Intravascular blood extraction systems, devices, and methods

Abstract

An intravascular blood extraction system for bloodletting through a previously placed peripheral intravascular catheter, the intravascular blood extraction system having a cannula within a protective housing and / or a plurality of structures and / or within structures, the cannula forms a laminar fluid path extending from a distal fluid inlet to a lateral or proximal fluid outlet orifice directly coupled to the protective housing and / or the plurality of structures and / or structures, and a slider or plunger actuator is coupled to the fluid outlet orifice of the cannula such that distal advancement of the slider advances the cannula within the fluid vessel.

Description

Priority claim

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 490,242, filed on March 14, 2023, entitled “INTRAVASCULAR BLOOD EXTRACTION SYSTEMS, DEVICES, AND METHODS,” which is incorporated herein by reference in its entirety. Incorporated by Reference

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Background Art

[0003] Blood sampling is an essential element of many medical procedures and / or treatments. Fluid sampling is typically performed by venipuncture using a sharp needle to gain intravenous access.

[0004] Although outpatient venipuncture and other forms of vascular access may be a simple matter in relatively healthy patients, such access is often required for patients who are admitted to a healthcare facility for multiple days, subjecting the patient to multiple venipunctures. Typically, blood extraction via venipuncture is the most invasive procedure for hospitalized patients, who experience an average of two or more fluid collection events per day. Although venipuncture is common and provides a high-quality fluid sample, it is strongly associated with high patient dissatisfaction due to needle stick pain and other complications such as sleep loss, infection, nerve damage, accidental arterial puncture, thrombosis, vessel depletion, and hematoma. In addition, needle handling increases the risk of accidental needle stick injuries to providers. Finally, patients with difficult IV access experience multiple failed attempts, which leads to significant clinical delays, lost productivity, and patient and provider dissatisfaction.

[0005] One possible alternative to venipuncture is the use of peripheral intravenous catheters (PIVCs). Most in-patients have a PIVC placed, but there are many factors that reduce the likelihood of success of the procedure. Fluid collected through a PIVC must meet many requirements for accurate laboratory analysis, such as acceptable fluid volume and quality, that the sample is not hemolyzed, clotted, contaminated, and / or diluted. Typically, the initial fluid draw must be discarded to remove potential contaminants from the fluid sample. If the fluid quality is not suitable, the analytical test cannot be performed and a redraw is required. Redraws also result in significant clinical delays, loss of productivity, and patient and provider dissatisfaction. In addition, fluid sampling through a PIVC increases the risk of hemolysis (rupture of red blood cells), sample contamination from infusing solutions and medications in a previously placed peripheral catheter, local catheter kinking from excessive catheter movement, and catheter migration out of the vascular system. Furthermore, fluid draw success rates through a PIVC are reduced due to the likelihood of occlusion and / or catheter damage increasing as the catheter dwell time lengthens. Finally, there is a risk of fluid flow contamination if aseptic technique is not used when accessing a previously placed peripheral catheter.

[0006] For these reasons, it would be desirable to provide improved methods and systems for needle-free blood extraction using previously placed peripheral catheters and structures. It would be particularly desirable to provide simplified systems and components to remedy, reduce, or avoid one or more of the disadvantages mentioned herein. It would be even more desirable to provide components that are clearly visible to the user and configured to be used and manipulated in a simple, intuitive manner. At least some of these goals will be met by the various embodiments described below. SUMMARY

[0007] Systems, devices, and methods for phlebotomy through a previously placed peripheral intravascular catheter are described herein.

[0008] The present disclosure relates generally to vascular blood extraction systems, devices, and methods. Specifically, in some embodiments, the present disclosure relates to systems, devices, and methods for placing a cannula within a previously placed peripheral intravascular catheter. The cannula is used to transfer a small volume of fluid from a patient to a fluid collection container coupled to a vascular blood extraction system.

[0009] A blood extraction system can include a system or device that can be coupled with a previously placed peripheral intravascular catheter positioned in a patient's blood vessel. The system can include a cannula, a housing and / or structure, a slider, and a mechanism to couple to a previously placed peripheral catheter, the cannula within a flexible and / or collapsible protective sheath and / or structure to maintain sterility of the cannula during a blood extraction procedure. The cannula can be composed of a single or multiple materials to increase its column strength. The slider moves the cannula from a first position within the protective housing and / or structure to a distal position outside of the protective housing and / or structure. A distal end portion of the housing and / or structure can be configured with a mechanism to couple the blood extraction system to a previously placed peripheral intravascular catheter or similar connector and / or connection. The slider can be coupled to the housing and / or structure and / or to the cannula and disposed outside and inside the housing and / or structure of the device.

[0010] In some embodiments, a blood extraction system can allow a user to draw a fluid sample through a previously placed peripheral intravascular catheter. The cannula of the blood extraction system is advanced distally within the internal diameter of the catheter, creating a laminar flow fluid path within the previously placed catheter and the blood extraction device. This laminar flow fluid path allows for successful extraction of fluid from a patient's vascular system into a fluid collection device coupled to the blood extraction system.

[0011] In some examples, the laminar flow fluid path of the blood extraction system can include a distal fluid port at the distal end of the cannula and a lateral fluid port on the lateral surface of the intravascular blood extraction housing and / or structure. The lateral port can include a connector capable of facilitating coupling of a fluid collection device (e.g., a vacuum reservoir). The location of the lateral port of the laminar flow fluid path and the connector represents a more ergonomic way of attaching a fluid collection device.

[0012] In some examples, the laminar flow fluid path of the blood extraction system can include a distal inlet at the distal end of the cannula and a proximal outlet near the proximal end of the cannula. The proximal outlet includes a port that couples, engages, or is positioned within a fluid transfer chamber that is directly coupled to the distal lateral port of the laminar flow fluid path. The distal inlet and proximal outlet port comprise the laminar flow fluid path within the cannula. The proximal outlet port, as described herein, is positioned distal of the distal end of the slider. The cannula, as described herein, has a proximal outlet port to allow fluid to follow the laminar flow fluid path and exit into a fluid collection chamber. The fluid collection chamber, as described herein, is sealed around the cannula using a polymer seal, valve, or gasket. The fluid collection chamber is directly coupled to the housing. The seal of the fluid collection chamber prevents fluid leakage or vacuum pressure decay during use. The seal, as described herein, can be positioned within the fluid transfer chamber to create a seal around the cannula. The location or spacing of these seals, valves, or gaskets can allow the cannula proximal port to move to a position within the fluid transfer chamber.

[0013] The cannula can be directly coupled to the slider and coupled within a flexible and / or collapsible protective sheath. As described herein, the flexible and / or collapsible protective sheath can be connected to the distal end of the housing and / or structure and directly coupled to the distal end of the slider. The slider moves the cannula from a first position within the protective sheath and housing to a distal position outside of the protective housing and / or structure. The flexible and / or collapsible protective sheath can appear to expand in the first position and collapse in the second position. The flexible and / or collapsible protective sheath maintains a sterile barrier around the cannula at all times.

[0014] In some embodiments, the laminar flow fluid path of the blood extraction system can include a distal inlet at the distal end of the cannula and a lateral outlet distal to the slider. While the slider lateral outlet can be coupled to a distal lateral aperture of the protective housing and / or structure, forming a laminar flow fluid path between the distal inlet point on the cannula. The cannula as described herein has a proximal outlet aperture to allow fluid to follow the laminar flow fluid path and exit into the fluid collection chamber. The slider outlet aperture with a seal, valve, or gasket connection as described herein can open when the slider is coupled to the structure including the lateral aperture. The seal connected to the slider prevents fluid leakage or vacuum pressure decay during use. The fluid path can include multiple internal diameters through the fluid path. The structure of the lateral aperture can allow the slider outlet aperture to move into place and couple to the lateral aperture of the laminar flow fluid path located on the protective housing and / or structure.

[0015] The cannula can be directly coupled to the slider and coupled within a flexible and / or collapsible protective sheath. As described herein, the flexible and / or collapsible protective sheath can be connected to the distal end of the housing and / or structure and directly coupled to the distal end of the slider. The slider moves the cannula from a first position within the protective sheath and housing to a distal position outside of the protective housing and / or structure. The flexible and / or collapsible protective sheath can appear to expand in the first position and collapse in the second position. The flexible and / or collapsible protective sheath maintains a sterile barrier around the cannula at all times.

[0016] In some embodiments, the cannula is protected by a collapsible and flexible sheath disposed within the housing and / or structure of the intravascular blood extraction device. The collapsible and flexible sheath can have a distal end coupled to the protective housing and / or structure and a proximal end coupled to the distal end of the slider. The slider moves the cannula from a first position within the protective housing and / or structure to a distal position outside of the protective housing and / or structure. The flexible and / or collapsible protective sheath can appear to expand in the first position and collapse in the second position as described herein. The flexible and / or collapsible protective sheath maintains a sterile barrier around the cannula at all times.

[0017] In some examples, the fluid transfer tube is directly connected to the proximal end of the shuttle and coupled to the lateral orifice of the blood extraction device, thereby forming a laminar fluid path between the distal end of the blood extraction system and the lateral orifice. As described herein, the fluid transfer tube can comprise a flexible tube and be coiled within a flexible and / or collapsible protective sheath.

[0018] In some examples, the fluid transfer tube can comprise a single non-coiled flexible tube disposed within the housing and / or structure of the blood extraction device. The flexible tube is coupled to the proximal end of the shuttle and is allowed to move with the shuttle from the first position to the second position.

[0019] In some embodiments, the cannula is directly coupled to the plunger actuator. The plunger actuator can comprise an outlet port connected to the lateral orifice of the blood extraction system by a flexible transfer tube. In this example, the fluid transfer tube is directly connected to the plunger actuator outlet port and coupled to the lateral orifice of the blood extraction device, thereby forming a laminar fluid path between the distal end of the blood extraction system and the lateral orifice. As described herein, the fluid transfer tube can comprise a flexible tube and be coiled within a flexible and / or collapsible protective sheath. The flexible and / or collapsible protective sheath maintains a sterile barrier around the cannula at all times.

[0020] In some embodiments, the cannula comprises a polymeric and / or metallic reinforcing structure along the length of the cannula. The reinforcing structure can be oriented coaxially and / or circumferentially with the cannula and extend the entire length of the cannula or the reinforcing structure can be located in one or more segments in the cannula. The reinforcing structure can comprise a multilayer tube and methods of making the same, while the multilayer tube comprises a first inner polymeric layer and a second outer polymeric layer, wherein the reinforcing structure is found.

[0021] In some examples, the inner layer of the cannula can be constructed of one or more hydrophobic materials. The one or more materials can be PTFE or similar materials to facilitate the transfer of fluid from the vascular system to a fluid collection device coupled to the extraction device.

[0022] In one aspect, an intravascular blood extraction system is provided having a cannula having a laminar flow fluid path extending from a distal fluid inlet aperture to a lateral outlet aperture disposed within a protective handle, housing and / or structure. The laminar flow fluid path has a distal fluid inlet aperture and a lateral fluid outlet aperture, the laminar flow fluid path extending proximally through the protective housing and / or structure and / or one or more lumens within the structure to the lateral fluid outlet aperture of the laminar flow fluid path. The fluid outlet aperture includes means for connecting a fluid collection device. Also present is a slider or plunger actuator coupled to the fluid outlet aperture of the cannula such that distal advancement of the slider advances the cannula from the distal end of the handle, protective housing and / or structure. The handle, protective housing and / or structure has a distal end and a proximal end with distal mechanisms to couple the device with a previously placed peripheral catheter. In some embodiments, there is also a flexible and / or collapsible sheath including means for isolating the cannula from external contamination. In other aspects, the intravascular blood extraction device has a cannula coupled to the distal end of a slider or the distal end of a plunger actuator or the cannula is reinforced with one or more materials. In another aspect, the cannula has a laminar flow fluid path with a fluid path sealer coupled to the proximal end of the housing to prevent backflow through the proximal aperture.

[0023] In this and other embodiments, the cannula is sealed and protected from contamination by the use of a flexible and / or collapsible sheath, optionally, the laminar flow fluid path has multiple apertures and lumens within the protective housing and / or structure, optionally, the laminar flow fluid path includes a hydrophobic material, optionally, the laminar flow fluid path includes a flexible and / or collapsible transfer tube disposed within the protective housing and / or structure. In yet other embodiments, the laminar flow fluid path extends from the distal inlet aperture of the cannula to the lateral outlet aperture of the protective housing and / or structure.

[0024] Additionally or alternatively, a laminar flow fluid path extends from a distal inlet orifice of the cannula to a proximal outlet orifice of the protective housing and / or structure. In further aspects, a slider is partially positioned within and / or movable within the confines of the protective housing and / or structure to move the cannula from a first position within the protective housing and / or structure to a second position outside of the handle, protective housing and / or structure. In further aspects, the slider has a fluid path directly coupled to the proximal fluid outlet orifice of the cannula and extending laterally to a lateral fluid outlet orifice of the protective housing and / or structure, or the slider has a fluid path directly coupled to the proximal fluid outlet orifice of the cannula and extending to a fluid path outlet orifice of the slider when decoupled from the lateral outlet orifice of the protective housing and / or structure, or the fluid path outlet orifice of the slider is sealed when decoupled to prevent fluid leakage and / or pressure decay loss. In still other aspects, the intravascular blood extraction device has a fluid path outlet orifice of the slider that is opened when coupled to the lateral outlet orifice of the protective housing and / or structure using a seal, valve, gasket or other mechanism. In still other alternatives, the protective housing and / or structure includes a seal, valve, gasket or other mechanism to prevent fluid leakage and / or pressure decay around the cannula, chamber and / or other components within the protective housing and / or structure.

[0025] In other aspects, a method is provided for collecting blood from an existing indwelling catheter or other placed vascular access component by coupling a blood extraction device to a previously placed peripheral catheter at least partially disposed within a patient's fluid pathway. The blood extraction device includes at least one cannula having a distal inlet and a proximal outlet orifice that is inserted through a proximal end of the previously placed peripheral catheter and advanced distally. There is a slider or plunger actuator coupled to the proximal outlet orifice of the cannula to assist in insertion and retraction of the cannula into and from the previously placed peripheral catheter. Next, there is a step of coupling a fluid collection device to a lateral outlet orifice of the housing to transfer fluid from the patient into the fluid collection device in an ergonomic and compact form. In some embodiments, the cannula proximal end is coupled to a distal end of a flexible tube. The flexible tube can include one or more coiled portions disposed in a helical manner about a longitudinal axis of the cannula. The distal end of the flexible tube is in communication with a blood collection port in the handle or housing. The blood collection port can be advantageously positioned in any of a number of different locations depending on the arrangement of the cannula and slider. By way of example and not limitation, the blood collection port can be positioned in a side wall or proximal face of the handle, housing or protective structure.

[0026] In one embodiment, a blood extraction device is provided having a housing with a proximal end and a distal end. There is a blood collection orifice in a blood collection port formed in a wall of the housing and a coupler disposed on the distal end of the housing, the coupler being adapted and configured to interface with a catheter or peripheral vascular device. A slider is externally accessible from the housing and movable relative to the housing proximal end and the housing distal end. There is also a cannula having a proximal end and a distal end and a cannula lumen extending from a distal opening to a proximal opening, the cannula being within the housing and coupled to the slider, wherein the cannula distal end is movable beyond the coupler by axial movement of the slider, wherein the blood extraction device is in a first position when the cannula is within the housing and there is no fluid path between the distal opening of the cannula and the blood collection orifice, and the blood extraction device is in a second position when the cannula distal end is external to the housing and a fluid path is established between the cannula distal opening and the blood collection orifice. Additionally, the cannula lumen proximal opening is in a sidewall of the cannula or the cannula lumen proximal opening is at an end of a curved proximal segment of the cannula. In some embodiments, there can be a fluid path sealer within the cannula lumen, wherein a distal end of the fluid path sealer is proximate the lumen proximal opening in the sidewall. In some embodiments, there is also a protective sheath surrounding the cannula, the protective sheath being in an expanded state when the blood extraction device is in the first position and the protective sheath being in a compressed position when the blood extraction device is in the second position. In other aspects, the sheath is distal to the blood collection orifice or proximal to the blood collection orifice when the protective sheath is in the compressed position. All methods and devices described herein (in any combination) can be envisioned herein and can be used to achieve the benefits as described herein.

[0027] In another aspect, a blood extraction device is provided having a housing with a proximal end and a distal end, and a blood collection orifice in a blood collection port formed in a wall of the housing. A coupler is provided on the distal end of the housing, the coupler adapted and configured to engage with a catheter or peripheral vascular device. A slider is accessible from outside the housing and movable relative to the proximal end of the housing and the distal end of the housing. A cannula having a proximal end and a distal end and a cannula lumen extending from a distal opening to a proximal opening is present, the cannula being within the housing and coupled to the slider, wherein the cannula distal end is movable beyond the coupler by axial movement of the slider. The blood extraction device is in a first position when the cannula is within the housing and the cannula lumen proximal opening is closer to the proximal end of the housing than the distal end of the housing, and the blood extraction device is in a second position when the cannula distal end is outside the housing, and the cannula lumen proximal end is spaced from the blood collection orifice a distance less than in the first position. In some alternatives, the cannula lumen proximal opening is in a side wall of the cannula, but in other variations, the cannula lumen proximal opening is coupled to a flexible tube section in communication with the blood collection orifice. In one alternative, the flexible tube section includes a plurality of coils, and the distance between adjacent coils is greater in the first position than in the second position. A protective sheath can also be present around the cannula, the protective sheath being in an expanded state when the blood extraction device is in the first position, and the protective sheath being in a compressed position when the blood extraction device is in the second position, or the protective sheath is proximal to the blood collection orifice when the protective sheath is in the compressed position. In one aspect, the slider is configured as a plunger actuator extending from the proximal end of the housing, wherein movement of the plunger actuator causes corresponding movement of the cannula lumen distal opening and the cannula lumen proximal opening, while also changing the distance between the cannula lumen proximal opening and the blood collection orifice. In one variation, distal movement of the plunger actuator decreases the distance between adjacent coils in the plurality of coils in the flexible tube section.

[0028] In another alternative, a blood extraction device is provided having a housing with a proximal end and a distal end, and a blood collection aperture located in a blood collection port formed in a wall of the proximal end of the housing. A coupler is provided on the distal end of the housing, the coupler being adapted and configured to engage with a catheter or peripheral vascular device. There is also a fixed slide accessible from outside the housing and a movable slide, the movable slide being movable relative to the proximal distal end of the housing. There is a cannula having a proximal end and a distal end and a cannula lumen extending from the distal opening to the proximal opening, the cannula being within the housing and coupled to the movable slide, wherein the cannula distal end is movable beyond the coupler by axial movement of the movable slide, wherein the blood extraction device is in a first position when the cannula is within the housing and in a second position when the cannula distal end is outside the housing and the cannula proximal opening and the blood collection aperture are closer to the fixed slide than in the first position. In one alternative, there is a protective sheath around the cannula between the fixed slide and the movable slide, the protective sheath being in an expanded state when the blood extraction device is in the first position and in a compressed position when the blood extraction device is in the second position. In some embodiments, the cannula lumen proximal opening is coupled to a flexible tube segment in communication with the blood collection aperture. The flexible tube segment can include a plurality of windings, and the spacing between adjacent windings is greater in the first position than in the second position, or the flexible tube segment includes a plurality of windings, and the spacing between adjacent windings is the same in the first position as compared to the second position. The spacing between the fixed slide and the movable slide in the second position can also be less than the spacing between the fixed slide and the movable slide in the first position.

[0029] In yet another alternative, there is a blood extraction device having a housing with a coupler disposed at a distal end of the housing, the coupler configured to engage a catheter assembly. There is a slider in communication with the housing and a cannula including a distal end, the slider configured to move between a distal end and a proximal end of a handle, the cannula configured to be extendable through the distal end of the handle as the slider is advanced distally in the handle. Further, a blood collection device is in fluid communication with a proximal end of the cannula as the cannula distal end extends into a blood vessel. There are alternatives where the cannula includes a discontinuous lumen between the cannula distal end and the cannula proximal end, the discontinuous lumen can be configured to transition from a discontinuous lumen to a continuous lumen as the cannula proximal end is aligned with the blood collection device coupled to an orifice on the handle. In another variation, the cannula includes a discontinuous lumen having a linear segment distal to a flexible segment coiled within an interior of the handle, or the cannula includes a discontinuous lumen having a linear segment extendable from the distal end of the handle and a flexible segment coiled within an interior of the handle, where the lumen is configured to direct blood to flow in a first direction through the linear segment and in an opposite direction through the flexible segment. In these and other embodiments, there is also an orifice extending from an exterior of the handle to an interior of the handle and configured to couple with the blood collection device on an exterior of the orifice, where the cannula proximal end is in communication with the orifice. There can also be an orifice extending from an exterior of the handle to an interior of the handle and configured to couple with the blood collection device on an exterior of the orifice, where the cannula proximal end is in communication with the orifice. In another aspect, there can be a fluid transfer chamber configured to transfer blood between the cannula proximal end and the blood collection device, where the fluid transfer chamber is within the handle. In some embodiments, the slider is a plunger extending through a proximal end of the handle to the cannula. The blood collection device is a vacuum reservoir assembly configured to couple and be in fluid communication with the orifice positioned on the handle. In still other aspects, the cannula is configured to transition from a stowed position to an extended position, where the cannula distal end extends beyond the handle distal end as the slider is advanced distally through the handle. In another aspect, the cannula includes a lateral opening to a lumen extending between a proximal end and a distal end, the cannula opening configured to be aligned for fluid communication with the blood collection device as the slider advances the cannula sufficiently beyond the handle distal end. There can also be a fluid transfer chamber positioned distal to the interior of the handle, where the cannula is advanceable through the fluid chamber by one or more seals configured to seal the fluid chamber as the cannula is extended or retracted through the handle to align the cannula lateral opening with the fluid transfer chamber interior. In still other aspects, the cannula lumen is configured to become continuous as the lateral opening is aligned with the fluid transfer chamber interior, or the cannula lumen is in fluid communication with the blood collection device along a deployment length, the deployment length including a length of the fluid transfer chamber within the interior of the handle.

[0030] In still other aspects, a blood collection device is provided having a handle having a proximal end and a distal end with a hollow interior extending between the proximal end and the distal end, and a coupler positioned at the distal end configured to engage a catheter assembly. There is a fluid transfer chamber at the distal end within the handle interior, and a slider accessible from the exterior of the handle, the fluid transfer chamber having seals positioned proximal and distal of the fluid transfer chamber, the slider having a portion extending into the handle interior and configured to be advanced distally from the proximal side of the handle to the proximal side of the fluid transfer chamber. There is a cannula having a lumen extending between a proximal end and a distal end, and a lateral opening on the cannula between the cannula proximal end and the cannula distal end, the cannula being axially aligned and extending from the slider through the fluid transfer seals and out the distal end of the handle, wherein the lumen is configured to be advanced by the slider beyond the proximal side of the fluid transfer chamber into fluid communication with the fluid transfer chamber to provide a continuous lumen from the cannula distal end through the lateral opening into the fluid transfer chamber and to the blood collection device in communication with the fluid transfer chamber.

[0031] In yet another embodiment, there is a blood extraction device having a handle having a proximal end and a distal end with a hollow interior extending between the proximal end and the distal end, wherein a coupler is positioned at the distal end configured to engage a catheter assembly, and an orifice extending through the handle, the orifice having an engagement element on the exterior of the orifice configured to engage a blood collection device. There is also a slider plunger accessible from the exterior of the handle and extending into the handle interior, the slider plunger configured to be advanced distally through the handle with a cannula, the cannula having a lumen extending through a linear distal portion and through a flexible proximal portion in helical communication with a segment of the slider plunger within the handle interior, the cannula linear portion being axially aligned with the handle and configured to extend from the handle distal end to establish blood flow from a blood vessel as the slider is advanced distally within the handle. In some alternatives, there are convolutions of the cannula flexible portion helically around the plunger, the convolutions configured to compress as the slider is advanced distally to deploy the cannula distal end beyond the handle. In one alternative, the orifice is positioned at the distal end of the handle, and the proximal end of the cannula is in fluid communication with the orifice. In another alternative, there are convolutions of the cannula flexible portion helically around the plunger, the convolutions configured to elongate as the slider is advanced distally to deploy the cannula distal end beyond the handle. In yet another variation, the orifice is positioned at the proximal end of the handle, and the proximal end of the cannula is in fluid communication with the orifice.

[0032] In still other alternatives, the various blood collection devices described above and herein can be advantageously used in a variety of different methods for collecting blood from a patient's blood vessel using an indwelling catheter, based on a number of unique attributes and design configurations of various embodiments. In one exemplary aspect, there is a step of coupling a distal end of a blood extraction device of any of the above or herein described blood extraction devices to an indwelling catheter or other peripheral vascular access device in communication with a patient's blood vessel. Next, there is a step of advancing a cannula distal end beyond a housing of the blood extraction device and into the patient's blood vessel, wherein advancing the cannula distal end is capable of establishing fluid communication between the patient's blood vessel and a blood collection aperture in the housing of the blood extraction device via a proximal cannula lumen opening. Blood is collected using the blood collection aperture in the housing. BRIEF DESCRIPTION OF DRAWINGS

[0033] A better understanding of the features and advantages of the methods and devices described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the application are utilized, and the accompanying drawings of which: Figure 1 is an illustration of an intravascular blood extraction device according to an embodiment, wherein an example of a cannula extends beyond a protective housing and / or structure and / or distal end of the structure, as described herein. The blood extraction device has a lateral exit aperture for connection to a fluid collection device.

[0034] Figure 2 is an illustration of an intravascular blood extraction device according to an embodiment, wherein an example of a cannula is retracted within a protective housing and / or structure and / or structure, as described herein. The blood extraction device has a lateral exit aperture for connection to a fluid collection device.

[0035] Figure 3 is an illustration of an intravascular blood extraction device according to an embodiment, wherein an example of a laminar flow fluid path within a distal end of a slider is directly coupled to a cannula protected by a flexible and / or collapsible sheath disposed within a protective housing and / or structure, as described herein.

[0036] Figure 4 is an illustration of an intravascular blood extraction device according to an embodiment, wherein an example of a cannula extends distally beyond a distal end of a housing and / or structure, as described herein.

[0037] Figure 5 is an illustration of an intravascular blood extraction device according to an embodiment, wherein an example of a laminar flow fluid path within a distal end of a slider is directly coupled to a cannula protected by a flexible and / or collapsible sheath disposed within a protective housing and / or structure, as described herein.

[0038] Figure 6is an illustration of an intravascular blood extraction device according to an embodiment, with an example of a cannula extending distally beyond the distal end of the housing and / or structure, as described herein.

[0039] Figure 7 is an illustration of an intravascular blood extraction device according to an embodiment, with an example of a laminar flow fluid path within the distal end of the plunger actuator directly coupled to a cannula protected by a flexible and / or collapsible fluid transfer tube disposed within a protective housing and / or structure, as described herein.

[0040] Figure 8 is an illustration of an intravascular blood extraction device according to an embodiment, with an example of a cannula extending distally beyond the distal end of the housing and / or structure, as described herein.

[0041] Figure 9 is an illustration of an intravascular blood extraction device according to an embodiment, with an example of a laminar flow fluid path within the distal end of the plunger actuator directly coupled to a cannula protected by a flexible and / or collapsible fluid transfer tube disposed within a protective housing and / or structure, as described herein.

[0042] Figure 10 is an illustration of an intravascular blood extraction device according to an embodiment, with an example of a cannula extending distally beyond the distal end of the housing and / or structure, as described herein.

[0043] Figure 11 is a cross-section of an intravascular blood extraction device as shown in Figure 8 with additional detail of the flow path through the lumen. DETAILED DESCRIPTION

[0044] An intravascular blood extraction device can include a cannula disposed at least partially within a housing and / or structure. The housing can also be referred to as a handle. The cannula can be configured to traverse the length of a previously placed catheter until access to a fluid vessel is achieved. Once access to the vessel is achieved, it can be desirable for the cannula to be advanced beyond the distal end of the catheter into the vessel. A cannula structure of a predetermined length of a single or multiple materials can be selectively manipulated (e.g., advanced or retracted) to a desired location within the vessel. The cannula structure can provide added functionality, control, and effectiveness to the device.

[0045] An intravascular blood extraction device as described herein can include a single or multiple material cannula that is coaxial or circumferentially oriented. For example, a stiffer cannula cross-sectional geometry using a single or multiple material. As described herein, the cannula can have a circumference that includes a soft and trauma resistant outer polymer layer, a lubricious inner layer that includes a section of laminar flow fluid path, and a stiffer layer within the two aforementioned layers to provide rigidity and column strength to the cannula. Wherein, as described herein, the stiffening layer can be composed of a single material or multiple materials to impart the desired rigidity to the cannula.

[0046] In some examples, the coaxial stiffening section within the outer and inner layers of the cannula can be positioned along the length of the cannula (e.g., a stripped section). Whereas the coaxial stiffening section can encompass the total circumference of the cannula (0 to 360 degrees) or be partially disposed within the circumference (e.g., less than 350 degrees, less than 340 degrees, less than 330 degrees, less than 320 degrees, less than 310 degrees, less than 300 degrees, less than 270 degrees, less than 180 degrees or greater). In some examples, as described herein, more than one stiffening section can be included along the length of the cannula such that the circumference of the cannula can be composed of multiple stiffening sections.

[0047] In some examples, the stiffening layer of the cannula can include a softer distal end. For example, the softer distal end can provide a trauma resistant tip insertion into the vasculature while maintaining the necessary rigidity and structure of the cannula proximal to the tip section. Whereas, as described herein, the softer section can have a predetermined length of at least 0.5 mm and extend proximally along the length of the cannula.

[0048] As described herein, an intravascular blood extraction device may include a cannula having a proximal end directly connected to an inlet port of a plunger actuator. As described herein, the plunger actuator is partially located within the housing and / or structure of the intravascular blood extraction device and extends proximally outside the housing and / or structure of the intravascular blood extraction device. The plunger has an inlet port connected to the proximal end of the cannula at the distal end of the plunger actuator. The inlet port and outlet port of the plunger are located at the distal end of the plunger actuator and form a laminar flow path with the distal end of the cannula. The outlet port of the plunger actuator is connected to the lateral top of the intravascular blood extraction device using a flexible transmission tube. In this embodiment, the laminar flow path is created by a fluid path from the distal end of the cannula and a flexible transmission tube directly connected to the lateral top of the intravascular blood extraction system, with the cannula extending within the fluid path formed between the inlet port and outlet port of the plunger actuator. In some examples, the protective housing and / or structure is sealed to protect the cannula from contamination. The housing and / or structure seals distally around the cannula and proximally around the plunger actuator to prevent contamination of the cannula when in the first position. In some examples, a plunger actuator as described herein can move the cannula from a first position within the protective housing and / or structure to a distal position outside the protective housing and / or structure. The distal portion of the protective housing and / or structure can be configured with a mechanism for coupling the blood extraction system to a previously placed peripheral intravascular catheter or similar connector and / or connection.

[0049] The intravascular blood extraction device as described herein may include a cannula protected by a collapsible and flexible sheath disposed within the housing and / or structure of the intravascular blood extraction device. The cannula is directly coupled to the distal end of the slider and is located within the flexible and / or collapsible protective sheath. The slider is connected to the cannula and is partially disposed outside the protective housing and / or structure and is used to move the cannula from a first position within the protective housing and / or structure to a second position outside the intravascular blood extraction device. The flexible and / or collapsible protective sheath may appear expanded in the first position and contracted in the second position. The flexible and / or collapsible protective sheath maintains a sterile barrier around the cannula at all times.

[0050] The collapsible, flexible sheath has a distal end and a proximal end and is coupled to the distal end of the protective housing and / or structure and the distal end of the slider. The slider moves the cannula from a first position within the protective sheath and / or protective structure to a distal position outside the protective sheath and / or protective structure. The flexible and / or collapsible protective sheath can appear expanded in the first position and contracted in the second position. The flexible and / or collapsible protective sheath maintains a sterile barrier around the cannula at all times.

[0051] Figure 1An example of an intravascular blood extraction device 100a as described herein in its second and open laminar fluid pathway position is shown, which has been extended forwardly, thus cannula 101 is partially disposed outside of protective housing and / or structure 102. An example of a blood extraction device with a forwardly extended cannula is shown, where the cannula distal orifice 103, which is directly coupled to the distal end 105 of the slider 106, is moved to the most distal position within the protective housing and / or structure. A fluid pathway sealer 107 is attached to the proximal end for the protective housing and / or structure to prevent backflow through the cannula fluid pathway 108 until the cannula proximal orifice 109 is within the fluid transfer chamber 110. The distal end 115 of the fluid pathway sealer 107 is aligned with the lateral blood collection orifice 111, as shown in Figure 1 and Figure 2 The proximal opening of the cannula is aligned with the fluid sealer distal end 115, as shown in Figure 1 The fluid transfer chamber 110 is directly coupled to the lateral top orifice 111, thus forming the laminar fluid pathway of the intravascular blood extraction device. The fluid transfer chamber is sealed around the cannula with seals, valves, and / or grommets 112a, 112b, and 112c to prevent fluid leakage or vacuum pressure decay during use. The fluid pathway formed between the distal end of the cannula and the lateral orifice female luer has a continuous inner diameter of the same size or multiple inner diameters of different sizes to allow fluid flow without hemolysis or to assist fluid flow during use.

[0052] The lateral orifice 111 is a female luer to which a fluid collection holder and / or syringe can be coupled. The flexible and / or collapsible protective sheath 113 retracts when the slider moves the cannula distal orifice from a first position within the protective housing and / or structure to a second position outside of the protective housing and / or structure of the intravascular blood extraction device. In this example, fluid is extracted through the fluid pathway of the cannula past the cannula proximal orifice into the fluid transfer chamber. The transfer chamber is connected to a lateral top end device (not shown) in which fluid is collected.

[0053] The device 100a can include a protective housing 102 with a coupler 200 positioned on the distal end of the housing 102 and adapted to couple with a catheter or other vascular access component, where the cannula 101 can extend through and into a blood vessel. A slider 106 can be moved distally or proximally to adjust the deployed length of the cannula 101. In some examples, the slider 106 and slider distal end 105 compress the protective sheath 113 around the cannula 101 within the housing 102 and proximal to the fluid transfer chamber 110 when the cannula 101 is deployed.

[0054] In some examples, the lumens of the devices described herein can be discontinuous. As shown inFigure 1 and Figure 2 As shown, the cannula 101 has a lumen from the distal aperture 103 to the proximal aperture 109. Thus, the lumen from the distal aperture 103 is not continuous and does not provide a fluid path until the cannula 101 is deployed and the proximal aperture 109 is positioned within the fluid transfer chamber 109. In some examples, the fluid path sealer 107 is extendable within the cannula lumen and prevents fluid flow proximally in the lumen beyond the distal end of the fluid path sealer 107. As Figure 1 shown, the fluid path sealer is positioned within the cannula 101 such that when the cannula 101 is deployed, the proximal aperture does not lead to the fluid transfer chamber 110 until the cannula has been sufficiently deployed over the fluid path sealer 107.

[0055] The seals 112a, 112b, 112c are shown as cross section seals positioned within the protective housing 102 and around the exterior of the cannula to prevent fluid flow outside the cannula. There can be one or more seals positioned in and throughout the protective housing to prevent fluid from being unexpectedly transferred through the device outside the cannula. Some other examples of seals can include seals around the lateral tip 111 of the protective housing 102. The lateral tip (e.g., coupling feature) can be configured to interface with a vacuum reservoir assembly for transferring fluid from the cannula outward to a receptacle or container such as a vacutainer.

[0056] Figure 2 An example of the intravascular blood extraction device 100a is shown in its first and closed configuration with the cannula 101 retracted within the protective housing and the proximal aperture 109 misaligned with the fluid transfer chamber 110, where the position as described herein has the cannula initially disposed within the protective housing and / or structure 102, and the flexible and / or collapsible protective sheath 115 is shown extended when the cannula is initially disposed within the protective housing and / or structure and the slider is moved to the most proximal position of the intravascular blood extraction device. The protective sheath 113 is now in an expanded configuration with the slider 106 in a proximal position within the protective housing 102, while the cannula 101 and distal aperture 108 are in a stowed configuration.

[0057] Figure 3 and Figure 4An example of an intravascular blood extraction device 100b is shown with a cannula 121 having a distal end 122 and a slider outlet port 124, where the distal end 122 is in a first position within a protective housing and / or structure 123. The slider outlet port 124 can be coupled to a lateral orifice port 125 on the protective housing 123. When the cannula 121 traverses the slider 126 through a slider distal end 126a, the cannula 121 extends from the distal opening 122 through a bend 129 to the slider outlet port 129. The slider outlet port 124 can be fluidly coupled to the opening 125, thus allowing fluid into the laminar flow fluid path through the lateral orifice of the laminar flow fluid path when the two ports are fully engaged. As described herein, the device 100b shows another example of a discontinuous lumen through the cannula 121 from the distal end 122 that can be deployed into a blood vessel, and the proximal open slider outlet port 129 is sealed or otherwise not in fluid communication with the lateral orifice 125 of the protective housing. This discontinuous lumen remains not fluidly aligned or in communication with the lateral orifice 125 until the slider 126 is advanced distally and the cannula is moved distally to bring the slider outlet port 124 into fluid communication with the lateral orifice 125 through the coupler 127.

[0058] In some examples, the slider outlet port 124 can be in communication with the lateral orifice 125, which can include a seal, valve, or gasket connection 127 to open the slider outlet port 124 when the slider 126 is coupled to the lateral orifice 125 of the intravascular blood extraction device in its most distal or forward-most position. As described herein, the slider outlet port 124 has a seal, valve, or gasket connection 129 to prevent fluid leakage or vacuum pressure decay during use. The position or spacing of these seals, valves, or gaskets can allow the slider outlet port to be moved into place and coupled to the lateral orifice of the laminar flow fluid path.

[0059] In some examples, the cannula is initially disposed within the protective housing 123 through a protective sheath 130. In some examples, the protective sheath 130 can be collapsible when the slider 126 is advanced distally through the housing 123. As shown, the device 100b is in a ready-to-use configuration or retracted configuration with the protective sheath expanded. For example, as shown, when the cannula 121 is initially disposed within the protective housing 123 and / or structure and the slider 126 is moved to the most proximal position of the intravascular blood extraction device 100b, the device is in its first and closed laminar flow fluid path position and the extended flexible and / or collapsible protective sheath 130 is shown. Figure 3

[0060] Figure 4 An example of an intravascular blood extraction device 100b is shown with a cannula 121 having a distal end 122 and a slider outlet port 124, where the distal end 122 is in a first position within a protective housing and / or structure 123. The slider outlet port 124 can be coupled to a lateral orifice port 125 on the protective housing 123. When the cannula 121 traverses the slider 126 through a slider distal end 126a, the cannula 121 extends from the distal opening 122 through a bend 129 to the slider outlet port 129. The slider outlet port 124 can be fluidly coupled to the opening 125, thus allowing fluid into the laminar flow fluid path through the lateral orifice of the laminar flow fluid path when the two ports are fully engaged. As described herein, the device 100b shows another example of a discontinuous lumen through the cannula 121 from the distal end 122 that can be deployed into a blood vessel, and the proximal open slider outlet port 129 is sealed or otherwise not in fluid communication with the lateral orifice 125 of the protective housing. This discontinuous lumen remains not fluidly aligned or in communication with the lateral orifice 125 until the slider 126 is advanced distally and the cannula is moved distally to bring the slider outlet port 124 into fluid communication with the lateral orifice 125 through the coupler 127. Figure 3 ​The device, where the cannula 121 deploys beyond the distal end of the housing 123 through the coupling mechanism 200, where the distal opening 122 of the cannula 121 is ready to direct blood flow through the cannula to a collection device (not shown) as the slider outlet port 124 is now in fluid communication with the lateral aperture 125 and flow can travel through the cannula 121 out of the protective housing for collection. The slider 126 is in an advanced position within the handle 123, where the slider distal end 126a compresses the protective sheath 130. In some examples, the deployment length of the cannula 121 can be based on the length the slider 126 is advanced through the handle interior 123a.

[0061] In some examples, when the slider is moved to the most distal position of the intravascular blood extraction device, the cannula is in its second and open laminar fluid path position, where the cannula extends forward and is partially disposed outside of the protective housing and / or structure, showing the compressed flexible and / or collapsible protective sheath 130.

[0062] Figure 5 and Figure 6 An example is shown of when the slider 145 is moved to the most proximal position of the intravascular blood extraction device 100c, which has a cannula 143 configured to provide a fluid path initially disposed within a protective housing and / or structure 141, and showing the extended flexible and / or collapsible protective sheath 142. As described herein, the slider 145 is disposed within the handle or protective housing and / or structure 141 to move the cannula from a first position within the protective sheath and / or structure 142 to a distal position outside of the protective sheath and / or structure. The distal portion of the housing and / or structure 200 can be configured with a mechanism to couple the blood extraction system to a previously placed peripheral intravascular catheter or similar connector and / or connection. The slider 145 can be coupled to the housing and / or structure and / or to the cannula and disposed outside and within the housing and / or structure of the device. In this cross-sectional view, as with the other sliders described herein, the slider 145 can extend through the protective housing, with a portion of the slider on the outside and engageable by a user, and another portion of the slider within the protective housing 141 configured to manipulate the cannula 143 between a deployed configuration and a retracted configuration. In any of the examples described herein, the protective housing can be circular or any other geometry that allows for the example arrangement of features and elements described herein and also allows for a sealable interior environment to prevent accidental flow of fluid outside of the cannula.

[0063] As described herein, the device includes a discontinuous lumen. In some examples, the lumen can be in fluid communication with an opening or other aperture (e.g., Figure 1discontinuity, opening or other orifice remains out of fluid communication with the port on the housing for blood withdrawal until the cannula is advanced to align the orifice with the fluid transfer chamber. In other examples, the lumen can be discontinuous in that it involves a configuration of the cannula that passes through the device. For example, as shown in Figure 5 and Figure 6 the discontinuous cannula 143 has a linear section and a coiled or curved section 143 that can coil or spiral around the linear portion of the cannula, providing a reverse flow path direction from the distal end of the cannula to the lateral orifice or port 146 on the housing. The flexible tube 144 has a distal end 144a that communicates with the proximal end of the cannula 143. The distal end 144a can be positioned within and movable with the slider distal end 145a, as shown in Figure 5 and Figure 6 The distal end 144a has a bend, loop or kink that causes blood to flow distally from the proximal portion of the housing toward the outlet 144d at the coupler 146 in a reverse direction. Thereafter, the now distally directed flow moves along the flexible tube 144 through one or more coiled sections 144b. In one embodiment, the coiled sections 144b are disposed about the longitudinal axis of the cannula and / or housing to provide a path to the more distally positioned collection port 146. While the coils are disposed for distal movement of the flow in the embodiments of devices 100c and 100d, the flexible coils can also be used to continue distal blood movement to a more proximal portion of the handle or housing, as best seen in device 100e (see Figure 9 and Figure 10 ).

[0064] In some examples, the fluid path forms a laminar flow fluid path and extends between the distal end of the cannula and the lateral orifice of the intravascular blood withdrawal device. The laminar flow fluid path, including the cannula fluid path directly coupled to the slider distal end and the flexible transfer tube 144 connected to the distal end of the slider 145 and the lateral orifice of the intravascular blood withdrawal device. The flexible transfer tube 144b can be within a flexible and / or collapsible protective sheath 142. While the fluid path formed between the distal end of the cannula and the lateral orifice luer is of a continuous inner diameter of the same size or multiple inner diameters of different sizes to allow fluid flow without hemolysis or to assist fluid flow during use.

[0065] In some examples, when the cannula is initially disposed within the protective housing and / or structure and the slider is moved to the most proximal position of the intravascular blood withdrawal device, the cannula is initially disposed within the protective housing and / or structure 141 in its first and closed laminar flow fluid path position, and the flexible and / or collapsible protective sheath 142 is shown extended.

[0066] In some examples, when the slider is moved to the distal-most position 147 of the intravascular blood extraction device, the cannula is in its second and open laminar fluid path position in which the cannula extends forward and is partially disposed outside of the protective housing and / or structure 148, thereby showing the compressed flexible and / or collapsible protective sheath 146. Reference is made to Figure 5 , the device 100c is shown in a retracted or ready to use configuration in which the cannula 143 is retracted within the housing 141 and no flow path is established through the linear segment of the cannula 143 or the coiled segment of the cannula. In Figure 6 , the slider 145 is now advanced distally in which the cannula 148 is deployed and the distal opening of the cannula 143 is positionable intravascularly or through a catheter for preformed blood extraction. The flow path can now be considered continuous in that fluid can flow through the linear segment of the cannula 143, then over and through the coiled segments 144a, 144b, to the coiled segment distal opening 144c and outlet 144d, out of the protective housing through the coupler 146, to a vacuum reservoir or other collection device.

[0067] Figure 7 and Figure 8 An example of an intravascular blood extraction device 100d is shown having a cannula 151 with a proximal portion of a linear segment 152 transitioning to a coiled segment 158 and then outwardly to a lateral aperture 157 on a handle or housing 154. In some examples, the cannula 151 can be directly coupled to an inlet port of a plunger actuator stem 153. The plunger actuator 162 can extend from its proximal portion with the actuator stem 153 through the housing 154. The housing stem has an operational length 153a which is the amount of distal travel of the plunger actuator before it hard stops at the outer wall of the housing or handle. The plunger distance 153a corresponds to the cannula travel distance 153b (see Figure 8 ) when the device 100d is in a blood collection configuration. In this view of the handle, housing and / or structure, multiple sealed or protective housings for the cannula can be seen. The plunger has an inlet port 155 in the distal end of the plunger actuator which is coupled to the proximal end 152 of the cannula. In Figure 7 , the plunger actuator 162 is retracted proximally and the cannula 151 is in a stowed configuration within the housing 154. The linear segment of the cannula 151 is entirely within the housing 154 and the coiled or spiral segment is expanded through the handle interior. The proximal end of the cannula is coupled to a lateral aperture or port 157 on the housing in preparation for coupling to a fluid container during extraction.

[0068] In some examples, the plunger 153 can extend into the housing 154 through a proximal seal 160 to seal the interior of the housing 154. The outlet port 156 of the plunger actuator (e.g., the proximal end of the cannula) is connected to the lateral tip 157 of the intravascular blood extraction device using a flexible transfer tube 158 (e.g., the coiled section of the cannula 151). The transfer tube 158 is shown in its expanded configuration when the plunger is in its most proximal position. The laminar flow fluid path of this embodiment is created by the fluid path beginning at the distal end of the cannula 151 and the flexible transfer tube directly coupled to the lateral tip of the intravascular blood extraction system, with the cannula 151 extending within the fluid path formed between the inlet and outlet ports of the plunger actuator. The fluid path formed between the distal end of the cannula and the lateral tip luer is either a continuous inner diameter of the same size or multiple inner diameters of different sizes to allow fluid flow without hemolysis or to assist fluid flow during use.

[0069] Figure 8 The device is shown now in the deployed configuration Figure 7 with the cannula 151 extending beyond the distal end of the housing 154, the length of the extension 153b corresponding to the advancement of the plunger 162 through the housing 154. The cannula coiled or flexible section 158 is shown in a more compressed coil that still allows flow from the cannula distal opening to the port 157 on the housing that is in communication with the coiled section 158 of the lumen.

[0070] In some examples, the housing and / or structure seals 159 distally around the cannula and 160 proximally around the plunger actuator to prevent contamination of the cannula when in the first position.

[0071] In some examples, the plunger actuator as described herein can move the cannula from a first position within the protective housing and / or structure to a distal position outside of the protective housing and / or structure. The distal portion of the protective housing and / or structure can be configured with a mechanism for coupling the blood extraction system to a previously placed peripheral intravascular catheter or similar connector and / or connection.

[0072] In some examples, when the plunger 162 is moved to the most distal position of the intravascular blood extraction device, the cannula is in its second advanced position with the cannula extending forward and partially disposed outside of the protective housing and / or structure 154, the compressed flexible transfer tube 158 is shown.

[0073] Figure 9 and Figure 10Yet another example of an intravascular blood extraction device 100e is shown having a cannula 177 again having a linear segment or region on the distal side and a coiled or helical region 181 on the proximal side. The moving slider 173b can be used in combination with the fixed slider support 173a for leverage when the moving slider wall 173c is advanced distally to advance the cannula 177 from the handle or housing 176. The cannula 177 is coupled to the movable slider wall 173c and is deployed when the moving slider 173b is advanced distally toward the fixed slider support 173a. The flexible transfer tube or coiled segment 181 of the cannula can expand or contract depending on the cannula deployment and retraction. The coiled segment distal end 181a is in communication with the proximal opening of the cannula lumen. Flow in the transfer tube 181 passes through the coiled segment 181b to the proximal end 181c. The coiled segment proximal end 181c is in communication with the outlet structure 182, 182a and 182b as best seen in the view of Figure 10 .

[0074] The distal end portion of the handle, housing and / or structure 176 includes a port or coupler 178 configured to couple the blood extraction system 100e to a previously placed peripheral intravascular catheter or similar connector and / or connection. The slider 173b can be coupled to and movable relative to the housing and / or structure and cannula and disposed both outside and inside the protective housing and / or structure of the device.

[0075] In some examples, a flexible and / or collapsible sheath 179 is directly coupled to the distal end of the protective housing and / or structure 176 (see connection adjacent to the fixed slider 173a) and the moving slider 173b to prevent contamination of the cannula 177 prior to entry into a previously placed peripheral catheter. The cannula, flexible or collapsible sheath and moving slider 173b can also be supported by a track, wall or other suitable support structure such as structure 172. When the cannula 177 is in a first position within the protective housing and / or structure, the flexible and / or collapsible sheath 179 is in an extended state. (See Figure 9 ). When the cannula 177 is moved to a second position outside the protective sheath and / or structure, the flexible and / or collapsible sheath 179 is compressed in Figure 10 .

[0076] In some examples, the flexible transfer tube (e.g., coiled or helical segment of the cannula) 181 can be translated within the housing 176 with the linear cannula segment and moving slider 173b as shown in the movement between Figure 9 and Figure 10 . Optionally, the coiled segment 181 can also be configured to compress into a shorter axial spacing as shown in Figure 6 and Figure 8The linear cannula segment 175 can extend from the distal opening 177a to the coiled segment 181 in some examples, as the linear cannula segment 175 will transition through the slider 173b near the region 175. The spiral or flexible segment of the cannula 181 can then be coupled to an orifice or coupler 182 that is now positioned on the proximal end of the housing 176, which has an opening 182a that can be in fluid communication with the cannula 177 to allow blood flow through the cannula 177 when deployed into a blood vessel or catheter assembly.

[0077] Figure 10 The example shown in FIG. 18 illustrates the formation of a laminar flow fluid path through the opening 182a between the distal end of the cannula 177a and the proximal end of the blood extraction device within the blood vessel. The flexible covering 179 has been compressed via distal movement of the slider proximal wall 173c, shortening the overall length of the housing or handle and moving the collection port 182 closer to the distal end of the housing. In some examples, the proximal end of the intravascular blood extraction system can include a coupler that is a female luer fitting 182 or similar structure to couple a fluid collection device or syringe. In some embodiments, there can be a distal opening 182b where the coupler 182 extends into the proximal end of the transfer tube 181. In some examples, the flexible transfer tube 181 is compressible and / or collapsible to allow the slider to move from a first position to a second position within the protective housing and / or structure 176. The fluid path formed between the distal end of the cannula and the proximal female luer fitting has a continuous inner diameter of the same size or multiple inner diameters of different sizes to allow fluid flow without hemolysis or to assist fluid flow during use.

[0078] It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and can be used as such. For example, while the concepts above are presented in the general context of use of respective systems and methods, it should be appreciated that these concepts can also be implemented as part of other techniques and structures.

[0079] Figure 11 An example of a blood extraction device as described herein is shown, with arrows indicating an example of a flow path therethrough. This example illustrates the flow of blood from the patient through the cannula 177, through the transfer tube 181, and into the collection port 182. The flexible covering 179 is shown compressed and shortened in length, and the collection port 182 is shown moved closer to the distal end of the housing 176. Figure 8device, where the cannula 151 is deployed to be intravascular and the plunger 162 is in a protracted position within the housing 150. Flow can continue through the linear portion of the cannula 151 and continue through the coiled or helical segment of the flexible cannula tubing 158, as indicated by arrow 250, and then to the port or orifice 157 for transport to a collection device such as a vacuum reservoir. Arrow 255 indicates a reversal or change in direction of flow from the linear portion, as blood can first travel in a proximal direction within the housing 150 and then travel in an opposite or distal direction to the helical segment of the cannula 151 to the coupler 157. When the lumens are continuous, flow can be established such that the flow is a single flow that travels in a first direction and then in a second direction. In some examples, flow through discontinuous lumens can travel in the opposite manner as shown. In some examples, the lumens can be discontinuous until the lumens are aligned with the fluid transport chamber, as shown. In some examples, the discontinuous lumens can travel through a first linear segment of the cannula that is discontinuous as it transitions to a flexible helical or coiled segment of the cannula to a port or orifice on the housing. Figure 11 Figure 1

[0080] When a feature or element is described as being "on" another feature or element, it can be directly on the other feature or element or intervening features and / or elements can also be present. In contrast, when a feature or element is described as being "directly on" another feature or element, there are no intervening features or elements present. It will also be appreciated by those of skill in the art that references to a structure or feature that is "connected", "attached", or "coupled" to another structure or feature can include fixed or removable connections, attachments, or couplings. In contrast, references to a structure or feature that is "directly connected", "directly attached" or "directly coupled" to another structure or feature indicate that there are no intervening structure or features present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is "adjacent" to another feature can have portions that overlap or underlie the adjacent feature.

[0081] ​​The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further 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 preclude 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 of the associated listed items and can be abbreviated as " / ".

[0082] Spatially relative terms, such as "under", "below", "lower", "over", "upper" and the like, can be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientations depicted in the figures. For example, if a device in the figures is inverted, elements described as "under" or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "under" can encompass both an orientation of "over" and "under". The device can be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal", and the like are used herein for the purpose of explanation only, unless specifically indicated otherwise.

[0083] While the terms "first" and "second" can be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms, unless the context clearly indicates otherwise. These terms can be used to distinguish one from another feature / element. Thus, a first feature / element discussed below could be termed a second feature / element and, similarly, a second feature / element discussed below could be called a first feature / element without departing from the teachings of the present application.

[0084] In this specification and the following claims, the term "comprise" and its variations such as "comprises" and "comprising" mean that the method and articles of manufacture can comprise the various components (e.g., compositions of matter and devices that include a combination of devices and methods) described therein, for example. The term "comprising" is to be read to mean the inclusion into an apparatus, method, or article of manufacture of any number of steps, components, or elements, which can be present or absent, optionally in a sub-combination thereof.

[0085] Generally, any apparatus and method described herein should be understood to encompass both the complete and sub-combinations of the components and / or steps, which can be selectively included in the method and articles of manufacture, and can be expressed as "consisting of or alternatively "consisting essentially of various components, steps, sub-components or sub-steps.

[0086] As used herein in the specification and claims, including the examples, and unless otherwise indicated, all numbers are to be understood as being "about" or "approximately" to allow for variations in measurement due to methods used in making or using the articles or manufacturing the devices. The phrase "about" or "approximately" can be used in describing magnitude and / or position as is meant to allow for variations of less than or equal to, plus or minus, 10% of the given value, unless otherwise indicated. For example, "about 10" or "approximately 10" can mean 9 to 11. Any numerical value, however, should be understood in every instance as being modified in all instances by the term "about" or "approximately" to encompass standard variations as would be expected by those of ordinary skill in the art. Any numerical value, herein, given out to more than one significant figure, should be interpreted as an approximation. Any numerical value, given herein as a possessed value, should be interpreted as a value which is less than or equal to, and greater than or equal to, that value, as well as the value itself, as would be understood by one of ordinary skill in the art. For example, if a value "X" is disclosed, then "less than or equal to X" as well as "greater than or equal to X" (e.g., where X is a numerical value) is also disclosed. It should also be understood that data given in a variety of different formats throughout the application and that the data represents endpoints and starting points as well as ranges for any combination of endpoints and ranges. For example, if a particular data point "10" and a particular data point "15" are disclosed, then "greater than (or equal to) 10 and less than (or equal to) 15", "greater than (or equal to) 10 and less than or equal to 15" and "greater than (or equal to) 10 to less than (or equal to) 15", would also be disclosed. It should also be understood that, where a particular single unit is disclosed, every unit between the two particular units is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0087] While various illustrative embodiments have been described above, it will be apparent to one of ordinary skill in the art that many modifications, substitutions and changes can be made to any of the above described embodiments without departing from the scope of the application as set forth in the claims. For example, the order of execution of the various described method steps can generally be changed from the specifically described order, and in other alternative embodiments one or more method steps can be skipped altogether. Optional features of the various device and system embodiments can be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the application as set forth in the claims.

[0088] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter can be practiced. As mentioned, other embodiments can be utilized and derived therefrom, such that structural and logical substitutions and changes can be made without departing from the scope of the disclosure. Such embodiments of the inventive subject matter can be referred to herein individually or collectively by the term "application" merely for convenience and without intending to voluntarily limit the scope of this application to any single application or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated, any arrangement or combination of components that accomplishes the same functions is within the scope of the disclosure. The disclosure is intended to cover any and all adaptive or variational changes, combinations or modifications in the art within the scope of the various embodiments.

Claims

1. A blood extraction device comprising: a housing having a proximal end and a distal end; a blood collection orifice in a blood collection port formed in a wall of the housing; a coupler disposed on the distal end of the housing, the coupler adapted and configured to engage a catheter or a peripheral vascular device; a slider accessible from outside the housing and movable relative to the housing proximal end and the housing distal end; and a cannula having a proximal end and a distal end and a cannula lumen extending from the distal opening to the proximal opening, the cannula being within the housing and coupled to the slider, wherein the cannula distal end is movable beyond the coupler by axial movement of the slider, wherein the blood extraction device is in a first position when the cannula is within the housing and a fluid path does not exist between the distal opening of the cannula and the blood collection orifice, and wherein the blood extraction device is in a second position when the cannula distal end is outside the housing and a fluid path is established between the cannula distal opening and the blood collection orifice.

2. The device according to claim 1, wherein The proximal opening of the cannula lumen is located in the side wall of the cannula.

3. The device according to claim 1, wherein The proximal opening of the cannula lumen is located at the end of the curved proximal section of the cannula.

4. The device of claim 2, further comprising a fluid path sealer within the cannula lumen, wherein a distal end of the fluid path sealer is adjacent a proximal opening of the lumen in the sidewall.

5. The device according to claims 1-3, further comprising a protective sheath surrounding the cannula, wherein the protective sheath is in an expanded state when the blood extraction device is in the first position, and the protective sheath is in a compressed position when the blood extraction device is in the second position.

6. The device according to claim 5, wherein When the protective sheath is in the compressed position, the sheath is distal to the blood collection orifice or proximal to the blood collection orifice.

7. A blood extraction device comprising: a housing having a proximal end and a distal end; a blood collection orifice in a blood collection port formed in a wall of the housing; a coupler disposed on the distal end of the housing, the coupler adapted and configured to engage a catheter or a peripheral vascular device; a slider accessible from outside the housing and movable relative to the housing proximal end and the housing distal end; and a cannula having a proximal end and a distal end and a cannula lumen extending from a distal opening to a proximal opening, the cannula being within the housing and coupled to the slider, wherein the cannula distal end is movable beyond the coupler by axial movement of the slider, wherein the blood extraction device is in a first position when the cannula is within the housing and the cannula lumen proximal opening is closer to the housing proximal end than the housing distal end, and wherein the blood extraction device is in a second position when the cannula distal end is outside the housing and the cannula lumen proximal end is spaced less than the spacing in the first position from the blood collection orifice.

8. The device according to claim 7, wherein The proximal opening of the cannula lumen is located in the side wall of the cannula.

9. The device according to claim 7, wherein The proximal opening of the cannula lumen is coupled to a flexible tubing segment that communicates with the blood collection orifice.

10. The device according to claim 9, wherein The flexible pipe section includes a plurality of windings, and a spacing between adjacent windings is greater in the first position than in the second position.

11. The device according to claims 7-10, further comprising a protective sheath surrounding the cannula, wherein the protective sheath is in an expanded state when the blood extraction device is in the first position and is in a compressed position when the blood extraction device is in the second position.

12. The device according to claim 11, wherein When the protective sheath is in the compressed position, the sheath is proximate the blood collection orifice.

13. The device according to claims 7-12, wherein: The slider is configured as a plunger actuator extending from the proximal end of the housing, wherein movement of the plunger actuator causes corresponding movement of the distal opening of the cannula lumen and the proximal opening of the cannula lumen, while also changing the spacing between the proximal opening of the cannula lumen and the blood collection orifice.

14. The device according to claim 13, wherein Distal movement of the plunger actuator reduces the spacing between adjacent windings of the plurality of windings in the flexible tubing segment.

15. A blood extraction device comprising: a housing having a proximal end and a distal end; a blood collection orifice in a blood collection port formed in the wall of the proximal end of the housing; a coupler disposed on the distal end of the housing, the coupler adapted and configured to engage a catheter or a peripheral vascular device; a fixed slider and a movable slider, wherein the fixed slider and the movable slider are accessible from outside the housing, and the movable slider is movable relative to the proximal and distal ends of the housing; and a cannula having a proximal end and a distal end and a cannula lumen extending from the distal opening to the proximal opening, the cannula being within the housing and coupled to the movable slider, wherein the cannula distal end is movable beyond the coupler by axial movement of the movable slider, wherein the blood extraction device is in a first position when the cannula is within the housing, and the blood extraction device is in a second position when the cannula distal end is outside the housing and the cannula proximal opening and the blood collection orifice are closer to the fixed slider than in the first position.

16. The device according to claim 15, further comprising a protective sheath surrounding the cannula between the fixed slider and the movable slider, the protective sheath being in an expanded state when the blood extraction device is in the first position, and the protective sheath being in a compressed position when the blood extraction device is in the second position.

17. The device according to claim 15, wherein The proximal opening of the cannula lumen is coupled to a flexible tubing segment that communicates with the blood collection orifice.

18. The device according to claim 17, wherein The flexible pipe section includes a plurality of windings, and a spacing between adjacent windings is greater in the first position than in the second position.

19. The device according to claim 17, wherein The flexible pipe section includes a plurality of windings, and a spacing between adjacent windings is the same in the first position as in the second position.

20. The device according to any one of claims 15 to 19, wherein The distance between the fixed slider and the movable slider is smaller in the second position than in the first position.

21. A blood extraction device comprising: a housing having a coupler disposed at a distal end of the housing, the coupler configured to engage a catheter assembly; a slider in communication with the housing, the slider being configured to move between a distal end and a proximal end of the handle; a cannula including a distal end, the cannula being configured to extend through the distal end of the handle when the slider is advanced distally in the handle; A blood collection device is in fluid communication with the proximal end of the cannula when the distal end of the cannula is extended into a blood vessel.

22. The blood extraction device according to claim 21, wherein: The cannula includes a discontinuous lumen between the cannula distal end and the cannula proximal end, the discontinuous lumen being configurable to transition from the discontinuous lumen to a continuous lumen when the cannula proximal end is aligned with the blood collection device coupled to the aperture on the handle.

23. The blood extraction device according to claim 21, wherein: The cannula includes a discontinuous lumen having a linear section distal to a flexible section coiled within the interior of the handle.

24. The blood extraction device according to claim 21, wherein The cannula includes a discontinuous lumen having a linear section extending from the distal end of the handle and a flexible section coiled within an interior of the handle, wherein the lumen is configured to direct blood flow in a first direction through the linear section and in an opposite direction through the flexible section.

25. The blood extraction device of claim 21, further comprising an orifice extending from the handle exterior to the handle interior and configured to couple with the blood collection device on the exterior of the orifice, wherein the cannula proximal end communicates with the orifice.

26. The blood extraction device of claim 24, further comprising an orifice extending from the handle exterior to the handle interior and configured to couple with the blood collection device on the exterior of the orifice, wherein the cannula proximal end communicates with the orifice.

27. The blood extraction device of claim 21, further comprising a fluid transfer chamber configured to transfer blood between the cannula proximal end and the blood collection device, wherein the fluid transfer chamber is within the handle.

28. The blood extraction device according to claim 21, wherein The slider is a plunger that extends through the proximal end of the handle to the cannula.

29. The blood extraction device according to claim 21, wherein The blood collection device is a vacuum reservoir assembly configured to couple to and be in fluid communication with the aperture positioned on the handle.

30. The blood extraction device according to any one of claims 21 to 29, wherein: The cannula is configured to transition from a stowed position to an extended position, wherein the cannula distal end extends beyond the handle distal end when the slider is advanced distally through the handle.

31. The blood collection device of claim 21, wherein: The cannula includes a lateral opening to a lumen extending between a proximal end and a distal end, the cannula opening being configured to align for fluid communication with the blood collection device when the slider advances the cannula sufficiently beyond the handle distal end.

32. The blood extraction device according to claim 31 further includes a fluid transfer chamber positioned at the distal side of the handle interior, wherein the cannula is capable of being advanced through the fluid chamber through one or more seals to align the cannula lateral opening with the interior of the fluid transfer chamber, and the one or more seals are configured to seal the fluid chamber when the cannula is extended or retracted through the handle.

33. The blood collection device according to claim 32, wherein: The cannula lumen is configured to become continuous when the lateral opening is aligned with the interior of the fluid transfer chamber.

34. The blood collection device of claim 32, wherein: The cannula lumen is in fluid communication with the blood collection device along a deployed length, which includes a length of the fluid transfer chamber within the interior of the handle.

35. A blood collection device comprising: a handle having a proximal end and a distal end, the handle having a hollow interior extending between the proximal end and the distal end; a coupler positioned at the distal end, the coupler configured to engage the catheter assembly; a fluid transferring chamber at a distal end within the interior of the handle, the fluid transferring chamber having seals positioned on proximal and distal sides of the fluid transferring chamber; a slider accessible from an exterior of the handle, a portion of the slider extending into an interior of the handle, and the slider configured to be advanced distally from a proximal side of the handle to the proximal side of the fluid transfer chamber; a cannula having a lumen extending between a proximal end and a distal end, the cannula being axially aligned and extending from the slider, through the fluid transfer seal, and out the distal end of the handle; and a lateral opening on the cannula between the proximal end and the distal end of the cannula, wherein the lumen is configured to be advanced by the slider beyond the proximal side of the fluid transfer chamber into fluid communication with the fluid transfer chamber to provide a continuous lumen from the distal end of the cannula through the lateral opening into the fluid transfer chamber and to a blood collection device in communication with the fluid transfer chamber.

36. A blood extraction device comprising: a handle having a proximal end and a distal end, the handle having a hollow interior extending between the proximal end and the distal end; a coupler positioned at the distal end, the coupler configured to engage the catheter assembly; an aperture extending through the handle, wherein the aperture has an engagement element on an outer side thereof configured to engage a blood collection set; a slider plunger accessible from an exterior of the handle and extending into an interior of the handle, the slider plunger being configured to be advanced distally through the handle; a cannula having a lumen extending through a linear distal portion and through a flexible proximal portion in helical communication with the slider-plunger section within the interior of the handle, the cannula linear portion being axially aligned with the handle and configured to extend from the distal end of the handle to establish blood flow from a blood vessel when the slider is advanced distally within the handle.

37. The blood extraction device according to claim 36, wherein: The windings of the cannula's flexible portion spiraled around the plunger are configured to compress when the slider is advanced distally to deploy the cannula's distal end beyond the handle.

38. The blood collection device of claim 37, wherein: The orifice is positioned at the distal end of the handle, and the proximal end of the cannula is in fluid communication with the orifice.

39. The blood collection device of claim 36, wherein: The coils of the cannula's flexible portion spiraled around the plunger are configured to extend when the slider is advanced distally to deploy the cannula's distal end beyond the handle.

40. The blood collection device of claim 39, wherein: The orifice is positioned at the proximal end of the handle, and the proximal end of the cannula is in fluid communication with the orifice.

41. A method of collecting blood from a patient's blood vessel via an indwelling catheter, comprising: coupling the distal end of a blood extraction device according to any one of claims 1 to 40 to the indwelling catheter; The cannula distal end is advanced beyond the housing of the blood extraction device and into the patient's blood vessel, wherein advancing the cannula distal end establishes fluid communication between the patient's blood vessel and the blood collection orifice in the housing of the blood extraction device via the proximal cannula lumen opening.

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