RU2780428C2 - Systems and methods for phlebotomy through peripheral intravenous catheter - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: group of inventions relates to medical equipment, namely to two options of a device for phlebotomy through an intravenous catheter and a method for phlebotomy through an intravenous catheter. In the first option, the device contains a catheter, which forms a lumen passing through a proximal end section and a distal end section of the catheter. The device has an introducer containing the first element and the second element. A section of the second element is located in the first element with the possibility of movement. The distal end section of the first element is made with the possibility of connection to an implanted peripheral intravenous line. The distal end section of the second element includes a catheter protective device. The second element is made with the possibility of movement relatively to the first element. The catheter protective device is located in the first element, when the second element is in a proximal position. The distal end section of the catheter protective device is made distally relatively to the first element and inside the implanted peripheral intravenous line, when the second element is in the second position. The distal end section of the catheter is isolated inside the catheter protective device and is moved with the second element as the second element is moved between the proximal position and the distal position. The catheter is made with the possibility of movement relatively to the second element to be positioned in the second configuration, when the second element is in the distal position, so that the distal end section of the catheter is located distally relatively to the catheter protective device. In the second option, the device contains an introducer. The introducer has a distal end section made with the possibility of connection to an implanted peripheral intravenous line. The introducer is made with the possibility of movement between the first configuration, in which the catheter protective device is placed inside the introducer, and the second configuration, in which the distal end section of the catheter protective device is located distally relatively to the introducer and inside the implanted peripheral intravenous line. The device has a drive mechanism attached to the catheter and made with the possibility of movement of the introducer between the first configuration and the second configuration. The distal end section of the catheter is isolated inside the catheter protective device and is moved with the catheter protective device as the introducer is moved from the first configuration to the second configuration. The drive mechanism is made with the possibility of movement relatively to the catheter protective device, when the introducer is in the second configuration, to position the distal end section of the catheter distally relatively to the catheter protective device. The method includes stages of: attachment of a fluid transfusion device to the peripheral intravenous line, application of the first and the second forces to the drive mechanism, creation of a fluid communication between the catheter and a fluid reservoir, collection of the volume of patient’s body fluid through the catheter into the fluid reservoir.

EFFECT: improvement of a system and a method for phlebotomy through a peripheral intravenous catheter.

22 cl, 79 dwg

Description

Cross-reference to related application

[1001] This application is a continuation of and claims priority from U.S. Patent Application No. 14/468,826, "Systems and Methods for Phlebotomy Through a Peripheral IV Catheter", filed August 26, 2014, which is a continuation in part of U.S. Patent Application No. 13/758,585 , "Systems and Methods for Phlebotomy Through a Peripheral IV Catheter", filed February 4, 2013, which is a continuation of U.S. Patent Application No. 13/456,900, "Systems and Methods for Phlebotomy Through a Peripheral IV Catheter", filed April 26, 2012 ., currently U.S. Patent No. 8,366,685, which is a partial continuation of U.S. Patent Application No. 13/234,857, "Systems and Methods for Phlebotomy Through a Peripheral IV Catheter", filed Sep. 16, 2011, which claims priority on U.S. Provisional Patent Application No. 61/479,223, "Systems and Methods for Phlebotomy Through a Peripheral IV Catheter", filed April 26, 2011, the disclosures of which are incorporated herein in their entirety. ku by sending.

State of the art invention

[1002] The embodiments described herein relate generally to medical devices. In particular, the embodiments described herein relate to systems and methods for phlebotomy through an intravenous catheter.

[1003] A typical hospitalized patient in a hospital has to deal with a needle every time a doctor orders a laboratory test. The standard procedure for drawing blood involves using a metal needle ("butterfly needle") to "puncture"patients' veins in their arms or hands. Drawing blood is a manual labor intensive process that, for the average patient, requires several hours of direct skilled labor during a typical hospital stay. In addition to being painful and a major source of patient dissatisfaction, the nurses or personnel who specialize in taking blood (phlebotomists) often have difficulty finding a vein in approximately 10-15% of patients, resulting in repeated painful attempts. piercing" veins. This results in significantly higher material and labor costs (needles and tubing should be discarded after each attempt), as well as increased pain and bruising of the patient.

[1004] Currently, the process of taking blood is inefficient, taking an average of 7-10 minutes, and more than 21 minutes for 10% of patients. These 10% of patients are referred to as patients with difficult vein access or simply patients with "bad veins". If superficial veins are not identified immediately, blood can be induced into the vein by massaging the arm from the wrist to the elbow, feeling the procedure site with the index and middle fingers, applying a warm, damp washcloth to the procedure site for 5 minutes, or lowering the limb from the bed to let the veins fill up. Each of these methods is labor intensive and therefore expensive.

[1005] Peripheral intravenous (PIV) catheters are administered to most patients during their hospitalization and are used to infuse fluids and drugs. However, these catheters are not intended for blood sampling. Aspiration failure rates reached 20-50% when PIV was left infused for more than a day. The blood drawn from the PIV is often hemolyzed (hemolysis is defined, for example, as the rupture of red blood cells and release of their contents into the surrounding fluid), resulting in a rejected sample and a repeat blood draw is required.

[1006] There are several mechanical barriers that can contribute to the disadvantages inherent in the extraction of blood from PIV. First, most catheters are formed from a soft bioreactive polymer, and the use of this material has resulted in potential narrowing or collapse of the catheter when negative pressure is applied for aspiration, or the catheter is twisted during insertion or manipulation, preventing backflow. In addition, with longer implantation, there is an accumulation of foreign substances (for example, fibrin/platelet clots), which are deposited on the catheter tip and inside the lumen. This accumulation explains the dependence of the failure rate on the implantation time. A third significant barrier is attributed to the "suction cup" effect, whereby the negative pressure created by aspiration through the catheter and the possible curvilinear path of the vein cause the catheter tip to adhere to the vein wall. As the negative pressure increases, the vein can rupture, resulting in "vein leakage", which is a major concern for phlebotomists during PIV aspiration.

[1007] Therefore, there is a need for an improved system and method for phlebotomy through a peripheral intravenous catheter.

The essence of the invention

[1008] This application describes systems and methods for phlebotomy through a peripheral intravenous catheter. In some embodiments, the device includes a catheter having a proximal end section and a distal end section and forming a lumen through it, an introducer containing a first element and a second element, a locking mechanism connected to the distal end of the first element, and a drive mechanism connected to the catheter . At least a portion of the second element is movable in the first element between a proximal position and a distal position relative to the first element. The second element includes a guide having a distal end portion that is located in a distal position relative to the first element when the second element is in a distal position. The locking mechanism is configured to connect the introducer to a peripheral intravenous line. At least a section of the drive mechanism is located in the second element and is movable from the first configuration to the second configuration to move the second element from its proximal position to its distal position. The drive mechanism is movable relative to the second element to be positioned in the second configuration when the second element is in its distal position. The catheter is positioned within the introducer when the actuator is in the first configuration, and positioned within and beyond the end of the peripheral intravenous line when the actuator is in the second configuration.

Brief description of the drawings

[1009] FIG. 1 and 2 are schematic representations of a device in a first configuration and a second configuration, respectively, in accordance with an embodiment.

[1010] FIG. 3 is a detailed schematic view of a device in a second configuration according to an embodiment.

[1011] FIG. 4 is a detailed schematic view of a device in a second configuration according to an embodiment.

[1012] FIG. 5 and 6 are sectional side views of a device in a first configuration and a second configuration, respectively, in accordance with an embodiment.

[1013] FIG. 6A is an enlarged view of a portion of the device shown in FIG. 6, labeled area X.

[1014] FIG. 7 and 8 are sectional side views of a device and an adapter in a first configuration and a second configuration, respectively, in accordance with an embodiment.

[1015] FIG. 9 is a perspective view of a device in a first configuration according to an embodiment.

[1016] FIG. 10 is an exploded view of the device shown in FIG. 9.

[1017] FIG. 11 is a perspective sectional view of the device shown in FIG. 9.

[1018] FIG. 12 is a perspective view of the device shown in FIG. 9 in the second configuration.

[1019] FIG. 13 is a sectional perspective view of the device shown in FIG. 9 in the second configuration.

[1020] FIG. 13A is an enlarged view of a portion of the device shown in FIG. 13, labeled region Y.

[1021] FIG. 14 is a sectional perspective view of the device shown in FIG. 9 in the third configuration.

[1022] FIG. 15 and 16 are side views of a device in a first configuration and a second configuration, respectively, in accordance with an embodiment.

[1023] FIG. 17 is a perspective view of the device shown in FIG. 15 in the second configuration.

[1024] FIG. 18 is an exploded side view of the device shown in FIG. 15 and an adapter according to the embodiment.

[1025] FIG. 19 is a side view of the device and adapter shown in FIG. 18 in the first configuration.

[1026] FIG. 20 is a side view of the device and adapter shown in FIG. 18 in the second configuration.

[1027] FIG. 21 is a perspective view of the device shown in FIG. 18 in the second configuration.

[1028] FIG. 22 is an enlarged view of a portion of the device shown in FIG. 18, labeled area Z in FIG. 21.

[1029] FIG. 23 and 24 are schematic representations of a device in a first configuration and a second configuration according to an embodiment.

[1030] FIG. 25 and 26 are schematic representations of a device in a first configuration and a second configuration according to an embodiment.

[1031] FIG. 27 and 28 are schematic views of a device in a first configuration and a second configuration according to an embodiment.

[1032] FIG. 29-37 are side views of various configurations of a catheter contained in a device according to an embodiment.

[1033] FIG. 38-43 show various views of dual port adapters in accordance with various embodiments.

[1034] FIG. 44 and 45 are views of single port adapters in accordance with embodiments.

[1035] FIG. 46 is a flowchart explaining the method of phlebotomy through a peripheral intravenous line according to the embodiment.

[1036] FIG. 47 is a perspective view of a liquid transfusion device according to another embodiment.

[1037] FIG. 48 is an exploded view of the liquid transfusion device shown in FIG. 47.

[1038] FIG. 49 is a perspective view of the first introducer element contained in the fluid transfusion device shown in FIG. 47.

[1039] FIG. 50 is a sectional view of the first introductor element taken along line 50-50 in FIG. 49.

[1040] FIG. 51 is a sectional view of the first introductor element taken along line 51-51 in FIG. fifty.

[1041] FIG. 52 is a sectional view of the first introductor element taken along line 52-52 in FIG. fifty.

[1042] FIG. 53 is a perspective view of a second introducer element contained in the fluid transfusion device shown in FIG. 47.

[1043] FIG. 54 is a sectional view of the second introductor element taken along line 54-54 in FIG. 53.

[1044] FIG. 55 is a sectional view of the first introductor element taken along line 50-50 in FIG. 49 and the second introducer element taken along line 54-54 in FIG. 53.

[1045] FIG. 56 is a perspective view of the drive mechanism contained in the liquid dispenser shown in FIG. 47.

[1046] FIG. 57 is a sectional view of the drive mechanism taken along line 57-57 in FIG. 56.

[1047] FIG. 58 is a rear view of the liquid dispenser shown in FIG. 47.

[1048] FIG. 59 is a sectional view of the liquid transfusion device taken along line 59-59 in FIG. 58 in the first configuration.

[1049] FIG. 60 is an enlarged view of a portion of the liquid transfusion device shown in FIG. 59, labeled area A1.

[1050] FIG. 61 is an enlarged view of a portion of the liquid transfusion device shown in FIG. 59, labeled area A2.

[1051] FIG. 62 is an enlarged view of a portion of the liquid transfusion device shown in FIG. 59, labeled area A3.

[1052] FIG. 63 is a sectional view of the liquid transfusion device taken along line 59-59 in FIG. 58 in the second configuration.

[1053] FIG. 64 is an enlarged view of a portion of the liquid transfusion device shown in FIG. 63, labeled area A4.

[1054] FIG. 65 is a sectional view of the liquid transfusion device taken along line 59-59 in FIG. 58 in a third configuration.

[1055] FIG. 66 is an enlarged view of a portion of the liquid transfusion device shown in FIG. 65, labeled area A5.

[1056] FIG. 67 and 68 are sectional views of the liquid transfusion device shown in FIG. 47, taken along lines 67-67, in the third configuration and the fourth configuration, respectively.

[1057] FIG. 69 is a plan view of a first introducer element according to another embodiment.

[1058] FIG. 70 is a rear view of the first element shown in FIG. 69.

[1059] FIG. 71 is a sectional view of the first element taken along line 71-71 in FIG. 70.

[1060] FIG. 72 is an enlarged view of a portion of the first element indicated in FIG. 71 as area A6.

[1061] FIG. 73 is a plan view of a drive mechanism according to another embodiment.

[1062] FIG. 74 is a rear view of the drive mechanism shown in FIG. 73.

[1063] FIG. 75 is a sectional view of the drive mechanism taken along line 75-75 in FIG. 74.

[1064] FIG. 76 is an enlarged view of the portion of the drive mechanism indicated in FIG. 75 as area A7.

[1065] FIG. 77 is a flowchart explaining a method of phlebotomy through a peripheral intravenous line according to another embodiment.

[1066] FIG. 78 and 79 are schematic representations of the distal end portion of a catheter in accordance with various embodiments.

Detailed description

[1067] This application describes systems and methods for phlebotomy through a peripheral intravenous catheter. In some embodiments, the device includes a catheter having a proximal end section and a distal end section and forming a lumen through it, an introducer containing a first element and a second element, a locking mechanism connected to the distal end of the first element, and a drive mechanism connected to the catheter . At least a portion of the second element is movable in the first element between a proximal position and a distal position relative to the first element. The second element includes a guide having a distal end portion that is located in a distal position relative to the first element when the second element is in a distal position. The locking mechanism is configured to connect the introducer to a peripheral intravenous line. At least a portion of the drive mechanism is located in the second element and is movable from the first configuration to the second configuration to move the second element from its proximal position to its distal position. The drive mechanism is movable relative to the second element to be positioned in the second configuration when the second element is in its distal position. The catheter is positioned within the introducer when the actuator is in the first configuration, and positioned within and past the end of the peripheral intravenous line when the actuator is in the second configuration.

[1068] In some embodiments, the device includes a catheter, a first introducer, a second introducer, and a drive mechanism. The catheter has a proximal end section and a distal end section and forms a lumen through it. The first introductor has a proximal end section, a distal end section and an inner surface limiting the channel. The distal end portion of the first introductor is configured to be connected to a peripheral intravenous line. The second introducer has a proximal end section and a distal end section. The distal end section of the second introducer includes a guide element. At least a section of the second introductor is movable in the first introductor so that the protrusion extending from the outer surface of the second introductor is located in the channel. The second introductor has a range of movement relative to the first introductor, defined at least in part by the channel. The drive mechanism is connected to the catheter and, at least partially, is located in the second introducer. The drive mechanism is configured to move the second introducer along at least a portion of the movement range to advance the distal end portion of the guide element along the peripheral intravenous line. The drive mechanism is movable from the first position relative to the second introducer, in which the catheter is located in the guide element, to the second position relative to the second introducer, in which the distal end section of the catheter passes beyond the distal end of the guide element.

[1069] In some embodiments, the method includes the step of connecting a fluid transfusion device to a peripheral intravenous line. The liquid transfusion device includes an introducer containing a first element and a second element. The second element includes a guide element and is movably located in the first element. The liquid transfusion device includes a drive mechanism movably located in the second element and a catheter connected to the drive mechanism. The first force is applied to the drive mechanism. The first force is sufficient to move the second element relative to the first element from the first position, in which the guide element is located in the first element, to the second position, in which the distal end portion of the guide element is inserted through the port of the peripheral intravenous line. A second force is applied to the drive mechanism. The second force is sufficient to move the drive mechanism relative to the second element, when the second element is in the second position, to advance the catheter from the first position, in which the catheter is located in the introducer, to the second position, in which the distal end section of the catheter passes beyond the end of the peripheral intravenous line. The fluid reservoir is connected to the fluid transfusion device such that the fluid reservoir is fluidly connected to the catheter. The catheter is withdrawn from the peripheral intravenous line after a volume of bodily fluid is infused into the fluid reservoir such that the catheter is positioned within the introducer.

[1070] In some embodiments, the device includes a cannula or catheter, an introducer, a locking mechanism, and a drive mechanism. The catheter includes a proximal end and a distal end and forms a lumen. The introducer includes a proximal end and a distal end and forms a lumen configured to receive at least a section of the catheter. The locking mechanism is connected to the distal end of the introducer and is configured to connect the introducer to a peripheral intravenous line. The drive mechanism is operatively connected to the catheter and is configured to move the catheter between the first configuration, in which the catheter is located essentially inside the introducer, and the second configuration, in which the catheter is located essentially outside the introducer. The catheter passes beyond the end of the peripheral intravenous line when in the second configuration.

[1071] In some embodiments, the method includes the step of connecting the introducer to a peripheral intravenous line (e.g., a saline gate device, a heparin gate device, or the like), wherein the introducer has a proximal end and a distal end. The method further includes the step of advancing the catheter from a first position within 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 is longer than the length of the peripheral IV line, and in other embodiments, the catheter in the second position is shorter than the peripheral IV line. The method includes attaching a container to the proximal end of the introducer such that the container is fluidly connected to the catheter. The method further includes retracting the catheter from the second position to the first position.

[1072] In some embodiments, the catheter has a proximal end and a distal end and forms a lumen through it. The introducer has a proximal end and a distal end and forms a lumen through it. The introducer is made with the possibility of accommodating the catheter. An adapter is connected to the introducer. The adapter has a distal end configured to connect 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 a catheter through it. The second lumen is perpendicular to the first lumen. The drive mechanism is operatively connected to the catheter and is configured to move the catheter between the first configuration and the second configuration. In the second configuration, the catheter passes beyond the distal end of the adapter.

[1073] In the context of this application, the terms "catheter" and "cannula" are used interchangeably to define an element configured to form a passage for moving bodily fluid from a first location to a second location (for example, a fluid passage to remove bodily fluid from the body). While the cannulas may be configured to receive a trocar, guidewire, or introducer to deliver the cannula to a volume within the patient's body, the cannulas referred to herein are not required to include or receive a trocar, guidewire, or introducer.

[1074] In the context of the present description, the terms "Y-adapter" and "T-adapter" are used to refer to a two-port intravenous expansion set. Therefore, the terms "Y-adapter" and "T-adapter" describe the generally general shape of a two-port IV expansion set. For example, the Y-adapter referred to herein is essentially "Y"-shaped, including one port at the first end and two ports at an angle to each other at the second end. In addition, the terms "Y-adapter" and "T-adapter" are for exemplary purposes only and are not intended to be limiting. For example, in some embodiments, the device may include a single port IV expansion kit (eg, a single port adapter) or a multiport IV expansion kit (eg, an adapter with more than two ports).

[1075] In the context of the present description, the terms "proximal" and "distal" refer to the direction, respectively, closer and further away from the user who will place the device in contact with the patient. Thus, for example, the end of the device that touches the patient's body first would be the distal end, and the opposite end of the device (eg, the end of the device manipulated by the user) would be the proximal end of the device.

[1076] As used herein, the term "rigidity" refers to the resistance of an object to deflection, deformation, and/or displacement under an applied force. Rigidity can be characterized in terms of the amount of force applied to an object and the resulting distance that a first region of the object deviates, deforms, and/or moves relative to a second region of the same object. When describing the stiffness of an object, the deflection distance can be measured as the deflection of a portion of the object that is different from the portion of the object to which the force is directly applied. In other words, in some objects the point of deflection is different from the point at which force is applied.

[1077] Rigidity is an extensive property of the described object and, therefore, depends on the material from which the object is formed, as well as on some of the physical characteristics of the object (for example, on the shape and on the boundary conditions). For example, the stiffness of an object can be increased or decreased by selectively including in the object a material having the desired modulus of elasticity, flexural modulus, and/or hardness. Modulus of elasticity is an intense (ie, intrinsic) property of a constituent material and describes the tendency of an object to elastically (ie, inconstantly) deform under an applied force. A material having a high modulus of elasticity will not deviate as much as a material having a low modulus of elasticity will deviate in the presence of the same applied force. Thus, the rigidity of the object can be increased, for example, by introducing into the object and/or constructing the object from a material having a high modulus of elasticity.

[1078] Similarly, material hardness is an intensive property of a constituent material and describes a measure of how resistant a material is to various types of permanent shape change when a force is applied. When discussing hardness and its effect on catheter stiffness, the Shore durometer hardness scale is commonly used. There are several scales for hardness, of which two are commonly used when describing plastics, polymers, elastomers, and/or rubbers, namely Type A and Type D, where Type A is usually used for softer materials and Type D is usually used for harder materials. The Shore hardness of a material is indicated by a number from 0 to 100, with higher numbers indicating a harder material, according to the type of scale. For example, the first material can be measured as having a hardness of 40A Shore on a Shore durometer, and the second material can be measured as having a hardness of 60D Shore on a Shore durometer. Therefore, following the Shore hardness scale, the second material is harder and therefore more rigid than the first material.

[1079] FIG. 1 and FIG. 2 are schematic diagrams of a device 1000 for phlebotomy through a peripheral intravenous line or catheter in a first configuration and a second configuration, respectively, in accordance with one embodiment. The device 1000 includes an introducer 1100, a cannula or catheter 1200, a locking mechanism 1131, and a drive mechanism 1500. The introducer 1100 includes a sheath 1110 having a proximal end 1120 and a distal end 1130 and defining a lumen 1113. The cannula/catheter 1200 is movably positioned inside the shell 1110 between the proximal end 1120 and the distal end 1130.

[1080] The proximal end 1120 includes a port 1121 so that the catheter/cannula 1200 can move from the first retracted configuration (FIG. 1) to the second extended configuration (FIG. 2). Similarly, the port 1121 at the proximal end 1120 of the introducer 1100 is configured such that the catheter 1200 can move through the port 1121 from the first configuration to the second configuration. Port 1121 may be any suitable port, such as an opening at the proximal end 1120 of introducer 1100. In addition, port 1121 may include any suitable sealing element, such as an o-ring or gasket. In some embodiments, port 1121 may be a self-sealing port and may be lubricated using any suitable lubricant to aid in movement and/or sealing of catheter 1200 therein.

[1081] The distal end 1130 of the introducer 1100 includes a locking mechanism 1131 configured to fluidly connect the peripheral IV line 1300 to the introducer 1100 and position the catheter 1200 in fluid communication with the peripheral IV line 1300. The locking mechanism 1131 may be any suitable locking mechanism that creates a fluid-tight seal. In some embodiments, the implementation of the locking mechanism may be a Luer lock (Luer Lok™) or similar mechanism. In some embodiments, the peripheral IV line 1300 is in a sealed configuration until the locking mechanism 1131 is connected to the IV line 1300. After the locking mechanism 1131 is connected to the IV line 1300, the seal may open to allow access for the catheter 1200 In some embodiments, the locking mechanism may include a backflow prevention mechanism, such as a single-way valve or the like. Therefore, the locking mechanism 1131 may be configured to allow the catheter 1200 to pass through the locking mechanism 1131, but to substantially prevent fluid from flowing out of the catheter 1200 through the locking mechanism 1131.

[1082] The catheter 1200 defines a lumen 1201 between the proximal end 1220 and the distal end 1230 and may have any suitable diameter and stiffness. In some embodiments, the catheter 1200 may be 16 gauge (16g) to 26 gauge (26g) in diameter and have a Shore hardness of approximately 20A Shore to 50D Shore. In some embodiments, catheter 1200 has a shore hardness of approximately 20A Shore to 90D Shore. In some embodiments, catheter 1200 has a Shore hardness of approximately 70A Shore to 85D Shore. Therefore, the catheter 1200 may be of any suitable diameter for insertion through the peripheral intravenous line 1300 and may be rigid enough to be advanced along the peripheral intravenous line 1300.

[1083] The actuator 1500 is operatively connected to the catheter 1200 via a groove or slot 1111 in the introducer 1100. The actuator 1500 is configured to move the catheter 1200 from the first configuration to the second configuration such that the distal end 1230 of the catheter 1200 is substantially , outside the introducer 1100, as shown in FIG. 2. In some embodiments, the length of the distal end 1230 of the catheter 1200 is greater than the length of the peripheral intravenous line 1300. Therefore, the distal end 1230 of the catheter 1200 extends beyond the distal end of the intravenous line 1300.

[1084] In some embodiments, catheter 1200 may be moved to a third configuration in which catheter 1200 is retracted into introducer 1100. The third configuration may be substantially similar to the first configuration (FIG. 1) in that catheter 1200 is located in introducer 1100, and hence the user does not come into contact with bodily fluids. In the first configuration and the third configuration, the device 1000 can be disconnected from or connected to the peripheral intravenous line 1300. In other words, the device 1000 can be in the first configuration before being connected to the peripheral intravenous line 1300, then remains in the first configuration for some a period of time after being connected to the peripheral IV line 1300. Similarly, the device 1000 may be moved to a third configuration, disconnected from the peripheral IV line 1300, and then left in the third configuration.

[1085] FIG. 3 is a detailed schematic of an apparatus 2000 according to an embodiment in a second configuration. In some embodiments, device 2000 is substantially the same as device 1000 described above with reference to FIG. 1 and 2. Therefore, aspects of the device 2000 are not described in detail in this application. Device 2000 includes an introducer 2100 and a catheter 2200. Catheter 2200 includes a proximal end 2220 and a distal end 2230. in the vein and outside the intravenous line), holes 2231 have the function of transporting bodily fluid (eg, blood) into the volume outside the catheter 2200. The set of holes 2231 may have any pattern around the circumference of the catheter 2200 and may include the end of the catheter 2200. Similarly, a catheter 2200 having a distal end 2230 may form an opening on the surface of the tip. Each hole 2231 may have any suitable shape or size, and not necessarily like any other hole contained in the set of holes 2231. In some embodiments, the catheter 2200 forms a single hole. For example, in some embodiments, the implementation of the catheter 2200 forms a single hole 2231 on the distal surface.

[1086] The proximal end 2220 of the catheter 2200 is fluidly connected to the locking mechanism 2221 as shown in FIG. 3. The locking mechanism 2221 may be any suitable locking mechanism, such as a Luer Lock™ or similar mechanism. Needle 2222 is fluidly connected to locking mechanism 2221 and is at least partially located within sheath 2223. Sheath 2223 may be of any material with suitable flexibility and/or compressibility such that needle 2222 may extend through sheath 2223 when engaged. with a conventional phlebotomy fluid container (e.g. a Vacutainer® type container). The locking mechanism 2221 is configured to connect to any suitable fluid container system, such as a Vacutainer® container holder (not shown in FIG. 3) and position the needle 2222 in fluid communication with the fluid container system. The shell 2223 is compressible when the locking mechanism 2221 is connected to the fluid container system. This solution scheme facilitates the passage of bodily fluids through the set of holes 2231 of the catheter 2200 as indicated in FIG. 3 arrow AA, through the catheter 2200 and out of the catheter 2200 through the needle 2222, as shown in FIG. 3 along the arrow BB.

[1087] FIG. 4 is a schematic representation of a device 3000 for phlebotomy through a peripheral intravenous catheter in a second configuration, in accordance with an embodiment. The device 3000 includes an introducer 3100 and a catheter 3200. The introducer 3100 includes a sheath 3110 defining a lumen 3113 between the proximal end 3120 and the distal end 3130 and configured to receive, at least partially, the catheter 3200. The distal end 3130 of the introducer 3100 includes a locking mechanism 3131 configured to fluidly couple the introducer 3100 to the peripheral IV line 3300 and position the catheter 3200 in fluid communication with the peripheral IV line 3300 when the catheter 3200 is in the second configuration. The locking mechanism 3131 may be any suitable locking mechanism that creates a fluid-tight seal. In some embodiments, the implementation of the locking mechanism 3131 may be a Luer lock (Luer Lok™) or a similar configuration. The shell 3110, having a predetermined rigidity, is configured such that when a force is applied to the proximal end 3120 (as indicated by arrow CC in FIG. 4), the shell 3110 is compressed along the axis AAA.

[1088] The compression of the sheath 3110 is such that the catheter 3200 advances into the second configuration. In other words, when the sheath 3110 of the introducer 3100 is compressed, the catheter 3200 moves from the first configuration, in which the catheter 3200 is located inside the introducer 3100 (as described above with reference to Fig. 1), to the second configuration, in which the distal end 3230 is located essentially , outside the introducer 3100, as shown in FIG. 4. In addition, the rigidity of the shell 3110 is an extensive property, and, as such, the shell may have a set of properties (i.e., material, thickness, shape, and/or similar properties) to allow the shell 3110 to be compressed along the AAA axis by force. of the desired amount applied at the proximal end 3120 of the introducer 3100. A set of properties allows the sheath 3110 to elastically (i.e., temporarily) deform so that when no more force is applied to the proximal end 3120 of the introducer 3100, the device 3000 returns to the first configuration. In the second configuration, the distal end 3230 of the catheter 3200 extends beyond the distal end of the peripheral intravenous line 3300. This solution design allows transportation of bodily fluid into a volume outside the catheter 3200 and, upon filling, the device 3000 can be placed in a third configuration substantially similar to the first configuration.

[1089] FIG. 5 and 6 are side views of an apparatus 4000 according to an embodiment in a first configuration and a second configuration, respectively. The device 4000 includes an introducer 4100 and a catheter 4200. The introducer 4100 includes a sheath 4110 defining a lumen 4113 between the proximal end 4120 and the distal end 4130 and is configured to receive, at least partially, the catheter 4200. The introducer 4100, although and shown in Fig. 5 cylindrical, may be of any suitable shape. In addition, the lumen 4113 formed by the inner walls of the shell 4110 need not have the same shape as the outer walls of the shell 4110. In other words, the inner and outer walls of the shell 4110 may have different cross-sectional shapes. The proximal end 4120 of the introducer 4100 is connected to a locking mechanism 4122. The locking mechanism 4122 may be any suitable locking mechanism, such as a Luer Lok™ or similar mechanism. The locking mechanism 4122 is configured to couple, when used, with a suitable fluid container system, such as a Vacutainer® holder (not shown in FIG. 5), to position the catheter 4200 in fluid communication with the fluid container system.

[1090] The distal end 4130 of the introducer 4100 includes a locking mechanism 4131 configured to fluidly connect the introducer 4100 to a peripheral intravenous line (not shown in FIG. 5). Thus, the locking mechanism 4131 can be configured to selectively position the catheter 4200 in fluid communication with a peripheral intravenous line. The locking mechanism 4131 may be any suitable locking mechanism that creates a fluid-tight seal. In some embodiments, the latch mechanism 4131 is in a sealed configuration until the latch mechanism 4131 is connected to an intravenous line. Once the locking mechanism 4131 is connected to the intravenous line, the seal can be opened to allow access to the catheter 4200. In addition, in the disengaged configuration, the locking mechanism 4131 of the distal end 4130 and the locking mechanism 4122 of the proximal end 4120 create a fluid-isolated volume to accommodate the catheter 4200. Similarly, before the proximal end locking mechanism 4122 and the distal end locking mechanism 4131 disengage, and before the catheter 4200 is in the second configuration, the catheter 4200 is sterile. In addition, the catheter 4200 in the second configuration, and after contact with the desired bodily fluid, can be moved to a third configuration (e.g., substantially similar to the first configuration), thereby isolating the distal end 4230 used.

[1091] Sheath 4110 has a predetermined stiffness such that when force is applied to the proximal end 4120 (as indicated by arrow DD in FIG. 6), sheath 4110 is compressed along the BBB axis. The compression of the sheath 4110 is such that the catheter 4200 advances into the second configuration. In other words, as the sheath 4110 of the introducer 4100 contracts, the catheter 4200 moves from a first configuration, in which the catheter 4200 is located within the introducer 4100, to a second configuration, in which the distal end 4230 is located substantially outside the introducer 4100 (for example, sheath 4110 is retracted). The properties of the shell 4110 may be any set of properties described herein, provided that applying the required amount of force to the proximal end 4120 allows the shell to be compressed along the axis of the BBB. In a second configuration, the distal end 4230 of the catheter 4200 extends beyond the distal end of the peripheral intravenous line and allows transportation of bodily fluid into a volume outside the catheter 4200.

[1092] The catheter 4200 includes a distal end 4230 and a tapered portion 4203. The tapered portion is such that the diameter of the catheter 4200 decreases at a predetermined location, as shown in FIG. 5. The taper angle θ may be any suitable angle, as long as the catheter 4200 is able to fully advance into the second configuration (FIG. 6). In addition, the angle θ of the cone is such that laminar flow (ie, smooth stratified flow) is provided. In some embodiments, the catheter 4200 may include a reinforcing wire 4202 as shown in FIG. 6A and can be configured to wrap around the walls of the catheter 4200 to provide the desired rigidity to the catheter 4200. In addition, the reinforcing wire 4202 wrapped around the catheter 4200 can provide the flexibility to advance along multiple lumen-forming walls (i.e., veins, arteries, peripheral intravenous lines and/or similar structures), without twisting or kinking. In addition, the reinforcing wire 4202 can provide sufficient rigidity to the catheter 4200 to facilitate its passage through the lumen.

[1093] The distal end 4230 of the catheter 4200 includes a set of holes 4231 such that, in a second configuration (e.g., when the distal end 4230 of the catheter 4200 is in a vein and outside the intravenous line), the holes 4231 perform the function of transporting bodily fluid (e.g., , blood) into the volume outside the catheter 4200. The set of holes 4231 may have any pattern around the circumference of the catheter 4200 and may include the end of the catheter 4200. Similarly, the catheter 4200 having a distal end 4230 may be substantially open at the surface tip. Although FIG. 6 and 6A represent the distal end 4230 of the catheter 4200 being substantially flat, the distal end 4230 may be any suitable shape (eg, conical or spherical) and may have edges rounded to any suitable degree. Each hole 4231 may be of any suitable shape or size, and not necessarily like any other hole contained in the set of holes 4231. The pattern of the set of holes 4231 is designed to introduce laminar flow through the catheter 4200 into a volume substantially outside the catheter 4200 and thereby thereby excluding hemolysis.

[1094] In some embodiments, the implementation of the blood collection system consists of two elements: (1) the above-described introducer/catheter assembly for blood collection; and (2) a Y adapter that is configured to attach to a standard 16g or 22g peripheral IV catheter. The Y-adapter includes a dedicated port for a blood draw device and another standard port for routine drug and fluid infusion.

[1095] For example, FIG. 7 includes a sectional view of a Y-adapter 5400 and a device 5000 in a first configuration, in accordance with an embodiment. The device 5000 includes an introducer 5100 and a catheter 5200. The introducer 5100 includes a sheath 5110 defining a lumen 5113 between the proximal end 5120 and the distal end 5130 and configured to receive, at least in part, the catheter 5200. The catheter 5200 includes proximal end 5220; and distal end 5230. Device 5000 may be substantially similar to device 4000 described above with reference to FIG. 5 and 6. Therefore, aspects of the device 5000 are not described in more detail in this application.

[1096] In some embodiments, the Y-adapter 5400 is configured to be connected between the introducer 5100 to an intravenous line 5440. The Y-adapter includes a distal end 5410 and defines a first port 5420 and a second port 5430. The first port 5420 of the Y-adapter 5400 forms a first lumen 5422 with a first diameter D ₁ . The first port 5420 is configured such that the first port 5420 is substantially similar in size, shape, configuration, and functionality to a conventional Y-adapter. In addition, the first port 5420 is configured such that the backflow of bodily fluid cannot exit the first port 5420. In particular, the first lumen 5422 defined by the walls of the first port 5420 may be such that the lumen 5422 restricts the backflow of bodily fluid (i.e. e. blood). In some embodiments, backflow can be prevented by a valve, screw cap, overlay cap, port, and/or the like.

[1097] The second port 5430 of the Y-adapter 5400 defines a second lumen 5432 with a second diameter D ₂ . As shown in FIG. 7, the second diameter D ₂ may be larger than the first diameter D ₁ . In other embodiments, the implementation of the second diameter D ₂ may be close to the first diameter D ₁ or less. In particular, the diameter D _{2 of} the second port 5430 is large enough to receive a catheter with a caliber up to, for example, 18g (gauge). The Y-adapter 5400 may be of any suitable material and/or a material similar to that of a conventional Y-adapter.

[1098] The first lumen 5422 defined by the first port 5420 and the second lumen 5432 defined by the second port 5430 converge into a common lumen 5401 to the distal end of the Y-adapter 5400 as shown in FIG. 7. The second port 5430 is configured such that the second lumen 5432 is substantially coaxial with the common lumen 5401. In addition, the common lumen 5401 may have a diameter substantially close to that of the second port 5430 D ₂ .

[1099] The second port 5430 is fluidly connected to a locking mechanism 5431 configured to connect the Y-adapter to the introducer 5100. The locking mechanism 5431 may be a Luer Lok™ or similar mechanism. In some embodiments, the Y-adapter 5400 is in a sealed configuration until connected to the locking mechanism 5131 at the distal end 5130 of the introducer 5100. Once the locking mechanism 5431 is attached to the introducer 5100, the seal may be opened to allow the catheter 5200 access to advance into the second configuration shown in FIG. 8 (note that the 5100 introducer is not shown connected to the Y-adapter in FIG. 8).

[1100] In some embodiments, the distal end 5410 of the Y-adapter 5400 is connected to a peripheral IV line 5440, such as a conventional peripheral IV line. In some embodiments, the Y-adapter 5400 is integrally formed with the peripheral IV line 5440. In some embodiments, the distal end 5410 of the Y-adapter 5400 may be attached to the peripheral IV line by any suitable locking mechanism. Similarly, the second port 5420 of the locking mechanism 5431, configured to attach the Y-adapter 5400 to the introducer 5100, may be integrally formed with the introducer 5100. In other words, in some embodiments, a separate introducer is not required, and the portion of the Y-adapter can serve as an introducer.

[1101] In the second configuration shown in FIG. 8, the distal end 5230 of the catheter 5200 is advanced substantially beyond the peripheral intravenous line 5440. The distal end 5230 of the catheter 5200 includes a set of holes 5231 such that, in the second configuration (i.e., when the distal end 5230 of the catheter 5200 is in the vein and outside the intravenous line), holes 5231 served the function of transporting bodily fluid (eg, blood) into the volume outside the catheter 5200. The set of holes 5231 may have any pattern around the circumference of the catheter 5200 and may include the end of the catheter 5200. Similarly, a catheter 5200 having a distal end 5230 may be substantially open at the tip surface. Each hole 5231 may be any suitable shape or size, and not necessarily like any other hole contained in the set of holes. The catheter 5200 in the second configuration, and after transporting the desired bodily fluid, can be placed in a third configuration (e.g., substantially similar to the first configuration shown in FIG. 7) to thereby isolate the used distal end 5230.

[1102] Although the introducer 5100 (FIGS. 7 and 8) has been described as being capable of significant compression to advance the catheter 5200, in other embodiments, the device may include a drive mechanism configured to move the catheter relative to the introducer. For example, FIG. 9-14 depict a device 6000 used for phlebotomy through a peripheral intravenous line. The device 6000 includes an introducer 6100, a cannula 6200, and an adapter 6400. The device 6000 may be of any suitable shape, size, or configuration and is configured to connect to, for example, a peripheral intravenous line (PIV) 6300.

[1103] The introducer 6100 includes a proximal end 6120 and a distal end 6130. As shown in FIG. 9-14, introducer 6100 is a substantially cylindrical tube configured to receive cannula 6200. Similarly, introducer 6100 includes a wall or a plurality of walls that define a lumen 6113 (FIG. 11) configured to selectively receive cannula 6200 The introducer 6100 and cannula 6200 may be formed from any suitable material having any desired hardness. In some embodiments, the cannula 6200 may have a hardness of 20A Shore to 50D Shore. In other embodiments, the cannula 6200 may have a Shore hardness of approximately 20A Shore to 95D Shore. In still other embodiments, the cannula 6200 may have a Shore hardness of approximately 70D Shore to 85D Shore.

[1104] The proximal end 6120 of the introducer 6100 is configured to connect to the end cap 6140. Thus, the end cap 6140 can be configured to substantially overlap and/or seal the proximal end 6120 of the introducer 6100. In some embodiments, the end cap 6140 configured to form a substantially fluid-tight seal with introducer 6100. Similarly, in some embodiments, end cap 6140 and proximal end 6120 of introducer 6100 form a substantially tight seal. In some embodiments, the end cap 6140 may be gripped by the user as the cannula 6200 is advanced.

[1105] The distal end 6130 of the introductor 6100 is connected to a locking mechanism 6131. The locking mechanism 6131 is configured to physically and fluidly attach the device portion 6000 to an existing PIV 6300. In some embodiments, the locking mechanism 6131 may be configured to be directly attached to an existing PIV 6300. In other embodiments, the locking mechanism 6131 may be coupled to an adapter 6400 and/or any other suitable intermediate structure, such as a known valve or cap.

[1106] The distal end 6130 of the introducer 6100 may be connected to the locking mechanism 6131 in any suitable manner. For example, in some embodiments, the distal end 6130 may be located within the locking mechanism portion 6131 such that the outer surface of the introducer 6100 forms a friction fit with the inner surface of the locking mechanism portion 6131. In other embodiments, the distal end 6130 of the introducer 6100 may be connected to the locking mechanism 6131 with glue. In still other embodiments, the locking mechanism 6131 may be integrally formed with the distal end 6130 of the introducer 6100. For example, in some embodiments, the locking mechanism 6131 may be formed from a material similar to that of the introducer 6100. In other embodiments, the introducer 6100 may be formed from the first material, and the locking mechanism 6131 may be formed from the second material, made with the possibility of multi-layer casting on the distal end 6130 in the manufacturing process.

[1107] As shown in FIG. 11, the locking mechanism 6131 includes a sealing member 6132 configured to form a substantially fluid-tight seal when the cannula 6200 is in the first configuration. Additionally, seal 6132 may be configured to receive, in use, a portion of cannula 6200 to allow distal advancement of cannula 6200 beyond seal 6132. Thus, seal 6132 may form a substantially fluid-tight seal around cannula 6200 such that the sealing member 6132 substantially prevents backflow into the sheath 6100. The sealing member 6132 may be of any suitable configuration, such as an o-ring, a one-way valve, a diaphragm, a check valve, or any other suitable sealing member. Although the sealing element is shown and described as being contained in the latch mechanism 6131, in some embodiments, this element may be contained in the latch mechanism 6131 and/or the adapter 6400. For example, in some embodiments, the latch mechanism 6131 may be connected to the adapter 6400 so that the sealing element contained in the adapter 6400 and/or the locking mechanism 6131 prevented the flow of bodily fluid in the proximal direction before advancing the cannula 6200, as further described in this application.

[1108] As shown in FIG. 10 and 11, the introducer 6100 further forms a guide 6111 for the drive mechanism. The driver guide 6111 may be a slot or opening defined by a wall of the introducer 6100 and is configured to receive a portion of the driver 6500. The driver guide 6111 may be configured to extend substantially the length of the introducer 6100. In some embodiments, the implementation the driver guide 6111 is configured to extend continuously through the distal end 6130 and the proximal end 6120 of the introducer 6100. The driver guide 6111 may have any suitable configuration and may be engaged with the driver portion 6500 in any suitable manner. For example, in some embodiments, the walls of the introducer 6100 defining the driver guide 6111 may form a friction fit with the driver portion 6500, as described in more detail herein.

[1109] Cannula 6200 defines lumen 6201 (FIG. 11) and is movable within introducer 6100. As described above with reference to FIG. 5, the cannula 6200 may be configured to include a first section 6205 having a first diameter and a second section 6210 having a second diameter less than the first diameter. In particular, the first section 6205 is located at the proximal end 6220 of the cannula 6200 and the second section 6210 is located at the distal end 6230 of the cannula 6200. Thus, for example, the diameter of the cannula 6200 is reduced at the distal end 6230 of the catheter 6200 to facilitate insertion of the catheter 6200 into a peripheral intravenous line, as described in more detail in this application.

[1110] As described above with reference to FIG. 6A, the distal end 6230 of the cannula 6200 may be configured to contain any suitable number of holes (not shown in FIGS. 9-14). For example, in some embodiments, the distal end 6230 of the cannula 6200 may include a substantially open end surface configured to accommodate the lumen 6201 in fluid communication with, for example, a vein. In some embodiments, the end surface may be substantially flat (e.g., perpendicular to the longitudinal axis of the cannula 6200. In other embodiments, the end surface may have any suitable configuration, such as a substantially bullet-shaped, conical, bulbous, or similar configuration. In still other embodiments, the end surface may be the end surface may be substantially at an angle to the longitudinal axis of the cannula 6200 (e.g., similar to the tip of a needle.) In addition, in some embodiments, the distal end 6230 may be configured to contain an open end surface and an opening located on the side surface of the cannula 6200. Thus, the side opening (not shown in FIGS. 9-14) can be configured to dispense a portion of bodily fluid even if the end face opening is obstructed (eg, by a clot or the like).

[1111] The drive mechanism 6500 is connected to the proximal end 6220 of the cannula 6200 and is configured to move the cannula 6200 relative to the introducer 6100 between the first configuration and the second configuration. In particular, the drive mechanism 6500 forms a substantially annular shape that defines a cavity 6510 configured to receive the proximal end 6120 of the introducer 6100 and the proximal end 6220 of the cannula 6200. Similarly, the drive mechanism 6500 is located around the introducer 6100 and cannula 6200. the mechanism 6500 is designed so that the guide element 6520 and the coupler 6530 continue from the inner surface of the drive mechanism 6500.

[1112] The guide element 6520 may have any suitable shape, size or configuration. For example, as shown in FIG. 10, the guide element 6520 is a relatively thin extension. Thus, the guide member 6520 is positioned within the drive guide 6111 when the drive mechanism 6500 is positioned around the introducer 6100. element 6520 within the driver guide 6111 may be such that the driver 6500 is substantially held in position relative to the introducer 6100 until forces are applied to the driver 6500 to move the driver 6500 into the second configuration. Similarly, the drive mechanism 6500 engages with the introducer 6100 such that the drive mechanism 6500 does not substantially move without user intervention (eg, applying force to the drive mechanism 6500). In other embodiments, the drive mechanism 6500 is not required to include a guide member 6520. In these embodiments, the drive mechanism 6500 may be configured to form a friction fit with the introducer 6100 when the drive mechanism 6500 is positioned around the introducer 6100 (e.g., the inner surface of a wall or walls forming the annular shape of the drive mechanism 6500 engages the outer surface of the introducer 6100 to form a friction fit).

[1113] the Coupling 6530 is located on the upper surface of the guide element 6520 (for example, the guide element 6520 is located between the coupling 6530 and the inner surface of the drive mechanism 6500). As shown in FIG. 11 and 13, the connector 6530 is connected to the proximal end 6220 of the cannula 6200. In some embodiments, the outer surface of the proximal end 6220 of the cannula 6200 forms a friction fit with the inner surface of the connector 6530. In other embodiments, the distal end 6220 of the cannula 6200 may be attached to the connector. coupling 6530 with adhesive. Thus, the proximal end 6220 of the cannula 6200 and the connector 6530 form a substantially fluid-tight seal.

[1114] The proximal end 6540 of the drive mechanism 6500 is connected to an additional cannula 6250, further configured to be connected to the protective casing 6270 of the container. The container guard 6270 defines a cavity 6271 configured to receive a fluid reservoir (eg, a conventional Vacutainer® type phlebotomy fluid container). In particular, the accessory cannula 6250 defines a lumen 6253 and includes a proximal end 6252 operable to mate with a locking mechanism 6524. The latching mechanism 6524 may be operable to mate with a container guard 6270. In addition, the locking mechanism 6524 includes a needle 6525 positioned within a sheath 6526 configured to pierce a portion of the fluid reservoir (e.g., as described above with reference to FIG. 3) when the fluid reservoir (not shown) is positioned within the protective casing 6270 container. Therefore, in the case of attaching the proximal end 6220 of the cannula 6200 to the coupling 6530 and attaching the additional cannula 6250 to the proximal end 6540 of the adapter 6500, the adapter 6500 is configured to accommodate the cannula 6200 (for example, the lumen 6201 formed by the cannula 6200) in a fluid communication position with an additional cannula 6250 (for example, the lumen 6253 of the additional cannula 6250) and a fluid reservoir (not shown).

[1115] Although the device 6000 is described as including an additional cannula 6250, in some embodiments, the device need not include an additional cannula 6250. In these embodiments, the cannula 6200 may form a continuous fluid flow path (e.g., lumen 6201) from distal end 6230, through the connector 6530 and into the protective cover 6270 of the container. In other embodiments, the container shroud 6270 may be configured to be physically and fluidly coupled to the drive mechanism 6500.

[1116] The adapter 6400 may be any suitable adapter 6400. For example, in some embodiments, the adapter may be a known Y-adapter or a T-adapter (eg, a two-port IV accessory kit). In other embodiments, the adapter may be similar in form and function to the adapter 5400 described above with reference to FIG. 7 and 8. As shown in FIG. 10, adapter 6400 is a T-adapter and includes a distal end 6410, a first port 6420, and a second port 6430. The distal end 6410 defines a port and includes a locking mechanism 6411 configured to connect to a peripheral intravenous line 6300. Thus , the locking mechanism 6411 may be any suitable known locking mechanism such that the distal end 6410 of the adapter 6400 can mate with the known PIV 6300.

[1117] The first port 6420 may be connected to the distal end 6427 of the inlet catheter 6425. In some embodiments, the distal end 6427 of the inlet catheter 6425 forms a frictional fit with the inner surface of the first port 6420. In some embodiments, the distal end 6427 of the inlet catheter 6425 may include itself a fitting configured to engage with the first port 6420 (for example, a threaded fitting). In other embodiments, the inlet catheter 6425 may be integrally formed with the first port 6420 of the adapter 6400. The inlet catheter 6425 further includes a proximal end 6426 configured to couple to the locking mechanism 6428. Thus, the inlet catheter 6425 may be inserted by a user (eg, a doctor, nurse, or the like) to deliver a fluid (eg, drug, or the like) into a peripheral intravenous line, and hence into a patient's vein. In some embodiments, the inlet catheter 6425 is substantially similar in shape and function to known inlet catheters. Therefore, with the adapter 6400 connected to the PIV 6300 and the PIV 6300 located inside the patient, the user can inject the desired fluid into the patient through the inlet catheter 6425, without additional preparation for the operation of the adapter 6400.

[1118] In use, a user (eg, a phlebotomist) may grip the actuator 6500 of the blood collection device 6000 to move the actuator 6500 in a distal direction, as indicated by the arrow EE in FIG. 12. Thus, the drive mechanism 6500 moves distally relative to the introducer 6100 to place the device in the second configuration. As described above, the user may apply sufficient force to the drive mechanism 6500 to overcome the friction between the walls of the introducer 6100 and the guide member 6520 of the drive mechanism 6500. direction simultaneously with the drive mechanism 6500 into the second configuration.

[1119] As indicated by the arrow FF in FIG. 13, the cannula 6200 is advanced through the sealing member 6132 contained in the locking mechanism 6131, through the lumen 6401 defined by the adapter 6400, and over the PIV 6300 such that the distal end 6230 of the cannula 6200 passes behind the PIV 6300. Thus, the distal end 6230 of the cannula 6200 is placed substantially within the patient's vein such that the lumen 6201 formed by the cannula 6200 is in fluid communication with the vein. As shown in FIG. 13A, the cannula 6200 may be advanced along the PIV 6300 such that the distal surface 6206 of the first portion 6205 of the cannula 6200 is placed in contact with the proximal surface 6301 of the PIV 6300 portion. Therefore, the distal surface 6206 of the cannula 6200 engages with the proximal surface 6301 of the PIV 6300 to prevent the cannula 6200 from advancing beyond the second configuration. Similarly, the distal surface 6206 is configured to contact the proximal surface 6301 of the PIV site 6300 to restrict the delivery of the cannula 6200. Although the first section 6205 and the second section 6210 of the cannula 6200 shown in FIG. 13A have substantially the same internal diameter, in other embodiments, the first section 6205 may have a significantly larger internal diameter than the second section 6210. In some embodiments, the internal wall or set of internal walls that define the lumen 6201 may include a tapered transition. between the first section 6205 and the second section 6210. In other embodiments, the interior wall or walls need not include a tapered section.

[1120] Although in FIG. 13 and not shown, a fluid container (e.g., a Vacutainer® container) may be placed in a cavity 6271 defined by the container guard 6270 such that the sheath 6256 is removed from the needle 6255 and the needle 6255 pierces the fluid container, which positions the container for fluid into a state of fluid communication with the patient's vein. In other embodiments, the fluid container may be integrally formed with the container guard 6270 and/or introducer such that movement of the drive mechanism 6500 may cause the needle 6255 to pierce the fluid container. In some embodiments, the fluid container is configured to set negative pressure (eg, a Vacutainer® container). In these embodiments, when the needle 6255 pierces the fluid container, the negative pressure inside the fluid container applies a suction force within the lumen 6253 of the accessory cannula 6250 and the lumen 6201 of the cannula 6200. The suction force is such that bodily fluid (e.g., blood) is withdrawn through the lumen 6201 of cannula 6200 and lumen 6253 of additional cannula 6250 and into the fluid container as indicated by arrow GG in FIG. 13. Thus, the phlebotomist can withdraw (eg draw) a given amount of blood through an existing peripheral intravenous line, without the need for additional needle punctures.

[1121] Once the desired amount of bodily fluid has been withdrawn, the user (eg, phlebotomist) may move the actuator 6500 proximally to position the device 6000 in a third (used) configuration as indicated by arrow HH in FIG. 14. In a third configuration, the cannula 6200 is substantially fluidly isolated from the volume outside the introducer 6100. Therefore, the introducer 6100 (eg, locking mechanism 6131) can be detached from the second port 6430 of the adapter 6400 and safely disposed of.

[1122] Although the device 6000 (shown and described with reference to Figs. 9-14) includes a one-piece introducer 6100, in some embodiments, the implementation of this device may include a composite introducer designed for telescopic movement. For example, FIG. 15-22 depict a device 7000 in accordance with an embodiment. As shown in FIG. 15-17, the device 7000 includes an introducer 7100 and a cannula 7200 and is movable between a first configuration (FIGS. 15) and a second configuration (FIGS. 16 and 17), as described in more detail herein.

[1123] The introducer 7100 includes a first element 7150 defining a first lumen 7155 and a second element 7160 defining a second lumen 7165. In some embodiments, the first element 7150 is a substantially cylindrical tube having a first diameter, and the second element 7160 is essentially a cylindrical tube having a second diameter larger than the first diameter. Thus, the lumen 7165 defined by the second element 7160 is configured to receive at least a portion of the first element 7155. In particular, the first element 7150 is movably positioned within the second element 7165 such that the introducer 7100 can be telescopically moved. Similarly, the second element 7160 is movable between a first position and a second position relative to the first element 7150. In addition, the second element 7160 includes a drive portion 7500 configured to be gripped by a user (e.g., a phlebotomist) to move the second element 7160 relative to the first element 7150.

[1124] The introducer 7100 includes a proximal end 7120 and a distal end 7130. The proximal end 7120 includes a port 7121. Port 7121 may be any suitable port. For example, in some embodiments, port 7121 is substantially the same as port 1121 described above with reference to FIG. 1 and 2. Thus, port 7121 is configured to receive the catheter portion 7200, as described in more detail herein. The distal end 7130 may be connected to a locking mechanism 7131. The locking mechanism 7131 may be any suitable mechanism, such as a Luer Lok™. In some embodiments, the latch mechanism 7131 may be substantially the same as the latch mechanism 6131 described above with reference to FIG. 9-14. Therefore, the locking mechanism 7131 is not described in more detail in this application.

[1125] The introducer 7100 is configured to receive at least a portion of the cannula 7200. 7220 of the cannula 7200 passes through the port 7121 of the introducer 7100. Therefore, the cannula 7200 is movable relative to at least a portion of the introducer 7100 between the first configuration and the second configuration, as further described herein.

[1126] The proximal end 7220 of the cannula 7200 is connected to a locking mechanism 7221. The locking mechanism 7221 may be any suitable locking mechanism, such as a Luer Lok™. In addition, the locking mechanism 7221 is connected to the needle 7222 such that when the proximal end 7220 of the cannula 7200 is connected to the locking mechanism 7221, the lumen (not shown in FIGS. 15-22) formed by the cannula 7200 is in the fluid communication position. with a lumen (not shown in FIGS. 15-22) formed by needle 7222. The distal end 7230 of cannula 7200 includes a first section 7205 having a first diameter and a second section 7210 having a second diameter smaller than the first diameter. As shown in FIG. 17, the cannula 7200 is configured to contain a cone between the first section 7205 and the second section 7210. The cone may be of any suitable configuration and may be substantially the same as the cone section 4203 described above with reference to FIG. 5.

[1127] As shown in the exploded view in FIG. 18, the locking mechanism 7131 is configured to couple to an adapter 7400. The adapter includes a distal end 7410, a first port 7420, and a second port 7430. The adapter 7400 may be any suitable adapter described herein. For example, in some embodiments, the adapter may be substantially the same as the adapter 6400 described above with reference to FIG. 9-14. In other embodiments, the adapter 7400 may be any known, such as a Y adapter or a T adapter. Therefore, the first port 7420 of the adapter 7400 is configured to connect to the inlet catheter 7425. The inlet catheter 7425 may have any suitable configuration. In some embodiments, the inlet catheter 7425 is substantially similar in shape and function to the inlet catheter 6425 described above with reference to FIG. 9-14. Therefore, the inlet catheter 7425 is not described in detail in this application.

[1128] The second port 7430 is configured to connect to the locking mechanism 7131. Thus, the second port 7430 and the locking mechanism 7131 can be configured to form a substantially fluid-tight seal. For example, in some embodiments, the second port 7430 may include a threaded connection configured to engage with the threaded connection of the locking mechanism 7131, thereby forming a substantially fluid-tight seal. In addition, the locking mechanism 7131 may include a sealing member (not shown in FIGS. 15-22) configured to selectively fluidly seal the lumen 7113 defined by the introducer 7100 from the lumen (not shown) defined by the adapter. For example, in some embodiments, the sealing element may be substantially similar in shape and function to the sealing element 6132 described above with reference to FIG. 11. The distal end 7410 of the adapter 7400 is configured to connect to the PIV 7300. In some embodiments, the PIV 7300 is a known PIV. Thus, the distal end 7410 of the adapter 7400 may include any suitable structural element configured to physically and fluidly couple the adapter 7400 to the PIV 7300.

[1129] As shown in FIG. 19, the device 7000 may be in such a first configuration that the second element 7260 of the introducer 7100 is positioned proximal to the first element 7150 of the introducer 7100. , and move the second element 7160 in the distal direction as indicated by arrow II in FIG. 20. Therefore, the introducer 7100 moves telescopically such that the second element 7160 moves relative to the first element 7150. Similarly, the overall length of the introducer 7100 decreases as the second element 7160 moves relative to the first element 7150. In addition, movement of the second element 7160 in the distal direction is such that the cannula 7200 moves distally. Therefore, the distal end 7230 of the cannula 7200 passes through the sealing member contained in the locking mechanism 7131 (as similarly described above with reference to FIGS. 11 and 13) and over the PIV 7300. As shown in the enlarged view in FIG. 22, the distal end 7230 of the cannula 7200 extends beyond the PIV 7300 to position the lumen (not shown) formed by the cannula 7200 in fluid communication with a portion of the patient's body (eg, a vein). In addition, in some embodiments, the adapter 7400 may be configured to include a sealing member 7470 configured to receive the cannula 6200. Thus, the sealing member 7470 may prevent backflow of bodily fluid into, for example, the sheath 7100.

[1130] With the device 7000 in the second configuration (eg, FIGS. 20-22), the user may position a fluid container (eg, a Vacutainer® container or any other suitable fluid container) within the container guard 7270 such that the container comes into engagement with the needle 7222. Thus, the needle 7222 can pierce a portion of the fluid container (not shown) to bring the fluid container into position in fluid communication with the lumen formed by the cannula 7200. In addition, when the distal end 7230 of the cannula is positioned 7200 within, for example, a patient's vein, the fluid container may be in a position of fluid communication with the vein. In some embodiments, such as those where the fluid container is a Vacutainer® container or the like, the fluid container may apply negative pressure (eg, the fluid container is a vacuum container). In these embodiments, the negative pressure provided by the fluid container may apply a suction force to the lumen formed by the cannula 7200 so that bodily fluid (eg, blood) is aspirated through the cannula 7200 and into the fluid container. Therefore, the phlebotomist can withdraw (eg, draw) a given amount of blood through an existing peripheral intravenous line, without the need for additional needle punctures.

[1131] Although the apparatus 7000 described above with reference to FIG. 15-22 includes an introducer 7100 with a first element 7150 and a second element 7160, in some embodiments, this device may include an introducer with any suitable number of sections or elements. For example, FIG. 23 and 24 depict an apparatus 8000 in accordance with an embodiment. Device 8000 includes at least an introducer 8100 and a cannula or catheter 8200 and is movable between a first configuration (FIG. 23) and a second configuration (FIG. 24).

[1132] The introducer 8100 includes a first element 8150, a second element 8160, and a third element 8170. In some embodiments, the first element 8150 may have a first diameter, the second element 8160 may have a second diameter greater than the first diameter, and a third element 8170 may have a third diameter larger than the second diameter. Therefore, at least a portion of the first element 8150 may be movable within the second element 8160. Similarly, at least a portion of the second element 8160 may be movable within the third element 8170. Therefore, the introducer 8100 may be configured to the ability to move it telescopically, as similarly described above with reference to the introducer 7100.

[1133] As shown in FIG. 23 and 24, the first element 8150 includes a set of protrusions 8156 located at the proximal end 8151 and the distal end 8152 of the first element 8150. The second element 8160 likewise includes a set of protrusions 8166 and a set of grooves 8167 located at the proximal end 8161 and the distal end. 8162 of the second element 8160. Similarly, the third element 8170 includes a set of grooves 8177 located at the proximal end 8171 and the distal end 8172 of the third element 8170. as described in more detail in this application.

[1134] The introducer 8100 includes a proximal end 8120 and a distal end 8130. The proximal end 8120 is configured to receive a portion of the catheter 8200. In particular, the catheter 8200 is movable within the introducer 8100 such that the proximal end 8220 passes through the 8120 introducer 8100. The distal end 8130 introducer 8100 is connected to the locking mechanism 8131. Locking mechanism 8131 can be any suitable locking mechanism described in this application. Therefore, the locking mechanism 8131 is not described in more detail in this application.

[1135] The catheter 8200 includes a proximal end 8220 and a distal end 8230. As described above, the proximal end 8220 is configured to extend through the proximal end 8120 of the introducer 8100 when the catheter 8200 is located within the introducer 8100. The proximal end 8220 is connected to the locking mechanism 8221 The locking mechanism 8221 is further connected to the needle 8222 and sheath 8223. The locking mechanism 8221, needle 822, and sheath 8223 may be substantially similar in form and function to the locking mechanism 2221, needle 2222, and sheath 2223, respectively, described above with reference to FIG. 3. Therefore, locking mechanism 8221, needle 8222, and sheath 8223 are not further described in this application.

[1136] As shown in FIG. 23, the device 8000 may be in a first configuration such that the introducer 8100 is in an unfolded configuration. Similarly, the third element 8170 of the introducer 8100 is in a proximal position relative to the second element 8160, and the second element 8160 is in a proximal position relative to the first element 8150. More specifically, in the first configuration, the grooves 8167 located at the distal end 8162 of the second element 8160 are in contact with protrusions 8156 located at the proximal end 8151 of the first element 8150. Similarly, the grooves 8177 located at the distal end 8172 of the third element 8170 are in contact with the protrusions 8166 located at the proximal end 8161 of the second element 8160. grooves 8167 and 8177, respectively, is such that the introducer 8100 is held in an unfolded (eg, expanded or expanded) configuration. In addition, the protrusions 8156 and 8166 can form a friction fit with the surface defining the grooves 8167 and 8177. Therefore, the introducer 8100 can be held in the first configuration until an external force is applied to the introducer 8100 to move the introducer into the second configuration.

[1137] For example, in use, a user (eg, a phlebotomist) may grip the introducer 8100 and apply a predetermined force as indicated by arrow JJ in FIG. 24. In this case, the applied force may be such that the third element 8170 moves distally relative to the second element 8160. Similarly, the second element 8160 moves distally relative to the first element 8150 (for example, the applied force is large enough to overcome the frictional force between projections 8156 and 8166 and the groove-forming surface 8167 and 8177, respectively). Therefore, the introducer 8100 moves into a second configuration in which the introducer 8100 is substantially folded or collapsed. In addition, the relative movement in the distal direction of the third element 8170 and the second element 8160 is such that the set of grooves 8167 at the proximal end 8161 and the distal end 8162 of the second element 8160 engages with the set of protrusions 8156 at the proximal end 8151 and the distal end 8152, respectively. , of the first element 8150. Similarly, a set of grooves 8177 at the proximal end 8171 and distal end 8172 of the third element 8170 engages with a set of protrusions 8166 at the proximal end 8161 and distal end 8162 of the second element 8160.

[1138] Thus, the introducer 8100 is in the second configuration and the set of protrusions 8156 and 8166 is engaged with the surfaces forming the set of grooves 8167 and 8177 to form a friction fit. Therefore, the introducer 8100 is held in the second configuration. In addition, the telescopic movement of the introducer 8100 is such that the catheter 8200 located inside the introducer 8200 is advanced through the locking mechanism 8131 as shown in FIG. 24. As described in this application, the locking mechanism 8131 can be connected to any suitable adapter and/or peripheral intravenous line. Therefore, in the second configuration, the catheter 8200 extends beyond the PIV to withdraw a portion of bodily fluid as described herein (eg, similar to the device 7000 described herein with reference to FIGS. 15-22).

[1139] Although the apparatus 6000 described above with reference to FIG. 9-14 includes an annular drive mechanism 6500, in some embodiments, this device may include any suitable drive mechanism. For example, FIG. 25 and 26 show a device 9000 according to an embodiment in a first configuration and a second configuration, respectively. The device 9000 includes an introducer 9100, a cannula 9200, and a drive mechanism 9570. The introducer 9100 includes a proximal end 9120 and a distal end 9230 and defines a lumen 9113. end 9220 and distal end 9230 and forms a lumen 9201. The introducer 9100 and cannula 9200 may be substantially similar in form and function to any introducer, cannula and/or catheter described herein. Therefore, introducer 9100 and cannula 9200 are not described in more detail in this application.

[1140] As shown in FIG. 25, the drive mechanism 9570 may be in the form of a mandrel or a wire. Therefore, the drive mechanism 9570 may be movably positioned within the cannula 9200. In addition, the drive mechanism 9570 may be rigid enough, for example, to advance the cannula 9200 through the introducer 9100, the locking mechanism 9131, and the existing PIV (not shown in FIGS. 25 and 26). ), essentially without twisting or bending. The drive mechanism 9570 may be movable in a proximal direction relative to the cannula 9200, as indicated by the arrow KK in FIG. 26. Therefore, the drive mechanism 9570 can be removed from the cannula 9200 and the cannula 9200 can be placed in a position in fluid communication with the fluid container. Thus, the cannula 9200 can facilitate the transfer of bodily fluid from the patient to the fluid container, as described above.

[1141] Although the embodiments described herein have included an introducer, in some embodiments, the device need not include an introducer. For example, FIG. 27 and 28 show an apparatus 10000 according to an embodiment in a first configuration and a second configuration, respectively. Device 10000 may include a cannula or catheter 10200 with a proximal end 10220 and a distal end 10230. Cannula 10200 may be substantially similar in shape or function to any cannula/catheter described herein. For example, in some embodiments, the proximal end 10220 includes a locking mechanism 10221, needle 10222, and sheath 10223 substantially similar to the locking mechanism 2221, needle 2222, and sheath 2223 described above with reference to FIG. 3.

[1142] The catheter 10200 is connected to a handle 10590 configured to be gripped by a user (eg, a phlebotomist). The device 10000 may further include a locking mechanism 10131. The locking mechanism 10131 may be substantially similar in form and function to the locking mechanism 6131 described above with reference to FIG. 11. Therefore, in use, the user can attach the locking mechanism 10131 to the PIV 10300 and form a fluid-tight seal. When the locking mechanism 10131 is connected to the PIV 10300, the user can grip the handle 10590 connected to the catheter 10200 to advance the catheter 10200 through the locking mechanism 10131 and PIV 10300 as indicated by the arrow LL in FIG. 28. Thus, the catheter 10200 can be placed in fluid communication with the fluid container, and when the catheter 10200 passes beyond the PIV 10300, the catheter 10200 can facilitate the transfer of bodily fluid from the patient into the fluid container, as described above.

[1143] Although this application describes specific cannulas or catheters containing a specific distal end configuration (i.e., with holes around the circumference, etc.), in some embodiments, the distal end of the catheter or cannula may include a different design, configured to facilitate the collection of blood through the catheter. For example, FIG. 29 depicts a catheter 11200 that includes a distal portion 11230 with a bullet tip 11232. The bullet tip 11232 includes an end portion 11233 that defines a single opening 11234 on the distal end surface of the bullet tip.

[1144] In some embodiments, for example, the catheter 11200' shown in FIG. 30, the bullet tip 11232' includes an end portion 11233' that defines an end hole 11234'. In these embodiments, the implementation of the bullet tip 11232' includes a set of side holes 11231'. End hole 11234' and side holes 11231' can be configured to create a laminar flow and perform the function of transporting bodily fluid (ie, blood) into the volume outside the catheter 11200'. Although holes 11231, 11231', 11234, and 11234' are depicted as having a specific configuration, the shape and orientation/relative position of the holes can be changed to facilitate fluid flow through the catheter.

[1145] As shown in FIG. 31, the bullet tip 11232' may be configured to contain a substantially closed, rounded end portion 11233'. Therefore, the 11232' bullet tip can be used to navigate through clots that exist within a peripheral intravenous line. Bullet tip 11232' includes a set of side holes 11231' which are operative to transport bodily fluid (ie, blood) into a volume outside the catheter 11200'.

[1146] In some embodiments, such as those shown in FIG. 32-34, the catheter 12200 includes a distal end 12230 with a stent-like skeleton wire tip 12241. The skeleton wire tip 12241 may be a flexible metal mesh configured to extend from the distal end 12230 of the catheter 12200. The skeleton wire tip 12241 may have the function of transporting bodily (i.e., blood) into a volume outside the catheter 12200. In some embodiments, the skeleton wire tip 12241 may include a capped end 12242. Capped end 12242 may have any suitable size, shape, or configuration, and, in some embodiments, may contain any suitable number of holes.

[1147] In some embodiments, the scaffold tip wire 12241 can be connected to the guidewire 12243 and used without an additional catheter, as shown in FIG. 35-37. Similarly, the 12241 scaffold wire can be inserted into an existing peripheral IV line with a guidewire and without the catheter shown in FIG. 10. Therefore, the skeleton wire tip 12241 can function as a stent and support the walls of a vein so that blood can be drawn through an existing peripheral intravenous line. In this configuration, the 12241 scaffold wire can be placed inside an existing peripheral IV line at any suitable location. For example, a skeleton wire tip can be placed near the distal end of an intravenous line.

[1148] As described above with reference to FIG. 9-14, the blood collection device 6000 may be attached to an adapter 6400, which is further connected to the PIV 6300. As mentioned, the adapter 6400 may be any suitable adapter. For example, in some embodiments, adapter 13400 may be any of the adapters 13400 shown in FIG. 38-43. In these embodiments, the adapters 13400 may be dual port adapters, such as Y adapters or T adapters. In these embodiments, adapters 13400 may include any of the locking mechanisms, valves, connectors, seals, and/or the like described herein.

[1149] Although in FIG. 38-43 show dual port adapters 13400, in some embodiments, the adapter may include a single port. For example, in some embodiments, adapter 14400 may be any adapter 14400 shown in FIG. 44 and 45. In these embodiments, adapter 14400 includes a single port configured to introduce fluid and/or withdraw fluid to or from the body.

[1150] FIG. 46 is a flowchart explaining a method for collecting blood through a peripheral intravenous line. In some embodiments, the method 100 includes connecting the introducer sheath to a peripheral intravenous line (PIV) at 102. For example, in some embodiments, the introducer sheath may include a locking mechanism located at a distal end portion configured to engage with a known PIV. Thus, the locking mechanism can physically and fluidly attach at least a portion of the introducer to the PIV. In some embodiments, the implementation of the adapter is located between the PIV and the locking mechanism.

[1151] The introductor sheath is configured to receive, at least partially, a catheter. The method 100 further includes advancing the catheter from a first position, in which the catheter is substantially inside the introducer, to a second position, in which the catheter is substantially outside the introducer, at 104. For example, in some embodiments, the catheter, at least operably connected to the drive mechanism such that a user can grip the drive mechanism to move the catheter in a distal direction relative to the introducer. Thus, the catheter moves distally and can be advanced through the locking mechanism, adapter (if present) and PIV. In addition, the catheter may be advanced so that the distal end of the catheter extends past the PIV and into a site (eg, vein) of the patient.

[1152] The method 100 includes attaching a container to the proximal end of the introducer sheath such that the container is in fluid communication with the catheter, at 106. In some embodiments, the proximal end of the catheter includes a needle configured to pierce a portion of the container to liquid, such as a Vacutainer® container. Therefore, the catheter is placed in a position in fluid communication with the fluid container. In particular, when the catheter is located within, for example, a patient's vein, the fluid container is positioned in fluid communication with the vein. Therefore, the required amount of bodily fluid (eg, blood) can be taken from the patient and stored in the fluid container.

[1153] After the desired amount of bodily fluid has been withdrawn, method 100 may include retracting the catheter from the second position to the first position at step 108. Therefore, the catheter may be moved in a proximal direction such that the distal end of the catheter is again positioned within the introducer . When the distal end of the catheter is located within the catheter, the introducer and/or locking mechanism may be configured to fluidly isolate the catheter from a volume outside the introducer. In this way, the introducer and catheter can be safely discarded without concern for the spread of fluid-borne pathogens.

[1154] FIG. 47-68 depict a device 15000 (also referred to in this application as a liquid transfusion device) in accordance with an embodiment. The transfusion device 15000 may be of any suitable shape, size, or configuration and may be connected to a PIV (not shown in FIGS. 47-68), such as through an adapter and/or locking mechanism. As described in more detail herein, the transfusion device 15000 can be manipulated to advance the catheter through an existing and/or established PIV (i.e., when the transfusion device 15000 is connected to the PIV) such that at least the end portion of the catheter located in a distal position relative to the PIV. In addition, when using peripheral intravenous lines, each having a shape, size and/or configuration that may vary depending on, for example, the manufacturer of the PIV and/or its intended use, the fluid transfusion device 15000 can be configured to connect the device 15,000 transfusing fluid with a PIV having any suitable configuration and then advancing at least a portion of the catheter through the PIV substantially without kinking, snagging, tearing, and/or other undesirable reshaping of the catheter.

[1155] As shown in FIG. 47, the transfusion device 15000 includes an introducer 15100, a catheter 15200, an actuator 15570, and an adapter 15450. The adapter 15450 may be any suitable adapter, such as a Y adapter or a Y adapter. For example, in this embodiment, the adapter 15450 is a T-adapter including a first port 15451 connected to the introducer 15100, a second port 15452 connected to a cannula 15455 which in turn is connected to a coupler 15456, and a third port 15453, which can be connected to a PIV (not shown). In some embodiments, ports 15451, 15452, and 15453 may be and/or include a Luer Lock™ or similar device that may provide a fluid-tight seal to ports 15451, 15452, 15453 when the adapter 15450 is not attached. to a device (eg, a transfusion device 15000, PIV, etc.). In some embodiments, adapter 15450 may be substantially the same as any of the adapters detailed above (eg, adapters 6400, 7400, and/or 13400). As such, the 15450 adapter is not described in more detail in this application.

[1156] The introducer 15100 of the transfusion device 15000 includes a first element 15150 and a second element 15160. The introducer 15100 may have any suitable shape, size, or configuration. For example, in some embodiments, the introducer 15100 may be located in and/or may have a telescoping solution(s) substantially, for example, similar to those described above with reference to the devices 7000 and/or 8000. In some embodiments, implementation of the introducer 15100 may have a shape that is, for example, similar to a syringe or similar device. As shown in FIG. 47-52, the first element 15150 includes a proximal end portion 15151, a distal end portion 15152, and an inner surface 15153. The inner surface 15153 defines an interior volume 15155 and a channel 15157. As shown in FIG. 48, the first element 15150 includes a first half 15150A and a second half 15150B, which can be connected to each other (for example, ultrasonic welding, adhesive, mechanical fasteners, one or more tabs, latches, pins, and/or the like) to form first element 15150. In some embodiments, the implementation of the connection of the first half 15150A with the second half 15150B (for example, during manufacture) to form the first element 15150 may facilitate the process of manufacturing the first element 15150. For example, in some embodiments, the formation of the first element 15150 from the first half 15150A and the second half 15150B can reduce unwanted variation in the shape and/or dimensions of the inner surface 15153 (e.g., due to taper angles and/or manufacturing tolerances) during manufacture, which can, in some cases, reduce the chance of twisting, bending, and/or deforming the catheter 15200 while using the device 15,000 fluid transfusions.

[1157] In other embodiments, the implementation of the first element 15150 can be formed in one piece (for example, injection molding and/or using any other suitable manufacturing process). That is, the first element 15150 may be formed from one piece or, instead, two pieces, namely the first half 15150A and the second half 15150B. Thus, with respect to the structural elements of the first element 15150, these structural elements may be formed and/or formed by the first half 15150A, formed and/or formed by the second half 15150B, jointly formed and/or formed by the first half 15150A and the second half 15150B, or when the first element 15150 is formed from a single piece, formed and/or formed by the corresponding section of the first element 15150. For example, in this embodiment, the first half 15150A and the second half 15150B together form the proximal end section 15151, the distal end section 15152 and the inner surface 15153 of the first element 15150 .

[1158] As shown in FIG. 49 and 50, the proximal end portion 15151 of the first element 15150 includes a grip flange 15159 extending radially from the outer surface of the first element 15150. , as described in more detail in this application. The distal end portion 15152 of the first element 15150 includes and/or is otherwise connected to a locking mechanism 15131. The locking mechanism 15131 may be essentially the same as any of these mechanisms described in this application. In some embodiments, the implementation of the locking mechanism 15131 may be a Luer lock (Luer Lok™) or similar mechanism. Essentially, the first end of the locking mechanism 15131 is connected to the distal end portion 15152 of the first element 15150, and the second end opposite the first end is connected to the adapter 15450 (eg, the first port 15451). Alternatively, in some cases, the second end of the locking mechanism 15131 may be connected directly to the PIV (not shown in Figs. 47-68).

[1159] As shown in FIG. 50, the locking mechanism 15131 includes a sealing element 15190 that is in contact with, for example, the distal surface of the first element 15150 to form a substantially fluid-tight seal. In use, the sealing member 15190 can accommodate a portion of the second member 15160 to allow the portion of the second member 15160 and/or the cannula 15200 to advance distally past the sealing member 15190 while maintaining a substantially fluid-tight seal around the portion of the second member 15160, which, essentially prevents backflow of fluid into the introducer 15100. The sealing element 15190 may have any suitable configuration, such as an o-ring, a single-way valve, a diaphragm, a self-tightening diaphragm, a check valve, or any other suitable sealing element, such as those described herein. application. Although the seal is shown and described as being contained in the latch mechanism 15131, in some embodiments, the seal may be contained in the latch mechanism 15131, adapter 15450, and/or first element 15150, as described above. In addition, the sealing element 15190 may be in contact with the site of the second element 15160 in such a way that a friction force is created between them. In some cases, the frictional force is sufficient to selectively limit the movement of the second element 15160 relative to the first element 15150, as described in more detail in this application.

[1160] As shown in FIG. 50-52, the first element 15150 includes a plurality of annular or similar walls that form an inner surface 15153. The inner surface 15153 may define a cross-sectional area of any suitable shape and/or size. For example, the cross-sectional area defined by the inner surface 15153 (i.e., the cross-sectional area of the inner volume 15155) may be substantially circular, with a size that is sufficient to accommodate at least a portion of the second element 15160, the catheter 15200 and/or drive mechanism 15570. Thus, the inner volume 15155 defined by the inner surface 15153 may be substantially cylindrical, with a size that is sufficient to accommodate at least a portion of the second element 15160. That is, the inner surface 15153 may have a diameter and/ or a perimeter that is greater than the diameter and/or perimeter of the outer surface of the second element 15160, as described in more detail in this application. Although the internal volume 15155 is shown and described as essentially cylindrical, in other embodiments, the implementation of this volume may have any suitable shape and/or size. For example, in some embodiments, the internal surface 15153 may define a substantially D-shaped cross-sectional area (eg, semicircular). In other embodiments, the internal surface 15153 may have a cross-sectional shape that varies along the length of the first element 15150.

[1161] As described above, the inner surface 15153 defines a channel 15157. The channel 15157 extends the length of the first element 15150 between the proximal end portion 15151 and the distal end portion 15152, as shown in FIG. 50. In particular, the solution scheme of the channel 15157 formed by the inner surface 15153 is such that the channel 15157 does not pass through the proximal end section 15151 or the distal end section 15152. In other words, the channel 15157 does not extend the entire length of the first element 15150. Thus , at least the distal end section of the channel 15157 is defined by the inner surface 15153. In addition, the channel 15157 is in fluid communication with the internal volume 15155. In other words, the channel 15157 may be contained in the internal volume 15155 and / or otherwise be covered by the mentioned volume. Also in other words, the inner surface 15153 may define a volume that includes a first section (eg, internal volume 15155) and a second section (eg, channel 15157).

[1162] As shown in FIG. 51 and 52, the layout of the interior surface 15153 may be such that the channel 15157 has a cross-sectional area CA ₁ at or near the proximal end portion 15151 of the first element 15150 (FIG. 51), and a second cross-sectional area CA ₂ at the distal end section 15152 of the first element 15150 or near this section (Fig. 52). For example, in some embodiments, the channel 15157 may be configured to deploy, flare, and/or otherwise expand along the length of the first element 15150 in a distal direction. As described in more detail in this application, the section of the second element 15160 may be located in the channel 15157, and the section of the inner surface 15153, limiting the channel 15157, may define, for example, the range of movement associated with the second element 15160 relative to the first element 15150.

[1163] As shown in FIG. 53 and 54, the second element 15160 of the introducer 15100 includes a proximal end portion 15161, a distal end portion 15162, an outer surface 15163 containing a first protrusion 15164, and an inner surface 15168 containing a second protrusion 15169. The second element 15160 also includes a guide element. 15180 and/or otherwise connected to said element. The second element 15160 may have any suitable shape, size or configuration. For example, as shown in FIG. 53, the second element 15160 may have a substantially cylindrical shape. That is, the outer surface 15163 of the second element 15160 forms and/or has a substantially circular cross-sectional shape. In some embodiments, the size and/or shape of the second element 15160 may be associated with and/or may substantially correspond to the size(s) and/or shape(s) of the inner surface 15153 of the first element 15150. Thus, at least a portion of the second element 15160 may be inserted into the first element 15150 and may be movable in the first element between, for example, a proximal position and a distal position (eg, telescopically).

[1164] As described above with reference to the first element 15150, the second element 15160 includes a first half 15160A and a second half 15160B, which can be connected to each other (for example, ultrasonic welding, adhesive, mechanical fasteners, one or more tabs, snaps, pins, and/or the like) to form the second element 15160. In other embodiments, the second element 15160 may be formed in one piece (eg, injection molding and/or any other suitable manufacturing process). Thus, with regard to the structural elements of the second element 15160, it should be understood that the said structural elements can be formed and/or formed by the first half 15160A, formed and/or formed by the second half 15160B, jointly formed and/or formed by the first half 15160A and the second half 15160B, or, when the first element 15160 is formed from one piece, formed and/or formed by the corresponding portion of the second element 15160. For example, in this embodiment, the first half 15160A and the second half 15160B together form the proximal end section 15161 and the distal end section 15162 of the second element 15160.

[1165] The inner surface 15168 of the second element 15160 defines an inner volume 15165. The inner surface 15168 may define a cross-sectional area of any suitable shape and/or size. For example, the cross-sectional area bounded by the inner surface 15168 (i.e., the cross-sectional area of the inner volume 15165) may have a substantially circular cross-sectional shape, with a size that is sufficient to accommodate at least a portion of the drive mechanism 15570 (for example, larger than the cross-sectional dimension of at least a portion of the drive mechanism 15570). As shown in FIG. 54, the second element 15160 may include a sealing element 15167 located at the most distal position within the internal volume 15165, and, approximately, a portion of the guide element 15180. As such, the sealing element 15167 forms a substantially fluid-tight and/or substantially a tight seal around the guide element 15180. The sealing element 15167 may have any suitable shape, size and/or configuration. For example, in some embodiments, the implementation of the sealing element 15167 may be formed from a flexible material, such as silicone, rubber and/or any other suitable elastomeric material. In some embodiments, sealing member 15167 may be configured to absorb bodily fluid that may otherwise flow proximally into interior volume 15165 (eg, bodily fluid flow substantially outside of catheter 15200). For example, in some embodiments, the implementation of the sealing element 15167 may be formed from absorbent material, such as material POREX® or similar material. In addition, the second protrusion 15169 extends from the inner surface 15168, for example, at or near the proximal end portion 15161 of the second element 15160. As described in more detail herein, the second protrusion 15169 can engage with the drive mechanism portion 15570 when the drive mechanism 15570 is located within the internal volume 15165.

[1166] The first protrusion 15164 of the second element 15160 extends from the outer surface 15163 at or near the distal end portion 15162 of the second element 15160. In other words, the first protrusion 15164 extends radially from the outer surface 15163. As such, when the second element 15160 is located within the interior volume 15155 of the first element 15150, the first protrusion 15164 is located in the channel 15157, as shown in FIG. 55.

[1167] The introductor 15100 solution scheme is such that when the second element 15160 is moved relative to the first element 15150, the first protrusion 15164 the first protrusion moves within the channel 15157. Essentially, the channel 15157 (and/or a portion of the inner surface 15153 forming the channel 15157) defines the range of movement of the second element 15160 relative to the first element 15150. For example, if the channel 15157 extends the length of the first element 15150 from the proximal end section 15151 to the distal end section 15152, then the range of movement associated with the second element 15160, given by the channel 15157, includes axial movement (eg, in the distal and/or proximal direction) of the second element 15160 within the first element 15150 between its proximal position and its distal position. Similarly, the increased width corresponding to the second cross-sectional area CA ₂ may define, for example, a range of rotational movement around the longitudinal center line CL of the first element 15150 (see, for example, FIG. 55), as described in more detail herein.

[1168] In some embodiments, the range of motion associated with the rotation of the second element 15160 (also referred to herein as the “rotational range”) depends on the axial position of the second element 15160 along the longitudinal center line CL of the first element. For example, in some embodiments, the inner surface 15153 defining the channel portion 15157 may be, for example, relatively tapered or the like, so that the range of rotational movement is continuously increased until the second element 15160 is located in a distal position relative to the first element 15150. In other embodiments, the interior surface 15153 may include any number of steps or rings, with each step or ring corresponding to channel section 15157 corresponding to a different range of rotational movement. For example, the inner surface 15153 may include a first ring corresponding to a rotation range of approximately 30 degrees, a second ring located distally about the first ring and corresponding to a rotation range of approximately 90 degrees, and a third ring located distally near the second ring. and corresponding to a range of rotational movement of approximately 180 degrees.

[1169] If the channel 15157 does not pass through the proximal end section 15151 or the distal end section 15152 of the first element 15150 (as described above), then the axial movement of the second element 15160 relative to the first element 15150 is limited by the length of the channel 15157. Thus, at least the section the second element 15160 is held in the internal volume 15155 and, in fact, is blocked from retraction on it. In addition, the section of the inner surface 15153, forming the proximal end section of the channel 15157, may include, for example, a rib 15158 (for example, a tide, ledge, stop, etc.), which can be configured to at least temporarily holding the first ledge 15164 and, therefore, the second element 15160 in a proximal position relative to the first element 15150, as described in more detail in this application.

[1170] As shown in FIG. 53 and 54, the guide member 15180 includes a proximal end portion 15181 and a distal end portion 15182. The proximal end portion 15181 is connected to and/or otherwise extends from the distal end portion 15162 of the second element 15160. In particular, the proximal end portion 15181 of the guide element 15180 is located inside the sealing element 15167, which, in turn, is located in the internal volume 15165 of the second element 15160. As shown in FIG. 54, at least a section of the sealing element 15167 is located in a proximal position relative to the guide element 15180. In other words, the proximal end section 15181 of the guide element 15180 does not pass through the sealing element 15167 located inside the distal end section 15162 of the second element 15160 and/or connected to this site, as described in more detail in this application.

[1171] In this embodiment, the guide element 15180 may be, for example, a cannula, a catheter, and/or the like. Essentially, the guide element 15180 defines a lumen 15183 that accommodates the section of the catheter 15200 for movement. of the first element 15150, the guide element 15180 is located in the first element 15150, and when the second element 15160 is moved to a distal position relative to the first element 15150, the distal end portion 15182 of the guide element 15180 at least partially extends beyond, for example, the distal end of the PIV ( not shown). In addition, the second element 15160 is located in the inner volume 15155 of the first element 15150 such that the guide element 15180 passes through the sealing element 15190. Therefore, the sealing element 15190 is in contact with the outer surface of the guide element 15180 and thereby forms a substantially impermeable fluid seal as described above.

[1172] The guide element 15180 may be of any suitable material with sufficient stiffness to allow the guide element 15180 to pass through the PIV sleeve substantially without twisting, tearing, and/or other plastic deformation. For example, in some embodiments, the guide element 15180 may be a metal hypotube (Hypotube) or similar element with hardness (for example, characteristic of the material used to form the guide element 15180) and / or stiffness (for example, dependent on both material and shape and guide element size 15180) sufficient to allow the guide element 15180 to pass through any suitable sleeve configuration contained in the PIV when the second element 15160 is moved from a proximal position to a distal position. As described in more detail in this application, the guide element 15180 can be advanced through at least the PIV section so that the distal end section 15182 is in a distal position relative to at least the PIV sleeve or mesh, and, after installation in the desired position, the catheter 15200 can be advanced within the lumen 15183 defined by the guide 15180 in a distal direction so that at least a portion of the catheter 15200 is positioned distally with respect to the guide 15180. /or substantially prevents the catheter 15200 from twisting, bending, tearing, squeezing, and/or otherwise deforming when the catheter 15200 is moved distally.

[1173] Although the guide element 15180 is shown and described as a cannula, catheter, and/or hypotube, in other embodiments, the guide element may have any suitable configuration. For example, in some embodiments, the implementation of the guide element may be an elongated structure with a substantially V-shaped or U-shaped cross section. Such a guiding element may, for example, form a channel or similar structural element adapted to receive and/or guide a section of the catheter. In other embodiments, the guide element 15180 may be a wire braid, tube, coil, helix, guide rail, and/or any other suitable element configured to receive and/or guide the catheter site. Thus, the design and/or configuration of the guide element 15180 can be associated with an amount of stiffness sufficient to allow the guide element 15180 to pass through the PIV and/or sufficient to guide the catheter 15200 to reduce, for example, the likelihood of catheter 15200 kinking when moving within introducer 15100.

[1174] As shown in FIG. 56-60, the drive mechanism 15570 of the transfusion device 15000 includes a proximal end section 15571 and a distal end section 15572 and forms a slot 15573. 15150. For example, a user can grip the grip portion 15579 to manipulate at least the drive mechanism 15570 of the transfusion device 15000, as described in more detail herein. The proximal end portion 15540 is connected to an additional cannula 15250, which includes a coupling 15254, which, in turn, is configured to be connected to a fluid container (for example, a Vacutainer® container or similar container (not shown in Figs. 47-68 )). As described in more detail herein, the actuator 15570 is coupled to the catheter 15200 such that when the coupler 15254 is connected to the fluid reservoir, the catheter 15200 is positioned in fluid communication with the fluid reservoir.

[1175] The drive mechanism 15570 may have any suitable shape, size or configuration. For example, as shown in FIG. 56, the second element 15160 may have a substantially cylindrical shape. In some embodiments, the size and/or shape of the second element 15160 may be associated with and/or may substantially correspond to the size(s) and/or shape(s) of the inner surface 15168 of the second element 15160. Therefore, at least a portion the drive mechanism 15570 can be inserted into the inner volume 15165 defined by the second element 15160 and can be moved therein between, for example, a proximal position and a distal position (eg, telescopically). In particular, as shown in FIG. 59 and 60, the drive mechanism 15570 may be positioned within the inner volume 15165 of the second member 15160 such that the second protrusion 15169 extending from the inner surface 15168 is located within the slot 15573 defined by the drive mechanism 15570. Thus, when the drive mechanism 15570 is moved axially (e.g. , in the distal direction or proximal direction) relative to the second element 15160, the second protrusion 15169 moves in the slot 15573. As described above, in some embodiments, the implementation of the drive mechanism 15570 can be placed between the first half 15160A and the second half 15160B of the second element 15160 before connection. Thus, the second protrusion 15169 can be inserted into the slot 15573 formed by the drive mechanism 15570. In other embodiments, the second protrusion 15169 can be movable in order to allow the insertion of the drive mechanism 15570 into the internal volume 15165, as described above with reference to the first element 15150 .

[1176] In some embodiments, the length of the slot 15573 may define the range of movement of the actuator 15570 relative to the second element 15160. In addition, if the slot 15573 does not pass through the proximal end portion 15571 or the distal end portion 15572 of the actuator 15570 (see, for example, FIG. 56 and 57), then at least a portion of the actuator 15570 is retained within the internal volume 15165 and substantially blocked from retraction thereto, as described with reference to the second element 15160). In addition, the surface of the drive mechanism 15570 forming the distal end portion of the slot 15573 may include, for example, a ledge, lug, rib, anvil, etc., which may be configured to at least temporarily hold the first ledge 15164 in a distal position relative to the drive mechanism 15570, as shown in FIG. 60. Therefore, the actuator 15570 can be held proximal to the second member 15160 until use, as described in more detail herein.

[1177] The drive mechanism 15500 is connected to the catheter 15200 and is configured to move the catheter 15200 relative to the introducer 15100, between the first configuration and the second configuration, as further detailed in this application. The catheter 15200 of the transfusion device 15000 has a proximal end 15206 and a distal end 15212 and forms a lumen 15209 through it (see, for example, FIGS. 56-62). As described above with reference to FIG. 5, the catheter 15200 includes a first portion 15205 (e.g., a proximal portion) having a first diameter and a second portion 15210 (e.g., a distal portion) having a second diameter smaller than the first diameter (see, e.g., FIG. 56) . In some embodiments, the diameter of the catheter 15200 at the second site 15210 may, for example, facilitate insertion of the catheter 15200 into a peripheral intravenous line, as described in more detail herein. In some embodiments, the catheter 15200 may be 16 gauge (16g) to 26 gauge (26g) in diameter and have a Shore hardness of about 20A Shore to about 95D Shore. In other embodiments, the catheter 15200 has a Shore hardness of approximately 20A Shore to 50D Shore. In still other embodiments, the catheter 15200 has a shore hardness of approximately 70A Shore to 85D Shore.

[1178] In some embodiments, the first section 15205 of the catheter 15200 may have a Shore hardness that is higher than the Shore hardness of the second section 15210. For example, in some embodiments, the first section 15205 may be formed from a first material or a first combination of materials, and the second section may be formed from a second material or a second combination of materials having a hardness lower than the hardness of the first material or the first combination of materials. In some embodiments, the first section 15205 and the second section 15210 may be co-extruded, for example. In other embodiments, the first section 15205 may, for example, be molded over a section of the second section 15210. In still other embodiments, the second section 15210 may be formed by stretching the end of the first section 15205. As such, the first section 15205 may have stiffness and/or hardness, which are sufficient to prevent twisting, squeezing, tearing and/or unwanted plastic deformation of the first section 15205, when it is advanced, for example, through the introducer 15100, as described in more detail in this application. The second section 15210 may have a stiffness and/or hardness that is less than the stiffness and/or hardness of the first section 15210 and, in essence, can be configured to bend, kink, elastically deform and/or otherwise change shape, which, in some cases, may reduce the likelihood of the second site 15210 puncturing vascular tissue when located in that tissue, and/or allow the second site 15210 to advance through kink, twist, turn, valve, and/or obstruction in, for example, the lumen formed by the PIV, as in more detail described in this application.

[1179] The first section 15205 of the catheter 15200 is connected to the drive mechanism 15570. In particular, as shown in FIG. 57, the first portion 15205 of the catheter 15200 extends along the length of the actuator 15570 such that the proximal end 15206 of the catheter 15200 is located at or near the proximal end portion 15571 of the actuator 15570. Therefore, the lumen 15209 formed by the catheter 15200 is in fluid communication with the additional catheter 15250, as described in more detail herein. The second section 15210 of the catheter 15200 may be placed in any suitable manner. For example, in some embodiments, the distal end 15212 of the catheter 15200 (i.e., located at the end of the second section 15210) may include a substantially open end surface configured to accommodate the lumen 15209 in fluid communication with, for example, vein. In some embodiments, the implementation of the distal end 15212 may include an open end surface and any number of holes located on one side (eg, circle) of the catheter 15200, as described above.

[1180] As shown in FIG. 62, in this embodiment, the distal end 15212 of the catheter 15200 is slanted or bevelled. In some cases, the bevelled distal end 15212 may facilitate the advancement of the catheter 15200 through a kink or bend, such as by rotating the catheter 15200 to align the beveled end with a kink angle or similar shape. In other embodiments, the distal end 15212 may have any suitable configuration, such as substantially flat, bullet-shaped, conical, bulbous, or the like. In still other embodiments, the distal end 15212 may be substantially open (as shown in FIG. 62) and may include one or more slots, notches, grooves, channels, and/or similar features that substantially intersect the distal the surface of the distal end 15212. In these embodiments, the slits may introduce discontinuity at and/or along the portion of the distal end 15212, which, in some embodiments, may reduce the rigidity of the distal end 15212 by allowing, for example, elastic deformation of the distal end 15212. In some embodiments, In some cases, elastic (ie, temporary) deformation of the distal end 15212 may facilitate advancement of the catheter 15200 behind and/or through twists, bends, corners, and the like. within a vascular structure, a PIV site, and/or a similar structure.

[1181] As shown in FIG. 60-62, the layout of the drive mechanism 15570 and catheter 15200 is such that when the drive mechanism 15570 is located inside the second element 15160 of the introducer 15100, at least a portion of the catheter 15200 is located in the guide element 15180. In particular, when the drive mechanism 15570 is located in a proximal position relative to the second element 15160, the second section 15210 of the catheter 15200 is located in the guide element 15180. element 15180, as described in more detail in this application.

[1182] In more detail, the section of the catheter 15200 is located in the sealing element 15167 of the second element 15160 and passes through it. As such, the outer surface of the portion of the catheter 15200 that is located in the sealing element 15167, and which is proximal to the guide element 15180, is in contact with the sealing element 15167, and, in essence, the sealing element 15167 forms a substantially fluid-tight seal with outer surface of this section of catheter 15200. Thus, when the catheter 15200 is located in the guide element 15180, and the sealing element 15167 forms a substantially fluid-tight seal with the distal end section 15181 of the guide element 15180 and the catheter section 15200, the sealing element 15167 holds and/ or substantially prevents the flow of bodily fluid inside the guide element 15180, but outside the catheter 15200, into a volume proximal to the sealing element 15167. Similarly, the sealing element 15167 may be adjacent to the guide element 15180 and catheter 15200 to contain the leakage of bodily fluid into a volume proximal to the sealing element 15167.

[1183] As shown in FIG. 59-60, prior to use, the transfusion device 15000 may be positioned in a first configuration (e.g., extended configuration) in which the second element 15160 is located at its proximal position relative to the first element 15150 and the actuator 15570 is located at its proximal position relative to the second element 15160. Therefore, the guide element 15180 is located inside the first element 15150 of the introducer 15100, and at least the second section 15210 of the catheter 15200 is located inside the guide element 15180. In more detail, as shown in FIG. 59, the catheter 15200 is at least partially located in the sheath 15100 when the transfusion device 15000 is in the first configuration. In some embodiments, the inner volume 15165 of the second element 15160 and the inner volume 15155 of the first element may be fluid-tightly sealed such that the inner volumes 15165 and 155 are each sterile. As a result, at least the catheter site 15200 is maintained in a substantially sterile environment prior to use.

[1184] Although the first section 15205 of the catheter 15200 is shown, for example, in FIG. 58 as extending through the slot 15573 of the drive mechanism 15570 and thus exposed to the outside environment, in other embodiments, the drive mechanism 15570 and/or catheter 15200 may include a pouch, sheath, wrapping material, sleeve, and/or the like. , which may be located on the section of the catheter 15200, which extends over the slot 15573 of the drive mechanism 15570 to keep the catheter section 15200 in a substantially sterile environment. Thus, the first section 15205 and the second section 15210 may be substantially sterile prior to use. In other embodiments, the second element 15160 of the introducer 15100 may include, for example, a sterilizing element (e.g., sponge, wipe, seal, etc.) located within the internal volume 15160, which may be configured to contact the outer surface of the catheter 15200 to thereby sterilize the portion of the catheter 15200 as the catheter 15200 moves relative to the second element.

[1185] While in the first configuration, the user (eg, phlebotomist) can manipulate the transfusion device 15000 to connect the first element 15150 of the introducer 15100 to the adapter 15450 (see, for example, FIG. 59). In other embodiments, the transfusion device 15000 can, for example, be pre-assembled with an adapter 15450. In yet other embodiments, the transfusion device 15000 can be used without an adapter 15450. In this embodiment, the locking mechanism 15131 located at the distal end portion 15152 of the first element 15150 connected to the first port 15451 of the adapter 15450. Although in FIG. 59-68 not shown, the third port 15453 of the 15450 adapter can be connected to the PIV. As a result, the introducer 15100 connects (eg, indirectly through the 15450 adapter or directly, if used without the 15450 adapter) to the PIV. Although in FIG. 59-68 not shown, a connector 15254 located at the end of the accessory cannula 15250 may be connected to a fluid reservoir or similar reservoir to position the lumen 15209 of the catheter 15200 in fluid communication with the fluid reservoir.

[1186] After connecting the PIV and the fluid reservoir, the user grabs the grip portion 15159 of the first element 15150 and the grip portion 15579 of the drive mechanism 15570 to apply force to the drive mechanism 15579. In particular, by gripping the grip portion 15159 of the first element 15150, part of the force applied to the actuator 15579, which would otherwise act on the PIV (eg, through the introducer 15100 and adapter 15450). In other words, the user may apply a counter force to the grip portion 15159 of the first element 15150 in response to a force applied to the drive mechanism 15570 that is sufficient to reduce and/or substantially eliminate the force that would otherwise be transmitted and would affect PIV.

[1187] The force applied to the grip portion 15579 of the drive mechanism 15570 moves the drive mechanism 15570 and the second element 15160 in a distal direction relative to the first element 15150 to thereby position the liquid transfusion device 15000 in the second configuration, as indicated by the arrow MM in FIG. 63. In particular, the actuator 15570 moves the second element 15160 from its proximal position to its distal position relative to the first element 15150 while the actuator 15570 remains in a relatively fixed position (eg, its proximal position) relative to the second element 15160. For example , as described above, the portion of the inner surface 15153 forming the proximal end portion of the channel 15157 may include, for example, a ledge, tide, rib, abutment, etc., which may be configured to at least temporarily hold the first protrusion 15164 and, therefore, the second element 15160 in a proximal position relative to the first element 15150. Similarly, the rib 15574, extending from the surface of the drive mechanism 15570, which forms the groove 15573, at least temporarily holds the second protrusion 15169 in a distal position relative to the drive mechanism 15570 , and, consequently, the drive me the mechanism 15570 is at least temporarily held in its proximal position relative to the second element 15160.

[1188] Essentially, the ribs 15158 and 15574 narrow the section of the channel 15157 and the groove 15573, respectively, to a width less than the width of the first projection 15164 and the second projection 15169, respectively. Thus, the second element 15160 can be held in a substantially proximal position until a force is applied to the second element 15160 (for example, either directly or indirectly) that is sufficient to move the first protrusion 15164 through the constricted portion of the channel 15157 (for example, correlated with ribs 15158). Therefore, in response to the force, the first protrusion 15164 may apply some of the force to the ribs 15158 of the inner surface 15153, which, in turn, may deform, bend, bend and/or reshape the inner surface 15153 sufficiently to allow the first protrusion 15164 pass by the said ribs (and/or otherwise overcome the force of friction between them). Similarly, the drive mechanism 15570 can be held in a substantially proximal position until sufficient force is applied to the drive mechanism 15570 to move the second protrusion 15169 through the constricted portion of the slot 15573 (eg, associated with the ribs 15574). Therefore, in response to the force, the second protrusion 15169 may apply a portion of the force to the ribs 15574 of the actuator 15570, which in turn may deform, bend, bend, and/or otherwise reshape the surface of the actuator 15570 sufficiently to allow the second ledge 15169 to pass by the said ribs (and/or otherwise overcome the frictional force between them).

[1189] As shown in FIG. 63, the drive mechanism 15570 and the second element 15160 move together relative to the first element 15150 under the action of a force applied to the grip portion 15579 of the drive mechanism 15570. Essentially, part of the force moves the first protrusion 15164 behind and/or through the ribs 15158 extending from the inner surface 15153 the first element 15150, while the ribs 15574 of the drive mechanism 15570 hold the second ledge 15169 in a substantially fixed position. Thus, the force sufficient to move the second element 15160 relative to the first element 15150 is less than the force sufficient to move the actuator 15570 relative to the second element 15160. This solution scheme may, for example, cause the second element 15160 to move relative to the first element 15150 to movement of the actuator 15570 relative to the second element 15160. In some embodiments, movement of the first protrusion 15164 past the ribs 15158 may, for example, correspond to and/or otherwise result in a tactile, tactile, visual, and/or audible output. For example, in some embodiments, the indicator may be an audible output such as a "click". In other embodiments, the indicator may be a visual output such as numeric indexes, labels, a status window, a color change of a status indicator element, a digital output to be presented on a display, and/or a similar indicator.

[1190] As shown in FIG. 64, moving the second element 15160 to a distal position with respect to the first element 15150 advances the guide element 15180 (associated with it) in the MM direction to a position in which at least the distal end portion 15182 of the guide element 15180 is located at the end of the PIV and passes beyond the given the end. In particular, as the second element 15160 is moved to its distal position, the guide element 15180 simultaneously advances through the port or mesh of the PIV (not shown). As described above, the guide element 15180 is designed to be stiff and/or formed from material(s) with a hardness that is sufficient to pass through the PIV port without substantially twisting, tearing, bending, plastic deformation (e.g., permanent deformation) etc. In addition, the guide element 15180 may have a length and hardness that is sufficient to pass through any suitable PIV for the purpose of positioning at least the distal end portion 15182 in a distal position relative to the end of the PIV. In other words, the guide element 15180 can be positioned such that when the second element 15160 is in its distal position relative to the first element 15150, the distal end portion 15182 of the guide element 15180 is located in the vascular structure and at least partially outside the PIV. In addition, if the actuator 15570 is held in a relatively fixed position with respect to the second member 15160, then the second portion 15210 of the catheter 15200 is held within the lumen 15183 defined by the guide member 15180, as shown in FIG. 64.

[1191] When the second element 15160 is in its distal position, the applied force acting on the capture portion 15579 moves the actuator 15570 from its proximal position to its distal position relative to the second element 15160. For example, the second element 15160 can be moved along its entire range movement (for example, formed at least in part by the channel 15157) to be located in its most distal position and, in essence, part of the applied force that caused the second element 15160 to move relative to the first element 15150, instead, essentially acts on drive mechanism 15570. As such, the force applied to the drive mechanism 15570 may be sufficient to move the second protrusion 15169 past the ribs 15574 located in the slot 15573, and, as a result, the drive mechanism 15570 moves from its proximal position to its distal position relative to second element 15160, as indicated by arrow NN in Fig. 65. In some embodiments, movement of the actuator 15570 from its proximal position to its distal position may correspond to and/or otherwise result in a tactile, tactile, visual, and/or audible output as described above.

[1192] As shown in FIG. 66, moving the actuator 15570 to its distal position relative to the second member 15160 advances the catheter 15200 in the NN direction to a position where at least the distal end portion 15212 of the catheter 15200 is located in and extends beyond the PIV. In addition, the catheter 15200 can be advanced so that the distal end portion 15212 of the catheter 15200 extends beyond the distal end portion 15182 of the guide member 15180. element 15160, and the second element 15160 is in its distal position relative to the first element 15150, the distal end portion 15212 of the catheter 15200 is located in the vascular structure and, at least partially, outside the PIV and the guide element 15180. Therefore, the lumen 15209 of the catheter 15200 can receive a flow of bodily fluid, which in turn can flow through the lumen 15209 to be transferred to the fluid reservoir. For example, in some embodiments, the fluid reservoir may be an evacuated reservoir, such as a Vacutainer® container, that can act by suction force through the lumen 15209 of the catheter 15200. Thus, bodily fluid (eg, blood) is aspirated through the lumen 15209 of the cannula 15200 and the lumen 15253 additional cannula 15250 and into the fluid container. Therefore, the phlebotomist can withdraw (eg, draw) a given amount of blood through an existing peripheral intravenous line, without the need for additional needle punctures.

[1193] As shown in FIG. 67 and 68, in some embodiments, it may be desirable to pivot the catheter 15200 relative to the first member 15150, thereby pivoting the distal end 15212 within the vascular structure (e.g., to prevent the distal end 15212 from sticking to the wall of the vascular structure). Therefore, in such cases, the user can manipulate, for example, the drive mechanism 15570 to rotate the drive mechanism 15570 and the second element 15160 relative to the first element 15150. that the actuator 15570 is held in a substantially fixed angular position with respect to the second element 15160. Therefore, manipulation of the actuator 15570 by the user can result in rotation of both the actuator 15570 and the second element 15160 relative to the first element 15150.

[1194] As described above, the channel 15157 may have a shape and/or cross-sectional area at or near the proximal end portion 15151 of the first element 15150 that correlates with and/or slightly exceeds the size of the first protrusion 15164, and thereby , limit the range of rotational movement of the second element 15160, when located in the proximal position. However, when the second element 15160 is in a distal position, the shape and/or cross-sectional area of the channel 15157 at or near the distal end portion 15152 of the first element 15150 (i.e., the second cross-sectional area CA ₂ ) may allow rotation of the second element 15160 approximately 30 degrees, approximately 60 degrees, approximately 90 degrees, approximately 120 degrees, approximately 180 degrees, approximately 210 degrees or more relative to the longitudinal center line CL. In other words, in some embodiments, the implementation of the second element 15160 can rotate clockwise or counterclockwise about the longitudinal center line CL and relative to the center position of the first projection 15164 (see, for example, Fig. 67) in the range from about 0 degrees to about 105 degrees , as indicated by the arrow OO in FIG. 68.

[1195] In some cases, said rotation of the drive mechanism 15570 and the second element 15160 may, for example, reduce the likelihood of suction of the distal end 15212 of the catheter 15200 against the wall of a vascular structure (eg, vein). For example, when the catheter 15200 is rotated, one or more holes formed by the distal end 15212 are also rotated, which in turn can reduce the likelihood of the distal end 15212 sticking to the wall of the vascular structure due to the suction force inside the catheter 15200 (for example, by means of an evacuated reservoir). for liquid or similar container). In some cases, it may be desirable to rotate the second element 15160 as the drive mechanism 15570 is moved to its distal position. Such rotation may, in some such cases, facilitate advancement of the catheter 15200 by rotating the catheter 15200 such that the beveled surface or similar surface (as described above) aligns with the twisted surface of the guide 15180 and/or the vascular structure. In some cases, the alignment of the beveled surface of the catheter 15200 and the twisted surface may facilitate the passage of the catheter 15200 through the twisted area.

[1196] In some cases, it may be desirable to move the catheter 15200 in the axial direction relative to the first element 15150 and/or the second element 15160. slot 15573 formed by the drive mechanism 15570 at a position that is proximal to the projections 15574. Thus, the second projection 15169 can move relatively freely within the slot 15563. they create a force of friction. As such, movement of the actuator 15570 in an axial direction (i.e., proximal direction and/or distal direction) may similarly result in axial movement of the second element 15160 relative to the first element 15150.

[1197] In other embodiments, it may not be desirable for the second element 15160 to move in the axial direction simultaneously with the drive mechanism 15570. position relative to, for example, PIV. In these embodiments, the implementation scheme of the guide element 15180 of the second element 15160 and the sealing element 15190 of the first element 15150 may, for example, limit and/or substantially prevent the axial movement of the second element 15160 relative to the first element 15150. In particular, as described above, the sealing element 15190 is positioned around and may be in contact with guide element 15180 to create both a substantially fluid-tight seal and some amount of friction. In some embodiments, the amount of friction (i.e., frictional force) and/or the amount of drag may be sufficient to limit and/or substantially prevent axial movement of the second element 15160 relative to the first element 15150. Thus, the drive mechanism 15570 can move axially relative to the second element 15160 until a force is applied to the second element 15160 that is sufficient to overcome the frictional force between the sealing element 15190 and the guide element 15180. However, when the actuator 15570 is in a substantially fixed angular or rotational position relative to the second element 15160, at least part of the force applied to rotate the drive mechanism 15570 is transmitted and/or otherwise acts on the second element 15160, and therefore, when the force is sufficient to overcome the frictional force between the sealing element 15190 and the guide element 15180, the drive th mechanism 15570 and the second element 15180 rotate relative to the first element, essentially simultaneously.

[1198] After the required amount of bodily fluid is withdrawn, the user (for example, a phlebotomist) can move the drive mechanism 15570 in the proximal direction to retract the catheter 15200. in a proximal direction that is sufficient to move at least the actuator mechanism 15570 from its distal position to its proximal position relative to the second element 15160. In some embodiments, the second element 15160 can be configured to move at least partially, along with drive mechanism 15570 from its distal position to its proximal position relative to the first element 15150. In some cases, the force may be sufficient to place the drive mechanism 15570 and the second element 15160 in their respective proximal positions. In addition, the solution scheme of the drive mechanism 15570 and introducer 15100 is such that the drive mechanism 15570 is blocked from being removed from the second element 15160, and the second element 15160 is blocked from being removed from the first element 15150, as described above. Thus, the guide element 15180 and the catheter 15200 can be located in a proximal position relative to the distal end of the first element 15150.

[1199] Although the drive mechanism 15570 and the second element 15160 are described above as moving under the action of a force applied by the user in the proximal direction, in other embodiments, the implementation of the drive mechanism 15570 and/or the second element 15160 can be configured to move in the proximal direction, at least at least semi-automatically. For example, in some embodiments, the introducer 15100 may include one or more pressing elements configured to apply force to move the second element 15160 and/or the actuator 15570 in the proximal direction. In more detail, the pressing member may exert a counter force in response to a force being applied to the actuator 15579. Thus, after the desired volume of bodily fluid is placed in the fluid reservoir, the user may stop exerting force on the actuator 15570, and as a result , the pressing element will be able to apply its force to move the second element 15160 and the drive mechanism 15570 in the distal direction. In other embodiments, the introducer 15100 may include a clamp member coupled to a return mechanism. In these embodiments, the user may place the second element 15160 and the actuator 15570 in their respective distal positions and may additionally apply a force in the distal direction that may activate the return mechanism (e.g., actuate a switch, detent, latch, tab, locking member, etc. .), which, in turn, can actuate the pressing element to apply force to the second element 15160 and the drive mechanism 15570 in the proximal direction. In some embodiments, activation of the return mechanism may be associated with a tactile, tactile, visual, and/or audible output that may switch from a first state to a second state during retraction, as described above.

[1200] Although the range of rotational movement of the second element 15160 relative to the first element 15150 is shown and described above as defined at least in part by the channel 15157, in other embodiments, the first element 15150 and the second element 15160 of the introducer 15100 may be located in any suitable manner. For example, in some embodiments, the inner surface 15153 of the first element 15150 may include a proximal portion having a first cross-sectional shape (e.g., a substantially D-shaped shape) and a distal portion having a second cross-sectional shape different from the first shape (e.g., substantially circular in shape), and the outer surface 15163 of the second element 15160 may include a proximal portion having a second cross-sectional shape and a distal portion having a second cross-sectional shape. As such, when the second element 15160 is located at a proximal position within the interior volume 15155 of the first element 15150, the cross-sectional shapes are substantially aligned, which in turn may limit the rotational movement of the second element 15160 relative to the first element 15150. Conversely, when the second element 15160 is advanced to a distal position within the internal volume 15155 of the first element 15150, the cross-sectional shapes are substantially misaligned, which in turn may allow rotational movement of the second element 15160 relative to the first element 15150.

[1201] Although the introducer 15100 and the drive mechanism 15570 are specifically shown and described above with reference to FIG. 47-68, in other embodiments, the device may include an introducer and/or drive mechanism in any suitable configuration while supporting substantially similar functionality. For example, FIG. 69-72 depicts a first element 16150 contained in an introducer (not shown in FIGS. 69-72) in accordance with another embodiment. As described above, the first element 16150 includes a proximal end section 16151, a distal end section 16152 and an inner surface 16153. The inner surface 16153 defines an internal volume 16155 and a channel 16157. The distal end section 16152 of the first element 16150 includes a locking mechanism 16131 and/ or otherwise associated with it. The locking mechanism 16131 may be essentially the same as any of those described in this application. In some embodiments, the implementation of the locking mechanism 16131 may be a Luer lock (Luer Lok™) or similar mechanism. As such, the first end of the locking mechanism 16131 is connected to the distal end portion 16152 of the first element 16150, and the second end opposite the first end may be connected to an adapter (eg, adapter 15450 shown in FIG. 47). Alternatively, in some cases, the second end of the locking mechanism 16131 can be attached directly to the PIV (not shown in Fig. 69-72).

[1202] As shown in FIG. 50, the locking mechanism 16131 includes a sealing element 16190 that is in contact with, for example, the distal surface of the first element 16150 to form a substantially fluid-tight seal. In use, the sealing element 16190 can accommodate, for example, a portion of the second element contained in the introducer and/or cannula or catheter (e.g., connected to a drive mechanism) to be advanced beyond the sealing element 16190 in a distal direction, while providing a substantially impermeable to sealing fluid around the portion of the second element and/or cannula or catheter, preventing substantially backflow of fluid into the volume proximal to the sealing element 16190 (and outside the second element and/or cannula or catheter). The sealing element 16190 may have any suitable configuration, such as an o-ring, a single-way valve, a diaphragm, a self-tightening diaphragm, a check valve, or any other suitable sealing element, such as those described in this application (for example, sealing element 15190). In addition, the location of the sealing element 16190 may be such that, upon contact with the guide element and/or catheter, the required friction force is created between them. In these embodiments, the friction force can be adjusted to resist and/or otherwise provide braking in response to the application of a force that would otherwise move the guide element (for example, connected to the second introducer element, as described above with reference to the introducer 15100 ) in the axial direction. As such, the drag generated by the frictional force generated between the sealing element 16190 and the guide element may, for example, hold the guide element, and thus the second introducer element with which it is connected, in a substantially fixed position relative to the first element, while simultaneously allowing movement, for example, of the catheter and/or the drive mechanism connected to it, in the axial direction relative to the introducer.

[1203] As described above, inner surface 16153 defines channel 16157. Channel 16157 extends the length of first element 16150 between proximal end portion 16151 and distal end portion 16152, as shown in FIG. 69. In particular, the solution scheme of the channel 16157 formed by the inner surface 16153 is such that the channel 16157 does not pass through the distal end section 16152. In other words, at least the distal end section of the channel 16157 is limited by the inner surface 16153. Thus, the channel may function similarly as described above with reference to the first element 15150.

[1204] As shown in FIG. 69 and 70, the proximal end portion of the channel 16157 may extend in a circumferential direction. In particular, in some embodiments, the implementation of the proximal end portion of the channel 16157 may form a sharp bend 16157A and/or may be essentially L-shaped. Therefore, the channel portion 16157 located at and/or near the end of the sharply curved portion 16157 may extend through the proximal end portion 16151 of the first element 16150. That is, the proximal end portion 16151 of the first element 16150 may define a substantially circular opening (i.e. corresponding to the internal volume 16155), which may include a cut section 16157B or a keyway section corresponding to the end section of a sharp bend 16157A of the channel 16157. Thus, the limited section of the channel 16157 can continue through the proximal end section 16151 of the first element 16150. 16157 may be essentially closed and/or limited by the inner surface, with the exception of the cut section 16157B.

[1205] In some embodiments, the implementation of the above decision scheme may allow the insertion of, for example, the second element of the introducer (for example, essentially the same as the second element 15160 of the introducer 15100) in the first element 16150. In some embodiments, the implementation of the second element may include a ledge (for example, similar or the same as the first protrusion 15164 of the second element 15160), which is inserted through, for example, a cut section 16157B and/or a keyway type hole corresponding to a sharply curved section 16157A of the channel 16157 (as described above). After the protrusion is inserted through the cut out section, the second element can be rotated or installed in such an orientation relative to the first element in which the protrusion is essentially aligned with the section of the channel 16157, which extends from the proximal end section 16151 of the first element 16150 to the distal end section 16152 of the first element 16150. Thus, when the second element is in said orientation, the proximal movement of the second element relative to the first element 16150 is thereby limited. Accordingly, the first element 16150 may function essentially the same as the first element 15150, described in detail above.

[1206] Similarly, FIG. 73-76 depict a drive mechanism 16570 in accordance with another embodiment. The drive mechanism 16570 includes a proximal end portion 16571 and a distal end portion 16572 and defines a slot 16573. The proximal end 16540 is connected to an additional cannula 16250, which in turn is configured to connect to a fluid reservoir (e.g., a Vacutainer® container or similar tank (not shown in Fig. 73-76)). As detailed above with reference to actuator 15570 and catheter 15200, actuator 16570 is coupled to catheter 16200 such that when accessory cannula 16250 is connected to the fluid reservoir, catheter 16200 is placed in fluid communication with the fluid reservoir.

[1207] As described above, the drive mechanism 16570 is designed to be inserted into the second element of the introducer (not shown in Fig. 73-76). For example, in some embodiments, the actuator 16570 may be inserted into a second element that is substantially similar or the same as the second element 15160 described above. As such, the second element may include an internal lip (e.g., second lip 15169), which may be located within the slot 16573. In particular, as shown in FIG. 75 and 76, the drive mechanism 16570 may include an opening 16578 that may be configured to provide access to the slot 16573. In some embodiments, the distal end portion of the slot 16573 may include such a sharply curved portion (for example, as described above with referring to the first element 16150) that the slot 16573 extends along the side and/or circumference of the drive mechanism 16570. Thus, the drive mechanism 16570 can be partially located in the second element and oriented so that the hole 16578 is aligned with the internal ledge. After the inner lip is inserted through said hole, the drive mechanism 16570 can be rotated or installed in such an orientation relative to the second element in which the inner lip is substantially aligned with the section of the slot channel 16573, which extends from the proximal end section 16571 of the drive mechanism 16570 to the distal end section 16572 of the drive mechanism 16570. Thus, when the drive mechanism 16570 is in this orientation, the proximal movement of the drive mechanism relative to the second element is thereby limited. Accordingly, the drive mechanism 16570 may function in substantially the same way as the drive mechanism 15570 detailed above.

[1208] FIG. 69 is a flowchart illustrating a method 200 for phlebotomy through a peripheral intravenous line, in accordance with another embodiment. The method includes connecting a fluid transfusion device to the PIV at 201. The fluid transfusion device may be any suitable device designed for phlebotomy through the PIV. For example, in this embodiment, the liquid transfusion device may be substantially the same as the liquid transfusion device 15000 described above with reference to FIG. 47-68. Essentially, the fluid transfusion device includes a drive mechanism and a catheter. The introducer includes a first element and a second element movably positioned within the first element, as described above with reference to FIG. 48-55. The second element is connected to the guide element. The drive mechanism is movably located in the second element and is connected to the catheter.

[1209] A first force is applied to the drive mechanism, which is sufficient to move the second element relative to the first element from the first position, in which the guide element connected to the second element is located inside the first element, to the second position, in which the distal end portion of the guide element is inserted through the PIV port, at step 202. Specifically, the force applied to the actuator moves the actuator and the second element distally relative to the first element while the actuator remains in a relatively fixed position (e.g., proximal position) relative to the second element. For example, in some embodiment, the second element may be configured to move relative to the first element under a force of a first magnitude, and the actuator may be configured to move relative to the second element under a force of a second magnitude greater than the first magnitude of the force. For example, in some embodiment, the first element may selectively engage with a portion of the second element to temporarily hold the second element in a first position relative to the first element. Likewise, the second element may selectively engage with the drive mechanism portion to temporarily hold the drive mechanism in the first position relative to the second element, as detailed above. In addition, the guide element may have a length and hardness that are each sufficient to allow the guide element to pass through the PIV port substantially without twisting, tearing, and/or other plastic deformation.

[1210] When the second element is in the second position (e.g., the distal position), a second force is applied to the actuator that is sufficient to move the actuator relative to the second element such that the distal end portion of the catheter extends beyond the end of the peripheral intravenous line, in step 203. In particular, the catheter may be at least partially located in the introductor prior to the movement of the drive mechanism relative to the second element so that at least the distal end portion of the catheter is located in the guide element. Therefore, in the state of connecting the drive mechanism to the catheter, the movement of the drive mechanism relative to the second member moves the catheter relative to the guide member. Therefore, when the actuator is in a distal position with respect to the second element, the catheter may extend through the PIV and guide element so that the distal end portion of the catheter is located in a distal position with respect to the guide element and PIV, as described above with reference to FIG. 65 and 66.

[1211] In some cases, it may be desirable to rotate the second element and/or the drive mechanism relative to the first element as the drive mechanism and/or the second element is moved relative to the first element. For example, as described above in some embodiments, the first element may define a channel configured to receive a portion of the second element. Therefore, the channel-forming surface may define, for example, a range of movement associated with the second element relative to the first element. As described above with reference to FIG. 51, 52, 67, and 68, the channel may define a range of movement of the second element relative to the first element, which may include, for example, translational movement (eg, in a proximal or distal direction) and rotational movement. In some cases, part of the first force and/or part of the second force may rotate the second element and the drive mechanism relative to the first element. This rotation may, for example, facilitate the advancement of the guide element and/or the catheter over the PIV site and/or the like. In other cases, force may be applied to the actuator when the distal end portion of the catheter extends past the end of the PIV to limit suction of the distal end portion of the catheter to the vascular structure in which it is located. Thus, the catheter can be rotated to reduce the likelihood of the distal end portion of the catheter sticking to the wall of the vascular structure within which it is located and/or to facilitate advancement of the catheter over an obstruction contained within the guide, PIV and/or vascular structure.

[1212] The fluid reservoir is attached to the fluid dispenser at 204. The fluid reservoir may be any suitable reservoir. For example, in some embodiments, the liquid reservoir may be an evacuated reservoir, such as a Vacutainer® container or similar reservoir. In addition, when the fluid reservoir is attached to the fluid transfusion device, the catheter is positioned in fluid communication with the fluid reservoir. Thus, bodily fluid can flow (eg, under negative pressure and/or suction force) out of the body, through the catheter, and into the fluid reservoir. In some instances, during collection of a volume of bodily fluid, it may be desirable to move at least the distal end portion of the catheter in an axial direction to, for example, limit and/or substantially prevent suction of the distal end portion of the catheter to, for example, the vascular structure in which it is located. Therefore, the user may apply force in a distal direction to appropriately advance the catheter in a distal direction, or may apply force in a proximal direction to appropriately retract the catheter in a proximal direction (eg, while still distal to the PIV). In addition, in some embodiments, the implementation of the first element of the introducer may include a sealing element and/or a similar element that can surround, for example, a guide element connected to the second introducer element. In these embodiments, the sealing element may be in contact with the guide element in such a manner that sufficient frictional force is generated between them to hold the second element in a substantially fixed position when the catheter is moved in a distal or proximal direction. Thus, the catheter and hence the drive mechanism can move relative to the introducer.

[1213] After a volume of bodily fluid has been drawn into the fluid container, the catheter is withdrawn from the PIV and positioned within the introducer at step 205. For example, in some cases, a third force is applied to the actuator. The third force may be applied, for example, in a proximal direction and may be sufficient to move at least the actuator from a distal position to a proximal position relative to the second element. In some embodiment, the third force may be applied by the user. In other embodiments, the implementation of the third force may be applied, for example, pressing or similar element in response to actuation, as described above. In some embodiments, the implementation of the second element may be configured to move, at least partially, together with the drive mechanism from a distal position to a proximal position relative to the first element. In addition, the solution scheme of the drive mechanism and the introducer is such that the drive mechanism is blocked from being withdrawn from the second element, and the second element is blocked from being removed from the first element, as described above. Thus, the guide element and the catheter can be placed in a proximal position relative to the distal end of the first element. In some cases, once the catheter and guide member are positioned proximal to the distal end of the first member, the transfusion device can be discarded.

[1214] The components of the blood sampling device and the Y-adapter can be packaged together or separately. The Y-adapter may also be sold in the same packaging as other IV line supplies. In some embodiments, the Y-adapter may remain on the IV line while the IV line is in the patient.

[1215] The blood sampling device can be used in conjunction with a variety of different peripheral intravenous lines. The device allows efficient blood sampling, while maintaining the integrity of the sample. In some embodiments, for example, the device will draw 20 ml of blood in about 1-2 minutes. When drawing blood, the blood flow can be laminar to eliminate turbulence in the catheter and thereby minimize hemolysis.

[1216] Although the blood collection device can be used in various settings (first aid station (ER), clinic, etc.), two example scenarios are described in this application. In the first scenario, the patient contains one peripheral intravenous line. In the second scenario, which is usually less common, the patient contains a dedicated second peripheral intravenous line directly for phlebotomy. Only one Y-adapter is required per patient and can be attached for the lifetime of the IV line, which is typically 3-4 days, for example. For each blood draw, a new blood draw device (eg, any of the devices described above) may be used.

[1217] The assembly of the blood sampling device may be the same in each scenario. First, the device is connected to a Y-adapter. Second, the catheter is advanced through the Y-adapter and pushed along the peripheral IV catheter into the patient's vein. After insertion into the vein, a syringe or negative pressure collection container/tube (eg, a Vacutainer® tube) is connected to the rear port and fluidly connected to the blood collection and storage catheter.

[1218] For example, the following scenario is proposed.

A nurse or phlebotomist inserts a peripheral intravenous line into the patient's arm. The peripheral IV line is inserted according to standard rules and a Y-adapter is attached. When it is time to draw blood, the healthcare provider may turn off the IV line, if it is on, for approximately 1 to 5 minutes to allow the drug or IV fluids to be dispensed from the blood draw site. To draw a blood sample, the healthcare worker attaches the blood collection device to the blood collection port on the Y-adapter, advances the internal catheter through the peripheral intravenous line and into the vein. Then, the healthcare professional may connect the negative pressure collection container(s)/vial(s) to the device (ie, place the vial in fluid communication with the blood collection device) to draw a blood sample. In use, the user may discard, for example, the first 3-6 ml of fluid or blood samples as "waste" and then use the next tube(s) as the intended sample. This “dump to waste” procedure ensures that all stagnant fluid, such as saline or drugs, is removed from the vein, peripheral IV line, and Y-adapter so as not to contaminate the sample being taken.

[1219] In a scenario where there is a dedicated peripheral IV line for blood collection, the healthcare professional inserts one peripheral IV line into the arm to administer the drug and another peripheral IV line into the opposite arm specifically for the purpose of blood collection. When the time for blood draw comes up, the health worker simply follows the steps above and, in this case, there is no need to wait 1-5 minutes to allow time for the distribution of fluid or drug, as in the first scenario.

[1220] Each of the components described in this application may be made in one piece or may be composed of parts. For example, as shown in FIG. 7, the Y-adapter 5400 and introducer 5100 are connected by locking mechanisms 5431 and 5131, respectively. The 5400 Y-adapter and the 5100 introducer can be one component where the 5400 Y-adapter is an integral part of the 5100 introducer and vice versa. In another example, although the first element 15150 of the introducer 15100 is shown and described above with reference to FIG. 48-52 including the first half 15150A and the second half 15150B, which, for example, are connected to each other during the manufacturing process to form the first element 15150, in other embodiments, the first element 15150 may be formed in one piece.

[1221] Similarly, the components described in this application can be assembled in any suitable way, for example, in the manufacturing process and/or at the place of use. For example, in some embodiments, the manufacturing process associated with the liquid transfusion device 15000 (and/or a device substantially similar to it) may include placing the second element 15160 in a desired position relative to the first half 15150A or the second half 15150B of the first element 15150 before how the first half 15150A and the second half 15150B are connected to each other to form the first element 15150. Thus, the second element 15160 can be positioned between the first half 15150A and the second half 15150 when the first half 15150A and the second half 15150B are connected to each other, and , as a result, the first protrusion 15164 can be positioned in the channel 15157 prior to the formation of the first element 15150, which, in some cases, may facilitate the assembly of the device 15000 transfusion of fluid, given that, at least partially, the channel 15157 is limited by the inner surface 15153.

[1222] In other embodiments, the projection 15164 may be, for example, spring-loaded and/or otherwise movable in a radial direction relative to the second element 15160. As such, the first element 15150 may be formed during manufacture (for example, by joining the first 15150A with the second half 15150B), and the second element 15160 can subsequently be placed in the internal volume 15155. For example, when the first half 15150A is connected to the second half 15150B to form the first element 15150, the second element 15160 can be placed in the desired position relative to the first element 15150, and the first protrusion 15164 can be moved in the radial direction to the center of the second element 15160 so that the end surface of the first protrusion 15164 is located essentially against the outer surface 15163 of the second element 15160. Therefore, the distal end portion 15162 of the second element 15160 can be inserted in the inner volume 15155. In addition, after the second element 15160 is placed in a position within the internal volume 15155 corresponding to the alignment of the first ledge 15164 and the channel 15157, the first ledge 15164 can move in the radial direction from the center of the second element 15160 (for example, under the action of spring force or similar force). Thus, the second element 15160 does not necessarily need to be placed between the first half 15150A and the second half 15150B before the first half 15150A and the second half 15150B are connected to each other to form the first element 15150.

[1223] Other aspects of the device shown and described can be modified to change device performance. For example, the holes in the set of holes described in this application at the distal end of the catheter can be of any pattern, size, shape and/or be in any number to create a preferred flow pattern through the catheter. In another example, any portion of the catheters described herein may be placed within a substantially sterile sleeve, bag, tube, sheath, and/or similar material that renders the catheter sterile prior to use of the device. In addition, although the components of the embodiments are described herein as having a given hardness and/or stiffness, in other embodiments, some components may be substantially rigid. For example, in some embodiments, introducer 6100 may be formed from a substantially rigid material. Likewise, any of the guide tubes and/or elements described herein may be formed from a rigid material such as metal or rigid plastic. For example, in some embodiments, the implementation of the guide element may be a metal hypotube or something similar. In some embodiments, the design of a catheter (e.g., catheter 15200) placed within a lumen formed by a guide element (e.g., guide element 15180) may be such that the catheter and guide element jointly define a stiffness that is equal to, for example, the sum of the catheter stiffness and stiffness of the guide element. Thus, in some embodiments, the guide element may have a stiffness that is substantially similar to that of a catheter, with the joint stiffness being sufficient to allow the guide element to pass through at least a portion of the PIV (e.g., a sleeve, grid or similar element).

[1224] In another example, any of the catheters, cannulas, flow tubes, and/or the like described herein may include and/or may otherwise contain, for example, a guidewire, reinforcing wire, lattice, and /or a matrix structure, a stent, a balloon and/or a similar element that can increase the rigidity associated with the catheter and/or otherwise limit and/or substantially prevent twisting, collapse and/or plastic deformation of at least a site catheter. For example, in some embodiments, the catheter 15200 may include, for example, a guidewire or the like, which may be positioned within the lumen 15209 while the catheter 15200 is placed in its distal position, which increases the rigidity associated with the catheter 15200. When the distal end 15212 of the catheter 15200 is in the desired position relative to the PIV (i.e., distal to the distal end of the PIV), the guidewire can be retracted through the lumen 15209 to exit the catheter 15200.

[1225] Although the second portion 15210 (eg, the distal end portion) of the catheter 15200 is shown and described in detail above, in other embodiments, the catheter may have a distal end portion in any suitable configuration. For example, in FIG. 78 schematically depicts a distal end portion 17212 of a catheter in accordance with another embodiment. As shown, the distal end section 17212 of the catheter may form a channel or similar structural element. In more detail, the first section of the catheter (not shown in Fig. 78) may have, for example, an annular cross-sectional shape, and the second section of the catheter (ie, the distal end section 17212) may have, for example, a semi-annular cross-sectional shape. In other words, the distal end portion 17212 may be, for example, cut, bevelled, milled, split in two, and/or similarly machined such that the distal end portion 15212 of the catheter has a semi-circular or semi-annular cross-sectional shape that forms a channel between the halves. The distal end 17212 solution diagram shown may, in some embodiments, allow for a reduction in size and/or caliber corresponding to the distal end 17212 of the catheter, which may otherwise be subject to kinking, obstruction, and/or occlusion. In addition, the semi-annular design of the distal end portion 17212 may increase the flow rate through the catheter, which may otherwise be limited due to the relatively small internal diameter of the catheter and/or the relatively small distal catheter opening.

[1226] In still other embodiments, the distal end portion of the catheter, such as those described herein, may include and/or may be connected to wound wire, braided braid, helically wound and/or twisted wire, helicoidally wound wire, wire mesh and/or the like. For example, in some embodiments, the implementation of the distal end portion of the catheter may include and/or may be formed from a relatively small wound or spiral wound wire. In some embodiments, the implementation of this wire can be, for example, tightly wound in the form of a substantially continuous cylindrical shape, thereby forming a section of the lumen. In some cases, this solution scheme may allow at least the distal end portion of the catheter to bend and/or flex without plastic deformation when the catheter is advanced in the distal direction. In some embodiments, the distal end solving coiled wire may function, for example, as a gimlet or similar element that can be rotated while advancing distally to remove, clear, and/or break obstructions such as, for example, a clot. In addition, although the catheter 15200 is shown and described in detail above, in some embodiments, the implementation of the distal end portion 15212 of the catheter 15200 may have any suitable configuration, such as those described in this application.

[1227] Various embodiments have been described above, however, it should be understood that they are presented by way of example only and not limitation. Where the above diagrams and/or embodiments indicate some components located in some orientations or positions, the scheme for solving the components can be modified. Although the above embodiments are shown and described in detail, it should be understood that various changes in form and detail are possible. For example, although the device or fixture 6000 is shown and described above as including an introducer 6100 with a relatively small drive mechanism guide 6111 (e.g., a slot), in other embodiments, the introducer may be, for example, a substantially U-shaped channel or something similar. In these embodiments, the implementation of the drive mechanism and the catheter can be located at least partially in the introducer and move relative to it, as described in this application. In addition, in these embodiments, the implementation of the catheter can be placed, for example, inside a sterile bag or sleeve. In other embodiments, the implementation of the introducer may be, for example, a guide rail or similar guide, along which can move the drive mechanism and the catheter. In these embodiments, the catheter may be placed inside a sterile bag or sleeve.

[1228] Although various embodiments are described as containing specific features and/or combinations of components, other embodiments are possible that contain a combination of any of the features and/or components from any of the above embodiments. For example, any of the devices described in this application may include a drive mechanism that can be connected to the catheter and perform the function of turning the catheter relative to, for example, a PIV or similar device. In another example, although the cannula 6200 is shown in FIG. 13A including a first section 6205 having a first diameter and a second section 6210 having a second diameter, in some embodiments, the cannula may include a first section and a second section of the same diameter. In addition, although the first element 15150 of the introducer 15100 is specifically shown and described as including a sealing element 15190, in other embodiments, the first element 15150 may include a sealing element substantially similar in shape and function to the sealing element 16190 contained in the first element. 16150 described above with reference to FIG. 69-72, or vice versa. Similarly, the first element 16150 and/or the drive mechanism 16570 (or features contained therein) may be contained in, for example, the device 15000 transfusion of liquid.

[1229] In another example, any of the catheters and/or cannulas described in this application may contain a distal end section with any suitable solution scheme. For example, although the distal end portion 15212 of the catheter 15200 is shown to be substantially cylindrical, with an angled or beveled tip, in other embodiments, the distal end portion 15212 and/or the second portion 15210 of the catheter 15200 may have any suitable solution scheme. For example, in FIG. 79 schematically depicts a distal end portion 18212 of a catheter in accordance with another embodiment. As shown, the distal end portion 18212 defines a set of holes 18216 arranged in echelon orientation, for example. In particular, the second section 18210 of the catheter 18200 may form a set of holes located around its circumference, similar to the set of holes 1231, 2231 and/or 4231 described above with reference to the catheters 1200, 2200 and 4200, respectively. In these embodiments, the openings of the set may be substantially circular, oblong, polygonal, elliptical, and/or any other suitable shape, size, or pattern. Therefore, the set of holes 18216 may, for example, increase the flow rate into the distal end portion 18212 of the catheter, and the layered and/or offset design of the set of holes 18212 may allow the distal end portion 18212 to remain rigid enough to restrict and/or substantially , prevent collapse of the distal end section 18212.

[1230] In cases where the above methods and/or schemes mean some events and/or sequences of operations of the method occurring in some order, the order of some of the events and/or sequences of operations of the method can be modified. In addition, some events can be executed simultaneously in parallel processes, if possible, and also be executed sequentially.

Claims (36)

1. Device for phlebotomy through an intravenous catheter, containing: a catheter having a proximal end portion and a distal end portion, wherein the catheter defines a lumen passing through the proximal end portion and the distal end portion of the catheter; and introducer containing the first element and the second element, wherein at least a section of the second element is located in the first element with the possibility of movement, while the distal end section of the first element is configured to be connected to an implanted peripheral intravenous line, and the distal end section of the second element includes a protective catheter means; wherein the second element is movable relative to the first element between a proximal position and a distal position, the catheter guard being located in the first element when the second element is in the proximal position; wherein at least the distal end portion of the catheter shield is distal to the first element and within the implanted peripheral intravenous line when the second element is in the second position; wherein the distal end portion of the catheter is isolated within the catheter guard and moves with the second element as the second element moves between a proximal position and a distal position; wherein the catheter is movable relative to the second element to be positioned in the second configuration when the second element is in a distal position such that the distal end portion of the catheter is positioned distal to the catheter guard. 2. The device according to claim 1, further comprising: an adapter connected between the introducer and the implanted peripheral intravenous line; moreover, the protective means of the catheter is made proximally relative to the adapter when the second element is in the proximal position; wherein the catheter guard is configured to pass through the lumen of the adapter to position at least the distal end portion of the catheter guard distal to the adapter when the second element is in a distal position. 3. The device according to claim 1, further comprising: a drive mechanism attached to the catheter; and the drive mechanism is configured to move the second element relative to the first element from the proximal position to the distal position in response to the first force applied to the drive mechanism, and is configured to move the catheter relative to the second element in response to the second force applied to the drive mechanism. 4. The device of claim 1, wherein the catheter guard at least partially covers the distal end portion of the catheter when the second element is moved from a proximal position to a distal position. 5. The device of claim. 1, wherein the catheter guard is configured to limit contact of the catheter with the internal portion of the implanted peripheral intravenous line when the second element is moved from a proximal position to a distal position. 6. The device according to claim. 1, in which the distal end of the second element contains a seal configured to be in contact with at least one of the outer surface of the protective means of the catheter or the outer surface of the catheter and configured to prevent the flow of bodily fluid into the internal volume of the introducer proximal to the seal and outside the catheter. 7. The device of claim. 1, in which the catheter guard passes through at least one of the sleeve, mesh or valve of the implanted peripheral intravenous line, when the second element is in a distal position such that the distal end surface of the catheter guard located distally with respect to at least one of the sleeve, mesh or valve. 8. The device according to p. 1, in which the implanted peripheral intravenous line is located at least partially inside the patient's vein; wherein the catheter is movable relative to the second element when the second element is in a distal position to position the distal surface of the catheter distally relative to the distal surface of the implanted peripheral intravenous line and within the patient's vein. 9. The device according to p. 8, in which the proximal end section of the catheter is made with the possibility of fluid connection with the reservoir for the liquid; wherein the catheter is designed to transfuse the volume of blood from the vein through the catheter lumen and into the fluid reservoir when the second element is in the distal position, and the catheter is located distally relative to the distal surface of the implanted peripheral intravenous line and inside the patient's vein. 10. Device for phlebotomy through an intravenous catheter, containing: a catheter having a proximal end portion and a distal end portion, wherein the catheter defines a lumen passing through the proximal end portion and the distal end portion of the catheter; an introducer that defines an internal volume, wherein the introducer has a distal end portion configured to connect to an implanted peripheral intravenous line; wherein the introducer is movable between the first configuration, in which the catheter guard is located inside the introducer, and the second configuration, in which at least the distal end section of the catheter guard is located distal to the introducer and inside the implanted peripheral intravenous line; and a drive mechanism attached to the catheter and configured to move the introducer between the first configuration and the second configuration; wherein at least the distal end portion of the catheter is isolated within the catheter guard and moves with the catheter guard as the introducer moves from the first configuration to the second configuration; wherein the drive mechanism is movable relative to the catheter guard when the introducer is in the second configuration to position the distal end portion of the catheter distal to the catheter guard. 11. The device of claim 10, wherein the catheter guard at least partially covers the distal end portion of the catheter when the introducer is moved from the first configuration to the second configuration. 12. The device according to p. 10, in which the protective means of the catheter is located in the area of the implanted peripheral intravenous line, when the introducer is in the second configuration; and the catheter guard is positioned between the outer surface of the at least distal end portion of the catheter and the inner surface of the implanted peripheral intravenous line portion prior to movement of the catheter relative to the catheter guard. 13. The device of claim. 10, in which the drive mechanism is held in a fixed position relative to the site of the introducer, when the drive mechanism moves the introducer from the first configuration to the second configuration. 14. The device according to claim. 10, in which the drive mechanism is held in a fixed position relative to the introducer section when the drive mechanism moves the introducer from the first configuration to the second configuration, and the drive mechanism is movable relative to the introducer section to move the catheter relative to the catheter protector, after the introducer is moved to the second configuration. 15. The device of claim 10 wherein the catheter guard has a first stiffness and the catheter has a second stiffness below the first stiffness. 16. The device according to p. 10, in which the distal end surface of the protective means of the catheter is configured to be located inside the implanted peripheral intravenous line when the introducer is in the second configuration; wherein the drive mechanism is configured to move the catheter relative to the catheter guard to position the distal end surface of the catheter outside and distally of the peripheral intravenous line. 17. A method for phlebotomy through an intravenous catheter, including the steps: connecting the transfusion device to a peripheral intravenous line located at least partially within the patient's vein; wherein the liquid transfusion device comprises an introducer, a drive mechanism and a catheter attached to the drive mechanism; applying a first force to a drive mechanism to move the introducer from a first configuration, in which the catheter guard is located within the introducer, to a second configuration, in which at least the distal end portion of the catheter guard is located distal to the introducer and within the peripheral intravenous line; wherein at least the distal end portion of the catheter is isolated within the catheter guard and moves with the catheter guard as the introducer moves from the first configuration to the second configuration; applying a second force to a drive mechanism for moving the catheter relative to the catheter guard to position the distal end portion of the catheter distal to the catheter guard; creating a fluid communication between the catheter and the fluid reservoir; and a volume of the patient's bodily fluid through the catheter into the fluid reservoir. 18. The method of claim 17, wherein the catheter guard at least partially covers the distal end portion of the catheter when the introducer is moved from the first configuration to the second configuration. 19. The method according to p. 17, in which the protective means of the catheter is located in the area of the peripheral intravenous line, when the introducer is in the second configuration, before applying the second effort; wherein the catheter guard is located between the outer surface of at least the distal end portion of the catheter and the inner surface of the peripheral intravenous line portion. 20. The method of claim 17 wherein the catheter guard is configured to limit contact between the catheter and the interior portion of the peripheral intravenous line. 21. The method of claim 17, wherein applying a second force to the actuator to move the catheter relative to the catheter guard positions the distal end surface of the catheter distal to the distal end surface of the peripheral intravenous line and within the patient's vein. 22. The method of claim 17, wherein connecting the transfusion device to the peripheral intravenous line includes connecting the transfusion device to the adapter such that the adapter is located between the transfusion device and the peripheral intravenous line.

Images