Blood collection device and method of use

Abstract

A blood extraction device having a handle includes a coupler formed at a distal end and a lumen extending proximally from an opening distal of the coupler to a proximal end of the handle through a hollow interior. An extension port is positioned on the handle and configured to form fluid communication between the handle interior and an extension set. A plunger has a plunger body between a distal seal and a proximal seal, a fluid passageway along the plunger body, and a lumen extending through a distal end of the plunger body to a cannula extending distally from the plunger body. A slider has an elongate body with a hinged section between a slider tab and a proximal end of the plunger body, wherein the tab is positioned outside of the hollow interior of the handle and configured to engage an exterior of the handle in a folded configuration.

Description

[0001] Priority requirements This patent application claims priority to U.S. Provisional Patent Application No. 63 / 564,966, filed March 13, 2024, entitled “BLOOD COLLECTION DEVICE AND METHODS OF USE,” which is incorporated herein by reference in its entirety.

[0002] By incorporating via reference All publications and patent applications mentioned in this specification are incorporated herein by reference in their entirety, to the extent that each individual publication or patent application is specifically and individually indicated to be incorporated by reference.

[0003] background Accessing a patient's vascular system via catheter provides a convenient and minimally invasive opportunity for blood draw and medication administration. However, prolonged catheter placement is often associated with obstruction in or near the distal end of the catheter within the vessel, which hinders effective blood draw. Existing obstructions, vascular tortuosity, and vascular valves are additional examples of conditions and circumstances that limit or complicate access via catheter.

[0004] Establishing or re-establishing vascular access in these situations is challenging, given the small size of the catheters being placed, the connections to the catheters, and the need to provide sufficient flow rates of blood from the blood vessels to the vacuum blood collection tube assembly.

[0005] For these reasons, it is desirable to provide improved methods, systems, and apparatus for blood extraction via catheters and catheter assemblies. In particular, it is desirable to provide simplified deployment systems and components configured for direct and intuitive use and manipulation to establish or re-establish blood flow and collection via a placed catheter. At least some of these objectives will be met by the following various embodiments.

[0006] Overview of this disclosure This article describes the blood collection device and its usage.

[0007] Typically, a blood collection device may include a handle having a folding shaft coupled to a plunger. The folding shaft allows for a more compact design. The folding shaft may be formed of shape memory metal or other wires or braids that can be bent and unfolded to provide sufficient column strength to advance the blood collection plunger and associated cannula. In another embodiment, the folding shaft has a movable hinge portion between its proximal and distal ends. The movable hinge provides a compact shape element to reduce the curvature profile of the folding shaft against the body of the blood collection device. In use, the folded plunger shaft is unfolded into an axial configuration collinear with the lumen of the blood collection cannula. The shaft is used to advance the plunger and cannula distally until the distal end of the cannula is in fluid communication with the blood vessel associated with the indwelling catheter. Continued distal advancement will communicate the distal end of the lumen with the blood collection lumen in the plunger via a blood collection container.

[0008] Typically, a blood collection device may include a handle comprising a proximal handle portion, a connector, and a hollow interior. The proximal handle portion is operatively coupled to a distal handle portion. The connector is formed at the distal end of the distal handle portion and has a lumen extending proximally from an opening at the distal end of the connector. The hollow interior extends proximally from the connector lumen to an opening at the proximal end of the proximal handle portion. An extension port is positioned on the handle, wherein a lumen extends through the extension port and is in fluid communication with the hollow interior of the handle. An extension kit is coupled to the extension port. A plunger includes a plunger body extending between a distal seal and a proximal seal, communicating along a fluid passage of the plunger body and a lumen extending distally through the plunger body. A cannula is in fluid communication with the plunger lumen and extends distally from the plunger body. A slider has an elongated body with a hinged section positioned between a slider tab and the proximal end of the plunger body, wherein the tab is positioned outside the hollow interior of the handle and configured to engage the outside of the handle in a folded configuration.

[0009] The example and any other examples described herein may further include one or more of the following. The cannula may be adapted to transition from a first configuration to a deployment configuration, in which the distal end of the cannula is positioned within the connector lumen, as the plunger is advanced distally through the hollow interior of the handle via a slide member. The cannula may be configured to provide fluid communication between a blood vessel and an extension kit as the distal plunger seal is advanced distally beyond the extension port lumen. The plunger may be configured to provide fluid communication between the extension kit and a blood vessel for cannula deployment of any length when the plunger fluid channel is aligned with the extension port lumen. The blood collection device may also include a static fluid seal positioned distally within the hollow interior of the handle near the connector lumen, the static fluid seal being adapted to receive a cannula extending therethrough. In the blood collection device of claim 4, the static fluid seal may be configured to provide a fluid seal around the cannula exterior and the proximal end of the connector lumen. The blood collection device may further include a venting opening distal to the distal handle portion, wherein a static fluid seal includes a protrusion adapted to communicate with the venting opening to retain the seal in proper position within the distal handle portion. A connector lumen extends through the protrusion axially aligned with the hollow interior of the handle. The blood collection device may further include a connector arm extending distally from the connector and configured to engage an indwelling catheter. The elongated slider body includes a distal section and a proximal section separated by a hinged section, wherein the proximal opening of the handle is X-shaped and adapted to receive the elongated slider body extending therethrough. The hinged section of the elongated slider body may be flexible and configured to fold the proximal portion of the elongated slider body to the outer surface of the handle in a retracted configuration.

[0010] The example and any other examples described herein may further include one or more of the following. The blood collection device may also include a post on the exterior of the handle, configured to releasably engage with a sliding tab in a retracted configuration. The blood collection device may also include a positioning mark disposed on the handle and configured to indicate the length of cannula deployment. The blood collection device may also include a cap configured to cover the connector lumen. The hollow interior of the handle may be a lumen in circumferential communication with a distal plunger seal and a proximal plunger seal. According to claim 14, the hollow interior lumen includes a diameter configured to prevent cannula kinking. The hollow interior of the handle includes a diameter configured to prevent cannula kinking. The diameter of the hollow interior of the handle may be configured to circumferentially contact the distal plunger seal and the proximal plunger seal. The ratio of the diameter of the hollow interior to the outer diameter of the cannula is less than 5:1.

[0011] Typically, a method of collecting blood samples using any of the devices described herein may include attaching a handle to an indwelling catheter, unfolding the elongated body of the slide, advancing a plunger distally through the interior of the hollow handle, and further advancing the plunger and slide distally until the distal end of the cannula is in fluid communication with a blood vessel, providing fluid communication from the cannula to the extension kit through the plunger body and the extension port lumen.

[0012] The example described herein, and any other examples, may further include one or more of the following. The method may also include adjusting the length of the cannula deployment through the indwelling catheter by further distally advancing the plunger within the hollow handle. The method may also include advancing the cannula beyond an obstruction to provide fluid communication from the blood vessel to the extension kit. The method may also include maintaining fluid communication between the cannula and the extension kit along the length of the plunger body. The method may also include removing the cap from the connector before deploying the elongated body of the slider.

[0013] Typically, a blood collection device may include a handle, a connection area on a distal handle section, an extension port on the distal handle section, an extension kit, a plunger, a cannula lumen, and a slider. The handle has a proximal handle section fixed to the distal handle section, wherein a central lumen extends through the proximal handle section and the distal handle section. The connection area has a lumen axially aligned with the central lumen of the handle and an arm extending distally from the distal handle section, the arm being configured to engage an indwelling catheter. The extension port has a lumen extending through the extension port from the central lumen of the handle. The extension kit communicates with the lumen of the extension port. The plunger has a body extending between a distal seal and a proximal seal, wherein a fluid passage is positioned along the plunger body. The cannula lumen has a distal opening in fluid communication with the plunger fluid passage. The slider has an elongated body extending proximally from the plunger to a tab, wherein the elongated body of the slider is configured to fold onto the outside of the handle in a retracted configuration, wherein the plunger body and the cannula are axially aligned with the central lumen of the handle.

[0014] The example described herein, and any other examples, may further include one or more of the following: A slider is configured to deploy during use to axially align with the plunger. The plunger is configured to be advanced distally through the central lumen of the handle until the plunger body is aligned with the expansion port lumen. The cannula lumen and the plunger define a first flow path segment. The first flow path segment is discontinuous with the expansion kit until the plunger is advanced distally to alignment with the expansion port lumen. The first flow path segment is configured to be airlocked. The expansion port lumen and the expansion kit define a second flow path segment. The first flow path segment is configured to be in fluid communication with the first flow path segment when the plunger body is aligned with the expansion port lumen. The cannula lumen is configured to extend distally through the connecting segment lumen via an indwelling catheter. The cannula lumen is configured to be advanced distally from the handle through the connecting segment lumen to contact intravascular fluid.

[0015] Typically, a method for aspirating blood via an indwelling catheter may include the following steps: attaching a distal end of a blood aspiration device to the indwelling catheter, the blood aspiration device including a central lumen extending through a proximal handle portion and a distal handle portion, wherein the cannula is axially aligned with the central lumen and attached to a plunger having a body extending between a distal seal and a proximal seal; advancing the plunger distally through the central lumen, wherein an elongated slide extends proximally from the plunger and through the proximal end of the handle; advancing the plunger until the cannula extends through the indwelling catheter into a blood vessel; and completing a flow path from the blood vessel to an extension kit, which is attached to an extension portion on the distal handle portion, when the plunger body is advanced to alignment with the lumen extending through an extension port.

[0016] The example described herein, and any other examples, may further include one or more of the following. The method may also include disengaging the tab from a post on the outer surface of the handle, wherein the tab is positioned at the proximal end of the elongated slide; and deploying the elongated slide to axially align it with the plunger body. The steps of completing the flow path also include distally advancing a first flow path segment defined by the cannula lumen and the plunger body; aligning the plunger body with a second flow path segment defined by the expansion port lumen and the expansion kit. The first flow path segment is gas-locked until the distal plunger seal is distally advanced beyond the expansion port lumen. Attached Figure Description

[0017] A better understanding of the features and advantages of the methods and apparatus described herein will be obtained by referring to the following detailed description of illustrative embodiments and the accompanying drawings: Figure 1 This is a perspective view of a blood collection device, in which a folded plunger is in a retracted configuration and positioned proximally within a handle. The handle has a proximal end with a connector configured to engage a catheter in use. A cannula extends from the distal end of the plunger and is configured to extend via the movement of a slider engaged with the proximal end of a slider extension that extends through the distal end of a clamp between the slider and the proximal end of the plunger.

[0018] Figure 2 yes Figure 1 Another perspective view of the blood collection device in a close-proximity configuration aligned with the catheter assembly. The plunger remains in a folded and retracted configuration, with the slider extension and the slider held in a clamped position against the outside of the handle by the clamp portion of the clamp.

[0019] Figure 3 From Figure 2The perspective view of the proximal side of the blood collection device shown shows the plunger still in a retracted configuration at the proximal end inside the handle, and now shows the slider extension extended and roughly aligned with the plunger axis, ready to be advanced distally to transfer the plunger from the proximal position to the deployment configuration.

[0020] Figure 4 yes Figure 1 and Figure 2 The image shows a detailed perspective view of the proximal end of the blood collection device, in which the slider and slider extension are in a folded, stowed configuration, with the handle cap holding the slider extension against the outside of the handle.

[0021] Figure 5 yes Figure 4 A further detailed side view of the proximal end of the clamp and handle, wherein the proximal end of the plunger is visible due to its retracted configuration that is positioned proximally inside the handle.

[0022] Figure 6A and Figure 6B Individually shown Figure 5 The distal perspective view and distal outline view of the handle cap.

[0023] Figure 6C yes Figure 6A and Figure 6B The proximal perspective view of the clip shown includes further details of the outer or proximal side of the clip, including the proximal end of the clip portion channel and the sliding extension lumen extending from the proximal end of the clip to the distal end of the cap.

[0024] Figure 7 From Figure 3 A perspective view of a portion of a blood collection device taken from the proximal end, showing the slider and slider extension being released from the clamp, unfolded, and aligned with the slider and cannula.

[0025] Figure 8 This is a perspective view of the slider as seen from the far end, with the section of the slider extension extending from there.

[0026] Figure 9A This is a side view of a plunger, which includes a portion of a cannula extending from the distal end of the plunger and a sliding extension extending from the proximal end of the plunger.

[0027] Figure 9B This is a detailed cross-sectional view of the distal region of the plunger, showing the distal seal surrounding the plunger and located distal to the collar, which is configured to prevent proximal displacement of the seal during distal advance of the slide.

[0028] Figure 9CThis is a detailed cross-sectional view of the proximal end of the plunger, showing a proximal collar positioned distal to the proximal seal and configured to prevent distal displacement of the proximal seal when the plunger retracts.

[0029] Figure 10A It is a side view showing in detail the distal portion of the blood collection device, in which the plunger is in a position that is pushed distally inside the handle, and the cannula is deployed accordingly from the distal end of the handle connector.

[0030] Figure 10B yes Figure 10A The cross-section taken at indicator "5" shows the arrangement of the middle section of the plunger relative to the inside of the handle.

[0031] Figure 11 yes Figure 1 A detailed view of the connector at the distal portion of the device handle shown, including the cannula in a retracted position within the handle and the connector protrusion.

[0032] Figure 12 It shows Figure 1 The distal portion of the blood collection device shown is now in a deployment configuration, in which the plunger is advanced distally within the handle, and the distal seal has been extended through the handle's expansion port to form a continuous lumen and flow path that extends through the plunger into the interior of the handle and exits the vacuum blood collection tube (not shown).

[0033] Figures 13A to 13F The diagram illustrates the subsequent advancement of the plunger within the handle, while maintaining a flow path as the plunger advances further within the handle, with the plunger body remaining aligned with the handle extension port, thereby maintaining a flow path from the blood vessel, through the cannula, through the distal end of the plunger, and then into the handle and out through the extension port to the vacuum collection tube.

[0034] Figures 14A to 14E This illustrates different configurations or deployment arrangements when the cannula is deployed distally within the handle according to the advance of the slider and plunger (from... Figure 14A The collapsed configuration in the middle Figure 14E (the largest deployment configuration in) Figure 1 Blood collection device.

[0035] Figure 15 It shows Figure 1 The blood collection device is now coupled to a variant of the catheter assembly, which includes a conventional catheter hub coupled to a catheter adapter, which includes a collar and a closure system adapter that provides a catheter extension port that can be selectively accessed, and the device connector protrusion is not in the coupled or mated position as shown in the figure.

[0036] Figure 16 This is a perspective view of another example of a blood collection device, in which the folding plunger is in a retracted configuration and positioned proximally within the handle, while the slider is clamped or held on the outside of the handle.

[0037] Figure 17 yes Figure 16 The image shows a proximal perspective view of the device now coupled to the catheter assembly, with the slider unclamped and deployed in a ready-to-use configuration. In this configuration, the slider and its extension are axially aligned with the plunger, ready to advance the plunger distally, thereby advancing the cannula accordingly to establish blood flow through the device and to the vacuum blood collection tube assembly coupled to it.

[0038] Figure 18 This is another near-side perspective view, showing the cross-sectional geometry of the slider extension and the corresponding geometry of the near-side cover of the handle.

[0039] Figure 19A yes Figure 16 A detailed view of the proximal end of the device shows the hinge or bend of the flexible section of the slider extension and the corresponding arrangement of the slider extension through the proximal cover of the handle, wherein the slider is located proximal to the handle, in the same position it might be in when in a folded or stowed configuration.

[0040] Figure 19B yes Figure 19A The device is shown in the diagram, which is rotated clockwise to further illustrate the plunger flow channel within the handle, in which blood can flow when the plunger is advanced into fluid communication with the extension kit coupled to the handle.

[0041] Figure 19C Observation from the near end Figure 19B Another view of the device shows additional details of the arrangement of the slider extension extending through the proximal cover of the handle, wherein the flexible slider extension section is in a hinged configuration to facilitate storing the slider on the handle post.

[0042] Figure 19D yes Figure 1 The cross-section of the plunger in the device, positioned distally within the handle, shows the space or volume between the plunger body and the interior of the handle, and... Figure 19E Compared to the plunger example in the text, Figure 19E Shown Figure 16 The plunger in the device has a fluid passage and a large circumference, thereby reducing the space between the outside of the plunger and the inside of the handle.

[0043] Figure 20A Is it like this? Figure 19AThe side view of the device illustrated shows a slider connected to the handle post in a retracted configuration, wherein the slider remains against the handle.

[0044] Figure 20B This is a close-up perspective view of the slider, which is held on the handle post in a retracted configuration near the middle section of the handle, as is possible when the slider is in the retracted configuration.

[0045] Figure 21 This is a proximal perspective view of the proximal section of the handle, in which the slider is now in an unclamped configuration and ready for use, while the plunger is still in the proximal position, the slider and plunger are axially aligned, and the cannula is ready to be advanced distally.

[0046] Figure 22A This is another close-perspective detailed view, in which the slider is aligned with the plunger and cannula, ready to advance distally to establish a flow path. The plunger is in a proximal position or a retracted configuration, and the cannula extending distally from the plunger has not yet been deployed from the distal end of the handle.

[0047] Figure 22B yes Figure 22A The device shown, wherein the slider and the slider extension are from Figure 22A The view in the middle is pushed to the distal side, and the slider extension is pushed into the inside of the handle, thereby shifting the distal push of the plunger toward the distal end inside the handle, while the cannula is deployed accordingly.

[0048] Figure 22C yes Figure 22B The side view of the device shown illustrates the position of the plunger after it has been advanced by the slider and slider extension, such that the plunger is now in fluid communication with the extension port of the handle.

[0049] Figures 23A to 23D A view of the distal section of the handle is shown, in which a valve is configured to seal the inside of the handle to prevent any flow that may occur outside the cannula through the connector protrusion.

[0050] Figure 24 This is a side view showing the distal end of the handle, where the connecting area engages with a cap above a protrusion of the connecting area, and the connecting area may be in a storage configuration before use.

[0051] Figure 25 yes Figure 24 The cross-section of the view in the image further illustrates an example of the connection area that joins to the cap.

[0052] Figure 26 and Figure 27 It was previously in Figure 24 The perspective view of the hat shown in the image.

[0053] Figure 28A It is a side view of a blood extraction device including a cap at the distal end of the handle, and Figure 28B A cross-section of the distal handle portion is shown, in which the cannula is positioned.

[0054] Figures 29A to 29C Various views of another exemplary seal are shown, which can be statically positioned within the handle near the distal end inside the hollow handle.

[0055] Figure 30 It is a method for completing the blood extraction fluid path.

[0056] Detailed description The blood collection device described herein may have a cannula configured to extend through a catheter to provide blood flow from a patient's blood vessels via the cannula or catheter. The cannula may communicate with a slider configured to slide through a housing. The housing may include a handle having a groove from proximal to distal, such that the groove can be configured to accommodate movement of the slider between the proximal and distal sides of the handle. A tube seal may be positioned within the handle and configured to provide a seal for a lumen via the cannula and the slider. The lumen may be discontinuous until the slider is advanced into fluid communication with a port on the handle. The seal may further extend into the port to provide complete sealing of the slider path and fluid communication with the port.

[0057] Figure 1 This is a perspective view of the blood collection device 100, in which the plunger 200 is in a retracted, folded configuration and positioned proximally within the handle 105. The handle 105 has a proximal end 106 with a connector 150 configured to engage a catheter in use. An insertion cannula 120 extending distal to the plunger 200 is configured to extend via a slider 110, which is coupled to... Figure 1 The proximal end of the slider extension 115 shown extends as a wire (e.g., Nitino wire) between the proximal ends of the slider 110 and the plunger 200, passing through the distal end of the handle cap 175. The slider extension 115 is configured to function as a push wire with sufficient column strength to advance the distal side of the slider 110 to the plunger 200, and then to the cannula 120 extending from the distal end of the plunger.

[0058] In this folded, stowed configuration, the flow path or lumen from the distal opening of the cannula 120 to the vacuum blood collection tube assembly 129 is discontinuous and sealed to prevent blood from flowing through the cannula 120 into the vacuum blood collection tube assembly (e.g., extension kit 130). The vacuum blood collection tube 129 is an example of a blood collection container that is in fluid communication with the handle interior 108 and the plunger flow path 107 when the plunger 200 is advanced distally in the handle 105 to establish blood flow through the cannula 120 and into the handle interior surrounding the plunger 200. The vacuum blood collection tube is coupled to the handle extension port 125 via a tube 126, which has a clamp 127 between the extension port 125 and the extension kit Luer connector 128.

[0059] In some examples, the flow path may be a fluid path extending proximally through the distal end of the cannula and into the plunger. For example, the path of blood flowing from a vessel through the cannula and the plunger (e.g., the plunger body). In some examples, the flow path is discontinuous because it may be discontinuous to the vacuum blood collection tube before the plunger is advanced in the handle to align with the extension port, the extension port lumen, the extension kit, and continues to align with the vacuum blood collection tube. In any example, as described herein, to complete the flow path, plunger alignment can begin when the distal plunger seal has been advanced distally beyond the extension port, thus forming a fluid connection between the distal end of the cannula and the extension port. In some examples, once established, the flow path can be maintained through different deployment lengths of the cannula as the plunger body aligns with the extension port. For example, the flow path can be maintained between the distal and proximal seals of the plunger along any deployment / extension length of the cannula.

[0060] At the distal end of the handle 105 is a coupling mechanism including a connector 150 having a protrusion 155 extending from the connector 150 and axially aligned with the cannula 120. The connector 150 can be configured and adapted to engage any catheter assembly or other vascular access component for use in combination with the device 100 to establish or re-establish blood flow.

[0061] In some examples, the handle 105 may have one or more engagement features 135 positioned on or around the handle to support user engagement and manipulation of the device 100.

[0062] like Figure 1As illustrated herein, the device described herein can be described in different configurations. For example, a retracted configuration may exist, in which the plunger 200 is located proximally inside the handle, and the slider 110 is held externally to the handle by a clip 175 configured to receive and retain the slider extension. Other examples of configurations may include a ready-to-use configuration, a partially deployed configuration, a deployed configuration, a retracted configuration, etc. Each configuration may include a different arrangement of one or more elements or features associated with cannulation deployment and the establishment of blood flow from the blood vessel to the extension kit 130.

[0063] Figure 2 A blood collection device 100 is shown in a near-proximity configuration aligned with catheter assembly 250. The plunger 200 remains in a retracted configuration, with the slider extension 115 and the slider held in a clamped position against the outside of the handle by a clamp portion of the handle cap. Here, the connector protrusion 155 is aligned in place with catheter hub 255 such that cannula 120 is aligned with catheter 265. Cannula 120 is configured to be advanced through catheter assembly 250 and through catheter 265 into the blood vessel where the catheter is placed. As cannula 120 is advanced distally beyond catheter 265, cannula 120 may be adapted to clear any obstructions that may be present distal to catheter 265 to establish or re-establish blood flow through catheter 265, or, when cannula 120 is aligned with extension port 125, to directly draw blood through device 100 (including through cannula 120) and into the plunger flow path.

[0064] exist Figure 2 In this configuration, the slider 110 remains in the retracted position, and the slider extension 115 communicates with the clamp 175 at the distal end of the handle. Therefore, the cannula 120 is retracted within the handle 105, and a flow path is not yet established when the plunger 200 is in the proximal position and not aligned with the extension port 125. In some examples, the catheter assembly may also include an extension kit for independent use without engagement with the device 100, or for separate vascular access without engagement with the device 100.

[0065] Figure 3 From Figure 2The diagram shows a proximal perspective view of the blood collection device 100, with the plunger 200 still in a retracted configuration at its proximal end within the handle. A slider extension 115 is shown released and unfolded from the handle clamp 175 and generally aligned with the axis of the plunger 200. A slider 110, coupled to the distal end of the slider extension 115, is prepared to advance and transmit distal advance to the plunger 200, shifting the plunger 200 from a proximal position to a deployment configuration by advancing the cannula 120 at the proximal end of the plunger through the catheter 265 until a flow path is established at the completion of the lumen from the blood vessel to the vacuum blood collection tube assembly 129. A connector 150 engages with the catheter hub 255 and maintains alignment of the device 100 with the catheter assembly 250. The slider 110 is positioned proximal to the handle 105 at a length corresponding to the length of the slider extension 115. The length of the slider extension 115 provides the deployment length of the cannula 120. In some examples, the length of the slider extension 115 may also be related to the displacement length of the plunger 200 within the handle 105. For example, as Figure 3 As shown, the plunger 200 is in the proximal position, with a travel length from the shown position to the distal end inside the handle. Therefore, the cannula 120 can be deployed or extended from the handle 105 at any length corresponding to the proximal and distal positions. In some examples, the slider 110 can be advanced and retracted to adjust or accommodate the length of cannula deployment as needed to facilitate surgery and establish blood flow or blood aspiration to the extension port 125.

[0066] Figure 4 yes Figure 1The detailed perspective view of the proximal end of the blood collection device shown depicts a slider 110 and slider extension 115 in a folded, stowed configuration, with a clip 175 holding the slider extension 115 against the outside of the handle. A plunger 200 is located adjacent to the clip 175 within the handle 105 and in a proximal position, with the cannula 120 extending distally from the plunger. In this detailed view, the plunger 200 is shown having a distal plunger seal 210 and a proximal plunger seal 205. The section of the plunger extending between the proximal and distal ends has a circumference or perimeter smaller than the inner circumference of the handle. The flow path space 107 can be configured to allow blood to flow from the cannula 120 into the space 107. Therefore, blood in the space 107 will be retained or confined within the space 107 between the distal seal 210 and the proximal seal 205. The length of the plunger between the seals provides an adjustable deployment length while maintaining a flow path or fluid communication to the extension kit 130. For example, a flow path can be initiated when the distal seal 210 has been advanced distally through the expansion port 125 and blood enters the space 107. From this point, the cannula 120 can be extended further while maintaining the flow path, and blood continues to flow through the cannula to the expansion kit 130 until the proximal plunger seal 205 has been advanced distally beyond the expansion port 125. Conversely, after the flow path has been established, if the plunger retracts, causing the distal seal 210 to retract proximally from the expansion port 125, the flow path can then be closed and the lumen defining the flow path can return to a discontinuous state.

[0067] Still referencing Figure 4 As can be seen, clip 175 has a slider extension channel 180, which is configured to receive a slider extension 115 passing through it and is adapted to hold the slider extension 115 until the slider 110 is released and converted to a ready configuration. Clip 175 may include an upper portion and a lower portion 185. The lower portion 185 may be adapted to serve as a cap attached to the distal end of handle 105. A slider extension lumen 186 may extend through the lower portion of slider 185 and is configured to receive the slider extension 115 passing through it.

[0068] In some examples, the position of the clip 175 on the distal end of the handle 105 can be adapted to reduce or minimize the slider extension section 116, which can be formed in the slider extension 115 between the distal end of the handle and the slider 175 when the slider 110 is in a retracted configuration. The slider extension 115 can be seen extending from the distal end 112 of the slider, and as shown, the slider 110 remains against the handle 105 when clamped.

[0069] Figure 5 yes Figure 4A further detailed side view of the handle cap 175 (e.g., a clip) and the proximal end of the handle. The proximal end of the plunger 200 is visible when the plunger 200 is in a retracted configuration, positioned proximally inside the handle. The proximal plunger seal 205 is configured to seal the space 107 by extending from the plunger 200 and contacting the inner surface of the handle. The seal provided by the proximal plunger seal 205 and the distal plunger seal 210 (not shown) provides a seal for the flow path of the included space 107 (between the central region of the plunger body and the inner surface of the handle). The clip 175 is shown in detail, wherein the slider extension 115 is partially visible, extending through the handle cap into the handle and engaging the proximal end of the plunger 200. The clip 175 has a clip portion (e.g., an upper portion) extending along the outer surface of the handle 105, which has a channel 180 adapted to receive and retain the slider extension 115 in the retracted configuration. The handle cap body 185 is configured to engage the proximal end of the handle 105, and a protrusion 190 from the handle cap body extends toward the plunger 200 into the interior of the handle. A lumen 186 extends through the handle cap protrusion 190 and is configured to receive a sliding extension 115 from the outside of the handle to the proximal end of the plunger.

[0070] Additional details on clip 175 Figure 6A and Figure 6B As shown in the image. (Reference) Figure 6A A clip 175 is shown, having a cap body 185 and a clip portion positioned above the cap body 185. A cap protrusion 190 extends away from the cap body 185 and is shown having a lumen 186 extending therethrough. A distal surface 187 of the cap body 185 is configured to engage a proximal surface of a handle. In some examples, the protrusion 190 may include a diameter or geometry complementary to the internal geometry of the handle to support communication between the handle 105 and the clip 175. Figure 6B The outline diagram shows the channel 180 extending through the clip portion and the sliding extension lumen 186 passing through the cap body 185 and the cap protrusion 190.

[0071] Figure 6C yes Figure 6A and Figure 6BThe diagram shows a proximal perspective view of the clip 175, with details of the outer or proximal side of the clip 175, including a proximal end 188 and a slider extension channel 180, as well as a slider extension lumen 186 extending from the proximal end 188 of the clip to the distal end of the cap protrusion 190. The slider extension lumen 186 is shown here as a generally circular lumen. However, in some examples, the lumen 186 has a geometry complementary to the slider extension to support alignment. In some examples, the lumen 186 allows the slider extension 115 to slide through it. In some examples, the slider extension can pass through the clip lumen 186 and can be allowed to rotate. In such examples, rotation of the slider extension 115 can be translated into rotation of the plunger 200. In this configuration, the rotation of the plunger may be irrelevant to the flow path because the space 107 surrounds the plunger body, supporting 360-degree fluid communication around the plunger. In some examples, the lumen 186 or similar structure described herein can prevent rotation of the slider extension 115 and maintain alignment of the slider, slider extension, and plunger.

[0072] Figure 7 This is a perspective view taken from the proximal end of a portion of the blood collection device 100, where the slider 110 and slider extension 115 are released from the clamp 175, unfolded, and aligned with the cannula 120 still positioned proximally within the handle. The length of the slider extension 115 from the proximal end of the plunger to the distal end of the slider provides the capability for distal advance of the plunger and deployment of the cannula through the catheter during use. In this view, the slider extension 115 is shown extending through the body of the clamp 175 via a slider extension lumen 186 that passes through a protrusion of the body of the clamp 175. From this perspective, it can be understood that distal advance of the slider 110 from the indicated position allows the slider extension 115 to travel through the clamp 175 to distally advance the plunger 200 and the cannula 120. The distal seal 210 and the proximal seal 205 maintain a seal in space 107 but allow the plunger to advance as the slider 110 moves.

[0073] Figure 8 This is a perspective view of the slider 110 as seen from the distal end, with a segment of the slider extension 115 extending from this distal end. The slider 110 has a slider body shown as a single piece, which has a plurality of engagement features 111 positioned on an upper and lower surface. The engagement features 111 can be configured to support control of cannulation deployment via transfer of the slider from a proximal position to a distal position. The slider extension 115 can be fixed or integrated with the slider 110 such that the slider 110 can be advanced distally or retracted proximally, thereby causing distal advancement or proximal retraction of the slider extension 115.

[0074] Figure 9A This is a side view of plunger 200, including a portion of cannula 120 extending from the distal end 213 of the plunger and a sliding extension 115 extending from the proximal end of the plunger. Plunger 200 is shown having a proximal seal 205 communicating with a proximal portion of the plunger body and a distal seal 210 communicating with a distal portion of the plunger body. An elongated body of plunger 200 extends between the proximal and distal portions and includes a smaller cross-sectional geometry compared to the proximal and distal portions to allow for a flow path space 107, as described herein.

[0075] Figure 9B This is a detailed cross-sectional view of the distal region of plunger 200, showing a distal seal 210 surrounding plunger 200 and distal to collar 211, collar 211 being configured to prevent proximal displacement of seal 210 during distal advance of slider 110. An opening 212 in the slider body proximal to collar 211 can be in fluid communication with the lumen of cannula 120 extending to engage with distal end 213 of plunger 200. Plunger opening 212 can be configured to guide fluid (e.g., blood) flow through cannula lumen and into the handle interior (e.g., space 107) surrounding the plunger elongated body. As described herein, the plunger elongated body segment can have a cross-section with a diameter smaller than the handle interior. Therefore, when cannula 120 is advanced into a blood vessel and plunger 200 is advanced distally through handle 105, blood can flow through cannula 120, out of plunger opening 212, and into space 107 between plunger elongated body and handle interior.

[0076] Figure 9C This is a detailed cross-sectional view of the proximal end of the plunger, showing a proximal collar 207 positioned distal to the proximal seal 205 and configured to prevent distal displacement of the proximal seal 205 when the plunger 110 retracts. A portion of the slider extension 115 is visible in this view and extends from the proximal end of the plunger 200 to the slider (not shown). Distal to the proximal collar 207, the plunger elongated body can be seen to have a smaller diameter or cross-section compared to the proximal collar and the proximal seal. Therefore, blood entering the space 107 between the plunger elongated bodies can be contained within the space between the proximal and distal collars of the plunger. In some examples, the plunger collars (e.g., the proximal and distal collars) can prevent blood from flowing out of the plunger space 107. Additionally, the proximal seal 205 and the distal seal 210 can also prevent blood from flowing out of the plunger space 207.

[0077] Figure 10AThis is a side view showing in detail the distal portion of the blood collection device 100, with the plunger 200 in a distally advanced position inside the handle, and the cannula 120 correspondingly deployed from the distal end of the handle connector 150. Space 107 is now aligned with extension port 125, establishing fluid communication between the cannula 120 and extension port 125. The cannula 120 extends beyond the distal tip 160 of the connector protrusion, as is possible when the cannula 120 is in use and inserted into a blood vessel.

[0078] Figure 10B yes Figure 10A A cross-section taken at indicator "5" shows the arrangement of the middle section of plunger 200 relative to the interior of handle 105. Space 107 can be understood as the space where blood flows and exists as it continues to flow through expansion port 125 and expansion kit 130. Figures 16-2 In some embodiments shown in 2, the plunger described herein may have one or more different features or configurations, such as a larger circumferential or perimeter geometry, because this can reduce the need for the space 107 with blood flow channels or other features of the plunger described herein.

[0079] Figure 11 This is a detailed view of the connector 150 located at the distal portion of the device handle 105, including the cannula 120 in a retracted position within the handle 105 and the connector protrusion 155. The connector 150 may be adapted to engage any catheter or catheter assembly with the connector arm 151. Each connector arm 151 may have a proximal gripping portion 153 and a distal gripping portion 154 extending from the arm 151 toward the connector protrusion 155. Each arm 151 and gripping portions 154 / 153 are adapted to contact, retain, and allow or disengage the catheter assembly. The protrusion 155 may be adapted to be inserted into the catheter assembly. For example, the protrusion 155 may be adapted to puncture a valve within the catheter assembly. The protrusion 155 has a lumen 152 axially aligned with the cannula 120. Figure 11 As shown, the cannula 120 retracts into the device 100, and the distal section is positioned within the protrusion lumen 152. The distal end of the protrusion 160 is shown as a tapered section, which is further adapted to pierce or traverse a valve or diaphragm as needed.

[0080] In this detailed view at the distal end, the handle interior may have a sealing position 156 at the distal end of the handle interior 108 and be configured to receive a valve positioned therein. The distal taper 109 of the handle interior may also be geometrically complementary to the distal end of the plunger. In some examples, the plunger may be in the most distal position because it can be stopped by the distal end of the handle interior.

[0081] Figure 12The distal portion of the blood collection device 100, now in a deployment configuration, is shown, with the plunger 200 advanced distally within the handle 105 and the distal seal 210 having passed through the extension port 125 of the handle, creating a continuous lumen and flow path that extends through the plunger opening and space 107 into the interior of the handle and outwards into a vacuum blood collection tube (not shown). In this position, the flow path is initially established when the plunger body length is aligned with the extension port 125 of the handle. It is also shown here, and in some examples, that the handle 105 may have more than one segment. For example, the handle may include a distal handle portion 105b coupled to the proximal handle portion 105a. The interior may be a continuous geometry or a continuous surface to provide a consistent seal for the plunger seals 205 and 210 when they can pass over the seam of the handle portion.

[0082] Figures 13A to 13F The illustration shows subsequent advancement of the plunger 200 within the handle, while maintaining a flow path as the plunger 200 is further advanced within the handle 105, while the plunger body remains aligned with the handle extension port 125, thereby maintaining a flow path from the blood vessel, through the cannula 120, through the distal plunger 213, and then into the handle and out through the extension port 125 to the extension kit 130. Reference Figure 13A and Figure 13B The relative positions of the plunger 200, which maintains the flow path through the cannula 120 to the expansion port 125, are shown. Figure 13B The diagram shows the relative position of slider 110 as it is advanced toward the proximal end of the handle. Slider 110 is away from the proximal end of the handle and corresponds to... Figure 13A The plunger position is shown in the diagram. This could be an intermediate position of the slider / plunger, where a continuous lumen is formed when the flow path space 107 is aligned with the expansion port 125.

[0083] Figure 13C and Figure 13D The further advance of the slider 110 near the proximal end of the handle 105 and the corresponding advance relative to the extension port 125 of the handle 105 are shown, while maintaining a flow path through and around the plunger body to the extension port 125.

[0084] at last, Figure 13E and Figure 13FThe slider 110 is shown in its most distal position near the proximal end of the handle 105, the plunger body is in its most distal position within the handle 109, and the flow path is maintained at the most proximal end of the plunger body, which includes a plunger proximal seal 205 that closes the interior of the handle near the plunger. As shown here, the distal end of the plunger is positioned in a distal taper 109 within the handle, where the distal end of the plunger can be restricted to prevent further distal deployment. The length of the plunger 200 and the potential deployment length can be any length that allows for any deployment length, including maintaining fluid communication or a flow path along the entire length of the plunger between the proximal seal 205 and the distal seal 210.

[0085] Figures 14A to 14E This illustrates different configurations or deployment arrangements when the cannula 120 is deployed distally within the handle 105 according to the advance of the slider 110 and the plunger 200 (from... Figure 14A The expanded but collapsed configuration in the middle Figure 14E The blood collection device 100 is in the maximum distal deployment configuration. The device 100, which is connected to the catheter assembly 250 and the plunger 200, is in a deployment-ready configuration because the device 100 can be aligned axially with the plunger 200 and the cannula 120 through the inside of the handle, and cannula 120 can be advanced or deployed accordingly.

[0086] Figure 14B A blood collection device 100 is shown, wherein a slider 110 is advanced distally within a handle 105 to provide fluid communication with an extension port 125 of the handle 105, while the plunger body is aligned with the extension port 125, and the slider 110 has been advanced distally to deploy a cannula 120 through a connector, the deployment action corresponding to the distal advancement of the slider 110.

[0087] Figure 14C The device 100 is shown, in which the slider 110, plunger 200 and cannula 120 are drawn from... Figure 14B The previous view is further extended distally, while the slider advance can be configured to deploy the cannula 120 beyond the catheter assembly 250 with catheters of different lengths using a blood collection device of the same length, or to address vascular obstruction or tortuosity as needed using a blood collection device of the same length. The deployment length 120a shown herein can be correlated with the length 115a of the slider extension 115 and can be adjusted based on the remaining length of the slider extension 115 extending from the proximal end of the handle. In any example, the device described herein may have an indicator on the slider extension to indicate the deployment length to the user.

[0088] Figure 14D The device 100 is shown, wherein the plunger 200 and Figure 14CThe position shown, and closer to the maximum deployment length of the cannula, is further advanced distally because the slider 110 has already advanced further towards the proximal end of the handle 105 when the slider 110 approaches the maximum advancement position. The deployment length 120b has increased compared to the deployment length 120a, wherein the remaining slider extension length 115b is greater than... Figure 14C The slider extension shown as 115a is shorter. The extension port 125 remains aligned between the plunger and the space 107 between the proximal seal 205 and the distal seal 210.

[0089] at last, Figure 14E The device 100 is shown in its maximum deployment configuration, with the plunger 200 advanced to a distal position within the handle 105, thereby maintaining fluid communication with the extension port 125 at the proximal end of the plunger body. As seen here, the extension port 125 is adjacent to the proximal seal 205, which is located at the furthest extension length of the cannula 120.

[0090] Figure 15 The device 100 illustrates another configuration of the catheter assembly, which includes an adapter 262 coupled to a catheter hub 261. The adapter 262 adapts the catheter hub to a closed catheter system that can be coupled to the device 100. As described herein, the device's connector can be adapted to engage any type or style of catheter, catheter assembly, or associated adapter.

[0091] Figure 16 This is a perspective view of another example of a blood collection device 300, in which the plunger 375 is in a folded, retracted configuration and positioned proximally within the handle 305, while the slider 350 is clamped or held externally on the handle. The handle 305 has a proximal end with a connector 315 configured to engage a catheter in use. An insertion cannula 320 extending distally from the plunger 375 is configured to be advanced distally by the transfer of the slider 350, which is coupled to the proximal end of a hinged slider extension that extends between the slider 350 and the proximal end of the plunger 375, passing through the distal end of the cap 310. In this retracted configuration, the flow path or lumen from the distal opening of the insertion cannula 320 to the vacuum blood collection tube assembly 330 is discontinuous and sealed to prevent blood from flowing through the insertion cannula 320 into the vacuum blood collection tube assembly.

[0092] In this example of the blood collection device, the slider extension includes distinct sections, including a proximal section 355 and a distal section 365 separated by a flexible hinge section 360. The slider extension is configured to flex or bend at the hinge section 360, thereby providing a more compact profile when the slider 350 is attached to the handle 305. At the distal end of the handle 305, pressure relief openings 307 are present near and adjacent to the connector 315 or located at the connector 315. These openings 307 can be configured to release pressure from within the handle 305 by displacing a volume of gas from the internal volume of the handle as the plunger 375 is advanced distally. For example, a distal plunger seal 377 can compress the air volume within the handle as the plunger 375 is advanced distally, and pressure from within the handle can be released through the openings 307. As further described herein, the pressure relief openings 307 can also be adapted to receive and retain a valve or seal located distally within the handle.

[0093] Figure 17 This is a proximal perspective view of the device 300 now connected to the catheter assembly 250, wherein the slider 350 is disassembled and unfolded into a ready-to-use configuration, with the slider 350 and slider extensions (e.g., 355, 360, 365) axially aligned with the plunger 375. The plunger 375 is advanced distally, thereby correspondingly advancing the cannula 320 to establish blood flow through the device 300 and to the vacuum blood collection tube assembly connected to the device 300. The cap 310 is configured to receive the slider extension during use when the slider extension is advanced or retracted.

[0094] Figure 18 yes Figure 17 Another perspective view of the device shows a slider post 309 on the outside of the handle when the slider 350 is disengaged and ready for distal advance. The slider post 309 can engage the slider 350 in a retracted configuration to hold the slider against the handle 305. From this angle, it can also be seen that the proximal section 355 of the slider extension has an "X" cross-sectional geometry and extends through the cap cavity 311, having a geometry complementary to the slider extension. This example of the device allows for distal advance and proximal retraction as described herein, where the cap prevents rotation of the slider 350 and the plunger 375. Furthermore, the slider extension geometry increases the strength of the support and post to push the plunger 375 against any frictional engagement between the plunger seal and the handle interior. The plunger 375 is also in a different configuration with a larger body whose circumference is slightly less than or equal to the circumference of the handle interior. As shown, the plunger 375 is advanced distally to fluidly communicate with the extension port 308, and the cannula 320 extends beyond the conduit 265, as is possible when a flow path has been established.

[0095] Figure 19A This is a detailed view of the proximal end of device 300, with the plunger in a folded configuration. The view shows the articulated section 360, which provides increased flexibility to the slider extension, allowing the slider extension to curve, bend, flex, or turn from the compact curves of the distal and proximal portions 355 when the slider 350 is in a retracted configuration. In this illustrative embodiment, portion 360 has an elliptical cross-section compared to the quadrilateral clover or "+" shaped portions near and away from the flexed portions or movable articulation 360. The proximal and distal portions of the slider extension may include tracks or protrusions 356 forming an "X" cross-sectional geometry. As shown, the articulated section 350 does not include protrusions 356 because the articulated section 350 has increased flexibility compared to other sections having tracks 356. Figure 19A The details also reveal a distal plunger seal 377 at the distal end of the plunger, from which the cannula extends. The proximity of the plunger to the cap 310 will indicate the retracted configuration, as the cannula will retract accordingly into the handle.

[0096] Figure 19B yes Figure 19A The device view shown is rotated clockwise in a side view to expose more details of the plunger 375 and flow channel 380 within the handle 305. The flow channel 380 is a channel extending along the plunger between the proximal seal 376 and the distal seal 377, in which blood can flow after exiting the cannula 320 and the plunger lumen 381 when the plunger 375 is advanced into fluid communication with the extension kit 330 coupled to the handle 305. This example of the plunger 375 has a larger circumference that is generally complementary to the inner circumference of the handle. Therefore, blood flow from the cannula may be restricted when filling the space or volume between the plunger exterior and the handle interior. Therefore, the flow channel 381 provides fluid communication when in fluid communication with the extension port 308. As shown here, the flow channel 381 still extends along almost the entire length of the plunger 375, thereby allowing adjustable deployment or extension length of the cannula 320 while maintaining fluid connection or communication with the extension port. The proximal seal 376 and the distal seal 377 still provide a sealing space therebetween to restrict any blood flow beyond the length of the flow channel 381.

[0097] Figure 19C It is observed from a near-side perspective. Figure 19AAnother view of the device shows the plunger in a folded, stowed configuration. Additional details of the cap 310 and cap lumen 311 are also shown, with the corresponding "X" geometry of lumen 311 matching or complementing the cross-section of the distal portion 365 of the slider extension. Alignment is maintained as the proximal portion of the slider extension 355 passes through lumen 311 when the slider 350 is advanced distally to extend the cannula 320.

[0098] Figure 19D yes Figure 1 The cross-section of the plunger 200, located at the distal end within the handle 105 of the device 100, shows the space 208 or volume between the plunger body and the interior of the handle, and... Figure 19E An example of plunger 375 was compared. Figure 19E It shows Figure 16 The plunger of the device 300 has a fluid passage 380 and a large circumference, thereby reducing the space between the outside of the plunger and the inside of the handle. Figure 19D The plunger 200 provides greater space around the plunger body, allowing blood flow into the space around the plunger body in space 208 when the plunger is aligned with the extension port 125. As described herein, blood in space 208 can allow for continuous lumen flow as the plunger rotates. Figure 19E Another exemplary plunger 375 shows that space 208 is no longer available for blood flow. In this example, flow is completely or substantially restricted to the fluid passage 380 of the plunger. The cap of the handle 305 includes geometry complementary to the “X” cross-section of the slider extension 355, which prevents the slider from rotating to maintain alignment of the fluid passage 380 with the extension port 325 when the plunger is in fluid communication with the extension kit 330.

[0099] Figure 20A and Figure 20B A detailed view of the handle 305 near its central portion is shown, where the slider 350 can be engaged with the handle post 309 when in the retracted configuration. Reference Figure 20A The slider 350 is connected to the post 309 extending from the handle 305. The proximal portion of the slider extension 355 can be partially viewed in a compact manner adjacent to the outside of the handle. Depending on the retracted and connected position of the slider 350 to the handle, the cannula 120 retracts, although the distal end is not visible. Figure 20B A detailed view of the slider 350 is shown from a near-side view above the slider 350, exposing the slider post opening 351 and the slider post 309 located therein, the slider 350 being able to be coupled to the post 309 in a retracted configuration.

[0100] Figure 21This is a proximal perspective view of the proximal section of the handle 305, where the slider 350 is now in an unclamped configuration, ready for use, and the plunger 375 remains in the proximal position, with the slider 350 axially aligned with the plunger 375, and the cannula 320 ready for distal advancement. As described herein, the cap 310 and the cap lumen 311 are configured to receive the slider extension passing through them. It can be seen here that the cross-sectional geometry of the slider extension and the complementary geometry of the cap lumen 311 can be understood as remaining aligned with each other when the slider 350 is advanced distally to allow the slider extension to extend through the cap lumen 311. In this example, the distal section 365, the proximal section 355, and the hinged section 360 can pass through the lumen 311 and are prevented from rotating or causing the plunger 375 to rotate. As described herein, the plunger fluid passage 380 is maintained in a position relative to the inside of the handle such that when the plunger 375 is fully advanced, the flow passage 380 can be aligned with the extension port 308 and this fluid connection or communication can be maintained without displacement due to rotation of the plunger 375.

[0101] Figure 22A This is another close-peripheral detailed view, in which the slider 350 is aligned with the plunger 375 and the cannula 320, ready to be advanced distally to establish a flow path. The plunger 375 is in a proximal position or a retracted configuration, and the cannula 320 extending distally from the plunger 375 is not yet deployed from the distal end of the handle. This detailed view also shows another perspective view of a slider post 309 on the handle 305, which has a distal tip configured to engage with the opening 351 of the slider 350 when the slider is engaged with the slider post 309. Figure 22A In the configuration shown, the slider 350 is released from the pile 309 and is in a linear position, wherein the hinged section 360 is linearly aligned with the proximal section 355 and the slider 350 offset away from the pile, as shown in the figure.

[0102] Figure 22B yes Figure 22A The device shown has a slider 350 and a slider extension pushed distally into the handle, causing the distal thrust of the plunger 375 to shift toward the distal end of the handle 305, with the cannula 320 deployed accordingly. Figure 22A In this configuration, the articulated section 360 is now located inside the handle, and the slide 350 is adjacent to the cap 310. The position of the plunger 375 indicates that the flow channel 380 is aligned with the expansion port 308, and the fluid lumen from the cannula 320 through the plunger 375 and the expansion port 308 can be considered continuous. The distal end of the handle 305 is coupled to the catheter assembly 250, which is used to obtain blood from within the blood vessel to draw blood into a vacuum blood collection tube coupled to the expansion kit 330.

[0103] Figure 22B Another view of the device in Figure 22C The diagram is shown in a side view to illustrate the arrangement of the plunger 375 within the handle 305 and the flow channel 380 that is in fluid communication with the extension port 308 and extends to the extension kit 330. A slider 350 is located near the proximal end of the handle and the cap 310. However, additional length of the proximal section 355 of the slider extension remains as needed, allowing for further distal extension of the cannula 320. The fluid communication between the plunger 375 and the extension port can accommodate the additional extension because the proximal seal 376 remains positioned proximal to the extension port 308.

[0104] While various embodiments have been described in detail, it should be understood that many alternative embodiments are possible and within the scope of the embodiments of the invention. For example, the various component sizes and proportions of the blood aspiration device described herein can be adapted and configured for use with different catheter lengths. For instance, the device described herein can be adapted to advance the distal end of the blood aspiration catheter beyond the furthest point of the indwelling catheter to establish fluid communication with a blood vessel. In various alternative configurations, components of the blood aspiration device are modified for use with indwelling catheters of lengths of 0.5”, 0.75”, 1”, 1.25”, 1.5”, 1.75”, 2”, 2”, 2.25”, 2.5” or greater, or any length between these values.

[0105] In addition to the plunger details regarding its position and alignment described herein, the plunger can be adapted to reduce the amount of blood wasted during blood extraction. For example, the plunger described herein can help form a flow path that reduces the amount of blood drawn beyond the blood vessel into the vacuum blood collection tube or collection device. For instance, plunger 375 minimizes the amount of blood flowing through the plunger body within the handle and around the plunger body by restricting blood flow from the cannula to the flow channel 380, thereby reducing the amount of blood remaining in the device or lumen after the blood extraction procedure. In another example, the plunger (e.g., plunger 200) may have a perimeter, length, seal, flow path, channel, lumen, or opening configured to minimize the amount of blood within the flow path from the cannula to the collection device.

[0106] In some examples, the devices described herein may have valves, seals, or gaskets positioned at or near the distal end inside the handle. These valves allow the cannula to extend through them and provide a seal around the outside of the cannula to reduce or prevent any blood from flowing out of the connector protrusion or catheter assembly from the outside of the cannula within the connector protrusion.

[0107] Figures 23A to 23DA view of the distal segment of handle 305 is shown, in which valve 400 is shown, configured to seal the interior of the handle to prevent any flow that might occur outside the cannula 320 via connector protrusion 355. Valve 400 shows cannula 320 extending through valve 400 and valve extensions 405 and 410, configured to communicate with pressure relief opening 307 to hold valve 400 in a distal position within the handle. Figure 23A In the diagram, the distal end of connector 315 is shown transparently to expose valve 400 located distally within the handle. The valve may have one or more features configured to hold the valve in place. Here, protrusions 405 and 410 extend outward from the valve periphery and align with pressure relief opening 307 of handle 305. The extension or protrusion of valve 400 may be configured to communicate with the pressure relief opening or other structure within handle 305 to hold the valve in place when cannula 320 extends through the valve and protrudes from the distal end of the handle.

[0108] refer to Figure 23B The valve 400 can be seen in the proximal perspective view, showing the interior of a recess on the proximal side adapted for alignment of the cannula 320 through the center of the valve 400. The valve extension 405 can be seen to have a semi-circular shape corresponding to the geometry of the opening 307. When the valve extension 405 is positioned within the pressure relief opening 307, the proximal facet 406 of the extension 405 allows partial opening of the pressure relief opening 307. In this way, the valve extension can be positioned within the pressure relief opening 307 while still providing pressure relief through the opening between the valve facet 406 and the pressure relief opening 307.

[0109] Figure 23C Another perspective view of the distal end of the handle and valve 400 is provided, with additional details showing the location of the cannula 320 passing through the valve 400 and through the connector protrusion 355. The location of the valve 400 in this distal region inside the handle provides a seal around the cannula 320 and abuts against the lumen of the connector protrusion leading to the interior of the handle away from the valve 400. Therefore, the valve prevents any unintentional flow of fluid along the outside of the cannula 320 through the connector protrusion 355 into the interior of the handle.

[0110] The distal end of the handle 305 Figure 23D The top plan view shown exposes the arrangement of valve extension 405 and facet 406 within pressure relief opening 307. Although not visible in this view, valve extension 410 similarly extends from valve 400 on the opposite side through another pressure relief opening 307. The space between facet 406 and the inner surface of pressure relief opening 307 can be configured to provide continuous support for releasing pressure from inside the handle without limiting the function of valve 400 in sealing the interior of the handle with the connector protrusion lumen.

[0111] Figure 24 This is a side view showing the distal end of the handle 505, where the coupling region 530 engages with a cap 550 above a protrusion 510 of the coupling region 530, and this coupling region 530 may be in a storage configuration before use. In this partial view of the distal handle portion, a vent opening 507 is visible, where the insertion tube 520 is positioned axially aligned with the interior of the handle. The coupling arm 515 engages with the cap 550 and holds the proximal end of the cap connected until the cap is removed for use. Further details are provided in... Figure 25 The middle is shown as Figure 24 The cross-sectional view further details an example of the engagement region 530 that engages with the cap 550. The distal end 511 of the protrusion is now visible within the cap 550, and the cannula 520 is in a retracted configuration within the engagement lumen extending through the protrusion. This cross-sectional view also reveals the location of the seal 535 at the distal end of the handle interior 506. As previously described, the seal may be positioned distally within the handle interior (e.g., close to the engagement lumen extending through the protrusion) and configured to receive the cannula extending therethrough. A static seal (e.g., seal 535) can provide a fluid seal against the engagement lumen outside the cannula to prevent blood from flowing into the handle interior outside the cannula (e.g., a flow path).

[0112] Figure 26 and Figure 27 It was previously in Figure 24 The perspective view of the cap 550 is shown. These perspective views highlight the proximal opening 560, which is configured to receive the coupling protrusion therein. The proximal cap end 555 has a raised periphery configured to contact and be held by the arm of the coupling mechanism of the blood extraction device when the cap is positioned on the device, as before use.

[0113] In some examples, the internal dimensions of the handle can be configured to prevent kinking or bending during cannulation or deployment. For example, the internal diameter of the handle can be configured / optimized to minimize the ability of the cannula to bend if it comes into contact with any structure or obstruction in the catheter or blood vessel during use (e.g., valve blockage, etc.). The internal dimensions of the handle can be sufficient to allow the plunger body to move through it (e.g., distally and / or proximally). For example, the internal diameter of the handle can allow for a seal against the plunger body seal, and the plunger body can be large enough to reduce any unwanted volume around the plunger body. The cannula can then be configured for use with catheters of different sizes / gauges. For example, the cannula can be configured for use with 18ga, 20ga, 22ga, 24ga, or more or fewer, or any size between. In any example of cannula size, the inner diameter of the handle can be large enough to allow contact with the cannula and prevent excessive bending or kinking. As illustrative examples of some dimensions, the inner diameter of the handle can be 0.1”, 0.105”, 0.110”, 0.115”, 0.120”, 0.125”, 0.130”, 0.135” or larger or smaller or any diameter in between. As illustrative examples of some dimensions, the cannula described herein may have an outer diameter of 0.010”, 0.015”, 0.020”, 0.025”, 0.030” or larger or smaller, or any diameter in between. For example, the handle inner diameter may be 0.125” and the cannula outer diameter may be 0.026”. For example, the handle inner diameter may be 0.125” and the cannula outer diameter may be 0.017”. For example, the handle inner diameter may be 0.125” and the cannula outer diameter may be 0.020”. In any example, the ratio of the handle inner diameter to the cannula outer diameter may be 10:1, 9:1, 8:1, 7:1, 6:1, 5:1, 4:1, 3:1, 2:1 or larger or smaller, or any ratio in between.

[0114] Figure 28A and Figure 28B Some exemplary configurations of the cannula's arrangement within the hollow handle are shown. See also Figure 28B The cross-section of handle 500 at point "X" shows the arrangement of the cannula axially aligned with handle 505 and the inner surface 508 of the hollow handle interior. As described, the distance 600 between the outer surfaces of cannula 520 (e.g., any cannula described herein) can be optimized to prevent excessive bending or kinking of the cannula as it extends through the handle into the blood vessel. The diameter of the hollow interior (e.g., the lumen of the central handle) can be substantially uniform from the distal to the proximal end of the handle interior and provides contact with the plunger seal and prevents kinking of the cannula.

[0115] Figures 29A to 29CVarious views of another exemplary seal are shown, which can be statically positioned within the handle near the distal end inside the hollow handle.

[0116] The device described herein can improve blood collection procedures, including establishing blood flow for collection or re-establishing blood flow through a blocked or otherwise occluded catheter. The device can be configured for a single catheter length or for multiple catheter lengths. The catheter can be a standard catheter or a catheter as described herein adapted for coupling to the device described herein. For example, the catheter can be adapted for coupling to a male Luer connector or the distal end of the device described herein during use. Improved coupling and functionality of the blood collection device can reduce harm to the patient and improve the collection of fluid samples through various extension kits and extension ports. The simplified device described herein offers a removable-seal configuration or a tube-seal configuration with improved collection technology for blood aspiration.

[0117] In some examples, the flow path (e.g., the fluid path / lumen through the cannula and plunger) can be sealed and provided with an airlock to prevent fluid from entering the flow path until the plunger is aligned with the extension port. In some cases, when the device described herein is used to aspirate blood from a vessel through an existing indwelling catheter, the indwelling catheter is typically fluid-locked or otherwise filled with saline or other biocompatible fluids between use / insertion. Therefore, the device described herein can be configured to provide blood aspiration, resulting in initial blood aspiration without removing fluid from the fluid lock of the indwelling catheter. In this way, the device of this invention is configured to prevent unnecessary waste of blood during initial aspiration. The airlock or seal of the flow path can be configured to facilitate cannula deployment through the indwelling catheter and provide sufficient pressure to prevent the catheter fluid lock from entering the flow path before fluid connection with the extension port is established. Blood can then flow through the flow path into the vacuum blood collection tube once the cannula is fully deployed into the vessel and the flow path is continuous to the extension kit (e.g., a vacuum blood collection tube). In some examples, vacuum blood collection tubes can support blood flow after the device configuration has transitioned from a discontinuous flow path to a complete / continuous flow path because the vacuum blood collection tube can be set with existing negative pressure. Therefore, as the plunger is advanced distally to fluidly communicate with the extended port, the negative pressure of the vacuum blood collection tube can facilitate the aspiration of blood from the vessel through the distal end of the cannula.

[0118] As described herein, the flow path of a blood collection device can be discontinuous from the distal end of the blood collection or vascular access cannula to the vacuum blood collection tube until the sealed plunger is advanced distally to align with an extension kit (e.g., an extension port) of the handle. The complete blood flow path can be considered as a first flow path and a second flow path. The first flow path includes the distal end of the blood collection cannula, the lumen of the blood collection cannula, an internal fluid path within the sealed plunger, through or around the sealed plunger to the blood outlet of the sealed plunger. The second flow path extends from the inlet of the blood collection cannula or the opening in the handle, thereby providing a flow path to the blood collection device or vacuum blood collection tube. Subsequently, in some examples, the advancement of the sealed plunger serves a dual purpose: advancing the blood collection cannula beyond the indwelling catheter and into the blood vessel, and fluidly aligning the plunger blood flow path with the extension kit outlet or handle outlet.

[0119] While not wishing to be bound by theory, it is reasonable to believe that in some embodiments of the sealed plunger blood collection device, cavitation (e.g., airlocks) within the handle and the movable plunger seal can be pushed out along with the blood collection cannula, thereby clearing the contents of the indwelling catheter lumen. One advantage of advancing an air-filled blood collection cannula through the indwelling catheter lumen is that fluid in the cannula lumen is partially or completely expelled. Standard practice is to fill the indwelling catheter lumen with saline or heparin. If these fluids are not removed, they may be collected into the blood sample and impair blood collection. Depending on the specific arrangement of the blood collection device, the size or amount of cavitation will vary. On the other hand, cavitation is provided in a portion of the internal volume of the handle and in a sealed or external portion of the plunger body space disposed within the handle. Advantageously, various embodiments of cavitation or airlocks can be configured to prevent fluid from flowing through the flow path until the distal end of the cannula is advanced into the blood vessel and the plunger is in fluid communication with the extension kit, thus completing the flow path from the distal end of the cannula to the vacuum blood collection tube.

[0120] One advantage of the sealed plunger blood extraction device described herein is the novel method 700 for completing the fluid flow path to extract blood, such as... Figure 30 As shown. In one aspect, in step 705, a method is provided to complete the blood extraction flow path by first connecting the handle of the blood extraction device to an indwelling catheter in the blood vessel. (See...) Figure 17 Next, step 710 involves moving the sealing plunger within the handle to advance the blood extraction cannula through the lumen of the indwelling catheter. Following this, step 715 involves moving the distal end of the blood extraction cannula beyond the lumen of the indwelling catheter and into a blood vessel. (See...) Figure 18 Finally, step 720 involves aligning a portion of the sealing plunger with the inlet of the blood extraction container to complete the blood extraction flow path. (See...) Figure 22C 。 In other respects, a step may also exist: advancing a cavitation within the blood aspiration cannula, performed before the step of completing the blood aspiration flow path. The step of advancing the cavitation may occur during the step of moving the sealing plunger and / or during the step of moving the distal end of the blood aspiration cannula. In another variation, it should be understood that the step of moving the distal end of the blood aspiration cannula beyond the lumen of the indwelling catheter and into the blood vessel corresponds to an indwelling catheter length of 0.5”, 0.75”, 1”, 1.25”, 1.5”, 1.75”, 2”, 2”, 2.25”, 2.5”, or 3.0”.

[0121] In another aspect, the blood collection device, intravascular catheter, catheter hub, vascular access device, and guide element or needle of the vascular access device may include any or all aspects, features, characteristics, or combinations thereof taken from any combination of the following commonly owned applications: International Application No. PCT / US2021 / 054046, filed October 7, 2021, entitled “Intravascular Catheter With Integrated Guide Structure”; International Application No. PCT / US2023 / 065556, filed April 7, 2023, entitled “Intravascular Catheter With Integrated Guide Structure”; International Application No. PCT / US2023 / 074699, filed September 20, 2023, entitled “Guide Element for Intravascular Access Device”; and International Application No. PCT / US2023 / 074699, filed December 15, 2022, entitled “Hypodermic Needles and U.S. Provisional Patent Application No. 63 / 387,688 entitled “Methods of Manufacture”; U.S. Provisional Patent Application No. 63 / 477,378 entitled “Intravascular Access Device”, filed December 27, 2022; and U.S. Provisional Patent Application No. 63 / 482,901 entitled “Guide Element for Intravascular Access”, filed February 2, 2023, are each incorporated herein by reference in their entirety for all purposes.

[0122] In other embodiments, aspects of the various alternatives described herein may include one or more features or variations of the methods and apparatus described in U.S. Provisional Patent Application No. 63 / 587,438 (hereinafter referred to as the “'438 application”), filed October 2, 2023, entitled “Blood Collection Device and Methods of Use”. In one exemplary embodiment, Figure 5 The sliding and flow port embodiments can be used with blood collection catheters of a range of different lengths, allowing the blood collection device to be paired with catheters of a specific length, as shown in Figures 54-60 of application '438. In yet another exemplary variant, the above modifications regarding... Figure 16 Figure 20 illustrates the extension kit for various embodiments of the '438 application. The '438 application is incorporated herein by reference for all purposes.

[0123] It should be recognized that all combinations of the foregoing concepts and other concepts discussed in more detail below (provided that such concepts do not contradict each other) are intended to be part of the inventive subject matter disclosed herein and can be used to achieve the benefits described herein.

[0124] The process parameters and order of the steps described and / or illustrated herein are given by way of example only and may vary as needed. For example, while the steps shown and / or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order shown or discussed. The various example methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein, or include additional steps beyond those disclosed.

[0125] When a feature or element is described herein as "on another feature or element," it may be directly on the other feature or element, or there may be intermediate features or elements present. Conversely, when a feature or element is described as "directly on another feature or element," no intermediate features or elements are present. It should be understood that when a feature or element is described as "connected," "attached," or "joined" to another feature or element, it may be directly connected, attached, or joined to the other feature or element, or there may be intermediate features or elements present. Conversely, when a feature or element is described as "directly connected," "directly attached," or "directly joined" to another feature or element, no intermediate features or elements are present. Although described or illustrated with respect to one embodiment, the features and elements thus described or illustrated can be applied to other embodiments. Those skilled in the art will understand that a structure or feature referring to being "adjacent" to another feature may have portions overlapping with or below the adjacent feature.

[0126] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the invention. For example, unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the” as used herein are intended to equally include the plural forms. It should also be understood that the terms “comprises” and / or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term “and / or” includes any and all combinations of one or more related listed items and may be abbreviated as “ / .”

[0127] Spatial terms such as “under,” “below,” “lower,” “over,” and “upper” may be used herein to describe the relationship of one element or feature as shown in the accompanying drawings to one or more other elements or features. It should be understood that spatial terms are intended to encompass different orientations of the device in use or operation, other than those depicted in the drawings. For example, if the device in the drawings is reversed, an element described as “below” or “beneath” would be oriented “over”. Thus, the exemplary term “below” can encompass both orientations above and below. The device may be otherwise oriented (rotated 90 degrees or otherwise), and the spatial terms used herein are interpreted accordingly. Similarly, unless otherwise specifically stated, terms such as “upwardly,” “downwardly,” “vertical,” and “horizontal” are used herein for illustrative purposes only.

[0128] While the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context otherwise requires. These terms may be used to distinguish one feature / element from another. Therefore, without departing from the teachings of the invention, the first feature / element discussed below may be referred to as the second feature / element, and similarly, the second feature / element discussed below may be referred to as the first feature / element.

[0129] In this specification and the appended claims, unless the context otherwise requires, the term "comprise" and its variations such as "comprises" and "comprising" mean that various components may be used together in a method and article of manufacture (e.g., components and apparatus, including devices and methods). For example, the term "comprising" will be understood to imply the inclusion of any of the stated elements or steps, but does not exclude any other elements or steps.

[0130] Generally, any apparatus and method described herein should be understood as inclusive, but all or a subset of the components and / or steps may alternatively be exclusive and may be expressed as “consisting of various components, steps, sub-components or sub-steps” or alternatively “consisting substantially of various components, steps, sub-components or sub-steps”.

[0131] As used herein in the specification and claims, including in the examples, and unless otherwise expressly stated, all figures may be read as if they begin with the words “about” or “approximately,” even if the term is not explicitly stated. The phrase “about” or “approximately” may be used when describing magnitude and / or location to indicate that the described value and / or location is within a reasonably expected range of value and / or location. For example, numerical values ​​may have values ​​of + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical value given herein should also be understood to include about or approximately that value, unless the context otherwise requires. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical ranges listed herein are intended to include all subranges contained therein. It should also be understood that, as those skilled in the art will properly understand, when a value is disclosed, "less than or equal to" that value, "greater than or equal to" that value, and possible ranges between values ​​are also disclosed. For example, if the value "X" is disclosed, then "less than or equal to X" and "greater than or equal to X" (e.g., where X is a numerical value) are also disclosed. It should also be understood that throughout the application, data is provided in a variety of different formats, and this data represents the endpoints and starting points and ranges of any combination of data points. For example, if specific data point "10" and specific data point "15" are disclosed, it should be understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15, as well as between 10 and 15, are considered disclosed. It should also be understood that each unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0132] While various illustrative embodiments have been described above, any of several changes may be made to the various embodiments without departing from the scope of the invention as described in the claims. For example, in alternative embodiments, the order in which the various described method steps are performed may typically be changed, and in other alternative embodiments, one or more method steps may be skipped together. Optional features of the various apparatus and system embodiments may be included in some embodiments but not in others. Therefore, the foregoing description is provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0133] The examples and illustrations included herein are shown by way of illustration, not limitation, of specific embodiments in which the subject matter can be practiced. As mentioned, other embodiments can be utilized and derived therefrom, allowing for structural and logical substitutions and changes without departing from the scope of this disclosure. For convenience only, such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term "invention," and if actually more than one is disclosed, it is not intended to actively limit the scope of this application to any single invention or inventive concept. Thus, while specific embodiments have been illustrated and described herein, any arrangement considered to achieve the same purpose may replace the specific embodiments shown. This disclosure is intended to cover any and all modifications or variations of the various embodiments. After reading the above description, those skilled in the art will understand the combinations of the above embodiments and other embodiments not specifically described herein.

Claims

1. A blood collection device, comprising: - A handle, the handle comprising: -- A proximal handle portion, which is operatively connected to a distal handle portion. -- A connector formed at the distal end of the distal handle portion, having a lumen extending proximally from an opening at the distal end of the connector, and -- A hollow interior, the hollow interior extending proximally from the connector lumen to the proximal end of the proximal handle portion; - An extension port, the extension port being positioned on the handle, wherein a lumen extends through the extension port and is in fluid communication with the hollow interior of the handle; - An expansion kit, which is connected to the expansion port; - A plunger, the plunger comprising a plunger body extending between a distal seal and a proximal seal, and communicating along a fluid passage of the plunger body with a lumen extending through a distal end of the plunger body; - A cannula, which is in fluid communication with the plunger lumen and extends distally from the plunger body; and - A slider having an elongated body having a hinged section positioned between a slider tab and the proximal end of the plunger body, wherein the tab is positioned outside the hollow interior of the handle and configured to engage the exterior of the handle in a folded configuration.

2. The blood collection device according to claim 1, wherein, The cannula is adapted to change from a first configuration to a deployment configuration when the plunger is advanced distally through the hollow interior of the handle via the slider, in which the distal end of the cannula is positioned within the connector lumen.

3. The blood collection device according to claim 2, wherein, The cannula is configured to provide fluid communication between the blood vessel and the expansion kit when the distal plunger seal is advanced distally beyond the lumen of the expansion port.

4. The blood collection device according to any one of claims 1 to 3, wherein, The plunger is configured to provide fluid communication between the extension kit and the blood vessel for any length of cannula deployment when the plunger fluid channel is aligned with the extension port lumen.

5. The blood collection device of claim 1, further comprising a static fluid seal located at a distal end of the hollow interior of the handle near the connector lumen, the static fluid seal being adapted to receive the cannula extending therethrough.

6. The blood collection device according to claim 5, wherein, The static fluid seal is configured to provide a fluid seal around the outside of the cannula and the proximal end of the connector lumen.

7. The blood collection device according to claim 5, further comprising a venting opening at the distal end adjacent to the distal handle portion, wherein, The static fluid seal includes a protrusion adapted to communicate with the vent opening to hold the seal in place within the distal handle portion.

8. The blood collection device according to claim 1, wherein, The connector tube extends through a protrusion aligned axially with the hollow interior of the handle.

9. The blood collection device of claim 1, further comprising a connector arm extending distally from the connector and configured to engage an indwelling catheter.

10. The blood collection device according to claim 1, wherein, The elongated body of the slider includes a distal section and a proximal section separated by the hinge section, wherein the proximal opening of the handle is X-shaped and adapted to receive the elongated slider body extending therethrough.

11. The blood collection device according to any one of claims 1 to 10, wherein, The hinge section of the elongated body of the slider is flexible and is configured to fold the proximal portion of the elongated body of the slider to the outer surface of the handle in a collapsed configuration.

12. The blood collection device according to any one of claims 1 to 11, further comprising a post located on the exterior of the handle, the post being configured to be releasably coupled to the sliding tab in a retracted configuration.

13. The blood collection device of claim 1, further comprising a positioning mark disposed on the handle and configured to indicate the length of cannula deployment.

14. The blood collection device of claim 1, further comprising a cap configured to cover the lumen of the connector.

15. The blood collection device according to any one of claims 1 to 14, wherein, The hollow interior of the handle is a cavity that is circumferentially connected to the distal plunger seal and the proximal plunger seal.

16. The blood collection device according to claim 15, wherein, The hollow internal lumen includes a diameter configured to prevent the cannula from twisting.

17. The blood collection device according to claim 1, wherein, The hollow interior of the handle includes a diameter configured to prevent the cannula from twisting.

18. The blood collection device according to claim 1, wherein, The diameter of the hollow interior of the handle is configured to circumferentially contact the distal plunger seal and the proximal plunger seal.

19. The blood collection device according to claim 1, wherein, The ratio of the diameter of the hollow interior to the outer diameter of the insertion tube is less than 5:

1.

20. A method for collecting a blood sample using any one of the apparatuses according to claims 1 to 19, the method comprising: Connect the handle to the indwelling catheter; Unfold the elongated body of the slider; The plunger is pushed distally through the interior of the hollow handle; The plunger and the slider are further advanced distally until the distal end of the cannula is in fluid communication with the blood vessel; Fluid communication from the cannula to the extension kit is provided through the plunger body and the extension port lumen.

21. The method of claim 20, further comprising adjusting the length of the cannula deployment through the indwelling catheter by further distally advancing the plunger within the hollow handle.

22. The method of claim 20, further comprising advancing the cannula beyond an obstacle to provide fluid communication from the blood vessel to the extension kit.

23. The method of claim 20, further comprising maintaining fluid communication between the cannula and the extension kit along the length of the plunger body.

24. The method of claim 20, further comprising removing the cap from the connector before unfolding the elongated body of the slider.

25. A blood collection device, comprising: A handle having a proximal handle section fixed to a distal handle section, wherein a central lumen extends through the proximal handle section and the distal handle section; The connection area on the distal handle section has a lumen axially aligned with the central lumen of the handle and an arm extending distally from the distal handle section, the arm being configured to engage an indwelling catheter. An extension port on the distal handle section, the extension port having a lumen extending from the central lumen of the handle through the extension port; An expansion kit is connected to the expansion port lumen; A plunger having a body extending between a distal seal and a proximal seal, wherein a fluid passage is positioned along the plunger body; The cannula lumen has a distal opening that is in fluid communication with the plunger fluid passage; and A slider having an elongated body extending proximally from the plunger to a tab, wherein the elongated body of the slider is configured to fold to the outside of the handle in a retracted configuration, wherein the plunger body and the cannula are axially aligned with the central lumen of the handle.

26. The blood extraction device according to claim 25, wherein, The slider is configured to unfold during use to axially align with the plunger.

27. The blood extraction apparatus according to claim 25 or claim 26, wherein, The plunger is configured to advance distally through the central lumen of the handle until the plunger body is aligned with the expansion port lumen.

28. The blood extraction device according to claim 25, wherein, The cannula and the plunger define a first flow path segment.

29. The blood extraction device according to claim 28, wherein, The first flow path segment is discontinuous with the expansion kit until the plunger is advanced distally to align with the expansion port lumen.

30. The blood extraction device according to claim 28 or 29, wherein, The first flow path segment is configured to be airlocked.

31. The blood extraction device according to claim 28, wherein, The extended port lumen and the extended kit define a second flow path segment.

32. The blood extraction device according to claim 31, wherein, The first flow path segment is configured to be in fluid communication with the first flow path segment when the plunger body is aligned with the expansion port lumen.

33. The blood extraction device according to any one of claims 25 to 31, wherein, The cannula lumen is configured to extend distally through the connecting section lumen via an indwelling catheter.

34. The blood extraction device according to claim 25, wherein, The cannula lumen is configured to be advanced distally from the handle through the connecting section lumen to contact the fluid within the blood vessel.

35. A method for drawing blood via an indwelling catheter, the method comprising the following steps: The distal end of a blood extraction device is connected to an indwelling catheter, the blood extraction device including a central lumen extending through a proximal handle portion and a distal handle portion, wherein the cannula is axially aligned with the central lumen and connected to a plunger having a body extending between a distal seal and a proximal seal; The plunger is advanced distally through the central lumen, wherein an elongated slider extends proximally from the plunger and passes through the proximal end of the handle; Advance the plunger until the cannula extends through the indwelling catheter and into the blood vessel; and When the plunger body is advanced to align with the lumen extending through the expansion port, the flow path from the blood vessel to the expansion kit, which is coupled to the extension portion on the distal handle portion, is completed.

36. The method of claim 35, further comprising disconnecting the tab from a post on the outer surface of the handle, wherein the tab is positioned at the proximal end of the elongated slider; and extending the elongated slider to axially align it with the plunger body.

37. The method of claim 35, wherein, The steps of completing the flow path further include advancing the first flow path segment defined by the cannula lumen and the plunger body distally; and aligning the plunger body with the second flow path segment defined by the expansion port lumen and the expansion kit.

38. The method according to any one of claims 37, wherein, The first flow path segment is airlocked until the distal plunger seal is pushed distally beyond the extended port lumen.

Images