US20200229747A1 - Systems and methods for phlebotomy through a peripheral iv catheter - Google Patents

Abstract

An apparatus for performing phlebotomy through a peripheral intravenous line. The apparatus includes an introducer and a catheter configured to advance the catheter through a peripheral intravenous line. A y-adapter with a port of larger diameter is configured to receive the catheter and place in fluid communication with the peripheral intravenous line. When advanced the catheter is configured to transport a bodily fluid (i.e. blood) to a volume outside of the body.

Description

CROSS-REFERENCE TO RELATED APPLICATION
• This application is a continuation of U.S. patent application Ser. No. 13/456,900, entitled “Systems and Methods for Phlebotomy through a Peripheral IV Catheter,” filed Apr. 26, 2012, which is a Continuation-in-part of application Ser. No. 13/234,857 entitled “Systems and Methods for Phlebotomy through a Peripheral IV Catheter,” filed on Sep. 16, 2011, which claims priority under 35 U.S.C. 119(e) to Provisional Application Ser. No. 61/479,223 entitled “Systems and Methods for Phlebotomy Through a Peripheral IV Catheter,” filed on Apr. 26, 2011, each of which is incorporated herein by reference in its entirety.
BACKGROUND
• The embodiments described herein relate generally to medical devices. More particularly, the embodiments described herein relate to systems and methods for phlebotomy through an intravenous catheter.
• The typical hospitalized patient encounters a needle every time a doctor orders a lab test. The standard procedure for blood extraction involves using a metal needle (“butterfly needle”) to “stick” patients' veins in their arms or hands. Blood drawing is a manual, labor-intensive process, with the average patient requiring hours of direct skilled labor during a typical hospital stay. This needle stick is not only painful and a major source of patient dissatisfaction, but the nurses or specialized blood drawing personnel (phlebotomists) often have difficulty finding the vein in approximately 10-15% of patients, resulting in multiple, painful “stick” attempts. This results in significantly higher material and labor costs (needles and tubing must be disposed of after every attempt) and increased patient pain and bruising.
• The current process for drawing blood is inefficient, taking on average 7-10 minutes, and more than 21 minutes for 10% of patients. These 10% of patients are referred to as Difficult Intra-Venous Access or more commonly as “tough stick” patients. If superficial veins are not readily apparent, blood can be forced into the vein by massaging the arm from wrist to elbow, tapping the site with the index and middle finger, applying a warm, damp washcloth to the site for 5 minutes, or by lowering the extremity over the bedside to allow the veins to fill. Each of these methods is time consuming and therefore costly.
• Peripheral IV catheters (PIVs) are inserted into most patients while they are hospitalized and used for infusing fluids and medications. However, they are not designed for blood extractions. The failure rates for aspiration reach 20-50% when PIVs have been left inserted for more than a day. Blood extracted from PIVs is often hemolyzed (e.g., defined as the rupture of red blood cells and the release of their contents into surrounding fluid) resulting in a discarded sample and the need to repeat the blood collection.
• There are several mechanical barriers that can contribute to the shortcomings of extracting blood from a PIV. First, most catheters are formed from a soft bio-reactive polymer, the use of this material has led to a potential narrowing or collapse of the catheter as the negative pressure is applied for aspiration or the catheter is kinked during insertion or manipulation, preventing backflow. Additionally, with longer indwelling times comes an increase in debris (e.g., fibrin/platelet clots) that build up on the tip of the catheter and within the lumen. This explains the relationship between failure rate and indwelling time. A third significant barrier is attributed to a “suction cup” effect, wherein the negative pressure created by aspiration through the catheter and the possible curved path of a vein result in the tip of the catheter adhering to the wall of the vein. As the negative pressure increases the vein can rupture resulting in “blowing the vein,” a major concern for phlebotomists during aspiration through a PIV.
• Thus, a need exists for an improved system and method for phlebotomy through a peripheral intravenous catheter.
SUMMARY
• Systems and methods for phlebotomy through a peripheral intravenous catheter are described herein. In some embodiments, an apparatus includes a cannula or catheter, an introducer, a locking mechanism, and an actuator. The cannula includes a proximal end and a distal end and defines a lumen. The introducer includes a proximal end and a distal end and defines a lumen configured to receive at least a portion of the cannula. The locking mechanism is coupled to the distal end of the introducer and is configured to couple the introducer to a peripheral intravenous line. The actuator is operatively coupled to the cannula and is configured to move the cannula between a first configuration, in which the cannula is substantially within the introducer, and a second configuration, in which the cannula is substantially outside the introducer. The cannula extends past an end of the peripheral intravenous line when in the second configuration.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIGS. 1 and 2 are schematic illustrations of an apparatus in a first configuration and a second configuration, respectively, according to an embodiment.
• FIG. 3 is a detailed schematic illustration of an apparatus in a second configuration, according to an embodiment.
• FIG. 4 is a detailed schematic illustration of an apparatus in a second configuration, according to an embodiment.
• FIGS. 5 and 6 are cross-sectional side views of an apparatus in a first configuration and a second configuration, respectively, according to an embodiment.
• FIG. 6A is an enlarged view of a portion of the apparatus ofFIG. 6, indicated by the region X.
• FIGS. 7 and 8 are cross-sectional side views of an apparatus and an adapter in a first configuration and a second configuration, respectively, according to an embodiment.
• FIG. 9 is a perspective view of an apparatus in a first configuration, according to an embodiment.
• FIG. 10 is an exploded view of the apparatus illustrated inFIG. 9.
• FIG. 11 is a cross-sectional perspective view of the apparatus illustrated inFIG. 9.
• FIG. 12 is a perspective view of the apparatus illustrated inFIG. 9, in a second configuration.
• FIG. 13 is a cross-sectional perspective view of the apparatus illustrated inFIG. 9, in the second configuration.
• FIG. 13A is an enlarged view of a portion of the apparatus ofFIG. 13, indicated by the region Y.
• FIG. 14 is a cross-sectional perspective view of the apparatus illustrated inFIG. 9, in a third configuration.
• FIGS. 15 and 16 are a side view of an apparatus in a first configuration and a second configuration, respectively, according to an embodiment.
• FIG. 17 is a perspective view of the apparatus illustrated inFIG. 15, in the second configuration.
• FIG. 18 is an exploded side view of the apparatus ofFIG. 15 and an adapter, according to an embodiment.
• FIG. 19 is a side view of the apparatus and adapter illustrated inFIG. 18, in a first configuration.
• FIG. 20 is a side view of the apparatus and the adapter illustrated inFIG. 18, in a second configuration.
• FIG. 21 is a perspective view of the apparatus illustrated inFIG. 18, in the second configuration.
• FIG. 22 is an enlarged view of a portion of the apparatus ofFIG. 18, indicated by the region Z inFIG. 21.
• FIGS. 23 and 24 are schematic illustrations of an apparatus in a first configuration and a second configuration, according to an embodiment.
• FIGS. 25 and 26 are schematic illustrations of an apparatus in a first configuration and a second configuration, according to an embodiment.
• FIGS. 27 and 28 are schematic illustrations of an apparatus in a first configuration and a second configuration, according to an embodiment.
• FIGS. 29-37 are side views of various catheter configurations included in an apparatus, according to an embodiment.
• FIGS. 38-43 are various views of two-port adapters, according to various embodiments.
• FIGS. 44 and 45 are views of single-port adapters, according to embodiments.
• FIG. 46 is a flowchart illustrating a method of phlebotomy through a peripheral intravenous line, according to an embodiment.
DETAILED DESCRIPTION
• Systems and methods for phlebotomy through a peripheral intravenous catheter are described herein. In some embodiments, an apparatus includes a cannula or catheter, an introducer, a locking mechanism, and an actuator. The catheter includes a proximal end and a distal end and defines a lumen. The introducer includes a proximal end and a distal end and defines a lumen configured to receive at least a portion of the catheter. The locking mechanism is coupled to the distal end of the introducer and is configured to couple the introducer to a peripheral intravenous line. The actuator is operatively coupled to the catheter and is configured to move the catheter between a first configuration, in which the catheter is substantially within the introducer, and a second configuration, in which the catheter is substantially outside the introducer. The catheter extends past an end of the peripheral intravenous line when in the second configuration.
• In some embodiments, a method includes coupling an introducer to a peripheral intravenous line (e.g., saline locked device, heparin locked device, or the like), the introducer having a proximal end and a distal end. The method further includes advancing a catheter from a first position inside the introducer and outside the peripheral intravenous line to a second position substantially outside the introducer and inside the peripheral intravenous line. In some embodiments, the catheter has a length greater than a length of the peripheral intravenous line, while in other embodiments, the catheter, in the second position, is shorter than the peripheral intravenous line. The method includes coupling a container to the proximal end of the introducer such that the container is fluidically coupled to the catheter. The method further includes withdrawing the catheter from the second position to the first position.
• In some embodiments, a catheter has a proximal end and a distal end and defines a lumen therethrough. An introducer has a proximal end and a distal end and defines a lumen therethrough. The introducer is configured to receive the catheter therein. An adapter is coupled to the introducer. The adapter has a distal end configured to be coupled to a peripheral intravenous line. The adapter defines a first lumen and a second lumen. The first lumen has a first diameter and is configured to receive the catheter therethrough. The second lumen is orthogonal to the first lumen. An actuator is operatively coupled to the catheter and is configured to move the catheter between a first configuration and a second configuration. The catheter extends past the distal end of the adapter in the second configuration.
• As used herein, the terms “catheter” and “cannula” are used interchangeably to define an element configured to define a passageway for moving a bodily fluid from a first location to a second location (e.g., a fluid passageway to move a bodily fluid out of the body). While cannulas can be configured to receive a trocar, a guide wire, or an introducer to deliver the cannula to a volume inside the body of a patient, the cannulas referred to herein need not include or receive a trocar, guide wire, or introducer.
• As used in this specification, the terms “Y-adapter” and “T-adapter” are used to refer to a dual port IV extension set. In this manner, the terms “Y-adapter” and “T-adapter” generally describe an overall shape of the dual port IV extension set. For example, as used herein, a Y-adapter is substantially “Y” shaped including a single port at a first end and two ports angularly disposed at a second end. Furthermore, the terms “Y-adapter” and “T-adapter” are included by way of example only and not limitation. For example, in some embodiments, an apparatus can include a single port IV extension set (e.g., a single port adapter) or a multi port IV extension set (e.g., an adapter with more than two ports).
• As used in this specification, the words “proximal” and “distal” refer to the direction closer to and away from, respectively, a user who would place the device into contact with a patient. Thus, for example, the end of a device first touching the body of the patient would be the distal end, while the opposite end of the device (e.g., the end of the device being manipulated by the user) would be the proximal end of the device.
• As used herein, the term “stiffness” relates to an object's resistance to deflection, deformation, and/or displacement by an applied force. Stiffness can be characterized in terms of the amount of force applied to the object and the resulting distance through which a first portion of the object deflects, deforms, and/or displaces with respect to a second portion of the object. When characterizing the stiffness of an object, the deflected distance may be measured as the deflection of a portion of the object different from the portion of the object to which the force is directly applied. Said another way, in some objects, the point of deflection is distinct from the point where force is applied.
• Stiffness is an extensive property of the object being described, and thus is dependent upon the material from which the object is formed as well as certain physical characteristics of the object (e.g., shape and boundary conditions). For example, the stiffness of an object can be increased or decreased by selectively including in the object a material having a desired modulus of elasticity, flexural modulus, and/or hardness. The modulus of elasticity is an intensive property of (i.e., is intrinsic to) the constituent material and describes an object's tendency to elastically (i.e., non-permanently) deform in response to an applied force. A material having a high modulus of elasticity will not deflect as much as a material having a low modulus of elasticity in the presence of an equally applied stress. Thus, the stiffness of the object can be increased, for example, by introducing into the object and/or constructing the object of a material having a high modulus of elasticity.
• Similarly, a material's hardness is an intensive property of the constituent material and describes the measure of how resistant the material is to various kinds of permanent shape change when a force is applied. In discussing the hardness and the subsequent effect on the stiffness of a catheter, the Shore durometer scale is generally used. There are several scales for durometers with two commonly used in describing plastics, polymers, elastomers, and/or rubbers, namely, type A and type D, where type A is generally used for softer materials and type D is generally used for harder materials. The Shore durometer of a material is denoted by a number between 0 and 100, with higher numbers indicating a harder material, followed by the type of scale. For instance, a first material can be measured as having a Shore durometer of 40 Shore A and a second material can be measured as having a Shore durometer of 60 Shore D. Therefore, according to the Shore durometer scale, the second material is harder and thus, more stiff than the first material.
• FIGS. 1 and 2 are schematic illustrations of anapparatus1000 for phlebotomy through a peripheral intravenous line or catheter in a first configuration and second configuration, respectively, according to an embodiment. Theapparatus1000 includes anintroducer1100, a cannula orcatheter1200, alock mechanism1131, and anactuator1500. Theintroducer1100 includes asheath1110 having aproximal end1120 and adistal end1130 and defining alumen1113. The catheter/cannula1200 is movably disposed withinsheath1110 between theproximal end1120 and thedistal end1130.
• Theproximal end1120 includes aport1121, such that the catheter/cannula1200 can move from the first, retracted configuration (FIG. 1) to the second, extended configuration (FIG. 2). Similarly stated, theport1121 at theproximal end1120 of theintroducer1100 is configured such that thecatheter1200 may move through theport1121 from the first configuration to the second configuration. Theport1121 can be any suitable port such as, for example, an opening in theproximal end1120 of theintroducer1100. Furthermore, theport1121 can include any suitable seal member such as an o-ring or a gasket. In some embodiments, theport1121 can be a self-sealing port and can be lubricated using any suitable lubrication to aid in the movement and/or sealing of thecatheter1200 therein.
• Thedistal end1130 of theintroducer1100 includes alocking mechanism1131 configured to fluidically couple a peripheralintravenous line1300 to theintroducer1100 and place thecatheter1200 into fluid communication with the peripheralintravenous line1300. Thelocking mechanism1131 can be any suitable locking mechanism that creates a fluid-tight seal. In some embodiments, the locking mechanism can be a Luer lock or similar configuration. In some embodiments, the peripheralintravenous line1300 is in a sealed configuration until thelocking mechanism1131 is coupled to theintravenous line1300. Once thelocking mechanism1131 is coupled to theintravenous line1300, the seal can be opened to allow access for thecatheter1200. In some embodiments, the locking mechanism can include a back flow prevention mechanism such as a one way valve or the like. In this manner, thelock mechanism1131 can be configured to allow thecatheter1200 to pass through thelock mechanism1131 but substantially prevent a fluid flow, outside thecatheter1200, through thelock mechanism1131.
• Thecatheter1200 defines a lumen1201 between aproximal end1220 and adistal end1230 and may be any suitable diameter and stiffness. In some embodiments, thecatheter1200 can be between a 16-gauge and 26-gauge and have a Shore durometer of approximately 20 Shore A to 50 Shore D. In some embodiments, thecatheter1200 has a Shore durometer of approximately 20 Shore A to 95 Shore D. In some embodiments, thecatheter1200 has a Shore durometer of approximately 70 Shore D to 85 Shore D. In this manner, thecatheter1200 can be any suitable diameter to be inserted through the peripheralintravenous line1300 and can be sufficiently stiff to be advanced through the peripheralintravenous line1300.
• Theactuator1500 is operatively coupled to thecatheter1200 through a groove orslot1111 in theintroducer1100. Theactuator1500 is configured to move thecatheter1200 from the first configuration to the second configuration such that thedistal end1230 of thecatheter1200 is substantially outside theintroducer1100, as shown inFIG. 2. In some embodiments, the length of thedistal end1230 of thecatheter1200 is greater than the length of the peripheralintravenous line1300. In this manner, thedistal end1230 of thecatheter1200 extends past the distal end of theintravenous line1300.
• In some embodiments, thecatheter1200 can be moved to a third configuration in which thecatheter1200 is retracted back into theintroducer1100. The third configuration can be substantially similar to the first configuration (FIG. 1) in that thecatheter1200 is positioned in theintroducer1100, thus, the user does not come into contact with bodily fluids. While in the first configuration and the third configuration, theapparatus1000 can be disconnected from or connected to a peripheralintravenous line1300. Said another way, theapparatus1000 can be in the first configuration before it is coupled to the peripheralintravenous line1300, then remain in the first configuration for a period of time after being coupled to the peripheralintravenous line1300. Similarly, theapparatus1000 can be moved to the third configuration, be disconnected from the peripheralintravenous line1300, and then remain in the third configuration.
• FIG. 3 is a detailed schematic illustration of anapparatus2000 according to an embodiment in a second configuration. In some embodiments, theapparatus2000 is substantially similar to theapparatus1000 described above in reference toFIGS. 1 and 2. Therefore, aspects of theapparatus2000 are not described in detail herein. Theapparatus2000 includes anintroducer2100 and acatheter2200. Thecatheter2200 includes aproximal end2220 and adistal end2230. Thedistal end2230 of thecatheter2200 includes a set ofopenings2231 such that when in the second configuration (e.g., when thedistal end2230 of thecatheter2200 is in the vein and outside the intravenous line) theopenings2231 act to transport a bodily fluid (e.g., blood) to a volume outside thecatheter2200. The set ofopenings2231 can be of any arrangement on the circumference of thecatheter2200 and can include the end of thecatheter2200. Similarly stated, thecatheter2200 having thedistal end2230 can define an opening at the tip surface. Eachopening2231 can be of any suitable shape or size and are not necessarily similar to any other opening included in the set ofopenings2231. In some embodiments, thecatheter2200 defines a single opening. For example, in some embodiments, thecatheter2200 defines asingle opening2231 at the distal surface.
• Theproximal end2220 of thecatheter2200 is fluidically coupled to alocking mechanism2221, as shown inFIG. 3. Thelocking mechanism2221 can be any suitable locking mechanism such as a Luer lock or the like. Aneedle2222 is fluidically coupled to thelocking mechanism2221 and at least partially disposed within asheath2223. Thesheath2223 can be any material with a suitable flexibility and/or compressibility such that theneedle2222 can extend through thesheath2223 when engaged with a conventional phlebotomy fluid container (e.g., a Vacutainer®). Thelocking mechanism2221 is configured to be coupled to any suitable fluid containment system such as a Vacutainer® holder (not shown inFIG. 3) and place theneedle2222 in fluid communication with the fluid containment system. Thesheath2223 is configured to compress when thelocking mechanism2221 is coupled to the fluid containment system. This arrangement facilitates the passage of bodily fluids through the set ofopenings2231 of thecatheter2200, as shown inFIG. 3 by arrow AA, through thecatheter2200, and exiting thecatheter2200 through theneedle2222, as shown inFIG. 3 by arrow BB.
• FIG. 4 is a schematic illustration of anapparatus3000 for phlebotomy through a peripheral intravenous catheter in a second configuration according to an embodiment. Theapparatus3000 includes anintroducer3100 and acatheter3200. Theintroducer3100 includes asheath3110 defining alumen3113 between aproximal end3120 and adistal end3130 and configured to house, at least partially, thecatheter3200. Thedistal end3130 of theintroducer3100 includes alocking mechanism3131 configured to fluidically couple theintroducer3100 to a peripheralintravenous line3300 and place thecatheter3200 into fluid communication with the peripheralintravenous line3300, when thecatheter3200 is in the second configuration. Thelocking mechanism3131 can be any suitable locking mechanism that creates a fluid-tight seal. In some embodiments, thelocking mechanism3131 can be a Luer lock or similar configuration. Thesheath3110, having a given stiffness, is configured such that when applying a force to the proximal end3120 (as indicated by the arrow CC inFIG. 4), thesheath3110 compresses along an axis AAA.
• The compression of thesheath3110 is such that thecatheter3200 is advanced to the second configuration. Said another way, as thesheath3110 of theintroducer3100 is compressed, thecatheter3200 moves from a first configuration where in thecatheter3200 is disposed within the introducer3100 (as described above with respect toFIG. 1) to a second configuration wherein thedistal end3230 is substantially outside theintroducer3100, as shown inFIG. 4. Furthermore, the stiffness of thesheath3110 is an extensive property and as such can have a set of properties (i.e. material, thickness, shape and/or the like) to allow thesheath3110 to compress along the axis AAA with the desired amount of force applied at theproximal end3120 of theintroducer3100. The set of properties allow thesheath3110 to elastically deform (i.e. non-permanently) such that when the force is no longer applied to theproximal end3120 of theintroducer3100, theapparatus3000 returns to the first configuration. In the second configuration, thedistal end3230 of thecatheter3200 extends past the distal end of the peripheralintravenous line3300. This arrangement allows for the transport of a bodily fluid to a volume outside thecatheter3200 and when complete, theapparatus3000 can be placed in a third configuration, substantially similar to the first configuration.
• FIGS. 5 and 6 are side views of anapparatus4000 according to an embodiment in a first configuration and a second configuration, respectively. Theapparatus4000 includes anintroducer4100 and acatheter4200. Theintroducer4100 includes asheath4110 defining alumen4113 between aproximal end4120 and adistal end4130 and is configured to house, at least partially, thecatheter4200. Although shown inFIG. 5 as being cylindrical, theintroducer4100 can be any suitable shape. Moreover, thelumen4113, defined by the interior walls of thesheath4110 is not necessarily the same shape as the exterior walls of thesheath4110. Said a different way, the interior and exterior walls of thesheath4110 can have a different cross sectional shape. Theproximal end4120 of theintroducer4100 is coupled to alocking mechanism4122. Thelocking mechanism4122 can be any suitable locking mechanism such as a Luer lock or the like. In use, thelocking mechanism4122 is configured to couple to a suitable fluid containment system such as a Vacutainer® holder (not shown inFIG. 5) to place thecatheter4200 in fluid communication with the fluid containment system.
• Thedistal end4130 of theintroducer4100 includes alocking mechanism4131 configured to fluidically couple theintroducer4100 to a peripheral intravenous line (not shown inFIG. 5). In this manner, thelocking mechanism4131 can be configured to selectively place thecatheter4200 into fluid communication with the peripheral intravenous line. Thelocking mechanism4131 can be any suitable locking mechanism that creates a fluid-tight seal. In some embodiments, thelocking mechanism4131 is in a sealed configuration until thelocking mechanism4131 is coupled to the intravenous line. Once thelocking mechanism4131 is coupled to the intravenous line, the seal can be opened to allow access for thecatheter4200. In addition, while in the unlocked configuration, thelocking mechanism4131 of thedistal end4130 and thelocking mechanism4122 of theproximal end4120 create a fluidically isolated housing for thecatheter4200 therein. Stated similarly, prior to the proximalend locking mechanism4122 and distalend locking mechanism4131 being unlocked and before thecatheter4200 is in the second configuration, thecatheter4200 is sterile. Furthermore, thecatheter4200, when in the second configuration and having contacted the desired bodily fluid, can be moved to a third configuration (e.g., substantially similar to the first configuration) thereby isolating the useddistal end4230.
• Thesheath4110 has a given stiffness such that when a force (as indicated by the arrow DD inFIG. 6) is applied to theproximal end4120, thesheath4110 compresses along an axis BBB. The compression of thesheath4110 is such that thecatheter4200 is advanced to the second configuration. Said another way, as thesheath4110 of theintroducer4100 is compressed, thecatheter4200 moves from the first configuration wherein thecatheter4200 is disposed within theintroducer4100 to the second configuration wherein thedistal end4230 is substantially outside the introducer4100 (e.g., thesheath4110 retracts). The properties of thesheath4110 can be any set of properties discussed herein such that applying a desired amount of force toproximal end4120 allows the sheath to compress along axis BBB. In the second configuration, thedistal end4230 of thecatheter4200 extends past the distal end of the peripheral intravenous line and allows for the transport of a bodily fluid to a volume outside of thecatheter4200.
• Thecatheter4200 includes adistal end4230 and taperedportion4203. The tapered portion is such that the diameter of thecatheter4200 is reduced at a given location, as shown inFIG. 5. The taper angle θ can be any suitable angle such that thecatheter4200 is allowed to advance fully to the second configuration (FIG. 6). Moreover, the taper angle θ is such that a laminar flow (i.e., smooth layered flow) is achieved. In some embodiments, thecatheter4200 can include astiffening wire4202, as shown inFIG. 6A, and can be configured to coil around the walls of thecatheter4200 providing thecatheter4200 with a desired stiffness. Moreover, thestiffening wire4202, being coiled around thecatheter4200, can provide the flexibility to advance through a set of walls defining a lumen (i.e., veins, arteries, peripheral intravenous line, and/or the like) without kinking or binding. In addition, thestiffening wire4202 can provide thecatheter4200 with enough stiffness to facilitate its advancement through the lumen.
• Thedistal end4230 of thecatheter4200 includes a set ofopenings4231 such that when in the second configuration (e.g., when thedistal end4230 of thecatheter4200 is in the vein and outside the intravenous line) theopenings4231 act to transport a bodily fluid (i.e., blood) to a volume outside thecatheter4200. The set ofopenings4231 can be of any arrangement on the circumference of thecatheter4200 and can include the end of thecatheter4200. Similarly stated, thecatheter4200 having thedistal end4230 can be substantially open at the tip surface. AlthoughFIGS. 6 and 6A show thedistal end4230 of thecatheter4200 as substantially flat, thedistal end4230 may be any suitable shape, (e.g. conical or spherical) and can have any suitable degree of rounded edges. Eachopening4231 can be of any suitable shape or size and are not necessarily similar to anyother opening4231 included in the set ofopenings4231. The arrangement of the set ofopenings4231 is configured to introduce a laminar flow throughcatheter4200 to a volume substantially outside thecatheter4200 and thus avoid hemolysis.
• In some embodiments, a blood collection system consists of two elements: (1) the introducer/catheter blood collection assembly described above; and (2) a y-adapter that is configured to attach to a standard 16 g or 22 g peripheral IV catheter. The y-adapter includes a dedicated port for the blood collection device and another standard port for conventional medicine and fluid infusion.
• For example,FIG. 7 includes a cross-sectional view of a y-adapter5400 and anapparatus5000 in a first configuration, according to an embodiment. Theapparatus5000 includes anintroducer5100 and acatheter5200. Theintroducer5100 includes asheath5110 defining alumen5113 between aproximal end5120 and adistal end5130 and configured to house, at least partially, thecatheter5200. Thecatheter5200 includes a proximal end5220 and adistal end5230. Theapparatus5000 can be substantially similar to theapparatus4000 described above with reference toFIGS. 5 and 6. Therefore, aspects of theapparatus5000 are not described in further detail herein.
• In some embodiments, the y-adapter5400 is configured to be coupled between theintroducer5100 andintravenous line5440. The y-adapter includes adistal end5410 and defines afirst port5420 and asecond port5430. Thefirst port5420 of the y-adapter5400 defines afirst lumen5422 with a first diameter D₁. Thefirst port5420 is configured such that thefirst port5420 is substantially similar in size, shape, configuration, and functionality of a conventional y-adapter. Moreover, thefirst port5420 is configured such that the backflow of a bodily fluid cannot exit thefirst port5420. More specifically, thefirst lumen5422 defined by the walls of thefirst port5420 can be such that thelumen5422 restricts the backflow of a bodily fluid (i.e. blood). In some embodiments, the backflow can be prevented using a valve, screw cap, flip cap, port, and/or the like.
• Thesecond port5430 of the y-adapter5400 defines asecond lumen5432 with a second diameter D₂. As shown inFIG. 7, the second diameter D₂can be configured to be larger than first diameter D₁. In other embodiments, the second diameter D₂can be similar or smaller than the first diameter D₁. More particularly, the diameter D₂of thesecond port5430 is large enough to accept up to, for example, an 18-gauge catheter. The y-adapter5400 can be of any suitable material and/or be of similar material to that of a conventional y-adapter.
• Thefirst lumen5422 defined by thefirst port5420 and thesecond lumen5432 defined by thesecond port5430 converge to acommon lumen5401 before thedistal end5410 of the y-adapter5400, as shown inFIG. 7. Thesecond port5430 is configured such that thesecond lumen5432 is substantially coaxial with thecommon lumen5401. Furthermore, thecommon lumen5401 can have a diameter substantially similar to the diameter D₂of thesecond port5430.
• Thesecond port5430 is fluidically coupled to alocking mechanism5431 configured to couple the y-adapter to theintroducer5100. Thelocking mechanism5431 can be a Luer lock or the like. In some embodiments, the y-adapter5400 is in a sealed configuration until coupled to thelocking mechanism5131 at thedistal end5130 of theintroducer5100. Once thelocking mechanism5431 is coupled to theintroducer5100, the seal can be opened to allow access for thecatheter5200 to advance to a second configuration, shown inFIG. 8 (note theintroducer5100 is not shown coupled to the y-adapter inFIG. 8).
• In some embodiments, thedistal end5410 of the y-adapter5400 is coupled to a peripheralintravenous line5440 such as, for example, a conventional peripheral intravenous line. In some embodiments, the y-adapter5400 is monolithically formed with the peripheralintravenous line5440. In some embodiments, thedistal end5410 of the y-adapter5400 can be coupled to a peripheral intravenous line using any suitable locking mechanism. Similarly, thesecond port5420 of thelocking mechanism5431 configured to couple the y-adapter5400 to theintroducer5100 can monolithically formed with theintroducer5100. Said another way, in some embodiments, a separate introducer is not required, but rather a portion of the y-adapter can serve as the introducer.
• When in the second configuration as shown inFIG. 8, thedistal end5230 of thecatheter5200 is advanced substantially past the peripheralintravenous line5440. Thedistal end5230 of thecatheter5200 includes a set ofopenings5231 such that when in the second configuration (i.e., when thedistal end5230 of thecatheter5200 is in the vein and outside the intravenous line) theopenings5231 act to transport a bodily fluid (i.e., blood) to a volume outside thecatheter5200. The set ofopenings5231 can be of any arrangement on the circumference of thecatheter5200 and can include the end of thecatheter5200. Similarly stated, thecatheter5200 having thedistal end5230 can be substantially open at the tip surface. Eachopening5231 can be of any suitable shape or size and are not necessarily similar to any other opening included in the set of openings. Thecatheter5200, in the second configuration and having transported the desired bodily fluid, can be placed in a third configuration (e.g., substantially similar to the first configuration shown inFIG. 7), thereby isolating the useddistal end5230.
• While the introducer5100 (FIGS. 7 and 8) is described as being configured to be substantially compressed to advance thecatheter5200, in other embodiments, an apparatus can include an actuator configured to move the catheter relative to the introducer. For example,FIGS. 9-14 illustrate anapparatus6000 used for phlebotomy through a peripheral intravenous line. Theapparatus6000 includes anintroducer6100, acannula6200, and anadapter6400. Theapparatus6000 can be any suitable shape, size, or configuration and is configured to be coupled to, for example, a peripheral intravenous line (PIV)6300.
• Theintroducer6100 includes aproximal end6120 and adistal end6130. As shown inFIGS. 9-14, theintroducer6100 is a substantially cylindrical tube configured to receive thecannula6200. Similarly stated, theintroducer6100 includes a wall or set of walls that define a lumen6113 (FIG. 11) configured to selectively receive thecannula6200. Theintroducer6100 andcannula6200 can be formed from any suitable material having any given durometer. In some embodiments, thecannula6200 can have a durometer between 20 Shore A and 50 Shore D. In other embodiments, thecannula6200 can have a Shore durometer of approximately 20 Shore A to 95 Shore D. In still other embodiments, thecannula6200 can have a Shore durometer of approximately 70 Shore D to 85 Shore D.
• Theproximal end6120 of theintroducer6100 is configured to be coupled to anend cap6140. In this manner, theend cap6140 can be configured to substantially close off and/or seal theproximal end6120 of theintroducer6100. In some embodiments, theend cap6140 is configured to form a substantially fluid-tight seal with theintroducer6100. Similarly stated, in some embodiments, theend cap6140 and theproximal end6120 of theintroducer6100 define a substantially hermetic seal. In some embodiments, theend cap6140 can be grasped by a user as thecannula6200 is advanced.
• Thedistal end6130 of theintroducer6100 is coupled to alock mechanism6131. Thelock mechanism6131 is configured to physically and fluidically couple a portion of theapparatus6000 to the existingPIV6300. In some embodiments, thelock mechanism6131 can be configured to be directly coupled to the existingPIV6300. In other embodiments, thelock mechanism6131 can be coupled to theadapter6400 and/or any other suitable intervening structure, such as, for example, a known valve or cap.
• Thedistal end6130 of theintroducer6100 can be coupled to thelock mechanism6131 in any suitable manner. For example, in some embodiments, thedistal end6130 can be disposed within a portion of thelock mechanism6131 such that an outer surface of theintroducer6100 defines a friction fit with the inner surface of the portion of thelock mechanism6131. In other embodiments, thedistal end6130 of theintroducer6100 can be coupled to thelock mechanism6131 via an adhesive. In still other embodiments, thelock mechanism6131 can be monolithically formed with thedistal end6130 of theintroducer6100. For example, in some embodiments, thelock mechanism6131 can be formed from a similar material as theintroducer6100. In other embodiments, theintroducer6100 can be formed from a first material and thelock mechanism6131 can be formed from a second material configured to be over-molded thedistal end6130 during a manufacturing process.
• As seen inFIG. 11, thelock mechanism6131, includes aseal member6132 configured to define a substantially fluid tight seal when thecannula6200 is in the first configuration. Furthermore, in use, theseal member6132 can be configured to receive a portion of thecannula6200 to allow thecannula6200 to advance, in the distal direction, beyond theseal member6132. In this manner, theseal member6132 can form a substantially fluid tight seal around thecannula6200 such that theseal member6132 substantially prevents a backflow into theintroducer6100. Theseal member6132 can be any suitable configuration such as, for example, an o-ring, a one way valve, a diaphragm, a check valve, or any other suitable seal member. While shown and described as being included in thelocking mechanism6131, in some embodiments, a seal member can be included in thelocking mechanism6131 and/or theadapter6400. For example, in some embodiments, thelocking mechanism6131 can be coupled to theadapter6400 such that the seal member included in theadapter6400 and/or thelocking mechanism6131 prevents a flow of bodily fluid in the proximal direction prior to advancing thecannula6200, as further described herein.
• As seen inFIGS. 10 and 11, theintroducer6100 further defines anactuator track6111. Theactuator track6111 can be a slit or opening defined by the wall of theintroducer6100 and is configured to receive a portion of theactuator6500. Theactuator track6111 can be configured to extend substantially along the length of theintroducer6100. In some embodiments, theactuator track6111 is configured to continuously extend through thedistal end6130 and theproximal end6120 of theintroducer6100. Theactuator track6111 can be any suitable configuration and can engage the portion of theactuator6500 in any suitable manner. For example, in some embodiments, the walls of theintroducer6100 defining theactuator track6111 can form a friction fit with the portion of theactuator6500, as described in further detail herein.
• Thecannula6200 defines a lumen6201 (FIG. 11) and is configured to be movably disposed within theintroducer6100. As described above with reference toFIG. 5, thecannula6200 can be configured to include afirst portion6205 having a first diameter and asecond portion6210 having a second diameter, smaller than the first. More specifically, thefirst portion6205 is disposed at aproximal end6220 of thecannula6200 and thesecond portion6210 is disposed at adistal end6230 of thecannula6200. In this manner, for example, the diameter of thecannula6200 is reduced at thedistal end6230 of thecatheter6200 to facilitate the insertion of thecatheter6200 into the peripheral intravenous line, as described in further detail herein.
• As described above with reference toFIG. 6A, thedistal end6230 of thecannula6200 can be configured to include any suitable number of openings (not shown inFIGS. 9-14. For example, in some embodiments, thedistal end6230 of thecannula6200 can include a substantially open end surface configured to place thelumen6201 in fluid communication with, for example, a vein. In some embodiments, the end surface can be substantially flat (e.g., perpendicular to a longitudinal axis of thecannula6200. In other embodiments, the end surface can be any suitable configuration such as, for example, substantially bullet-shaped, conical, bulbous, or the like. In still other embodiments, the end surface can be substantially angled with respect to the longitudinal axis of the cannula6200 (e.g., similar to the tip of a needle). Furthermore, in some embodiments, thedistal end6230 can be configured to include the open end surface and an opening disposed on the side of thecannula6200. In this manner, the side opening (not shown inFIGS. 9-14) can be configured to transfer a portion of a bodily fluid even if the opening disposed at the end surface is obstructed (e.g., by a clot or the like).
• Theactuator6500 is coupled to theproximal end6220 of thecannula6200 and is configured to move thecannula6200, relative to theintroducer6100, between a first configuration and a second configuration. More specifically, theactuator6500 defines a substantially annular shape defining acavity6510 configured to receive theproximal end6120 of theintroducer6100 and theproximal end6220 of thecannula6200. Similarly stated, theactuator6500 is disposed about theintroducer6100 and thecannula6200. Furthermore, theactuator6500 is configured such that aguide member6520 and acoupler6530 extend from an inner surface of theactuator6500.
• Theguide member6520 can be any suitable shape, size, or configuration. For example, as shown inFIG. 10, theguide member6520 is a relatively thin extension. In this manner, theguide member6520 is disposed within theactuator track6111 when theactuator6500 is disposed about theintroducer6100. In some embodiments, the walls of theintroducer6100 defining theactuator track6111 define a friction fit with a portion of theguide member6520. The arrangement of theguide member6520 within theactuator track6111 can be such that theactuator6500 is substantially maintained in a given location, relative to theintroducer6100, until a force is applied to theactuator6500 to move theactuator6500 towards the second configuration. Similarly stated, theactuator6500 engages theintroducer6100 such that theactuator6500 substantially does not move without a user's intervention (e.g., applying a force to the actuator6500). In other embodiments, theactuator6500 need not include aguide member6520. In such embodiments, theactuator6500 can be configured to define a friction fit with theintroducer6100 when theactuator6500 is disposed about the introducer6100 (e.g., an inner surface of the wall or walls defining the annular shape of theactuator6500 engage an outer surface of theintroducer6100 to define the friction fit).
• Thecoupler6530 is disposed on a top surface of the guide member6520 (e.g., theguide member6520 is disposed between thecoupler6530 and the inner surface of the actuator6500). As shown inFIGS. 11 and 13, thecoupler6530 is coupled to theproximal end6220 of thecannula6200. In some embodiments, an outer surface of theproximal end6220 of thecannula6200 defines a friction fit with the inner surface of thecoupler6530. In other embodiments, thedistal end6220 of thecannula6200 can be coupled to thecoupler6530 via an adhesive. In this manner, theproximal end6220 of thecannula6200 and thecoupler6530 form a substantially fluid tight seal.
• A proximal end6540 of theactuator6500 is coupled to asecondary cannula6250 further configured to be coupled to acontainer shroud6270. Thecontainer shroud6270 defines acavity6271 configured to receive fluid reservoir (e.g., a conventional phlebotomy fluid container such as a Vacutainer®). More specifically,secondary cannula6250 defines alumen6253 and includes aproximal end6252 configured to be coupled to a lock mechanism6524. The lock mechanism6524 can be configured to be coupled to thecontainer shroud6270. In addition, the lock mechanism6524 includes a needle6525 disposed within a sheath6526 configured to pierce a portion of the fluid reservoir (e.g., as described above with reference toFIG. 3) when the fluid reservoir (not shown) is disposed within thecontainer shroud6270. Therefore, with theproximal end6220 of thecannula6200 coupled to thecoupler6530 and thesecondary cannula6250 coupled to the proximal end6540 of theadapter6500, theadapter6500 is configured to place the cannula6200 (e.g., thelumen6201 defined by the cannula6200) in fluid communication with the secondary cannula6250 (e.g., thelumen6253 of the secondary cannula6250) and the fluid reservoir (not shown).
• While described as including thesecondary cannula6250, in some embodiments, theapparatus6000 need not include thesecondary cannula6250. In such embodiments, thecannula6200 can define a continuous fluid path (e.g., lumen6201) from thedistal end6230, through theconnector6530, and to thecontainer shroud6270. In other embodiments, thecontainer shroud6270 can be configured to be physically and fluidically coupled to theactuator6500.
• Theadapter6400 can be anysuitable adapter6400. For example, in some embodiments, an adapter can be a known Y-adapter or T-adapter (e.g., a dual port IV extension set). In other embodiments, an adapter can be similar in form and function to theadapter5400, described above with reference toFIGS. 7 and 8. As shown inFIG. 10, theadapter6400 is a T-style adapter and includes adistal end6410, afirst port6420, and asecond port6430. Thedistal end6410 defines a port and includes alock mechanism6411 configured to be coupled to the peripheralintravenous line6300. In this manner, thelock mechanism6411 can be any suitable known lock mechanism such that thedistal end6410 of theadapter6400 can engage a knownPIV6300.
• Thefirst port6420 can be coupled to adistal end6427 of aninlet catheter6425. In some embodiments, thedistal end6427 of theinlet catheter6425 forms a friction fit with an inner surface of thefirst port6420. In some embodiments, thedistal end6427 of theinlet catheter6425 can include a fitting configured to engage the first port6420 (e.g., a threaded fitting). In other embodiments, theinlet catheter6425 can be monolithically formed with thefirst port6420 of theadapter6400. Theinlet catheter6425 further includes aproximal end6426 configured to couple to alock mechanism6428. In this manner, theinlet catheter6425 can be engaged by a user (e.g., a physician, nurse, or the like) to administer a fluid (e.g., a medicine or the like) to the peripheral intravenous line and thus, the vein of a patient. In some embodiments, theinlet catheter6425 is substantially similar in form and function as known inlet catheters. Therefore, with theadapter6400 coupled to thePIV6300 and thePIV6300 disposed within a patient, a user can administer a given fluid to the patient via theinlet catheter6425 without requiring further training in the functioning of theadapter6400.
• In use, a user (e.g., a phlebotomist) can engage theactuator6500 of theblood draw apparatus6000 to move theactuator6500 in the distal direction, as indicated by the arrow EE inFIG. 12. In this manner, theactuator6500 moves in the distal direction relative to theintroducer6100 to place the apparatus in the second configuration. As described above, the user can apply a sufficient amount of force to theactuator6500 such that the friction between the walls of theintroducer6100 and theguide member6520 of theactuator6500 is overcome. With thecannula6200 coupled to thecoupler6530 of theactuator6500, thecannula6200 is moved in the distal direction concurrently with theactuator6500 toward the second configuration.
• As indicated by the arrow FF inFIG. 13, thecannula6200 is advanced through theseal member6132 included in thelock mechanism6131, through alumen6401 defined by theadapter6400 and through thePIV6300 such that thedistal end6230 of thecannula6200 extends beyond thePIV6300. In this manner, thedistal end6230 of thecannula6200 is substantially disposed within the vein of the patient such that thelumen6201, defined by thecannula6200, is in fluid communication with the vein. As shown inFIG. 13A, thecannula6200 can be advanced through thePIV6300 such that adistal surface6206 of thefirst portion6205 of thecannula6200 is placed in contact with aproximal surface6301 of a portion of thePIV6300. Thus, thedistal surface6206 of thecannula6200 engages theproximal surface6301 of thePIV6300 to prevent thecannula6200 from being advanced beyond the second configuration. Similarly stated, thedistal surface6206 is configured to contact theproximal surface6301 of the portion of thePIV6300 to limit the travel of thecannula6200. While thefirst portion6205 and thesecond portion6210 of thecannula6200 shown inFIG. 13A include a substantially similar inner diameter, in other embodiments, thefirst portion6205 can have a substantially larger inner diameter than thesecond portion6210. In some embodiments, an inner wall or a set of inner walls that define thelumen6201 can include a tapered transition between thefirst portion6205 and thesecond portion6210. In other embodiments, the inner wall or walls need not include a tapered portion.
• While not shown inFIG. 13, a fluid container (e.g., a Vacutainer®) can be disposed within thecavity6271 defined by thecontainer shroud6270 such that thesheath6256 is withdrawn from theneedle6255 and theneedle6255 pierces the fluid container, thereby placing the fluid container in fluid communication with the vein of the patient. In other embodiments, the fluid container can be monolithically formed with thecontainer shroud6270 and/or with the introducer and the movement of theactuator6500 can urge theneedle6255 to pierce the fluid container. In some embodiments, the fluid container is configured to define a negative pressure (e.g., a Vacutainer®). In such embodiments, when theneedle6255 pierces the fluid container, the negative pressure within the fluid container introduces a suction force within thelumen6253 of thesecondary cannula6250 and thelumen6201 of thecannula6200. The suction force is such that a bodily fluid (e.g., blood) is drawn through thelumen6201 of thecannula6200 and thelumen6253 of thesecondary cannula6250 and into the fluid container, as indicated by the arrow GG inFIG. 13. In this manner, a phlebotomist can collect (e.g., draw) a given amount of blood through an existing peripheral intravenous line without the need for additional needle sticks.
• With the desired amount of bodily fluid collected, the user (e.g., phlebotomist) can move theactuator6500 in the proximal direction, thereby placing theapparatus6000 in a third (used) configuration, as indicated by the arrow HH inFIG. 14. In the third configuration, thecannula6200 is substantially fluidically isolated from a volume outside the introduce6100. Therefore, the introducer6100 (e.g., the lock mechanism6131) can be decoupled from thesecond port6430 of theadapter6400 and safely discarded.
• While the apparatus6000 (shown and described with respect toFIGS. 9-14) includes a single piece introducer6100, in some embodiments, an apparatus can include a multi-piece introducer configured for telescopic motion. For example,FIGS. 15-22 illustrate anapparatus7000 according to an embodiment. As shown inFIGS. 15-17, theapparatus7000 includes anintroducer7100 and acannula7200 and is configured to be moved between a first configuration (FIG. 15) and a second configuration (FIGS. 16 and 17), as described in further detail herein.
• Theintroducer7100 includes afirst member7150 defining a first lumen7155 and asecond member7160 defining a second lumen7165. In some embodiments, thefirst member7150 is a substantially cylindrical tube having a first diameter and thesecond member7160 is a substantially cylindrical tube having a second diameter, larger than the first diameter. In this manner, the lumen7165 defined by thesecond member7160 is configured to receive at least a portion of the first member7155. More specifically, thefirst member7150 is movably disposed within the second member7165 such that theintroducer7100 can be moved in a telescopic motion. Similarly stated, thesecond member7160 is configured to move between a first position and a second position, relative to thefirst member7150. Furthermore, thesecond member7160 includes anactuator portion7500 configured to be engaged by a user (e.g., a phlebotomist) to move thesecond member7160 relative to thefirst member7150.
• Theintroducer7100 includes aproximal end7120 and adistal end7130. Theproximal end7120 includes aport7121. Theport7121 can be any suitable port. For example, in some embodiments, theport7121 is substantially similar to theport1121, described above with reference toFIGS. 1 and 2. In this manner, theport7121 is configured to receive a portion of thecatheter7200, as described in further detail herein. Thedistal end7130 can be coupled to alock mechanism7131. Thelock mechanism7131 can be any suitable mechanism such as, for example, a Luer lock. In some embodiments, thelock mechanism7131 can be substantially similar to thelock mechanism6131 described above with reference toFIGS. 9-14. Therefore, thelock mechanism7131 is not described in further detail herein.
• Theintroducer7100 is configured to receive at least a portion of thecannula7200. More specifically, thecannula7200 includes aproximal end7220 and adistal end7230 and is at least partially disposed within theintroducer7100 such that theproximal end7220 of thecannula7200 extends through theport7121 of theintroducer7100. In this manner, thecannula7200 is configured to move relative to at least a portion of theintroducer7100 between a first configuration and a second configuration, as further described herein.
• Theproximal end7220 of thecannula7200 is coupled to alock mechanism7221. Thelock mechanism7221 can be any suitable lock mechanism, such as, for example, a Luer lock. Furthermore, thelock mechanism7221 is coupled to aneedle7222 such that when theproximal end7220 of thecannula7200 is coupled to thelock mechanism7221, a lumen (not shown inFIGS. 15-22) defined by thecannula7200 is placed in fluid communication with a lumen (not shown inFIGS. 15-22) defined by theneedle7222. Thedistal end7230 of thecannula7200 includes afirst portion7205, having a first diameter, and asecond portion7210, having a second diameter, smaller than the first diameter. As shown inFIG. 17, thecannula7200 is configured to include a taper between thefirst portion7205 and thesecond portion7210. The taper can be any suitable configuration and can be substantially similar to thetaper portion4203 described above with reference toFIG. 5.
• As shown in the exploded view ofFIG. 18, thelock mechanism7131 is configured to be coupled to anadapter7400. The adapter includes adistal end7410, afirst port7420, and asecond port7430. Theadapter7400 can be any suitable adapter described herein. For example, in some embodiments, the adapter can be substantially similar to theadapter6400 described above with reference toFIGS. 9-14. In other embodiments, theadapter7400 can be any known adapter, such as, for example, a Y-adapter or a T-adapter. In this manner, thefirst port7420 of theadapter7400 is configured to be coupled to aninlet catheter7425. Theinlet catheter7425 can be any suitable configuration. In some embodiments, theinlet catheter7425 is substantially similar in form and function to theinlet catheter6425 described above with reference toFIGS. 9-14. Therefore, theinlet catheter7425 is not described in detail herein.
• Thesecond port7430 is configured to be coupled to thelock mechanism7131. In this manner, thesecond port7430 and thelock mechanism7131 can be configured to form a substantially fluid tight seal. For example, in some embodiments, thesecond port7430 can include a threaded coupling configured to engage a threaded coupling of thelock mechanism7131, thereby defining the substantially fluid tight seal. Furthermore, thelock mechanism7131 can include a seal member (not shown inFIGS. 15-22) configured to selectively fluidically isolate alumen7113 defined by theintroducer7100 from a lumen (not shown) defined by the adapter. For example, in some embodiments, the seal member can be substantially similar in form and function to theseal member6132 described above with reference toFIG. 11. Thedistal end7410 of theadapter7400 is configured to be coupled to a peripheral intravenous line (PIV)7300. In some embodiments, thePIV7300 is a known PIV. In this manner, thedistal end7410 of theadapter7400 can include any suitable feature configured to physically and fluidically couple theadapter7400 to thePIV7300.
• As shown inFIG. 19, theapparatus7000 can be in the first configuration such that he second member7260 of theintroducer7100 is disposed in a proximal position relative to thefirst member7150 of theintroducer7100. In use, a user (e.g., a phlebotomist) can engage theactuator7500 included in thesecond member7160 of theintroducer7100 and move thesecond member7160 in the distal direction, as indicated by the arrow II inFIG. 20. In this manner, theintroducer7100 moves in a telescopic motion such that thesecond member7160 moves relative to thefirst member7150. Similarly stated, an overall length of theintroducer7100 is reduced when thesecond member7160 moves relative thefirst member7150. Furthermore, the distal movement of thesecond member7160 is such that thecannula7200 is moved in the distal direction. In this manner, thedistal end7230 of thecannula7200 passes through the seal member included in the lock mechanism7131 (as similarly described above in reference toFIGS. 11 and 13) and through thePIV7300. As shown in the enlarged view ofFIG. 22, thedistal end7230 of thecannula7200 extends beyond thePIV7300 to place a lumen (not shown) defined by thecannula7200 in fluid communication with a portion of a body of a patient (e.g., a vein). Furthermore, in some embodiments, theadapter7400 can be configured to include aseal member7470 configured to receive thecannula6200. In this manner, theseal member7470 can prevent a backflow of a bodily fluid into, for example, theintroducer7100.
• With theapparatus7000 in the second configuration (e.g.,FIGS. 20-22), the user can dispose a fluid container (e.g., a Vacutainer®, or any other suitable fluid container) within acontainer shroud7270 such that the container engages theneedle7222. In this manner, theneedle7222 can pierce a portion of the fluid container (not shown) to place the fluid container in fluid communication with the lumen defined by thecannula7200. In addition, with thedistal end7230 of thecannula7200 disposed within, for example, the vein of the patient, the fluid container can be placed in fluid communication with the vein. In some embodiments, such as those where the fluid container is a Vacutainer® or the like, the fluid container can define a negative pressure (e.g., the fluid container is an evacuated container). In such embodiments, the negative pressure defined by the fluid container can introduce a suction force to the lumen defined by thecannula7200 such that a bodily fluid (e.g., blood) is drawn through thecannula7200 and into the fluid container. In this manner, a phlebotomist can collect (e.g., draw) a given amount of blood through an existing peripheral intravenous line without the need for additional needle sticks.
• While theapparatus7000 described above with reference toFIGS. 15-22 includes anintroducer7100 with afirst member7150 and asecond member7160, in some embodiments, an apparatus can include an introducer with any suitable number of portions or members. For example,FIGS. 23 and 24 illustrate anapparatus8000 according to an embodiment. Theapparatus8000 includes at least an introducer8100 and a cannula orcatheter8200 and is configured to be moved between a first configuration (FIG. 23) and a second configuration (FIG. 24).
• The introducer8100 includes afirst member8150, asecond member8160, and athird member8170. In some embodiments, thefirst member8150 can have a first diameter, thesecond member8160 can have a second diameter, larger than the first diameter, and thethird member8170 can have a third diameter, larger than the second diameter. In this manner, at least a portion of thefirst member8150 can be movably disposed within thesecond member8160. Similarly, at least a portion of thesecond member8160 can be movably disposed within thethird member8170. In this manner, the introducer8100 can be configured to be moved in a telescopic motion, as similarly described above with respect to theintroducer7100.
• As shown inFIGS. 23 and 24, thefirst member8150 includes a set ofprotrusions8156 disposed at aproximal end8151 and adistal end8152 of thefirst member8150. Thesecond member8160 similarly includes a set ofprotrusions8161 and a set ofgrooves8161 disposed at aproximal end8161 and adistal end8162 of thesecond member8160. In a similar manner, thethird member8170 includes a set ofgrooves8171 disposed at aproximal end8171 and adistal end8172 of thethird member8170. The set ofprotrusions8156 and8166 are configured to selectively engage the set ofgrooves8167 and8177, respectively, as described in further detail herein.
• The introducer8100 includes aproximal end8120 and adistal end8130. Theproximal end8120 is configured to receive a portion of thecatheter8200. More specifically, thecatheter8200 is movably disposed within the introducer8100 such that aproximal end8220 extends through theproximal end8120 of the introducer8100. Thedistal end8130 of the introducer8100 is coupled to alock mechanism8131. Thelock mechanism8131 can be any suitable lock mechanism described herein. Therefore, thelock mechanism8131 is not described in further detail.
• Thecatheter8200 includes theproximal end8220 and adistal end8230. As described above, theproximal end8220 is configured to extend through theproximal end8120 of the introducer8100 when thecatheter8200 is disposed within the introducer8100. Theproximal end8220 is coupled to alock mechanism8221. Thelock mechanism8221 is further coupled to aneedle8222 and asheath8223. Thelock mechanism8221, the needle822, and thesheath8223 can be substantially similar in form and function to thelock mechanism2221, theneedle2222, and thesheath2223, respectively, described above with reference toFIG. 3. Therefore, thelock mechanism8221, theneedle8222 and thesheath8223 are not further described herein.
• As shown inFIG. 23, theapparatus8000 can be in the first configuration such that the introducer8100 is in a non-collapsed configuration. Similarly stated, thethird member8170 of the introducer8100 is in a proximal position, relative to thesecond member8160, and thesecond member8160 is in a proximal position, relative to thefirst member8150. Expanding further, in the first configuration, thegrooves8167 disposed at thedistal end8162 of thesecond member8160 are in contact with theprotrusions8156 disposed at theproximal end8151 of thefirst member8150. Similarly, thegrooves8177 disposed at thedistal end8172 of thethird member8170 are in contact with theprotrusions8166 disposed at theproximal end8161 of thesecond member8160. The arrangement of theprotrusions8156 and8166 within thegrooves8167 and8177, respectively, is such that the introducer8100 is maintained in the non-collapsed (e.g., extended or telescoped configuration). Furthermore, theprotrusions8156 and8166 can form a friction fit with a surface defining thegrooves8167 and8177. In this manner, the introducer8100 can be maintained within the first configuration until an external force is applied to the introducer8100 to move the introducer towards the second configuration.
• For example in use, a user (e.g., a phlebotomist) can engage the introducer8100 and apply a given force, as indicated by the arrow JJ inFIG. 24. In this manner, the applied force can be such that thethird member8170 moves in the distal direction relative to thesecond member8160. Similarly, thesecond member8160 is moved in the distal direction relative to the first member8150 (e.g., the applied force is sufficiently large to overcome the friction force between theprotrusions8156 and8166 and the surface defining thegrooves8167 and8177, respectively). Therefore, the introducer8100 is moved to the second configuration in which the introducer8100 is substantially collapsed or compressed. Furthermore, the relative distal movement of thethird member8170 and thesecond member8160 is such that the set ofgrooves8167 at theproximal end8161 and thedistal end8162 of thesecond member8160 engage the set ofprotrusions8156 at theproximal end8151 and thedistal end8152, respectively, of thefirst member8150. Similarly, the set ofgrooves8177 at theproximal end8171 and thedistal end8172 of thethird member8170 engage the set ofprotrusions8166 at theproximal end8161 and thedistal end8162 of thesecond member8160.
• In this manner, the introducer8100 is in the second configuration and the set ofprotrusions8156 and8166 engage the surfaces defining the set ofgrooves8167 and8177 to define a friction fit. Thus, the introducer8100 is maintained in the second configuration. Furthermore, the telescopic motion of the introducer8100 is such that thecatheter8200 disposed within theintroducer8200 is advanced through thelock mechanism8131, as shown inFIG. 24. As described herein, thelock mechanism8131 can be coupled to any suitable adapter and/or peripheral intravenous line. Therefore, when in the second configuration, thecatheter8200 extends beyond the PIV to draw a portion of a bodily fluid, as described herein (e.g., similar to theapparatus7000 described herein with reference toFIGS. 15-22).
• While theapparatus6000 described above with reference toFIGS. 9-14 includes an annular shapedactuator6500, in some embodiments, an apparatus can include any suitable actuator. For example,FIGS. 25 and 26 illustrate anapparatus9000 according to an embodiment, in a first configuration and a second configuration, respectively. Theapparatus9000 includes anintroducer9100, acannula9200, and anactuator9570. Theintroducer9100 includes aproximal end9120 and adistal end9230 and defines alumen9113. Thedistal end9230 is configured to be coupled to alock mechanism9131. Thecannula9200 includes aproximal end9220 and adistal end9230 and defines alumen9201. Theintroducer9100 and thecannula9200 can be substantially similar in form and function to any introducer and cannula/catheter described herein. Therefore, theintroducer9100 and thecannula9200 are not described in further detail herein.
• As shown inFIG. 25, theactuator9570 can be configured to be a stylet or wire. In this manner, theactuator9570 can be movably disposed within thecannula9200. Furthermore, theactuator9570 can be sufficiently stiff such as to advance thecannula9200 through theintroducer9100, thelock mechanism9131, and an existing PIV (not shown inFIGS. 25 and 26) substantially without kinking or creasing. Theactuator9570 can be configured to be moved in the proximal direction relative to thecannula9200, as indicated by the arrow KK inFIG. 26. In this manner, theactuator9570 can be removed from thecannula9200 and thecannula9200 can be placed in fluid communication with a fluid container. Thus, thecannula9200 can facilitate a transfer of a bodily fluid from a patient to the fluid container, as described above.
• While the embodiments described herein have included an introducer, in some embodiments, an apparatus need not include an introducer. For example,FIGS. 27 and 28 illustrate anapparatus10000 according to an embodiment, in a first configuration and a second configuration, respectively. Theapparatus10000 can include a cannula orcatheter10200 with aproximal end10220 and adistal end10230. Thecannula10200 can be substantially similar in form and function to any cannula/catheter described herein. For example, in some embodiments, theproximal end10220 includes alock mechanism10221, aneedle10222, and asheath10223, substantially similar to thelock mechanism2221, theneedle2222, and thesheath2223 described above with respect toFIG. 3.
• Thecatheter10200 is coupled to ahandle10590 configured to be engaged by a user (e.g., a phlebotomist). Theapparatus10000 can further include alock mechanism10131. Thelock mechanism10131 can be substantially similar in form and function to thelock mechanism6131 described above with reference toFIG. 11. Therefore, in use, a user can couple thelock mechanism10131 to a peripheral intravenous line (PIV)10300 and define a fluid tight seal. With thelock mechanism10131 coupled to thePIV10300, the user can engage thehandle10590 coupled thecatheter10200 to advance thecatheter10200 through thelock mechanism10131 and thePIV10300, as indicated by the arrow LL inFIG. 28. Thus, thecatheter10200 can be placed in fluid communication with a fluid container and with thecatheter10200 extended beyond thePIV10300, thecatheter10200 can facilitate a transfer of a bodily fluid from a patient to the fluid container, as described above.
• While specific cannulas or catheters are described herein as including a distal end of a particular configuration (i.e., with circumferential openings, etc.), in some embodiments the distal end of the catheter or cannula can include a different structure configured to facilitate the drawing of blood through the catheter. For example,FIG. 29 illustrates acatheter11200 that includes adistal end11230 with a bullet-shapedtip11232. The bullet-shapedtip11232 includes anend portion11233 that defines asingle opening11234 at a distal end surface of the bullet-shaped tip.
• In some embodiments, such as, for example, acatheter11200′ shown inFIG. 30, a bullet-shapedtip11232′ includes anend portion11233′ that defines anend opening11234′. In such embodiments, the bullet-shapedtip11232′ includes a set of side-wall openings11231′. Theend opening11234′ and theside openings11231′ can be configured to produce a laminar flow and act to transport a bodily fluid (i.e., blood) to a volume outside thecatheter11200′. While theopenings11231,11231′,11234, and11234′ are illustrated as having a particular configuration, the shape and orientation/relative position of the openings can be varied to facilitate the fluid flow through the catheter.
• As shown inFIG. 31 the bullet-shapedtip11232″ can be configured to include a substantially closedrounded end portion11233″. In this manner, the bullet-shapedtip11232″ can be used to move through clots existing within a peripheral intravenous line. The bullet-shapedtip11232″ includes a set of side-wall openings11231″ that are operative to transport a bodily fluid (i.e., blood) to a volume outside thecatheter11200″.
• In some embodiments, for example those shown inFIGS. 32-34, acatheter12200 includes adistal end12230 with awireframe tip12241 having a stent-like configuration. Thewireframe tip12241 can be a flexible mesh configured to extend away from thedistal end12230 of thecatheter12200. Thewireframe tip12241 can act to transport a bodily flow (i.e., blood) to a volume outside thecatheter12200. In some embodiments, thewireframe tip12241 can include a cappedend12242. The cappedend12242 can be any suitable size, shape, or configuration and, in some embodiments, can include any suitable number of openings.
• In some embodiments, thewireframe tip12241 can be connected to aguide wire12243 and used without an additional catheter, as shown inFIGS. 35-37. Similarly stated, thewireframe tip12241 can be inserted into an existing peripheral intravenous line via a guide wire and without the catheter ofFIG. 10. In this manner, thewireframe tip12241 can act as a stent and support the walls of the vein such that blood can be drawn through the existing peripheral intravenous line. In such a configuration, thewireframe tip12241 can be positioned within the existing peripheral intravenous line at any suitable location. For example, the wireframe tip can be positioned adjacent the distal end of the intravenous line.
• As described above with reference toFIGS. 9-14, theblood draw apparatus6000 can be coupled to theadapter6400 which is further coupled to thePIV6300. As stated, theadapter6400 can be any suitable adapter. For example, in some embodiments, anadapter13400 can be any of theadapters13400 shown inFIGS. 38-43. In such embodiments, theadapters13400 can be dual port adapters such as Y-adapters or T-adapters. In such embodiments, theadapters13400 can include any suitable locking mechanisms, valves, coupling members, seal members, and/or the like, described herein.
• WhileFIGS. 38-43 illustratedual port adapters13400, in some embodiments, an adapter can include a single port. For example, in some embodiments, anadapter14400 can be eitheradapter14400 shown inFIGS. 44 and 45. In such embodiments, theadapter14400 includes a single port configured to administer a fluid and/or withdraw a fluid to or from the body.
• FIG. 46 is a flowchart illustrating a method for drawing blood through a peripheral intravenous line. In some embodiments, amethod100 includes coupling an introducer sheath to a peripheral intravenous line (PIV), at102. For example, in some embodiments, the introducer sheath can include a locking mechanism disposed at a distal end portion configured to engage a known PIV. In this manner, the locking mechanism can physically and fluidically couple at least a portion of the introducer with the PIV. In some embodiments, an adapter is disposed between the PIV and the locking mechanism.
• The introducer sheath is configured to house, at least partially, a catheter. Themethod100 further includes advancing the catheter from a first position, in which the catheter is substantially within the introducer, to a second position in which the catheter is substantially outside the introducer, at104. For example, in some embodiments, the catheter is at least operatively coupled to an actuator such that a user can engage the actuator to move the catheter in a distal direction, relative to the introducer. Thus, the catheter moves in the distal direction and can be advanced through the locking mechanism, the adapter (if present), and the PIV. Furthermore, the catheter can be advanced such that a distal end of the catheter extends beyond the PIV and into a portion of a patient (e.g., a vein).
• Themethod100 includes coupling a container to a proximal end of the introducer sheath such that the container is fluidically coupled to the catheter, at106. In some embodiments, a proximal end of the catheter includes a needle configured to pierce a portion of a fluid container, such as, for example, a Vacutainer®. In this manner, the catheter is placed in fluid communication with the fluid container. More specifically, with the catheter disposed within, for example, a vein of the patient, the fluid container is placed in fluid communication with the vein. In this manner, a desired amount of a bodily fluid (e.g., blood) can be drawn from the patient and stored in the fluid container.
• With the desired amount of bodily fluid collected, themethod100 can include withdrawing the catheter from the second position towards the first position, at108. In this manner, the catheter can be moved in the proximal direction such that the distal end of the catheter is again disposed within the introducer. With the distal end of the catheter disposed within the introducer, the introducer and/or the locking mechanism can be configured to fluidically isolate the catheter from a volume outside the introducer. Thus, the introducer and catheter can be safely disposed of without concern of spreading fluid borne pathogens.
• The components of the blood draw apparatus and the Y-adapter can be packaged together or separately. The Y-adapter can also be sold in a package with other IV dressing materials. In some embodiments, the Y-adapter can remain on the IV as long as the IV is in the patient.
• The blood draw apparatus can be used with a variety of peripheral IVs. The apparatus allows efficient blood draw while still maintaining the integrity of the sample. In some embodiments, for example, the apparatus will facilitate 20 ml of blood to be drawn in approximately 1-2 minutes. While extracting blood, the blood flow can be laminar to avoid turbulence in the catheter, thereby minimizing hemolysis.
• While the blood draw apparatus can be used in a variety of settings (ER, in-patient, etc.), two examples of scenarios are described herein. In the first scenario, the patient has a single peripheral IV. In the second scenario, which is typically less common, the patient has a dedicated second peripheral IV just for phlebotomy purposes. Only one y-adapter is required per patient, and can be attached for the life of the IV, for example, which is typically 3-4 days. A new blood draw apparatus (e.g., any of those described above) can be used for each blood draw.
• The assembly of the blood draw apparatus can be the same in either scenario. First, the apparatus is coupled to the y-adapter. Second, the catheter is advanced through the y-adapter and pushed through the peripheral IV catheter into the patient's vein. Once in the vein, a syringe or a negative pressure collection container/tube (e.g., a Vacutainer® tube) is connected to the rear port and fluidically coupled to the catheter to draw and store blood.
• The following scenario is provided by way of example. The nurse or phlebotomist inserts a peripheral IV into a patient's arm. The peripheral IV is inserted following standard guidelines and the y-adapter is attached. When it is time to draw blood, the provider can turn off the IV, if it is on, for approximately 1-5 minutes to allow medicine or IV fluids to disperse from the blood-drawing site. To draw the blood sample, the provider attaches the blood draw apparatus to the blood draw port on the y-adapter, advances the internal catheter through the peripheral IV and into the vein. Next, the provider can attach the negative pressure collection container(s)/tube(s) to the apparatus (i.e., place the tube in fluid communication with the blood draw apparatus) to extract the blood sample. In use, a user can discard, for example, the first 3-6 ml of the fluid or blood sample as “waste” then using the next tube(s) as the intended sample. This “wasting” procedure ensures all of the dead space fluid, like saline or medications, is cleared from the vein, peripheral IV and y-adapter as to not contaminate the testing sample being drawn.
• In the scenario in which there is a dedicated peripheral IV line for blood draw purposes, the provider inserts a peripheral IV into one arm to administer medicine and another peripheral IV into the opposite arm specifically for blood drawing purposes. When it is time to draw blood, the provider simply follows the steps mentioned above and there is no need to wait the 1-5 minutes to allow fluid or medicine dispersal as in the first scenario.
• Each of the components discussed herein can be monolithically constructed or can be a combination of parts. For example, in reference toFIG. 7, the y-adapter5400 and theintroducer5100 are coupled usinglocking mechanisms5431 and5131, respectively. The y-adapter5400 and theintroducer5100 can be the same component, wherein the y-adapter5400 is an integral part of theintroducer5100 and vice-versa. Other aspects of the apparatus shown and described can be modified to affect the performance of the apparatus. For example, the openings in the set of openings described herein at the distal end of the catheter can be in any arrangement, size shape, and/or number, to create preferable flow conditions through the catheter.
• While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. For example, while thecannula6200 is shown inFIG. 13A as including thefirst portion6205 having the first diameter and thesecond portion6210 having the second diameter, in some embodiments, a cannula can include a first portion and a second portion of similar diameter.
• Where methods and/or schematics described above indicate certain events and/or flow patterns occurring in certain order, the ordering of certain events and/or flow patterns may be modified. Additionally certain events may be performed concurrently in parallel processes when possible, as well as performed sequentially. While various embodiments have been described as having particular features and/or combinations of components, other embodiments are possible having a combination of any features and/or components from any of embodiments as discussed above.

Claims (31)

1.-20. (canceled)

21. A method of using a fluid transfer device having an introducer, a catheter, and an actuator, the method comprising:

coupling an adapter to a peripheral intravenous line configured to be at least partially disposed in a vein of a patient;

coupling the introducer to the adapter such that the adapter is disposed between the introducer and a port of the peripheral intravenous line; and

moving the actuator relative to the introducer to advance the catheter from a first position in which the catheter is proximal to the adapter to a second position in which a portion of the catheter extends through the adapter and the peripheral intravenous line such that a distal end portion of the catheter extends beyond the peripheral intravenous line.

22. The method ofclaim 21, further comprising:

coupling the adapter to a port of the peripheral intravenous line.

23. The method ofclaim 21, wherein the distal end portion of the catheter includes a plurality of openings, the plurality of openings configured to be distal to the peripheral intravenous line when the catheter is in the second position.

24. The method ofclaim 21, wherein the catheter has a length sufficient to place the distal end portion of the catheter distal to a distal end of the peripheral intravenous line when the catheter is in the second position and the adapter is coupled between the introducer and the peripheral intravenous line.

25. The method ofclaim 21, wherein the introducer has a distal end portion that includes a lock configured to couple the introducer to the adapter.

26. The method ofclaim 21, wherein moving the actuator includes moving the actuator along a fixed length of the introducer.

27. The method ofclaim 21, wherein moving the actuator includes moving a proximal end portion of the introducer toward a distal end portion of the introducer.

28. The method ofclaim 21, further comprising:

establishing fluid communication between the catheter and a fluid reservoir; and

transferring a volume of bodily fluid from the patient to the fluid reservoir via the catheter when the peripheral intravenous line is disposed in the vein of the patient and the catheter is in the second position.

29. A method of using a fluid transfer device having an introducer, a catheter, and an actuator, the method comprising:

inserting a distal end portion of a peripheral intravenous line into a vein of a patient;

coupling, after the inserting, the introducer to an adapter connected to a port of the peripheral intravenous line; and

moving the actuator relative to the introducer to advance the catheter from a first position in which the catheter is proximal to the port to a second position in which a portion of the catheter extends through the adapter and the peripheral intravenous line such that a distal end of the catheter is disposed in the vein in a distal position relative to the peripheral intravenous line.

30. The method ofclaim 29, wherein the peripheral intravenous line defines a lumen between the port and the distal end portion of the peripheral intravenous line, and

wherein moving the actuator relative to the introducer to advance the catheter from the first position to the second position is such that the actuator advances the catheter through the lumen of the peripheral intravenous line without kinking.

31. The method ofclaim 29, wherein coupling the introducer to the adapter includes coupling a distal end portion of the introducer to the adapter via a lock included in the distal end portion of the introducer.

32. The method ofclaim 31, wherein the lock includes a seal,

the catheter is proximal to the seal when the catheter is in the first position, at least a distal end portion of the catheter is distal to the seal when the catheter is in the second position.

33. The method ofclaim 29, further comprising:

establishing fluid communication between the catheter and a fluid reservoir; and

transferring a volume of bodily fluid from the vein of the patient to the fluid reservoir via the catheter when the catheter is in the second position.

34. The method ofclaim 29, further comprising:

coupling the adapter to the port of the peripheral intravenous line such that the adapter is disposed between the port and a distal end portion of the introducer.

35. The method ofclaim 34, wherein the catheter has a length sufficient to place the distal end of the catheter distal to the peripheral intravenous line when the catheter is in the second position and the adapter is coupled between the port and the distal end portion of the introducer.

36. A method of using a fluid transfer device having an introducer, a catheter, and an actuator, the method comprising:

coupling the introducer to an adapter, the adapter connected to a peripheral intravenous line configured to be at least partially disposed in a vein of a patient;

moving the actuator relative to the introducer to advance the catheter from a first position in which the catheter is proximal to the adapter to a second position in which a portion of the catheter extends through the adapter and the peripheral intravenous line such that a distal end of the catheter is distal to a distal end of the peripheral intravenous line;

establishing fluid communication between the catheter and a fluid reservoir; and

transferring a volume of bodily fluid from the patient to the fluid reservoir via the catheter when the peripheral intravenous line is disposed in the vein of the patient and the catheter is in the second position.

37. The method ofclaim 36, wherein a distal end portion of the catheter is configured to support the vein as the volume of bodily fluid is transferred from the patient to the fluid reservoir.

38. The method ofclaim 36, further comprising:

coupling the adapter to a port of the peripheral intravenous line.

39. The method ofclaim 36, wherein the catheter has a length sufficient to place the distal end of the catheter distal to the distal end of the peripheral intravenous line when the catheter is in the second position and the adapter is coupled between the introducer and the peripheral intravenous line.

40. The method ofclaim 36, wherein moving the actuator includes moving the actuator along a fixed length of the introducer.

41. The method ofclaim 36, wherein moving the actuator includes moving a proximal end portion of the introducer toward a distal end portion of the introducer.

42. The method ofclaim 36, wherein the catheter is disposed within the introducer when in the first position.

43. The method ofclaim 36, wherein the adapter has a first port and a second port, the introducer configured to couple to one of the first port or the second port.

44. The method ofclaim 36, wherein the peripheral intravenous line has a first port and a second port, the adapter configured to be connected to one of the first port or the second port of the peripheral intravenous line.

45. A method of using a fluid transfer device having an introducer, a catheter, and an actuator, the method comprising:

coupling the introducer to a port of a peripheral intravenous line, the peripheral intravenous line configured to be at least partially disposed in a vein of a patient;

moving the actuator relative to a portion of the introducer to advance the catheter from a first position inside the introducer and outside the peripheral intravenous line to a second position substantially outside the introducer and at least partially inside the peripheral intravenous line;

establishing fluid communication between the catheter and a fluid reservoir;

transferring a volume of bodily fluid from the vein of the patient to the fluid reservoir; and

moving the actuator relative to the portion of the introducer and after the transferring to retract the catheter from the second position to the first position.

46. The method ofclaim 45, wherein moving the actuator to advance and retract the catheter includes sliding the actuator along a fixed length of the introducer to move the catheter between the first position and the second position.

47. The method ofclaim 45, wherein moving the actuator to advance the catheter includes moving a proximal end portion of the introducer toward a distal end portion of the introducer and moving the actuator to retract the catheter includes moving the proximal end portion of the introducer away from the distal end portion of the introducer.

48. The method ofclaim 45, wherein a distal end portion of the catheter includes a plurality of openings, the plurality of openings configured to be distal to the peripheral intravenous line when the catheter is in the second position.

49. The method ofclaim 45, wherein coupling the introducer to the port of the peripheral intravenous line includes coupling a distal end portion of the introducer to an adapter connected to the port of the peripheral intravenous line.

50. The method ofclaim 49, wherein the catheter has a length sufficient to place a distal end of the catheter distal to the peripheral intravenous line when the catheter is in the second position and the adapter is coupled between the distal end portion of the introducer and the peripheral intravenous line.

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