is visible, are formed from the end plug and are therefore elastic.

To obtain the necessary elasticity for radial compression at the distal end and yet have the columnar strength to move longitudinally along the bore of the male connector 50, the valve member 34 may be formed from a rigid central valve tube. or semi-rigid 82 having the flexible end plug 80 disposed at its distal end 76. The end plug is configured to have an external dimension at rest substantially equivalent to the largest internal diameter 79 of the bore of the male connector to effectively seal the distal end of the valve element within the bore along its length. When the valve member moves distally within the bore, such that the end plug is within the distally tapering portion 77 of the bore, which has a diameter smaller than the natural resting outer diameter of the end plug , the end plug is then compressed radially inward. As such, the flow opening 74 formed in the end plug, which is naturally in an open configuration, closes due to distal movement of the valve member and corresponding compression of the end plug into the position that is set. gradually narrows distally from the caliber. In this manner, the distal end 58 of the internal gauge is completely sealed by the end plug when the valve member is in its distally pushed position, and no fluid flow is allowed into or out of the blood collection device when it is it is disconnected before and after use. It can also be seen that the distal surface 76 of the end plug is substantially washed with the distal end 58 of the male connector and is therefore accessible for surface contact or sterilization.

ES 2 383 073 T3

Referring further to FIG. 3, the male connector 32 is formed with the flange of the proximally projecting body member 40 extending from the annular perimeter of the flat wall or base 62. In one embodiment, the stop 46 is disposed within the flange of the body member and substantially around the proximally projecting spring support 48. The external diameter 47 of the stop is slightly larger than the internal diameter of the flange of the body member, so the stop will have a "press fit" within the flange of the body member and will remain in place. place due to this size difference. A central portion 90 of the stop, having an outer diameter smaller than the internal diameter of the flange of the body member, extends in a proximal direction to form a proximally oriented annular cavity 92 between the central portion and the flange of the member. constituting a body for receiving the open distal end of the collection bottle 42. In one embodiment, the outer diameter of the center portion is large enough to achieve a tight seal fit with the inner surface of the bottle. The outer surface of the bottle is captured by the flange of the body member through a series of assembly means, including but not limited to horizontal or vertical ribs 94, a friction-tight fit, solvent bonding, or ultrasonic welding. other.

However, in another embodiment, it may be desirable to detachably mount the male connector 32 on the bottle 42 to be able to selectively access the contents of the bottle by completely removing the connector. As such, in the embodiment shown, spaced longitudinally inward projecting ribs 94 are formed around the inner surface of the body member flange to frictionally engage the outer surface of the bottle and securely secure. such that the bottle can be disassembled into place within the flange of the body member, with the seal of the bottle being held on this internal surface by the stop.

Still referring to Figure 3, stop 46 is further formed with a central counterbore 96 with distal and proximal bore portions 98 and 100 to accommodate axial movement of valve element 34 within internal bore 50. The diameter of the part of the distal bore 98 is substantially equivalent to that of the internal bore, so that the distal bore is effectively a continuation of the internal bore. The proximal hole portion 100 is larger in diameter than the distal hole portion to create space for outward flexing of the spring legs 70 and for blood flow through the flow passage 52 as the valve is displaced in the proximal direction, as explained in more detail below.

In one embodiment, valve element 34 includes a side hole 102 located substantially at the proximal end of the valve element that interconnects with a longitudinal hole 52 disposed along axis 66 of the valve element. Together, the side hole, longitudinal hole, and opening 74 through end plug 80 form the flow passage 52. In the embodiment shown in Figure 3 and other figures, side hole 102 is actually a transverse hole that extends completely through valve tube 82. The valve tube may actually have more side holes, or only one, depending on the realization. The length of the valve tube and the location of the side hole at its proximal end are selected so that the side hole is located within the stop 46 when the valve element is in the non-flow configuration shown in Figure 3. The stop seals side hole when in non-flow setting. In this manner, any partial vacuum within the collection bottle 42 (FIG. 2) will be maintained as long as the blood collection device 20 is in a non-use state. Thus, there are two seals: the opening 74 in the distal end 76 of the valve element will be compressed closed due to the radial compression applied by the male connector 32; and the side hole at the proximal end 84 of the valve member will be sealed by the distal portion 98 of the counterbore 96 of the stopper. The above shows only exemplary embodiments. It should be appreciated that other configurations of installation may be employed so that the male connector can be sealed onto the collection bottle. For example, the exterior of the distal end of the bottle can be installed so that it can be sealed within the flange of the body member and the side hole can be configured along the valve element to be sealed by the inner surface of the gauge. 50 of the male connector when the valve element is located in the non-flow configuration, to effectively eliminate the cap while still allowing the initial partial vacuum of the bottle to be maintained.

Turning now to Figure 5, an enlarged perspective view of the distal end 58 of the male connector 32 is shown showing in more detail the threaded collar 36, the body member 38, the flange of the body member 40 and distal end 76 of valve member 34. The threaded collar is located coaxially around the tubular male connector and provides internal threads 108 that will mate with external threads on a female Luer connector to lock the male and female connectors together once engaged. In this embodiment, the threaded collar is fixed in position with respect to the member constituting a body; however, a freely rotating threaded collar can also be used. In this embodiment further, the flange of the body member 40 is formed with one or more circumferential recesses 44 around its perimeter. These recesses facilitate assembly and disassembly of the collection bottle 42 (Figure 2) within the flange of the body member, allowing access to the distal edge of the bottle and allowing the flange of the body member to flex slightly radially. outwardly to engage or press the bottle into the proximally oriented annular cavity 92 formed between the flange of the body member and the stop 46.

ES 2 383 073 T3

As also shown in FIG. 5, valve member 34 includes two radially outwardly extending activation arms 54 that extend beyond outer surface 112 of the tubular body. In the embodiment shown, the activation arms are substantially opposite each other to allow symmetrical mating with a female connector, but it should be appreciated that other numbers and arrangements of the activation arms may be employed. The side openings or notches 56 are formed in the male connector 32 to accommodate the respective activation arms and allow their axial movement together with the valve element 34 itself. As they extend beyond the circumference of the male body, the activation arms they will engage the proximally oriented edge of the female connector as the female connector contacts the male connector of the blood collection device to establish the connection. Therefore, any further movement of the female connector in the proximal direction, such as when the female connector is threaded onto the male connector, will move the valve element in the proximal direction via the activation arms.

Figure 5A presents a top view of the male connector 32, the threaded collar 36, and the body constituting member 38 showing that the activation arms 54 extend beyond the outer surface 112 of the male connector. The length of such an extension would depend on the tolerances between male and female Luer connectors and the amount of depth desired for engagement with the female Luer connector. More specifically, the valve member must move some distance before the distal opening 74 opens and before the proximal side hole 102 (Figure 3) becomes unsealed. Similarly, if the male connector 32 is to be mated with a female connector having an internal valve, that female valve cannot be opened unless the female connector mates to the male connector by a certain distance. The length that the activation arms extend beyond the outer surface of the male connector depends on these factors and is selected accordingly. In one embodiment, the activation arms extended beyond the outer surface of the male connector by one mm.

Figure 6 presents an enlarged cross-sectional perspective view of the blood collection device 20 of Figure 5 rotated ninety degrees with the valve element 34 now activated through the mating of the male connector 32 with a conventional female luer connector, which it is not shown to preserve clarity of illustration of the embodiment of the present invention. When the valve element is displaced in the proximal direction as shown, the two proximally projecting spring legs 70 that form the spring device 60 are forced to flex outward as they are pushed in the proximal direction and must straddle. additionally on the spreader bar 68. Before the bifurcation zone 120 formed between the spring legs reaches the distal surface 122 of the spacer, the activation arms 54 (part of one shown) will engage with the stop surfaces 124 (shown in Figure 5) formed at the bottom of the side openings 56 to prevent any further proximal movement of the valve element.

Continuing with reference to FIG. 6, the passageway for flow 52 through valve element 34 is shown again and terminates at through hole 56 at proximal end 84 of valve tube 82. As described above, the transverse hole is positioned along the valve tube to be located within the portion of the relatively larger proximal hole 100 in stop 46 when the valve element is in its most proximal position, as shown shown in figure 6. In this way, the transverse hole is no longer sealed within the relatively smaller distal hole portion 98 of the stopper, but is exposed to allow flow into the bottle 42 (FIG. 2).

Referring now briefly to FIG. 7, an enlarged, cross-sectional perspective view of the male connector 32 of FIG. 6 is shown showing the distal end 76 of the valve member 34 displaced proximally within the internal bore 50. In this position, the end plug 80 is now located proximal to the distally tapering portion 77 of the inner bore so as not to be already radially compressed and is now expanded outwardly to its natural resting configuration within the relatively larger main bore. with opening 74 now open for flow in the flow configuration. As such, when the blood collection device of the present invention is connected to a female Luer connector to activate the valve element, then a complete flow path is formed from the female connector through the opening for flow into the plug of the distal end of the valve member, through the through hole 67 and the through hole 68 which constitutes the passage for flow, and then into the blood collection bottle.

Due to the non-flow configuration of device 20 shown in Figure 5 and the flow configuration shown in Figure 6 caused by movement of valve element 34, the initial partial vacuum within the bottle is maintained when it is in the non-flow configuration. flow rate and is applied to the patient for blood collection in the flow setting. This partial vacuum acts to effectively draw the patient's blood into the vial for quick and convenient sample collection. In this regard, it will be further appreciated that the flexibility of the end plug serves to further seal the end plug both within the internal bore itself and within the side notches 56 so that fluid can only pass through the passage for the flow 52.

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Referring further to Figure 7 and the top perspective view of the male connector 32 shown in Figure 8, the flow opening 74 formed in the end plug 80 is shown to be substantially elliptical in shape when the plug is in its configuration. naturally uncompressed, as it would be when no forces are applied to it, such as when it is not mounted within the male connector 32. The end plug returns to this natural configuration with the flow port 74 in the open configuration when the male connector 32 is connected to a female Luer connector, as in Figure 1. It will be appreciated that the shape of the opening 74 may also be referred to as as a nose shape and that other shapes of an opening, such as folded or pleated, may be used. Other forms of aperture can be formed in the end plug to selectively close when the end plug operates in response to distal movement of the valve member.

Referring now to Figure 9, there is shown an enlarged, cross-sectional perspective view of the male connector 32 rotated ninety degrees from Figure 5 and also in the non-flow configuration. As best shown in this view, radially opposed outwardly extending activation arms 54 may be formed at the distal end of valve member 76 to create some "T" shaped cross section. As also shown and explained above, since the external surface 112 of the male connector is configured to engage the internal tapering surface of a conventional female Luer connector and the activation arms extend radially beyond the external surface of the male body, it will be appreciated that as the female connector advances proximally to connect to the male connector, the proximal edge of the female connector will engage the activation arms. Thereafter, further proximal movement of the female connector in engagement with the male connector will move the valve member in a proximal direction to allow blood flow into the vial (not shown). The lower edges of the side grooves 56, in which the activation arms travel, serve as a stop 124 to prevent excessive displacement of the valve element.

Continuing with reference to FIG. 9, spring support 48 is shown to include two clamps 64 positioned adjacent center gauge 50 so as not to interfere with axial movement of valve element 34 therein. The spreader bar 68 around which the legs of the spring device 70 are straddled to flexibly bias the valve element in the distal direction is configured to span the distance between the proximal ends 126 of the clamps.

As shown, the blood collection device 20 in these embodiments is configured to integrally include the distally projecting male connector 32, the circumferential threaded collar 36, the body constituting member 38, the spring support clamps. 64 and the flange of the member constituting an annular body 40. As such, those skilled in the art will appreciate that these devices are well suited for fabrication as an integrated single valve housing component 128 through an injection molding process. Thus, housing 128 can be formed from a wide variety of medical grade plastics such as rigid or semi-rigid thermoplastics including, but not limited to, high-density polyethylene, polypropylene, polycarbonate, ABS, acrylic, or any of the olefins. . Similarly, abutment 46 can also be formed from a horizontal injection molding technique. Since, in one embodiment, the stopper is designed to snap-fit ​​the flange of the member that constitutes a body of the male connector 40 and to selectively seal the transverse hole of the valve element 102, it is preferred that the stopper be made of a flexible, compliant material such as silicone rubber, thermoplastic vulcano, or thermoplastic elastomer. Once the abutment has been formed in a different molding operation, it can then simply be snapped into the flange of the member constituting a body of the male connector.

Referring now to Figures 10 and 11, perspective views of a complete and partial valve member 34 in accordance with the embodiment are shown to illustrate the construction and fabrication of the valve member. Shown in FIG. 10 is a relatively rigid valve tube 82 configured at its proximal end 84 with transverse hole 102 and proximally projecting spaced spring legs 70 that form spring device 60 for urging the valve member in a direction. distal within the internal bore of male connector 32. Radially outwardly extending tabs 130 are formed at the distal end 140 which form a proximal layer of the activation arms 54 to provide the arms with the structural integrity and rigidity necessary to transmit the downward forces exerted by the female luer connector at proximal movement of the valve element during connection to male connector 32. It will be appreciated that the valve member tube 82 is also well suited for an injection molding manufacturing process and, as such, can be made from any number of rigid and semi-rigid medical grade thermoplastics.

Referring briefly again to FIG. 4, to form the distally tapering portion 77 of the inner bore of male connector 50 in a molding process, it may be necessary to form an opening through spreader bar 68 to accommodate the extractor. from the core of the mold (see Figure 3 for the bar, although the opening for the core extractor is not shown). In this case, the spring legs 70 of the valve element 34 that form its proximal spring device 60 may be configured with a wider distance to further engage the spacer bar.

Turning now to FIG. 11, a complete valve member 34 is shown as it would be installed in the blood collection device 20 in accordance with the present invention. The flexible end plug 80 has been

ES 2 383 073 T3 disposed over the distal end 140 of the valve element tube 82 to seal the passageway for flow 52. As shown, the end plug is configured to cover the tabs 130 of the tube for form the distal layers 132 of the completed activation arms 54. It will be appreciated that the end plug can be formed from various flexible, compressible materials such as silicone rubber, thermoplastic vulcanite, or thermoplastic elastomer in a different molding operation and then installed on the valve element tube in a secondary operation that involves a bonding process or the like. As an alternative, the end plug may be overmolded directly onto the tube of the valve element in the same core in which the valve element itself was formed using techniques known in the art. To facilitate overmolding of the end plug over the tabs at the distal end of the tube, each tab may be formed with one or more mounting holes 134 to allow the plug material to flow on either side of the tabs and, once hardened or cured, fix the plug in place. To overmold the plug onto the post and continue to form the internal geometry of the plug, a core extractor must be made from the proximal end of the post, which requires the flow passage 52 to initially intersect the bifurcation zone 120 formed between spring legs 70 and then subsequently plugged through a fill molding process or through a different secondary operation. The flow opening 74 of the end plug 80 may be formed as part of the molding process or in a secondary punching or cutting operation.

Still referring to FIG. 11, with the valve member 34 formed in this way, the distal layers 132 of the activation arms 54, as well as the entire end plug 80, are flexible and compressible. As such, as the end plug engages the proximal edge and even a portion of the internal surface of the female Luer connector as it is engaged with the male connector 32, the activation arms will effectively seal within the side notches 56 and against the mating surfaces of the female connector to prevent unwanted leakage around the end plug and only allow fluid flow through the flow port 74 when activated.

During use, the blood collection device 20 in accordance with the present invention may be connected to a female Luer connector 22 or other such connector that forms part of the IV administration set of the patient 24 (Figure 1) to draw blood from the patient into the bottle 42 for collection and subsequent testing. In accordance with the principles of operation of the blood collection device of the exemplary embodiment, when the male connector 32 is in its rest position, as shown in Figures 35A, the valve element 34 is in the non-flow configuration. within internal gauge 50 to compress flexible end plug 80 to close flow opening 74. At the same time, with the valve element in its distal, non-flowing or closed position, the transverse hole 102 at the proximal end of the valve element is sealed within the counterbore distal hole 98 of the stopper 46 to further prevent flow through. valve member and to maintain the initial partial vacuum within the collection bottle 42. Next, when a female connector 22 is engaged with the male connector 32, proximal movement of the female connector causes the female connector to engage the actuating arms 54 which consequently moves the valve element in a proximal direction to move the blood collection device to its flow or activated position as shown in Figures 6-8. In doing this, the passageway for flow 52 through the valve element is essentially open at both ends to allow flow therethrough. At the distal end, the flow opening 74 is open as the end plug expands to its uncompressed configuration within the larger bore bore of the male connector 50 and, at the proximal end, the transverse hole 102. exiting the stopper 98 to be exposed to the partial vacuum in the bottle 42. In this flow configuration of the valve element, the partial vacuum in the vial cooperates with the patient's own blood pressure to draw blood through the male connector and into the vial of the blood collection device. When the desired amount of blood has been collected, the device can simply be disconnected from the female connector to allow the valve element to return to its distal, non-flow configuration, or closed position, thereby resealing the male connector and trapping to the blood collected within the device.

It should be appreciated that, in addition to the application shown in Figure 1, the male connector 32 can be attached to other medical devices, such as a conventional female Luer connector that does not have an internal valve.

Those skilled in the art will appreciate that the blood collection device 20 of the present invention is therefore configured to allow needle-free access to and collection of an IV administration set. 24 with the ease and simplicity of male to female Luer connection and the operability of a pre-vacuum, selectively open collection vial achieved without the risks associated with handling the additional vial and known and used shielded needle cannulas in technique. It will further be appreciated that the device can be centrifuged like conventional septum-covered vials and then the blood can be drawn from the collection vial in the same manner as it was collected, through the connection of the male connector with a typical female connector. configured on a blood testing machine or the like. Blood can also be drawn by machines equipped with conventional needle cannulas, by removing the member constituting a male connector body from the vial prior to placing the vial in the machine.

Therefore, the blood collection device of the present invention is well suited for the safe and effective collection of blood from an IV line of the patient. Although a particular form of the

In the invention, it will also be apparent to those skilled in the art that various modifications can be made without departing from the scope of the invention. For example, the circular luer opening of the devices can be altered to other shapes for a customized purpose, such as when using specialty drugs. The side hole at the proximal end of the valve tube may have a different position or have a different number of holes. In another embodiment, it may not be necessary to seal the proximal hole of the valve tube. Accordingly, the invention is not intended to be limited except by the appended claims.